Near-term infants had significantly more medical problems and increased hospital costs compared with contemporaneous full-term infants. Near-term infants may represent an unrecognized at-risk neonatal population.
The placebo response is a major issue in clinical trials for psychiatric disorders. Possible contributing factors to this problem include diagnostic misclassification, issues concerning inclusion/exclusion criteria, outcome measures’ lack of sensitivity to change, measurement errors, poor quality of data entry and verification, waxing and waning of the natural course of illness, regression toward the mean phenomenon, patient and clinician expectations about the trial, study design issues, non-specific therapeutic effects, and high attrition. Over the past few decades, researchers have attempted to reduce the placebo effect in a variety of ways. Unfortunately, approaches with very little or no benefit have included restricting enrollment to selected populations, rater training, requirement of same rater, and placebo lead-in phases. Some benefits, although often marginal, have been derived from standardizing diagnostic procedures, managing clinicians’ overestimation of change, simplification of study visits and assessments, minimizing non-specific, therapeutic effects, extending trial duration, reducing number of sites, increasing the sensitivity of outcome measures, and reducing the number of treatment arms. Thus far, there has been no attempt to develop new study designs aimed at reducing the placebo effect. We are proposing a novel study design, called ‘Sequential Parallel Comparison Design’, suitable for double-blind, placebo-controlled trials in psychiatric disorders. This design is aimed at reducing both the overall placebo response rate and the sample size required for such trials. Its usefulness in clinical research needs to be tested empirically. If this study design were to be found to meet its stated goals, this could markedly facilitate the process of clinical development of new compounds for the treatment of psychiatric disorders.
Objective-The Diagnostic and Statistical Manual of Mental Disorders (DSM) is designed primarily as a clinical tool. Yet high rates of diagnostic "crossover" among the anorexia nervosa subtypes and bulimia nervosa may reflect problems with the validity of the current diagnostic schema, thereby limiting its clinical utility. This study was designed to examine diagnostic crossover longitudinally in anorexia nervosa and bulimia nervosa to inform the validity of the DSM-IV-TR eating disorders classification system.Method-A total of 216 women with a diagnosis of anorexia nervosa or bulimia nervosa were followed for 7 years; weekly eating disorder symptom data collected using the Eating Disorder Longitudinal Interval Follow-Up Examination allowed for diagnoses to be made throughout the follow-up period.Results-Over 7 years, the majority of women with anorexia nervosa experienced diagnostic crossover: more than half crossed between the restricting and binge eating/purging anorexia nervosa subtypes over time; one-third crossed over to bulimia nervosa but were likely to relapse into anorexia nervosa. Women with bulimia nervosa were unlikely to cross over to anorexia nervosa.Conclusions-These findings support the longitudinal distinction of anorexia nervosa and bulimia nervosa but do not support the anorexia nervosa subtyping schema.With the preparation for the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders under way, the validity of the DSM-IV-TR classification system for eating disorders has been called into question (1). In the current diagnostic system, anorexia nervosa and bulimia nervosa are recognized as full syndrome eating disorders with specific criteria sets. DSM is designed to serve primarily as a clinical tool, providing "clear descriptions of diagnostic categories in order to enable clinicians and investigators to diagnose, communicate about, study, and treat people with various mental disorders" (DSM-IV-TR, p. xxxvii). Yet the high rates of diagnostic "crossover," such as movement from anorexia nervosa to bulimia nervosa, may reflect problems with the validity of the current diagnostic schema for eating disorders, thereby limiting its utility.
Physicians treating patients with anorexia nervosa should carefully assess patterns of alcohol use during the course of care because one third of women who had alcoholism and died had no history of alcohol use disorder at intake.
These results may explain the long-term efficacy of interpersonal therapy for bulimia nervosa and suggest that focused body image work during relapse prevention may enhance long-term recovery from eating disorders.
ObjectiveTo review perioperative results and late survival after thoracoabdominal aneurysm repair (TAA), in particular to assess the impact over time of epidural cooling (EC) on spinal cord ischemic complications (SCI). Summary Background DataA variety of operative approaches and protective adjuncts have been used in TAA to minimize the major complications of perioperative death and SCI. There is no consensus with respect to the optimal approach. MethodsFrom January 1987 to November 2001, 337 consecutive TAA repairs were performed by a single surgeon. Clinical features included prior aortic grafts in 97 (28.8%) and emergent operation in 82 (24.6%), including rupture in 46 (13.6%) and dissection in 63 (19%). Operative management consisted of a clamp/sew technique with adjuncts in 93%. EC (since July 1993) to prevent SCI was used in 194 (57.6%) repairs. Variables associated with the end points of operative mortality and postoperative SCI were assessed with the Fisher exact test and logistic regression; late survival was estimated with the Kaplan-Meier method. ResultsOperative mortality was 8.3% and was associated with nonelective operation, intraoperative hypotension, total transfusion requirement, and the postoperative complications of paraplegia, renal failure, and pulmonary insufficiency. Postoperative renal failure and transfusion requirement were independent correlates of mortality. SCI of any severity occurred in 38 of 334 (11.4%) operative survivors, with 22/38 (6.6% of cohort) sustaining total paraplegia. EC reduced the risk of SCI in patients with types I-III TAA (10.6% vs. 19.8%, P ϭ .04). Independent correlates of SCI over the entire study interval included types I/II TAA, rupture, cross-clamp duration, sacrifice of T9 -L1 intercostal vessels, and intraoperative hypotension. Late survival rates at 2 and 5 years were 81.2 Ϯ 3% and 67.2 Ϯ 5%. ConclusionsEC has decreased the risk of SCI after TAA repair. Decreasing the substantial proportion (nearly 25%) of patients requiring nonelective operation will improve results. Late survival is equal to that after routine AAA repair, indicating that the considerable resource expenditure required for TAA repair is worthwhile.Despite advances in endoluminal grafting for isolated thoracic and infrarenal aortic aneurysm, open operation remains the only feasible treatment option for thoracoabdominal aneurysm (TAA). Since TAA extent is relatively uncommon in the spectrum of degenerative aneurysm disease, experience and clinical reports have been largely concentrated in a modest number of centers. Even in such environments, operative mortality is generally in the 10%
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.