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. 2024 Aug 22;2024(8):CD007374. doi: 10.1002/14651858.CD007374.pub3

McMurray 2002.

Study characteristics
Methods Study design
  • Parallel RCT

  • Study duration: not reported

  • Follow‐up: 6, 9 and 12 months

  • Country: USA

  • Centre: multicentre (2 sites)

Participants Study characteristics
  • Inclusion criteria: ESKD requiring KRT with either HD or PD in combination with a T1DM or T2DM diagnosis

  • Exclusion criteria: not reported


Baseline characteristics
  • Number: intervention group (45); control group (38)

  • Mean age ± SD (years): intervention group (63.0 ± 13.5); control group (60.9 ± 11.7)

  • Gender (M/F): intervention group (24/21); control group (21/17)

  • Mean duration of diabetes ± SD (years): intervention group (20.5 ± 13.0); control group (22.0 ± 11.7)

  • Months on KRT ± SD: intervention group (32.4 ± 22.8); control group (33.2 ± 11.7)

  • Dialysis type (HD/PD): intervention group (37/8); control group (33/5)


Co‐morbidities
  • None reported other than diabetes

Interventions Intervention group (education + routine treatment)
  • Education programme content: self‐management education; diabetes care monitoring and management; motivational coaching

  • Provider: diabetes care manager (and renal dietitian)

  • Modality: face‐to‐face, one‐on‐one with the patient

  • Routine treatment: glycaemic control, antihypertensive drugs, weight‐maintaining diet, dialysis


Control group (routine treatment)
  • Glycaemic control, antihypertensive drugs, weight‐maintaining diet, dialysis


Co‐interventions or additional treatments
  • None reported


Duration of interventions
  • Intervention was over 12 months

Outcomes Reported outcomes
  • Diabetes QoL (Diabetes form 2.1)

  • Self‐knowledge

  • Self‐management behaviours

  • Glycaemic control (HbA1c%)

  • Foot care

  • Overall death

Notes Additional information
  • A priori published protocol: not reported, unable to locate online

  • Conflicts of interest/disclosures: not reported

  • Funding: "Supported in part by the Renal Care Group and a grant from The Kidney Foundation of Indiana".

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Quote: "Patients meeting inclusion criteria were randomly assigned to control or study groups. At the Jefferson unit, randomization occurred by assigning patients who underwent HD Monday, Wednesday, and Friday to the study group and Tuesday, Thursday, and Saturday to the control group. At the Marion unit, the reverse schedule was used for randomization. Patients undergoing PD were numerically randomized"
Comment: the study states that it was randomised, but no details of the randomisation sequence are provided. Furthermore, patients were randomised according to the day of the week that they underwent surgery (the justification being allocation concealment). For PD patients, insufficient detail was provided, but they were said to be "numerically randomized."
Quote: "Because the HD treatment environment is a close‐knit one, separation of the control and study groups by treatment days was chosen in hopes of reducing knowledge diffusion and discussion among patients between the two groups. It also was important to remove any physician biases"
Quote: "Because the HD treatment environment is a close‐knit one, separation of the control and study groups by treatment days was chosen in hopes of reducing knowledge diffusion and discussion among patients between the two groups. It also was important to remove any physician biases"
Quote: "Patients undergoing PD were numerically randomized"
Allocation concealment (selection bias) Unclear risk Quote: "Because the HD treatment environment is a close‐knit one, separation of the control and study groups by treatment days was chosen in hopes of reducing knowledge diffusion and discussion among patients between the two groups. It also was important to remove any physician biases"
Comment: no information about allocation concealment methods was described. Separation of the control and study groups by treatment days may have helped conceal which treatment groups they were in, but this is unclear
Blinding of participants and personnel (performance bias)
All objective outcomes Low risk Quote: "Because the HD treatment environment is a close‐knit one, separation of the control and study groups by treatment days was chosen in hopes of reducing knowledge diffusion and discussion among patients between the two groups. It also was important to remove any physician biases. Physicians in the dialysis facility cared for patients in either the study group or control group. There was no crossover of physician care"
Comment: it appears that participants were blinded to treatment groups
Blinding of participants and personnel (performance bias)
All subjective outcomes Low risk Comment: appears that participants were blinded to treatment groups
Blinding of outcome assessment (detection bias)
All objective outcomes Low risk Quote: "Physicians in the dialysis facility cared for patients in either the study group or control group. There was no crossover of physician care."
Comment: somewhat unclear description of whether the physicians were blinded. Very unclear if other outcomes assessors were blinded
Blinding of outcome assessment (detection bias)
All subjective outcomes High risk Quote: "Physicians in the dialysis facility cared for patients in either the study group or control group. There was no crossover of physician care."
Comment: unclear description of whether the physicians were blinded and other outcomes assessors. The subjective outcomes reported could be influenced by lack of blinding, and knowledge of the assigned intervention could impact the outcome measures
Incomplete outcome data (attrition bias)
All outcomes Low risk Comment: no loss to follow‐up
Selective reporting (reporting bias) Unclear risk Comment: all outcomes planned in the methods were reported in the results; clinically important outcomes were unstated, such as CV disease incidence. There was no a priori protocol or trial registration.
Trial registration: not reported, unable to locate online
Other bias Unclear risk Comment: conflicts of interest or disclosures are not reported