Development Of Core Outcome Set Research Articles

Development of a core outcome set for psychological therapy trials on acute psychiatric inpatient wards

BackgroundConsensus on what outcomes should be included in trials of psychological therapies on acute psychiatric inpatient wards is currently lacking. Inclusion of different viewpoints, including service user perspectives, is crucial in ensuring that future trials measure outcomes which are meaningful and important. Development of a Core Outcome Set (COS), a minimum standardised set of outcomes to be measured and reported, would help improve synthesis and interpretation of clinical trial data in this area.MethodsStage 1 of the COS development involved compiling a comprehensive long-list of outcomes from key sources including i) a systematic review of outcomes from published trials, ii) online survey of key stakeholders (service users, carers, healthcare professionals, researchers, and end users of research), iii) qualitative interviews with service users and carers. Stage 2 involved stakeholder groups short-listing the outcomes using consensus methods (e-Delphi survey). The final outcome set was derived from the short-list at a consensus meeting of stakeholders, facilitated by an Independent Chair.ResultsA long-list of 68 outcomes was compiled from the systematic review (n = 30 trials), online stakeholder survey (n = 100 participants) and qualitative interviews (n = 15 participants). Fifty stakeholders took part in the e-Delphi study, where the long-list was cut down to a short-list of 12 outcomes over 2 rounds. Nine stakeholders took part in the final consensus meeting, and after some outcomes were removed and/or amalgamated, a final set of 6 outcomes was recommended for inclusion in the COS. These were Ability to Cope, Hopefulness, Quality of Life, Psychosis Symptoms, Mood, and Self-Harm Behaviours.ConclusionsWidespread future adoption of the COS will reduce research waste by ensuring that outcomes are more easily comparable across trials, and that the full range of stakeholder priorities are represented in trial outcomes. This makes it more likely that effective therapies will be identified in a timely fashion and successfully implemented in routine clinical practice. The final 6-outcome COS should be feasible to implement given the need keep participant burden to a minimum in inpatient trials. Further work is needed to make recommendations for the best outcome measurement instruments to use, including the use of patient-reported outcomes alongside clinician-rated measures.Trial registrationNot applicable.

Core outcome set for studies evaluating interventions to prevent or treat delirium in long-term care older residents: international key stakeholder informed consensus study.

Trials of interventions to prevent or treat delirium in older adults resident in long-term care settings (LTC) report heterogenous outcomes, hampering the identification of effective management strategies for this important condition. Our objective was to develop international consensus among key stakeholders for a core outcome set (COS) for future trials of interventions to prevent and/or treat delirium in this population. We used a rigorous COS development process including qualitative interviews with family members and staff with experience of delirium in LTC; a modified two-round Delphi survey; and virtual consensus meetings using nominal group technique. The study was registered with the Core Outcome Measures in Effectiveness Trials (COMET) initiative (https://www.comet-initiative.org/studies/details/796). Item generation identified 22 delirium-specific outcomes and 32 other outcomes from 18 qualitative interviews. When combined with outcomes identified in our earlier systematic review, and following an item reduction step, this gave 43 outcomes that advanced to the formal consensus processes. These involved 169 participants from 12 countries, and included healthcare professionals (121, 72%), researchers (24, 14%), and family members/people with experience of delirium (24, 14%). Six outcomes were identified as essential to include in all trials of interventions for delirium in LTC, and were therefore included in the COS. These are: 'delirium occurrence'; 'delirium related distress'; 'delirium severity'; 'cognition including memory', 'admission to hospital' and 'mortality'. This COS, endorsed by the American Delirium Society and the European and Australasian Delirium Associations, is recommended for use in future clinical trials evaluating delirium prevention or treatment interventions for older adults residing in LTC.

Core outcome set for intervention research on snakebite envenomation in South Asia

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...

Diagnostic criteria and core outcome set development for necrotising otitis externa, symptomatic evaluation in patients awaiting septoplasty and early versus late tracheostomy in critically ill patients.

Diagnostic criteria and core outcome set development for necrotising otitis externa, symptomatic evaluation in patients awaiting septoplasty and early versus late tracheostomy in critically ill patients.

