Screening for Breast Cancer: Evidence Report and Systematic Review for the US Preventive Services Task Force.

Importance: Breast cancer is a leading cause of cancer mortality for US women. Trials have established that screening mammography can reduce mortality risk, but optimal screening ages, intervals, and modalities for population screening guidelines remain unclear. Objective: To review studies comparing different breast cancer screening strategies for the US Preventive Services Task Force. Data Sources: MEDLINE, Cochrane Library through August 22, 2022; literature surveillance through March 2024. Study Selection: English-language publications; randomized clinical trials and nonrandomized studies comparing screening strategies; expanded criteria for screening harms. Data Extraction and Synthesis: Two reviewers independently assessed study eligibility and quality; data extracted from fair- and good-quality studies. Main Outcomes and Measures: Mortality, morbidity, progression to advanced cancer, interval cancers, screening harms. Results: Seven randomized clinical trials and 13 nonrandomized studies were included; 2 nonrandomized studies reported mortality outcomes. A nonrandomized trial emulation study estimated no mortality difference for screening beyond age 74 years (adjusted hazard ratio, 1.00 [95% CI, 0.83 to 1.19]). Advanced cancer detection did not differ following annual or biennial screening intervals in a nonrandomized study. Three trials compared digital breast tomosynthesis (DBT) mammography screening with digital mammography alone. With DBT, more invasive cancers were detected at the first screening round than with digital mammography, but there were no statistically significant differences in interval cancers (pooled relative risk, 0.87 [95% CI, 0.64-1.17]; 3 studies [n = 130 196]; I2 = 0%). Risk of advanced cancer (stage II or higher) at the subsequent screening round was not statistically significant for DBT vs digital mammography in the individual trials. Limited evidence from trials and nonrandomized studies suggested lower recall rates with DBT. An RCT randomizing individuals with dense breasts to invitations for supplemental screening with magnetic resonance imaging reported reduced interval cancer risk (relative risk, 0.47 [95% CI, 0.29-0.77]) and additional false-positive recalls and biopsy results with the intervention; no longer-term advanced breast cancer incidence or morbidity and mortality outcomes were available. One RCT and 1 nonrandomized study of supplemental ultrasound screening reported additional false-positives and no differences in interval cancers. Conclusions and Relevance: Evidence comparing the effectiveness of different breast cancer screening strategies is inconclusive because key studies have not yet been completed and few studies have reported the stage shift or mortality outcomes necessary to assess relative benefits.

Maternal Epidemiology of Brachial Plexus Birth Injuries in California: 1996 to 2012.

OBJECTIVE: This study aimed to evaluate the incidence of brachial plexus birth injury (BPBI) and its associations with maternal demographic factors. Additionally, we sought to determine whether longitudinal changes in BPBI incidence differed by maternal demographics. STUDY DESIGN: We conducted a retrospective cohort study of over 8 million maternal-infant pairs using California's Office of Statewide Health Planning and Development Linked Birth Files from 1991 to 2012. Descriptive statistics were used to determine BPBI incidence and the prevalence of maternal demographic factors (race, ethnicity, age). Multivariable logistic regression was used to determine associations of year, maternal race, ethnicity, and age with BPBI. Excess population-level risk associated with these characteristics was determined by calculating population attributable fractions. RESULTS: The incidence of BPBI between 1991 and 2012 was 1.28 per 1,000 live births, with peak incidence of 1.84 per 1,000 in 1998 and low of 0.9 per 1,000 in 2008. Incidence varied by demographic group, with infants of Black (1.78 per 1,000) and Hispanic (1.34 per 1,000) mothers having higher incidences compared with White (1.25 per 1,000), Asian (0.8 per 1,000), Native American (1.29 per 1,000), other race (1.35 per 1,000), and non-Hispanic (1.15 per 1,000) mothers. After controlling for delivery method, macrosomia, shoulder dystocia, and year, infants of Black (adjusted odds ratio [AOR] = 1.88, 95% confidence interval [CI] = 1.70, 2.08), Hispanic (AOR = 1.25, 95% CI = 1.18, 1.32), and advanced-age mothers (AOR = 1.16, 95% CI = 1.09, 1.25) were at increased risk. Disparities in risk experienced by Black, Hispanic, and advanced-age mothers contributed to a 5, 10, and 2% excess risk at the population level, respectively. Longitudinal trends in incidence did not vary among demographic groups. Population-level changes in maternal demographics did not explain changes in incidence over time. CONCLUSION: Although BPBI incidence has decreased in California, demographic disparities exist. Infants of Black, Hispanic, and advanced-age mothers are at increased BPBI risk compared with White, non-Hispanic, and younger mothers. KEY POINTS: · The incidence of BPBI has decreased over time.. · Demographic disparities in BPBI incidence and risk exist.. · Infants of Black, Hispanic, and advanced age mothers are at greatest risk of BPBI..

Frontline physician burnout during the COVID-19 pandemic: national survey findings.

