Review of Malpractice Litigations Involving Vesicovaginal and Rectovaginal Fistulas Following Elective Hysterectomy for Benign Indications in the United States From 1970 to 2020.

OBJECTIVE: The aims of this study were to review malpractice litigations involving vesicovaginal and rectovaginal fistulas after elective hysterectomy for benign indications in the United States and identify the most common themes in allegations by the plaintiffs and defenses by the defendants. METHODS: Using the Lexis Nexis legal database, we searched for and reviewed all U.S. malpractice litigations pertinent to this question between 1970 and 2020. RESULTS: Out of 82 cases that were identified and reviewed, 17 cases met our inclusion and exclusion criteria. These cases were decided between 1973 and 2019. Nine cases involved total abdominal hysterectomies, 1 involved total laparoscopic hysterectomy (TLH), 1 involved total vaginal hysterectomy (TVH), and the rest were not specified. Fifteen cases involved vesicovaginal fistulas and 2 involved rectovaginal fistulas. Three cases were ruled in favor of the plaintiffs, with monetary compensation ranging from $250,000 to $753,722 (approximately $364,120 to $1.8 million when adjusted for inflation), whereas 14 cases were ruled in favor of the defending surgeons. Common allegations were negligence in 15 cases and lack of informed consent in 2 cases. Factors that strengthened the defendants' arguments were thorough documentation, informed consent, and prompt referral to specialists. Intraoperative cystoscopy may have benefited in some cases. CONCLUSIONS: Thorough documentation, informed consent, and prompt referral to specialists strengthened the defendants' legal arguments. Intraoperative cystoscopy may also be beneficial.

A Risk-Based Screening Approach to Patients Needing Surgery During the De-Escalation Phase of COVID-19 Pandemic.

Since the outbreak of COVID-19 pandemic, many national and international surgical societies have produced guidelines regarding the management of surgical patients. During the mitigation phase of the pandemic, most documents suggested to consider postponing elective procedures, unless this might have impacted the life expectancy of patients. As awareness and knowledge about COVID-19 are gradually increasing, and as we enter a phase when surgical services are resuming their activities, surgical strategies have to adapt to this rapidly evolving scenario. This is particularly relevant when considering screening policies and the associated findings. We herein describe a risk-based approach to the management of patients with surgical diseases, which might be useful in order to limit the risks for healthcare workers and patients, while allowing for resuming elective surgical practice safely.

Claims in orthopedic foot/ankle surgery, how can they help to improve quality of care? A retrospective claim analysis.

BACKGROUND: Orthopedic foot/ankle surgery is a high risk specialty when it comes to malpractice claims. This study aims to evaluate the incidence, characteristics and outcome of claims in this area. METHODS: This was a retrospective, 10-year claim analysis, with data from an anonymous database. Baseline claim/claimant characteristics were collected from all orthopedic foot/ankle-related cases. RESULTS: Of 460 claims in total, most were related to delay in/wrong diagnosis or to (complications of) elective surgical procedures. Whether a claim was settled was related to type of injury (fracture) and type of claim (diagnostic mistake). Median amount disbursed in settled claims was €12,549. Claim incidence did not increase over the years. CONCLUSION: Missed fracture diagnosis and "failed"/disappointing results of elective surgical procedures were the most common causes for claims. Sufficient knowledge of missed (foot) fractures and clear communication/expectation management before elective procedures could help to improve quality of healthcare and patient satisfaction.

Certificate-of-Need State Laws and Elective Posterior Lumbar Fusions: Is It Time to Repeal the Mandate?

