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Topics: pulmonary embolism, pulmonary embolism, massive, acute, clinical practice guideline, american college of physicians, best practice
Clinical Guidelines | 
Ali S. Raja, MD; Jeffrey O. Greenberg, MD; Amir Qaseem, MD, PhD, MHA; Thomas D. Denberg, MD, PhD; Nick Fitterman, MD; and Jeremiah D. Schuur, MD, MHS, for the Clinical Guidelines Committee of the American College of Physicians*
Description:Pulmonary embolism (PE) can be a severe disease but is also difficult to diagnose, given its nonspecific signs and symptoms. Because of this, testing of patients with suspected acute PE has risen drastically. However, the overuse of some tests, particularly computed tomography (CT) and plasma d-dimer, may not improve care while potentially leading to patient harm and unnecessary expense. Methods:The literature search encompassed studies indexed by MEDLINE (1966–2014; English-language only) and included all clinical trials and meta-analyses on diagnostic strategies, decision rules, laboratory tests, and imaging studies for the diagnosis of PE. This document is not based on a formal systematic review, but instead seeks to provide practical advice based on the best available evidence and recent guidelines. The target audience for this paper is all clinicians; the target patient population is all adults, both inpatient and outpatient, suspected of having acute PE. Best Practice Advice 1:Clinicians should use validated clinical prediction rules to estimate pretest probability in patients in whom acute PE is being considered. Best Practice Advice 2:Clinicians should not obtain d-dimer measurements or imaging studies in patients with a low pretest probability of PE and who meet all Pulmonary Embolism Rule-Out Criteria. Best Practice Advice 3:Clinicians should obtain a high-sensitivity d-dimer measurement as the initial diagnostic test in patients who have an intermediate pretest probability of PE or in patients with low pretest probability of PE who do not meet all Pulmonary Embolism Rule-Out Criteria. Clinicians should not use imaging studies as the initial test in patients who have a low or intermediate pretest probability of PE. Best Practice Advice 4:Clinicians should use age-adjusted d-dimer thresholds (age × 10 ng/mL rather than a generic 500 ng/mL) in patients older than 50 years to determine whether imaging is warranted. Best Practice Advice 5:Clinicians should not obtain any imaging studies in patients with a d-dimer level below the age-adjusted cutoff. Best Practice Advice 6:Clinicians should obtain imaging with CT pulmonary angiography (CTPA) in patients with high pretest probability of PE. Clinicians should reserve ventilation–perfusion scans for patients who have a contraindication to CTPA or if CTPA is not available. Clinicians should not obtain a d-dimer measurement in patients with a high pretest probability of PE.
Topics: pulmonary embolism, massive, acute, diagnostic imaging, pretest probability of disease, dimers, best practice, american college of physicians, clinical practice guideline
Ideas and Opinions | 
Tarig Elraiyah, MBBS, MSc; Michael R. Gionfriddo, PharmD; Victor M. Montori, MD, MSc; and Mohammad Hassan Murad, MD, MPH
Black box warnings (BBWs) are the highest-level warnings issued by the U.S. Food and Drug Administration for medications. Despite their potential importance, BBWs have been the subject of controversy, due in part to their opaque connection to the underlying body of evidence. In this article, the authors propose a new structure for presenting BBWs that takes into consideration the fundamental principles of evidence-based medicine.
Topics: black box warning
Ideas and Opinions | 
Alison Bateman-House, PhD, MPH, MA; Laura Kimberly, MSW, MBE; Barbara Redman, PhD, MBE; Nancy Dubler, LLB; and Arthur Caplan, PhD
Some terminally ill patients want to use drugs and devices that are too early in their development to be approved by the U.S. Food and Drug Administration. As a result, some states have recently passed “right-to-try” laws that authorize patients to request these treatments from the manufacturer. Several other states are considering similar legislation. What is uncertain is whether these laws provide the benefits they promise.
