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.

Rapid cycling bipolar affective disorder: lack of relation to hypothyroidism.

Thyroid indices were measured after an extended period of medication-free evaluation averaging 6 weeks in 67 consecutively admitted patients with bipolar illness. Thyroid hormone levels -- thyroxine (T4), free T4 and triiodothyronine (T3) -- were not significantly different in the 31 rapid cyclers (> or = 4 affective episodes/year) than in 36 non-rapid cyclers. Analysis of covariance indicated a non-significant trend relation between higher T4 and a greater number of affective episodes in the year prior to admission and male gender when age was covaried. Several previous reports, primarily in medicated subjects, have suggested a link between rapid cycling patients and decreased peripheral thyroid indices (low hormone levels and elevated TSH), but now the majority of studies do not support such a relation. Among those in the literature, this study includes patients studied for the longest time off medications and further suggests that the commonly-cited relation between subclinical hypothyroidism and rapid cycling bipolar illness be reevaluated.

Antidepressant-induced mania and cycle acceleration: a controversy revisited.

OBJECTIVE: The longitudinal course of 51 patients with treatment-refractory bipolar disorder was examined to assess possible effects of heterocyclic antidepressants on occurrence of manic episodes and cycle acceleration. METHOD: Using criteria established from life charts, investigators rated the patients' episodes of mania or cycle acceleration as likely or unlikely to have been induced by antidepressant therapy. Discriminant function analyses were performed to assess predictors of vulnerability to antidepressant-induced mania or cycle acceleration. Further, the likelihood of future antidepressant-induced episodes in persons who had had one such episode was assessed. RESULTS: Thirty-five percent of the patients had a manic episode rated as likely to have been antidepressant-induced. No variable was a predictor of vulnerability to antidepressant-induced mania. Cycle acceleration was likely to be associated with antidepressant treatment in 26% of the patients assessed. Younger age at first treatment was a predictor of vulnerability to antidepressant-induced cycle acceleration. Forty-six percent of patients with antidepressant-induced mania, but only 14% of those without, also showed antidepressant-induced cycle acceleration at some point in their illness. CONCLUSIONS: Mania is likely to be antidepressant-induced and not attributable to the expected course of illness in one-third of treatment-refractory bipolar patients, and rapid cycling is induced in one-fourth. Antidepressant-induced mania may be a marker for increased vulnerability to antidepressant-induced cycle acceleration. Antidepressant-induced cycle acceleration (but not antidepressant-induced mania) is associated with younger age at first treatment and may be more likely to occur in women and in bipolar II patients.

Carbamazepine prophylaxis in refractory affective disorders: a focus on long-term follow-up.

Twenty-four patients with refractory affective disorders who were taking carbamazepine were followed in an open-label fashion for an average of 4 years. Carbamazepine, usually in combination with lithium and other previously ineffective medications, reduced the number and severity of manic and depressive episodes. An overall illness index of morbidity (duration x severity) decreased 72% in the first year and 66% in the second year of carbamazepine treatment. One-half of the patients (N = 11) who were followed for more than 2 years showed a pattern of continued improvement (stable); the other half showed loss of prophylaxis (escape). Those showing the escape pattern had a more rapidly deteriorating course of illness in the 4 years before the study than those showing the stable improvement. Clinical and mechanistic implications of these findings are discussed, including the phenomenon of contingent tolerance as a possible explanation for the emergence of loss of efficacy in a subgroup of patients.

Factors associated with relapse during maintenance treatment of affective disorders.

