Muz 2017.
Study characteristics | ||
Methods | Study design
Study dates
|
|
Participants | Study characteristics
Baseline characteristics
|
|
Interventions | Intervention classification
Treatment group
Control group
Co‐interventions
|
|
Outcomes | Outcomes reported
|
|
Notes | Additional information
|
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Random selection of samples was performed." Comment: 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 | Not reported. However, interventions were different and participants and/or investigators could be aware of the treatment assigned |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "Visual Analogue Scale (VAS) score, Piper fatigue scale, and Pittsburgh Sleep Quality Index (PSQI) were determined via face‐to‐face interview and patient documents. In the first week (the first follow‐up), second week (second follow‐up), and third week (third follow‐up), Visual Analogue Scale (VAS) score and Piper fatigue scale were obtained by the researcher." 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/investigators 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 | Figure 1 reported the number of participants who did not complete the follow‐up. 27/41 participants in the intervention group and 35/39 participants in the control group completed the study (> 5% lost to follow‐up, with differences between groups) |
Selective reporting (reporting bias) | High risk | Information about the protocol and the statistical analysis plan were not reported. Fatigue was reported using multiple eligible outcome measurements (scales, time points). Fatigue was reported in a format that was extractable for meta‐analysis. All outcomes that should be addressed (fatigue, cardiovascular disease, and death) were not reported |
Other bias | Low risk | There was no evidence of different baseline characteristics, or different non‐randomised co‐interventions between groups. Funding was unlikely to influence the data analysis and authors had no conflicts of interest. The study seemed to be free from other source of bias |