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Core domain and outcome measurement sets for shoulder pain trials are needed: systematic review of physical therapy trials.

ABSTRACT: To explore the outcome domains and measurement instruments reported in published randomized controlled trials of physical therapy interventions for shoulder pain (rotator cuff disease, adhesive capsulitis, or nonspecific shoulder pain).We included trials comparing physical therapy to any other intervention for shoulder pain, indexed up to March 2015 in CENTRAL, MEDLINE, EMBASE, or CINAHL Plus. Two authors independently selected trials for inclusion and extracted information on the domains and measurement instruments reported.We included 171 trials. Most trials measured pain (87%), function (72%), and range of movement (67%), whereas adverse events, global assessment of treatment success, strength, and health-related quality of life were measured in 18-27% of trials, and work disability and referral for surgery were measured in less than 5% of trials. Thirty-five different measurement instruments for pain and 29 for function were noted. Measurement of function increased markedly from 1973 to 2014. In rotator cuff disease trials, there was a more frequent measurement of pain and strength and a less frequent measurement of range of movement compared with adhesive capsulitis trials.There was wide diversity in the domains and measurement instruments reported. Our results provide the foundation for the development of a core domain and outcome measurement set for use in future shoulder pain trials.

SUBMITTER: Page MJ

PROVIDER: S-EPMC4711903 | biostudies-literature | 2015 Nov

REPOSITORIES: biostudies-literature

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Core domain and outcome measurement sets for shoulder pain trials are needed: systematic review of physical therapy trials.

Page Matthew J MJ McKenzie Joanne E JE Green Sally E SE Beaton Dorcas E DE Jain Nitin B NB Lenza Mario M Verhagen Arianne P AP Surace Stephen S Deitch Jessica J Buchbinder Rachelle R

Journal of clinical epidemiology 20150616 11

<h4>Objectives</h4>To explore the outcome domains and measurement instruments reported in published randomized controlled trials of physical therapy interventions for shoulder pain (rotator cuff disease, adhesive capsulitis, or nonspecific shoulder pain).<h4>Study design and setting</h4>We included trials comparing physical therapy to any other intervention for shoulder pain, indexed up to March 2015 in CENTRAL, MEDLINE, EMBASE, or CINAHL Plus. Two authors independently selected trials for inclu ...[more]

PMID: 26092288

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Project description:BackgroundTissue-agnostic drug development provides a paradigm shift in precision medicine and requires innovative trial designs. However, outcome selection for such trials can prove challenging. The objectives of this review were to: (i) Identify and map core outcome sets (COS), across 11 immune-mediated inflammatory diseases (IMIDs) in order to facilitate the selection of relevant outcomes across the conditions for innovative trials of tissue-agnostic drug therapies. (ii) Compare outcomes or endpoints recommended by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) to identify and highlight similarities and differences.MethodsThe Core Outcome Measures in Effectiveness Trials (COMET), International Consortium for Health Outcomes Measurement (ICHOM), FDA and EMA databases were searched from inception to 28th December 2019. Two reviewers independently screened titles and abstracts of retrieved entries and conducted the subsequent full text screening. Hand searching of the reference lists and citation searching of the selected publications was conducted. The methodological quality of the included peer-reviewed articles was independently assessed by the reviewers based on the items of the COS-Standards for Development recommendations (COS-STAD) checklist. Core outcomes from the included publications were extracted and mapped across studies and conditions. Regulatory guidance from FDA and EMA, where available for clinical trials for the IMIDs, were obtained from their databases and recommendations on outcomes to measure directly compared.ResultsForty-four COS publications were included in the final analysis. Outcomes such as disease activity, pain, fatigue, quality of life, physical function, work limitation/productivity, steroid use and biomarkers were recommended across majority of the conditions. There were significant similarities and differences in FDA and EMA recommendations. The only instance where either regulatory body directly referenced a COS was for jSLE-both referenced the Paediatric Rheumatology International Trials Organization (PRINTO) COS.ConclusionsThe findings from this systematic review provide valuable information to inform outcome selection in tissue-agnostic trials for IMIDs. There is a need for increased collaboration between regulators and COS developers and inclusion of regulators as key stakeholders in COS development to enhance the quality of COS.Trial registrationNot registered.

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Core domain and outcome measurement sets for shoulder pain trials are needed: systematic review of physical therapy trials.

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Core domain and outcome measurement sets for shoulder pain trials are needed: systematic review of physical therapy trials.

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