[Summary text]
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
Intervention
Control
Included criteria: Females, 11-18 years, AN according to DSM-IV, BMI below 10th percentile, at first hospital admission for AN, living within 60 minutes commute of the treating department.
Excluded criteria: Organic brain disease, psychotic or bipolar disorder, substance dependence or abuse, serious self-injurious behaviour, insufficient knowledge of the German language, or an IQ below 85.
Pretreatment: The baseline characteristics weremuch the same between groups (table 1, s.1225)Inpt: n=85, daypt:n=87
Intervention Characteristics
Intervention
Control
Adfærdssymptomer (restriktiv spisning, tvangsmotion, binge, purge), EOT
Adfærdssymptomer (restriktiv spisning, tvangsmotion, binge, purge), LFU
Andel af sund kropsvægt/BMI, EOT
Andel af sund kropsvægt/BMI, LFU
Psykologiske spiseforstyrrelsessymptomer, EOT
Psykologiske spiseforstyrrelsessymptomer, LFU
Recovery rate
Dropout
Livskvalitet
Indlæggelser, LFU
Sponsorship source:
Country: G
erman Ministry for Education and Research
Country: Germany
Setting: 6 hospitals, inpatient and daypatient
Comments: none
Authors name: Prof. Beate Herpertz-Dahlmann
Institution: Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital of the RWTH Aachen
Email: bherpertz-dahlmann@ukaachen.de
Address: Neuenhofer Weg 21, D - 52074 Aachen, Germany
Nkr 46 Anoreksi on 12/03/2016 05:48
Outcomes
Recovery rate: angivet som antal og %
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
Intervention
Control
Included criteria: Aged between12 and 18 years, with a DSM-IV diagnosis of AN of less than 3 years’ duration, were medically unstable, lived within a 2-h drive of the treatment center and were not receiving other psychotherapy during the RCT.
Excluded criteria: Illness duration of more than 3 years, evidence of psychosis, mania, substance abuse or significant intercurrent medical illnesses other than nutrition-related complications of AN.
Pretreatment: ResultsThe only significant differences between study siteswas the age of the participants, reflecting the differentadmission age criteria of each site (SCHN-W: mean=14.14 years, S.D.=1.07; WH: mean=16.25 years, S.D. =1.03, t80 =−8.644, p<0.05, η2=0.48, very large effect)and the duration of illness prior to hospitalization,with patients from WH (mean=9.83 months, S.D. =8.29)diagnosed on average 3.4 months later than SCHN-Wpatients (mean=6.42 months, S.D. =4.24), (t80 =2.07,p<0.05, η2= 0.05, moderate effect size). There were nodifferences in baseline variables (Table 1) or protocoladherence (Table 2) between treatment groups. Sixpatients (7.3%) were within 1 s.D. of community normsfor the EDE at baseline; however, a comprehensive
Intervention Characteristics
Intervention
Control
Adfærdssymptomer (restriktiv spisning, tvangsmotion, binge, purge), EOT
Adfærdssymptomer (restriktiv spisning, tvangsmotion, binge, purge), LFU
Andel af sund kropsvægt/BMI, EOT
Andel af sund kropsvægt/BMI, LFU
Psykologiske spiseforstyrrelsessymptomer, EOT
Psykologiske spiseforstyrrelsessymptomer, LFU
Recovery rate, LFU (min. 1 year)
Dropout, EOT
Livskvalitet
Indlæggelser
Sponsorship source: This work was fully funded by the National Healthand Medical Research Council (NHMRC) of Australia(Grant ID 457235)
Country: Australia
Setting: Two sited inpatient study
Comments: none
Authors name: Dr S. Madden
Institution: Department og Psychological Medicine, The Sidney Children´s Hospitals Network
Email: Sloane.Madden@health.nsw.gov.au
Address: Westmead Campus, Locked Bag 4001, Westmead, NSW 2145, Australia
Birte Smidt on 16/03/2016 02:43
Interventions
Participants in the MS arm were subsequentlydischarged to out-patient FBT if they had no markersof medical instability for 72 h after nasogastric feedswere ceasedParticipants in the WR arm continuedin hospital on supported meals without nasogastricfeeding once they had no markers of medical instabilityfor 72 h, until they reached 90% EBW before dischargeto out-patient FBT.
Birte Smidt on 21/03/2016 18:01
Outcomes
jeg fandt ikke tal for dropouts,livskvalitet,adfærd
Comment, no study
Comment, no study
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.
Quote: "The randomisation sequence was computer generated. The randomisation procedure was a covariate-adaptive procedure according to Rosenberger and Lachin. 24 Balanced randomisation 25 was applied to balance the treatment arms within the sites and to stratify for age (age <14 years and ≥14 years, because anorexia nervosa at childhood onset might be associated with a worse prognosis 26 ) and for BMI at the time of admission (<15·5 kg/m² and ≥15·5 kg/m², because the higher BMI bracket has been noted to be an important prognostic factor 21 )."
Quote: "randomized in clusters of six using a block size of two. Each new cluster was randomized through a blind random binary list created by an exter- nal statistician."
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.
Quote: "The independent Clinical Trials Centre in Marburg, Germany, did a centralised, concealed randomisation to either DP or IP (1:1) by fax at the beginning of week 3, after the patients were enrolled into the study."
Quote: "the use of clusters unblinded recruitment staff to the group status of participants, this design was chosen to prevent potential problems of drop-out if participants from different groups were treated alongside one another"
Judgement Comment: Recruitment staff was not blinded to group status of participants.
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.
Quote: "Patients and therapists could not be masked to treatment allocation."
Judgement Comment: Not possible to blind patients and therapist.
Judgement Comment: Blinding of participants not possible.
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.
Assessors were initially masked but some patients inadvertently revealed their treatment allocation; masking was maintained for the primary outcome (BMI).
Judgement Comment: not reported.
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.
Quote: "Because readmission mostly occurred in starved patients with a very low bodyweight and usually led to a treatment- induced renewed weight gain, we decided to use the admission BMI at readmission in relapsed patients to consider a worst-case scenario."
Judgement Comment: Low attrition, intention-to-treat analysis.
Judgement Comment: Low attrition, intention-to-treat analyses
State how the possibility of selective outcome reporting was examined by the review authors and what was found.
SIAB-EX results not 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.