Table 2.
First author & publication year | Country, design & funding | Outcome definition | Inclusion (1) & exclusion (2) criteria | Study size | Sample size calculation and power | Comparable at baseline | Adequate random sequence generation | Adequate allocation concealment | Adequate blinding | Adequate follow-up | Attrition, % (range) | ITT data |
---|---|---|---|---|---|---|---|---|---|---|---|---|
Wilkes, 2013 [41] | USA, cluster RCT, non-profit | Primary & Secondary | 1 | N ≥ 200 | yes | yes | unclear | yes | HCP: yes Participants: yes OA: unclear |
noa | ≤20% (0–20%) | yesb |
Landrey, 2013 [42] | USA, parallel RCT, non-profit | Primary & Secondary | 1, 2 | N ≥ 200 | nr | yes | unclear | nr | HCP: nr Participants: nr OA: yes |
yes | ≥20% (6.60–51.16%) | no |
Krist, 2007 [43, 44](Woolf, 2005) | USA, parallel RCT, non-profit | Primary & Secondary | 1, 2 | N ≥ 200 | nr | Partialc | yes | yes | HCP: no Participants: nr OA: unclear |
yes | < 20% (0–13.29%)d | yesb |
Gatellari, 2003 [45] | Australia, parallel RCT, non-profit | Primary | 1 | N ≥ 200 | ire | yes | yes | yes | HCP: yes Participants: yes OA: unclear |
yes | ≥20% (13.71–27.82%) | no |
ir incomplete reporting, nr not reported, HCP Healthcare Professionals, OA Outcome Assessors, ITT Intention To Treat
aFollow-up was driven by the timing of the standardised patient visit and varied from 6 to 16 weeks depending on the study arm
bWilkes 2013: ITT for physician-reported screening behaviour and role in decision-making, doctors’ recommendations towards screening, physician-reported outcomes. Krist 2007: ITT for decisional conflict, PSA tests ordered by physicians or self-reported by patients, but unclear for other outcomes
cMore physicians from the website and brochure groups reported to know the group patients were in, with a ratio of 1:3:3 between groups. This was intentionally done to be free of other potential biases
dUnclear for two outcomes
eReported on power only