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. 2019 May 1;2019(5):CD004780. doi: 10.1002/14651858.CD004780.pub4

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:
  1. Organic brain disease

  2. Psychotic or bipolar disorder

  3. Substance dependence or abuse

  4. Serious self‐injurious behaviour

  5. Insufficient knowledge of the German language

  6. IQ below 85

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 1Description: 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 2Description: 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
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
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