OBJECTIVES: Our study aimed to assess whether elective posterior lumbar fusions (PLFs) performed in states with Certificate-of-Need (CON) laws versus states without CON laws had lower utilization rates, lower costs, and better quality of care. METHODS: The 2005-2014 100% Medicare Standard Analytical File was queried to identify patients undergoing elective 1- to 3-level PLF. Differences in per-capita utilization, 90-day reimbursements, and proportion of high-volume between CON and No-CON states were reported. Multivariate analyses were used to analyze 90-day complications and readmissions. RESULTS: A total of 188,687 patients underwent an elective 1- to 3-level PLF in a CON state and 167,642 patients in a No-CON state during 2005-2014. The average per capita utilization of PLFs was lower in CON states as compared with No-CON states (14.5 vs. 15.4 per 10,000 population; P < 0.001). Average 90-day reimbursements between CON and No-CON states differed by a small amount ($22,115 vs. $21,802). CON states had a higher proportion of high-volume facilities (CON vs. No CON-40.9% vs. 29.9%; P < 0.05) and lower proportion of low-volume facilities (CON vs. No-CON-37.2% vs. 45.0%; P < 0.05). PLFs performed in CON states had slightly lower odds of 90-day complications (odds ratio 0.97 [95% confidence interval 0.96-0.99]; P < 0.001) and readmissions (odds ratio 0.95 [95% confidence interval 0.93-0.97]; P < 0.001). CONCLUSIONS: The presence of CON laws was associated with lower utilization of elective 1- to 3-level PLFs and a greater number of high-volume facilities. However, their effect on quality of care, via reduction of 90-day readmissions and 90-day complications, is minimally significant.

Otolaryngology in the Time of Corona: Assessing Operative Impact and Risk During the COVID-19 Crisis.

OBJECTIVE: Limited research exists on the coronavirus disease 2019 (COVID-19) pandemic pertaining to otolaryngology-head and neck surgery (OHNS). The present study seeks to understand the response of OHNS workflows in the context of policy changes and to contribute to developing preparatory guidelines for perioperative management in OHNS. STUDY DESIGN: Retrospective cohort study. SETTING: Pediatric and general adult academic medical centers and a Comprehensive Cancer Center (CCC). SUBJECTS AND METHODS: OHNS cases from March 18 to April 8, 2020-the 3 weeks immediately following the Ohio state-mandated suspension of all elective surgery on March 18, 2020-were compared with a 2019 control data set. RESULTS: During this time, OHNS at the general adult and pediatric medical centers and CCC experienced 87.8%, 77.1%, and 32% decreases in surgical procedures as compared with 2019, respectively. Aerosol-generating procedures accounted for 86.8% of general adult cases, 92.4% of pediatric cases, and 62.0% of CCC cases. Preoperative COVID-19 testing occurred in 7.1% of general adult, 9% of pediatric, and 6.9% of CCC cases. The majority of procedures were tiers 3a and 3b per the Centers for Medicare & Medicaid Services. Aerosol-protective personal protective equipment (PPE) was worn in 28.6% of general adult, 90% of pediatric, and 15.5% of CCC cases. CONCLUSION: For OHNS, the majority of essential surgical cases remained high-risk aerosol-generating procedures. Preoperative COVID-19 testing and intraoperative PPE usage were initially inconsistent; systemwide guidelines were developed rapidly but lagged behind recommendations of the OHNS department and its academy. OHNS best practice standards are needed for preoperative COVID-19 status screening and PPE usage as we begin national reopening.

COVID-19 financial resources for physicians.

The appropriate focus in managing the COVID-19 pandemic in the United States has been addressing access and delivery of care to the population affected by the outbreak. All sectors of the U.S. economy have been significantly affected, including physicians. Physician groups of all specialties and sizes have experienced the financial effects of the pandemic. Hospitals have received billions of dollars to support and enable them to manage emergencies and cover the costs of the disruption. However, many vascular surgeons are under great financial pressure because of the postponement of all nonemergency procedures. The federal government has announced a myriad of programs in the form of grants and loans to reimburse physicians for some of their expenses and loss of revenue. It is more than likely that unless the public health emergency subsides significantly, many practices will experience dire consequences without additional financial assistance. We have attempted to provide a concise listing of such programs and resources available to assist vascular surgeons who are small businesses in accessing these opportunities.

