[Summary text]
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
Intervention
Control
Included criteria: DSM-IV criteria for anorexia nervosa, including subclinical anorexia if weight was between 85-90 % of normal weight.
Excluded criteria: BMI below 13.5; currently receiving other psychological or pharmacological treatments; a comorbid physical or psychiatric disorder, with the exception of depression or anxiety secondary to the anorexia nervosa; current drug or alcohol abuse; self-harming behavior over the past 12 months; other indications for hospitalization such as severe physical complications or suicidal ideation; or a recent history of untreated physical or psychological trauma or sexual abuse.
Pretreatment: None.
Intervention Characteristics
Intervention
Control
ED behavior (end of treatment)
ED behavior (longest FU (min. 1 yr))
Body weight (end of treatment)
Body weight (longest FU (min. 1 yr))
Psychological symptoms (end of treatment)
Psychological symptoms (longest FU (min. 1 yr))
Recovery rate (longest FU (min. 1 yr))
Dropout (end of treatment)
Quality of life (longest FU (min. 1 yr))
Family function (longest FU (min. 1 yr))
Body weight (end of treatment)
Psychological symptoms (end of treatment)
Sponsorship source: the Prince Henry Hospital Coast Centenary Grant for partially supporting the research
Country: Australia
Setting: Outpatient treatment
Comments: n/a
Authors name: Jillian Ball
Institution: School of Psychiatry, University of New South Wales
Email: jillian@unsw.edu.au
Address: University of New South Wales, 6th Floor, Parkes East, Prince of Wales Hospital, High Street, Randwick, NSW 2031, Australia.
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
Intervention
Control
Included criteria: Participants were eligible if they were between the ages of 12 and 18 years, living with theirparents, or legal guardians, and met the DSM-IV criteria for AN excluding the amenorrheacriterion. Weight thresholds (IBW < 86%) for study entry were calculated using theCDC weight charts, growth curve trajectories and Metropolitan Life charts.Participants meeting the binge eating and purging subtype and adolescents on a stable doseof antidepressant or anxiolytic medications for a period of two months who still met entrycriteria were eligible.Bothadolescent participants and their families were required to be available for the one yeartreatment duration.
Excluded criteria: Participants were excluded from the study if there was a currentpsychotic disorder, dependence on drugs or alcohol, physical condition known to influenceeating or weight (e.g. diabetes mellitus, pregnancy), or previous treatment with FBT or AFT.
Pretreatment: The subjects in the control group are significantly older than the intervention group.The global EDE score is significantly lower at baseline in the intervention group.
Intervention Characteristics
Intervention
Control
ED behavior (end of treatment)
ED behavior (longest FU (min. 1 yr))
Body weight (end of treatment)
Body weight (longest FU (min. 1 yr))
Psychological symptoms (end of treatment)
Psychological symptoms (longest FU (min. 1 yr))
Recovery rate (longest FU (min. 1 yr))
Dropout (end of treatment)
Quality of life (longest FU (min. 1 yr))
Family function (longest FU (min. 1 yr))
Sponsorship source: Funding support for this study was provided by NIH grant R01-MH-070621 to Dr. Lock and NIH grant R01-MH-070620 to Dr. Le Grange.
Country: USA
Setting: Outpatient. Stanford University and The University of Chicago
Comments: None
Authors name: James Lock
Institution: Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine
Email: jimlock@stanford.edu
Address: Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, 401Quarry Road, Stanford, CA 94305
Louise Linde on 04/02/2016 00:44
Population
FBT er intervention og AFT er kontrol.Restriktiv AN % ikke opgivet.
Louise Linde on 04/02/2016 03:24
Outcomes
Kropsvægt er ved EOT opgivet som BMI percentil for alder og køn. Kropsvægt ved længste follow-up er angivet i %EBW
Nkr 46 Anoreksi on 11/02/2016 03:50
Outcomes
EOT er baseline-adjusted scores.
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
Intervention
Control
Included criteria: Female adolescents aged 11 to 20 meeting DSM-III-R criteria for anorexia nervosa and residing at home with one or both parents.
Excluded criteria: None stated.
Pretreatment: mean age for EOIT group was significantly younger than the mean age for the BFST group.
Intervention Characteristics
Intervention
Control
ED behavior (end of treatment)
ED behavior (longest FU (min. 1 yr))
Body weight (end of treatment)
Body weight (longest FU (min. 1 yr))
Psychological symptoms (end of treatment)
Psychological symptoms (longest FU (min. 1 yr))
Recovery rate (longest FU (min. 1 yr))
Dropout (end of treatment)
Quality of life (longest FU (min. 1 yr))
Family function (longest FU (min. 1 yr))
Sponsorship source: Partial support from NIMH grant
Country: USA
Setting: Outpatient
Comments: None
Authors name: Arthur L. Robin
Institution: Child psychiatry and psychology department, Children's hospital of Michigan
Email: arobin@med.wayne.edu
Address: Children's Hospital of Michigan, 3901 Beaubien Blvd., Detroit, M1 48201
Louise Klokker Madsen on 05/02/2016 02:11
Population
Co-morbidity, whole sample: 54% mood disorder, 13% anxiety.Weight, I: 86.5 pounds, C: 86.8 poundsHeight, I: 63 inches, C: 61 inches
Louise Klokker Madsen on 05/02/2016 03:20
Outcomes
ED behavior measured by EAT, Teen
Wrong comparator
Wrong intervention
Wrong outcomes
Wrong study design
Wrong study design
Wrong intervention
Wrong study design
Wrong comparator
Wrong comparator
Wrong study design
Wrong comparator
Wrong patient population
Wrong comparator
Wrong study design
Wrong study design
Wrong outcomes
Wrong outcomes
Wrong comparator
Wrong intervention
Wrong comparator
Wrong patient population
Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence
Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment
Performance bias due to knowledge of the allocated interventions by participants and personnel during the study
Detection bias due to knowledge of the allocated interventions by outcome assessors
Attrition bias due to amount, nature or handling of incomplete outcome data
Reporting bias due to selective outcome reporting
Bias due to problems not covered elsewhere in the table
Describe the method used to generate the allocation sequence in sufficient detail to allow an assessment of whether it should produce comparable groups.
