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

Whitney 2012.

Methods RCT
Participants Country: UK
 Diagnostic tool: DSM‐IV
 No. screened: 95
 No. randomised: Total: 48; IFW: 23; FDW: 25
 No. started trial: No detail
 No. dropped out during intervention:Total: 6; IFW: 3; FDW: 3
 No. dropped out during follow‐up:Total: 11; IFW: 5; FDW: 6
 No. analysed (OC): BMI (long‐term follow‐up), IFW: 21, FDW: 23, SEED AN (long‐term follow‐up), IFW 15, FWD 14, SEED BN (long‐term follow‐up), IFW: 15, FWD: 14, IIP (long‐term follow‐up), IFW: 11, FWD: 14
 Mean age in years (SD): Total: 25 (9.15)
 Age range: No detail 
 Gender %: Total: 4% (1) male; 96% (47) female, IFW: 1 male; 22 female, FDW: 0 male; 25 female
 Subtype: Total: no specific detail on subtype but text states “the patients primarily had the restricting type of AN. Approximately 20‐25% used vomiting or laxatives, and approximately half reported using excessive exercise”
 No detail by group
 Age of onset: No detail
 Duration of illness (months): Total : 56% had a duration of ± 5 years; 25% had ± 10 years, IFW: range 1 ‐ 20 years, FDW: range <1 ‐ >20 years
 Baseline weight: No detail
 Baseline BMI: Total : 13.3 (1.6); No detail by group
 Baseline eating disorder scale score, IFW: SEED AN 13.3 (1.6), FDW: SEED AN 13.2 (1.5)
 Baseline purging (vomiting at least once a day): Total: IFW: 6 (26%), FDW: 4 (16%)
 Comorbidity: No detail
 Details on living arrangements: Total: IFW: 65% living in family unit (52% parents; 9% spouse; 4% children); FDW: 88% living in family unit (80% parents; 8% spouse; 0% children)
 Family education/employment/income: Detail of highest education, occupation, employment status and income/support for participants reported in Table 2
 Recruitment strategy: Consecutive referrals to the inpatient eating disorder unit
 
 Exclusion criteria:
  1. Previous family work on the Gerald Russell Eating Disorders Unit

  2. Currently receiving family therapy at the Michael Rutter Centre for Children and Adolescents

  3. Required more intensive family work due to disclosed abuse within the family

  4. Self‐discharge (within 6 weeks, before randomisation)

Interventions Setting of care: Inpatient
 Training/qualification of care provider(s): Yes: “six experienced eating disorder therapists from diverse mental health professional backgrounds (e.g. nurses, social workers, and doctors) all with training in family work” pg. 9
 Treatment manual: No detail
 Supervision of treatment: Yes: “All participated in training workshops prior to the commencement of the study with regular supervision throughout the study” pg. 9
 Adherence to treatment: Yes: “Typically two therapists were involved in both interventions. The sessions were video‐taped for supervision and to ensure treatment fidelity” pg. 9 
 
 Intervention group 1Description: Specific family therapy
 Involved 2 phases: 1. engaging family, dispelling myths about AN, reducing parental guilt, instilling confidence in parents that they can help child; 2. problem‐ and symptoms‐oriented focus with emphasis on parental coping strategies, functional analysis of difficulties in managing AN in the home, reduction of hostile, over‐critical or over‐protective interactions
 Length: 18 hours of treatment in 1 ‐ 2 hour weekly or fortnightly sessions with 3 follow‐up sessions
 
 Intervention group 2Description: Standard family systems therapy
 Highly structured intervention working with 2 families over 3 days with the aim to promote rapport between families to share difficulties and strengths in managing and including shared meals. Day 1 focus on family difficulties; Day 2 focus on current family functioning and organisation around AN; Day 3 teaching philosophies that underpin health behaviour change
 Length: 18 hours of treatment over 3 days followed by 3 hour‐long follow‐up sessions
Outcomes Eating psychopathology
 SEED (Kordy 2005)
 
