Dataset Information

Effect of a Mammography Screening Decision Aid for Women 75 Years and Older: A Cluster Randomized Clinical Trial.

ABSTRACT:

Importance

Guidelines recommend that women 75 years and older be informed of the benefits and harms of mammography before screening.

Objective

To 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 participants

A 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.

Interventions

Receipt of the DA (DA arm) or a home safety (HS) pamphlet (control arm) before a PCP visit.

Main outcomes and measures

Participants 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.

Results

Of 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 relevance

Providing 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 registration

ClinicalTrials.gov Identifier: NCT02198690.

SUBMITTER: Schonberg MA

PROVIDER: S-EPMC7171581 | biostudies-literature |

REPOSITORIES: biostudies-literature

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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: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:BackgroundThe cost-effectiveness of screening mammography beyond age 75 years remains unclear.ObjectiveTo estimate benefits, harms, and cost-effectiveness of extending mammography to age 80, 85, or 90 years according to comorbidity burden.DesignMarkov microsimulation model.Data sourcesSEER (Surveillance, Epidemiology, and End Results) program and Breast Cancer Surveillance Consortium.Target populationU.S. women aged 65 to 90 years in groups defined by Charlson comorbidity score (CCS).Time horizonLifetime.PerspectiveNational health payer.InterventionScreening mammography to age 75, 80, 85, or 90 years.Outcome measuresBreast cancer death, survival, and costs.Results of base-case analysisExtending biennial mammography from age 75 to 80 years averted 1.7, 1.4, and 1.0 breast cancer deaths and increased days of life gained by 5.8, 4.2, and 2.7 days per 1000 women for comorbidity scores of 0, 1, and 2, respectively. Annual mammography beyond age 75 years was not cost-effective, but extending biennial mammography to age 80 years was ($54 000, $65 000, and $85 000 per quality-adjusted life-year [QALY] gained for women with CCSs of 0, 1, and ≥2, respectively). Overdiagnosis cases were double the number of deaths averted from breast cancer.Results of sensitivity analysisCosts per QALY gained were sensitive to changes in invasive cancer incidence and shift of breast cancer stage with screening mammography.LimitationNo randomized controlled trials of screening mammography beyond age 75 years are available to provide model parameter inputs.ConclusionAlthough annual mammography is not cost-effective, biennial screening mammography to age 80 years is; however, the absolute number of deaths averted is small, especially for women with comorbidities. Women considering screening beyond age 75 years should weigh the potential harms of overdiagnosis versus the potential benefit of averting death from breast cancer.Primary funding sourceNational Cancer Institute and National Institutes of Health.