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      A systematic review finds Core Outcome Set uptake varies widely across different areas of health

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          Abstract

          Objective

          The aim of our review was to bring together studies that had assessed the uptake of core outcome sets (COS) to explore the level of uptake across different COS and areas of health.

          Study Design and Setting

          We examined the citations of 337 COS reports to identify studies that had assessed the uptake of a particular COS in randomized controlled trials (RCTs) or systematic reviews (SRs).

          Results

          We identified 24 studies that had assessed uptake in RCTs and two studies that had assessed uptake in SRs. The studies covered a total of 17/337 (5%) COS. Uptake rates reported for RCTs varied from 0% of RCTs (gout) to 82% RCTs (rheumatoid arthritis) measuring the full COS. Studies that assessed uptake of individual core outcomes showed a wide variation in uptake between the outcomes. Suggested barriers to uptake included lack of validated measures, lack of patient and other key stakeholder involvement in COS development, and lack of awareness of the COS.

          Conclusions

          Few studies have been undertaken to assess the uptake of COS in RCTs and SRs. Further studies are needed to assess whether COS have been implemented across a wider range of disease categories and to explore the barriers and facilitators to COS uptake.

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          Comparison of PubMed, Scopus, Web of Science, and Google Scholar: strengths and weaknesses.

          Matthew E. Falagas, Eleni Pitsouni, George Malietzis … (2008)
          The evolution of the electronic age has led to the development of numerous medical databases on the World Wide Web, offering search facilities on a particular subject and the ability to perform citation analysis. We compared the content coverage and practical utility of PubMed, Scopus, Web of Science, and Google Scholar. The official Web pages of the databases were used to extract information on the range of journals covered, search facilities and restrictions, and update frequency. We used the example of a keyword search to evaluate the usefulness of these databases in biomedical information retrieval and a specific published article to evaluate their utility in performing citation analysis. All databases were practical in use and offered numerous search facilities. PubMed and Google Scholar are accessed for free. The keyword search with PubMed offers optimal update frequency and includes online early articles; other databases can rate articles by number of citations, as an index of importance. For citation analysis, Scopus offers about 20% more coverage than Web of Science, whereas Google Scholar offers results of inconsistent accuracy. PubMed remains an optimal tool in biomedical electronic research. Scopus covers a wider journal range, of help both in keyword searching and citation analysis, but it is currently limited to recent articles (published after 1995) compared with Web of Science. Google Scholar, as for the Web in general, can help in the retrieval of even the most obscure information but its use is marred by inadequate, less often updated, citation information.
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            Systematic Review of the Empirical Evidence of Study Publication Bias and Outcome Reporting Bias

            Kerry Dwan, Douglas G. Altman, Juan A. Arnaiz … (2008)
            Background The increased use of meta-analysis in systematic reviews of healthcare interventions has highlighted several types of bias that can arise during the completion of a randomised controlled trial. Study publication bias has been recognised as a potential threat to the validity of meta-analysis and can make the readily available evidence unreliable for decision making. Until recently, outcome reporting bias has received less attention. Methodology/Principal Findings We review and summarise the evidence from a series of cohort studies that have assessed study publication bias and outcome reporting bias in randomised controlled trials. Sixteen studies were eligible of which only two followed the cohort all the way through from protocol approval to information regarding publication of outcomes. Eleven of the studies investigated study publication bias and five investigated outcome reporting bias. Three studies have found that statistically significant outcomes had a higher odds of being fully reported compared to non-significant outcomes (range of odds ratios: 2.2 to 4.7). In comparing trial publications to protocols, we found that 40–62% of studies had at least one primary outcome that was changed, introduced, or omitted. We decided not to undertake meta-analysis due to the differences between studies. Conclusions Recent work provides direct empirical evidence for the existence of study publication bias and outcome reporting bias. There is strong evidence of an association between significant results and publication; studies that report positive or significant results are more likely to be published and outcomes that are statistically significant have higher odds of being fully reported. Publications have been found to be inconsistent with their protocols. Researchers need to be aware of the problems of both types of bias and efforts should be concentrated on improving the reporting of trials.
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              How to select outcome measurement instruments for outcomes included in a “Core Outcome Set” – a practical guideline