 Behavioural indices
 Weight change (BMI)
 
 Global pathology and interpersonal functioning
 Inventory of Interpersonal Problems
 
 Family functioning
 LEE scale
 
 Other
 Measurement at baseline, discharge (mean 5.3 months (6 months for carers)) and at 3‐year follow‐up
Notes Included in individual family therapy vs group family therapy comparison
 Family therapy in both cases categorised as other
 Funded by: Psychiatry Research Trust
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "randomly allocated" pg. 4, no detail
Allocation concealment (selection bias) Low risk Quote: "the randomisation administrator informed the clinical team of the group assignment. The randomisation sequence had been generated independently from the clinical team and was placed in numbered sealed envelops" pg. 5
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Therapists and participants cannot be blinded in trials of family‐based therapy
Incomplete outcome data (attrition bias) 
 All outcomes High risk
  1. Reasons for missing data were not clearly reported and there was no investigation of the impact of missing data on the outcome

  2. No ITT analysis

  3. There were large amounts of missing data for the secondary outcomes

Selective reporting (reporting bias) Low risk
  1. Means and SDs for all measures stated in the Methods section were reported

  2. There is no remission measure included

Other bias Unclear risk
  1. Baseline imbalance ‐ numbers of participants living with parents

  2. Therapist delivered both interventions

  3. Unclear reporting of dropouts/missing data

  4. In text report 2 family randomised to FDW received IFW but were analysed according to randomisation

  5. In Figure 5 flow chart it is evident that one other family received work but refused assessment, but figure indicates that there are primary outcome measure data for the full 25 randomised (notes suggest BMI was obtained from clinical notes)

  6. Figure 5 also indicates 3 families randomised to IFW did not receive this intervention and it is unclear how they were analysed

  7. In the IFW group only 22 of the 23 randomised had primary outcome measured

  8. For the 3‐year follow‐up, Figure 5 indicates 23 out of 25 had data for the primary outcome in the FDW group, and 21 of 23 had data for the primary outcome

  9. Far fewer had data for the secondary outcomes

  10. Numbers also vary between Figure 5 and Table 4

  11. BMI was often obtained through participant notes, and it is unclear if this assessment was blinded

ABW: average body weight; BFT: behavioural family therapy; BMI: body mass index; BN: bulimia nervosa; BPRS‐E: brief psychiatric rating scale‐expanded; CBT: cognitive behavioural therapy; CCEI: Crown‐Crisp experimental index; CDI: children's depression inventory; CYBOCS: children's Yale‐Brown obsessive‐compulsive scale; DASS: depression, anxiety and stress scale; DICA: diagnostic interview for children and adolescents; DP: day patient; EAT: eating attitudes test; EDE: eating disorder examination; EDI: eating disorder inventory; EDS: eating disorder scale; EFS: family health scale; FAD: family assessment device; FBT: family‐based therapy; GOAS: global outcome assessment scale; IBC: interactive behaviour code; HAMD: Hamilton depression scale; HRQ: helping relationship questionnaire; IBW: ideal body weight; IP: inpatient; ITT: intention‐to‐treat; LOCF: last observation carried forward; MDD: major depressive disorder; MI: motivational interviewing; MMPW: mean matched population weight; MRAOF: Morgan‐Russell outcome scale; MRGAS: Morgan‐Russell global assessment scale; MRS: Morgan Russell scale; OC: observed case; OP: outpatient; PVA: parent versus anorexia; RSE: Rosenberg self‐esteem (scale); SAS: social adjustment scale; SCFI: standardised clinical family interview; SCL‐90‐R: symptom check list‐revised; SD: standard deviation; SEED: short evaluation of eating disorders; STAI: state‐trait anxiety inventory; SyFT: systematic family therapy; TAU: treatment as usual; TSPE: Therapy suitability and patient expectancy; YBCSEDS: Yale‐Brown‐Cornell eating disorder scale