Journal of Trauma & Orthopaedics - Vol 9 / Iss 2

Journal of Trauma and Orthopaedics Volume 09 | Issue 02 | June 2021 | The Journal of the British Orthopaedic Association | boa.ac.uk

> 250,000 training

opportunities ‘lost’ The impact of COVID-19 on orthopaedic training p30

Pandemic Fallout

THRs drop by 43%; TKRs by 51%

Effects of COVID-19 pandemic on hip and knee joint replacement p38

Placebo surgery: fake news or real deal p54

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Journal of Trauma and Orthopaedics

Contents

In this issue...

3 5

From the Executive Editor Deborah Eastwood

From the President Bob Handley

6 BOA Latest News 8 News: BOA Annual Congress 2021 16 News:

New BOA clinical trials partnership announcement!

19 News: Conference Listing 2021/22 20 Features:

BOA Burnout and Wellbeing Survey Infographic and Results: time for a culture change?

Ben Caesar, Christopher Jukes, James Nutt, Callum Counihan, William Butler-Manuel and Maryam Ahmed

26 Features:

The new T&O curriculum Rob Gregory, Lisa Hadfield-Law and Deepa Bose

30 Features:

The impact of COVID-19 on orthopaedic training Rob Gregory and Mark Bowditch

34 Features:

The UK Non-Arthroplasty Hip Registry Ajay Malviya and Vikas Khanduja

62

38 Features:

Effects of COVID-19 pandemic on hip and knee joint replacement surgery in 2020 as demonstrated by data from the National Joint Registry (NJR) Derek Pegg, Adrian Sayers, Michael Whitehouse and Timothy Wilton

42 Features:

58 Subspecialty:

Tourniquet use in knee replacement – the why, the what and how to do without Jonathan Phillips, Ben Waterson, Andrew Toms and Keith Eyres

46 Trainee:

Returning to trauma and orthopaedic training with SuppoRTT Iris Kwok, Zoe Little and Kash Akhtar

50 Medico-legal:

Current medico-legal considerations in the orthopaedic treatment of Jehovah’s Witnesses Simon Britten

54 Subspecialty:

Placebo surgery: fake news or real deal David Beard and Marion Campbell

Are surgical placebo controls ethically justifiable?

Charles Weijer

62 Subspecialty:

Getting placebo controls of surgery to work (in orthopaedics) – the CSAW experience Naomi Merritt and Marcus Jepson

65 Subspecialty:

The last word on placebo- controlled surgical trials Shiraz A Sabah and Abtin Alvand

Andrew Oliver Ransford John Knowles Stanley

68 In Memoriam:

Download the App The Journal of Trauma and Orthopaedics (JTO) is the official publication of the British Orthopaedic Association (BOA). It is the only publication that reaches T&O surgeons throughout the UK and every BOA member worldwide. The journal is also now available to everyone around the world via the JTO App. Read the latest issue and past issues on the go, with an advanced search function to enable easy access to all content. Available at the Apple App Store and GooglePlay – search for JTO @ BOA.

We are committed to sustainable forest management and this publication is printed by Buxton Press who are certified to ISO14001:2015 Standards (Environmental Management System).

Buxton prints only with 100% vegetable based inks and uses alcohol free printing solutions, eliminating volatile organic compounds as well as ozone damaging emissions.

JTO | Volume 09 | Issue 02 | June 2021 | boa.ac.uk | 01

AO UK & Ireland 2021 Courses & Seminars AO Trauma Courses

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Basic Principles of Fracture Management for Surgeons, Dublin, Ireland

Feb 25th - 2nd

Principles of Fracture Management, for - 28 CJaann26celled ORP, Dublin, Ireland th

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- 11 CFaebn10 celled th

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Mar Ca nchc7elled th

Managing Paediatric Musculoskeletal Injuries, Leeds, UK Introductory Course for Undergraduates, Edinburgh, UK Basic Principles of Fracture Management for Surgeons, Edinburgh, UK *NEW BLENDED*

March 8th - 11th

March 23 - 24 Foot & Ankle Reconstruction, London, UK Cancelled rd

th

April 28 - 30 Cancelled thrd

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Current Concepts Cadaveric update for Trauma, Coventry, UK

Introductory Course for Undergraduates, Cancelled June 20 Leeds, UK th rd

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June 21 - 22 Cancelled st rd

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Basic Principles of Fracture Management ORP, Leeds, UK

Basic Principles of Fracture Management June 21 - 24 Cancelled for Surgeons, Leeds, UK st rd

th th

i Advanced Principles of Fracture June 23 - 25to Change Subject Management for Surgeons, Leeds, UK rd

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June 22 - 25 Cancelled ndrd

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Advanced Principles of Fracture Management ORP, Leeds, UK

Sept 6th - 8th

Pelvic & Acetabular with anatomical specimens, Bristol, UK

Sept 27th - 29th

Management of Fractures of the Hand, Leeds, UK

Sept 30th - 1st

Management of Fractures of the Wrist, Leeds, UK

Nov 7th

Introductory Course for Undergraduates, Hertfordshire, UK

Nov 8th - 11th

Basic Principles of Fracture Management for Surgeons, Hertfordshire, UK

AO CMF Courses Postponed to September

CMF Undergraduate Course

Postponed to September

Management of Facial Trauma, Leeds, UK

Postponed to September

Principles in Craniomaxillofacial Management for ORP, Leeds, UK

AO Spine Courses July 15th - 16th Sept 24th - 25th

Spine Principles Course – Degeneration, Liverpool, UK

Spine Principles Level Specimen course, Spinal Tumors Coventry, UK

AO Recon Courses July 8th - 9th

Principles of Total Hip & Knee Arthroplasty, Birmingham, UK

AO VET Courses June 13th - 15th June 13th - 15th

Principles in Small Animal Fracture Management, Oxford, UK

Advanced Techniques in Small Animal Fracture Management, Oxford, UK

Promoting excellence in patient care and treatment outcomes in trauma and musculosketal disorders www.aouk.org | www.aofoundation.org

Credits JTO Editorial Team l l l l l

Deborah Eastwood (Executive Editor) Hiro Tanaka (Editor) David Warwick (Medico-Legal Editor) Ran Wei (Trainee Editor) David Beard (Guest Editor)

BOA Executive l Bob Handley

(President)

BOA Staff Executive Office Chief Operating Officer

- Justine Clarke

Personal Assistant to the Executive

- Celia Jones

Education Advisor

- Lisa Hadfield-Law

l Don McBride

(Immediate Past President)

Policy and Programmes

l John Skinner

(Vice President)

Director of Policy and Programmes

l Deborah Eastwood (Vice President Elect)

Programmes and Committees Officer

l Mark Bowditch (Honorary Treasurer)

Educational Programmes Assistant

l Simon Hodkinson (Honorary Secretary) l Phil Turner

BOA Elected Trustees l Bob Handley (President) l Don McBride

(Immediate Past President) l John Skinner

(Vice President) l Deborah Eastwood (Vice President Elect) l Mark Bowditch (Honorary Treasurer) l Simon Hodkinson (Honorary Secretary) l l l l l l l l l l l l l

Phil Turner Colin Esler Grey Giddins Robert Gregory Fares Haddad Anthony Hui Andrew Manktelow Ian McNab Fergal Monsell Amar Rangan Sarah Stapley Arthur Stephen Hiro Tanaka

- Julia Trusler

- Harriet Wollaston - Eliza Khalid

Communications and Operations Director of Communications and Operations

- Annette Heninger

Marketing and Communications Officer

- Sabrina Nicholson

Membership and Governance Officer

- Natasha Wainwright

Publications and Web Officer

- Nick Dunwell

Finance Director of Finance - Liz Fry Deputy Finance Manager - Megan Gray Finance Assistant - Hayley Oliver Interim Finance Assistant - Chuks Nwandei

Events and Specialist Societies Head of Events - Charlie Silva Events Administrator - Venease Morgan Interim Events Coordinator - Amy Robinson Exhibitions and Sponsorship Coordinator

- Emily Farman

UKSSB Executive Assistant - Henry Dodds

Copyright

Copyright© 2021 by the BOA. Unless stated otherwise, copyright rests with the BOA. Published on behalf of the British Orthopaedic Association by: Open Box M&C

Advertising

All advertisements are subject to approval by the BOA Executive Board. If you’d like to advertise in future issues of the JTO, please contact the following for more information: Open Box M&C, Premier House, 13 St Paul’s Square, Birmingham B3 1RB Email: inside@ob-mc.co.uk | Telephone: +44 (0)121 200 7820

Disclaimer

The articles and advertisements in this publication are the responsibility of the contributor or advertiser concerned. The publishers and editor and their respective employees, officers and agents accept no liability whatsoever for the consequences of any inaccurate or misleading data, opinions or statement or of any action taken as a result of any article in this publication.

BOA contact details

The British Orthopaedic Association, 38-43 Lincoln’s Inn Fields, London WC2A 3PE Telephone: 020 7405 6507

From the Executive Editor Deborah Eastwood

T

he image on the front cover represents a stark view of what 2020 meant for us and for our patients. We were essentially closed for business. The figures in terms of lost opportunities to fix people and lost opportunities to train our colleagues are huge and there has been a significant impact on the quality of life of those we care for, those we support and ourselves. The full cost has yet to be counted.

Our ‘Restart’ and ‘Recovery’ plans seem to involve asking teams to work harder and longer – not necessarily recognised strategies for efficient and effective healthcare delivery with a tired workforce. Certainly there is some evidence to support the use of hot/cold sites and the BOAST Providing a Continuous Safe Elective Orthopaedic Environment may help us protect a resourced bed base in the future and to utilise it well. The article from the NJR (page 38) highlights figures from 2020 showing both a sharp drop and significant variation in elective activity. Northern Ireland and Wales were particularly badly affected and significant variation is seen across England with, for example, one region managing only 33% of their ‘usual’ TKR activity. Some of the variation may be explained by the availability of hot/ cold sites. The overall reduction, whichever way you look at it, is immense and recovery will not be instantaneous – the politicians and the public must not be fooled by the offer of a ‘quick fix’; there is none.

Now is the time for innovative thinking and to ensure that we challenge for change to improve MSK health for all. We are being asked to define areas for improvement rapidly without, I fear, the realisation that it takes time to develop a good and workable idea. We must ensure that change is not enacted just for change’s sake.

If we want to think about change, then the articles on sham/placebo surgery (page 54) are entertaining and informative in equal measure and certainly do challenge the way we think about our surgical equipoise and how we deliver surgical research. We do have to question.

All those of us who train are also going to have to get to grips with the new curriculum (page 26) – please do not leave it too late to learn about the MCRs, CiPs and the GPS – as our President says in his editorial, acronyms are on the up and we must be up with them.

The contribution from the medico-legal team (page 50) regarding the management of our patients who are Jehovah’s Witnesses may make you consider ideas that you have previously taken for granted and reminds us that informed consent is a two way process - the surgeon must be informed, and this article does inform.

Another contribution that perhaps challenges our practice is the article on the use of tourniquets in total knee replacement surgery (page 42).

Our trauma colleagues might feel that this is just the tip of the iceberg in asking us to challenge our views on tourniquet use more generally. Why not join the debate and submit your views to the Transient Journal?

Thank you to the 1,300 people who responded to our Burnout Survey in January – the wellbeing of you and your team is important, so please take care and be kind to yourself and those around you (page 20). n

JTO | Volume 09 | Issue 02 | June 2021 | boa.ac.uk | 03

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◊Trademark of Smith+Nephew. All Trademarks acknowledged. ©May 2021 Smith+Nephew 30031-uki References 1. National Joint Registry for England, Wales and Northern Ireland: 17th Annual Report. Available at: http://www.njrcentre.org.uk/njrcentre Accessed 23 September 2020.2. Davis ET, Pagkalos J, Kopjar B. Bearing surface and survival of cementless and hybrid total hip arthroplasty in the National Joint Registry of England, Wales, Northern Ireland and the Isle of Man. JBJS OA. 2020;5:e0075. Available from: JBJS OA. 3. National Joint Registry for England, Wales and Northern Ireland: POLARSTEM cementless (Oxinium/XLPE/R3 cup) bespoke summary report. 14 August 2019. Available at: http://bit.ly/POLAR3_Aug2019 Orthopaedic Data Evaluation Panel (ODEP). Available at http://www.odep.org.uk Accessed 17/05/2021. **Compared to all other cementless stems in NJR, p<0.001 We thank the patients and staff of all the hospitals in England, Wales and Northern Ireland who have contributed data to the National Joint Registry. We are grateful to the Healthcare Quality Improvement Partnership (HQIP), the NJR Steering Committee and staff at the NJR Centre for facilitating this work. The views expressed represent those of the authors and do not necessarily reflect those of the National Joint Registry Steering Committee or the Health Quality Improvement Partnership (HQIP) who do not vouch for how the information is presented.

The data used for this analysis was obtained from the National Joint Registry (“NJR”). The Healthcare Quality Improvement Partnership (“HQIP”), the NJR and/or its contractor, Northgate Public Services (UK) Limited (“NPS”) take no responsibility for the accuracy, currency, reliability and correctness of any data used or referred to in this report, nor for the accuracy, currency, reliability and correctness of links or references to other information sources and disclaims all warranties in relation to such data, links and references to the maximum extent permitted by legislation.

From the President

Who cares wins Bob Handley

I quite like being a doctor. In your late teens in some interview or statement you may well have said that “I am good at science, play the piano and have a gold Duke of Edinburgh award” and then with an air of inevitability added “I like helping people”.

C

orny as this last statement may sound, I do believe that most of us have this motive, but it may become concealed by events or fade with career weariness. In Oxford we now have a system of COTW (consultant of the week), which involves seven days of mainly not operating; doing ward rounds, clinics, call etc. I did anticipate that this would be a chore, but providing continuity for patients, juniors and ward staff is appreciated by them and pleasingly satisfying to me. It seems that I did not mislead the sub-dean in my medical school interview too much.

As part of our craft speciality we do of course help people as we complete our technical work, but there are other opportunities to find if we are not too blinkered. Currently, there is an increasing number of patients in the limbo between primary and secondary care. GP’s are using about 30% of their consultation time with patients who are already on a waiting list. Surgeons have the prospect of operating above baseline activity to catch-up. So who has time to venture into the limbo land to assist the patients circling there? It is a conundrum that was explored in the recent Coping with Covid webinar focused on supporting patients; Joe Dias showed what could be achieved, but then not all of us are Joe. There is no panacea, but the active management of the waiting list and at least giving patients reason to believe that both in primary and secondary will live up to the second part of our labels and ‘care’.

The blinkers may also shield us from the worries of trainees.

Rob Gregory has explored the consequences of the curtailment of normal surgical activity on training. There looms the prospect of some extensions to training becoming necessary with the consequent disruption of fellowships, job plans and life in general. Even if not in our gift to change the landscape exactly as trainees would wish, an appreciation and accommodation of their problems is another way to fulfil the ambition we once expressed to the sub-dean. We should at least remember that every case is a training opportunity.

The burnout survey involving the BOA was not designed to compare ourselves to others but to be more aware of our own problems. Unsurprisingly, many who completed it displayed signs of burnout, and it was a reminder for each of us to be alert to the problems our colleagues may have. However, what I found salutary was the much higher incidence of burnout in the juniors.

Particularly in the last year the consultants amongst us are more likely to have had a variety of advantages in this regard; stability in our surroundings, being with family, having a garden, perhaps a dog and no doubt more besides. The juniors may well have been isolated from many of these advantages. In the earlier Coping with Covid webinar with a theme of supporting surgeons Tony Clayson would definitely have impressed his sub-dean having forged and then assumed a position with the Trust to look after the wellbeing of colleagues of all specialities.

The recovery will have much bureaucracy, many acronyms, new initiatives, finance, irritation, zooms and more besides and we will do our best to participate, but in amongst all this we should take off the blinkers, look around, be true to our interview and care. n JTO | Volume 09 | Issue 02 | June 2021 | boa.ac.uk | 05

Latest News

NIHR Senior Investigator appointments Each year, the NIHR invites applications into a round of open competition to decide who it awards the prestigious research roles to, based on individuals it feels can make the most significant impacts in patient and people-based research. The BOA would like to congratulate Professor Jonathan Rees, Professor Ashley Blom and Professor Andrew Carr on their appointments as NIHR Senior Investigators for 2021!

New BOASTs Published The BOA Orthopaedic Committee has published its first elective BOAST: ‘Providing a Continuous Safe Elective Orthopaedic Environment’. This BOAST discusses the principles underlying our need for resources often called ‘Ring-fenced beds’ and highlights the standards we expect to deliver.

As this issue goes to print three new BOASTs - ‘Cervical spine clearance in the trauma patient’; ‘The Use of Intraoperative Tourniquets’ and ‘Paediatric forearm fractures’ – are ready for publication, so keep an eye out for these on our website, www.boa.ac.uk/boasts.

Recently Published Guidance Peripheral nerve block follow up algorithm RAUK, in collaboration with BOA, has developed an algorithm to guide the management of unexpected or persistent neurological symptoms after peripheral nerve blocks and surgery. To see the algorithm, please see the BOA website.

Centre for Perioperative Care Guideline published The CPOC has recently published its Guideline for Perioperative Care for People with Diabetes Mellitus Undergoing Elective and Emergency Surgery. This can be found on their website: www.cpoc.org.uk.

06 | JTO | Volume 09 | Issue 02 | June 2021 | boa.ac.uk

BOA Virtual Courses

The BOA Training Orthopaedic Trainers (TOTs) course and the Training Orthopaedic Educational Trainers course are now running entirely online as Virtual TOTs (V-TOTs) and Virtual TOES (V-TOES). Both are facilitated by the BOA Educational Advisor Lisa Hadfield-Law.

• Training Orthopaedic Trainers (V-TOTs) Much of the work for V-TOTs can be done at a time, place and pace convenient to participants, with attendance at live virtual meetings to supplement personal learning.

Learning is monitored through learning logs with written feedback from expert faculty.

The V-TOTs course will last for approximately six weeks.

• BOA Virtual Training Orthopaedic Education Supervisors (V-TOES) V-TOES will be offered through two routes, and either you can join a small cohort on a paid-for course (‘Regular V-TOES’) or in many regions we have been holding a ‘regional V-TOES’ at the request of the TPD, (check with your TPD for more information).

If you are interested in either course, find out more at www.boa.ac.uk/v-tots or www.boa.ac.uk/v-toes.

BOA Virtual Ortho Update Course 2022 ––– Saturday 8th January This one day course will give delegates the opportunity to access new understanding and support preparation for the FRCS exam. We will provide the facility for delegates to participate in Case Based Discussion (CBDs) online, across a range of critical condition topics, which are essential to their training, and join lectures delivered by expert clinicians.

Registration for this course will open in June!

Further information can be found on the BOA website, www.boa.ac.uk/OrthoUpdate.

Regional TOES update Lisa Hadfield-Law and the BOA began in December 2019 delivering regional TOES (Training Orthopaedic Educational Supervisors) courses to support preparation for the new curriculum, initially face-to-face and virtually more recently. In total, we’ve successfully run 10 courses, with 369 participants; all fully subsidised by the BOA. Participants have provided valuable and positive feedback, and TPDs Alex Trompeter and Matt Solan from London South and KSS described this as “a hugely valuable experience” and found it beneficial to hold this as part of a regional meeting.

Latest News

COVID-19 and BOA activities: The BOA continues to be very active on a wide range of issues relating to and resulting from the COVID-19 pandemic. Key activities at the time of going to press in early May are as follows.

Responding to growing waiting times

#BestMSKHealth programme The NHS England BestMSKHealth programme was launched just as the previous (March 2021) JTO went to press and it is gathering momentum rapidly. Andrew Bennett, National Clinical Director for MSK at NHS England and NHS Improvement, is behind the initiative, which has 10 workstreams. The BOA is fully engaged across these workstreams, particularly those directly relevant to our work, such as ‘restoration and optimisation of orthopaedics’ and ‘falls, fragility fractures and osteoporosis’, and spinal and paediatric programmes. There is a strong emphasis on collaborative working across the health professionals caring for patients with musculoskeletal conditions, and linking up primary, community and secondary care.

In March, the BJJ published major new research from Edinburgh University on EQ5D scores for those awaiting hip and knee surgery, which showed that a much higher proportion of people have a score below zero than pre-pandemic.

The BOA, BASK and BHS prepared a joint response to highlight the significant issues of growing waiting times. We have also continued to monitor and report on the waiting times data published across the UK, and we are hoping to obtain more breakdowns, such as for paediatric orthopaedics where possible.

Guidance for members

The BOA and several specialist societies have recently finalised a position paper on ‘caring for patients awaiting surgery’, which focuses on reviewing and prioritising patients on the current waiting list. This is now available on our website at: www.boa.ac.uk/caring-forpatients-awaiting-surgery.

Webinars The BOA and RCS Edinburgh held a joint webinar in April on ‘Recovery of Orthopaedics – challenges and opportunities’, chaired by Phil Turner, BOA Past President, and with presentations from Deborah Eastwood, Vice President Elect and Julia Trusler, Director of Policy and Programmes. A recording is now available to watch, and we have also posted online our answers to questions posed during the session where it hadn’t been possible to answer these on the night.

In May we held the latest in our ‘Coping with COVID’ series of webinars.

This webinar focussed on ‘Managing recovery and supporting patients’ and a recording is available to watch on the BOA website at: www.boa.ac.uk/copingwithCOVID.

