Open AccessDetermine what to measure and how to measure in clinical trials for the treatment of pressure injury
Author(s) -
Jiyuan Shi,
Ya Gao,
Liangliang Si,
Xinping Ma,
Ming Liu,
Lan Xiang,
Junmei Zhang
Publication year - 2020
Publication title -
medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.59
H-Index - 148
eISSN - 1536-5964
pISSN - 0025-7974
DOI - 10.1097/md.0000000000019311
Subject(s) - medicine , delphi method , clinical trial , randomized controlled trial , medline , outcome (game theory) , systematic review , health care , set (abstract data type) , medical physics , surgery , pathology , statistics , mathematics , mathematical economics , political science , law , economics , economic growth , computer science , programming language
Background: A core outcome set (COS) is an agreed minimum set of outcomes that should be reported in all clinical trials in specific areas of health care. A considerable amount of trials did not report essential outcomes or outcomes measurement methods, which makes it challenging to evaluate the efficacy and safety of treatment strategies for pressure injury (PI) and produced significant heterogeneity of reported outcomes. It is necessary to develop a COS, which can be used for clinical trials in PI treatment. Methods/Design: The development of this COS will be guided by an advisory group composed of clinicians, senior nurses, patients, and methodologists. We will search six databases and 2 registry platforms to identify currently reported PI treatment outcomes and outcome measurement instruments in randomized controlled trials, meta-analysis, and systematic reviews. We will also conduct a semi-structured interview with clinicians, nurses, and adult PI patients to collect their opinions on important outcomes. Each outcome of the initial list generated from systematic review and interviews will be scored and reach a consensus through two rounds of international Delphi survey with all key stakeholders. A face-to-face consensus meeting with key stakeholders will be conducted to finish a final COS and recommend measurement instruments for each outcome. Results: We will develop a COS that should be reported in future clinical trials to evaluate the effectiveness of PI treatment. Discussion: The COS will follow current guidance to develop a high-quality COS in the field of PI treatment to reduce heterogeneity in trial reporting, facilitate valid comparisons of new therapies, and improve the quality of clinical trials.