Table 2.
Domain and item No | Minimum standard item |
Scope | |
1 | Setting (eg, research, routine care, or both) |
2 | Health condition (eg, colorectal cancer) |
3 | Population (eg, all patients, localised or advanced cancer, women or children) |
4 | Intervention (eg, trials of all interventions, surgery only) |
Relevant stakeholder(s) | |
5 | Those who will use the core outcome sets in research (eg, clinical trialists, industry) |
6 | Healthcare professionals with experience of patients with the condition (eg, clinical experts, practitioners, investigators with particular experience of the condition) |
7 | Patients with the condition or their representatives (eg, patients, public, participants who have experienced the condition, family members, carers) |
Transparent consensus process | |
8 | Initial list of outcomes considered both healthcare professionals' and patients' views |
9 | A scoring process and consensus definition is described a priori |
10 | Criteria for including, dropping, or adding outcomes are described a priori |
11 | Care is taken to avoid ambiguity of language used in the list of outcomes |
COS-STAD=core outcome set-standards for development.