Plastic Surgery and the Malpractice Industry.

SUMMARY: The current status of the plastic surgeon in the medical liability spectrum and ways to avoid litigation are explored by using pooled national data from the Medical Professional Liability Association, private information from Applied Medico-Legal Solutions RRG, and a detailed literature search. The medical liability system in the United States costs $55.6 billion, or 2.4 percent of total health care spending. Plastic surgery accounts for 3.31 percent of reported claims and 3.16 percent of paid claims. Total payments for plastic surgeons represent 1.75 percent of the total paid for all specialties. Malpractice awards are relatively light for plastic surgeons. Nevertheless, they still have a 15 percent chance per year of being sued. However, 93 percent of cases will close with a dismissal or a settlement, and only 7 percent will go to trial. Of these, the plastic surgeon will prevail in 79 percent. Most importantly, 75 percent of all cases will result in no payment. To minimize the chances of a lawsuit, plastic surgeons should maintain excellent communication with their patients and participate in shared decision-making. They should take a leadership role and buy in to the performance of perioperative checklists, embrace patient education, and actively participate in Maintenance of Certification. They should be transparent in their dealings with patients by preoperatively declaring their policies on revisions, refunds, complications, and payments. Plastic surgeons must maintain complete and accurate medical records and participate in hospital-based programs of prophylaxis. They should be aware that postoperative infection is the single costliest adverse outcome and proactively deal with it.

The VACCINES Act: Deciphering Vaccine Hesitancy in the Time of COVID-19.

Since the COVID-19 pandemic first hit Wuhan, China, in December 2019, scientists have been racing to develop and test novel vaccines to protect against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The speed of scientific discovery related to COVID-19 is unprecedented. With several vaccine candidates already being tested in clinical trials, we pose the question: what will the vaccine hesitant do in the face of this pandemic?

Patient information in radiology: medico-legal considerations.

Information constitutes a basic right of the patient and a legal obligation of the physicians. Radiological daily practice has evolved mainly by introducing the care rule of radiologists. This active rule is leading to add new medico-legal challenges. Patient Information is considered as a cornerstone of the valid consent to radiological investigations. A lack of information constitutes a fault against medical humanism being able to engage civil or administrative medical liability. Therefore, radiologists must be aware and familiar with their obligations towards patients, including the requirement to provide adequate information.

Primary Care Providers' Preferences and Concerns Regarding Specific Visual Displays for Returning Hemoglobin A1c Test Results to Patients.

Purpose. Patient portals of electronic health record systems currently present patients with tables of laboratory test results, but visual displays can increase patient understanding and sensitivity to result variations. We sought to assess physician preferences and concerns about visual display designs as potential motivators or barriers to their implementation. Methods. In an online survey, 327 primary care physicians (>50% patient care time) recruited through the online e-community/survey research firm SERMO compared hemoglobin A1c (HbA1c) test results presented in table format to various visual displays (number line formats) previously tested in public samples. Half of participants also compared additional visual formats displaying target goal ranges. Outcome measures included preferred display format and whether any displays were unacceptable, would change physician workload, or would induce liability concerns. Results. Most (85%-89%) respondents preferred visual displays over tables for result communications both to patients tested for diagnosis purposes and to diagnosed patients, with a design with color-coded categories most preferred. However, for each format (including tables), 11% to 23% rated them as unacceptable. Most respondents also preferred adding goal range information (in addition to standard ranges) for diagnosed patients. While most physicians anticipated no workload changes, 19% to 32% anticipated increased physician workload while 9% to 28% anticipated decreased workload. Between 32% and 40% had at least some liability concerns. Conclusions. Most primary care physicians prefer visual displays of HbA1c test results over table formats when communicating results to patients. However, workload and liability concerns from a minority of physicians represent a barrier for adoption of such designs in clinical settings.

Medical radiological procedures: which information would be chosen for the report?