BACKGROUND: Physician burnout and wellbeing are an ongoing concern. Limited research has reported on the impact of the COVID 19 pandemic on burnout over time among U.S. physicians. METHODS: We surveyed U.S. frontline physicians at two time points (wave one in May-June 2020 and wave two in Dec 2020-Jan 2021) using a validated burnout measure. The survey was emailed to a national stratified random sample of family physicians, internists, hospitalists, intensivists, emergency medicine physicians, and infectious disease physicians. Burnout was assessed with the Professional Fulfillment Index Burnout Composite scale (PFI-BC). Responses were weighted to account for sample design and non-response bias. Random effects and quantile regression analyses were used to estimate change in conditional mean and median PFI-BC scores, adjusting for physician, geographic, and pandemic covariates. RESULTS: In the random effects regression, conditional mean burnout scores increased in the second wave among all respondents (difference 0.15 (CI: 0.24, 0.57)) and among respondents to both waves (balanced panel) (difference 0.21 (CI: - 0.42, 0.84)). Conditional burnout scores increased in wave 2 among all specialties except for Emergency medicine, with the largest increases among Hospitalists, 0.28 points (CI: - 0.19,0.76) among all respondents and 0.36 (CI: - 0.39,1.11) in the balanced panel, and primary care physicians, 0.21 (CI: - 0.23,0.66) among all respondents and 0.31 (CI: - 0.38,1.00) in the balanced panel. The conditional mean PFI-BC score among hospitalists increased from 1.10 (CI: 0.73,1.46) to 1.38 (CI: 1.02,1.74) in wave 2 in all respondents and from 1.49 (CI: 0.69,2.29) to 1.85 (CI: 1.24,2.46) in the balanced panel, near or above the 1.4 threshold indicating burnout. Findings from quantile regression were consistent with those from random effects. CONCLUSIONS: Rates of physician burnout during the first year of the pandemic increased over time among four of five frontline specialties, with greatest increases among hospitalist and primary care respondents. Our findings, while not statistically significant, were consistent with worsening burnout; both the random effects and quantile regressions produced similar point estimates. Impacts of the ongoing pandemic on physician burnout warrant further research.

Interventions for Tobacco Cessation in Adults, Including Pregnant Persons: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force.

Importance: It has been estimated that in 2018 nearly 20% of adults in the US were currently using a tobacco product. Objective: To systematically review the effectiveness and safety of pharmacotherapy, behavioral interventions, and electronic cigarettes for tobacco cessation among adults, including pregnant persons, to inform the US Preventive Services Task Force. Data Sources: PubMed, PsycInfo, Database of Abstracts of Reviews of Effects, Cochrane Database of Systematic Reviews, Centre for Reviews and Dissemination of Health Technology Assessment; surveillance through September 25, 2020. Study Selection: Systematic reviews of tobacco cessation interventions and randomized clinical trials that evaluated the effects of electronic cigarettes (e-cigarettes) or pharmacotherapy among pregnant persons. Data Extraction and Synthesis: Independent critical appraisal and data abstraction; qualitative synthesis and random-effects meta-analyses. Main Outcomes and Measures: Health outcomes, tobacco cessation at 6 months or more, and adverse events. Results: Sixty-seven reviews addressing pharmacotherapy and behavioral interventions were included as well as 9 trials (N = 3942) addressing e-cigarettes for smoking cessation and 7 trials (N = 2285) of nicotine replacement therapy (NRT) use in pregnancy. Combined pharmacotherapy and behavioral interventions (pooled risk ratio [RR], 1.83 [95% CI, 1.68-1.98]), NRT (RR, 1.55 [95% CI, 1.49-1.61]), bupropion (RR, 1.64 [95% CI, 1.52-1.77]), varenicline (RR, 2.24 [95% CI, 2.06-2.43]), and behavioral interventions such as advice from clinicians (RR, 1.76 [95% CI, 1.58-1.96]) were all associated with increased quit rates compared with minimal support or placebo at 6 months or longer. None of the drugs were associated with serious adverse events. Five trials (n = 3117) reported inconsistent findings on the effectiveness of electronic cigarettes on smoking cessation at 6 to 12 months among smokers when compared with placebo or NRT, and none suggested higher rates of serious adverse events. Among pregnant persons, behavioral interventions were associated with greater smoking cessation during late pregnancy (RR, 1.35 [95% CI, 1.23-1.48]), compared with no intervention. Rates of validated cessation among pregnant women allocated to NRT compared with placebo were not significantly different (pooled RR, 1.11 [95% CI, 0.79-1.56], n = 2033). Conclusions and Relevance: There is strong evidence that a range of pharmacologic and behavioral interventions, both individually and in combination, are effective in increasing smoking cessation in nonpregnant adults. In pregnancy, behavioral interventions are effective for smoking cessation, but data are limited on the use of pharmacotherapy for smoking cessation. Data on the effectiveness and safety of electronic cigarettes for smoking cessation among adults are also limited and results are inconsistent.

Primary Care Access to New Patient Appointments for California Medicaid Enrollees: A Simulated Patient Study.

