Author + information
- aPopulation Health Research Institute, McMaster University, Hamilton, Ontario, Canada
- bDepartment of Medicine, McMaster University, Hamilton, Ontario, Canada
- cSchool of Nursing, McMaster University, Hamilton, Ontario, Canada
- ↵∗Address for correspondence:
Dr. Jeff S. Healey, McMaster University, Department of Medicine, 237 Barton Street East, Hamilton, Ontario L8L 2X2, Canada.
Atrial fibrillation (AF) is increasingly common with advancing age and is associated with morbidity, mortality, health care costs, and patient symptoms (1). Although anticoagulant therapy is a cornerstone of treatment for patients with AF that substantially reduces stroke risk (2), most patients who seek medical attention due to AF do so in search of symptom relief (3). Clinical trials evaluating pharmacological and ablative therapy for rate and rhythm control typically assess clinical outcomes such as stroke, heart failure, and death and surrogates such as left ventricular function or measurements of AF frequency and burden (4,5). However, the use of implanted cardiac monitors has shown that AF burden and patient symptoms are not well correlated (6,7), highlighting the need to evaluate patient symptoms more directly.
Patient-reported outcomes (PROs) are a useful way to measure the impact of AF treatments, reflecting patients’ needs and preferences. PROs can be either generic (e.g., EQ-5D) or AF specific (e.g., the Atrial Fibrillation Effect on QualiTy-of-life [AFEQT] instrument) (8) and require that the source of the outcome measurement be reported directly from patients, not clinicians. PROs have received less attention in early AF trials with few trials using a PROs as a primary outcome. However, PROs have been integrated into the CONSORT (Consolidated Standards of Reporting Trials) statement in the U.S. Food and Drug Administration Center for Drug Evaluation and Research, aiming to incorporate PROS as efficacy endpoints in support of labeling claims (9).
Using a repository of registered AF clinical trials from 1999 to 2018, Steinberg et al. (8) in this issue of JACC: Clinical Electrophysiology, documented the fact that a minority of clinical trials reported PROs and that those studies that included PROs seldom used validated AF-specific tools. However, the analysis detected an increase in the use of PROs in the most recent 3 years, reflecting a growing trend toward patient-centered outcomes in research. Use of PROs was heterogeneous among different types of trials reported in more than one-third of procedural trials (e.g., catheter ablation) and of trials funded by industry but in only 2% of trials funded by the U.S. National Institutes of Health. However, the use of PROs in peer-reviewed studies is likely to increase given the recent initiatives and funding to support patient-centered outcomes research, such as the PCORI (Patient-Centered Outcomes Research Institute) in the United States and Canada’s SPOR (Strategy for Patient-Oriented Research) developed by Canadian Institutes of Health Research.
The use of a single trial repository to measure current PRO usage has limitations, as much of the data in this repository was either incomplete or not current. Thus, the low use of PROs may have in part reflected under-reporting to the Clinical Trials.gov repository. The current study might also have underestimated the use of PROs as the search terms used in this analysis omitted some common anxiety and psychosocial measurements. The identification of all PROs is also challenging as PROs are commonly reported as secondary outcomes or in secondary publications. A formal systematic review could clarify when and where PROs are included in AF research and if they are used as primary or secondary outcomes (10).
Moving forward, clinical trials in patients with AF will need to focus on more than just stroke and AF recurrence or burden. Heart failure is now the most common cause of both death and hospitalization in AF patients, and recurrent hospital visits for AF remain frequent (11). It has also become increasingly clear that AF burden has an imperfect correlation with patient symptoms (7). Combining PROs with markers of AF burden would be a better way to assess the clinically relevant impact of rhythm control strategies. Steinberg et al. (8) have shown us that such a strategy is not yet common but may be showing signs of increased popularity. Linking specific AF PROs to current practice guidelines and consensus statements could lead to increased uptake and reporting of PROs in future AF trials. Finally, investment in strategically focused AF research networks by PCORI in partnership with the American Heart Association offers new opportunities to expand the inclusion of PROs in future AF trials (12).
↵∗ Editorials published in JACC: Clinical Electrophysiology reflect the views of the authors and do not necessarily represent the views of JACC: Clinical Electrophysiology or the American College of Cardiology.
Dr. Healey has received research grants and speaking fees from Bristol-Myers Squibb and Pfizer; and has received speaking fees from Servier. Dr. Carroll has reported that she has no relationships relevant to the contents of this paper to disclose.
All authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC: Clinical Electrophysiology author instructions page.
- 2019 American College of Cardiology Foundation
- Oldgren J.,
- Healey J.S.,
- Ezekowitz M.,
- et al.
- Marrouche N.F.,
- Brachmann J.,
- Andresen D.,
- et al.
- Israel C.W.,
- Gronefeld G.,
- Ehrlich J.R.,
- et al.
- Verma A.,
- Champagne J.,
- Sapp J.,
- et al.
- Steinberg B.A.,
- Dorian P.,
- Anstrom K.J.,
- et al.
- Allan K.S.,
- Henry S.,
- Aves T.,
- et al.
- American Heart Association