OBJECTIVES:This study aims to address the status of children's and caregivers' participation in the development of paediatric core outcome sets (COS). METHODS:We included all paediatric COS from a previous systematic review and searched the Core Outcome Measures in Effectiveness Trials database to 26 February 2024 for recent paediatric COS. We used descriptive and thematic analysis methods to present the characteristics of the included COS and to describe children's and caregivers' participation in the development, including any facilitators and barriers. We assessed the degree of participation of children and caregivers in two steps: by rating whether their views were considered in forming the outcome list (yes/no) and then whether their views were integrated in determining the most important outcomes (fully integrated/partially integrated/not integrated). RESULTS:A total of 114 paediatric COS were included. 60 (53%) COS involved children and caregivers in the development process. 29 (48%) of the 60 COS considered children's and caregivers' views in forming the initial outcome list, which was most often conducted by interview (n=12 of 29, 41%). Regarding determining the most important outcomes, 35 (58%) of the 60 COS fully integrated children's and caregivers' views, and the most common method was the Delphi survey with consensus meeting (n=29 of 35, 83%); the youngest child participants were aged 7 years. The most frequently mentioned facilitator of children's and caregivers' participation was the engagement of patient groups or organisations. CONCLUSION AND RELEVANCE:We evaluated the degree of children's and caregivers' participation in the development of COS and found that strategies to promote children's and caregivers' participation should be constructed.

BackgroundThe 2019 WHO strategy to reduce snakebite burden emphasises the need for fostering research on snakebite treatments. A core outcome set (COS) is a consensus minimal list of outcomes that should be measured in research on a particular condition. We aimed to develop a COS for snakebite research in South Asia, the region with the highest burden.MethodsWe used data from a systematic review of outcomes to develop a long list of outcomes which were rated in two rounds of online Delphi survey with healthcare providers, patients and the public, and potential COS users to develop a COS for intervention research on snakebite treatments in South Asia for five intervention groups. Subsequently, meetings, consultations and workshops were organised to reach further consensus. We defined the consensus criteria a priori.ResultsOverall, 72 and 61 people, including patients and the public, participated in round I and round II of the Delphi, respectively. Consensus COSs (including definition and time points) were developed for interventions that prevent adverse reaction to snake antivenom (three outcomes), specifically manage neurotoxic manifestations (five outcomes), specifically manage haematological manifestations (five outcomes) and those that act against snake venom (seven) outcomes. A priori criteria for inclusion in COS were not met for COS on interventions for management of the bitten part.ConclusionThe COS contributes to improving research efficiency by standardising outcome measurement in South Asia. It also provides methodological insights for future development of COS, beyond snakebite.

Abstract Background Core outcome sets (COS) standardise the outcomes reported in clinical trials and research, reducing outcome heterogeneity and enabling evidence synthesis. Most neonatal COS have been developed in high-income country (HIC) contexts and may not reflect the priorities, health system capacities, or disease burden of low- and middle-income countries (LMICs). Kenya’s neonatal mortality rate remains high at 21 per 1000 live births, yet no COS exists for neonatal care and research in Kenya or, more broadly, in sub-Saharan Africa. This study aimed to develop a contextually appropriate COS for neonatal care and research in Kenya, and to assess the feasibility of adapting an existing HIC COS for use in an LMIC setting. Methods A mixed qualitative and consensus-based approach was used, guided by the COMET handbook. The process comprised three phases: a rapid review of outcomes reported in neonatal trials from sub-Saharan Africa compared with an existing HIC COS; qualitative stakeholder engagement through key informant interviews (KIIs) and focus group discussions (FGDs) with healthcare providers, national-level policymakers, and mothers of previously admitted neonates at two Kenyan hospitals representing urban and rural settings; and an in-person consensus workshop using the nominal group technique with 13 multidisciplinary stakeholders. Thematic analysis followed Braun and Clarke’s six-phase framework. Outcomes endorsed by ≥ 70% of consensus meeting participants were included in the final COS. Results Seventeen stakeholders participated in KIIs, and 15 mothers participated in two FGDs. Sixteen candidate outcomes were presented at the consensus meeting. Five outcomes achieved immediate universal consensus: survival, length of hospital stay, ability to feed/weight gain/growth, cognitive ability, and visual impairment/retinopathy of prematurity (RoP). Following discussion and voting, a further seven outcomes were endorsed: impact on mothers and wider family, financial costs to the mother, pain, adverse events due to medicines, respiratory distress, quality of life, and sepsis/infections. The final COS comprises twelve outcomes. Seven overlapped with the existing HIC COS, though with contextually adapted definitions. Five outcomes are Kenya-specific, reflecting the out-of-pocket payment structure, high comorbidity burden, and family-centred care priorities of the Kenyan health system. Conclusions Adapting an HIC neonatal COS for use in an LMIC context is feasible, but requires systematic definitional adaptation, engagement with existing local frameworks such as WHO Essential Newborn Care guidelines, and attention to diagnostic capacity constraints. The Kenya COS captures both clinical and life-impact outcomes, reflecting the priorities of diverse stakeholder groups including mothers. Realising its value requires phased implementation sensitive to urban–rural differences in facility capacity, investment in workforce training, and stronger collaboration between clinicians and researchers to ensure outcome measurement serves both care improvement and evidence generation. Trial registration This is not a clinical trial. Clinical trial number: not applicable.

