Table 1 COS-STAP checklist

Title

1a

Identify in the title that the paper describes the protocol for the planned development of a COS

1

Abstract

1b

Provide a structured abstract

2–3

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

4–7

2b

Describe the specific objectives with reference to developing a COS

8

 Scope

3a

Describe the health condition(s) and population(s) that will be covered by the COS

8

3b

Describe the intervention(s) that will be covered by the COS

8

3c

Describe the context of use for which the COS is to be applied

8

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

10–11

 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

9

5b

Describe how outcomes may be dropped/combined, with reasons

9

 Consensus process

6

Describe the plans for how the consensus process will be undertaken

11–13

 Consensus definition

7a

Describe the consensus definition

11

 Analysis

7b

Describe the procedure for determining how outcomes will be added/combined/dropped from consideration during the consensus process

11–12

 Outcome scoring/feedback

8

Describe how outcomes will be scored and summarised, describe how participants will receive feedback during the consensus process

12

 Missing data

9

Describe how missing data will be handled during the consensus process

12

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)

13, 15

 Dissemination

11

Describe any plans to communicate the results to study participants and COS users, inclusive of methods and timing of dissemination

13

Administrative information

 Funders

12

Describe sources of funding, role of funders

15

 Conflicts of interest

13

Describe any potential conflicts of interest within the study team and how they will be managed

15