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PubMed1993

Plasma alprazolam concentrations. Relation to efficacy and side effects in the treatment of panic disorder.

A series of 237 patients with DSM-III-diagnosed panic disorder, or agoraphobia with panic attacks, received alprazolam as part of the placebo-controlled Cross-National Collaborative Panic Study. After a 1-week drug-free period, alprazolam dosage was titrated upward with the objective of reaching 6.0 mg/d in all patients. At week 3 of treatment, alprazolam plasma levels were significantly correlated with daily dosage (regression slope: 11.7 ng/mL per milligram per day) but with considerable individual variation. Among patients with spontaneous panic attacks, 70% of those with plasma alprazolam levels greater than 20 ng/mL achieved complete remission vs 31% of those with levels less than 20 ng/mL. Situational panic attack remission increased in frequency with increasing plasma levels, but the relationship was not significant. Patient- and physician-rated global improvement and Hamilton Anxiety and Depression Scale score reductions were maximal at 20 to 39 ng/mL, with no further benefit at higher levels. Central nervous system-depressant side effects increased in frequency with higher plasma levels. Between weeks 3 and 8 of treatment, physicians were permitted to adjust dosage (maximum: 10 mg/d) to optimize response. At week 8, the dose-concentration relationship was essentially identical (regression slope: 10.8 ng/mL per milligram per day), but plasma levels were no longer related to efficacy or side effects. Thus, monitoring of plasma alprazolam concentrations may have a clinically useful role during short-term treatment of panic disorder.

Adolescent↗
PubMed1998

Study of behavioral phenotypes: goals and methodological considerations.

The study of behavioral phenotypes associated with genetic syndromes has gained increasing momentum over the past two decades. In this paper, the definition of behavioral phenotypes is presented and the complexities and obstacles to progress in this field are summarized. Also described are the goals of such investigations, including the need for syndrome delineation, provision of guidance for clinical management, contributions to understanding brain-behavior relations, advancements in developmental theory, and gaining understanding of the genetic bases of behavior. Methodological issues addressed in relation to such goals include the need for cross-disciplinary collaboration, concerns regarding sampling methods and comparison group selection, and developmental considerations. The complexity of cognitive abilities, the limitations of existing tests and measures, and ways of approaching the study of behavior are discussed. A final comment concerns the potential risks of research in behavioral phenotypes.

Behavioral Symptoms↗
PubMed1992

Assessing impairment in patients with panic disorder: the Sheehan Disability Scale.

The DSM-III-R incorporates both distress (symptoms) and disability (impairment) in the definition of a psychiatric disorder. In psychiatric research there is a wide array of instruments used to measure symptom severity, but a limited selection for the assessment of impairment. The psychometric properties of one such instrument, The Sheehan Disability Scale (Sheehan 1983), are evaluated in this paper. The data analyzed come from two studies of patients with panic disorder, the Cross National Collaborative Panic Study--Phase I and the Panic Depression Study. In this report both the alpha coefficients and factor analyses indicate that the reliability of the scale is acceptable. The factor structure of the items and the sensitivity to change of their composite demonstrate satisfactory construct validity. The criterion-related validity is substantiated by the significant relationship between symptomatology and impairment. These analyses were limited to patients with panic disorder. Further work is needed to evaluate the instrument in assessing patients with other disorders.

Activities of Daily Living↗
PubMed1990

Consistencies and discrepancies in self- and observer-rated anxiety scales. A comparison between the self- and observer-rated Marks-Sheehan scales.

The Marks-Sheehan anxiety scales are the only scales where self-ratings and observer ratings are perfectly matched by the number, the content and the scaling of the items. Therefore these scales are an excellent tool to investigate the compatibility and to study different structures in self- and observer ratings. This was done by using the data material on the Marks-Sheehan scales of the Cross National Collaborative Panic Study. In this study 1168 outpatients who met the DSM-III criteria for panic disorder were randomly allocated either to alprazolam, imipramine or placebo treatment. Our results show that the Marks-Sheehan scales are highly comparable to other established rating scales. Both scales have a similar stable and consistent factor pattern for somatic symptoms but not for psychic symptoms of anxiety. Our results provide empirical evidence that the low consistencies between self- and observer ratings reported so far can be improved by using a rating scale which matches up item for self- and observer ratings. However, other sources of disagreement can only be solved by more elaborated item descriptions and training of patients as well as raters to obtain a better compatibility between self- and observer rating scales.