AIMS AND OBJECTIVES: The aim of this study was to properly define the information regarding patient exposure to Ionizing Radiations in the radiological report, according to the European Directive 2013/59/EURATOM (EU 2013/59 art.58(b)). For this purpose, we evaluated the results from other Member States EU 2013/59 transpositions and from Guidelines recommendation published by International Organizations involved in diagnostic radiology. A practical way for implementing art.58 is also traced. MATERIALS AND METHODS: Dosimetric quantities, such as exposure, absorbed dose and effective dose which may be included in radiological report, were first analyzed; then, in order to define international state of art of Member States EU 2013/59 transposition, a Web research using French, English, Spanish and German key words was performed. RESULTS: EU 2013/59 transposition for 5 Member States was reported. Especially regarding art.58, a European project reports that few European countries (11 of 28) have identified the dose metrics to be used in radiological report. Scientific organizations supporting clinical radiologists and medical physicists have published Guidelines reporting parameters useful to quantify the radiation output and to assess patient dose. CONCLUSIONS: Our research revealed that there is not a shared interpretation of patient exposure information to be included in radiological report. Nevertheless, according to scientific community, authors believe that the exposure is the most appropriate information that could be included in radiological report. Alternatively, but with more expensiveness, a risk index based on effective dose could be used. Moreover, the systematic exposure information recorded could be useful for dose estimates of population from medical exposure.

A Menu to Evaluate Factors Influencing Implementation of Obesity Prevention Early Care and Education Regulations.

CONTEXT: In recent years, several states have adopted new regulations concerning nutrition, physical activity, and screen time in early care and education (ECE) settings to help prevent childhood obesity. OBJECTIVE: To disseminate a menu of factors that facilitate and/or impede implementation of obesity prevention regulations in ECE settings. DESIGN: To create the menu, we condensed and categorized factors identified in the literature and through field work by placing them within domains. We applied the menu by conducting semistructured interviews during a pilot test assessing implementation of ECE regulations in Colorado. SETTING AND PARTICIPANTS: We first interviewed state and local government agency leaders responsible for policy oversight, and state employees and contractors who acted as intermediaries to direct implementers. We then interviewed directors at ECE centers in the Denver, Colorado, area. We selected 21 ECE centers for a site visit on the basis of feasibility, percentage of low-income families, and diversity in race and ethnicity at each center. Seven centers participated. MAIN OUTCOME MEASURES: Minor and major facilitators and impediments to implementation of childhood obesity prevention regulations in ECE settings. RESULTS: The resulting menu includes 7 domains and 39 factors influential for implementation of ECE regulations. Of these 39 factors, interviewees identified 7 facilitating factors (4 major and 3 minor) and 2 impeding factors (both major). Major facilitating factors were buy-in from parents/caregivers, training and communication provided by governing authority and their contractors, and low level of change required by the regulations themselves. Major impeding factors were timing of implementation and balancing the demands of the regulations against other priorities. CONCLUSIONS: The menu developed by our research team, combined with existing frameworks in dissemination and implementation research, can be used by researchers, practitioners, and policy makers to anticipate factors that facilitate and/or impede implementation of ECE policies to prevent childhood obesity.

Patient-Reported Breast Density Awareness and Knowledge after Breast Density Legislation Passage.

RATIONALE AND OBJECTIVES: To determine awareness and knowledge of breast density and breast density legislation among women receiving routine mammography following passage of Massachusetts breast density legislation. MATERIALS AND METHODS: A survey assessing breast density awareness and knowledge was administered to all women receiving screening mammography over two separate 1-week periods at an academic medical center following implementation of mandatory breast density notification. Survey questions queried sociodemographic factors, breast density knowledge, legislation awareness, and medical decision-making intent. RESULTS: Of 1000 survey recipients, 338 (33.8%) returned their survey. Most women were surprised (207/338; 61.2%) to receive their breast density notification letter and unaware (302/338; 89.9%) of newly implemented breast density legislation. The majority (185/338; 54.7%) of survey respondents self-reported having dense breasts. Only 61.1% (113/185) of women with dense breasts reported that their personal breast density increased breast cancer risk, while only 60.0% (78/130) of women with non dense breasts reported that their personal breast density did not increase breast cancer risk. Significant differences between women with dense and nondense breasts were observed related to intention to follow-up with a health practitioner (118/185; 63.8% vs. 66/130; 50.8%, p = 0.03) and views on necessity of supplemental screening based on personal breast density (83/185; 45.1% vs. 20/130; 15.4%, p < 0.01). CONCLUSIONS: Despite implementation of state breast density laws since 2009, confusion and misinformation about breast density persists among women receiving mammography screening. Innovative tools that more effectively inform patients, may be required to improve communication and patient understanding about breast density and subsequent breast care management.

Naloxone laws facilitate the establishment of overdose education and naloxone distribution programs in the United States.