PURPOSE: We undertook a study to evaluate variation in the availability of primary care new patient appointments for Medi-Cal (California Medicaid) enrollees in Northern California, and its relationship to emergency department (ED) use after Medicaid expansion. METHODS: We placed simulated calls by purported Medi-Cal enrollees to 581 primary care clinicians (PCCs) listed as accepting new patients in online directories of Medi-Cal managed care plans. Data from the California Health Interview Survey, Medi-Cal enrollment reports, and California hospital discharge records were used in analyses. We developed multilevel, mixed-effect models to evaluate variation in appointment access. Multiple linear regression was used to examine the relationship between primary care access and ED use by county. RESULTS: Availability of PCC new patient appointments to Medi-Cal enrollees lacking a PCC varied significantly across counties in the multilevel model, ranging from 77 enrollees (95% CI, 70-81) to 472 enrollees (95% CI, 378-628) per each available new patient appointment. Just 19% of PCCs had available appointments within the state-mandated 10 business days. Clinicians at Federally Qualified Health Centers had higher availability of new patient appointments (rate ratio = 1.56; 95% CI, 1.24-1.97). Counties with poorer PCC access had higher ED use by Medi-Cal enrollees. CONCLUSIONS: In contrast to findings from other states, access to primary care in Northern California was limited for new patient Medi-Cal enrollees and varied across counties, despite standard statewide reimbursement rates. Counties with more limited access to primary care new patient appointments had higher ED use by Medi-Cal enrollees.

Do provider birth attitudes influence cesarean delivery rate: a cross-sectional study.

BACKGROUND: When used judiciously, cesarean sections can save lives; but in the United States, prior research indicates that cesarean birth rates have risen beyond the threshold to help women and infants and become a contributor to increased maternal mortality and rising healthcare costs. Healthy People 2020 has set the goal for nulliparous, term, singleton, vertex (NTSV) cesarean birth rate at no more than 23.9% of births. Currently, cesarean rates vary from 6% to 69% in US hospitals, unexplained by clinical or demographic factors. This wide variation in cesarean use is also seen among individual providers of intrapartum care. Previous research of birth attitudes found providers of intrapartum care hold widely differing views, which may be a key underlying factor influencing practice variation; however, further study is needed to determine if differences in attitudes are associated with differences in clinical outcomes. The purpose of this study was to estimate the association between individual provider attitudes towards birth and their low-risk primary cesarean rate. METHODS: Four hundred providers were drawn from a stratified random sample of all California providers of intrapartum care in 2013 and surveyed for their attitudes towards various aspects of labor and birth. Providers' NTSV cesarean birth rates were obtained for 2013 and 2014. Covariates included gender, years of experience, practice location, and primary hospital's NTSV cesarean rate. We used adjusted multivariate Poisson regression to compare cesarean rates and linear regression to compare attitude scores of providers meeting versus not meeting the Healthy People 2020 (HP2020) goal. RESULTS: Two hundred nine total participants (obstetricians, family physicians, and midwives) completed surveys, of which 109 perform cesareans. Providers' NTSV cesarean rate was significantly associated with their composite attitudes score [IRR for each one-point increase 1.21 (95% CI 1.002-1.45)]. Physicians meeting the HP2020 goal held attitudes which were significantly more favorable towards vaginal birth: mean 2.70 (95% CI 2.58-2.83) versus 2.91 (95% CI 2.82-3.00), p < 0.01. CONCLUSIONS: Provider attitudinal differences are associated with NTSV cesarean rates. Those meeting the HP2020 goal hold attitudes more favorable towards vaginal birth. These findings may present a modifiable target for quality improvement initiatives to decrease low risk primary cesareans.

Prostate-Specific Antigen-Based Screening for Prostate Cancer: Evidence Report and Systematic Review for the US Preventive Services Task Force.

