Legal Standard Of Care Research Articles

Summary Paper of the Updated 2023 European Association of Urology Guidelines on Urological Trauma

ContextThe European Association of Urology (EAU) Guidelines Panel for Urological Trauma has produced guidelines in order to assist medical professionals in the management of urological trauma in adults for the past 20 yr. It must be emphasised that clinical guidelines present the best evidence available to the experts, but following guideline recommendations will not necessarily result in the best outcome. Guidelines can never replace clinical expertise when making treatment decisions for individual patients regarding other parameters such as experience and available facilities. Guidelines are not mandates and do not purport to be a legal standard of care. ObjectiveTo present a summary of the 2023 version of the EAU guidelines on the management of urological trauma. Evidence acquisitionA systematic literature search was conducted from 1966 to 2022, and articles with the highest certainty evidence were selected. It is important to note that due to its nature, genitourinary trauma literature still relies heavily on expert opinion and retrospective series. Evidence synthesisDatabases searched included Medline, EMBASE, and the Cochrane Libraries, covering a time frame between May 1, 2021 and April 29, 2022. A total of 1236 unique records were identified, retrieved, and screened for relevance. ConclusionsThe guidelines provide an evidence-based approach for the management of urological trauma. Patient summaryTrauma is a serious public health problem with significant social and economic costs. Urological trauma is common; traffic accidents, falls, intrapersonal violence, and iatrogenic injuries are the main causes. Developments in technology, continuous training of medical professionals, and improved care of polytrauma patients reduce morbidity and maximise the opportunity for quick recovery.

Imaging Recommendations for Diagnosis, Staging, and Management of Prostate Cancer

AbstractThe Prostate Carcinoma Guidelines Panel have formulated these guidelines to assist medical professionals in the evidence-based management of prostate cancer. These have been formulated by a panel consisting of Indian multidisciplinary group of radiologists, uro-oncologists, urologists, radiation oncologists, medical oncologists, and pathologists. These recommendations present the best evidence available to the clinicians; however, using these recommendations will not always result in the best outcome. They aid in decision making for individual patients; however, these will never replace clinical expertise when making treatment decisions. Taking personal values and preferences or individual circumstances of patients into account is necessary for final treatment decision. Guidelines are not mandatory and should not to be referred as a legal standard of care.

WAPM-World Association of Perinatal Medicine practice guidelines: fetal central nervous system examination

These practice guidelines follow the mission of the World Association of Perinatal Medicine (WAPM) in collaboration with the Perinatal Medicine Foundation, bringing together groups and individuals throughout the world, with the goal of improving the ultrasound assessment of the fetal central nervous system (CNS) anatomy. In fact, this document provides further guidance for healthcare practitioners for the evaluation of the fetal CNS during the mid-trimester ultrasound scan with the aim to increase the ability in evaluating normal fetal anatomy. Therefore, it is not intended to establish a legal standard of care. This document is based on consensus among perinatal experts throughout the world, and serves as a guideline for use in clinical practice.

Understanding Mordel: obtaining informed consent for trisomy screening

The landmark decision of Montgomery has established that the patient's right to self-determination and autonomy underpins the doctrine of informed consent. The case of Mordel threw into question the process of obtaining informed consent and whether it was being sufficiently secured in the context of Down's syndrome screening. This case conveyed a paradigm shift to the role of the midwife and sonographers when obtaining consent for screening and the requisite legal standard of care they owe to expectant parents. However, many key issues remain unanswered from the decision in Mordel, in particular, what steps must healthcare professionals take to discharge their duty of care in the process of securing informed consent from expectant parents for screening.

Ethical and legal issues of tracheostomy ventilation in patients with amyotrophic lateral sclerosis

Doctors owe a legal duty of care to patients, of which legal standard of care, especially on advice, evolves over time. With the modified Montgomery test, informed consent involves a process of best interests decision-making accompanied by disclosure of relevant information in a comprehensible fashion, to the patient. Ethical issues confronting treatment decision and advice are also manifold and have to be confronted. For example, in amyotrophic lateral sclerosis (ALS), an incurable disease, death is usually due to respiratory failure. Tracheostomy ventilation (TV) may be the only alternative to death, yet patients on TV may be subject to the relentless progression of ALS resulting in a locked-in state. Through a case vignette of invasive ventilation for ALS, we examine the ethical and legal issues regarding choice of assisted ventilation in these patients, especially for TV, to ensure reasoned and defensible methodology in patient care. We also include a tracheostomy counselling info kit applicable for use prior to tracheostomy insertion.

