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Table 3 Core outcome set-STAndardised protocol items

From: COHESION: core outcomes in neonatal encephalopathy (protocol)

 Title 1a Identify in the title that the paper describes the protocol for the planned development of a COS Page 0
 Abstract 1b Provide a structured abstract Page 0–1
 Background and objectives 2a Describe the background and explain the rationale for developing the COS, and identify the reasons why a COS is needed and the potential barriers to its implementation Pages 2–7
 2b Describe the specific objectives with reference to developing a COS   Pages 6–7
 Scope 3a Describe the health condition(s) and population(s) that will be covered by the COS Pages 2–5
 3b Describe the intervention(s) that will be covered by the COS   Pages 2–7
 3c Describe the context of use for which the COS is to be applied   Pages 6–7
 Stakeholders 4 Describe the stakeholder groups to be involved in the COS development process, the nature of and rationale for their involvement and also how the individuals will be identified; this should cover involvement both as members of the research team and as participants in the study Pages 14, 17–20
 Information sources 5a Describe the information sources that will be used to identify the list of outcomes. Outline the methods or reference other protocols/papers Pages 9–16
 5b Describe how outcomes may be dropped/combined, with reasons   Pages 16–20
 Consensus process 6 Describe the plans for how the consensus process will be undertaken Pages 16–20
 Consensus definition 7a Describe the consensus definition Page 18
 7b Describe the procedure for determining how outcomes will be added/combined/dropped from consideration during the consensus process   Pages 16–20
 Outcome scoring/feedback 8 Describe how outcomes will be scored and summarised, describe how participants will receive feedback during the consensus process Pages 17–18
 Missing data 9 Describe how missing data will be handled during the consensus process Pages 17–18
 Ethics approval/informed consent 10 Describe any plans for obtaining research ethics committee/institutional review board approval in relation to the consensus process and describe how informed consent will be obtained (if relevant) Page 26
 Dissemination 11 Describe any plans to communicate the results to study participants and COS users, inclusive of methods and timing of dissemination Pages 19–20
 Funders 12 Describe sources of funding, role of funders Page 26
 Conflicts of interest 13 Describe any potential conflicts of interest within the study team and how they will be managed Page 26