Use Of Core Outcome Set Research Articles

Interventions facilitating the involvement of relatives of patients with acquired brain injury or malignant brain tumour: A scoping review.

To identify and map the evidence on interventions facilitating the involvement of relatives of patients with an acquired brain injury (ABI) or a malignant brain tumour (MBT). An ABI or a MBT are severe diseases that have profound impact on the lives of patients and their relatives. The well-being of the patient may be deteriorated, and relatives may experience a new role and changing caregiving tasks. Involvement of relatives seems essential, and there is a need for identifying interventions facilitating the involvement. Scoping review. The Joanna Briggs Institute methodology was used in this review and the review was reported in accordance with the PRISMA extension for scoping reviews. The literature search was conducted in MEDLINE, Embase, CINAHL and Cochrane Library. Reference lists of included studies, Google Scholar and Web of Science were also searched. In total, 46 studies were included of which 36 (78%) involved patients with stroke. Median duration of study interventions were 8 weeks, and nurses were involved as providers of the intervention in 23 (50%) studies. Thirty (65%) studies used a multicomponent intervention. Thirty-five unique outcomes were identified using 60 unique outcome measurements. Interventions facilitating the involvement of relatives differed importantly in key characteristics of study interventions, and in relation to the context in which they were used. There was no consensus regarding choice of outcomes and outcome measurements. Our results highlight the complexity of interventions in this field. To our knowledge this is the first scoping review examining interventions facilitating the involvement of relatives of patients with an acquired brain injury or a malignant brain tumour. This review suggests a clear definition of 'involvement' in future research and there is a need of development of a core outcome set for use in interventions facilitating the involvement. The scoping review was reported in accordance with the PRISMA extension for scoping reviews. The authors decided to undertake this scoping review without patient and public contribution. However, the protocol was published prior to review conduct and available to the public but we did not receive any comments on it.

P-773 The absence and heterogeneity of pregnancy outcome definitions in randomized controlled trials of infertility: an overview of the literature

Abstract Study question What proportion of infertility trials reported pregnancy and live birth, how often were these outcomes defined, and what is the consistency in their definitions? Summary answer Almost 2/3 of infertility trials did not report live birth. One in four did not define clinical pregnancy. There was considerable heterogeneity in outcome definitions. What is known already The absent or inconsistent outcome definitions in randomized controlled trials (RCTs) complicate the interpretation of the trial results and undermine evidence synthesis. While reporting live births in infertility trials has been a long-running recommendation, the extent to which this is adhered to is unclear. Furthermore, it is unknown if the use of core outcome sets in infertility has improved the standardization of outcome reporting and what is the uptake of its recommendation on reporting live birth. Study design, size, duration We studied all RCTs in reproductive medicine published between 2012 and 2023. We aim to ascertain i) whether clinical pregnancy, ongoing pregnancy and live birth were reported; and ii) whether and how these pregnancy outcomes were defined. Participants/materials, setting, methods We systematically searched Embase, Medline and CENTRAL for RCTs in reproductive medicine from 2012 to 2023. RCTs involving infertile women that reported either biochemical pregnancy, clinical pregnancy, ongoing pregnancy, or live birth were eligible, while conference abstracts, secondary analyses or non-English written RCTs were not. Two authors independently screened articles. We used text-mining to extract pregnancy definitions in R. The accuracy of automatic data extraction was verified with a random sample of 20 articles. Main results and the role of chance After screening 5708 articles, 1,311 were included, of which 21 have been retracted. Manual checks of 20 papers confirmed the accuracy of text-mining. Among 1311 RCTs, 61% of articles reported pregnancy without data on live birth, while only 14% of all RCTs reported on clinical pregnancy, ongoing pregnancy and live birth; 13% of RCTs reported pregnancy without specifying a definition (biochemical, clinical or ongoing). Definitions for clinical pregnancy, ongoing pregnancy and live birth were not provided in 27% (270/1010), 39% (153/389) and 68% (373/549) of articles reporting data on respectively clinical pregnancy, ongoing pregnancy and live birth. Among 740 clinical pregnancy definitions, 46% included gestational age (weeks), ranging from 3 to 16 weeks, typically at 6 to 7 weeks in 40% of definitions. Gestational sac and fetal heartbeat appeared respectively in 64% and 55% of the definitions. Of 236 ongoing pregnancy definitions, 94% included gestational age (weeks), stretching from 6 to 28 weeks, typically at 12 weeks in 52% of definitions. Gestational sac and fetal heartbeat appeared in 9% and 63% of the definitions, respectively. Among 176 live birth definitions, 64% used a gestational age (weeks) threshold, varying from 20 to 34 weeks, typically at week 24 in 30% of definitions. Limitations, reasons for caution While we optimized the text-mining algorithm attempting to identify all types of outcome definitions and manually curated all extracted definitions, there were definitions that we incorrectly omitted. Wider implications of the findings Despite recommendations to report live births in core outcome sets, only a third of RCTs did so, highlighting a disconnection between the advocated outcome and what researchers are reporting. The significant lack and variability of pregnancy definitions underscore the imperative to increase the dissemination and uptake of standardized pregnancy outcomes. Trial registration number Not applicable