Five case studies were selected from a group of 22 patients with affective illness who have been followed during carbamazepine prophylaxis in an NIMH naturalistic prospective followup study. They highlight several factors which may be associated with relapse during maintenance treatment: (1) noncompliance; (2) breakthrough episodes with dose reduction; (3) illness exacerbation during psychosocial stress; and (4) progressive emergence of the illness or tolerance to therapeutic effects of psychotropic medications. Attention to these factors may lead to new and better management, as illustrated in case 5. The utility of a life charting approach is emphasized in delineating past and present course of illness, considering the relevance of cycling pattern and past treatment efficacy in selection of present pharmacological interventions, and helping to formulate a multifactorial concept of the interplay of biological and psychosocial factors in the evolution or exacerbation of mood disorders. Clinical recommendations and new areas of study are offered for a more comprehensive approach to maintenance treatment of affective disorders.

Dysphoric mania. Clinical and biological correlates.

Patients studied at peak severity of a manic episode showed substantial degrees of depression (dysphoria) and anxiety. Compared with nondysphoric manics (n = 26), the dysphoric manics (n = 22) had a significantly greater number of previous hospitalizations, and they displayed less rapid cycling both in the year before and during the index hospitalization admission. The severity of manic dysphoria tended to correlate with the number of previous hospitalizations, a finding that was highly significant in women (n = 27). Medication-free manic patients (n = 22) had significant elevations in cerebrospinal fluid norepinephrine concentrations compared with depressed and euthymic patients and normal volunteers, and the degree of elevation correlated significantly with the degree of manic dysphoria, anger, and anxiety rated at the time of the lumbar puncture. Patients with dysphoric mania, recognized by Kraepelin to have poor prognoses, have been reported to respond poorly to lithium carbonate but may be among those who respond to carbamazepine. Clinical, biologic, and pharmacologic response characteristics of manic subgroups, particularly those with extreme dysphoric components to their illness, appear to be clinically meaningful and deserving of further investigation.

Treatment undertaken without express consent.

The issue of patient consent has recently become the focus of much attention and litigation. Under the doctrine of informed consent, physicians must make adequate disclosures to patients before proceeding with treatment, unless the circumstances make obtaining the patient's express consent impracticable. This article explores the rules whereby physicians may render treatment under such circumstances.

Suicide and course of illness in major affective disorder.

The relationship between a history of attempted suicide and prior course of illness was explored in 87 patients with major affective disorder. Fifty-eight percent of bipolar (n = 67) and 50% of unipolar (n = 20) patients had a history of a suicide attempt. Females were more likely to have made an attempt (67%) than males (42%) and were equally likely to have made a violent attempt. Course of illness and prior history of psychosis were similar in patients with and without a history of an attempt. However, in patients who made an attempt, the severity of the worst attempt was positively correlated with the duration of illness. Greater numbers of prior attempts were associated with greater lethality of the worst attempt. Suicidal ideation for the period of most severe depression in the prior 12 months did not correlate with any measure of lethality of suicide attempt. These data not only suggest the need for further studies of suicide in relationship to the longitudinal course of affective illness, but also the need for continuous reappraisal of suicidal risk in patients with recurrent affective disorders.

The business of medicine: problems with the corporate practice doctrine.

Recent changes in the American medical care system, such as new forms of practice used by physicians and hospitals, have presented new and uncertain legal issues. This Article discusses these changes and how older legal doctrines, such as the corporate practice of medicine, have become outdated and are in need of change. Furthermore, efforts to remedy these outmoded legal policies are explored as well as ways for the practicing attorney to avoid the problems they cause.

Physician responsibility for the cost of unnecessary medical services.

Most diagnostic and therapeutic services are ordered by physicians, but physicians practicing under fee-for-service conditions have few incentives to contain the costs of medical care. Without such incentives, effective cost control through mechanisms such as Professional Standards Review Organizations have been disappointing. Several legal approaches might be used to increase physicians' responsibility for the cost of unnecessary services--expansion of tort law, implied contact, redesign of insurance mechanisms, equitable estoppel and informed consent. However, increasing physician responsibility will require uniform but flexible definitions of medical necessity, reliable means for predeterming the need for services and effective penalties or incentives. We propose a peer-review system that would incorporate the sharing of financial risk among physician, hospital, insurer and patient in the fee-for-service sector.