Informed Consent and Digit Replantation: Current State and Recommendations for Ethical Patient Care.

The importance of informed consent and the value of shared decision-making in hand surgery are well-established and particularly critical in the setting of digit amputation when considering replantation. Informed consent requires an understanding of not only the immediate and long-term risks and benefits of surgery, as well as the risks and alternatives involved, but also the capacity of the patient to make a medical decision. However, patients who have acutely sustained a disfiguring trauma are often in distress and may not fully process the consent discussion. Digit replantation is an "elective emergency"-the decision must be made immediately but is not lifesaving-which poses a difficult dilemma: are surgeons acting in patients' best interests by pursuing replantation if we engage those patients in informed consent discussions when they may not have capacity? This article explores the relevant bioethical principles associated with digit replantation, summarizes updated literature regarding informed consent and shared decision-making, and provides recommendations for patient education materials to standardize informed consent discussions for surgeons approaching patients at this unique intersection of considering revision amputation versus replantation.

Utilizing Computer-Assisted Design and Virtual Surgical Planning for Correction of Unilateral Lambdoid Synostosis.

Unilateral lambdoid synostosis is the rarest form of single-suture craniosynostosis. Although various surgical approaches have been described, cranial vault remodeling remains the predominant approach. To aid in surgical planning, preoperative virtual surgical modeling using a patient's presenting computed tomography scan can be used to increase reconstructive precision and to reduce operative time. Presented is a 7-month-old male with unilateral lambdoid synostosis who underwent medically modeled cranial vault reconstruction.

Prophylactic Desexualizing Mastectomy for an Intellectually Disabled Woman: Protective Measure or Disregard for Autonomy?

Historically, sterilization of the so-called feeble-minded has been advocated in the name of eugenics. Surrogate decision-making that impacts sexuality of the intellectually disabled presents significant ethical dilemmas. We describe a 19-year-old intellectually disabled woman who presented with her legal decision-maker for surgical correction of her asymmetric chest and hypoplastic breast. The decision-maker requested a mastectomy to make the patient's breasts as inconspicuous as possible, and to reduce the risk of sexual assault and pregnancy. This case covers the ethical considerations on whether or not to prophylactically desexualize an intellectually disabled woman.

Evaluation of Drug Trials in High-, Middle-, and Low-Income Countries and Local Commercial Availability of Newly Approved Drugs.

Importance: Clinical research supporting US Food and Drug Administration (FDA) drug approvals is largely conducted outside the US. Objective: To characterize where drugs were tested for FDA approval and to determine how commonly and quickly these drugs received marketing approval in the countries where they were tested, both overall and by country income level and geographical region. Design, Setting, and Participants: This cross-sectional analysis of trials supporting FDA approval of novel drugs in 2012 and 2014, sponsored by large drug companies, did not involve human participants. The settings were the countries hosting trials supporting US drug approval. Data sources included Drugs@FDA, ClinicalTrials.gov, PubMed, Google Scholar, EMBASE, and drug regulatory agency websites. Data analysis was completed March through September 2020. Main Outcomes and Measures: The primary outcomes were the proportion of drugs approved for marketing in the countries where they were tested for FDA approval within 1, 2, 3, 4, and 5 years of FDA approval and the proportion of countries contributing participants to trials supporting FDA approvals receiving market access to the drugs they helped test within 1, 2, 3, 4, and 5 years of FDA approval. Results: In 2012 and 2014, the FDA approved 34 novel drugs sponsored by large companies, on the basis of a total of 898 trials, 563 of which had location information available. Each drug was tested in a median (interquartile range [IQR]) of 25 (18-37) unique countries, including a median (IQR) of 20 (13-25) high-income countries, 6 (4-11) upper-middle-income countries, and 1 (0-2) low-middle-income country. One drug was approved for marketing in all testing countries within 1 year of FDA approval and 15% (5 of 34 drugs) were approved in all testing countries within 5 years of FDA approval. Of the 70 countries contributing research participants for FDA drug approvals, 7% (5 countries) received market access to drugs they helped test within 1 year of FDA approval and 31% (22 countries) did so within 5 years. Access within 1 year occurred in 13% (5 of 39) of high-income countries, 0 of 22 upper-middle-income countries (0%), and 0 of 9 lower-middle-income countries (0%), whereas at 5 years access rates were 46% (18 of 39 countries), 9% (2 of 22 countries), and 22% (2 of 9 countries), respectively. Approvals were faster in high-income countries (median [IQR], 8 [0-11] months) than in upper-middle-income countries (median [IQR], 11 [5-29] months) or lower-middle-income countries (median [IQR], 17 [11-27] months) after FDA approval. Access was lowest in African countries. Conclusions and Relevance: These findings suggest that substantial gaps exist between where FDA-approved drugs are tested and where they ultimately become available to patients, raising concerns about the equitable distribution of research benefits at the population level.