JTO | Volume 09 | Issue 02 | June 2021 | boa.ac.uk | 07

News

BOA Annual Congress 2021 21st – 24th September, P&J Live, The Event Complex Aberdeen (TECA) www.boa.ac.uk/Congress #BOAAC21 in 1986 before being appointed a Consultant in 1995. He left the Navy in 1999 to join the NHS in Portsmouth. After a period as clinical director his interest in education started as the RCS Tutor and progressed to being the Training Programme Director for T&O in Wessex for eight years and membership of the SAC for five years. He Chairs the Education and Careers Committee of the BOA. The 2021 Presidents Guest Lecture will be delivered in Aberdeen by Professor Stephen Powis, National Medical Director, NHS England.

For more information please see the BOA website.

Registration

U

nder the theme of Tackling Infection, the 2021 Congress will take place 21st – 24th September at P&J Live, The Event Complex Aberdeen (TECA). This year’s programme will include Hunterian Professorship Lectures from both 2020 and 2021 with topics covering ankle, hip, infection and knee.

Programme Update The programme will include the BOA keynote lectures, plenary speakers and an update from the BOA President, Bob Handley on his Presidential year. We have been working closely once again with the specialist societies to deliver revalidation and hot topic sessions.

Sessions also include Hunterian lectures, Practicalities of Coding, BOA Ortho Committee – Patient access to elective care, BOA Research Committee – Changing Clinical Practice, Curriculum Update and Diversity to name a few. Please keep an eye on the website for updates on the Congress programme, www.boa.ac.uk/programme.

Guest Lecturers The Howard Steel Lecture will be presented

by Mr Oliver Budd, chartered civil engineer, COWI. Oliver has experience working on a variety of road and rail bridges and enjoys getting to grips with large complex projects. He has given papers at international conferences and has interests including better design, high strength materials, and minimising embodied carbon in bridges.

08 | JTO | Volume 09 | Issue 02 | June 2021 | boa.ac.uk

The Robert Jones Lecture will be given

by Sarah Muirhead-Allwood, Consultant Orthopaedic Surgeon. Sarah attended St Thomas’ Hospital Medical School and orthopaedic training was undertaken at University College Hospital the Westminster Hospital and the Royal National Orthopaedic hospitals. During the time spent at the RNOH she worked closely with Professor Peter Walker in the Biomechanical Engineering department on the development of custom implants for primary and revision surgery and has also been closely involved with other commercial projects of implant design. In 2012 she left the RNOH and has since continued in private practice and now collaborates with the Biomedical Engineering Department at Imperial College.

The King James IV Lecture will be delivered by Martin McNally. Martin is Lead Surgeon at the Oxford Bone Infection Unit in the Nuffield Orthopaedic Centre, Oxford University Hospitals.

The Sir Walter Mercer Lecture will be given by Professor Robin Paton. Professor Paton is a Consultant Orthopaedic Surgeon with a specialist interest in Children’s Orthopaedics.

The Naughton Dunn Lecture will be delivered by the Simon Hodkinson, BOA Honorary Secretary, Consultant Orthopaedic Surgeon. Simon trained in London at St Bartholomew’s Hospital from 1977-82 and started his surgical training with the Navy

General Congress registration is now open and will close at 23:59 on Sunday 5th September.

Late registration will open at 00:00 on Monday 6th September until the close of Congress. Register for the BOA Annual Congress today through the BOA website, www.boa.ac.uk/Congress.

Travel and Accommodation How will you be getting to Aberdeen? Logan Air have given BOA Annual Congress delegates 30% off selected routes. We are also currently working with suppliers to secure rail discounts for delegates travelling to Aberdeen from across the country.

For more information please visit www.boa.ac.uk/ venue-and-travel.

Book your exclusive accommodation rates online, through BCD M&E with HotelMap, the BOA Annual Congress 2021’s official hotel booking partners. Find out more online, www.boa.ac.uk/ accommodation.

Exhibition and Sponsorship Opportunities The BOA Annual Congress puts you in a room with over 2,200 healthcare professionals. Join us to build a quality database, increase your sales, meet competitors and keep up to date with the needs of your customers. With over 80 exhibitors every year this is a must attend event that provides you with the platform to sell your business products/ services to prospective clients. Maximise your exposure at the Annual Congress by taking advantage of our Programme, Digital Advertising and Sponsorship opportunities.

If you are interested in any of the opportunities at Congress please contact the BOA Events Team, 020 7406 1754, or find out more online, www.boa.ac.uk/exhibition-sponsorship.

Medical

IMPROVE THE CHANCES

REDUCE RISK FOR INFECTION Reduction of infection risk* using dual antibiotic-loaded bone cement in high risk patients

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News

ZimmerBiomet Lower Limb Travelling Fellowship Haris Naseem

T

he ZimmerBiomet Lower Limb Fellowship, awarded to Haris Naseem, was spent at the Russian Ilizarov Scientific Centre for Restorative Traumatology and Orthopaedics in Kurgan, Russia, where Gavriil Abramovich Ilizarov discovered and applied the principle of ‘tension-stress.’ I aimed to gain experience of this method in a high volume centre, understand the scope of its application, meet surgeons from a variety of international backgrounds, gain historical perspective in an area of interest to me and ultimately use this to benefit patients in the UK.

This was a four week structured Fellowship that was comprised of theatre time, case discussions, lectures and workshops with Saturday mornings reserved for sawbone work, with the opportunity to scrub in and assist with cases in theatre.

Surgeons were extremely experienced with techniques and circular frames were applied efficiently with a heavy reliance on knowledge of anatomical landmarks over intra-operative

radiography. They were supported by a multi-disciplinary team, with patients often staying at the centre for their entire duration of time in circular frames, giving them access to optimised nursing care and rehabilitation.

The pathology observed was varied and included traumatic and elective conditions in both the paediatric and adult population.

Examples included limb lengthening, non-union surgery, acute fracture fixation in the upper and lower limbs, the management of the diabetic foot and bone infection.

Whilst the majority of the work performed at the centre uses the Ilizarov apparatus, internal fixation is available for certain cases, as is joint replacement surgery.

In summary I felt that my objectives for going were achieved and also that the visit took place at the right time as I had attained CCT and had Fellowship experience in this technique prior to the visit. I would like to thank the Ilizarov Scientific Centre for hosting me and also the BOA for the generous award of the Zimmer Travelling Fellowship.

Please visit www.boa.ac.uk/travellingfellowships to read Haris’ full report and other reports by BOA Travelling Fellows. n

British Hip Society (BHS) update Andy Hamer

T

he British Hip Society has not been immune to the effects of the pandemic and has made the difficult decision to move its traditional March Annual Scientific Meeting to a fully virtual meeting in June 2021. By the time you read this, the meeting will have taken place with a number of Topic in Focus sessions, free papers, guest lecturers and industry seminars. A summary of the meeting will appear in a future edition of the JTO.

The BHS has continued to help its members during these difficult times by holding a number of webinars looking at the development of Revision Hip Networks and plan an ongoing educational webinar series titled ‘The BHS Midweek Special: Every Day is a School Day’. This series of case based discussions with experts in the field is the brainchild of Vikas Khanduja and will be held monthly throughout 2021-22.

The BHS have also established a Culture and Diversity Committee who are developing a mentorship programme, engaging with Doctors of Tomorrow, creating inspirational videos and establishing a network of research mentors who can advise junior doctors on research projects.

The BHS are closely involved in a national project looking at the improvements that can be made to revision hip surgery prompted by Professor Tim Briggs and the GIRFT process. The society has produced four BOASTs for revision for infection, dislocation, aseptic loosening and instability which will be published via the BOA. In addition, the BHS have developed a democratically elected Revision Hip Network National Advisory Panel with representatives from across the UK, to bring local expertise and knowledge to the question of how Revision Hip networks might look.

Please visit the BHS website for more information, https://britishhipsociety.com. n

10 | JTO | Volume 09 | Issue 02 | June 2021 | boa.ac.uk

News

British Society for Surgery of the Hand (BSSH) update Sue Fullilove Despite the pandemic, the BSSH has gone from strength to strength.

Scientific Meetings Weary of the loss of study leave and CPD to COVID-related cancellation, BSSH has run a very successful virtual Spring Scientific Meeting, with full main and parallel sessions, and as many registrations as the face-toface meeting attracts. The next meeting is in Oxford (let’s hope not our offices again), followed by a Christmas meeting in Exeter.

International Meetings BSSH is Guest Society at the Indian meeting in Chennai in August (either face to face or virtually) and at the American meeting in San Francisco in October, with many UK surgeons contributing to the scientific programmes of each meeting. We are also on the podium during the European (FESSH) virtual meeting in June.

European Journal of Hand Surgery (JHSE) BSSH continues to run the JHSE, which maintains its position as the highest impact factor Hand Surgery Journal in the world. We recently started an on-line International Journal club which is proving extremely popular.

BSSH International Travelling Fellows This prestigious Fellowship launches in August 2021 and will run annually thereafter. Its aim is to foster international links and friendships across the speciality, to facilitate sharing of education, research and best practice in Hand Surgery. Four International Hand Societies have each been invited to select and nominate an eligible candidate. The four successful Fellows, this year from France, India,

America and Australia will travel to three UK hand surgery centres.

The Visiting Fellowship culminates at the BSSH Autumn Scientific Meeting with attendance at the Society Dinner.

Education – Home and Overseas All of our educational programmes are being delivered virtually now, including that to the LMICs that we support. Remote consultation continues to be provided to surgeons in our LMICs. Mentoring of Hand Surgeons BSSH has identified a need for mentoring of young hand surgeons.

In June, a Mentoring Programme launches, with professional training of the first BSSH Mentors.

Research BSSH continues to punch above its weight. Two more NICE guidelines are in production, and several million pounds worth of funded research is now underway, in the areas of Hand and Wrist surgery identified as priority by the BSSH / James Lind Association partnership.

Patients Like all MSK surgeons, we are concerned about the delays to treatment that many of our patients are experiencing and we are initiating several workstreams to raise the profile of hand surgery and help ensure it is adequately resourced. We are also driving to improve the patient resources on our website. n

Orthopaedic Trauma Society (OTS) update

T

he last year has been transformative and the Orthopaedic Trauma Society has embraced this impetus.

The pandemic highlighted the individualised burdens and contingencies across the country and the inherent potential learning, particularly in orthopaedic trauma. Observing this, the OTS made membership free to all those undertaking orthopaedic trauma on-call at consultant level. The society has always advocated for advancing practice, particularly in contentious areas through networking, lively debate and sharing of ideas by those invested in

12 | JTO | Volume 09 | Issue 02 | June 2021 | boa.ac.uk

orthopaedic trauma. The previous annual meetings have been testament to this and invited faculty have been amazed by the level of discussion, the intensity and the ability to effect palpable change on a national scale. This year, with a free membership, the meeting will combine all the elements of discussion and consensus. Although there will be a slightly diminished live audience, there are over 1,200 enrolled remote attendees, making it the best ever representation of those undertaking fracture care across the UK. The Society remains determined to be representative and responsive to the real-world concerns and this year marks a

Michael Kelly

massive step. The programme developed by Jayne Ward and the Education Committee is a direct response to questions and feedback and looks very exciting (www.orthopaedictrauma. org.uk/index.php).

For those who have not already joined, please consider. Going forwards, the Society will facilitate an increasingly active and pertinent repository of discussion, expertise and sharing to keep the UK and Ireland at the forefront of orthopaedic trauma innovation.

This complements Bob Handley’s year as President and the Trauma Group initiatives such as the BOA Trauma Exchange. It also adds to the commitment to training through BOTA as well as the ongoing Trauma Revalidation programme at the annual Congress in placing orthopaedic trauma front and centre with solutions rather than problems. n

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News

British Society for Children’s Orthopaedic Surgery (BSCOS) update Colin Bruce and Dan Perry Research continues to grow within BSCOS, with collaboratives really leading the way Under cover of COVID-19 restrictions the postponed 2020 joint meeting of BSCOS and IPOS (Israeli Paediatric Orthopaedic Society) was conducted virtually on 1st February 2021. It was a great success, not least thanks to two keynote speakers in the shape of Professor Chris Colton presenting ‘Observations on the structure and function of the growth plate’ and Sharon Eylon, the President of IPOS, presenting her experience of ‘Rehabilitation after Major Trauma’.

Access to the recorded meeting is available to BSCOS members: https://bscos.talkingslideshd.com/home.

BSCOS has consumed much of its energy in recent years promoting our research agenda. The SCIENCE study (medial epicondyles) and CRAFFT study (severe wrist fractures) are going from strength to strength, with SCIENCE recently surpassing 100 recruits and CRAFFT surpassing 50. More than 70 hospitals are now involved in these studies – including almost every big children’s hospital in the UK. In addition, hospitals in New Zealand and Australia are now joining these studies, with a separate US bid to mirror them in North America.

The FORCE (torus fractures) study has now completed, and results are awaited. This managed to recruit nearly 1,000 torus fractures to an RCT – even in the midst of a global pandemic proving just how common these injuries are.

The BOSS study has presented the results to BSCOS, and we now await the publication of the final papers summarising this work – BOSS was the start of the BSCOS research journey.

The expansion of the cerebral palsy CPIPS pathway continues to deliver high-quality evidence in a difficult area to research.

There remain more studies ahead, with severe stable SCFE, Salter Harris II fractures of the ankle, the identification of osteomyelitis and the treatment of cerebral palsy all identified by NIHR as areas for imminent funding.

Children’s orthopaedics was a research free zone, though now is a leading light in NIHR research.

This is thanks to the collaborative efforts between BSCOS and the OTS, and all surgeons with a thirst to treat children with high quality evidence. n

BritSpine 2021 update Patrick Statham - UKSSB Chair

B

ritSpine is a meeting of clinicians and scientists involved in the care of people with spinal conditions, promoting collaboration and understanding between them. This is reflected in the diverse subjects that were addressed at the biennial BritSpine, on 10th – 12th March 2021, with speakers from China, Singapore, Australia, Egypt, Europe North and South America. The meeting was all virtual, due to COVID-19 restrictions, so all talks were pre-recorded, but speakers were online to answer questions, articulated by the attendees channelled through the moderators.

The conference started with what we had learnt from COVID; particularly benefits and limitations of technology to assess patients virtually. Professor Sallie Lamb talked on the aging spine and the BOOST trial; Professor Sahota showed evidence for intervention

14 | JTO | Volume 09 | Issue 02 | June 2021 | boa.ac.uk

and management of vertebral and sacral osteoporotic fractures. Professor Alison Macgregor showed the detailed personal management of the British Olympic rowing team, and how she brought science to the sport.

Professor Joost van Middendop gave a critical analysis of ‘time is spine’, concluding that there is no good current evidence favouring early spinal cord decompression in acute traumatic spinal cord injury, but significant publication bias. Cauda equina syndrome was discussed from the perspective of first symptoms and triage, and from the difficulties in rehabilitation. There were illuminating talks on protecting professional rugby players from injury (James Robson), and surgery for cervical spine injuries in sport (Rick Nelson).

A wonderful personal account of spinal

cord injury from Dr Gwyn Jones taught us not to tell people they are ‘lucky’ when they are not! The future management of back pain was discussed fully, including the shape of future clinical trials.

Two important trials; NERVES (Martin Wilby) spinal injections vs microsurgery, and SCOPIC (Professor Nadine Foster) (targeted physiotherapy for radicular pain) publicised their results.

The meeting was filled with politics, papers and posters, and finished with an excellent session on spinal oncology; protons, genomics, and enbloc spinal resections, courtesy of the wonderful Professor Stefano Boriani. Best presentations prizes followed, after which we all made the journey back from the meeting to home in record time! n

Power to protect surgical incisions.

Proven clinical results in orthopaedic surgery.

In a randomised controlled trial (RCT) on revision total hip and knee arthroplasty patients, 3M™ Prevena Therapy reduced complications and readmissions compared to silver impregnated dressings.1

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Learn more and request a product demo at www.3M.co.uk/Prevena 1 Newman JM, Siqueira MBP, Klika AK, Molloy RM, Barsoum WK, Higuera CA. Use of Closed Incisional Negative Pressure Wound Therapy After Revision Total Hip and Knee Arthroplasty in Patients at High Risk for Infection: A Prospective, Randomized Clinical Trial. J Arthroplasty. 2019 Mar;34(3):554–559. † 10.7% for Prevena Therapy (8/79) vs. 23.8% for silver impregnated dressing (10/80) : 23.8% -10.7% / 23.8% = 57% ‡ 2.5% for Prevena Therapy (2/79) vs. 12.5% for silver impregnated dressing (10/80) : 12.5% -2.5% / 12.5% = 80% Note: Specific indications, contraindications, warnings, precautions and safety information exist for these products and therapies.

Please consult a clinician and product instructions for use prior to application. This material is intended for healthcare professionals. © 2021 3M. All rights reserved. 3M and the other marks shown are marks and/or registered marks. Unauthorised use prohibited. PRA-PM-EU-00481 (03/21). OMG168046.

News

New BOA clinical trials partnership announcement!

D

eveloping clinical research infrastructure in T&O surgery across the UK is an endeavour that goes hand in hand with the BOA mission – Caring for patients, supporting surgeons. After six successful years working with the British Orthopaedic Association Surgical Research Centre in York, the BOA was keen to expand this project further. Following a competitive process, with bids from numerous academic centres throughout the UK, the BOA is delighted to announce that grants have been awarded to two centres: Exeter Clinical Trials Unit and Nottingham Clinical Trials Unit.

Below you can find out a little more about each clinical trials unit (CTU) and their exciting plans for the next three years.

Exeter CTU

Over the coming three years, their plan is to identify and develop new and existing T&O researchers, developing new and innovative trials that deliver answers to complex clinical questions. In particular, they plan to provide wrap around development of orthopaedic researchers by: • Finding, networking and developing people and ideas

‘‘

• Providing targeted and specific training • Providing an expert team for strategic T&O study development, design and delivery through an experienced, UKCRC-registered clinical trials unit

Professor Sallie Lamb, Associate Dean for Research in the College of Medicine and Health at University of Exeter Exeter CTU is delighted to have been awarded this funding from the BOA. We will be working in partnership with the BOA to provide methodological support and collaboration to T&O researchers across the UK. This includes the development of ambitious young investigators, with online training and ongoing mentoring, in the design and delivery of efficient trials to answer important research questions from patients and professionals in the T&O community.

‘‘

Exeter CTU works in partnership with researchers and clinicians across the trial lifecycle: refining research questions, optimising study design, developing funding applications, trial set-up and delivery, analysis, write up and dissemination.

• Mentoring and partnering • Building a sustainable pipeline of success

Nottingham CTU

• Sandpit events and research co-production workshops • Increasing trainee involvement through the NIHR Associate PI scheme • Strengthening patient and public involvement and engagement in T&O surgical research • Research methods CPD short courses and training webinars They will work with other CTUs conducting T&O surgical research to develop a comprehensive approach to supporting research that maximises coverage and minimises duplication.

The BOA is very grateful to the BOA members, patients and members of the public who have donated or fundraised for Joint Action (the BOA Orthopaedic Research Appeal), which has allowed this funding to happen.

For more information on Joint Action, and how to donate, see page 18.

16 | JTO | Volume 09 | Issue 02 | June 2021 | boa.ac.uk

‘‘

Professor Alan Montgomery, Director NCTU Nottingham Clinical Trials Unit is delighted to partner with the BOA to further develop clinical trials research in trauma and orthopaedic surgery.

We are excited to be combining our expertise in clinical trial design, development and delivery, with the enthusiasm and experience of T&O clinical researchers in the UK. This initiative will enable us to work closely together to tackle the major T&O research questions that impact on patients and the NHS.

‘‘

NCTU designs and conducts high quality, high impact national and international multicentre trials across a range of health topics to improve health and wellbeing. For this initiative, NCTU plans to develop clinical trials in trauma and orthopaedics, focussing on engagement and training, including:

medi UK can help patients remotely that have developed ROM deficit, during lockdown.

While patients are unable to visit face-to-face, our JAS GL technology can: • Help post-op & trauma patients remotely that aren’t getting required ROM • Prevent future surgery or MUA • Be used safely and easily as home therapy • A solution for every joint, except hip and spine • Full company support is available via user videos, telephone and video assistance.

For further information, please email JAS@mediuk.co.uk or call 01432 373500

News

Joint Action update

W

e would like to thank every single person that took part in the Captain Tom 100 challenge between Friday 30th April and Monday 3rd May 2021, celebrating Captain Tom Moore’s birthday and raising the much needed funds for Joint Action, the Orthopaedic Research Appeal of the BOA, www.boa.ac.uk/joint-action.

While much of the world’s attention has been focused on the disease COVID-19, the needs of people with musculoskeletal disease have not gone away and sadly in many cases the need has grown. We know that thousands of people across the UK have experienced long waits for surgery and cancellations of other medical appointments. The BOA has continued to focus on the needs of these patients, and Joint Action, its research appeal, is forging ahead with ambitious plans for 2021.

We are pleased to announce that from 1st June 2021 the BOA is funding two new Clinical Trials Units, at University of Exeter and University of Nottingham see page 16 for further information.

Four months to go! Taking place Sunday 3rd October 2021, support our Virgin Money London Marathon runners by donating to Joint Action online, www.virginmoneygiving.com/ fund/JAlondonmarathon.

