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At JAMA Internal Medicine, we receive many manuscripts describing studies designed to improve health care quality, safety, or value. We applaud these efforts, as we strongly believe that changes in health care delivery and process should be driven by evidence. We also believe, however, that it is time to raise the bar on the methods, analysis, and reporting of quality improvement studies, as well as the threshold for those that are worthy of publication in this journal.
Studies should have results that are generalizable; if the problem exists only in 1 center or the intervention can be performed only in a limited number of facilities, the priority for publication would be markedly lower. Studies should document that the intervention actually resulted in better health outcomes, rather than focus only on changes in health care processes, use, or costs. Studies should examine potential adverse outcomes as well as benefits. In addition, we encourage the evaluation of costs, including the costs of the intervention, to enable the determination of value.
At a minimum, quality improvement studies should have a concurrent control group to minimize the effect of temporal trends, which can have a substantial association with the quality of health care. Better yet, quality improvement studies should use randomization and blinding. Using the electronic health record to accomplish randomization and to collect study outcomes makes randomization and blinding more feasible than in the past.
Even though many quality improvement studies test an intervention with face validity or some prior evidence of benefit, studies should receive institutional review board review and approval, although we recognize that review boards will use their judgment to determine which studies require informed consent from individual patients. Studies should be registered at Clinicaltrials.gov before the study starts, prespecifying the population to be enrolled and outcomes to be ascertained. We encourage higher-quality reporting guided by SQUIRE (Standards for Quality Improvement Reporting Excellence) guidelines.1
We recognize that it may be impractical to randomize and blind some quality improvement interventions. Nonetheless, providing strong evidence to support practice change requires that investigators approach or meet these criterion standards whenever practical. For example, clustered randomization2 and randomized stepped wedge designs3 are often feasible when randomization of individual patients is not. And blinding of outcome assessment is almost always feasible, even when blinding of the intervention itself is not.
In summary, the editors of JAMA Internal Medicine wish to initiate a quality improvement effort for quality improvement studies. We aim to ensure that the evidence supporting the effectiveness and safety of quality improvement interventions is rigorous and generalizable. We look forward to receiving reports of studies whose design, conduct, and analyses are most likely to generate compelling valid evidence, and help clinicians improve the health of their patients.
Corresponding Author: Deborah Grady, MD, MPH, Department of Medicine, University of California San Francisco, 550 16th St, 6th Floor, PO Box 0558, San Francisco, CA 94143 (email@example.com).
Published Online: November 27, 2017. doi:10.1001/jamainternmed.2017.6875
Conflict of Interest Disclosures: None reported.
Grady D, Redberg RF, O’Malley PG. Quality Improvement for Quality Improvement Studies. JAMA Intern Med. 2018;178(2):187. doi:10.1001/jamainternmed.2017.6875