Does content of informed consent forms make surgeons vulnerable to lawsuits?

BACKGROUND: Written informed consent forms (ICFs) are important for ensuring that physicians disclose core information to patients to help them autonomously decide about treatment and for providing substantial evidence for the surgeon in case of a legal dispute. This paper aims to assess the legal and ethical appropriateness and sufficiency of the contents of ICFs designed for several elective surgical procedures currently in use in Turkish hospitals. METHODS: One hundred and twenty-six forms were randomly selected and were analyzed for 22 criteria. The results were compared using the Fisher' exact test, and 95% confidence intervals were calculated. RESULTS: More than 80% of ICFs contained information about the risks of the proposed treatment, the diagnosis of the patient, and the patient's voluntariness/willingness, as well as a designated space for the signatures of the patient and the physician and a description of the proposed treatment. Some ICFs were designed for obtaining blanket consent for using patients' specimens. CONCLUSIONS: The ICFs for general elective surgery contain many deficiencies regarding disclosure of information, and there is significant variation among primary healthcare providers. Unrealistic expectations regarding the surgery or the post-operative recovery period due to insufficient information disclosure may lead patients, who experience post-surgical inconveniences, to file lawsuits against their surgeons. Although all ICFs, regardless of their institution, are generally insufficient for defending hospital administrations or surgeons during a lawsuit, ICFs of private hospitals might be considered better equipped for the situation than those of state or university hospitals. However, further research is needed to show if private hospitals have lower lawsuit rates or better lawsuit outcomes than state or university hospitals in Turkey.

[Obtaining Informed Consent for Anesthesia in Elective Surgery at a Tertiary-Care Hospital: Practices and Ethical-Legal Context]. / Obtenção de Consentimento Informado para Anestesia em Cirurgia Eletiva num Hospital Terciário: Práticas e Contexto Ético-Legal.

INTRODUCTION: Informed consent is an active process of the doctor-patient relationship, based on ethical and legal principles. The anesthetic act has inherent risks, which should be subject of specific consent. The aim of this study was to evaluate the degree of implementation of written specific informed consent for anesthesia in the context of elective surgery. MATERIAL AND METHODS: An observational prospective study, at a tertiary university hospital, in 230 patients aged 60 years or older, undergoing elective surgery between May and July 2017. Eligible patients who consented to participate were interviewed clinically on the day before surgery. In the postoperative period, the anesthetic technique and the existence of the written informed consent for the anesthetic and surgical procedures were assessed. Patients who were unable to give informed consent or those admitted in the Intensive Care Unit after surgery were excluded. RESULTS: Written informed consent for the surgical procedure was obtained for 225 (97.8%), while it was obtained in just 96 (41.7%) patients for the anesthetic act. There was a higher prevalence of stroke, anemia, and higher Charlson and physical American Society of Anesthesiologists scores in patients without written informed consent for the anesthetic act. DISCUSSION: We identified a low implementation of written informed consent for anesthesia. This situation may have important implications in the context of disciplinary, civil or criminal liability. CONCLUSION: Despite its importance, the practice of written informed consent for anesthesia in this institution is not yet implemented on a regular basis.

