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Ideas and Opinions | 
Scott D. Halpern, MD, PhD; and Ezekiel J. Emanuel, MD, PhD
Since the early 1980s, many aspects of care near the end of life in the United States have changed dramatically. Yet, despite nearly 30 years of efforts to get persons in the United States to engage in advance care planning, few patients do. In light of this pernicious status quo, the call from the Institute of Medicine Committee on Approaching Death for sweeping overhauls in the delivery of end-of-life care is greatly needed. This commentary discusses the Institute of Medicine report, particularly the committee's recommendation to reimburse physicians for engaging patients in advance care planning.
Topics: palliative care, advance care planning, physician payment, incentives, terminally ill, end-of-life care
Ideas and Opinions | 
Philip A. Pizzo, MD
The co-chair of an Institute of Medicine committee on care at the end of life discusses changes needed in the care of patients approaching death and argues that treating physicians should remain fully present even after their patients enter palliative care or hospice programs.
Topics: end-of-life care, terminally ill, hospice care, palliative care
Ideas and Opinions | 
Debra L. Ness, MS; and Beverley H. Johnson, BSN
There may be no truer test of a health care system than how it supports persons with advanced illness or at the end of life and the loved ones who care for them. In that regard, our health care system struggles and often fails, and this failure contributes to soaring health care costs that put enormous strain on families and our economy. This commentary discusses the Institute of Medicine report “Dying in America: Improving Quality and Honoring Individual Preferences Near the End of Life,” which the authors believe will drive constructive conversations that advance the kind of rational debate that is the essential foundation for better policy and practice.
Topics: end-of-life care, patient-centered care, terminally ill, palliative care, partnerships, family-centered care
In September 2014, the Institute of Medicine released its fifth full report on end-of-life issues and identified recommendations within 5 domains. One recommendation is to educate and engage the public by providing fact-based information about the care of persons with advanced serious illness to encourage advance care planning and informed choices based on the needs and values of individuals. This commentary notes that this is the first Institute of Medicine report on the end of life to explicitly mention public health as having a role in this arena and discusses the promise that this approach offers.
Topics: end-of-life care, terminally ill, public health medicine, advance care planning
Original Research | 
Brian L. Sprague, PhD; Natasha K. Stout, PhD; Clyde Schechter, MD, MA; Nicolien T. van Ravesteyn, PhD; Mucahit Cevik, MS; Oguzhan Alagoz, PhD; Christoph I. Lee, MD, MSHS; Jeroen J. van den Broek, MS; Diana L. Miglioretti, PhD; Jeanne S. Mandelblatt, MD, MPH; Harry J. de Koning, MD, PhD; Karla Kerlikowske, MD, MS; Constance D. Lehman, MD, PhD; and Anna N. A. Tosteson, ScD
Background:Many states have laws requiring mammography facilities to tell women with dense breasts and a negative screening mammography result to discuss supplemental screening tests with their providers. The most readily available supplemental screening method is ultrasonography, but little is known about its effectiveness. Objective:To evaluate the benefits, harms, and cost-effectiveness of supplemental ultrasonography screening for women with dense breasts. Design:Comparative modeling with 3 validated simulation models. Data Sources:Surveillance, Epidemiology, and End Results Program; Breast Cancer Surveillance Consortium; and medical literature. Target Population:Contemporary cohort of women eligible for routine screening. Time Horizon:Lifetime. Perspective:Payer. Intervention:Supplemental ultrasonography screening for women with dense breasts after a negative screening mammography result. Outcome Measures:Breast cancer deaths averted, quality-adjusted life-years (QALYs) gained, biopsies recommended after a false-positive ultrasonography result, and costs. Results of Base-Case Analysis:Supplemental ultrasonography screening after a negative mammography result for women aged 50 to 74 years with heterogeneously or extremely dense breasts averted 0.36 additional breast cancer deaths (range across models, 0.14 to 0.75 deaths), gained 1.7 QALYs (range, 0.9 to 4.7 QALYs), and resulted in 354 biopsy recommendations after a false-positive ultrasonography result (range, 345 to 421 recommendations) per 1000 women with dense breasts compared with biennial screening by mammography alone. The cost-effectiveness ratio was $325 000 per QALY gained (range, $112 000 to $766 000 per QALY gained). Supplemental ultrasonography screening for only women with extremely dense breasts cost $246 000 per QALY gained (range, $74 000 to $535 000 per QALY gained). Results of Sensitivity Analysis:The conclusions were not sensitive to ultrasonography performance characteristics, screening frequency, or starting age. Limitation:Provider costs for coordinating supplemental ultrasonography were not considered. Conclusion:Supplemental ultrasonography screening for women with dense breasts would substantially increase costs while producing relatively small benefits. Primary Funding Source:National Cancer Institute.