BACKGROUND: The opioid overdose crisis in the United States continues to worsen. Opioid overdose mortality is entirely preventable with timely administration of naloxone. Since 2001, many states have passed laws to create an enabling environment for the implementation of overdose education and naloxone distribution (OEND) programs. We assessed whether state-level naloxone laws and their provisions stimulated the implementation of OEND programs in the United States. METHODS: Covering the period from 2000 to 2014, we utilized five data sources including the Westlaw legal database, the Prescription Drug Abuse Policy System, the Harm Reduction Coalition's OEND database, National Center of Health Statistics and the United States Census. Random effects logistic regression models with robust variances were used to examine the association of naloxone access laws and their provisions with OEND program implementation as of 2014. RESULTS: At the end of 2014, 8% of counties had OEND programs implemented within them. Counties within states that had a naloxone law (aOR = 28.98; p < 0.001) or a law with any one of the six provisions - third party (aOR = 12.86; p = 0.001), standing order (aOR = 11.45; p < 0.001), possession (aOR = 45.97; p < 0.001), prescriber immunity (aOR = 5.19; p = 0.007), dispenser immunity (aOR = 3.50; p = 0.028) or layperson dispensing (aOR = 12.91; p = 0.001) - had increased odds of an OEND program implemented within them, compared to counties within states without a law or specific provision, respectively. CONCLUSION: Our findings suggest that naloxone laws facilitated the implementation of OEND programs. With only 8% of counties having an OEND program within them, future studies should investigate strategies to improve the implementation of OEND programs.

Effects of Legislation Regulating Abortion in Arizona.

INTRODUCTION: Abortion is a common and safe procedure in the United States, the regulation of which varies by state. Since 2011, hundreds of state-level abortion restrictions have been enacted by legislatures across the country. This study describes the effects of two such regulations enacted in 2011 in Arizona, (A.R.S.) 36-2153 and 36-2155, that imposed a 24-hour waiting period requiring two separate in-person clinic visits before obtaining an abortion and banned advanced practice clinicians such as physician assistants, nurse practitioners, and nurse midwives from inducing medication abortions by prescribing mifepristone. MATERIALS AND METHODS: We conducted a pre-post study to describe the effect of Arizona's scope of practice law on abortion provision by county. Using publicly available data, we compared patterns of abortion provision in 2009 and 2010 (before the laws) with 2012 and 2013. Our primary objective was to compare the proportion of abortions performed with medication by prescription of mifepristone (versus abortions performed surgically, known as aspiration abortions) before and after the laws were enacted. Our secondary objectives were to report the number of counties that lost an abortion provider and the change in the proportion of abortions performed before 14 weeks' gestation of pregnancy after the enactment of the laws. RESULTS: After enactment of the laws, the proportion of Arizona's 15 counties with abortion clinics decreased from 33% to 13%. Over this time, the proportion of abortions performed with medication in Arizona decreased by 17.4% (95% CI, 16.6%-18.3%; p = .0002), from 47.6% to 30.2%. Similarly, the proportion of abortions performed before 14 weeks' gestation in Arizona decreased by 3.3% (95% CI, 2.8%-3.8%; p = .0002) after the enactment of these laws. DISCUSSION: The proportion of abortions performed with medication and the proportion of abortion performed before 14 weeks' gestation in Arizona were negatively affected by the enactment of these laws. These findings are not explained by national temporal trends in abortion, because the proportion of abortions performed with medication increased and early abortions remained stable over the same time period in the United States as a whole. CONCLUSIONS: Proponents of laws restricting the provision of abortion such as these claim to improve the safety of abortion, but they actually seem to decrease access to abortion, as defined by the number of counties with abortion providers, and subsequently lead to delays in abortion. These data should inform future policies by providing an example of how such laws affect women seeking abortion.

Proof of patient information: Analysis of 201 judicial decisions.

