Table 5

Frequency of rationales, study designs, main findings and recommendations from non-randomised studies designed study to consider recruitment within proposed hypothetical RCTs (ie, Category D studies, commonly known as community consultations)

Recruitment study characteristic	Description	Frequency in Category D recruitment studies (n=11)*
Rationale	Patients too unwell to provide IC	9
	Limited time for IC in host RCT due to the clinical condition requiring urgent treatment	6
	To explore the accuracy of decisions made by NOK when acting as SDM	1
Recruitment study design	Questionnaire survey	5
	Face-to-face interview	4
	Telephone survey	1
	Focus group meetings	1
Recommendations for optimising recruitment in future RCTs or main findings†	To use a physician as a SDM	4
	To use NOK as a SDM	4
	To use EFIC	3
	Not to use NOK as a SDM	2
	To provide RCT information verbally and allow a verbal consent process	1
	To allow recruitment in prehospital setting	1
	To perform community consultations to estimate host RCT recruitment rates†	1
	Not to use a physician as a SDM	1
	Not to use EFIC	1
	To perform community consultations to aid selection of relevant study outcomes†	1

*Each study may appear more than once in the relevant characteristics section (eg, if it described >1 rationale or produced >1 finding/recommendation).
†Items reported as main findings, but not recommendations for optimising recruitment.
EFIC, exception from informed consent; IC, informed consent; NOK, next of kin; RCT, randomised controlled trial; SDM, surrogate decision-maker.