Parts of this abstract have been reproduced from Flohr C, Rosala-Hallas A, Jones AP, Beattie P, Baron S, Browne F, et al.; TREAT Trial Investigators. Efficacy and safety of ciclosporin versus methotrexate in the treatment of severe atopic dermatitis in children and young people (TREAT): a multicentre parallel-group assessor-blinded clinical trial. Br J Dermatol 2023;189:674–84. https://doi.org/10.1093/bjd/ljad281. This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) licence, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: https://creativecommons.org/licenses/by/4.0/. The text below includes minor additions and formatting changes to the original text. Background Atopic dermatitis is a chronic, inflammatory skin disease characterised by intensely itchy skin. Atopic dermatitis has the highest disease burden among cutaneous diseases as measured by disability-adjusted life-years and approximately 20% of United Kingdom children experience atopic dermatitis, of whom 16% have moderate or severe forms. Treatment options for severe childhood atopic dermatitis are limited, and this is compounded by the lack of widely available information regarding short- and long-term side effects and cost-effectiveness of different treatments. Ciclosporin is the most commonly used systemic treatment for severe paediatric atopic dermatitis, but methotrexate is being increasingly used as an alternative first-line systemic treatment. Although these medications are regularly used off-licence in children with severe atopic dermatitis, there had been no firm evidence about the effectiveness, safety, cost-effectiveness, or impact on quality of life from an adequately powered randomised controlled trial using systemic medication in children. Design and methods The TREatment of severe Atopic dermatitis Trial addressed this gap, assessing potential differences in the speed of onset, effectiveness, side-effect profiles and reduction in flares post treatment between ciclosporin and methotrexate, and the cost-effectiveness of the drugs. Treatment impact on quality of life was also examined in addition to whether filaggrin genotype influences treatment response. Furthermore, the trial studied the immunological effects of ciclosporin and methotrexate. TREatment of severe Atopic dermatitis Trial was a multicentre, parallel-group, assessor-blind randomised controlled trial of 15 months duration (9-month treatment phase, 6-month follow-up period). In total, 103 children aged 2–16 years with moderate to severe atopic dermatitis, unresponsive to topical treatment were randomised (1 : 1) to receive methotrexate (0.4 mg/kg/week) or ciclosporin (4 mg/kg/day). Objectives The trial had two primary outcomes: change from baseline to 12 weeks in Objective Severity Scoring of Atopic Dermatitis and time to first significant flare following treatment cessation. Results The TREatment of severe Atopic dermatitis Trial found that ciclosporin had a faster onset of results compared to methotrexate up until approximately 20 weeks on treatment, with a mean difference in change between baseline and 12 weeks of −5.69 (97.5% CI −10.81 to −0.57, p = 0.013). Following this time point, methotrexate became more effective up to the end of treatment and showed better longer-term disease control; however, there was no statistically significant difference between treatment groups in the time to first significant flare after treatment cessation (log-rank test p = 0.15; HR = 1.55; 97.5% CI 0.77 to 3.10, p = 0.16). These results were supported by the immunological readouts measured during the study, suggesting the methotrexate-driven