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Ideas and Opinions | 
John Frye, MA; and Stuart J. Youngner, MD
A growing number of states has legalized physician-assisted suicide (PAS). The authors argue that refusal by many physician professional organizations to provide clinical guidance on the care of patients actively seeking assistance in dying does a disservice to their members. They propose that organizations' active engagement can better help clinicians responsibly meet the needs of their patients while still respecting the diverse opinions and choices about participation in PAS.
Topics: patient-centered care, suicide, assisted, professional organizations
Original Research | 
Thomas M. Gill, MD; Jack M. Guralnik, MD, PhD; Marco Pahor, MD; Timothy Church, MD, PhD; Roger A. Fielding, PhD; Abby C. King, PhD; Anthony P. Marsh, PhD; Anne B. Newman, MD; Christine A. Pellegrini, PhD; Shyh-Huei Chen, PhD; Heather G. Allore, PhD; Michael E. Miller, PhD,, for the LIFE Study Investigators
Background:The total time a patient is disabled likely has a greater influence on his or her quality of life than the initial occurrence of disability alone. Objective:To compare the effect of a long-term, structured physical activity program with that of a health education intervention on the proportion of patient assessments indicating major mobility disability (MMD) (that is, MMD burden) and on the risk for transitions into and out of MMD. Design:Single-blinded, parallel-group, randomized trial. (ClinicalTrials.gov: NCT01072500) Setting:8 U.S. centers between February 2010 and December 2013. Participants:1635 sedentary persons, aged 70 to 89 years, who had functional limitations but could walk 400 m. Intervention:Physical activity (n = 818) and health education (n = 817). Measurements:MMD, defined as the inability to walk 400 m, was assessed every 6 months for up to 3.5 years. Results:During a median follow-up of 2.7 years, the proportion of assessments showing MMD was substantially lower in the physical activity (0.13 [95% CI, 0.11 to 0.15]) than the health education (0.17 [CI, 0.15 to 0.19]) group, yielding a risk ratio of 0.75 (CI, 0.64 to 0.89). In a multistate model, the hazard ratios for comparisons of physical activity with health education were 0.87 (CI, 0.73 to 1.03) for the transition from no MMD to MMD; 0.52 (CI, 0.10 to 2.67) for no MMD to death; 1.33 (CI, 0.99 to 1.77) for MMD to no MMD; and 1.92 (CI, 1.15 to 3.20) for MMD to death. Limitation:The intention-to-treat principle was maintained for MMD burden and first transition out of no MMD, but not for subsequent transitions. Conclusion:A structured physical activity program reduced the MMD burden for an extended period, in part through enhanced recovery after the onset of disability and diminished risk for subsequent disability episodes. Primary Funding Source:National Institute on Aging, National Institutes of Health.
