一项针对首次生育母亲产后心理健康问题一级预防的心理教育干预措施的整群随机对照试验的经济评估方案。

Protocol for economic evaluation alongside a cluster-randomised controlled trial of a psychoeducational intervention for the primary prevention of postnatal mental health problems in first-time mothers.

作者信息

Ride Jemimah, Rowe Heather, Wynter Karen, Fisher Jane, Lorgelly Paula

机构信息

Centre for Health Economics, Monash University, Clayton, Victoria, Australia.

Jean Hailes Research Unit, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.

出版信息

BMJ Open. 2014 Oct 3;4(10):e006226. doi: 10.1136/bmjopen-2014-006226.

DOI:10.1136/bmjopen-2014-006226

PMID:25280810

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4187457/

Abstract

INTRODUCTION

Postnatal mental health problems, which are an international public health priority, are a suitable target for preventive approaches. The financial burden of these disorders is borne across sectors in society, including health, early childhood, education, justice and the workforce. This paper describes the planned economic evaluation of What Were We Thinking, a psychoeducational intervention for the prevention of postnatal mental health problems in first-time mothers.

METHODS AND ANALYSIS

The evaluation will be conducted alongside a cluster-randomised controlled trial of its clinical effectiveness. Cost-effectiveness and costs-utility analyses will be conducted, resulting in estimates of cost per percentage point reduction in combined 30-day prevalence of depression, anxiety and adjustment disorders and cost per quality-adjusted life year gained. Uncertainty surrounding these estimates will be addressed using non-parametric bootstrapping and represented using cost-effectiveness acceptability curves. Additional cost analyses relevant for implementation will also be conducted. Modelling will be employed to estimate longer term cost-effectiveness if the intervention is found to be clinically effective during the period of the trial.

ETHICS AND DISSEMINATION

Approval to conduct the study was granted by the Southern Health (now Monash Health) Human Research Ethics Committee (24 April 2013; 11388B). The study was registered with the Monash University Human Research Ethics Committee (30 April 2013; CF12/1022-2012000474). The Education and Policy Research Committee, Victorian Government Department of Education and Early Childhood Development approved the study (22 March 2012; 2012_001472). Use of the EuroQol was registered with the EuroQol Group; 16 August 2012.

TRIAL REGISTRATION NUMBER

The trial was registered with the Australian New Zealand Clinical Trials Registry on 7 May 2012 (registration number ACTRN12613000506796).

摘要

引言

产后心理健康问题是国际公共卫生重点关注领域，是预防性干预措施的合适目标。这些疾病的经济负担由社会各部门承担，包括卫生、幼儿、教育、司法和劳动力部门。本文描述了“我们当时在想什么”这一针对初产妇预防产后心理健康问题的心理教育干预措施计划进行的经济评估。

方法与分析

该评估将与一项关于其临床疗效的整群随机对照试验同时进行。将开展成本效益分析和成本效用分析，得出抑郁症、焦虑症和适应障碍综合30天患病率每降低一个百分点的成本估计值以及每获得一个质量调整生命年的成本估计值。将使用非参数自助法处理这些估计值的不确定性，并通过成本效益可接受性曲线来表示。还将进行与实施相关的额外成本分析。如果在试验期间发现该干预措施具有临床疗效，将采用建模方法来估计其长期成本效益。

伦理与传播

该研究已获得南部卫生（现为莫纳什卫生）人类研究伦理委员会批准（2013年4月24日；11388B）。该研究已在莫纳什大学人类研究伦理委员会注册（2013年4月30日；CF12/1022 - 2012000474）。维多利亚州政府教育与幼儿发展部教育与政策研究委员会批准了该研究（2012年3月22日；2012_001472）。欧洲五维度健康量表（EuroQol）的使用已在欧洲五维度健康量表组织注册；2012年8月16日。