Quality Markers in Cardiology. INCARDIO (Indicadores de Calidad en Unidades Asistenciales del Area d

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Quality Markers in Cardiology. INCARDIO (Indicadores de Calidad en Unidades Asistenciales

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del Area de Cardiología)

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Indicadores de Calidad en Unidades Asistenciales del Area de Cardiología (INCARDIO)

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Spanish Society of Cardiology, developed in collaboration with the Sociedad Española de Cirugía

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Torácica -Cardiovascular (SECTCV)

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Task force members: Jose Lopez-Sendon (Chairman), José Ramón Gonzalez Juanatey (Co-

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Ramón López Mínguez, Alicia Maceira, Domingo Pascual-Figal, Alessandro Sionis, José Luis

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(SECTCV): José J Cuenca Castillo and Jose Luis Pomar Moya-Prats

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Chairman), Spanish Society of Cardiology: Regina Dalmau, Esteban González Torrecilla, José

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Zamorano; representatives from the Sociedad Española de Cirugía Torácica -Cardiovascular

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Authors Institutions:

Reviewers: American Heart Association European Society of Cardiology Spanish Ministry of Health Related Societies in Spain, including Cardiac Surgery Society, related working groups of the Spanish Society of Cardiology Other

Address for correspondence: Jose Lopez-Sendón Cardiology Department Hospital Universitario La Paz Paseo de la Castellana 261 Madrid 28036 Phone: +34 639148765 e-mail jlopez-sendon@gmail.com

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Table of Contents

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1.2 Need for quality standards

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2.1. Objectives

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3. Method

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3.2 Main components for quality metrics recommendations

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3.4 Funding and relationship with the industry

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4.1 Grading of quality markers. Levels / Class? (Strenght ?) of recommendation and evidence

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4.3 Clusters to assess overall quality in clinical practice

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5.1. Mortality

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5.3 Stroke

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6.1. Selection of populations

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7. Reporting

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7.2 Reporting format

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8.1 Clinical cardiology and hospital related markers

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8.3 Acute cardiac care measures related to better results in clinical practice

1. Preamble

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1.1 Background

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2. Scope of the document

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2.2 Implementation and further development

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3.1 Task force

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3.3 Document preparation, review and approval method.

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4. Components considered for defining quality metrics

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4.2 Type of hospital

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5. Main markers to measure quality of results (Outcomes) in clinical practice

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5.2 Length of hospitalization and re-admission

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6. Adjustment of outcome metrics

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6.2 Risk adjustment

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7.1 Media

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8. Quality markers related with better results in clinical practice (performance metrics)

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8.2. Cardiac imaging measures related to better results in clinical practice

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8.4 Interventional cardiology measures related to better results in clinical practice October 2014

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8.5 Electrophysiology and complex arrhythmias measures related to better results in clinical practice

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8.7 Cardiac rehabilitation measures related with better results in clinical practice

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9. Current limitations

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11. Concluding remarks

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13. References

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14.1 Appendix Table 1. Population selection and corrections recommended comparing outcomes between different

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14.3. Appendix Table 3. Risk adjustment variables. Institute for Clinical Evaluation Science

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8.6 Heart failure measures related to better results in clinical practice

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8.8 Cardiac surgery measures related with better results in clinical practice

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10. Future challenges

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12. Abbreviations / Glossary

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14. Appendix / Supplementary material

hospitals

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14.2. Appendix Table 2. ICD-9-MC codes

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14.4. Appendix Table 4. Quality measures related with better results in clinical practice. General, hospital related; Clinical cardiology

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1. Preamble

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Physician / patient relationship is still the core of medical practice but the extraordinary advance in medicine

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treatment procedures and strategies associated with improvement of quality of life and clinical outcomes. Guidelines are

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strategies for specific diseases and medical conditions, and following guidelines have proved to improve outcomes (1-10).

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I, level of evidence A) (11-15). Most important, the complexity of the individual patient and the organization of medicine

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followed in a significant number of cases, with important individual, institutional and country differences in clinical

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accreditation and re-accreditation, availability to technologies, innovation and resources in general (including costs) make

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In this complex field, evaluation of quality is of paramount importance, and significant individual and collective

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including the definition and identification of metrics in selected populations (41-61), public reporting (62-74) and systems

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(85))

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1.1 Background

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progressively led to the development of medical specialties and evidence based medicine, that tries to identify diagnostic,

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authoritative documents that recommend, with different strength and levels of evidence, the best possible treatment

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Yet, only a fraction of the recommendations in cardiology guidelines are fully evidence based (Class of recommendation

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itself make clinical practice ever more challenging and clear recommendations associated with better outcomes are nor

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practice (8, 16-40). Organization, teamwork, standard procedures, diagnostic and treatment algorithms, staff qualification,

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the process of care delivery and certainly the evaluation of quality in medicine more challenging than ever.

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(scientific societies, health care authorities) efforts have been made in the last 30 years, in particular in cardiology,

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to enhance the adherence to recommendations (e.g.: accreditation and pay for performance reports) (75-93, 93b) (Fig. 1;

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Figure 1. Quality improvement programs in cardiovascular care. Green: quality measurement programs; red: public reporting; purple: pay for performance programs (85).

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In general, in cardiology, the process of quality measurement, benchmarking, quality report enhancement and auditing is

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European countries (88, 94-100), with an outstanding example of organization in the Society for Cardiothoracic Surgery

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developed different reports on quality metric standards for cardiology, including a significant number of metrics (56-61).

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1.2 Need for quality standards

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programs to adjudicate fellowship, food quality, voting systems for best hospitals organized by official or non-official

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of how quality is measured most of the times and often, these are perception opinions biased in someway. Multiple

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or registries that seldom provide reliable information to measure quality. Moreover, some of the quality standards and

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104) There is a lack of universal standards, participation is often voluntary, data offered for benchmarking may be biased

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select the one that fit best. However, quality can be measured both in the process of organization and delivery of care and,

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associated with progressive improvement in performance and outcomes (94, xx).

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2. Scope of the document

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Defining the quality standards and the best markers to measure overall performance results is a responsibility of the

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metrics to assess the overall quality of results in clinical practice in the specialty of Cardiology. The recommendations in

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practice in cardiology by describing a range of quality markers that help to understand the results of clinical practice and

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This document focuses on cardiology quality measures for inpatient care. The quality of outpatient care will be

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The main objectives were the following:

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more advance in the US than in Europe, although the process is centrally organized and highly advanced in some

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in Great Britain & Ireland (94). In Spain, the National Ministry of Health and some of the Autonomic Communities have

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Quality is often based on perception. Hospital volumes, latest technology, waiting lists, selection of hospitals in matching

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organizations, non-medical publications and sometimes obscure announcements in internet and public press, are examples

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organizations, official and private, developed standards for quality and benchmarking in a voluntary basis, using opinions

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programs to improve outcomes presented controversial results that may add confusion rather that usefulness (85, 101-

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or may lack of quality controls. Too many parameters may be included in a list without priorities were each hospital can

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most important in the final results of clinical practice: clinical outcomes. Furthermore, benchmarking itself may be

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2.1 Objectives

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Scientific Societies. The Spanish Society of Cardiology prepared this document to help defining quality markers and

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this document are aimed to assist clinicians, health care authorities and general pubic to evaluate the results of clinical

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provide benchmarking to hospitals of similar characteristics.

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considered in other documents.

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1.

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2.

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end-point in a clinical trial, reliable clinical outcomes is self evident and probably the best choice)

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Select the best simple measures (metrics?) of outcomes, the final quality of cardiology practice (like a primary

Identify the measures (metrics?) of cardiology practice (performance measures) that are known to positively influence desirable outcomes (like surrogates in clinical trials)

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2.2 Implementation and further development

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societies and health care authorities should implement the best possible program to measure quality, ascertain the

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action are highly recommended:

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The intention of this document is limited to identify and recommend the use of quality metrics. Beyond that, scientific

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reliability of the data through audits and to make it public using the metrics defined in this document. Three steps of

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Obtain a minimal set of data from all hospitals using obligatory audits or registries. In Spain a National Health Care

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System obligatory database includes information form all hospital discharge reports (CMBD) (96) using de ICD-9

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the RECALCAR (REsultados de CALidad en CARdiologĂ­a) (39) program.

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codes (104b). The Spanish Society of Cardiology is planning to measure outcomes using the CBMD registry within

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2.

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3.

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3. Method

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dedicated task force to identify and define quality markers in cardiology. Experts were identified and invited to cover

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electrophysiology and arrhythmias, heart failure, cardiac rehabilitation and cardiac surgery. The aim was to write a

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in the specialty of Cardiology. All ESC (98) and AHA/ACC (99) guidelines were reviewed and recommendations related

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quality metrics, performance metrics and quality programs was performed.

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3.2 Main components to consider for quality metrics recommendations

Benchmarking of hospital outcomes and public, controlled, access to data (the latter a responsibility and decision of the Health Care Authorities).

Certification / accreditation of hospitals according to results (Responsibility of Health Care authorities)

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3.1 INCARDIO (Indicadores de Calidad en CardiologĂ­a) Task force. The Spanish Society of Cardiology organized a

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eight areas of expertise: clinical cardiology, cardiac imaging, acute cardiac care, interventional cardiology,

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consensus document recommending quality markers and metrics to assess the overall quality of results in clinical practice

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with quality standards were included in the document. Beyond the guidelines, an informal review of the literature for

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The following issues related to quality metrics and evaluation were identified and defined: 1.