Introdução: O consentimento informado é um processo ativo na relação médico-doente, assente em valores éticos e legais. O ato anestésico tem riscos inerentes, que devem ser alvo de consentimento específico. O objetivo deste estudo foi avaliar o grau de implementação do consentimento informado escrito para o ato anestésico no contexto de cirurgia eletiva. Material e Métodos: Estudo observacional prospetivo, num hospital terciário e universitário, em 230 doentes com idade igual ou superior a 60 anos submetidos a cirurgia eletiva entre maio e julho de 2017. Aos doentes elegíveis que consentiram participar, foi realizada entrevista clínica no dia prévio à cirurgia. No pós-operatório, foi averiguada a técnica anestésica realizada, e a existência do consentimento informado por escrito para o ato anestésico e cirúrgico. Doentes incapazes de dar consentimento informado ou admitidos na unidade de cuidados intensivos após cirurgia foram excluídos. Resultados: Em 225 (97,8%) dos doentes, verificou-se a obtenção, por escrito, do consentimento informado para o ato cirúrgico, mas apenas em 96 (41,7%) verificou-se a obtenção por escrito do consentimento informado para o ato anestésico. De entre os doentes sem registo de consentimento informado para o ato anestésico, foram mais prevalentes antecedentes de acidente vascular cerebral, anemia e scores de Charlson e de estado físico conforme à Sociedade Americana de Anestesiologia mais elevados. Discussão: Identificámos uma baixa implementação do consentimento informado escrito para o ato anestésico. Esta situação pode ter importantes implicações em contexto de responsabilidade disciplinar, civil ou penal. Conclusão: Apesar da sua importância, a prática do consentimento informado escrito para o ato anestésico nesta instituição não está implementada regularmente.

Patient consent in the post-Montgomery era: A national multi-speciality prospective study.

BACKGROUND: The Montgomery ruling has had a wide-ranging impact on the consent process and has been the subject of new guidelines by bodies, including the Royal College of Surgeons (RCSEng). This is the first study to examine the current standard of consent for surgical procedures at a national level. METHOD: A national collaborative research model was used, with prospective data collection performed across hospitals in Scotland. Variables associated with the consent process were audited across three surgical specialities (general surgery, urology and orthopaedics) and measured against standards set by RCSEng, the Scottish Public Services Ombudsman and medical defence organisations. RESULTS: A total of 289 cases were identified from 12 hospitals. The majority of patients were reviewed by a consultant surgeon in clinic (79.9%) or on the day of surgery (55.4%). The clinic consent rate was 27.0%, while a copy of the documented discussion was only provided to 4.2% of patients. On the day of surgery, the benefits, risks and alternatives to the planned procedure were discussed in less than half of cases. This rate was similar across different clinician grades, while marked variation was seen across hospitals. CONCLUSION: In this prospective multi-centre study we have demonstrated wide variation in the consent processes in many surgical specialities across Scotland. Following the Montgomery ruling, we have demonstrated the current consent process in elective surgery is likely to be substandard, and may require additional steps to be taken by clinicians to ensure patients are fully informed to make decisions regarding their treatment.

Medical Malpractice Lawsuits Involving Surgical Residents.

Importance: Medical malpractice litigation against surgical residents is rarely discussed owing to assumed legal doctrine of respondeat superior, or "let the master answer." Objective: To better understand lawsuits targeting surgical trainees to prevent future litigation. Design, Setting, and Participants: Westlaw, an online legal research database containing legal records from across the United States, was retrospectively reviewed for malpractice cases involving surgical interns, residents, or fellows from January 1, 2005, to January 1, 2015. Infant-related obstetric and ophthalmologic procedures were excluded. Exposures: Involvement in a medical malpractice case. Main Outcomes and Measures: Data were collected on patient demographics, case characteristics, and outcomes and were analyzed using descriptive statistics. Results: During a 10-year period, 87 malpractice cases involving surgical trainees were identified. A total of 50 patients were female (57%), and 79 were 18 years of age or older (91%), with a median patient age of 44.5 years (interquartile range, 45-56 years). A total of 67 cases (77%) resulted in death or permanent disability. Most cases involved elective surgery (61 [70%]) and named a junior resident as a defendant (24 of 35 [69%]). Cases more often questioned the perioperative medical knowledge, decision making errors, and injuries (53 [61%]: preoperative, 19 of 53 [36%]) and postoperative, 34 of 53 [64%]) than intraoperative errors and injuries (43 [49%]). Junior residents were involved primarily with lawsuits related to medical decision making (21 of 24 [87%]). Residents' failure to evaluate the patient was cited in 10 cases (12%) and lack of direct supervision by attending physicians was cited in 48 cases (55%). A total of 42 cases (48%) resulted in a jury verdict or settlement in favor of the plaintiff, with a median payout of $900 000 (range, $1852 to $32 million). Conclusions and Relevance: This review of malpractice cases involving surgical residents highlights the importance of perioperative management, particularly among junior residents, and the importance of appropriate supervision by attending physicians as targets for education on litigation prevention.

