Table 3.
Core outcome set-STAndardised protocol items
| TITLE/ABSTRACT | |||
| 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 |
| INTRODUCTION | |||
| 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 | |
| METHODS | |||
| 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 | |
| ANALYSIS | |||
| 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 and DISSEMINATION | |||
| 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 |
| ADMINISTRATIVE INFORMATION | |||
| 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 |