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Background The concept of core outcome sets (COS) has been introduced in China for about 10 years. In recent years, some Chinese researchers also committed to developing COS, though the majority of COS are ongoing. However, there were more than 500 published COS for research in the COMET database by 2020. The extent of availability of COS for the top 25 diseases with the highest burden in China is unknown. In addition, the uptake of COS in clinical trials for these diseases is unknown, along with the knowledge, perceptions, and views of the clinical trialist community in China on the use of COS in relation to choosing outcomes for their research. Methods The main burden of disease in China will be identified. Then we will search the COMET database to identify if there are ongoing or completed relevant COS research A COS published since 2012 would be preferred to one published before 2012 for the analysis of COS uptake if one meets the eligibility criteria. We will extract scopes of published eligible COS, including condition, population, interventions, and core outcomes. Then we will search the Chinese Clinical Trial Registry using disease names for each disease that has a published COS. We will assess the overlap in scope between clinical trials and COS. Then we will conduct an online survey and semi-structured interviews to identify the knowledge and perceptions of COS among primary investigators of included clinical trials. Discussion This research will fill in gaps between COS and the burden of disease in China. Understanding clinical trialists'knowledge and perceptions of COS may help dissemination and application of COS in the future. Trial registration This research is registered in Core Outcome Measures in Effectiveness: https://www.comet-initiative.org/Studies/Details/2563.

The Harmonising Outcome Measures for Eczema (HOME) initiative established a core outcome set (COS) for atopic eczema (AE) clinical trials in 2019. This set encompasses four core outcome domains and corresponding measurement instruments: clinical signs (EASI), patient-reported symptoms (POEM and NRS 11 point for worst itch over the last 24 h), quality of life (DLQI/CDLQI/IDQoLI), and long-term control (Recap or ADCT). Following its roadmap, the HOME initiative is now focused on supporting implementation of the COS. To identify barriers and facilitators to implementation of the COS, and to guide the effort to promote COS uptake, a virtual consensus meeting was held over 2 days (September 25–26, 2021) attended by 55 participants (26 healthcare professionals, 16 methodologists, 5 patients, 4 industry representatives, and 4 students). Implementation themes were identified by a pre-meeting survey distributed to HOME members, presentations, and whole-group discussion. Participants were divided into five multi-professional small groups which ranked their top 3 most important themes, followed by whole-group discussion and anonymous consensus voting (consensus criteria: < 30% disagreement). Three most important implementation themes were identified and agreed upon: (1) awareness and stakeholder engagement, (2) universal applicability of the COS, and (3) ensuring minimum administrative burden. Working groups to address these issues are now a priority for the HOME initiative. The results from this meeting will inform the development of a HOME Implementation Roadmap in an effort to support other COS groups planning for effective implementation of their core sets.

Heterogeneity in what and how outcomes are measured in childhood obesity prevention trials limits evidence synthesis and evaluation of intervention effectiveness. Core Outcome Sets (COS) and Core Outcome Measurement Sets (COMS) can standardize measurement and reporting across trials, but only if they are used by trialists. This study examined trialists’ awareness and attitudes toward two childhood obesity–related COS and factors influencing their use; characteristics of Outcome Measurement Instruments (OMIs) used in childhood obesity prevention trials; and how trialists choose these OMIs. An online, international, cross-sectional survey was conducted including trialists engaged in designing and/or conducting childhood obesity prevention trials in children aged 0–5 years. Trialists were recruited via peer-reviewed publications, the Transforming Obesity Prevention for CHILDren Collaboration and professional contacts. The survey examined trialist characteristics, awareness, and use of existing COS, OMI characteristics, and factors influencing trialist selection of OMIs. Quantitative data were analyzed descriptively; qualitative data were analyzed using content analysis. The majority of the 46 trialists who completed the survey were senior-career researchers (61%; n = 28), with 1 to 38 years' experience in childhood obesity prevention trials. Seventy percent (n = 32) were familiar with COS in general; 84% (n = 26) of these were familiar with one or both childhood obesity–related COS. These trialists' COS use was limited by perceived participant burden, cost, and lack of knowledge; availability of guidelines, and resources facilitated COS use. Trialists favored measuring outcomes using existing (83%; n = 38) and adapted (80%; n = 37) questionnaires, and anthropometric measures (80%; n = 37). Quantitative and qualitative data indicated that measurement properties (eg, reliability, validity), cost, perceived burden, ease of use, and feasibility were the most important factors influencing trialists’ OMI choice. Trialists’ awareness and use of childhood obesity–related COS is positive, and may be enhanced through provision of guidance and resources to support COS and COMS use. Development of COMS should consider trialist-reported factors related to feasibility and measurement properties. Such considerations can enhance COS and COMS use in trials, reducing outcome heterogeneity, and improving evaluation of intervention effectiveness to prevent childhood obesity. •Most trialists are familiar with COS and two childhood obesity–related COS.•Burden, cost, and poor knowledge were barriers to COS use.•Available guidelines and relevant/comprehensive COS were facilitators of COS use.•Reliability, cost, and time to complete influence measurement instrument choice.

