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Prescription drug liability: the learned intermediary and informed consent.
Prescription drugs are the most often used therapy in health care. Because they are dangerous and sometimes cause severe side effects, it is important for drug manufacturers, health care providers, and patients to understand their responsibilities regarding prescription drug liability. The learned intermediary doctrine, exacting a duty from the drug manufacturer to warn the doctor of prescription drug properties, is discussed. The doctrine of informed consent is reviewed as a cause of action where a doctor fails to inform a patient of prescription drug properties. Application of the medical community and patient-centered standards as they relate to informed consent cases is made.
Open-heart surgical centers. Standards and monitoring.
This article contains the essence of a report presented to the Council of The American Association for Thoracic Surgery (AATS) by an Ad Hoc Committee on Issues composed of the authors, on October 13, 1976. Because of urgent demand to have this information immediately available, early publication was desirable. However, to have official endorsement of the AATS would have necessitated waiting until April, 1977, the date of the next meeting of the Association. Since this would delay publication of this information for more than one year, it was considered reasonable by the Council that it be published as a free-standing statement of the authors.
The multicenter study of epilepsy surgery: recruitment and selection for surgery.
PURPOSE: Multiple studies have examined predictors of seizure outcomes after epilepsy surgery. Most are single-center series with limited sample size. Little information is available about the selection process for surgery and, in particular, the proportion of patients who ultimately have surgery and the characteristics that identify those who do versus those who do not. Such information is necessary for providing the epidemiologic and clinical context in which epilepsy surgery is currently performed in the United States and in other developed countries. METHODS: An observational cohort of 565 surgical candidates was prospectively recruited from June 1996 through January 2001 at six Northeastern and one Midwestern surgical centers. Standardized eligibility criteria and protocol for presurgical evaluations were used at all seven sites. RESULTS: Three hundred ninety-six (70%) study subjects had resective surgery. Clinical factors such as a well-localized magnetic resonance imaging (MRI) abnormality and consistently localized EEG findings were most strongly associated with having surgery. Of those who underwent intracranial monitoring (189, 34%), 85% went on to have surgery. Race/ethnicity and marital status were marginally associated with having surgery. Age, education, and employment status were not. Demographic factors had little influence over the surgical decision. More than half of the patients had intractable epilepsy for >/=10 years and five or more drugs had failed by the time they initiated their surgical evaluation. During the recruitment period, eight new antiepileptic drugs were approved by the Food and Drug Administration for use in the United States and came into increasing use in this study's surgical candidates. Despite the increased availability of new therapeutic options, the proportion that had surgery each year did not fluctuate significantly from year to year. This suggests that, in this group of patients, the new drugs did not provide a substantial therapeutic benefit. CONCLUSIONS: Up to 30% of patients who undergo presurgical evaluations for resective epilepsy surgery ultimately do not have this form of surgery. This is a group whose needs are not currently met by available therapies and procedures. Lack of clear localizing evidence appears to be the main reason for not having surgery. To the extent that these data can address the question, they suggest that repeated attempts to control intractable epilepsy with new drugs will not result in sustained seizure control, and eligible patients will proceed to surgery eventually. This is consistent with recent arguments to consider surgery earlier rather than later in the course of epilepsy. Postsurgical follow-up of this group will permit a detailed analysis of presurgical factors that predict the best and worst seizure outcomes.
[Surveillance of infections in chronic hemodialysis patients].
OBJECTIVE: To confirm rates of infections from a previous survey in chronic hemodialysis patients; to get information about incidents and manipulations of vascular access-site, number and reasons of hospitalisation; to asses a relationship between the frequency of vascular access-site infections (VASI) and quality of care during the procedures of vascular access-site use. DESIGN: Prospective, multicenter survey performed from February 2000 to January 2001, including all patients underwent chronic hemodialysis in 5 participating centers. Standardized definitions used and different clinical and biological risk factors recorded. RESULTS: 429 patients for a total of 4273 dialysis months (DM) were enrolled. 245 infections in 164 infected patients were reported. The overall rate was 5.73 infections per 100 DM (18 VASI, 25 bacteraemia, 84 respiratory, 29 urinary tract, 1 endocarditis and 88 other infections). 50% of infections were microbiologically documented. 19 of 21 antibiotics resistant microorganisms were meticillin resistant Staphylococcus aureus. Compared to the incidence rate of fistula (0.05 per 1000 days of follow-up) or prosthesis related VASI (0.11), the incidence rate of catheter related VASI (0.65) was significantly higher. Poor hygiene and duration of catheter use were the significant risk factors for VASI showed by logistic analysis regression. VASI and bacteraemia occurred more frequently after incident or manipulation of the vascular access-site. The decrease of VASI between the 2 periods of survey was significantly higher in centers having reduced the catheter use and implemented written protocols. CONCLUSIONS: This second period of surveillance has confirmed the frequency of infections rate in chronic hemodialysis patients and particularly bacteraemia and VASI. This study has allowed to establish risk factors for infections and showed that VASI in hemodialysis are related to factors in part preventable.
