Core Outcome Set For Interventions Research Articles

Development of a core outcome set for interventions to prevent stillbirth.

To develop a core outcome set for trials investigating interventions to prevent stillbirth. Outcomes identified from a systematic literature review and semi-structured interviews with parents in Australia and the UK were entered into a two-round online Delphi survey and focus group/consensus meetings. A core outcome set containing 11 outcomes in two categories. Five outcomes were related to the mother; fetal loss, onset of and mode of delivery, maternal mortality or near miss, psychological and social impact on the women, women's knowledge. Six outcomes were related to the baby; timing of stillbirth, neonatal mortality, gestational age at delivery, birthweight, congenital anomaly, NICU/SCBU or other higher-level neonatal care length of stay. Implementation and dissemination of this core outcome set in future trials will contribute towards coordinated outcome reporting and advancing usefulness of research to guide clinical practice.

Developing a core outcome set for interventions to improve discharge from mental health inpatient services: a survey, Delphi and consensus meeting with key stakeholder groups

ObjectiveTo develop a core set of outcomes to be used in all future studies into discharge from acute mental health services to increase homogeneity of outcome reporting.DesignWe used a cross-sectional...

COSUTI: a protocol for the development of a core outcome set (COS) for interventions for the treatment of uncomplicated urinary tract infection (UTI) in adults

BackgroundUrinary tract infections (UTIs) are the second most common infection presenting in the community. Clinical guidelines and decision aids assist health practitioners to treat a UTI; however, treatment practices vary due to patient needs and context of presentation. Numerous trials have evaluated the effectiveness of treatment interventions for UTI; however, it is difficult to compare the results between trials due to inconsistencies between reported outcomes. Poor choice of outcome measures can lead to impairment of evidence synthesis due to the inability to compare outcomes between trials with similar aims. Transparency in selecting and reporting outcomes can be mitigated through the development of an agreed minimum set of outcomes that should be reported in clinical trials, referred to as a core outcome set (COS). This paper presents the protocol for the development of a COS for interventions in the treatment of uncomplicated UTI in adults.MethodsThis COS development consists of three phases. Phase 1 is a systematic review, which aims to identify the core outcomes that have been reported in trials and systematic reviews of interventions treating uncomplicated UTI in adults. Phase 2 consists of a three-round online Delphi survey with stakeholders in the area of treatment interventions for UTI. The aim of this online Delphi survey is to achieve consensus on the importance of the outcomes emerging from Phase 1 of this research. Phase 3 is a consensus meeting to finalise the COS that should be reported in trials evaluating the effectiveness of interventions for the treatment of UTI.DiscussionIt is hoped that the development of a COS for interventions for the treatment of uncomplicated UTI in adults will be adopted as a minimum set of outcomes that should be reported and measured within this context. If the findings from clinical trials related to treatment interventions for UTI are to impact on policy and practice, it is important that the findings from different treatment interventions are comparable across trials.

CHronic Rhinosinusitis Outcome MEasures (CHROME), developing a core outcome set for trials of interventions in chronic rhinosinusitis.

Evaluating the effectiveness of treatments in chronic rhinosinusitis (CRS) have been limited by both a paucity of high quality randomised trials, and the heterogeneity of outcomes in those that have been reported. Core outcome sets (COS) are an agreed, standardized set of outcomes that should be measured and reported by future trials as a minimum and will facilitate future meta-analysis of trial results in systematic reviews (SRs). We set out to develop a core outcome set for interventions for adults with CRS. A long-list of potential outcomes was identified by a steering group utilising a literature review, thematic analysis of a wide range of stakeholders' views and systematic analysis of currently available Patient Reported Outcome Measures (PROMs). A subsequent e-Delphi process allowed 110 patients and healthcare practitioners to individually rate the outcomes in terms of importance, on a Likert scale. After 2 rounds of the iterative Delphi process, the 54 initial outcomes were distilled down to a final core-outcome set of 15 items, over 4 domains. The authors hope inclusion of these core outcomes in future trials will increase the value of research on interventions for CRS in adults. It was felt important to make recommendations regarding how these outcomes should be measured, although additional work is now required to further develop and revalidate existing outcome measures.

CHronic Rhinosinusitis Outcome MEasures (CHROME), developing a core outcome set for trials of interventions in chronic rhinosinusitis

Statement of problem: Evaluating the effectiveness of treatments in chronic rhinosinusitis (CRS) have been limited by both a paucity of high quality randomised trials, and the heterogeneity of outcomes in those that have been reported. Core outcome sets (COS) are an agreed, standardized set of outcomes that should be measured and reported by future trials as a minimum and will facilitate future meta-analysis of trial results in systematic reviews (SRs). We set out to develop a core outcome set for interventions for adults with CRS. Method(s) of study: A long-list of potential outcomes was identified by a steering group utilising a literature review, thematic analysis of a wide range of stakeholders’ views and systematic analysis of currently available Patient Reported Outcome Measures (PROMs). A subsequent e-Delphi process allowed 110 patients and healthcare practitioners to individually rate the outcomes in terms of importance, on a Likert scale. Main results: After 2 rounds of the iterative Delphi process, the 54 initial outcomes were distilled down to a final core-outcome set of 15 items, over 4 domains. Principal conclusions: The authors hope inclusion of these core outcomes in future trials will increase the value of research on interventions for CRS in adults. It was felt important to make recommendations regarding how these outcomes should be measured, although additional work is now required to further develop and revalidate existing outcome measures.