Pickett 2012.
Methods |
Study design: patient‐randomized trial Unit of allocation: patient Unit of analysis: patient Power calculation: unclear |
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Participants |
Care setting: level of care: unclear; ambulatory care; USA
Health professionals: unknown number; type: unclear; unclear level of training Patients: 428; mental illness; male and female |
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Interventions |
Single intervention: patient‐mediated intervention Quote: "...BRIDGES [Building Recovery of Individual Dreams and Goals] is an 8‐week, manualized peer‐led education course designed to empower adults with psychiatric disabilities and enhance their recovery...Topics covered in the BRIDGES curriculum include: self‐advocacy; communication and problem‐solving skills; philosophy of recovery; social support; psychiatric diagnoses, medications and mental health treatment; and crisis planning." page 424 Usual care (control): Quote: "As described above, a total of 216 participants were randomly assigned to a BRIDGES course waiting list (control condition) and were guaranteed an opportunity to receive BRIDGES from the study after completing their third and final interview. During their participation in the project, control group participants received services as usual..." page 425 |
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Outcomes | Patient self‐advocacy (continuous) | |
Notes |
Additional information Number of approached patients (eligible): not reported Number of patients per physician: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Randomization was performed by UIC SRL [University of Illinois Survey Research Laboratory] research staff at the end of each T1 interview. A random allocation sequence programmed into the CAPI administration software blinded both interviewers and participants to subjects’ study assignment (Gluud 2006)." page 422 |
Allocation concealment (selection bias) | Low risk | Quote: "Randomization was performed by UIC SRL research staff at the end of each T1 interview. A random allocation sequence programmed into the CAPI administration software blinded both interviewers and participants to subjects’ study assignment (Gluud 2006)." page 422 |
Blinding (performance bias and detection bias) Participant‐reported outcome | Low risk | Quote: "A random allocation sequence programmed into the CAPI administration software blinded both interviewers and participants to subjects’ study assignment (Gluud 2006). To monitor the integrity of the blind, interviewers were asked at the end of each follow‐up interview whether subjects had directly or indirectly shared their study status; this occurred in only 7.2 % of all T2 and T3 interviews." page 422 |
Incomplete outcome data (attrition bias) Participant‐reported outcome | Low risk | Quote: "A total of 343 subjects (80.1 %) completed T2 interviews, and 320 subjects (74.8 %) completed T3 interviews, for an attrition rate of 25.2 %. There were no statistically significant differences in follow‐up rates between intervention and control conditions. At T2, interviews were completed by 171 (80.7 %) intervention group participants and 172 (79.6 %) control group participants (X1 2 = 0.071, p = .810). At T3, assessments were completed by 157 (74.1 %) intervention group participants 163 (75.5 %) of the control group (X1 2 = 0.112, p = .740)." page 427 |
Selective reporting (reporting bias) | Low risk | Comment: there is selective outcome reporting because of the objective of the paper. The other outcomes were reported in another paper. ClinicalTrials.gov: NCT01297985 |
Other bias | High risk | Quote: "although we assessed changes in participants’ self‐reported empowerment and self‐advocacy, we did not observe their interactions with their treatment providers. Thus, we do not know if BRIDGES participants actually asked questions and/or asserted themselves in treatment discussions with providers." page 428 |
Baseline measurement? Participant‐reported outcome | Low risk | Comment: see table 2. |
Protection against contamination? | Low risk | Quote: "No BRIDGES classes were offered outside of the study in any of the sites during the intervention or 6‐months follow‐up period; thus, the intervention was not available to any control group participants." page 425 |
Baseline characteristics patients | Low risk | Comment: reported and similar (See table 1). |
Baseline characteristics healthcare professionals | Unclear risk | Comment: no report of characteristics. |