Core Outcome Set For Research Research Articles

Choosing important health outcomes for comparative effectiveness research: 5th annual update to a systematic review of core outcome sets for research.

A systematic review of core outcome sets (COS) for research is updated annually to populate an online database. It is a resource intensive review to do annually but automation techniques have potential to aid the process. The production of guidance and standards in COS development means that there is now an expectation that COS are being developed and reported to a higher standard. This is the fifth update to the systematic review and will explore these issues. Searches were carried out to identify studies published or indexed in 2018. Automated screening methods were used to rank the citations in order of relevance. The cut-off for screening was set to the top 25% in ranked priority order, following development and validation of the algorithm. Studies were eligible for inclusion if they reported the development of a COS, regardless of any restrictions by age, health condition or setting. COS were assessed against each of the Core Outcome Set-STAndards for Development (COS-STAD). Thirty studies describing the development of 44 COS were included in this update. Six COS (20%) were deemed to have met all 12 criteria representing the 11 minimum standards for COS development (range = 4 to 12 criteria, median = 10 criteria). All 30 COS studies met all four minimum standards for scope. Twenty-one (70%) COS met all three minimum standards for stakeholders. Twenty-three studies (77%) included patients with the condition or their representatives. The number of countries involved in the development of COS ranged from 1 to 39 (median = 10). Six studies (20%) met all four minimum standards [five criteria] for the consensus process. Automated ranking was successfully used to assist the screening process and reduce the workload of this systematic review update. With the provision of guidelines, COS are better reported and being developed to a higher standard.

Choosing important health outcomes for comparative effectiveness research: 4th annual update to a systematic review of core outcome sets for research.

BackgroundThe Core Outcome Measures in Effectiveness Trials (COMET) database is a publically available, searchable repository of published and ongoing core outcome set (COS) studies. An annual systematic review update is carried out to maintain the currency of database content.MethodsThe methods used in the fourth update of the systematic review followed the same approach used in the original review and previous updates. Studies were eligible for inclusion if they reported the development of a COS, regardless of any restrictions by age, health condition or setting. Searches were carried out in March 2018 to identify studies that had been published or indexed between January 2017 and the end of December 2017.ResultsForty-eight new studies, describing the development of 56 COS, were included. There has been an increase in the number of studies clearly specifying the scope of the COS in terms of the population (n = 43, 90%) and intervention (n = 48, 100%) characteristics. Public participation has continued to rise with over half (n = 27, 56%) of studies in the current review including input from members of the public. The rate of inclusion of all stakeholder groups has increased, in particular participation from non-clinical research experts has risen from 32% (mean average in previous reviews) to 62% (n = 29). Input from participants located in Australasia (n = 17; 41%), Asia (n = 18; 44%), South America (n = 13; 32%) and Africa (n = 7; 17%) have all increased since the previous reviews.ConclusionThis update included a pronounced increase in the number of new COS identified compared to the previous three updates. There was an improvement in the reporting of the scope, stakeholder participants and methods used. Furthermore, there has been an increase in participation from Australasia, Asia, South America and Africa. These advancements are reflective of the efforts made in recent years to raise awareness about the need for COS development and uptake, as well as developments in COS methodology.

Validated outcomes in the grafting of autologous fat to the breast– the VOGUE Study: Development of a core outcome set for research and audit studies

Validated outcomes in the grafting of autologous fat to the breast– the VOGUE Study: Development of a core outcome set for research and audit studies

Development of a Core Outcome Set for research on critically ill obstetric patients: A study protocol.

Current data on critical illness during pregnancy are insufficient for evidence-based decision making. Core outcome sets are promoted to improve reporting of outcomes important to decision makers. We aim to develop a Core Outcome Set for research on critically ill obstetric patients (COSCO study). We will perform a systematic review of studies on critical illness in pregnancy and focus groups or interviews with women who were critically ill while being pregnant. These data will inform an international Delphi survey where stakeholders will rank proposed outcomes. Selected outcomes will be brought forward to a consensus meeting where core outcomes will be defined. We will then complete a second consensus process to define measures for each core outcome. The Core Outcome Set on Critically ill Obstetric patients study aims to develop a set of core outcomes to be part of all studies on critically ill obstetric patients. Implementation of this core outcome set will help improve future research efforts.Trial registration: This study is registered on the COMET-initiative website (COS #916). This systematic review is registered on PROSPERO (CRD #42017071944).

Validated Outcomes in the Grafting of Autologous Fat to the Breast: The VOGUE Study. Development of a Core Outcome Set for Research and Audit.