Effect of male partners' involvement and support on reproductive, maternal and child health and well-being in East Africa: A scoping review.

East African countries have high rates of maternal and child mortality and morbidity. Studies have shown that the involvement of male partners in reproductive health can benefit maternal and child health (MCH). This scoping review aims to provide an overview of the evidence across East Africa that describes male partner involvement and its effect on maternal, reproductive, and child well-being. Ten databases were searched to identify quantitative data on male's involvement in East Africa. Studies reporting qualitative data, "intention to use" data or only reporting on male partner's education or economic status were excluded. Studies were organized into five a priori categories: antenatal care (ANC), human immunodeficiency virus, breastfeeding, family planning, and intimate partner violence with further categories developed based on studies included. A total of 2787 records were identified; 644 full texts were reviewed, and 96 studies were included in this review. Data were reported on 118,967 mothers/pregnant women and 15,361 male partners. Most of the studies (n = 83) were reported from four countries Ethiopia (n = 49), Kenya (n = 14), Tanzania (n = 12) and Uganda (n = 10). The evidence indicates that male partner involvement and support is associated with improved reproductive, MCH across a wide range of outcomes. However, the studies were heterogeneous, using diverse exposure and outcome measures. Also, male partners' lack of practical and emotional support, and engagement in violent behaviors towards partners, were associated with profound negative impacts on MCH and well-being. The body of evidence, although heterogeneous, provides compelling support for male involvement in reproductive health programs designed to support MCH. To advance research in this field, an agreement is needed on a measure of male partner "involvement." To optimize benefits of male partners' involvement, developing core outcome sets and regional coordination are recommended.

Inclusion of harm outcomes in core outcome sets requires careful consideration

ObjectivesThe objective of this study was to determine the proportion of all published core outcome set (COS) studies that include an adverse event or harm outcome, to determine the proportion of individual vs pooled harms, and to investigate characteristics that influence their inclusion. MethodsWe examined the extent to which a sample of 100 published COS studies (from January 2021 to January 2023) include both pooled and individual harms in the final COS. One investigator extracted the information from the COS studies, which was cross-checked against previous COS investigational research, and where possible verified with COS authors or a pharmacologist. Using Qualtrics™, we conducted a personalized online survey of developers of the 100 COS to ask them about the importance, their experiences, and methodological approaches for dealing with harms within their COS development studies. ResultsOne hundred COS were identified from 91 separate COS studies, the majority of which considered most of the minimum standards for development. Two-thirds (65%) of the COS included at least 1 harm outcome. In total, 1104 core outcomes were identified across the 100 COS, of which 184 (17%) were harm outcomes (154 individual vs 56 pooled). Individual harms were more likely to be included in a final COS if they were developed for single treatment interventions (50%) compared to those being developed for multitreatment modalities (39%). Some COS developers adopted outcome frameworks as part of their COS development process to facilitate the inclusion of harm outcomes in their final COS. A third (33%) of respondents felt that harm outcomes should be included in all COS but over half (56%) thought this would be dependent on some aspect of the scope of the COS and improved methodology and awareness of how to deal with harm outcomes in the COS development process. ConclusionHarm outcomes are already included in many COS either as individual or pooled harms. It is evident that there are some challenges with regards to both the methodology and necessity to include harms within a COS (pooled or individual. COS developers should carefully consider the need to include important harms outcomes in relation to the scope of the COS that they are developing.

Involving different stakeholders in prioritising outcomes to assess healthcare systems response for type 1 diabetes management: Using co-creation approaches in Peru.

