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PubMed1993

The role of insurance claims databases in drug therapy outcomes research.

The use of insurance claims databases in drug therapy outcomes research holds great promise as a cost-effective alternative to post-marketing clinical trials. Claims databases uniquely capture information about episodes of care across healthcare services and settings. They also facilitate the examination of drug therapy effects on cohorts of patients and specific patient subpopulations. However, there are limitations to the use of insurance claims databases including incomplete diagnostic and provider identification data. The characteristics of the population included in the insurance plan, the plan benefit design, and the variables of the database itself can influence the research results. Given the current concerns regarding the completeness of insurance claims databases, and the validity of their data, outcomes research usually requires original data to validate claims data or to obtain additional information. Improvements to claims databases such as standardisation of claims information reporting, addition of pertinent clinical and economic variables, and inclusion of information relative to patient severity of illness, quality of life, and satisfaction with provided care will enhance the benefit of such databases for outcomes research.

Clinical Trials as Topic↗
PubMedDate not supplied

A DBMS-based medical teleconferencing system.

This article presents the design of a medical teleconferencing system that is integrated with a multimedia patient database and incorporates easy-to-use tools and functions to effectively support collaborative work between physicians in remote locations. The design provides a virtual workspace that allows physicians to collectively view various kinds of patient data. By integrating the teleconferencing function into this workspace, physicians are able to conduct conferences using the same interface and have real-time access to the database during conference sessions. The authors have implemented a prototype based on this design. The prototype uses a high-speed network test bed and a manually created substitute for the integrated patient database.

Computer Graphics↗
PubMed2005

Long-term safety and tolerability of oxcarbazepine in children: a review of clinical experience.

Relatively few well-designed studies have demonstrated the long-term safety and tolerability of newer antiepileptic drugs (AEDs) in a large group of children. Extensive clinical data from the worldwide Clinical Development Program (CDP) and a compassionate use program on the safety and tolerability of oxcarbazepine in children are presented. Oxcarbazepine is a newer AED that is indicated for use as monotherapy and adjunctive therapy in children (United States 4 years of age, Europe 6 years of age) with partial epilepsy. The most common adverse events (10%) in the CDP were headache (32.5%), somnolence (31.5%), vomiting (27.6%), and dizziness (23.1%), whereas in the compassionate use program (clinical practice situation), the most common adverse events (1%) reported were rash (2.7%), fatigue (1.6%), nausea (1.2%), and somnolence (1.2%). These data indicate that oxcarbazepine has a good long-term safety and tolerability profile, whether given as monotherapy or adjunctive therapy, in children with partial seizures.

Adolescent↗
PubMed2000

Evidence-based analysis of prophylactic treatment of asymptomatic retinal breaks and lattice degeneration.

PURPOSE: To assess the quality of information in the literature regarding the benefits of prophylactic treatment of asymptomatic retinal tears and lattice degeneration. CLINICAL RELEVANCE: Asymptomatic retinal breaks occur in approximately 7% of patients over age 40, and lattice degeneration is present in approximately 8% of the general population. Because retinal breaks cause retinal detachment and lattice degeneration is associated with approximately 30% of retinal detachments, prophylactic treatment of these lesions has sometimes been recommended. LITERATURE REVIEWED: A panel of vitreoretinal experts performed a literature review of all publications regarding prevention of retinal detachment that have been published in English. These articles were then used to prepare recommendations for patient care in an American Academy of Ophthalmology Preferred Practice Pattern (PPP). Each recommendation was rated according to: (1) its importance in the care process and (2) the strength of evidence supporting the given recommendation. RESULTS: Most recommendations were rated as A (most important to patient care). Only a single publication was graded as I (providing strong evidence in support of a recommendation), and this was not a prospective trial. Of the few publications rated as II (substantial evidence), most were studies documenting a lack of treatment benefit. Because of an absence of level I and level II studies in the literature, level III (consensus of expert opinion) was the basis for most recommendations in the PPP. CONCLUSIONS: The current literature regarding prevention of retinal detachment does not provide sufficient information to support strongly prophylactic treatment of lesions other than symptomatic flap tears. Prospective randomized trials of prophylactic therapy are indicated. Eyes highly predisposed to retinal detachment should be considered for such studies.

Adult↗
PubMed2002

Cochrane corner.

Explore the source record for details and available documents.

Clinical Trials as Topic↗
PubMed2001

The tolerability of lamotrigine in elderly patients with epilepsy.

