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. 2015 Aug 17;2015:912481. doi: 10.1155/2015/912481

Table 2.

Risk of bias in included studies.

Bias Study ID
Lundström et al. 2006 [23] Sarikkola et al. 2011 [25] Serrano-Aguilar et al. 2012 [24]
Random sequence generation (selection bias) Unclear risk
“The patients were randomly assigned to ISCS or to DSCS.” No further description of randomization procedure
Low risk
“Randomization was performed using sealed envelopes after the preoperative examination”
Low risk
“A computer-generated sequence was used”

Allocation concealment
(selection bias)
Unclear risk
Not described in paper
Unclear risk
Patients (and staff) knew after the preoperative assessment but before the surgery to which group they belonged
Unclear risk
“Random numbers were obtained for all patients on the waiting list before participants were selected on the basis of the inclusion and exclusion criteria. Randomization was performed sequentially for blocks of 200 patients.” Unclear whether those including the patients in the study were aware of the randomization status before inclusion/exclusion

Blinding of participants and personnel (performance bias) High risk
Not possible to blind patients or personnel to whether the patient had ISBCS or different date bilateral surgery
High risk
Not possible to blind patients or personnel to whether the patient had ISBCS or different date bilateral surgery
High risk
Not possible to blind patients or personnel to whether the patient had ISBCS or different date bilateral surgery

Blinding of outcome assessment (detection bias) Unclear risk
Not reported
Unclear risk
Not reported
Unclear risk
Not reported

Incomplete outcome data
(attrition bias)
Unclear risk
High rate of exclusion after randomization/drop-outs (8/96 = 8.3%), not possible to assess whether this influenced the outcome since the characteristics of drop-outs were not compared to non-drop-outs
Low risk
96.0% in Group 1 and 97.3% in Group 2 were treated per protocol. 491/507 randomized patients had 1 month follow-up
Low risk
Low number of exclusions and drop-outs (<5% at the 1 month postoperative examination)

Selective reporting (reporting bias) Low risk
Important outcomes were reported
Low risk
Important outcomes were reported
Low risk
Important outcomes were reported

Other bias Low risk
Not likely in this study
Low risk
Not likely in this study
Low risk
Not likely in this study

Risk of bias was assessed according to the Cochrane Handbook [15].