Table 4 Recommendations for stakeholder selection and the integration of stakeholder views in the development of core outcome sets

1

Identify all potential stakeholder groups and subgroups from the literature and expert opinion.

Study Steering Group to consider all stakeholders and justify and document choice

2

The final sample size will be informed by the number of subgroups. Each subgroup should include sufficient numbers of individuals to ensure adequate representation of that group’s views. Further work is required to determine optimal numbers. Decisions regarding target numbers of individuals for each subgroup to be made, documented and justified by the study Steering Group.

Any anticipated problems with recruitment and possible fall-back positions to be documented

3

Analyse prespecified stakeholder groups and subgroups separately using a multiple homogeneous panel approach. Item prioritisation criteria should then be applied to each individual stakeholder subgroup to determine which items are to be carried forward to the next round/consensus meeting and results presented to the Steering Group for consideration

4

Any item which meets the cut-off criteria for inclusion in any prespecified stakeholder subgroup should ideally be carried forward to the next round/consensus meeting irrespective of whether the item is prioritised by the group as a whole. If there are a large number of subgroups (for example, >5) or some much smaller than others, higher thresholds may be necessary for an item to be retained if prioritised by a single subgroup only or consensus may be defined with combination criteria; for example, items are only retained if inclusion criteria are met by 2 or more subgroups. Decisions regarding these criteria should be discussed and agreed by the Steering Group and the rationale for the decisions recorded

5

Any item for which uncertainty remains should be carried forward to the next Delphi round or discussed at consensus meetings. Any reason(s) why this should not be done should be discussed by the Steering Group and the justifications recorded

6

If consensus is not achieved following the Delphi process, one or more consensus meetings are advocated. Meetings should be attended by representatives of each prespecified stakeholder subgroup. Any reason(s) why this should not be done should be discussed by the Steering Group and the justifications recorded