Whittaker Karen, Sutton Chris, Burton Chris
Department of Nursing, University of Central Lancashire, Preston PR1 2HE, UK.
J Epidemiol Community Health. 2006 Oct;60(10):858-64. doi: 10.1136/jech.2005.044214.
To evaluate trials of parenting programmes, regarding their use of intention to treat (ITT).
Individual trials included in two relevant Cochrane systematic reviews were scrutinised by two independent reviewers. Data on country of origin, target audience, trial type, treatment violations, use of ITT, and the management of missing data were extracted.
Thirty trial reports were reviewed. Three reported the use of an ITT approach to data analysis. Nineteen reported losing subjects to follow up although the implications of this were rarely considered. Insufficient detail in reports meant it was difficult to identify study drop outs, the nature of treatment violations, and those failing to provide outcome assessments. In two trials, study drop outs were considered as additional control groups, violating the basic principle of ITT.
It is recommended that future trial reports adhere to CONSORT guidelines. In particular ITT should be used for the main analyses, with strategies for managing treatment violations and handling missing data being reported a priori. Those conducting trials need to acknowledge the social nature of these programmes can sometimes result in erratic parent attendance and participation, which would only increase the chances of missing data. The use of approaches that can limit the proportion of missing data is therefore recommended.
评估育儿项目试验中意向性分析（ITT）的使用情况。
两名独立评审员对两项相关Cochrane系统评价中纳入的个体试验进行了审查。提取了有关原产国、目标受众、试验类型、治疗违规情况、ITT的使用以及缺失数据管理的数据。
审查了30份试验报告。3份报告采用了ITT方法进行数据分析。19份报告称有受试者失访，不过很少考虑其影响。报告细节不足意味着难以确定研究中的退出者、治疗违规的性质以及未提供结局评估的人员。在两项试验中，研究中的退出者被视为额外的对照组，这违反了ITT的基本原则。
建议未来的试验报告遵循CONSORT指南。特别是主要分析应采用ITT，并事先报告处理治疗违规和处理缺失数据的策略。进行试验的人员需要认识到这些项目的社会性质有时会导致家长出勤和参与不稳定，这只会增加数据缺失的可能性。因此，建议使用能够限制缺失数据比例的方法。
