Dataset Information

The Impact of a Risk-Based Breast Cancer Screening Decision Aid on Initiation of Mammography Among Younger Women: Report of a Randomized Trial.

ABSTRACT: Background. Guidelines recommend that initiation of breast cancer screening (BCS) among women aged 40 to 49 years include a shared decision-making process. The objective of this study is to evaluate the effect of a breast cancer screening patient decision-aid (BCS-PtDA) on the strength of the relationship between individual risk and the decision to initiate BCS, knowledge, and decisional conflict. Methods. We conducted a randomized clinical trial of a BCS-PtDA that included individual risk estimates compared with usual care. Participants were women 39 to 48 years of age with no previous mammogram. Primary outcomes were strength of association between breast cancer risk and mammography uptake at 12 months, knowledge, and decisional conflict. Results. Of 204 participants, 65% were Black, the median age (interquartile range [IQR]) was 40.0 years (39.0-42.0), and median (IQR) breast cancer lifetime risk was 9.7% (9.2-11.1). Women who received mammography at 12 months had higher breast cancer lifetime risk than women who had not in both intervention (mean, 95% CI): 12.2% (10.8-13.6) versus 10.5% (9.8-11.2), P = 0.04, and control groups: 11.8% (10.4-13.1) versus 9.9% (9.2-10.6), P = 0.02. However, there was no difference between groups in the strength of association between mammography uptake and breast cancer risk (P = 0.87). Follow-up knowledge (0-5) was greater in the intervention versus control group (mean, 95% CI): 3.84 (3.5-4.2) versus 3.17 (2.8-3.5), P = 0.01. There was no change in decisional conflict score (1-100) between the intervention versus control group (mean, 95% CI): 24.8 (19.5-30.2) versus 32.4 (25.9-39.0), P = 0.07. Conclusions. The BCS-PtDA improved knowledge but did not affect risk-based decision making regarding age of initiation of BCS. These findings indicate the complexity of changing behaviors to incorporate objective risk in the medical decision-making process.

SUBMITTER: Schapira MM

PROVIDER: S-EPMC6350139 | biostudies-literature | 2019 Jan-Jun

REPOSITORIES: biostudies-literature

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The Impact of a Risk-Based Breast Cancer Screening Decision Aid on Initiation of Mammography Among Younger Women: Report of a Randomized Trial.

Schapira Marilyn M MM Hubbard Rebecca A RA Seitz Holli H HH Conant Emily F EF Schnall Mitchell M Cappella Joseph N JN Harrington Tory T Inge Carrie C Armstrong Katrina K

MDM policy & practice 20190117 1

<b>Background.</b> Guidelines recommend that initiation of breast cancer screening (BCS) among women aged 40 to 49 years include a shared decision-making process. The objective of this study is to evaluate the effect of a breast cancer screening patient decision-aid (BCS-PtDA) on the strength of the relationship between individual risk and the decision to initiate BCS, knowledge, and decisional conflict. <b>Methods.</b> We conducted a randomized clinical trial of a BCS-PtDA that included individ ...[more]

PMID: 30729166

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Project description:Guidelines recommend that women 75 years and older should be informed of the benefits and risks of mammography before being screened. However, few are adequately informed.To develop and evaluate a mammography screening decision aid (DA) for women 75 years and older.We designed the DA using international standards. Between July 14, 2010, and April 10, 2012, participants completed a pretest survey and read the DA before an appointment with their primary care physician. They completed a posttest survey after their appointment. Medical records were reviewed for follow-up information.Boston, Massachusetts, academic primary care practice. Eligible women were aged 75 to 89 years, English speaking, had not had a mammogram in 9 months but had been screened within the past 3 years, and did not have a history of dementia or invasive or noninvasive breast cancer. Of 84 women approached, 27 declined to participate, 12 were unable to complete the study for logistical reasons, and 45 participated.The DA includes information on breast cancer risk, life expectancy, competing mortality risks, possible outcomes of screening, and a values clarification exercise.Knowledge of the benefits and risks of screening, decisional conflict, and screening intentions; documentation in the medical record of a discussion of the risks and benefits of mammography with a primary care physician within 6 months; and the receipt of screening within 15 months. We used the Wilcoxon signed rank test and McNemar test to compare pretest-posttest information.The median age of participants was 79 years, 69% (31 of 45) were of non-Hispanic white race/ethnicity, and 60% (27 of 45) had attended at least some college. Comparison of posttest results with pretest results demonstrated 2 findings. First, knowledge of the benefits and risks of screening improved (P <?.001). Second, fewer participants intended to be screened (56% [25 of 45] afterward compared with 82% [37 of 45] before, P =?.03). Decisional conflict declined but not significantly (P =?.10). In the following 6 months, 53% (24 of 45) of participants had a primary care physician note that documented the discussion of the risks and benefits of screening compared with 11% (5 of 45) in the previous 5 years (P <?.001). While 84% (36 of 43) had been screened within 2 years of participating, 60% (26 of 43) were screened within 15 months after participating (? 2 years since their last mammogram) (P =?.01). Overall, 93% (42 of 45) found the DA helpful.A DA may improve older women's decision making about mammography screening.

