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Background

Payers frequently rely on budget impact model (BIM) results to help determine drug coverage policy and its effect on their bottom line. It is unclear whether BIMs typically overestimate or underestimate real-world budget impact.

Objective

We examined how different modeling assumptions influenced the results of 6 BIMs from the Institute for Clinical and Economic Review (ICER).

Study Design

Retrospective analysis of pharmaceutical sales data.

Methods

From ICER reports issued before 2016, we collected estimates of 3 BIM outputs: aggregate therapy cost (ie, cost to treat the patient population with a particular therapy), therapy uptake, and price. We compared these against real-world estimates that we generated using drug sales data. We considered 2 classes of BIM estimates: those forecasting future uptake of new agents, which assumed “unmanaged uptake,” and those describing the contemporaneous market state (ie, estimates of current, managed uptake and budget impact for compounds already on the market).

Results

Differences between ICER's estimates and our own were largest for forecasted studies. Here, ICER's uptake estimates exceeded real-world estimates by factors ranging from 7.4 (sacubitril/valsartan) to 54 (hepatitis C treatments). The “unmanaged uptake” assumption (removed from ICER's approach in 2017) yields large deviations between BIM estimates and real-world consumption. Nevertheless, in some cases, ICER's BIMs that relied on current market estimates also deviated substantially from real-world sales data.

Conclusions

This study highlights challenges with forecasting budget impact. In particular, assumptions about uptake and data source selection can greatly influence the accuracy of results.  相似文献   
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Introduction

Physician communication impacts patient outcomes. However, communication skills, especially around difficult conversations, remain suboptimal, and there is no clear way to determine the validity of entrustment decisions. The aims of this study were to 1) describe the development of a simulation-based mastery learning (SBML) curriculum for breaking bad news (BBN) conversation skills and 2) set a defensible minimum passing standard (MPS) to ensure uniform skill acquisition among learners.

Innovation

An SBML BBN curriculum was developed for fourth-year medical students. An assessment tool was created to evaluate the acquisition of skills involved in a BBN conversation. Pilot testing was completed to confirm improvement in skill acquisition and set the MPS.

Outcomes

A BBN assessment tool containing a 15-item checklist and six scaled items was developed. Students' checklist performance improved significantly at post-test compared to baseline (mean 65.33%, SD = 12.09% vs mean 88.67%, SD = 9.45%, P < 0.001). Students were also significantly more likely to have at least a score of 4 (on a five-point scale) for the six scaled questions at post-test. The MPS was set at 80%, requiring a score of 12 items on the checklist and at least 4 of 5 for each scaled item. Using the MPS, 30% of students would require additional training after post-testing.

Comments

We developed a SBML curriculum with a comprehensive assessment of BBN skills and a defensible competency standard. Future efforts will expand the mastery model to larger cohorts and assess the impact of rigorous education on patient care outcomes.  相似文献   
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We present the case of 7‐year‐old African American girl with loose anagen syndrome. Although this is a common cause of hair loss in Caucasian children, and there have been reports of cases occurring in dark‐skinned children of North African and Middle Eastern descent, to our knowledge there have been no cases reported in black children of sub‐Saharan African ancestry. We present this case to broaden the differential diagnosis of hair loss in African Americans.  相似文献   
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Background

A history of childhood maltreatment and psychopathology are common in adults with obesity.

Objectives

To report childhood maltreatment and to evaluate associations between severity and type of childhood maltreatment and lifetime history of psychopathology among adults with severe obesity awaiting bariatric surgery.

Setting

Four clinical centers of the Longitudinal Assessment of Bariatric Surgery Research Consortium.

Methods

The Childhood Trauma Questionnaire, which assesses presence/severity (i.e., none, mild, moderate, severe) of physical abuse, mental abuse, physical neglect, mental neglect, and sexual abuse, was completed by 302 female and 66 male bariatric surgery patients. Presurgery lifetime history of psychopathology and suicidal ideation/behavior were assessed with the Structured Clinical Interview for DSM-IV and the Suicidal Behavioral Questionnaire-Revised, respectively. Presurgery lifetime history of antidepressant use was self-reported.

Results

Two thirds (66.6%) of females and 47.0% of males reported at least 1 form of childhood trauma; 42.4% and 24.2%, respectively, at greater than or equal to moderate severity. Among women, presence/greater severity of childhood mental or physical abuse or neglect was associated with a higher risk of history of psychopathology (i.e., major depressive disorder, posttraumatic stress disorder, other anxiety disorder, alcohol use disorder, binge eating disorder), suicidal ideation/behavior and antidepressant use (P for all ≤ .02). These associations were independent of age, race, education, body mass index, and childhood sexual abuse. Childhood sexual abuse was independently associated with a history of suicidal ideation/behavior and antidepressant use only (P for both ≤ .05). Statistical power was limited to evaluate these associations among men.

Conclusion

Among women with obesity, presence/severity of childhood trauma was positively associated with relatively common psychiatric disorders.  相似文献   
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