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Should This Patient Receive an Antidepressant?: Grand Rounds Discussion From Beth Israel Deaconess Medical Center: Annals of Internal Medicine: Vol 167, No 3
Depression is a major public health problem and a common cause of disability. To help physicians choose among available treatment options, the American College of Physicians recently issued a guideline titled “Nonpharmacologic Versus Pharmacologic Treatment of Adult Patients with Major Depressive Disorder.” The evidence review done for the guideline found no statistically significant difference in the efficacy of second-generation antidepressants (SGAs) versus most other treatments for this disorder. However, rates of adverse events and discontinuation were generally higher in patients treated with SGAs. This Beyond the Guidelines reviews the guideline and includes a discussion between 2 experts on how they would apply it to a 64-year-old man with depression who is reluctant to begin medication. They review the data on which the guideline is based, discuss the limitations of applying the data to real-world settings, review how they would incorporate patient preferences when making treatment decisions, and outline options for patients in whom first-line therapy has failed.
Screening for Occult Cancer in Patients With Unprovoked Venous Thromboembolism: A Systematic Review and Meta-analysis of Individual Patient Data: Annals of Internal Medicine: Vol 167, No 6
Background: Screening for cancer in patients with unprovoked venous thromboembolism (VTE) often is considered, but clinicians need precise data on cancer prevalence, risk factors, and the effect of different types of screening strategies. Purpose: To estimate the prevalence of occult cancer in patients with unprovoked VTE, including in subgroups of different ages or those that have had different types of screening. Data Sources: MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials up to 19 January 2016. Study Selection: Prospective studies evaluating cancer screening strategies in adults with unprovoked VTE that began enrolling patients after 1 January 2000 and had at least 12 months of follow-up. Data Extraction: 2 investigators independently reviewed abstracts and full-text articles and independently assessed risk of bias. Data Synthesis: 10 eligible studies were identified. Individual data were obtained for all 2316 patients. Mean age was 60 years; 58% of patients received extensive screening. The 12-month period prevalence of cancer after VTE diagnosis was 5.2% (95% CI, 4.1% to 6.5%). The point prevalence of cancer was higher in patients who had extensive screening than in those who had more limited screening initially (odds ratio [OR], 2.0 [CI, 1.2 to 3.4]) but not at 12 months (OR, 1.4 [CI, 0.89 to 2.1]). Cancer prevalence increased linearly with age and was 7-fold higher in patients aged 50 years or older than in younger patients (OR, 7.1 [CI, 3.1 to 16]). Limitation: Variation in patient characteristics and extensive screening strategies; unavailability of long-term mortality data. Conclusion: Occult cancer is detected in 1 in 20 patients within a year of receiving a diagnosis of unprovoked VTE. Older age is associated with a higher cancer prevalence. Although an extensive screening strategy initially may detect more cancer cases than limited screening, whether this translates into improved patient outcomes remains unclear. Primary Funding Source: None. (PROSPERO: CRD42016033371)
Holding Providers Accountable for Health Care Outcomes
Federal public reporting and payment programs have increasingly emphasized the measurement of outcomes (such as readmission, health care–associated infections, and mortality). Yet, the criteria for assessing whether outcome measures are accurate and valid enough to use for public reporting, payment, and accreditation are not well-defined. An outcome measure should be used only if the outcome can be influenced substantially by providers (that is, a strong process–outcome link exists) and statistical adjustment can be made for differences in patient populations across providers so that differences in outcomes are truly attributable to differences in the care provided. Validly distinguishing differences in quality of care across providers requires precision in both the design of the outcome measure and the actual recording of all the measure's elements. Four criteria are proposed to assess outcome measures. First, strong evidence should exist that good medical care leads to improvement in the outcome within the time period for the measure. Second, the outcome should be measurable with a high degree of precision. Third, the risk-adjustment methodology should include and accurately measure the risk factors most strongly associated with the outcome. Fourth, implementation of the outcome measure must have little chance of inducing unintended adverse consequences. These criteria were applied to 10 outcome measures currently used or proposed for accountability programs. Three measures met all 4 criteria; 5, including all 4 claims-based 30-day mortality measures, failed to meet 1 or more criteria. Patient-reported outcome measures are problematic, because low response rates may cause bias. These findings raise concerns and suggest the need for a national dialogue about how to judge outcome measures currently in use or proposed for the future.
