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 characteristicDescriptionFrequency in Category D recruitment studies (n=11)*
RationalePatients too unwell to provide IC9
Limited time for IC in host RCT due to the clinical condition requiring urgent treatment6
To explore the accuracy of decisions made by NOK when acting as SDM1
Recruitment study designQuestionnaire survey5
Face-to-face interview4
Telephone survey1
Focus group meetings1
Recommendations for optimising recruitment in future RCTs or main findings†To use a physician as a SDM4
To use NOK as a SDM4
To use EFIC3
Not to use NOK as a SDM2
To provide RCT information verbally and allow a verbal consent process1
To allow recruitment in prehospital setting1
To perform community consultations to estimate host RCT recruitment rates†1
Not to use a physician as a SDM1
Not to use EFIC1
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.