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. 2015 Mar 16;2015(3):CD004020. doi: 10.1002/14651858.CD004020.pub3

Toda 2001.

Methods RCT; randomisation performed by date of birth. Blinded assessments of level of pain according to VAS, Lequesne index, radiographic outcome
Participants American College of Rheumatology criteria for knee osteoarthritis (n = 90)
 All female
 Mean age (years): 65
 Mean varus (FTA; degrees): 181
Degree of OA according to Kellgren & Lawrence: II = 55, III = 27, IV = 8
Interventions I = strapped insole (n = 46) vs C = lateral wedge insole (n = 44)
 Follow‐up: 8 weeks, 6 months and 2 years
Outcomes VAS, Lequesne (pain) index score, radiographic changes
Notes In Table 3 of the first publication, median value of final VAS score in strapped insole group is incorrect
 No between‐groups analysis was performed
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Quote: "Randomisation was performed by date of birth"
Allocation concealment (selection bias) High risk Quote: "Randomisation was performed by date of birth"
Blinding (performance bias and detection bias) 
 All outcomes High risk Participants were not blinded; outcome assessors were blinded; study used patient‐reported outcome measures; radiographic changes were measured blinded
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Participants were not blinded to the intervention. Research nurse was blinded to objectives of the study
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Study used patient‐reported outcome measures (PROMs). Outcome assessor of PROMS, namely, the participant, was not blinded in this study. However participant and research nurse were blinded to objectives of the study
Incomplete outcome data (attrition bias) 
 All outcomes High risk No intention‐to‐treat analysis
Selective reporting (reporting bias) Low risk Complete data were reported