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Displaying 731 - 740 of 1286 in Annals of Internal Medicine
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The Productivity Requirements of Implementing a Medical Scribe Program
Background: Economic analyses of medical scribes have been limited to individual, specialty-specific clinics. Objective: To determine the number of additional patient visits various specialties would need to recover the costs of implementing scribes in their practice at 1 year. Design: Modeling study based on 2015 data from the Centers for Medicare & Medicaid Services (CMS) and National Ambulatory Medical Care Survey. Scribe costs were based on literature review and a third-party contractor model. Revenue was calculated from direct visit billing, CPT (Current Procedural Terminology) billing, and data from the National Ambulatory Medical Care Survey. Data Sources: 2015 data from CMS and the National Ambulatory Medical Care Survey. Target Population: Health care providers. Time Horizon: 1 year. Perspective: Office-based clinic. Outcome Measures: The number of additional patient visits a physician must have to recover the costs of a scribe program at 1 year. Results of Base-Case Analysis: An average of 1.34 additional new patient visits per day (295 per year) were required to recover scribe costs (range, 0.89 [cardiology] to 1.80 [orthopedic surgery] new patient visits per day). For returning patients, an average of 2.15 additional visits per day (472 per year) were required (range, 1.65 [cardiology] to 2.78 [orthopedic surgery] returning visits per day). The addition of 2 new patient (or 3 returning) visits per day was profitable for all specialties. Results of Sensitivity Analysis: Results were not sensitive to most inputs, with the exception of hourly scribe cost and inclusion of CPT revenue. Limitation: Use of Medicare data and failure to account for indirect costs, downstream revenue, or changes in documentation quality. Conclusion: For all specialties, modest increases in productivity due to scribes may allow physicians to see more patients and offset scribe costs, making scribe programs revenue-neutral. Primary Funding Source: University of Chicago Medicine's Center for Healthcare Delivery Science and Innovation and the Bucksbaum Institute.
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.
Addressing Patient Bias Toward Health Care Workers: Recommendations for Medical Centers
Some patients engage in behavior or use language that demeans clinicians on the basis of their social identity traits, such as race, ethnicity, sex, disability, gender presentation, and sexual orientation, and some patients even request reassignment of involved clinicians. Despite the importance and prevalence of this problem, many medical centers lack an organizational approach for addressing patient conduct. Policy development can be daunting because organizations may encounter various barriers, including reluctance of staff to have difficult conversations about race or other identity traits; uncertainty about what constitutes an appropriate response to the spectrum of demeaning behaviors and who should make this determination; what, if any, support should be offered to targeted clinicians; whether these incidents should be reported and to whom; and whether the medical center's response should differ depending on whether nurses, trainees, or other clinicians are involved. These determinations have important implications for patients' informed consent rights, clinicians' employment rights, and medical centers' obligations to protect patients' health while adhering to workplace antidiscrimination laws and institutional commitments to diversity, equality, and inclusion. This article addresses these considerations and offers guidance to organizations on devising effective policies that meet the needs of medical centers, patients, and health care workers across services and roles, including physicians, nurses, and trainees.
Utility, Appropriateness, and Content of Electronic Consultations Across Medical Subspecialties: A Cohort Study: Annals of Internal Medicine: Vol 172, No 10
Background: Electronic consultations (e-consults) can facilitate patient access to specialists, minimize travel, and reduce unnecessary in-person visits. However, metrics to enable study of e-consults and their effect on processes and patient care are lacking. Objective: To assess novel metrics of e-consult appropriateness and utility. Design: Retrospective cohort study. Setting: Primary and specialty care practices at 2 large academic and 2 community hospitals of an integrated health system. Participants: Patients with e-consult requests to 5 specialties—hematology, infectious disease, dermatology, rheumatology, and psychiatry—between October 2017 and November 2018. Measurements: The appropriateness of e-consult inquiries was assessed by review of medical records and defined as meeting the following 4 criteria: not answerable by reviewing evidence-based summary sources (“point-of-care resource test”), not merely requesting logistic information, having appropriate clinical urgency, and having appropriate patient complexity. Interrater agreement in assessments of e-consult appropriateness was assessed by the κ statistic. Utility of e-consults was assessed by the rate of avoided visits (AVs), defined by the absence of an in-person visit to the same specialty within 120 days. Results: Overall, 6512 eligible e-consults were made by 1096 referring providers to 121 specialist consultants. Inquiries were characterized as diagnostic, therapeutic, for provider education, or at the request of the patient. Most consultations were answered within 1 day, with variation across specialties (73.1% for psychiatry to 87.8% for infectious disease). Overall, 70.2% of e-consults met all 4 criteria for appropriateness; the frequency of unmet criteria varied among specialties. Raters agreed on the appropriateness of 94% of e-consults (κ = 0.57 [95% CI, 0.36 to 0.79]), indicating moderate agreement. The overall rate of AVs across the 5 specialties was 81.2%; the highest rate was in psychiatry (92.6%) and the lowest in dermatology (61.9%). Limitation: Generalizability is unknown outside a single integrated health system, where requesting and consulting providers share a common electronic health record. Conclusion: Novel metrics to assess the appropriateness and utility of e-consults provide meaningful insight into practice, provide a rubric for comparison in future studies in additional settings, and suggest areas to improve resource use and patient care. Primary Funding Source: None.
Caring for the Transgender Patient: Grand Rounds Discussion From Beth Israel Deaconess Medical Center: Annals of Internal Medicine: Vol 172, No 3
The term transgender refers to persons whose gender identity is different from that recorded at birth. Similar to other marginalized populations, transgender patients commonly experience discrimination in the health care setting, and they may not have access to medical professionals who can provide competent care. In addition to primary medical and preventive health care, transgender patients need access to gender-affirming interventions, including hormone therapy and surgeries. In 2017, the Endocrine Society updated its clinical practice guideline for the care of transgender persons on the basis of the best available evidence from systematic reviews and individual studies. Among its general requirements for adolescents and recommendations for adults were the following: Involvement of a mental health professional who is knowledgeable about the diagnostic criteria for gender dysphoria and criteria for gender-affirming treatment, has training and experience in assessing psychopathology, and is willing to participate in ongoing care. Hormone therapy should be offered to transgender adult patients, with levels maintained within the normal range for gender identity and treatment appropriately monitored. Clinicians involved in the care of transgender adult patients should be knowledgeable about diagnostic criteria for gender dysphoria/gender incongruence, the use of medical and surgical gender-affirming interventions, and appropriate monitoring for reproductive organ cancer risk. Here, 2 clinicians with expertise in this area debate whether psychological evaluation is warranted in a transgender patient requesting gender-affirming hormones or surgery, the potential risks and benefits of estrogen therapy, and the role of the primary care practitioner in the care of transgender persons.