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The legal status of clinical practice parameters: an annotated bibliography.

An important recent development in American medicine has been the strong push in the last few years toward the formal creation, dissemination, and enforcement of explicit clinical practice guidelines or parameters relating to the quality and efficacy of various medical interventions, parameters that would guide the decisions and actions of physicians and other health care providers (1-3). Medical societies (4), governmental agencies such as the federal Agency for Health Care Policy and Research, and insurers are utilizing a variety of approaches to the development of practice parameters for medical diagnosis and intervention, including informal consensus development, formal consensus development, evidence-based guideline development, and explicit guideline development (5). The number and variety of practice parameters has burgeoned in response to the wide national variations in medical practice patterns, without corresponding differences in clinical outcomes, that have been documented by health services researchers. Several commentators have expressed serious skepticism about the probable impact of practice parameters, surmising that they will be used extensively in a negative manner in medical malpractice litigation (6, 7). Many physicians in particular have asked "how they [practice parameters] can be implemented without courting the ruin of the individual practitioner" (8). In response to these anxieties, a new medicolegal literature has arisen to address the relationship between the development of clinical practice parameters and the physician's exposure to malpractice litigation and adverse judgments, as well as the implications for malpractice insurance premiums. This growing literature has now achieved a critical mass. The major contributions to this corpus at present are listed and annotated below.

Humans↗

Informed consent in China: status quo and its future.

Informed consent is one of the fundamental rights of a patient. However it used to be ignored in mainland China and was neither academically discussed nor a matter of practical concern until recent years. Paternalism was dominant in the practice of traditional Chinese medicine which was intensely influenced by Confucianism. The historic medical paternalism was reinforced under communism and the planned economy due to the communist beliefs. But is has been frequently challenged in recent years with patients' awakening awareness of rights and the advent of rights-defending litigation culture in the course of the transformation to market economy. Nevertheless, the current Chinese laws lag behind this patients' awakening awareness and litigation culture. The resulting deficiency in Chinese laws governing medical relations has created dilemmas and chaos in the resolution of medical disputes. In conclusion, the author appeals for the amendment of Chinese law and tries to point out how it should be amended.

China↗

Emotional risk factors and postconcussional disorder.

Emotional risk factors were examined in 129 litigant and nonlitigant patients diagnosed with Postconcussional Disorder (PCD) following Mild Traumatic Brain Injury (MTBI). According to Millon Clinical Multiaxial Inventory (MCMI) criteria, four subgroups emerged: (a) 14.7% met criteria for an Axis I disorder, (b) 24.8% for an Axis II disorder, (c) 24.0% for bout Axis I and II disorders, and (d) 36.4% fell below threshold for psychopathology. Thus, 63.5% endorsed emotional pathology. Of the four groups, those with both Axis I and II psychopathology presented the greatest number of emotional complaints in a clinical interview and manifested the lowest neurocognitive test scores. Motor skills, verbal abilities, memory functioning, and IQ were primarily affected. With the exception of post-morbid emotional complaints, no significant differences were identified between litigants and nonlitigants. Our analysis suggests that the combination of both Axis I and II psychopathology is associated with greater impairment following MTBI.

Adult↗

Expert witness testimony: rules of engagement.

Overlooked in most legislative remedies to address the medical malpractice (MMP) crisis is stringent prohibition against the use of "junk science'' in the courtroom and defining the qualifications of an expert witness. Expert witnesses should be required to: (1) to disclose information materially related to the reliability of expert testimony. (2) Filing of a "Daubert brief'': a summary of the plaintiff's expert's opinion along with a resume outlining his/her knowledge, skill, experience, training and education, reputation in the field relevant to the litigation, and complete details of the methodology employed by the expert. (3) An oath or declaration that acknowledges the duty to disclose to the court all information known to the person to be material to the reliability of the expert witness. Rules of evidence: The "Frye test'' or the "general acceptance rule'' has been used by judges to exclude expert testimony unless it is "sufficiently established to have gained general acceptance in the particular field in which it belongs.'' Stricter standards need to be legislated at the state level. The mandatory use of scientific panels by judges in all MMP cases is needed. Legislative relief has been sought by the medical community to address the serious disconnect between negligence and MMP litigation. The use of junk science in the courtroom remains largely unaddressed in the judicial system. Medical societies and legislatures must act to define an expert witness and restrain plaintiff's attorneys from using junk science to influence juries.

