Maternal Mortality: A National Institutes of Health Pathways to Prevention Panel Report.

The National Institutes of Health's (NIH) Pathways to Prevention panel on postpartum health provides a consensus statement on the evidence, research gaps, and future priorities to prevent maternal morbidity and mortality. The panel reviewed an NIH-commissioned evidence review and workshop that included epidemiologic studies, demonstration interventions, and other maternal morbidity and mortality research to create these national recommendations. The panel concludes that a maternal morbidity and mortality crisis reflects a systemic failure of current U.S. health care, research efforts, and social policies. The panel recommends improving maternal health through a "maternal morbidity and mortality prevention moonshot" that adopts a comprehensive, multilevel life course conceptual framework; strengthens the research methods used within the science of maternal health; establishes and conducts national prevention, treatment, and policy interventions; and reimburses evidence-informed clinical approaches to improve maternal health across the life course. Without a national focus on fundamentally transformative interventions and other initiatives aimed at redressing structural racism and inequities in health care, current interventions and clinical advances in maternal morbidity and mortality prevention will remain tragically insufficient.

Does de-implementation of low-value care impact the patient-clinician relationship? A mixed methods study.

BACKGROUND: The importance of reducing low-value care (LVC) is increasingly recognized, but the impact of de-implementation on the patient-clinician relationship is not well understood. This mixed-methods study explored the impact of LVC de-implementation on the patient-clinician relationship. METHODS: Adult primary care patients from a large Virginia health system volunteered to participate in a survey (n = 232) or interview (n = 24). Participants completed the Patient-Doctor Relationship Questionnaire (PDRQ-9) after reading a vignette about a clinician declining to provide a low-value service: antibiotics for acute sinusitis (LVC-antibiotics); screening EKG (LVC-EKG); screening vitamin D test (LVC-vitamin D); or an alternate vignette about a high-value service, and imagining that their own primary care clinician had acted in the same manner. A different sample of participants was asked to imagine that their own primary care clinician did not order LVC-antibiotics or LVC-EKG and then respond to semi-structured interview questions. Outcomes data included participant demographics, PDRQ-9 scores (higher score = greater relationship integrity), and content analysis of transcribed interviews. Differences in PDRQ-9 scores were analyzed using one-way ANOVA. Data were integrated for analysis and interpretation. RESULTS: Although participants generally agreed with the vignette narrative (not providing LVC), many demonstrated difficulty comprehending the broad concept of LVC and potential harms. The topic triggered memories of negative experiences with healthcare (typically poor-quality care, not necessarily LVC). The most common recommendation for reducing LVC was for patients to take greater responsibility for their own health. Most participants believed that their relationship with their clinician would not be negatively impacted by denial of LVC because they trusted their clinician's guidance. Participants emphasized that trusted clinicians are those who listen to them, spend time with them, and offer understandable advice. Some felt that not providing LVC would actually increase their trust in their clinician. Similar PDRQ-9 scores were observed for LVC-antibiotics (38.9), LVC-EKG (37.5), and the alternate vignette (36.4), but LVC-vitamin D was associated with a significantly lower score (31.2) (p < 0.05). CONCLUSIONS: In this vignette-based study, we observed minimal impact of LVC de-implementation on the patient-clinician relationship, although service-specific differences surfaced. Further situation-based research is needed to confirm study findings.

Vaccine Policy in the United States.

In an era when the success of the US vaccination policies to date is threatened by vaccine hesitancy, it is important for clinicians to have a working understanding of how vaccines are developed and recommended for use in the United States and how federal and state governments are coordinated to ensure a safe and effective vaccine supply. This article discusses the federal agencies involved in vaccine development and recommendation, other organizations involved in vaccine policy, and the role of vaccine-related public health law in promoting universal vaccination.

Screening for Pancreatic Cancer: US Preventive Services Task Force Reaffirmation Recommendation Statement.