strengthening of the skin barrier. The data also suggest no significant benefit for increased kidney monitoring to detect renal dysfunction. A reduced need for renal monitoring would reduce both financial and carbon costs of care for patients moving forward. Limitations The primary limitations for this project include missing data from patient diaries, a small sample size for a randomised controlled trial comparing two active treatments, and a lack of hepatotoxicity marker collection. Conclusions The results of the TREatment of severe Atopic dermatitis Trial have changed the treatment paradigm for the use of conventional systemic medication, favouring methotrexate, especially because the health economics analysis found that methotrexate is more cost-effective than ciclosporin. The findings of the TREatment of severe Atopic dermatitis Trial have been incorporated into updates of international treatment guidelines for atopic dermatitis. Future work Looking forward, it would be clinically useful to conduct longer-term, real-world studies to determine the optimal duration of methotrexate treatment for atopic dermatitis. It will also be useful to take advantage of atopic dermatitis registers for future research – these provide a wealth of real-world data that can be harnessed for clinical knowledge. Funding This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Efficacy and Mechanism Evaluation programme as award number 13/50/12. Plain language summary Atopic dermatitis, also known as ‘eczema’, is a skin disease that presents with itchiness and inflammation (redness, skin dryness, flaking, and thickening). About one-fifth of United Kingdom children have atopic dermatitis and 16% of those children have moderate or severe disease. There are few treatment options available for children with severe atopic dermatitis, and there is a lack of information about the short- and long-term effectiveness of the available medications. The main option for systemic treatment (drug therapies that work throughout the whole body) is ciclosporin, but a medication called methotrexate is being increasingly used. Even though many clinicians prescribe these medications, there was not much information available about the effectiveness, safety, or overall costs. The TREatment of severe Atopic dermatitis Trial compared the effectiveness, cost, and safety of ciclosporin and methotrexate in children with severe atopic dermatitis. TREatment of severe Atopic dermatitis Trial was a randomised control trial (children are randomly assigned to take either ciclosporin or methotrexate) where patients took one medication for 9 months and we watched their disease for 6 months after the end of treatment. One hundred and three children, between the ages of 2 and 16, were in our trial. The two main goals of TREatment of severe Atopic dermatitis Trial were to assess changes in disease severity and the amount of time it took for disease to come back after stopping medication. We found that ciclosporin worked faster than methotrexate up until around 20 weeks on treatment. After this, methotrexate became more effective up to the end of treatment. There was also reduced disease activity after treatment was stopped in the methotrexate group, compared to ciclosporin. This was supported by the immunological readouts, which suggested a strengthening of the skin barrier. The results have changed the treatment model for use of conventional systemic medication, favouring methotrexate, also because we found that the medication is more cost-effective. The trial is registered ISRCTN15837754 (registered 9 March 2016).

