Sklar 1998.
Study characteristics | ||
Methods | Study design
Study dates
|
|
Participants | Study characteristics
Baseline characteristics
|
|
Interventions | Intervention classification
Intervention group 1
Intervention group 2
Co‐interventions
|
|
Outcomes | Outcomes reported
|
|
Notes | Additional information
|
|
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: "Patients were blinded with respect to the type of membrane used during all dialysis treatments throughout the study." Comment: Not reported if investigators were blind. However, interventions were different and investigators could be aware of the treatment assigned |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "Levels of post dialysis fatigue were determined by analysis of 6‐hour logs of sleep and perception of fatigue recorded by patients after each of these dialysis treatments. At the completion of the study, the patients submitted their log sheets to one of the investigators." Comment: 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. Other objective outcomes were assessed |
Incomplete outcome data (attrition bias) All outcomes | High risk | Quote: "Five patients were not included in the data analysis because they were individuals who destabilized medically (2) or submitted incomplete log sheets (3)." Comment: Overall, 16/21 participants completed the study (> 5% lost to follow‐up, difference between groups could not be assessed). Reasons for discontinuations seemed to be not related to the treatment allocation |
Selective reporting (reporting bias) | High risk | Information about the protocol and the statistical analysis plan were not reported. It was not reported if multiple eligible outcome measurements (scales and time points) were pre‐specified. It was unclear if the reported approach to analysing this outcome was pre‐specified or influenced by the results. Fatigue at the end of treatment was not reported in a format that was extractable for meta‐analysis (cross‐over study: data related to the first period were not clearly reported). All outcomes that should be addressed (fatigue, cardiovascular disease, and death) were not reported |
Other bias | Unclear risk | Baseline characteristics between groups were not reported. Funding was unlikely to influence the data analysis and conflicts of interest were not reported |