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. |