Congenital melanocytic naevi (CMN) are birthmarks that can cover large areas of the body. CMN can significantly impact individuals' lives due to perceived stigma, the risk for melanoma development and neurological complications. To treat and prevent these complications, adequate research and guidelines are needed. In this review, we present a summary of the Dutch multidisciplinary guideline and the lessons learned from the implementation and information developed additionally in collaboration with the patient association. We also introduce the core outcomes of the OCOMEN project to standardize outcomes for both research and care of CMN. The next step is the development of the instruments internationally.

Studies evaluating cosmetic gynecological interventions have followed variable methodology and reported a diversity of outcomes. Such variations limit the comparability of studies and the value of research-based evidence. The development of core outcome sets (COS) and core outcome measures sets (COMS) would help address these issues, ensuring a minimum of outcomes important to all stakeholders, primarily women requesting or having experienced cosmetic gynecological interventions. This protocol describes the methods used in developing a COS and COMS for cosmetic gynecological interventions. An international steering group within CHORUS, including health care professionals, researchers, and women with experience in cosmetic gynecological interventions from 4 continents, will guide the development of COS and COMS. Potential outcome measures and outcomes will be identified through comprehensive literature reviews. These potential COS and COMS will be entered into an international, multi-perspective web-based Delphi survey where Delphi participants judge which domains will be core. A priori thresholds for consensus will get established before each Delphi round. The Delphi survey results will be evaluated quantitatively and qualitatively in subsequent stakeholder group consensus meetings in the process of establishing \"core\" outcomes. Dissemination and implementation of the resulting COS and COMS within an international context will be promoted and reviewed. This protocol presents the steps in developing a COS and COMS for cosmetic gynecological interventions. Embedding the COS and COMS for cosmetic gynecological interventions within future clinical trials, systematic reviews, and practice guidelines could contribute to enhancing the value of research and improving overall patient care. Core Outcome Measures in Effectiveness Trials (COMET) 1592; https://tinyurl.com/n8faysuh. PRR1-10.2196/28032.

There is increasing recognition that insufficient attention has been paid to the choice of outcomes measured in clinical trials. The lack of a standardized outcome classification system results in inconsistencies due to ambiguity and variation in how outcomes are described across different studies. Being able to classify by outcome would increase efficiency in searching sources such as clinical trial registries, patient registries, the Cochrane Database of Systematic Reviews, and the Core Outcome Measures in Effectiveness Trials (COMET) database of core outcome sets (COS), thus aiding knowledge discovery. A literature review was carried out to determine existing outcome classification systems, none of which were sufficiently comprehensive or granular for classification of all potential outcomes from clinical trials. A new taxonomy for outcome classification was developed, and as proof of principle, outcomes extracted from all published COS in the COMET database, selected Cochrane reviews, and clinical trial registry entries were classified using this new system. Application of this new taxonomy to COS in the COMET database revealed that 274/299 (92%) COS include at least one physiological outcome, whereas only 177 (59%) include at least one measure of impact (global quality of life or some measure of functioning) and only 105 (35%) made reference to adverse events. This outcome taxonomy will be used to annotate outcomes included in COS within the COMET database and is currently being piloted for use in Cochrane Reviews within the Cochrane Linked Data Project. Wider implementation of this standard taxonomy in trial and systematic review databases and registries will further promote efficient searching, reporting, and classification of trial outcomes.

