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Choosing important health outcomes for comparative effectiveness research: a systematic review.

ABSTRACT: A core outcome set (COS) is a standardised set of outcomes which should be measured and reported, as a minimum, in all effectiveness trials for a specific health area. This will allow results of studies to be compared, contrasted and combined as appropriate, as well as ensuring that all trials contribute usable information. The COMET (Core Outcome Measures for Effectiveness Trials) Initiative aims to support the development, reporting and adoption of COS. Central to this is a publically accessible online resource, populated with all available COS. The aim of the review we report here was to identify studies that sought to determine which outcomes or domains to measure in all clinical trials in a specific condition and to describe the methodological techniques used in these studies.We developed a multi-faceted search strategy for electronic databases (MEDLINE, SCOPUS, and Cochrane Methodology Register). We included studies that sought to determine which outcomes/domains to measure in all clinical trials in a specific condition.A total of 250 reports relating to 198 studies were judged eligible for inclusion in the review. Studies covered various areas of health, most commonly cancer, rheumatology, neurology, heart and circulation, and dentistry and oral health. A variety of methods have been used to develop COS, including semi-structured discussion, unstructured group discussion, the Delphi Technique, Consensus Development Conference, surveys and Nominal Group Technique. The most common groups involved were clinical experts and non-clinical research experts. Thirty-one (16%) studies reported that the public had been involved in the process. The geographic locations of participants were predominantly North America (n?=?164; 83%) and Europe (n?=?150; 76%).This systematic review identified many health areas where a COS has been developed, but also highlights important gaps. It is a further step towards a comprehensive, up-to-date database of COS. In addition, it shows the need for methodological guidance, including how to engage key stakeholder groups, particularly members of the public.

SUBMITTER: Gargon E

PROVIDER: S-EPMC4059640 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

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Choosing important health outcomes for comparative effectiveness research: a systematic review.

Gargon Elizabeth E Gurung Binu B Medley Nancy N Altman Doug G DG Blazeby Jane M JM Clarke Mike M Williamson Paula R PR

PloS one 20140616 6

<h4>Background</h4>A core outcome set (COS) is a standardised set of outcomes which should be measured and reported, as a minimum, in all effectiveness trials for a specific health area. This will allow results of studies to be compared, contrasted and combined as appropriate, as well as ensuring that all trials contribute usable information. The COMET (Core Outcome Measures for Effectiveness Trials) Initiative aims to support the development, reporting and adoption of COS. Central to this is a ...[more]

PMID: 24932522

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Project description:BackgroundThe Core Outcome Measures in Effectiveness Trials (COMET) database is a publically available, searchable repository of published and ongoing core outcome set (COS) studies. An annual systematic review update is carried out to maintain the currency of database content.MethodsThe methods used in the fourth update of the systematic review followed the same approach used in the original review and previous updates. Studies were eligible for inclusion if they reported the development of a COS, regardless of any restrictions by age, health condition or setting. Searches were carried out in March 2018 to identify studies that had been published or indexed between January 2017 and the end of December 2017.ResultsForty-eight new studies, describing the development of 56 COS, were included. There has been an increase in the number of studies clearly specifying the scope of the COS in terms of the population (n = 43, 90%) and intervention (n = 48, 100%) characteristics. Public participation has continued to rise with over half (n = 27, 56%) of studies in the current review including input from members of the public. The rate of inclusion of all stakeholder groups has increased, in particular participation from non-clinical research experts has risen from 32% (mean average in previous reviews) to 62% (n = 29). Input from participants located in Australasia (n = 17; 41%), Asia (n = 18; 44%), South America (n = 13; 32%) and Africa (n = 7; 17%) have all increased since the previous reviews.ConclusionThis update included a pronounced increase in the number of new COS identified compared to the previous three updates. There was an improvement in the reporting of the scope, stakeholder participants and methods used. Furthermore, there has been an increase in participation from Australasia, Asia, South America and Africa. These advancements are reflective of the efforts made in recent years to raise awareness about the need for COS development and uptake, as well as developments in COS methodology.

