ACP Comment Letter Regarding the Physician Fee Schedule Proposed Rule for CY 2017

ACP Comment Letter to CMS Regarding CY 2018 Medicare Physician Fee Schedule Proposed Rule

Screening for Anxiety in Adolescent and Adult Women: A Systematic Review for the Women's Preventive Services Initiative: Annals of Internal Medicine: Vol 173, No 1

Background: Anxiety disorders are infrequently recognized during routine health care even though they are common in adolescent girls and adult women. Purpose: To evaluate evidence on the effectiveness of screening for anxiety disorders in primary care in improving symptoms, function, and quality of life; harms of screening; accuracy of screening instruments; and effectiveness and harms of treatments. Data Sources: English-language searches of Ovid MEDLINE, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and Health and Psychosocial Instruments (1 January 1996 to 4 November 2019); ClinicalTrials.gov (November 2019); and reference lists of studies and reviews. Study Selection: Studies that enrolled adolescent girls and adult women not currently diagnosed with anxiety disorders, including pregnant or postpartum women, and compared clinical outcomes and harms between women who were and were not screened; diagnostic accuracy studies of screening instruments; and systematic reviews of randomized trials of behavioral and pharmacologic treatments. Data Extraction: Dual extraction and quality assessment of individual studies. Data Synthesis: No studies evaluated the overall effectiveness or harms of screening. Thirty-three studies and 2 systematic reviews (171 studies; 112 574 participants) evaluated the diagnostic accuracy of 27 screening instruments and their variations against a clinical diagnosis or other instruments. Most demonstrated moderate to high accuracy for adults (Generalized Anxiety Disorder scale: sensitivity, 70% to 97%; specificity, 50% to 89%), pregnant and postpartum women (Edinburgh Postnatal Depression Scale: sensitivity, 74%; specificity, 64%), and adolescents (Screen for Child Anxiety Related Emotional Disorders: sensitivity, 64% to 74%; specificity, 64% to 73%). Anxiety symptoms improved with cognitive behavioral therapy (246 randomized controlled trials; 17 209 participants) and antianxiety medications (126 randomized controlled trials; 8225 participants). Limitation: Limited data on long-term harms of treatment and no treatment trials in pregnant or postpartum women. Conclusion: Evidence on the overall effectiveness and harms of screening for anxiety is insufficient. Most screening instruments are moderately to highly accurate. Behavioral therapies and antianxiety medications effectively improve anxiety symptoms. Primary Funding Source: Health Resources and Services Administration.

Increases in Actual Health Care Costs and Claims After Firearm Injury

Background: The incidence of firearm injury and death in the United States is increasing. Although the health care–related effect of firearm injury is estimated to be high, existing data are largely cross-sectional, do not include data on preinjury and postinjury health care visits and related costs, and use hospital charges rather than actual monetary payments. Objective: To compare actual health care costs (that is, actual monetary payments) and utilizations within the 6 months before and after an incident (index) firearm injury. Design: Before–after study. Setting: Blue Cross Blue Shield plans of Illinois, Texas, Oklahoma, New Mexico, and Montana. Participants: Plan members continuously enrolled for at least 12 months before and after an index firearm injury sustained between 1 January 2015 and 31 December 2017. Measurements: Eligible costs, out-of-pocket costs, and firearm injury–related International Classification of Diseases, Ninth or 10th Revision, codes. Results: Total initial (emergency department [ED]) health care costs for persons with index firearm injuries who were discharged from the ED were $8 158 786 ($5686 per member). Total initial (hospital admission) costs for persons with index firearm injuries who required hospitalization were $41 255 916 ($70 644 per member). Compared with the 6 months before the index firearm injury, in the 6 months after, per-member costs increased by 347% (from $3984 to $17 806 per member) for those discharged from the ED and 2138% (from $4118 to $92 151 per member) for those who were hospitalized. The number of claims increased by 187% for patients discharged from the ED and 608% for those who were hospitalized. Limitation: Firearm injury intent was not specified because of misclassification concerns. Conclusion: In the 6 months after a firearm injury, patient-level health care visits and costs increased by 3 to 20 times compared with the 6 months prior. The burden of firearm injury on the health care system is large and quantifiable. Primary Funding Source: None.