Early Elective Delivery Disparities between Non-Hispanic Black and White Women after Statewide Policy Implementation.

BACKGROUND: In 2011, Oregon implemented a policy that reduced the state's rate of early (before 39 weeks' gestation) elective (without medical need) births. OBJECTIVE: This analysis measured differential policy effects by race, examining whether Oregon's policy was associated with changes in non-Hispanic Black-White disparities in early elective cesarean and labor induction. METHODS: We used Oregon birth certificate data, defining prepolicy (2008-2010) and postpolicy (2012-2014) periods, including non-Hispanic Black and White women who gave birth during these periods (n = 121,272). We used longitudinal spline models to assess policy impacts by race and probability models to measure policy-associated changes in Black-White disparities. RESULTS: We found that the prepolicy Black-White differences in early elective cesarean (6.1% vs. 4.3%) were eliminated after policy implementation (2.8% vs. 2.5%); adjusted models show decreases in the odds of elective early cesarean among Black women after the policy change (adjusted odds ratio, 0.47; 95% confidence interval, 0.22-1.00; p = .050) and among White women (adjusted odds ratio, 0.79; 95% confidence interval, 0.67-0.93; p = .006). Adjusted probability models indicated that policy implementation resulted in a 1.75-percentage point narrowing (p = .011) in the Black-White disparity in early elective cesarean. Early elective induction also decreased, from 4.9% and 4.7% for non-Hispanic Black and non-Hispanic White women to 3.8% and 2.5%, respectively; the policy was not associated with a statistically significant change in disparities. CONCLUSIONS: A statewide policy reduced racial disparities in early elective cesarean, but not early elective induction. Attention to differential policy effects by race may reveal changes in disparities, even when that is not the intended focus of the policy.

The concept of a waiting period for preoperative patient consent: Prospective study of 51 shoulder arthroscopy cases.

INTRODUCTION: The French Code of Public Health (CSP) does not explicitly require that patients should be given a certain amount of time to think about a procedure, except for cosmetic surgery, where 15 days is required (Art. L 6322-2 CSP). We hypothesized that patients require a waiting period during their decision-making process for scheduled shoulder arthroscopy procedure. MATERIALS AND METHODS: This prospective observational study of 51 patients analysed the concept of a waiting period based on a 10-item questionnaire. A comparative statistical approach was used and the P values were calculated using a paired Wilcoxon rank-sum test. RESULTS: Of the 51 patients, 42 (82%) rejected the concept of a waiting period before the procedure and 37 patients (73%) did not want a mandatory waiting period imposed by law. DISCUSSION: This study looked at the decision-making process during scheduled orthopaedic surgery and differentiated between the conscious and unconscious approach corresponding to an active and passive waiting period. A waiting period does not allow patients to make a conceptually deliberative decision that conforms to the criteria defined by the French Health Authority. This study rejects the need for a mandatory waiting period imposed on surgeons and patients as it does not integrate itself into the informative model of ethical decision-making for scheduled shoulder arthroscopy. TYPE OF STUDY: Prospective, observational; level of evidence IV.

[Limited Data for Second Opinion Programs: a Systematic Review]. / Kaum aktuelle Daten zu Zweitmeinungsverfahren vorhanden ­ eine systematische Übersichtsarbeit.