Topics: physical activity, follow-up, disability, elderly, mobility, health education
Original Research | 
Xabier García-Albéniz, MD, PhD; John Hsu, MD, MBA, MSCE; Michael Bretthauer, MD, PhD; and Miguel A. Hernán, MD, DrPH
Includes: Supplemental Content
Background:No randomized, controlled trials of screening colonoscopy have been completed, and ongoing trials exclude persons aged 75 years or older. The Medicare program, however, reimburses screening colonoscopy without an upper age limit. Objective:To evaluate the effectiveness and safety of screening colonoscopy to prevent colorectal cancer (CRC) in persons aged 70 to 74 and those aged 75 to 79 years. Design:Large-scale, population-based, prospective study. The observational data were used to emulate a target trial with 2 groups: colonoscopy screening and no screening. Setting:United States. Participants:1 355 692 Medicare beneficiaries (2004 to 2012) aged 70 to 79 years at average risk for CRC who used Medicare preventive services and had no previous diagnostic or surveillance colonoscopies in the past 5 years. Measurements:8-year risk for CRC and 30-day risk for adverse events. Results:In beneficiaries aged 70 to 74 years, the 8-year risk for CRC was 2.19% (95% CI, 2.00% to 2.37%) in the screening colonoscopy group and 2.62% (CI, 2.56% to 2.67%) in the no-screening group (absolute risk difference, −0.42% [CI, −0.24% to −0.63%]). Among those aged 75 to 79 years, the 8-year risk for CRC was 2.84% (CI, 2.54% to 3.13%) in the screening colonoscopy group and 2.97% (CI, 2.92% to 3.03%) in the no-screening group (risk difference, −0.14% [CI, −0.41 to 0.16]). The excess 30-day risk for any adverse event in the colonoscopy group was 5.6 events per 1000 individuals (CI, 4.4 to 6.8) in the 70- to 74-year age group and 10.3 per 1000 (CI, 8.6 to 11.1) in the 75- to 79-year age group. Limitation:CRC-specific mortality was not available, but CRC incidence and stage were studied at diagnosis. Conclusion:Screening colonoscopy may have had a modest benefit in preventing CRC in beneficiaries aged 70 to 74 years and a smaller benefit in older beneficiaries. The risk for adverse events was low but greater among older persons. Primary Funding Source:National Institutes of Health.
Topics: colonoscopy, medicare, colorectal cancer, elderly, follow-up
Ideas and Opinions | 
Catherine Frazee, DLitt, LLD; and Harvey Max Chochinov, MD, PhD
In Carter v. Canada, the Supreme Court of Canada issued a landmark ruling that found that the criminal code ban on medical assistance in dying (MAID) for persons with grievous medical conditions and intolerable suffering was unconstitutional. The editorialists discuss the road to legalizing MAID and reflect on the controversy and aftermath of the ruling.
Topics: medical assistance, terminally ill, dacarbazine/doxorubicin/ifosfamide/mesna protocol
Editorials | 
Patricia P. Katz, PhD; and Russell Pate, PhD
The report in Annals by Gill and colleagues adds to the growing literature on the benefits of physical activity, focusing on an elderly population at high risk for mobility limitations and other health conditions. This editorial notes that we have spent the past several decades proving that physical activity is a powerful tool to improve human health and that the focus now should turn to delivering this health-enhancing intervention to the population.
Topics: exercise, physical activity
Topics: exercise, disability, elderly, mobility
Ideas and Opinions | 
Susan L. Norris, MD, MPH, MSc; and Lisa Bero, PhD
The GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach is a widely used and well-accepted system for grading the quality of evidence and strength of recommendations in guidelines. This commentary discusses some of its limitations and proposes means for advancement.
Original Research | 
Jonas F. Ludvigsson, MD, PhD; Peter Ström, MSc; Cecilia Lundholm, MSc; Sven Cnattingius, MD, PhD; Anders Ekbom, MD, PhD; Åke Örtqvist, MD, PhD; Nils Feltelius, MD, PhD; Fredrik Granath, PhD; and Olof Stephansson, MD, PhD
Background:Earlier studies reporting varying risk estimates for congenital malformation in offspring of mothers undergoing vaccination against H1N1 influenza during pregnancy did not consider the potential role of confounding by familial (genetic and shared environmental) factors. Objective:To evaluate an association between maternal H1N1 vaccination during pregnancy and offspring malformation, with familial factors taken into account. Design:Population-based prospective study. Setting:Sweden. Participants:Liveborn offspring born between 1 October 2009 and 1 October 2011 to mothers receiving monovalent AS03-adjuvanted H1N1 influenza vaccine (Pandemrix [GlaxoSmithKline]) during pregnancy. A total of 40 983 offspring were prenatally exposed to the vaccine, 14 385 were exposed within the first trimester (14 weeks), and 7502 were exposed during the first 8 weeks of pregnancy. Exposed offspring were compared with 197 588 unexposed offspring. Corresponding risks in exposed versus unexposed siblings were also estimated. Measurements:Congenital malformation, with subanalyses for congenital heart disease, oral cleft, and limb deficiency. Results:Congenital malformation was observed in 2037 (4.97%) exposed offspring and 9443 (4.78%) unexposed offspring. Adjusted risk for congenital malformation was 4.98% in exposed offspring versus 4.96% in unexposed offspring (risk difference, 0.02% [95% CI, −0.26% to 0.30%]). The corresponding risk differences were 0.16% (CI, −0.23% to 0.56%) for vaccination during the first trimester and 0.10% (CI, −0.41% to 0.62%) for vaccination in the first 8 weeks. Using siblings as comparators yielded no statistically significant risk differences. Limitations:The study was based on live births, and the possibility that data on miscarriage or induced abortion could have influenced the findings cannot be ruled out. Study power was limited in analyses of specific malformations. Conclusion:When intrafamilial factors were taken into consideration, H1N1 vaccination during pregnancy did not seem to be linked to overall congenital malformation in offspring, although risk increases for specific malformations could not be ruled out completely. Primary Funding Source:Swedish Research Council and Swedish Council for Working Life and Social Research.
