Choosing important health outcomes for comparative effectiveness research: An updated systematic review and involvement of low and middle income countries.
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ABSTRACT: Background
Core outcome sets (COS) comprise a minimum set of outcomes that should be measured and reported in all trials for a specific health condition. The COMET (Core Outcome Measures in Effectiveness Trials) Initiative maintains an up to date, publicly accessible online database of published and ongoing COS. An annual systematic review update is an important part of this process.Methods
This review employed the same, multifaceted approach that was used in the original review and the previous two updates. This approach has identified studies that sought to determine which outcomes/domains to measure in clinical trials of a specific condition. This update includes an analysis of the inclusion of participants from low and middle income countries (LMICs) as identified by the OECD, in these COS.Results
Eighteen publications, relating to 15 new studies describing the development of 15 COS, were eligible for inclusion in the review. Results show an increase in the use of mixed methods, including Delphi surveys. Clinical experts remain the most common stakeholder group involved. Overall, only 16% of the 259 COS studies published up to the end of 2016 have included participants from LMICs.Conclusion
This review highlights opportunities for greater public participation in COS development and the involvement of stakeholders from a wider range of geographical settings, in particular LMICs.
SUBMITTER: Davis K
PROVIDER: S-EPMC5810981 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BACKGROUND:A COS represents an agreed minimum set of outcomes that should be measured and reported in all trials of a specific condition. The COMET (Core Outcome Measures in Effectiveness Trials) initiative aims to collate and stimulate the development and application of COS, by including data on relevant studies within a publically available internet-based resource. In recent years, there has been an interest in increasing the development of COS. Therefore, this study aimed to provide an update of a previous review, and examine the quality of development of COS. A further aim was to understand the reasons why individuals are searching the COMET database. METHODS:A multi-faceted search strategy was followed, in order to identify studies that sought to determine which outcomes/domains to measure in clinical trials of a specific condition. Additionally, a pop up survey was added to the COMET website, to ascertain why people were searching the COMET database. RESULTS:Thirty-two reports relating to 29 studies were eligible for inclusion in the review. There has been an improvement in the description of the scope of a COS and an increase in the proportion of studies using literature/systematic reviews and the Delphi technique. Clinical experts continue to be the most common group involved in developing COS, however patient and public involvement has increased. The pop-up survey revealed the most common reasons for visiting the COMET website to be thinking about developing a COS and planning a clinical trial. CONCLUSIONS:This update demonstrates that recent studies appear to have adopted a more structured approach towards COS development and public representation has increased. However, there remains a need for developers to adequately describe details about the scope of COS, and for greater public engagement. The COMET database appears to be a useful resource for both COS developers and users of COS.
| S-EPMC4718543 | biostudies-literature
Project description:BackgroundThe COMET (Core Outcome Measures in Effectiveness Trials) Initiative promotes the development and application of core outcome sets (COS), including relevant studies in an online database. In order to keep the database current, an annual search of the literature is undertaken. This study aimed to update a previous systematic review, in order to identify any further studies where a COS has been developed. Furthermore, no prioritization for COS development has previously been undertaken, therefore this study also aimed to identify COS relevant to the world's most prevalent health conditions.MethodsThe methods used in this updated review followed the same approach used in the original review and the previous update. A survey was also sent to the corresponding authors of COS identified for inclusion in this review, to ascertain what lessons they had learnt from developing their COS. Additionally, the COMET database was searched to identify COS that might be relevant to the conditions with the highest global prevalence.ResultsTwenty-five reports relating to 22 new studies were eligible for inclusion in the review. Further improvements were identified in relation to the description of the scope of the COS, use of the Delphi technique, and the inclusion of patient participants within the development process. Additionally, 33 published and ongoing COS were identified for 13 of the world's most prevalent conditions.ConclusionThe development of a reporting guideline and minimum standards should contribute towards future improvements in development and reporting of COS. This study has also described a first approach to identifying gaps in existing COS, and to priority setting in this area. Important gaps have been identified, on the basis of global burden of disease, and the development and application of COS in these areas should be considered a priority.
