Core outcome sets and core outcome measures: a primer
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Core outcome sets and core outcome measures: a primer Murad Alam1 · Sarah A. Ibrahim1 · Bianca Y. Kang1 · Arianna F. Yanes2 · Bharat B. Mittal3 · Daniel I. Schlessinger4 · David Zloty5 · Emily Poon1 · Erica H. Lee6 · Joseph F. Sobanko2 · Naomi Lawrence7 · Ramona Behshad8 · Ian A. Maher9 Received: 14 October 2020 / Accepted: 20 October 2020 © Springer-Verlag GmbH Germany, part of Springer Nature 2020
Keywords Core outcome set · Core outcome measure · COS · Outcomes · Clinical trial · Research Many questions regarding optimal therapeutics for specific patient problems remain to be answered. Clinical trials to address such questions may not be available. If they are, these trials may be underpowered due to the expense and logistical complexity of larger, multicenter trials. Pooling the results of small trials of the same therapy or intervention in a meta-analysis may also be fraught. Often, such trials assess subtly different outcomes, and therefore data cannot be combined or added together. Even if the outcomes are the same across trials, the specific outcome measures used to quantify them may not be. The Cochrane Collaboration and other groups that produce systematic reviews of clinical trials have become
* Murad Alam m‑[email protected] 1
Department of Dermatology, Feinberg School of Medicine, Northwestern University, 676 N St. Clair Street, Suite 1600, Chicago, IL 60611, USA
2
Department of Dermatology, Hospital of the University of Pennsylvania, Philadelphia, PA, USA
3
Department of Radiation Oncology, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA
4
Division of Dermatology, Department of Internal Medicine, Washington University in St. Louis, St. Louis, MO, USA
5
Department of Dermatology and Skin Science, University of British Columbia, Vancouver, BC, Canada
6
Dermatology Service, Memorial Sloan Kettering Cancer Center, New York, NY, USA
7
Division of Dermatology, Section of Procedural Dermatology, Cooper Hospital, Rowan University, Camden, NJ, USA
8
Department of Dermatology, Saint Louis University School of Medicine, Saint Louis, MO, USA
9
Department of Dermatology, University of Minnesota, Minneapolis, MN, USA
increasingly concerned about this limitation. Trials measuring different outcomes may represent research waste, being less than the sum of their parts. Post-hoc attempts to overcome the disparity in outcomes across trials are usually unsuccessful. One solution would be to encourage researchers investigating a condition or disease to use a common set of outcomes and outcome measures. These outcomes would ideally be incorporated at the time trials were being designed, and before data collection were initiated. Assuming different investigators were willing to measure the same outcomes, a process would be required for developing these so-called “core outcomes” [1]. Since one investigator’s preferred outcomes and outcome measures may be substantially dissimilar from those favored by another, a decentralized process would be
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