18 | JTO | Volume 09 | Issue 02 | June 2021 | boa.ac.uk

News

Conference Listing 2021/22: BLRS (British Limb Reconstruction Society) www.blrs.org.uk

CSOS (Combined Services Orthopaedic Society) www.csos.co.uk

WOC (World Orthopaedic Concern) www.wocuk.org

BSSH (British Society for Surgery of the Hand) www.bssh.ac.uk

BHS (British Hip Society)

15 April - 18 June 2021, Virtual

5 June 2021, Virtual

www.britishhipsociety.com 9-11 June 2021, Virtual

OTS (Orthopaedic Trauma Society) www.orthopaedictrauma.org.uk 10-11 June 2021, Virtual

22 July 2021, Portsmouth

8-10 September 2021, Oxford

BORS (British Orthopaedic Research Society) www.borsoc.org.uk

BOA (British Orthopaedic Association) www.boa.ac.uk

13-14 September 2021, Virtual

21-24 September 2021, Aberdeen

BESS (British Elbow and Shoulder Society) www.bess.org.uk 30 June 2021, Virtual

EFORT (European Federation of National Associations of Orthopaedics and Traumatology) www.efort.org

30 June - 2 July 2021, Hybrid-Vienna

BOOS (British Orthopaedic Oncology Society) www.boos.org.uk 8 October 2021, Bristol Virtual EFORT Congress - VEChybrid Main theme: Sustainable Professional Practice

BTS (British Trauma Society) www.bts-org.co.uk 24-25 November 2021, Virtual

BIOS (British Indian Orthopaedic Society)

www.britishindianorthopaedicsociety.org.uk 2-3 July 2021, Hybrid-Cardiff

BSS (British Scoliosis Society) www.britscoliosissoc.org.uk November 2021, Edinburgh

BOTA (British Orthopaedic Trainees’ Association) www.bota.org.uk

BSCOS (British Society for Children’s Orthopaedic Surgery)

BOSTAA (British Orthopaedic Sports Trauma & Arthroscopy Association) www.bostaa.ac.uk

CAOS (The International Society for Computer Assisted Orthopaedic Surgery)

6-7 July 2021, Virtual

14 July 2021, Virtual

www.bscos.org.uk 10-11 March 2022, Maidstone

www.caos-international.org 8-11 June 2022, Brest

JTO | Volume 09 | Issue 02 | June 2021 | boa.ac.uk | 19

Features

Ben Caesar is a Consultant T&O Surgeon based in Brighton with an interest in major trauma and sports injuries, who joined the Army at the age of 39 as a reservist just as he became a consultant; he changed to a regular commission three years later. Over the past nine years, he has deployed on three operational tours and is currently posted to 16 Medical Regiment in Colchester. He has set up and leads a clinic for Service Personnel and Veterans (the Chavasse Clinic) and has an interest in burnout and wellbeing in healthcare.

BOA Burnout and Wellbeing Survey Infographic and Results: time for a culture change?

Ben Caesar, Christopher Jukes, James Nutt, Callum Counihan, William Butler-Manuel and Maryam Ahmed In early 2021, the BOA Burnout and Wellbeing Survey was launched. It was run through the BOA by a team based at the Trauma and Orthopaedic Department in Brighton, who have processed and analysed the 1,298 responses, approximately 25% of the BOA membership.

The problem?

Christopher Jukes is an ST7 Orthopaedic Registrar in Brighton. Currently only ‘at risk’ of burnout.

James Nutt is an ST8 Orthopaedic Registrar at Brighton and Sussex University Hospital.

20 | JTO | Volume 09 | Issue 02 | June 2021 | boa.ac.uk

Burnout has been defined as ‘a state of physical, emotional and mental exhaustion that results from long-term involvement in work situations that are emotionally demanding1.

Since Freudenberger defined burnout in 1974, the appreciation and awareness of burnout in doctors has been well established2-4. However, with the arrival of COVID-19 and the added stresses at work and home, burnout and wellbeing have been increasingly discussed.

In this journal in December 2020, the issue of the pandemic of burnout was raised5. High levels of burnout have been shown to increase medical errors6-8, reduce job satisfaction9-11 and push doctors in to early retirement12-14. Burnout also impacts doctors’ general wellbeing with higher rates of depression15,16 alcoholism17 and suicidal ideation18,19.

Addressing health and wellbeing in Trauma and Orthopaedics as a specialty is going to be essential in the upcoming return to routine elective surgery as the estimate of 1.4 million hip and knee replacements on waiting lists within the NHS was based on estimations to November 202020. The upcoming drive to alleviate the

elective orthopaedic backlog will potentially take a heavy toll on a specialty which is already battling with high levels of burnout.

The mental health challenges faced by healthcare workers as a result of the current coronavirus pandemic highlighted in the British Medical Journal21 made the clear distinction that many will face issues of moral injury. Moral injury is a term that describes the distress experienced when circumstances clash with one’s moral or ethical code; although not a mental health illness, it may lead to the development of negative thoughts that in turn can contribute to the development of mental difficulties such as depression, post-traumatic stress disorder (PTSD) and suicidal ideation.

It also matches to one of Maslach’s six drivers of burnout, values mismatch22. Pair a highpressure job with a population that is unlikely to seek support or treatment in times of difficulty, such as surgeons, then the conditions are ripe for burnout to ensue23.

Burnout has consequences such as reduced emotional and physical wellbeing, absenteeism, and personnel turnover. Naturally this can have substantial costs not just for individuals, but for organisations both short and long term. It is

Features

Callum Counihan is a core surgical trainee keen on pursuing trauma and orthopaedics. His interests outside of work include men’s lacrosse and powerlifting.

William Butler-Manuel is a Foundation Year 1 doctor who recently graduated from University College London.

He has an iBSc in orthopaedic science and is hoping to pursue a career in orthopaedics.

worth noting therefore that burnout can be ‘contagious’ and has the ability to spread throughout individual units and organisations. A single individual who may be experiencing stress and feel out of control of their situation can quickly create a net negative attitude change to a department or team. This is a well-studied but poorly quantified phenomenon and can include the protagonist forming well-founded or strong arguments upon which to hang their frustration. Empathetic colleagues can fairly easily become swept up with the negative feelings24.

“High levels of burnout have been shown to increase medical errors, reduce job satisfaction and push doctors in to early retirement. Burnout also impacts doctors’ general wellbeing with higher rates of depression, alcoholism and suicidal ideation.”

If burnout is not addressed and the wellbeing of staff brought to the forefront of everyone’s agenda in healthcare, then we risk not only the problems highlighted above but also a huge financial cost to our institutions. A study from the US estimated on a national scale, the conservative base-case model estimate was that approximately $4.6 billion in costs related to physician turnover and reduced clinical hours were attributable to burnout each year in the United States. This estimate ranged from $2.6 billion to $6.3 billion in multivariate probabilistic sensitivity analyses.

At an organisational level, the annual economic cost associated with burnout related to turnover and reduced clinical hours was approximately $7,600 per employed physician each year25. This can be extrapolated roughly to a cost of $900 million or £665 million in the UK per annum based on approximately 120,000 NHS doctors and the current exchange rate in April 2021.

Methodology

Maryam Ahmed is an Orthopaedic Registrar in the Kent, Surrey and Sussex rotation.

The research group, based in Brighton, produced a survey utilising the Copenhagen Burnout Inventory26, the Office for National Statistics (ONS) questions for measuring ethnic group and national identity27 sex, gender identity and sexual orientation28 for quantitative data analysis.

For the qualitative data, a number of free text questions were included to ask about the cause of stress at work and at home, and there was a further section for any additional information or comments.

Statistical analysis was performed where appropriate utilising t-test or chi-squared calculations.

The data has then been presented in the accompanying infographic to this paper and is discussed in our key findings.

The key findings 1. 40% of respondents reported a Copenhagen Burnout Inventory (CBI) score of over 50, which indicates burnout.

2. A further 50% of respondents were just below this threshold and have been classified as at risk of burnout due to the cyclical and dynamic nature of this condition. They had CBI scores of between 25-50, which is in keeping with other published literature29-31.

3. Those with protected characteristics, i.e. gender, race or sexuality, were found to be statistically more at risk than white, male heterosexuals. These two groupings were 49% and 51% of respondents respectively. The CBI scores over 50 were 45.6% for the BAME, Female, LGBTQ+ group versus 33.6% for the white, male heterosexual group. The t-test on this result was highly statistically significant (p<0.001).

4. Trainees were more at risk of burnout than consultants. 49.1% of trainees who responded had CBI scores over 50, whereas only 35.7% of consultants who responded had CBI scores over 50. The t-test and chi squared tests were both highly statistically significant (p<0.001) 5. Staff and Associate Specialists (SAS) in T&O had a similar burnout rate to the trainees and, whilst smaller in number, this was of a similar magnitude with 52.1% of SAS T&O surgeons having a CBI score over 50, compared to consultants at 35.7%. This was again highly statistically significant (p<0.001) on both t-test and chi squared tests. What was not possible to unpick from the data was how much of this effect was as part of the high levels of BAME ethnicity within the SAS T&O surgeons, or the grade at which they were working. Further work is therefore required to address the concerns of this severely affected portion of the BOA membership. For simplicity and clarity, we have not included a further image within the infographic but have highlighted our concerns to the BOA Wellbeing Initiative.

6. The analysis of the qualitative data is presented in a pair of word clouds generated

by WordItOut. 7. The key work stressors were management, time pressures, COVID-19 and a number of differing ways of expressing the problems around waiting lists and elective operating. >>

JTO | Volume 09 | Issue 02 | June 2021 | boa.ac.uk | 21

BURNOUT

Think You're OK? Data Says Otherwise

90%

of us are NOT OK

Severe Burnout 4%

Burnout 36%

At risk 50%

Not affected 10%

BAME, Female, LGBTQ+ Some are worse affected (p<0.001)

White Male Hetrosexual

Score <50 (54.32%)

Score <50 (66.41%)

Score >50 (45.68%)

Score >50 (33.59%)

Trainees

Consultants

As are Trainees (p<0.001) Score <50 (50.91%)

Score <50 (64.27%)

Score >50 (49.09%)

Score >50 (35.73%)

Stressors Contributing to Burnout At work

22 | JTO | Volume 09 | Issue 02 | June 2021 | boa.ac.uk

At home

Features

There were also enough mentions of problems with colleagues and bullying for these to appear in the list.

8. The key stressors at home revolved around family stresses, particularly children, childcare and home-schooling, however money and the stress of lockdown was also mentioned regularly. (The word ‘partner’ is utilised in the word cloud as it came up in equal numbers to the word ‘wife,’ therefore these numbers were combined.

It was felt that the word ‘partner’ was more appropriate.)

Discussion These survey findings were scrutinised by the research group and discussed at the BOA Wellbeing Initiative. It was felt that the survey findings reflected cultural problems within T&O in the UK. There is clearly a gender imbalance with only 15% of survey respondents being female.

This is despite over 50% of medical school entrants being female. Not only are women underrepresented but they are more at risk of burnout, with 53% having a CBI score over 50 compared to only 36% of men.

A similar finding was true for Black, Asian and Minority Ethnic (BAME) T&O surgeons, in that they too reported a higher rate of burnout compared to their white colleagues, 44% had a CBI score over 50 compared to 35% in the white cohort. The BAME cohort accounted for 33.3% of the survey respondents.

Whilst only a small percentage of the respondents identified as LGBTQ+, they also demonstrated a higher score than heterosexual T&O surgeons. Those who declared a sexuality had the following CBI scores above 50; heterosexual 39%, homosexual 55% and bisexual 50%.

When we created a group of those with protected characteristics of race, gender and sexuality and compared them with white, heterosexual males, the numbers were nearly equal. The BAME, Female, LGBTQ+ cohort were 49% (637) of respondents and the white, heterosexual males were 51% (661).

When these two groups were compared, those with protected characteristics had a 45.6% burnout rate compared to the white, heterosexual male group who had a 33.6% burnout rate. This was compared with a t-test and had a p value <0.001, and so deemed to be highly statistically significant.

The qualitative data gives more insight into what may be driving these levels of burnout.

When viewed with the concept of the six areas of work life described in Maslach’s paper22, the words that were mentioned most frequently as stressors make sense.

Maslach’s model described six areas

that encompass the central relationships with burnout: workload, control, reward, community, fairness and values. Where there are chronic mismatches between people and their work setting in terms of some or all of these six areas, burnout arises.

Management, time-pressures, COVID-19, and problems with waiting lists and elective practice point squarely toward a lack of control, workload pressure and a mismatch in values where difficult choices are being made.

These decisions are often made by people within organisations who are not the clinicians, i.e., ‘management’.

possible due to the pandemic. Couples were separated by distance for work, and then prohibited from meeting due to the pandemic restrictions. Many respondents reported significant financial difficulties either due to their own income decreasing or because partners were furloughed or having to undertake childcare at home. As a profession, we still seem to operate in an antiquated, patriarchal manner towards our home life, which may explain to some degree, the low number of women opting for a career in Trauma and Orthopaedics.

“Burnout has consequences such as reduced emotional and physical wellbeing, absenteeism, and personnel turnover. Naturally this can have substantial costs not just for individuals, but for organisations both short and long term. It is worth noting therefore that burnout can be ‘contagious’ and has the ability to spread throughout individual units and organisations. A single individual who may be experiencing stress and feel out of control of their situation can quickly create a net negative attitude change to a department or team.”

Problems with colleagues and bullying confirm what is being seen within the quantitative data, and reflects a mismatch in the areas of fairness, community and values. Reward and fairness are also an issue when career progression is not forthcoming and is something that was cited as an issue particularly within the SAS grade. Our data corroborates research from the USA32,33 which has highlighted issues of microaggression and a decrease in psychological safety amongst surgeons, in particular women and underrepresented minorities34,35.

The stressors outside of work cannot be viewed through Maslach’s model, but the predominant issues at this difficult time revolved around family, children, homeschooling and money. Problems within long-term relationships adding additional stress to an already testing time. What was clear from some of the additional comments, which for reasons of confidentiality will not be shared in detail, was that many of the respondents were dealing with significant illness within their families, both physical and mental, which they were not able to share with colleagues. There were tragic situations where family members had died and normal grieving had not been

The stressors for trainees were often a combination of a lack of training opportunities, uncertainty around exams, young families, separation from partners and the redeployment to other departments.

Many did not feel able to speak up about these issues.

The BOA has expressed its aims as, to care for patients, support surgeons and transform lives by focusing on professional practice, training and education, and research. The vision of the BOA is a vibrant, sustainable, representative orthopaedic community delivering high quality, effective care to fully informed patients36.

Given the data from this survey run in conjunction with the BOA, the BOA Wellbeing Initiative is being launched to support surgeons to provide the high-quality care for our patients by ensuring a shift in focus and culture so that all Trauma and Orthopaedic surgeons and the teams they work with feel included, supported and psychologically safe. This initiative will start with a webpage on the BOA site to help those interested look at ways to care for themselves, support their teams and foster change within their organisations. n

References References can be found online at www.boa.ac.uk/publications/JTO.

JTO | Volume 09 | Issue 02 | June 2021 | boa.ac.uk | 23

Features

The BOA Wellbeing Initiative Deborah Eastwood - on behalf of the BOA Back in January when we launched the BOA Burnout and Wellbeing survey we were critiqued, and rightly so, on various social media platforms for being ‘heavy’ on the burnout and ‘light’ on the wellbeing – well, we hope our wellbeing initiative will help correct that balance.

I

would like to thank our colleagues in the wellbeing working group, Ben Caesar, Tony Clayson, Sue Deakin, Richard Dodds, Joanna Maggs, Suddhajit Sen and Raju Ramesh who gave up some of their free time to help us design and develop the webpage: we had many interesting discussions identifying resources that we thought would be helpful.

We were guided as always

by Lisa Hadfield-Law and Julia Trusler, and had valuable input from Parashar Ramanuj, a Consultant Psychiatrist at the RNOH.

We believe that if we are here to care for patients, support surgeons and thus transform lives, we must also care for ourselves, support our teams and foster change within the organisations we work with and work for. These three strands, the individual, the team and the organisation form the basis for our webpage content – content which is quite different from that which you would normally find on our pages. We hope you will enjoy dipping in and out of the pages and we would welcome your feedback to foster change within the BOA!

If we don’t take wellbeing seriously

now, we’ve got a big problem trying

to get our staff, ourselves and our

colleagues to resume the work

we know is so important.

Our teams have been fragmented over the last year and may be in need of some care and attention if not a bit of a rebuild: we can help, we can be kind, we can ask the questions and

‘‘

‘‘

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listen to the answers and help to put right the things that are wrong. Support is a much valued commodity and as with groceries on the supermarket shelves – it can be in short supply in pandemic periods – but we can and must adapt to the situation we are in. Life is opening up and we can and will relearn how to be there for others so that they can do the same for us.

Click on the ‘team’ link for some ideas.

As the saying goes, there is no ‘I’ in team but there is an ‘m’ and an ‘e’ – so you do need to take care of yourself to be part of the team.

Even if you are one of the 10% who are ‘fine’ why not click the ‘individual’ link on our page and check how you are?

As an organisation we are changing; we thrive on engagement, diversity and inclusion so please let us know how we can help you.

You can access the wellbeing initiative website pages at: www.boa.ac.uk/wellbeing. n

Deborah Eastwood

Ben Caeser

Tony Clayson

Richard Dodds

Joanna Maggs

Suddhajit Sen

Sue Deakin

Raju Ramesh

BOA Wellbeing Working Group

Lisa Hadfield-Law

Julia Trusler

Parashar Ramanuj

Provided support and guidance to the Wellbeing Working Group

Easier for the surgeon, better for the patient

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Features

The new T&O curriculum Rob Gregory, Lisa Hadfield-Law and Deepa Bose The implementation of any new curriculum is naturally greeted by its users with anxiety and frustration, enthusiasm being a rare initial response. As we recover from the impact of COVID-19, the prospect of having to adapt to the first major curriculum change for seven years may seem daunting, but the changes reflect a desire to improve training advocated by most of us for many years.

O

ur curriculum is a living entity that must evolve in response both to the way in which healthcare delivery changes and to advances in knowledge about how we learn, but must also evolve in a way that raises the standards of the care we deliver.

Rob Gregory is a Consultant T&O surgeon who works in Durham. He has a longstanding interest in surgical training and is currently Chair of the SAC for T&O. He is also a Trustee of the BOA.

So, what can we expect? The principal change relates to the way in which trainees are assessed through the Multiple Consultant Report (MCR). This more holistic approach to assessment is based on the new Generic Professional Capabilities (GPCs), with assessment of these Capabilities in Practice (CiPs) being fundamental.

What hasn’t changed is the vast majority of the syllabus – which is why the exam remains unaltered.

“The recent shift towards an outcome based, rather than time based, curriculum continues, but it is envisaged that most trainees will still require six years from ST3 to progress to CCT.”

The recent shift towards an outcome based, rather than time based, curriculum continues, but it is envisaged that most trainees will still require six years from ST3 to progress to CCT. Whilst the outcomes are well defined, the means of achieving those outcomes are less clear and this perhaps represents the major challenge for us. If we take the example of research, the current requirements are easy to list, and everyone knows for example the importance of completing a Research Methodologies Course. Whilst the new requirements are no less difficult to list, the authors of the new curriculum were constrained by the GMC, in

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their ability to influence the means by which evidence of compliance can be demonstrated.

The arguments in favour of the continued inclusion of mandatory courses were pressed strongly, but ultimately with little success, and as a result we have been left with ATLS (or the ETC) as the sole mandatory course. This may well be a cause of confusion amongst trainees, trainees and TPDs alike, and may prove to be a source of friction if funding bodies refuse to accept that courses previously held in high esteem and often delivered nationally, fail to deliver ‘value for money’ and their goals must be achieved by other, more nebulous means. We must hope that pragmatism prevails, and that the quality of training is maintained in these areas.

Implementation

Increasing numbers of programmes have started to use the MCR format in shadow form to assess their trainees, and the response appears to be almost universally favourable. The value of the process lies in the constructive nature of the conversations that can potentially involve large numbers of colleagues, not necessarily all doctors, who have contact with the trainee in a wide range of clinical environments.

Although the MCR is restricted in terms of who can make entries, contributions from all established clinical team members can help the trainee identify areas of strength and weakness. No longer are we assessing isolated

Features

events such as how well a trainee can perform an operation, we can now assess how well a trainee can communicate in the operating theatre whilst operating, a quality just as important as the possession of technical skills.

Lisa Hadfield-Law has spent 20 years in clinical practice and surgical education. She has managed an orthopaedic/trauma service of a teaching hospital and has insight into the circumstances and challenges facing surgical teams.

She is Education Advisor to the British Orthopaedic Association & AOUKI, and contributes to the T&O SAC, FST Advisory Board and ISCP Management group.

How will training programme directors (TPDs) make sure their trainers and trainees are ready for all these changes? The BOA has fully funded the Virtual Training Orthopaedic Educational Supervisors (V-TOES) programme regionally, in conjunction with TPDs. Supervisors are asked to spare just eight hours with the vast majority being spent at a time convenient to suit them, with just one fixed two hour live virtual session. So, supervisors can take a day’s study leave without bringing departments to a standstill. We have worked hard to limit the preparation to activities that supervisors will be able to use on a repetitive basis and this should save them significant time and effort in the future.

The new curriculum addresses concerns expressed by many surgeons about the over-refined structure of ISCP with too many tick boxes and forms. If our trainees need to acquire professional judgement, insight and the ability to work with others, alongside operative skills, then this programme should help supervisors make the necessary changes work for them and their trainees. At the end of the event, participants can: • Assess how the changes to the T&O curriculum will affect us all • Integrate the new GCPs and CiPs • Make the best use of assessment tools including the MCR • Maximise their trainer portfolio • Use assessment of reflective writing to support trainee progress

Deepa Bose is a Consultant in orthopaedic trauma and limb reconstruction at the Queen Elizabeth Hospital Birmingham.

She is Vice Chair of the Specialist Advisory Committee for Trauma & Orthopaedics, and the lead for CESR application reviews. She has also contributed to the revision of the curriculum. She holds an MSc in Medical Education and is a member of the Academy of Medical Educators.

The programme is facilitated by TPDs themselves alongside the BOA educational advisor and trained virtual teacher. The BOA has now run over 80 fully online programmes and have trained over 1,500 T&O supervisors, examples of some of the feedback being as follows: “You have excelled delivering this in my humble opinion. All the very best for your great legacy - a generation of better prepared orthopaedic surgeons (of all grades, even us 52-year-olds)”.