Key factors in the choice of appropriate outcomes for clinical trials.

Health research is the foundation of medical knowledge and healthcare system recommendations. Therefore, choosing appropriate outcomes in studies of therapeutic interventions is a fundamental step in producing evidence and, subsequently, for decision-making. In this article, we propose three key factors for the choice of outcomes: the inclusion of patient-reported outcomes, since they focus on the patient's perception of their health status and quality of life; the consideration of clinically relevant outcomes, which are direct measurements of the patient's health status and, therefore, will be decisive in decision-making; and the use of core outcome sets, a tool that standardizes the measurement and interpretation of outcomes, facilitating the production and synthesis of appropriate evidence for the evidence ecosystem. The correct choice of outcomes will help health decision-makers and clinicians deliver appropriate patient-centered care and optimize the use of resources in healthcare and clinical research.

The development of a Core Outcome Set for clinical trials targeting interventions aiming to improve adherence to appropriate polypharmacy in older people – A Delphi consensus study

Abstract Introduction Older people encounter challenges when taking polypharmacy. Different interventions have been applied to improve adherence to polypharmacy. However, there are few high-quality studies, and little consideration has been given to the outcomes selected to measure the effectiveness of interventions.[1] To produce high-quality studies and accurately report adherence-related outcomes, developing a Core Outcome Set (COS) is important.[2] A COS is the minimum number of outcomes that should be reported and measured in future trials in a specific health field to reduce outcomes’ inconsistencies across trials.[2] Aim This study aimed to develop a COS for use in clinical trials aiming at improving adherence to appropriate polypharmacy in older patients. Methods A list of outcomes related to adherence to polypharmacy (n=13) was compiled from previous semi-structured interviews with stakeholders. The Delphi panel consisted of experts in adherence, polypharmacy and gerontology, including journal editors, academics, non-National Health Service doctors, nurses and pharmacists who were identified by searching researchers’ publication profiles using Google Scholar and Scopus. Senior editors and editor-in-chief of peer-reviewed journals were identified by searching journal information. Public members were identified by searching for contact emails of staff members in public charities/organisations representing older people’s healthcare needs (e.g. AgeUK). Additionally, identified participants received invitation emails asking them to forward the email to other participants and experts who might be interested in this study (i.e. snowball sampling). The 13 outcomes were distributed in three online Delphi questionnaires between February and April 2023 using an online SoGoSurvey® platform. All outcomes were rated according to their degree of importance using a nine-point Likert scale (1 to 3 = unimportant; 4 to 6 = important but not critical; 7 to 9 = critical). Following each round, response rates and the distribution of scores were calculated to classify outcomes into ‘consensus in’, ‘consensus out’ and ‘no consensus’. An outcome was considered very important if ≥80% of participants scored it as ‘critical’ and ≤15% scored it as ‘unimportant’. Results The Delphi panel (Round 1, n=57; Round 2, n=53; Round 3, n=50) comprised different professionals, including 38 academics, 23 pharmacists, 12 doctors, six journal editors, three nurses and four public members, some of whom had multiple roles, e.g. doctor and academic. Participants were distributed over four continents, mostly from Europe (n=39). Both Australia and America had identical representation (n=8), while two participants represented Asia. Consensus was reached following the third round on seven outcomes, namely: medication adherence across multiple medications (100.0%), treatment burden (96.2%), health-related quality of life (96.2%), healthcare utilisation (83.0%), adverse events and side effects (83.0%), patient-carer satisfaction (82%), and cost-effectiveness (81.1%). Conclusion Seven outcomes were considered of critical importance to stakeholders. This study is the first to develop a COS for interventions targeting adherence to appropriate polypharmacy in older patients. However, most of our participants were academics and pharmacists from Europe, whilst other participant categories and continents were less well-represented. A future nominal group technique study will be conducted to discuss the results obtained from previous Delphi questionnaires, followed by selecting the appropriate outcome measurement instruments to measure these outcomes.