Engaging diverse stakeholders in developing core outcome sets (COSs) can produce more meaningful metrics as well as research responsive to patient needs. The most common COS prioritisation method, Delphi surveys, has limitations related to selection bias and participant understanding, while qualitative methods like group discussions are less frequently used. This study aims to test a co-creation approach to COS development for type 1 diabetes (T1DM) in Peru. Using a co-creation approach, we aimed to prioritise outcomes for T1DM management in Peru, incorporating perspectives from people with T1DM, caregivers, healthcare professionals, and decision-makers. A set of outcomes were previously identified through a systematic review and qualitative evidence synthesis. Through qualitative descriptive methods, including in-person workshops, each group of stakeholders contributed to the ranking of outcomes. Decision-makers also discussed the feasibility of measuring these outcomes within the Peruvian healthcare system. While priorities varied among participant groups, all underscored the significance of monitoring healthcare system functionality over mortality. Participants recognized the interconnected nature of healthcare system performance, clinical outcomes, self-management, and quality of life. When combining the rankings from all the groups, metrics related to economic impact on the individual and structural support, policies promoting health, and protecting those living with T1DM were deemed more important in comparison to measuring clinical outcomes. We present the first COS for T1DM focused on low-and-middle-income countriesand show aspects of care that are relevant in this setting. Diverse prioritisation among participant groups underscores the need of inclusive decision-making processes. By incorporating varied perspectives, healthcare systems can better address patient needs and enhance overall care quality.

Treatment options for patients with pilonidal sinus disease: PITSTOP, a mixed-methods evaluation.

There is no consensus on optimal management of pilonidal disease. Surgical practice is varied, and existing literature is mainly single-centre cohort studies of varied disease severity, interventions and outcome assessments. A prospective cohort study to determine: • disease severity and intervention relationship • most valued outcomes and treatment preference by patients • recommendations for policy and future research. Observational cohort study with nested mixed-methods case study. Discrete choice experiment. Clinician survey. Three-stage Delphi survey for patients and clinicians. Inter-rater reliability of classification system. Thirty-one National Health Service trusts. Patients aged > 16 years referred for elective surgical treatment of pilonidal disease. Surgery. Pain postoperative days 1 and 7, time to healing and return to normal activities, complications, recurrence. Outcomes compared between major and minor procedures using regression modelling, propensity score-based approaches and augmented inverse probability weighting to account for measured potential confounding features. Clinician survey: There was significant heterogeneity in surgeon practice preference. Limited training opportunities may impede efforts to improve practice. Cohort study: Over half of patients (60%; N = 667) had a major procedure. For these procedures, pain was greater on day 1 and day 7 (mean difference day 1 pain 1.58 points, 95% confidence interval 1.14 to 2.01 points, n = 536; mean difference day 7 pain 1.53 points, 95% confidence interval 1.12 to 1.95 points, n = 512). There were higher complication rates (adjusted risk difference 17.5%, 95% confidence interval 9.1 to 25.9%, n = 579), lower recurrence (adjusted risk difference -10.1%, 95% confidence interval -18.1 to -2.1%, n = 575), and longer time to healing (>34 days estimated difference) and time to return to normal activities (difference 25.9 days, 95% confidence interval 18.4 to 33.4 days). Mixed-methods analysis: Patient decision-making was influenced by prior experience of disease and anticipated recovery time. The burden involved in wound care and the gap between expected and actual time for recovery were the principal reasons given for decision regret. Discrete choice experiment: The strongest predictors of patient treatment choice were risk of infection/persistence (attribute importance 70%), and shorter recovery time (attribute importance 30%). Patients were willing to trade off these attributes. Those aged over 30 years had a higher risk tolerance (22.35-34.67%) for treatment failure if they could experience rapid recovery. There was no strong evidence that younger patients were willing to accept higher risk of treatment failure in exchange for a faster recovery. Patients were uniform in rejecting excision-and-leave-open because of the protracted nursing care it entailed. Wysocki classification analysis: There was acceptable inter-rater agreement (κ = 0.52, 95% confidence interval 0.42 to 0.61). Consensus exercise: Five research and practice priorities were identified. The top research priority was that a comparative trial should broadly group interventions. The top practice priority was that any interventions should be less disruptive than the disease itself. Incomplete recruitment and follow-up data were an issue, particularly given the multiple interventions. Assumptions were made regarding risk adjustment. Results suggest the burden of pilonidal surgery is greater than reported previously. This can be mitigated with better selection of intervention according to disease type and patient desired goals. Results indicate a framework for future higher-quality trials that stratify disease and utilise broad groupings of common interventions with development of a patient-centred core outcome set. This trial is registered as ISRCTN95551898. This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 17/17/02) and is published in full in Health Technology Assessment; Vol. 28, No. 33. See the NIHR Funding and Awards website for further award information.

