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Biomedical subjects

Andrew D Feld

Publications and source records attributed to Andrew D Feld.

11 recordsLinked to original sources

Reports of "satisfactory relief" by IBS patients receiving usual medical care are confounded by baseline symptom severity and do not accurately reflect symptom improvement.

BACKGROUND: Treatment trials for irritable bowel syndrome (IBS) usually define a responder as a patient who reports satisfactory relief or adequate relief of symptoms at the end of the trial. However, these measures have not been adequately validated. AIMS: (1) Compare a binary satisfactory relief measure to alternative ways of defining a treatment responder. (2) Determine whether baseline IBS symptom severity or psychological distress influence the sensitivity of these outcome measures. METHODS: A total of 350 patients (81% females, average age 50 yr) who had a medical diagnosis of IBS and satisfied Rome II criteria, were recruited from Group Health Cooperative of Puget Sound. At baseline the Irritable Bowel Severity Scale (IBSS) was used to assess symptom severity and to classify patients as mild, moderate, or severe. Psychological distress and IBS-specific quality of life (IBS-QOL) were also assessed. After 6 months treatment with standard medical care, IBSS and IBS-QOL were reassessed, and patients were asked whether they had experienced satisfactory relief and whether they were somewhat or markedly better. RESULTS: Initial severity of IBS significantly affected the proportion who reported satisfactory relief (mild, 72%; moderate, 53%; severe, 44%) and the proportion who were somewhat or markedly better (mild, 62%; moderate, 44%; severe, 38%), but did not affect the proportion with a 50% reduction in symptoms (mild, 26%; moderate, 25%; severe, 23%). Although mild patients were the most likely to report satisfactory relief, they showed no average decrease in symptom severity or improvement in IBS-QOL. Conversely, severe patients, who were the least likely to report satisfactory relief, had the largest reductions in IBS symptom severity and the largest improvements in IBS-QOL. Psychological distress had no significant effect on the responder rate after adjusting for IBS symptom severity. CONCLUSIONS: These data from a descriptive study suggest that satisfactory relief is confounded with initial IBS symptom severity and is poorly correlated with the amount of symptom improvement. Confirmation of these findings in a clinical trial is needed.

Clinical Trials as Topic↗

Expert witness malfeasance: how should specialty societies respond?

There is little doubt that severe distortions are present in the legal adjudication of professional medical liability. The medical expert witness plays an important, often crucial, role in the medical liability cases. The expert assesses medical information, interprets and explains medical uncertainty, medical research, and customary practice for a nonscientific jury, and offers an expert level opinion as to whether the standard of medical care was met. When expert witnesses not merely disagree, but misrepresent data, misrepresent their background credentials and expertise, and offer egregiously false testimony, the legal process is violated and verdicts may be distorted. Many medical and surgical professional organizations, including the American Medical Association, have adopted programs that provide guidelines for members who serve as medical expert witnesses in professional liability cases. The American Association of Neurological Surgeons (AANS) was the first to develop a program to deal with irresponsible expert witness testimony. That program involves a published code of conduct, which outlines the expectations of society regarding expert witness testimony, and potential consequences for noncompliance. To date, the AANS program has withstood court challenge, in fact, has received judicial praise. Other medical societies, including the American College of Gastroenterology (ACG), have reviewed efforts by others and are considering developing their own programs.

American Medical Association↗

The Health Insurance Portability and Accountability Act (HIPAA): its broad effect on practice.

The Health Insurance Portability and Accountability Act (HIPAA), and its final rule, raised fears among practitioners of new and complex regulations that might interfere with medical practice, lead to inadvertent liability and unwanted expense. It generated a dizzying set of health-care administrative activities and a new work for legal consultants. It has extensive scope, and includes most health plans and practitioners. It has regulated both privacy and security, including electronic, paper, and oral communications. However, after a HIPAA compliant office structure is established, and the privacy notice is reviewed and signed by the patient, disclosure of medical information for treatment, payment or "health-care operations" is permitted without recurrent consent forms, thus allowing substantially familiar patterns of doctor-to-doctor communication about treatment. Further, the initial approach to enforcement appears to some legal observers to be more likely corrective rather than punitive, although providers remain uneasy over the mere possibility of criminal penalties. As regards medical research, uncertainties about the application of HIPAA seem less resolved and more variably interpreted by different institutions, with ongoing fear in the research community that important public health and epidemiologic research activity may be compromised by well meaning IRBs using inconsistent, overly strict or erroneous interpretation of the intent of HIPAA regulations.

Biomedical Research↗

Malpractice, tort reform, and you: an introduction to risk management.

The current malpractice crisis has been called the "perfect storm". Doctors are finding practice costs unsustainable. Patients are finding access to care jeopardized. Cost of care is escalating. The system does not deter medical error, compensate most injured victims, produce any result quickly. These factors are creating enough of a crisis to urgently address and merit prompt solution. However, if history is any guide, the debate over malpractice will continue to rage. Reforms will likely be slow. Thus the practicing gastroenterologist, while working for or supporting efforts toward a solution, is well advised to keep up to date with the practice of gastroenterology, but also understand the medical legal matters and have a risk management strategy that will hopefully help keep the malpractice crisis a theoretical rather than personal concern. The following articles in this series are intended to help.