Importance: Prostate cancer is the second leading cause of cancer death among US men. Objective: To systematically review evidence on prostate-specific antigen (PSA)-based prostate cancer screening, treatments for localized prostate cancer, and prebiopsy risk calculators to inform the US Preventive Services Task Force. Data Sources: Searches of PubMed, EMBASE, Web of Science, and Cochrane Registries and Databases from July 1, 2011, through July 15, 2017, with a surveillance search on February 1, 2018. Study Selection: English-language reports of randomized clinical trials (RCTs) of screening; cohort studies reporting harms; RCTs and cohort studies of active localized cancer treatments vs conservative approaches (eg, active surveillance, watchful waiting); external validations of prebiopsy risk calculators to identify aggressive cancers. Data Extraction and Synthesis: One investigator abstracted data; a second checked accuracy. Two investigators independently rated study quality. Main Outcomes and Measures: Prostate cancer and all-cause mortality; false-positive screening results, biopsy complications, overdiagnosis; adverse effects of active treatments. Random-effects meta-analyses were conducted for treatment harms. Results: Sixty-three studies in 104 publications were included (N = 1 904 950). Randomization to PSA screening was not associated with reduced risk of prostate cancer mortality in either a US trial with substantial control group contamination (n = 76 683) or a UK trial with low adherence to a single PSA screen (n = 408 825) but was associated with significantly reduced prostate cancer mortality in a European trial (n = 162 243; relative risk [RR], 0.79 [95% CI, 0.69-0.91]; absolute risk reduction, 1.1 deaths per 10 000 person-years [95% CI, 0.5-1.8]). Of 61 604 men screened in the European trial, 17.8% received false-positive results. In 3 cohorts (n = 15 136), complications requiring hospitalization occurred in 0.5% to 1.6% of men undergoing biopsy after abnormal screening findings. Overdiagnosis was estimated to occur in 20.7% to 50.4% of screen-detected cancers. In an RCT of men with screen-detected prostate cancer (n = 1643), neither radical prostatectomy (hazard ratio [HR], 0.63 [95% CI, 0.21-1.93]) nor radiation therapy (HR, 0.51 [95% CI, 0.15-1.69]) were associated with significantly reduced prostate cancer mortality vs active monitoring, although each was associated with significantly lower risk of metastatic disease. Relative to conservative management, radical prostatectomy was associated with increased risk of urinary incontinence (pooled RR, 2.27 [95% CI, 1.82-2.84]; 3 trials; n = 1796) and erectile dysfunction (pooled RR, 1.82 [95% CI, 1.62-2.04]; 2 trials; n = 883). Relative to conservative management (8 cohort studies; n = 3066), radiation therapy was associated with increased risk of erectile dysfunction (pooled RR, 1.31 [95% CI, 1.20-1.42]). Conclusions and Relevance: PSA screening may reduce prostate cancer mortality risk but is associated with false-positive results, biopsy complications, and overdiagnosis. Compared with conservative approaches, active treatments for screen-detected prostate cancer have unclear effects on long-term survival but are associated with sexual and urinary difficulties.

Screening for Cervical Cancer With High-Risk Human Papillomavirus Testing: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force.

Importance: Cervical cancer can be prevented with detection and treatment of precancerous cell changes caused primarily by high-risk types of human papillomavirus (hrHPV), the causative agents in more than 90% of cervical cancers. Objective: To systematically review benefits and harms of cervical cancer screening for hrHPV to inform the US Preventive Services Task Force. Data Sources: MEDLINE, PubMed, PsycINFO, and the Cochrane Collaboration Registry of Controlled Trials from January 2011 through February 15, 2017; surveillance through May 25, 2018. Study Selection: Randomized clinical trials (RCTs) and cohort studies comparing primary hrHPV screening alone or hrHPV cotesting (both hrHPV testing and cytology) with cytology (Papanicolaou [Pap] test) screening alone. Data Extraction and Synthesis: Two investigators independently reviewed abstracts and full-text articles and quality rated included studies; data were qualitatively synthesized. Main Outcomes and Measures: Invasive cervical cancer; cervical intraepithelial neoplasia (CIN); false-positive, colposcopy, and biopsy rates; psychological harms. Results: Eight RCTs (n = 410 556), 5 cohort studies (n = 402 615), and 1 individual participant data (IPD) meta-analysis (n = 176 464) were included. Trials were heterogeneous for screening interval, number of rounds, and protocol. For primary hrHPV screening, evidence was consistent across 4 trials demonstrating increased detection of CIN 3 or worse (CIN 3+) in round 1 (relative risk [RR] range, 1.61 [95% CI, 1.09-2.37] to 7.46 [95% CI, 1.02-54.66]). Among 4 hrHPV cotesting trials, first-round CIN 3+ detection was not significantly different between screening groups; RRs for cumulative CIN 3+ detection over 2 screening rounds ranged from 0.91 to 1.13. In first-round screening, false-positive rates for primary hrHPV screening ranged from 6.6% to 7.4%, compared with 2.6% to 6.5% for cytology. For cotesting, false-positives ranged from 5.8% to 19.9% in the first round of screening, compared with 2.6% to 10.9% for cytology. First-round colposcopy rates were also higher, ranging 1.2% to 7.9% for primary hrHPV testing, compared with 1.1% to 3.1% for cytology alone; colposcopy rates for cotesting ranged from 6.8% to 10.9%, compared with 3.3% to 5.2% for cytology alone. The IPD meta-analysis of data from 4 cotesting trials and 1 primary hrHPV screening trial found lower risk of invasive cervical cancer with any hrHPV screening compared with cytology alone (pooled RR, 0.60 [95% CI, 0.40-0.89]). Conclusions and Relevance: Primary hrHPV screening detected higher rates of CIN 3+ at first-round screening compared with cytology. Cotesting trials did not show initial increased CIN 3+ detection. Both hrHPV screening strategies had higher false-positive and colposcopy rates than cytology, which could lead to more treatments with potential harms.

Ultrasonography versus computed tomography for suspected nephrolithiasis.

