Mohamed 2013.
Study characteristics | ||
Methods | Study design
Study dates
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Participants | Study characteristics
Baseline characteristics
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Interventions | Intervention classification
Intervention group 1
Intervention group 2
Co‐interventions
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Outcomes | Outcomes reported
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Notes | Additional information
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Sequence generation methods were not reported in sufficient detail to permit judgement |
Allocation concealment (selection bias) | Unclear risk | Method of allocation concealment was not reported in sufficient detail to permit judgement |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "Participants were randomised in an open‐label fashion." Comment: An open‐label study was considered as high risk of bias |
Blinding of outcome assessment (detection bias) All outcomes | High risk | The outcomes were assessed with an appropriate measure, without differences between groups. However, subjective measures were used, it was not stated whether outcomes were assessed without knowledge of treatment allocation, and knowledge of treatment assignment may have influenced reporting. Participant beliefs about the superiority/inferiority of either intervention could have influenced their assessment of the outcome, but there was no evidence that this was likely. However, objective and subjective outcomes were assessed |
Incomplete outcome data (attrition bias) All outcomes | High risk | Quote: "One patient withdrew in the third week from the higher DGC group." Comment: The number of patients who completed the study was not clearly stated. It was unclear if there was evidence that the results were not biased by missing outcome data |
Selective reporting (reporting bias) | High risk | Information about the protocol and the statistical analysis plan were not reported. Outcomes information were not reported in sufficient detail to permit judgment. All outcomes that should be addressed (fatigue, cardiovascular disease, and death) were not reported |
Other bias | Unclear risk | No data were available to assess the possible imbalance between groups. Funding and conflicts of interest were not reported |