Ahmadipour 2010.
| Methods | Randomized controlled trial | |
| Participants | The study location was the Isfahan Diabetes Institute, Isfahan, Iran 50 participants were randomized to the intervention group and 50 participants were randomized to the control group The inclusion criteria were patients with type 2 diabetes mellitus taking oral hypoglycemic agents for at least 1 year and had given informed consent |
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| Interventions | Intervention: DIARY CHECKLIST
The intervention group was asked to complete a diary checklist about how they took their drugs during the study period. The duration was 12 weeks Control: COLLECTION OF MEDICATION SHELLS The control group patients were asked to collect the shells of oral hypoglycemic agents after taking in a pocket. Duration was 12 weeks |
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| Outcomes | The measures of adherence were a diary checklist about how the drugs were taken The patient outcome was HbA1c level measured using a chromatographic method |
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| Notes | There is a discrepancy between the abstract and the text of the article in terms of the number of participants in the control and intervention groups. According to abstract there are 100 participants divided equally into 2 groups, but in figure 1, as well as in methods, there are 30 participants in the intervention group and 57 in the control | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Insufficient information on method of randomization (pg 1 Abstract). A number of 100 type 2‐diabetic patients were selected through systematic sampling method and then were randomly allocated to 2 groups of equal number (pg 3 Methods) |
| Allocation concealment (selection bias) | Unclear risk | Not described. Participants were selected from the patients list of the Institute through a systematic sampling method and then they were randomly allocated to 2 groups |
| Selective reporting (reporting bias) | Unclear risk | No protocol and no details about what outcomes would be looked at, only that HbA1c was measured in each group |
| Other bias | Unclear risk | Intervention and control not adequately described. Discrepancy in sample size description |
| Blinding of outcome assessment (detection bias) Adherence measure | Unclear risk | (PRIMARY) MEDICINE SHELLS ‐ Insufficient information. Blinding not mentioned |
| Blinding of outcome assessment (detection bias) Adherence measure | Unclear risk | (PRIMARY) CHECKLIST DIARY ‐ Insufficient information. Blinding not mentioned |
| Blinding of outcome assessment (detection bias) Patient outcome | Unclear risk | (PRIMARY) HBA1C LEVEL ‐ Insufficient information. Blinding not mentioned |
| Blinding of participants (performance bias) Adherence measure | High risk | (PRIMARY) CHECKLIST DIARY ‐ Patients would have been aware due to the nature of the intervention |
| Blinding of participants (performance bias) Adherence measure | High risk | (PRIMARY) MEDICINE SHELLS ‐ Patients likely to be aware of the intervention due to its nature |
| Blinding of participants (performance bias) Patient outcome | Low risk | (PRIMARY) HBA1C LEVEL ‐ Blinding not mentioned but lack of blinding of the participant is not likely to affect this outcome |
| Blinding of personnel (performance bias) Adherence measure | Unclear risk | (PRIMARY) MEDICINE SHELLS ‐ Insufficient information. Blinding not mentioned |
| Blinding of personnel (performance bias) Adherence measure | Unclear risk | (PRIMARY) CHECKLIST DIARY ‐ Insufficient information. Blinding not mentioned |
| Blinding of personnel (performance bias) Patient outcome | Unclear risk | (PRIMARY) HBA1C LEVEL ‐ Insufficient information. Blinding not mentioned |
| Incomplete outcome data (attrition bias) Adherence measure | Unclear risk | (PRIMARY) CHECKLIST DIARY ‐ Insufficient information provided. However, there appears to be an error in paper regarding the number of participants randomized to each group. States in Abstract Methods (pg 1): "A number of 100 type 2‐diabetic patients were selected through systematic sampling method and then were randomly allocated to two groups of equal number" but then states twice in the article (pg 4 under Results), including Figure 1, that there were 57 at the end of the study in the "reference" (control) group |
| Incomplete outcome data (attrition bias) Adherence measure | Unclear risk | (PRIMARY) MEDICINE SHELLS ‐ Insufficient information provided. However, there appears to be an error in paper regarding the number of participants randomized to each group. States in Abstract Methods (pg 1): "A number of 100 type 2‐diabetic patients were selected through systematic sampling method and then were randomly allocated to two groups of equal number" but then states twice in the article (pg 4 under Results), including Figure 1, that there were 57 at the end of the study in the "reference" (control) group |
| Incomplete outcome data (attrition bias) Patient outcome | Unclear risk | (PRIMARY) HBA1C LEVEL ‐ Insufficient information provided. However, there appears to be an error in paper regarding the number of participants randomized to each group. States in Abstract Methods (pg 1): "A number of 100 type 2‐diabetic patients were selected through systematic sampling method and then were randomly allocated to two groups of equal number" but then states twice in the article (pg 4 under Results), including Figure 1, that there were 57 at the end of the study in the "reference" (control) group |