Skip to main content
. 2023 Aug 31;2023(8):CD013074. doi: 10.1002/14651858.CD013074.pub2

Chow 2010.

Study characteristics
Methods Study design
  • Parallel RCT


Study dates
  • Duration of follow‐up: intervention was performed for 6 weeks, follow‐up was 12 weeks in total

  • Time frame: 2005 (months not reported)

Participants Study characteristics
  • Setting: multicentre (2 local regional hospitals in Hong Kong)

  • Country: Hong Kong

  • Inclusion criteria: patients undergoing PD; able to access a telephone after discharge from the hospital

  • Exclusion criteria: on intermittent PD or HD and those with planned admissions for special treatment procedures; patients with Tenckhoff catheters in situ for less than 3 months


Baseline characteristics
  • Number (analysed/randomised): intervention group (43/50); control group (42/50)

  • Mean age ± SD (years): intervention group (59.4 ± 13.97); control group (54.5 ± 12.8)

  • Sex (M/F): intervention group (28/15); control group (24/18)

  • Dialysis type: PD

  • Mean dialysis vintage ± SD (years): intervention group (3.0 ± 2.6); control group (3.5 ± 2.6)

  • Comorbidities

    • CVD: not reported

    • Diabetes: intervention group (19/43); control group (16/42)

    • Hypertension: not reported

    • Depression (clinician diagnosis): not reported

Interventions Intervention classification
  • Non‐pharmacological intervention

  • Indication: study targeting fatigue


Intervention group
  • Nurse‐led case management programme for 6 weeks


Control group
  • Routine hospital discharge service for 6 weeks


Co‐interventions
  • All the patients had received routine, intensive training prior to the start of the dialysis regimen

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

  • QoL

    • Chinese version of the KDQOL‐SF: assessed before the intervention, at completion of the 6‐week intervention and 6 weeks after completion of the programme

      • Symptoms/problems

      • Effects of kidney disease

      • Burden of kidney disease

      • Work status

      • Cognitive function

      • Quality of social interactions

      • Sexuality

      • Sleep

      • Social support

      • Dialysis staff encouragement

      • Patient satisfaction

    • Chinese version of the SF‐36

      • Physical Function

      • Role‐Physical

      • Role‐Emotional

      • Social Function

      • Pain

    • General Health

    • Emotional well‐being (mental health)

    • Energy/fatigue (vitality)

  • Death: assessed until the end of treatment

Notes Additional information
  • Funding: Research Grants Council of Hong Kong (PolyU 5435/05H)

  • 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: "The study was a randomised controlled trial with a pre‐test and post‐test."
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: "The data were collected in 2005 at three time intervals using a structured self‐report questionnaire. [...] Data collection was through face‐to‐face 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 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 Quote: "The 100 patients who joined the study were randomly assigned to either the study or control group. There were 50 patients in each of the treatment arms. At week 12, 43 of the 50 study patients and 42 of the 50 controls had completed the follow‐up questionnaires. A total of 85 patients completed the protocol and were included in the analysis (Figure 1)."
Comment: 43/50 participants in the intervention group and 42/50 participants in the control group completed the study (> 5% loss to follow‐up). 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. 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 Low risk There was no evidence of different baseline characteristics, or different non‐randomised co‐interventions between groups. Funding was unlikely to influence the data analysis and authors had no conflicts of interest. The study seemed to be free from other source of bias