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PubMed2002

Stereoselective pharmacokinetics and pharmacodynamics of anti-asthma agents.

OBJECTIVE: To review the previously published studies on pharmacokinetics and pharmacodynamics of chiral drugs used in the treatment of asthma. DATA SOURCES: Primary and review articles were identified with a MEDLINE search (1980-May 2001) and through secondary sources. STUDY SELECTION AND DATA EXTRACTION: All English-language studies and reviews obtained from the MEDLINE search pertaining to stereoselective pharmacokinetics and pharmacodynamics of chiral anti-asthma drugs were assessed. DATA SYNTHESIS: Several anti-asthma drugs (e.g., beta(2)-adrenergic agonists, leukotriene modifiers) are chiral and marketed as racemates, which consist of equal proportions of 2 enantiomers. Significant stereoselectivity has also been reported in pharmacodynamics and pharmacokinetics of the beta(2)-agonists. The enantiomers of beta(2)-agonists in the R configuration are primarily responsible for the bronchodilating effects of the racemate. The plasma concentrations of the enantiomers of anti-asthma drugs may differ as a reflection of stereoselectivity in clearance, volume of distribution, and route of administration. CONCLUSIONS: Stereoselectivity in the pharmacokinetics of anti-asthma drugs may complicate the relationship between dose and/or plasma concentration of racemic drug versus effect relationship. An appreciation of the stereoselective pharmacokinetics and pharmacodynamics of chiral anti-asthma drugs may optimize the use of these agents in asthmatic patients.

Absorption↗
PubMed2005

Medications associated with weight gain.

OBJECTIVE: To review available literature regarding weight gain associated with commonly prescribed drugs and adjunctive therapy used to limit weight gain. DATA SOURCES: Information was retrieved from a MEDLINE English-literature search between 1995 and July 2005, with a major subject heading of weight gain/drug effects excluding complementary alternative medicines. Other limits applied included human subjects and individuals >19 years of age. Additionally, references from retrieved articles were reviewed to identify other literature sources. STUDY SELECTION AND DATA EXTRACTION: Changes in weight are generally reported as a primary or secondary outcome of many studies. Where possible, prospective, randomized, controlled trials were preferred; however, many studies were retrospective or open label. Meta-analyses and recent reviews, especially those providing a detailed description of the proposed mechanism involved in weight gain beyond the scope of this article, were included. Limited information was available from case reports. Studies were categorized by therapeutic area including psychiatry, neurology, diabetes, and other miscellaneous drug therapy. Medications used to intentionally stimulate appetite for weight gain, such as megesterol acetate, were not included. DATA SYNTHESIS: Weight gain with medication is usually associated with individual agents within a class. The tendency to cause weight gain is often related to differential specificity and sensitivity of binding to receptors involved with appetite regulation. CONCLUSIONS: Clinically significant weight gain is associated with some commonly prescribed medicines. There is wide interindividual variation in response and variation of the degree of weight gain within drug classes. Where possible, alternative therapy should be selected, especially for individuals predisposed to overweight and obesity.

Antidepressive Agents↗
PubMed2006

Human papillomavirus vaccines.