Topics: cost effectiveness, mammography, ultrasonography, breast, breast, breast neoplasm screening, breast density, breast cancer
Topics: vitamin d deficiency, vitamin d, screening
Reviews | 
Erin S. LeBlanc, MD, MPH; Bernadette Zakher, MBBS; Monica Daeges, BA; Miranda Pappas, MA; and Roger Chou, MD
Background:Vitamin D deficiency has been associated with adverse health outcomes. Purpose:To systematically review benefits and harms of vitamin D screening in asymptomatic adults. Data Sources:Ovid MEDLINE (through the third week of August 2014), Cochrane Central Register of Controlled Trials, and Cochrane Database of Systematic Reviews. Study Selection: Randomized trials of screening for and treatment of vitamin D deficiency and case–control studies nested within the Women's Health Initiative. Data Extraction:One investigator abstracted data, a second reviewed data for accuracy, and 2 investigators independently assessed study quality using predefined criteria. Data Synthesis:No study examined the effects of vitamin D screening versus no screening on clinical outcomes. Vitamin D treatment was associated with decreased mortality versus placebo or no treatment (11 studies; risk ratio [RR], 0.83 [95% CI, 0.70 to 0.99]), although benefits were no longer seen after trials of institutionalized persons were excluded (8 studies; RR, 0.93 [CI, 0.73 to 1.18]). Vitamin D treatment was associated with possible decreased risk for having at least 1 fall (5 studies; RR, 0.84 [CI, 0.69 to 1.02]) and falls per person (5 studies; incidence rate ratio, 0.66 [CI, 0.50 to 0.88]) but not fractures (5 studies; RR, 0.98 [CI, 0.82 to 1.16]). Vitamin D treatment was not associated with a statistically significant increased risk for serious adverse events (RR, 1.17 [CI, 0.74 to 1.84]). Limitation:Variability across studies in 25-hydroxyvitamin D assays and baseline levels, treatment doses, use of calcium, and duration of follow-up. Conclusion:Treatment of vitamin D deficiency in asymptomatic persons might reduce mortality risk in institutionalized elderly persons and risk for falls but not fractures. Primary Funding Source:Agency for Healthcare Research and Quality.
Topics: vitamin d deficiency, vitamin d, screening
Clinical Guidelines | 
Michael L. LeFevre, MD, MSPH, on behalf of the U.S. Preventive Services Task Force*
Description:New USPSTF recommendation on screening for vitamin D deficiency in adults. Methods:The USPSTF reviewed the evidence on screening for and treatment of vitamin D deficiency, including the benefits and harms of screening and early treatment. Population:This recommendation applies to community-dwelling, nonpregnant adults aged 18 years or older who are seen in primary care settings and are not known to have signs or symptoms of vitamin D deficiency or conditions for which vitamin D treatment is recommended. Recommendation:The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for vitamin D deficiency in asymptomatic adults. (I statement)
Topics: vitamin d deficiency, vitamin d, screening
Editorials | 
Robert P. Heaney, MD; and Laura A. G. Armas, MD
In this issue, the U.S. Preventive Services Task Force reports that it was unable to find evidence for or against testing for vitamin D deficiency. The editorialists urge practitioners to measure vitamin D status in patients to provide them with patient-specific, personally applicable information that will hopefully improve adherence.
