[Summary text]
Study design: Randomized controlled trial
Study grouping: Parallel group.
Included criteria: All patients met DSM-IV criteria for BPD as assessed by SCID-II.
Excluded criteria: Patients who also met the diagnostic criteria for antisocial or paranoid PD at the time of assessment were excluded from the randomization. Patients with severe substance abuse (on a daily basis) requiring specialist treatment were also excluded. Only patients older than 21 years and with a global assessment of functioning (GAF) score above 34 were included in the randomization.
Pretreatment: None known
Interpersonelle problemer ved længste FU (6 måneder)
Symptombelastning ved behandlingsafslutning;
Drop-out ved behandlingsafslutning;
Socialt funktionsniveau ved længste follow-up
Sponsorship source: All seven contributing authors declare the following: We have had no commercial associationsor interests which might pose a conflict of interest in general or in connection with the presentstudy and paper.
Country: Denmark
Setting: Outpatient
Comments: none
Authors name: Carsten René Jørgensen,
Institution: Department of Psychology, Aarhus University, Denmark
Email: carsten@psy.au.dk
Address: Correspondence address: Carsten Rene Jørgensen,Department of Psychology, Aarhus UniversityBartholins Alle 9, Building 1350, DK-8000 Aarhus C
Study design: Randomized controlled trial
Study grouping: Parallel group
Included criteria: Participants were between 18 and 60 years old and had at least two suicidal or nonsuicidal self-injurious episodes in the past 5 years, with at least one occurring in the past 3 months.
Excluded criteria: Exclusion criteria included substance dependence in the preceding 30 days; a diagnosis of psychotic disorder, bipolar I disorder, delirium, dementia, or mental retardation; a medical condition that precluded psychiatric medications; a serious medical condition requiring hospitalization within the coming year; living outside of a 40-mile radius of Toronto; and having plans to leave the province in the next 2 years.
Pretreatment: none known
Intervention Characteristics
Intervention
Control
Livskvalitet ved længste follow up;
Borderline sværhedsgrad ved længste FU;
Interpersonelle problemer ved længste FU;
Symptombelastning ved behandlingsafslutning;
Drop-out ved behandlingsafslutning;
Selvmordsrelateret adfærd ved behandlingsafslutning;
Selvmordsforsøg ved behandlingsafslutning;
Sponsorship source: Supported entirely by the Canadian Institutes for Health Research (grant 200204MCT-101123).
Country: Canada
Setting: Outpatient
Comments: None
Authors name: Shelley F. McMain
Institution: Centre for Addiction and Mental Health, Toronto; the Department of Psychiatry, University of Toronto
Email: shelley_mcmain@camh.net
Address: From the Centre for Addiction and Mental Health, Toronto; the Department of Psychiatry, University of Toronto; McMaster University, Hamilton, Ontario, Canada; St. Michael’s Hospital, Toronto; the Department of Psychiatry, Schulich School of Medicin
No manualised treatment group or control group
Wrong study design
Wrong intervention
Wrong intervention
Wrong patient population
Wrong patient population
No manualised treatment group or control group
Wrong study design
Wrong comparator
Wrong comparator
No manualised treatment group or control group
Wrong intervention
Wrong intervention
Wrong comparator
No manualised treatment group or control group
Wrong study design
a correction
Wrong intervention
No manualised treatment group or control group
No manualised treatment group or control group
Wrong intervention
Wrong study design
Wrong study design
protocol
Wrong study design
Wrong intervention
A commentary
No manualised treatment group or control group
Wrong study design
Wrong patient population
Wrong intervention
Not multimodal treatent
Not multimodal treatent
No manualised treatment group or control group
No manualised treatment group or control group
Not multimodal treatent
Not multimodal treatent
Not multimodal treatent
Letter to editor
Wrong intervention
No manualised treatment group or control group
No manualised treatment group or control group
No manualised treatment group or control group
No manualised treatment group or control group
No manualised treatment group or control group
No manualised treatment group or control group
No manualised treatment group or control group
Wrong intervention
Wrong patient population
No manualised treatment group or control group
Not multimodal treatent
No manualised treatment group or control group
No manualised treatment group or control group
protocol
protocol
Wrong intervention
No manualised treatment group or control group
Wrong study design
No manualised treatment group or control group
Wrong comparator
