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Original Research | 
Rahul K. Nayak, BSE; David Wendler, PhD; Franklin G. Miller, PhD; and Scott Y.H. Kim, MD, PhD
Includes: Supplemental Content
Background:Significant debate surrounds the issue of whether written consent is necessary for pragmatic randomized, controlled trials (RCTs) with low risk. Objective:To assess the U.S. public's views on alternatives to written consent for low-risk pragmatic RCTs. Design:National experimental survey (2 × 2 factorial design) examining support for written consent versus general notification or verbal consent in 2 research scenarios. Setting:Web-based survey conducted in December 2014. Participants:2130 U.S. adults sampled from a nationally representative, probability-based online panel (response rate, 64.0%). Measurements:Respondent's recommendation to an ethics review board and personal preference as a potential participant for how to obtain consent or notification in the 2 research scenarios. Results:A majority of respondents in each of the 4 groups (range, 60.3% to 71.5%) recommended written informed consent, and personal preferences were generally in line with that advice. Most (78.9%) believed that the pragmatic RCTs did not pose additional risks, but 62.5% of these respondents would still recommend written consent. In contrast, a substantial minority in all groups (28.5% to 39.7%) recommended the alternative option (general notification or verbal consent) over written consent. Limitation:Framing effects could have impacted respondents' attitudes, and nonrespondents may have differed in levels of trust toward research or health care institutions. Conclusion:A majority of the public favored written informed consent over the most widely advocated alternatives for low-risk pragmatic RCTs; however, a substantial minority favored general notification or verbal consent. Primary Funding Source:Time-sharing Experiments for the Social Sciences and Intramural Research Program of the National Institutes of Health Clinical Center.
Topics: ethics, informed consent
Topics: cardiovascular disease risk factors, blood pressure
Reviews | 
Raveendhara R. Bannuru, MD, PhD; Timothy E. McAlindon, MD; Matthew C. Sullivan, BA; John B. Wong, MD; David M. Kent, MD; and Christopher H. Schmid, PhD
Background:Placebo controls are essential in evaluating the effectiveness of medical treatments. Although it is unclear whether different placebo interventions for osteoarthritis vary in efficacy, systematic differences would substantially affect interpretation of the results of placebo-controlled trials. Objective:To evaluate the effects of alternative placebo types on pain outcomes in knee osteoarthritis. Data Sources:MEDLINE, EMBASE, Web of Science, Google Scholar, and Cochrane Database from inception through 1 June 2015 and unpublished data. Study Selection:149 randomized trials of adults with knee osteoarthritis that reported pain outcomes and compared widely used pharmaceuticals against the following 4 placebos: oral, intra-articular, topical, and oral plus topical. Data Extraction:Study data were independently double-extracted; study quality was assessed by using the Cochrane risk of bias tool. Data Synthesis:Placebo effects that were evaluated by using a network meta-analysis with 4 separate placebo nodes (differential model) showed that intra-articular placebo (effect size [95% credible interval], 0.29 [0.09 to 0.49]) and topical placebo (effect size, 0.20 [credible interval, 0.02 to 0.38]) had significantly greater effect sizes than did oral placebo. This differential model showed marked differences in the relative efficacies and hierarchy of the active treatments compared with a network model that considered all placebos equivalent. In the model accounting for differential effects, intra-articular and topical therapies were superior to oral treatments in reducing pain. When these differential effects were ignored, oral nonsteroidal anti-inflammatory drugs were superior. Limitations:Few studies compared different placebos directly. The study could not decisively conclude whether disease severity and co-interventions systematically differed between trials evaluating different placebos. Conclusion:All placebos are not equal, and some can trigger clinically relevant responses. Differential placebo effects can substantially alter estimates of the relative efficacies of active treatments, an important consideration for the design of clinical trials and interpretation of the results. Primary Funding Source:Agency for Healthcare Research and Quality.