Standard of Care for the Practicing Structural Engineer

AbstractAll engineers have a personal standard to which they practice; however, the legal standard of care is the standard to which engineers will be held if sued for professional negligence (also ...

Medical Malpractice Reform

The purpose of this chapter is to assess the theoretical and empirical evidence regarding the efficacy of medical malpractice liability and limitations to it in achieving better healthcare outcomes, and to identify the unresolved issues that merit further attention from scholars. First, we will explore the theoretical and legal background on medical malpractice. Our discussion here is just a sketch of the issues, but it lays out the basic framework from which most scholars have worked. We next turn to the available empirical evidence by focusing on three basic areas of study: (1) the impact of malpractice limitations on payouts and litigation; (2) the effect of malpractice limitations on overall healthcare costs; and (3) the effect of malpractice on two major cost drivers in the healthcare system: cardiac and obstetrics practice. We conclude that limitations on liability did not, and likely cannot, significantly reduce healthcare costs. Finally, we discuss new and important trends in the literature regarding reforms to standards of care and the role of clinical practice guidelines as well as communication and disclosure programs. There is some evidence that healthcare providers are very sensitive to the legal standard of care, and correctly setting the standard of care is one of the greatest challenges faced by the healthcare system. Thus, standard setting in conjunction with medical liability has potential to improve medical treatment.

Medical Uncertainty and Physician Innovation

Uncertainty pervades medical practice. Rapid scientific advances and substantial patient heterogeneity in both treatment responses and value preferences make it impossible for even the most knowledgeable practitioner to confidently identify the “right” option for every patient. Uncertainty is particularly acute when a physician deliberately deviates from generally accepted practices in an attempt to improve patient care. Unlike drug and device manufacturers, innovative physicians are not subject to mandatory public regulation by the FDA or any other government agency. The question of how to regulate physician behavior thus largely falls to the tort system. Innovation by definition involves a departure from customary practice, so adherence to custom in defining the legal standard of care essentially requires physicians to solely bear the liability costs of novel interventions. This regime protects patients from unnecessary risks associated with untested treatments, but may also unduly deter physicians from tailoring individualized treatment plans that address patients’ particular needs and circumstances. This Article proposes a fiduciary framework for regulating medical uncertainty and physician innovation. The proposed approach mandates close scrutiny of the decision-making process but deference to the substance of medical decisions. Under this model, a physician should be held liable for failing to act in her patient’s best interests, taking into account the patient’s unique clinical condition and value preferences. Within these constraints, however, patients should have the freedom to choose – and assume the associated risks and uncertainties – from among a range of reasonable alternatives. If a physician satisfactorily discharges her fiduciary disclosure duties, she should be shielded from liability for providing an innovative treatment that rationally advances the patient’s interests. This legal scheme strikes a desirable balance that respects patient autonomy, minimizes unnecessary risk, and encourages medical progress.

Korean Guidelines for Colonoscopic Polypectomy

There are indirect evidences to suggest that 80% of colorectal cancers (CRC) develop from adenomatous polyps and that, on average, it takes 10 years for a small polyp to transform into invasive CRC. In multiple cohort studies, colonoscopic polypectomy has been shown to significantly reduce the expected incidence of CRC by 76% to 90%. Colonoscopic polypectomy is performed frequently in primary, secondary and tertiary and medical centers in Korea. However, there are no evidence-based, procedural guidelines for the appropriate performance of this procedure, including the technical aspects. For the guideline presented here, Pubmed, Medline, and Cochrane Library literature searches were performed. When little or no data from well-designed prospective trials were available, an emphasis was placed on the results from large series and reports from recognized experts. Thus, these guidelines for colonoscopic polypectomy are based on a critical review of the available data as well as expert consensus. Further controlled clinical studies are needed to clarify aspects of this statement, and revision may be necessary as new data become available. This guideline is intended to be an educational device to provide information that may assist endoscopists in providing care to patients. This guideline is not a rule and should not be construed as a legal standard of care or as encouraging, advocating, requiring, or discouraging any particular treatment. Clinical decisions for any particular case involve a complex analysis of the patient's condition and the available courses of action.