Importance: Pancreatic cancer is an uncommon cancer with an age-adjusted annual incidence of 12.9 cases per 100 000 person-years. However, the death rate is 11.0 deaths per 100 000 person-years because the prognosis of pancreatic cancer is poor. Although its incidence is low, pancreatic cancer is the third most common cause of cancer death in the United States. Because of the increasing incidence of pancreatic cancer, along with improvements in early detection and treatment of other types of cancer, it is estimated that pancreatic cancer may soon become the second-leading cause of cancer death in the United States. Objective: To update the 2004 US Preventive Services Task Force (USPSTF) recommendation on screening for pancreatic cancer. Evidence Review: The USPSTF reviewed the evidence on the benefits and harms of screening for pancreatic cancer, the diagnostic accuracy of screening tests for pancreatic cancer, and the benefits and harms of treatment of screen-detected or asymptomatic pancreatic cancer. Findings: The USPSTF found no evidence that screening for pancreatic cancer or treatment of screen-detected pancreatic cancer improves disease-specific morbidity or mortality, or all-cause mortality. The USPSTF found adequate evidence that the magnitude of the benefits of screening for pancreatic cancer in asymptomatic adults can be bounded as no greater than small. The USPSTF found adequate evidence that the magnitude of the harms of screening for pancreatic cancer and treatment of screen-detected pancreatic cancer can be bounded as at least moderate. The USPSTF reaffirms its previous conclusion that the potential benefits of screening for pancreatic cancer in asymptomatic adults do not outweigh the potential harms. Conclusions and Recommendation: The USPSTF recommends against screening for pancreatic cancer in asymptomatic adults. (D recommendation).

Risk Assessment, Genetic Counseling, and Genetic Testing for BRCA-Related Cancer: US Preventive Services Task Force Recommendation Statement.

Importance: Potentially harmful mutations of the breast cancer susceptibility 1 and 2 genes (BRCA1/2) are associated with increased risk for breast, ovarian, fallopian tube, and peritoneal cancer. For women in the United States, breast cancer is the most common cancer after nonmelanoma skin cancer and the second leading cause of cancer death. In the general population, BRCA1/2 mutations occur in an estimated 1 in 300 to 500 women and account for 5% to 10% of breast cancer cases and 15% of ovarian cancer cases. Objective: To update the 2013 US Preventive Services Task Force (USPSTF) recommendation on risk assessment, genetic counseling, and genetic testing for BRCA-related cancer. Evidence Review: The USPSTF reviewed the evidence on risk assessment, genetic counseling, and genetic testing for potentially harmful BRCA1/2 mutations in asymptomatic women who have never been diagnosed with BRCA-related cancer, as well as those with a previous diagnosis of breast, ovarian, tubal, or peritoneal cancer who have completed treatment and are considered cancer free. In addition, the USPSTF reviewed interventions to reduce the risk for breast, ovarian, tubal, or peritoneal cancer in women with potentially harmful BRCA1/2 mutations, including intensive cancer screening, medications, and risk-reducing surgery. Findings: For women whose family or personal history is associated with an increased risk for harmful mutations in the BRCA1/2 genes, or who have an ancestry associated with BRCA1/2 gene mutations, there is adequate evidence that the benefits of risk assessment, genetic counseling, genetic testing, and interventions are moderate. For women whose personal or family history or ancestry is not associated with an increased risk for harmful mutations in the BRCA1/2 genes, there is adequate evidence that the benefits of risk assessment, genetic counseling, genetic testing, and interventions are small to none. Regardless of family or personal history, the USPSTF found adequate evidence that the overall harms of risk assessment, genetic counseling, genetic testing, and interventions are small to moderate. Conclusions and Recommendation: The USPSTF recommends that primary care clinicians assess women with a personal or family history of breast, ovarian, tubal, or peritoneal cancer or who have an ancestry associated with BRCA1/2 gene mutations with an appropriate brief familial risk assessment tool. Women with a positive result on the risk assessment tool should receive genetic counseling and, if indicated after counseling, genetic testing. (B recommendation) The USPSTF recommends against routine risk assessment, genetic counseling, or genetic testing for women whose personal or family history or ancestry is not associated with potentially harmful BRCA1/2 gene mutations. (D recommendation).

Screening for HIV Infection: US Preventive Services Task Force Recommendation Statement.