INTRODUCTION: The ruling by the French Court of Cassation dated February 25, 1997 obliged doctors to provide proof of the information given to patients, reversing more than half a century of case law. In October 1997, it was specified that such evidence could be provided by "all means", including presumption. No hierarchy in respect of means of proof has been defined by case law or legislation. The present study analyzed judicial decisions with a view to determining the means of proof liable to carry the most weight in a suit for failure to provide due patient information. MATERIAL AND METHOD: A retrospective qualitative study was conducted for the period from January 2010 to December 2015, by a search on the LexisNexis® JurisClasseur website. Two hundred and one judicial decisions relating to failure to provide due patient information were selected and analyzed to study the characteristics of the practitioners involved, the content of the information at issue and the means of proof provided. The resulting cohort of practitioners was compared with the medical demographic atlas of the French Order of Medicine, considered as exhaustive. RESULTS: Two hundred and one practitioners were investigated for failure to provide information: 45 medical practitioners (22±3%), and 156 surgeons (78±3%) including 45 orthopedic surgeons (29±3.6% of surgeons). Hundred and ninety-three were private sector (96±1.3%) and 8 public sector (4±1.3%). Hundred and one surgeons (65±3.8% of surgeons), and 26 medical practitioners (58±7.4%) were convicted. Twenty-five of the 45 orthopedic surgeons were convicted (55±7.5%). There was no significant difference in conviction rates between surgeons and medical practitioners: odds ratio, 1.339916; 95% CI [0.6393982; 2.7753764] (Chi2 test: p=0.49). Ninety-two practitioners based their defense on a single means of proof, and 74 of these were convicted (80±4.2%). Forty practitioners based their defense on several means of proof, and 16 of these were convicted (40±7.8%). There was a significant difference in conviction rate according to reliance on single or multiple evidence of delivery of information: odds ratio, 0.165; 95% CI [0.07; 0.4] (Chi2 test: p=1.1×10-5). DISCUSSION: This study shows that surgeons, and orthopedic surgeons in particular, are more at risk of being investigated for failure to provide due patient information (D=-0.65 [-0.7; -0.6]). They are not, however, more at risk of conviction (p=0.49). Being in private practice also appeared to be a risk factor for conviction of failure to provide due information. Offering several rather than a single means of proof of delivery of information significantly reduces the risk of conviction (p=1.1×10-5). LEVEL OF EVIDENCE: Level IV: Retrospective study.

Medical abortion reversal: science and politics meet.

Medical abortion is a safe, effective, and acceptable option for patients seeking an early nonsurgical abortion. In 2014, medical abortion accounted for nearly one third (31%) of all abortions performed in the United States. State-level attempts to restrict reproductive and sexual health have recently included bills that require physicians to inform women that a medical abortion is reversible. In this commentary, we will review the history, current evidence-based regimen, and regulation of medical abortion. We will then examine current proposed and existing abortion reversal legislation. The objective of this commentary is to ensure physicians are armed with rigorous evidence to inform patients, communities, and policy makers about the safety of medical abortion. Furthermore, given the current paucity of evidence for medical abortion reversal, physicians and policy makers can dispel bad science and misinformation and advocate against medical abortion reversal legislation.

Variables That Impact Medical Malpractice Claims Involving Plastic Surgeons in the United States.

BACKGROUND: Medical malpractice lawsuits contribute directly and indirectly to the cost of healthcare in the United States. Reducing medical malpractice claims represents an often unrecognized opportunity for improving both the quality and affordability of healthcare. OBJECTIVES: The aim of this study was to better understand variables of the informed consent process that may contribute to reducing malpractice claims in plastic surgery. METHODS: A prospective multiple choice questionnaire was distributed via email to all of the 1694 members of the American Society for Aesthetic Plastic Surgery (ASAPS) to evaluate attitudes and practices of informed consent in relation to medical malpractice. RESULTS: A total of 129 questionnaires obtained from plastic surgeons were eligible for analysis (response rate 7.6%). Respondents who provided procedure-specific brochures to their patients were significantly less likely to be sued for medical malpractice (P = 0.004) than those who did not. Plastic surgeons that participated in malpractice carrier-required courses on avoiding medical malpractice litigation had a similarly significantly reduced likelihood of lawsuits. (P = 0.04). CONCLUSIONS: Variables that may reduce malpractice claims, and thereby both improve the quality and affordability of healthcare, include: (1) the use of procedure-specific patient education brochures; and (2) physician participation in malpractice insurance carrier-required courses. These findings should be of interest to physicians, hospitals, and insurance companies.

Correct information to patients undergoing breast-conserving surgery: the medicolegal significance.

Many of the women newly diagnosed with breast cancer not have access to all the information they need to make the surgical and treatment choices that are most appropriate for them. Research clearly shows that lumpectomy and other breast-conserving surgeries are just as safe as mastectomy for most women with early stage disease, and yet approximately half will undergo the more disfiguring procedures, but many healthy women who have strong family histories of breast cancer consider prophylactic mastectomies, and their decisions are also based on very limited information, because there are few studies showing the effectiveness of that procedure. This paper delineates how to avoid limited information and biased recommendations is important for a conscious and informed choice by the patients.

