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

Babamohammadi 2006.

Study characteristics
Methods Study design
  • Parallel RCT


Study dates
  • Duration of follow‐up: 1 month

  • Time frame: not reported

Participants Study characteristics
  • Setting: not reported

  • Country: Iran

  • Inclusion criteria: patients treated with HD from 2 to 8 years; patients had reading skill

  • Exclusion criteria: patients afflicted by mental disease


Baseline characteristics
  • Number (analysed/randomised): intervention group (not reported/19); control group (not reported/18)

  • Mean age ± SD (years): intervention group (56.37 ± 15.38); control group (57.83 ± 16.64)

  • Sex (M/F): intervention group (12/7); control group (11/7)

  • Dialysis type: HD

  • Mean dialysis vintage ± SD (years): intervention group (2.3 ± 2.0); control group (1.6 ± 2.1)

  • 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
  • Home‐care educational program


Control group
  • No intervention


Co‐interventions
  • Not reported

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

  • Vital signs: SBP and DBP, weight, temperature and pulse

    • Health assessment forms: assessed before and after the treatment

  • Clinical signs: severity of nausea, vomiting, headache, bone pain, weakness and fatigue, itching and general condition

    • Health assessment forms: assessed before and after the treatment

  • Laboratory signs (BUN, creatinine, sodium, potassium, phosphorous and HCT): assessed before and after the treatment

Notes Additional information
  • Funding: not reported

  • 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 Quote: "37 patients afflicted by chronic renal insufficiency were chosen and put into two categories randomly,"
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: "Demographic data questionnaire and health assessment form and rating scale (designed by researchers) were used to collect the data."
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. However, objective and subjective outcomes were assessed
Incomplete outcome data (attrition bias)
All outcomes High risk It was not clear if outcome data were provided for all patients. it 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 was 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 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 There was no evidence of different baseline characteristics, or different non‐randomised co‐interventions between groups. Funding was not reported and authors had no conflicts of interest