Topics: osteoarthritis, pain, placebo effect, osteoarthritis, knee, anti-inflammatory agents, non-steroidal
Original Research | 
Paul Muntner, PhD; Jeff Whittle, MD; Amy I. Lynch, PhD; Lisandro D. Colantonio, MD; Lara M. Simpson, PhD; Paula T. Einhorn, MD; Emily B. Levitan, PhD; Paul K. Whelton, MD; William C. Cushman, MD; Gail T. Louis, RN; Barry R. Davis, MD; and Suzanne Oparil, MD
Background:Variability of blood pressure (BP) across outpatient visits is frequently dismissed as random fluctuation around a patient's underlying BP. Objective:To examine the association of visit-to-visit variability (VVV) of systolic BP (SBP) and diastolic BP with cardiovascular disease (CVD) and mortality outcomes. Design:Prospective cohort study. Setting:Post hoc analysis of ALLHAT (Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial). Participants:25 814 ALLHAT participants. Measurements:The VVV of SBP was defined as the SD across SBP measurements obtained at 7 visits conducted from 6 to 28 months after ALLHAT enrollment. Participants without CVD events during the first 28 months of follow-up were followed from the 28-month visit through the end of active ALLHAT follow-up. Outcomes included fatal coronary heart disease (CHD) or nonfatal myocardial infarction (MI), all-cause mortality, stroke, and heart failure. Results:During follow-up, 1194 fatal CHD or nonfatal MI events, 1948 deaths, 606 strokes, and 921 heart failure events occurred. After multivariable adjustment, including for mean SBP, the hazard ratio comparing participants in the highest versus lowest quintile of SD of SBP (≥14.4 mm Hg vs. <6.5 mm Hg) was 1.30 (95% CI, 1.06 to 1.59) for fatal CHD or nonfatal MI, 1.58 (CI, 1.32 to 1.90) for all-cause mortality, 1.46 (CI, 1.06 to 2.01) for stroke, and 1.25 (CI, 0.97 to 1.61) for heart failure. Higher VVV of diastolic BP was also associated with CVD events and mortality. Limitation:Long-term outcomes were not available. Conclusion:Higher VVV of SBP is associated with an increased risk for CVD and mortality. Future studies should examine whether reducing VVV of BP lowers this risk. Primary Funding Source:National Institutes of Health.
Topics: heart failure, blood pressure, mortality, coronary heart disease, allhat trial, cardiovascular diseases, cerebrovascular accident, ischemic stroke, antihypertensive agents
In this issue, Bannuru and colleagues present a network meta-analysis that examines the relative efficacy of different placebos given for knee osteoarthritis. The editorialists discuss how patient expectancy and contextual factors influence placebo effect. They believe that randomized, placebo-controlled trial reports need to better recognize and account for placebo effects when comparing interventions.
Topics: knee region, knee joint, needle device, osteoarthritis, knee
Original Research | 
Alexander T. Sandhu, MD; R. Adams Dudley, MD, MBA; and Dhruv S. Kazi, MD, MSc, MS
Includes: Supplemental Content
Background:In 2014, the American Board of Internal Medicine (ABIM) substantially increased the requirements and fees for its maintenance-of-certification (MOC) program. Faced with mounting criticism, the ABIM suspended certain content requirements in February 2015 but retained the increased fees and number of modules. An objective appraisal of the cost of MOC would help inform upcoming consultations about MOC reform. Objective:To estimate the total cost of the 2015 version of the MOC program (“2015 MOC”) and the incremental cost relative to the 2013 version (“2013 MOC”). Design:Decision analytic model. Data Sources:Published literature. Target Population:All ABIM-certified U.S. physicians. Time Horizon:10 years (2015 to 2024). Perspective:Societal. Intervention:2015 MOC. Outcome Measures:Testing costs (ABIM fees) and time costs (monetary value of physician time). Results of Base-Case Analysis:Internists will incur an average of $23 607 (95% CI, $5380 to $66 383) in MOC costs over 10 years, ranging from $16 725 for general internists to $40 495 for hematologists-oncologists. Time costs account for 90% of MOC costs. Cumulatively, 2015 MOC will cost $5.7 billion over 10 years, $1.2 billion more than 2013 MOC. This includes $5.1 billion in time costs (resulting from 32.7 million physician-hours spent on MOC) and $561 million in testing costs. Results of Sensitivity Analysis:Costs are sensitive to time spent on MOC and MOC credits obtainable from current continuing education activities. Limitation:Precise estimates of time required for MOC are not available. Conclusion:The ABIM MOC program will generate considerable costs, predominantly due to demands on physician time. A rigorous evaluation of its effect on clinical and economic outcomes is warranted to balance potential gains in health care quality and efficiency against the high costs identified in this study. Primary Funding Source:University of California, San Francisco, and the Department of Veterans Affairs.
