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

Russell 1987.

Methods RCT
Participants Country: United Kingdom
 Diagnostic tool: DSM‐III + extreme self‐induced weight loss, fear of fatness psychopathology, endocrine disorder (amenorrhoea in females, sexual dysfunction in males)
 No. screened: No detail
 No. randomised: Total : 80; Family therapy: 41 (includes the BN participants); Individual therapy: 38 (includes the BN participants)
 No. dropped out after randomisation and before start of trial: Total: Group 1 (AN, onset < 18 onset, < 3 yrs duration): 1a ‐ 0, 1b ‐ 0, Group 2 (AN < 18 onset, > 3 yrs duration): 2a ‐ 1, 2b ‐ 1, Group 3 (AN > 19 onset): 3a ‐ 1, 3b ‐ 0
 No. dropped out during intervention (did not receive a year of therapy): Total :  17; Family Therapy (a) Group 1 = 1, Group 2 = 2; Group 3 = 3; Individual therapy (b) Group 1 = 7, Group 2 = 3; Group 3 = 0
 No. dropped out during follow‐up: 5 years (total only): 3 died; had data on 77 (63 from clinical interview; 1 telephone interview; 3 returned a questionnaire; indirect information from parents or GP) (for 7 participants who refused 5‐year follow‐up they used 3‐year outcomes)
 No. analysed: 1 year: Family therapy 5 did not get included in 1‐year analysis; Individual therapy 2 in individual therapy did not get included in 1‐year analysis, 5 years: total 77
 
 NOTE: for this study most data are not given by intervention group but by subgroup: Group 1: AN, onset < 18 onset , < 3 yrs duration; Group 2: AN < 18 onset, > 3 yrs duration; Group 3: AN > 19 onset (Group 4 was made up of participants with BN)
 
 Mean age in years (SD): Group 1 (AN, onset < 18 onset,< 3 yrs duration): 16.6 (1.7); Group 2 (AN < 18 onset, > 3 yrs duration): 20.6 (4.0); Group 3 (AN > 19 onset): 27.7 (7.8)
 Age Range: No details
 Gender %: Total (including BN group): 9% male; 91% female
 Subtype: No details
 Age of onset in years (SD): Group 1 (AN, onset < 18 onset,< 3 yrs duration): 15.3 (1.8); Group 2 (AN < 18 onset, > 3 yrs duration): 14.3 (2.4); Group 3 (AN > 19 onset): 24.6 (5.8)
 Duration of illness: Group 1: by definition < 3 yrs duration; Group 2: by definition > 3 yrs duration; Group 3: by definition no details
 Baseline weight (on discharge from inpatient admission): Group 1 (AN, onset < 18 onset, < 3 yrs duration): 88.9 (7.4) ABW%; Group 2 (AN < 18 onset, > 3 yrs duration): 91.4 (5.5) ABW%; Group 3 (AN > 19 onset): 85.8 (7.3) ABW%
 Paper stated that the participants were generally severe with an average admission weight of 69.9% ABW
 Baseline BMI: No details
 Baseline eating disorder scale score: No details
 Baseline purging: No details
 Comorbidity: Paper stated “most patients‐complicated by episodes of self harm severe depression or personality disorder” with no other details given
 Details on living arrangements:Total : 64 single, 8 married, 3 separated/divorced; 60 were living with parents, 12 were living with a spouse or co‐habiting, 8 lived alone
 Family education/employment/income: No details
 Recruitment strategy: No details
 
 Exclusion criteria: No details
Interventions Setting of care: Outpatient (following inpatient refeeding for an average of 10.4 weeks)
 Training/qualification of care provider(s): Yes: 3 social workers and 1 psychologist
 Treatment manual: No details
 Supervision of treatment: Yes
 Adherence to treatment: No details
 
 Intervention group 1Description: Family‐based therapy
 Length: 1 year from the date of discharge from hospital
 
 Intervention group 2Description: Individual supportive therapy
 Included supportive problem‐centred counselling, education with elements of cognitive, interpretive and strategic therapy
 Length: 1 year from the date of discharge from hospital
Outcomes Eating psychopathology
 Morgan Russell Assessment Schedule (Morgan 1988)
 
 Behavioural indices
 BMI
 Menstruation
 Good outcome/Intermediate outcome/
 Poor outcome
 Need for readmission
 
 General psychopathology and Obsessionality
 CCEI (Crown 1979)
Notes Included in family therapy vs individual psychological intervention. Family therapy categorised as family‐based therapy
 Dare 1990 and Russell 1987 refer to the acute study and Eisler 1997 is the follow‐up study.
 1‐year follow‐up data are the equivalent to end of treatment
 5‐year mortality data are still being checked by authors and will be provided
 Funded by: Medical Research Council, Britain
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Personal communication stated stratified randomisation by diagnostic and prognostic groups
Allocation concealment (selection bias) Low risk Personal communication stated sealed envelopes were used
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
  1. “it was not possible to maintain “blindness to the two forms of treatment...to facilitate objective assessments, one of us...assessed the patients at follow‐up and was not involved in the provision of therapy" pg. 1048.

  2. 5‐year outcomes ‐ “assessed by 1 of 2 independent research psychologists" pg. 1026 Eisler 1997

  3. Personal communication confirmed that a number of research assistants were involved over the years in the study, all of whom were independent of the treatment and delivery team. Participants were reminded not to reveal their treatment but it was not always possible

Incomplete outcome data (attrition bias) 
 All outcomes High risk
  1. It appears that ITT analysis was undertaken for those who started therapy (i.e. excluding the 7 who dropped out prior to start). However, in Table 7 it states “Data on one patient were not available” and no other information is provided

  2. ITT analysis was not undertaken for the outcome ‘good outcome’. However, there is some discussion in the section Interpretation of the Effects of “Dropping Out” on outcome results (page 1054), and the types of dropouts and their distribution

  3. Personal communication stated that all participants were followed up regardless of how much treatment they received

  4. ITT analysis was used for the main comparison of the general outcome on the MR scale, which included all participants regardless of the treatment they received

  5. Other comparisons excluded participants who refused treatment, but participants were followed up

Selective reporting (reporting bias) High risk
  1. There is no publication of 3‐year outcomes, despite mention that assessments were undertaken at three years

  2. There is no reporting for some of the subgroups and no overall results for each intervention group. They state they could not do the analysis of the whole group (i.e. with subgroups collapsed for each intervention group) due to the interaction between the type of treatment and prognostic group

  3. Group totals for eating disorder psychopathology and weight obtained by personal communication

Other bias High risk
  1. Virtually no between‐intervention group data or information

  2. Uneven treatment dosages (FT = 10.5 sessions; Indv = 15.9 sessions) which was stated to be due to the fact that if a participant lost weight, the intensity of treatment was increased

  3. Pre‐therapy imbalance ‐ ABW % on start of therapy (i.e. reported discharge ABW%) in Group 2 (AN < 18 onset, > 3 yrs duration)

  4. Differences in the mean ABW% given for Group 2 (compare tables 1 and 7), due to missing data unaccounted for from 1 participant). Difficult to judge whether pre‐therapy ABWs are significantly different. 

  5. Data reporting anomalies ‐ subgroup numbers are inconsistently reported. Compare tables 1 and 7. Table 18 indicates that there were just 15 people in Group 2 at the start of the therapy, but in table 7 it indicates there are 18. This relates to difficulties in assessing numbers of dropouts and the numbers included in analyses

  6. Possible contamination with therapists delivering both interventions