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

Lock 2005.

Methods RCT
Participants Country: USA
 Diagnostic tool: DSM‐IV, with some partially weight‐restored participants included, and requirement of only 1 instead of 3 missed menstrual periods
 No. screened: 241
 No. randomised: 86, Short‐term FT: 44; Long‐term FT: 42
 No. started trial: No details
 No. dropped out during intervention: Total: 9; Short‐term FT: 2; Long‐term FT: 7
 No. dropped out during follow‐up: Total: 8; Short‐term FT: 5; Long‐term FT: 3
 No. analysed: Total: 86 (at 6 and 12 months) (LOCF); Short‐term FT: 44; Long‐term FT: 42
 Short‐term FT: OC BMI 37; EDE20 at 12 months
 Long‐term FT: OC BMI 34; EDE15 at 12 months
 
 Mean age (SD): Short‐term FT: 15.2 (1.6) years; Long‐term FT: 15.2 (1.7) years
 Age range in years: 12 ‐ 18 (not given by group)
 Gender: Total: 9 male: 77 female; Short‐term FT: 5 (11%):39 (89%); Long‐term FT: 4 (9%):38 (91%)
 Subtype: Short‐term FT: purging (7) 16%; restricting (37) 84%; Long‐term FT: purging (9) 21%; restricting (33) 79%
 Age of onset: No details
 Duration of illness: Total : 30% had been previously hospitalised but not stated by group whether treated or untreated; Short‐term FT: 11.3 (10.4) months; Long‐term FT: 12.0 (9.9) months
 Baseline weight (SD): Short‐term FT: 44.6 (5.5) kg; Long‐term FT: 46.7 (7.2) kg
 Baseline BMI: Total: 17.1 (1.4); Short‐term FT: 17.0 (1.3); Long‐term FT: 17.3 (1.5)
 Baseline eating disorder scale score (EDE eating concern): Short‐term FT: 1.35 (1.13); Long‐term FT: 1.04 (1.33)
 Baseline eating disorder scale score (EDE restraint): Short‐term FT: 2.76 (1.97); Long‐term FT: 2.64 (1.96)
 Baseline eating disorder scale score (EDE shape concerns): Short‐term FT: 2.61 (1.73); Long‐term FT: 2.41 (1.67)
 Baseline eating disorder scale score (EDE weight concern): Short‐term FT: 2.32 (1.51); Long‐term FT: 1.96 (1.52)
 Baseline purging: No details
 Comorbidity: Total: 36% (n = 31) had any psychiatric illness; 24% (n = 21) had MDD or DYS; 14% (n = 12) had anxiety disorder; 5% (n = 4) other
 Details on living arrangement: Short‐term FT: living in an ‘intact family’ 82% (n = 36); Long‐term FT: living in an ‘intact family’ 74% (n = 31)
 Family education/employment/income: Short‐term FT: 9% < 50 K; 33% 50 ‐ 100 K; 57% > 100 K; Long‐term FT: 10% < 50 K; 43% 50 ‐100 K; 48%, > 100 K
 Recruitment strategy: Recruited by referral from paediatricians and therapists to a specialty evaluation clinic for child and adolescent eating disorders
 
 Exclusion criteria:
  1. Serious medical condition (diabetes mellitus)

  2. Psychiatric illness (psychosis)

Interventions Setting of care: Outpatient, with some hospitalised before treatment
 Training/qualification of care provider(s): Yes: 3 Masters Level psychologists, 1 child/adolescent psychiatrist
 Treatment manual: Yes: “therapists were all trained in the manual based version of family based treatment"
 Supervision of treatment: Yes: Weekly supervision
 Adherence to treatment: Unclear: “a manual based form of family based treatment was used” pg. 667(Lock 2006)
 
 Intervention group 1Description: Short‐term family therapy
 Family‐based therapy but consisting of only Phase 1 and 2 (refeeding and problem‐solving for issues that interfere with refeeding)
 Length; 6 months
 
 Intervention group 2Description: Family‐based therapy
Labelled 'Long Term Family Therapy' in report. Consists of Phases 1, 2 and 3
 Length: 12 months
Outcomes Eating psychopathology
 EDE (Cooper 1987a; Cooper 1987b)
 Behavioural indices
 BMI
 Menstruation
 General Psychopathology and Obsessionality
 Schedule for Affective Disorders and Schizophrenia for School‐Aged Children (Kaufman 1997)
 YBC‐ED scale (Sunday 1995)
 Global pathology and interpersonal functioning
 Child Behaviour Checklist; Youth Self Report Checklist (Achenbach 1991)
 Family Functioning
 Family Environment Scale
Notes Included in short family therapy vs long family therapy comparison
 Family therapy in both cases categorised as family‐based therapy
 Funded by: NIH Career Development Award
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: “randomised subjects were stratified...by duration of illness”; “ within each stratum using the Efron biased coin procedures by a research assistant not involved in assessments” pg. 634
Allocation concealment (selection bias) Unclear risk Quote: “randomised by a research assistant not involved in assessment to either a short or long term treatment”
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 Low risk Quote: “assessments were conducted by trained assessors who were not involved with the treatment of patients‐not told which group that the patient was randomised to for treatment” pg. 634
Incomplete outcome data (attrition bias) 
 All outcomes High risk
  1. Numbers are not reported for each group and reasons for dropout are reported but not for each group

  2. “Primary analysis was by intention‐to‐treat” for analysis for year 1 appears to include all participants, but this is not the case for long‐term outcomes

  3. ITT analysis: for year 1 but not for long‐term outcomes

Selective reporting (reporting bias) High risk
  1. Authors report that they collected data on family functioning, but the data are not reported in a format that is useable for analysis

  2. Authors state they collect EDE measures. However the data are not presented in a useable format, and thus the Yale‐Brown Scale was used for the eating disorder psychopathology analysis measure

Other bias Low risk No other problems noted