Topics: sensitivity analysis, american board of internal medicine
Tobacco is a “wicked problem,” which refers to complex social problems with large economic burdens that resist simple solutions and bedevil policymakers. This commentary discusses a recent Institute of Medicine report that addresses how agent-based models might guide tobacco control policy. These computational models explore how individual elements of the system behave as a function of individual characteristics or interactions with each other and with the environment.
Topics: institute of medicine (u.s.), tobacco use, tobacco
Original Research | 
Meenakshi Bewtra, MD, MPH, PhD; Craig W. Newcomb, MS; Qufei Wu, MS; Lang Chen, PhD; Fenglong Xie, MS; Jason A. Roy, PhD; Cary B. Aarons, MD; Mark T. Osterman, MD, MSCE; Kimberly A. Forde, MD, MHS; Jeffrey R. Curtis, MD, MS, MPH; and James D. Lewis, MD, MSCE
Includes: Supplemental Content
Background:Ulcerative colitis (UC) can be treated with surgery or medications. Patients often must choose between long-term immunosuppressant therapy or total colectomy. Whether one of these treatment approaches has a mortality benefit is uncertain. Objective:To determine whether patients with advanced UC treated with elective colectomy have improved survival compared with those treated with medical therapy. Design:Retrospective matched cohort study. Setting:Data from all 50 states for Medicaid beneficiaries (2000 to 2005), Medicare beneficiaries (2006 to 2011), and dual-eligible persons (2000 to 2011). Patients:830 patients with UC pursuing elective colectomy and 7541 matched patients with UC pursuing medical therapy. Measurements:The primary outcome was time to death. Cox proportional hazards models were used to compare the survival of patients with advanced UC treated with elective colectomy or medical therapy. The models controlled for significant comorbid conditions through matched and adjusted analysis. Results:The mortality rates associated with elective surgery and medical therapy were 34 and 54 deaths per 1000 person-years, respectively. Elective colectomy was associated with improved survival compared with long-term medical therapy (adjusted hazard ratio [HR], 0.67 [95% CI, 0.52 to 0.87]), although this result did not remain statistically significant in all sensitivity analyses. Post hoc analysis by age group showed improved survival with surgery in patients aged 50 years or older with advanced UC (HR, 0.60 [CI, 0.45 to 0.79]; P = 0.032 for age-by-treatment interaction). Limitations:Retrospective nonrandomized analysis is subject to residual confounding. The source cohort was derived from different databases throughout the study. Sensitivity and secondary analyses had reduced statistical power. Conclusion:Elective colectomy seemed to be associated with improved survival relative to medical therapy among patients aged 50 years or older with advanced UC. Primary Funding Source:National Institutes of Health and Agency for Healthcare Research and Quality.
Topics: colectomy, ulcerative colitis, medical management, mortality, surgical procedures, elective, therapeutics
Summaries for Patients | 
Topics: ulcerative colitis, mortality, medical management
Editorials | 
David B. Sachar, MD
In this issue, Bewtra and colleagues report a study that compared the outcomes of medical versus surgical treatment of ulcerative colitis. This editorial explains why this study shows that simply keeping a patient's colon intact is not a sufficient long-term measure of therapeutic success in ulcerative colitis. The goal of therapy should be not only to avoid surgery, but also to make the patient well.