Key Evidence Supporting Prescription Opioids Approved by the U.S. Food and Drug Administration, 1997 to 2018

Background: Little is known about the evidence required by the U.S. Food and Drug Administration (FDA) for new approvals of opioid analgesics. Objective: To characterize the quality of safety and efficacy data in new drug applications (NDAs) for opioid analgesics approved by the FDA between 1997 and 2018. Design: Cross-sectional analysis. Setting: Data from ClinicalTrials.gov, FDA reviews, and peer-reviewed publications. Participants: Patients with pain who participated in phase 3 pivotal trials. Intervention: FDA-approved opioid analgesics. Measurements: Key characteristics of each NDA, including the number, size, and duration of pivotal trials; trial control groups; the use of enriched trial populations; and systematically measured safety outcomes. Results: Most of the 48 NDAs evaluated were for new dosage forms (n = 25 [52.1%]) or new formulations (n = 9 [18.8%]); only 1 (2.1%) was for a new molecular entity. Of 39 NDAs approved for treating chronic pain, only 21 products were supported by at least 1 pivotal trial; these trials (n = 28) had a median duration of 84 days (interquartile range [IQR], 25 to 84 days) and enrolled a median of 299 patients (IQR, 174 to 525 patients). Seventeen (81%) of these products were approved on the basis of designs that excluded patients who could not tolerate the drugs, had early adverse effects, or reported few immediate benefits. Among NDAs for chronic pain, 8 (20.5%) included pooled safety reviews that reported systematic assessment of diversion, 7 (17.9%) reported systematic measurement of nonmedical use, and 15 (38.5%) assessed development of tolerance. Eight of 9 products for acute pain were supported by at least 1 pivotal trial; the pivotal trials (n = 19) had a median duration of 1 day (IQR, 1 to 2 days) and enrolled a median of 329 patients (IQR, 199 to 456 patients). Although all but 1 of the 48 approved NDAs were for previously approved moieties, analysis of available NDAs for referent products yielded similar findings. Limitations: The analysis was limited to approved opioids. Animal studies and nonpivotal trials were excluded. Evidence for safety in NDAs was presented for chronic pain only. Conclusion: Between 1997 and 2018, the FDA approved opioids on the basis of pivotal trials of short or intermediate duration, often in narrowly defined pain populations of patients who could tolerate the drug. Systematic collation of certain important safety outcomes was rare. Primary Funding Source: None.

Transparent Reporting of Multivariable Prediction Models in Journal and Conference Abstracts: TRIPOD for Abstracts

Clear and informative reporting in titles and abstracts is essential to help readers and reviewers identify potentially relevant studies and decide whether to read the full text. Although the TRIPOD (Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis) statement provides general recommendations for reporting titles and abstracts, more detailed guidance seems to be desirable. The authors present TRIPOD for Abstracts, a checklist and corresponding guidance for reporting prediction model studies in abstracts. A list of 32 potentially relevant items was the starting point for a modified Delphi procedure involving 110 experts, of whom 71 (65%) participated in the web-based survey. After 2 Delphi rounds, the experts agreed on 21 items as being essential to report in abstracts of prediction model studies. This number was reduced by merging some of the items. In a third round, participants provided feedback on a draft version of TRIPOD for Abstracts. The final checklist contains 12 items and applies to journal and conference abstracts that describe the development or external validation of a diagnostic or prognostic prediction model, or the added value of predictors to an existing model, regardless of the clinical domain or statistical approach used.

Vicarious Trauma: The Hazard and Joy of Caring for Refugees

Factors Influencing Physician Practices' Adoption of Behavioral Health Integration in the United States: A Qualitative Study: Annals of Internal Medicine: Vol 173, No 2

Background: Behavioral health integration is uncommon among U.S. physician practices despite recent policy changes that may encourage its adoption. Objective: To describe factors influencing physician practices' implementation of behavioral health integration. Design: Semistructured interviews with leaders and clinicians from physician practices that adopted behavioral health integration, supplemented by contextual interviews with experts and vendors in behavioral health integration. Setting: 30 physician practices, sampled for diversity on specialty, size, affiliation with parent organizations, geographic location, and behavioral health integration model (collaborative or co-located). Participants: 47 physician practice leaders and clinicians, 20 experts, and 5 vendors. Measurements: Qualitative analysis (cyclical coding) of interview transcripts. Results: Four overarching factors affecting physician practices' implementation of behavioral health integration were identified. First, practices' motivations for integrating behavioral health care included expanding access to behavioral health services, improving other clinicians' abilities to respond to patients' behavioral health needs, and enhancing practice reputation. Second, practices tailored their implementation of behavioral health integration to local resources, financial incentives, and patient populations. Third, barriers to behavioral health integration included cultural differences and incomplete information flow between behavioral and nonbehavioral health clinicians and billing difficulties. Fourth, practices described the advantages and disadvantages of both fee-for-service and alternative payment models, and few reported positive financial returns. Limitation: The practice sample was not nationally representative and excluded practices that did not implement or sustain behavioral health integration, potentially limiting generalizability. Conclusion: Practices currently using behavioral health integration face cultural, informational, and financial barriers to implementing and sustaining behavioral health integration. Tailored, context-specific technical support to guide practices' implementation and payment models that improve the business case for practices may enhance the dissemination and long-term sustainability of behavioral health integration. Primary Funding Source: American Medical Association and The Commonwealth Fund.