Background Awareness of COS development and use among Chinese researchers has increased since the concept was introduced in China in 2012. An increasing number of COS have been registered and completed by Chinese developers. The status of relevant COS research led by Chinese researchers and their quality remains unclear. Methods An electronic search will be conducted in the COMET, ChiCOS, and Chinese literature databases (CNKI, WanFang, and SinoMed). According to different study types (registration entry, protocol, or completed research), the information of the included studies will be extracted into different Excel tables. The extracted information depends on the type of study. The findings of the review will be presented descriptively. For protocol, we will check the quality with COS-STAP. For completed research, we will check the quality with COS-STAR and COS-STAD. In addition, we will conduct a comparative analysis to determine how many entries in the ChiCOS database have not been registered in the COMET database. Discussion This study will provide valuable insights into the current state of COS in China. This is essential for a better understanding of the barriers and facilitators to COS development and application. Study registration This research is registered in Core Outcome Measures in Effectiveness: https://www.comet-initiative.org/Studies/Details/3277.

INTRODUCTION:A growing number of paediatric core outcome sets (COS) have been developed in the past 20 years. Previous studies have provided many useful insights into the uptake of COS. In addition to the awareness of COS among clinical trialists, the COS development process (especially patient participation) and the actions of the developers can promote COS uptake. However, the uptake of COS in paediatric clinical trials needs to be further explored. The aim of this study is to provide information on the rationale and use of paediatric COS in clinical trials, and to analyse in depth the awareness and views of COS developers and clinical trialists about the development and use of COS. METHODS AND ANALYSIS:We will include all paediatric COS identified in our previous systematic review and those subsequently included in the Core Outcome Measures in Effectiveness Trials (COMET) database. We will extract the target condition, population, intervention, list of core outcomes and the details of patient involvement. Next, we will search the Clinicaltrials.gov and WHO International Clinical Trials Registry Platform for trials on health conditions addressed by the identified COS. We will assess the comparability of the scopes in each COS-trial pair and determine for the outcomes in each clinical trial if they match exactly or generally, or if they do not match, with the outcomes of their respective COS. Finally, we will conduct a survey and semistructured interviews among COS developers and clinical trialists to examine their views. ETHICS AND DISSEMINATION:Ethical approval for the study has been granted by the ethics committee of the Institute of Health Data Science, Lanzhou University (No. HDS-202405-01). This study was registered on COMET (https://www.comet-initiative.org/Studies/Details/3122).

Background: Outcome measurement is essential to progress clinical practice and improve patient care.Aim: To develop a Core Outcome Set for best care for the dying person.Design: We followed the Core Outcome Measures in Effectiveness Trials (COMET) Initiative guidelines, which involved identifying potential outcomes via a systematic literature review (n = 619 papers) and from participants in the "iLIVE" project (10 countries: 101 patients, 37 family members, 63 clinicians), followed by a two-round Delphi study, and a consensus meeting.Setting/participants: Clinicians, researchers, family members, and patient representatives from 20 countries participated in the Delphi Rounds 1 (n = 462) and 2 (n = 355). Thirty-two participants attended the consensus meeting.Results: From the systematic review and the cohort study we identified 256 and 238 outcomes respectively, from which we extracted a 52-outcome list covering areas related to the patients' physical, psychosocial, and spiritual dimensions, family support, place of care and care delivery, relational aspects of care, and general concepts. A preliminary 13-outcome list reached consensus during the Delphi. At the consensus meeting, a 14-item Core Outcome Set was ratified by the participants.Conclusions: This study involved a large and diverse sample of key stakeholders in defining the core outcome set for best care for the dying person, focusing on the last days of life. By actively integrating the perspectives of family carers and patient representatives from various cultural backgrounds this Core Outcome Set enriches our understanding of essential elements of care for the dying and provides a solid foundation for advancing quality of end-of-life care.

BACKGROUND:Inconsistent, varied and selective outcome reporting is problematic in clinical trials. Core outcome sets (COS) standardise the outcomes that should be measured and reported in all trials in a specific area of health or health care. We reviewed available cancer COS and assessed their uptake in cancer clinical trials through surveying members of the European Organisation for Research and Treatment of Cancer (EORTC). METHODS:This study employs an exploratory cross-sectional design across two phases. The Core Outcome Measures in Effectiveness Trials (COMET) Initiative database was searched for cancer-specific COS on June 1st, 2023. Awareness and use of COS amongst EORTC trialists was assessed in November 2023 via an online survey. RESULTS:We identified a total of 85 cancer-related COS on the COMET database. Of these, 69 related to the tumour types as categorised by the EORTC and their disease orientated groups. A total of 710 EORTC members responded, of whom half (50%) stated they were unfamiliar with COS. Relevant COS were available to over a quarter of respondents, with a tenth utilising available COS. Those who chose not to use an available COS cited volume of outcomes, lack of time and infrastructure for implementation as key barriers. CONCLUSIONS:While COS are becoming increasingly available to, and acknowledged by, cancer clinical trialists, their implementation is currently still limited. Our findings indicate that further development of COS to fill gaps for missing tumour types, greater involvement of trialists in the COS development process, and increased awareness and understanding of COS amongst trialists are all required to ensure widespread implementation of COS in cancer clinical trials.