OBJECTIVE: To review the pharmacology, efficacy, safety, tolerability, and pharmacoeconomics of Cervarix and Gardasil, 2 human papillomavirus (HPV) vaccines. DATA SOURCES: English-language articles were obtained by MEDLINE search (1966-February 2006) using the key words human papillomavirus vaccine, Cervarix, and Gardasil. Bibliographies of selected articles were used to identify additional sources. STUDY SELECTION AND DATA EXTRACTION: All available published articles or abstracts reporting the results of human studies of HPV vaccines were reviewed for inclusion in this article. Additional information about ongoing clinical trials was obtained from manufacturers' Web sites. DATA SYNTHESIS: Cervarix and Gardasil are recombinant vaccines against HPV. Cervarix targets HPV-16 and -18, which are responsible for 70% of cervical cancers. Gardasil also targets HPV-16 and -18, plus the HPV-6 and -11 types responsible for more than 80% of genital warts. Both vaccines have been effective in preventing persistent infection with targeted HPV types and in preventing cervical intraepithelial lesions, while Gardasil has also been effective in preventing vulvar and vaginal neoplasia and genital warts. Both vaccines have been well tolerated, with the most common adverse effects occurring at the injection site. Phase III trials are ongoing to further evaluate vaccine efficacy. CONCLUSIONS: Cervarix and Gardasil are effective for prevention of HPV infection and cervical lesions. Issues remaining to be addressed include duration of protection, efficacy for prevention of cervical cancer, optimal age for vaccination, feasibility of application to the developing world, the ideal combination of HPV subtypes, and the most efficient combination of vaccination and cervical cancer screening.

Clinical Trials as Topic↗
PubMed2006

The Program Evaluation and Monitoring System: a key source of data for monitoring evidence-based HIV prevention program processes and outcomes.

The Centers for Disease Control and Prevention (CDC) Division of HIV/AIDS Prevention (DHAP) has responded to the need for accurate and timely data to monitor and evaluate federally funded HIV prevention programs by designing and implementing the Program Evaluation and Monitoring System (PEMS). PEMS is a national data reporting system that includes a standardized set of HIV prevention data variables, Web-based software for data entry and management, data collection and evaluation guidance and training, and software implementation support services. This article discusses the purposes of evaluation and the need for and development of PEMS and also describes how PEMS strengthens the monitoring and evaluation of HIV prevention services nationally and program planning, management, and monitoring locally. PEMS data may be used by prevention stakeholders at all levels to examine program fidelity, adaptation and tailoring, and key program health service utilization and behavioral outcomes. PEMS provides a strong foundation to bring a program closer to its intended goals and to serve the needs of the clients and the community, provides a means for agencies to fulfill their reporting mandates and funding obligations, and enables the CDC to monitor HIV prevention efforts in a consistent, efficient, and effective manner across the United States.

Centers for Disease Control and Prevention, U.S.↗
PubMed2003

Childhood behavior disorders and injuries among children and youth: a population-based study.

CONTEXT: While an association between pediatric behavioral disorders and injuries is generally acknowledged, no studies have measured the risk for injury in the context of a large, population-based study that is free of cohort biases. OBJECTIVES: To examine the association between childhood behavior disorders ([CBDs] as indicated by prescription for methylphenidate [MPH]) and a variety of injury outcomes, and to evaluate the risk for injury among these children after controlling for known demographic correlates. DESIGN: Population-based database analysis of all children in British Columbia (BC) under the age of 19 as of December 31, 1996; comparison of those who had been prescribed MPH and therefore placed in the CBD group (n = 16, 806) and those who were not (n = 1,010,067). Demographic information collected was as follows: age, sex, measures of socioeconomic status, and region of residence. OUTCOME MEASURES: Common types of childhood injury in BC: International Classification of Diseases, Ninth Revision N-codes (fractures, open wounds, poisoning/toxic effect, concussion, intracranial, burns) and E-codes (falls, postoperative complications, motor vehicle accidents, struck by object, adverse effects of drugs, suffocation, drowning). DATA SOURCE: BC Linked Health Data Set and the BC Triplicate Prescription Program. RESULTS: After controlling for known demographic correlates, odds for injury was greater among those treated with MPH and presumed to have a behavioral disorder, when injury was characterized either by type (1.67; 99% confidence interval: 1.54-1.81) or cause (1.52; 99% confidence interval: 1.40-1.66) of injury. This increased risk extended to unexpected categories of injury such as postoperative complications and adverse effects of drugs. CONCLUSIONS: Children with CBDs have >1.5 times the odds of sustaining injuries of a variety of types from a variety of causes, even after controlling for known demographic correlates, than those without behavioral disorders. The risks for these children extend beyond those that might be directly associated with impulsivity and overactivity. Injury prevention strategies aimed at this group of children and youth would be beneficial. Policy-makers should account for increased risk of a wide variety of injuries in this group of children and youth.