Levels / Class? (Strength?) of recommendation and evidence

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2.

Type of Hospital

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3.

Clusters to assess overall quality in clinical practice

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4.

Main markers to assess quality of results (Outcomes) in clinical practice

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5.

Performance measurements related with better results in clinical practice.

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Cost and cost effectiveness becomes an important component of quality performance (53), but this was not considered in

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this document. Future documents on quality will consider this issue

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3.3 Document preparation, review and approval method

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cardiology societies, related health care societies and health care authorities and formally reviewed by the European

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consideration and the final document (will be) approved by the ESC and AHA.

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meeting was held 18 December 2013. A 1st draft with initial tables was circulated in December 2013. A 2nd draft was

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A 3rd draft was sent to ESC and AHA (15 August 2014)

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As soon as the comments / recommendations are received, a 5th draft will be prepared for approval by ESC, AHA / ACC

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The final document will be send to related scientific societies in Spain and the Spanish Ministry of Health before

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The original document was prepared by the Task Force and then exposed to the comments and suggestions of different

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Society of Cardiology (ESC) and by the American Heart Association (AHA). All comments (will be) taken into

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The task force was constituted in September 2013; the 1st Task force meeting was in 26th October 2014, a 2nd Task force

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ready in June 2014 and discussed during a 3rd Task force meeting in June 25

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This is the 4rd draft intended to be formally submitted to the ESC and AHA for review (September 13, 2014)

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(October 2014?)

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publication (simultaneous edition in Spanish and English) in the Revista EpaĂąola de CardiologĂ­a.

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3.4 Funding and relationship with the industry

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All members of the Task Force were volunteers with no fees or payment for the service. No funding from the industry

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interest (to be included at the end of the document).

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The cost of organizing the task force, meetings and secretarial assistance was cover by the Spanish Society of Cardiology.

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was received to prepare this document. Members of the task force were required to disclose all possible conflicts of

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4. Components considered for defining quality metrics

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For grading possible quality markers the following aspects were considered (Table 1): a/ clinical and practical relevance,

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the literature. Four levels (or Class?) were established. Level 1 includes metrics with the most relevance (major

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audits and self evident or recommended as Class I Level of evidence A in ESC, AHA guidelines (98, 99). Class 4

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difficult or impossible to audit or if mentioned in guidelines was considered as level of evidence C. Levels 2 and 3 are

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4.1. Grading of quality markers. Levels / Class? (Strength?) of recommendation and evidence.

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b/ source and difficulty to obtain the information, c/ difficulty to audit and ascertain the information and d/ evidence in

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outcomes), reliable, possible to obtain in the majority of the hospitals without the need for extra registries, available for

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includes opinions, use of data that needs a dedicated database difficult or impossible to obtain in the majority of hospitals,

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defined in table 1.

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Table 1. Grading of quality markers / metrics

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4.2. Type of hospital

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techniques and technologies (interventional cardiology units, specialized cardiac care, surgery etc.) in single hospitals that

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certain hospitals making impossible to compare the results without establishing a ranking of hospitals with similar

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Intermediate and High complexity according to the size of the hospital (number of beds), number of cardiology

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Hospitals differ in size, organization, volumes, technology and the complexity of cardiology requires grouping of

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complement the cardiology activity of smaller hospitals. High risk and highly complex patients may be transferred to

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resources and patients (39). For quality benchmarking the task force established 3 types of hospitals defined as Low,

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admissions, organization (dedicated cardiology unit), resources (intensive cardiac care unit, electrophysiology and

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Accordingly, a high complexity hospital admits at least 1000 patients (per year) in a dedicated cardiac unit and is able to

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reference centers, such as heart transplant, complex adult congenital heart diseases, complex pulmonary hypertension,

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administration, long-term hospitalization, health care associations, hospital clusters etc.)

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arrhythmia unit, interventional cardiac unit and cardiac surgery and need to transfer patients to other hospitals (Table 2).

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treat all cardiology conditions, with the exception of some pathologies that usually should be grouped in national level

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etc.). This categorization is arbitrary and may need some refinement in the future (e.g.: university, public, private

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Table 2. Type of hospital (reference: Modified form RECALCAR (39))

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Assessing out-of-hospital practice is not considered reliable (at least in Spain) at this moment and is not the objective of

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4.3. Clusters to assess overall quality in clinical practice

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technology, staffing of the hospital and cardiac unit, organization, certification and accreditation, reputation and patient

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all should be taken in consideration in every hospital. These parameters are detailed in the sections dedicated to the

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electrophysiology, interventional cardiology laboratories and cardiac surgery. Others reflect performance in clinical

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this document.

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Quality of care parameters may be grouped in clusters (Table 3), including institution characteristics, available

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opinion (57, xxx ). All of them may influence outcomes, most are clearly identified in guidelines for clinical practice and

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different cardiology units. Some indicate the minimal requirements for accreditation of specific cardiology units such as

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practice and others are directly related with outcomes measurements. Benchmarking for some of these parameters may be

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and even more difficult to audit for accuracy. Nevertheless, health care authorities should consider the specific

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Individual hospitals may monitor selected parameters as quality controls and reference to identify weakness and

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Of special interest are the organization of safety programs (e.g.: staff and patient radiation, bleeding, infections, medical

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Teamwork is always recommended and is mandatory between hospitals that transfer patients in a routine basis.

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difficult, and obtaining the appropriate information may require a dedicated database difficult to standardize or complete,

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requirements for special units and may use some of them for benchmarking and, most important, for accreditation.

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opportunities for improvement.

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errors) and other local programs to improve quality.

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Table 3. Quality of Care Clusters Cluster Institution

Technology

Staffing Organization

Certifications / accreditations

Medical activity Delivery of Care

Other

Outcomes

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Metrics Type of hospital (I, II, III) University Teaching (students, residents, nurses, physicians) Volumes Accreditations Technology Central Units Research Budget Basic technology. (ECG, ECG monitoring, Holter, Echo, stress tests) Complex technology, may be shared with other hospital areas (CMR, CCT, nuclear medicine) Certified specialists, physicians, nurses Volumes Cardiac unit Subspecialty Units (Imaging Lab, Cath lab, electrophysiology unit Surgery Unique programs (e.g. heart transplant program, adult congenital heart diseases unit, complex pulmonary hypertension unit) Multidisciplinary teams Staff Units & labs Techniques Patient volumes 24 / 7 / 365 medical care Waiting lists Local protocols, Clinical pathways Local protocols for derivation to other hospital Heart Team Safety programs (e.g.: staff and patient radiation, bleeding, medical errors) Local programs to improve quality Continuous medical education programs Research 360ยบ evaluation of staff, skills, attitude, professionalism Patient opinion Reputation. Other institutions opinions Mortality Morbidity Nยบ of days in hospital Readmissions Iatrogenia

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5. Main markers to measure quality of results (Outcomes) in clinical practice (Table 4)

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of all other possible parameters related with quality of care and should be clearly selected for benchmarking and offered

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for guideline recommendations (xx): a/ mortality, b/ hospitalization related and c/ stroke. All are included in the

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Spain) (96) and may be audited. Myocardial infarction in-house and after hospital discharge is not included in this

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during the first few days after hospital admission for acute coronary syndromes (105-107).

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performance measures (xx) and is included in different programs to evaluate quality of care (xx). It may be classified as

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recommended metric by this Task Force, as different modalities of mortality need adjudication for uniformity and that

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5.2 Length of Hospitalization and re-admission is the second set of quality metrics recommended by this Task Force. It

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reflects quality of care, impacts health care cost, is commonly used in quality programs (xx) and is also included in the

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different countries where hospitalization may be driven not only by medical but also social reasons. In addition, the

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adjudicate. Ideally, hospitalization should be measured in a predetermined period of time (e.g.: 1 or three months) but

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hospitalizations during the first month after admission is preferred and recommended. The Task Force also recommends

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index hospital and any other hospital for the same patient. (This may be different in some countries where transfer to

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5.3 Stroke during the index hospitalization has been selected for its relevance, relationship with iatrogenia and

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In addition, for some cardiac units, safety parameters are also recommended in the corresponding sections.

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Outcomes are the ultimate parameters for measuring quality of care in cardiology. Outcomes are the result and interaction

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to the public. Three were selected reflecting the principal outcomes in major cardiology trials and the strongest reference

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Minimal Basic Hospital Data Set) CMBD (Conjunto MĂ­nimo BĂĄsico de Datos at hospital discharge, required by low in

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selected set of metric outcomes due to the difficulties to standardize the diagnosis in large populations, in particular

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5.1 Mortality. The relevance of mortality is self-evident, in some clinical settings is related with guideline adherence and

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overall mortality, cardiovascular mortality or other types. All cause mortality during the index hospitalization is the

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will not be possible except in dedicated registries.

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depends on the reason for admission, required treatments an adherence to guidelines, complications and comorbidities;

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CMBD. On the other hand, hospitalization may not be reliable as an outcome metric to compare results of practice in

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reason for rehospitalisation may be dependent of other conditions or comorbidities, always difficult to properly

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reliable measurements will be difficult. Hence, the number of days in hospital from admission to discharge and re-

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any cause re-hospitalizations at 1 month after discharge for simplicity. Length of stay and readmission should include the

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hospices may be excluded????).