Adult↗
PubMed1990

Self- and observer assessment in anxiolytic drug trials: a comparison of their validity.

Self-rating scales are considered to be less useful for comparing different treatments in anxiety patients than observer-rating scales. However, the empirical evidence for this assumption is not adequate. A self-rating inventory of 35 items related to anxiety was perfectly parallel with an observer-rating inventory. Both instruments were used in the Cross National Collaborative Panic Study to compare the efficacy of imipramine, alprazolam and placebo in an 8-week drug trial in a sample of 1168 outpatients. The variance of the self-rating assessments was about two times higher. Both scales were equally sensitive to change; however, the measurement of change by means of the self-rating scale was slightly less consistent. The discriminative power of the observer-rating scale between placebo and active treatment was two to three times higher than that of the self-rating scale; consequently the observer-rating procedure provides a more valid instrument when the efficacies of different anxiolytic treatments are compared between different groups of patients.

Adult↗
PubMed1991

Subtyping panic disorder by major depression and avoidance behaviour and the response to active treatment.

In order to establish the clinical validity of currently used ways of subtyping panic disorder the predictive power of associated current avoidance behaviour and (secondary) major depression for the response to active treatment (alprazolam, imipramine) was tested. The analysis was based on the data from the Cross-National-Collaborative-Panic-Study. Limited support for validity evidenced by predicting drug response was found for grading panic disorder by the severity of avoidance behaviour; patients with panic attacks and agoraphobia are more responsive to imipramine (compared with alprazolam) when using the reduction of the total number of panic attacks (or of spontaneous panic attacks) as the outcome criterion; patients without any avoidance behaviour did better with alprazolam (compared with imipramine).

Adult↗
PubMed1991

Avoidance behaviour: a predictor of the efficacy of pharmacotherapy in panic disorder?

The impact of the avoidance behaviour on the psychopharmacological treatment of panic disorder was explored in the Cross National Collaborative Panic Study (n = 1134 patients); in this double blind randomized trial alprazolam, imipramine and placebo were compared during an 8-week treatment period. Patients with extensive avoidance behaviour (agoraphobia) had the most profit from the active drugs. Counter expectancy these specific drug effects were most pronounced in avoidance behaviour. Active drugs (in particular imipramine) were especially more effective than placebo if the patients presented with associated avoidance behaviour. The results suggest that agoraphobia defines more a particular type of anxiety disorder overlapping with panic disorder than merely a severe state of panic disorder.

Adult↗
PubMed1994

Assessing the needs of women and clinicians for the management of menopause in an HMO.

OBJECTIVE: To determine the perceived needs of perimenopausal women regarding the management of menopause and the resource needs of the clinicians who treat them. SETTING: A large staff and group network model health maintenance organization (HMO) in New England. PARTICIPANTS: A random sample of 790 perimenopausal women aged 45-60 years who were members of the HMO in 1991, and a random sample of 180 clinicians in internal medicine, family practice, and obstetrics/gynecology practicing in the HMO during 1991. METHOD: Mailed surveys of women and clinicians were designed to assess possible needs and attitudes that could lead to the improvement of care for menopausal women. The chi-square test was used to determine differences in perceived needs and satisfaction levels among women with differences in self-reported menopausal status. The Kruskal-Wallis one-way analysis of variance and the Mann-Whitney U test were used in the clinician survey to test for differences among specialties and between genders. RESULTS: The key findings include that: 1) most (81%) of the women wanted to see a woman clinician, 2) many (50%) were interested in a menopause support group, 3) 30% reported that their care for menopause had been fair to poor, 4) only 55% of the primary care specialists (including internal medicine and family practice) reported high confidence in their abilities to treat menopause, compared with 68% of the obstetric/gynecology clinicians, and 5) 56% of the clinicians surveyed said that support from the HMO to their practices for the treatment of menopause was fair to poor. CONCLUSIONS: There is an opportunity for better care for perimenopausal women as reported by two sources, HMO clinicians and members. To provide this care, clinicians may need explicit guidelines as well as administrative supports such as educational materials and specialty access. Since the capability for menopausal care from clinicians in obstetrics/gynecology is perceived to be higher than that from primary care clinicians, an opportunity for cross-specialty collaboration and training may exist.