Development of a core outcome set for use in research evaluations of interventions for venous leg ulceration: International eDelphi consensus

IntroductionVenous leg ulceration (VLU) is a chronic, recurring condition with associated pain, malodour, impaired mobility and susceptibility to infection which in turn significantly impacts an individual's health-related quality of life. Randomised controlled trials (RCTs) aim to determine the efficacy of interventions to improve outcomes. To be useful, these outcomes should be consistently and fully reported across RCTs. A core outcome set (COS) is an agreed-upon standardised set of outcomes which should be, at a minimum, reported in all RCTs for a given indication including that of VLU. AimTo gain consensus on which outcome domains and outcomes should be considered as core and therefore included in all RCTs of interventions in VLU treatment. MethodTwo sequential, two round e-Delphi surveys were completed. The first gained consensus on core outcome domains and the second on core outcomes within those domains. Participants included: people with direct experience of having VLUs and their carers, healthcare professionals whose practice included VLU care and researchers within wound care (clinical, academic, industry). ResultsFive outcome domains; healing, pain, quality of life, resource use and adverse events, and 11 outcomes were rated as core by participants. The patient and not the limb or ulcer was the preferred unit of analysis for reporting. RecommendationsWe recommend investigators report on all five outcome domains, regardless of the type of intervention being evaluated. Future research is needed to identify measurement methods for the 11 identified outcomes. We also recommend investigators follow the CONSORT guidelines (http://www.consort-statement.org/).

Study found increasing use of core outcome sets in Cochrane systematic reviews and identified facilitators and barriers

ObjectivesIn 2019, only 7% of Cochrane systematic reviews (SRs) cited a core outcome set (COS) in relation to choosing outcomes, even though a relevant COS existed but was not mentioned (or cited) for a further 29% of SRs. Our objectives for the current work were to (1) examine the extent to which authors are currently considering COS to inform outcome choice in Cochrane protocols and completed SRs, and (2) understand author facilitators and barriers to using COS. Study Design and SettingWe examined all completed Cochrane SRs published in the last 3 months of 2022 and all Cochrane protocols published in 2022 for the extent to which they: (a) cited a COS, (b) searched for COS, (c) used outcomes from existing COS, and (d) reported outcome inconsistency among included studies and/or noted the need for COS. One investigator extracted information; a second extractor verified all information, discussing discrepancies to achieve consensus. We then conducted an online survey of authors of the included SRs to assess awareness of COS and identify facilitators and barriers to using COS to inform outcome choice. ResultsObjective 1: We included 294 SRs of interventions (84 completed SRs and 210 published SR protocols), of which 13% cited specific COS and 5% did not cite but mentioned searching for COS. A median of 83% of core outcomes from cited COS (interquartile range [IQR] 57%–100%) were included in the corresponding SR. We identified a relevant COS for 39% of SRs that did not cite a COS. A median of 50% of core outcomes from noncited COS (IQR 35%–72%) were included in the corresponding SR. Objective 2: Authors of 236 (80%) of the 294 eligible SRs completed our survey. Seventy-seven percent of authors noted being aware of COS before the survey. Fifty-five percent of authors who did not cite COS but were aware of them reported searching for a COS. The most reported facilitators of using COS were author awareness of the existence of COS (59%), author positive perceptions of COS (52%), and recommendation in the Cochrane Handbook regarding COS use (48%). The most reported barriers related to matching of the scope of the COS and the SR: the COS target population was too narrow/broad relative to the SR population (29%) or the COS target intervention was too narrow/broad relative to the SR intervention (21%). Most authors (87%) mentioned that they would consider incorporating missing core outcomes in the SR/update. ConclusionSince 2019, there is increasing consideration and awareness of COS when choosing outcomes for Cochrane SRs of interventions, but uptake remains low and can be improved further. Use of COS in SRs is important to improve outcome standardization, reduce research waste, and improve evidence syntheses of the relevant effects of interventions across health research.

The outcomes measured and reported in intracranial meningioma clinical trials: A systematic review.