Topics: ulcerative colitis
Original Research | 
Deborah Cook, MD; Marilyn Swinton, MSc; Feli Toledo, MDiv; France Clarke, RRT; Trudy Rose, BA, MTS; Tracey Hand-Breckenridge, MDiv; Anne Boyle, BScN, MD; Anne Woods, MD, MDiv; Nicole Zytaruk, RN; Diane Heels-Ansdell, MSc; and Robert Sheppard, MD
Includes: Supplemental Content
Background:Dying in the complex, efficiency-driven environment of the intensive care unit can be dehumanizing for the patient and have profound, long-lasting consequences for all persons attendant to that death. Objective:To bring peace to the final days of a patient's life and to ease the grieving process. Design:Mixed-methods study. Setting:21-bed medical–surgical intensive care unit. Participants:Dying patients and their families and clinicians. Intervention:To honor each patient, a set of wishes was generated by patients, family members, or clinicians. The wishes were implemented before or after death by patients, families, clinicians (6 of whom were project team members), or the project team. Measurements:Quantitative data included demographic characteristics, processes of care, and scores on the Quality of End-of-Life Care–10 instrument. Semistructured interviews of family members and clinicians were transcribed verbatim, and qualitative description was used to analyze them. Results:Participants included 40 decedents, at least 1 family member per patient, and 3 clinicians per patient. The 159 wishes were implemented and classified into 5 categories: humanizing the environment, tributes, family reconnections, observances, and “paying it forward.” Scores on the Quality of End-of-Life Care–10 instrument were high. The central theme from 160 interviews of 170 persons was how the 3 Wishes Project personalized the dying process. For patients, eliciting and customizing the wishes honored them by celebrating their lives and dignifying their deaths. For families, it created positive memories and individualized end-of-life care for their loved ones. For clinicians, it promoted interprofessional care and humanism in practice. Limitation:Impaired consciousness limited understanding of patients' viewpoints. Conclusion:The 3 Wishes Project facilitated personalization of the dying process through explicit integration of palliative and spiritual care into critical care practice. Primary Funding Source:Hamilton Academy of Health Science Research Organization, Canadian Intensive Care Foundation.
Topics: intensive care unit, terminally ill, end-of-life care
In this issue, Cook and colleagues report their experience with an approach to humanize terminal care by identifying and implementing final wishes for dying patients. The editorialist notes that skeptics may argue that the study proves little that can be generalized in time or place. However, he believes that it ably demonstrates a pragmatic intervention to promote personalized care for dying adult patients and encourages clinicians to test the notion themselves by endeavoring to fulfill personalized wishes solicited from patients, families, or one another at the time of letting go in an intensive care unit.