Project description:BackgroundAn annual update to a systematic review of core outcome sets (COS) for research ensures that the COMET database is up-to-date. The aims of this study were to: (i) identify COS that were published or indexed in 2019 and to describe the methodological approaches used in these studies; (ii) investigate whether children have been included as participants in published COS development studies, and which methods have been used to facilitate their participation; iii) update a previous exercise to identify COS relevant to the most burdensome global diseases and injuries.MethodsMEDLINE and SCOPUS were searched to identify studies published or indexed between (and inclusive of) January 2019 and December 2019. Automated screening methods were used to rank the citations in order of relevance; the top 25% in ranked priority order were screened for eligibility. COS were assessed against each of the Core Outcome Set-STAndards for Development (COS-STAD). A search of the COMET database was undertaken to identify COS relevant to the 25 leading causes of disease burden.ResultsThirty-three studies, describing the development of 37 COS, were included in this update. These studies have been added to the COMET database, which now contains 370 published (1981-2019) COS studies for clinical research. Six (18%) of the 33 studies in this update were deemed to have met all of the minimum standards for COS development (range = 4 to 12 criteria, median = 9 criteria). Of the 370 COS studies published to date, 82 COS have been developed for paediatric health conditions and children would have been eligible to participate in 68/82 of these studies. Eleven of these 68 (16%) COS studies have included children as participants within the development process, most commonly through participation in Delphi surveys. Relevant COS were identified for 22/25 leading causes of global disease burden.ConclusionThere has been a demonstrated increase in COS developed for both research and routine practice, and consistently high inclusion of patient participants. COS developed for paediatric conditions need to further incorporate the perspectives of children, alongside parents and other adults, and adopt research methods fit for this purpose. COS developers should consider the gaps identified in this update as priorities for COS development.

Project description:BACKGROUND:As mobile technology continues expanding, researchers have been using mobile phones to conduct health interventions (mobile health-mHealth-interventions). The multiple features of mobile phones offer great opportunities to disseminate large-scale, cost-efficient, and tailored messages to participants. However, the interventions to date have shown mixed results, with a large variance of effect sizes (Cohen d=-0.62 to 1.65). OBJECTIVE:The study aimed to generate cumulative knowledge that informs mHealth intervention research. The aims were twofold: (1) to calculate an overall effect magnitude for mHealth interventions compared with alternative interventions or conditions, and (2) to analyze potential moderators of mHealth interventions' comparative efficacy. METHODS:Comprehensive searches of the Communication & Mass Media Complete, PsycINFO, Web of Knowledge, Academic Search Premier, PubMed and MEDLINE databases were conducted to identify potentially eligible studies in peer-reviewed journals, conference proceedings, and dissertations and theses. Search queries were formulated using a combination of search terms: "intervention" (Title or Abstract) AND "health" (Title or Abstract) AND "*phone*" OR "black-berr*" (OR mHealth OR "application*" OR app* OR mobile OR cellular OR "short messag*" OR palm* OR iPhone* OR MP3* OR MP4* OR iPod*) (Title or Abstract). Cohen d was computed as the basic unit of analysis, and the variance-weighted analysis was implemented to compute the overall effect size under a random-effects model. Analysis of variance-like and meta-regression models were conducted to analyze categorical and continuous moderators, respectively. RESULTS:The search resulted in 3424 potential studies, the abstracts (and full text, as necessary) of which were reviewed for relevance. Studies were screened in multiple stages using explicit inclusion and exclusion criteria, and citations were evaluated for inclusion of qualified studies. A total of 64 studies were included in the current meta-analysis. Results showed that mHealth interventions are relatively more effective than comparison interventions or conditions, with a small but significant overall weighted effect size (Cohen d=0.31). In addition, the effects of interventions are moderated by theoretical paradigm, 3 engagement types (ie, changing personal environment, reinforcement tracking, social presentation), mobile use type, intervention channel, and length of follow-up. CONCLUSIONS:To the best of our knowledge, this is the most comprehensive meta-analysis to date that examined the overall effectiveness of mHealth interventions across health topics and is the first study that statistically tested moderators. Our findings not only shed light on intervention design using mobile phones, but also provide new directions for research in health communication and promotion using new media. Future research scholarship is needed to examine the effectiveness of mHealth interventions across various health issues, especially those that have not yet been investigated (eg, substance use, sexual health), engaging participants using social features on mobile phones, and designing tailored mHealth interventions for diverse subpopulations to maximize effects.

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Choosing important health outcomes for comparative effectiveness research: a systematic review.

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Choosing important health outcomes for comparative effectiveness research: a systematic review.

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