Topics: vitamin d deficiency, disease prevention, screening, nutrients, vitamin d
Original Research | 
Zhihong Liu, MD; Haitao Zhang, MD; Zhangsuo Liu, MD; Changying Xing, PhD; Ping Fu, MD; Zhaohui Ni, MD; Jianghua Chen, MD; Hongli Lin, MD; Fuyou Liu, MD; Yongcheng He, MD; Yani He, MD; Lining Miao, MD; Nan Chen, MD; Ying Li, MD; Yong Gu, MD; Wei Shi, MD; Weixin Hu, MD; Zhengzhao Liu, MD; Hao Bao, MD; Caihong Zeng, PhD; and Minlin Zhou, MD
Includes: Supplemental Content
Background:Treatment of lupus nephritis (LN) remains challenging. Objective:To assess the efficacy and safety of a multitarget therapy consisting of tacrolimus, mycophenolate mofetil, and steroid compared with intravenous cyclophosphamide and steroid as induction therapy for LN. Design:24-week randomized, open-label, multicenter study (ClinicalTrials.gov number: NCT00876616). Setting:26 renal centers in China. Patients:Adults (age 18 to 65 years) with biopsy-proven LN. Intervention:Tacrolimus, 4 mg/d, and mycophenolate mofetil, 1.0 g/d, versus intravenous cyclophosphamide with a starting dose of 0.75 (adjusted to 0.5 to 1.0) g/m2 body surface area every 4 weeks for 6 months. Both groups received 3 days of pulse methylprednisolone followed by a tapering course of oral prednisone therapy. Measurements:The primary end point was complete remission at 24 weeks. Secondary end points included overall response (complete and partial remission), time to overall response, and adverse events. Results:After 24 weeks of therapy, more patients in the multitarget group (45.9%) than in the intravenous cyclophosphamide group (25.6%) showed complete remission (difference, 20.3 percentage points [95% CI, 10.0 to 30.6 percentage points]; P < 0.001). The overall response incidence was higher in the multitarget group than in the intravenous cyclophosphamide group (83.5% vs. 63.0%; difference, 20.4 percentage points [CI, 10.3 to 30.6 percentage points]; P < 0.001), and the median time to overall response was shorter in the multitarget group (difference, −4.1 weeks [CI, −7.9 to −2.1 weeks]). Incidence of adverse events did not differ between the multitarget and intravenous cyclophosphamide groups (50.3% [91 of 181] vs. 52.5% [95 of 181]). Limitation:The study was limited to 24 weeks of follow-up. Conclusion:Multitarget therapy provides superior efficacy compared with intravenous cyclophosphamide as induction therapy for LN. Primary Funding Sources:National Basic Research Program of China, National Key Technology R&D Program.
Topics: prednisone, mycophenolate mofetil, cyclophosphamide, lupus nephritis, methylprednisolone, steroids, tacrolimus, adverse event, complete remission, neoadjuvant therapy, follow-up, renal biopsy
Summaries for Patients | 
Topics: prednisone, mycophenolate mofetil, cyclophosphamide, lupus nephritis, methylprednisolone, neoadjuvant therapy, steroids, tacrolimus, adverse event, complete remission
Clinical Guidelines | 
Richard M. Kaufman, MD; Benjamin Djulbegovic, MD, PhD; Terry Gernsheimer, MD; Steven Kleinman, MD; Alan T. Tinmouth, MD; Kelley E. Capocelli, MD; Mark D. Cipolle, MD, PhD; Claudia S. Cohn, MD, PhD; Mark K. Fung, MD, PhD; Brenda J. Grossman, MD, MPH; Paul D. Mintz, MD; Deborah A. Sesok-Pizzini, MD; Aryeh Shander, MD; Gary E. Stack, MD, PhD; Kathryn E. Webert, MD, MSc; Robert Weinstein, MD; Babu G. Welch, MD; Glenn J. Whitman, MD; Edward C. Wong, MD; and Aaron A.R. Tobian, MD, PhD
Background:Platelet transfusions are administered to prevent or treat bleeding in patients with quantitative or qualitative platelet disorders. The AABB (formerly, the American Association of Blood Banks) developed this guideline on appropriate use of platelet transfusion in adult patients. Methods:These guidelines are based on a systematic review of randomized, clinical trials and observational studies that reported clinical outcomes on patients receiving prophylactic or therapeutic platelet transfusions. A literature search from 1900 to September 2014 with no language restrictions was done. Examined outcomes included all-cause mortality, bleeding-related mortality, bleeding, and number of platelet units transfused. An expert panel reviewed the data and developed recommendations using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework. Recommendation 1:The AABB recommends that platelets