Adolescent↗
PubMed1976

The use of utilization review records as a source of data on nursing home care.

Data form the Utah nursing home Utilization Review Program, 1970-73, provide a description of the population of nursing home patients in Utah and changes over time in patient medication and measures of activity. These data are analyzed according to type of care in home: personal, intermediate, or comprehensive. The collection of data in utilization review programs can help to evaluate the quality of care as well as appropriateness of placement, provided the information collected is designed with these ends in mind.

Adult↗
PubMed1995

Effect of platelet count on serum and plasma potassium: evaluation using database information from two hospitals.

The availability of retrospective data from potassium (K+) analyses from two hospitals, one using serum and the other plasma for electrolyte measurements, offered us the possibility to investigate the effect of blood platelet count on serum and plasma K+ concentrations. A weak correlation between plasma K+ and platelet count was observed. The in vitro increase of serum K+ in proportion to the platelet count has clinical significance in conditions, where it may impede the detection of an underlying true K+ disorder. Nomograms and correction factors, based on the correlation between platelet count and serum K+, have been suggested also in some recent reports. In the present study unselected routine patient data was used as source data. The effect of platelet count on the concentration of K+ in serum was lower than reported in previous studies, as indicated by the regression analysis. An increase of 1000 x 10(9)/l in the blood platelet count would cause an increase of about 0.7 mmol/l in the serum K+ concentration (p < 0.0001, r = 0.155). The weak correlation between platelet count and serum K+ does not support the application of platelet-count-based correction of serum K+ level in thrombocytosis. The laboratory should notify the clinician of the significance of the in vitro increase of K+ caused by increased platelet count. K+ should be measured from plasma in such cases.

Artifacts↗
PubMed2001

Hereditary cancer syndromes.

OBJECTIVE: To summarize the biological basis, clinical implications, identification, and medical management of syndromes associated with increased risk of common adult cancers. DATA SOURCES: Recent studies and data available from molecular and clinical analysis of genes responsible for autosomal-dominant inheritance of cancer risk. DATA SYNTHESIS: Several hereditary cancer syndromes have been identified for which there are increasingly effective diagnostic and management options. Specific hereditary susceptibility syndromes have been characterized that increase the risk of malignancies of the breast, ovary, colon, endometrium, and endocrine organs. Following a summary of the biological basis of hereditary cancer risk in adults, the identification of such syndromes by clinical and laboratory means is reviewed. Finally, management options for individuals with these syndromes are summarized. CONCLUSIONS: Advances in gene discovery have allowed the diagnosis of recently characterized hereditary cancer syndromes to enhance medical management for individuals with inherited susceptibility to common cancers.

Adenomatous Polyposis Coli↗
PubMed2006

Birt-Hogg-Dubé syndrome: clinicopathologic findings and genetic alterations.

CONTEXT: Birt-Hogg-Dubé (BHD) syndrome is a rare clinicopathologic condition transmitted in an autosomal dominant fashion. This complex entity is characterized by cutaneous fibrofolliculomas, kidney tumors, pulmonary cysts, and spontaneous pneumothorax. Recently, the gene possibly responsible for the clinical manifestations of BHD syndrome has been cloned and characterized. The few reviews of BHD syndrome found in the English literature mostly focus on the skin lesions or genetics, with limited information on other pathologic changes, particularly the kidney lesions. OBJECTIVE: To review the literature on this subject with a special emphasis on BHD syndrome-associated renal pathology as well as recent advances in molecular genetic discovery of the BHD syndrome. DATA SOURCES: We used all data available after performing a literature search using MEDLINE and searching under the headings "Birt-Hogg-Dubé," "hybrid oncocytic tumors," and "folliculin." CONCLUSIONS: The presence of BHD syndrome should be investigated in any patient with multiple bilateral kidney tumors, especially if the predominant histologic type is chromophobe renal cell carcinoma or the so-called hybrid oncocytic tumor. The genetic alteration for BHD syndrome has been mapped to chromosome 17p12q11, and the gene in this region has been cloned and believed to be responsible for the BHD syndrome. The function of the BHD product, called folliculin, is still unknown, although it is speculated to be a tumor suppressor gene. Numerous mutations have been described in the BHD gene. Studies are ongoing to determine the relationship between the BHD gene and development of sporadic renal cell carcinoma and other lesions.