Comparing Health Outcomes of Privileged US Citizens With Those of Average Residents of Other Developed Countries.

Importance: The average health outcomes in the US are not as good as the average health outcomes in other developed countries. However, whether high-income US citizens have better health outcomes than average individuals in other developed countries is unknown. Objective: To assess whether the health outcomes of White US citizens living in the 1% and 5% richest counties (hereafter referred to as privileged White US citizens) are better than the health outcomes of average residents in other developed countries. Design, Setting, and Participants: This comparative effectiveness study, conducted from January 1, 2013, to December 31, 2015, identified White US citizens living in the 1% (n = 32) and 5% (n = 157) highest-income counties in the US and measured the following 6 health outcomes associated with health care interventions: infant and maternal mortality, colon and breast cancer, childhood acute lymphocytic leukemia, and acute myocardial infarction. The study used Organisation for Economic Co-operation and Development data, CONCORD-3 cancer data, and Medicare data to compare their outcomes with all residents in 12 other developed countries: Australia, Austria, Canada, Denmark, Finland, France, Germany, Japan, the Netherlands, Norway, Sweden, and Switzerland. Statistical analysis took place from July 25, 2017, to August 29, 2020. Main Outcomes and Measures: Infant mortality; maternal mortality; 5-year survival of patients with colon cancer, breast cancer, or childhood acute lymphocytic leukemia; and 30-day age-standardized case fatality after acute myocardial infarction. Results: The infant mortality rate among White US citizens in the 5% highest-income counties was 4.01 per 1000, and the maternal mortality rate among White US citizens in the 5% highest-income counties was 10.85 per 100 000, both higher than the mean rates for any of the 12 comparison countries. (The infant mortality rate for the top 1% counties was 3.54 per 1000, and the maternal mortality rate was 10.05 per 100 000.) The 5-year survival rate for White US citizens in the 5% highest-income counties was 67.2% (95% CI, 66.7%-67.7%) for colon cancer, higher than that of average US citizens (64.9% [95% CI, 64.7%-65.1%]) and average citizens in 6 countries, comparable with that of average citizens in 4 countries, and lower than that of average citizens for 2 countries. The 5-year survival rate for breast cancer among White US women in the 5% highest-income US counties was 92.0% (95% CI, 91.6%-92.4%), higher than in all 12 comparison countries. The 5-year survival rate for White children with acute lymphocytic leukemia in the 5% highest-income US counties was 92.6% (95% CI, 90.7%-94.2%), exceeding the mean survival rate for only 1 country and comparable with the mean survival rates in 11 countries. The adjusted 30-day acute myocardial infarction case-fatality rate for White US citizens in the 5% highest-income US counties was 8% below the rate for all US citizens and was 5% below the rate for all US citizens in the 1% highest-income US counties; these estimates were similar to the median outcome of other high-income countries. Conclusions and Relevance: This study suggests that privileged White US citizens have better health outcomes than average US citizens for 6 health outcomes but often fare worse than the mean measure of health outcomes of 12 other developed countries. These findings imply that even if all US citizens experienced the same health outcomes enjoyed by privileged White US citizens, US health indicators would still lag behind those in many other countries.

Medical Student Patient Outreach to Ensure Continuity of Care During the COVID-19 Pandemic.

