Table 1.

Inclusion/exclusion criteria applied in three steps to patient engagement initiatives for selection for in-depth review and gap analysis

Step	Inclusion criteria	Exclusion criteria
1
What is the PE initiative type?*	(i) Framework, guidance or guideline (ii) Process (iii) Case study	(i) Training or education** (ii) Advocacy**
Does the PE initiative cover one or more of the three key stages in medicines development?	(i) Research priority setting (ii) Clinical trial design (iii) Early dialogues with regulators and HTA bodies (iv) More than one of these	(i) None of these (ii) Solely benefit/risk (iii) Post market access
Were patients/patient groups/carers directly engaged in the initiative?	(i) Yes to one or more of these	(i) Solely a thought leader (ii) Non-patient expert engagement (iii) Solely being the subject of research
2
What context is the PE occurring in?	(i) Medicines development	(i) Comparative effectiveness research (ii) Other secondary or tertiary care (iii) Health care or health policy
3
(i) Removal of duplicates (ii) Removal of initiatives over 10 years old (iii) Removal of initiatives where insufficient information was available to make a meaningful assessment using the gap tool (i.e. single source, very limited information on the how, why, when and outcomes) and included where information was available but was unable to be shared due to confidentiality issues, or not available within the timeframe of in-depth review)

Step 1; *or has PE included within it; **If initiatives sole purpose appeared to be training, education or advocacy

PE patient engagement, HTA Health Technology Assessment