Korean Guideline for Colonoscopic Polypectomy

There is indirect evidence to suggest that 80% of colorectal cancers (CRC) develop from adenomatous polyps and that, on average, it takes 10 years for a small polyp to transform into invasive CRC. In multiple cohort studies, colonoscopic polypectomy has been shown to significantly reduce the expected incidence of CRC by 76% to 90%. Colonoscopic polypectomy is performed frequently in primary outpatient clinics and secondary and tertiary medical centers in Korea. However, there are no evidence-based, procedural guidelines for the appropriate performance of this procedure, including the technical aspects. For the guideline presented here, PubMed, Medline, and Cochrane Library literature searches were performed. When little or no data from well-designed prospective trials were available, an emphasis was placed on the results from large series and reports from recognized experts. Thus, these guidelines for colonoscopic polypectomy are based on a critical review of the available data as well as expert consensus. Further controlled clinical studies are needed to clarify aspects of this statement, and revision may be necessary as new data become available. This guideline is intended to be an educational device to provide information that may assist endoscopists in providing care to patients. This guideline is not a rule and should not be construed as a legal standard of care or as encouraging, advocating, requiring, or discouraging any particular treatment. Clinical decisions for any particular case involve a complex analysis of the patient's condition and the available courses of action.

CRIMINAL CHILD NEGLECT AND THE "FREE RANGE KID": IS OVERPROTECTIVE PARENTING THE NEW STANDARD OF CARE?

In the last generation, American parenting norms have shifted strongly in favor of Intensive Parenting, placing particular emphasis on protecting children from risks of harm. Recently, a backlash to this trend has emerged. “Free Range” parenting is based on the concern that coddling children through overprotection inhibits the development of their independence and responsibility. Indeed, a growing body of literature suggests that parental overreaction to remote and even illusory risks of physical harm is exposing children to far more serious risks to their well-being and development. But the powerful influence of media has sensationalized the risks to children, skewing popular perceptions of the genuine risks children face and of what constitutes a reasonable or appropriate response to such risks. Consequently, individuals who do not buy into Intensive Parenting norms, including those from different cultural and socio-economic backgrounds, may be subjecting themselves to criminal prosecution for child neglect and endangerment. The criminal statutes are, for the most part, very vague, leaving these prosecutions—which amount to little more than one person’s second-guessing the parenting choices of another—in the discretion of prosecutors, who bring the charges, and of juries, who render verdicts. If prosecutors and jurors share the media-fed misperceptions of risk, overprotective parenting becomes the de facto legal standard of care. To counter this possibility, it is necessary to define criminal child neglect with far greater specificity and to allow defendants to introduce expert testimony to put the actual risks to children, as well as the downside risk of the precautions themselves, in perspective. Absent such changes, fear of prosecution may effectively force parents to conform to the overprotective parenting norm, to the detriment of society, families, and the children themselves.

Europäische Gesellschaft für Gastrointestinale Endoskopie (ESGE): Empfehlungen (2009) zum klinischen Einsatz der Video-Kapsel-Endoskopie bei Dünndarm-, Ösophagus- und Kolonerkrankungen

These recommendations on video capsule endos-copy, an emerging technology with an impact on the practice of endoscopy, were developed by the European Society of Gastrointestinal Endoscopy (ESGE) Guidelines Committee. The first draft of each section was prepared by one or two members of the writing team, who were selected as -experts on the content of that section on the basis of their published work. They used evidence-based methodology, performing MEDLINE and PubMed literature searches to identify relevant clinical studies. Abstracts from scientific meetings were included only if there was no published full paper on a particular topic. If there was disagreement, the first author of the Guideline made the final decision. Recommendations were graded according to the strength of the supporting evidence ( ). The draft guideline was critically reviewed by all authors and submitted to the ESGE councillors for their critical review be-fore approval of the final document. The ESGE Guidelines Committee acknowledges that this doc-ument is based on a critical review of the data available at the time of preparation and that further studies may be needed to clarify some -aspects. Moreover, this Guideline may be revised as necessary to account for changes in technology, new data, or other aspects of clinical practice. This document should be regarded as supplying recommendations only to gastroenterologists in providing care to their patients. It is not a set of rules and should not be construed as establishing a legal standard of care, or as encouraging, advocating, requiring, or discouraging any particular treatment. These recommendations must be interpreted according to the clinician’s knowledge, expertise, and clinical judgment in the management of individual patients and, if necessary, a course of action that varies from recommenda-tions must be undertaken.