Topics: pregnancy, congenital abnormality, relationship - sibling, vaccination, influenza virus vaccine, h1n1, swine influenza, offspring
Original Research | 
Kirstin W. Scott, MPhil, PhD; E. John Orav, PhD; David M. Cutler, PhD; and Ashish K. Jha, MD, MPH
Includes: Supplemental Content
Background:Growing evidence shows that hospitals are increasingly employing physicians. Objective:To examine changes in U.S. acute care hospitals that reported employment relationships with their physicians and to determine whether quality of care improved after the hospitals switched to this integration model. Design:Retrospective cohort study of U.S. acute care hospitals between 2003 and 2012. Setting:U.S. nonfederal acute care hospitals. Participants:803 switching hospitals compared with 2085 nonswitching control hospitals matched for year and region. Intervention:Hospitals' conversion to an employment relationship with any of their privileged physicians. Measurements:Risk-adjusted hospital-level mortality rates, 30-day readmission rates, length of stay, and patient satisfaction scores for common medical conditions. Results:In 2003, approximately 29% of hospitals employed members of their physician workforce, a number that rose to 42% by 2012. Relative to regionally matched controls, switching hospitals were more likely to be large (11.6% vs. 7.1%) or major teaching hospitals (7.5% vs. 4.5%) and less likely to be for-profit institutions (8.8% vs. 19.9%) (all P values <0.001). Up to 2 years after conversion, no association was found between switching to an employment model and improvement in any of 4 primary composite quality metrics. Limitations:The measure of integration used depends on responses to the American Hospital Association annual questionnaire, yet this measure has been used by others to examine effects of integration. The study examined performance up to 2 years after evidence of switching to an employment model; however, beneficial effects may have taken longer to appear. Conclusion:During the past decade, hospitals have increasingly become employers of physicians. The study's findings suggest that physician employment alone probably is not a sufficient tool for improving hospital care. Primary Funding Source:Agency for Healthcare Research and Quality and National Science Foundation Graduate Research Fellowship.
Topics: hospitals, employment
On 21 September 2016, the United Nations is holding a high-level meeting on antimicrobial resistance in New York City. The authors, who are leaders in the U.S. infectious diseases community, summarize key aspects of the problem of antimicrobial resistance and share their views about an appropriate response to this international threat to public health.