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antithrombotic therapy use. It is included in the CMBD. Stroke is a metric included in some quality programs (xx)

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Table 4. Principal markers to assess overall quality of results in clinical practice

6. Adjustment of outcomes metrics

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The probability of a patient dying is considered to be a combination of his or her individual risk factors (case history) and

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outcomes metrics reliable to compare the results of clinical practice. Overall mortality may be biased by the prevalent

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may be confusing. Accordingly, corrections should be provided. Two strategies are recommended: selection of uniform

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Cardiovascular mortality is difficult to adjudicate; accordingly total mortality in selected populations is recommended.

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Comparisons should be made only between similar hospitals and the proposed metrics should be used only in highly

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treatment (GRDs) (39, 57, 112-114, xx). GRDs group relatively homogeneous diagnosis and procedures but usually split

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patients that may only be admitted by some very selected hospitals (such as out of hospital cardiac arrest unconscious at

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cardiac surgery) should be excluded from analysis rather that corrected for risk (xx), The problem is than some times the

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even worse, some of these very high risk subset of patients (xx,xx) hare simply not included in the ICD-9 codes (e.g.

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very selected hospitals with a special program (e.g.: hypothermia) . Exclusion of these GRDs could provide more uniform

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populations for benchmarking.

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the quality of the care provided (hospital-specific functionality). (109-111). Some corrections are needed to make

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diagnosis at admission, transfer of selected higher risk cases from other hospitals, hospitals or admission strategies, and

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populations and the use of risk scores.

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6.1. Selection of populations

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prevalent, well defined, high risk specific populations with prognosis known to be highly dependent on overall cardiology

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into too many groups, some times arbitrarily. It is recommended that extreme high risk an low prevalence groups or

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admission, cardiogenic shock at admission, endocarditis at admission, trauma and patients with complications of non-

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diagnosis at admission is imprecise (e.g.: cardiogenic shock) or only evident after hospitalization (e.g.: endocarditis) or

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prehospital cardiac arrest admitted unconscious to the hospital) and by efficiency organization programs are derived to

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and reliable groups for benchmarking. Table 1 in Appendix, supplementary material, indicates the selection of uniform

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Only selected, well defined GRDs, representing challenging, complex procedures should be used (39, 57, 112-114, xx)

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failure, catheter ablation (xx), and pacemaker / CDI, CRT device implantation (xx). With regard to surgery selected

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surgery (xx). Table 2 in the appendix, supplementary material illustrates de ICD codes for clustering.

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STEMI, non-ST elevation ACS, staged PCI, TAVI, catheter ablation, pacemaker, ICD and CRT implant, heart failure,

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combined valvular and CABG surgery). In all, all cause mortality during hospitalization, hospital length of stay and

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recommended reference values. The reference values for each GRD are indicated in Table 2 in the appendix,

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These include STEMI, heart failure, out of hospital cardiac arrest admitted unconscious to the hospital, TAVI, heart

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populations include, 1st time, staged, isolated CABG, aortic and mitral valve replacement, combined CABG and valvular

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Table 5 shows the recommended GRDs to assess overall quality of results in clinical practice (115 - 130). These include

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staged 1st aortic and mitral valve replacement, staged 1st CABG surgery, staged 1st mitral valve repair and staged

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readmissions 1 month after discharge and stroke during hospitalization should be measured. Table 5 also shows the

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supplementary material.

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Table 5. Grading of quality markers/metrics. Recommended GRDs to assess overall quality of results in clinical practice.

a: Observed mortality, (mean value) b: Expected mortality corrected for the Logistic Euroscore for this population

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6.2. Risk adjustment Some corrections are needed for risk adjustment. Table 6 summarizes the advantages and inconveniences of the most

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and validated risk scores will provide further refinement and make the metrics more reliable for benchmarking.

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some are to complex and difficult to ascertain for large populations as some important parameters (e.g.: biological

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for heart failure (137 - 139). In these circumstances, the use of other adjustment models such as the model published

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described in table 3 in the appendix, (supplementary material) in 1999, using SPSS 15.0 may be used. In addition to

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143) take into consideration a specific effect at the ‘‘hospital’’ level. One problem is that the ICES adjustment model

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reliability of this correction in different conditions (general, acute coronary syndromes, stable coronary artery disease,

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recommended in guidelines for clinical practice should be used. These include the GRACE or TIMI risk scores for

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others. (Add comment on predicted mortality).

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ratio of the predicted mortality (which considers, on an individual basis, the functionality of the hospital in which the

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of all the hospitals), multiplied by the crude mortality rate (110, 142), but these metrics may be more difficult to

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Universal standardization for risk correction should be a priority of Scientific Societies committed to improve

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common strategies for risk adjustment. At least, corrections should be made for age and gender. The use of specific

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Whenever possible, the use of simple risk scores validated in clinical practice are highly recommended (131 - 136) but

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markers) may not be routinely used in some hospitals and will not be available in many patients. This may be the case

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by the Institute for Clinical Evaluative Sciences (ICES) of Ontario, Canada (140), considering the risk factors

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the patients’ demographic and clinical variables, hierarchical models of risk adjustment (multilevel models) (140 –

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is not universally used, making difficult to benchmark statistics from different countries/systems. Furthermore, the

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bleeding, heart failure, surgical and other invasive procedures. Hence, whenever possible, more specific risk scores,

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acute coronary syndromes (131,132), Euro2 risk score (133), SINTAX (134), CRUSSADE (xx), Hassled, (134) and

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More complex adjustments permit the calculation of other indexes such as the risk-standardized mortality ratio (the

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patient is being treated) to the expected mortality (which considers a standard functionality according to the average

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understand and the lack of universal standardization makes benchmarking unreliable

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the benchmarking reliability in quality of care

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Table 6. Risk adjustment corrections commonly use for benchmarking of outcomes Type of correction

Pros

Cons

None

• Real figures • Good to compare global results in very large populations, specially when no selection bias is expected (e.g.: benchmarking between countries or in same country through different periods of time)

• Different risk profiles impact the results, specially in not very large populations or biased population

• Classic when comparing global results in large populations when no population selection bias is expected

• Incomplete refinement of population risk

Age and gender

• Hospitals admitting the worst cases have the worst results

• May be unreliable in relatively small populations

• Generally accepted; used in many statistic reports of large populations Hospital clusters

General risk correction

Disease specific risk scores (e.g.: Euro score II, GRACE, TIMI, SYNTAX, Hassled, Stroke,

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• Corrects for bias of patient admission in different types of hospitals

• Insufficient for risk correction • Hospitals admitting the worst cases have the worst results

• Some scores validated (e.g.: ICES (140)) and in use in quality benchmarking

• Not compare and validated against disease specific risk scores

• More accurate than general risk scores

• Best for specific registries; probably the best if universally accepted for risk correction in benchmarking

• Validated for specific populations

• No universal risk score for all clinical settings with different risk factors for outcomes

• Recommended in guidelines for risk stratification and treatment strategies in clinical practice

• No universally accepted / used for quality benchmarking

Risk standardized mortality ratios

• Difficult to understand by nonprofessional observers

• Not universally used

Risk score calculated in study populations used for benchmarking

• Probably the best correction for benchmarking in a single study (e.g.: specific registry)

• Impossible to apply universally

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• Some risk scores include data not available in large populations (e.g.: Heart failure) • Predicted mortality may be inaccurately calculated • Unreliable to compare very different populations (different registries, databases, countries)

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7. Reporting

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general public. Reporting of quality measures for outcomes should be transparent and available to all interested

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publications, and scientific publications open to public access. Publication of quality measures, in particular for

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scientific societies decide an otherwise political strategy. Use of internet for benchmark reporting is recommended but

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7.2. Reporting format

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general, rates are better understood and preferred for benchmarking (143-146). Using terms as first, best, last, worst,

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Table 7 summarizes different types of reporting results for benchmarking. Simple data is preferred for clarity.

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7.1. Media. Results of quality audits are of interest to physician and medical personnel health care authorities and

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populations. However, the appropriate media for reporting should be restricted to Health Care Authorities

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outcomes benchmarking should be discouraged form non-scientific publications, unless the health care authorities or

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within the control of health care authorities or scientific societies

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Rates, crude and risk adjusted is preferred to other forms of reporting (e.g.: odds ratios, predicted mortality) as in

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in benchmark reporting is discouraged?.

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Table 7. Reporting for benchmarking

Type of report

Pros

Cons

Selected populations vs. all

• More uniform populations for benchmarking

• Not real figures for the complete population

• Corrects for confounders

• No universal selection criteria accepted

e.g.: STEMI excluding prehospital cardiac arrest unconscious at hospital arrival e.g.: exclusion of low prevalence and very high risk populations (trauma, endocarditis, xxxx

• More uniform results without need for other corrections

Crude observed values

• Represent the real problem

(Number or %)

• Easy to understand

• Benchmarking between different registries etc. unreliable • Unreliable for smaller populations

• Good for large populations Risk corrected figures

• Corrects for risk population between clusters

• No universal risk correction accepted

Observed vs. predicted (expected) ratios

• Better describe performance for benchmarking

• More difficult to understand than crude or percent values when reporting for non professional readers • No really validated algorithms to calculate expected values • Usually, expected figures are higher than observed

371 October 2014

18 372

Graphic representation is preferred over table for clarity. Graphs for clustering should include numbers in different

374

also included and a possible reference value (e.g.: target value recommended in guidelines) should also be included as

376

Tables may include detailed information but may be confusing or at least distracting the main target for benchmarking

378

addition to ratios and other information (Fig. 3) (144).

