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Table 2 Quality analysis of RCT according to the Cochrane Collaboration’s risk of bias tool [20]

From: Effectiveness of decision aids for female BRCA1 and BRCA2 mutation carriers: a systematic review

Publication Armstrong (2005) [22] Schwartz (2009) [23] Hooker (2011) [24] Metcalfe (2017) [25]
Criterion
Adequate sequence generation + + + +
Adequate allocation concealment + ? ? ?
Blinding of participants and personnel (−)b (−)c (−)c
Blinding of outcome assessors + -a -a -a, d
No incomplete outcome data ? ? ? ?
No selective outcome reporting + + + +
No other sources of bias + + + +
RISK OF BIAS Unclear High High High
  1. + Met criterion;? Unclear; − Unmet criterion; RCT: randomized controlled trial
  2. aPatient-Reported Outcome Measures (PROMs) with unblinded patients
  3. bpatients and outcome assessors blinded, staff not blinded
  4. cpatients not blinded, blinding of staff not or not completely mentioned
  5. dresearch assistant blinded but likely that blinding has been broken