“Superb course, which far surpassed my expectations, and found the ‘homework’ highly relevant and applicable to my current practice”.

“I’d go so far as to say that this is far superior to the more traditional course with face-to-face contact time. I think you’ve done an outstanding job”. >>

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Features

help trainers and trainees tackle sensitive conversations around performance.

For those who are not able to access a V-TOES programme, there are briefing videos on the on the BOA website (www.boa. ac.uk/curriculum) and useful information, including the curriculum itself, can be found on the ISCP website (www.iscp.ac.uk/ iscp/curriculum-2021).

Summary We are confident that the changes deliver more flexibility for trainees in how they demonstrate achievement of learning, and a more holistic evaluation of their capabilities compared to the snapshots previously provided by rigid numbers of WBAs. CiPs reflect the reality of how consultants work, and if trainees can demonstrate increasing competence in these, the transition from trainee to consultant should be both smoother and better.

Our V-TOES programmes have allowed us to iron out our wrinkles. The screencasts and activities in the learning log have helped to identify areas which might have caused problems in the future. For example, what happens to the CiP around managing an emergency take if the trainee is at an elective only hospital and how do you record areas for development in the GPCs without also recording that the trainee has not reached the expected level for their stage of training? It was trainers and trainees who located these wrinkles before the formal launch of the curriculum.

The two hour live virtual session is driven by unresolved issues from the learning logs. These are usually concerned with: • How will we engage our unwilling colleagues?

• How will we use WBA in the future?

• What’s the difference between a learning agreement and a PDP?

We hope that we have explained the need for a new curriculum and the rationale behind the changes in the way trainees will now be assessed. Although some assessment methods are quite different and will take time to bed in, it is important to recognise that by and large most areas remain unchanged. WBAs for critical conditions, index procedures, and competencies related to minimum logbook numbers, are still required.

Research and quality improvement objectives have remained unchanged and even though most courses are no longer mandatory, trainees may find that the best way to demonstrate a good grasp of research methodologies is to complete a research methodology course!

“The new curriculum addresses concerns expressed by many surgeons about the over-refined structure of ISCP with too many tick boxes and forms. If our trainees need to acquire professional judgement, insight and the ability to work with others, alongside operative skills, then this programme should help supervisors make the necessary changes work for them and their trainees.”

How does it work?

The BOA sets up a group in MS Teams for participants in each cohort. So far these have ranged from 12 to 70 individuals. Each participant is issued with a learning log in their channel file which they complete and have reviewed, either by a facilitator or a colleague who will:

• Won’t this take much more time?

• How can we engage other specialties in the interspecialty CBDs? • What’s the point in creating a trainer profile?

• Confirm that all modules are complete • Provide some written feedback in their partner’s learning log • Pass to the TPD if there are any problems e.g. failure to complete etc.

We are now in the process of designing an optional module dealing with difficult feedback conversations. Supervisors now have a balanced curriculum with integrated assessment tools that work. The next step is to

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Postgraduate training in T&O in the UK and Northern Ireland is amongst the most rigorous and robust anywhere in the world.

We are proud that our curriculum continues to grow and develop to meet the needs of our trainees and in turn, our patients, and are confident that both trainers and trainees will rise to the challenges posed by the latest version. n

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Features

The impact of COVID-19 on orthopaedic training Rob Gregory and Mark Bowditch

The size of the problem

Rob Gregory is a Consultant T&O surgeon who works in Durham. He has a longstanding interest in surgical training and is currently Chair of the SAC for T&O. He is also a Trustee of the BOA.

Even in the early stages of the global pandemic it was apparent that orthopaedic training would be at risk, but the precise focus of harm was unclear. With international travel severely restricted, fellowships were threatened; courses, conferences and meetings were cancelled; alternative teaching methods were untested; and redeployment cut off access to traditional work-based assessments. But in reality, the specialty has been able to adapt to such a degree that many necessary changes are now seen as innovative benefits and a return to training as practiced in the pre-COVID era is now rarely discussed. It is only in the area of the acquisition of surgical skills gained in the operating theatre that there has been a real impact, and the impact for large groups of trainees has been devastating.

Both the current and the new curriculum require access to 1,800 operative cases, but it is rare for trainees to fail to reach this target, with a mean case total at CCT historically being much higher at 2,150. The nature of this requirement is often misunderstood: 1,800 is an indicative rather than mandatory figure and was selected as it was felt to represent the surgical exposure required to gain the competencies that are mandatory.

Mark Bowditch is a Consultant at the Ipswich NHS Trust where he was appointed in 2000. He is Head of School of Surgery East of England, Past Chair of the SAC in T&O, and the current BOA Treasurer.

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We are fortunate in having e-logbook evidence to help us quantify the impact of COVID-19. A comparative analysis of data entries over the course of the last two years (Figures 1-3) shows that whilst there has been a small (15%) but significant reduction in trauma entries, it is elective case numbers that have been hit most severely with over a quarter of a million (58%) training opportunities lost. This represents an average of around 260 cases lost per trainee in the first year of COVID-19. When this figure is considered alongside the ‘reserve’ of 350 cases, and alongside the fact that trainees have been restricted in their ability to access the full range of subspecialties demanded by the curriculum, the potential consequences are clear.

Figure 1: Total e-logbook entries, UK, T&O, 2019-21

Figure 2: Elective e-logbook entries, UK, T&O, 2019-21

Figure 3: Trauma e-logbook entries, UK, T&O, 2019-21

The e-logbook data, whilst starkly demonstrating the impact of COVID-19, can only be used as an indirect predictor of the numbers of trainees who will require a training extension this year, but at current rates, the 350-case reserve average will have been exceeded by time of the summer ARCP round.

Features

Further evidence that can be used to try to predict the number of training extensions that will be required can be derived from ARCP outcome analysis (Figure 4) which demonstrates that in 2020 around a third of trainees were given an Outcome 10. Whilst only a small proportion were given the training extension through Outcome 10.2, the remainder are at risk of requiring training extensions this year. Given that there is little likelihood that the influence of COVID-19 on training will disappear in the foreseeable future, the spectre of training extensions may well be with us for several years and we are obliged to try to mitigate this by maximising access to operative training for all trainees, not just those approaching CCT. But does it matter if large numbers of trainees require a training extension? Unless additional funding is made available, it would be impossible to maintain input at ST3 to the previously predicted levels and bottlenecks at junior doctor levels would be inevitable. We are approaching a time when due to the waiting list legacy of COVID-19, pressure on consultants to meet service targets will escalate and a reduction in the size of the pool of appropriately trained surgeons to fill vacant consultant posts would be disastrous.

Figure 4: ARCP outcome analysis

The solution In common with all other surgical specialties, T&O is a craft specialty that demands hands-on training opportunities to achieve the necessary competencies to allow independent, safe practice across its full breadth as a consultant.

No regulator of training, training provider, School of Surgery, or Royal College could accept

an end point to training without having the confidence of this goal having been achieved.

This is clearly under great threat from the lack of access to operating and must be mitigated or removed.

There are a number of possible solutions that we can identify, these being as follows: • There should be a rapid restoration of the opportunity to operate. T&O must be given sufficient level of prioritisation and resources to access the facilities required to meet the waiting list demands, including access to beds, staff, theatres and rehabilitation facilities. The BOA has made this its top priority in discussions with the Royal Colleges, NHSE and patient partnerships.

• We need to maximise the use of every available theatre-based training opportunity as the system recovers, wherever the activity is undertaken. A heavy reliance will be inevitably be placed on NHS providers, but the Independent Sector (IS) has an important role to play. Regarding its training role, IS contracts should be less ambiguous and novel ideas such as tariff uplifts for the facilitation of training should be considered. >>

JTO | Volume 09 | Issue 02 | June 2021 | boa.ac.uk | 31

Features

• Consultants have, now more than ever, a responsibility to consider the construction of operating lists with pro-active planning of which cases will be allocated to the trainee as a first surgeon opportunity.

Lists without trainees attached should be publicised in advance as such, to allow trainees to decide how to spend their training time. This may require a re-evaluation of how clinics are run, remembering that trainees are allocated to healthcare providers not simply to meet service demands.

• The requirements of trainees should be considered on an individual basis. It has been suggested that a blanket extension of training time for all trainees should be given but this is unnecessary, counter-productive and would penalise those trainees who have been fortunate enough, perhaps by virtue of having a large, planned trauma commitment, not to have been significantly affected by COVID-19. The needs of individual trainees should be uppermost in the minds of all those with whom the trainee has contact, whether TPD, AES or CS. Whilst we must accept that some trainees will undoubtedly need more time, others may avoid the need to be given training extensions if a more focused approach to the allocation of their remaining training time is given. CoPSS – the group representing the Heads of Schools of Surgery – has asked

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HEE for additional TPD/AES time (and funding) in order to undertake this type of gap analysis assessment, and to build bespoke personal recovery plans. This could include secondments to other units or even alternative programmes. Trainee passports, either within or external to programmes have been suggested and the idea deserves exploration.

More than ever, the often underappreciated work of the TPDs and committed educational supervisors needs to be recognised and support must be provided if difficult decisions need to be made.

• If a training extension is required, we need to ensure that the post provided will deliver the competencies denied by COVID-19. More time, without the opportunity to gain these competencies, will just be wasted time.

• With a full complement of ST3s recruited in 2021, there is an inevitability that financial pressures will emerge, but what in effect would be a temporary expansion of training posts should be possible (TPD survey Dec 2020) and funding already exists locally for many non-training posts currently occupied by doctors hoping to enter the formal training system in the near future. An enlightened and flexible approach to funding from local healthcare providers is required and pro-active, constructive dialogue with post-graduate deans should provide a means of facilitating the necessary expansion.

• An alternative approach to funding the training expansion would be to reduce the entry into ST3 but this temptation should be avoided at all costs as it would be counter-productive, not least when considering long term quality workforce provision, something that T&O, when compared with other specialties, has proudly been able to maintain by proactive workforce planning through the BOA and SAC. We are facing a time of unrecognisable service demands, we need more well-trained surgeons, not fewer.

Conclusions It is clear that providing maximum access to theatre-based training is a current priority but even with the widespread roll-out of the national vaccination programme a resumption of elective operating to pre-COVID levels in the near future is unrealistic. The persistent reluctance of the Independent Sector to facilitate training should be challenged more firmly but we should recognise that it is the NHS providers that have the greatest ability to support our trainees. We mustn’t let service demands obscure the need to give equal priority to training, and every one of us with a training role should ensure that no training opportunity is lost. n #NotrainingTodayNosurgeonsTomorrow

Because saving a patient needn’t threaten our planet Environmental damage is the world’s leading cause of premature death. Yet a single operation can produce up to 814kg of CO2e.

As surgeons, it is our responsibility to reduce our damaging impact on the environment and public health. That’s why the College is taking action on sustainability – from advocating for greener patient pathways to minimising single use equipment.

To find out more and to get involved, visit: rcseng.ac.uk/sustainability

Together, we’re changing the face of surgery.

Join us.

Features

The UK Non-Arthroplasty Hip Registry Ajay Malviya and Vikas Khanduja

The UK Non-Arthroplasty Hip Registry was established in 2012 with the support of the British Hip Society (BHS) under the leadership of Prof John Timperley, Consultant Orthopaedic Surgeon at the Princess Elizabeth Orthopaedic Centre in Exeter.

Ajay Malviya is Chair – NAHR, Consultant Orthopaedic Surgeon – Northumbria Healthcare NHS Foundation Trust.

Vikas Khanduja is Past Chair – NAHR, Consultant Orthopaedic Surgeon – Addenbrooke’s, Cambridge.

O

ver the last two decades there has been an exponential rise in the number of hip preservation procedures being performed in the UK, but at the time of the conception of the registry it was noted that in contrast to joint replacement surgery, there was a lack of outcomes data outside of small scale published series. However, evidence has evolved in time with the FASHIoN and FAIT randomised controlled trials led by Prof Damian Griffin (Coventry) and Prof Sion Glyn Jones (Oxford) at the forefront of world research. The results of these studies combined with longitudinal ‘real world’ data from the NAHR will be central in guiding future patient selection, treatment and improve outcomes.

of their time to the Registry not just by contributing patients but also by ensuring updates, improving the quality of data analyses, working on surgeon and patient compliance, maintaining finances, website development (www.nahr.co.uk) and annual reports. At the recent BHS AGM in March 2021, expansion of the NAHR Board was approved. It was decided to invite applications for the role of regional representatives (10 in total), to improve local referral pathways and surgeon engagement. It is an exciting opportunity for all surgeons to be closely involved with the NAHR.

NAHR Board

We currently have more than 15,000 patient pathways registered in the NAHR under 106 contributing surgeons. The latest monthly report from Amplitude (Figure 2) shows that after the initial drop in March/April 2020 in

The board has changed over time and currently consists of six surgeons from across the country (Figure 1) who dedicate a significant amount

Jon Conroy Figure 1: Board Members

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Tony Andrade

Tim Board

Number of pathways, contributing surgeons and the effect of the pandemic

Marcus Bankes

Callum McBryde

Vikas Khanduja

Features

patient pathways, there was a gradual increase until a further drop due to the second wave of the pandemic in October 2020. Subsequently, there has been slow resumption of activity representing the effect of the pandemic on the provision of elective services.

Annual Report The 6th Annual report was published in March 2021 and demonstrates the benefits of hip preservation surgery in a large cohort of patients undergoing hip arthroscopy and pelvic and femoral osteotomy for hip dysplasia. However, the report also highlights the two problems of patient and surgeon compliance which is common to all voluntary and PROMs based registries.

Unfortunately, the number of surgeons actively contributing last year has decreased to 49 compared with 59 in 2019 and 65 in 2018.

Figure 3: Number of cases per surgeon

Figure 4: i-HOT-12 Score completion

Figure 2: Monthly report

The reason is unclear given that the annual number of patients entered has continued to increase up to 2019. The NAHR user group is determining whether this represents low volume surgeons stopping hip preservation surgery or not submitting data. There remain a few high-volume surgeons contributing the majority of the data with over 58% of data submitted by only 10 surgeons (Figure 3). As entering data is not mandatory, it is likely operations are being performed by surgeons not entering data and this is an area that the Registry, the BHS as well as health care commissioners are keen to address.

One of the greatest challenges that faces any registry that collects PROM data is patient compliance in completing the forms during follow-up. Figure 4 shows the rate of collection of the Index scores at various time intervals with the six-month collection for 2020 at around 45%.

The user group in collaboration with Amplitude are looking at a variety of measures to increase completion rates and this a major focus for the NAHR over the next year.

COVID-19 surveillance The younger and medically fit patients that are typically treated in our practice with day case procedures were considered the ideal cases for the resumption of elective services. It was therefore essential that we put systems in place to ensure safe resumption of elective operating. As a team, we embedded the COVID-19 surveillance audit into the NAHR, one of the features which we will see more of as the registry matures.

As of 1st June 2020, all patients entered in the NAHR receive an additional set of questions.

These include an introductory email to the patient at the time of the surgery to establish what protocols were in place to ensure that they had their intervention in a safe environment and whether they understood the implications of having an elective procedure during this time.

It is followed up with a 30-day and 90-day email to establish whether they developed any COVID-19 related complications. During this period (Figure 5), of the 551 patients entered, 349 had completed their baseline scores with a 63% compliance. Of these, 298 had completed their 30-day questionnaire and 232 their 90-day questionnaire. The results are being monitored and will be presented at the BHS Annual meeting in June 2021.

Instant reporting upgrade From the various discussions we have had with our members, it was apparent that some have found it difficult to analyse their own data entered into the registry. At its inception in 2012, the expectation to critically analyse the data was different as the registry was in its nascency, and the initial challenge was to ensure that the data entry process was functional. It was therefore important that we improved the functionality, specifically to allow the surgeon to prepare a report for their appraisal and provide more granularity to their own data. Over the last year, we have worked on this functionality together with Amplitude and the upgrades are now in place. The NAHR members are now able to objectively examine their own data and compare outcomes with the national averages.

Please use the link ‘NAHR PROCEDURE CHART’ in the reports section of the portal to access this functionality (Figure 6). >>

JTO | Volume 09 | Issue 02 | June 2021 | boa.ac.uk | 35

Features

An open application process for availing the NAHR dataset has been created by the user group to encourage further research (only those contributing data to the Registry regularly are eligible to apply). All research proposals are evaluated by the user group at regular intervals.

Education programme

Figure 5: Latest COVID-19 surveillance data

This will be beneficial not just for appraisal but additionally for audits and research and to assess what works best in an individual’s service.

Research There has been significant amounts of progress in this area. Stellar work done by the team has resulted in a number of presentations at the free paper session of the BHS Annual meeting in 2020. We have also had the first paper from NAHR published in JBJS Am reporting on outcomes of periacetabular osteotomy (PAO) with others to follow. The key message from the recent publication is that PAO is a successful surgical intervention for hip dysplasia and acetabular retroversion in the short term and with significant improvement in patientreported outcome scores maintained up to two years postoperatively.

Our study looking at the role of hip arthroscopy for femoroacetabular impingement (FAI)

has shown that 67% of patients achieved improvement in scores over and above the minimum clinically important difference (MCID). Pincer pathology, high-grade chondral lesions and higher preoperative scores are predictors of lower improvement in scores.

Age above 40 and high BMI are also associated with poorer outcomes. Labral repair leads to significantly better improvement in scores as compared with labral debridement.

For a registry to be able to provide this level of information in its ninth year is an achievement and the BHS and the NAHR would like to thank all the members of the user group, the surgeons, administrative staff and the patients that have contributed data to make this possible. There is no doubt that there is still an immense amount of work to be done especially around patient and surgeon compliance. We hope that continued engagement with all of these groups will continue to improve data collection and quality, allowing future reports to shed even more light on this complex area of hip surgery.

Over the last three years, the nonarthroplasty group has secured a regular place for a ‘Topic in Focus’ at the BHS Annual Meeting and also one session at the Annual BOA meeting. There is a rolling education programme in place and for the BHS Annual meeting in June 2021, we are planning to have a case-based discussion involving AVN of the hip and periarticular pathologies around the hip (Greater trochanteric pain syndrome and Posterior hip pain) with a panel of national and international experts debating and providing insights into the management of these conditions. This will provide a different perspective to the other themes that we have been presenting thus far. In addition, the BHS Education Committee, led by Vikas Khanduja, has launched an ambitious series of webinars every month. The NAHR group has been allocated four of these sessions and we will be covering FAI, Hip Dysplasia, AVN of hip and Periarticular pathologies around the hip in detail.

The NAHR has demonstrated promising progress on several fronts and would like to obtain more feedback on how we can improve the service delivered to the surgeons. Specifically, with regards the plan to restructure the team with appointment of ten regional representatives to help champion local engagement. Please contact us if interested (nahr@britishhipsociety.com).

We also have some exciting plans for research and travelling fellowships and are exploring options for a sustainable and financially viable solution. In the long-term we aim to establish and support regional and national MDTs for complex case discussion on a regular basis.

The team is a firm believer of “If you do not measure it, you cannot improve it”. We aim to create a comprehensive, self-sustaining and robust system to measure patient outcomes and improve patient care.

Figure 6: Reports Dashboard

36 | JTO | Volume 09 | Issue 02 | June 2021 | boa.ac.uk

We would encourage all surgeons involved in hip preservation surgery to contribute, and if you are encountering difficulties assistance can be provided. The registration link is available on the NAHR website (www.nahr.co.uk). n

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Features

Derek Pegg is a Consultant Trauma and Orthopaedic Surgeon in Mid Cheshire Hospitals Foundation Trust, Leighton Hospital, Crewe.

He is Chair of both NJR Regional Clinical Coordinators Committee and NJR Data Quality Committee.

Effects of COVID-19 pandemic on hip and knee joint replacement surgery in 2020 as demonstrated by data from the National Joint Registry (NJR) Derek Pegg, Adrian Sayers, Michael Whitehouse and Timothy Wilton On behalf of NJR (ahead of annual report September 2021)

We live history, in the present, while it is only future analysis that can provide a true portrayal of our times.

Adrian Sayers is a Medical Statistician at Musculoskeletal Research Unit, Translational Health Sciences, Bristol Medical School, Southmead Hospital, Bristol. He is the senior statistician for the NJR lot 2 contract for Statistical Analysis, Support and Associated Services.

T

he COVID-19 pandemic continues to exert a profound influence on the lives of individuals and societies around the world. As anticipated in the early phases of the response to the health crisis, it is having a significant effect on orthopaedic surgeons’ ability to provide joint replacement surgery (JRS) for patients. The National Joint Registry (NJR) provides independent and accurate data on this aspect of healthcare. Such data demonstrates that there has been over a 50% reduction in provision of JRS over the last twelve months. To alleviate this shortfall, if all hospital units were able to return to pre-pandemic levels along with an ambitious 10% increase in activity, we would see a minimum of five years before the ‘backlog’ is fully conquered. These estimates do not account for the ‘natural’ annual increase in the volume of service provision for joint replacements of approximately 5% that has been observed consistently to occur in the NJR data. Current trends suggest this backlog is continuing to increase and there is speculation that ‘catch up’ will take very much longer, even if considerable resources and investment can be provided.

Last year was an unusual time for the provision of joint replacement surgery. By presenting analysis of registry data from 2020, we can clearly

38 | JTO | Volume 09 | Issue 02 | June 2021 | boa.ac.uk

demonstrate significant lowering of the volume of activity and get some insight into projected increases needed for recovery. At the time of writing (April 2021) volumes continue to be lower in comparison to pre-pandemic levels.

Plans for recovery to previous levels of surgery are starting to be implemented in some hospital units but many other units continue to struggle, and some have barely re-commenced JRS. The ability to catch up with lost activity is a huge challenge everywhere, but we know, even as lockdown is lifted, that we may well face further issues in the months and years ahead, such as repeated waves of COVID-19.