380

a hospital or hospital cluster (self benchmarking). Figure 4 illustrates this type of graphic (145). Combined reporting

373

hospitals or hospitals clusters, as well as graphs for trends through different periods of time. Median values should be

375

a reference target for outcomes in a particular metric (Fig. 2) (114).

377

Tables should be complemented with figures with the main outcomes, preferably with actual values in % format, in

379

Trends in outcomes through different periods of time are encouraged to illustrate the progress of a particular marker in

381

of metrics may illustrate a possible relationship between changes in treatment strategies and outcomes (Fig. 5) (146).

382 383 384 385 386 387 388

Figure 2. Graphic reporting of metrics for benchmarking between different hospital clusters. Data from: Admission-based in-hospital case-fatality rates within 30 days after admission for AMI, 2009 (or nearest year (114). Suggested reference rate (105)

October 2014

19

389 390 391 392 393 394

395 396 397 398 399

Figure 3. Graphic reporting differences in hospital mortality after surgical procedures (non-cardiac) differences between European countries in the 7 days study. Adjusted odds ratios graph and table including detailed data (144)

Figure 4. Trends in outcomes for mortality after first-time aortic valve replacement (AVR) (145)

October 2014

20

400 401 402

Figure 5 Combined reporting of metrics illustrating the change in the use of effective treatments in acute myocardial infarction and mortality. Berlin registry (146)

October 2014

21 403

6. Quality markers related with better results in clinical practice (Performance measures).

405

with better results in clinical practice are grouped in two sections: a/ resources directly related to patient care (hospital

407

diagnosis, treatment, prevention and patient education (including local protocols, multidisciplinary teams, waiting list,

409

related with better outcomes, but these are not appropriate to measure the quality of results and must not be considered in

411

imaging, acute cardiac care, interventional cardiology, electrophysiology and complex arrhythmias, heart failure, cardiac

413

sometimes beyond the expertise of general cardiology. Some may be already accredited by the ESC (cardiac imaging,

415

AHA recognizes heart failure as a subspecialty. Cardiac surgery, obviously a different specialty, is also included in the

417

disease, or complex pulmonary hypertension units are accredited in Spain as units for national reference (147) through a

419

document. The task force recommends the referral of these patients to the same hospital to facilitate teamwork.

421

8.1. Clinical cardiology and hospital related markers (Table 8 and Appendix table 4, supplementary material) (JL

423

Some quality markers are recommended in all hospitals for accreditation of cardiology units (e.g. staffing, technology,

425

are recommended in all hospitals. (Arguably), the most relevant recommendations are the use of local protocols for

427

internal medicine and other medical specialties, with special reference to primary care. Table 8 shows the most relevant?

429

cardiology and hospital related markers. JL Zamorano: include appropriate references. As many as needed

404

These refer to measures of processes that are known to positively influence desirable outcomes. Common markers related

406

volumes, desired technology, staffing, organization, patient services, accreditation), and b/ process of delivery care for

408

safety and patient education). These metrics are the reference for a better health care organization and some (many) are

410

the same level as outcomes. Eight different sections have been identified: Clinical cardiology and hospital related, cardiac

412

rehabilitation and cardiac surgery. Most of them are perceived as subspecialties in cardiology and require specific training

414

electrophysiology and complex arrhythmias, acute coronary care, interventional cardiology and rehabilitation?). The

416

document for its intrinsic relationship with cardiology. Special units such as heart transplant, adult congenital heart

418

dedicated process of selection, are audited every two years following a predefined protocol and are not included in this

420 422

Zamorano references missing).

424

volumes); others are intended for internal quality controls, to identify problems and opportunities for improvement and

426

diagnosis and treatment, based in the ESC / AHA guidelines and approved by the hospital as well as team work with

428

/ selected metrics and Table 4 in the Appendix (supplementary material), a more detailed description of clinical

October 2014

22

Structure. Resources directly related to patient care Nยบ dedicated ICCU beds. Recommended 4-5 beds / 100.000 inhabitants Hospital volumes TTE, in all hospitals. TEE and stress echo, CCT, PET-CT Scanner, NMR, in Desired type II and III hospitals. 3D echo in type III hospitals; Technology Certified cardiologist responsible for cardiac unit in hospitals > 300.000 Staffing Nurses with cardiology experience. Recommended in type II and III h.

Dedicated cardiac unit: Recommended in hospitals with a population > 300.000 Organization Cardiologist on call / 24 hours Recommended in hospitals type II and III Patient services Rehabilitation program. Recommended in all hospitals, in house or in a reference hospital External accreditation of specific units Accreditation Process of delivery care for diagnosis, treatment, prevention and patient education Local protocols for diagnosis and treatment based on ESC /AHA-ACC Local protocols guidelines for prevalent GRDs: IHD, AF, valvular, HF. Recommended in all hospitals Multidisciplinary protocols with related specialties Multidisciplinary Avoid duplicity of units in the same hospital (e.g.: heart failure) protocols Heart Team Regional STEMI protocol Hospital approved protocols for derivation to other hospitals in case of need for other services: Recommended in hospitals w/out the required technology Waiting list for 1st medical outpatient visit < 40 days. Recommended in all Waiting list hospitals < 1,7 / 1000 population covered by hospital All hospitals should identify possible safety problems and organized local Safety. quality programs in a yearly basis. Safety quality index?

Outcomes in selected populations as described in text and table # 5 Results Adherence to local protocols for diagnosis and treatment based on ESC / Quality controls: AHA/ACC guidelines Recommended > 90% in all hospitals Adherence to guidelines

432

JL Zqamorano

Reference

Difficulty Auditable

Table 8. Performance measures related with better results in clinical practice. General, hospital related. Clinical cardiology Clinical cardiology Metric Recommendations Relevance

430 431

2 2 3 1 2 3 1 1 1 1

2 2 2 2

2 2 2 2

1 2 2 1 2 2

1 2 2 1 2 2 1 2 2 1 2 2 1 1 1

Spanish requirement

1 2 2

1 3 3

433

8.2. Performance measures related with better results in clinical practice. Specific Units. Cardiac Imaging. (Table

435

and its complexity require specific training and team work with radiologist. Technology should be available in all

437

in all hospitals. More complex techniques require specific training and certification and teamwork with radiologists

439

accreditation is highly recommended in particular in hospital type II and III. Quality controls include accreditation, low

441

radiation dose are recommended in all cases.

434

9) (149-182). Cardiac imaging constitutes the core for diagnosis in cardiology and the rapid development in recent years

436

hospitals, in-house or in reference hospitals. TTE performed by well-trained cardiologists is recommended in all patients,

438

(nuclear imaging, CCT and CMR). Accreditation of image laboratories by the ESC or other official agencies for

440

inter-observer variability and prompt systematic reports. Protocols for reducing radiation dose in CCT scans and report or

October 2014

23

Table 9. Performance measures related with better results in clinical practice. Specific Units. Cardiac Imaging Cardiac imaging

Metric

Recommendation

Structure. Resources directly related to patient care TTE, TEE, stress echo: recommended: > 1500 and 300 / studies / staff / y) Hospital volumes CCT studies (recommended > 250 / year) CMR studies (recommended > 300 / year)* TTE, in all hospitals. TEE and stress echo, in type II and III hospitals.

Desired technology CCT, PET-CT Scanner and CMR in-house hospitals II and III or in reference hospital. 3D echo in type III hospitals.

Staffing Cardiac Imaging certified cardiologists (recommended ≥ 1 per technique: Echo, CMR, CCT), Level 2/3 Certified technicians (recommended ≥ 1 per technique) in all hospitals Official accreditation (ESC or similar) of Echo lab, CCT lab, CMR lab Accreditation TT Echocardiography available 24/7/365 in hospitals II and III Patient services Process of delivery of care for diagnosis and treatment For indications based on ESC /AHA.ACC guidelines for each technique Local protocols Protocols to reduce All cases < 15 mSv radiation from CCT

Outpatient, non–urgent, studies, recommended 100% < 30 days Hospitalized patient, recommended <24h Urgent cases: recommended availability 24/7/365 Safety. Quality control programs focussed on safety Complications of stress test requiring specific treatment <10% Notification of contrast induced complications (ECHO, CCT, CMR) in 100% of cases Recommended availability for urgent cases: 24 / 7 / 365 Quality controls measures Adherence to local protocols based Recommended > 90% on ESC / AHA-ACC guidelines < 5% Nº of non interpretable echo studies Recommended 100% of cases Digital archive of studies < 10% recommended Inter-observer variability Complete, definitive report, delivery < 24 hours Structured report of studies (recommended > 90%) Recommended in 100% of cases (CCT) Report of radiation dose Waiting list

445

1 1 1 1

2 2 2 2

Reference s

443 444

Table 9 shows the most relevant? / selected metrics in cardiac imaging.