OBJECTIVES:The annual systematic review update of published core outcome sets (COSs) by the Core Outcome Measures in Effectiveness Trials Initiative allows assessment of adherence to development standards. The objectives of this study were to assess the quality of COS development and the approach to the inclusion of adverse event outcomes. STUDY DESIGN AND SETTING:Studies reporting the development of a COS, published or indexed in 2022 and 2023, were identified using systematic review methods previously applied. Adherence to internationally agreed consensus-based standards for COS development was assessed. An existing outcome taxonomy was used to classify the core outcomes from all studies. The approach to consideration and inclusion of adverse event outcomes was examined. RESULTS:Fifty-eight COS development studies were included in the 2022 update and a further 40 studies in the 2023 update. Scope specification standards were fully met in all studies. Stakeholder inclusion standards were fully met in 38 (66%) and 34 (85%) of the 2022 and 2023 studies, respectively; the proportion meeting all four standards for the consensus process was lower, 13 (22%) and 13 (33%), respectively. The consideration of adverse events in the COS development process varied. Around half (54, 49%) of 2022-2023 COS included either the adverse events domain or specifically named adverse events as core outcomes. CONCLUSION:Continued improvement in adherence to recognized standards, including patient participation, is evident; however, further improvement is needed in relation to the consensus process standards. COS developers should be explicit about and explain the rationale for their approach to consideration of adverse events.

No formal assessment of a method to measure the carbon emissions from a clinical trial has been undertaken in the low- and middle-income country setting. We aimed to evaluate the UK-based National Institute of Health Research (NIHR) method for tracking trial emissions for applicability and adaptability to the South African context. Objectives included to (1) identify gaps in trial activity data, (2) locate local emission factor sources, (3) quantify emissions and (4) investigate modifications required to ensure the method was locally applicable. We adopted an application and implementation approach. We established a formal stakeholder structure focused on sustainable clinical trials to guide and support our approach. We selected a large cluster-randomised trial of a health service delivery intervention conducted across multiple urban and rural sites as an exemplar typical of local conditions to test the NIHR method. We created a trial process map outlining ten recommended activity stages for carbon emissions and an Excel workbook to calculate emissions for each stage. We prioritised calculations of those activities for which we had the most complete data: paper usage and printing, local travel between sites, and electricity consumption at the trial head office and at trial sites. We extracted activity data from organisational financial instruments. The study took place between December 2023 and March 2024. We identified a lack of publicly available local emission factor sources. Paper usage and printing activities took place at trial set-up and during intervention delivery and emitted 2274.88 kgCO2e. Field staff travel between trial sites during intervention delivery and follow-up resulted in approximately 80,000 km travelled between 2016 and 2019 contributing 17,891 kgCO2e. Electricity consumption was based on full-time equivalent staff and yielded 12,515 kgCO2e during the 4-year period. We observed large differences between UK and available SA emission factors with SA emission factors far higher than those in the UK. We found that with minor modifications, the NIHR guidance is applicable to the SA context. It is a highly adaptable framework permitting tracking of activities across trial stages. A lack of locally available emission factors reduces accuracy and emission results should be viewed as indicative.

