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Validity a) Patient flow illustrated in diagram? (yes/ no) b) Description of complete patient flow? c) Non-participants mentioned (i.e. patients meeting criteria but ...
Table 3: Important methodological aspects adapted from CONSORT [20,21] Ref
Methods paragraph a) Sample size calculation? (yes/ no) b) Period of recruitment listed? (yes/ no) c) Described how patients were assessed for eligibility? (yes/ no) d) Allocation concealment method (described/ not mentioned) e) Blinding of those assessing outcomes (yes/ not mentioned)
[19]
a) No b) Yes (1/11/93-> 31/11/96) c) Yes, both for patients and surgeons d) Not mentioned d) Yes
[23]
a) No b) Yes (1995-97) c) Yes c) Not mentioned d) Not mentioned
[25]
a) No b) Yes (18-month period, dates not mentioned) c) Yes d) Not mentioned e) Not mentioned
[24]
a) No b) Yes (February 1993- December 95) c) No d) Yes e) Not mentioned
Validity a) Patient flow illustrated in diagram? (yes/ no) b) Description of complete patient flow? c) Non-participants mentioned (i.e. patients meeting criteria but refusing participation)? (yes/ no) d) Non-participants characteristics compared with those included? (yes/ no) If yes: potential for selection bias was discussed? e) Accounting for participants not followed? (yes/ no) If yes: Analyses performed to uncover potential skewed withdrawal? (yes/no) Potential bias discussed? f) Clearly described categorisation and follow-up of possible intervention-group patients not wanting the intervention? (yes/ no) a) No diagram. b) No, numbers of patients followed up by interview not available. c) Yes (10 surgeons) d) No e) No f) Yes (14, they were intention-to-treat analysed) a) No b) No, “Drop-out of intervention patients” and patients followed up with questionnaires not available. c) Yes (85 did not wish to participate) d) Participants were younger (p