Expert Testimony↗

Cape Plc: South African mineworkers' quest for justice.

Communities in South Africa, especially those in Limpopo and Northern Cape, have been decimated by the mining operations of Cape Plc. South African victims of asbestos-related disease have only recently begun to be awarded (modest) compensation settlements through litigation, as a result of collective efforts on their behalf. The tortuous case of Cape, which knowingly exposed thousands of innocent people, especially black workers, to damaging environmental concentrations of asbestos, is detailed. After fierce and prolonged skirmishing in the courts, a decision in favor of the claimants allowed the case to be tried in the English High Court. Cape reached a settlement agreement with the claimants in 2001, but was unable to meet its terms. Renewed litigation in 2002 resulted in the signing of three new settlement agreements in 2003. These have yet to be put into effect, but it is hoped that the recent developments represent a turning point in the fortunes of South African asbestos victims.

Adult↗

Cross sectional study of performance indicators for English Primary Care Trusts: testing construct validity and identifying explanatory variables.

BACKGROUND: The performance of Primary Care Trusts in England is assessed and published using a number of different performance indicators. Our study has two broad purposes. Firstly, to find out whether pairs of indicators that purport to measure similar aspects of quality are correlated (as would be expected if they are both valid measures of the same construct). Secondly, we wanted to find out whether broad (global) indicators correlated with any particular features of Primary Care Trusts, such as expenditure per capita. METHODS: Cross sectional quantitative analysis using data from six 2004/05 PCT performance indicators for 303 English Primary Care Trusts from four sources in the public domain: Star Rating, aggregated Quality and Outcomes Framework scores, Dr Foster mortality index, Dr Foster equity index (heart by-pass and hip replacements), NHS Litigation Authority Risk Management standards and Patient Satisfaction scores from the Star Ratings. Forward stepwise multiple regression analysis to determine the effect of Primary Care Trust characteristics on performance. RESULTS: Star Rating and Quality and Outcomes Framework total, both summary measures of global quality, were not correlated with each other (F = 0.66, p = 0.57). There were however positive correlations between Quality and Outcomes Framework total and patient satisfaction (r = 0.61, p < 0.001) and between screening/'additional services' indicators on the Star Ratings and Quality and Outcomes Framework (F = 24, p < 0.001). There was no correlation between different measures of access to services. Likewise we found no relationship between either Star Rating or Litigation Authority Standards and hospital mortality (F = 0.61, p = 0.61; F = 0.31, p = 0.73). CONCLUSION: Performance assessment in healthcare remains on the Government's agenda, with new core and developmental standards set to replace the Star Ratings in 2006. Yet the results of this analysis provide little evidence that the current indicators have sufficient construct validity to measure the underlying concept of quality, except when the specific area of screening is considered.

Catchment Area, Health↗

How low is too low, revisited: sentence repetition and AVLT-recognition in the detection of malingering.

Sentence Repetition (SR) and Rey Auditory Verbal Learning Test-Recognition Task (AVLT-R) scores of 5 groups of examinees (severe traumatic brain injury [TBI], mild TBI nonlitigants, normal controls, mild TBI litigants, and actors) were compared with the intent of determining cutoffs for the detection of malingering. Cutoff scores were set below the minimum of the severe TBI group, resulting in a specificity of 100% for both tests. At this level of specificity, the AVLT-R detected 10 of the 20 known actors (50% sensitivity), whereas SR correctly identified 14 of the 20 actors (70% sensitivity). Among litigants with mild injury, 12.24% were identified by the AVLT-R and 6.12% by SR as malingerers. These findings are similar to those found utilizing a variety of other common neuropsychological instruments. Employing commonly used neuropsychological tests as measures of motivation is both practical and clinically useful.

Accidents, Traffic↗

Malpractice arising from negligent psychotherapy: ethical, legal, and clinical implications of Osheroff v. Chestnut Lodge.

Traditionally, there have been few legal actions brought against psychotherapists that allege negligent psychotherapy and negligent treatment of psychiatric disorders. However, in the case of Osheroff v. Chestnut Lodge, a patient-physician (Dr. Osheroff) sued Chestnut Lodge, a private psychiatric facility, for negligence based on the staff's decision to apply a psychodynamic model of treatment (through psychotherapy) and not a biological model. The case sparked a heated debate between adherents of the psychodynamic model and those of the biological model. This article explores the implications of the Osheroff litigation for mental health professionals. It is proposed that an interactive informed consent process be used to protect psychotherapists against Osheroff-type litigation.

