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

Sklar 1998.

Study characteristics
Methods Study design
  • Cross‐over RCT


Study dates
  • Duration of follow‐up: 1 week

  • Time frame: not reported

Participants Study characteristics
  • Setting: multicentre (Department of Medicine, United Health Services Hospitals, Binghamton; State University of New York, Health Science Center at Syracuse, Syracuse, NY; and the Guthrie Research Institute, Sayre, PA)

  • Country: USA

  • Inclusion criteria: patients receiving maintenance HD treatments affected by post‐dialysis fatigue

  • Exclusion criteria: not reported


Baseline characteristics
  • Number (analysed/randomised): intervention group 1 (8/not reported); intervention group 2 (8/not reported)

  • Mean age ± SD (years): overall (61 ± 12)

  • Sex (M/F): overall (9/7)

  • 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
  • Pharmacological intervention

  • Indication: study targeting fatigue


Intervention group 1
  • Cuprophan low flux dialyser membranes


Intervention group 2
  • Polymethylmethacrylate low‐flux dialyser membranes


Co‐interventions
  • Each patient was dialysed 3 times/week on a Baxter SPS 550 machine

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

  • TNF alfa (pre and post‐dialysis): assessed during the first and last dialysis treatments

  • Change in the body weight (pre and post‐dialysis): assessed during the first and last dialysis treatments

  • SBP (pre and post‐dialysis): assessed during the first and last dialysis treatments

  • Change in osmolarity (pre and post‐dialysis): assessed during the first and last dialysis treatments

  • Fatigue score

    • 6‐hour logs of sleep (fatigue scores were calculated as the sum of the hours of sleep and the hours of fatigue experienced by patients for up to 6 hours after each dialysis treatment): assessed until the end of treatment

    • Fatigue index questionnaire (each domain rated from 1 to 5): assessed during the first and last dialysis treatments

      • Intensity

      • Duration

      • Frequency

Notes Additional information
  • Funding: Donald Guthrie Foundation for Research and Education, Sayre, PA, and the Arthur T. Cantwell Foundation, Coudersport, PA

  • Conflicts of interest/disclosures: not reported

  • Trial registration identification number: not applicable

  • 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 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