Carcinoma, Renal Cell↗
PubMed2026

GWAS Meta-analysis Identifies Novel Associated Loci and Points to Causal Tissues in Central Serous Chorioretinopathy.

OBJECTIVE: To define CSC genetic architecture and identify implicated ocular tissues, cell types, genes, and circulating proteins. DATA SOURCES: Genome-wide data were assembled from FinnGen, All of Us, Mass General Brigham Biobank, Million Veteran Program, and a Dutch chronic CSC cohort. Serum protein quantitative trait loci, human single-cell ocular atlases, and UK Biobank macular optical coherence tomography (OCT) imaging were used for downstream analyses. STUDY SELECTION: Five European-ancestry cohorts with genome-wide data and cohort-specific CSC case-control definitions were included, comprising 2,584 cases and 1,044,455 controls. Variants present in at least 2 cohorts were meta-analyzed. DATA EXTRACTION AND SYNTHESIS: Cohort-level GWASs were adjusted for age, age squared, sex, genotyping array or batch, and 10 genetic principal components, then combined using fixed-effects inverse-variance meta-analysis. Post-GWAS analyses included gene prioritization, colocalization, Mendelian randomization, single-cell disease-relevance scoring, and testing of a CSC genetic risk score in UK Biobank OCT images. MAIN OUTCOMES AND MEASURES: Genome-wide significant CSC loci, effector genes and proteins, tissue and cell-type enrichment, and CSC-relevant OCT abnormalities. RESULTS: Across 11,068,938 variants, 10 loci reached genome-wide significance (P < 5 &#xd7; 10-8), including 3 novel loci near TGFB1, LINC00551, and LOC105375630 and 7 replicated loci near CFH, CD46, NOTCH4, PREX1, PTPRB, GATA5, and TNFRSF10A. Integrative analyses prioritized 10 candidate effector genes. Colocalization and Mendelian randomization implicated circulating TNFRSF10A, TGFB1, and CASP10 levels. Single-cell analyses localized genetic risk to sclera (P = 2.0 &#xd7; 10-4) and vascular endothelial cells (P = 4.0 &#xd7; 10-4), with fibroblast enrichment. In UK Biobank, OCT abnormalities were more frequent in the top vs bottom 1% of CSC genetic risk (18 of 109 [16.5%] vs 8 of 134 [6.0%]; odds ratio, 4.05; 95% CI, 1.65-10.87; P = .002). CONCLUSIONS AND RELEVANCE: In this GWAS meta-analysis, CSC susceptibility localized predominantly to scleral and vascular biology rather than primary retinal pigment epithelial dysfunction. These findings support CSC as a sclerovascular disorder and nominate complement regulation, endothelial signaling, and extracellular matrix pathways for future study.

Journal Article↗
PubMed1990

NIH conference. Antiretroviral therapy in AIDS.