OBJECTIVES:To review and synthesize available evidence on carbon emissions associated with clinical trials to inform future research on design and delivery of greener trials. STUDY DESIGN AND SETTING:We performed a scoping review by following the Joanna Briggs Institute guidance and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews. A systematic search was conducted on MEDLINE (Ovid) from January 1, 2007, to April 15, 2024, with no geographic and language restrictions complemented by forward and backward citation analysis (snowballing). We included all types of research literature within the context of clinical trials reporting any aspect related to trial specific carbon emissions. RESULTS:Twenty-two articles were identified as eligible and included in the review. Most included studies (n = 17, 77%) were published between 2020 and 2024. Over half of the included studies (n = 13, 59%) were primary research articles with the majority reporting carbon audits of trials and their associated processes. The remaining literature comprised secondary studies (n = 3, 14%) and opinion pieces (n = 6, 27%). Diverse and evolving approaches to studying trial-related carbon emissions were identified alongside several carbon hotspots including those associated with trial-related travel, trial facilities, and sample lifecycle. CONCLUSION:The literature on carbon emissions associated with clinical trials has focused on studies reporting carbon audits of trials and their associated processes. Efforts have been made to quantify the trial carbon output with variability in methods and carbon output. Despite the development and evolution of carbon measurement tools, strategies to mitigate trial specific carbon emissions are still much in need. PLAIN LANGUAGE SUMMARY:Clinical trials are important to the development of medicine and health care but they have great unintended environmental impacts, especially in the form of carbon emissions. We looked at the literature to understand how carbon emissions generated by clinical trials were measured, which components across trials were carbon heavy, and what could be done to reduce the carbon output of clinical trials. We found 22 relevant articles of which 13 were primary research studies. Twelve of these primary studies measured carbon output of a range of trials. Their results varied considerably because of the variability of a host of factors, such as the number of trials analyzed, trial duration, geographical scope, trial processes measured and methods for quantifying carbon emissions. Despite varied definitions of carbon hotspots, several trial activities, including trial-related travels and meetings, trial facilities, and sample and laboratory activities, were found to be carbon heavy across studies. The remaining primary research surveyed the awareness of trial carbon impact. The rest of the 22 articles consist of three secondary research studies and six opinion papers. All of them called for attention to the carbon emissions of clinical trials and offered recommendations for reducing the carbon footprint of trials. This review identified evidence that was dedicated to measuring carbon footprint of clinical trials. Despite the challenge to compare their results because of their different approaches to carbon measurement, several carbon intensive trial processes were found to be common across studies. We still require research on how to minimize the carbon output of clinical trials.

This is a secondary analysis of a multicentre randomized controlled trial of ciclosporin and methotrexate in children and young people (CYP) with severe atopic dermatitis (AD). Longitudinal trough ciclosporin and erythrocyte methotrexate polyglutamate (MTX-PG) concentrations were measured to evaluate their associations with treatment response and adverse events. Both ciclosporin (4 mg kg-1 daily) and methotrexate (0.4 mg kg-1 weekly) led to a significant reduction in disease severity scores over the 36-week treatment period. Higher trough ciclosporin concentrations were associated with lower disease severity scores and may serve as a useful tool for therapeutic drug monitoring of ciclosporin in CYP with AD. However, in contrast to a previously published study, steady-state erythrocyte-MTX-PG concentrations showed no significant association with treatment response. Drug concentrations were comparable between patients with and without drug-related adverse events.

Introduction To increase the sustainability of healthcare, clinical trials must assess the environmental impact of interventions alongside clinical outcomes. This should be guided by Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) and Consolidated Standards of Reporting Trials (CONSORT) extensions, which will be developed by The Implementing Climate and Environmental Outcomes in Trials Group. The objective of the scoping review is to describe the existing methods for reporting and measuring environmental outcomes in randomised trials. The results will be used to inform the future development of the SPIRIT and CONSORT extensions on environmental outcomes (SPIRIT-ICE and CONSORT-ICE).Methods and analysis This protocol outlines the methodology for a scoping review, which will be conducted in two distinct sections: (1) identifying any existing guidelines, reviews or methodological studies describing environmental impacts of interventions and (2) identifying how environmental outcomes are reported in randomised trial protocols and trial results. A search specialist will search major medical databases, reference lists of trial publications and clinical trial registries to identify relevant publications. Data from the included studies will be extracted independently by two review authors. Based on the results, a preliminary list of items for the SPIRIT and CONSORT extensions will be developed.Ethics and dissemination This study does not include any human participants, and ethics approval is not required according to the Declaration of Helsinki. The findings from the scoping review will be published in international peer-reviewed journals, and the findings will be used to inform the design of a Delphi survey of relevant stakeholders.Open science Registered with Open Science 28 of February 2025.