Disclosure↗

Physicians' perceptions of the risk of being sued.

We explore the deterrent effect of the tort system by assessing physician perceptions of the risk of being sued and the impact of those perceptions on their own practice. The data are from a mailed survey conducted in 1989 of a random sample of physicians who were practicing in New York State in 1984. The survey results were compared to the actual risk of suit using the between-group (Wald) test and logistic regression methods. We also surveyed physicians about practice changes undertaken in the last ten years, factors influencing practice standards, and the costs of being sued and included these in the analysis. On average, physicians estimate that 19.5 out of one hundred of their colleagues will be sued in a given year, approximately three times the actual rate, with significant differences by specialty, location, and suit history. Perceived risk is associated with self-reported changes in test-ordering frequency and reduction in practice scope. The median number of days lost from practice to defend a malpractice suit was three to five, and 6 percent of the physicians surveyed incurred some out-of-pocket expenses. These findings suggest that physicians respond to the messages sent by litigation in a manner consistent with the deterrent theory of tort litigation.

Age Factors↗

Medical malpractice in Michigan: an economic analysis.

We analyzed the factors determining the amount of the recovery on claims based on medical malpractice. Our data set, which previously was not explored, consists of 20,428 claims arising within Michigan that were closed between 1978 and 1990. During this period, major changes were made in the law governing malpractice litigation. We determine the effect of these changes and of various other factors affecting medical malpractice claims. We analyze the effect of a statute that was designed to curtail "forum shopping" by attorneys for plaintiffs. This statute was initially successful in curbing such activity, but its effect seems to be diminishing. In addition, we compare mediation awards with settlement payments, and settlement payments with the expected value of claims in litigation. Evidence suggests that a mediation award is the mediation panel's estimate of a settlement payment appropriate for the case, and that cases are settled for substantially less than their expected value at trial.

Health Care Reform↗

Evidence-based medicine and the law: the courts confront clinical practice guidelines.

This article examines how courts are likely to apply evidence-based medicine, and particularly clinical practice guidelines (CPGs), in healthcare litigation involving quality-of-care and entitlement-to-benefits (coverage) claims. Exploring the "politics" of the current situation, it observes that, just as clinicians have been reluctant to use CPGs in practice, courts have been, and likely will continue to be, slow to apply them in deciding cases., The article analyzes extant and proposed statutory approaches to legitimizing and promoting courts' use of CPGs. It concludes by renewing the author's earlier and controversial proposal to establish a voluntary federal program for certifying guidelines and directing courts to give certified CPGs greater weight in healthcare litigation.

Certification↗

Compensation for medical injury in New Zealand: does "'no-fault" increase the level of claims making and reduce social and clinical selectivity?

The issues of patient safety and quality of care have gained policy attention with a growing appreciation of the scale and impact of medical injury in health systems. While the focus is clearly on the prevention of iatrogenic injury, the question of patient compensation is now also considered important, if only because in fault-based tort systems the fear of litigation may itself be a barrier to the disclosure and open discussion of medical error. No-fault systems, by contrast, do not require proof of culpability, and thus may both reduce barriers to compensation and increase disclosure of error. Little evidence, however, is available on the performance of such systems. This article reports on the analysis of two data sources-a sample of hospital admissions and a complete set of compensation claims for medical injury. Both are for the same year and region of New Zealand, a country that has maintained a no-fault system of accident compensation for a quarter of a century. Just over 2 percent of hospital admissions were associated with an adverse event that was potentially compensable under scheme criteria. While the claims process was well targeted, the level of claims making and receipt was low, with the ratio of successful claims to potentially compensable events being approximately 1:30. Comparison of social and clinical characteristics of the two data sets revealed a degree of selectivity. Compared with the hospital events, the typical successful claimant was younger and female and was much more likely to have experienced a surgical adverse event that, while unexpected, was not due to substandard care. It is concluded that, in interpreting these results, account needs to be taken of a number of features unique to the New Zealand system. These include: the limited payoff for a compensation claim (no pain and suffering or lump sum, free hospital care); the relative complexity of the grounds for claim (either rarity and severity or practitioner error); and a history of limited litigation for medical error. This suggests that, while the New Zealand system is well targeted, cheap, and free of financial and legal barriers, a change in legal doctrine alone has not in itself been sufficient to remove completely the selective and low level of claims making traditionally associated with patient compensation under tort.

