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Real-world effect of antidepressants for depressive disorder in primary care: protocol of a population-based cohort study.
BMJ Mental Health ( IF 5.2 ) Pub Date : 2020-08-01 , DOI: 10.1136/ebmental-2020-300149
Franco De Crescenzo 1, 2 , Cesar Garriga 3 , Anneka Tomlinson 4 , Carol Coupland 5 , Orestis Efthimiou 6 , Seena Fazel 4 , Julia Hippisley-Cox 3 , Andrea Cipriani 2, 4
Affiliation  

Introduction Clinical guidelines recommend antidepressants as the first line of treatment for adults with moderate-to-severe depression. Randomised trials provide the best evidence on the comparative effectiveness of antidepressants for depression, but are limited by a short follow-up and a highly selected population. We aim to conduct a cohort study on a large database to assess acceptability, efficacy, safety and tolerability of antidepressant monotherapy in people with depressive disorder in primary care. Methods and analysis This is a protocol for a cohort study using data from the QResearch primary care research database, which is the largest general practice research database in the UK. We will include patients registered for at least 1 year from 1 January 1998, diagnosed with a new episode of depression and on antidepressant and a comparison group not on antidepressant. The exposure of interest will be treatment with antidepressant medications. Our outcomes will be acceptability (treatment discontinuation due to any cause), efficacy (clinical response and remission); safety (adverse events (AEs) and all-cause mortality); and tolerability (dropouts due to any AE) measured at 2 months, 6 months and 1 year. For each outcome, we will estimate the absolute risks for all antidepressants, and relative effects between antidepressants using Cox’s proportion hazards models. We will calculate HRs and 99.9% CIs for each outcome of interest. Discussion The main limitation is the observational nature of our study, while the major strengths include the large representative population contained in QResearch and the possibly high generalisability.

中文翻译:

抗抑郁药对初级保健中抑郁症的现实影响:基于人群的队列研究方案。

简介 临床指南建议将抗抑郁药作为成人中度至重度抑郁症的一线治疗方法。随机试验提供了抗抑郁药治疗抑郁症相对有效性的最佳证据,但受到随访时间短和人群选择严格的限制。我们的目标是在一个大型数据库上进行一项队列研究,以评估初级保健中抑郁症患者抗抑郁单一疗法的可接受性、有效性、安全性和耐受性。方法和分析 这是一项队列研究方案,使用来自 QResearch 初级保健研究数据库的数据,该数据库是英国最大的全科实践研究数据库。我们将纳入自 1998 年 1 月 1 日起登记至少 1 年、诊断为新发抑郁症且正在服用抗抑郁药物的患者,以及未服用抗抑郁药物的对照组。感兴趣的暴露将是抗抑郁药物的治疗。我们的结果将是可接受性(由于任何原因而停止治疗)、疗效(临床反应和缓解);安全性(不良事件(AE)和全因死亡率);2 个月、6 个月和 1 年测量的耐受性(由于任何 AE 导致的退出)。对于每个结果,我们将使用 Cox 比例风险模型估计所有抗抑郁药物的绝对风险以及抗抑郁药物之间的相对效应。我们将为每个感兴趣的结果计算 HR 和 99.9% CI。讨论 主要限制是我们研究的观察性质,而主要优势包括 QResearch 中包含的大量代表性人群以及可能的高普遍性。
更新日期:2020-07-22
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