Attitude of Health Personnel↗
PubMed2006

Law and emotion: a proposed taxonomy of an emerging field.

Scholars from diverse fields have begun to study the intersection of emotion and law. The notion that reason and emotion are cleanly separable--and that law rightly privileges and admits only of the former--is deeply engrained. Law and emotion scholarship proceeds instead from the belief that the legal relevance of emotion is both significant and deserving of (and amenable to) close scrutiny. It is organized around six approaches, each of which is defined and discussed: emotion-centered, emotional phenomenon, emotion theory, legal doctrine, theory of law; and legal actor. Drawing on the analytic value of the proposed taxonomy, any exploration of law and emotion should strive to identify which emotion(s) it takes as its focus; distinguish implicated emotion-driven phenomena; explore relevant and competing theories of the emotions; limit itself to a particular type of legal doctrine; expose underlying theories of law; and make clear which legal actors are implicated. Directions for future research are discussed and cross-disciplinary collaboration encouraged.

Classification↗
PubMed1990

Depression and panic anxiety: the effect of depressive co-morbidity on response to drug treatment of patients with panic disorder and agoraphobia.

Numerous studies have established that there is increased co-morbidity of depressive symptoms among patients with panic disorder with and without agoraphobia, but questions remain as to whether the symptom pattern and clinical course are similar to that of primary depressions. The Cross-National Collaborative Panic Study was initiated to study the effects of alprazolam, a triazolobenzodiazepine, in the treatment of panic disorder. In the first phase, which included more than 500 subjects, alprazolam was compared against placebo. In the second phase, alprazolam was compared with imipramine and placebo in a double-blind, randomized, controlled trial. Results of both the first and second phases will be reviewed as they bear on the issue of drug treatment of secondary depression accompanying panic disorder. The presence of depressive symptoms does not adversely influence anti-panic and anti-phobic response to medication. Equivalent drug-placebo differences occur on multiple measures of anxiety--including the number and intensity of panic attacks, phobias, anticipatory anxiety, and overall anxiety.

Agoraphobia↗
PubMedDate not supplied

Children on child protective service caseloads: prevalence and nature of serious emotional disturbance.

A multivariate, criterion-referenced approach was used to assess prevalence of serious emotional disturbance among children on protective service case loads. Of 140 recipients of protective services, 72% were statistically indistinguishable from children in Washington State's most intensive mental health treatment programs. School problems, substance abuse, and antisocial behaviors were common in the sample, as were family histories of mental illness or substance abuse. Greatest service needs included family support groups, outpatient treatment, school-based treatment, and diagnostic services. These results underline the importance of structural changes to facilitate cross-system collaboration between mental health and protective services.

Adolescent↗
PubMed1992

Cutoff assignment strategies for enhancing randomized clinical trials.

The randomized clinical trial (RCT) is the preferred method for assessing the efficacy of treatments. Recent ethical and logistical criticisms suggest that new variations of the traditional RCT are needed. Some of these criticisms may be addressed with new hybrid designs that combine random assignment with assignment by one or more cutoff values on a baseline variable (e.g., severity of illness). In a simple version of such a "cutoff-based" RTC, persons scoring below a cutoff score on a baseline measure (i.e., the least severely ill) are automatically assigned to the control-treated group, those scoring above a second, higher cutoff (i.e., the most ill) are automatically assigned to the test-treated group, and those scoring in the interval between the cutoff scores (i.e., the moderately ill) are randomly assigned to either group. Depending on the baseline score, the patient is assigned to treatment either randomly or by the need-based, clinically related baseline score. Six cutoff-based design variations are studied via simulations and compared with the traditional RCT and the single-cutoff (i.e., regression-discontinuity) design. All variations yield unbiased estimates of the treatment effect but estimates differ in efficiency, with the RCT being most efficient and the single-cutoff design being least efficient. Secondary analyses of data from the Cross-National Collaborative Study of the Effects of Alprazolam (Xanax) on panic are conducted for each variation by selectivity discarding cases from the original dataset to stimulate cutoff-based assignment. The results confirm the simulations and illustrate how cutoff-based designs might look with real data.