We hope this article will provide the nations’ health economy with objective insight into the effects COVID-19 has had on this type of elective surgery, assist in evaluating the magnitude of the challenge and help us return to pre-pandemic levels of JRS provision. It could also help calculate the time and potential resource required to regain the lost activity which will be crucial for complete recovery.

We reviewed NJR data in total for years 2018 through to March 2021. We looked at hip and knee operations, performed in 2020. This was compared with 2019 activity, preceding the

Features

activity, while in the East Midlands only 41% of hip and 33% knee JRS was achieved (Table 2).

COVID-19 pandemic. We also reviewed the activity data across regions, and for both NHS and independent sector units.

Michael Whitehouse is a Professor of Trauma and Orthopaedics at Bristol Medical School, University of Bristol and Consultant Trauma and Orthopaedic Surgeon at North Bristol NHS Trust. He is a member of the NJR lot 2 contract for Statistical Analysis, Support and Associated Services.

Absolute numbers for both NHS and Independent providers both fell but as expected, proportionally less so for Independent units (Table 3). >>

Analysis of the data from Northern Ireland, Wales and England (Scotland has its own registry and does not submit data to the NJR) enables comparison of the effects of the pandemic on the devolved healthcare regions. Further separation of England into regions allows variation due to structural and organisational differences to be highlighted.

In 2020, the NJR recorded 59,343 primary hip and 53,888 knee primary joint replacement procedures (to date*). This represents 57% and 49% of the usual activity of primary procedures compared with 2019, across the whole of the NJR’s geographical footprint. Early data demonstrates this significant loss of activity has continued into 2021 (Figure 1). Thus analysis of the last twelve months (financial year 2020/21) is likely to see significantly greater reduction in overall activity, although the precise figures cannot yet be provided since some data is still being entered for the last few months (historically the ‘missing’ data due to delayed entry are unlikely to provide more than a further 15% for the first three months of 2021).

Across the devolved health economies of Northern Ireland and Wales, we saw a greater reduction in activity compared to England, (Table 1) and hence the recovery period may be longer.

Across the regions in England’s NHS units there was also variation in activity, London having been able to maintain 62% hip and 56% knee

Timothy Wilton is a Consultant Orthopaedic Surgeon at Department of Orthopaedics, Royal Derby Hospital, Derby, with specialist interests in knee and hip replacement surgery. He is Medical Director of the NJR.

England

Wales

Northern Ireland

Primary Hip

58%

38%

50%

Primary Knee

50%

29%

35%

Table 1: Primary Joint Replacement for Hip and Knee in 2020 as percentage of activity for 2019.

Hip

Knee

East Midlands

41%

33%

East of England

49%

41%

London

62%

56%

North East

57%

52%

North West

48%

41%

South Central

57%

49%

South East Coast

55%

50%

South West

50%

41%

West Midlands

50%

43%

Yorkshire & Humber

46%

37%

Table 2: Activity for Hip & Knee JRS for the regions in England for 2020 as % of activity for 2019.

Location

Joint

Funding

2019 (% of total)

2020 (% of total)

Change 2019-2020

NHS

Hip

Public

60,664 (58%)

29,197 (49%)

-52%

NHS

Hip

Private

1,136 (1%)

682 (1%)

-40%

ISTC

Hip

Public

3,591 (4%)

2,037 (3%)

-43%

ISTC

Hip

Private

69 (0.06%)

209 (0.3%)

+300%

Independent

Hip

Public

23,430 (22%)

13,133 (22%)

-44%

Independent

Hip

Private

15,396 (15%)

14,085 (24%)

-9%

All Locations

Hip

104,286 (100%)

59,343 (100%)

-43%

NHS

Knee

Public

63,363 (57%)

25,820 (48%)

-59%

NHS

Knee

Private

835 (0.8%)

474 (1%)

-43%

ISTC

Knee

Public

4,231 (4%)

2,118 (4%)

-50%

ISTC

Knee

Private

80 (0.07%)

146 (0.3%)

+183%

Independent

Knee

Public

28,296 (26%)

14,602 (27%)

-48%

Independent

Knee

Private

13,963 (13%)

10,688 (20%)

-23%

All Locations

Knee

110,768 (100%)

53,848 (100%)

-51%

Table 3: Primary Procedures by funding type, provider and joint-type for the whole of the NJR.

JTO | Volume 09 | Issue 02 | June 2021 | boa.ac.uk | 39

Features

Authorities in England for primary and revision surgery combined.

Table 3 illustrates figures across all providers and across both public and independent funding. Knee replacement activity has fallen proportionally more than hip replacement surgery, other than the small number of ISTC cases privately funded.

Clearly COVID-19 has had a severe and detrimental effect on JRS in all geographical areas shown. Although the spring of 2020 had virtually zero activity there has been a steady partial recovery. However, the data demonstrates that this is still far short of pre-pandemic levels of activity. As a result, the backlog of patients awaiting surgery continues to increase.

Figure 1: Number of procedures by operation week and operation year.

Figure 2: NJR Regions for England. Activity in 2019 and 2020.

Figure 1 shows how all JRS activity recorded on the NJR fell dramatically at the end of March 2020 (week 13) and then a slow but steady recovery started more than eight weeks later. Recovery then peaked at the end of October, week 40, with a steady decline until mid-December, at week 51. This reflects issues with the prevalence of COVID-19 variants and increase in related hospital admissions during this period. Several geographical regions struggled at different times with community incidents and the demand this placed on secondary care, in general.

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Table 1 shows in the case of primary surgery, a greater loss of activity is seen with knee surgery than with hip surgery across the devolved health economies. This is also seen across all regions in England when looking at data for both primary and revision surgery. Total hip replacements performed for management of a fractured neck of femur may account for some of the relative preservation of total hip numbers vs total knees.

Figure 2 demonstrates variation in NHS units across the former Strategic Health

The burning question is not only when will some units be able to return to their previous orthopaedic productivity levels but also where and when will increased activity allow catch up with the backlog of patients awaiting JRS? Estimates based on this data suggest, with an expected >50% reduction over 2020/21, and an ambitious increased activity for each unit by 10%, it will take over five years for recovery to pre-pandemic levels. However, even before COVID-19 coloured the landscape, demands and waiting times for JRS were increasing.

There is no short-term fix and it would be valuable to see recovery as part of a planned medium and long term solution.

As ever with healthcare, cause and resolutions are multi-factorial and therefore it becomes very difficult to give precise calculations and time-to-recovery estimates given the number of variables involved in the delivery of JRS in the context of wider healthcare delivery. The effects and response to COVID-19 potentially change with every mutation COVID-19 throws at mankind.

We have fortunately seen early encouraging signs that successful vaccinations will provide some degree of protection for the often elderly and vulnerable who are commonly undergoing major joint replacement surgery.

This is an obvious beacon of hope when many of us have witnessed the devastating effects COVID-19 can have on both colleagues and patients. This appears particularly so for patients in the peri-operative and immediate post-operative period following major surgery such as JRS for trauma1. At the time of writing, the full effects of COVID-19 have yet to be realised. We can estimate that the current trends demonstrate that during the financial year 2020/21 we will see well over 50% loss of activity, proportionally greater in NHS units, over this 12-month period. It is our ability to return to above pre-pandemic levels of surgery that will minimise the devastating and disabling effects that joint

Features

pathology can have on the individuals and the distress this can cause to immediate family and friends. Orthopaedic patients surveyed during the pandemic reported an increase in their symptoms and associated feelings being ‘worse than death’2. There is also a sense that there will be an increased burden such patients are likely to place on community care services in their aftercare, as well as hospitals; and the very real danger that some will have sub optimal results because of the delay in their surgery.

a small effect of reducing the waiting list for such surgery, this won’t in any way improve the health outcomes for these individual patients, nor will it lessen the overall societal burden of future disability due to arthritis which will still have to be managed by the health service, as well as individual patients and their carers.

*The registry is only as good and accurate as the data input, in a timely manner. In 2019 80% of data was uploaded within one month and 90% within three months, therefore small changes in total numbers for the last quarter may still occur, as ongoing data quality audit confirms data accuracy with hospital units.

Over the last year, there has been an increase in the number of excess deaths as shown by national mortality figures.

It is epidemiologists who will only truly be able to ‘judge our present by analysis in the future’.

How many delayed cases of JRS will have a sub-optimal outcome as a result of the delay as a consequence of COVID-19? How many cases will have an earlier need for revision surgery?

Only the future holds the answer. For now, we know we have a problem that currently has no easy answer, but it seems likely that the longer we continue to accumulate an increased waiting list burden, the worse will be the consequences for our arthritic patients in terms of both delay, and quite possibly quality of outcome.

We continue to be grateful for the continued work of all those responsible for data entry into the NJR, the surgeons and all the patients who consent to their data being held on the NJR, helping drive forward safety, quality and shaping joint replacement surgery for the future.

“The burning question is not only when will some units be able to return to their previous orthopaedic productivity levels but also where and when will increased activity allow catch up with the backlog of patients awaiting JRS?”

One of the many unknowns will also be how many patients either succumbed to COVID-19 or other health issues, before they were due to undergo arthroplasty surgery? Or how many patients will have decided to change their decision to have surgery by considering the additional risk of COVID-19 and all that it entails; thus tipping their risk stratification and informed decision towards continued conservative management rather than subject themselves to the risks of surgery at this time. While such decisions might have

Data provided by Northgate Public Services NJR Lot 1 contract for NJR data management, data solutions and associated services. n

References 1. COVIDSurg Collaborative. Mortality and pulmonary complications in patients undergoing surgery with perioperative SARSCoV-2 infection: an international cohort study. Lancet. 2020;396(10243):27-38.

2. Clement ND, Scott CEH, Murray JRD, Howie CR, Deehan DJ, IMPACT-Restart Collaboration. The number of patients “worse than death” while waiting for a hip or knee arthroplasty has nearly doubled during COVID-19 pandemic. Bone Joint J. 2021;103-B(4):672-80.

JTO | Volume 09 | Issue 02 | June 2021 | boa.ac.uk | 41

Features

Jonathan Phillips is a specialist knee arthroplasty, trauma and revision surgeon, appointed at the Royal Devon and Exeter Hospital in 2015.

He is a member of the ODEP and Beyond Compliance committees, as well as both the Primary and Revision BASK Knee Arthroplasty Working Groups.

Ben Waterson undertook his specialist training in orthopaedic surgery in Edinburgh and undertook the adult lower limb reconstruction fellowship in Vancouver. He was awarded a Medical Doctorate (MD) from Edinburgh University for his research in the field of knee surgery and the impact of alignment on total knee replacements. He has been working as a consultant in the Exeter Knee Reconstruction Unit since 2018 and is an Honorary Senior Lecturer at Exeter University.

Tourniquet use in knee replacement – the why, the what and how to do without Jonathan Phillips, Ben Waterson, Andrew Toms and Keith Eyres

A recent Cochrane review published in December 2020 re-opened the debate of tourniquet use during knee replacement and suggested we minimise its use. However, a 2016 survey of 547 consultant knee surgeons, members of the British Association of Surgery for the Knee (BASK), demonstrated that 90% used a tourniquet during total knee replacement surgery, the majority of whom did not wish to stop doing so1.

Why use a tourniquet?

Tourniquet advocates explain that the use of a tourniquet enables more accurate and quicker surgery due to the presence of a blood-free field2.

There is also an argument that cement penetration into the bone is improved if there this a dry bed into which cement can interdigitate. There is evidence for this in hip replacement surgery too where obviously without the use of a tourniquet; modern cementing techniques involve washing and drying the prepared bone surfaces, suction catheters and pressurisation of cement both before and after implantation3. There is a risk that poor cementation and pressurisation may lead to earlier implant loosening, although this link in knees is not as clear as in hips.

Surgical training is still largely apprentice-based.

Therefore, if surgeons train to perform surgery using a tourniquet, it is likely that they will continue to use one throughout their career.

42 | JTO | Volume 09 | Issue 02 | June 2021 | boa.ac.uk

What is the argument not to use a tourniquet?

While tourniquets may provide a bloodfree field to allow for more accurate and/or efficient surgery, it does so at the compromise of producing an essentially avascular limb for the duration of the surgery.

When a limb is avascular, tissues are unable to undertake aerobic respiration, and as such this may lead to an increase in anaerobic metabolic products or rhabdomyolysis4. There are time limits suggested for the length of time for tourniquet use (a maximum of two hours is generally recommended). Beyond this time period, the use of a tourniquet may have a detrimental effect not only on the tissues of the limb, but it also increases the risk of reperfusion injury once the tourniquet is released. The release of anaerobic metabolites can cause an adverse effect to the cardiovascular system5.

Features

Tourniquets are applied in the mid-thigh region and may not fit well for certain body types (such as overweight patients with significant adipose tissue and short legs). Frequently this is the typical knee replacement patient. A poorly fitted tourniquet may either reduce access to the more proximal end of the incision or move during the case leading to a compromise of sterility.

Andrew Toms is the Professor of Orthopaedics at the Princess Elizabeth Orthopaedic Centre, Exeter. He trained on the Stoke / Oswestry rotation and in Vancouver, Canada. He currently sits on the NJR Editorial Board, the Bone & Joint Infection Registry board, BASK Research Group and the RCS Robotic Advisory Group for Orthopaedics.

“While tourniquets may provide a blood-free field to allow for more accurate and/or efficient surgery, it does so at the compromise of producing an essentially avascular limb for the duration of the surgery.”

Tourniquets may fail intra-operatively, or the position of the tourniquet on the leg may change during the procedure such that the delivered pressure to the tissues drops below the systolic blood pressure but remains above the diastolic blood pressure, leading to a venous-tourniquet, where bleeding can appear worse and may only be resolved through deflating the tourniquet mid-procedure, while still having compromised exposure due to the presence of the tourniquet near the wound.

Tourniquet pain is well described in the literature and can be avoided by not using a tourniquet6.

Keith Eyres is a Consultant Orthopaedic Surgeon practicing at the Nuffield Health Exeter Hospital and the Royal Devon and Exeter NHS Foundation Trust.

He specialises in hip and knee replacement, knee revision and rheumatoid surgery.

There is an additional risk of pressure injury and chemical injury from tourniquet usage.

The pressure injury can cause subcutaneous fat necrosis, permanent soft tissue damage, nerve palsy and local pressure injury to the skin.

Careful tourniquet application should limit this type of injury as long as the recommended time limits are adhered to. The use of alcoholic preparations for pre-operative skin cleansing can lead to a chemical burn if left in contact with the skin beneath the tourniquet.

A blood-free field may allow a clearer view during dissection or approach, however it may also risk masking iatrogenic injury of the vessels, a well-recognised risk in knee replacement surgery. Although this risk is very low, subtle vascular injuries may be missed intraoperatively if a tourniquet is used for the entire case, which may have devastating consequences for the patient. There are also patients with calcified vessels where compression may cause plaque fracture and thrombosis.

Advocates of tourniquet use have argued that blood loss is decreased. Indeed, there are publications demonstrating reduced blood loss intra-operatively, however the total blood loss (intra- and post-operatively) has been found to be similar with or without a tourniquet7,8. Modern anaesthesia techniques, with the use of tranexamic acid and improved pre-operative assessment to avoid performing surgery in patients with anaemia, have all meant that the concerns regarding blood loss post-knee replacement are far less of an issue, and blood transfusion after primary arthroplasty is now very uncommon.

Operating without a tourniquet means that small arterial bleeders (such as from the lateral geniculate vessels) are identified and cauterised intra-operatively, thereby reducing the risk of post-operative haematoma.

Many of these issues have led to some surgeons applying a tourniquet but only inflating it during the cementation process. Thereby, surgeons gain the benefit of using a tourniquet without the risks of a prolonged tourniquet time. As mentioned earlier, modern cementing techniques in total hip replacement do not rely on tourniquet use and in vitro lab testing shows that the same result is achievable in the knee using a cement gun and suction catheter to overcome the back bleeding pressure.

Bleeding from bony surfaces at the time of cementation can be overcome through surgical technique described below3.

Are there any drawbacks to not using a tourniquet?

The main drawback to not using a tourniquet is that visibility can be poor, making careful dissection harder particularly in the presence of inflamed synovium or if the anaesthetist is unable to avoid hypertension.

An additional minor concern can be the intra-operative appearance, which can be unappealing to surgeons used to a strict bloodless field. There is also increased risk of a splash hazard particularly while performing aerosol generating procedures (AGPs) such as during power-tool use.

What does the evidence say?

A recent Cochrane review published in December 2020 based on 41 randomised controlled studies including 2,819 people concluded6: “The evidence indicates that knee replacement surgery performed with a tourniquet increases the risk of serious complications needing additional healthcare, many of which will be avoided if a tourniquet is not used. Most people do very well after knee replacement, but like any major surgery, there are risks and use of a tourniquet may exacerbate these.” >>

JTO | Volume 09 | Issue 02 | June 2021 | boa.ac.uk | 43

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The findings published in the review6 stated: • Pain on the first day after surgery is probably worse with a tourniquet.

On average, on a scale of 0 to 10 (higher scores = worse pain), people operated on with a tourniquet rated their pain as 5.81.

People operated on without a tourniquet rated their pain as 4.56 (average difference: 1.25 points).

• Knee function one year after surgery is probably similar with or without a tourniquet. On average, on a scale of 0 to 100 (higher scores = better functioning), people operated on with a tourniquet rated their knee function as 89.74. People operated on without a tourniquet rated their knee function as 90.03 (average difference: 0.29 points).

Although this is not compelling evidence for surgery without a tourniquet, it should be enough to make us question why we use a tourniquet. Our unit has performed tourniquet-free knee arthroplasty for over fifteen years, with low rates of revision surgery and high rates of patient satisfaction and many publications.

The Exeter cementation technique for tourniquet-free knee replacement Where possible, spinal anaesthesia is used to provide a more hypotensive anaesthetic.

Our experience has shown that the cut bone and incised soft tissues bleed less when sedation is added to reduce patient agitation or restlessness. Since 2012, we have used two grams of intravenous

• Satisfaction with treatment may be similar with or without a tourniquet.

Six months after the operation, 94% of people operated on with or without a tourniquet were ‘extremely’ or ‘very’ satisfied with their treatment.

• There may be little or no difference in health-related quality of life with or without a tourniquet. On average, on a scale of 0 to 100 (higher scores = better quality of life), people operated on with a tourniquet rated their quality of life as 54.64.

People who had surgery without a tourniquet rated their quality of life as 56.17 (average difference: 1.53 points).

• Serious adverse events such as blood clots in the leg or lung, infection, or reoperation other than to replace the artificial joint are probably more likely to occur with a tourniquet. Five per cent of people operated on with a tourniquet reported serious adverse events compared to 2.9% of people operated on without a tourniquet.

Figure 1: Femoral Condyle with intraosseous suction in place.

Figure 2: Intraoperative distal femoral cutting jig.

44 | JTO | Volume 09 | Issue 02 | June 2021 | boa.ac.uk

tranexamic acid on induction which has improved the surgical field. However, it is important to administer this at least 15 minutes before surgery starts. Diathermy should be used to cauterise bleeding vessels during the capsulotomy and applied to the meniscal beds. Another key step is to use a cannula with suction attached, inserted into the femur during bone preparation and placed close to the cut bone surfaces before cementation. Finally, infiltration of high-volume (usually 140-160ml) low dose local anaesthetic with adrenalin (adjusted to body weight) into the capsule and soft tissues throughout the knee, consolidates the advantage of being able to cauterise bleeding areas prior to wound closure.

Positioning of the patient, prepping and draping is much easier without a tourniquet in place especially in shorter obese limbs and this is an obvious advantage in revision surgery when the length of the procedure precludes tourniquet use. The leg is supported with a side thigh support and a foot bolster. After skin incision with the knee flexed, the capsule is opened and the patella everted or subluxed after knee extension. When the knee is flexed back into position again bleeding from the cut capsule stops.

The cannula with trocar (Biomet or Wolff needle) is inserted into the area of the medial femoral condyle to the depth of the venting holes two centimetres from the bone surface. The position is marked with a pen. When the trocar is removed, the femoral canal can be reamed allowing decompression of blood and fat from within the femoral canal (Figure 1). Careful positioning of the cannula avoids contact with fixation pin placement of the distal cutting block or the four in one cutting jig (Figure 2).

The suction attached to the cannula is set at a low suction pressure and aspirates minimal amounts of blood but dramatically reduces blood spray when the bone surfaces are cut. This drying effect is greater when the femur has not been perforated for example when navigation or robotic surgery is performed.

Features

The tibia is cut and prepared in a standard way and the joint is balanced. Infiltration of 50ml of local anaesthetic into the posterior capsule is performed before cementing.

Either the femur or tibia can be cut first depending upon surgeon preference and both techniques are routinely performed at our centre.

Prior to cementation, place the leg in extension and carefully observe for bleeding, particularly from the lateral meniscal bed or at the notch if the posterior cruciate ligament has been removed. The benefit of not using a tourniquet is that all bleeding points can be addressed intra-operatively using diathermy.

At the time of tibial cementation, the trocar and cannula is placed into the tibial metaphysis to allow bone washing and drying. The recommended point of needle insertion is medial to the tuberosity heading laterally and parallel to the cut bone surface approximately 15mm below the surface and angled to avoid the cavity for the tibial tray and keel. We have found that using the softer lateral metaphysis (in a varus knee in particular) is adequate for preparation of the whole of the tibia and avoids the risk of iatrogenic fracture in sclerotic bone (Figure 3). The suction cannula technique has been previously published and has demonstrated improved cement penetration in an in vitro setting (Bucher). It is postulated that an improved cement mantle may improve long term implant survival. In osteoporotic bone there is a risk of over penetration of bone cement, in which cases we either turn off the suction on tray insertion or do not use the suction needle technique.