Adult↗

A risk assessment and management strategy for community nursing.

Many nursing interventions carry risks of harm to the patient, the nurse or the general public, and the potential for subsequent litigation or censure. This article proposes a six-point risk management strategy, which, if implemented, could reduce the chance of potential harm and litigation within a community nursing service. The strategy encompasses organizational, cultural, clinical, employee, environmental, and incident-reporting issues. A policy statement is proposed from which a risk management strategy could be developed. This is underpinned by the acceptance and ownership of risk management by all managers and clinicians, which is best achieved through a culture of honesty and openness, and where the management of risk is considered one of the fundamental duties of every member of staff. The strategy aims to enable the creation of a more coordinated, systematic and focused approach to the management of risks.

Community Health Nursing↗

Is childbirth safe in the UK and are there enough obstetricians? Letter to a chief executive.

If you are at term after a normal pregnancy and are not lucky enough to live in Portsmouth, then your chance of losing the baby during labour is higher in Great Britain than in nine other European countries, including Slovenia. The NHS Litigation Authority have put aside 1.3 billion Pounds for the next 5 years to cover litigation relating to cases of cerebral palsy, the majority of which will occur in GP- and midwife-led units. The European work directive will severely restrict staff grade and consultant hours of work over the next few years and this can only be made up by appointing more consultants.

Female↗

Advancing human rights through constitutional protection for gays and lesbians in South Africa.

As a consequence of the 1994 adoption of a justiciable Bill of Rights in South Africa, with an equality provision prohibiting discrimination on the ground of sexual orientation, a coalition of gay and lesbian organisations set about implementing a progressive agenda of gay and lesbian rights litigation. In striking down the offence of sodomy, the Constitutional Court established a jurisprudence of gay and lesbian rights to equality, dignity and privacy that proved to be the foundation for significant litigation around family law issues. Subsequent to the sodomy judgement, the Court has ruled that same-sex couples who are in permanent life partnerships should be entitled to the same rights as married couples to immigration, employment benefits, custody and adoption of children. Despite the extensive equality jurisprudence of the Court, it is still uncertain whether it will rule in the future in favour of same-sex marriage or in favour of a civil union/domestic partnership model.

Federal Government↗

Long-term disability after neck injury. a comparative study.

Claims for personal injury after whiplash injury cost the economy of the United Kingdom more than pound 3 billion per year, yet only very few patients have radiologically demonstrable pathology. Those sustaining fractures of the cervical spine have been subjected to greater force and may reasonably be expected to have worse symptoms than those with whiplash injuries. Using the neck disability index as the outcome measure, we compared pain and functional disability in four groups of patients who had suffered injury to the cervical spine. After a mean follow-up of 3.5 years, patients who had sustained fractures of the cervical spine had significantly lower levels of pain and disability than those who had received whiplash injuries and were pursuing compensation (p < 0.01), but had similar levels to those whiplash sufferers who had settled litigation or had never sought compensation. Functional recovery after neck injury was unrelated to the physical insult. The increased morbidity in whiplash patients is likely to be psychological and is associated with litigation.

Accidents, Traffic↗

Legal challenges to managed care cost containment programs: an initial assessment.

The success of managed care cost containment innovations depends on many factors, including how courts decide litigation challenging various cost containment initiatives. Although such litigation is just emerging, enough cases have been reported to enable an initial assessment of court rulings. To date there is no evidence that courts have systematically impeded cost containment initiatives. Few courts seem willing to usurp legislative choices in formulating health policy or to obstruct the market in organizing and delivering health care services. The anticipated role of the courts as policymakers in shaping health care delivery has yet to emerge.

Cost Control↗

The impact of state managed care liability statutes.

Since the mid-1990s ten states have enacted statutes that have created tort liability for patient harm caused by managed care organizations, and similar liability has been considered in Congress. This study is the first attempt to evaluate the impact of these state statutes on liability exposure and litigation activity. These statutes have resulted in little or no litigation and are not seen as creating any fundamentally new type of liability exposure. This muted effect is not attributable primarily to ERISA preemption but, rather, to the costs and complexities of suing a health plan, which deter lawyers from including this additional defendant in medical malpractice cases. The main drivers of increased liability concerns are the large class-action lawsuits that are pending under federal law and the few state cases with massive punitive-damage verdicts prior to these statutes. This suggests that a federal liability statute is not likely to greatly increase liability exposure unless it allows such suits.

Employee Retirement Income Security Act↗