文章基本信息

标题：An RCT of a decision aid to support informed choices about taking aspirin to prevent colorectal cancer and other chronic diseases: a study protocol for the SITA (Should I Take Aspirin?) trial
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作者：Shakira Milton ; Jennifer McIntosh ; Finlay Macrae 等
期刊名称：Trials
印刷版ISSN：1745-6215
电子版ISSN：1745-6215
出版年度：2021
卷号：22
期号：1
页码：1-17
DOI：10.1186/s13063-021-05365-8
出版社：BioMed Central
摘要：Australian guidelines recommend that all people aged 50–70 years old actively consider taking daily low-dose aspirin (100–300 mg per day) for 2.5 to 5 years to reduce their risk of colorectal cancer (CRC). Despite the change of national CRC prevention guidelines, there has been no active implementation of the guidelines into clinical practice. We aim to test the efficacy of a health consultation and decision aid, using a novel expected frequency tree (EFT) to present the benefits and harms of low dose aspirin prior to a general practice consultation with patients aged 50–70 years, on informed decision-making and uptake of aspirin. Approximately five to seven general practices in Victoria, Australia, will be recruited to participate. Patients 50–70 years old, attending an appointment with their general practitioner (GP) for any reason, will be invited to participate in the trial. Two hundred fifty-eight eligible participants will be randomly allocated 1:1 to intervention or active control arms using a computer-generated allocation sequence stratified by general practice, sex, and mode of trial delivery (face-to-face or teletrial). There are two co-primary outcomes: informed decision-making at 1-month post randomisation, measured by the Multi-dimensional Measure of Informed Choice (MMIC), and self-reported daily use of aspirin at 6 months. Secondary outcomes include decisional conflict at 1-month and other behavioural changes to reduce CRC risk at both time points. This trial will test the efficacy of novel methods for implementing national guidelines to support informed decision-making about taking aspirin in 50–70-year-olds to reduce the risk of CRC and other chronic diseases. The Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12620001003965 . Registered on 10 October 2020.
关键词：Preventive medicine ; General practice ; Primary care ; Cancer prevention ; Bowel cancer ; Colorectal cancer ; Aspirin ; Guideline implementation ; Chemoprevention ; Decision Aid ; Informed decision making