Mandated High School Concussion Education and Collegiate Athletes' Understanding of Concussion.

CONTEXT: Concussions in student-athletes are a serious problem. Most states have enacted legislation mandating concussion education for student-athletes, under the assumption that education leads to better self-reporting of concussions and improved knowledge of symptoms. OBJECTIVES: (1) To determine the effect of state-based concussion legislation on the proportion of student-athletes receiving concussion education and to assess the moderation of this effect by gender and sport and (2) to assess the effect of concussion education on student-athletes' knowledge of concussion symptoms and likelihood of seeking treatment after a concussion. DESIGN: Cross-sectional study. SETTING: Private university. PATIENTS OR OTHER PARTICIPANTS: A total of 249 National Association of Intercollegiate Athletics collegiate athletes attending St Xavier University; 160 were surveyed prelegislation and 89 were surveyed postlegislation. MAIN OUTCOME MEASURE(S): Participants completed an anonymous survey that assessed previous involvement in concussion-education programs, degree of self-reporting after a concussion, and ability to enumerate symptoms. RESULTS: The number of athletes who reported having received education increased after the implementation of concussion legislation; however, almost 25% still reported not having received education. Athletes who played football were more likely to report having received education than those who played volleyball. The student-athletes' ability to name a diversity of concussion symptoms or to report seeking medical attention after a concussion did not improve in the postlegislation period relative to the prelegislation period. CONCLUSIONS: Legislation has been passed in all 50 states to address concussions in student-athletes; however, improvements are still needed. Concussion education must be delivered in a uniform, effective manner to all student-athletes across sports and genders. Concussion education should emphasize the diversity of symptoms, especially cognitive and behavioral symptoms. We must develop and disseminate evidence-based educational programs that are clinically proven to be effective in improving athletes' knowledge and behaviors.

Allegations of Failure to Obtain Informed Consent in Spinal Surgery Medical Malpractice Claims.

Importance: Predictive factors associated with increased risk of medical malpractice litigation have been identified, including severity of injury, physician sex, and error in diagnosis. However, there is a paucity of literature investigating informed consent in spinal surgery malpractice. Objective: To investigate the failure to obtain informed consent as an allegation in medical malpractice claims for patients undergoing a spinal procedure. Design, Setting, and Participants: In this retrospective cohort study, a national medicolegal database was searched for malpractice claim cases related to spinal surgery for all years available (ie, January 1, 1980, through December 31, 2015). Main Outcomes and Measures: Failure to obtain informed consent and associated medical malpractice case verdict. Results: A total of 233 patients (117 [50.4%] male and 116 [49.8%] female; 80 with no informed consent allegation and 153 who cited lack of informed consent) who underwent spinal surgery and filed a malpractice claim were studied (mean [SD] age, 47.1 [13.1] years in the total group, 45.8 [12.9] years in the control group, and 47.9 [13.3] years in the informed consent group). Median interval between year of surgery and year of verdict was 5.4 years (interquartile range, 4-7 years). The most common informed consent allegations were failure to explain risks and adverse effects of surgery (52 [30.4%]) and failure to explain alternative treatment options (17 [9.9%]). In bivariate analysis, patients in the control group were more likely to require additional surgery (45 [56.3%] vs 53 [34.6%], P = .002) and have more permanent injuries compared with the informed consent group (46 [57.5%] vs 63 [42.0%], P = .03). On multivariable regression analysis, permanent injuries were more often associated with indemnity payment after a plaintiff verdict (odds ratio [OR], 3.12; 95% CI, 1.46-6.65; P = .003) or a settlement (OR, 6.26; 95% CI, 1.06-36.70; P = .04). Informed consent allegations were significantly associated with less severe (temporary or emotional) injury (OR, 0.52; 95% CI, 0.28-0.97; P = .04). In addition, allegations of informed consent were found to be predictive of a defense verdict vs a plaintiff ruling (OR, 0.41; 95% CI, 0.17-0.98; P = .046) or settlement (OR, 0.01; 95% CI, 0.001-0.15; P < .001). Conclusions and Relevance: Lack of informed consent is an important cause of medical malpractice litigation. Although associated with a lower rate of indemnity payments, malpractice lawsuits, including informed consent allegations, still present a time, money, and reputation toll for physicians. The findings of this study can therefore help to improve preoperative discussions to protect spinal surgeons from malpractice claims and ensure that patients are better informed.