Relevance Difficulty Auditable

442

2 2 2 2

160-161 162 149-159

1 2 2

149-159

1 2 2 1 2 2 1 2 2

149-159 149-159

1 2 2 163-174 1 3 2 171-173 1 2 2 M 149 1 2 2 M 149 1 2 2 M 149 2 2 3

2 3 4

168-170

2 2 4

159, 28, 30

2 3 3 1 3 2

159, 177, 180

159, 180

159, 177, 180

1 1 2 181, 182

446

8.3. Acute cardiac care measures related to better results in clinical practice (Table 10) (105, 107, 117, 183-186).

448

general intensive care physicians, following well-defined protocols for prevalent pathologies such as acute myocardial

450

implemented in all cases. Patients with STEMI should be immediately referred to hospitals with availability for primary

452

department and in medical wards in type II and III hospitals. A dedicated intensive care cardiology unit is highly

447

Acute cardiac care requires teamwork with out-of-hospital professionals, emergency department, internal medicine and

449

infarction and acute coronary syndromes in general. Protocols following the guidelines must be prepared, approved and

451

PCI. Well-trained nurses are of upmost importance not only in the intensive care unit but also in the emergency

453

recommended in type III hospitals and in lower volume hospitals a general intensive care unit should have specific October 2014

24 454

protocols to transfer patients with STEMI, cardiogenic shock and other conditions following predetermined protocols. In

456

highly recommended.

458

controls should focus on antithrombotic complications. Table 10 shows the most relevant? / selected metrics in acute

460 461

Table 10. Performance measures related with better results in clinical practice. Specific Units. Acute Cardiac Care

455

hospitals admitting patients with need of intensive cardiology care at least 1 cardiologist certified in acute cardiac care in

457

Outcomes include mortality in STEMI, acute coronary syndromes, hospital readmissions and stroke. Local safety

cardiac care.

Metric

Recommendation

Structure. Resources directly related to patient care 4-5 ICCU beds / 100.000 inhabitants Hospital volumes Intensive care environment technology (including: Volumetric pump/automatic Desired technology

Reference s

Acute coronary care / Intensive cardiac care Relevance Difficulty Auditable

459

1 2 2 186 186

syringe, mechanical respirators, intra-aortic balloon pump, external pacemaker/defibrillator, temporary pacemakers, blood clot metre (ACT), glucose level measurement kit, echocardiography, X-ray fluoroscopy)

Staffing

Accreditation Patient services

Nurses with > 1 year cardiology experience At least 1 cardiologist certified in acute coronary care (Optimal: 1 / 3-4 beds) Cardiologist on call 24/h (recommended in hospitals > 300.000) At least 1 cardiologist accredited in acute cardiac care Any accreditation conferred by any external organizations Regional network for STEMI and other ACS Cath lab available 24h Hypothermia program Bundle of care service for sudden death Risk stratification (GRACE, TIMI, CRUSADE)

Regional network for STEMI and other ACS Process of delivery care for diagnosis, treatment, prevention and patient education STEMI and Non-STEMI protocols Local protocols based on ESC /AHA- Optimal Medical treatments according to ESC / AHA â&#x20AC;&#x201C; ACC guidelines ACC guidelines Prehospital systems, emergency department, cardiac unit.

Multidisciplinary protocols Heart failure: Cardiac unit, internal medicine, emergency department Quality controls Adherence to ESC / Patients with primary PCI in STEMI: Recommended > % AHA-ACC Time to call-door-balloon/lytic: Recommended < % guidelines Patients with dual antiplatelet therapy in ACS: Recommended > % % Patients with statins at discharge: Recommended > % Infections: Recommended < % Safety Transfusions: Recommended < %

462

October 2014

1 1 1 2 2 3 186 1 3 2 186 186 2 2 2 186 1 2 1 105 1 2 1 105 1 2 3 117 1 2 3 117 105, 107, 2 193

1 2 1 105 105, 106, 2 2 107, 117, 183 2 3 3 referen ces 2 2 2 195 1 2 2 184-185

2 2 2 186

186

25 463

8.4. Interventional cardiology measures related to better results in clinical practice (Table 11) (106,187-270). The

465

cardiology as well as on the volumes performed in each hospital and for each interventional cardiologist. Fellows in

467

to the local regulations. This may have legal implications. Accreditation should be considered in all cases. Low volume

469

disease should be permitted only in selected type III hospitals with specific training and accreditation. Adherence to local

471

Outcomes metrics include STEMI and ACS mortality, as well as TAVI mortality, stroke and elective PCI mortality. The

473

hospitalization.

464

results of percutaneous cardiac interventions are highly dependent on the expertise and training in interventional

466

training activity may have a negative impact in outcomes and responsibilities for fellows should be controlled according

468

interventions (TAVI, closure of atrial appendage an foramen ovale, valvular interventions and adult congenital heart

470

protocols based on guidelines and heart team decisions for non-urgent interventions should be considered in all cases.

472

main safety control is focused on bleeding and vascular complications requiring surgery or prolongation of

474 475

October 2014

26 476 477 478

Table 11. Performance measures related with better results in clinical practice. Specific Units. Interventional cardiology

479

October 2014

27 480

8.5 Electrophysiology and complex arrhythmias measures related to better results in clinical practice (Table

482

the interventional cardiologists. Indications for ablation and other techniques including CRT and ICD implantation

484

proper evidence of benefit in clinical trials. In all cases the indication should follow a Heart Team approach

486

should regulate the activity and responsibilities of fellows in training.

488

focus of complications requiring surgery, transfusions or prolongation of hospitalization.

481

12). (120-122, 239-263), Interventional treatment of complex arrhythmias requires accreditation of both the lab and

483

are rapidly changing. Ablation procedures in some arrhythmias (e.g. atrial fibrillation) are increasing rapidly without

485

following the guidelines. Again, accreditation of units and staff is crucial for outcomes and legal responsibilities

487

Outcomes should include complex arrhythmological procedures and device implantation mortality. Safety should

489 490 491 492 493 494 495 496

Complex invasive arrhythmological procedures may be defined as procedures performed by <50% of the country´s labs, including (x): Ventricular tachycardia catheter ablation, Atrial fibrillation catheter ablation, Left atrial tachycardia/flutter ablation, Percutaneous/surgical epicardial procedures, Referred repeat procedures post failure in other centres .

Non-complex invasive arrhythmological procedures include: Catheter ablation of the different substrates in paroxysmal supraventricular tachycardia sand atrioventricular nodal ablation.

October 2014

28 Table 12. Performance measures related with better results in clinical practice. Specific Units. Electrophysiology and complex arrhythmias

Electrophysiology and arrhythmias

Recommendation

Structure. Resources directly related to patient care Complex procedures: Atrial Fibrillation. Recommended > 50 Hospital volumes procedures/year Complex procedures: Ventricular tachycardia. Recommended only in labs with >100 general catheter ablation procedures/y.

Non-complex procedures (Ablation of paroxysmal supraventricular tachycardia, AV nodal ablation, and common atrial flutter.

Recommended >100 procedures/year.

Pacemaker implants (>12 implants/y per operator), ICDs (>10 implants/y), and CRTs (>10 implants/y) Accredited Arrhythmia Unit in hospitals >100 invasive EP procedures/y Desired technology Dedicated RX lab >2 certified cardiologists accredited in arrhythmias Staffing Certified cardiologist accredited in arrhythmias responsible for the unit NÂş nurses assigned to arrhythmia unit, experience > 1 y: â&#x2030;Ľ2 Accredited Arrhythmia Unit (EHRA, SEA, Certification ISO 9001:2008) Accreditation Arrhythmia Ablation, Pacemaker AND ICD, CRT implantation Patient services Arrhythmia outpatient clinic Process of delivery care Protocols for diagnosis and Indications of ablation procedures treatment according to ESC / Indications for implantation of ICD and CRT AHA-ACC Guidelines HEART TEAM approach for indications of catheter ablation, CRT and ICD

Reference s

Metric

Relevance Difficulty Auditable

497 498 499

2 2 1 239-242 2 2 2 120, 242, 243 2 2 1 242, 243 2 2 1 244, 245 2 2 2 2 2 2 2 2

2 2 2 2 2 2 2 2

1 1 1 1 1 1 1 1

242, 246

1 2 2 1 2 2 2 2 2

120, 253 254, 255 256,257

242, 247-249

248-251 248,250, 252 248 250-252 248, 249 248, 249

Quality controls Rate of patients with anticoagulant therapy prescribed for non-valvular atrial fibrillation at discharge Safety: Complications resulting in death or requiring surgery, transfusion or delay in hospital discharge after ablation and device implantation

500 501 502

Recommended: > 85% Recommended: < 7%

258, 259,

2

1 2 262, 263

1

2 3

120, 121, 122 , 123, 123b 239,241, 253,

8.6 Heart failure measures related to better results in clinical practice (Table 13). (125-127, 264-269).

503

Diagnosis and treatment of heart failure in changing rapidly and increasing in complexity and adherence to

505

admission to the hospitals, the majority present comorbidities that require specific treatment and cardiac care must

507

in cardiology or internal medicine is crucial and is strongly recommended. Some type of heart failure unit is highly

504

guidelines in clearly related with better outcomes including survival. Many patients require treatment before

506

be continued after discharge of the patient from the hospital in all cases. Teamwork as opposed to admitting patients

508

recommended in all hospital. Outcomes include mortality and readmissions to the hospital.

