Publications

IMPORTANCE: There is currently no guidance on how to approach surveillance mammography for older breast cancer survivors, particularly when life expectancy is limited.

OBJECTIVE: To develop expert consensus guidelines that facilitate tailored decision-making for routine surveillance mammography for breast cancer survivors 75 years or older.

EVIDENCE: After a literature review of the risk of ipsilateral and contralateral breast cancer events among breast cancer survivors and the harms and benefits associated with mammography, a multidisciplinary expert panel was convened to develop consensus guidelines on surveillance mammography for breast cancer survivors 75 years or older. Using an iterative consensus-based approach, input from clinician focus groups, and critical review by the International Society for Geriatric Oncology, the guidelines were refined and finalized.

FINDINGS: The literature review established a low risk for ipsilateral and contralateral breast cancer events in most older breast cancer survivors and summarized the benefits and harms associated with mammography. Draft mammography guidelines were iteratively evaluated by the expert panel and clinician focus groups, emphasizing a patient's risk for in-breast cancer events, age, life expectancy, and personal preferences. The final consensus guidelines recommend discontinuation of routine mammography for all breast cancer survivors when life expectancy is less than 5 years, including those with a history of high-risk cancers; consideration to discontinue mammography when life expectancy is 5 to 10 years; and continuation of mammography when life expectancy is more than 10 years. Individualized, shared decision-making is encouraged to optimally tailor recommendations after weighing the benefits and harms associated with surveillance mammography and patient preferences. The panel also recommends ongoing clinical breast examinations and diagnostic mammography to evaluate clinical findings and symptoms, with reassurance for patients that these practices will continue.

CONCLUSIONS AND RELEVANCE: It is anticipated that these expert guidelines will enhance clinical practice by providing a framework for individualized discussions, facilitating shared decision-making regarding surveillance mammography for breast cancer survivors 75 years or older.

IMPORTANCE: Guidelines recommend targeting preventive interventions toward older adults whose life expectancy is greater than the intervention's time to benefit (TTB). The TTB for statin therapy is unknown.

OBJECTIVE: To conduct a survival meta-analysis of randomized clinical trials of statins to determine the TTB for prevention of a first major adverse cardiovascular event (MACE) in adults aged 50 to 75 years.

DATA SOURCES: Studies were identified from previously published systematic reviews (Cochrane Database of Systematic Reviews and US Preventive Services Task Force) and a search of MEDLINE and Google Scholar for subsequently published studies until February 1, 2020.

STUDY SELECTION: Randomized clinical trials of statins for primary prevention focusing on older adults (mean age >55 years).

DATA EXTRACTION AND SYNTHESIS: Two authors independently abstracted survival data for the control and intervention groups. Weibull survival curves were fit, and a random-effects model was used to estimate pooled absolute risk reductions (ARRs) between control and intervention groups each year. Markov chain Monte Carlo methods were applied to determine time to ARR thresholds.

MAIN OUTCOMES AND MEASURES: The primary outcome was time to ARR thresholds (0.002, 0.005, and 0.010) for a first MACE, as defined by each trial. There were broad similarities in the definition of MACE across trials, with all trials including myocardial infarction and cardiovascular mortality.

RESULTS: Eight trials randomizing 65 383 adults (66.3% men) were identified. The mean age ranged from 55 to 69 years old and the mean length of follow-up ranged from 2 to 6 years. Only 1 of 8 studies showed that statins decreased all-cause mortality. The meta-analysis results suggested that 2.5 (95% CI, 1.7-3.4) years were needed to avoid 1 MACE for 100 patients treated with a statin. To prevent 1 MACE for 200 patients treated (ARR = 0.005), the TTB was 1.3 (95% CI, 1.0-1.7) years, whereas the TTB to avoid 1 MACE for 500 patients treated (ARR = 0.002) was 0.8 (95% CI, 0.5-1.0) years.

CONCLUSIONS AND RELEVANCE: These findings suggest that treating 100 adults (aged 50-75 years) without known cardiovascular disease with a statin for 2.5 years prevented 1 MACE in 1 adult. Statins may help to prevent a first MACE in adults aged 50 to 75 years old if they have a life expectancy of at least 2.5 years. There is no evidence of a mortality benefit.

BACKGROUND AND OBJECTIVES: Adults older than 75 years are overscreened for cancer, especially those with less than 10-year life expectancy. This study aimed to learn the effects of providing primary care providers (PCPs) with scripts for discussing stopping mammography and colorectal cancer (CRC) screening and with information on patient's 10-year life expectancy on their patients' intentions to be screened for these cancers.

