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. 2019 Dec 12;19(8):1–108.

Table A2:

Risk of Biasa Among Nonrandomized Trials (ROBINS-I Tool)

Author, Year Pre-intervention At Intervention Postintervention
Confounding Study Participation Selection Classification of Interventions Deviations from Intended Intervention Missing Data Measurement of Outcomes Selection of Reported Results
Mitsuishi et al, 201848 Low to moderate risk; length of follow-up not provided. There could be bias if length of follow-up affects outcomes differently between intervention groups. Also unknown confounders cannot be ruled out Low risk; before-after study makes it unlikely that selection factors were associated with type of intervention Low risk; nothing indicates that SMBG users would be misclassified as flash users or vice versa Low risk; nothing indicates that intended SMBG users would use flash or vice versa Low risk; nothing suggests that data were missing Low risk; there could be subjectivity in the quality-of-life measurements, but all reported quality-of-life scales have been validated Unknown risk; no information to assess unknown risks
Al Hayek et al, 201747 Low to moderate risk; unknown duration of SMBG use. Potential for bias if length of follow-up differs between intervention groups. Also unknown confounders cannot be ruled out Low risk; before-after study makes it unlikely that selection factors were associated with type of intervention Low risk; nothing indicates that SMBG users would be misclassified as flash users or vice versa Low risk; nothing indicates that intended SMBG users would use flash or vice versa Low risk; nothing suggests that data were missing Low risk; there could be subjectivity in the quality of life measurements, but all reported quality of life scales have been validated Unknown risk; no information to assess unknown risks
Moreno-Fernandez et al, 201850 Low to moderate risk; unknown confounders cannot be ruled out Low risk; nothing indicates that interventions or other selection factors dictated who would participate in study Low risk; nothing indicates that SMBG users would be misclassified as flash users or vice versa Low risk; nothing indicates that intended SMBG users would use flash or vice versa Low risk; nothing suggests that data were missing Low risk; nothing suggests systematic errors in outcome measurements Unknown risk; no information to assess unknown risks

Abbreviations: ROBINS-I, Risk of Bias in Non-randomized Studies—of Interventions; SMBG, self-monitoring of blood glucose.

a

Possible risk-of-bias levels: low, moderate, serious, critical, and no information.