Topics: statutes and laws, double effect
Reviews | 
Jennifer Pillay, BSc; Marni J. Armstrong, PhD, RCEP; Sonia Butalia, MD, MSc; Lois E. Donovan, MD; Ronald J. Sigal, MD, MPH; Pritam Chordiya, BDS, MSc; Sanjaya Dhakal, MBBS, MPH; Ben Vandermeer, MSc; Lisa Hartling, PhD; Megan Nuspl, BSc; Robin Featherstone, MLIS; and Donna M. Dryden, PhD
Background:Whether behavioral approaches for self-management programs benefit individuals with type 1 diabetes is unclear. Purpose:To determine the effects of behavioral programs for patients with type 1 diabetes on behavioral, clinical, and health outcomes and to investigate factors that might moderate effect. Data Sources:6 electronic databases (1993 to June 2015), trial registries and conference proceedings (2011 to 2014), and reference lists. Study Selection:35 prospective controlled studies involving participants of any age group that compared behavioral programs with usual care, active controls, or other programs. Data Extraction:One reviewer extracted and another verified data. Two reviewers assessed quality and strength of evidence (SOE). Data Synthesis:Moderate SOE showed reduction in glycated hemoglobin (HbA1c) at 6 months after the intervention compared with usual care (mean difference, −0.29 [95% CI, −0.45 to −0.13]) percentage points and compared with active controls (−0.44 [CI, −0.69 to −0.19]) percentage points. At end of intervention and 12 months' follow-up or longer, there were no statistically significant differences in HbA1c (low SOE) for comparisons with usual care or active control. Compared with usual care, generic quality of life at program completion did not differ (moderate SOE). Other outcomes had low or insufficient SOE. Adults appeared to benefit more for glycemic control at program completion (−0.28 [CI, −0.57 to 0.01]) percentage points than did youth (−0.12 [CI, −0.43 to 0.19]) percentage points. Program intensity appeared not to influence effectiveness; some individual delivery appears beneficial. Limitations:All studies had medium or high risk of bias. There was scarce evidence for many outcomes. Conclusion:Behavioral programs for type 1 diabetes offer some benefit for glycemic control, at least at short-term follow-up, but improvement for other outcomes has not been shown. Primary Funding Source:Agency for Healthcare Research and Quality.
Topics: diabetes mellitus, type 1, follow-up, hemoglobin a, glycosylated, glucose control, diabetes mellitus, type 2, diabetes mellitus
Original Research | 
Jane J. Kim, PhD; Nicole G. Campos, PhD; Stephen Sy, MS; Emily A. Burger, PhD; Jack Cuzick, PhD; Philip E. Castle, PhD, MPH; William C. Hunt, MS; Alan Waxman, MD, MPH; Cosette M. Wheeler, PhD, on behalf of the New Mexico HPV Pap Registry Steering Committee
Background:Studies suggest that cervical cancer screening practice in the United States is inefficient. The cost and health implications of nonadherence in the screening process compared with recommended guidelines are uncertain. Objective:To estimate the benefits, costs, and cost-effectiveness of current cervical cancer screening practice and assess the value of screening improvements. Design:Model-based cost-effectiveness analysis. Data Sources:New Mexico HPV Pap Registry; medical literature. Target Population:Cohort of women eligible for routine screening. Time Horizon:Lifetime. Perspective:Societal. Intervention:Current cervical cancer screening practice; improved adherence to guidelines-based screening interval, triage testing, diagnostic referrals, and precancer treatment referrals. Outcome Measures:Reductions in lifetime cervical cancer risk, quality-adjusted life-years (QALYs), lifetime costs, incremental cost-effectiveness ratios, and incremental net monetary benefits (INMBs). Results of Base-Case Analysis:Current screening practice was associated with lower health benefit and was not cost-effective relative to guidelines-based strategies. Improvements in the screening process were associated with higher QALYs and small changes in costs. Perfect adherence to screening every 3 years with cytologic testing and adherence to colposcopy/biopsy referrals were associated with the highest INMBs ($759 and $741, respectively, at a willingness-to-pay threshold of $100 000 per QALY gained); together, the INMB increased to $1645. Results of Sensitivity Analysis:Current screening practice was inefficient in 100% of simulations. The rank ordering of screening improvements according to INMBs was stable over a range of screening inputs and willingness-to-pay thresholds. Limitation:The effect of human papillomavirus vaccination was not considered. Conclusions:The added health benefit of improving adherence to guidelines, especially the 3-year interval for cytologic screening and diagnostic follow-up, may justify additional investments in interventions to improve U.S. cervical cancer screening practice. Primary Funding Source:U.S. National Cancer Institute.