should be transfused prophylactically to reduce the risk for spontaneous bleeding in hospitalized adult patients with therapy-induced hypoproliferative thrombocytopenia. The AABB recommends transfusing hospitalized adult patients with a platelet count of 10 × 109 cells/L or less to reduce the risk for spontaneous bleeding. The AABB recommends transfusing up to a single apheresis unit or equivalent. Greater doses are not more effective, and lower doses equal to one half of a standard apheresis unit are equally effective (Grade: strong recommendation; moderate-quality evidence). Recommendation 2:The AABB suggests prophylactic platelet transfusion for patients having elective central venous catheter placement with a platelet count less than 20 × 109 cells/L (Grade: weak recommendation; low-quality evidence). Recommendation 3:The AABB suggests prophylactic platelet transfusion for patients having elective diagnostic lumbar puncture with a platelet count less than 50 × 109 cells/L (Grade: weak recommendation; very low-quality evidence). Recommendation 4:The AABB suggests prophylactic platelet transfusion for patients having major elective nonneuraxial surgery with a platelet count less than 50 × 109 cells/L (Grade: weak recommendation; very low-quality evidence). Recommendation 5:The AABB recommends against routine prophylactic platelet transfusion for patients who are nonthrombocytopenic and have cardiac surgery with cardiopulmonary bypass (CPB). The AABB suggests platelet transfusion for patients having CPB who exhibit perioperative bleeding with thrombocytopenia and/or evidence of platelet dysfunction (Grade: weak recommendation; very low-quality evidence). Recommendation 6:The AABB cannot recommend for or against platelet transfusion for patients receiving antiplatelet therapy who have intracranial hemorrhage (traumatic or spontaneous) (Grade: uncertain recommendation; very low-quality evidence).
Topics: hemorrhage, platelet count measurement, platelet transfusion, thrombocytopenia, blood platelets
Reviews | 
J. Bruin Rugge, MD, MPH; Christina Bougatsos, MPH; and Roger Chou, MD
Includes: Supplemental Content
Background:In 2004, the U.S. Preventive Services Task Force found insufficient evidence to recommend thyroid screening. Purpose:To update the 2004 U.S. Preventive Services Task Force review on the benefits and harms of screening and treatment of subclinical and undiagnosed overt hypothyroidism and hyperthyroidism in adults without goiter or thyroid nodules. Data Sources:MEDLINE and Cochrane databases through July 2014. Study Selection: Randomized, controlled trials and observational studies of screening and treatment. Data Extraction:One investigator abstracted data, and a second investigator confirmed; 2 investigators independently assessed study quality. Data Synthesis:No study directly assessed benefits and harms of screening versus no screening. For subclinical hypothyroidism (based on thyroid-stimulating hormone levels of 4.1 to 11.0 mIU/L), 1 fair-quality cohort study found that treatment of subclinical hypothyroidism was associated with decreased risk for coronary heart disease events versus no treatment. No study found that treatment was associated with improved quality of life, cognitive function, blood pressure, or body mass index versus no treatment. Effects of treatment versus no treatment showed potential beneficial effects on lipid levels, but effects were inconsistent, not statistically significant in most studies, and of uncertain clinical significance (difference, −0.7 to 0 mmol/L [−28 to 0 mg/dL] for total cholesterol levels and −0.6 to 0.1 mmol/L [−22 to 2 mg/dL] for low-density lipoprotein cholesterol levels). Treatment harms were poorly studied and sparsely reported. Two poor-quality studies evaluated treatment of subclinical hyperthyroidism but examined intermediate outcomes. No study evaluated treatment versus no treatment of screen-detected, undiagnosed overt thyroid dysfunction. Limitations:English-language articles only, no treatment study performed in the United States, and small trials with short duration that used different dosage protocols. Conclusion:More research is needed to determine the clinical benefits associated with thyroid screening. Primary Funding Source:Agency for Healthcare Research and Quality.
