McMurran 2016.
Study characteristics | ||
Methods | 12‐week trial with 2 arms
Duration of trial: 12 weeks Country: UK Setting: community (outpatient) |
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Participants |
Methods of recruitment of participants: referred to PEPS team. Participants were recruited from mental health services in 3 UK NHS trusts.
Sample size: subsample = 183 Diagnosis of borderline personality disorder: Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM‐IV) Means of assessment: International personality disorder examination (IPDE) Mean age: no data on subsample. Full sample for PEPS therapy = 38.6 years (standard deviation = 10.9), full sample for TAU = 37.8 years (standard deviation = 11) Sex: approximately 75% female Comorbidity: not stated Inclusion criteria
Exclusion criteria
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Interventions |
Experimental group
Treatment name: PEPS therapy, internet‐based control group with no psychoeducation + TAU
Number randomised to group: 93
Duration: 12 weeks Control/comparison group Comparison name: TAU Number randomised to group: 90 Duration: 12 weeks Both groups Concomitant psychotherapy: not stated Concomitant pharmacotherapy: allowed Proportions of participants taking standing psychotropic medication during trial observation period: unclear |
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Outcomes |
Primary
Secondary
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Notes |
Sample size calculation: yes Ethics approval: yes Comments from review authors:
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Randomisation was based on a computer generated pseudo‐random code using random permuted blocks of randomly varying size created by the Nottingham Clinical Trials Unit [NCTU] in accordance with their standard operating procedure and held on a secure server. Allocation was stratified by recruiting centre and sex." (p xxiv) |
Allocation concealment (selection bias) | Low risk | Quote: "The sequence of treatment allocations was concealed until recruitment, data collection, and all other trial‐related assessments were complete. The investigator, or an authorised designee, accessed the treatment allocation for each participant by means of a remote, internet‐based randomisation system developed and maintained by the NCTU. Allocation was therefore fully concealed from recruiting staff." (p 14) |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "At the start of each follow‐up, participants were reminded of the importance of not disclosing their treatment allocation to the research assistant using a suggested unblinding script (See Appendix 9). If the research assistant was inadvertently unblinded to treatment allocation before completing the final follow‐up, a record of the incident of unblinding was made. Researchers also reported whether or not they were aware of the treatment allocation at the time of completing the primary end‐point assessments. Owing to changes in personnel over the course of the trial, in some cases, end‐point assessments were conducted by researchers who were not unblinded. A record was made of the blinding status of the researcher conducting the final follow‐up data collection." (p 16). "Data analysts remained blinded to allocation during the study by having access to only aggregate data and no access to data that could reveal treatment arm, such as course attendance". "Most of the outcome data were obtained from self‐report questionnaires from participants who were not blind to treatment allocation". (p 16) |
Incomplete outcome data (attrition bias) All outcomes | Low risk |
Comment: Participants were analysed as randomised, and all were included in the primary analysis by imputation of missing data. Quotes: "We obtained robust variance estimates in all regression models to allow for the potential clustering effect of receiving therapy in groups in the PEPS arm." (p 8) "The primary analysis (ITT) compared the mean SFQ score between PEPS and usual treatment at 72 weeks postrandomisation follow‐up, adjusted for baseline SFQ score and stratification variables (centre and gender), and implemented using maximum likelihood‐based generalised linear modelling." (p 12) "The pattern of missing data was investigated by examining variables recorded at baseline that were associated with ‘missingness’ of SFQ score at the 72‐week follow‐up. Multiple imputation and analysis of multiple imputed data sets were conducted using ‘mi’ procedures in Stata. The imputation model contained site, age, sex,ethnicity, social status, PD category (simple or complex), SFQ at baseline and 24 weeks, baseline EQ‐5D health state score, baseline HADS score, baseline SPSI‐R score and baseline three main problems score, and 20 data sets were imputed." (p 12) |
Selective reporting (reporting bias) | Low risk | Comment: in terms of outcomes, protocol and full‐text report matched. |
Other bias | High risk |
Treatment adherence Comment: adherence was self‐rated by the therapist. Attention bias Comment: mean number of treatment weeks: TAU non‐completer = 30 (SD = 25.7), completer = 80.2 (SD = 9,8); PEPS non‐completer = 36.7 (SD = 23,4), completer = 80.3 (SD = 10.4). Seemed that both groups got equal amount of therapy. Allegiance bias Comment: authors (MM, CD) have allegiance to PEPS therapy. Vested interest Comment: The National Institute for Health Research (NIHR) Health Technology Assessment programme funded this study. Hywel Williams is the Deputy Director of this programme but was not involved in the funding decision for this programme. |