OBJECTIVE: To review recent developments of antiretroviral therapy for the acquired immunodeficiency syndrome (AIDS) and related disorders. DATA SOURCES, STUDY SELECTION, AND DATA EXTRACTION: An edited and updated summary of a Clinical Staff Conference held 26 October 1988 at the National Institutes of Health. The speakers discussed their own work as well as related work from other groups. DATA SYNTHESIS: The discovery that human immunodeficiency virus (HIV) causes AIDS has permitted the development of rational antiviral therapy for this disease. Various steps in the replicative cycle of HIV can be targeted for intervention. More basic research into the life cycle of HIV is therefore likely to yield new therapeutic approaches. In 1985, nucleoside analogues called dideoxynucleosides were discovered to be potent inhibitors of HIV replication in vitro. Dideoxynucleosides selectively inhibit HIV reverse transcriptase after they are phosphorylated intracellularly to 5'-triphosphates. One dideoxynucleoside, 3'-azido-2',3'-dideoxythymidine (AZT or zidovudine) has been found to prolong the life of patients with AIDS. This drug can partially reverse HIV dementia and decrease short-term progression to AIDS; it has been approved for treating HIV-infected patients with fewer than 500 CD4+ cells/mm3. AZT is only a first step in developing new therapy for AIDS. Its use is associated with toxicities, particularly bone marrow suppression. Several groups have reported the development of AZT-resistant strains of HIV. Other dideoxynucleosides whose toxicity profiles differ from that of AZT have also shown activity against HIV in early clinical studies. Large-scale, randomized trials of these drugs are now under way. Studies have shown that the binding of HIV to CD4 may be blocked by genetically engineered forms of CD4 and that HIV protease may be inhibited by substrate analogues. Protease inhibitors are an excellent area for further study in patients. Antisense oligonucleotide therapy may target the regulatory genes of HIV and is also being considered. CONCLUSION: With these advances, AIDS is gradually changing from an imminently fatal disease to one that can be managed with the judicious use of drugs and biologics. Progress against AIDS will continue, provided that researchers adhere to the principles of controlled trials.

Acquired Immunodeficiency Syndrome↗
PubMed2006

Cost-effectiveness of a vaccine to prevent herpes zoster and postherpetic neuralgia in older adults.

BACKGROUND: The Shingles Prevention Study showed that a varicella-zoster virus (VZV) vaccine administered to adults 60 years of age or older reduced the incidence of herpes zoster from 11.12 to 5.42 cases per 1000 person-years. Median follow-up was 3.1 years, and relative risk reduction was 51.3% (95% CI, 44.2% to 57.6%). OBJECTIVE: To assess the extent to which clinical and cost variables influence the cost-effectiveness of VZV vaccination for preventing herpes zoster in immunocompetent older adults. DESIGN: Decision theoretical model. DATA SOURCES: English-language data published to March 2006 identified from MEDLINE on herpes zoster rates, vaccine effectiveness, quality of life, medical resource use, and unit costs. TARGET POPULATION: Immunocompetent adults 60 years of age or older with a history of VZV infection. TIME HORIZON: Lifetime. PERSPECTIVE: U.S. societal. INTERVENTIONS: Varicella-zoster virus vaccination versus no vaccination. OUTCOME MEASURES: Incremental quality-adjusted survival and cost per quality-adjusted life-year (QALY) gained. RESULTS OF BASE-CASE ANALYSIS: By reducing incidence and severity of herpes zoster, vaccination can increase quality-adjusted survival by 0.6 day compared with no vaccination. One scenario in which vaccination costs less than 100,000 dollars per QALY gained is when 1) the unit cost of vaccination is less than 200 dollars, 2) the age at vaccination is less than 70 years, and 3) the duration of vaccine efficacy is more than 30 years. RESULTS OF SENSITIVITY ANALYSIS: Vaccination would be more cost-effective in "younger" older adults (age 60 to 64 years) than in "older" older adults (age > or =80 years). Longer life expectancy and a higher level of vaccine efficacy offset a lower risk for herpes zoster in the younger group. Other factors influencing cost-effectiveness include quality-of-life adjustments for acute zoster, unit cost of the vaccine, risk for herpes zoster, and duration of vaccine efficacy. LIMITATIONS: The effectiveness of VZV vaccination remains uncertain beyond the median 3.1-year duration of follow-up in the Shingles Prevention Study. CONCLUSIONS: Varicella-zoster virus vaccination to prevent herpes zoster in older adults would increase QALYs compared with no vaccination. Resolution of uncertainties about the average quality-of-life effects of acute zoster and the duration of vaccine efficacy is needed to better determine the cost-effectiveness of zoster vaccination in older adults.