              Cecilia Prinsen, Sunita Vohra, Michael Rose … (2016)
              Background In cooperation with the Core Outcome Measures in Effectiveness Trials (COMET) initiative, the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) initiative aimed to develop a guideline on how to select outcome measurement instruments for outcomes (i.e., constructs or domains) included in a “Core Outcome Set” (COS). A COS is an agreed minimum set of outcomes that should be measured and reported in all clinical trials of a specific disease or trial population. Methods Informed by a literature review to identify potentially relevant tasks on outcome measurement instrument selection, a Delphi study was performed among a panel of international experts, representing diverse stakeholders. In three consecutive rounds, panelists were asked to rate the importance of different tasks in the selection of outcome measurement instruments, to justify their choices, and to add other relevant tasks. Consensus was defined as being achieved when 70 % or more of the panelists agreed and when fewer than 15 % of the panelists disagreed. Results Of the 481 invited experts, 120 agreed to participate of whom 95 (79 %) completed the first Delphi questionnaire. We reached consensus on four main steps in the selection of outcome measurement instruments for COS: Step 1, conceptual considerations; Step 2, finding existing outcome measurement instruments, by means of a systematic review and/or a literature search; Step 3, quality assessment of outcome measurement instruments, by means of the evaluation of the measurement properties and feasibility aspects of outcome measurement instruments; and Step 4, generic recommendations on the selection of outcome measurement instruments for outcomes included in a COS (consensus ranged from 70 to 99 %). Conclusions This study resulted in a consensus-based guideline on the methods for selecting outcome measurement instruments for outcomes included in a COS. This guideline can be used by COS developers in defining how to measure core outcomes. Electronic supplementary material The online version of this article (doi:10.1186/s13063-016-1555-2) contains supplementary material, which is available to authorized users.
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                Author and article information

                Contributors
                Karen L. Hughes
                Journal
                Journal ID (nlm-ta): J Clin Epidemiol
                Journal ID (iso-abbrev): J Clin Epidemiol
                Title: Journal of Clinical Epidemiology
                Publisher: Elsevier
                ISSN (Print): 0895-4356
                ISSN (Electronic): 1878-5921
                Publication date PMC-release: 1 January 2021
                Publication date (Print): January 2021
                Volume: 129
                Pages: 114-123
                Affiliations
                [a ]MRC North West Hub for Trials Methodology Research, Department of Health Data Science, University of Liverpool, Block F Waterhouse Building, 1-5 Brownlow Street, Liverpool L69 3GL, United Kingdom
                [b ]Centre for Public Health, Institute of Clinical Sciences, Block B, Queen's University Belfast, Royal Victoria Hospital, Grosvenor Road, Belfast BT12 6BA, United Kingdom
                Author notes
                [∗ ]Corresponding author. MRC North West Hub for Trials Methodology Research, Department of Health Data Science, University of Liverpool, Block F Waterhouse Building, 1-5 Brownlow Street, Liverpool L69 3GL, UK. Tel.: +44 (0)151 794 9753. Karen.Hughes@ 123456liverpool.ac.uk
                Article
                Publisher Item ID: S0895-4356(20)31115-X
                DOI: 10.1016/j.jclinepi.2020.09.029
                PMC ID: 7815247
                PubMed ID: 32987162
                SO-VID: 8554a72e-a7c9-48ba-8d14-44cf32dd6d76
                Copyright © © 2020 The Authors
                License:

                This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).

                History
                Date accepted : 9 September 2020
                Categories
                Subject: Original Article

                ScienceOpen disciplines: Public health
                Keywords: core outcome set,cos,uptake,clinical trials,systematic reviews,research waste
                Data availability:
                ScienceOpen disciplines: Public health
                Keywords: core outcome set, cos, uptake, clinical trials, systematic reviews, research waste

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