Analysis of Response Data for Assessing Treatment Effects in Comparative Clinical Studies

In comparative studies, treatment effect is often assessed using a binary outcome that indicates response to the therapy. Commonly used summary measures for response include the cumulative and current response rates at a specific time point. The current response rate is sometimes called the probability of being in response (PBIR), which regards a patient as a responder only if they have achieved and remain in response at present. The methods used in practice for estimating these rates, however, may not be appropriate. Moreover, whereas an effective treatment is expected to achieve a rapid and sustained response, the response at a fixed time point does not provide information about the duration of response (DOR). As an alternative, a curve constructed from the current response rates over the entire study period may be considered, which can be used for visualizing how rapidly patients responded to therapy and how long responses were sustained. The area under the PBIR curve is the mean DOR. This connection between response and DOR makes this curve attractive for assessing the treatment effect. In contrast to the conventional method for analyzing the DOR data, which uses responders only, the above procedure includes all patients in the study. Although discussed extensively in the statistical literature, estimation of the current response rate curve has garnered little attention in the medical literature. This article illustrates how to construct and analyze such a curve using data from a recent study for treating renal cell carcinoma. Clinical trialists are encouraged to consider this robust and clinically interpretable procedure as an additional tool for evaluating treatment effects in clinical studies.

A Cautionary Tale: The 2019 Orphaning of Hahnemann's Graduate Medical Trainees

Hahnemann University Hospital provided care for Philadelphians starting in 1848, but its recent history has been riddled with financial turmoil that culminated in its rapid closure in summer 2019. As the hospital shuttered its doors to patients, it also orphaned 583 medical trainees. This crisis exposed vulnerabilities in graduate medical education (GME). In a firsthand account of the situation that developed in Philadelphia and reached academic institutions across the country, the authors reflect on lessons learned that may help leaders at other institutions mitigate the inevitable difficulties that arise when academic hospitals close. These lessons pertain to handling panic and administrative burdens in the aftermath of closure, the importance of well-defined processes, a clear understanding of GME funding, and strategies for placement of trainees that minimize disruption of their education.

Medication for Opioid Use Disorder: A National Survey of Primary Care Physicians

Brief Cognitive Tests for Distinguishing Clinical Alzheimer-Type Dementia From Mild Cognitive Impairment or Normal Cognition in Older Adults With Suspected Cognitive Impairment: A Systematic Review: Annals of Internal Medicine: Vol 172, No 10

Background: The accuracy and harms of brief cognitive tests for identifying clinical Alzheimer-type dementia (CATD) are uncertain. Purpose: To summarize evidence on accuracy and harms of brief cognitive tests for CATD in older adults with suspected cognitive impairment. Data Sources: Electronic bibliographic databases (from inception to November 2019) and systematic review bibliographies. Study Selection: English-language, controlled observational studies in older adults that evaluated the accuracy of brief cognitive tests (standalone tests; memory, executive function, and language tests; and brief multidomain batteries) for distinguishing CATD from mild cognitive impairment (MCI) or normal cognition as defined by established diagnostic criteria. Studies with low or medium risk of bias (ROB) were analyzed. Data Extraction: Two reviewers rated ROB. One reviewer extracted data; the other verified extraction accuracy. Data Synthesis: Fifty-seven studies met analysis criteria. Many brief, single cognitive tests were highly sensitive and specific for distinguishing CATD from normal cognition. These included standalone tests (clock-drawing test, median sensitivity 0.79 and specificity 0.88 [8 studies]; Mini-Mental State Examination, 0.88 and 0.94 [7 studies]; Montreal Cognitive Assessment, 0.94 and 0.94 [2 studies]; and Brief Alzheimer Screen, 0.92 and 0.97 [1 study]), memory tests (list delayed recall, 0.89 and 0.94 [5 studies]), and language tests (category fluency, 0.92 and 0.89 [9 studies]). Accuracy was lower in distinguishing mild CATD from normal cognition and distinguishing CATD from MCI. No studies reported on testing harms. Limitations: Studies were small. Few test metrics were evaluated by multiple studies. Few studies directly compared different tests, scores, cut points, or test combinations. Conclusion: Many brief, single cognitive tests accurately distinguish CATD from normal cognition in older adults but are less accurate in distinguishing mild CATD from normal cognition or CATD from MCI. No studies reported on testing harms. Primary Funding Source: Agency for Healthcare Research and Quality. (PROSPERO: CRD42018117897)

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