Topics: thyroid diseases, subclinical hypothyroidism
Original Research | 
Dan Yamin, PhD; Shai Gertler; Martial L. Ndeffo-Mbah, PhD; Laura A. Skrip, MPH; Mosoka Fallah, PhD; Tolbert G. Nyenswah, MPH; Frederick L. Altice, MD, MA; and Alison P. Galvani, PhD
Includes: Supplemental Content
Background:The Ebola outbreak that is sweeping across West Africa is the largest, most volatile, and deadliest Ebola epidemic ever recorded. Liberia is the most profoundly affected country, with more than 3500 infections and 2000 deaths recorded in the past 3 months. Objective:To evaluate the contribution of disease progression and case fatality to transmission and to examine the potential for targeted interventions to eliminate the disease. Design:Stochastic transmission model that integrates epidemiologic and clinical data on incidence and case fatality, daily viral load among survivors and nonsurvivors evaluated on the basis of the 2000–2001 outbreak in Uganda, and primary data on contacts of patients with Ebola in Liberia. Setting:Montserrado County Liberia, July to September 2014. Measurements:Ebola incidence and case fatality records from 2014 Liberian Ministry of Health and Social Welfare. Results:The average number of secondary infections generated throughout the entire infectious period of a single infected case, R0, was estimated as 1.73 (95% CI, 1.66 to 1.83). There was substantial stratification between survivors (R0Survivors), for whom the estimate was 0.66 (CI, 0.10 to 1.69) and nonsurvivors (the R0Nonsurvivors), for whom the estimate was 2.36 (CI, 1.72 to 2.80). The nonsurvivors had the highest risk for transmitting the virus later in the course of disease progression. Consequently, the isolation of 75% of infected individuals in critical condition within 4 days from symptom onset has a high chance of eliminating the disease. Limitations:Projections are based on the initial dynamics of the epidemic, which may change as the outbreak and interventions evolve. Conclusion:These results underscore the importance of isolating the most severely ill patients with Ebola within the first few days of their symptomatic phase. Primary Funding Source:National Institutes of Health.
Topics: disease progression, disease transmission, ebola virus disease, liberia, epidemic control, ebola virus, viral load result
Ideas and Opinions | 
Henry M. Wu, MD; Jessica K. Fairley, MD; James Steinberg, MD; and Phyllis Kozarsky, MD
Recommendations for evaluation of patients with possible Ebola virus disease have focused on hospital emergency departments and inpatient units as the loci of care. However, patients may instead present to ambulatory settings. The authors describe a dedicated travel clinic–based program for such evaluation that uses existing phone triage systems, provides assessment by infectious disease experts, and ensures appropriate isolation and infection control.
Topics: ebola virus, ambulatory care services, ebola virus disease
Ideas and Opinions | 
Mark G. Kortepeter, MD, MPH; Philip W. Smith, MD; Angela Hewlett, MD; and Theodore J. Cieslak, MD
Medical centers in the United States are coming to grips with the need to prepare for care of patients with Ebola virus disease. The authors of this commentary discuss the challenges of treating these patients in a conventional setting and call for a network of strategically located regional referral centers serving designated catchment areas.
Topics: ebola virus, containment of biohazards, ebola virus disease, nosocomial infection
Ideas and Opinions | 
Andrew Hantel, MD; and Christopher Olusola Olopade, MD, MPH
A World Health Organization advisory panel recently concluded that it is ethical to use experimental medications and vaccines that have not been formally approved or tested in humans to treat persons with Ebola in the current West African epidemic. The authors of this commentary urge the medical community to focus on implementing the current standard of care fairly while maintaining principled experimentation to provide a better future standard.
Topics: ebola virus, ebola virus disease, epidemic, experimental treatment, compassionate use, ebola vaccines
Federal agencies proposing any significant regulatory action are required to evaluate the regulation's costs and benefits. The U.S. Food and Drug Administration (FDA) prepared an economic impact analysis of a proposed rule for graphic warning labels on tobacco products. This commentary discusses the analysis and finds fault with the FDA's decision to include the “lost pleasure” from tobacco use as a cost in economic impact analyses of tobacco regulations.
Topics: cost-benefit analysis, cigarettes, government regulations, tobacco
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