Objective: According to a new legislation that will be set up in 2016, patients with an indication for elective surgery have the right to obtain a second opinion. The Federal Joint Committee has to provide a list of indications where this legislation will come into effect. The aim of this systematic review is to summarize available data on second opinion programs and to analyze the indications that should be covered by the new legislation. Methods: Medline, Embase, Proquest and Google scholar were searched for relevant studies in March 2015. To be included, primary studies had to deal with a surgical, orthopedic or gynecological elective procedure, and report agreement between first and second opinion. Study selection and critical appraisal were carried out by 2 reviewers independently. Disagreements were resolved by discussion. Data were extracted and analyzed. Results: In total, 17 studies fulfilled all inclusion criteria. All but one study were from the United States and only 3 studies have been published since 2000. The majority of studies were published in the 70 s and 80 s. Overall, agreement rates varied substantially from 43.0% to 95.5%. Most studies dealt with hysterectomy (n=6), cholecystectomy (n=5) and knee surgery (n=5). Median agreement rates for these procedures were 77.9% (range: 72.7-92.0%), 92.0% (88.2-95.5%) and 85.6% (76.1-93.5%), respectively, in obligatory second opinion programs and 63.0% (58.0-66.7%) and 87.0% (78.0-87.9%) in voluntary second opinion programs. Not enough data were available for knee surgery. Conclusions: Current data on second opinion programs is very limited. There is no data for Germany. Following this, it remains unclear which data or evidence will be used by the Federal Joint Committee to set up the new legislation. However, the findings suggest a potential for second opinion programs. They should be investigated in controlled trials in future.

Legislation regulating availability of breast cancer treatment with particular focus on prophylactic mastectomy.

Breast cancer is one of the most common diseases in the Polish society. In 2015, around 17,000 Polish women were diagnosed with this type of cancer. A comparison of relative survival rates for different European countries shows that the Polish oncological care system is inefficient in terms of breast cancer treatment. Women in Poland have substantially lower chances of surviving the first five years a er being diagnosed than women in most other European countries. An inspiration, and at the same time the main theme of the paper is assessing the availability of a controversial treatment, i.e. risk-reducing mastectomy, to patients at high risk of breast cancer. The primary goal connected with this issue is an analysis of breast cancer prevention in Poland in light of applicable provisions of law and, in a broader context, availability of oncological services in the scope of breast cancer prevention and treatment in Poland. The following research methods were adopted in the implementation of the above mentioned objectives: non-systematic review of the PubMed medical database, review of literature and other available sources of information, including press releases, conference materials and online sources. Furthermore, relevant acts of law have been selected and analysed, with the use of a pre-specified glossary of key terms. Cancers are becoming an increasingly big issue. Every year the incidence rates are higher, and in consequence the number of patients receiving cancer-related benefits grows. The current legal regulations governing the availability of cancer-related benefits seem to be insuficient.

Early elective delivery and vaginal birth after cesarean in rural US maternity hospitals.

INTRODUCTION: The purpose of this study was to describe policies on early elective delivery (EED) and vaginal birth after cesarean (VBAC) in rural US maternity hospitals and to measure whether hospital policies differ by staffing, facilities, or birth volume. METHODS: Data came from a telephone survey, conducted among all rural maternity hospitals in nine US states from November 2013 to March 2014, to report on EED and VBAC at the hospital level. The associations between EED and VBAC and hospital characteristics were analyzed using χ2 and Fisher's exact tests. RESULTS: Most rural maternal hospitals (70.1%) had a 'hard stop' EED policy, whereby elective delivery before 39 weeks gestation was prohibited. Less than half of the rural hospitals surveyed allowed VBACs (38.1%). Rural hospitals with a higher birth volume (p=0.001), with a dedicated obstetric operating room (p<0.001), and where obstetricians and certified nurse-midwives attended deliveries (p=0.010 and p=0.030, respectively) were more likely to allow VBAC deliveries. Hospitals where family physicians and general surgeons attended deliveries were less likely to allow VBAC deliveries (p=0.002 and p=0.040, respectively). CONCLUSIONS: Most rural US maternity hospitals have a hard stop EED policy, consistent with evidence and guideline recommendations. Access to VBAC varies across rural settings, possibly owing to capacity limitations to provide this option. Further research is needed to determine whether and how best to safely implement national recommendations for EED and VBAC policies across a range of rural settings.