OBJECTIVE: To determine the tolerability of lamotrigine in elderly patients with epilepsy. DESIGN: Pooled data from 13 lamotrigine clinical trials. SETTING: Multicentre clinical trials conducted in primary care and neurology practices. PARTICIPANTS: 208 elderly patients (aged > or = 65 years) were identified: 146 lamotrigine-treated patients, 53 carbamazepine-treated patients and 9 phenytoin-treated patients. INTERVENTIONS: Extent of exposure, incidence of drug-related adverse events, serious adverse events and study withdrawals were examined. RESULTS: The median duration of exposure for lamotrigine monotherapy and add-on therapy was 24.1 and 47.4 weeks, respectively. The median daily dosage of lamotrigine was 100 mg for monotherapy (range 75 to 500 mg) and 300 mg for add-on therapy (range 25 to 700 mg). Overall, the incidence of drug-related adverse events was lower for lamotrigine than comparator drugs: 49% (72/146) for lamotrigine compared with 72% (38/53) for carbamazepine (p = 0.006), and 89% (8/9) for phenytoin (p = 0.035) although patient numbers in each treatment group were not comparable. Patients receiving lamotrigine reported incidences of somnolence (p = 0.012), rash (p = 0.034), and headache (nonsignificant) that were one-half the incidence reported with carbamazepine monotherapy. Rash was the most common reason for study withdrawal: 4% (6/146) lamotrigine, 17% (9/53) carbamazepine and 0% phenytoin. Seven (5%, 7/146) lamotrigine-treated patients, 4 (8%, 4/53) carbamazepine-treated patients and 1 (11%, 1/9) phenytoin-treated patient experienced drug-related serious adverse events. CONCLUSION: Lamotrigine, used in the currently prescribed adult dosage regimen, was well tolerated in elderly patients with epilepsy.

Aged↗
PubMedDate not supplied

[Therapeutic information: how to transmit current scientific data. Group VALIDATA].

The information on therapeutics is moving at a high path for various causes. Now, tools for informing correctly the prescriber do exist. However, they require the operation of suitable structures. The mainstem of the system consists of an intermediary which should comply with appropriate rules. It will work from an exhaustive collection of pertinent information. This will allowed by the extensive use of literature data banks and clinical trial registries kept with the help of international collaboration. It will rank the strength of evidence of the collected data according to their internal validity. It will elaborate overviews from validated data obtained from meta-analysis, and messages readily readable by the users, and accessible whenever needed. Overviews will be used to set up guidelines, references, editorials... Data banks will be accessible to researchers, teachers, officers concerned by health care.

Clinical Trials as Topic↗
PubMed2000

Trial summary software.

Medical practice is most strongly founded when based on the results of well conducted clinical trials. Clinical trial results normally enter the domain of medical knowledge and practice through their publication in scientific journals. This in itself poses problems of accessibility and selection. The results of this is a slow and selective diffusion of new medical facts which has a consequent cost in human lives and human suffering. In an attempt to shorten this information path initiatives such as the Cochrane collaboration produce and maintain systematic reviews by speciality of the current state of knowledge. The ability to store a representation of a clinical trial in a standard form seems to us to be a necessary condition for the efficient and reproducible preparation of systematic reviews. Furthermore the consequent increased accessibility of research results due to the existence of the summaries would itself be of great use. In this aim a relational database client server system was developed and we publish here the results of our preliminary findings, including the data model, which we feel is an important contribution to the future discussion and development of computer based representations of clinical trial protocols and results and their use in clinical decision making.

Clinical Trials as Topic↗
PubMed2006

Adverse event reporting in publications compared with sponsor database for cancer clinical trials.

PURPOSE: Prospectively planned collection and analysis of adverse event (AE) data are essential parts of well-conducted clinical trials. The AE data in a trial sponsor's database should be comparable with what is stipulated in the protocol and with the AE data published. We examined whether the published AE data differ from those in the sponsor's database and from the data collection requirements stated in study protocols. METHODS: We searched the National Cancer Institute (NCI) Clinical Data Update System (CDUS) for studies that used the Common Toxicity Criteria version 2.0 and for which a final study publication was available. We extracted from the protocols information pertaining to AE collection and reporting methods and compared it with the methods cited in the article. We also compared the AE data in the trial publication with the AE data submitted by the investigators to CDUS. RESULTS: We identified 22 studies meeting the criteria for this review. There was considerable inconsistency between AE collection and reporting methods cited in the protocols versus final publications. AE data in the article and CDUS were not identical. Twenty-seven percent of article high-grade AEs could not be matched to agent-attributable AEs in the CDUS. Twenty-eight percent of CDUS high-grade AEs could not be matched to AEs in the corresponding article. In 14 of 22 articles, the number of high-grade AEs in CDUS differed from the number in the articles by 20% or more. CONCLUSION: Lack of consistency in and reporting of AEs are associated with NCI database and trial publication AE data discrepancy.

Adverse Drug Reaction Reporting Systems↗
PubMed1999

Description of the Genetic Analysis Workshop 11 Collaborative Study on the Genetics of Alcoholism.

Problem 1 of Genetic Analysis Workshop 11 consists of data from a family study of the genetics of alcoholism and related traits contributed by the six centers making up the National Institute for Alcohol Abuse and Alcoholism sponsored by the Collaborative Study on the Genetics of Alcoholism (COGA). The family data included 1,214 members of 105 pedigrees ascertained for having three or more individuals affected with alcoholism. Data available to workshop participants included clinical phenotypes, personality measures, smoking behavior, event-related potentials, platelet monamine oxidase B activity, and a genome scan of 296 markers.

Alcoholism↗