| S-EPMC5156438 | biostudies-literature
Project description: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.
| S-EPMC4059640 | biostudies-literature
Project description:ObjectivesPatient and public involvement (PPI) is argued to lead to higher quality health research, which is more relatable to and helps empower the public. We synthesised the evidence to look for examples of PPI in health research in low/middle-income countries (LMICs), looking at levels of involvement and impact. Additionally, we considered the impact of who was undertaking the research on the level of involvement and reported impact.DesignSystematic review.Data sourcesEMBASE, Medline and PsychINFO, along with hand-searching references, grey literature, Google search and expert advice.Eligibility criteriaAny health research with evidence of patient or public involvement, with no language restrictions dated from 1978 to 1 Dec 2017.Data extraction and synthesisData relating to stage and level of involvement, as well as impact, were extracted by one researcher (NC), and a coding framework was developed using an inductive approach to examine the impact of PPI on research. Extracted data were then independently coded by a second lay researcher (RK) to validate the data being collected. Discrepancies were referred to a third independent reviewer (MT) for review and consensus reached.ResultsSixty-two studies met the inclusion criteria. The review revealed the most common stage for PPI was in research planning, and the most common level of involvement was collaboration. Most studies did not provide evidence of effectiveness or elaborate on the impact of PPI, and they tended to report impact from the researcher's perspective. Where impact was mentioned, this generally related to increased relevance to the community, empowerment of participants and alterations in study design.ConclusionsThe literature describing approaches to and impact of PPI on LMIC health research is sparse. As PPI is essential to conducting high-quality research, it should be fully reported and evaluated at the end of the research project.
| S-EPMC6528003 | biostudies-literature
Project description:BACKGROUND:A systematic review of core outcome sets (COS) for research is updated annually to populate an online database. It is a resource intensive review to do annually but automation techniques have potential to aid the process. The production of guidance and standards in COS development means that there is now an expectation that COS are being developed and reported to a higher standard. This is the fifth update to the systematic review and will explore these issues. METHODS:Searches were carried out to identify studies published or indexed in 2018. Automated screening methods were used to rank the citations in order of relevance. The cut-off for screening was set to the top 25% in ranked priority order, following development and validation of the algorithm. Studies were eligible for inclusion if they reported the development of a COS, regardless of any restrictions by age, health condition or setting. COS were assessed against each of the Core Outcome Set-STAndards for Development (COS-STAD). RESULTS:Thirty studies describing the development of 44 COS were included in this update. Six COS (20%) were deemed to have met all 12 criteria representing the 11 minimum standards for COS development (range = 4 to 12 criteria, median = 10 criteria). All 30 COS studies met all four minimum standards for scope. Twenty-one (70%) COS met all three minimum standards for stakeholders. Twenty-three studies (77%) included patients with the condition or their representatives. The number of countries involved in the development of COS ranged from 1 to 39 (median = 10). Six studies (20%) met all four minimum standards [five criteria] for the consensus process. CONCLUSION:Automated ranking was successfully used to assist the screening process and reduce the workload of this systematic review update. With the provision of guidelines, COS are better reported and being developed to a higher standard.
| S-EPMC6907830 | biostudies-literature
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.
| S-EPMC6310275 | biostudies-literature
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.