Autologous fat grafting is an important part of the reconstructive surgeon's toolbox when treating women affected by breast cancer and subsequent tumor extirpation. The debate over safety and efficacy of autologous fat grafting continues within the literature. However, work performed by the authors' group has shown significant heterogeneity in outcome reporting. Core outcome sets have been shown to reduce heterogeneity in outcome reporting. The authors' goal was to develop a core outcome set for autologous fat grafting in breast reconstruction. The authors published their protocol a priori. A Delphi consensus exercise among key stakeholders was conducted using a list of outcomes generated from their previous work. These outcomes were divided into six domains: oncologic, clinical, aesthetic and functional, patient-reported, process, and radiologic. In the first round, 55 of 78 participants (71 percent) completed the Delphi consensus exercise. Consensus was reached on nine of the 13 outcomes. The clarity of the results and lack of additional suggested outcomes deemed further rounds to be unnecessary. The VOGUE Study has led to the development of a much-needed core outcome set in the active research front and clinical area of autologous fat grafting. The authors hope that clinicians will use this core outcome set to audit their practice, and that researchers will implement these outcomes in their study design and reporting of autologous fat grafting outcomes. The authors encourage journals and surgical societies to endorse and encourage use of this core outcome set to help refine the scientific quality of the debate, the discourse, and the literature. Therapeutic, V.

NETS1HD: study protocol for development of a core outcome set for use in determining the overall success of Hirschsprung's disease treatment.

BackgroundUse of core outcome sets in research has been proposed as a method for countering the problems caused by heterogeneity of outcome measure reporting. Heterogeneity of outcome measure reporting occurs in Hirschsprung’s disease (HD) research and is limiting the development of a robust evidence base to support clinical practice.MethodsCandidate outcome measures have been identified through a systematic review. These outcome measures will form the starting point for a three-phase online Delphi process to be carried out in parallel by three panels of experts. Panel 1 is a neonatal panel; panel 2 is a non-neonatal panel; and panel 3 is a lay panel. In round 1, experts will be asked to score the previously identified outcome measures from 1 to 9 based on how important they think the measures are in determining the overall success of their/their child’s/their patient’s HD. In round 2, experts will be presented with the same list of outcome measures and graphical representations of how their panel scored that outcome in round 1. They will be asked to re-score the outcome measure, taking into account how important other members of their panel felt it to be. In round 3, experts will again be asked to re-score each outcome measure, but this time they will receive a graphical representation of the distribution of scores from all three panels, which they should take into account when re-scoring. Following round 3 of the Delphi process, 40 experts will be invited to attend a face-to-face consensus meeting. Participants will be invited in a purposive manner to obtain balance between the different panels. Results of the Delphi process will be discussed, and outcomes will be re-scored. Outcome measures where >70% of participants at the meeting scored it 7–9 and <15% scored it 1–3 will form the core outcome set.DiscussionDevelopment of a core outcome set will help to reduce heterogeneity of outcome measure reporting in HD. This will increase the quality of research taking place and ultimately improve care provided to infants with HD.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1693-6) contains supplementary material, which is available to authorized users.

Proceedings of the 5th Meeting of the Core Outcome Measures in Effectiveness Trials (COMET) Initiative.

Proceedings of the 5th Meeting of the Core Outcome Measures in Effectiveness Trials (COMET) Initiative.

Development of a core outcome set for research and audit studies in reconstructive breast surgery.

BackgroundAppropriate outcome selection is essential if research is to guide decision‐making and inform policy. Systematic reviews of the clinical, cosmetic and patient‐reported outcomes of reconstructive breast surgery, however, have demonstrated marked heterogeneity, and results from individual studies cannot be compared or combined. Use of a core outcome set may improve the situation. The BRAVO study developed a core outcome set for reconstructive breast surgery.MethodsA long list of outcomes identified from systematic reviews and stakeholder interviews was used to inform a questionnaire survey. Key stakeholders defined as individuals involved in decision‐making for reconstructive breast surgery, including patients, breast and plastic surgeons, specialist nurses and psychologists, were sampled purposively and sent the questionnaire (round 1). This asked them to rate the importance of each outcome on a 9‐point Likert scale from 1 (not important) to 9 (extremely important). The proportion of respondents rating each item as very important (score 7–9) was calculated. This was fed back to participants in a second questionnaire (round 2). Respondents were asked to reprioritize outcomes based on the feedback received. Items considered very important after round 2 were discussed at consensus meetings, where the core outcome set was agreed.ResultsA total of 148 items were combined into 34 domains within six categories. Some 303 participants (51·4 per cent) (215 (49·5 per cent) of 434 patients; 88 (56·4 per cent) of 156 professionals) completed and returned the round 1 questionnaire, and 259 (85·5 per cent) reprioritized outcomes in round 2. Fifteen items were excluded based on questionnaire scores and 19 were carried forward to the consensus meetings, where a core outcome set containing 11 key outcomes was agreed.ConclusionThe BRAVO study has used robust consensus methodology to develop a core outcome set for reconstructive breast surgery. Widespread adoption by the reconstructive community will improve the quality of outcome assessment in effectiveness studies. Future work will evaluate how these key outcomes should best be measured.