Başak İnce, Matthew D. Phillips, Zohra Zenasni, James Shearer, Bethan Dalton, Madeleine Irish, Daniela Mercado, Hannah Webb, Catherine McCombie, Katie Au, Nikola Kern, Sam Clark-Stone, Frances Connan, A. Louise Johnston, Stanimira Lazarova, Ewa Zadeh, Ciarán Newell, Tayeem Pathan, Jackie Wales, Rebecca Cashmore, Sandra Marshall, Jon Arcelus, Paul Robinson, Sarah Byford, Sabine Landau, Vanessa Lawrence, Hubertus Himmerich, Janet Treasure, Ulrike Schmidt
{"title":"失败试验剖析之二：DAISIES 试验的结果、挑战和经验教训","authors":"Başak İnce, Matthew D. Phillips, Zohra Zenasni, James Shearer, Bethan Dalton, Madeleine Irish, Daniela Mercado, Hannah Webb, Catherine McCombie, Katie Au, Nikola Kern, Sam Clark-Stone, Frances Connan, A. Louise Johnston, Stanimira Lazarova, Ewa Zadeh, Ciarán Newell, Tayeem Pathan, Jackie Wales, Rebecca Cashmore, Sandra Marshall, Jon Arcelus, Paul Robinson, Sarah Byford, Sabine Landau, Vanessa Lawrence, Hubertus Himmerich, Janet Treasure, Ulrike Schmidt","doi":"10.1002/erv.3058","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Objective</h3>\n \n <p>The relative merits of inpatient or day-treatment for adults with anorexia nervosa (AN) are unknown. The DAISIES trial aimed to establish the non-inferiority of a stepped-care day patient treatment (DPT) approach versus inpatient treatment as usual (IP-TAU) for improving body mass index (BMI) at 12 months in adults with AN. The trial was terminated due to poor recruitment. This paper presents outcomes and investigates the reasons behind the trial's failure.</p>\n </section>\n \n <section>\n \n <h3> Method</h3>\n \n <p>Fifteen patients with AN (of 53 approached) participated and were followed-up to 6 or 12 months. Summary statistics were calculated due to low sample size, and qualitative data concerning treatment experiences were analysed using thematic analysis.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>At baseline, participants in both trial arms rated stepped-care DPT as more acceptable. At 12 months, participants' BMIs had increased in both trial arms. Qualitative analysis highlighted valued and challenging aspects of care across settings. Only 6/12 sites opened for recruitment. Among patients approached, the most common reason for declining participation was their treatment preference (<i>n</i> = 12/38).</p>\n </section>\n \n <section>\n \n <h3> Conclusions</h3>\n \n <p>No conclusions can be drawn concerning the effectiveness of IP-TAU and stepped-care DPT, but the latter was perceived more positively. Patient-related, service-related and systemic factors (COVID-19) contributed to the trial's failure. Lessons learnt can inform future studies.</p>\n </section>\n </div>","PeriodicalId":3,"journal":{"name":"ACS Applied Electronic Materials","volume":null,"pages":null},"PeriodicalIF":4.3000,"publicationDate":"2023-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/erv.3058","citationCount":"0","resultStr":"{\"title\":\"Autopsy of a failed trial part 2: Outcomes, challenges, and lessons learnt from the DAISIES trial\",\"authors\":\"Başak İnce, Matthew D. Phillips, Zohra Zenasni, James Shearer, Bethan Dalton, Madeleine Irish, Daniela Mercado, Hannah Webb, Catherine McCombie, Katie Au, Nikola Kern, Sam Clark-Stone, Frances Connan, A. Louise Johnston, Stanimira Lazarova, Ewa Zadeh, Ciarán Newell, Tayeem Pathan, Jackie Wales, Rebecca Cashmore, Sandra Marshall, Jon Arcelus, Paul Robinson, Sarah Byford, Sabine Landau, Vanessa Lawrence, Hubertus Himmerich, Janet Treasure, Ulrike Schmidt\",\"doi\":\"10.1002/erv.3058\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div>\\n \\n \\n <section>\\n \\n <h3> Objective</h3>\\n \\n <p>The relative merits of inpatient or day-treatment for adults with anorexia nervosa (AN) are unknown. The DAISIES trial aimed to establish the non-inferiority of a stepped-care day patient treatment (DPT) approach versus inpatient treatment as usual (IP-TAU) for improving body mass index (BMI) at 12 months in adults with AN. The trial was terminated due to poor recruitment. This paper presents outcomes and investigates the reasons behind the trial's failure.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Method</h3>\\n \\n <p>Fifteen patients with AN (of 53 approached) participated and were followed-up to 6 or 12 months. Summary statistics were calculated due to low sample size, and qualitative data concerning treatment experiences were analysed using thematic analysis.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Results</h3>\\n \\n <p>At baseline, participants in both trial arms rated stepped-care DPT as more acceptable. At 12 months, participants' BMIs had increased in both trial arms. Qualitative analysis highlighted valued and challenging aspects of care across settings. Only 6/12 sites opened for recruitment. Among patients approached, the most common reason for declining participation was their treatment preference (<i>n</i> = 12/38).</p>\\n </section>\\n \\n <section>\\n \\n <h3> Conclusions</h3>\\n \\n <p>No conclusions can be drawn concerning the effectiveness of IP-TAU and stepped-care DPT, but the latter was perceived more positively. Patient-related, service-related and systemic factors (COVID-19) contributed to the trial's failure. 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Autopsy of a failed trial part 2: Outcomes, challenges, and lessons learnt from the DAISIES trial
Objective
The relative merits of inpatient or day-treatment for adults with anorexia nervosa (AN) are unknown. The DAISIES trial aimed to establish the non-inferiority of a stepped-care day patient treatment (DPT) approach versus inpatient treatment as usual (IP-TAU) for improving body mass index (BMI) at 12 months in adults with AN. The trial was terminated due to poor recruitment. This paper presents outcomes and investigates the reasons behind the trial's failure.
Method
Fifteen patients with AN (of 53 approached) participated and were followed-up to 6 or 12 months. Summary statistics were calculated due to low sample size, and qualitative data concerning treatment experiences were analysed using thematic analysis.
Results
At baseline, participants in both trial arms rated stepped-care DPT as more acceptable. At 12 months, participants' BMIs had increased in both trial arms. Qualitative analysis highlighted valued and challenging aspects of care across settings. Only 6/12 sites opened for recruitment. Among patients approached, the most common reason for declining participation was their treatment preference (n = 12/38).
Conclusions
No conclusions can be drawn concerning the effectiveness of IP-TAU and stepped-care DPT, but the latter was perceived more positively. Patient-related, service-related and systemic factors (COVID-19) contributed to the trial's failure. Lessons learnt can inform future studies.
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