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.

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.

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.

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.

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.

Supplemental Nutrition Assistance Program: Nutrition Education and Obesity Prevention Grant Program. Final rule.

This rule adopts the interim rule implementing the Supplemental Nutrition Assistance Program (SNAP) nutrition education and obesity prevention grant program with changes as provided in this rule. This rule also amends SNAP regulations to implement section 28 of the Food and Nutrition Act (FNA) of 2008, as added by section 241 of the Healthy, Hunger-Free Kids Act (HHFKA) of 2010, to award grants to States for provision of nutrition education and obesity prevention programs. These programs provide services for eligible individuals that promote healthy food choices consistent with the current Dietary Guidelines for Americans (DGAs). The rule provides State agencies with requirements for implementing section 28, including the grant award process and describes the process for allocating the Federal grant funding for each State's approved SNAP-Ed plan authorized under the FNA to carry out nutrition education and obesity prevention services each fiscal year. This final rule also implements section 4028 of the Agricultural Act of 2014 (Farm Bill of 2014), which authorizes physical activity promotion in addition to promotion of healthy food choices as part of this nutrition education and obesity prevention program.

Patient information in orthopedic and trauma surgery. Fundamental knowledge, legal aspects and practical recommendations.

Providing information to surgery patients is a form of health-care governed by clearly defined therapeutic and medicolegal rules, and in particular in France by the Act of March 4, 2002 and the Code of Good Practice. The patient's right to information is implemented in a face-to-face consultation, which should be fully codified, and in a specific clinical examination, followed by information regarding the affected organ, pathology, treatment options, possible surgery, and the preconditions, risks and results associated with the procedure. Information should be personalized and as complete as possible, communicating the state of knowledge as validated by scientific societies and medical institutions. State of the art technology (dedicated website, on-line information suites, etc.) is indispensable but needs to be mastered and to adhere to the guidelines of the Council of the National Order of Medicine. Information traceability, the retraction period and proof of content of the information are essential. A signed document delivered in an informative atmosphere optimizes the exercise. Patient information is an ethical and medicolegal obligation, but above all is the expression and demonstration of the health-care potential of the practitioner and our contribution to reducing the information gap, reinforcing the cement holding our society together.

[Patients' rights--doctors' duties]. / Patientenrechte--Arztpflichten (I).

On 26 February 2013 the new "Law on Patients' Rights" (hereinafter also the "Law") became effective. This Law strengthens patients' rights vis-à-vis the insurdnce company and also regulates patients' rights regarding their relation to the doctor. This has consequences for the laws on medical liability all doctors must consider. The doctor's performance is and remains a service and such service does not hold any guarantee of success. Nevertheless, this Law primarily reads as a "law on the duties of physicians". To duly take into account these duties and to avoid mistakes and misinterpretation of the Law, the Ethics Committee of the Consortium of Osteosynthesis Trauma Germany (AOTRAUMA-D) has drafted comments on the Law. Brief summaries of its effects are to be found at the end of the respective comment under the heading "Consequences for Practice". The text of the law was influenced particularly by case law, as continuously developed by the German Federal Court of Justice ("BGH"). The implementation of the Law on Patients' Rights was effected by the newly inserted sections 630a to 630h of the German Civil Code (the "BGB"), which are analysed below. The following comments are addressed to physicians only and do not deal with the specific requirements and particularities of the other medical professions such as physiotherapy, midwifery and others so on. Special attention should be paid to the comments on the newly inserted Duty to inform, which has to be fullfilled prior to any diagnostic or therapeutic procedure (sec. 630c para 2 sentence 1 BGB). Under certain conditions the doctor also has to inform the patient about the circumstances that lead to the presumed occurance of a therapeutic or diagnostic malpractice (sec. 630c para. 2 sentence 2 BGB), based on the manifestation of an undesired event or an undesired outcome. As before, the patient's valid consent to any procedure (sec. 630d BGB) is directly linked to the comprehensive and timely provision of information (sec. 630e BGB). Comprehensive documentation obligations regarding all procedures are stipulated in sec. 630f BGB. As before, the burden of proof still rests with the patient, unless a severe malpractice has been established (sec. 630h BGB). The definition of "severe malpractice" remains unchanged and is based on the case law of the Federal Court of Justice (BGH). The patient's obligations to preserve his or her health and to actively support the process of recovery and securing a positive outcome of the treatment are not explicitly mentioned in the Law. Nevertheless, the patient and the physician need to work closely together to achieve a successful result of the treatment. In case the patient does not give his or her cooperation, the physician should consider terminating the treatment relationship.

