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

Mohamed 2014.

Study characteristics
Methods Study design
  • Quasi‐RCT


Study dates
  • Duration of follow‐up: 3 months

  • Time frame: November to December 2013

Participants Study characteristics
  • Setting: single‐centre (Hemodialysis Unit at Public Fayoum Hospital, Ministry of Health)

  • Country: Egypt

  • Inclusion criteria: recently diagnosed with kidney failure and requiring HD at least 3 months; patients had to be sedentary for 6 months or more; ≥ 18 years; able to communicate

  • Exclusion criteria: acute heart and lung disease; acute infectious diseases; Hb < 10 g/dL; physical or mental disability preventing the proper performance of the protocol


Baseline characteristics
  • Number (analysed/randomised): intervention group (40/40); control group (40/40)

  • Mean age ± SD (years): not reported

  • Sex (M/F): intervention group (18/22); control group (20/20)

  • 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
  • Educational nursing intervention protocol for 2 weeks


Control group
  • Standard nursing instruction and routine hospital care


Co‐interventions
  • All adult patients were scheduled for HD

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

  • Fatigue

    • PFS (Appendix 3): assessed pre and post‐test and after 3 months

      • Behavioural

      • Affective

      • Sensory

      • Cognitive/mood

  • General knowledge in CKD and HD

    • Structured Knowledge Questionnaires Sheet (40 questions; each right answer got one score, while no answer take zero score): assessed pre and post‐test and after 3 months

      • General information about CKD

      • General information about HD

      • Clinical manifestation

      • Diagnostic evaluation

      • Knowledge about nutrition

      • Self–care measures

      • Knowledge about complication

  • Laboratory results (Hb, sodium, potassium, blood urea, creatinine): assessed pre‐ and post‐test and after 3 months

Notes Additional information
  • Funding: not reported

  • Conflicts of interest/disclosures: not reported

  • 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 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: "The patient assessment sheet was filled by the researcher through personal interview."
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. It was not stated if the interviewer was blinded to the treatment allocation
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Table 3 reported that all participants completed the study. However, it was not clearly stated if some participants discontinued
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 Unclear risk There was no evidence of different baseline characteristics, or different non‐randomised co‐interventions between groups. Funding and conflicts of interest were not reported