A review of core outcome sets (COS) developed for different settings finds there is a subset of outcomes relevant for both research and routine care

ObjectivesTo compare the outcomes selected for the same condition in core outcome sets (COSs) for research with those in COS for the routine care setting. MethodsA sample of COS was created from the most frequent five health areas within previous systematic reviews of COS for research and COS for routine care. Outcomes were extracted and categorized using an outcome taxonomy. Frequency of outcome domains included within COS were analyzed in subgroups according to research or care setting, patient involvement in COS development and health area. Matched sets of COS were created, where at least one research COS and one routine care COS exist for the same health condition, to identify the outcomes that were recommended for both settings. A similar process was used for a subset of paired COS matched in scope for both intervention and population as well as health condition. ResultsThe sample of COS comprised: 246 COS for research only, 76 COS for routine care only and 55 COS for both research and routine care. Across the 18 sets matched by health condition the median number (range) of outcomes included in both research COS and routine care COS was 6 (3-15), with differences noted across health areas. For the 11 paired COS matched by scope and health condition, the corresponding figures were 2 (2-8). Across all settings, COS that did not include patients as participants were less likely to include life impact outcomes. ConclusionWithin a given health condition, a small number of core outcomes were found to be relevant for both research and care, offering a meaningful starting point for linking research and real-world evaluation.

Toward a core outcome set for faecal incontinence-A systematic review of outcomes reported in the literature.

Faecal incontinence (FI) is a prevalent issue which can have a detrimental impact on the patient's quality of life. Current international guidelines lack strong treatment recommendations due to few studies in the field, in combination with the heterogeneity in outcome reporting. To address this, a core outcome set (COS) is proposed to standardize outcome reporting in FI studies, facilitating meta-analyses and enhancing therapeutic recommendations. Through several steps outlined by COMET 'what' to measure will be determined prior to determining 'how' to measure these outcomes. This systematic review aims to identify 'what' outcomes have been used in FI intervention studies so far in adult patients as a starting phase for the development of a future COS for FI. Medline, Embase and the Cochrane library were searched to identify all outcomes reported in comparative effectiveness trials assessing one or more treatment option in adult patients suffering from FI. The outcomes were categorized according to the Core Outcome Measurement in Effectiveness Trials (COMET) taxonomy to standardize outcome terminology, assess completeness, and inform subsequent steps in COS development. A total of 109 studies were included, which revealed 51 unique outcomes classified into 38 domains within four core areas. On average four outcomes were reported per study (range 1-11). The most commonly reported outcomes were "severity of FI" (83%), "quality of life" (64%), "number of FI episodes" (40%), "anorectal motor function" (39%), and "frequency of bowel movements" (16%). This systematic review offers an overview of outcomes reported in FI studies, highlighting the heterogeneity between studies. This heterogeneity emphasizes the need for standardizing outcome reporting which can be established through the creation of a COS.

Surgical Handover Core Outcome Measures (SH-CORE): a protocol for the development of a core outcome set for trials in surgical handover

BackgroundSurgical handover is associated with a significant risk of care failures. Existing research displays methodological deficiencies and little consensus on the outcomes that should be used to evaluate interventions in this area. This paper reports a protocol to develop a core outcome set (COS) to support standardisation, comparability, and evidence synthesis in future studies of surgical handover between doctors.MethodsThis study adheres to the Core Outcome Measures in Effectiveness Trials (COMET) initiative guidance for COS development, including the COS-Standards for Development (COS-STAD) and Reporting (COS-STAR) recommendations. It has been registered prospectively on the COMET database and will be led by an international steering group that includes surgical healthcare professionals, researchers, and patient and public partners. An initial list of reported outcomes was generated through a systematic review of interventions to improve surgical handover (PROSPERO: CRD42022363198). Findings of a qualitative evidence synthesis of patient and public perspectives on handover will augment this list, followed by a real-time Delphi survey involving all stakeholder groups. Each Delphi participant will then be invited to take part in at least one online consensus meeting to finalise the COS.Ethics and disseminationThis study was approved by the Royal College of Surgeons in Ireland (RCSI) Research Ethics Committee (202309015, 7th November 2023). Results will be presented at surgical scientific meetings and submitted to a peer-reviewed journal. A plain English summary will be disseminated through national websites and social media. The authors aim to integrate the COS into the handover curriculum of the Irish national surgical training body and ensure it is shared internationally with other postgraduate surgical training programmes. Collaborators will be encouraged to share the findings with relevant national health service functions and national bodies.DiscussionThis study will represent the first published COS for interventions to improve surgical handover, the first use of a real-time Delphi survey in a surgical context, and will support the generation of better-quality evidence to inform best practice.Trial registrationCore Outcome Measures in Effectiveness Trials (COMET) initiative 2675. http://www.comet-initiative.org/Studies/Details/2675.

