Embracing the promise of patient reported outcome measures in cardiology

Over recent decades, progress in cardiology has tended to be technology driven and evaluated by outcomes determined by clinicians. The advent of evidence-based medicine has mandated the development of large-scale clinical trials in which treatment success is evaluated according to endpoints that are clearly defined, easily measured, and capable of being assessed and applied in a defined population. However, the results of such trials have historically concentrated on outcomes such as longevity of life and survival. These are easier to quantify and have traditionally been prioritized over patient reported outcome measures (PROMs). Whilst ‘hard endpoints’ remain important to patients, they need to be supplemented by measures of quality of life, symptoms, and function—which, by their nature, are more subjective and dependent on the individual patient’s perspective on the impact of their illness.1 PROMs are self-reported, psychometrically validated tools that are used to quantify aspects including well-being, health-related quality of life, comfort, activities of daily living, and symptoms from patients’ perspective alone.2 Some PROMs can be applied to a broad range of cardiovascular disease populations for ease of use within clinical practice. Others are disease-specific to cater to the nuances attached to specific treatments.3 They offer a mechanism for formally evaluating (and often enumerating) important aspects of lived experiences with a health condition without interpretation by clinicians or others,4 and have wide applicability in routine care, quality monitoring and improvement, clinical trials, regulatory affairs, reimbursement, and health economic evaluation.3 Clinical trials have shown that a poor health-related quality of life is significantly associated with future cardiovascular events,5 and incorporating the routine use of PROMs could help identify patients that are at particular risk of an adverse clinical outcome. The routine use of PROMs in clinical practice may promote shared decision-making and ultimately enhance patient experience and satisfaction with the care that they receive.6 In addition, analysis of the data derived from correctly constructed PROMs in clinical trials may improve knowledge of how decision-making may be influenced by factors such as age, culture, ethnicity, socioeconomic status, and employment. Informed by a Global Cardiovascular Outcomes Consortium, we have recently set out a comprehensive suite of clinician-determined clinical outcome measures that may be evaluated in patients with a range of cardiovascular diseases.7 This work was undertaken to address an unmet need for consistent reporting of clinical outcome measures to improve the quality and generalizability of research and the usefulness of registries in cardiology in order to improve outcomes for our patients.1 Whilst these clinical outcomes are clearly important, they are only part of the story: for some people, improvements in survival may mean life-years gained with a limited quality of life.8 Clinicians should listen to and measure patient reported outcomes to understand how they live, to help us measure what matters, align our clinical care with what is important to the patient and identify targets for therapeutic interventions. Despite this, in practice, a clinical-based judgement concerning a patient's health-related quality of life is often part of a clinician's decision on whether or not to offer potentially lifesaving treatments. PRO tools are often not used in preference for clinician-based clinical assessments. For example, the clinician-determined New York Heart Association score is often used alongside ejection fraction to determine eligibility for implantable cardioverter defibrillator and cardiac resynchronization therapies instead of a validated heart failure PROM.9 Knowledge of the factors that may influence patient expectations, their interpretation of the risks and benefits of treatment options, and their ultimate long-term assessment of the success of health care interventions will help to individualize patient care. This has been shown in other specialities, for example in oncology, where routine collection and use of PROMs has been shown to enhance both clinician-patient interactions, increasing clinician awareness of patients’ symptoms, alongside improved symptom management with concomitant improvements in patient well-being and satisfaction.10,11 However, corresponding examples of the use of PROMS are lacking in cardiology. Despite this, an increasing interest in patient-centred care has precipitated a proliferation in the development of PROMs in cardiology, and there are now over one hundred instruments to choose from.3 To that end, the abundance of PROMs options presents a challenge for both clinicians and researchers in selecting the most appropriate instrument. In addition to their varying methodological robustness in terms of the psychometric properties, many have logistical barriers such as licencing restrictions, cost to use, and many have only been validated in one language.12 Although widely used in other specialties, the current PROMs landscape in cardiology is complicated and esoteric. Selecting an instrument that is psychometrically valid, practical to administer, and accessible to the patient population of interest is critical—and is not straightforward. We propose, as a first step, the formulation of a checklist to evaluate the logistical barriers to using PROMs in clinical practice. Supported by patient participants, methodology experts, and the Global Cardiovascular Outcomes Consortium, we must now evaluate, synthesize, and prioritize PROMs to identify those that are most useful for researchers and cardiologists across Europe. As we have done for ‘hard outcomes’, we will present a menu of considerations for selecting appropriate PROMs to ensure that quality of care outcomes includes patient-centred outcomes. A.B.S. and A.B. have no conflicts of interest to declare. C.W. reports institutional grants from the British Heart Foundation (BHF) and National Institute for Health Research (NIHR), and unpaid roles with EHJ Quality of Care and Clinical Outcomes (Associate Editor), and NICE Indicator Advisory Committee. J.D. reports royalties or licenses from Oxford University Press; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events for PassPACES; support for attending meetings and/or travel from the European Society of Cardiology Patient Forum. J.S reports institutional grants from the NIHR, BHF, Barts Charity, and Medtronic. C.P.G reports grants or contracts from the Alan Turing Institute, BHF, NIHR, Horizon 2020, Abbott Diabetes, Bristol Myers Squibb, and ESC; consulting fees from AI Nexus, AstraZeneca, Amgen, Bayer, Bristol Myers Squibb, Boehringer-Ingelheim, Cardiomatics, Chiesi, Daiichi Sankyo, GPRI Research B.V., Menarini, Novartis, iRhythm, Organon, The Phoenix Group; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from AstraZeneca, Boston Scientific, Menarini, Novartis, Raisio Group, Wondr Medical, Zydus; support for attending meetings and/or travel from AstraZeneca; participation on a data safety monitoring board or advisory board from DANBLOCK trial, TARGET CTCA trial; leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid from EHJ Quality of Care and Clinical Outcomes (Deputy Editor), NICE Indicator Advisory Committee, European Society of Cardiology Quality Indicator Committee (Chair); stock or stock options from Cardiomatics; receipt of equipment, materials, drugs, medical writing, gifts, or other services from EchoNous.