509

October 2014

29 510 511

512 513 514

Table 13. Performance measures related with better results in clinical practice. Specific Units. Heart Failure Units

8.7. Cardiac rehabilitation measures related with better results in clinical practice (Table 14). (105, 107, 270-312).

515

Cardiac rehabilitation is not only controlled exercise training. Furthermore, the main focus should be the education of the

517

secondary prevention. In many cases cardiac rehabilitation is neglected, especially for long-term secondary prevention.

519

for secondary prevention. Teamwork especially with general physicians is essential.

516

patient for life style, adherence to medical treatment for the specific condition and use of appropriate strategies for

518

Cardiac rehabilitation units or programs should be implemented to offer all patients appropriate counselling and follow up

October 2014

30 520

Quality controls should include access to rehabilitation programs to all patients with ischemic heart disease and

522 523 524

Table 14. Performance measures related with better results in clinical practice. Specific Units. Cardiac rehabilitation

521

adherence to guidelines during long-term follow-up.

525 526

October 2014

31 527

8.8. Cardiac surgery measures related with better results in clinical practice (Table 15). (128, 129, 313-331).

529

without exception. Curiously, in general, quality controls in cardiac surgery have been implemented in many

531

anaesthesiologist, nurses and referring cardiologists highly impact on outcomes.

533

well-defined surgical procedures such as 1st time CABG, aortic and mitral valve surgery.

528

Cardiac surgery is not an alien specialty to clinical cardiology. On the contrary, teamwork is required in all cases,

530

hospitals and countries during the last few years. Hospital volumes, training and expertise of surgeons,

532

Outcomes are relatively easy to measure and should focus on mortality and length of hospitalization in prevalent,

534 535

Table 15. Performance measures related with better results in clinical practice. Specific Units. Cardiac surgery

Recommendation

Structure. Resources directly related to patient care Major cardiac surgery procedures. Recommended: >500 / year or > 70 Hospital volumes / cardiac surgeron / year Dedicated Cardiac surgery operating rooms, at least 1 full time Desired technology Fully staffed and equipped Cardiac Surgery Intensive Care Unit Certified cardiac surgeons Staffing Anaesthesiologists, intensivist and cardiac surgeon accredited in post cardiac surgery intensive care Nurses assigned to cardiac surgery, experience > 1 y / operating room Accredited cardiac surgery unit Accreditation Urgent cardiac surgery Patient services Scheduled priority system Prevention of infections protocol Process of delivery care Risk evaluation using protocols: Euro Score2, SINTAX, other Protocols for evaluation and Protocols for indication of cardiac surgery, major procedures treatment according HEART TEAM approach for all major surgery indications to ESC / AHA-ACC Scheduled priority system Guidelines Transfer protocols from hospitals type I and II to III Use of medication for secondary prevention at hospital discharge.

Recommended > 90% in all hospitals Quality controls ESC / AHA-ACCC Guideline adherence Recommended: > 90% in patients without Prescription of appropriate medication for contraindications secondary prevention at hospital discharge

536

October 2014

Reference s

Metric

Relevance Difficulty Auditable

Cardiac Surgery

1 1 1 128,313 2 1 1 1

1 2 2 2

2 2 313 2 2

1 1 1 1 1

2 1 1 2 2

2 1 1 2 128 2 128

1 1 1 1 1

2 2 2 2 2

2 129 2 2 129, 321, 322 2 2 105, 107, 129, 280, 297

105, 107,

1 2 2 129, 280, 297

32 537

9. Current limitations and future challenges

538

9.1. Capture of information. Prospective, obligatory, audited data reports would be arguably the best way of

540

detailed and specific information, but its validity will depend on the universal inclusion of patients and the quality od

542

waiting for a better time for closing the patient´s file and never included in a data base; illustrating the need for

544

registries including a selected number of patients, may do not represent true values for benchmarking.

546

importance in modern cardiology. One example is the lack of specific codes for STEMI, one diagnose that is

548

to differentiate a simple episode of ventricular fibrillation recovered with an electric shock from a complex cardiac

550

appropriate coding required in data quality assessment standards.

552

positive and negative interpretations (typically, hospitalization for heart failure is difficult to adjudicate in clinical

554

9.2.3. Future challenges. Quality measures, especially outcome metrics, should be transparent and to avoid

556

and agreement between scientific societies, medical organizations and health care authorities. The following fields

539

capturing simple, core information. Dedicated data registries e.g.: TAVI or STEMI registries may include a more

541

the audits. The coding of worst and most important cases (e.g.: deceased soon after admission) may be left in a shelf,

543

serious and detailed audits. Retrospective data collection may yield a different type of information. Voluntary

545

9.2. Coding. ICD-9-CM codes do not clearly permit the identification of GRDs that are perceived as of the upmost

547

currently being included in the majority of quality control programs; another example is the lack of appropriate codes

549

arrest in a patient admitted unconscious to the hospital. Future editions (ICD-10 and subsequent), should include the

551

Diagnosis itself may not be as reliable as desirable. Heart failure diagnosis presents a significant number of false

553

trials)

555

confusions in benchmarking a universally accepted standardization is necessary. This will require the collaboration

557

need future refinement and represent a clear unmet need and an opportunity for improvement:

558

a.

Standardization of metrics for outcomes and to less extent standardization of measures of care quality

559

b.

Standardization of data capture

560

c.

Standardization of risk corrections

561

d.

Standardization of reporting

October 2014

33 562

10. Concluding remarks

563

This document proposes two sets of quality metrics in cardiology. 1/ Outcomes in selected high risk or high

565

performance, typically adherence to ESC / AHA-ACC guideline recommendations. In some cases outcomes

567

hospitals. Both will be helpful to measure quality in clinical practice, benchmarking an in some cases

569

perfect and will need future refinement. Most important, it is recognized that standardization and endorsement of

571

opportunity for improvement.

564

prevalent GRDs, including mortality, hospital related metrics and stroke and 2/ Measures of quality

566

would only be reliable in high volume hospitals, while performance measures can be apply to virtually all

568

accreditation of specific cardiology units. Data capture, codification, risk correction and reporting are far from

570

quality markers is of extraordinary importance and the responsibility of scientific societies, representing a unique

October 2014

34 572 573 574 575 576 577 578 579 580 581 582 583 584 585 586 587 588 589 590 591 592 593 594 595 596 597 598 599 600 601 602 603 604 605 606 607 608 609 610 611 612

11. Abbreviations, Glossary ACC American College of Cardiology ACE-i: Angiotensine Converting Enzyme Inhibitors AHA: American Heart Association ACS: Acute Coronary Syndromes CABG: Coronary artery bypass grafting CCT: Cardiac Computarized Tomography CMR: Cardiac Magnetic Resonance CRT: Cardiac Resynchronization Therapy GRACE risk score: Global Registry of Acute Coronary Events risk score CMBD: (Conjunto mínimo base de datos) Minimal Basic Hospital Data Set at discharge from hospitals required by low; National Spanish Health Care system. (Domingo Pascual please review definition and provide reference) CME: Continuous Medical Education ED: Emergency Department EHRA: European Heart Rhythm Association ESC: European Society of Cardiology EURO score. European System for Cardiac Operative Risk Evaluation GRDs: Diagnosis Related Groups. Groups ICD-9 codes according to recommendations in the Spanish National Health Care system. (Domingo Pascual please review definition and provide reference) HF: Heart Failure IABP: Intra Aortic Balloon Pump ICD: Implantable Cardiac Defibrillator ICD-9-CM: International Classification of Diseases- Clinical Modification, ICCU: Intensive Cardiac Care Unit ISO certification: IVUS: Intravascular Ultrasound Heart Team: Multidisciplinary team for invasive procedures decisions NCDR: National Cardiovascular Data Registry NMR: Nuclear Magnetic Resonance MSTC: Multi Slice Computed Tomography OCT: Optical Coherence Tomography PCI: Percutaneous coronary intervention 1º PCI: Primary percutaneous coronary intervention in STEMI patients, first 24 h.

SAMUR, SUMA: Out of hospital medicalized systems SYNTAX risk score: SYNergy between PCI with TAXsus and cardiac Surgery risk score SEA: Sección de Electrofisiología y Arritmias (Sociedad Española de Cardiología) STEMI: ST elevation myocardial infarction TAVI: Trans catheter Aortic Valve Implantation TIMI: Thrombolysis In Myocardial Infarction Volumes: Number of patients, staff, procedures, etc.

October 2014

N inth R evision

35 613 614 615 616 617 618 619 620 621 622 623 624 625 626 627 628 629 630 631 632 633 634 635 636 637 638 639 640 641 642 643 644 645

12. References Following guidelines improve outcomes 1.

Fox KAA, Goodman SG, Klein W, Brieger D, Steg PhG, Dabbous O, Avezum Á, for the GRACE Investigators.

Management of acute coronary syndromes. Variations in practice and outcome. Findings from the Global Registry of Acute Coronary Events (GRACE). Eur Heart J 2002;23:1177-89.

2.

LaBresh KA, Ellrodt AG, Gliklich R, et al. Get with the guidelines for cardiovascular secondary prevention: pilot results. Arch Intern Med 2004;164:203-209.

2b Granger CB, Steg PG, Peterson E, MD, López-Sendón J, Van de Werf F, MD, Kline-Rogers E, Allegrone J Dabbous O, Klein W, Fox KAA, Eagle K, for the GRACE Investigators. Medication performance measures and mortality following acute coronary syndromes. Am J Med 2005;118:858–865

3.