Meningioma clinical trials have assessed interventions including surgery, radiotherapy, and pharmacotherapy. However, agreement does not exist on what, how, and when outcomes of interest should be measured. To do so would allow comparative analysis of similar trials. This systematic review aimed to summarize the outcomes measured and reported in meningioma clinical trials. Systematic literature and trial registry searches were performed to identify published and ongoing intracranial meningioma clinical trials (PubMed, Embase, Medline, CINAHL via EBSCO, and Web of Science, completed January 22, 2022). Reported outcomes were extracted verbatim, along with an associated definition and method of measurement if provided. Verbatim outcomes were deduplicated and the resulting unique outcomes were grouped under standardized outcome terms. These were classified using the taxonomy proposed by the "Core Outcome Measures in Effectiveness Trials" (COMET) initiative. Thirty published articles and 18 ongoing studies were included, describing 47 unique clinical trials: Phase 2 n = 33, phase 3 n = 14. Common interventions included: Surgery n = 13, radiotherapy n = 8, and pharmacotherapy n = 20. In total, 659 verbatim outcomes were reported, of which 84 were defined. Following de-duplication, 415 unique verbatim outcomes remained and were grouped into 115 standardized outcome terms. These were classified using the COMET taxonomy into 29 outcome domains and 5 core areas. Outcome measurement across meningioma clinical trials is heterogeneous. The standardized outcome terms identified will be prioritized through an eDelphi survey and consensus meeting of key stakeholders (including patients), in order to develop a core outcome set for use in future meningioma clinical trials.

The outcomes measured and reported in observational studies of incidental and untreated intracranial meningioma: A systematic review

Abstract Background The clinical management of patients with incidental intracranial meningioma varies markedly and is often based on clinician choice and observational data. Heterogeneous outcome measurement has likely hampered knowledge progress by preventing comparative analysis of similar cohorts of patients. This systematic review aimed to summarize the outcomes measured and reported in observational studies. Methods A systematic literature search was performed to identify published full texts describing active monitoring of adult cohorts with incidental and untreated intracranial meningioma (PubMed, EMBASE, MEDLINE, and CINAHL via EBSCO, completed January 24, 2022). Reported outcomes were extracted verbatim, along with an associated definition and method of measurement if provided. Verbatim outcomes were de-duplicated and the resulting unique outcomes were grouped under standardized outcome terms. These were classified using the taxonomy proposed by the “Core Outcome Measures in Effectiveness Trials” (COMET) initiative. Results Thirty-three published articles and 1 ongoing study were included describing 32 unique studies: study designs were retrospective n = 27 and prospective n = 5. In total, 268 verbatim outcomes were reported, of which 77 were defined. Following de-duplication, 178 unique verbatim outcomes remained and were grouped into 53 standardized outcome terms. These were classified using the COMET taxonomy into 9 outcome domains and 3 core areas. Conclusions Outcome measurement across observational studies of incidental and untreated intracranial meningioma is heterogeneous. The standardized outcome terms identified will be prioritized through an eDelphi survey and consensus meeting of key stakeholders (including patients), in order to develop a Core Outcome Set for use in future observational studies.

The NeoPACE study: study protocol for the development of a core outcome set for neonatal palliative care

BackgroundNeonatal death is the leading category of death in children under the age of 5 in the UK. Many babies die following decisions between parents and the neonatal team; when a baby is critically unwell, with the support of healthcare professionals, parents may make the decision to stop active treatment and focus on ensuring their baby has a ‘good’ death. There is very little evidence to support the clinical application of neonatal palliative care and/or end-of-life care, resulting in variation in clinical provision between neonatal units. Developing core outcomes for neonatal palliative care would enable the development of measures of good practice and enhance our care of families. The aim of this study is to develop a core outcome set with associated tools for measuring neonatal palliative care.MethodThis study has four phases: (1) identification of potential outcomes through systematic review and qualitative interviews with key stakeholders, including parents and healthcare professionals (2) an online Delphi process with key stakeholders to determine core outcomes (3) identification of outcome measures to support clinical application of outcome use (4) dissemination of the core outcome set for use across neonatal units in the UK. Key stakeholders include parents, healthcare professionals, and researchers with a background in neonatal palliative care.DiscussionDeveloping a core outcome set will standardise minimum reported outcomes for future research and quality improvement projects designed to determine the effectiveness of interventions and clinical care during neonatal palliative and/or end-of-life care. The core outcome set will provide healthcare professionals working in neonatal palliative and/or end-of-life support with an increased and consistent evidence base to enhance practice in this area.Trial registrationThe study has been registered with the COMET initiative (https://www.comet-initiative.org/Studies/Details/1470) and the systematic review is registered with the International Prospective Register of Systematic Reviews (PROSPERO) (CRD42023451068).