BACKGROUND: There is a lack of consensus about whether the initial imaging method for patients with suspected nephrolithiasis should be computed tomography (CT) or ultrasonography. METHODS: In this multicenter, pragmatic, comparative effectiveness trial, we randomly assigned patients 18 to 76 years of age who presented to the emergency department with suspected nephrolithiasis to undergo initial diagnostic ultrasonography performed by an emergency physician (point-of-care ultrasonography), ultrasonography performed by a radiologist (radiology ultrasonography), or abdominal CT. Subsequent management, including additional imaging, was at the discretion of the physician. We compared the three groups with respect to the 30-day incidence of high-risk diagnoses with complications that could be related to missed or delayed diagnosis and the 6-month cumulative radiation exposure. Secondary outcomes were serious adverse events, related serious adverse events (deemed attributable to study participation), pain (assessed on an 11-point visual-analogue scale, with higher scores indicating more severe pain), return emergency department visits, hospitalizations, and diagnostic accuracy. RESULTS: A total of 2759 patients underwent randomization: 908 to point-of-care ultrasonography, 893 to radiology ultrasonography, and 958 to CT. The incidence of high-risk diagnoses with complications in the first 30 days was low (0.4%) and did not vary according to imaging method. The mean 6-month cumulative radiation exposure was significantly lower in the ultrasonography groups than in the CT group (P<0.001). Serious adverse events occurred in 12.4% of the patients assigned to point-of-care ultrasonography, 10.8% of those assigned to radiology ultrasonography, and 11.2% of those assigned to CT (P=0.50). Related adverse events were infrequent (incidence, 0.4%) and similar across groups. By 7 days, the average pain score was 2.0 in each group (P=0.84). Return emergency department visits, hospitalizations, and diagnostic accuracy did not differ significantly among the groups. CONCLUSIONS: Initial ultrasonography was associated with lower cumulative radiation exposure than initial CT, without significant differences in high-risk diagnoses with complications, serious adverse events, pain scores, return emergency department visits, or hospitalizations. (Funded by the Agency for Healthcare Research and Quality.).

Factors Associated with Opioid Dose Increases: A Chart Review of Patients' First Year on Long-Term Opioids.

Objective: To examine encounter-level factors associated with opioid dose increases during patients' first year on opioid therapy for chronic pain. Design: Case-control study analyzing all opioid prescriptions for patients with chronic pain during their first year after opioid initiation. Cases were patients who experienced an overall dose escalation of ≥ 30 mg morphine equivalents over the 1-year period; controls did not experience overall dose escalation. Main measures were encounter type, opioid dose change, documented prescribing rationale, documentation of guideline-concordant opioid-prescribing practices. Two coders reviewed all encounters associated with opioid prescriptions. Analysis of factors associated with dose increases and provider documentation of prescribing rationale was conducted using multiple logistic regression. Results: There were 674 encounters coded for 66 patients (22 cases, 44 controls). Fifty-three percent of opioid prescriptions were associated with telephone encounters; 13% were associated with e-mail encounters. No prescribing rationale was documented for 43% of all opioid prescriptions and 25% of dose increases. Likelihood of dose increase and documentation of prescribing rationale did not significantly differ for cases versus controls. Compared with face-to-face encounters, dose increases were significantly less likely for telephone (OR 0.18, 95% CI 0.11-0.28) and e-mail (OR 0.23, 95% CI 0.12-0.47) encounters; documentation of prescribing rationale was significantly more likely for e-mail (OR 5.06, 95% CI 1.87-13.72) and less likely for telephone (OR 0.30, 95% CI 0.18-0.51) encounters. Conclusion: Most opioid prescriptions were written without face-to-face encounters. One quarter of dose increases contained no documented prescribing rationale. Documented encounter-level factors were not significantly associated with overall opioid dose escalation.

Supplemental Screening for Breast Cancer in Women With Dense Breasts: A Systematic Review for the U.S. Preventive Services Task Force.

BACKGROUND: Screening mammography has lower sensitivity and specificity in women with dense breasts, who experience higher breast cancer risk. PURPOSE: To perform a systematic review of reproducibility of Breast Imaging Reporting and Data System (BI-RADS) density categorization and test performance and clinical outcomes of supplemental screening with breast ultrasonography, magnetic resonance imaging (MRI), and digital breast tomosynthesis (DBT) in women with dense breasts and negative mammography results. DATA SOURCES: MEDLINE, PubMed, EMBASE, and Cochrane database from January 2000 to July 2015. STUDY SELECTION: Studies reporting BI-RADS density reproducibility or supplemental screening results for women with dense breasts. DATA EXTRACTION: Quality assessment and abstraction of 24 studies from 7 countries; 6 studies were good-quality. DATA SYNTHESIS: Three good-quality studies reported reproducibility of BI-RADS density; 13% to 19% of women were recategorized between "dense" and "nondense" at subsequent screening. Two good-quality studies reported that sensitivity of ultrasonography for women with negative mammography results ranged from 80% to 83%; specificity, from 86% to 94%; and positive predictive value (PPV), from 3% to 8%. The sensitivity of MRI ranged from 75% to 100%; specificity, from 78% to 94%; and PPV, from 3% to 33% (3 studies). Rates of additional cancer detection with ultrasonography were 4.4 per 1000 examinations (89% to 93% invasive); recall rates were 14%. Use of MRI detected 3.5 to 28.6 additional cancer cases per 1000 examinations (34% to 86% invasive); recall rates were 12% to 24%. Rates of cancer detection with DBT increased by 1.4 to 2.5 per 1000 examinations compared with mammography alone (3 studies). Recall rates ranged from 7% to 11%, compared with 7% to 17% with mammography alone. No studies examined breast cancer outcomes. LIMITATIONS: Good-quality evidence was sparse. Studies were small and CIs were wide. Definitions of recall were absent or inconsistent. CONCLUSION: Density ratings may be recategorized on serial screening mammography. Supplemental screening of women with dense breasts finds additional breast cancer but increases false-positive results. Use of DBT may reduce recall rates. Effects of supplemental screening on breast cancer outcomes remain unclear. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality.