RESEARCH DESIGN AND METHODS: Patient participants, identified via PCP appointment logs, completed a questionnaire pre- and postvisit. Primary care providers were given scripts for discussing stopping screening and information on patient's 10-year life expectancy before these visits. Primary care providers completed a questionnaire at the end of the study. Patients and PCPs were asked about discussing stopping cancer screening and patient life expectancy. Patient screening intentions (1-15 Likert scale; lower scores suggest lower intentions) were compared pre- and postvisit using the Wilcoxon signed-rank test.

RESULTS: Ninety patients older than 75 years (47% of eligible patients reached by phone) from 45 PCPs participated. Patient mean age was 80.0 years (SD = 2.9), 43 (48%) were female, and mean life expectancy was 9.7 years (SD = 2.4). Thirty-seven PCPs (12 community-based) completed a questionnaire. Primary care providers found the scripts helpful (32 [89%]) and thought they would use them frequently (29 [81%]). Primary care providers also found patient life expectancy information helpful (35 [97%]). However, only 8 PCPs (22%) reported feeling comfortable discussing patient life expectancy. Patients' intentions to undergo CRC screening (9.0 [SD = 5.3] to 6.5 [SD = 6.0], p < .0001) and mammography screening (12.9 [SD = 3.0] to 11.7 [SD = 4.9], p = .08) decreased from pre- to postvisit (significantly for CRC). Sixty-three percent of patients (54/86) were interested in discussing life expectancy with their PCP previsit and 56% (47/84) postvisit.

DISCUSSION AND IMPLICATIONS: PCPs found scripts for discussing stopping cancer screening and information on patient life expectancy helpful. Possibly, as a result, their patients older than 75 years had lower intentions of being screened for CRC.

CLINICAL TRIALS REGISTRATION NUMBER: NCT03480282.

BACKGROUND: Despite guidelines recommending not to continue cancer screening for adults > 75 years old, especially those with short life expectancy, primary care providers (PCPs) feel ill-prepared to discuss stopping screening with older adults.

OBJECTIVE: To develop scripts and strategies for PCPs to use to discuss stopping cancer screening with adults > 75.

DESIGN: Qualitative study using semi-structured interview guides to conduct individual interviews with adults > 75 years old and focus groups and/or individual interviews with PCPs.

PARTICIPANTS: Forty-five PCPs and 30 patients > 75 years old participated from six community or academic Boston-area primary care practices.

APPROACH: Participants were asked their thoughts on discussions around stopping cancer screening and to provide feedback on scripts that were iteratively revised for PCPs to use when discussing stopping mammography and colorectal cancer (CRC) screening.

RESULTS: Twenty-one (47%) of the 45 PCPs were community based. Nineteen (63%) of the 30 patients were female, and 13 (43%) were non-Hispanic white. PCPs reported using different approaches to discuss stopping cancer screening depending on the clinical scenario. PCPs noted it was easier to discuss stopping screening when the harms of screening clearly outweighed the benefits for a patient. In these cases, PCPs felt more comfortable being more directive. When the balance between the benefits and harms of screening was less clear, PCPs endorsed shared decision-making but found this approach more challenging because it was difficult to explain why to stop screening. While patients were generally enthusiastic about screening, they also reported not wanting to undergo tests of little value and said they would stop screening if their PCP recommended it. By the end of participant interviews, no further edits were recommended to the scripts.

CONCLUSIONS: To increase PCP comfort and capability to discuss stopping cancer screening with older adults, we developed scripts and strategies that PCPs may use for discussing stopping cancer screening.

Starting breast cancer screening at age 40 versus 50 may increase potential harms frequency with a small mortality benefit. Younger women's screening decisions, therefore, may be complex. Shared decision-making (SDM) is recommended for women under 50 and may support women under 55 for whom guidelines vary. How women with limited health literacy (LHL) approach breast cancer screening decision-making is less understood, and most SDM tools are not designed with their input. This phenomenological study sought to characterize mammography counseling experiences among women with LHL and primary care providers (PCPs). Women ages 40-54 with LHL who had no history of breast cancer or mammogram within 9 months were approached before a primary care visit at a safety-net hospital. PCPs at this site were invited to participate. Qualitative interviews explored mammography counseling experiences. Patients also reviewed sample information materials. A constant comparison technique generated four themes salient to 25 patients and 20 PCPs: addressing family history versus comprehensive risk assessment; potential mammography harms discussions; information delivery preferences; and integrating pre-visit information tools. Findings suggest that current counseling techniques may not be responsive to patient-identified needs. Opportunities exist to improve how mammography information is shared and increase accessibility across the health literacy spectrum.