Using patient and care partner experiences to confirm outcomes of relevance for inclusion in a core outcome set for trials of physical rehabilitation in critical illness: A qualitative interview study

BackgroundIncorporating the perspectives of patients and care partners is crucial in the development of core outcome sets. One effective approach for achieving this involvement is by seeking input to refine the outcomes for consensus.The objectives of the study were to: i) to determine patient and care partner views on outcomes that should be measured in trials of physical rehabilitation interventions across the critical illness recovery continuum; (ii) to map these views with a pre-established list of thirty outcomes for potential inclusion in a core outcome set for these trials; and (iii) to identify any new outcomes that could be considered for inclusion. MethodsA qualitative semistructured telephone interview study was conducted with a convenience sample of post–critical illness patients and care partners, as part of core outcome set development work. Anonymised interview transcripts were analysed using a framework approach, and exemplary narrative quotes from participants were reported used to illustrate outcome reporting. FindingsFourteen participants were recruited (male:female ratio = 8:6, age range [minimum–maximum]: 50–80 years, 13 former patients, one spouse). Time since intensive care unit discharge ranged from less than 1 year to 10 years at the time of interview. Participants described a range of outcomes that could be measured in trials of physical rehabilitation after critical illness that mapped closely with the pre-established list. No new outcomes were introduced by participants during the interviews. Experiences described by participants commonly reflected outcomes related to physical ability and performance, functional level, activities of daily living, and emotional and mental wellbeing. Participants spoke to how the different outcomes directly impacted their day-to-day lives and highlighted their priorities centred around resumption of tasks and activities that had value to them at personal, functional, and societal level. ConclusionQualitative interviews confirmed the relevance of existing outcomes for potential inclusion in a core outcome set for trials of physical rehabilitation interventions across the critical illness recovery continuum. The added significance of our findings is to provide real-world meaning to these outcomes. RegistrationCOMET Initiative, ID288, https://www.comet-initiative.org/studies/details/288.

Outcomes of interventions in neonatal sepsis: A systematic review of qualitative research.

While a systematic review exists detailing neonatal sepsis outcomes from clinical trials, there remains an absence of a qualitative systematic review capturing the perspectives of key stakeholders. Our aim is to identify outcomes from qualitative research on any intervention to prevent or improve the outcomes of neonatal sepsis that are important to parents, other family members, healthcare providers, policymakers, and researchers as a part of the development of a core outcome set (COS) for neonatal sepsis. A literature search was carried out using MEDLINE, EMBASE, CINAHL, and PsycInfo databases. Publications describing qualitative data relating to neonatal sepsis outcomes were included. Drawing on the concepts of thematic synthesis, texts related to outcomes were coded and grouped. These outcomes were then mapped to the domain headings of an existing model. Out of 6777 records screened, six studies were included. Overall, 19 outcomes were extracted from the included studies. The most frequently reported outcomes were those in the domains related to parents, healthcare workers and individual organ systemas such as gastrointestinal system. The remaining outcomes were classified under the headings of general outcomes, miscellaneous outcomes, survival, and infection. The outcomes identified in this review are different from those reported in neonatal sepsis clinical trials, thus highlighting the importance of incorporating qualitative studies into COS development to encapsulate all relevant stakeholders' perspectives.

Fostering connections at OMERACT 2023: A collaborative approach to Core Outcome Set development

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Development of a Core Outcome Set for Family and Community Nursing: Protocol for a Delphi Study.

