Dataset Information

Effects of different information brochures on women's decision-making regarding mammography screening: study protocol for a randomized controlled questionnaire study.

ABSTRACT:

Background

In order to give informed consent for mammography screening, women need to be told the relevant facts; however, screening information often remains vague because of the worry that detailed information might deter women from participating in recommended screening programs. Since September 2010, German women aged 50 to 69 invited for mammography screening have received a new, comprehensive information brochure that frankly discusses the potential benefit and harm of mammography screening. In contrast, the brochure that was in use before September 2010 contained little relevant information.The aim of this study is to compare the impact of the two different brochures on the intention of women to undergo mammography screening, and to broaden our understanding of the effect that factual information has on the women's decision-making.

Methods

This is a controlled questionnaire study comparing knowledge, views and hypothetical preferences of women aged 48-49 years after receiving the old versus the new information brochure. German GP's in the region of North Rhine-Westfalia will be asked by mail and telephone to participate in the study. Eligible women will be recruited via their general practitioners (GPs) and randomized to groups A ('new brochure') and B ('old brochure'), with an intended recruitment of 173 participants per group. The study is powered to detect a 15% higher or lower intention to undergo mammography screening in women informed by the new brochure.

Discussion

This study will contribute to our understanding of the decision-making of women invited to mammography screening. From both ethical and public health perspectives, it is important to know whether frank, factual information leads to a change in the intention of women to participate in a recommended breast cancer screening program.

Trial registration

DRKS00004271.

SUBMITTER: Gummersbach E

PROVIDER: S-EPMC3851440 | biostudies-literature | 2013 Oct

REPOSITORIES: biostudies-literature

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Publications

Effects of different information brochures on women's decision-making regarding mammography screening: study protocol for a randomized controlled questionnaire study.

Gummersbach Elisabeth E in der Schmitten Jürgen J Abholz Heinz-Harald HH Wegscheider Karl K Pentzek Michael M

Trials 20131001

<h4>Background</h4>In order to give informed consent for mammography screening, women need to be told the relevant facts; however, screening information often remains vague because of the worry that detailed information might deter women from participating in recommended screening programs. Since September 2010, German women aged 50 to 69 invited for mammography screening have received a new, comprehensive information brochure that frankly discusses the potential benefit and harm of mammography ...[more]

PMID: 24083811

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Project description:IntroductionWomen are largely unaware that mammography screening can cause overdetection of inconsequential disease, leading to overdiagnosis and overtreatment of breast cancer. Evidence is lacking about how information on overdetection affects women's breast screening decisions and experiences. This study investigates the consequences of providing information about overdetection of breast cancer to women approaching the age of invitation to mammography screening.Methods and analysisThis is a randomised controlled trial with an embedded longitudinal qualitative substudy. Participants are a community sample of women aged 48-50 in New South Wales, Australia, recruited in 2014. Women are randomly allocated to either quantitative only follow-up (n=904) or additional qualitative follow-up (n=66). Women in each stream are then randomised to receive either the intervention (evidence-based information booklet including overdetection, breast cancer mortality reduction and false positives) or a control information booklet (including mortality reduction and false positives only). The primary outcome is informed choice about breast screening (adequate knowledge, and consistency between attitudes and intentions) assessed via telephone interview at 2?weeks postintervention. Secondary outcomes measured at this time include decision process (decisional conflict and confidence) and psychosocial outcomes (anticipated regret, anxiety, breast cancer worry and perceived risk). Women are further followed up at 6?months, 1 and 2?years to assess self-reported screening behaviour and long-term psychosocial outcomes (decision regret, quality of life). Participants in the qualitative stream undergo additional in-depth interviews at each time point to explore the views and experiences of women who do and do not choose to have screening.Ethics and disseminationThe study has ethical approval, and results will be published in peer-reviewed journals. This research will help ensure that information about overdetection may be communicated clearly and effectively, using an evidence-based approach, to women considering breast cancer screening.Trial registration numberAustralian New Zealand Clinical Trials Registry ACTRN12613001035718.

Project description:BackgroundThe decision to participate or not in breast cancer screening is complex due to the trade-off between the expected benefit of breast cancer mortality reduction and the major harm of overdiagnosis. It seems ethically necessary to inform women so that they can actively participate in decision-making and make an informed choice based on their values and preferences. The objective of this study is to assess the effects of receiving information about the benefits and harms of screening on decision-making, in women approaching the age of invitation to mammography screening.MethodsA two-stage, randomized controlled trial (RCT). In the first stage, 40 Basic Health Areas (BHAs) will be selected and randomized to intervention or control. In the second stage, women within each BHA will be randomly selected (n = 400). Four breast cancer screening programs (BCSPs) of the Spanish public health system, three in Catalonia and one in the Canary Islands will participate in the study. Women in the intervention arm will receive a leaflet with detailed information on the benefits and harms of screening using mammography. Women in the control arm will receive a standard leaflet that does not mention harms and recommends accepting the invitation to participate in the biennial examinations of the BCSP. The primary outcome is informed choice, a dichotomous variable that combines knowledge, attitudes, and intentions. Secondary outcomes include decisional conflict; confidence in the decision made; anxiety about screening participation; worry about breast cancer; anticipated regret; time perspective; perceived importance of benefits/harms of screening; perceived risk of breast cancer; and leaflet acceptability. Primary and secondary outcomes are assessed 2-3 weeks after the intervention.DiscussionThis is the first RCT that assesses the effect of informing about the benefits and harms of breast cancer screening in Spain in women facing the decision to be screened using mammography. It aims to assess the impact of information on several decisional outcomes and to contribute to paving the road towards shared decision-making in breast cancer screening in our country.Trial registrationClinicalTrials.gov registry, ID: NCT03046004 . Retrospectively registered on 4 February 2017. Trial name: InforMa study.

