From: Core Outcome Set-STAndardised Protocol Items: the COS-STAP Statement
TITLE/ABSTRACT | ||
Title | 1a | Identify in the title that the paper describes the protocol for the planned development of a COS |
Abstract | 1b | Provide a structured abstract |
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 |
2b | Describe the specific objectives with reference to developing a COS | |
Scope | 3a | Describe the health condition(s) and population(s) that will be covered by the COS |
3b | Describe the intervention(s) that will be covered by the COS | |
3c | Describe the context of use for which the COS is to be applied | |
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 |
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 |
5b | Describe how outcomes may be dropped/combined, with reasons | |
Consensus process | 6 | Describe the plans for how the consensus process will be undertaken |
Consensus definition | 7a | Describe the consensus definition |
7b | Describe the procedure for determining how outcomes will be added/combined/dropped from consideration during the consensus process | |
ANALYSIS | ||
Outcome scoring/feedback | 8 | Describe how outcomes will be scored and summarised, describe how participants will receive feedback during the consensus process |
Missing data | 9 | Describe how missing data will be handled during the consensus process |
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) |
Dissemination | 11 | Describe any plans to communicate the results to study participants and COS users, inclusive of methods and timing of dissemination |
ADMINISTRATIVE INFORMATION | ||
Funders | 12 | Describe sources of funding, role of funders |
Conflicts of interest | 13 | Describe any potential conflicts of interest within the study team and how they will be managed |