Topics: cervical cancer, human papillomavirus, new mexico, cost-effectiveness analysis, cervical cancer screening, cytology, biopsy, guidelines, colposcopy, cancer
Reviews | 
Jennifer Pillay, BSc; Marni J. Armstrong, PhD, RCEP; Sonia Butalia, MD, MSc; Lois E. Donovan, MD; Ronald J. Sigal, MD, MPH; Ben Vandermeer, MSc; Pritam Chordiya, BDS, MSc; Sanjaya Dhakal, MBBS, MPH; Lisa Hartling, PhD; Megan Nuspl, BSc; Robin Featherstone, MLIS; and Donna M. Dryden, PhD
Includes: Supplemental Content
Background:Behavioral programs may improve outcomes for individuals with type 2 diabetes, but there is a large diversity of behavioral interventions and uncertainty about how to optimize the effectiveness of these programs. Purpose:To identify factors moderating the effectiveness of behavioral programs for adults with type 2 diabetes. Data Sources:6 databases (1993 to January 2015), conference proceedings (2011–2014), and reference lists. Study Selection:Duplicate screening and selection of 132 randomized, controlled trials evaluating behavioral programs compared with usual care, active controls, or other behavioral programs. Data Extraction:One reviewer extracted and another verified data. Two reviewers independently assessed risk of bias. Data Synthesis:Behavioral programs were grouped on the basis of program content and delivery methods. A Bayesian network meta-analysis showed that most lifestyle and diabetes self-management education and support programs (usually offering ≥11 contact hours) led to clinically important improvements in glycemic control (≥0.4% reduction in hemoglobin [Hb] A1c), whereas most diabetes self-management education programs without added support—especially those offering 10 or fewer contact hours—provided little benefit. Programs with higher effect sizes were more often delivered in person than via technology. Lifestyle programs led to the greatest reductions in body mass index. Reductions in HbA1c seemed to be greater for participants with a baseline HbA1c level of 7.0% or greater, adults younger than 65 years, and minority persons (subgroups with ≥75% nonwhite participants). Limitations:All trials had medium or high risk of bias. Subgroup analyses were indirect, and therefore exploratory. Most outcomes were reported immediately after the interventions. Conclusion:Diabetes self-management education offering 10 or fewer hours of contact with delivery personnel provided little benefit. Behavioral programs seem to benefit persons with suboptimal or poor glycemic control more than those with good control. Primary Funding Source:Agency for Healthcare Research and Quality. (PROSPERO registration number: CRD42014010515)
Topics: diabetes mellitus, type 2, hemoglobin a, glycosylated, diabetes mellitus
Ideas and Opinions | 
John R. Ball, MD, JD; and Erin Balogh, MPH
To date, reduction of diagnostic error has not been emphasized in efforts to improve patient safety in health care. Recognizing this, the Institute of Medicine assembled a panel to evaluate the existing knowledge about diagnostic error and to propose solutions. This commentary highlights key points from the resulting September 2015 report, “Improving Diagnosis in Health Care”.
Topics: diagnostic errors, engineering, institute of medicine (u.s.)
Original Research | 
Sanjay Basu, MD, PhD; Russell S. Phillips, MD; Asaf Bitton, MD, MPH; Zirui Song, MD, PhD; and Bruce E. Landon, MD, MBA, MSc
Background:Physicians have traditionally been reimbursed for face-to-face visits. A new non–visit-based payment for chronic care management (CCM) of Medicare patients took effect in January 2015. Objective:To estimate financial implications of CCM payment for primary care practices. Design:Microsimulation model incorporating national data on primary care use, staffing, expenditures, and reimbursements. Data Sources:National Ambulatory Medical Care Survey and other published sources. Target Population:Medicare patients. Time Horizon:10 years. Perspective:Practice-level. Intervention:Comparison of CCM delivery approaches by staff and physicians. Outcome Measures:Net revenue per full-time equivalent (FTE) physician; time spent delivering CCM services. Results of Base-Case Analysis:If nonphysician staff were to deliver CCM services, net revenue to practices would increase despite opportunity and staffing costs. Practices could expect approximately $332 per enrolled patient per year (95% CI, $234 to $429) if CCM services were delivered by registered nurses (RNs), approximately $372 (CI, $276 to $468) if services were delivered by licensed practical nurses, and approximately $385 (CI, $286 to $485) if services were delivered by medical assistants. For a typical practice, this equates to more than $75 000 of net annual revenue per FTE physician and 12 hours of nursing service time per week if 50% of eligible patients enroll. At a minimum, 131 Medicare patients (CI, 115 to 140 patients) must enroll for practices to recoup the salary and overhead costs of hiring a full-time RN to provide CCM services. Results of Sensitivity Analysis:If physicians were to deliver all CCM services, approximately 25% of practices nationwide could expect net revenue losses due to opportunity costs of face-to-face visit time. Limitation:The CCM program may alter long-term primary care use, which is difficult to predict. Conclusion:Practices that rely on nonphysician team members to deliver CCM services will probably experience substantial net revenue gains but must enroll a sufficient number of eligible patients to recoup costs. Primary Funding Source:None.