Anderson HV, Shaw RE, Brindis RG, et al. Relationship between procedure indications and outcomes of percutaneous coronary interventions by American College of Cardiology/American Heart Association Task Force Guidelines. Circulation 2005; DOI:10.1161/CIRCULATIONAHA.105.553727.

4.

LaBresh KA, Fonarow GC, Smith SC, et al. Improved treatment of hospitalized coronary artery disease patients with the get with the guidelines program. Crit Pathw Cardiol 2007;6:98-105.

5.

Jernberg T, Johanson P, Claes Held, Svennblad B, Lindbäck J, Wallentin L, for SWEDEHEART/RIKS-HIA. Association between adoption of evidence-based treatment and survival for patients with ST-elevation myocardial infarction" JAMA 2011; 305: 1677-1684.

6.

Mukherjee D. Implementation of evidence-based therapies for myocardial infarction and survival. JAMA 2011; 305: 1710-1711.

7.

t Source al "Evaluating reference: theD performance ande, A S e of

American Society of Nuclear Cardiology

appropriate-ness criteria for myocardial perfusion imaging at a community teaching hospital" ASNC 2011; Abstract 32.34.

8.

Girotra S, Nallamothu BK, Spertus JA, Li Y, Krumholz HM, Chan PS, for the American Heart Association Get with the Guidelines–Resuscitation Investigators. Trends in survival after in-hospital cardiac arrest. N Engl J Med. 2012;367:1912-1920.

9.

Morrison LJ, Neumar RW, Zimmerman JL, Link MS, Newby LK, McMullan PW Jr, Vanden Hoek T, Halverson CC, Doering L, Peberdy MA, Edelson DP; on behalf of the American Heart Association Emergency Cardiovascular Care Committee, Council on Cardiopulmonary, Critical Care, Perioperative and Resuscitation, Council on Cardiovascular Nursing, Council on Clinical Cardiology, and Council on Peripheral Vascular Disease. Strategies for improving survival after in-hospital cardiac arrest in the United States: 2013 consensus recommendations: a consensus

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from

10.1161/CIR.0b013e31828b2770

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10. Lee Schwamm. Get with the guidelines-stroke is associated with sustained improvement in care for patients

649 650 651

11. Lori Mosca, for the Expert Panel/WritingGroup. Summary of the American Heart Association’s Evidence-Based

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652 653 654 655 656

hospitalized with acute stroke or TIA. Circulation. DOI: 10.1161/CIRCULATIONAHA.108.783688.

2No full evidence in guidelines

Guidelines for Cardiovascular Disease Prevention in Women. Arteriosclerosis, Thrombosis, and Vascular Biology.2004; 24: 394-396 12. Tricoci P, MD, Allen JM, MA; Kramer JM, Califf RM, MD; Smith SC. Scientific Evidence Underlying the ACC/AHA Clinical Practice Guidelines. JAMA. 2009;301:831-841 13. Roos M, Brodbeck J, Sarkozy A, Chierchia GM, De Asmundis C, Brugada P, A Critical Analysis of the Scientific Evidence Behind International Guidelines Related to Cardiac Arrhythmias. Circ Arrhythm Electrophysiol.

2011;4:202-210

657 658 659

14. Neuman MD, Goldstein JN, Cirullo MA, Schwartz JS.Durability of Class I American College of

661

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309. RD 43 Hamm LF, Sanderson BK, Ades PA, Berra K, Kaminsky LA, Roitman JL, Williams MA. J Cardiopulm Rehabil Prev. 2011 Jan-Feb;31(1):2-10. doi: 10.1097/HCR.0b013e318203999d Core competencies for cardiac rehabilitation/secondary prevention professionals: 2010 update: position statement of the American Association of Cardiovascular and Pulmonary Rehabilitation.

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Virginia.

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http://bluebook.scts.org/#CrudeMortality http://www.scts.org 128 Surgery 3, National Quality Forum. National Voluntary Consensus Standards for Cardiac Surgery. www.qualityforum.org last consulted 25th may 2014 129 Surgery 4 Writing Committee Members, L. David Hillis, Peter K. Smith, Jeffrey L. Anderson, Bittl, Charles R. Bridges, John G. Byrne, Joaquin E. Cigarroa, Verdi J. DiSesa, Loren F. et al. Association Task Force on Practice Guidelines 2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery: Executive Summary: A Report of the American College of Cardiology Foundation/American Heart Circulation. 2011;124:2610-2642;

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316. Hannan EL, Wu C, Ryan TJ, et al. Do hospitals and surgeons with higher coronary artery bypass graft surgery volumes still have lower risk-adjusted mortality? Circulation. 2003;108(7):795-801.

317. Nowicki ER, Weintruab RW, et al. Mitral valve repair and replacement in Northern New England. Am Heart J. 2003;145(6):1058-1062.

318. Peterson ED, Coombs LP, et al. Procedural volume as a marker of quality for CABG surgery. JAMA. 2004;291:195-201.

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322. Shroyer ALW, Marshall G, Warner BA, et al: No continuous relationship between Veterans Affairs hospital coronary artery bypass grafting surgical volume and operative mortality. Ann Thorac Surg, 61:17-20, 1996.

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Sabaté M, Cánovas S, García E, Hernández Antolín R, Maroto L, Hernández JM, Alonso Briales JH, Muñoz García AJ, Gutiérrez-Ibañes E, Rodríguez-Roda J, colaboradores del Grupo Nacional TAVI. In-hospital and Mid-term Predictors of Mortality After Transcatheter Aortic Valve Implantation: Data From the TAVI National Registry 2010-2011 . Rev Esp Cardiol. 2013;66:949-58 Patel N, De Maria GL, Kassimis G, Rahimi K, Bennett D, Ludman P, Banning AP, Outcomes After Emergency Percutaneous Coronary Intervention in Patients With Unprotected Left Main Stem Occlusion. The BCIS National Audit of Percutaneous Coronary Intervention 6-Year Experience. J Am Coll Cardiol Cardiovasc Interventions 2014; Rahimi K, Bennett, D PHD,x Conrad N, Williams TM, Basu J, Dwight J, Woodward M, Patel A, McMurray J, MacMahon S. Risk prediction in patients with heart failure. A Systematic Review and Analysis. J am Coll Cardiol HF 2014. doi.org/1 0.1016/j.jchf.2014.04.008 28. Senni M, Parrella P, De Maria R, et al. Predicting heart failure outcome from cardiac and comorbid conditions: the 3C-HF score. Int J Cardiol 2013;163:206–11 29. Pocock SJ, Ariti CA, McMurray JJ, et al. Predicting survival in heart failure: a risk score based on 39 372 patients from 30 studies. Eur Heart J 2013;34:1404–13 30. Peterson PN, Rumsfeld JS, Liang L, et al. A validated risk score for in-hospital mortality in patients with heart failure from the American Heart Association get with the guidelines program. Circ Cardiovasc Qual Outcomes 2010;3:25–32.

31. Lee DS, Stitt A, Austin PC, et al. Prediction of heart failure mortality in emergent care: a cohort study. Ann Intern Med 2012;156:767–75, W-261, W-262. a number of risk prediction tools are suitable for use in clinical practice, in particular when the outcome of interest is death. For example, the recently reported model by Senni et al. (28) has a very good discriminatory ability for predicting death at 1 year (C statistic of 0.88), has been externally validated (C statistic of 0.83), and enables calculation of risk in a wide range of patients with heart failure on the basis of easily obtainable risk markers. Another useful recent model used information from 30 prospective studies and approximately 40,000 patients with heart failure to derive a simple risk calculator for prediction of death for up to 3 years (29). The very large size of this study and the derivation of patients from wide geographic regions provide a uniquely robust and generalizable October 2014

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68 tool to quantify the prognosis of individual patients. However, these 2 models did not include BNP because such information was not available and it may be that inclusion of such biomarkers could further improve the predictive ability of these For prediction of death early after presentation to the hospital or emergency department, we found the risk models reported by Peterson et al. (30) and Lee et al. (31) to be particularly valuable because of their high discriminative abilities, independent validation in large cohorts of patients with heart failure with a wide spectrum of risk, and the relative simplicity of the risk calculators from the usersâ&#x20AC;&#x2122; perspective.

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69 14. Appendix / Supplementary material

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14.1 Appendix Table 1. Population selection and corrections recommended to compare outcomes between different

1695

14.3. Appendix Table 3. Risk adjustment variables. Institute for Clinical Evaluation Science

hospitals

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14.2. Appendix Table 2. ICD-9-MC codes

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14.4. Appendix Table 4. Quality measures related with better results in clinical practice. General, hospital related; Clinical cardiology

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Incardio

Cardiovascular mortality Exclusion of patients transferred from other hospitals, except when all patients are transfer from hospitals I and II to the same type III hospital Exclusion of patients with rare diseases and GRDs with very low intensity cases Exclude patients with extreme high risk Exclusion of patients with confusing diagnosis or no cardiac diagnosis as main reason for admission Cluster by GRDs Select, well-defined, high-risk specific populations with prognosis known to be highly dependent on overall cardiologic treatment quality.

1

1

1

1

1

1

2

1

1

2

2

1

1

1

1

2

1

1

1

2

2

2

2

1

3

2

1

2

1

1

2

1

Describe outcomes in medical and surgical groups For specified, prevalent, high-risk populations: Attribute GRDs to several specialties if different specialists may treat them.

