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PubMed2005

Patterns and quality of treatment for patients with schizophrenia in routine psychiatric practice.

OBJECTIVES: This study provided generalizable national data on the treatment of adult patients with schizophrenia in the United States and assessed conformance with the practice guideline treatment recommendations of the Schizophrenia Patient Outcomes Research Team and the American Psychiatric Association. METHODS: National data from the American Psychiatric Institute for Research and Education's 1999 Practice Research Network study of psychiatric patients and treatments were used to examine treatment patterns for 151 adult patients with schizophrenia. Analyses were performed and adjusted for the weights and sample design to generate nationally representative estimates. RESULTS: Findings indicated that patients with schizophrenia who were treated by psychiatrists had complex clinical problems and were markedly disabled. Forty-one percent of patients had a comorbid axis I disorder, and 75 percent were currently unemployed. Thirty-five percent were currently experiencing medication side effects, and 37 percent were currently experiencing problems with treatment adherence. Although most patients received guideline-consistent psychopharmacologic treatment, treatment was characterized by significant polypharmacy. Rates of conformance with the guideline recommendations were significantly lower for psychosocial recommendations than for psychopharmacologic recommendations. Although 69 percent of patients received at least some psychosocial treatment, none of the unemployed patients received vocational rehabilitation services in the past 30 days. CONCLUSIONS: These data suggest unmet need for psychosocial treatment services among individuals with schizophrenia. These findings raise questions about whether currently available antipsychotic medications are being used optimally or whether they offer limited effectiveness for patients with complex clinical problems who are treated in routine psychiatric practice.

Adolescent↗
PubMed1998

Prevalence of varicose veins in an Italian elderly population.

The prevalence of varicose veins (VV) in the elderly population of the Campania Region, in Southern Italy, was estimated. A random sample of the people aged more than 65 years was drawn by means of a stratified multistage sampling design warranting that observed percentages were direct estimates of population percentages. The investigation covered 1319 subjects, 560 (42.5%) men and 759 (57.5%) women, their ages ranging from 66 to 96 years with an average value of 74.2 years, who were interviewed and visited by trained physicians. VV were defined as any reticular or truncal visible varicosities of the lower limbs, and investigated symptoms were heaviness, pain, nightly cramps, edema, eczema, hyperpigmentation, and ulceration. Some variables were studied as risk factors: age, sex, lifetime occupation, smoking, alcohol, hypertension, diabetes, and obesity; previous treatment and use of elastic stockings were also studied. Statistical associations were evaluated by Chi-square test, a two-tailed P value of 0.05 being assumed as significance level. In total, 391 (29.6%) subjects were reported to be affected by VV, but the clinical examination was positive in only 362 (27.4%) with a good correspondence between answers and clinical findings. Prevalence was greatly affected by sex, the percentage being two times higher in women (35.2%) than in men (17%). VV developed after a pregnancy in 40.5% of women, but a high percentage of women (38.2%) also reported menopause as a time starting point. No significant association between reported risk factors and VV was found among men, whereas obesity was strongly related to VV in women. One or more symptoms were reported in 92.1% of persons affected by VV, but no previous therapy was reported by 58.9% of subjects. Only 16.9% of patients used elastic stockings with a significant difference between men (7.4%) and women (20.2%).

Age Distribution↗
PubMed1991

Matching three classifications of secondary students to differential levels of study guides.

This study examined the effectiveness of matching three classifications of secondary students (17 with learning disabilities, 18 remedial, and 47 nondisabled) to differential levels of study guides. The students, 45 males and 37 females, were enrolled in science and social studies classes in middle school and high school. In one treatment, students were assigned multilevel study guides containing different levels of referential cues, with the guides implemented through three instructional groups: teacher-directed, dyadic, and independent. In another treatment, the same students were assigned single-level study guides that did not contain referential cues, with the guides implemented as an independent activity. An equivalent time samples design was arranged, with six multilevel and six single-level treatments randomly assigned in two-session blocks. The dependent measures consisted of two types of test items, factual and interpretive. The results of group analyses indicated that multilevel study guides were more effective than single-level study guides in all classes and overall on factual questions, with individual analyses verifying that the greatest benefit occurred for the teacher-directed students. On interpretive test items, the results of group analyses favored the multilevel study guides in high school social studies and overall, with individual analyses revealing few remarkable differences for students in any instructional group. A trend analysis revealed little practice effect over time in either treatment. Several methodological and clinical issues involved in matching heterogeneous students to differential levels of textbook instruction in secondary programs are discussed.

Achievement↗
PubMedDate not supplied

Dissemination of diabetes care guidelines: lessons learned from community health centers.

