McMurray 2002.
| Study characteristics | ||
| Methods | Study design
|
|
| Participants | Study characteristics
Baseline characteristics
Co‐morbidities
|
|
| Interventions | Intervention group (education + routine treatment)
Control group (routine treatment)
Co‐interventions or additional treatments
Duration of interventions
|
|
| Outcomes | Reported outcomes
|
|
| Notes | Additional information
|
|
| 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 |