1

1

1

1

1

1

September 12, 2014

Comments

Comparable clusters should be based on patient volume, technology, organization and transfer of patients Corrects for early hospitals discharge. Simplifies measurements. Perceived by the task force as better than outcomes at different times (hospital discharge, 3 months, 6 months, 1 year) Quality metric dependent on too many different clusters of confounders (patient risk, transfers bias form other hospitals, proportion of very high risk and very low risk patients, other) Same comment as overall mortality. CV mortality very difficult to ascertain if not adjudicated Corrects for higher mortality risk in patients only admitted to some hospitals. Some hospitals, because of attitude, local protocols or location may be more vulnerable than others.

2

Corrections for severity of illness

Corrections for risk of death

Reference

Auditable

MORTALITY, length of stay and stroke Classify hospitals in comparable clusters according to volume, technology and organization Recommended time measurements: 1 month after hospital admission Overall mortality

Difficulty

Metric

Relevance

Appendix Table 1. Population selection and corrections recommended to compare outcomes between different hospitals

70

These cases are considered as confounders. e.g.: pre hospital cardiac arrest admitted unconscious, endocarditis.

This include cardiogenic shock at admission, terminal illness, etc.

These cases are considered as confounders; e.g.: trauma, non-cardiac surgery GRDs group relatively homogeneous diagnosis and procedures. Usually split into too many groups, some times arbitrarily. Only selected, well defined GRDs, representing challenging, complex procedures should be used. These include STEMI, heart failure, out of hospital cardiac arrest. TAVI, heart failure, Catheter ablation, pacemaker / CDI, CRT device implantation. With regard to surgery examples include, 1st time, staged, isolated CABG, aortic and mitral valve replacement, combined CABG and valvular surgery.

Emergency surgery should be excluded. 1st time surgery preferred Use of ICD9 codes should be a standard, but need clustering of related codes. For some GRDs, ICD9 does not properly reflect some contemporary diagnosis such as ST elevation myocardial infarction.

Severity of illness should be calculated using appropriate (validated) scales/scores, the same as used in clinical practice. Other options for correction of severity of illness could be considered if evidence based or lack of appropriate risk scores (e.g.: heart failure) Risk of death should be calculated using the same appropriate scales/scores as used in clinical practice.

Other options for correction could be considered if evidence based or lack of appropriate risk scores Surgical and medical identify two different populations with different outcomes Helps to determine different outcomes according to staff expertise and unit organization. Differences will be minimized if teamwork and common protocols are used. These typically included heart failure patients.

Describe outcomes for patients 1st admitted to cardiology units or to other hospital departments

Incardio Appendix Table 2. Recommended ICD-9-MC codes (104b)

September 12, 2014

71

Incardio

Appendix Table 3. Variables for risk adjustment. Institute for Clinical Evaluation Science (139)

September 12, 2014

72

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September 12, 2014

Difficulty

Auditable

Structure. Resources directly related to patient care Nยบ cardiology beds Hospital volumes Nยบ dedicated ICCU beds (recommended 4-5 beds / 100.000 inhabitants) Nยบ patients discharged from type II hospitals > 500; from type III > 1000 Dedicated cardiac unit: Recommended in type II and III hospitals covering a Desired technology population > 300.000 Dedicated ICCU. Recommended in type III hospitals Echocardiographs. TTE, all hospitals. TEE and stress echo in type II and III hospitals; 3D echo in type III hospitals Interventional cardiology labs. 1 in type II, at least 2 in type III hospitals MS-CT, type II and III hospitals PET-CT Scanner, type II and III hospitals NMR, type II and III hospitals Heart protected hospital. Defibrillators in all floors of all hospital buildings.

Telemetry ECG monitoring in non-intensive care cardiology wards Holter monitoring systems. Recommended in all hospitals Certified cardiologist responsible for cardiac unit in hospitals > 300.000 Staffing Certified cardiologists, recommended in all hospitals Cardiologist certified in echocardiography (at least 2 years training) (at least 1 recommended in type III hospitals, or hospitals performing over 1000 studies / year or performing stress echo or TEE) Cardiologist certified in interventional cardiology (at least 2 years training) (at least 1 recommended in type II and III hospitals) Cardiologist certified in electrophysiology and complex arrhythmias (at least 2 years training) (at least 1 recommended in type II and III hospitals) Nurses with > 1-year cardiology experience. Recommended in type II and III h.

Other: secretaries, paramedics, social workers, etc.

Dedicated cardiac unit: Recommended in type II and III; or hospitals covering a Organization population > 300.000 Dedicated ICCU. Recommended in type III hospitals Cardiac imaging unit. Recommended in type III hospitals Cardiologist 24 h in hospital, recommended in type II and III hospitals

Relevance

Appendix Table 4. Quality measures related with better results in clinical practice. General, hospital related. Clinical cardiology Clinical cardiology Metric Recommendations References and comments

2 2 1

2 2 2

3 3 3

1

2

3

1

2

3

1

2

3

1 1 1 1 1 1

2 2 2 2 2 2

2 2 2 2 2 2

1 1

2 2

2 2

1

2

2

1

2

2

1

2

2

1 1

2 2

2 2

1

2

2

1

2

2

1

2

2

S7 (S-7)

73

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Patient services

Accreditation Certification of qualification conferred by external organizations

Local protocols for diagnosis and treatment based on ESC /AHA.ACC guidelines Multidisciplinary protocols

September 12, 2014

Cath Lab unit: recommended in type II and III hospitals 1 2 Electrophysiology Unit. Recommended in type III hospitals 1 2 Cardiology outpatient clinics. Recommended in all hospitals 1 2 Day hospital. Recommended in all hospitals 1 2 Established and hospital approved protocols for derivation to other hospitals in case of need for other services: Transplant, cath lab, electrophysiology, adult 1 2 congenital heart diseases, cardiac surgery, rehabilitation program.

Recommended in all hospitals without the required technology.

Cardiologist on call / 24 hours Recommended in hospitals II and III hospitals 1 2 Rehabilitation program. Recommended in all hospitals, in house or in a 1 2 reference hospital Palliative Care / Hospice program 2 2 Wound management services 2 2 Pain management program 2 2 Translators 2 2 Social workers 1 2 Home care 1 2 ISO certified units Accreditation of Cath Lab (ESC) Accreditation of ECHO Lab (ESC) Accreditation of Electrophysiology Lab (ESC) Accredited continuous medical accreditation programs, for cardiologists, 1 2 residents and nurses Other accreditations Honours, awards Reputation Impact factor Process of delivery care for diagnosis, treatment, prevention and patient education Local protocols based on guidelines recommendations for prevalent GRDs: IHD, AF, valvular, HF. Recommended in all hospitals Appropriate use of 1 2 limited resource technologies With, but no only: emergency department, internal medicine, anaesthesiology, general intensive care unit, nephrology, radiology, central lab, primary care physicians.

1 2 Use of common, approved protocols in prevalent GRDs. Recommended in all hospitals.

Avoid duplicity of units in the same hospital (e.g.: heart failure) STEMI: SUMA / SAMUR, cardiac unit, emergency department. Regional 1 2 STEMI protocol Cardio toxicity. Recommended in type II and III hospitals 1 2 Adult congenital heart diseases (selected hospitals) 1 2 Endocarditis recommended in type II and III hospitals 1 2

74

2 2 2 2 2 2 2 2 2 2 2 2 2

2

2

2

2 2 2 2

S3

Incardio

Waiting list for 1st medical outpatient visit Safety. Quality control programs focussed on safety

Patient education

Results Outcomes in selected populations Adherence to local protocols based on ESC / ACC guidelines Heart-team. Indications for elective interventional cardiology (coronary, structural and electrophysiology)

September 12, 2014

75 Nursing programs. Recommended in all hospitals Primary care programs. Recommended in all hospitals Quality control programs on yearly basis (e.g. door to balloon time in STEMI).

Recommended in hospitals II and III hospitals Primary and secondary prevention program. Recommended in all hospitals Patient and population education program. Recommended in all hospitals Established and hospital approved protocols for derivation to other hospitals in case of need for other services: Transplant, cath lab, electrophysiology, cardiac surgery, rehabilitation program, adult congenital heart diseases, complex pulmonary hypertension. Recommended in all hospitals without the required technology < 40 days. Recommended in all hospitals < 1,7 / 1000 population covered by hospital Including, but not only: Infections, transfusions, medical errors, malpractice, patient complains All hospitals should identify possible safety problems and organized local quality programs in a yearly basis Medical report at discharge, including diagnosis, process of care in hospital, treatment, recommendations life style, primary and secondary prevention and scheduled visit if necessary. Recommended for all patients in all hospitals Educational deliverables e.g.: booklets, charts for recording symptoms. Control of adherence to treatment and recommendations Patient web page Teaching sessions disease oriented for patients and relatives Rehabilitation programs including education in primary and secondary cardiovascular prevention Control of adherence to treatment and recommendations programs As described in text and table # 5 Recommended > 90% in all hospitals

1 1

2 2

2 2

1

2

3

1 1

2 2

2 2

1

2

2

1

1

1

1

2

2

1

3

3

1

2

2

1 1

2 2

2 2

1

2

2

1

2

2

1

3

3

1

2

2

Recommended in all patients in all hospitals

National Health Care System requirement in Spain Safety quality index?