Aripiprazole/Sertraline Combination: Clinical and Cost-Effectiveness in Comparison With Quetiapine for the Treatment of Bipolar Depression (ASCEnD Trial)—Protocol for a Nested Qualitative Study

IF 3 3区医学 Q2 HEALTH CARE SCIENCES & SERVICES Health Expectations Pub Date : 2024-09-04 DOI:10.1111/hex.70018

Isobel Hoppe, Stuart Watson, Caroline Kemp, Fiona Turnbull, Firoza Davies, John Gibson, Lumbini Azim, Lauren Wall, Niraj Ahuja, Sarah Al-Ashmori, Sally Keys, Thomas Kabir, Carolyn A. Chew-Graham

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Abstract

Introduction

Bipolar disorder is a recurrent mental health disorder with a prevalence rate of 1.4%. On average, there can be a delay of 9.5 years from the initial presentation of symptoms to a confirmed diagnosis. Individuals living with bipolar disorder have a reduced life expectancy. There is limited evidence regarding the effectiveness of antidepressants in treating bipolar disorder. The ASCEnD clinical trial will test the clinical and cost-effectiveness of the aripiprazole/sertraline combination in comparison with quetiapine for the treatment of bipolar depression (individuals who suffer from depressive episodes in bipolar disorder) and will include a nested qualitative study.

Methods

The qualitative study will use semi-structured interviews to explore pilot trial participants' and clinicians' perspectives on recruitment procedures, the acceptability of the intervention, the management of bipolar disorder and attitudes to medication combinations.

Conclusion

Findings will inform recruitment strategies and optimise training for the participating sites in the ASCEnD full trial. They will also help to illuminate the lived experience of people with bipolar disorder and the clinicians who work with people with bipolar disorder. The discussion will explore perspectives on the delay in diagnosis, having a diagnosis, the impact of living with bipolar disorder and attitudes to treatment, including drug combinations.

Patient or Public Contribution

A Lived Experience Advisory Panel (LEAP) has been convened with the support of the McPin Foundation, which will contribute to the ASCEnD trial and its nested qualitative study to provide input on the design and delivery of the trial and qualitative study, analysis of qualitative data and dissemination of findings.

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阿立哌唑/舍曲林复方制剂：阿立哌唑/舍曲林联合用药：与喹硫平治疗双相抑郁症的临床和成本效益比较（ASCEnD 试验）--巢式定性研究方案。

简介躁郁症是一种反复发作的精神疾病，发病率为 1.4%。从最初出现症状到确诊，平均需要延迟 9.5 年。躁郁症患者的预期寿命会缩短。关于抗抑郁药治疗躁郁症的有效性，目前证据有限。ASCEnD临床试验将检验阿立哌唑/舍曲林联合用药与喹硫平治疗双相抑郁症（双相情感障碍抑郁发作患者）的临床和成本效益比较，并将包括一项嵌套定性研究：定性研究将采用半结构化访谈的方式，探讨试点试验参与者和临床医生对招募程序、干预措施的可接受性、双相情感障碍的管理以及对联合用药的态度等方面的看法：研究结果将为 ASCEnD 全面试验的招募策略提供参考，并为参与试验的机构优化培训。这些研究结果还将有助于了解躁郁症患者和从事躁郁症患者工作的临床医生的生活经历。讨论将从延迟诊断、确诊、双相情感障碍对生活的影响以及对治疗（包括联合用药）的态度等角度展开：在麦克平基金会（McPin Foundation）的支持下，我们成立了一个生活经验咨询小组（LEAP），该小组将参与 ASCEnD 试验及其嵌套定性研究，为试验和定性研究的设计和实施、定性数据的分析以及研究结果的传播提供意见。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Health Expectations 医学-公共卫生、环境卫生与职业卫生

CiteScore

5.20

自引率

9.40%

发文量

251

审稿时长

>12 weeks

期刊介绍： Health Expectations promotes critical thinking and informed debate about all aspects of patient and public involvement and engagement (PPIE) in health and social care, health policy and health services research including: • Person-centred care and quality improvement • Patients'' participation in decisions about disease prevention and management • Public perceptions of health services • Citizen involvement in health care policy making and priority-setting • Methods for monitoring and evaluating participation • Empowerment and consumerism • Patients'' role in safety and quality • Patient and public role in health services research • Co-production (researchers working with patients and the public) of research, health care and policy Health Expectations is a quarterly, peer-reviewed journal publishing original research, review articles and critical commentaries. It includes papers which clarify concepts, develop theories, and critically analyse and evaluate specific policies and practices. The Journal provides an inter-disciplinary and international forum in which researchers (including PPIE researchers) from a range of backgrounds and expertise can present their work to other researchers, policy-makers, health care professionals, managers, patients and consumer advocates.