Project description:ImportanceGuidelines recommend that women 75 years and older be informed of the benefits and harms of mammography before screening.ObjectiveTo test the effects of receipt of a paper-based mammography screening decision aid (DA) for women 75 years and older on their screening decisions.Design, setting, and participantsA cluster randomized clinical trial with clinician as the unit of randomization. All analyses were completed on an intent-to-treat basis. The setting was 11 primary care practices in Massachusetts or North Carolina. Of 1247 eligible women reached, 546 aged 75 to 89 years without breast cancer or dementia who had a mammogram within 24 months but not within 6 months and saw 1 of 137 clinicians (herein referred to as PCPs) from November 3, 2014, to January 26, 2017, participated. A research assistant (RA) administered a previsit questionnaire on each participant's health, breast cancer risk factors, sociodemographic characteristics, and screening intentions. After the visit, the RA administered a postvisit questionnaire on screening intentions and knowledge.InterventionsReceipt of the DA (DA arm) or a home safety (HS) pamphlet (control arm) before a PCP visit.Main outcomes and measuresParticipants were followed up for 18 months for receipt of mammography screening (primary outcome). To examine the effects of the DA, marginal logistic regression models were fit using generalized estimating equations to allow for clustering by PCP. Adjusted probabilities and risk differences were estimated to account for clustering by PCP.ResultsOf 546 women in the study, 283 (51.8%) received the DA. Patients in each arm were well matched; their mean (SD) age was 79.8 (3.7) years, 428 (78.4%) were non-Hispanic white, 321 (of 543 [59.1%]) had completed college, and 192 (35.2%) had less than a 10-year life expectancy. After 18 months, 9.1% (95% CI, 1.2%-16.9%) fewer women in the DA arm than in the control arm had undergone mammography screening (51.3% vs 60.4%; adjusted risk ratio, 0.84; 95% CI, 0.75-0.95; P = .006). Women in the DA arm were more likely than those in the control arm to rate their screening intentions lower from previsit to postvisit (69 of 283 [adjusted %, 24.5%] vs 47 of 263 [adjusted %, 15.3%]), to be more knowledgeable about the benefits and harms of screening (86 [adjusted %, 25.5%] vs 32 [adjusted %, 11.7%]), and to have a documented discussion about mammography with their PCP (146 [adjusted %, 47.4%] vs 111 [adjusted %, 38.9%]). Almost all women in the DA arm (94.9%) would recommend the DA.Conclusions and relevanceProviding women 75 years and older with a mammography screening DA before a PCP visit helps them make more informed screening decisions and leads to fewer women choosing to be screened, suggesting that the DA may help reduce overscreening.Trial registrationClinicalTrials.gov Identifier: NCT02198690.

Project description:IntroductionBreast cancer (BC) is the primary cancer among women. The World Health Organization recommends a bilateral screening mammogram every 2 years for women aged 50 to 74 years. However, it has been shown that there is an absence of information about the benefits and risks of screening. Shared medical decision-making is important to ensure patients are involved in the decision process. Decision aids can facilitative this decision-making process. This article presents a protocol to evaluate the effect of a decision aid on participation rates in the French organized BC screening program.Methods and analysisDesign and setting. The design is a 2 arm randomized controlled study, performed in the Pays de la Loire region (French West Coast). Randomization will be based on general medicine practices (Primary Care).ParticipantsWomen aged between 50 and 74 years, eligible for BC screening. In this region, there are 75000 women, and 2800 general practitioners eligible for recruitment.InterventionIn the « Decision aid for organized cancer screening » arm, the intervention will distribute invitation letters to eligible women combined with the provision of decision aid to these women and their general practitioners and an incentive to implement shared medical decision-making. In the « Standard organized cancer screening » arm, only the screening invitation will be sent to eligible women.Primary endpointBC screening participation rates will be assessed after an 18-month follow-up period.Statistical analysisIn this non-inferiority trial, the percentage of women who are up-to-date with their screening at 18 months after the intervention will be compared across arms using a generalized mixed linear model.DiscussionThe research team expect to demonstrate that providing a better explanation of the benefits and risks of BC screening is not at odds with screening participation. The study results should help policy makers thinking about implementing shared medical decision-making within the framework of organized BC screening programs in the future.Ethics and disseminationOn 6 December 2021, the protocol received a favorable opinion from the French Committee for the Protection of Persons (2021-A01583-38). This study is registered with ClinicalTrials.gov, number NCT05607849. (Version 1, November 7, 2022; https://www.clinicaltrials.gov/ct2/show/NCT05607849). The study findings will be used for publication in peer-reviewed scientific journals and presentations in scientific meetings.