To adopt or adapt an existing neonatal core outcome set in Kenya: a study protocol

BackgroundDevelopment and use of core outcome set(s) (COS) in research can reduce research wastage by ensuring that a minimum set of outcomes are always reported on. Neonatal morbidity and mortality are a big burden in low- and middle-income countries (LMICs). Research is continuously being undertaken to reduce this burden. Currently, there is no COS for neonatal research in LMICs but there exists one for neonatal research in high-income countries (HICs).ObjectivesTo determine outcomes that are useful for neonatal care in Kenya to inform whether an existing COS should be adopted or adapted. To assess the feasibility of a routine data collection system to collect data of the agreed-on COS.MethodsA review of existing literature on neonatal research in LMICs followed by a qualitative study of key stakeholders in neonatal care. To explore whether to adapt or adopt, in two hospitals, two focus group discussions with 6–8 parents/caregivers will be undertaken (one each in two hospitals). Key informant interviews will also be conducted with 6 health care providers in each of the hospitals. At the policy-making level, we will conduct 10 key informant interviews. Qualitative data will be analyzed thematically. A consensus meeting will be undertaken with key stakeholders, who will be presented with an overview of the COS developed for HICs, key findings from the literature, and the qualitative study to determine context-appropriate COS. The agreed-on outcomes will be counterchecked against the case records in the two hospitals. The feasibility of collecting the outcomes on a routine electronic research database, the Clinical Information Network that collects standardized data at admission and discharge, will be explored. The congruence (or not) of the outcomes will be documented and be used to enrich the discussion and provide a snapshot of the feasibility of the health information system to collect routine data on the COS.ConclusionsA COS for use in neonatal care in Kenya will help enhance outcome measurements and reporting not just in research but also in routine practice. This will enhance the comparability of interventions in trials and routine settings leading to reduced research wastage and likely improved quality of care. Additionally, the methodology used for this work can be adopted in other settings as a means of adopting or adapting an existing COS.

Awareness and experiences on core outcome set development and use amongst stakeholders from low- and middle- income countries: An online survey.

Harmonization of outcomes to be measured in clinical trials can reduce research waste and enhance research translation. One of the ways to standardize measurement is through development and use of core outcome sets (COS). There is limited involvement of low- and middle-income country (LMIC) stakeholders in COS development and use. This study explores the level of awareness and experiences of LMIC stakeholders in the development and use of COS. We conducted an online survey of LMIC stakeholders. Three existing COS (pre-eclampsia, COVID-19, palliative care) were presented as case scenarios, and respondents asked to state (with reason(s)) if they would or would not use the COS if they were working in that area. Quantitative data were analyzed descriptively while qualitative data were analyzed thematically. Of 81 respondents, 26 had COS experience, 9 of whom had been involved in COS development. Personal research interests and prevalence of disease are key drivers for initiation/participation in a given COS project. Most respondents would use the COS for pre-eclampsia (18/26) and COVID-19 (19/26) since the development process included key stakeholders. More than half of the respondents were not sure or would not use the palliative care COS as they felt stakeholder engagement was limited and it was developed for a different resource setting. Respondents reported that use of COS can be limited by (i) feasibility of measuring the outcomes in the COS, (ii) knowledge on the usefulness and availability of COS and (iii) lack of wide stakeholder engagement in the COS development process including having patients and carers in the development process. To ensure the development and use of COS in LMICs, collaborations are essential in awareness raising on COS utility, training, and COS development. The COS also needs to be made accessible in locally understandable languages and feasible to measure in LMICs.

Using behavioural science to enhance use of core outcome sets in trials: protocol.

Core outcome sets (COS) represent agreed-upon sets of outcomes, which are the minimum that should be measured and reported in all trials in specific health areas. Use of COS can reduce outcome heterogeneity, selective outcome reporting, and research waste, and can facilitate evidence syntheses. Despite benefits of using COS, current use of COS in trials is low. COS use can be understood as a behaviour, in that it is something trialists do, or not do, adequately. The aim of this study is to identify strategies, informed by behaviour change theory, to increase COS use in trials. The project will be conducted in two stages, informed by the behaviour change wheel (BCW). The BCW is a theoretically based framework that can be used to classify, identify, and develop behaviour change strategies. In Stage 1, barriers and enablers to COS use will be extracted from published studies that examined trialist's use of COS. Barriers and facilitators will be mapped to the components of COM-B model (capability, opportunity, and motivation), which forms part of the BCW framework. Stage 2 will build on Stage 1 findings to identify and select intervention functions and behaviour change techniques to enhance COS use in trials. The findings of this study will provide an understanding of the behavioural factors that influence COS use in trials and what strategies might be used to target these factors to increase COS use in trials.