Project description:BACKGROUND:In Spain, women invited to breast screening are not usually informed about potential harms of screening. The objective of the InforMa study is to assess the effect of receiving information about the benefits and harms of breast screening on informed choice and other decision-making outcomes, in women approaching the age of invitation to mammography screening. METHODS:Two-stage randomised controlled trial. In the first stage, 40 elementary territorial units of the public healthcare system were selected and randomised to intervention or control. In the second stage, women aged 49-50 years were randomly selected. The target sample size was 400 women. Women in the intervention arm received a decision aid (DA) with detailed information on the benefits and harms of screening. Women in the control arm received a standard leaflet that did not mention harms and recommended accepting the invitation to participate in the Breast Cancer Screening Program (BCSP). The primary outcome was informed choice, defined as adequate knowledge and intentions consistent with attitudes. Secondary outcomes included decisional conflict, worry about breast cancer, time perspective, opinions about the DA or the leaflet, and participation in the BCSP. RESULTS:In the intervention group, 23.2% of 203 women made an informed choice compared to only 0.5% of 197 women in the control group (p < 0.001). Attitudes and intentions were similar in both study groups with a high frequency of women intending to be screened, 82.8% vs 82.2% (p = 0.893). Decisional conflict was significantly lower in the intervention group. No differences were observed in confidence in the decision, anxiety, and participation in BCSP. CONCLUSIONS:Women in Spain lack knowledge on the benefits and harms of breast screening. Providing quantitative information on benefits and harms has produced a considerable increase in knowledge and informed choice, with a high acceptance of the informative materials. TRIAL REGISTRATION:Trial identifier NCT03046004 at ClinicalTrials.gov registry. Registered on February 4 2017. Trial name: InforMa study.

Project description:BackgroundThe prevalence of complementary medicine product (CMP) use by pregnant or breastfeeding Australian mothers is high, however, there is limited data on factors influencing women's decision-making to use CMPs. This study explored and described the factors influencing women's decisions take a CMP when pregnant or breastfeeding.MethodsQualitative in-depth interviews and focus group discussions were held with 25 pregnant and/or breastfeeding women who currently used CMPs. Participants' health literacy was assessed using a validated single-item health literacy screening question and the Newest Vital Sign. Interview and focus group discussions were audio-recorded, transcribed verbatim and thematically analysed.ResultsParticipants were a homogenous group. Most had higher education, medium to high incomes and high health literacy skills. They actively sought information from multiple sources and used a reiterative collation and assessment process. Their decision-making to take or not to take CMPs was informed by the need to establish the safety of the CMPs, as well as possible benefits or harms to their baby's or their own health that could result from taking a CMP. Their specific information needs included the desire to access comprehensive, consistent, clear, easy to understand, and evidence-based information. Women preferred to access information from reputable sources, namely, their trusted health care practitioners, and information linked to government or hospital websites and published research. A lack of comprehensive, clear, consistent, or evidence-based information often led to decisions not to take a CMP, as they felt unable to adequately establish its safety or benefits. Conversely, when the participants felt the CMPs information they collected was good quality and from reputable sources, it reassured them of the safety of the CMP in pregnancy and/or breastfeeding. If this confirmed a clear benefit to their baby or themselves, they were more likely to decide to take a CMP.ConclusionsThe participants' demographic profile confirms previous research concerning Australian women who use CMPs during pregnancy and lactation. Participants' high health literacy skills led them to engage in a reiterative, information-seeking and analysis process fuelled by the need to find clear information before making the decision to take, or not to take, a CMP.

Project description:BACKGROUND:As breast cancer screening guidelines have changed recently, additional investigation is needed to understand changes in women's behavior after using breast cancer screening patient decision aids (BCS-PtDAs) and the potential effect on mammography utilization. This systematic review and meta-analysis sought to evaluate the effect of BCS-PtDAs on changes in women's intentions to undergo screening mammography and whether women deciding to begin or discontinue screening mammography displayed similar changes in screening intentions after using a BCS-PtDA. METHODS:We searched Medline, Scopus, PsycINFO, CENTRAL, Health and Psychosocial Instruments, Health Technology Assessment Database, PsycARTICLES, and cited references in eligible papers for randomized controlled trials (RCTs) and observational studies, published through August 24, 2016. The proportions of women who did and not intend to undergo screening and who were uncertain about undergoing screening mammography were pooled, using risk ratios (RR) and random effects. According to the protocol, RCTs or observational studies and any language were considered eligible for systematic review if they included data about women for which shared decision making is recommended. RESULTS:We ultimately included six studies with screening intention data for 2040 women. Compared to usual care, the use of BCS-PtDAs in three RCTs resulted in significantly more women deciding not to undergo screening mammography (RR 1.48 [95% CI 1.04-2.13]; P?=?0.03), particularly for younger (38-50 years) women (1.77 [1.34-2.34]; P?<?0.001). The use of BCS-PtDAs had a non-significant effect on the intentions of older women (69-89 years) to discontinue screening. CONCLUSIONS:The use of BCS-PtDAs increased younger women's reluctance to undergo screening for breast cancer. The implementation of such BCS-PtDAs in clinical practice would be expected to result in a 77% increase in the number of younger women (aged 38-50) who do not intend to be screened, and as a consequence, may reduce utilization of screening mammography. REGISTRATION:The protocol of this review is registered in the PROSPERO database, #CRD42016036695.

Dataset Information

Effects of different information brochures on women's decision-making regarding mammography screening: study protocol for a randomized controlled questionnaire study.

Background

Methods

Discussion

Trial registration

Publications

Effects of different information brochures on women's decision-making regarding mammography screening: study protocol for a randomized controlled questionnaire study.

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