Topics: death, intensive care unit
Reviews | 
Ethan M. Balk, MD, MPH; Amy Earley, BS; Gowri Raman, MD, MS; Esther A. Avendano, BA; Anastassios G. Pittas, MD, MS; and Patrick L. Remington, MD, MPH
Includes: Supplemental Content
Background:Trials have shown efficacy of rigorous diet and physical activity promotion programs to reduce diabetes incidence and improve glycemic measures in adults at increased risk for type 2 diabetes. Purpose:To evaluate diet and physical activity promotion programs for persons at increased risk for type 2 diabetes, primarily to reduce diabetes risk and decrease body weight and glycemia. Data Sources:MEDLINE, the Cochrane Central Register of Controlled Trials, CAB Abstracts, Global Health, and Ovid HealthSTAR from 1991 through 27 February 2015, with no language restriction. Study Selection:8 researchers screened articles for single-group or comparative studies of combined diet and physical activity promotion programs with at least 2 sessions over at least 3 months in participants at increased risk for type 2 diabetes. Data Extraction:7 researchers extracted data on study design; participant, intervention, and outcome descriptions; and results and assessed study quality. Data Synthesis:Fifty-three studies (30 of diet and physical activity promotion programs vs. usual care, 12 of more intensive vs. less intensive programs, and 13 of single programs) evaluated 66 programs. Compared with usual care, diet and physical activity promotion programs reduced type 2 diabetes incidence (risk ratio [RR], 0.59 [95% CI, 0.51 to 0.66]) (16 studies), decreased body weight (net change, −2.2% [CI, −2.9% to −1.4%]) (24 studies) and fasting blood glucose level (net change, −0.12 mmol/L [−2.2 mg/dL] [CI, −0.20 to −0.05 mmol/L {−3.6 to −0.9 mg/dL}]) (17 studies), and improved other cardiometabolic risk factors. Evidence for clinical events was limited. More intensive programs were more effective. Limitations:Wide variation in diet and physical activity promotion programs limited identification of features most relevant to effectiveness. Evidence on clinical outcomes and in children was sparse. Conclusion:Combined diet and physical activity promotion programs are effective at decreasing diabetes incidence and improving cardiometabolic risk factors in persons at increased risk. More intensive programs are more effective. Primary Funding Source:Centers for Disease Control and Prevention Community Preventive Services Task Force.
Topics: physical activity, diabetes mellitus, type 2, diet, diabetes prevention, diabetes mellitus
Reviews | 
Rui Li, PhD; Shuli Qu, MPH; Ping Zhang, PhD; Sajal Chattopadhyay, PhD; Edward W. Gregg, PhD; Ann Albright, PhD; David Hopkins, MD; and Nicolaas P. Pronk, PhD
Background:Diabetes is a highly prevalent and costly disease. Studies indicate that combined diet and physical activity promotion programs can prevent type 2 diabetes among persons at increased risk. Purpose:To systematically evaluate the evidence on cost, cost-effectiveness, and cost–benefit estimates of diet and physical activity promotion programs. Data Sources:Cochrane Library, EMBASE, MEDLINE, PsycINFO, Sociological Abstracts, Web of Science, EconLit, and CINAHL through 7 April 2015. Study Selection:English-language studies from high-income countries that provided data on cost, cost-effectiveness, or cost–benefit ratios of diet and physical activity promotion programs with at least 2 sessions over at least 3 months delivered to persons at increased risk for type 2 diabetes. Data Extraction:Dual abstraction and assessment of relevant study details. Data Synthesis:Twenty-eight studies were included. Costs were expressed in 2013 U.S. dollars. The median program cost per participant was $653. Costs were lower for group-based programs (median, $417) and programs implemented in community or primary care settings (median, $424) than for the U.S. DPP (Diabetes Prevention Program) trial and the DPP Outcome Study ($5881). Twenty-two studies assessed the incremental cost-effectiveness ratios (ICERs) of the programs. From a health system perspective, 16 studies reported a median ICER of $13 761 per quality-adjusted life-year (QALY) saved. Group-based programs were more cost-effective (median, $1819 per QALY) than those that used individual sessions (median, $15 846 per QALY). No cost–benefit studies were identified. Limitation:Information on recruitment costs and cost-effectiveness of translational programs implemented in community and primary care settings was limited. Conclusion:Diet and physical activity promotion programs to prevent type 2 diabetes are cost-effective among persons at increased risk. Costs are lower when programs are delivered to groups in community or primary care settings. Primary Funding Source:None.