Exploring the perspectives of selectors and collecters of trial outcome data: an international qualitative study

IntroductionSelecting and collecting data to support appropriate primary and secondary outcomes is a critical step in designing trials that can change clinical practice. In this study, we aimed to investigate who contributes to the process of selecting and collecting trial outcomes, and how these people are involved. This work serves two main purposes: (1) it provides the trials community with evidence to demonstrate how outcomes are currently selected and collected, and (2) it allows people involved in trial design and conduct to pick apart these processes to consider how efficiencies and improvements can be made.MethodsOne-with-one semi-structured interviews, supported by a topic guide to ensure coverage of key content. The Framework approach was used for thematic analysis of data, and themes were linked through constant comparison of data both within and across participant groups. Interviews took place between July 2020 and January 2021. Participants were twenty-nine international trialists from various contributor groups, working primarily on designing and/or delivering phase III pragmatic effectiveness trials. Their experience spanned various funders, trial settings, clinical specialties, intervention types, and participant populations.ResultsWe identified three descriptive themes encompassing the process of primary and secondary outcome selection, collection, and the publication of outcome data. Within these themes, participants raised issues around the following: 1) Outcome selection: clarity of the research question; confidence in selecting trial outcomes and how confidence decreases with increased experience; interplay between different interested parties; how patients and the public are involved in outcome selection; perceived impact of poor outcome selection including poor recruitment and/or retention; and use of core outcome sets. 2) Outcome collection: disconnect between decisions made by outcome selectors and the practical work done by outcome collectors; potential impact of outcome measures on trial participants; potential impact on trial staff workload; and use of routinely collected data. 3) Publication of outcome data: difficulties in finding time to write and revise manuscripts for publication due to time and funding constraints. Participants overwhelmingly focused on the process of outcome selection, a topic they talked about unprompted. When prompted, participants do discuss outcome collection, but poor communication between selectors and collectors at the trial design stage means that outcome selection is rarely linked with the data collection workload it generates.DiscussionPeople involved in the design and conduct of trials fail to connect decisions around outcome selection with data collection workload. Publication of outcome data and effective dissemination of trial results are hindered due to the project-based culture of some academic clinical trial research.

Current trends, barriers, and facilitators of use of core outcome sets in Cochrane systematic reviews: Protocol.

Background: Core outcome sets (COS) represent agreed-upon minimum outcomes that should be reported in all studies in a given topic area. Cochrane reviews are considered among the most rigorously conducted systematic reviews (SRs). In 2019, seven of the first 100 published Cochrane SRs (7%) cited a COS in relation to choosing outcomes. A relevant COS existed but was not mentioned (or cited) for 27 of the remaining 93 SRs (29%). Among Cochrane Review Group editors surveyed in 2019, 86% felt that COS should definitely/possibly be used in Cochrane SRs. As of September 2019, the Cochrane Handbook recommends that SR teams consult resources that host relevant COS when choosing outcomes for the SR. Objectives: (1) Examine the extent to which authors are currently considering COS to inform outcome choice in Cochrane protocols and completed SRs. (2) Understand author barriers and facilitators of using COS in Cochrane protocols and completed SRs. Methods: We will examine the extent to which all Cochrane SRs published in the last 3 months of 2022 and all Cochrane protocols published in 2022: (a) cited a COS, (b) searched for COS, and (c) reported outcome inconsistency among included studies and/or noted the need for COS. One investigator will extract information from SRs and protocols; a second extractor will verify all information, discussing discrepancies to achieve consensus. Using Jisc Online Surveys ®, we will conduct an online anonymous survey of authors of all the included completed SRs and protocols to assess author awareness of COS and identify barriers and facilitators of using COS to inform outcome choice. Discussion: This study will provide key information regarding uptake of COS by Cochrane SR authors and the barriers and facilitators that they experience. Our findings will inform approaches to increasing awareness and uptake of COS in future SRs, both with and beyond Cochrane.

P09.03.A DEVELOPMENT OF A CORE OUTCOME SET FOR USE IN ADULT PRIMARY GLIOMA PHASE III INTERVENTIONAL TRIALS - A MIXED METHODS STUDY