Topics: drug resistance, microbial, united nations, antibiotics
Reviews | 
Mohammed Y. Khanji, MB, BCh; Vinícius V.S. Bicalho, MD; Claudia N. van Waardhuizen, MSc; Bart S. Ferket, PhD; Steffen E. Petersen, DPhil; and M.G. Myriam Hunink, PhD
Background:Many guidelines exist for screening and risk assessment for the primary prevention of cardiovascular disease in apparently healthy persons. Purpose:To systematically review current primary prevention guidelines on adult cardiovascular risk assessment and highlight the similarities and differences to aid clinician decision making. Data Sources:Publications in MEDLINE and CINAHL between 3 May 2009 and 30 June 2016 were identified. On 30 June 2016, the Guidelines International Network International Guideline Library, National Guideline Clearinghouse, National Library for Health Guidelines Finder, Canadian Medical Association Clinical Practice Guidelines Infobase, and Web sites of organizations responsible for guideline development were searched. Study Selection:2 reviewers screened titles and abstracts to identify guidelines from Western countries containing recommendations for cardiovascular risk assessment for healthy adults. Data Extraction:2 reviewers independently assessed rigor of guideline development using the Appraisal of Guidelines for Research and Evaluation II instrument, and 1 extracted the recommendations. Data Synthesis:Of the 21 guidelines, 17 showed considerable rigor of development. These recommendations address assessment of total cardiovascular risk (5 guidelines), dysglycemia (7 guidelines), dyslipidemia (2 guidelines), and hypertension (3 guidelines). All but 1 recommendation advocates for screening, and most include prediction models integrating several relatively simple risk factors for either deciding on further screening or guiding subsequent management. No consensus on the strategy for screening, recommended target population, screening tests, or treatment thresholds exists. Limitation:Only guidelines developed by Western national or international medical organizations were included. Conclusion:Considerable discrepancies in cardiovascular screening guidelines still exist, with no consensus on optimum screening strategies or treatment threshold. Primary Funding Source:Barts Charity.
Topics: cardiovascular diseases, cardiovascular disease risk factors, guidelines, consensus
Original Research | 
Zhishun Liu, MD, PhD; Shiyan Yan, PhD; Jiani Wu, MD; Liyun He, MD, PhD; Ning Li, MD; Guirong Dong, MD; Jianqiao Fang, MD, PhD; Wenbin Fu, MD; Lixin Fu, MD, PhD; Jianhua Sun, MD, PhD; Linpeng Wang, MD; Shun Wang, MD; Jun Yang, MD; Hongxing Zhang, MD; Jianbin Zhang, MD, PhD; Jiping Zhao, MD; Wei Zhou, MD; Zhongyu Zhou, MD; Yanke Ai, PhD; Kehua Zhou, MD, DPT; Jia Liu, MD, PhD; Huanfang Xu, MD, PhD; Yuying Cai, MD, PhD; and Baoyan Liu, MD
Includes: Supplemental Content
Background:Acupuncture has been used for chronic constipation, but evidence for its effectiveness remains scarce. Objective:To determine the efficacy of electroacupuncture (EA) for chronic severe functional constipation (CSFC). Design:Randomized, parallel, sham-controlled trial. (ClinicalTrials.gov: NCT01726504) Setting:15 hospitals in China. Participants:Patients with CSFC and no serious underlying pathologic cause for constipation. Intervention:28 sessions of EA at traditional acupoints or sham EA (SA) at nonacupoints over 8 weeks. Measurements:The primary outcome was the change from baseline in mean weekly complete spontaneous bowel movements (CSBMs) during weeks 1 to 8. Participants were followed until week 20. Results:1075 patients (536 and 539 in the EA and SA groups, respectively) were enrolled. The increase from baseline in mean weekly CSBMs during weeks 1 to 8 was 1.76 (95% CI, 1.61 to 1.89) in the EA group and 0.87 (CI, 0.73 to 0.97) in the SA group (between-group difference, 0.90 [CI, 0.74 to 1.10]; P < 0.001). The change from baseline in mean weekly CSBMs during weeks 9 to 20 was 1.96 (CI, 1.78 to 2.11) in the EA group and 0.89 (CI, 0.69 to 0.95) in the SA group (between-group difference, 1.09 [CI, 0.94 to 1.31]; P < 0.001). The proportion of patients having 3 or more mean weekly CSBMs in the EA group was 31.3% and 37.7% over the treatment and follow-up periods, respectively, compared with 12.1% and 14.1% in the SA group (P < 0.001). Acupuncture-related adverse events during treatment were infrequent in both groups, and all were mild or transient. Limitations:Longer-term follow-up was not assessed. Acupuncturists could not be blinded. Conclusion:Eight weeks of EA increases CSBMs and is safe for the treatment of CSFC. Additional study is warranted to evaluate a longer-term treatment and follow-up. Primary Funding Source:Ministry of Science and Technology of the People's Republic of China through the Twelfth Five-Year National Science and Technology Pillar Program.