No manualised treatment group or control group
Wrong patient population
Wrong patient population
Wrong study design
Wrong study design
A commentary
Wrong study design
protocol
No manualised treatment group or control group
No manualised treatment group or control group
Wrong patient population
Wrong study design
Not multimodal treatent
Not multimodal treatent
Not multimodal treatent
abstract only
Not multimodal treatent
No manualised treatment group or control group
Wrong patient population
abstract only
Not multimodal treatent
Wrong patient population
Wrong patient population
Wrong patient population
Wrong patient population
abstract only
Wrong patient population
Not multimodal treatent
Not multimodal treatent
Wrong study design
Not multimodal treatent
No manualised treatment group or control group
No manualised treatment group or control group
protocol
Not multimodal treatent
Not multimodal treatent
Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence
111 SCID-II diagnosed patients with BPD were randomly assigned to either 2 years of outpatient mentalization-based (n = 74) or supportive group psychotherapy (SP; n = 37)
After baseline assessments, eligible participants were randomly assigned to treatment arms using a pregenerated block randomization scheme developed and held by the statistician, who prepared 45 sealed envelopes, each containing the group allocations in random order for four participants
Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment
Randomization was conducted by an individual outside the clinic. Two-thirds (n = 74) of the 111 patients included in the study were randomized to combined treatment, while one-third (n = 37) were offered supportive group therapy.
Eligible participants were randomly assigned to treatment arms using a pregenerated block randomization scheme developed and held by the statistician, who prepared 45 sealed envelopes, each containing the group allocations in random order for four participants
Performance bias due to knowledge of the allocated interventions by participants and personnel during the study
All participants received written and oral information about the study, thus not blinded to the treatment received. Most likely the personnel weren't blinded either.
Therapists in both treatment arms were well experienced in the treatment of borderline personality disorder, were trained in their respective approaches, and attended weekly supervision meetings. Patients provided written informed consent prior to enrollment.
Detection bias due to knowledge of the allocated interventions by outcome assessors
All clinical interviews were conducted by a member of staff (a psychologist or psychiatrist), and the patients were known to the team. Thus, the team was not blind to the original treatment group when doing the GAF assessment. An independent rater (the first author, blind to treatment group) GAF rated 15 patients based on extensive clinical notes from 1.5-year follow-up interviews, and the reliability of the GAF rating was analysed using Cronbach’s Alpha. The reliability was high, Cronbach’s Alpha = 0.94 for GAF-F and 0.87 for GAF- S (both P's = 0.0005)
Assessments were conducted by a board-certified psychiatrist and doctoral-level clinicians who were blinded to treatment group.
Patients were assessed for DSM-IV diagnoses by assessors who were well trained on study instruments and blind to treatment assignment. Assessors were polled after the treatment phase to ascertain whether they could correctly guess participants’ treatment assignment; they did not know treatment assignment for 86% of the cases, suggesting that blinding was largely maintained.
Attrition bias due to amount, nature or handling of incomplete outcome data
Thus, we decided only to include patients who completed the 2-year treatment (and quick responders) in order to get the best possible picture of the longer term development of patients who completed one of the two treatments. We neither conducted intent-to-treat analysis (primarily because of missing outcome data) nor did we impute missing data. The analysis is thus based on 58 of 63 (92%) patients who completed 2 years of either combined MBT treatment (n Œ 40) or supportive group therapy (n = 18) (see Figure 1)."
Judgement Comment: Drop-out rates high 16/58 (27,6%) for IV gr and 6/27 (22,2%) for 'con' gr. Could be upgraded to unclear according to RoB 2 algorithm Fig 4 and Fig 5
Relatively large portion of dropouts.
Reporting bias due to selective outcome reporting
Protocol not available, all stated outcomes are reported
The follow-up study included the same measures as the original study. Protocol available - and all stated outcomes reported
Bias due to problems not covered elsewhere in the table
No control group
No control group