Radiation-Induced Breast Cancer Incidence and Mortality From Digital Mammography Screening: A Modeling Study.

BACKGROUND: Estimates of risk for radiation-induced breast cancer from mammography screening have not considered variation in dose exposure or diagnostic work-up after abnormal screening results. OBJECTIVE: To estimate distributions of radiation-induced breast cancer incidence and mortality from digital mammography screening while considering exposure from screening and diagnostic mammography and dose variation among women. DESIGN: 2 simulation-modeling approaches. SETTING: U.S. population. PATIENTS: Women aged 40 to 74 years. INTERVENTION: Annual or biennial digital mammography screening from age 40, 45, or 50 years until age 74 years. MEASUREMENTS: Lifetime breast cancer deaths averted (benefits) and radiation-induced breast cancer incidence and mortality (harms) per 100,000 women screened. RESULTS: Annual screening of 100,000 women aged 40 to 74 years was projected to induce 125 breast cancer cases (95% CI, 88 to 178) leading to 16 deaths (CI, 11 to 23), relative to 968 breast cancer deaths averted by early detection from screening. Women exposed at the 95th percentile were projected to develop 246 cases of radiation-induced breast cancer leading to 32 deaths per 100,000 women. Women with large breasts requiring extra views for complete examination (8% of population) were projected to have greater radiation-induced breast cancer risk (266 cancer cases and 35 deaths per 100,000 women) than other women (113 cancer cases and 15 deaths per 100,000 women). Biennial screening starting at age 50 years reduced risk for radiation-induced cancer 5-fold. LIMITATION: Life-years lost from radiation-induced breast cancer could not be estimated. CONCLUSION: Radiation-induced breast cancer incidence and mortality from digital mammography screening are affected by dose variability from screening, resultant diagnostic work-up, initiation age, and screening frequency. Women with large breasts may have a greater risk for radiation-induced breast cancer. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality, U.S. Preventive Services Task Force, National Cancer Institute.

Economic Evaluation of Telemedicine for Patients in ICUs.

OBJECTIVE: Despite telemedicine's potential to improve patients' health outcomes and reduce costs in the ICU, hospitals have been slow to introduce telemedicine in the ICU due to high up-front costs and mixed evidence on effectiveness. This study's first aim was to conduct a cost-effectiveness analysis to estimate the incremental cost-effectiveness ratio of telemedicine in the ICU, compared with ICU without telemedicine, from the healthcare system perspective. The second aim was to examine potential cost saving of telemedicine in the ICU through probabilistic analyses and break-even analyses. DESIGN: Simulation analyses performed by standard decision models. SETTING: Hypothetical ICU defined by the U.S. literature. PATIENTS: Hypothetical adult patients in ICU defined by the U.S. literature. INTERVENTIONS: The intervention was the introduction of telemedicine in the ICU, which was assumed to affect per-patient per-hospital-stay ICU cost and hospital mortality. Telemedicine in the ICU operation costs included the telemedicine equipment-installation (start-up) costs with 5-year depreciation, maintenance costs, and clinician staffing costs. Telemedicine in the ICU effectiveness was measured by cumulative quality-adjusted life years for 5 years after ICU discharge. MEASUREMENTS AND MAIN RESULTS: The base case cost-effectiveness analysis estimated telemedicine in the ICU to extend 0.011 quality-adjusted life years with an incremental cost of $516 per patient compared with ICU without telemedicine, resulting in an incremental cost-effectiveness ratio of $45,320 per additional quality-adjusted life year (= $516/0.011). The probabilistic cost-effectiveness analysis estimated an incremental cost-effectiveness ratio of $50,265 with a wide 95% CI from a negative value (suggesting cost savings) to $375,870. These probabilistic analyses projected that cost saving is achieved 37% of 1,000 iterations. Cost saving is also feasible if the per-patient per-hospital-stay operational cost and physician cost were less than $422 and less than $155, respectively, based on break-even analyses. CONCLUSIONS: Our analyses suggest that telemedicine in the ICU is cost-effective in most cases and cost saving in some cases. The thresholds of cost and effectiveness, estimated by break-even analyses, help hospitals determine the impact of telemedicine in the ICU and potential cost saving.

Amputation trends for patients with lower extremity ulcers due to diabetes and peripheral artery disease using statewide data.