Age Factors↗
PubMed1999

Organizational and environmental factors associated with nursing home participation in managed care.

OBJECTIVE: To develop and test a model, based on resource dependence theory, that identifies the organizational and environmental characteristics associated with nursing home participation in managed care. DATA SOURCES AND STUDY SETTING: Data for statistical analysis derived from a survey of Directors of Nursing in a sample of nursing homes in eight states (n = 308). These data were merged with data from the On-line Survey Certification and Reporting System, the Medicare Managed Care State/County Data File, and the 1995 Area Resource File. STUDY DESIGN: Since the dependent variable is dichotomous, the logistic procedure was used to fit the regression. The analysis was weighted using SUDAAN. FINDINGS: Participation in a provider network, higher proportions of resident care covered by Medicare, providing IV therapy, greater availability of RNs and physical therapists, and Medicare HMO market penetration are associated with a greater likelihood of having a managed care contract. CONCLUSION: As more Medicare recipients enroll in HMOs, nursing home involvement in managed care is likely to increase. Interorganizational linkages enhance the likelihood of managed care participation. Nursing homes interested in managed care should consider upgrading staffing and providing at least some subacute services.

Contract Services↗
PubMedDate not supplied

Tips for complying with JCAHO's most challenging laboratory standards.

OBJECTIVE: Suggest how to comply with the JCAHO standards which have proven to be most challenging in the survey process. DATA SOURCES: JCAHO Laboratory Survey data. CONCLUSION: Previous prior planning is the key to meeting the standards set forth by the JCAHO.

Forms and Records Control↗
PubMed1999

Impact of a DRG-based hospital financing system on quality and outcomes of care in Italy.

OBJECTIVE: To examine potential changes in quality of care associated with a recent financing system implementation in Italy: in 1995, hospital financing reform implemented in Italy included the introduction of a DRG-based hospital financing system with the goals of controlling the growth of hospital costs and making hospitals more accountable for their productivity. DATA SOURCES: Hospital discharge abstract data from 1993 through 1996 for all hospitals (N=32) in the Friuli-Venezia-Giulia region of Italy. Regional population data were used to calculate rates. STUDY DESIGN: Changes between 1993 and 1996 in hospital admissions, length of stay, mortality rates, severity of illness, and readmission rates were studied for nine common medical and surgical conditions: appendicitis, diabetes mellitus, colorectal cancer, cholecystitis, bronchitis/chronic obstructive pulmonary disease (COPD), bacterial pneumonia, coronary artery disease, cerebrovascular disease, and hip fracture. PRINCIPAL FINDINGS: The total number of ordinary hospital admissions decreased from 244,581 to 204,054 between 1993 and 1996, a population-based decrease of 17.3 percent (p<.001). The mean length of stay decreased from 9.1 days to 8.8 days, resulting in a 21.1 percent decrease in hospital bed days (p<.001). Day hospital use increased sevenfold from 16,871 encounters in 1993 to 108,517 encounters in 1996. The largest decrease in hospital admissions among study conditions was a 41 percent decrease for diabetes (from 2.25 per 1,000 in 1993 to 1.31 in 1996, p<.001). For eight of the nine conditions, severity of illness increased. Differences between severity-adjusted expected and observed in-hospital mortality rates were small. CONCLUSIONS: Observed trends showed a decrease in ordinary hospital admissions, an increase in day hospital admissions, and a greater severity of illness among hospitalized patients. There was little or no change in mortality and readmission rates. Administrative data can be used to track changes in patterns of care and to identify potential quality problems deserving further review.

Diagnosis-Related Groups↗