Topics: acupuncture therapy discipline, constipation, chronic, follow-up, acupuncture procedure, electroacupuncture
Original Research | 
Patricia Jabre, MD, PhD; Wulfran Bougouin, MD, MPH; Florence Dumas, MD, PhD; Pierre Carli, MD, PhD; Corinne Antoine, MD; Laurent Jacob, MD, PhD; Benjamin Dahan, MD; Frankie Beganton, MS; Jean-Philippe Empana, MD, PhD; Eloi Marijon, MD, PhD; Nicole Karam, MD, MPH; Alexandre Loupy, MD, PhD; Carmen Lefaucheur, MD, PhD; Daniel Jost, MD, PhD; Alain Cariou, MD, PhD; Frédéric Adnet, MD, PhD; Thomas D. Rea, MD, MPH; and Xavier Jouven, MD, PhD
Includes: Supplemental Content
Background:In patients with out-of-hospital cardiac arrest (OHCA), care requirements can conflict with the need to promptly focus efforts on organ donation in patients who are pronounced dead. Objective:To evaluate objective criteria for identifying patients with OHCA with no chance of survival during the first minutes of cardiopulmonary resuscitation to enable prompt orientation toward organ donation. Design:Retrospective assessment using OHCA data from 2 registries and 1 trial. Setting:France (Paris Sudden Death Expertise Center [SDEC] prospective cohort [2011 to 2014] and PRESENCE multicenter cluster randomized trial [ClinicalTrials.gov: NCT01009606] [2009 to 2011]) and the United States (King County, Washington, prospective cohort [2006 to 2011]). Patients:1771 patients from the Paris SDEC 1-year cohort (2011 to 2012) and 5192 from the validation cohorts. Measurements:Evaluation of 3 objective criteria (OHCA not witnessed by emergency medical services personnel, nonshockable initial cardiac rhythm, and no return of spontaneous circulation before receipt of a third 1-mg dose of epinephrine), survival rate at hospital discharge among patients meeting these criteria, performance of the criteria, and number of patients eligible for organ donation. Results:In the Paris SDEC 1-year cohort, the survival rate among the 772 patients with OHCA who met the objective criteria was 0% (95% CI, 0.0% to 0.5%), with a specificity of 100% (CI, 97% to 100%) and a positive predictive value of 100% (CI, 99% to 100%). These results were verified in the validation cohorts. Ninety-five (12%) patients in the Paris SDEC 1-year cohort may have been eligible for organ donation. Limitation:Several patients had unknown outcomes. Conclusion:3 objective criteria enable the early identification of patients with OHCA with essentially no chance of survival and may help in decision making about the organ donation process. Primary Funding Source:French Ministry of Health.
Topics: acupuncture therapy discipline, constipation, chronic, electric stimulation, acupuncture procedure
Jabre and colleagues evaluated objective criteria for identifying patients with out-of-hospital cardiac arrest (OHCA) with no chance of survival during the first minutes of cardiopulmonary resuscitation to enable prompt orientation toward organ donation. In this editorial, the authors discuss the evidence base for deciding when and where to terminate resuscitation efforts in patients with OHCA and highlight areas where further research is needed.