Negligence and the legal standard of care: what is ‘reasonable’ conduct?

Medical negligence has become a big issue for medical practitioners. Fear of the law, and of litigation, has led to claims of defensive medical practice among doctors and nurses. At the heart of this lies the legal definition of the standard of care, where the law seeks to determine when conduct is 'reasonable' (and thus not negligent), or 'unreasonable' (and thus a breach of the legal duty of care and potentially negligent). In this article the author clarifies what the law means by 'reasonableness' with respect to nurses, drawing on both the law and the NMC Code. Furthermore, the article shall demonstrate that the law is not something to be fearful of but, rather, demands a standard no higher than that of the NMC.

Patient Welfare under the Legal Standard of Care

Abstract Presuming that the standard of care reflected in the physician reimbursement scheme harms patients, German and US courts enforce their traditional legal standard of care in malpractice lawsuits. This paper summarizes the literature, evaluates the legal standard in microeconomic terms and determines the insurers' and courts' impact on patient welfare. The legal standard proves to be inefficiently high. By contrast, patient welfare is maximized when insurers apply a two-part reimbursement scheme that induces physicians not to comply with the legal standard. If this is infeasible, another reimbursement scheme is suggested.

Practice Guideline for the Performance of Physiologic Evaluation of Extremity Arteries

These guidelines are an educationaltool designed to assist practitioners inproviding appropriate radiologic carefor patients. They are not inflexiblerules or requirements of practice andare not intended, nor should they beused, to establish a legal standard ofcare. For these reasons and those setforth below, the American College ofRadiology cautions against the use ofthese guidelines in litigation in whichthe clinical decisions of a practitionerare called into question.The ultimate judgment regardingtheproprietyofanyspecificprocedureor course of action must be made bythe physician or medical physicist inlight of all the circumstances pre-sented. Thus, an approach that differsfrom the guidelines, standing alone,does not necessarily imply that the ap-proach was below the standard ofcare. To the contrary, a conscientiouspractitioner may responsibly adopt acourse of action different from that setforth in the guidelines when, in thereasonable judgment of the practitio-ner, such course of action is indicatedby the condition of the patient, limita-tions on available resources, or ad-vances in knowledge or technologysubsequent to publication of theguidelines. However, a practitionerwho employs an approach substan-tially different from these guidelines isadvised to document in the patientrecord information sufficient to ex-plain the approach taken.The practice of medicine involvesnot only the science, but also the art ofdealing with the prevention, diagno-sis, alleviation, and treatment of dis-ease. The variety and complexity ofhuman conditions make it impossibleto always reach the most appropriatediagnosis or to predict with certainty aparticular response to treatment.Therefore, it should be recognizedthat adherence to these guidelines willnot assure an accurate diagnosis or asuccessful outcome. All that should beexpected is that the practitioner willfollow a reasonable course of actionbased on current knowledge, availableresources, and the needs of the patientto deliver effective and safe medicalcare. The sole purpose of these guide-linesistoassistpractitionersinachiev-ing this objective.

Veränderungen der medizinischen Standards und Anpassungsnotwendigkeit der rechtlichen Sorgfaltsmaßstäbe aus zivilrechtlicher Sicht

The legal standard of medical care is laid down in Sect. 276 of the German Civil Code (principle of due diligence). It applies to both contractual and tortious liability and likewise to the treatment of patients insured under the statutory health insurance scheme and self-payers. The legal standard of care conforms to the clinical standards because medical liability means medical professional liability. Liability law does not distinguish between different standards of care in the treatment of patients insured under the statutory health insurance scheme on the one hand and privately insured patients on the other. Changes in clinical standards immediately affect liability law without the need for formal adaptation of the legal standard of care. Liability law cannot claim more diligence than that owed from a medical point of view. Legislative changes that result in a lowering of medical standards (reduction in the quality of treatment) will have to be accepted by liability law, even if these are regulations pertaining to Social Law (SGB V, Book 5 of the German Social Code). In this respect, the principle of legal unity applies. In consideration of this kind of changes the due diligence requirements for the treatment of patients insured under the statutory health insurance scheme and privately insured patients remain basically equal. If these changes lead to an increase of risk for the patient, the resulting liabilities are not to be attributed to the therapist. What remains to be seen is whether there will be an increased attempt to minimise risk by "additionally purchasing health care services".