Background: In response to the COVID-19 pandemic, the Yale New Haven Health System began rescheduling nonurgent outpatient appointments as virtual visits in March 2020. While Yale New Haven Health expanded its telemedicine infrastructure to accommodate this shift, many appointments were delayed and patients faced considerable uncertainty. Objective: Medical students created the Medical Student Task Force (MSTF) to help ensure continuity of care by calling patients whose appointments were delayed during this transition to telemedicine. Methods: Eighty-five student volunteers called 3765 internal medicine patients with canceled appointments, completing screening for 2197 patients. Volunteers screened for health care needs, assessed preferences for future appointments, and offered emotional support and information about COVID-19. Urgent or emergent patient concerns were triaged and escalated to providers. In this analysis, we used a mixed-methods approach: call information and provider responses were analyzed quantitatively, and patient feedback was analyzed qualitatively via thematic analysis. Results: Ninety-one percent of patients screened found the MSTF calls helpful. Twenty-one percent of patients reported health concerns, with 1% reporting urgent concerns escalated to and addressed by providers. Themes of patient comments included gratitude for outreach and social contact, utility of calls, and well-wishes for health care workers. Conclusions: By calling patients whose appointments had been canceled during a rapid transition to telemedicine, the MSTF helped bridge a potential gap in care by offering patients communication with their care teams, information, and support. We propose that this model could be used in other care systems urgently transitioning to outpatient telemedicine, whether during ongoing outbreaks of COVID-19 or other public health emergencies.

Drug Reimbursement Regulation in 6 Peer Countries.

The US has nearly 4.5% of the world's population but accounts for more than 40% of global drug spending. With the upcoming 2020 election, a top priority of many voters is to better control drug prices and reform the pharmaceutical market. In this Special Communication, the drug price mechanisms and government regulations used in 6 representative peer countries are evaluated: Australia, France, Germany, Norway, Switzerland, and the United Kingdom. Drug price regulation is compared with that currently used in the US. Eight key lessons from the regulations used in these countries and which elements are incorporated into the bills currently making their way through the US Congress are evaluated (2 from the US House of Representatives and 1 from the US Senate). None of these bills is as systemic or comprehensive in its drug pricing mechanisms and regulations as the schemes in the other countries.

Accuracy Of The Relative Value Scale Update Committee's Time Estimates And Physician Fee Schedule For Joint Replacement.

Even though relative value units guide 70 percent of physician payment, little research has assessed their accuracy. We analyzed actual service time for total hip and knee replacements at two academic hospitals in the period January 1, 2013-October 1, 2016, using electronic health record time-stamp data, and we compared that time with the Medicare Physician Fee Schedule and most recent Relative Value Scale Update Committee recommendations. We found that the committee and fee schedule overestimated the operating time of original hip replacements by 18 percent and original knee replacements by 23 percent. Revision hip replacements were overestimated by 61 percent and knee replacements by 48 percent. In a multivariate analysis we found that faster operating time was not associated with more complications or admissions to the intensive care unit. Complication rates varied tenfold across physicians and twofold across hospitals. The fee schedule and the committee significantly overestimated operating times for original and revision hip and knee replacements. Policy makers should use empirical time-stamp data instead of self-reported estimates to determine physician payment.

Large-Scale Epidemiologic Studies of Cardiovascular Diseases in China: Need for Improved Data Collection, Methods, Transparency, and Documentation.

With the advent of international precision medicine initiatives, it is important to evaluate existing large-scale studies to inform future investigation. This study sought to review, describe, and evaluate all large-scale cardiovascular disease (CVD) studies completed in China. We undertook a review of all large-scale CVD studies completed in China to describe and evaluate their design, implementation, and dissemination in published medical reports. Seventeen studies met the inclusion criteria. There were substantial variations in study design, geographic location, and data collection. Most studies lacked standard study names, did not publish their methods, and provided no publicly available data. Few studies included underdeveloped regions or minority groups. Most published articles contained only descriptions of the average population at risk of CVD, and no study predicted individual CVD risk or identified people at high risk. Future CVD studies in China may need to incorporate stronger systematic data collection methods, increased data transparency, clearer documentation, and standard study names to most gain from China's burgeoning field of CVD research.