Topics: cardiopulmonary resuscitation, organ donation, out-of-hospital cardiac arrest, resuscitation
Original Research | 
Jennifer McNeely, MD, MS; Li-Tzy Wu, ScD, RN, MA; Geetha Subramaniam, MD; Gaurav Sharma, PhD; Lauretta A. Cathers, PhD; Dace Svikis, PhD; Luke Sleiter, MPH; Linnea Russell, BA; Courtney Nordeck, BA; Anjalee Sharma, MSW; Kevin E. O’Grady, PhD; Leah B. Bouk, CCRC; Carol Cushing, BBA, RN; Jacqueline King, MS; Aimee Wahle, MS; and Robert P. Schwartz, MD
Includes: Supplemental Content
Background:Substance use, a leading cause of illness and death, is underidentified in medical practice. Objective:The Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS) tool was developed to address the need for a brief screening and assessment instrument that includes all commonly used substances and fits into clinical workflows. The goal of this study was to assess the performance of the TAPS tool in primary care patients. Design:Multisite study, conducted within the National Drug Abuse Treatment Clinical Trials Network, comparing the TAPS tool with a reference standard measure. (ClinicalTrials.gov: NCT02110693) Setting:5 adult primary care clinics. Participants:2000 adult patients consecutively recruited from clinic waiting areas. Measurements:Interviewer- and self-administered versions of the TAPS tool were compared with a reference standard, the modified World Mental Health Composite International Diagnostic Interview (CIDI), which measures problem use and substance use disorder (SUD). Results:Interviewer- and self-administered versions of the TAPS tool had similar diagnostic characteristics. For identifying problem use (at a cutoff of 1+), the TAPS tool had a sensitivity of 0.93 (95% CI, 0.90 to 0.95) and specificity of 0.87 (CI, 0.85 to 0.89) for tobacco and a sensitivity of 0.74 (CI, 0.70 to 0.78) and specificity of 0.79 (CI, 0.76 to 0.81) for alcohol. For problem use of illicit and prescription drugs, sensitivity ranged from 0.82 (CI, 0.76 to 0.87) for marijuana to 0.63 (CI, 0.47 to 0.78) for sedatives; specificity was 0.93 or higher. For identifying any SUD (at a cutoff of 2+), sensitivity was lower. Limitations:The low prevalence of some drug classes led to poor precision in some estimates. Research assistants were not blinded to participants' TAPS tool responses when they administered the CIDI. Conclusion:In a diverse population of adult primary care patients, the TAPS tool detected clinically relevant problem substance use. Although it also may detect tobacco, alcohol, and marijuana use disorders, further refinement is needed before it can be recommended broadly for SUD screening. Primary Funding Source:National Institute on Drug Abuse.
Topics: ethanol, tobacco, prescription drug, twin anemia-polycythemia sequence, primary health care, self administration
Original Research | 
Christine Sinsky, MD; Lacey Colligan, MD; Ling Li, PhD; Mirela Prgomet, PhD; Sam Reynolds, MBA; Lindsey Goeders, MBA; Johanna Westbrook, PhD; Michael Tutty, PhD; and George Blike, MD
Includes: Supplemental Content
Background:Little is known about how physician time is allocated in ambulatory care. Objective:To describe how physician time is spent in ambulatory practice. Design:Quantitative direct observational time and motion study (during office hours) and self-reported diary (after hours). Setting:U.S. ambulatory care in 4 specialties in 4 states (Illinois, New Hampshire, Virginia, and Washington). Participants:57 U.S. physicians in family medicine, internal medicine, cardiology, and orthopedics who were observed for 430 hours, 21 of whom also completed after-hours diaries. Measurements:Proportions of time spent on 4 activities (direct clinical face time, electronic health record [EHR] and desk work, administrative tasks, and other tasks) and self-reported after-hours work. Results:During the office day, physicians spent 27.0% of their total time on direct clinical face time with patients and 49.2% of their time on EHR and desk work. While in the examination room with patients, physicians spent 52.9% of the time on direct clinical face time and 37.0% on EHR and desk work. The 21 physicians who completed after-hours diaries reported 1 to 2 hours of after-hours work each night, devoted mostly to EHR tasks. Limitations:Data were gathered in self-selected, high-performing practices and may not be generalizable to other settings. The descriptive study design did not support formal statistical comparisons by physician and practice characteristics. Conclusion:For every hour physicians provide direct clinical face time to patients, nearly 2 additional hours is spent on EHR and desk work within the clinic day. Outside office hours, physicians spend another 1 to 2 hours of personal time each night doing additional computer and other clerical work. Primary Funding Source:American Medical Association.
