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Diagnostic workup and costs of a single supplemental molecular breast imaging screen of mammographically dense breasts.

ABSTRACT: The purpose of this study was to examine additional diagnostic workup and costs generated by addition of a single molecular breast imaging (MBI) examination to screening mammography for women with dense breasts.Women with mammographically dense breasts presenting for screening mammography underwent adjunct MBI performed with 300 MBq (99m)Tc-sestamibi and a direct-conversion cadmium-zinc-telluride dual-head gamma camera. All subsequent imaging tests and biopsies were tracked for a minimum of 1 year. The positive predictive value of biopsies performed (PPV3), benign biopsy rate, cost per patient screened, and cost per cancer detected were determined.A total of 1651 women enrolled in the study. Among the 1585 participants with complete reference standard, screening mammography alone prompted diagnostic workup of 175 (11.0%) patients and biopsy of 20 (1.3%) and yielded five malignancies (PPV3, 25%). Results of combined screening mammography plus MBI prompted diagnostic workup of 279 patients (17.6%) and biopsy of 67 (4.2%) and yielded 19 malignancies (PPV3, 28.4%). The benign biopsy rates were 0.9% (15 of 1585) for screening mammography alone and 3.0% (48 of 1585) for the combination (p < 0.001). The addition of MBI increased the cost per patient screened from $176 for mammography alone to $571 for the combination. However, cost per cancer detected was lower for the combination ($47,597) than for mammography alone ($55,851).The addition of MBI to screening mammography of women with dense breasts increased the overall costs and benign biopsy rate but also increased the cancer detection rate, which resulted in a lower cost per cancer detected than with screening mammography alone.

SUBMITTER: Hruska CB

PROVIDER: S-EPMC5036572 | biostudies-literature | 2015 Jun

REPOSITORIES: biostudies-literature

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Diagnostic workup and costs of a single supplemental molecular breast imaging screen of mammographically dense breasts.

Hruska Carrie B CB Conners Amy Lynn AL Jones Katie N KN O'Connor Michael K MK Moriarty James P JP Boughey Judy C JC Rhodes Deborah J DJ

AJR. American journal of roentgenology 20150601 6

<h4>Objective</h4>The purpose of this study was to examine additional diagnostic workup and costs generated by addition of a single molecular breast imaging (MBI) examination to screening mammography for women with dense breasts.<h4>Subjects and methods</h4>Women with mammographically dense breasts presenting for screening mammography underwent adjunct MBI performed with 300 MBq (99m)Tc-sestamibi and a direct-conversion cadmium-zinc-telluride dual-head gamma camera. All subsequent imaging tests ...[more]

PMID: 26001247

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Project description:BackgroundIncreased breast density augments breast cancer risk and reduces mammography sensitivity. Supplemental breast MRI screening can significantly increase cancer detection among women with dense breasts. However, few women undergo this exam, and screening is consistently lower among racially minoritized populations. Implementation strategies informed by behavioral economics ("nudges") can promote evidence-based practices by improving clinician decision-making under conditions of uncertainty. Nudges directed toward clinicians and patients may facilitate the implementation of supplemental breast MRI.MethodsApproximately 1600 patients identified as having extremely dense breasts after non-actionable mammograms, along with about 1100 clinicians involved with their care at 32 primary care or OB/GYN clinics across a racially diverse academically based health system, will be enrolled. A 2 × 2 randomized pragmatic trial will test nudges to patients, clinicians, both, or neither to promote supplemental breast MRI screening. Before implementation, rapid cycle approaches informed by clinician and patient experiences and behavioral economics and health equity frameworks guided nudge design. Clinicians will be clustered into clinic groups based on existing administrative departments and care patterns, and these clinic groups will be randomized to have the nudge activated at different times per a stepped wedge design. Clinicians will receive nudges integrated into the routine mammographic report or sent through electronic health record (EHR) in-basket messaging once their clinic group (i.e., wedge) is randomized to receive the intervention. Independently, patients will be randomized to receive text message nudges or not. The primary outcome will be defined as ordering or scheduling supplemental breast MRI. Secondary outcomes include MRI completion, cancer detection rates, and false-positive rates. Patient sociodemographic information and clinic-level variables will be examined as moderators of nudge effectiveness. Qualitative interviews conducted at the trial's conclusion will examine barriers and facilitators to implementation.DiscussionThis study will add to the growing literature on the effectiveness of behavioral economics-informed implementation strategies to promote evidence-based interventions. The design will facilitate testing the relative effects of nudges to patients and clinicians and the effects of moderators of nudge effectiveness, including key indicators of health disparities. The results may inform the introduction of low-cost, scalable implementation strategies to promote early breast cancer detection.Trial registrationClinicalTrials.gov NCT05787249. Registered on March 28, 2023.