Factors influencing incidence and type of postmastectomy breast reconstruction in an urban multidisciplinary cancer center.

BACKGROUND: On January 1, 2011, New York State amended the Public Health Law to ensure that patients receive "information and access to breast reconstruction surgery." The purposes of this study were to investigate the early impact of this legislation on reconstruction rates and to evaluate the influence of patient variables versus physician variables on the incidence and type of breast reconstruction performed. METHODS: A retrospective study was conducted on all patients who underwent mastectomy between January 1, 2010, and December 31, 2011. Reconstruction rates were analyzed in relation to timing of legislation, breast surgeon variables, plastic surgeon faculty status, type of reconstruction, and patient variables. RESULTS: Two hundred fifty-eight patients met inclusion criteria. The overall reconstruction rate was 56.59 percent. There was no statistically significant increase in reconstruction rate after the 2011 legislation (OR, 0.45; p = 0.057). Patients whose breast surgeon was female were more likely to undergo reconstruction (OR, 5.17; p = 0.001). Patients who were Asian (OR, 0.22; p = 0.002), older than 60 years (OR, 0.09; p = 0.001), or had stage 3 and 4 cancer (OR, 0.04; p = 0.03) were less likely to undergo reconstruction. Patients reconstructed by a hospital-employed plastic surgeon were significantly more likely to undergo autologous versus implant reconstruction (OR, 6.85; p = 0.001) and to undergo microsurgical versus nonmicrosurgical autologous reconstruction (78.2 percent versus 0 percent; p = 0.001). CONCLUSIONS: Breast surgeon sex and plastic surgeon faculty status were the factors that most affected the rate and type of reconstruction, respectively. Legislation mandating the discussion of breast reconstruction options had no impact on reconstruction rate. CLINICAL QUESTION/LEVEL OF EVIDENCE: Risk, II.

Toward safe accessibility of opioid pain medicines in Vietnam and other developing countries: a balanced policy method.

Moderate or severe pain is common among people with advanced cancer and other life-threatening illnesses. Yet despite agreement that pain relief is a human right, the poorest 80% of the world's population rarely have access to strong opioid analgesics. Excessively restrictive opioid policies, especially in developing countries, both stem from and propagate misguided fears about opioids, so-called opiophobia. Because opiophobia, like any norm, is historically, socially, and culturally situated, efforts to change opiophobic policies will be most effective if guided by awareness of their historical, social, and cultural determinants. We describe some of these determinants in Vietnam and report on results of an ongoing project there to allay opiophobia and improve safe access to opioids for medical uses. We used a method that entails working with committed local partners, including a high-level official from the Ministry of Health, to review all Vietnamese policies governing opioid accessibility to identify the barriers; devising an action plan to safely reduce or circumnavigate the barriers; obtaining buy-in for the plan from all stakeholders, including drug regulators and the police; and assisting the Ministry of Health to implement the plan. Since the start of the project, morphine consumption has increased each year and as of 2010 was ninefold greater than in 2003, and the number of hospitals offering palliative care has increased from three to 15. We conclude that this balanced policy method appears to be helping to reduce barriers to opioid access in Vietnam and should be used in other developing countries.

[Frequency-specific analysis of the hVOR Prior of Cochlear Implant Operation]. / Frequenzspezifische Untersuchung des hVOR im Vorfeld einer CI-Operation.

Dizziness is one of the most common postoperative complications after a cochlear-implant (CI) surgery. With our prospective, matched-paired controlled study, we could demonstrate that patients with distinctive sensorineural hearing loss--even without any complaints of dizziness--already have a reduced horizontal vestibular-ocular-reflex (hVOR). Compared to controls, CI patients presented with a significantly reduced gain. 9 out of 17 CI patients showed physiological results in rotatory testing and video head thrust testing. One patient presented with pathological results in both tests. Remarkably, there were 2 patients who presented with pathological head impulse testing but normal values in rotatory testing and 5 patients who showed normal gains in video head impulse testing but abnormal rotatory tests. These findings clearly show the importance of a differentiated, frequency-dependent pre-operative vestibular assessment including rotatory testing and video-head impulse testing. Additionally, only an accurate pre-operative vestibular testing allows evaluating possible post-operative dizziness related complications and should be documented precisely, also for forensic reasons. This is the key to differentiate post-operative dizziness from an pre-operatively existing vestibular disorder that possibly might not be clinically apparent by the time of testing.