Skip to main content
. 2022 Dec 20;26(6):501–509. doi: 10.4103/ijem.ijem_3_22

Supplementary Table 1.

Risk of bias assessment table

Burnett-Bowie 2009 Risk Of Bias Author Judgement
Random Sequence Generation (Selection Bias) Low Risk Randomised, double-blind, placebo controlled study
Allocation Concealment (Selection Bias) Low Risk Subjects were randomized by computer-generated assignment in a blinded 1 : 1 ratio
Blinding Of Participants & Personal (Performance Bias) Low Risk Yes, double blinded RCT
Blinding Of Outcome Assessment (Detection Bias) Low Risk Yes, double blinded RCT
Incomplete Outcome Data (Attrition Bias) High Risk 69 out of 88 patients completed the study (78.4%) Hence attrition rate was high (>20%)
Selective Reporting (Reporting Bias) Low Risk All pre-specified outcomes were reported
Other Biases Low Risk This work was supported by National Institute of Health grants K23-RR-161310 (to BZL), R01-AG-025099-03 (to BZL), M01-RR-01066 (to the Mallinckrodt GCRC) and AstraZeneca Pharmaceuticals.

Colleluori 2020 Risk Of Bias Author Judgement

Random Sequence Generation (Selection Bias) Low Risk Randomised, double-blind, placebo controlled study
Allocation Concealment (Selection Bias) Low Risk Participants were randomized by the MEDVAMC pharmacy from a list generated by a research biostatistician to one of two treatment groups
Blinding Of Participants & Personel (Performance Bias) Low Risk Yes, double blinded RCT
Blinding Of Outcome Assessment (Detection Bias) Low Risk Yes, double blinded RCT
Incomplete Outcome Data (Attrition Bias) High Risk 17 out of 23 patients completed the study (73.91%). Hence attrition rate was high (>20%)
Selective Reporting (Reporting Bias) Low Risk All Pre-Specified Outcomes Were Reported
Other Biases Low Risk This research did not receive any specific grant from any funding agency in the public, commercial, or not-for profit sector.

Leder 2004 Risk Of Bias Author Judgement

Random Sequence Generation (Selection Bias) Low Risk Randomised, double-blind, placebo controlled study
Allocation Concealment (Selection Bias) Low Risk Subjects were randomized by computer-generated assignment
Blinding Of Participants & Personal (Performance Bias) Low Risk Yes, double blinded RCT
Blinding Of Outcome Assessment (Detection Bias) Low Risk Yes, double blinded RCT
Incomplete Outcome Data (Attrition Bias) Low Risk All patient outcomes reported. NO drop-outs
Selective Reporting (Reporting Bias) Low Risk All Pre-Specified Outcomes Were Reported
Other Biases Low Risk This work was supported by National Institutes of Health Grant K23-RR16310 (to B.Z.L.), the Massachusetts General Hospital Clinical Research Center grant (RR-1066), and AstraZeneca Pharmaceuticals.

Leder 2005 Risk Of Bias Author Judgement

Random Sequence Generation (Selection Bias) Low Risk Randomised, double-blind, placebo controlled study
Allocation Concealment (Selection Bias) Low Risk Subjects were randomized by computer-generated assignment
Blinding Of Participants & Personal (Performance Bias) Low Risk Yes, double blinded RCT
Blinding Of Outcome Assessment (Detection Bias) Low Risk Yes, double blinded RCT
Incomplete Outcome Data (Attrition Bias) Low Risk All patient outcomes reported. NO drop-outs
Selective Reporting (Reporting Bias) Low Risk All Pre-Specified Outcomes Were Reported
Other Biases Low Risk This work was supported by National Institutes of Health Grant K23-RR16310 (to B.Z.L.), the Massachusetts General Hospital Clinical Research Center grant (RR-1066), and AstraZeneca Pharmaceuticals.