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. 2022 May 13;2022(5):CD013525. doi: 10.1002/14651858.CD013525.pub2

1. Risk of bias table for RoB 2 – including judgements.

Study, outcome Bias arising from the randomization process Bias due to deviations from intended intervention Bias due to missing outcome data Bias in measurement of the outcome  Bias in selection of the reported result Overall
Avraham 2012
 
Pain scores at two hours post‐misoprostol administration
Low
 
Quote: "The 61 women were randomized at the time of misoprostol administration into two treatment groups by providing a sealed envelope, using a computer‐generated random list, with serial numbers from 1 to 61."
Low
 
Quote: "The 61 women were randomized at the time of misoprostol administration into two treatment groups by providing a sealed envelope, using a computer‐generated random list, with serial numbers from 1 to 61."
Low
 
Quote: "Two women, one in each group, did not show up for follow‐up, and data about the success of the abortion were not established. They were considered in our analysis as failure of the medical abortion."
 
Comment: missing outcome data between the two groups were similar in proportion and the reason for missing were similar.
Low
 
Quote: "this was a randomized, placebo‐controlled, double‐blind trial." 
 
Comment: Using ROB2 tool, assessed as 'Probably No' for this domain therefore LOW risk.
Low
 
Comment: the study was analyzed and reported based on the authors plan
Low
 
Comment: No other sources of bias were identified
Friedlander 2018
 
Pain scores at multiple time points (immediately after misoprostol administration and then at 2, 6, 12, 24 and 72 hours later)
Low
 
Quote: "A researcher not involved in the conduct of the study used a computer‐generated randomization scheme of varied block sizes"
Low
 
Quote: "A researcher not involved in the conduct of the study ... placed the allocated study capsule in sequentially numbered bags identified only by study identification number so as to maintain blinding of participants and researchers."
Low
 
Comment: Using ROB2 tool: Domain 5.1 = Yes, 5.2 = No, 5.3 = No
Low
 
Comment: Using ROB2 tool: Domain 4.1 =No, 4.2 = No, 4.3 = No Information, 4.4 = No
Low 
 
Comment: Study appears to have reported on all outcomes selected in analysis plan
Low
 
Comment: No other specific concerns regarding sources of bias
Livshits 2009
 
Pain scores at two hours post‐misoprostol administration
Low
 
Quote: "This was a prospective, double‐blind, randomized controlled trial.... We randomized the 120 women into two treatment groups by providing a sealed envelope by using a computer‐generated random list that included serial numbers from 1 to 120. The envelope was given by the nurse at the time at which the patient received the misoprostol tablets."
Low
 
Quote: "This was a prospective, double‐blind, randomized controlled trial....We randomized the 120 women into two treatment groups by providing a sealed envelope by using a computer‐generated random list that included serial numbers from 1 to 120. The envelope was given by the nurse at the time at which the patient received the misoprostol tablets...The ibuprofen and paracetamol tablets were identical in size, color, and shape."
Low
 
Quote: "We randomized the 120 women into two treatment groups by providing a sealed envelope by using a computer‐generated random list that included serial numbers from 1 to 120. The envelope was given by the nurse at the time at which the patient received the misoprostol tablets...The ibuprofen and paracetamol tablets were identical in size, color, and shape."
Low 
 
Comment: Appears nurses were assessing outcomes and also blind to nature of trial medications
Low 
 
Comment: ROB2 Tool Domain 5.1 = Probably Yes, 5.2 = No, 5.3 = Probably No. The authors listed all analyses for table 2 but only show the ones that were significant, but can infer from text that remaining were not significant.
Low
 
Comment: There did not appear to be any other significant sources of bias
Raymond 2013
Worst pain in the 24‐hour period following misoprostol
 
Low
 
Quote: "The one‐to‐one randomization scheme was stratified by site and used randomly permuted blocks with sizes of eight and 20 generated by computer by the study statistician before the start of enrollment."
Low
 
Quote: "If she was eligible, staff assigned her to either the prophylactic regimen group or the therapeutic regimen group by opening the next unused consecutively numbered opaque envelope containing a random assignment."
Low
 
Comment: Missing data accounted for and any sections missing identified in results tables. All variables analysed as ordinal ‐ nearly all data available.
High              
 
Comment: ROB2 tool questions 4.1 = No, 4.2 = No, 4.3 = Yes, 4.4 = Yes, 4.5 = Probably Yes.
Low
 
Comment: ROB2 tool questions 5.1 = Probably Yes, 5.2 = Probably No, 5.3 = Probably No
Some concerns
 
Comment: Recall scores of pain for those who did not complete diary will be affected by recall bias, however the number of participants doing this in both groups is small and so may not affect overall result, but cannot tell as results aggregated.