Herpertz‐Dahlmann 2014.
Methods | Randomised non‐inferiority trial | |
Participants | Country: Germany
Diagnostic tool: DSM‐ IV
No. screened: 660
No. randomised: Total: 176
No. started trial: Total: 172; IP: 85; DP: 87
No. dropped out during intervention: Total: 29; IP: 10; DP: 19
No, dropped out during follow‐up: Total: 11; IP: 10; DP: 1
No. analysed (observed case): Differing N for various outcomes Mean age in years (SD): IP: 15·2 (1·5); DP: 15·3 (1·5) Age range in years: No detail Gender %: Female 100% Subtype purging %: No detail Subtype restricting %: No detail Age of onset: No detail Duration of illness (weeks): IP: 53·7 (39·6); DP: 42·4 (33·1) Baseline weight: No detail Baseline BMI: IP: 15·1 (1·2); DP: 14·9 (1·5) Baseline eating disorder scale score (MRAOS): IP 5·0 (1·7); DP: 5·6 (1·7) Baseline eating disorder scale score (EDI‐II Global Score): IP: 272·5 (59·4); DP: 248·8 (58·2) Baseline purging: No detail Comorbidity (Any): IP: 33 (44%); DP: 28 (38%), Affective, Anxiety, Obsessive Compulsive and Attention Deficit Hyperactivity Disorders Details on living arrangements: No detail Family education/employment/income: No detail Recruitment strategy: Multi‐site: 6 centres in Germany Exclusion criteria:
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Interventions | Setting of care: Inpatient and outpatient
Training/qualification of care provider(s): No detail
Treatment manual: No detail
Supervision of treatment: No detail
Adherence to treatment: No detail
Intervention group 1
Description: Inpatient therapy
Admission to IP for medical observation or stabilisation during the first 3 weeks of the study. Multimodal multidisciplinary treatment programme based on weight restoration, nutritional counselling, CBT, and family therapy but undertaken in inpatient setting Length: Mean 14.6 weeks Intervention group 2 Description: Day patient therapy Admission to IP for medical observation or stabilisation during the first 3 weeks of the study. Multimodal multidisciplinary treatment programme based on weight restoration, nutritional counselling, CBT, and family therapy but undertaken in day‐patient setting Length: Mean 16.5 weeks |
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Outcomes |
Eating psychopathology Morgan Russell Outcome Scales (MRAOS) Eating Disorders Inventory (EDI‐II) Global Score Behavioural indices BMI Number of eating disorder readmissions Costs, loss to follow‐up General Psychopathology and Obsessionality Brief Symptom Inventory |
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Notes | The differences between the IP and DP are unclear. It is not clearly stated how the treatments differed beyond the initial 3 week IP admission. Descriptions for discharge criteria and interventions appear to be the same. The family therapy component is not described. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation sequence to randomly assign participants to continued IP or DP after 3 weeks of inpatient care |
Allocation concealment (selection bias) | High risk | Patients and therapists could not be masked to treatment allocation |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Therapists and participants cannot be blinded in trials of family‐based therapy |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Assessors were initially masked but some participants inadvertently revealed their treatment allocation; masking was maintained for the primary outcome of BMI |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Differences in numbers at post‐intervention analysis and 12‐month follow‐up. Fewer participants included in post‐intervention analysis compared to follow‐up. Modified ITT analysis reported. There is an imbalance in the missing data across conditions (i.e. missing data from 10 participants in inpatient condition and only missing data from 1 in day patient condition). |
Selective reporting (reporting bias) | Low risk | Outcomes appear to have been reported |