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Table 1 Checklist of the items that groups should consider when reporting the development of a COS of domain concepts (that is, ‘what’ to measure)

From: Developing core outcome sets for clinical trials: issues to consider

Section/topic # Checklist item
Title 1 Identify the report as a study to develop a COS.
Structured summary 2 Provide a structured summary including, as applicable: background, objectives, data sources, participant eligibility criteria, study methods, results, limitations, conclusions, and implications of key findings.
Rationale 3 Describe the rationale for the development of a COS in the context of what is already known. This may include a review of outcomes in previous trials or systematic reviews.
Objectives 4 Provide an explicit statement of questions being addressed with reference, as applicable, to: health condition, population, and types of intervention(s).
Protocol and registration 5 Indicate if a study protocol exists, and where it can be accessed (for example, web address)
Eligibility criteria 6 Specify participant eligibility criteria, including stakeholder group, the rationale for involving them, and how participants were identified and sampled.
Information sources 7 Describe all information sources (for example, systematic review, databases with dates of coverage, contact with study authors) provided to participants before the start of and during the consensus process. If no information on previously measured outcomes is provided, this should be clearly stated together with details of the method for obtaining information on outcomes of importance from the participants.
Consensus process 8 Describe method to determine consensus and the rationale. A checklist for reporting Delphi methods applied to the development of COS has previously been recommended [29].
Outcome scoring 9 Describe how outcomes will be scored during the consensus exercise, and how scores will be summarized across participants during each stage of the consensus process.
Definition of consensus 10 Clearly describe any pre-determined definition of consensus. Describe procedure for determining how outcomes will be included or excluded from consideration at each stage of the consensus process.
Participants 11 Give the total number of participants invited and the number involved in each aspect of the study. Give the proportion of each type of participant from the various stakeholder groups involved. Present any data collected on participant characteristics.
Results of the consensus process 12 As a minimum, provide a comprehensive list of all the outcomes that participants agreed should be included in the core set. Describe a measure of group response and distribution of response for each outcome considered during the process.
Summary of evidence 13 Summarize the main findings regarding the level of consensus and the content of the COS. Consider its relevance to key groups e.g. patients and the public, healthcare providers, and policy makers, and any potential barriers to implementation.
Limitations 14 Discuss limitations in terms of stakeholder and geographical coverage. Describe methods used for assessing risk of bias, in relation to information provided to participants beforehand, attrition, any lack of anonymity, etc.
Conclusions 15 Provide a general interpretation of the results in the context of other evidence, and implications for future research.
Funding 16 Describe sources of funding and the role of the funder in the study.
Conflicts of interest 17 Describe any conflicts of interest within the study team, for example researchers who have developed an outcome measurement instrument applicable to the scope of the COS.