Elsevier

The Lancet

Volume 383, Issue 9924, 5–11 April 2014, Pages 1222-1229
The Lancet

Articles
Day-patient treatment after short inpatient care versus continued inpatient treatment in adolescents with anorexia nervosa (ANDI): a multicentre, randomised, open-label, non-inferiority trial

https://doi.org/10.1016/S0140-6736(13)62411-3Get rights and content

Summary

Background

In-patient treatment (IP) is the treatment setting of choice for moderately-to-severely ill adolescents with anorexia nervosa, but it is costly, and the risks of relapse and readmissions are high. Day patient treatment (DP) is less expensive and might avoid problems of relapse and readmission by easing the transition from hospital to home. We investigated the safety and efficacy of DP after short inpatient care compared with continued IP.

Methods

For this multicentre, randomised, open-label, non-inferiority trial, we enrolled female patients (aged 11–18 years) with anorexia nervosa from six centres in Germany. Patients were eligible if they had a body-mass index (BMI) below the tenth percentile and it was their first admission to hospital for anorexia nervosa. We used a computer-generated randomisation sequence to randomly assign patients to continued IP or DP after 3 weeks of inpatient care (1:1; stratified for age and BMI at admission). The treatment programme and treatment intensity in both study groups were identical. The primary outcome was the increase in BMI between the time of admission and a 12-month follow-up adjusted for age and duration of illness (non-inferiority margin of 0·75 kg/m2). Analysis was done by modified intention to treat. This trial is registered with the International Standard Randomised Controlled Trial Number Register, number ISRCTN67783402, and the Deutsches Register Klinischer Studien, number DRKS00000101.

Findings

Between Feb 2, 2007, to April 27, 2010, we screened 660 patients for eligibility, 172 of whom we randomly allocated to treatment: 85 to IP and 87 to DP. DP was non-inferior to IP with respect to the primary outcome, BMI at the 12-month follow-up (mean difference 0·46 kg/m2 in favour of DP (95% CI, −0·11 to 1·02; pnon-inferiority<0·0001). The number of treatment-related serious adverse events was similar in both study groups (eight in the IP group, seven in the DP group). Three serious adverse events in the IP group and two in the DP group were related to suicidal ideation; one patient in the DP attempted suicide 3 months after she was discharged.

Interpretation

DP after short inpatient care in adolescent patients with non-chronic anorexia nervosa seems no less effective than IP for weight restoration and maintenance during the first year after admission. Thus, DP might be a safe and less costly alternative to IP. Our results justify the broad implementation of this approach.

Funding

German Ministry for Education and Research.

Introduction

Anorexia nervosa is a severe psychiatric disorder with substantial morbidity and mortality; less than half of patients fully recover.1 Anorexia nervosa typically emerges during adolescence, a developmentally sensitive period, showing the need for effective age-appropriate intervention strategies. Guidelines of European countries and the USA2, 3, 4, 5 consider inpatient treatment (IP) as the treatment of choice for moderately or severely ill adolescent patients with anorexia nervosa or those who have not improved with outpatient treatment. Increasing admission rates for anorexia nervosa have been noted in continental Europe (Germany6 and Czech Republic7). In England,8 hospital admissions for eating disorders rose by 16% from 2011 to 2012, three quarters were related to anorexia nervosa. Adolescent girls accounted for more than half of these admissions to hospital, which caused a substantial burden on the health service budget. Moreover, the duration of hospital stays for anorexia nervosa increased by more than 4 weeks during the past decade in the UK.9 By contrast with the situation in Europe, in the USA, treatment of anorexia nervosa has changed from long-term admission to hospital to brief inpatient stabilisation, mostly followed by outpatient treatment.10, 11 This approach has been criticised10, 11 because of increasing readmission rates and insufficient weight gain in outpatient treatment, both of which might lengthen the illness and have a “pernicious effect on physical health and self-efficacy”.12

Altogether, the substantial financial costs arising from IP and the high relapse and readmission rates have challenged the opinion that IP is advantageous over other treatment settings13 and suggest that different treatment options should be developed.9

Day patient treatment (DP) for anorexia nervosa might be an alternative to IP.2 Typical DP treatment in Germany offers a structured eating disorder programme from 0800 h to 1630 h on weekdays. In addition to being less costly than IP, DP has other advantages. First, the skills learnt by patients in DP might be more easily transferred to everyday life. Second, adolescents experience admission to hospital as more coercive than do adult patients.14 Third, patients are able to maintain contact with their social networks, thus supporting social competence. This component is of importance because patients with anorexia nervosa have many social difficulties.15

However, little is known about the efficacy of DP for patients with anorexia nervosa. Although older adolescents were included in some open studies in adult populations,16, 17, 18 there is only one small (n=26) uncontrolled study of a DP programme for young patients (aged 12–18 years).19 In that study, patients benefited from DP, as evidenced by statistically and clinically significant weight gain and a reduction in eating-disorder behaviours.

The restoration of healthy bodyweight is one of the key aims in the treatment of anorexia nervosa;2, 3, 5 weight gain during IP and the maintenance of weight gain after intensive treatment have been shown to be important prognostic factors.20, 21 Thus, the change in weight between the time of admission and a 12-month follow-up period is an important endpoint in anorexia nervosa treatment trials.

We know of no other randomised controlled trial of DP versus IP. Thus, in this study, we aimed to show non-inferiority of a stepped-care model of DP after brief inpatient stabilisation compared with continued IP in a randomised controlled trial of adolescents with anorexia nervosa.

Section snippets

Study design and participants

We did a randomised, multicentre, open-label, controlled, parallel-group, non-inferiority trial at five university hospitals and one major general hospital for general child and adolescent psychiatry in various regions of Germany. All sites offered specialised treatment for adolescent anorexia nervosa. Female patients were eligible for inclusion if they were aged 11–18 years, had a diagnosis of anorexia nervosa according to Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV), a

Results

Between Feb 2, 2007, to April 27, 2010, we screened 660 patients for eligibility, 172 of whom we randomly allocated to treatment: 85 to IP and 87 to DP (figure 1). When comparing the patients who agreed to participate and those who did not, participants were slightly younger than non-participants (mean age 15·2 years [SD 1·5] vs 15·6 years [SD 1·6]; p=0·040) and had a lower BMI (mean 15·0 kg/m2 [SD 1·3] vs 15·8 kg/m2 [SD 1·3]; p=0·0001) at the time of admission. The baseline characteristics

Discussion

Our findings suggest that DP after 3 weeks of inpatient care was non-inferior to IP in terms of weight gain and maintenance between the time of admission and a 12-month follow-up. The findings were consistent for both the modified intention-to-treat and per-protocol analyses (including all sensitivity analyses), indicating that the study was not biased by non-adherence.

Substantial weight gain and improvement of eating disorders were achieved by patients in both groups, with changes generally

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