Topics: medicare, primary health care, chronic care, reimbursement mechanisms, sensitivity analysis, nurses, chronic disease
Reviews | 
Carrie D. Patnode, PhD, MPH; Jillian T. Henderson, PhD, MPH; Jamie H. Thompson, MPH; Caitlyn A. Senger, MPH; Stephen P. Fortmann, MD; and Evelyn P. Whitlock, MD, MPH
Background:Tobacco use is the leading cause of preventable death in the United States. Purpose:To review the effectiveness and safety of pharmacotherapy and behavioral interventions for tobacco cessation. Data Sources:5 databases and 8 organizational Web sites were searched through 1 August 2014 for systematic reviews, and PubMed was searched through 1 March 2015 for trials on electronic nicotine delivery systems. Study Selection:Two reviewers examined 114 articles to identify English-language reviews that reported health, cessation, or adverse outcomes. Data Extraction:One reviewer abstracted data from good- and fair-quality reviews, and a second checked for accuracy. Data Synthesis:Fifty-four reviews were included. Behavioral interventions increased smoking cessation at 6 months or more (physician advice had a pooled risk ratio [RR] of 1.76 [95% CI, 1.58 to 1.96]). Nicotine replacement therapy (RR, 1.60 [CI, 1.53 to 1.68]), bupropion (RR, 1.62 [CI, 1.49 to 1.76]), and varenicline (RR, 2.27 [CI, 2.02 to 2.55]) were also effective for smoking cessation. Combined behavioral and pharmacotherapy interventions increased cessation by 82% compared with minimal intervention or usual care (RR, 1.82 [CI, 1.66 to 2.00]). None of the drugs were associated with major cardiovascular adverse events. Only 2 trials addressed efficacy of electronic cigarettes for smoking cessation and found no benefit. Among pregnant women, behavioral interventions benefited cessation and perinatal health; effects of nicotine replacement therapy were not significant. Limitation:Evidence published after each review's last search date was not included. Conclusion:Behavioral and pharmacotherapy interventions improve rates of smoking cessation among the general adult population, alone or in combination. Data on the effectiveness and safety of electronic nicotine delivery systems are limited. Primary Funding Source:Agency for Healthcare Research and Quality.
Topics: pregnancy, pharmacotherapy, smoking cessation, behavior therapy, adverse event, tobacco use cessation
Description:Update of the 2009 U.S. Preventive Services Task Force (USPSTF) recommendation on counseling and interventions to prevent tobacco use and tobacco-related disease in adults, including pregnant women. Methods:The USPSTF reviewed the evidence on interventions for tobacco smoking cessation that are relevant to primary care (behavioral interventions, pharmacotherapy, and complementary or alternative therapy) in adults, including pregnant women. Population:This recommendation applies to adults aged 18 years or older, including pregnant women. Recommendations:The USPSTF recommends that clinicians ask all adults about tobacco use, advise them to stop using tobacco, and provide behavioral interventions and U.S. Food and Drug Administration–approved pharmacotherapy for cessation to adults who use tobacco. (A recommendation) The USPSTF recommends that clinicians ask all pregnant women about tobacco use, advise them to stop using tobacco, and provide behavioral interventions for cessation to pregnant women who use tobacco. (A recommendation) The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of pharmacotherapy interventions for tobacco cessation in pregnant women. (I statement) The USPSTF concludes that the current evidence is insufficient to recommend electronic nicotine delivery systems for tobacco cessation in adults, including pregnant women. The USPSTF recommends that clinicians direct patients who smoke tobacco to other cessation interventions with established effectiveness and safety (previously stated). (I statement)
Topics: pregnancy, pharmacotherapy, behavior therapy, smoking cessation
Topics: pharmacotherapy, smoking cessation
In this issue, Basu and colleagues provide a comprehensive and rigorous model of costs and revenue projections for Medicare's new code that will enable reimbursement for chronic care management (CCM) services. The editorialist discusses the challenges and implications of CCM for smaller practices and why it may further widen the gulf between independent physicians and large institutional practices.
Topics: primary health care, chronic care
Containing health care costs requires the reduction of overtreatment and constraint of health care prices. Provisions of the Affordable Care Act (ACA) help to reign in overuse within the Medicare and private markets. However, the author argues that, although the ACA addresses health care prices within Medicare, it is relatively silent on price control in the private market and that provisions that tend to promote the consolidation of providers and reduce competition may command higher prices.
