Personalised informed choice on evidence and controversy on mammography screening: study protocol for a randomized controlled trial

Abstract

BackgroundIn Italy women aged 50–69 are invited for a population-based breast cancer (BC) screening. Physicians, policy makers and patients associations agree on the need to inform women about the benefits and harms in order to permit an informed decision. Decision aids (DA) are an effective way to support people in their decisions about health. This trial aims to assess women’s informed choices, according to their health literacy and values, on participating or not in BC screening for the first time. Benefits, harms and controversies are presented.Methods/designThe impact of the DA will be evaluated in a randomized controlled trial with a two-week follow-up. Women will be randomized via web to DA or a standard brochure. We will invite 8160 women, to obtain a final sample of 816 women. The primary outcome will be informed choice, measured on the basis of knowledge, attitudes and intentions on BC screening. Secondary outcomes are participation rate, satisfaction on information and decisional conflict.DiscussionThe web DA will be open-source and implemented on BC screenings and its efficacy for increasing informed choice will be tested. This model could be applied to other healthcare settings, cancer screenings, and public health programs.Trial registrationThe protocol for this trial was registered with the Clinicaltrials.gov registry on March 16, 2017: NCT03097653.

A dynamic web-based decision aid to improve informed choice in organised breast cancer screening. A pragmatic randomised trial in Italy

“…21 For the primary analysis, done on an intention-to-treat basis in accordance with the protocol, all the women randomised, compliant to follow-up, were included in the final analysis. 21 The proportions of women were compared with a chi-square test (two-sided, P < 0.05). A t test was used for continuous endpoints (two sided, P < 0.05).…”

“…Six regional organised screening programmes invited women eligible for a first invitation-aged >50 years in 4 screening programmes and aged >45 years in 2, without personal history of BC-with an official letter sent about 30 days before the screening invitation. According to the protocol published elsewhere, 21 three programmes participated since the beginning, three additional programmes joined the study later due to the difficulties to achieve the required sample size.…”

“…as part of organised mammography screening programmes' practice. 21 The aim was to compare DA with a web-based standard static brochure (SB).…”

Making decisions about antipsychotics: a qualitative study of patient experience and the development of a decision aid

“…A recent Cochrane review of decision aids concluded that people exposed to such aids report to be better informed and have a more active role in decision making [50]. Trial data suggests that decision aids improve patients’ knowledge of risks and benefits [51] and reduce decisional conflict [52]. In depression, decision aids have been demonstrated to encourage a more active role in decision-making [53] and improved decisional comfort, knowledge and satisfaction, despite failing to improve medication adherence [54].…”

Challenging the Results and Consequences of Cancer Screening Programs.

“…The need to describe confounders applies to all types of clinical studies, but above all to screening studies. Several authors reported that screening studies are sensitive to the effects of the IC (13)(14)(15)(16)(17)(18) and to risk factors of individual participants. The authors of these studies require a careful consideration of an appropriate IC in experimental studies and recommend the use of a decision aid (15).…”