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

Beder 1999.

Methods
  • Study design: parallel RCT

  • Time frame: not reported

  • Follow‐up period: 3 months

Participants
  • Country: USA

  • Setting: single centre (Winthrop University Hospital Dialysis Center)

  • Inclusion criteria: patients with ESRD undergoing HD

  • Number (analysed/randomised): treatment group (23/23); control group (23/23)

  • BDI score at baseline indicated 76% of the cohort registered mild to moderate levels of depression and 24% were moderately to severely depressed)

  • Mean age: treatment group (60.7 years); control group (63.3 years)

  • Sex (M/F): treatment group (14/9); control group (15/8)

  • Antidepressant medication: not reported

  • Exclusion criteria: not reported

Interventions Treatment group
  • Social worker services with counselling component


Control group
  • Social worker services


Co‐interventions
  • Not reported

Outcomes
  • Depression

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

  • Psychosocial Adjustment

    • Psychosocial Adjustment to Illness Scale (PAIS)

  • Death (all causes)

  • Hospitalisation

Notes
  • Funding Source: not reported

  • There was no reported registration of the trial within a trial registry, as trial registration was not required in 1999

  • Corresponding author: not reported

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "Random assignment to each group–the process whereby cases are assigned to experimental and control groups–ensured that each case had the same probability of being assigned to either group."
Comment: Sequence generation methods were not reported in sufficient detail to perform an adjudication
Allocation concealment (selection bias) Unclear risk Quote: "The issue of confidentiality was assured as each patient participating in the study was assigned a number by the researcher. All records pertaining to the study were kept off‐site in the office of the researcher."
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 Quote: "Patients were not told whether they were in the experimental or control group."
Comment: The methods of intervention and control treatment were physically different, and therefore masking of treatment allocation for participants and investigators was unlikely
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Quote: "Upon gaining consent to participate, patients were administered the Beck Depression Inventory (BDI‐II) and the Psychosocial Adjustment to Illness Scale by the researcher."
Comment: BDI‐II and the Psychosocial Adjustment to Illness Scale used a subjective measure which was likely to be influenced by knowledge of treatment allocation
Incomplete outcome data (attrition bias) 
 All outcomes High risk Quote. "A total of 55 participants were initially interviewed in the study. Before reaching their three month re interview date, four participants died, one began dialysis at home, and four were hospitalised too long to remain in the study (over one week). The final sample consisted of 46 participants; 23 participants were in the experimental group and 23 formed the control group."
Comment: Overall, 9/55 were lost to the follow up for reasons that appeared unrelated to treatment (> 10% loss to follow‐up, it seems that there was not 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. life participation, fatigue, dialysis withdrawal, adverse events)
Other bias Low risk No evidence of other sources of bias