IMPORTANCE: Approximately 1.1 million persons in the United States are currently living with HIV, and more than 700 000 persons have died of AIDS since the first cases were reported in 1981. There were approximately 38 300 new diagnoses of HIV infection in 2017. The estimated prevalence of HIV infection among persons 13 years and older in the United States is 0.4%, and data from the Centers for Disease Control and Prevention show a significant increase in HIV diagnoses starting at age 15 years. An estimated 8700 women living with HIV give birth each year in the United States. HIV can be transmitted from mother to child during pregnancy, labor, delivery, and breastfeeding. The incidence of perinatal HIV infection in the United States peaked in 1992 and has declined significantly following the implementation of routine prenatal HIV screening and the use of effective therapies and precautions to prevent mother-to-child transmission. OBJECTIVE: To update the 2013 US Preventive Services Task Force (USPSTF) recommendation on screening for HIV infection in adolescents, adults, and pregnant women. EVIDENCE REVIEW: The USPSTF reviewed the evidence on the benefits and harms of screening for HIV infection in nonpregnant adolescents and adults, the yield of screening for HIV infection at different intervals, the effects of initiating antiretroviral therapy (ART) at a higher vs lower CD4 cell count, and the longer-term harms associated with currently recommended ART regimens. The USPSTF also reviewed the evidence on the benefits (specifically, reduced risk of mother-to-child transmission of HIV infection) and harms of screening for HIV infection in pregnant persons, the yield of repeat screening for HIV at different intervals during pregnancy, the effectiveness of currently recommended ART regimens for reducing mother-to-child transmission of HIV infection, and the harms of ART during pregnancy to the mother and infant. FINDINGS: The USPSTF found convincing evidence that currently recommended HIV tests are highly accurate in diagnosing HIV infection. The USPSTF found convincing evidence that identification and early treatment of HIV infection is of substantial benefit in reducing the risk of AIDS-related events or death. The USPSTF found convincing evidence that the use of ART is of substantial benefit in decreasing the risk of HIV transmission to uninfected sex partners. The USPSTF also found convincing evidence that identification and treatment of pregnant women living with HIV infection is of substantial benefit in reducing the rate of mother-to-child transmission. The USPSTF found adequate evidence that ART is associated with some harms, including neuropsychiatric, renal, and hepatic harms, and an increased risk of preterm birth in pregnant women. The USPSTF concludes with high certainty that the net benefit of screening for HIV infection in adolescents, adults, and pregnant women is substantial. CONCLUSIONS AND RECOMMENDATION: The USPSTF recommends screening for HIV infection in adolescents and adults aged 15 to 65 years. Younger adolescents and older adults who are at increased risk of infection should also be screened. (A recommendation) The USPSTF recommends screening for HIV infection in all pregnant persons, including those who present in labor or at delivery whose HIV status is unknown. (A recommendation).

Examining an Evidence-Based Medicine Culture in Residency Education.

BACKGROUND AND OBJECTIVES: Reports of innovations in evidence-based medicine (EBM) training have focused on curriculum design and knowledge gained. Little is known about the educational culture and environment for EBM training and the extent to which those environments exist in family medicine residencies in the United States. METHODS: A literature review on this topic identified a validated EBM environment scale intended for learner use. This scale was adapted for completion by family medicine residency program directors (PDs) and administered through an omnibus survey. Responses to this scale were analyzed descriptively with program and PD demographics. An EBM culture score was calculated for each program and the results were regressed with the correlated demographics. RESULTS: In our adapted survey, family medicine PDs generally rated their residencies high on the EBM culture scale, but admitted to challenges with faculty feedback to residents about EBM skills, ability to protect time for EBM instruction, and clinician skepticism about EBM. In linear regression analysis, the mean summary score on the EBM scale was lower for female PDs and in programs with a higher proportion of international medical school graduates. CONCLUSIONS: To improve the culture for EBM teaching, family medicine residency programs should focus on faculty engagement and support and the allocation of sufficient time for EBM education.

Risk Assessment for Cardiovascular Disease With Nontraditional Risk Factors: US Preventive Services Task Force Recommendation Statement.

Importance: Cardiovascular disease (CVD) is the most common cause of death among adults in the United States. Treatment to prevent CVD events by modifying risk factors is currently informed by the Framingham Risk Score, the Pooled Cohort Equations, or similar CVD risk assessment models. If current CVD risk assessment models could be improved by adding more risk factors, treatment might be better targeted, thereby maximizing the benefits and minimizing the harms. Objective: To update the 2009 US Preventive Services Task Force (USPSTF) recommendation on using nontraditional risk factors in coronary heart disease risk assessment. Evidence Review: The USPSTF reviewed the evidence on using nontraditional risk factors in CVD risk assessment, focusing on the ankle-brachial index (ABI), high-sensitivity C-reactive protein (hsCRP) level, and coronary artery calcium (CAC) score; the health benefits and harms of CVD risk assessment and treatment guided by nontraditional risk factors combined with the Framingham Risk Score or Pooled Cohort Equations compared with using either risk assessment model alone; and whether adding nontraditional risk factors to existing CVD risk assessment models improves measures of calibration, discrimination, and risk reclassification. Findings: The USPSTF found adequate evidence that adding the ABI, hsCRP level, and CAC score to existing CVD risk assessment models results in small improvements in discrimination and risk reclassification; however, the clinical meaning of these changes is largely unknown. Evidence on adding the ABI, hsCRP level, and CAC score to the Pooled Cohort Equations is limited. The USPSTF found inadequate evidence to assess whether treatment decisions guided by the ABI, hsCRP level, or CAC score, in addition to risk factors in existing CVD risk assessment models, leads to reduced incidence of CVD events or mortality. The USPSTF found adequate evidence to conceptually bound the harms of early detection and interventions as small. The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of using the ABI, hsCRP level, or CAC score in risk assessment for CVD in asymptomatic adults to prevent CVD events. Conclusions and Recommendation: The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of adding the ABI, hsCRP level, or CAC score to traditional risk assessment for CVD in asymptomatic adults to prevent CVD events. (I statement).

