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

SWIFT 2020.

Study characteristics
Methods Study design
  • Cluster RCT


Study dates
  • Duration of follow‐up: 12 months

  • Time frame: April 2021 to September 2023

Participants Study characteristics
  • Setting: multicentre (4 units)

  • Country: Australia

  • Inclusion criteria: HD; ≥ 18 years; willing and able to adhere to all trial requirements and able to provide informed consent

  • Exclusion criteria: < 18 years; unable to provide informed consent


Baseline characteristics
  • Number (analysed/randomised): intervention group (not reported/109); control group (not reported/117)

  • Mean age ± SD (years): overall (62, SD 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 reporting fatigue


Intervention group
  • Regular symptom monitoring with feedback to people receiving HD and their clinicians


Control group
  • Usual care


Co‐interventions
  • Not reported

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

  • Symptoms severity

    • IPOS‐Renal (Appendix 3): baseline, 3 months, 6 months, 9 months, 12 months. The IPOS‐Renal is a 15‐symptom checklist measures self‐reported:

      • Pain

      • Shortness of breath

      • Weakness

      • Nausea

      • Vomiting

      • Poor appetite

      • Constipation

      • Sore mouth

      • Drowsiness

      • Poor mobility

      • Itching

      • Difficulty sleeping

      • Restless legs

      • Skin changes

      • Diarrhoea

  • HRQoL

    • HRQoL and EQ‐5D‐5L questionnaire (intervention group): baseline, 6 months, 12 months

    • HRQoL alone (control group): baseline, 6 months, 12 months

  • Death

  • Healthcare utilisation

  • Cost‐effectiveness

  • Withdrawal from dialysis: up to 12 months

  • Fatigue

    • SONG‐HD fatigue score: baseline, 6 months, 12 months

  • HD duration, frequency and adequacy: up to 12 months

  • Hospitalisations: up to 12 months

Notes Additional information
  • Funding: Australian NHMRC Project Grant #1159051; KHA Project Grant KHA2018‐RM; NHMRC TRIP Fellowship#1150989 RM; BEAT‐CKD NHMRC Program Grant #1159051, NHMRC Investigator Grant #1196033, Queensland AdvancingClinical Research Fellowship Grant

  • Conflicts of interest/disclosures: none

  • Trial registration identification number: ACTRN12620001061921

  • A priori published protocol was reported

  • Abstract

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "The randomisation takes place, on a state‐by‐state basis using the method of minimisation as they agree to participate. The randomisation was stratified based upon location (state), metropolitan or regional, private or public unit or prior or current use of the IPOS‐Renal questionnaire for symptom monitoring within each centre and cluster size."
Allocation concealment (selection bias) Low risk Quote: "The trial statistician concealed until the site initiation visit. Access to the allocations is limited to the CI (RLM), the trial statistician (CB), the CTC trial operations coordinator (PW) and ANZDATA Registry Manager (Ms. Kylie Hurst) to minimise risk of inadvertently influencing sites or prematurely revealing allocation."
Blinding of participants and personnel (performance bias)
All outcomes High risk Quote: "Blinding to allocation is not possible within clusters due to the nature of the intervention; however, all staff compiling and analysing outcome data will be blinded to allocation."
Comment: 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: "Blinding to allocation is not possible within clusters due to the nature of the intervention; however, all staff compiling and analysing outcome data will be blinded to allocation."
Comment: Fatigue was assessed with an appropriate measure. 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 subjective outcomes were assessed
Incomplete outcome data (attrition bias)
All outcomes High risk Not reported in sufficient detail to perform adjudication
Selective reporting (reporting bias) High risk Information about the protocol were 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 not extractable for meta‐analysis. All outcomes that should be addressed (fatigue, cardiovascular disease, and death) were not reported
Other bias Unclear risk Quote: "The study sponsor and the study founders (Australian NHMRC, Kidney Health Australia), did not have any role or ultimate authority in study design; collection, management, analysis, interpretation of data, writing of the report, or the decision to submit the report for publication."
Comment: Baseline characteristics were not reported. Funding did not influence the data analysis and authors did not have conflicts of interest