Abstract BACKGROUND Glioma patients’ high symptom burden and the poor prognosis of high grade glioma has emphasised quality of survival and overall health-related quality of life (HRQOL) throughout the disease trajectory in clinical trials. Patient-reported outcomes (PROs) allow insight into how investigative treatment affects patients’ perceived functioning, complementing other outcome data (e.g. survival, radiological response) in clinical decision-making. Creating robust evidence requires effective data synthesis and meta-analyses across trials, underpinned by consistent trial outcome measurement, analysis and reporting. However, a standard ontology is lacking in cancer clinical trials, and brain tumours specifically, and selective outcome reporting is common. Core outcome set (COS) development is one means to improve data synthesis. The COBra project aimed to develop a COS for use in glioma phase III trials in support of those goals. Given stakeholder interest in PROs and prioritising the patient perspective, we also undertook initial exploration of which items could be patient reportable. MATERIAL AND METHODS A COS for adult primary glioma phase III interventional trials was developed through: (1) trial registry review and systematic review of qualitative studies; (2) interviews with glioma patients and caregivers; (3) outcome list de-duplication; (4) two-round Delphi process and outcome list rating; (5) a consensus meeting to finalise the COS. Patient-reportable COS outcomes were identified by cross-referencing the final COS outcomes with outcomes and PRO measures (PROMs) reported in the trial registry review. Activities were guided by UK Patient and Public Involvement standards and public contributors were core research team members. RESULTS A COS consisting of 19 outcomes grouped into seven outcome domains (Survival, Adverse Events, Activities of Daily Living, HRQOL, Seizure Activity, Cognitive Function and Physical Function) was finalised for use in glioma trials using this structured approach. Mapping PROMs identified in the registry review suggests that sub-domains of 6/7 outcome domains in the final COS can be patient-reported (adverse events, activities of daily living, HRQOL, seizure activity, neurocognitive function, physical function). Other currently unidentified instruments may also be suitable. Further research will identify appropriate measurement tools, promote accessible PRO delivery, and validate this COS for wider use. CONCLUSION A COS for glioma trials was developed, comprising seven outcome domains. Development of this COS coincides with growing regulatory interest in patient-reported data. To optimise data synthesis and prioritise the patient perspective, opportunities to collect data in this way should be promoted and taken. As such, this COS could be considered for use in registrational trials after further validation.

Current trends, barriers, and facilitators of use of core outcome sets in Cochrane systematic reviews: Protocol

Background: Core outcome sets (COS) represent agreed-upon minimum outcomes that should be reported in all studies in a given topic area. Cochrane reviews are considered among the most rigorously conducted systematic reviews (SRs). In 2019, seven of the first 100 published Cochrane SRs (7%) cited a COS in relation to choosing outcomes. A relevant COS existed but was not mentioned (or cited) for 27 of the remaining 93 SRs (29%). Among Cochrane Review Group editors surveyed in 2019, 86% felt that COS should definitely/possibly be used in Cochrane SRs. As of September 2019, the Cochrane Handbook recommends that SR teams consult resources that host relevant COS when choosing outcomes for the SR. Objectives: (1) Examine the extent to which authors are currently considering COS to inform outcome choice in Cochrane protocols and completed SRs. (2) Understand author barriers and facilitators of using COS in Cochrane protocols and completed SRs. Methods: We will examine the extent to which all Cochrane SRs published in the last 3 months of 2022 and all Cochrane protocols published in 2022: (a) cited a COS, (b) searched for COS, and (c) reported outcome inconsistency among included studies and/or noted the need for COS. One investigator will extract information from SRs and protocols; a second extractor will verify all information, discussing discrepancies to achieve consensus. Using Jisc Online Surveys®, we will conduct an online anonymous survey of authors of all the included completed SRs and protocols to assess author awareness of COS and identify barriers and facilitators of using COS to inform outcome choice. Discussion: This study will provide key information regarding uptake of COS by Cochrane SR authors and the barriers and facilitators that they experience. Our findings will inform approaches to increasing awareness and uptake of COS in future SRs, both with and beyond Cochrane.

Hospital-to-home transitions for children with medical complexity: part 2—a core outcome set

Appropriate outcome measures as part of high-quality intervention trials are critical to advancing hospital-to-home transitions for Children with Medical Complexity (CMC). Our aim was to conduct a Delphi study and focus groups to identify a Core Outcome Set (COS) that healthcare professionals and parents consider essential outcomes for future intervention research. The development process consisted of two phases: (1) a three-round Delphi study in which different professionals rated outcomes, previously described in a systematic review, for inclusion in the COS and (2) focus groups with parents of CMC to validate the results of the Delphi study. Forty-five professionals participated in the Delphi study. The response rates were 55%, 57%, and 58% in the three rounds, respectively. In addition to the 24 outcomes from the literature, the participants suggested 12 additional outcomes. The Delphi rounds resulted in the following core outcomes: (1) disease management, (2) child’s quality of life, and (3) impact on the life of families. Two focus groups with seven parents highlighted another core outcome: (4) self-efficacy of parents. Conclusion: An evidence-informed COS has been developed based on consensus among healthcare professionals and parents. These core outcomes could facilitate standard reporting in future CMC hospital to home transition research. This study facilitated the next step of COS development: selecting the appropriate measurement instruments for every outcome.What is Known:• Hospital-to-home transition for Children with Medical Complexity is a challenging process.• The use of core outcome sets could improve the quality and consistency of research reporting, ultimately leading to better outcomes for children and families.What is New:• The Core Outcome Set for transitional care for Children with Medical Complexity includes four outcomes: disease management, children’s quality of life, impact on the life of families, and self-efficacy of parents.