Alprazolam↗
PubMed1990

Sleep studies and neurochemical correlates in panic disorder and agoraphobia.

Although panic disorder is classified by the DSM III among the anxiety disorders, there is evidence from epidemiological and neurochemical studies that links panic to the affective disorders. In addition several of the effective pharmacological treatments suggest, as in the depressive disorders, serotonergic involvement. As part of the evaluation of patients who would take part in the Cross National Collaborative Panic study, polysomnography, the dexamethasone suppression test and platelet imipramine binding and 5HT-uptake were scheduled. 44 patients who met DSM III criteria on the SCID interview schedule for Panic Disorder consented to enter the study. After being medication free for two weeks, these patients had three consecutive all night polysomnograms, followed by a dexamethasone suppression test and platelet study of imipramine binding and 5HT-uptake. In our studies we were unable to find for the panic group as a whole a correlation with reported parameters of sleep architecture in endogenous depression. Similarly the imipramine binding differentiated the panickers from the depressed group. Only the 5HT-uptake was similar in both groups. We also found a subgroup of panickers who resembled depressives in terms of the imipramine binding, 5HT-uptake platelet studies and REM latency. In the analysis of the imipramine and 5HT-uptake over the treatment period, we noted changes which suggest a role for serotonin, certainly in a subgroup of panickers and possibly for the group of panic disorder as a whole.

Adult↗
PubMed1995

Results of the NIDA treatment demonstration grants' cocaine workgroup: characteristics of cocaine users and HIV risk behaviors.

This journal issue includes seven articles (six plus this introduction) from the "cocaine workgroup" of the National Institute on Drug Abuse (NIDA) treatment demonstration grants. In this introduction, results of the first attempts to compare data from seven disparate demonstration grant sites are summarized: Overall, rates of recent cocaine use were high in all locations, injection drug use was common, age of first drug use was between 14 and 17 years with age of first cocaine use between 20 and 25 years, arrests were common at all sites especially among cocaine injectors, and polydrug use was the norm. Interestingly, both gender and ethnic status were significantly associated with polydrug use and marijuana use among the cocaine users. These results indicated that it is possible to define variables precisely for analysis across sites and laid the groundwork for the next set of analyses in which the common theme of human immunodeficiency virus (HIV) risk behaviors among cocaine abusers was agreed upon. This next set of analyses are included in the following six papers. Overall, these reports confirm recent data about the association of cocaine use with HIV risk behaviors. They extend considerably the literature on the association of cocaine with HIV risk behaviors, and the report from New York in which therapeutic community treatment was shown to be feasible and possibly useful to methadone clients represents an interesting and new finding. In conclusion, cross-site collaborations can take different forms and this collection of papers represents one successful approach.

Adolescent↗
PubMed1994

An illustrative statistical analysis of cutoff-based randomized clinical trials.

Cutoff-based randomized clinical trials (RCTs) are designed to balance ethical and scientific concerns. Patients scoring below a cutoff score on a baseline measure (i.e. the least severely ill) are assigned to the control-treated group, those scoring above a second cutoff score (i.e. the most severely ill) are assigned to the test-treated group, and those scoring within the interval (i.e. the moderately ill) are randomly assigned. This paper provides a formal illustration on the statistical analysis of cutoff-based RCTs using data from the Xanax Cross-National Collaborative Study. To overcome problems specific to cutoff-based designs, we generally recommend a backward elimination approach that tests interactions before main effects.

