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

Crisp 1991.

Methods RCT
Participants Country: UK
 Diagnostic tool: DSM‐IIIR
 No. screened: No detail
 No. randomised: 90: Inpatient (includes FT): 30; Outpatient (includes FT): 20; Outpatient group: 20; Assessment only: 20
 No. started trial: 73: Inpatient (includes FT): 18; Outpatient (includes FT): 18; Outpatient group: 17 (1 died); Assessment only: 20
 No dropped out during intervention: (not fully reported): Outpatient (includes FT): 3 (attended 5 sessions or fewer); Assessment only: 14 dropped out in the sense that they sought treatment elsewhere
 No. analysed:  90 (LOCF): Inpatient (includes FT): 30; Outpatient (includes FT): 20; Outpatient group: 20; Assessment only: 20
 Mean age in years (SD): Total: 22: Inpatient (includes FT): 23.2 (4.9); Outpatient (includes FT): 21.2 (5.1); Outpatient group: 19.7 (2.6); Assessment only: 21.9 (4.5)
 Age range in years: Total: 20 ‐ 23 (not given by group) Note ‐ the review authors note that this age range is inconsistent with the mean ages provided per treatment group (i.e. outpatient group mean is stated as 19.7).
 Gender: All female participants
 Subtype: No detail
 Age of onset in years (SD): Inpatient (includes FT): 19.8 (4.7); Outpatient (includes FT): 18.4 (3.9); Outpatient group: 17.4 (3.9); Assessment only: 17.4 (3.2)
 Duration of illness in months (SD): Total: 39; range 4 ‐ 107 months; Inpatient (includes FT): 41.0 (30.17); Outpatient (includes FT): 33.4 (25.9); Outpatient group: 27.5 (25.8); Assessment only: 53.5 (52.9)
 Baseline weight in kgs: Inpatient (includes FT): 40.8 (6.1); Outpatient (includes FT): 40.3 (3.8); Outpatient group: 40.2 (6.0); Assessment only: 41.0 (6.1)
 Baseline deviation below MMPW % (SD): Inpatient (includes FT): 28.0 (9.4); Outpatient (includes FT): 26.5 (6.9); Outpatient group: 26.2 (8.7); Assessment only: 25.0 (8.5)
 Baseline BMI: Inpatient (includes FT): 15.3; Outpatient (includes FT): 15.5; Outpatient group: 15.5; Assessment only: 15.7
 Baseline eating disorder scale score (MRS): Inpatient (includes FT): 3.5 (0.2); Outpatient (includes FT): 3.9 (0.3); Outpatient group: 3.8 (0.4); Assessment only: 3.5 (0.3)
 Baseline purging ("usually vomiting"): Inpatient (includes FT): 5; Outpatient (includes FT): 5; Outpatient group: 5; Assessment only: 7
 Baseline Purging ("usually bulimic"): Inpatient (includes FT): 3; Outpatient (includes FT): 2; Outpatient group: 5; Assessment only: 3
 Comorbidity: No details
 Details on living arrangements: No details
 Family education/employment/income: No details
 Recruitment strategy: Not stated other than “successive referrals” to treatment centre
Exclusion criteria:
  1. Not residing close enough for outpatient treatment (> 40 miles)

