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. 2019 Dec 2;2019(12):CD004542. doi: 10.1002/14651858.CD004542.pub3

Lii 2007.

Methods
  • Study design: parallel RCT

  • Time frame: not reported

  • Follow‐up period: 3 months

Participants
  • Country: Taiwan

  • Setting: multicentre (3 HD units of 2 hospitals in northern Taiwan)

  • Inclusion criteria: aged over 18 years and literate in Mandarin or Taiwanese languages; diagnosed with ESKD and receiving routine HD treatment and consented to participate

  • BDI score at baseline: treatment group (15.90 ± 9.89); control group (12.18 ± 8.92)

  • Number (analysed/randomised): treatment group (20/30); control group (28/30)

  • Mean age ± SD (years): not reported

  • Sex (M/F): treatment group (10/10); control group (13/15)

  • Antidepressant medication: not reported

  • Exclusion criteria: history of psychiatric disorders or severe systemic diseases, such as migrating cancer, rheumatoid arthritis or severe congestive heart failure and/or quadriplegic

Interventions Treatment group
  • CBT and self‐efficacy theory. The therapy ran for 2 hours/ week for 2 months, in 2 small‐group session (10 to 15/group)


Control group
  • Usual care and a self‐care booklet


Co‐interventions
  • Not reported

Outcomes
  • Self‐care self‐efficiency

    • Strategies Used by People to Promote Health (SUPPH)

      • Coping

      • Stress reduction

      • Decision making

      • Enjoyment of life

  • Depression

    • BDI‐II: absence of depression (scores of 0 to 9), mild depression (10 to 19), moderate depression (20 to 29), relatively severe depression (30 to 39), severe depression (40 to 63)

  • HRQoL

    • Short Form‐36 (SF‐36)

      • Physical functioning

      • Role limitations owing to physical health problems

      • Bodily pain

      • Social functioning

      • General mental health

      • Role limitations owing to emotional health problems

      • Vitality

      • General health perceptions

Notes
  • Funding source: not reported

  • Trial registration identification number: not reported

  • Corresponding author: S.L. Tsay (sltsay@ntcn.edu.tw)

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "An independent research assistant (unaware of the baseline data) carried out the concealed randomisation procedure using a random computer‐generated list."
Comment: Random computer‐generated list is considered as low risk of bias
Allocation concealment (selection bias) Unclear risk Quote: "An independent research assistant (unaware of the baseline data) carried out the concealed randomisation procedure using a random computer‐generated list."
Comment: Method of allocation concealment was not reported in sufficient detail to perform an adjudication
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Blinding of participants and/or the investigators was not reported. The methods of intervention and control treatment were physically different. Participants and investigators could be aware on the treatment allocation group
Blinding of outcome assessment (detection bias) 
 All outcomes High risk The outcomes were considered subjective. The Strategies Used by People to Promote Health (SUPPH), the BDI‐II and the Short Form‐36 (SF‐36) were self‐reported measurements. As such, the outcome assessment was conducted by participants who could be aware of the treatment received. We judged the outcome assessment to be at high risk of bias for these outcome measures
Incomplete outcome data (attrition bias) 
 All outcomes High risk Quote: "Out of 60 original patients randomly assigned into experimental or control groups, 48 completed the study. [...] After intervention for eight weeks, there were 12 patients who dropped out, including 10 in the treatment group and two in the control group. Reasons for dropout included obligations at home, transfers to another haemodialysis unit or time conflicts."
Comment: 10/30 in the intervention group and 2/30 in the control group were lost to the follow‐up (> 10% loss to follow‐up; there was a differential loss between groups)
Selective reporting (reporting bias) High risk There was no published protocol for this study. This study did not report many patient‐centred outcomes that might be expected for a study of this type (i.e. fatigue, death, dialysis withdrawal, adverse events)
Other bias Low risk No evidence of other sources of bias