Background:Core Outcome Sets (COS) define the minimum outcomes that should be measured and reported in all clinical trials for a specific health condition or health area. The aim was to develop 2 COS for intracranial meningioma to be used in future clinical studies: COSMIC: Intervention for effectiveness trials and COSMIC: Observation for studies of incidental/untreated meningioma. Methods:A study advisory group was formed with representation from international stakeholder groups: EORTC BTG, ICOM, EANO, SNO, RANO-PRO, BNOS, SBNS, BIMS, TBTC, International Brain Tumour Alliance, and Brainstrust. Outcomes of potential relevance to key stakeholders were identified and rationalized to populate 2 eDelphi surveys. Participants were recruited internationally and asked to rate each outcome on its importance for inclusion in the COS. The 2 final COS were ratified through 2, one-day, online consensus meetings. Results:The COSMIC: Intervention eDelphi survey contained 25 items and was completed by 199 participants. Following the consensus meeting, 15 outcomes were included. The COSMIC: Observation eDelphi survey contained 17 items and was completed by 129 participants. Sixteen outcomes were included. Eight core outcomes were common to both COS; tumor growth, physical, emotional, and neurocognitive functioning, overall quality of life, progression-free survival, meningioma-specific mortality and overall survival. Role and social functioning were core outcomes in COSMIC: Observation but not COSMIC: Intervention. Conclusions:Uptake of these COS in relevant future meningioma clinical studies will ensure that stakeholder-determined, critically important outcomes are consistently measured and reported across similar clinical studies.

INTRODUCTION:The WHO has declared climate change the defining public health challenge of the 21st century. Incorporating climate and environmental outcomes in randomised trials is essential for enhancing healthcare treatments' sustainability and safeguarding global health. To implement such outcomes, it is necessary to establish a framework for unbiased and transparent planning and reporting. We aim to develop extensions to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT 2025) and Consolidated Standards of Reporting Trials (CONSORT 2025) statements by introducing guidelines for reporting climate and environmental outcomes. METHODS AND ANALYSIS:This is a protocol for SPIRIT and CONSORT extensions on reporting climate and environmental outcomes in randomised trials termed SPIRIT-Implementing Climate and Environmental (ICE) and CONSORT-ICE. The development of the extensions will consist of five phases: phase 1-project launch, phase 2-review of the literature, phase 3-Delphi survey, phase 4-consensus meeting and phase 5-dissemination and implementation. The phases are expected to overlap. The SPIRIT-ICE and CONSORT-ICE extensions will be developed in parallel. The extensions will guide researchers on how and what to report when assessing climate and environmental outcomes. ETHICS AND DISSEMINATION:The protocol was submitted to the Danish Research Ethics Committees, Denmark in June 2025. Ethics approval is expected in September 2025. The SPIRIT and CONSORT extensions will be published in international peer-reviewed journals.

Heading in football (soccer) is a complex skill involving deliberate head-to-ball contact, which may pose short-, medium-, and long-term risk to player brain health. However, understanding header exposure during matches and training sessions, as well as comparing header incidence between studies is currently challenging given the lack of standardisation in descriptors, definitions, and reporting methods. This Delphi study aimed to establish a consensus on the descriptors, definitions, and reporting methods for heading in football research to improve consistency and quality. The study involved 167 participants from diverse football-related backgrounds including coaches, players, medical personnel, and researchers, with consensus achieved to include 27 descriptors in minimum reporting criteria for heading in football research. An additional 27 descriptors were also defined for inclusion in an expanded framework. The operational definition of a header was standardised as "a head-to-ball contact where the player makes a deliberate movement to redirect the trajectory of the ball using their head." The consensus framework provides a standardised approach to heading in football research to enhance data quality and comparability across studies. Improved header incidence data quality has the potential to contribute significantly to our understanding of the risks associated with heading in football to inform future research and practice guidelines.