Judgement Comment: Cochrane
Judgement Comment: Efron’s biased coin design was used to balance treatmentwithin sites.
Judgement Comment: Cochrane:Correspondence from author stated ‘coin tossing’ was used
Describe the method used to conceal the allocation sequence in sufficient detail to determine wether intervention allocations could have been foreseen in advance of, during, enrolement.
Judgement Comment: Cochrane
Judgement Comment: Randomization was performed separately for each site by a biostatistician in the Data and Coordinating Center (DCC) under independent management from either intervention site.
Judgement Comment: Cochrane:Correspondence from author suggested concealment was notpossible, however, this was followed by a description of blinding
Describe all measures used, if any to blind study participants and personnel from knowledge of which intervention a participant received. Provide any information relating to whether the intended blinding was effective.
Judgement Comment: Cochrane
Judgement Comment: Cochrane:Correspondence from author stated that this was no possibleexcept for those coding the family interactions
Describe all measures used, if any to blind outcome assessors from knowledge of which intervention a participant received. Provide any information relating to whether the intended blinding was effective.
Judgement Comment: Cochrane
Judgement Comment: Independent assessors not involved in treatment delivery conducted all assessments.
Judgement Comment: Cochrane:Correspondence from author stated that this was no possibleexcept for those coding the family interactions
Describe the completeness of outcome data for each main outcome, including attrition and exlusions from the analysis. State whether attrition and exclusions were reported, the numbers in each intervention group (compared with total randomized participants), reasons for attrition/exclusions where reported, and any re-inclusions in analyses performed by the review authors.
Judgement Comment: Cochrane: 1. There is not a full description of why people left theintervention in each group.2. There are three hospitalisations but it is unclear fromwhich groups.3. No intention-to-treat (ITT) analysis4. On the main outcome they do compare ITT to completeranalysis.
Judgement Comment: There is not a full description of why people left the intervention in each group. More than 30% of the participants in one group is hospitalized during the trial and only 15 % from the other group. Only intention-to-treat (ITT) analysis on main outcome.There was a significant difference in assessment follow-up rates between the two intervention sites at all time points
Judgement Comment: Cochrane:1. From the text of the paper, data for dropouts not reportedor analysed. There appear to be 7 dropouts from the tables butit is unclear from the description of numbers and reasons inthe text.2. Correspondance from the author suggested 1 out of 20dropped out from the family therapy group duringintervention and 4 out of 21 dropped out from the individualpsychotherapy group. Dropouts by follow-up reported as 5 outof 20 for the family therapy group and 6 out of 21 from theindividual psychotherapy group.3. Intention-to-treat data not provided nor analysed inpaper.
State how the possibility of selective outcome reporting was examined by the review authors and what was found.
Judgement Comment: Cochrane:1. Do not report outcomes from the Eating Conflictsubscale of the Interaction Behaviour Code.2. Authors report that they collect data on both general andfamily functioning, but the data are not reported in a formatthat is usable for analysis.
Judgement Comment: The main article does not report all assessment tools. Smaller articles on the same sample report other measures.
Judgement Comment: Cochrane:1. Measures taken and reported in earlier papers (1995;BSQ and EDI BD) not reported in later paper. Family conflictnot reported in 1999 paper. 1994 paper mentions body shapequestionnaire, EDI and EAT however not reported in the1999 paper. Authors do report on every measure described inthe methods section in the 1999 paper.2. Report on within group changes for many outcomes3. Authors report that they collect data on dropouts, but thedata are not reported in a format that is usable for analysis
State any important concerns about bias not addressed in the other domains in the tool. If particular questions/entries were re-specified in the review's protocol, responses should be provided for each question/entry.
Judgement Comment: Cochrane:1. Small sample size2. Baseline imbalance - for sub-type of AN3. Inaccurate with conflict in reporting (state 60% in“good” category but then report N=7 in each group for“good”, which is less than 60%)
Judgement Comment: Baseline imbalance: younger group in FBT and lower EDE than AFT.Not certain why/when the N's change when reporting % of hospitalizations and remission.
Judgement Comment: Cochrane:1. (1999 paper) Imbalance at the commencement oftreatment:11 pts from BFST and 5 pts from EOIT werehospitalized for refeeding. Duration of stay not specified bygroup, or for all patients2. Uneven treatment duration - not standardised and notreported for all groups3. Uneven/inconsistent N’s for most measures with noexplanation of why N’s vary across measures4. Baseline imbalances: mean age in EOIT Groupsignificantly younger; difference in EAT scores and BDI scoreswith the BFST group in the clinical range on the BDI and theEOIT group not in the clinical range5. No reporting of between group differences6. Randomised before final assessment for inclusion