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Clinical Database Registries
Without some form of clinical audit, it is difficult to know if healthcare is being delivered efficiently or effectively and even more difficult to demonstrate to others.
The purpose of clinical database registries is to improve the safety and/or quality of healthcare provided to patients by collecting key clinical information from individual healthcare encounters. This enables risk-adjusted outcomes to be used in evidencebased quality improvement. Cabrini leads the development and application of a number of high quality clinical database registries.
Cabrini Monash Colorectal Neoplasia Database
Bowel cancer is a major cause of illness, disability and death worldwide. Complete and accurate data remain the key requirements to describe processes and outcomes of care for all patients with bowel cancer. Registries play a critical role in cancer surveillance allowing us to evaluate survival, new cases and deaths. The primary purpose of this surgical audit is to monitor outcomes and report on quality of care and report this back to the treating clinicians. Clinicians, researchers and others use audit data to answer questions like, “What is the surgical complication rate after treatment for bowel cancer?”, “Should malignant polyps be treated differently depending on their location?” and “What are the predictive factors of a complete pathological response in patients with locally advanced rectal cancer?” Bowel cancer is the third most common type of newly diagnosed cancer in Australia and is the second biggest cancer killer. The Colorectal Database Registry, conceived and entirely funded by the Cabrini Monash Department of Surgery in 2007, implemented in 2010, is now a well-established registry capturing data on patients with either bowel cancer or benign bowel neoplasia surgically treated at Cabrini Health and other Monash affiliated hospitals, including The Alfred, Peninsula Health and Monash Medical Centre, Dandenong. In 2013, the Colorectal Surgical Society of Australia and New Zealand (CSSANZ) developed the Bi-National Colorectal Cancer Audit (BCCA), a minimally scaled duplicate version, with participation from over 97 sites across Australia and New Zealand contributing data from over 38,000 patients. The registry allows surgeons to benchmark their performance amongst their peers, ensuring a commitment to the highest standards of patient care. The role of the database manager is to also inform patients of the leading-edge research we are conducting in collaboration with laboratories at Monash Biomedicine Discovery Institute, Department of Anatomy and Developmental Biology. Patients willing to provide consent allow us to collect valuable clinical samples such as tumour and
normal tissue, enabling us to undertake research projects as follows: 1. Tissue microarray (TMA) TMAs allow multiple sources of tissue to be analysed simultaneously and allow for the rapid identification of prognostic and predictive biomarkers resulting in improved patient management. 2. Organoids Organoids are miniature replicas of both cancer and normal tissue, grown in the laboratory, providing scientists with model systems to assist researchers to quickly identify and optimise targeted anticancer therapies. 3. Human tissue-slice assay A model for studying the development of colorectal cancer as well as providing a novel platform for testing new immunotherapy drugs on thin slices of tumour tissue in culture.
Patient Reported Outcome Measures (PROMS) We are excited to announce a standardised set of colorectal cancer PROMS is currently being incorporated into the registry and will allow direct patient entry of data relating to all aspects of quality of life and functional outcomes following surgical treatment for bowel cancer. What matters most are the outcomes that patients experience and this data will provide a feedback loop between the patient and the clinician to ensure optimised treatment for all patients.
The Australian Rheumatology Association Database (ARAD) collects long-term observational data about the outcomes of Australians with inflammatory arthritis (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and juvenile idiopathic arthritis). Its primary aim is to determine CABRINI MONASH COLORECTAL NEOPLASIA DATABASE 69 yrs THE AVERAGE AGE OF PATIENTS AT DIAGNOSIS the long-term safety and effectiveness of biologic disease modifying antirheumatic drugs (bDMARDs). ARAD is participating in the value-based prescribing of bDMARDs, a coordinated national program, a large ($8.4m) grant funded by the federal Department of Health. This program aims to optimise use of biologics in Australia. A survey of ARAD participants was conducted to evaluate their attitudes with respect to biologic therapy and biosimilars. A separate study evaluating their experience of COVID-19 was also conducted in collaboration with the COVID-19 Global Rheumatology Alliance.