The tibial surface is washed with pulsed lavage and dilute aqueous chlorhexidine (Chlorhexidine Acetate BP 0.02%; Baxter, Norfolk), and dried with the suction needle, a standard sucker and a dry swab prior to cementation.

We currently favour Simplex HV for cementation due to its longer working time and we apply the cement to the surface using a gun (particularly now as most cement can be mixed in a gun with vacuum suction) although it can be applied to the cut surface using spatula.

The key action is to get a swift seal of the cut surface with cement so that the suction effect is optimised, and cement can be seen being pulled down into the trabeculae. With cement pre-coating of the tibial component the implant is impacted into place. The cement and implant surfaces must be dry prior to implantation.

The cannula is removed after implant positioning and reinserted into the previously marked medial femoral aspiration hole. The femoral surface is washed and dried and a perfect surface for cementation is presented (Figure 4). The femoral component is pre-coated with cement and a horseshoe-shape of cement is applied manually or by gun to the dry cut bone surface and will appear to be pulled into the fixation holes and trabeculae.

When the implant has been impacted the leg is extended fully and the patella is cemented.

There is no need to aspirate the patella bone.

Figure 3: Tibial suction catheter in situ.

During the cementation phase the second 50ml syringe of LIA is injected into the medial and lateral gutters and capsule Figure 4: Femoral suction turned on showing rapid blanching of distal femur. regions. Any residual bleeding should be addressed at this stage to minimise Conclusion post-operative haematoma formation.

The latest evidence from a Cochrane review The final syringe of LIA is infiltrated into has demonstrated that tourniquet use during the subcutaneous areas and the wound is knee replacement surgery increases the risk closed in a standard manner. Removal of the of serious complications. This increase is suction needle must be documented as part modest, but we believe it is an unnecessary of the ‘count’ and the needle itself checked to risk and that tourniquet use can be avoided by confirm it is intact. using a few simple techniques.

A similar technique is used for uni-condylar replacement noting that the cannula is inserted into the tibia away from the cut surface to prevent fracture propagation and then introduced into the respective femoral condyle to achieve dry bone surfaces. For patella-femoral replacement, the needle is only inserted into the medial femoral condyle to achieve the desired effect.

The risks and benefits of tourniquet use have been discussed and for those surgeons wishing to stop using a tourniquet, the method used at Exeter has been described. n

References References can be found online at: www.boa.ac.uk/publications/JTO.

JTO | Volume 09 | Issue 02 | June 2021 | boa.ac.uk | 45

Trainee

Returning to trauma and orthopaedic training with SuppoRTT Iris Kwok, Zoe Little and Kash Akhtar The landscape of orthopaedic training is continually evolving, with an increasing number of trainees taking time out during their training.

Fortunately, the current training pathway has a degree of flexibility to facilitate and nurture this diverse and well-rounded workforce.

T Iris Kwok is an ST8 trainee on the Royal London rotation.

She has a specialist interest in foot and ankle surgery and trauma. As a departmental rota coordinator and registrar representative, she has helped trainees transition back to work following time out of training.

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rainees can take time out of training for a variety of reasons – to undertake academic research, to pursue interests outside of medicine (for example, setting up a business or participate in competitive sport), taking parental leave or fulfilling family responsibilities, studying for an MBA or higher educational degree, or needing time out for personal sickness.

This is thus an issue that impacts both male and female trainees alike, and can occur at all stages of training.

According to a study on return to work on Higher Surgical Trainees in 2018, the most common concerns trainees had surrounding returning to work following time out of programme were operative skills and skill fade, diminished confidence and the ability to manage worklife balance2. In recent years, increasing emphasis has been placed in ensuring safe and supported return to clinical practice after a period of time out. The Bawa-Garba case in 2015 that shook the medical profession brought the issue of patient safety to the forefront. This was formally addressed following the ACAS agreement in 2016, stemming from safety concerns of returning trainees raised in the Junior Doctors Contract.

The SuppoRTT (Supported Return to Training Programme) programme was therefore established by HEE in 2017 to address these issues across all specialties and provide a structured process for trainees and trainers. 11 offices across England are responsible for establishing and implementing the programme within their local areas.

“An interruption in training can have an impact on ones’ clinical skills, knowledge and confidence on return to work, particularly in a craft-based speciality such as trauma and orthopaedics.”

An interruption in training can have an impact on ones’ clinical skills, knowledge and confidence on return to work, particularly in a craft-based speciality such as trauma and orthopaedics. Previously, trainees were expected to return to full clinical duties with on calls and emergency operating in full swing, often in a completely new trust. This has potentially serious implications for patient safety, trainee confidence and rate of return to training altogether. These issues have been well-described in other surgical specialties1.

Trainee

As a large amount of resources have been put into this programme, with £10 million recurrent annual funding from the Department of Health and Social Care, trainees should be aware of what the programme offers in order to utilise it fully when needed.

What the SuppoRTT programme offers Zoe Little is an ST7 trainee on the South West London rotation, aspiring hand surgeon and mother of two young girls.

Having returned to training twice following maternity leave she is keen to improve the experience of returning trainees and helped deliver the KSS/London T&Ospecific SuppoRTT courses.

The programme is accessible by all trainees who are returning to work after absence from training for three months or more, regardless of the reason. Up to £3,000 of funding is available per trainee to support their return to work, including: • Attendance on courses • Working in a supernumerary capacity or enhanced shadowing in clinical sessions • Participation in simulated clinical training Funding is not reimbursed to the trainee directly but is provided to the department to cover course expenses or any supernumerary and/or locum cover required to support the trainee’s safe return to clinical work.

Before taking time out: When possible, for predictable out of programme activities, a pre-absence meeting is held with the trainee’s Educational Supervisor (ES) or Training Programme Director (TPD), after which a form is completed by the trainee on the HEE website at least 3 months before taking time out.

Kash Akhtar is a Reader in Orthopaedic Surgery and Surgical Education at Barts and the London Medical School (QMUL). He is also an Honorary Consultant in Trauma & Orthopaedic Surgery at Barts Health NHS Trust. He is the Training Programme Director for the Royal London Rotation, a member of the Specialist Advisory Committee and on the BASK Executive Committee. His clinical practice is in knee surgery, with a particular interest in multiligament knee injuries and his research interests are focused on psychomotor skills, simulation and non-technical skills.

During time out: The trainee is encouraged to register online with the SuppoRTT programme during the period away from training.

Before returning to work: The trainee should arrange a meeting with the ES or TPD approximately 8 - 12 weeks before their anticipated return date, and a pre-return form is completed. A return to training plan should consider: • Supervised clinical sessions for a period of time • The use of keeping-in-touch (KIT) days, of shared parental leave in touch (SPLIT) days • Courses or training days to refresh skills and knowledge • Phased return to work and flexible working arrangements where appropriate • Preparation for next Annual Review of Competency Progression (ARCP) After returning to work: A return review meeting is held with the ES or TPD towards the end of the supervised period to address any concerns and arrange any further targeted training.

T&O-specific return to training Other specialties have been more progressive in delivering specialty-specific return to work training. For example, the Royal College of Anaesthetists has an established national programme called Giving Anaesthesia Safely Again (‘GasAgain’). This award-winning programme is structured to provide strategies for managing a safe return to work. This includes simulation scenarios to refresh an anaesthetist’s skills, alongside a series of workshops with short lectures to update clinicians on the latest developments in the world of anaesthesia. The course provides essential updates (such as resuscitation, patient safety checks) whilst giving returners the opportunity to build their confidence managing common and unusual emergency scenarios again. The course is delivered four times a year across the UK. T&O is still in the early stages of developing a specialty-specific return to work programme. In October 2020, three orthopaedic trainees from Southwest Thames and the Kent, Surrey, Sussex (KSS) rotations piloted what we believe to be the first T&O-specific return to training course, supervised by Shirley Chan (Colorectal Surgeon and Supported Return to Training Champion for KSS School of Surgery) and Sarah Siddiqui (HEE’s National Supported Return to Training fellow for 2019-2020). This was tagged onto the already-established South London and KSS T&O ‘Reg Ready’ course which was running every October for new incoming ST3 trainees.

All London returning trainees were invited to attend the course. In the morning, returning trainees joined the Reg Ready course, where common trauma and on call scenarios were discussed in an interactive ‘quick-fire’ format.

There was also a session on ‘How day-to-day clinical work is different in COVID-19’, as some trainees were out of training at the time of the first wave of the pandemic.

The afternoon was specific to trainees returning to training only, where a small group session of eight participants discussed various issues pertaining to return to training and returning to on call work. The experiences of three trainees who had previously returned after time out were shared. Concerns were discussed in an open, relaxed and friendly manner. Other aspects of training such as how to juggle and navigate LTFT training, and how to access helpful resources were also discussed.

The course was attended by both male and female trainees, with reasons for time out from training ranging from research work to personal sickness, to maternity and parental leave. The course received extremely positive feedback, and all participants were glad that they attended this prior to re-commencing work. >>

JTO | Volume 09 | Issue 02 | June 2021 | boa.ac.uk | 47

Trainee

4) Being supernumerary in outpatient or fracture clinic – so that the trainee is not under undue time pressure to see patients.

5) Doubling up with another trainee with trauma operating – to help get used to conducting an effective theatre team brief, setting up the patient and image intensifier, familiarisation with implant equipment and kit, etc.

6) Having a mentor in the department – this could be a consultant or a fellow colleague who is already known to the trainee.

7) Regular meetings (e.g. weekly) with ES and at the end of the enhanced supervision period.

This ‘settling in’ period would typically last for one month, but should be tailored according to the individual’s needs and discussed between the trainee and the individual department prior to return to work. The rota coordinator and service managers should be involved with this discussion.

Future directions

The second iteration of the course took place in April 2021 and was run virtually due to COVID-19 restrictions - this allowed trainees from all over the country to take part, and also included a session on updates to orthopaedic guidelines as well as a mock trauma meeting.

Again, the feedback was excellent and the virtual nature of it did not seem to be a barrier to the participants being willing to express and discuss their concerns about return to training.

“As a trainee returning to training in COVID-19 times, the opportunity to be supported in trauma operating and on calls was invaluable. This programme helps trainees rapidly get back up to their pre-absence level, which may have traditionally taken much longer, especially if the trainee is returning as LTFT.” – ST7 NE Thames T&O trainee, returning after a year of maternity leave.

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Facilitating a smooth return to training General return to work guidance has been published by the Academy of Medial Royal Colleges3, however, there is currently no surgery or T&O-specific guidance. Although individual circumstances and requirements need to be taken into account (such as the level of training and experience prior to taking time out of training, where the trainee is in relation to sitting their FRCS Tr & Orth exams and so forth), suggestions for a safe return to work in the initial ‘settling in’ or enhanced supervision period for a trainee include: 1) Having the option to return to a hospital and department which is already familiar to the trainee – rather than rotating to a new hospital.

Perhaps it is time for us trauma and orthopaedic surgeons to take our cue from other specialties (anaesthetics4, obstetrics and gynaecology5 and the paediatrics6) and embrace the ever-changing landscape in surgical training with an increasing number of trainees taking time out of training. More work should be put into the development of formal T&O-specific return to work guidance and courses, so that T&O trainees nationwide could benefit from a safer, smoother return to training. As overall numbers of returners at specific time points are relatively small, this could take the form of a virtual meeting.

Additional resources • JCST: Guidance on the Management of Surgical Trainees Returning to Clinical Training After Extended Leave: www.jcst. org/-/media/files/jcst/key-documents/ return-to-work-guidance-final.pdf.

• HEE SuppoRTT programme: www.hee. nhs.uk/our-work/supporting-doctorsreturning-training-after-time-out.

• SuppoRTT return to training: https://mysupportt.com/. n

2) Doubling up with another trainee for on calls.

References

3) No out-of-hours on calls, such as overnight shifts.

References can be found online at www.boa.ac.uk/publications/JTO.

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36th Edinburgh International Trauma Symposium & Instructional Trauma Course 16th to 30th August 2021

IN VIEW OF THE COVID PANDEMIC, THE PROGRAMME WILL ONCE AGAIN BE RUN ENTIRELY ON-LINE FOR 2021.

The Symposium will not be held as a physical meeting in Edinburgh in August this year. Instead, we intend to deliver the same high quality education via our website on a virtual platform as we did in August 2020.

As usual, there will be an Instructional Course aimed at trainees and those requiring an over-view and update in orthopaedic trauma, running in parallel with the Trauma Symposium, aimed at established surgeons interested in recent developments, debates, and controversies.

HIGHLIGHTS OF THESE COURSES INCLUDE:

• An experienced and enthusiastic faculty of national and international experts.

• Our programme of Instructional and Symposium talks, available to watch whenever convenient.

• Webinars delivered during the fortnight of 16th-30th August 2021.

Additional material including cadaveric dissections of surgical approaches and techniques.

• EARLY BIRD DISCOUNT AVAILABLE, BOOK BEFORE 31ST MAY 2021 Further information and a detailed programme are available on our website: www.trauma.co.uk or by email: symposium@trauma.co.uk.

SPONSORED BY The Orthopaedic Trauma Society

www.trauma.co.uk symposium@trauma.co.uk.

Medico-legal

Current medico-legal considerations in the orthopaedic treatment of Jehovah’s Witnesses Simon Britten

During the middle and late 19th century many religious study groups sprang up dedicated to examining the Bible closely to try to reconcile the diverse doctrines of the major Christian faiths and try to understand Biblical prophesies and their fulfilments.

The modern day organisation of Jehovah’s Witnesses traces its roots back to one such group.

Simon Britten is a Consultant Trauma & Orthopaedic Surgeon in Leeds specialising in lower limb reconstruction and he is the current Secretary of the British Limb Reconstruction Society. He has been awarded the taught degree of Master of Laws with Distinction in Medical Law and Ethics by De Montfort University Leicester. He is a member of the BOA Medicolegal Committee and faculty member of the BOA course ‘Law for Orthopaedic Surgeons’.

I

n 2020, Jehovah’s Witnesses worldwide numbered 8.7 million members actively engaged in various forms of public ministry. This number does not include children or those attending meetings. At their annual meeting to memorialise the death of Christ in spring 2020, there were approximately 18 million in attendance worldwide.

Jehovah’s Witnesses are not opposed to medicine and they seek out and appreciate quality professional medical care. They have a high regard for life and emphasise a healthy lifestyle. As a patient group they strive to be well disciplined and apt to follow clinical advice, including adhering to post-operative directions and rehabilitation. To some clinicians this may seem inconsistent with their refusal of the transfusion of whole blood and its primary components, when transfusion has an established place in modern medicine alongside many advancements in blood conservation and transfusion-alternative strategies. Witnesses are generally well informed and fully appreciate that their stance could be life threatening in extreme circumstances, so why is their viewpoint so strongly held?

Jehovah’s Witnesses state that their beliefs are Bible based and their stand against the transfusion of whole blood and its primary components is principally a scriptural stand and secondarily a medical stand. They note various

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references to blood throughout the Bible, and they see a great sensitivity to blood, animal or human, from God; on several occasions the use of blood in any way, be it dietary, commercial or otherwise is strictly proscribed. Such references can be found in the Old Testament – for example Genesis 9:3,4 and Leviticus 17:13,14, and in the New Testament – Acts 15:19,20. They believe blood is symbolic of life itself, and their wilful disregard of its sanctity could jeopardise future hopes beyond present existence. Their strength of feeling is therefore unsurprising.

Legal and ethical issues Judge Cardozo in 1914 stated that “… every human being of adult years and sound mind has a right to determine what should be done with his body…”1 However, it has taken until the early 21st century for autonomy to supersede ‘doctor knows best’ paternalism.

Legal and ethical support of the adult Jehovah’s Witness who refuses a blood transfusion can be found in the Human Rights Act, with Article 8, the so called ‘autonomy article’ – right to respect for family and private life; and Article 9 – the right to freedom of thought, belief and religion2. For the clinician faced with an adult’s refusal to accept a blood transfusion, there is a conflict between the clinician’s duty to preserve life, versus their duty to respect the right of an adult patient with capacity to make autonomous choices.

Medico-legal

Representation of a continuous circuit in cell salvage if requested by the individual Witness.

Image courtesy of Medical Illustration Department, Wythenshawe Hospital, MFT.

Benjamin N Cardozo, Associate Justice of the Supreme Court of the United States (1870 - 1938)

The European Court of Human Rights

It is well established in medical law that an adult with capacity can decline treatment, even if in so doing it may lead to the death of the individual. In the case of Re T (Adult: Refusal of Treatment), Master of the Rolls Lord Donaldson stated – “… every adult has the right and capacity to decide whether or not he will accept medical treatment, even if a refusal may risk permanent injury to his health or even lead to a premature death.”3

apply even if life is at risk. The ADD makes it clear that the individual refuses transfusions of whole blood and its primary components (red cells, white cells, plasma and platelets).

Jehovah’s Witnesses also refuse autologous predonation of blood and the use of any sample of their blood for crossmatching. In Northern Ireland, Scotland (‘Advance Directives’) and the Republic of Ireland (‘Advance Healthcare Directives’), while there are some subtle differences in the relevant legal frameworks, the broad principles are similar.

“Jehovah’s Witnesses are not opposed to medicine and they seek out and appreciate quality professional medical care. They have a high regard for life and emphasise a healthy lifestyle. As a patient group they strive to be well disciplined and apt to follow clinical advice, including adhering to post-operative directions and rehabilitation.”

On this basis, an adult Jehovah’s Witness with capacity has the right to decline a blood transfusion, even if they might die as a consequence. The decision to decline a transfusion of whole blood or any of its primary components may be recorded in advance in England and Wales by the use of an Advance Decision Document (ADD), which would take effect if the individual subsequently loses capacity to accept or refuse treatment.

Such an advance decision must be in writing, witnessed, and must stipulate that it is to

Where an adult patient with a valid ADD loses capacity, and the treatment proposed is covered by the terms of the ADD, the clinicians must respect the provisions of the ADD and avoid transfusion of whole blood or its primary components, unless there is evidence that at the time of signing the individual did not in fact have capacity or evidence that they have subsequently changed their mind. The clinicians may institute other appropriate

treatments unless specifically declined by the individual in Section 5 of the ADD. To proceed with a blood transfusion in the face of a valid ADD, i.e. without the individual’s consent, is unlawful, and may lead to jeopardy for the clinician with the courts and the regulator.

Where an adult patient loses capacity and there is no clear evidence of a valid ADD, treatment decisions must be made by the clinicians on the grounds of the patient’s best interests. However, when considering ‘best interests’, this does not only refer to their best interests from a clinical standpoint, but should also include consideration of any known cultural or religious beliefs and values4. Information provided by relatives, friends and the local Hospital Liaison Committee of Jehovah’s Witnesses can be extremely valuable. Even if it cannot be definitively proven that the individual had made an advance decision, but there are strong grounds to believe that they would have refused to consent to a specific treatment, the provision of that treatment may not be considered to be in their best interests and therefore would be unlawful.

Since 1991, Hospital Liaison Committees have been functioning in major cities in the United Kingdom, composed of Elders from various congregations of Jehovah’s Witnesses. They are trained to liaise between Witness patients, their families and clinical teams. They are available to provide support in all elective and emergency medical and surgical cases involving anaemia or haemorrhage via Hospital Information Services (Great Britain) 24-hour telephone 020 8371 3415, email hid.gb@jw.org. >>

JTO | Volume 09 | Issue 02 | June 2021 | boa.ac.uk | 51

Medico-legal

Jehovah’s Witnesses readily accept that the law does not give parents unlimited medical decision making authority for their children, and they appreciate that surgeons cannot provide a 100% assurance that major blood components would not be used in the treatment of a minor. The Royal College of Surgeons’ guidance ‘Caring for patients who refuse blood’ notes that – “surgeons have a legal and ethical responsibility to ensure the wellbeing of the child … this must always be their first consideration; however, every effort must be made to respect the beliefs of the family and avoid the use of blood or blood products wherever possible.”5 In England and Wales young people over the age of 16 can give legally valid consent to treatment. ‘Gillick competent’ children under the age of 16 can give consent if they are considered to have a sufficient level of competency to understand the issues involved. However, the courts have been willing to overrule the refusal of specific treatments by young people under the age of

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18 years old. Historically this willingness to overrule has been the outcome in the majority of cases of under-18s refusing blood. In Scotland, a cut off of 16 years old is consistent for both acceptance and refusal of treatments offered. In broad terms, the closer a young person is in age to the relevant age cut off point, the more weight the courts will give to the young person’s views.

In the case of planned surgery, there should be dialogue between the surgeon, anaesthetist, haematologist, child and family regarding the likelihood of life-threatening haemorrhage and possibility of blood transfusion, and the family’s position on the transfusion of blood as well as clinical strategies for avoiding transfusion. The HLC may assist in such discussions.

Following this discussion the multidisciplinary clinical team can consider whether they are prepared to proceed under the defined constraints. If not, they may wish to consider referral to another team with appropriate experience with such situations, if one exists.

The multidisciplinary team may conclude that they can only proceed with the option available of providing a blood transfusion despite parental refusal, acting as they see it in the best interests of the child. This is not without impact to the family and the doctorpatient relationship. The parents may be prepared to give consent to a procedure for their child, on the basis of genuine assurance that the treating team will make optimal use of all appropriate transfusion-alternative strategies so as to respect their beliefs and only give a transfusion if absolutely necessary. Most techniques suitable in adults to minimise the likelihood of intra- and postoperative blood transfusion are applicable in children’s surgery. Should careful consideration and constructive dialogue between the family and treating clinicians fail to provide satisfactory resolution, the treating clinicians may apply to the Court of Protection for a Specific Issue Order (SIO) to provide legal sanction for a specific action, such as giving a blood transfusion, without removing all parental authority6.