| S-EPMC7802923 | biostudies-literature
Project description:Background: Patient and public involvement (PPI) is an active partnership between the public and researchers in the research process. In dementia research, PPI ensures that the perspectives of the person with "lived experience" of dementia are considered. To date, in many lower- and middle-income countries (LMIC), where dementia research is still developing, PPI is not well-known nor regularly undertaken. Thus, here, we describe PPI activities undertaken in seven research sites across South Asia as exemplars of introducing PPI into dementia research for the first time. Objective: Through a range of PPI exemplar activities, our objectives were to: (1) inform the feasibility of a dementia-related study; and (2) develop capacity and capability for PPI for dementia research in South Asia. Methods: Our approach had two parts. Part 1 involved co-developing new PPI groups at seven clinical research sites in India, Pakistan and Bangladesh to undertake different PPI activities. Mapping onto different "rings" of the Wellcome Trust's "Public Engagement Onion" model. The PPI activities included planning for public engagement events, consultation on the study protocol and conduct, the adaptation of a study screening checklist, development and delivery of dementia training for professionals, and a dementia training programme for public contributors. Part 2 involved an online survey with local researchers to gain insight on their experience of applying PPI in dementia research. Results: Overall, capacity and capability to include PPI in dementia research was significantly enhanced across the sites. Researchers reported that engaging in PPI activities had enhanced their understanding of dementia research and increased the meaningfulness of the work. Moreover, each site reported their own PPI activity-related outcomes, including: (1) changes in attitudes and behavior to dementia and research involvement; (2) best methods to inform participants about the dementia study; (3) increased opportunities to share knowledge and study outcomes; and (4) adaptations to the study protocol through co-production. Conclusions: Introducing PPI for dementia research in LMIC settings, using a range of activity types is important for meaningful and impactful dementia research. To our knowledge, this is the first example of PPI for dementia research in South Asia.
| S-EPMC8021770 | biostudies-literature
Project description:Patient engagement in research is marked by partnership between clinicians, scientists, and people with lived experience of a disease, who jointly develop and implement research and disseminate results. Patient engagement in research has been shown to lead to more impactful and relevant findings. There is a global need for quality research contextualized for low- and middle-income countries (LMICs). Patient involvement in research could address this need, yet it remains a practice more commonly employed in high income countries. In this paper, the authors explore LMIC-specific challenges and opportunities for patient engagement in research. Limitations to patient engagement in research include gaps in health infrastructure, socioeconomic status, cultural stigma, and uncertain roles. Potential solutions to address these challenges include strategic national and international research partnerships, initiatives to combat stigma, and sensitization and training of stakeholders in patient engagement in research. Reflecting on their patient engagement experience with eye cancer research in Canada and Kenya, and supported by evidence of patient engagement in other low-resource settings, the authors provide a roadmap for patient engagement in research in LMICs.
| S-EPMC7196100 | biostudies-literature
Project description:Introduction:There is little research on emergency care delivery in low- and middle-income countries (LMICs). To facilitate future research, we aimed to assess the set of key metrics currently used by researchers in these settings and to propose a set of standard metrics to facilitate future research. Methods:Systematic literature review of 43,109 published reports on general emergency care from 139 LMICs. Studies describing care for subsets of emergency conditions, subsets of populations, and data aggregated across multiple facilities were excluded. All facility- and patient-level statistics reported in these studies were recorded and the most commonly used metrics were identified. Results:We identified 195 studies on emergency care delivery in LMICs. There was little uniformity in either patient- or facility-level metrics reported. Patient demographics were inconsistently reported: only 33% noted average age and 63% the gender breakdown. The upper age boundary used for paediatric data varied widely, from 5 to 20 years of age. Emergency centre capacity was reported using a variety of metrics including annual patient volume (n = 175, 90%); bed count (n = 60, 31%), number of rooms (n = 48, 25%); frequently none of these metrics were reported (n = 16, 8%). Many characteristics essential to describe capabilities and performance of emergency care were not reported, including use and type of triage; level of provider training; admission rate; time to evaluation; and length of EC stay. Conclusion:We found considerable heterogeneity in reporting practices for studies of emergency care in LMICs. Standardised metrics could facilitate future analysis and interpretation of such studies, and expand the ability to generalise and compare findings across emergency care settings.
| S-EPMC6234170 | biostudies-literature