Research Projects: Value-based prescribing of bDMARDS – Rachelle Buchbinder, Catherine Hill, Sam Whittle Patient Experience of COVID-19; Collaboration between ARAD and COVID-19 Global Rheumatology Alliance – Catherine Hill, Rachelle Buchbinder, David Liew, Phillip Robinson Australian rheumatoid arthritis (RA) biologic treatment pathways: Australian Rheumatology Association Database (ARAD) analysis – Ashley Fletcher, Rachelle Buchbinder Socioeconomic Differences in Opioid Use by People with Inflammatory Arthritis – Ashley Fletcher, Catherine Hill, Marissa Lassere, Rachelle Buchbinder Survey on biologic/biosimilar/vaccination – Alannah Quinlaven Dyadic coping survey – Manasi Mittinty Propensity score methods for estimating causal effects in non-experimental settings – Marissa Lassere
ARAD is now listed on the Australian Commission on Safety and Quality in Health Care list of registries. It aims to facilitate collaboration and awareness of registry activity among key stakeholders. ARAD supports three PhD students who completed their PhD in 2019-20 with Dr Rachel Black being awarded the
Barbara Cameron ARA Research Establishment Fellowship
AUSTRALIAN RHEUMATOLOGY ASSOCIATION DATABASE (ARAD) 5.7 yrs
MEAN FOLLOW UP TIME OF EACH PATIENT
(L-R) Dr Simon Wilkins, Karen Oliva and Caroline Xue. Karen Oliva received the prize for best Cancer Poster ‘Influence of primary site on metastatic distribution and survival or early-stage colorectal cancer’.
(Reassessing the Mortality Gap in Rheumatoid Arthritis in Australia). ARAD also supports four Rheumatology Advanced Trainees, one MD student and one Masters student, Dr Oscar Russell, who won the Best Oral Presentation by Clinical Trainee at The Queen Elizabeth Hospital Research Expo 2019. ARAD is also currently collaborating with the Australian Arthritis and Autoimmune Biobank Collaborative (A3BC), a large network of clinicians, researchers and scientists from across Australia who are working together to develop a national, data-linked, open-access biobanking network to integrate with the established ARAD questionnaire and data linkage framework. They have established a national, openaccess, best-practice biobank network to collect, process and store a broad range of biospecimens (blood, tissue, saliva, stool etc) from participants with rheumatic diseases and controls (including at-risk relatives). Biological data will be integrated with multiple datasets, including self-reported outcome/experience and environmental data, electronic medical records, commonwealth data (Medicare Benefits Scheme, Pharmaceutical Benefits Scheme, Australian Immunisation Register) and cancer/death registries. BRIGHTWAYS: A CABRINI BREAST CANCER SERVICE DATABASE 99.7% OF PATIENTS WITH A FIRST DIAGNOSIS OF
EARLY INVASIVE BREAST CANCER WERE REFERRED FOR DISCUSSION AT A BREAST MDT MEETING
Breast cancer is the most common cancer among Australian women and is the second leading cause of cancer related death in Australian women, after lung cancer. One in eight Australian women will be diagnosed with breast cancer in their lifetime. The rate of mortality is decreasing due to earlier detection by screening mammography and advances in treatment. Using the Brightways Breast Cancer Database, we aim to monitor and improve the quality of breast cancer treatment and outcomes at Cabrini. The information is used to: • Compare variations in care and outcomes with clinical quality indicators • Provide feedback to participating clinicians • Promote compliance with breast cancer guidelines • Reduce unfavourable variation • Support epidemiological studies and translational research
The registry was established in November 2016 and data has been collected for 1550 patients receiving treatment at Cabrini. This database supports management of multidisciplinary team (MDT) meetings, decision-making, cancer staging and patient treatment recommendations in line with Victorian Cancer Service performance indicators. Clinicians receive patient clinical and treatment summaries prior to the weekly MDT meetings. The recommended care plan and staging are recorded at the meeting and the care team receives a record of their patient’s care plan. Data for 2970 patients referred to the breast MDT meetings at Cabrini has been captured. An audit has been conducted to compare hospital admissions data with our database to ensure all patients, treatment and outcomes are captured. In 2019, 99.7% of patients with a first diagnosis of early invasive breast cancer were referred for discussion at
the breast MDT meeting.
CABRINI SITE COLLECTION: PROSTATE CANCER OUTCOMES REGISTRY – VICTORIA (PCOR-VIC) 54%
CURRENT ESTIMATED POPULATION COVERAGE, WITH THE AIM OF ACHIEVING 90%
The database is a powerful tool for translational bioinformatics. Unlike other cancer databases, this database has been specifically designed to capture complexity and variation in tumour heterogeneity and hormone-receptor expression for core biopsies, primary and metastatic tumours. The database also collects vital outcomes information including treatment modification, response to therapy, toxicity, disease progression, recurrence and cancer status at death. The information in our database will be integrated with research findings to identify new biomarkers for prognosis, improve our understanding of tumour behaviour and heterogeneity, rapidly evaluate the effectiveness of anti-cancer agents for specific tumour molecular subtypes and identify molecular subtypes and variation in hormone receptor expression, which may lead to a poorer response or drug resistance.
Research Projects 1.