Individualized Glycemic Control for U.S. Adults With Type 2 Diabetes: A Cost-Effectiveness Analysis: Annals of Internal Medicine: Vol 168, No 3
Background: Intensive glycemic control in type 2 diabetes (glycated hemoglobin [HbA1c] level <7%) is an established, cost-effective standard of care. However, guidelines recommend individualizing goals on the basis of age, comorbidity, diabetes duration, and complications. Objective: To estimate the cost-effectiveness of individualized control versus uniform intensive control (HbA1c level <7%) for the U.S. population with type 2 diabetes. Design: Patient-level Monte Carlo–based Markov model. Data Sources: National Health and Nutrition Examination Survey 2011–2012. Target Population: The approximately 17.3 million persons in the United States with diabetes diagnosed at age 30 years or older. Time Horizon: Lifetime. Perspective: Health care sector. Intervention: Individualized versus uniform intensive glycemic control. Outcome Measures: Average lifetime costs, life-years, and quality-adjusted life-years (QALYs). Results of Base-Case Analysis: Individualized control saved $13 547 per patient compared with uniform intensive control ($105 307 vs. $118 854), primarily due to lower medication costs ($34 521 vs. $48 763). Individualized control decreased life expectancy (20.63 vs. 20.73 years) due to an increase in complications but produced more QALYs (16.68 vs. 16.58) due to fewer hypoglycemic events and fewer medications. Results of Sensitivity Analysis: Individualized control was cost-saving and generated more QALYs compared with uniform intensive control, except in analyses where the disutility associated with receiving diabetes medications was decreased by at least 60%. Limitation: The model did not account for effects of early versus later intensive glycemic control. Conclusion: Health policies and clinical programs that encourage an individualized approach to glycemic control for U.S. adults with type 2 diabetes reduce costs and increase quality of life compared with uniform intensive control. Additional research is needed to confirm the risks and benefits of this strategy. Primary Funding Source: National Institute of Diabetes and Digestive and Kidney Diseases.
Functional Impairment and Decline in Middle Age: A Cohort Study: Annals of Internal Medicine: Vol 167, No 11
Background: Difficulties with daily functioning are common in middle-aged adults. However, little is known about the epidemiology or clinical course of these problems, including the extent to which they share common features with functional impairment in older adults. Objective: To determine the epidemiology and clinical course of functional impairment and decline in middle age. Design: Cohort study. Setting: The Health and Retirement Study. Participants: 6874 community-dwelling adults aged 50 to 56 years who did not have functional impairment at enrollment. Measurements: Impairment in activities of daily living (ADLs), defined as self-reported difficulty performing 1 or more ADLs, assessed every 2 years for a maximum follow-up of 20 years, and impairment in instrumental ADLs (IADLs), defined similarly. Data were analyzed by using multistate models that estimate probabilities of different outcomes. Results: Impairment in ADLs developed in 22% of participants aged 50 to 64 years, in whom further functional transitions were common. Two years after the initial impairment, 4% (95% CI, 3% to 5%) of participants had died, 9% (CI, 8% to 11%) had further ADL decline, 50% (CI, 48% to 52%) had persistent impairment, and 37% (CI, 35% to 39%) had recovered independence. In the 10 years after the initial impairment, 16% (CI, 14% to 18%) had 1 or more episodes of functional decline and 28% (CI, 26% to 30%) recovered from their initial impairment and remained independent throughout this period. The pattern of findings was similar for IADLs. Limitation: Functional status was self-reported. Conclusion: Functional impairment and decline are common in middle age, as are transitions from impairment to independence and back again. Because functional decline in older adults has similar features, current interventions used for prevention in older adults may hold promise for those in middle age. Primary Funding Source: National Institute on Aging and National Center for Advancing Translational Sciences through the University of California, San Francisco, Clinical and Translational Sciences Institute.
Benefits and Harms of Plant-Based Cannabis for Posttraumatic Stress Disorder: A Systematic Review: Annals of Internal Medicine: Vol 167, No 5
Background: Cannabis is available from medical dispensaries for treating posttraumatic stress disorder (PTSD) in many states of the union, yet its efficacy in treating PTSD symptoms remains uncertain. Purpose: To identify ongoing studies and review existing evidence regarding the benefits and harms of plant-based cannabis preparations in treating PTSD in adults. Data Sources: MEDLINE, the Cochrane Library, and other sources from database inception to March 2017. Study Selection: English-language systematic reviews, trials, and observational studies with a control group that reported PTSD symptoms and adverse effects of plant-based cannabis use in adults with PTSD. Data Extraction: Study data extracted by 1 investigator was checked by a second reviewer; 2 reviewers independently assessed study quality, and the investigator group graded the overall strength of evidence by using standard criteria. Data Synthesis: Two systematic reviews, 3 observational studies, and no randomized trials were found. The systematic reviews reported insufficient evidence to draw conclusions about benefits and harms. The observational studies found that compared with nonuse, cannabis did not reduce PTSD symptoms. Studies had medium and high risk of bias, and overall evidence was judged insufficient. Two randomized trials and 6 other studies examining outcomes of cannabis use in patients with PTSD are ongoing and are expected to be completed within 3 years. Limitation: Very scant evidence with medium to high risk of bias. Conclusion: Evidence is insufficient to draw conclusions about the benefits and harms of plant-based cannabis preparations in patients with PTSD, but several ongoing studies may soon provide important results. Primary Funding Source: U.S. Department of Veterans Affairs, Veterans Health Administration, Office of Research and Development, Quality Enhancement Research Initiative. (PROSPERO: CRD42016033623)