OBJECTIVE: This study reports all-payer amputation rates using state-based administrative claims data for high-risk patients with lower extremity (LE) ulcers and concomitant peripheral artery disease (PAD), diabetes mellitus (DM), or combination PAD/DM. In addition, we characterize patient factors that affect amputation-free survival. We also attempted to create a measure of a patient's ability to manage chronic diseases or to access appropriate outpatient care for ulcer management by accounting for hospital and emergency department (ED) visits in the preceding 60 days to determine how this also affects amputation-free survival. METHODS: Patients admitted to nonfederal hospitals, seen in an ED, or treated in an eligible ambulatory surgery center within California from 2005 through 2013 with an International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis code for a disease-specific LE ulcer were identified in the California Office of Statewide Health Planning and Development database. All subsequent hospital, ED, and ambulatory surgery center visits and procedures are captured to identify whether a patient underwent major amputation. Yearly amputation rates were determined to analyze trends. Amputation-free survival for the PAD, DM, and PAD/DM groups was determined. Cox modeling was used to evaluate the effect of patient characteristics. RESULTS: There were 219,547 patients identified with an incident LE ulcer throughout the state. Of these, 131,731 were DM associated, 36,193 were PAD associated, and 51,623 were associated with both PAD and DM. From 2005 to 2013, the number of patients with LE ulcers who required inpatient admission, presented to the ED, or had outpatient procedures was stable. However, there was a statistically significant increase in overall disease-associated amputation rates from 5.1 in 2005 to 13.5 in 2013 (P < .001). Patients with PAD/DM had the greatest increase in amputation rates from 10 per 100 patients with LE ulcers in 2005 to 28 per 100 patients in 2013 (P < .001). Despite that patients with PAD/DM were 8 years younger than patients with PAD only, they had similar amputation-free survival. Within all age groups, men had worse amputation-free survival than women did. Race did not predict amputation-free survival, but having multiple prior ED or hospital admissions was a significant predictor of worse amputation-free survival. CONCLUSIONS: Potentially preventable amputations associated with high-risk diseases are increasing among patients who require inpatient hospital admission, present to the ED, or require outpatient interventional treatment. This trend is most notable among patients with a combination of PAD and DM. Patients with repeated hospitalizations before admission for the LE ulcer had the highest risk of amputation.

Cost Analysis of the STONE Randomized Trial: Can Health Care Costs be Reduced One Test at a Time?

BACKGROUND: Decreasing the use of high-cost tests may reduce health care costs. OBJECTIVE: To compare costs of care for patients presenting to the emergency department (ED) with suspected kidney stones randomized to 1 of 3 initial imaging tests. RESEARCH DESIGN: Patients were randomized to point-of-care ultrasound (POC US, least costly), radiology ultrasound (RAD US), or computed tomography (CT, most costly). Subsequent testing and treatment were the choice of the treating physician. SUBJECTS: A total of 2759 patients at 15 EDs were randomized to POC US (n=908), RAD US, (n=893), or CT (n=958). Mean age was 40.4 years; 51.8% were male. MEASURES: All medical care documented in the trial database in the 7 days following enrollment was abstracted and coded to estimate costs using national average 2012 Medicare reimbursements. Costs for initial ED care and total 7-day costs were compared using nonparametric bootstrap to account for clustering of patients within medical centers. RESULTS: Initial ED visit costs were modestly lower for patients assigned to RAD US: $423 ($411, $434) compared with patients assigned to CT: $448 ($438, $459) (P<0.0001). Total costs were not significantly different between groups: $1014 ($912, $1129) for POC US, $970 ($878, $1078) for RAD US, and $959 ($870, $1044) for CT. Hospital admissions contributed over 50% of total costs, though only 11% of patients were admitted. Mean total costs (and admission rates) varied substantially by site from $749 to $1239. CONCLUSIONS: Assignment to a less costly test had no impact on overall health care costs for ED patients. System-level interventions addressing variation in admission rates from the ED might have greater impact on costs.

Cost-effectiveness of the PECARN rules in children with minor head trauma.

STUDY OBJECTIVE: To improve the efficiency and appropriateness of computed tomography (CT) use in children with minor head trauma, clinical prediction rules were derived and validated by the Pediatric Emergency Care Applied Research Network (PECARN). The objective of this study was to conduct a cost-effectiveness analysis comparing the PECARN traumatic brain injury prediction rules to usual care for selective CT use. METHODS: We used decision analytic modeling to project the outcomes, costs, and cost-effectiveness of applying the PECARN rules compared with usual care in a hypothetical cohort of 1,000 children with minor blunt head trauma. Clinical management was directed by level of risk as specified by the presence or absence of variables in the PECARN traumatic brain injury prediction rules. Immediate costs of care (diagnostic testing, treatment [not including clinician time], and hospital stay) were derived on single-center data. Quality-adjusted life-year losses related to the sequelae of clinically important traumatic brain injuries and to radiation-induced cancers, number of CT scans, number of radiation-induced cancers, number of missed clinically important traumatic brain injury, and total costs were evaluated. RESULTS: Compared with the usual care strategy, the PECARN strategy was projected to miss slightly more children with clinically important traumatic brain injuries (0.26 versus 0.02 per 1,000 children) but used fewer cranial CT scans (274 versus 353), resulted in fewer radiation-induced cancers (0.34 versus 0.45), cost less ($904,940 versus $954,420), and had lower net quality-adjusted life-year loss (-4.64 versus -5.79). Because the PECARN strategy was more effective (less quality-adjusted life-year loss) and less costly, it dominated the usual care strategy. Results were robust under sensitivity analyses. CONCLUSION: Application of the PECARN traumatic brain injury prediction rules for children with minor head trauma would lead to beneficial outcomes and more cost-effective care.

