Dataset Information

Evaluation of a Mammography Screening Decision Aid for Women Aged 75 and Older: Protocol for a Cluster-randomized Controlled Trial.

ABSTRACT: PURPOSE:There is insufficient evidence to recommend mammography for women >75 years. Guidelines recommend that older women be informed of the uncertainty of benefit and potential for harm, especially for women with short life expectancy. However, few older women are informed of harms of screening and many with short life expectancy are screened. Therefore, we aim to test whether a mammography screening decision aid (DA) for women >75 years affects their use of mammography, particularly for women with <10 year life expectancy. METHODS/DESIGN:The DA is a self-administered pamphlet that includes information on screening outcomes, tailored information on breast cancer risk, health, life expectancy, and competing mortality risks, and includes a values clarification exercise. We are conducting a large cluster randomized controlled trial (RCT) of the DA with the primary care provider (PCP) as the unit of randomization to evaluate its efficacy. We plan to recruit 550 women 75-89 years from 100 PCPs to receive either the mammography DA or a pamphlet on home safety for older adults (control arm) before a visit with their PCP, depending on their PCP's randomization assignment. The primary outcome is receipt of mammography screening assessed through chart abstraction. Secondary outcomes include effect of the DA on older women's screening intentions, knowledge, and decisional conflict, and on documented discussions about mammography by their PCPs. We will recruit women from 5 Boston-based primary care practices (3 community-based internal medicine practices and 2 academic practices), and 2 North Carolina-based academic primary care practices. DISCUSSION:It is essential that we test the DA in a large RCT to determine if it is efficacious and to substantiate the need for broad translation into clinical practice. Our DA has the potential to improve health care utilization and care in a manner dictated by patient preferences.

SUBMITTER: Schonberg MA

PROVIDER: S-EPMC4517685 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

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Evaluation of a Mammography Screening Decision Aid for Women Aged 75 and Older: Protocol for a Cluster-randomized Controlled Trial.

Schonberg Mara A MA Kistler Christine E CE Nekhlyudov Larissa L Fagerlin Angela A Davis Roger B RB Wee Christina C CC Marcantonio Edward R ER Lewis Carmen L CL Stanley Whitney A WA Crutchfield Trisha M TM Hamel Mary Beth MB

Journal of clinical trials 20140101

<h4>Purpose</h4>There is insufficient evidence to recommend mammography for women >75 years. Guidelines recommend that older women be informed of the uncertainty of benefit and potential for harm, especially for women with short life expectancy. However, few older women are informed of harms of screening and many with short life expectancy are screened. Therefore, we aim to test whether a mammography screening decision aid (DA) for women >75 years affects their use of mammography, particularly f ...[more]

PMID: 26229741

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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: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: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.

Project description:Guidelines recommend individualizing screening mammography decisions for women aged 75 years and older. However, little pragmatic guidance is available to help counsel patients.To provide an evidence-based approach for individualizing decision-making about screening mammography in older women.We searched PubMed for English-language studies in peer-reviewed journals published from January 1, 1990, to February 1, 2014, to identify risk factors for late-life breast cancer in women aged 65 years and older and to quantify the benefits and harms of screening mammography for women aged 75 years and older.Age is the major risk factor for developing and dying from breast cancer. Breast cancer risk factors that reflect hormonal exposures in the distant past, such as age at first birth or age at menarche, are less predictive of late-life breast cancer than factors indicating recent hormonal exposures such as high bone mass or obesity. Randomized trials of the benefits of screening mammography did not include women older than 74 years. Thus it is not known if screening mammography benefits older women. Observational studies favor extending screening mammography to older women who have a life expectancy of more than 10 years. Modeling studies estimate 2 fewer breast cancer deaths/1000 women who in their 70s continue biennial screening for 10 years instead of stopping screening at age 69. Potential harms of continued screening over 10 years include false-positive mammograms in approximately 200/1000 women screened and overdiagnosis (ie, finding breast cancer that would not have clinically surfaced otherwise) in approximately 13/1000 women screened. Providing information about life expectancy along with potential benefits and harms of screening may help older women's decision-making about screening mammography.For women with less than a 10-year life expectancy, recommendations to stop screening mammography should emphasize increased potential harms from screening and highlight health promotion measures likely to be beneficial over the short term. For women with a life expectancy of more than 10 years, deciding whether potential benefits of screening outweigh harms becomes a value judgment for patients, requiring a realistic understanding of screening outcomes.

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.

Dataset Information

Evaluation of a Mammography Screening Decision Aid for Women Aged 75 and Older: Protocol for a Cluster-randomized Controlled Trial.

Publications

Evaluation of a Mammography Screening Decision Aid for Women Aged 75 and Older: Protocol for a Cluster-randomized Controlled Trial.

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