Objective If clinical trials measure and report the outcomes included in core outcome sets (COS) for a given condition/disease as a minimum, this has the potential to improve comparability between trials and prevent research waste. Until now, the uptake of the Bronchiectasis and Hidradenitis Suppurativa (HS) COS has not been assessed.This study assessed the uptake of Bronchiectasis and HS COS using a review of trial registries, with entries taken from ClinicalTrials.gov and the WHO International Clinical Trial Registry Platform. This uptake assessment provides valuable information to inform COS refinement and uncover areas lacking uptake to inform further dissemination requirements.Methods For each trial, the outcomes included in the trial registry entry were extracted and compared with those included in the corresponding Bronchiectasis or HS COS. The Bronchiectasis COS consists of 18 outcomes, and the HS COS, 6.Results Of the trials registered after both COS were developed in 2018, 63% (12/19) of HS trials planned to measure the full COS, whereas for Bronchiectasis, 0% (0/24) of trials planned to measure the full COS. However, of the five priority outcomes to be measured for Bronchiectasis, 4% (1/24) of trials planned to measure all five outcomes.Both COS publications’ focus was to reach consensus on what outcomes should be measured. Despite both publications referring to the Core outcome Measures for Effectiveness Trials (COMET) Handbook, which discusses the importance of COS dissemination, implementation plans were not included in either publication.Conclusions The results suggest that uptake of the HS COS is relatively good, despite yearly fluctuations, whereas for Bronchiectasis, COS uptake is limited. Further research into standardised measurement tools for HS is expected to increase uptake. The focus for Bronchiectasis, however, will be to refine the COS for feasible application in clinical trials. Future COS development publications should use all resources from the COMET initiative to ensure feasible dissemination of the COS.

Objectives To support the use of the Core Outcome Measures in Effectiveness Trials taxonomy for health outcomes, its suitability and applicability must be assessed more broadly beyond that of its early piloting phases. Demonstration of its suitability in practice would provide further support for its use in aiding the development of core outcome sets (COS), systematic reviews, and searching in online resources, thereby aiding knowledge dissemination. Study Design and Setting A citation analysis identified published studies where the taxonomy had been applied. Analysis of these publications aimed to understand the type of publication, clinical area, reason for taxonomy use or adaptation, and any comments made by researchers who had applied the taxonomy. Results Of 315 papers identified, 200 were sampled and 193 publications relating to 184 projects were analyzed. Nearly one-third (58, 30%) of publications were related to the development of COS and half (98, 51%) were related to the development of reviews (systematic, scoping, and literature). In two-thirds (123, 67%) of the projects the taxonomy was applied for the classification of health outcomes and the vast majority (117, 95%) of these did so without making any changes. Conclusion This research confirms the taxonomy is sufficiently comprehensive and granular for the classification of all patient outcomes in health research. Its application can highlight a lack of attention being paid toward outcomes most important to patients. We encourage the adoption of this classification system to facilitate evidence searching. Plain Language Summary Patient health outcomes measure things that happen to patients relating to their health. These outcomes include clinical measures (such as blood pressure), life impact measures (such as effects on physical functioning), use of resources (such as number of hospital appointments), survival (such as how long someone survives after surgery), and harms (such as adverse events following treatment). In 2018, we developed a classification system (called a taxonomy) to help researchers organize the types of outcomes that they are collecting (perhaps when carrying out a clinical trial) or reporting (eg, when combining results from many studies in a systematic review). This taxonomy was designed to help researchers to more clearly present their results, as well as to allow them to search for outcomes online in a more organized manner. We used outcomes taken from many trials and reviews when developing the taxonomy, to make sure that all types of outcomes were covered, but we wanted to make sure that researchers found the taxonomy helpful in practice. This study has been carried out to understand the opinions of researchers who mentioned the taxonomy in their publications, to find out whether they thought any types of outcomes were missing. The study found that researchers found the taxonomy useful, either to classify their research outcomes or because they found our definitions of the different types of outcomes useful. Sometimes researchers wanted to be able to classify “who” reported the outcomes (such as patients) or wanted more specific definitions of the different types of outcomes included. We would encourage them to create subcategories within our taxonomy categories to cover these outcome features. A few researchers felt that they needed to add some extra outcome types, but this was because they did not realize that these outcomes would fit within one of the existing taxonomy groups. In summary, this study found that the taxonomy is useful to researchers to classify “what” patient health outcomes are recorded in their studies, and researchers are very welcome to contact us if they have any questions about how to use it or how to classify particular outcomes.