Dose escalation during the first year of long-term opioid therapy for chronic pain.

OBJECTIVE: To identify patient factors and health care utilization patterns associated with dose escalation during the first year of long-term opioid therapy for chronic pain. DESIGN: Retrospective cohort study using electronic health record data. SETTING: University health system. SUBJECTS: Opioid naïve adults with musculoskeletal pain who received a new outpatient opioid prescription between July 1, 2011 and June 30, 2012 and stayed on opioids for 1 year. METHODS: Mixed-effects regression was used to estimate patients' rate of opioid dose escalation. Demographics, clinical characteristics, and health care utilization for patients with and without dose escalation were compared. RESULTS: Twenty-three (9%) of 246 patients in the final cohort experienced dose escalation (defined as an increase in mean daily opioid dose of ≥30-mg morphine equivalents over 1 year). Compared with patients without dose escalation, patients with escalation had higher rates of substance use diagnoses (17% vs 1%, P = 0.01) and more total outpatient encounters (51 vs 35, P = 0.002) over 1 year. Differences in outpatient encounters were largely due to more non face-to-face encounters (e.g., telephone calls, emails) among patients with dose escalation. Differences in age, race, concurrent benzodiazepine use, and mental health diagnoses between patients with and without dose escalation were not statistically significant. Primary care clinicians prescribed 89% of opioid prescriptions. CONCLUSIONS: Dose escalation during the first year of long-term opioid therapy is associated with higher rates of substance use disorders and more frequent outpatient encounters, especially non face-to-face encounters.

Models in the development of clinical practice guidelines.

Clinical practice guidelines should be based on the best scientific evidence derived from systematic reviews of primary research. However, these studies often do not provide evidence needed by guideline development groups to evaluate the tradeoffs between benefits and harms. In this article, the authors identify 4 areas where models can bridge the gaps between published evidence and the information needed for guideline development applying new or updated information on disease risk, diagnostic test properties, and treatment efficacy; exploring a more complete array of alternative intervention strategies; assessing benefits and harms over a lifetime horizon; and projecting outcomes for the conditions for which the guideline is intended. The use of modeling as an approach to bridge these gaps (provided that the models are high-quality and adequately validated) is considered. Colorectal and breast cancer screening are used as examples to show the utility of models for these purposes. The authors propose that a modeling study is most useful when strong primary evidence is available to inform the model but critical gaps remain between the evidence and the questions that the guideline group must address. In these cases, model results have a place alongside the findings of systematic reviews to inform health care practice and policy.

Derivation of a clinical decision instrument to identify adult patients with mild traumatic intracranial hemorrhage at low risk for requiring ICU admission.

STUDY OBJECTIVE: The objective of this study is to derive a clinical decision instrument with a sensitivity of at least 95% (with upper and lower bounds of the 95% confidence intervals [CIs] within a 5% range) to identify adult emergency department patients with mild traumatic intracranial hemorrhage who are at low risk for requiring critical care resources during hospitalization and thus may not need admission to the ICU. METHODS: This was a prospective, observational study of adult patients with mild traumatic intracranial hemorrhage (initial Glasgow Coma Scale [GCS] score 13 to 15, with traumatic intracranial hemorrhage) presenting to a Level I trauma center from July 2009 to February 2013. The need for ICU admission was defined as the presence of an acute critical care intervention (intubation, neurosurgical intervention, blood product transfusion, vasopressor or inotrope administration, invasive monitoring for hemodynamic instability, urgent treatment for arrhythmia or cardiopulmonary resuscitation, and therapeutic angiography). We derived the clinical decision instrument with binary recursive partitioning (with a misclassification cost of 20 to 1). The accuracy of the decision instrument was compared with the treating physician's (emergency medicine faculty) clinical impression. RESULTS: A total of 600 patients with mild traumatic intracranial hemorrhage were enrolled; 116 patients (19%) had a critical care intervention. The derived instrument consisted of 4 predictor variables: admission GCS score less than 15, nonisolated head injury, aged 65 years or older, and evidence of swelling or shift on initial cranial computed tomography scan. The decision instrument identified 114 of 116 patients requiring an acute critical care intervention (sensitivity 98.3%; 95% CI 93.9% to 99.5%) if at least 1 variable was present and 192 of 484 patients who did not have an acute critical care intervention (specificity 39.7%; 95% CI 35.4% to 44.1%) if no variables were present. Physician clinical impression was slightly less sensitive (90.1%; 95% CI 83.1% to 94.4%) but overall similar to the clinical decision instrument. CONCLUSION: We derived a clinical decision instrument that identifies a subset of patients with mild traumatic intracranial hemorrhage who are at low risk for acute critical care intervention and thus may not require ICU admission. Physician clinical impression had test characteristics similar to those of the decision instrument. Because the results are based on single-center data without a validation cohort, external validation is required.