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

Li 2014b.

Study characteristics
Methods Study design
  • Parallel RCT


Study dates
  • Duration of follow‐up: 12 weeks

  • Time frame: 2010 to 2012 (months were not reported)

Participants Study characteristics
  • Setting: multicentre (renal units of two local regional hospitals in Guangdong province, China)

  • Country: China

  • Inclusion criteria: Mandarin‐speaking; able to communicate; access a telephone after discharge; agreed to participate

  • Exclusion criteria: receiving intermittent PD or HD; planned admissions for special treatment procedures; patients with Tenckhoff catheters in situ < 3 months; psychosis or dementia; dying or unable to communicate; transferred to another unit during their stay in hospital


Baseline characteristics
  • Number (analysed/randomised): intervention group (69/80); control group (66/80)

  • Mean age ± SD (years): intervention group (57.4 ± 12.8); control group (55.2 ± 11.9)

  • Sex (M/F): intervention group (42/27); control group (37/29)

  • Dialysis type: PD

  • Mean dialysis vintage ± SD (years): intervention group (3.2 ± 2.4); control group (3.5 ± 2.2)

  • Comorbidities

    • CVD: not reported

    • Diabetes: intervention group (33/69); control group (27/66)

    • Hypertension: not reported

    • Depression (clinician diagnosis): not reported

Interventions Intervention classification
  • Non‐pharmacological intervention

  • Indication: study targeting fatigue


Intervention group
  • Post‐discharge nurse‐led telephone support for 6 weeks


Control group
  • Routine hospital discharge care


Co‐interventions
  • Not reported

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

  • HRQoL

    • Chinese version of the KDQOL‐SF: assessed at baseline before discharge, 6 and 12 weeks after discharge

      • Symptom/problem

      • Effect on kidney disease

      • Burden of kidney disease

      • Cognitive function

      • Quality of social interaction

      • Sexual function

      • Work status

      • Social support

      • Staff encouragement

      • Physical functioning

      • Role‐physical

      • Patient satisfaction

      • Energy/fatigue

      • Sleep

      • Pain

      • General health perception

      • Emotional well‐being

      • Role‐emotional

      • Social function

      • Overall health

  • Blood chemistry (blood urea, creatinine, sodium, potassium, phosphate, albumin): assessed at baseline before discharge, 6 and 12 weeks after discharge

  • Complication control: assessed at baseline before discharge, 6 and 12 weeks after discharge

  • Readmission: assessed at baseline before discharge, 6 and 12 weeks after discharge

  • Clinic visit rates: assessed at baseline before discharge, 6 and 12 weeks after discharge

  • Adverse events: assessed until the end of treatment

  • Hospitalisation: assessed until the end of treatment

  • Death: assessed until the end of treatment

Notes Additional information
  • Funding: supported by Outstanding young talents training project of Guangdong Province (Grant No. LYM11035) and the Guangdong Natural Science Foundation, China (Grant No. S2011040005590)

  • 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) Low risk Quote: "The patients were assigned to the study or control group using fifty sets of computer‐generated random numbers."
Comment: Computer generation is considered as low risk of bias. No imbalance between intervention groups was apparent
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 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 160 patients who joined the study were randomly assigned to either the study or control group. There were 80 patients in each of the treatment arms. At week 12, 69 of the 80 (86.3%) study patients and 66 of the 80 (82.5%) controls had completed the follow‐up questionnaires. A total of 135 patients completed the protocol and were included in the analysis (Figure 1)."
Comment: 69/80 participants in the intervention group and 66/80 participants in the control group completed the study (> 5% lost to follow‐up, without differences between groups). 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