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7. State wide quality audit of MDMs. I Solo, Peter MacCallum, I Campbell, May 2019 Impact of multidisciplinary team meetings on the management of patients with breast cancer at Cabrini Hospitals in Melbourne. J Lai, Y Antill, G Richardson, M Vereker, S David, July 2019 Return to usual activities after breast cancer treatment. Monash University, S-Y Kim, D Kissane, S Birks, P Gregory, J Morgan, C Ooi, J Senior, I Bobevski, N Michael, M Vereker, G Richardson, Y Antill, L Lipton, December 2019 Whole genome sequencing project. T Jarde, Department of Anatomy and Developmental Biology, Monash Biomedicine Discovery Institute, May 2020 ASCO quality oncology initiative program. J A Chow, G Richardson, February 2020 A multi-centre national study of COVID-19 infection in cancer patients. C Lim, National Centre for Infection in Cancer, Department of Infectious Diseases, Peter MacCallum, May 2020 Development and Implementation of a Gynaecological Cancer Database, July 2020
The Prostate Cancer Outcomes Registry – Australia and New Zealand (PCOR-ANZ) database is building a populationbased prostate cancer clinical registry to improve the quality of care provided to men diagnosed with prostate cancer. According to the World Health Organisation, Australia and New Zealand have one of the highest rates of prostate cancer. Fortunately, the improvement in screening and treatment is contributing to better survival rates. An important part of helping more men survive is enabling best-practice treatment and improvements in quality of life. PCOR-ANZ aims to build understanding of the disease burden of prostate cancer, and aid the implementation of evidence-based support services. The registry collects treatment data as well as surveying patients’ quality of life before and after treatment. By reporting on these factors, the goal is to reduce the negative effects of urinary, bowel and sexual function and increase general physical health and mental wellbeing. The quality indicator reports to clinicians provide a cross-sectional view of clinical and demographic aspects of prostate cancer and patterns of care, which helps understand the uptake of evidence-based practice. By contribution to a robust dataset, patient data across many institutions assists in the design of clinical trials and identification of questions for study. Overall, clinicians and institutions can be provided with mortality and morbidity data associated with various risk and treatment groups, both for their own patients and the wider cohort of men with prostate cancer. PCOR-ANZ seeks to deliver data that is fully representative of prostate cancer practice and outcomes across Australia and New Zealand in the near future.
Highlights Quality Indicator (QI) reports for Cabrini were completed, helping provide clinicians with treatment outcomes to better inform practices. The first bi-national QI report from PCOR-ANZ was delivered in 2019. For the first time, more men who have been diagnosed with prostate cancer across the ANZ region have joined PCOR-ANZ than those who have not.
Melissa Vereker
DATA MANAGER AND MDT MEETING COORDINATOR
Melissa Vereker is the Data Manager for the Cabrini Monash Department of Medical Oncology and MDT Meeting Coordinator for Cabrini Breast Cancer Care. Since joining Cabrini in 2016, she has developed the Breast Cancer Database and the Breast MDT Meeting Database. Melissa has extensive experience in IT, clinical data management and cancer research. She has previously worked as a national IT Desktop Training Manager at Optus, Data Manager for the Department of General Surgery at The Alfred, Thyroid Cancer Registry Coordinator for the Monash Endocrine Surgery Unit and Research Associate at the Hudson Institute of Medical Research.
Melissa believes monitoring and measuring safety and patient care is an essential part of healthcare delivery. At Cabrini Breast Cancer Care, routine data collection is integrated with clinical practice to support the management of multidisciplinary team meetings, document patient treatment summaries and care plans, quality activities and research. Data is captured throughout the patient’s journey, from diagnosis to follow-up care. The data is used to measure quality of cancer care, compliance with best practice guidelines, identify areas for service improvement and ensure patients receive safe and effective treatment. The data will help improve the management, treatment and outcomes of future breast cancer patients, identify patients who may benefit from new treatments or clinical trials and evaluate long term effects and outcomes for treatment that was provided many years ago. Melissa is an Adjunct Associate at Monash University and a member of the MPCCC Advisory Group. She has presented at Cabrini Research Meetings, Cabrini Breast Cancer Care Governance Meetings, the Cabrini Oncology Craft Group Meeting and the Department of Biochemistry at Monash University.
Melissa has been an investigator for clinical and translational research projects including the ASCO quality oncology initiative program, impact of multidisciplinary team meetings on the management of patients with breast cancer at Cabrini hospital, return to usual activities after breast cancer treatment, state wide quality audit of multidisciplinary team meetings, patient self-reported outcomes of toxicity during chemotherapy and modelling human breast cancer disease using an experimental in vitro organoid culture system.
Melissa’s current interests are using health information technology to improve processes and outcomes in cancer care and breast/ gynaecological clinical research. Melissa is developing a web-based gynaecological cancer database. Prospective data will be collected for patients receiving treatment at Cabrini for ovarian, cervical, uterus, vulva, vagina and other gynaecological cancers. Information collected will include patient demographics, diagnosis, tumour characteristics, stage, treatment and outcomes. Melissa will also be involved in the establishment of the Department of Medical Informatics at the Cabrini Cancer Institute.