To examine current practices in late-phase trials published in major medical journals and examine trialists’ views about core outcome set (COS) use. A sequential multi-methods study was conducted. We examined late-phase trials published between October 2019 and March 2020 in JAMA, NEJM, The Lancet, BMJ, and Annals of Internal Medicine. The COMET database was searched for COS potentially relevant to trials not reporting using a COS; overlap of trial and COS outcomes was examined. An online survey examined awareness of, and decisions to search for and use a COS. Ninety-five trials were examined; 93 (98%) did not report using a COS. Relevant COS were identified for 31 trials (33%). Core outcomes were measured in 9 (23%) studies; all trials measured at least one core outcome. Thirty-one trialists (33%) completed our survey. The most common barrier to COS use was trialist's own outcome preferences and choice (68%). The most common perceived facilitator was awareness and knowledge about COS (90%). COS use in this cohort of trials was low, even when relevant COS were available. Increased use of COS in clinical trials can improve evaluation of intervention effects and evidence synthesis and reduce research waste.

The importance of including patients, carers, and the public in health research is well recognized, including the need to consider outcomes in health care research that reflect the priorities of patients. Core outcome sets (COS) define the minimum set of outcomes that should be measured and reported in research of a given condition, determined through consensus among key stakeholders. The Core Outcome Measures in Effectiveness Trials Initiative undertakes an annual systematic review (SR) to identify newly published COS to update its online database of COS for research. The objective of this study was to assess the impact of patient participation on COS. SR methods used in previous updates were applied to identify research studies published or indexed in 2020 and 2021 (conducted as separate reviews) that report development of a COS, regardless of any specifications relating to condition, population, intervention, or setting. Studies were assessed according to published standards for COS development, and core outcomes extracted from study publications were categorized according to an outcome taxonomy and added to an existing database of core outcome classifications of all previously published COS. The effect of patient participation on core domains was examined. Searches identified 56 new studies published in 2020 and 54 in 2021. All studies met all four minimum standards for scope, and 42 (75%) of the 2020 studies and 45 (83%) of the 2021 studies met all three standards for stakeholders involved. However, only 19 (34%) of the 2020 studies and 18 (33%) of the 2021 studies met all four standards for the consensus process. COS that involved patients or their representatives are more likely to include life impact outcomes (239, 86%) than COS without patient participation (193, 62%). Physiological/clinical outcomes are almost always specified at a granular level, whereas life impact outcomes are often described at a higher level. This study adds to the body of evidence demonstrating the importance and impact of including patients, carers, and the public in COS development, in particular by demonstrating that the impact of interventions on patients’ lives is more likely to be represented in COS that involve patients or their representatives. COS developers are encouraged to pay increased attention to methods and reporting relating to the consensus process. Further work is required to understand the appropriateness and rationale for the discrepancy in granularity levels between outcome domains.

Clinical research should ultimately improve patient care. For this to be possible, trials must evaluate outcomes that genuinely reflect real-world settings and concerns. However, many trials continue to measure and report outcomes that fall short of this clear requirement. We highlight problems with trial outcomes that make evidence difficult or impossible to interpret and that undermine the translation of research into practice and policy. These complex issues include the use of surrogate, composite and subjective endpoints; a failure to take account of patients’ perspectives when designing research outcomes; publication and other outcome reporting biases, including the under-reporting of adverse events; the reporting of relative measures at the expense of more informative absolute outcomes; misleading reporting; multiplicity of outcomes; and a lack of core outcome sets. Trial outcomes can be developed with patients in mind, however, and can be reported completely, transparently and competently. Clinicians, patients, researchers and those who pay for health services are entitled to demand reliable evidence demonstrating whether interventions improve patient-relevant clinical outcomes.

To review evidence about the uptake of core outcome sets (COS). A COS is an agreed standardized set of outcomes that should be measured and reported, as a minimum, in all clinical trials in a specific area of health or healthcare. This article provides an analysis of what is known about the uptake of COS in research. Similarities between COS and outcomes recommended by stakeholders in the evidence ecosystem is reviewed and actions taken by them to facilitate COS uptake described. COS uptake is low in most research areas. Common facilitators relate to trialist awareness and understanding. Common barriers were not including in the development process all specialties that might use the COS and the lack of recommendations for how to measure the outcomes. Increasingly, COS developers are considering strategies for promoting uptake earlier in the process, including actions beyond traditional dissemination approaches. An overlap between COS and outcomes in regulatory documents and health technology assessments is good. An increasing number and variety of organizations are recommending COS be considered. We suggest actions for various stakeholders for improving COS uptake. Research is needed to assess the impact of these actions to identify effective evidence-based strategies.