Humans↗
PubMed2006

Trends in emergency coronary artery bypass grafting after percutaneous coronary intervention, 1994-2003.

BACKGROUND: In the last decade, percutaneous coronary intervention (PCI) has undergone profound changes in techniques used to achieve revascularization and in patient selection. We examine trends in emergency surgical revascularization after PCI. METHODS: Using The Society of Thoracic Surgeons National Cardiac Surgery Database, we examined patients undergoing coronary artery bypass grafting within 6 hours of PCI from 1994 to 2003. Stratifying into groups of patients who had and had not suffered myocardial infarction within 24 hours of PCI followed by coronary artery bypass grafting (CABG), we tracked trends in characteristics, predicted risk, and clinical outcomes. RESULTS: The proportion of isolated CABG procedures done emergently after PCI decreased over 1994 to 1999 from 3,357 of 115,679 (2.9%) to 1,227 of 155,831 (0.8%), remaining stable through 2003. Those suffering myocardial infarction within 24 hours made up a constant proportion of isolated CABG as emergency after PCI (3,352 of 1,042,864; 0.3%) since 1997. Over the decade, the preoperative risk profile worsened, including more elderly patients and more with cerebrovascular disease and congestive heart failure. Operative mortality among these patients has risen with time (from 8.0% to 9.3%; p < 0.0001 for trend), particularly in the setting of acute myocardial infarction (from 14.1% to 16.6%; p < 0.0001 for trend). Similarly, postoperative complications have increased over time, most notably seen in the need for reoperation (10.62% to 24.56%), prolonged postoperative ventilation (25.65% to 54.58%), and renal failure (10.22% to 18.55%). CONCLUSIONS: In 2005, there remains a low but real need for emergent CABG after PCI, in which operative outcomes are less than ideal, especially in the postinfarction patient, representing an area for cross-specialty collaboration.

Angioplasty, Balloon, Coronary↗
PubMed2005

The new apheresis and blood and marrow transplantation-related current procedural terminology codes for payment of apheresis and blood and marrow transplantation services.

To address deficiencies in Current Procedural Terminology (CPT) codes that describe many of the clinical services offered to patients, several physicians in the blood and marrow transplantation and apheresis field joined with a coalition including the American Society of Hematology, American Society for Blood and Marrow Transplantation, American Association of Blood Banks, American Society of Clinical Oncology, American Society for Apheresis, National Marrow Donor Program, and American Red Cross to collaborate in addressing these deficiencies by designing new CPT codes. The CPT editorial panel approved 18 new or revised codes. All these codes were given permanent or temporary value by the relative value unit update committee, but not all values were approved by the Centers for Medicare & Medicaid Services (CMS), in particular, the cell-processing codes and the unrelated donor search code. Further discussions addressing these concerns are under way with the CMS. Use of these new codes allows apheresis and transplant centers to charge appropriately for these services. This will help transplant center contracts with CPT codes, with payers more specifically describing services offered to these patients. In turn, this will give better justification for payment. This may allow certain payments for services to increase and help transplant centers better allocate revenue from fixed global case rate payments. Details about the individual codes and their approval process are reviewed in this article.

Blood Component Removal↗
PubMed2006

Keeping abreast of advances in fetal cardiology.

Advances in genetics and computing have contributed to a better understanding of the mechanisms underlying cardiovascular development, its programming and possible therapeutic manipulation. Pre-conceptual folate can reduce the prevalence of cardiac malformations and improvements in imaging allow us to detect congenital heart disease and assess function at earlier gestations. Three- and four-dimensional imaging may improve the surgeons' understanding of complex vascular malformations as well as permitting remote diagnosis. Treatment of fetal arrhythmias may be rationalised by fetal electrocardiography and magnetocardiography and by further defining the natural history of complete heart block and mechanisms of tachyarrhythmia. Tissue engineering and robotics may improve the surgical outcome for children by creating conduits with growth potential thus reducing the need for multiple surgical procedures. These technologies may permit successful fetal surgical procedures. Cross discipline collaboration has been key in enabling these advances which have changed the face of fetal cardiology.

Cardiology↗