Topics: ambulatory care services, time and motion studies, electronic medical records, self-report, family medicine, cardiology
Sinsky and colleagues confirm what many practicing physicians have claimed: Electronic health records, in their current state, occupy a lot of physicians' time and draw attention away from their direct interactions with patients and from their personal lives. The editorialist discusses the implications of these observations and calls for changes to the health care system that will redirect physicians' focus from the computer screen to patients.
Topics: electronic medical records
Editorials | 
Milton Packer, MD; W. Mark Armstrong, MD; Joseph M. Rothstein, MD; and Michael Emmett, MD
Sandhu and colleagues' article supports the cost-effectiveness of sacubitril–valsartan in the treatment of heart failure. This analysis and others have reported favorable results associated with switching patients from conventional renin–angiotensin inhibitors to sacubitril–valsartan. The editorialists review the evidence for the benefits of this newer drug and explore reasons for what they believe is the slow adoption of sacubitril–valsartan in the management of heart failure.
Topics: valsartan, heart failure, prescribing behavior
Original Research | 
Alexander T. Sandhu, MD, MS; Daniel A. Ollendorf, PhD; Richard H. Chapman, PhD; Steven D. Pearson, MD, MSc; and Paul A. Heidenreich, MD, MS
Includes: Supplemental Content
Background:Sacubitril–valsartan therapy reduces cardiovascular mortality compared with enalapril therapy in patients with heart failure with reduced ejection fraction. Objective:To evaluate the cost-effectiveness of sacubitril–valsartan versus angiotensin-converting enzyme inhibitor therapy in patients with chronic heart failure. Design:Markov decision model. Data Sources:Clinical trials, observational analyses, reimbursement data from the Centers for Medicare & Medicaid Services, drug pricing databases, and Centers for Disease Control and Prevention life tables. Target Population:Patients with an average age of 64 years, New York Heart Association (NYHA) class II to IV heart failure, and a left ventricular ejection fraction of 0.40 or less. Time Horizon:Lifetime. Perspective:Societal. Intervention:Treatment with sacubitril–valsartan or lisinopril. Outcome Measures:Life-years, quality-adjusted life-years (QALYs), costs, heart failure hospitalizations, and incremental cost-effectiveness ratios. Results of Base-Case Analysis:The sacubitril–valsartan group experienced 0.08 fewer heart failure hospitalization, 0.69 additional life-year, 0.62 additional QALY, and $29 203 in incremental costs, equating to a cost per QALY gained of $47 053. The cost per QALY gained was $44 531 in patients with NYHA class II heart failure and $58 194 in those with class III or IV heart failure. Results of Sensitivity Analysis:Sacubitril–valsartan treatment was most sensitive to the duration of improved outcomes, with a cost per QALY gained of $120 623 if the duration was limited to the length of the trial (median, 27 months). No variations in other parameters caused the cost to exceed $100 000 per QALY gained. Limitation:The benefit of sacubitril–valsartan is based on a single clinical trial. Conclusion:Treatment with sacubitril–valsartan provides reasonable value in reducing cardiovascular mortality and morbidity in patients with NYHA class II to IV heart failure. Primary Funding Source:U.S. Department of Veterans Affairs and Institute for Clinical and Economic Review.
Topics: valsartan, heart failure, cost effectiveness, sensitivity analysis, heart failure with reduced ejection fraction, new york heart association classification, quality-adjusted life years, hospitalization
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