Developing a core outcome set for foot and ankle disorders in rheumatic and musculoskeletal diseases: A scoping review and report from the OMERACT 2022 foot and ankle special interest group session

ObjectivesFoot and ankle involvement is common in rheumatic and musculoskeletal diseases, yet high-quality evidence assessing the effectiveness of treatments for these disorders is lacking. The Outcome Measures in Rheumatology (OMERACT) Foot and Ankle Working Group is developing a core outcome set for use in clinical trials and longitudinal observational studies in this area. MethodsA scoping review was performed to identify outcome domains in the existing literature. Clinical trials and observational studies comparing pharmacological, conservative or surgical interventions involving adult participants with any foot or ankle disorder in the following rheumatic and musculoskeletal diseases (RMDs) were eligible for inclusion: rheumatoid arthritis (RA), osteoarthritis (OA), spondyloarthropathies, crystal arthropathies and connective tissue diseases. Outcome domains were categorised according to the OMERACT Filter 2.1. ResultsOutcome domains were extracted from 150 eligible studies. Most studies included participants with foot/ankle OA (63% of studies) or foot/ankle involvement in RA (29% of studies). Foot/ankle pain was the outcome domain most commonly measured (78% of studies), being the most frequently specified outcome domain across all RMDs. There was considerable heterogeneity in the other outcome domains measured, across core areas of manifestations (signs, symptoms, biomarkers), life impact, and societal/resource use. The group's progress to date, including findings from the scoping review, was presented and discussed during a virtual OMERACT Special Interest Group (SIG) in October 2022. During this meeting, feedback was sought amongst delegates regarding the scope of the core outcome set, and feedback was received on the next steps of the project, including focus group and Delphi methods. ConclusionFindings from the scoping review and feedback from the SIG will contribute to the development of a core outcome set for foot and ankle disorders in RMDs. The next steps are to determine which outcome domains are important to patients, followed by a Delphi exercise with key stakeholders to prioritise outcome domains.

Engaging pregnant individuals and healthcare professionals in an international mixed methods study to develop a core outcome set for studies on placenta accreta spectrum disorder (COPAS): a study protocol

IntroductionPlacenta accreta spectrum (PAS) disorder is a life-threatening condition that may result in serious maternal complications, including mortality. The placenta which is pathologically adherent to the uterine wall, places individuals...

Technical Review of Clinical Outcomes Assessments Across the Continuum of Alzheimer's Disease.

Insight into the relationship between concepts that matter to the people affected by Alzheimer's disease (AD) and the clinical outcome assessments (COAs) commonly used in AD clinical studies is limited. Phases 1 and 2 of the What Matters Most (WMM) study series identified and quantitatively confirmed 42 treatment-related outcomes that are important to people affected by AD. We compared WMM concepts rated as "very important" or higher to items included in COAs used commonly in AD studies. Twenty COAs designed to assess signs, symptoms, and impacts across the spectrum of AD were selected for review. Among these 20 COAs, only 5 reflected 12 or more WMM concepts [Integrated Alzheimer's Disease Rating Scale (iADRS), Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory (ADCS-ADL), Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory-Mild Cognitive Impairment (ADCS-ADL-MCI), Alzheimer's Disease Composite Scores (ADCOMS), and Clinical Dementia Rating; Clinical Dementia Rating-Sum of Boxes (CDR/CDR-SB)]. Multiple symptoms and impacts of AD identified as important and meaningful in the WMM studies map only indirectly at best to 7 of the 20 most widely used COAs. While many frequently used COAs in AD capture some concepts identified as important to AD populations and their care partners, overlap between any single measure and the concepts that matter to people affected by AD is limited. The highest singly matched COA reflects fewer than half (45%) of WMM concepts. Use of multiple COAs expands coverage of meaningful concepts. Future research should explore the content validity of AD COAs planned for AD trials based on further confirmation of the ecological validity of the WMM items. This research should inform development and use of core outcome sets that capture WMM items and selection or development of new companion tools to fully demonstrate clinically meaningful outcomes spanning WMM.