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. 2023 Aug 31;2023(8):CD013074. doi: 10.1002/14651858.CD013074.pub2

Lazarus 2020.

Study characteristics
Methods Study design
  • Parallel RCT


Study dates
  • Duration of follow‐up: 8 weeks

  • Time frame: not reported

Participants Study characteristics
  • Setting: single centre

  • Country: India

  • Inclusion criteria: 20 to 80 years; diagnosed with CKD and undergoing HD

  • Exclusion criteria: not reported


Baseline characteristics
  • Number (analysed/randomised): intervention group (100/100); control group (100/100)

  • Mean age ± SD (years): not reported

  • Sex (M/F): not reported

  • Dialysis type: HD

  • Dialysis vintage (years) (mean ± SD): not reported

  • Comorbidities

    • CVD: not reported

    • Diabetes: not reported

    • Hypertension: not reported

    • Depression (clinician diagnosis): not reported

Interventions Intervention classification
  • Non‐pharmacological intervention

  • Indication: study targeting fatigue


Intervention group
  • Olive‐oil massage


Control group
  • No intervention


Co‐interventions
  • Not reported

Outcomes Outcomes reported
  • Fatigue outcome measures used: validation data available

  • Fatigue

Notes Additional information
  • Funding: none

  • Conflicts of interest/disclosures: none

  • Trial registration identification number: not reported

  • A priori published protocol: not reported

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 Unclear risk Quote: "In a randomised double blind placebo controlled study."
Comment: Although the study was reported as a double blind study, it was not reported if participants and investigators were blinded to the treatment assigned
Blinding of outcome assessment (detection bias)
All outcomes High risk Fatigue was 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 Low risk All participants completed the study. There was no lost to follow‐up
Selective reporting (reporting bias) High risk Information about the protocol and the statistical analysis plan were not reported. Fatigue was reported with multiple eligible outcome measurements (scales and time points). 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 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 Unclear risk Baseline characteristics were not clearly reported. There were neither funding nor conflict of interests