Project description:BackgroundDecision aids can support informed choice in mammography screening, but for the German mammography screening programme no systematically evaluated decision aid exists to date. We developed a decision aid for women invited to this programme for the first time based on the criteria of the International Patient Decision Aids Standards Collaboration.ObjectiveTo determine whether a decision aid increases informed choice about mammography screening programme participation.MethodsA representative sample of 7,400 women aged 50 was drawn from registration offices in Westphalia-Lippe, Germany. Women were randomised to receive usual care (i.e., the standard information brochure sent with the programme's invitation letter) or the decision aid. Data were collected online at baseline, post-intervention, and 3 months follow-up. The primary outcome was informed choice. Secondary outcomes were the constituents of informed choice (knowledge, attitude, intention/uptake), decisional conflict, decision regret, and decision stage. Outcomes were analysed using latent structural equation models and χ2-tests.Results1,206 women participated (response rate of 16.3%). The decision aid increased informed choice. Women in the control group had lower odds to make an informed choice at post-intervention (OR 0.26, 95% CI 0.18-0.37) and at follow-up (OR 0.66, 95% CI 0.46-0.94); informed choices remained constant at 30%. This was also reflected in lower knowledge and more decisional conflict. Post-intervention, the uptake intention was higher in the control group, whereas the uptake rate at follow-up was similar. Women in the control group had a more positive attitude at follow-up than women receiving the decision aid. Decision regret and decision stage were not influenced by the intervention.ConclusionThis paper describes the first systematic evaluation of a newly developed decision aid for the German mammography screening programme in a randomised controlled trial. Our decision aid proved to be an effective tool to enhance the rate of informed choice and was made accessible to the public.Trial registrationGerman Clinical Trials Register DRKS00005176.

Project description:Importance:Younger women (aged ?50 years) who underwent breast conservation therapy may benefit from breast magnetic resonance imaging (MRI) screening as an adjunct to mammography. Objective:To prospectively determine the cancer yield and tumor characteristics of combined mammography with MRI or ultrasonography screening in women who underwent breast conservation therapy for breast cancers and who were 50 years or younger at initial diagnosis. Design, Setting, and Participants:This multicenter, prospective, nonrandomized study was conducted from December 1, 2010, to January 31, 2016, at 6 academic institutions. Seven hundred fifty-four women who were 50 years or younger at initial diagnosis and who had undergone breast conservation therapy for breast cancer were recruited to participate in the study. Reference standard was defined as a combination of pathology and 12-month follow-up. Interventions:Participants underwent 3 annual MRI screenings of the conserved and contralateral breasts in addition to mammography and ultrasonography, with independent readings. Main Outcomes and Measures:Cancer detection rate, sensitivity, specificity, interval cancer rate, and characteristics of detected cancers. Results:A total of 754 women underwent 2065 mammograms, ultrasonography, and MRI screenings. Seventeen cancers were diagnosed, and most of the detected cancers (13 of 17 [76%]) were stage 0 or stage 1. Overall cancer detection rate (8.2 vs 4.4 per 1000; P?=?.003) or sensitivity (100% vs 53%; P?=?.01) of mammography with MRI was higher than that of mammography alone. After the addition of ultrasonography, the cancer detection rate was higher than that by mammography alone (6.8 vs 4.4 per 1000; P?=?.03). The specificity of mammography with MRI or ultrasonography was lower than that by mammography alone (87% or 88% vs 96%; P?<?.001). No interval cancer was found. Conclusions and Relevance:After breast conservation therapy in women 50 years or younger, the addition of MRI to annual mammography screening improves detection of early-stage but biologically aggressive breast cancers at acceptable specificity. Results from this study can inform patient decision making on screening methods after breast conservation therapy.

Project description:BACKGROUND:We previously developed a pamphlet decision aid (DA) on mammography screening for women ≥ 75 years. However, implementing DAs in primary care may be challenging and may require support from non-physician healthcare team members. OBJECTIVE:To learn from primary care administrators, nurses, and staff their thoughts on how best to implement a mammography DA for women ≥ 75 years in practice. DESIGN:Qualitative study entailing in-person individual interviews using a semi-structured interview guide. PARTICIPANTS:Thirty-two non-physician healthcare team members (69.6% of those approached) participated from 8 different primary care practices (community and academic) in the Boston area or in Chapel Hill, NC. APPROACH:Participants were asked to provide feedback on the DA, their thoughts on ways to make the DA available to older women, and factors that would make it easier and/or harder to implement. KEY RESULTS:Participants felt the DA was clear, balanced, and understandable, but felt that it needed to be shorter for women with low health literacy. Most participants felt that as long as use of the DA was approved and supported by clinicians that women ≥ 75 years should receive the DA before a visit from staff (usually medical assistants) so that patients could ask their clinicians questions during the visit. Facilitators of DA use included its perceived helpfulness with decision-making, its format, and that existing systems (panel management, electronic medical record alerts) could be accessed to get the DA to patients especially at Medicare Annual Wellness visits. Participants perceived a need for training, albeit minimal, to provide the DA to patients. Barriers of DA use included competing demands on clinician and staff time. CONCLUSIONS:Participants felt that as long as use of the mammography DA for women ≥ 75 years was supported by clinicians, it would be feasible to implement with minimal refinements to existing healthcare system processes.

Dataset Information

The Impact of a Risk-Based Breast Cancer Screening Decision Aid on Initiation of Mammography Among Younger Women: Report of a Randomized Trial.

Publications

The Impact of a Risk-Based Breast Cancer Screening Decision Aid on Initiation of Mammography Among Younger Women: Report of a Randomized Trial.

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