[Summary text]
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
Intervention
Control
Included criteria: Patients diagnosed with anorexia nervosa, fulfilling diagnostic criteria of DSM-III-R (American Psychiatric Association, 1987). Being female.Having a duration of illness of less than ten years.Living within out-patient reach of the service.
Excluded criteria: None described.
Pretreatment: none reported.
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))
Hospitalizations (longest FU (min. 1 yr))
Sponsorship source: Marks and Spencer plc, St George's Hospital Special Trustees and the Worshipful Company of Grocers.
Country: England
Setting: Outpatient.
Comments: none
Authors name: A. H. Crisp
Institution: Department of Mental Health Sciences, St George's Hospital Medical School
Email: n/a
Address: Department of Mental Health Sciences, St George's Hospital Medical School, Cranmer Terrace, London, SWJ7 ORE
Gry KjæRsdam TelléUs on 17/02/2016 01:38
Outcomes
Jeg har valgt at tage udgangspunkt i Whole sample og ikke Compliers only.ED Behavior (longest FU):Det eneste jeg umiddelbart mener vi kan anvende til vurdering af ED behavior er change scoren i Nutrition scoren fra Morgan-Russell scalaen (jeg er dog langt fra sikker på om denne score kan anvendes til noget som outcomemål). Change score, Nutrition: Intervention 3.5 / control 2.9. SD er ikke oplyst men den kan jo udregnes ud fra SE (det har jeg dog ikke gjort).Menstruartion er jo ikke et adfærdssymptom men change score for menstruartion rapporteres ligeledes: Intervention 5.0 / control 4.2. Body Weight (longest FU):Mean weight gain: Intervention 10.2 kg og control 9.0 kg. Vi har også mean vægt ved follow up for controlgruppen (52.6 kg) men jeg kan ikke tyde resultatet for mean vægt ved follow up for interventiongruppen af figuren og det fremgår ikke af teksten(det er muligt det kan ses i en bedre kopi). Drop-out:Drop-out occurred in all three treatment groups, especially the out-patient group psychotherapy. Ud fra Tabel 2 ser det ud til at der var følgende drop-out: 3 i Intervention og 2 i control.
Nkr 46 Anoreksi on 18/02/2016 01:55
Outcomes
Only 12 sessions in both groups.End of treatment data are from one year after initial assessment. The two treatments differ in length - group psychotherapy lasted almost one year while individual therapy lasted "months".
Wrong study design
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.
90 patients were randomly allocated to one or other of the four options.
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.
no information
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.
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.
no information
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.
The mean number of out-patient sessions attended was nine and the mean number of out-patient groups attended was five. Dropouts not described. More people dropped out of group therapy.
State how the possibility of selective outcome reporting was examined by the review authors and what was found.
Some outcomes are only partially reported.
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.
Different duration of treatment arms. Length of treatment not clearly described. Amount of parent involvement in individual intervention not described. Number of parent group sessions completed not described.