Screening for Peripheral Artery Disease and Cardiovascular Disease Risk Assessment With the Ankle-Brachial Index: US Preventive Services Task Force Recommendation Statement.

Importance: Peripheral artery disease (PAD) is a manifestation of atherosclerosis in the lower limbs. It can impair walking and, in severe cases, can lead to tissue loss, infection, and amputation. In addition to morbidity directly caused by PAD, patients with PAD are at increased risk for cardiovascular disease (CVD) events, because atherosclerosis is a systemic disease that also causes coronary and cerebrovascular events. Objective: To update the 2013 US Preventive Services Task Force (USPSTF) recommendation on screening for PAD and CVD risk with the ankle-brachial index (ABI). Evidence Review: The USPSTF reviewed the evidence on whether screening for PAD with the ABI in generally asymptomatic adults reduces morbidity or mortality from PAD or CVD. The current review expanded on the previous review to include individuals with diabetes and interventions that include supervised exercise and physical therapy intended to improve outcomes in the lower limbs. Findings: The USPSTF found few data on the accuracy of the ABI for identifying asymptomatic persons who can benefit from treatment of PAD or CVD. There are few studies addressing the benefits of treating screen-detected patients with PAD; 2 good-quality studies showed no benefit of using the ABI to manage daily aspirin therapy in unselected populations, and 2 studies showed no benefit from exercise therapy. No studies addressed the harms of screening, although the potential exists for overdiagnosis, labeling, and opportunity costs. Studies that addressed the harms of treatment showed nonsignificant results. Therefore, the USPSTF concludes that the current evidence is insufficient and that the balance of benefits and harms of screening for PAD with the ABI in asymptomatic adults cannot be determined. Conclusions and Recommendation: The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for PAD and CVD risk with the ABI in asymptomatic adults. (I statement).

Practice characteristics and prior authorization costs: secondary analysis of data collected by SALT-Net in 9 central New York primary care practices.

BACKGROUND: An increase in prior authorization (PA) requirements from health insurance companies is placing administrative and financial burdens on primary care offices across the United States. As time allocation for these cases continues to grow, physicians are concerned with additional workload and inefficiency in the workplace. The objective is to estimate the effects of practice characteristics on time spent per prior authorization request in primary care practices. METHODS: Secondary analysis was performed using data on nine primary care practices in Central New York. Practice characteristics and demographics were collected at the onset of the study. In addition, participants were instructed to complete an "event form" (EF) to document each prior authorization event during a 4-6 week period; prior authorizations included requests for medication as well as other health care services. Stepwise Ordinary Least Squares (OLS) Regression was used to model Time in Minutes of each event as an outcome of various factors. RESULTS: Prior authorization events (N = 435) took roughly 20 minutes to complete (beta = 20.017, p < .001); Medicaid requests took less time (beta = -6.085, p < .001), and Electronic Health Record (EHR) system use reduced prior authorization time by about 5 minutes (beta = -5.086, p = .002). CONCLUSIONS: While prior authorization events impose substantial costs to primary care offices, it appears that Medicaid requests take less time than private payer requests. Results from the study provide support that Electronic Health Record usage may also reduce time required to complete prior authorization requests.

The impact of prior authorization requirements on primary care physicians' offices: report of two parallel network studies.

INTRODUCTION: US primary care physicians and their office staff have experienced large increases in time-consuming requirements for prior authorization (PA) of tests, medications, and other clinical services in recent years. This report presents results of 2 similar studies in which physicians and office staff self observed and reported the amount of time spent on PA activities. METHODS: Physicians and office staff from 12 primary care offices in northeastern United States recorded request type, reporter role, and time spent for each PA event at the time of the PA activity. Costs were estimated using salary data from the US Bureau of Labor Statistics (study 1) and from Salary.com (study 2). Time and costs were estimated for the practices in each study. RESULTS: The mean annual projected cost per full-time equivalent physician for PA activities ranged from $2,161 (study 1) to $3,430 (study 2). Using self-reporting at the time of the event, we found that preauthorization is a measurable burden on physician and staff time. CONCLUSIONS: Further studies that include cost-benefit analyses, estimates of opportunity costs and costs of delayed testing and treatment, as well as the "hassle factor" for patients and physicians, are warranted.