Family and community nurses (FCNs) play a crucial role in delivering primary care to patients within their homes and communities. A key aspect of their role involves various health interventions, which are influenced by their unique competencies, such as health promotion, advanced clinical knowledge, and strong interpersonal skills. However, it is essential to understand which specific health outcomes these interventions impact to better understand the relationship between FCNs' skills and the health results. This study aims to outline the steps we will take to develop a set of core outcomes. These outcomes will be particularly sensitive to the health interventions carried out by FCNs, providing a clearer picture of their practice's impact. A Delphi survey will be used for this research, conducted from January to December 2024. The process will involve 5 steps and input from 3 stakeholder categories. These stakeholders will help identify a preliminary list of outcomes that will form the basis of our core outcome set (COS). This guideline will be beneficial for a wide range of stakeholders involved in COS development, including COS developers, trialists, systematic reviewers, journal editors, policy makers, and patient groups. As of January 2024, we have successfully completed the first stage of the study, with the stakeholder group approving the reported outcomes and assigning participant lists for each stakeholder group. This study will provide a roadmap for identifying the key health outcomes influenced by the interventions of FCNs. The multistakeholder, multiphase approach will ensure a comprehensive and inclusive process. Ultimately, the findings will enhance our understanding of FCNs' impact on health outcomes, leading to more effective primary care strategies and policies. PRR1-10.2196/51084.

The methodological quality of systematic reviews regarding the Core Outcome Set (COS) development

BackgroundThe Core Outcome Measures in Effectiveness Trials (COMET) working group proposed core outcome sets (COS) to address the heterogeneity in outcome measures in clinical studies. According to the recommendations of COMET, performing systematic reviews (SRs) usually was the first step for COS development. However, the SRs that serve as a basis for COS are not specifically appraised by organizations such as COMET regarding their quality. Here, we investigated the status of SRs related to development of COS and evaluated their methodological quality.MethodsWe conducted a search on PubMed to identify SRs related to COS development published from inception to May 2022. We qualitatively summarized the disease included in SR topics, and the studies included in the SRs. We evaluated the methodological quality of the SRs using AMSTAR 2.0 and compared the overall quality of SRs with and without protocols using the Mann-Whitney U test.ResultsWe included 175 SRs from 23 different countries or regions, and they mainly focused on five diseases: musculoskeletal system or connective tissue disease (n = 19, 10.86%), injury, poisoning, or certain other consequences of external causes (n = 18, 10.29%), digestive system disease (n = 16, 9.14%), nervous system disease (n = 15, 8.57%), and genitourinary system disease (n = 15, 8.57%). Although 88.00% of SRs included randomized controlled trials (RCTs), only a few SRs (23.38%) employed appropriate tools to assess the risk of bias in RCTs. The assessment results on the basis of AMSTAR 2.0 indicated that most SRs (93.71%) were rated as ‘’critically low’’ to ‘’low’’ in terms of overall confidence. The overall confidence of SRs with protocols was significantly higher than that without protocols (P <.001). Compared to the SRs with protocols on Core Outcome Measures in Effectiveness Trials (COMET), SRs with protocols on PROSPERO were of better overall confidence (P = .017).ConclusionThe overall quality of published SRs regarding COS development was poor. Our findings emphasize the need for researchers to carefully select the disease topic and strictly adhere to the requirements of optimal methodology when conducting a SR for the establishment of a COS.

Harmonising outcome measurement for child focused domestic abuse interventions. Reflections on the development and implementation of a core outcome set.

There is appetite in the UK to better measure the impact of domestic violence and abuse (DVA) interventions on children. The spread of outcomes-based commissioning means outcome measurement is no longer just the territory of academic researchers but is now firmly within the purview of practitioners and policy makers. However, outcomes measured in trials only partially represent the views of those delivering and using services with respect to how success should be defined and captured. Even within trials there is huge inconsistency in the definition and measurement of important endpoints. This yields a body of evidence that is difficult to make sense of, defeating the ends for which it was produced - to improve the response to children and families who have experienced abuse. Development of Core Outcome Sets (COS) is seen as a solution to this problem, by establishing consensus across key stakeholder groups regarding a minimum standard for outcome measurement in trials, and increasingly in service delivery contexts. To date COS development has addressed outcomes relating to health conditions or interventions, with limited application to public health challenges. We reflect on our efforts to develop a COS to evaluate psychosocial interventions for children and families experiencing DVA. We highlight the value of COS development as a mechanism for improving evidence quality and the response to families experiencing abuse. Finally, we make recommendations to researchers and COS guideline developers to support this broader application of COS methodology.