Casimage project: a digital teaching files authoring environment.
The goal of the Casimage project is to offer an authoring and editing environment integrated with the Picture Archiving and Communication Systems (PACS) for creating image-based electronic teaching files. This software is based on a client/server architecture allowing remote access of users to a central database. This authoring environment allows radiologists to create reference databases and collection of digital images for teaching and research directly from clinical cases being reviewed on PACS diagnostic workstations. The environment includes all tools to create teaching files, including textual description, annotations, and image manipulation. The software also allows users to generate stand-alone CD-ROMs and web-based teaching files to easily share their collections. The system includes a web server compatible with the Medical Imaging Resource Center standard (MIRC, http://mirc.rsna.org) to easily integrate collections in the RSNA web network dedicated to teaching files. This software could be installed on any PACS workstation to allow users to add new cases at any time and anywhere during clinical operations. Several images collections were created with this tool, including thoracic imaging that was subsequently made available on a CD-Rom and on our web site and through the MIRC network for public access.
Academic medical centers' standards for clinical-trial agreements with industry.
BACKGROUND: Although industry sponsors provide approximately 70 percent of the funding for clinical drug trials in the United States, little is known about the legal agreements that exist between industry sponsors and academic investigators. We studied institutional standards regarding contractual provisions that restrict investigators' control over trials. METHODS: We used a structured, cross-sectional mail survey of medical-school research administrators responsible for negotiating clinical-trial agreements with industry sponsors. RESULTS: Of 122 institutions approached, 107 participated. There was a high degree of consensus among administrators about the acceptability of several contractual provisions relating to publications. For example, more than 85 percent reported that their office would not approve provisions giving industry sponsors the authority to revise manuscripts or decide whether results should be published. There was considerable disagreement about the acceptability of provisions allowing the sponsor to insert its own statistical analyses in manuscripts (24 percent allowed them, 47 percent disallowed them, and 29 percent were not sure whether they should allow them), draft the manuscript (50 percent allowed it, 40 percent disallowed it, and 11 percent were not sure whether they should allow it), and prohibit investigators from sharing data with third parties after the trial is over (41 percent allowed it, 34 percent disallowed it, and 24 percent were not sure whether they should allow it). Disputes were common after the agreements had been signed and most frequently centered on payment (75 percent of administrators reported at least one such dispute in the previous year), intellectual property (30 percent), and control of or access to data (17 percent). CONCLUSIONS: Standards for certain restrictive provisions in clinical-trial agreements with industry sponsors vary considerably among academic medical centers. Greater sharing of information about legal relationships with industry sponsors is desirable in order to build consensus about appropriate standards.
Utility values in Singapore Chinese adults with primary open-angle and primary angle-closure glaucoma.
PURPOSE: To evaluate utility values in Chinese glaucoma patients. PATIENT AND METHODS: Singapore Chinese residents (n = 213) with primary open-angle glaucoma or primary angle-closure glaucoma were recruited from a single tertiary ophthalmic center. Standard face-to-face interviews were conducted to ask about utility values (time trade-off and standard gamble for both death and blindness). Ocular information, including current visual acuity, intraocular pressure, visual field defect, and cup-disc ratio were also obtained. RESULTS: The mean time trade-off utility value was 0.88 (95% confidence interval 0.85, 0.91), and standard gamble for death and blindness were 0.94 (95% confidence interval 0.93, 0.96) and 0.95 (95% confidence interval 0.93, 0.97), respectively. Only 35.7% of patients were willing to trade time, and 34.3% willing to risk blindness in return for perfect vision. Both primary angle-closure glaucoma and primary open-angle glaucoma patients had similar utility values. After adjusting for age, gender, language spoken, educational level, and diagnosis, patients with better eye visual field PSD > 10 were 2.52 times (95% confidence interval 1.13, 5.61) more willing to trade time. In a multivariate model, the odds ratio of willingness to risk blindness for a complete hypothetical glaucoma cure was 9.88 (95% confidence interval 1.65, 59.23) for patients who had only visited an ophthalmologist 15 years or more ago, and 0.53 (95% confidence interval 0.27, 1.02) for patients who had previous trabeculectomy. CONCLUSION: Most Chinese glaucoma patients in Singapore are not willing to trade time or risk blindness. Patients with worse visual fields in the better-seeing eye are more willing to trade time; whereas patients who have not seen an ophthalmologist for at least 15 years or who had no history of a previous trabeculectomy are more willing to risk blindness.