The last decades saw remarkable change in the way healthcare professionals generate and consume medical knowledge. Information management technologies have evolved considerably, yet medical publications continue to use a referencing system that has changed very little since the turn of the 20th century. Research suggests that up to one in five referenced claims quotes the original text inaccurately. Many authors, perhaps inadvertently, contribute to this process by citing non-primary data and amplifying the errors of their predecessors. Erroneous claims are propagated, accumulate into false belief systems and generate inaccurate knowledge. Updating the referencing system to provide additional information to support each referenced claim (eg, the location of the referenced statement in the original text and the nature of that text) could, perhaps, address this cycle of inaccuracy. We believe such changes in the referencing system would prompt authors to rigorously verify referenced claims and provide readers with context to inform a critical evaluation of the text. We detail our proposal for changes in the notations used for referencing, as well as in the information provided within reference lists. We also discuss some barriers and solutions to the adoption of our proposal.

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.

INTRODUCTION: Guidelines recommend individualized breast cancer screening and prevention interventions for women in their 40s. Yet, few primary care clinicians assess breast cancer risk.

STUDY DESIGN: Pretest-Posttest trial.

SETTING/PARTICIPANTS: Women aged 40-49 years were recruited from one large Boston-based academic primary care practice between July 2017 and April 2019.

INTERVENTION: Participants completed a pretest, received a personalized breast cancer risk report, saw their primary care clinician, and completed a posttest.

MAIN OUTCOME MEASURES: Using mixed effects models, changes in screening intentions (0-100 scale [0=will not screen to 100=will screen]), mammography knowledge, decisional conflict, and receipt of screening were examined. Analyses were conducted from June 2019 to February 2020.

RESULTS: Patient (n=337) mean age was 44.1 (SD=2.9) years, 61.4% were non-Hispanic white, and 76.6% were college graduates; 306 (90.5%) completed follow-up (203 with 5-year breast cancer risk <1.1%). Screening intentions declined from pre- to post-visit (79.3 to 68.0, p<0.0001), especially for women with 5-year risk <1.1% (77.2 to 63.3, p<0.0001), but still favored screening. In the 2 years prior, 37.6% had screening mammography compared with 41.8% over a mean 16 months follow-up (p=0.17). Mammography knowledge increased and decisional conflict declined. Eleven (3.3%) women met criteria for breast cancer prevention medications (ten discussed medications with their clinicians), 22 (6.5%) for MRI (19 discussed MRI with their clinician), and 67 (19.8%) for genetic counseling (47 discussed with the clinician).

CONCLUSIONS: Receipt of a personalized breast cancer report was associated with women in their 40s making more-informed and less-conflicted mammography screening decisions and with high-risk women discussing breast cancer prevention interventions with clinicians.

TRIAL REGISTRATION: This study is registered at www.clinicaltrials.govNCT03180086.

OBJECTIVES: Since women ≥70 years with early stage, estrogen receptor positive (ER+), HER2 negative breast cancer face several preference-sensitive treatment decisions, the investigative team aimed to develop a pamphlet decision aid (DA) for such women.

MATERIALS AND METHODS: The content of the DA was informed by literature review, international criteria, and expert feedback, and includes information on benefits and risks of lumpectomy versus mastectomy, lymph node surgery, radiotherapy after lumpectomy, and endocrine therapy. It considers women's overall health and was written using low literacy principles. Women from two Boston-based hospitals who were diagnosed in the past 6-24 months were recruited to provide feedback on the DA and its acceptability. The DA was iteratively revised based on their qualitative input.

RESULTS: Of 48 eligible women contacted, 35 (73%) agreed to participate. Their mean age was 74.3 years; 33 (94%) were non-Hispanic white; and 24 (67%) were college graduates. Overall, 26 (74%) thought the length of the DA was just right, 29 (83%) thought all or most of the information was clear, 32 (91%) found the DA helpful, and 33 (94%) would recommend it. In open ended comments, participants noted that the DA was clear, well-organized, and would help women prepare for and participate in treatment decision-making.

CONCLUSIONS: The investigative team developed a novel breast cancer treatment DA that is acceptable to women ≥70 years with a history of ER+, HER2-, early stage breast cancer. Next, the DA's efficacy needs to be tested with diverse older women newly diagnosed with breast cancer.