  2. > 10 year duration of illness

  3. Males

Interventions Setting of care: Inpatient and outpatient
 Training/qualification of care provider(s): Paper states ‘trained and experienced’ no other details
 Treatment manual: No detail
 Supervision of treatment: No detail
 Adherence to treatment: No detail
Intervention group 1Description: Outpatient individual therapy and family therapy
 12 outpatient sessions including individual work which nearly always but to a variable extent included some family work (more with the younger participants). Family work emphasised establishment of boundaries, and addressing issues such as enmeshment, conflict avoidance (e.g. non‐communication) and attempted solving of family problems. Dietary counselling also included.
 Length: Several months
Intervention group 2Description: Outpatient group therapy for participants and outpatient group therapy for parents
 10 outpatient psychotherapy group meetings for the individual and 10 group meetings for parents separately. Issues addressed included conflict avoidance, sense of self, family relationships, identification of moods, meaning of weight and shape, management of impulse, communication and relationship skills, with parents additionally addressing support of each other in managing shared problems and difficulties over autonomy as well as parental discord and lifestyle issues. Dietary counselling also included
 Length: 10 sessions
Intervention group 3Description: Inpatient treatment
 Inpatient stay of several months including weight restoration with weekly individual therapy, family therapy, group therapy, dietary counselling and occupational therapy using psychodrama and projective art techniques. Followed by 12 sessions of outpatient treatment involving both the participant and the family
 Length: Several months of inpatient plus outpatient treatment over several months
Intervention group 4Description: 'One off' ‐ no further treatment
 Referred back to their family doctor or local consultant who received a detailed report of the assessment with advice on further management. “of those in option 4, 6 had no treatment of any kind, six had inpatient treatment, 5 had outpatient hospital treatment and 3 had very regular contact with GP. 6 patients spent almost the entire year in treatment” (pg. 329 Crisp 1991)
 Length: 'one off'
Outcomes Eating psychopathology
 Morgan Russell Assessment Schedule (Morgan 1988
Behavioural indices
 Well: weight within 15% MMPW; regular menstruation; normal eating
 Almost well: weight risen to above 85% of MMPW , menstruation returned (but not necessarily regular); aspects of abnormal eating may remain
 Significantly better: Weight risen to within 85% or still less but risen by 10%, and/or menstruation absent or sporadic; aspects of abnormal eating may remain
 No change: Weight less than 85% MMPW and/or increased by < 10% and/or menstruation absent or sporadic; abnormal eating
 Worse: weight loss has occurred or score lower on the Morgan Russell score; amenorrhoea still present
Notes Included in family therapy vs standard care/treatment as usual
 Family therapy categorised as other
 Also included in family therapy vs individual psychological intervention
 Family therapy categorised as other
 Funded by: Marks and Spencer plc, St George’s Hospital Special Trustees and Worshipful Company of Grocers
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No detail : Methods paper pg. 446 “ treatment option drawn by random allocation” with no other statement
Allocation concealment (selection bias) Unclear risk No detail
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 Unclear risk At 12 months "patients were seen by one of the team uninvolved in the treatment programs and as far as possibly unaware of the treatment allocation" but the methods paper (Gowers) states it was "not possible for the interviewer to be blind to the treatment given" pg. 453
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All participants were followed up regardless of compliance with treatment. Analysis included all 90 participants who were randomised
Selective reporting (reporting bias) High risk
  1. Vaguely stated hypotheses

  2. No report of restricting or purging behaviours at follow‐up despite these measures being taken at baseline

  3. 2‐year outcomes only reported for 2 groups. Authors report that they collected data on weight, relapse and dropouts but the data are not reported in a format that is useable for analysis

Other bias High risk
  1. Many “no treatment” participants received treatment

  2. Treatment dosages uneven

  3. 50% more allocation to inpatient group at randomisation

  4. Longer duration of illness in Group 4. Uneven age distribution across groups. Means range from 19.8 years to 17.4 years

  5. Inpatient group had lower mean weight at presentation but then no differences in compliers (i.e. those who took up treatment)

  6. Compliance was lower in the inpatient and non‐treatment groups

  7. Reporting anomalies in Gowers 1994 follow‐up paper, which provided outcomes for groups 2 and 4 only. Authors have stated that (pg. 171) “Only in one case (in the treatment group) was a follow‐up weight not obtained.” However, all follow‐up data are reported on N = 20, instead of N = 19. 

  8. Baseline data obtained before allocation to treatment groups when allocation contained potentially therapeutic interventions ‐ "all had an extensive family based and potentially therapeutically effective baseline assessment”

  9. Non‐standardised outcome assessment from assessors and in methods of obtaining outcome data