Project description:ImportanceImproved screening methods for women with dense breasts are needed because of their increased risk of breast cancer and of failed early diagnosis by screening mammography.ObjectiveTo compare the screening performance of abbreviated breast magnetic resonance imaging (MRI) and digital breast tomosynthesis (DBT) in women with dense breasts.Design, setting, and participantsCross-sectional study with longitudinal follow-up at 48 academic, community hospital, and private practice sites in the United States and Germany, conducted between December 2016 and November 2017 among average-risk women aged 40 to 75 years with heterogeneously dense or extremely dense breasts undergoing routine screening. Follow-up ascertainment of cancer diagnoses was complete through September 12, 2019.ExposuresAll women underwent screening by both DBT and abbreviated breast MRI, performed in randomized order and read independently to avoid interpretation bias.Main outcomes and measuresThe primary end point was the invasive cancer detection rate. Secondary outcomes included sensitivity, specificity, additional imaging recommendation rate, and positive predictive value (PPV) of biopsy, using invasive cancer and ductal carcinoma in situ (DCIS) to define a positive reference standard. All outcomes are reported at the participant level. Pathology of core or surgical biopsy was the reference standard for cancer detection rate and PPV; interval cancers reported until the next annual screen were included in the reference standard for sensitivity and specificity.ResultsAmong 1516 enrolled women, 1444 (median age, 54 [range, 40-75] years) completed both examinations and were included in the analysis. The reference standard was positive for invasive cancer with or without DCIS in 17 women and for DCIS alone in another 6. No interval cancers were observed during follow-up. Abbreviated breast MRI detected all 17 women with invasive cancer and 5 of 6 women with DCIS. Digital breast tomosynthesis detected 7 of 17 women with invasive cancer and 2 of 6 women with DCIS. The invasive cancer detection rate was 11.8 (95% CI, 7.4-18.8) per 1000 women for abbreviated breast MRI vs 4.8 (95% CI, 2.4-10.0) per 1000 women for DBT, a difference of 7 (95% CI, 2.2-11.6) per 1000 women (exact McNemar P = .002). For detection of invasive cancer and DCIS, sensitivity was 95.7% (95% CI, 79.0%-99.2%) with abbreviated breast MRI vs 39.1% (95% CI, 22.2%-59.2%) with DBT (P = .001) and specificity was 86.7% (95% CI, 84.8%-88.4%) vs 97.4% (95% CI, 96.5%-98.1%), respectively (P < .001). The additional imaging recommendation rate was 7.5% (95% CI, 6.2%-9.0%) with abbreviated breast MRI vs 10.1% (95% CI, 8.7%-11.8%) with DBT (P = .02) and the PPV was 19.6% (95% CI, 13.2%-28.2%) vs 31.0% (95% CI, 17.0%-49.7%), respectively (P = .15).Conclusions and relevanceAmong women with dense breasts undergoing screening, abbreviated breast MRI, compared with DBT, was associated with a significantly higher rate of invasive breast cancer detection. Further research is needed to better understand the relationship between screening methods and clinical outcome.Trial registrationClinicalTrials.gov Identifier: NCT02933489.

Project description:BACKGROUND:Given the growth in dense breast notification (DBN) legislation in the United States, we examined the association between different types of DBN laws and supplemental screening behaviors among women. METHODS:We surveyed in March-April 2018 a nationally representative sample of women aged 40-59 years who received a routine screening mammogram in the past 18 months. Survey items included the following topics regarding supplemental screening: discussing risks or benefits with a provider, knowledge about the risk of false positives, and utilization. We grouped women by state DBN into non-DBN, generic DBN (mentions breast density but not supplemental screening), DBN that mentions supplemental screening (DBN-SS), and DBN with mandated insurance coverage for supplemental screening (DBN-coverage), and estimated adjusted predicted probabilities for supplemental screening behaviors. RESULTS:Of 1641 women surveyed, 21.3% resided in non-DBN, 41.2% in generic DBN, 25.8% in DBN-SS, and 12.5% in DBN-coverage states. Overall, 23.0% of respondents had discussed supplemental screening with a provider, 11.3% of whom discussed the risks, and 49.5% discussed the benefits. In adjusted analysis, women living in DBN-coverage states were more likely to discuss supplemental screening (27.5%) than women in non-DBN states (13.6%); pairwise contrast 13.8% (95% CI, 2.1% to 25.6%; P = .01). They were also more likely to have received supplemental screening for increased breast density (19.3%) compared to women living in non-DBN (9.9%); contrast 9.4% (95% CI, 1.6% to 17.3%; P = .01), Generic DBN (7.3%); difference 12.0% (95% CI, 4.6% to 19.4%; P =< .001), and DBN-SS (8.8%); contrast 10.5% (95% CI, 2.6% to 18.5%; P < .01) states. CONCLUSIONS:Women in DBN-coverage states were more likely to discuss supplemental screening with their providers, and to undergo supplemental screening, compared to women in states with other types of DBN laws, or without DBN laws.

Dataset Information

Diagnostic workup and costs of a single supplemental molecular breast imaging screen of mammographically dense breasts.

Publications

Diagnostic workup and costs of a single supplemental molecular breast imaging screen of mammographically dense breasts.

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