Sharing Experiences in Selecting Clinical Outcome and Approving Validated Questionnaires : Insights from an Elderly Registry Study

Objectives: Underpinned by the context of a Korean traditional medicine cohort study on healthy aging, this research primarily aims to guide the selection of Clinical Outcome Assessments (COAs) for elderly healthy aging patient registry research, offering insights into the selection process; and secondly, to streamline the resource-intensive process of obtaining permissions for validated COAs, benefiting future traditional Korean medicine clinical researchers.Methods : In this study, we identified outcomes through a review of previous studies, followed by a process involving expert consultations to select the final outcomes. Subsequently, for the selected outcomes that were Clinical Outcome Assessments (COAs) developed tools, we searched in commercial databases to confirm the availability of Korean versions and the necessity of obtaining permissions. Finally, we obtained permissions for their utilization and, when needed, acquired the original instrument questionnaire through payment.Results: Through a literature review of existing observational studies, a total of 57 outcomes were selected, with 19 of them identified as COA instruments. Upon verifying usage permissions for these 19 instruments, it was found that 17 required author-specific permissions, and among these, 2 needed a purchase as they were commercially available.Conclusion: This study provides a detailed overview of outcome selection and permission acquisition for elderly patient registry research. It underscores the importance of Clinical Outcome Assessment (COA) tools and the rigorous approval process, aiming to enhance research reliability. Continuous verification of COA information is essential, and future research should explore Core Outcome Set (COS) development through consensus-building approaches like Delphi studies.

Defining domains: developing consensus-based definitions for foundational domains in OMERACT core outcome sets

ObjectiveTo develop a set of detailed definitions for foundational domains commonly used in OMERACT (Outcome Measures in Rheumatology) core domain sets. MethodsWe identified candidate domain definitions from prior OMERACT publications and websites and publications of major organizations involved in outcomes research for six domains commonly used in OMERACT Core Domain Sets: pain intensity, pain interference, physical function, fatigue, patient global assessment, and health-related quality of life. We conducted a two-round survey of OMERACT working groups, patient research partners, and then the OMERACT Technical Advisory Group to establish their preferred domain definitions. Results were presented at the OMERACT 2023 Methodology Workshop, where participants discussed their relevant lived experience and identified potential sources of variability giving the needed detail in our domain definitions. ResultsOne-hundred four people responded to both rounds of the survey, and a preferred definition was established for each of the domains except for patient global assessment for which no agreement was reached. Seventy-five participants at the OMERACT 2023 Methodology Workshop provided lived experience examples, which were used to contextualise domain definition reports for each of the five domains. ConclusionUsing a consensus-based approach, we have created a detailed definition for five of the foundational domains in OMERACT core domain sets; patient global assessment requires further research. These definitions, although not mandatory for working groups to use, may facilitate the initial domain-match assessment step of instrument selection, and reduce the time and resources required by future OMERACT groups when developing core outcome sets.

Strategies to promote implementation of core outcomes for medication adherence trials in rheumatology: A report from the OMERACT-Adherence Group

ObjectivesTo identify barriers, facilitators, and strategies for future implementation of the OMERACT-Adherence Core Outcome Set (COS) in medication adherence trials for rheumatic conditions. MethodsPreliminary Delphi survey findings were discussed at OMERACT 2023, utilising the Consolidated Framework for Implementation Research 2 to identify implementation barriers, facilitators, and solutions. ResultsImplementation strategies included simplifying the COS definitions, making it adaptabile for clinical practice and drug trials, adherence trial training workshops, and collaborating with key stakeholders such as payers and other COS developers. ConclusionOngoing collaboration with individuals and organisations within and beyond rheumatology ensures broader applicability of OMERACT-Adherence COS.