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Objective To compare the outcomes in published core outcome sets with the outcomes recommended in corresponding guidance documents from the European Medicines Agency (EMA) and US Food and Drug Administration (FDA), matched by health condition.Design Cross sectional analysis.Setting US and Europe.Population Sample of core outcome sets related to drugs, devices, and gene therapy that involved patients in the consensus process, published between 1 January 2015 and 31 December 2019; and corresponding EMA and FDA guidance documents.Main outcome measures The extent of matches between outcomes included within core outcome sets and those recommended in corresponding EMA and FDA guidance documents were assessed. Matches were considered to be general (ie, non-specific) or specific (ie, exact). General matches were assessed to determine whether the core outcome set or guidance document outcome was narrower.Results Relevant guidance documents were found for for 38 (39%) of 98 eligible published core outcome sets. Among outcomes in core outcome sets, medians of 70% (interquartile range 48-86%) and 52% (33-77%) were matches with outcomes recommended in EMA and FDA documents, respectively. Medians of 46% (27-68%) and 26% (18-46%) were specific matches with outcomes in EMA and FDA documents, respectively. When outcomes were generally matched, the outcomes from core outcome sets were more frequently narrower than the regulatory outcomes (83% and 75% for EMA and FDA, respectively).Conclusion Greater adoption of, and reference to, core outcome sets in regulatory guidance documents can encourage clinical trialists, especially those in industry, to measure and report consistent and agreed outcomes and improve the quality of guidance. Given the overlap between outcomes in core outcome sets and regulatory guidance, and given that most core outcome sets now involve patients in the consensus process, these sets could serve as a useful resource for regulators when recommending outcomes for studies evaluating regulated products. Developers are encouraged to appraise recommended outcomes in salient regulatory documents when planning a core outcome set.

Introduction Dry eye is a multifactorial chronic condition characterised by tear film insufficiency and instability, and ocular symptoms including foreign body sensation, itching, irritation, soreness and visual disturbance. The prevalence and incidence of dry eye are major determinants of the magnitude of economic and societal costs of the disease. This protocol proposes a systematic review and meta-analysis of the prevalence and incidence of dry eye in the USA.Methods and analysis Working with an information specialist, we will develop search strategies for Ovid Medline and Embase for population-based cross-sectional and cohort studies involving US-based populations that report the prevalence and/or incidence of dry eye. We will include studies involving persons of all ages from 1 January 2010 to the current date with no language restrictions. We will also hand-search references of included studies, dry eye epidemiology-related systematic reviews, clinical practice guidelines and literature provided by agencies and organisations. Two investigators will independently screen the titles and abstracts, and then full-text reports to determine eligibility. One investigator will extract study data and perform risk of bias assessments using tools designed specifically for prevalence and incidence studies. A second investigator will verify all extracted study data and risk of bias assessments. We will assess heterogeneity, qualitatively and quantitatively. When appropriate, we will meta-analyse prevalence and incidence estimates.Ethics and dissemination This review does not require approval by an ethics committee because it will use published studies. We will publish our results in a peer-reviewed journal and present at relevant conferences.PROSPERO registration number CRD42021256934.

Objectives A core outcome set (COS) is an agreed standardised minimum collection of outcomes that should be measured and reported in research in a specific area of health. Cochrane systematic reviews (‘reviews’) are rigorous reviews on health-related topics conducted under the auspices of Cochrane. This study examines the use of existing COS to inform the choice of outcomes in Cochrane systematic reviews (‘reviews’) and investigates the views of the coordinating editors of Cochrane Review Groups (CRGs) on this topic.Methods A cohort of 100 recently published or updated Cochrane reviews were assessed for reference to a COS being used to inform the choice of outcomes for the review. Existing COS, published 2 or more years before the review publication, were then identified to assess how often a reviewer could have used a relevant COS if it was available. We asked 52 CRG coordinating editors about their involvement in COS development, how outcomes are selected for reviews in their CRG and their views of the advantages and challenges surrounding the standardisation of outcomes within their CRG.Results In the cohort of reviews from 2019, 40% (40/100) of reviewers noted problems due to outcome inconsistency across the included studies. In 7% (7/100) of reviews, a COS was referenced in relation to the choice of outcomes for the review. Relevant existing COS could be considered for a review update in 35% of the others (33/93). Most editors who responded (31/36, 86%) thought that COS should definitely or possibly be used to inform the choice of outcomes in a review.Conclusions Systematic reviewers are continuing to note outcome heterogeneity but are starting to use COS to inform their reviews. There is potential for greater uptake of COS in Cochrane reviews.