Topics: physical activity, diabetes mellitus, type 2, diet, cost effectiveness, economics, community, life style
Clinical Guidelines | 
Nicolaas P. Pronk, PhD; and Patrick L. Remington, MD, MPH, on behalf of the Community Preventive Services Task Force*
Description:Community Preventive Services Task Force (Task Force) recommendation on the use of combined diet and physical activity promotion programs to reduce progression to type 2 diabetes in persons at increased risk. Methods:The Task Force commissioned an evidence review that assessed the benefits and harms of programs to promote and support individual improvements in diet, exercise, and weight and supervised a review on the economic efficiency of these programs in clinical trial, primary care, and primary care–referable settings. Population:Adolescents and adults at increased risk for progression to type 2 diabetes. Recommendation:The Task Force recommends the use of combined diet and physical activity promotion programs by health care systems, communities, and other implementers to provide counseling and support to clients identified as being at increased risk for type 2 diabetes. Economic evidence indicates that these programs are cost-effective.
Topics: physical activity, diabetes mellitus, type 2, diet, community, diabetes prevention
Annals Editors discuss their policy on publishing articles written by authors with ties to industry.
Topics: academia (organization)
In this issue, the Community Preventive Services Task Force delivers recommendations for healthcare systems and community organizations to offer combined diet and physical activity promotion programs that provide counseling and longitudinal support for persons at increased risk for type 2 diabetes. The editorialist notes that it is imperative that we promote these programs that have the potential to enable millions of Americans to evade a remaining lifetime burdened by the daily management of diabetes.
Topics: public health medicine, diabetes prevention, diet, diabetes mellitus, type 2
Because of concerns about the emergence of highly antibiotic-resistant bacteria, legislation was recently proposed to permit approval of new antibiotics on the basis of preliminary studies. In contrast, when staphylococci developed widespread resistance to penicillin in the 1950s, leading infectious disease experts argued strongly against similar proposals.
Topics: antibiotics
Ideas and Opinions | 
Elinore F. McCance-Katz, MD, PhD; and Ronald O. Valdiserri, MD, MPH
Faced with the high cost of new curative treatments for hepatitis C virus infection, Medicaid providers in 35 states and the District of Columbia have requirements limiting their access for persons who use drugs or alcohol.
Topics: intravenous drug user, hepatitis c virus, hepatitis c
Medicine and Public Issues | 
Soumitri Barua; Robert Greenwald, JD; Jason Grebely, PhD; Gregory J. Dore, MBBS, PhD; Tracy Swan; and Lynn E. Taylor, MD
The aim of this study was to systematically evaluate state Medicaid policies for the treatment of hepatitis C virus (HCV) infection with sofosbuvir in the United States. Medicaid reimbursement criteria for sofosbuvir were evaluated in all 50 states and the District of Columbia. The authors searched state Medicaid Web sites between 23 June and 7 December 2014 and extracted data in duplicate. Any differences were resolved by consensus. Data extracted were whether sofosbuvir was covered and criteria for coverage based on the following categories:liver disease stage, HIV co-infection, prescriber type, and drug or alcohol use. Of the 42 states with known Medicaid reimbursement criteria for sofosbuvir, 74% limit sofosbuvir access to persons with advanced fibrosis (Meta-Analysis of Histologic Data in Viral Hepatitis [METAVIR] fibrosis stage F3) or cirrhosis (F4). One quarter of states require persons co-infected with HCV and HIV to be receiving antiretroviral therapy or to have suppressed HIV RNA levels. Two thirds of states have restrictions based on prescriber type, and 88% include drug or alcohol use in their sofosbuvir eligibility criteria, with 50% requiring a period of abstinence and 64% requiring urine drug screening. Heterogeneity is present in Medicaid reimbursement criteria for sofosbuvir with respect to liver disease staging, HIV co-infection, prescriber type, and drug or alcohol use across the United States. Restrictions do not seem to conform with recommendations from professional organizations, such as the Infectious Diseases Society of America and the American Association for the Study of Liver Diseases. Current restrictions seem to violate federal Medicaid law, which requires states to cover drugs consistent with their U.S. Food and Drug Administration labels.
Topics: hepatitis c, medicaid, reimbursement mechanisms, sofosbuvir, hepatitis c virus, liver diseases
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