Topics: cost control, retinal blind spot, patient protection and affordable care act, medicare
Reviews | 
Michael Miligkos, MD, MS; Raveendhara R. Bannuru, MD, PhD; Hadeel Alkofide, MS, PhD; Sucharita R. Kher, MD; Christopher H. Schmid, PhD*; and Ethan M. Balk, MD, MPH*
Background:Leukotriene-receptor antagonists (LTRAs) are recommended as an alternative treatment in patients with mild asthma, but their effect compared with placebo is unclear. Purpose:To determine the benefits and harms of LTRAs as monotherapy or in combination with inhaled corticosteroids compared with placebo in adults and adolescents with asthma. Data Sources:MEDLINE and the Cochrane Central Register of Controlled Trials from inception through June 2015. Study Selection:Peer-reviewed, English-language, randomized, controlled trials in patients with asthma that reported the effect of LTRAs versus placebo on measures of asthma control. Data Extraction:Three researchers extracted data on study population, interventions, outcome measures, and adverse events. One researcher assessed risk of bias. Data Synthesis:Of the 2008 abstracts that were screened, 50 trials met eligibility criteria. Random-effects meta-analyses of 6 trials of LTRA monotherapy showed that LTRAs reduced the risk for an exacerbation (summary risk ratio [RR], 0.60 [95% CI, 0.44 to 0.81]). In 4 trials of LTRAs as add-on therapy to inhaled corticosteroids, the summary RR for exacerbation was 0.80 (CI, 0.60 to 1.07). Leukotriene-receptor antagonists either as monotherapy or add-on therapy to inhaled corticosteroids increased FEV1, whereas FEV1 percentage of predicted values was only improved in trials of LTRA monotherapy. Adverse event rates were similar in the intervention and comparator groups. Limitation:Variation in definitions and reporting of outcomes, high risk of bias in some studies, heterogeneity of findings, possible selective outcome reporting bias, and inability to assess the effect of asthma severity on summary estimates. Conclusion:Leukotriene-receptor antagonists as monotherapy improved asthma control compared with placebo, but which patients are most likely to respond to treatment with LTRAs remains unclear. Primary Funding Source:National Institutes of Health.
Topics: asthma, leukotriene receptor, antagonists, diamond, add-on code, agonists
Ideas and Opinions | 
Jeffrey L. Tokar, MD; John I. Allen, MD; and Michael L. Kochman, MD
In recent months, recognition of “superbug infections” from agents transmitted by specialized endoscopes used for endoscopic retrograde cholangiopancreatography has prompted investigation and development of action plans by the U.S. Food and Drug Administration, the Centers for Disease Control and Prevention, and professional medical societies. This commentary highlights the situation and the efforts under way to better understand the problem; develop creative solutions; and, above all, ensure patient safety.
Topics: duodenoscopes, risk reduction, endoscopes
Many physicians dislike the process of assessing patient satisfaction. This commentary, which references a 1925 speech delivered by Dr. Francis Weld Peabody, explains why physicians should pay attention to patient satisfaction and the process by which it is assessed.
Topics: client satisfaction, hate
The authors argue that clinicians, public health experts, and representatives of the public should be involved in examining the advisability of performing experiments intended to create potential pandemic pathogens, providing important perspectives on how to reduce the risks of such research, and increasing public confidence in scientists as responsible stewards.
Topics: engineering, genome, pathogenic organism, pandemic
Position Papers | 
Hilary Daniel, BS; Lois Snyder Sulmasy, JD, for the ACP Health and Public Policy Committee*
Telemedicine—the use of technology to deliver care at a distance—is rapidly growing and can potentially expand access for patients, enhance patient–physician collaboration, improve health outcomes, and reduce medical costs. However, the potential benefits of telemedicine must be measured against the risks and challenges associated with its use, including the absence of the physical examination, variation in state practice and licensing regulations, and issues surrounding the establishment of the patient–physician relationship. This paper offers policy recommendations for the practice and use of telemedicine in primary care and reimbursement policies associated with telemedicine use. The positions put forward by the American College of Physicians highlight a meaningful approach to telemedicine policies and regulations that will have lasting positive effect for patients and physicians.
Topics: telemedicine
Editorials | 
David A. Asch, MD, MBA
This issue contains an American College of Physicians position paper on telemedicine. The editorialist believes that the gains from telemedicine will come from delivering care to populations—sometimes highly specialized care, in totally different ways. The innovation that telemedicine promises is not just doing the same thing remotely that used to be done face to face but awakening us to the many things that we thought required face-to-face contact but actually do not.
Topics: telemedicine, economics
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