Recommendations and Considerations Related to Preparticipation Screening for Cardiovascular Abnormalities in Competitive Athletes: 2007 Update

Sudden deaths of young competitive athletes are tragic events that continue to have a considerable impact on the lay and medical communities.1–17 These deaths are usually due to a variety of unsuspected cardiovascular diseases and have been reported with increasing frequency in both the United States and Europe.1,5 Such deaths often assume a high public profile because of the youth of the victims and the generally held perception that trained athletes constitute the healthiest segment of society, with the deaths of well-known elite athletes often exaggerating this visibility. These counterintuitive events strike to the core of our sensibilities, periodically galvanizing discussion and action, and in the process raise practical and ethical issues related to detection of the responsible cardiovascular conditions. Preparticipation cardiovascular screening is the systematic practice of medically evaluating large, general populations of athletes before participation in sports for the purpose of identifying (or raising suspicion of) abnormalities that could provoke disease progression or sudden death.13,16 Indeed, identification of the relevant diseases may well prevent some instances of sudden death after temporary or permanent withdrawal from sports or targeted treatment interventions.15,17–21 In addition, the increasing awareness that automated external defibrillators (AEDs) may not always prove successful in the secondary prevention of sudden death for athletes with cardiovascular disease22 underscores the importance of preparticipation screening for the prospective identification of at-risk athletes and the prophylactic prevention of cardiac events during sports by selective disqualification. Although some critics have questioned the effectiveness of cardiovascular screening,23,24 overwhelming support for the principle of this public health initiative exists in both the medical and lay communities.13–16,25 The efficacy of the various athlete screening strategies is not easily resolved in the context of evidence-based investigative medicine. Recently, recommendations of the European Society of Cardiology (ESC)16 and International …

The US Public Health Service “treating tobacco use and dependence clinical practice guidelines” as a legal standard of care

Background: The important factors in evaluating the role of clinical practice guidelines (CPGs) in medical malpractice litigation have been discussed for several years, but have focused on broad policy implications...

Measuring Medical Practice Patterns: Sources of Evidence from Health Services Research

The prevailing approach for establishing the legal standard of care in medical malpractice litigation is for competing expert witnesses to testify based on their impressions and experience. Health services research is a field that includes the objective and scientific documentation of physician behavior. The data sources and research techniques of health services research thus offer litigants a more empirical approach to establishing the standard of care. To facilitate this endeavor, this Article provides lawyers an overview of health services research and its pertinent methods and data sources. Several examples are used to illustrate and analyze the efficacy of determining the legal standard of care with empirical evidence about how physicians actually behave when faced with particular clinical issues. The Authors ultimately propose not to displace expert witnesses, but rather to supplement subjective clinical testimony with more objective and scientifically sound evidence.

Proposed practice guidelines for continuous contact lens wear

The introduction of silicone‐containing hydrogel contact lenses (SCHCLs) for continuous wear (CW) presents practitioners with a unique challenge. To facilitate the transition, we propose a set of guidelines for the conduct of CW practice. The general concepts for the guide are derived from a range of similar codes of practice that have been produced for a range of aspects of eye care. The more general competencies required of eye care practice are assumed and are not discussed in detail. The document is based on the precept that the prescription of SCHCLs is an appropriate practice for suitably screened patients. Practitioners should acquire general and specific knowledge of information applicable to CW with SCHCLs. Support staff should be educated to handle a range of requirements specific to CW. There are no consulting room facilities required beyond those necessary for general optometric practice but we highly recommend that the CW practitioner use grading scales for anterior eye complications and a guide to corneal infiltrative conditions. More stringent examination protocols are required than for general contact lens practice, particularly in the selection of the patient. Patient management should be conducted to a medical standard of care. Documentation is critical and will involve general information about the product, an agreement, disclosure of risk factors, instructions for wear and care, recording of patient questions and answers provided, an informed consent form and detailed, accurate record keeping. A guideline such as this document cannot be positioned as a legal standard of care, but may be used in the formulation of such a standard.