Abstract

BackgroundThe COMET (Core Outcome Measures in Effectiveness Trials) Initiative promotes the development and application of core outcome sets (COS), including relevant studies in an online database. In order to keep the database current, an annual search of the literature is undertaken. This study aimed to update a previous systematic review, in order to identify any further studies where a COS has been developed. Furthermore, no prioritization for COS development has previously been undertaken, therefore this study also aimed to identify COS relevant to the world’s most prevalent health conditions.MethodsThe methods used in this updated review followed the same approach used in the original review and the previous update. A survey was also sent to the corresponding authors of COS identified for inclusion in this review, to ascertain what lessons they had learnt from developing their COS. Additionally, the COMET database was searched to identify COS that might be relevant to the conditions with the highest global prevalence.ResultsTwenty-five reports relating to 22 new studies were eligible for inclusion in the review. Further improvements were identified in relation to the description of the scope of the COS, use of the Delphi technique, and the inclusion of patient participants within the development process. Additionally, 33 published and ongoing COS were identified for 13 of the world’s most prevalent conditions.ConclusionThe development of a reporting guideline and minimum standards should contribute towards future improvements in development and reporting of COS. This study has also described a first approach to identifying gaps in existing COS, and to priority setting in this area. Important gaps have been identified, on the basis of global burden of disease, and the development and application of COS in these areas should be considered a priority.

Highlights

  • Comparative effectiveness research (CER) involves comparing the benefits and harms of interventions for clinical conditions, which will assist patients, providers, and policy makers in formulating informed decisions that will improve health care [1]

  • This study has described a first approach to identifying gaps in existing core outcome sets (COS), and to priority setting in this

  • As described in detail previously [4], studies were eligible for inclusion if they had applied methodology for determining which outcome domains or outcomes should be measured, or are important to measure, in clinical trials or other forms of health research

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Summary

Introduction

Comparative effectiveness research (CER) involves comparing the benefits and harms of interventions for clinical conditions, which will assist patients, providers, and policy makers in formulating informed decisions that will improve health care [1]. One important element of CER is to ensure that appropriate outcomes are measured in research, so that findings can be compared and contrasted across different studies, and useful evidence can be provided to decision makers. COS represent an agreed set of outcomes that should be measured and reported, as a minimum, in all clinical trials for a specific health condition [2]. The application of COS allows the results of clinical trials to be appropriately combined, minimizing waste [3] and ensuring that usable evidence is made available. The COMET (Core Outcome Measures in Effectiveness Trials) Initiative (www.cometinitiative.org) promotes the development and application of COS, by including pertinent individual studies in a publically available online database. The COMET (Core Outcome Measures in Effectiveness Trials) Initiative promotes the development and application of core outcome sets (COS), including relevant studies in an online database. No prioritization for COS development has previously been undertaken, this study aimed to identify COS relevant to the world’s most prevalent health conditions

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