Medico-legal

In an emergency with significant risk to life and insufficient time to obtain an SIO from a court, if dialogue with the parents and young person is unsuccessful in obtaining consent, blood should only be given where absolutely necessary to prevent severe detriment to the child’s health. An SIO should be sought as soon as possible. But note that the Royal College of Surgeons give the following advice – “If a child needs blood in an emergency, despite the surgeon’s best efforts to contain haemorrhage, it should be given.

The surgeon who stands by and allows a ‘minor’ patient to die in circumstances where blood might have avoided death may be vulnerable to criminal prosecution.”7

bypass, and organ transplantation.

Jehovah’s Witnesses are prepared to accept recombinant coagulation factor concentrates, interferons and interleukins; and drugs such as recombinant human erythropoietin (rHuEPO) and iron, which are not derived from blood. The use of human tissue, including bone grafting, skin grafting and free tissue transfer are potentially acceptable.

Patient Blood Management (PBM) is a collaboration between the National Blood Transfusion Committee and NHS Blood and Transplant Service, and is an evidence-based, multidisciplinary approach to optimising the care of all patients who might need transfusion. It involves avoiding unnecessary blood transfusion, the diagnosis and management of anaemia, preoptimisation where possible, meticulous surgical haemostasis, cell salvage, the use of anti-fibrinolytic agents to reduce bleeding, and the involvement of the patient in the decision making process8.

While the principles of PBM are advocated for all patients and aimed at the conservation of blood and its appropriate use rather than its absolute avoidance9, these principles have greatly assisted clinicians in the safe and effective treatment of Jehovah’s Witnesses.

“It is well established in medical law that an adult with capacity can decline treatment, even if in so doing it may lead to the death of the individual. In the case of Re T (Adult: Refusal of Treatment), Master of the Rolls Lord Donaldson stated – “...every adult has the right and capacity to decide whether or not he will accept medical treatment, even if a refusal may risk permanent injury to his health or even lead to a premature death.””

The point of contact for the surgeon and anaesthetist wishing to obtain an emergency SIO from the Court of Protection varies between hospitals and the time of day.

It may be any one of the hospital’s legal department, department of clinical risk, the senior hospital site manager on call, or senior nurse covering the site; and in turn they will contact the hospital solicitor to apply to the Court of Protection.

Treatment strategies and options While Jehovah’s Witnesses decline transfusion of whole blood and primary blood components, various other derivatives of primary blood components may be accepted by the Witness patient as a matter of personal choice. Such derivatives include albumin, coagulation factor concentrates such as cryoprecipitate and fibrinogen, immunoglobulins and fibrin glue.

Certain blood management techniques may also be considered as part of personal choice by the Witness, including use of cell salvage, acute normovolaemic haemodilution, and post-operative blood salvage from wound drains. Other advanced technologies considered to be a matter of personal choice include haemodialysis, cardiopulmonary

Detailed guidelines for patients who refuse blood transfusion in elective surgery where blood loss of >500 ml is anticipated, have been produced by the Association of Anaesthetists of Great Britain and Ireland10.

Pre-operatively consideration should be given to optimising red cell mass and discontinuing or substituting anticoagulants and anti-platelet agents. Unnecessary blood tests should be avoided and consideration given to use of paediatric sampling tubes.

Oral or intravenous iron and rHuEPO may be valuable.

Useful intra-operative techniques may include acute normovolaemic haemodilution, controlled hypotension, epidural anaesthesia,

maintenance of normothermia, point of care testing for arterial and venous blood gas sampling, thromboelastometry, use of a cell saver, fibrin sealants, administration of intravenous tranexamic acid and use of desmopressin. While Witnesses do not accept primary blood components such as fresh frozen plasma or platelets, useful adjuncts to haemorrhage control may include cryoprecipitate and other coagulation factors, depending on individual Witness preference.

Witnesses note that when considering intraoperative autologous techniques, in principle it is not essential to keep the Witness in continual contact with their own blood by means of a continuous loop or circuit.

Postoperatively blood tests should be minimised and the routine use of anticoagulants carefully balanced against the risks of additional blood loss. Following tourniquet use, post-operative cell salvage may be considered. A further dose of intravenous tranexamic acid may also be of benefit. Many of the above techniques are directly transferable to emergency scenarios.

Summary • Jehovah’s Witnesses do not accept the transfusion of whole blood or its primary components.

• The acceptance of derivatives of primary blood components and of techniques such as cell salvage are matters of personal choice.

• Adults with capacity may refuse treatment, even if it may lead to their death, and refusal in advance of blood transfusions can be set out by means of a signed and witnessed Advance Decision Document.

• The management of children of Jehovah’s Witnesses may give rise to some ethical challenges, which can often be resolved by dialogue between the family and treating team. On occasion it may be necessary to seek a decision from the Court of Protection. The Hospital Liaison Committee may be of assistance.

• Patient Blood Management has been developed to optimise care of all patients and minimise transfusion requirements, and optimal and rigorous use of PBM principles are useful in the management of Jehovah’s Witnesses, in elective and emergency settings. n

References References can be found online at: www.boa.ac.uk/publications/JTO.

JTO | Volume 09 | Issue 02 | June 2021 | boa.ac.uk | 53

Subspecialty

David Beard is Professor of Musculoskeletal and Surgical Science at the University of Oxford and the Rosetrees RCSEng Director of the Surgery and Interventional Trials Unit [SITU NDORMS]. He has an interest and expertise in placebo control for surgical trials including being coCI (with Professor Andy Carr) for the influential placebo controlled CSAW study on the shoulder. He was Co-CI and organiser (with Associate Professor Jonathan Cook) for the NIHR/MRC funded placebo control workshop, on which much of the content of these articles are based.

Placebo surgery: fake news or real deal David Beard and Marion Campbell

The word placebo is a familiar term in the world of drug trials and the concept of using a dummy or ‘sugar’ pill void of any known therapeutic value has helped distinguish ‘useful’ from ‘not so useful’ drugs for many decades.

P

lacebo controlled studies provide a level playing field for evaluation and account for any tricks of the mind and body that can produce or reinforce health benefits, be they behaviour based or more physiological. The placebo effect is real, powerful, often inconsistent, and fascinating.

But when at the dinner table someone says they design and conduct placebo trials in surgery, yes that’s right, surgery, involving tissue damage and blood loss, how can it not cause a wrinkled brow to the uninformed? Really? Surely not? Why? And How? Is the usual response.

Marion Campbell is Professor of Health Services Research and Vice Principal (Research) at the University of Aberdeen. She is a medical statistician and clinical trialist with a particular interest in the design, conduct and analysis of surgical and device trials. She has published widely on clinical trials methodology, and was Chief Investigator of the NIHR KORAL study which explored the acceptability and feasibility of placebo-controlled trials in surgery.

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There is lots to cover here. Why do we need such comparisons for surgery? Is it ethical (find out from our Canadian ethicist colleague Charles Weijer in the next article), how do we go about it? (dealt with by Naomi Merritt and Marcus Jepson in a later article), and what do surgeons think about using placebo control in surgery (see the final article in this subspecialty section, our Trainee Surgeon perspective from Shiraz Sabah).

Starting with the ‘Surely not?’. Well yes, and there is reasonable evidence to support this.

There have been over 90 placebo-controlled trials in surgery performed to date in specialties ranging from orthopaedics (our world for the JTO) to hernia repair1. They tend to be chosen for surgical procedures that have low invasiveness, those which are more questionable in terms of true therapeutic effect and those which rely on subjective measures such as reduction in pain as a measure of success.

This is eminently sensible. Few would volunteer for a placebo-controlled trial of open fracture fixation after falling off a ladder.

There is a broadest aspect of ‘Why’ and that is to both support and promote any surgical treatments that are proven to work (especially new ones), and to reduce or stop surgical treatments that do not. There is always some risk to a surgical operation and it seems foolish (and, more fundamentally, unethical) to expose anyone to risk if the treatment is largely ineffective (we say largely because trials are all about averages and no one can ever be certain).

Likewise, if a new surgical treatment (device or procedure) is suggested, it is appropriate to test it fully before releasing its use into the world at large – just like in the pharmaceutical industry.

The placebo control surgical design allows this.

It is beefy, authoritative and often practice changing, but needs to be treated with respect and careful consideration. It is a complex design, rather ‘prima donna’ in characteristics and can easily fall over. It also carries risk, so needs careful justification and planning.

In terms of a more specific ‘Why’ it comes back to the level playing field. All trials need a comparison treatment (or a comparison against no treatment) on which to base the assessment of benefit or not. Because the entire process of surgery, from listing to anaesthetic to recovery, can have components that influence the final outcome (over and above the actual surgical treatment), it is important that any comparison treatments assessing fundamental efficacy mimic each other as closely as possible.

The only difference should be the feature (or features) thought to produce the benefit – that is then omitted from the treatment for one ‘arm’ of the study. This is done ‘blind’, without anybody (except the surgeon) knowing which treatment group is which – including the patient. This is just the same as a drug trial

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where the active ingredient is removed from a drug to form a placebo. Unfortunately, it can be a little more complicated in surgery as it is not always clear what part of the surgery is responsible for giving the benefit. Regardless, the placebo-design is a unique method to find out whether any benefits are just the result of going through the (elaborate) surgical ‘process’ or are genuine effects of the operation.

It means that clinicians and commissioners of healthcare can make well informed decisions on what they provide for patients. Patients can be reassured that the surgery they are receiving has been proven to be beneficial.

Everybody is happy – or are they? Specific aspects will be covered in the next two articles, but let’s look at some of the potential trip hazards of placebo controlled surgical trials in ‘How’.

The ‘How’ can be a long story. From the early designs, trials with a placebo arm have become more sophisticated and better understood over time. There are firm roots in orthopaedics with famous trials of knee arthroscopy in which patients underwent full simulated surgery (a sham or placebo procedure) to find out its true effects2.

However, for this article, we can limit discussion to the more controversial aspects of placebo control, as all trials have at least some design issues.

“From the early designs, trials with a placebo arm have become more sophisticated and better understood over time. There are firm roots in orthopaedics with famous trials of knee arthroscopy in which patients underwent full simulated surgery (a sham or placebo procedure) to find out its true effects.”

Dealing with the component parts of the placebo control is the first thing to consider. Taking out the surgical component that hypothetically provides the benefit can be a problem in placebo trials. Firstly identifying it, and then ensuring that it can be isolated. For example in the placebo controlled trial of laminectomy,

currently being conducted in Australia (SUCCESS), the placebo arm involves all aspects of surgery except the decompression or removal of the bone. Not all surgical procedures lend themselves to this process of critical surgical element isolation and any observed benefit may be cumulative or confounded by unidentified ‘active elements’ within the surgical procedure. We have tried to make this process easier to understand by developing the ‘DITTO framework’ which may well be worth a further read3.

One of the most difficult operational aspects to navigate is overcoming the natural persona of surgical colleagues (i.e. that of a decision maker) to allow trial recruitment to occur under a heading of uncertainty. All studies of fundamental efficacy have to adhere to the principle of uncertainty where the outcome of the comparison for two or more interventions is unknown. This presents surgeons, who without the trial might ordinarily offer the surgical procedure to patients, to accept that what they are about to do (in terms of surgery), may not be optimal or even worthwhile. Furthermore, introducing a placebo element requires one step further.

Inside a placebo trial surgeons must be willing to complete the surgery without including the surgical element that is expected to provide the benefit. Such a conversation is >>

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a tall order in front of a patient about to undergo invasive surgery and could potentially lead to substantial confidence erosion and undermining potential. To display uncertainty usually goes against a surgeon’s natural instinct and everyone’s expectation that they are cloaked as the ‘bold decision maker’.

There is no real solution except to provide greater familiarity with issues of equipoise and uncertainty in surgery by education and greater discussion with patients and the public about clinical research. But more of this dilemma in a later article.

The ethics of asking a patient to enter a trial where they have a balanced chance of having surgery (and all the risk) without the supposed ‘good’ bit (although at that stage the ‘good’ is by definition unproven), is also a substantial ask and has occupied the ethical space of placebo trials for a while, (but more of that in Charles Weijer’s paper).

And lastly, what do we do if the placebo surgery is shown to have benefit? Either for the individual or in terms of trial results?

If, in a three-way trial comparing the full definitive surgery, a placebo surgical intervention and no treatment, both surgical

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procedures are better than no treatment but definitive surgery is no better than placebo, what do we do? Do we then discard the surgery in any form? Or do we offer a treatment that captures the benefit providing aspect, placebo or otherwise? After all, it might be cheaper than a definitive treatment.

These are difficult questions to answer and also circle back to the risk arguments and ethical aspects of placebo control. How much benefit do we have to achieve to justify the risk of an essentially placebo surgical procedure?

Again, we have no answers just yet, but are working hard to find out.

There is no question that placebo-controlled trials in surgery are useful and valuable, but they are demanding and complicated and certainly should not be considered for every surgical evaluation. Working with surgeons, ethicists, patients and researchers we have attempted to assist and guide those interested in the subject or who are setting up placebocontrolled trials with the publication of the ASPIRE guidelines4. This does not have all the answers though and whilst we have started the placebo-controlled surgical journey we have certainly not reached the end. All of us – surgeons, researchers, patients – are welcome to join us on that journey. n

References 1. Cousins S, Blencowe NS, Tsang C, et al.

Reporting of key methodological issues in placebo-controlled trials of surgery needs improvement: a systematic review. J Clin Epidemiol. 2020;119:109-16.

2. Moseley JB, O’Malley K, Petersen NJ, et al.

A controlled trial of arthroscopic surgery for osteoarthritis of the knee. N Engl J Med. 2002;347(2):81-8.

3. Cousins S, Blencowe NS, Tsang C, et al.

Optimizing the design of invasive placebo interventions in randomized controlled trials.

Br J Surg. 2020;107(9):1114-22.

4. Beard DJ, Campbell MK, Blazeby JM, et al.

Considerations and methods for placebo controls in surgical trials (ASPIRE guidelines).

Lancet. 2020;395(10226):828-38.

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Are surgical placebo controls ethically justifiable?

Charles Weijer A growing number of randomised controlled trials (RCTs) are putting surgical practice on a firm base of evidence. But surgical interventions that aim to improve pain or function pose a difficult challenge for trialists.

I Charles Weijer is Professor of Medicine, Epidemiology & Biostatistics, and Philosophy at Western University in London, Canada. He is a leading expert in the ethics of randomised controlled trials.

n these cases, psychological effects may interfere with our ability to fairly evaluate whether the surgical intervention itself is responsible for patient improvement. The use of a surgical placebo control creates, as Professors Beard and Campbell aptly put it in the previous article, a “level playing field” on which to evaluate these surgical interventions in RCTs. But can surgical placebo controls be justified ethically? When asked whether they were ‘supportive of trial with placebo arm being mounted’ to evaluate arthroscopic lavage of the knee, 50.6% of orthopaedic surgeons responded affirmatively1.

Others, however, expressed reservations about the proposed trial.

“Unethical!” read one comment1. Another surgeon said, “Sounds unethical to put a patient under risk by anaesthetising them… for placebo surgery!”1

Some health providers believe that placebo controls are unethical because they harm the patient. An orthopaedic surgeon said, “It’s not like giving glucose tablets which are non-invasive. It is not withholding treatment, it is invading somebody, it is in fact doing something, which can be potentially harmful which is the contentious and ethical issue for me.”1 An anaesthetist commented: “I would not anaesthetise someone for sham surgery. I just couldn’t!

I just think it’s immoral and unethical.” Both comments reflect the dictum primum non nocere, first do no harm.

“To answer the ethical question, we must consider five issues: the permissibility of harming patients; whether and how informed consent may be obtained; whether equipoise obtains; justifying the risks of the placebo control; and, finally, protections for vulnerable patients.”

To answer the ethical question, we must consider five issues: the permissibility of harming patients; whether and how informed consent may be obtained; whether equipoise obtains; justifying the risks of the placebo control; and, finally, protections for vulnerable patients.

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Harming patients

While a needless incision or anaesthetic in clinical practice would surely be unethical, the research context is different.

All health research involves nontherapeutic procedures—be it a questionnaire or additional blood draw—that expose participants to risks without the prospect of direct benefit.

In unusual cases, the risks undertaken purely for scientific ends may be substantial, as in a human challenge study in which healthy volunteers are intentionally exposed to an infectious agent.

What justifies exposing patients to risks in research for the benefit of others? Research ethics give a three-part answer to the

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question. First, such risks must be voluntarily assumed through informed consent. Second, the benefits and risks of study participation must stand in reasonable relation. Third, additional protections must be in place for vulnerable people. Thus, the use of a surgical placebo control may be justified when all three of these ethical conditions are satisfied.

Informed consent In an animated editorial, Lubowitz and colleagues question whether any patient would agree to participate in an RCT with a surgical placebo control. They say: “Really, what patient in his or her right mind, no matter how well intentioned to participate in research, would consent to sham surgery? We would not consent to the possibility of anaesthesia and sham surgery, nor do we believe our rightminded patients would do so”2.

I agree that patient recruitment is a challenge in surgical RCTs with a placebo control.

Nonetheless, many such trials have been conducted successfully3.

The more salient question is to how best to inform patients about these complex

studies in the consent process. Particular care must be exercised in describing the placebo control. Therapeutic misconception refers to the tendency of prospective participants to misconstrue nontherapeutic interventions as being designed for their benefit. In the context of surgical RCTs, the worry is that patients will wrongly think the placebo control a clinically indicated treatment or diagnostic intervention. As a result, researchers must carefully “avoid language in the consent process that might unwittingly promote any therapeutic misconception.”4 Moseley and colleagues, in their placebocontrolled trial of arthroscopic lavage of the knee, had participants write out and sign the following statement in their chart: “On entering this study, I realise that I may receive only placebo surgery. I further realise that this means that I will not have surgery on my knee joint. This placebo surgery will not benefit my knee arthritis.”5 Other evidence-based techniques to promote comprehension may be used, including clear and simple consent forms, one-on-one discussions with prospective participants, and formally testing comprehension6.

Equipoise Determining whether the benefits and risks of study participation stand in reasonable relation is complicated in surgical RCTs with a placebo control. Two questions must be answered. The first question is whether any placebo control condition is justified?

Answering this question appeals to the ethical concept of equipoise.

Equipoise is the most misunderstood concept in research ethics. Some believe that it refers to individual surgeon uncertainty regarding the preferred treatment for a patient. It does not7. Equipoise in fact refers to uncertainty at the level of the community of expert practitioners as to the preferred treatment.

Determining whether equipoise exists requires a review of the evidence supporting the treatment alternatives in an RCT. The use of (some sort of) a placebo control is consistent with equipoise when there is no effective treatment, the study intervention and placebo are added to standard treatment such that all patients in the trial receive standard treatment, or when there are substantial doubts about the evidence supporting a widely used treatment8. >>

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must provide a compelling argument to the research ethics committee that the scientific question could not be addressed adequately with a lower fidelity placebo.

Moseley and colleagues chose a low fidelity placebo control5.

The first option (no fidelity control) was rejected because it would have provided no information on the efficacy of arthroscopic lavage.

But why was a low fidelity placebo control chosen over a high fidelity placebo? I suspect that the researchers concluded that the rigour of such a control condition was sufficient, if not ideal.

Further, they may have thought the risks of general anaesthesia and non-clinically indicated arthroscopy too great to be justified by the knowledge to be gained.

Vulnerable patients

For instance, at the time of Moseley’s placebo control trial, arthroscopic lavage of the knee was widely used in clinical practice5. About 650,000 procedures were conducted each year in clinical practice. But the evidence base supporting arthroscopic lavage was weak: while half of patients experienced an improvement in pain, the mechanism of action of pain relief was unknown, and lavage did not arrest the progression of osteoarthritis. No RCT had evaluated rigorously arthroscopic lavage. Under these circumstances, equipoise supports the use of a placebo-controlled trial.

The more difficult question in surgical RCTs, however, is: precisely which placebo control is justified?

Risks of the placebo intervention If equipoise supports the use of some sort of placebo control in a surgical RCT, the second benefit-harm question is: Which control condition is justified? In the surgical context, placebo controls vary in their ‘fidelity’ to the surgical intervention under evaluation4.

In other words, placebo controls vary in the attributes they share with the study intervention.

Consider Moseley’s and colleagues RCT5.

When designing the trial, there were several options for the control condition. The first

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option—observation with medical management—has none of the attributes of arthroscopic lavage of the knee. Indeed, as a ‘no fidelity control’ we would hesitate to refer to it as a ‘placebo’ at all. The second option—sedation in the operating room, skin incisions, and water poured on the patient’s leg to simulate lavage—shares some of the attributes of the study intervention.

But it lacks other features of the surgical intervention, including general anaesthesia and penetration of the knee joint with an arthroscope. Accordingly, it is classified as a ‘low fidelity placebo control’. The third option—general anaesthesia and arthroscopy of the knee with no lavage—shares all of the attributes of the study intervention except the critical surgical element: lavage. It is, therefore, a ‘high fidelity placebo control’.

Each of these trial design options answers a different question, and each brings a different level of rigour to the assessment of the causal mechanism of the surgery. As a general rule, risks to participants track the fidelity of the placebo control; the higher the fidelity of the placebo, the greater the risk to participants4. From an ethical standpoint, the risks of study participation must be minimised consistent with sound scientific design4. Further, the importance of the knowledge to be gained must counterbalance risks to participants. Thus, researchers

Finally, surgical RCTs with a placebo control must offer adequate protections for vulnerable patients.