Compensation and Redress↗

Increased somatic complaints and health-care utilization in children: effects of parent IBS status and parent response to gastrointestinal symptoms.

OBJECTIVES: Irritable bowel syndrome (IBS) runs in families. The aims of this study were (i) to exclude biased perception by a mother with irritable bowel as the explanation for increased gastrointestinal (GI) symptoms in their children, (ii) to determine whether non-GI as well as GI symptoms run in families, and (iii) to determine whether parent IBS status and solicitous responses to illness exert independent effects on children's symptom reports, medical clinic visits, and school absences. METHODS: Two hundred and eight mothers with irritable bowel and their 296 children (cases: average age 11.9 yr; 48.6% male) and 241 nonirritable bowel mothers and their 335 children (controls: 11.8 yr; 49.0% male) were interviewed. Other factors assessed were stress, mother's and child's psychological symptoms, child's perceived competence, pain coping style, age, and sex. Children were interviewed apart from their parents. RESULTS: Case children independently reported more frequent stomach aches (F(591) = 9.22; p= 0.0025) and non-GI symptoms (F(562) = 21.03; p < 0.001) than control children. Case children also had more school absences (F(625) = 26.53; p < 0.0001), physician visits for GI symptoms (F(602) = 8.09; p= 0.005), and non-GI clinic visits (F(602) = 27.92; p < 0.001) than control children. Children whose mothers made solicitous responses to illness complaints independently reported more severe stomach aches (F(590) = 11.42; p < 0.001), and they also had more school absences for stomach aches (F(625) = 5.33; p < 0.05), but solicitous behavior did not significantly impact non-GI symptom reporting, clinic visits, or school absences. Differences between cases and controls remained significant after adjusting for potential moderators. CONCLUSIONS: (i) Frequent GI complaints in children whose mothers have irritable bowel are not explained by the mother's biased perceptions; (ii) children of mothers with irritable bowel have more non-GI as well as GI symptoms, disability days, and clinical visits; (iii) and parent IBS status and solicitous responses to illness have independent effects on the child's symptom complaints.

Absenteeism↗

Informed consent: not just for procedures anymore.

The ethical and legal requirement to obtain informed consent prior to performing a procedure or administering a treatment derives from the concept of personal (patient) autonomy. The competent patient, after receiving appropriate disclosure of the material risks of the procedure or treatment, understanding those risks, the benefits, and the alternative approaches, makes a voluntary and uncoerced informed decision to proceed. This article will present a general overview of the modern concept of informed consent as a process (mutual communication) rather than an event (document signing). The historical evolution of this concept and the legal rulings that have shaped the requirements of informed consent will be cited. The benefits of informed decision making as a communication and risk management tool are presented. This review is intended as general information, and not as legal advice, which should be sought from a health-care attorney.

Communication↗

Malpractice risks associated with colon cancer and inflammatory bowel disease.

Analyses of lawsuits against gastroenterologists suggest that the disorders of colon cancer and inflammatory bowel disease are among the more common disorders resulting in malpractice claims, with colon cancer suits receiving some of the highest monetary judgments. Unfortunately, that composite data does not specify the exact alleged wrongdoing, but uses global categories such as "errors of diagnosis." This review will focus on potential legal pitfalls regarding those disorders. The focus is on the legal theories, not the exact medical approach recommended, and is intended as general education, and not legal advice for any specific patient.

Colorectal Neoplasms↗

Legal risks in treating irritable bowel syndrome.

Physicians who treat irritable bowel syndrome (IBS) reasonably seek strategies to reduce the risk of malpractice. They are concerned that, in the absence of laboratory or radiographic markers specific for the disorder, what appears to be a reasonable diagnosis of IBS could lead to a malpractice claim if an alternate diagnosis is later discovered. Physicians need to understand the sources of malpractice risk, and risk management strategies related to these sources, to reduce their exposure to liability suits in this area. This article outlines these sources of risk, or conditions under which physicians may be sued, known as torts. The tort of negligence is covered, including its 4 elements: the duty to provide care to a patient, medical practice below the standard of care, the resultant harm, and the establishment of compensable damages. The concepts of informed consent and vicarious liability are also presented. This discussion is developed within the context of a risk management approach, to assist physicians in developing a preventative approach to malpractice liability when considering the diagnosis of IBS.

Diagnostic Errors↗

Medicolegal implications of colon cancer screening.

The treatment of colon cancer is a significant source of malpractice liability. Physicians are justifiably concerned about malpractice exposure as personal injury attorneys investigate standard and novel malpractice theories and claims. With the general acceptance of the importance of screening for colon cancer, screening for colon cancer is now defined as the standard of care. This has opened up a previously neglected area of malpractice liability. Physicians need to understand the sources of malpractice risk and risk-management strategies related to these sources to reduce their exposure to liability suits in this area. This article outlines these sources evolving from the tort of negligence, including the duty to provide care, practicing below the standards of care, the cause of the harm, and the actual establishment of harm. The concept of vicarious liability and its relationship to the tort of negligence also are discussed. This presentation is developed within the context of a risk-management approach to assist physicians in developing a preventive approach to malpractice liability.

Colonoscopy↗