Vulnerable patients are people who are at an increased risk of being wronged in research. Young children and adults who lack decision-making capacity are vulnerable, and additional protections for them include: the study hypothesis must require their inclusion; consent from a surrogate decision maker is required; and the risks of study participation must be no more than minimal risk. Minimal risk refers to the risks of daily life.

A threshold of minimal risk effectively precludes the inclusion of young children and incapable adults in surgical RCTs with a placebo control. In all or most cases, a lowor high-fidelity surgical placebo presents risks to patients that exceed those in their daily lives. Indeed, placebo controlled surgical trials are risky experiments. From a research ethics perspective, it is prudent to restrict their use to patients who can voluntarily assume those risks.

Competing interests CW receives consulting income from Cardialen, Eli Lilly & Company, and Research Triangle Institute International. n

References References can be found online at www.boa.ac.uk/publications/JTO.

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Getting placebo controls of surgery to work (in orthopaedics) – the CSAW experience Naomi Merritt and Marcus Jepson

Naomi Merritt is a Senior Clinical Trials Manager at the Surgical Intervention Trials Unit (SITU), Nuffield Department of Orthopaedics, Rheumatology & Musculoskeletal Sciences (NDORMS), University of Oxford. She managed the delivery of the Can Shoulder Arthroscopy Work?

(CSAW) study, the national shoulder surgery Randomised Controlled Trial (RCT) showcased in this article.

Marcus Jepson is a Senior Lecturer in the QuinteT research group at the University of Bristol. His research focuses on strategies to support clinicians to optimise recruitment to challenging randomised trials. He conducted the QuinteT recruitment intervention (QRI) on the CSAW study featured in this article.

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Many of the readers here will be familiar with the Oxford University led CSAW (Can Shoulder Arthroscopy Work) RCT. For those who are not, or need a refresher, the trial was designed to explore the efficacy of arthroscopic subacromial decompression for patients with subacromial pain, who had previously completed a programme of conservative management1 with a recruitment target of 300 randomised patients.

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his venture into surgical placebo trials was not taken lightly. There was much consideration of not only the ethical aspects and challenges of this type of research as Charles Weijer discusses in his article but also the practical uncertainties associated with such a study: Would the proposal of a surgical placebo RCT be accepted by stakeholders and their communities?

Would there be buy in and willingness to be actively involved?

Would surgeons be willing to enter their patients into the trial?

Would patients accept the uncertainty and consent to receive a treatment allocated through randomisation?

meeting where the proposed study was discussed, with a questionnaire distributed to those attending shoulder clinics, to match the cohort of the proposed RCT, and anecdotally via informal discussions with patients by the lead investigators. In all cases, there was a consensus from these patients that they would, theoretically, be willing to participate in such an RCT.

“The proposed trial design was presented and ‘hot topics’ such as ethical considerations and the placebo intervention were debated. The outcome of this pre-work was positive with consensus across stakeholder groups being in favour of the trial.”

Clinical research is often a long time in the development stage and the ‘work-up’ of CSAW was no exception. Various methods (formal and informal) were used to establish stakeholder views on the proposed trial.

Patient views were sought via a workshop

Alongside informal discussions within the orthopaedic surgical community, meetings were organised with representation from funding bodies, orthopaedic surgeons, physiotherapists, neurologists, ethicists, trial methodologists and statisticians. The proposed trial design was presented and ‘hot topics’ such as ethical considerations and the placebo intervention were debated. The outcome of this pre-work was positive with consensus across stakeholder groups being in favour of the trial. Importantly, debate around the placebo surgery arm of the trial

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found stakeholders unable to justify the use of skin nicks only, leading to a procedure whereby the aspects considered to be the critical surgical element would be omitted (as discussed earlier by DB and MC).

Hence, there was a need to ensure that the comparator was more than ‘just a sham’. The (ambitious) study design ultimately aimed to assess surgery vs no surgery; the need for a specific component of surgery; and a quantification of the placebo effect.

Having gained in-principle buy-in from the main protagonists, the next step in the process was actualising the planned RCT. The three study arms were: the ‘standard’ surgical arm of arthroscopic subacromial decompression (ASAD), to overcome the ethical and practical concerns of avoiding a purely sham procedure, the surgical ‘placebo’ comparator involved an investigative shoulder arthroscopy only (AO), and, thirdly, to compare surgery with a non-surgical intervention, a conservative management arm, initially named ‘active monitoring’. Study sites were identified and set up, typically with one ‘keen’ surgeon fulfilling the role of local collaborator and heading up their local team with support from a research nurse.

Recruitment to RCTs can be challenging at the best of times, and given the very different comparators at play here, those challenges were amplified in CSAW. In the early stages of the study, patient recruitment was slow. In an attempt to mitigate for this, a QuinteT recruitment Intervention (QRI)2 was incorporated into the study. Briefly, the QRI is a two-stage complex intervention, using standard and innovative qualitative research methods to 1) identify and understand recruitment challenges and 2) work with the study team to resolve those challenges. For CSAW this involved interviews with study management and staff involved in recruiting patients, along with audio-recording consultations with patients where the CSAW study was presented to them.

Rapid analysis of these data pointed to some of the common challenges in patient recruitment, previously seen in RCTs in other contexts.

For example, in interviews, whilst local collaborators were often willing to demonstrate their apparent support for the study, they ‘gave away’ that they were not considering (and thus, not approaching) all potentially eligible patients.

They also described their lack of equipoise towards the active monitoring arm, typically describing an expectation that the “surgical options are more likely to be of benefit”.

The audio recorded data of what actually happened in clinic discussions provided even more valuable insights into how the study was presented and discussed with patients. For example, it became apparent that ‘active monitoring’ was not being presented thus, rather as variations on a theme of “carry on with what you’ve been doing”, which proved to be less than appealing for the many patients with several months of physio behind them, typically referred by their GP to ‘go and see a surgeon’ who they expected to tell them that they would have surgery. Perhaps more interestingly given the ‘placebo’ theme of this collection of articles, neither surgeons nor patients experienced difficulty with the presentation, or acceptance of the arthroscopic only arm.

Most recruiters used a turn of phrase that described first arthroscopy only, closely followed by ASAD. For example: “(in the RCT) there are two surgical options: one is done arthroscopically where we just go in and wash it out… the other, as well as putting the camera in, we shave a bit of bone off too”.

We reflect therefore that maybe a consequence of having surgeons ‘on-board’ with the concept of a placebo arm made it more comfortable for them to describe to their patients. >>

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Where recruitment encounters broke down, analysis pointed to previously identified ‘hidden challenges’3 associated with RCT activities. For example, the way the randomisation process was described was off-putting for some: “your treatment will be chosen literally by the flip of a coin”4, apparent (misguided) patient preferences5 were not always explored: “My neighbour had an operation and did well” (despite the neighbour having a different diagnosis).

uncertainty, providing a balanced view (study arms), explaining randomisation, working with patient preferences (exploring and understanding these preferences), informed decision making (non-coercive), and guidance on how to make space for patient views.

“We believe that the success of surgical trials is dependent on the attitudes and commitment to the research question of participating clinicians, and ensuring that they are able to demonstrate that commitment to their (eligible) patients by presenting study information with equipoise”

Having identified recruitment challenges and recruitment successes, we sought to ensure these were shared with all of those engaged in recruiting to CSAW. All staff from recruiting centres were invited to attend a CSAW training day. This was an opportunity for staff involved in the recruitment of patients to share their experiences and the challenges and barriers they faced. Staff were encouraged to practice and develop their recruitment skills. A mix of teaching sessions and workshops covered topics such as, working through a recruitment conversation, conveying

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We provided ongoing support to study sites to help with recruitment, by amending training materials to reflect the emerging data from the QRI. A suite of training/ support materials were created and shared with existing recruiting centres, and follow-up visits were organised at sites where recruitment was slower than expected, and included training based on the qualitative evidence.

It is interesting and worthy of reflection, that the ‘placebo’ element of the CSAW study was not in any way the main hindrance to recruitment of patients. Rather the bigger melting pot of ‘clear obstacles’ to RCT recruitment (such as lack of on-site support for the study, finding time to explain the RCT to patients in busy, oversubscribed clinics, fewer than expected eligible patients coming through the door), combined with some CSAW specific ‘hidden challenges’ (less than appealing presentation of non-

surgical procedures, willingness to accept unexplored patient preferences) were the headline causes of difficulties.

What, then is our message here? We believe that the success of surgical trials is dependent on the attitudes and commitment to the research question of participating clinicians, and ensuring that they are able to demonstrate that commitment to their (eligible) patients by presenting study information with equipoise6.

Orthopaedic surgical trainee Shiraz Sabah gives us a good insight in the surgeon’s psyche in the next article and helps to explain why, in order to get a trial to work, there must be equipoise, interest, and willingness within the surgical community. Our experience on the CSAW study shows that in-depth pre-trial work can help to pre-empt and assess issues which may hinder the integrity of surgical trials. Monitoring recruitment activity and how the study is presented to patients helped us to identify those recruitment difficulties.

Supporting and training recruiters based on strategies to address those challenges helped to keep recruitment on track, and formal and anecdotal feedback indicated that CSAW training interventions led to site staff feeling more confident when presenting the study to potential recruits. Ultimately, the experience of the management group, and participating collaborators on CSAW demonstrates that patients may be willing to accept a ‘placebo’ allocation in a surgical trial7. n

References References can be found online at www.boa.ac.uk/publications/JTO.

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Shiraz Sabah is an orthopaedic registrar on the Stanmore rotation. He is currently the Rosetrees Trust research fellow within the Surgical Interventions Trials Unit (SITU) at the University of Oxford, where he is studying for a DPhil to understand patientrelevant outcomes following revision knee replacement.

Abtin Alvand is a Consultant knee surgeon at the Nuffield Orthopaedic Centre (NOC) and Honorary Senior Clinical Lecturer in Orthopaedic Surgery at the University of Oxford. He has a specialist interest in unicompartmental knee arthroplasty, revision knee arthroplasty, and prosthetic joint infection.

The last word on placebo-controlled surgical trials Shiraz A Sabah and Abtin Alvand

We’ve heard lots already about placebo-controlled trials in surgery, but it is fitting that the last word should go to the surgeon. After all, isn’t this where the buck stops? It is the surgeon who agrees to do an operation with a potentially key ingredient missing, and to follow-up the patient. With this in mind, this article asks you to consider whether you would enrol your patients into a placebo-controlled surgical trial? And, how would you feel about carrying out a placebo operation?

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he place to start is perhaps with an even more fundamental concept in surgical evaluation. Let’s ignore the placebo aspect for now and consider the question: How do you feel about the idea of a trial in surgery more generally? Or, asked in a more confrontational way: How willing are you to put your surgical decision-making to the test? What happens if some of the decisions you’ve been making (potentially for years) are suggested to be arbitrary or, even worse, wrong? As surgeons, we’ve been trained to be decision-makers. We’ve even trained those around us to recognise this as sacrosanct “clinical correlation is advised” remains very welcome in any report of an investigation offered up to us. The decision to operate or not is binary and absolute, though you can choose when and how. If you do decide to operate, the effects of surgery typically are not reversible. It is not a tablet that can be discontinued and the status quo returned. And so, surgical decisionmaking requires confidence. Indeed, some of us spend large parts of our careers developing, cultivating and perfecting this confidence. It’s the art of surgery, isn’t it? We’ve listened to the

surgical mantras: “In my hands, it works.” It is about “putting things back as you found them,” “knowing how to pick winners,” or something else that is difficult to measure: attention to detail; theatre principles; a look in the eye that you give the patient at the end of the day to say the operation could not have gone any better. But is this really the best we can give our patients?

When Christiaan Barnard did the first humanto-human heart transplant, he told his patient, Louis Washkansky, that he had “an 80% chance of success”1. It is difficult to know where this estimate came from, but it seems unlikely that there was much in the way of evidence to support it. We do know that Mr Washkansky died 18 days later. More than fifty years has passed since then, and most would now agree that confidence is best backed up by objective evidence. Indeed, one may find that for many of our current interventions the final beatitude is surgical equipoise. This is a state where we recognise that whilst we could do this operation or that operation (and indeed some do), when we look at the body of evidence, it is not clear which of these options is best for the population >>

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as a whole. However, similar to how “absence of evidence is not evidence for absence”2, remember that this does not necessarily mean that nobody knows which of these options is best, that the measurement of clinical outcome is perfect or that there are not some patients where we do know the best option. The clinical challenge is to marry these viewpoints for individual patients – appraisal of the current evidence, recognition of “confluences of interest”3, and acknowledging the tacit knowledge of experts.

Surgical trials are a tool to help us do this more consistently and fairly and to remove as many sources of bias as we can from the mix.

Sometimes it is a fundamental question that needs to be answered. Is the patient really better off with an operation at all compared to doing nothing? Take knee replacement,

was, in fact, published in 20154 and showed a benefit to total knee replacement versus non-operative treatment. What it did not tell us was why the operation was beneficial.

Which bits of the intervention made the all-important clinical difference? The skin incision? Resurfacing the bones? Balancing the ligaments?

Blessing the joint with a betadine lavage at the end of the case? Or, just doing something that the patient wanted you to do in the first place? It also does not tell us just how important it is to know which bit worked. Why does it matter?

If the operation works, it works, doesn’t it?

Except science is a search for ‘the truth’ and this is where we find ourselves with placebocontrolled surgery: a series of experiments where parts of an operation are deliberately left out to help us to understand the bits that really do matter.

“When Christiaan Barnard did the first human-to-human heart transplant, he told his patient, Louis Washkansky, that he had “an 80% chance of success”. It is difficult to know where this estimate came from, but it seems unlikely that there was much in the way of evidence to support it.” for example, millions have been performed to date, so you would expect a trial to have been undertaken to answer this question, right?

Indeed, it has. But, you would be forgiven for thinking this was ancient history. This trial

So, what kinds of placebo surgery have we seen? It will be no surprise to learn that the majority of trials have investigated arthroscopic procedures5. These procedures generally have low complication profiles and, whilst small incisions can sometimes hide a multitude of sins, the scars left behind are often difficult to see and more easily forgotten.

The theory behind informed consent for placebo-controlled trials is very well discussed

by Charles Weijer. However, the process of explaining to an individual patient that they are not expected to benefit from surgery and yet them wanting an operation anyway is perhaps also familiar. It probably is important what the placebo is in any surgical trial or, if the patient chooses not to enrol, what options are they then presented with? Would their surgeon do the (non-evidenced based) operation anyway? Or, is the trial the only chance of getting surgery? In particular, where diagnostic arthroscopy is used as the placebo-control, it is likely that many patients (and surgeons?) will envisage a benefit to the procedure (to understand more about the condition), no matter how well

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it is explained or sign-posted that no benefit is expected. For all of these reasons, the process of informed consent for placebocontrolled trials is challenging. The careful use of language (including avoiding emotive words like ‘sham’ or ‘fake’) and using tools to help with consent (such as decision aids) has been highlighted by recent guidelines6.

However, for many surgeons, this may be a significant departure from their normal consenting practices. Patients often look to the surgeon for reassurance before their procedure (Am I doing the right thing, doctor?) and it is worth thinking about how you would respond to that question in the setting of a placebo-controlled trial.

Indeed, we all understand that surgery can and does sometimes go wrong and the responsibility of performing a placebo operation on an individual patient is an important cross to bear for the surgeon.

It is worth considering: How would this responsibility weigh on me? You can even think of this on a more practical basis.

What would I tell the patient on the ward before they go home? We are used to telling patients that we worked hard, did our best and left things looking neat and tidy at the end of the case. With placebo-controlled

surgery, you may have intentionally not done that. Whilst the trial is likely to have been designed to prevent unblinding before an agreed timepoint, and patients will probably understand if you choose not to disclose, it may still sit uncomfortably. On the other hand, it is important to reflect that concerns around unnecessary surgery appear to weigh a lot less for operations that are already established, but with limited evidence for their efficacy. This is despite often far greater numbers of patients at-risk. Indeed, we sometimes seem to have things the wrong way round in surgery: when we decide to do a new operation, or to continue with an existing one, we have an understanding that it is effective, or that it makes sense that it should be effective, just because it is biologically plausible. Perhaps instead we should start from the opposite viewpoint: ineffective until proven effective?

Finally, do randomised trials really send a jolt through the system? Surely, that must be one of the key considerations when deciding whether to enrol in any surgical trial, but particularly one with a placebo control? Take knee arthroscopy for osteoarthritis. It was as long ago as 2002 that the first evidence was published

to suggest surgery had limited efficacy over placebo7. Whilst the rates of surgery do now appear to be decreasing8,9, implementation science perhaps still does not work quite as quickly as many would like it to10.

Nevertheless, such trials have galvanised the orthopaedic community to address these important clinical questions more directly resulting in positive outputs such as the development of national and international clinical guidelines11,12. Particularly in the UK, we have seen surgical trialists focus more on pragmatic study designs over the past decade. These are intended to better reflect real-life practices than explanatory trials with very strict inclusion and exclusion criteria.

The net result is that they are harder to bat away. More and better surgical evaluation is needed. This needs to be in conjunction with expert surgeons, who nearly all want the best for their patients. Placebo-controlled trials are likely to play an important part in this; however, we should remain hopeful that the day when these designs are no longer needed is not too far away. n

References References can be found online at www.boa.ac.uk/publications/JTO.

JTO | Volume 09 | Issue 02 | June 2021 | boa.ac.uk | 67

In Memoriam

Andrew Oliver Ransford 25th April 1940 – 24th January 2021 Obituary by Michael Edgar and Peter Baird

A

ndrew Ransford was not only the tallest orthopaedic surgeon of his generation, but achieved an equivalent stature in his distinguished, entrepreneurial career with his sharp mind and convivial manner.

Andrew, known as ‘Andy’, grew up in Zimbabwe. Supported by a Rhodesian Government Scholarship, he studied Medicine at Emmanuel College, Cambridge and then at University College Hospital Medical School, London, qualifying in 1965. At UCH, he was Captain of Rugby and later Club President.

Having passed the English FRCS in 1968, Andrew joined the Royal National Orthopaedic Hospital (RNOH) Training Programme, where he developed his interest in Spinal Surgery, writing the classic study into Halo-Pelvic Traction in 1975. After a Spinal Fellowship at Rancho Los Amigos Hospital, California, he was appointed Consultant Orthopaedic Surgeon at UCLH in 1977.

In 1980 he joined the Scoliosis Unit at Stanmore. Working with Michael Edgar and others, Andrew developed implants which improved surgical fixation. With more rigorous surgical correction, spinal cord monitoring became a necessary safety net. The sensory monitoring procedure, developed with Dr Stephen Jones of Queen Square became accepted world-wide.

In 1981, with neurosurgeon Alan Crockard, Andrew founded the British Cervical Spine Society. The widely used ‘Ransford Loop’ was developed for upper cervical surgical stabilisation. He opined that all spinal surgery should be multidisciplinary, eventually becoming a single specialty. Whilst simultaneously Presidents

John Knowles Stanley

30th March 1944 – 4th February 2021 Obituary by Ian Trail and John Black

J

ohn Knowles Stanley was born in Cardiff on 30th March 1944 but grew up in Oswestry in North Wales. From the Boys’ High School, he moved in 1962 to Liverpool University Medical School, qualifying in 1968. Subsequent to training in the Mersey region and following a travelling Fellowship to the United States in 1979 John was appointed a Consultant Hand Surgeon at Wrightington Hospital.

Under his leadership the unit there grew exponentially, developing a particular focus on the treatment of patients suffering with rheumatoid arthritis as well as other complex problems of the wrist. From 1991,

68 | JTO | Volume 09 | Issue 02 | June 2021 | boa.ac.uk

of the British Scoliosis Society and the Cervical Spine Society in 1995, he helped to form the British Association of Spinal Surgeons (BASS) and Britspine. With Alan Crockard he was instrumental in establishing the Danny Hill Surgical Skills Laboratory at the Royal College of Surgeons.

Health issues led to his early retirement in 1997 though with his spinal experience he remained in demand as a medico-legal expert until 2013. Andy travelled widely professionally and with his wife Penny and family he enjoyed skiing holidays and trips to Southern Africa to visit family. Even in his debilitating last illness, Andrew maintained his jovial outlook and cautious, questioning mind. He justified his reputation as the ‘The thinking man’s Orthopaedic surgeon’. n

he was joined by more consultant colleagues creating a renowned centre of innovation and excellence. At his retirement in 2009 the Wrightington Upper Limb Unit had thirteen Consultants, both orthopaedic and plastic, dealing with all conditions of the upper limb, from shoulder to elbow and hand, with a high national and international reputation.

John Stanley’s research activities, particularly in the introduction of hand and wrist prostheses, produced more than 100 peer reviewed papers in learned journals as well as countless presentations to learned societies. He wrote two books, supplied chapters for 20 more and delivered many eponymous lectures. He travelled widely, not only in the UK and Europe, but worldwide, particularly in America, Australia, France and Switzerland, resulting in a long list of honorary fellowships and memberships. A crowning academic accolade was the award in 1996 of a Chair in Hand Surgery by the University of Manchester, a considerable distinction. Finally in 2016 John was appointed as a ‘Pioneer in Hand Surgery’ by the International Society of Surgery of the Hand.

Not surprisingly, John Stanley was an active member of the British Society of the Hand, presenting at many meetings, serving on Council and becoming President in 1999. In 2006 his professional standing and the affection in which he was held by the wider surgical community led to his election to the Council of the Royal College of Surgeons. His College career culminated in his election as Vice-President from 2010 to 2012, a role in which he served with distinction and good humour.

John met his wife of 54 years Gail when they were both students at Liverpool University. Subsequently he was a proud father to Sian and James and grandfather to three grandchildren, Asa, Levan and Alexandra.

Both Sian and James followed their father into medicine, Sian a GP in Hertfordshire and James a Consultant Orthopaedic Surgeon in York. n

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