PURPOSE: This study was conducted to evaluate the impact of a provider problem-based learning (PBL) intervention on screening for complications of diabetes in community health centers. METHODS: A successive sampling design was used to compare selected standards of diabetes care delivered preintervention with the care delivered postintervention at 2 community health centers and 1 comparison centers. Two randomly assigned intervention sites received a PBL intervention focused on care guidelines for prevention of diabetes complications, with telephone follow-up over 12 months. Effects of the intervention were determined from an audit of 200 charts from each site. RESULTS: The odds of having a glycosylated hemoglobin test more than doubled from preintervention to postintervention, and the odds of having a foot examination more than tripled across centers. Measurement of creatinine and glycosylated hemoglobin were associated; the odds of having one test tripled when the other had been measured. Rates for documentation of patient education were significantly lower at the intervention site where free patient education booklets were distributed. CONCLUSIONS: Improvements in diabetes care were not consistent among community health centers. Interventions involving system and policy changes may be more effective in implementing and sustaining improvements than just provider education.

Adult↗
PubMedDate not supplied

Concomitant toxicokinetics: techniques for and interpretation of exposure data obtained during the conduct of toxicology studies.

Toxicokinetic analyses have become a routine component of preclinical toxicology studies with pharmaceutical candidates. Evaluation of plasma and/or tissue samples from animals used in toxicology studies (or concurrent satellite groups) provides information on dose proportionality, the potential for dose accumulation, and the sex and species differences in distribution and elimination. Toxicokinetic information is used by toxicologists, toxicology management, clinicians, institutional review boards, regulatory agencies to ensure that exposure has occurred in animal species to a sufficient extent to minimize the potential risk of toxicities in humans. The requirements for descriptive toxicokinetics change depending on the stage of development of new drug candidates. Early in development, documentation of exposure in 1 species and sex of laboratory animal might be enough to justify preliminary development costs and initiation of product development. Later in development, it becomes necessary to know how new drug candidates are distributed and eliminated following subchronic and chronic administration in multiple species and both sexes. Finally, knowledge of toxicokinetics is used to help establish doses in long-term oncogenicity studies. Scientific, public, and regulatory pressures have recently dictated that the number of animals used in toxicology studies be closely monitored and minimized. Toxicokinetic evaluation of new drug candidates by a staggered sampling design is now routinely performed in our laboratories to maximize information obtained while reducing animal use.

Animals↗
PubMed2004

Methodological issues in the measurement of birth preparedness in support of safe motherhood.

Behavior change interventions focusing on birth preparedness for pregnant women, their husbands, and adults in the community are common components of community-oriented Safe Motherhood programs in developing countries. Few studies have examined the effectiveness of these interventions, and existing studies are flawed due to study and sample design. This article highlights methodological issues that are often overlooked when measuring indicators of birth preparedness among multiple audiences for program evaluation purposes in household-based surveys. Solutions are proposed to address each of these problems in an effort to improve future research.

Birth Rate↗
PubMed1995

Teaching nursing research using two-way video technology.

Schools of nursing are meeting the needs of students by instituting distance education courses that use two-way video technology. This article describes the structural features of the classroom that are changed and provides strategies that can be effective for teaching nursing research. These strategies are related to: teaching and demonstrating use of statistical formulas; selecting and teaching use of software for data analysis; teaching about research design, sampling, and data collection procedures; and critiquing empirical articles.

Audiovisual Aids↗
PubMedDate not supplied

Comparing the areas under more than two independent ROC curves.

For a diagnostic test, the area under the associated receiver operating characteristic (ROC) curve is considered a measure of the efficacy of the test. Statistical methodology for the comparison of the areas under more than two independent ROC curves is developed. The jackknife is used to devise an F test using the pseudovalues as data. A Studentized range (SR) test is also considered using the original area estimates. A Monte Carlo study is performed to evaluate the significance level and power of the two test statistics. Both statistics conform well to the 0.10, 0.05, and 0.01 significance levels when the sampling design is balanced between cases with and without the disease. Power is also comparable. For unbalanced designs, the SR test on the original area estimates is very conservative while the F test on pseudovalues performs well. The F test is recommended as the method of choice for comparing the areas, although for balanced designs the SR test, with its computational simplicity, may be preferred.

Diagnosis↗
PubMed2000

Urinary incontinence and risk of death among community-living elderly people: results from the National Survey on Self-Care and Aging.

OBJECTIVES: The authors explored whether urinary incontinence (UI) is associated with higher mortality and, if so, whether adjustment for demographics, health, and functional status diminishes the association. METHODS: The Cox proportional hazards model was used with a nationally representative sample of community-living elderly people (N = 3,485). RESULTS: In an analysis adjusted for age, gender, education, and probability sampling design, participants with mild to moderate UI (hazard ratio [HR] = 1.51; 95% confidence interval [CI] = 1.09-2.08) and severe UI (HR = 1.54; 95% CI = 1.03-2.29) experienced a higher risk of death. Adjustment for health and functional status diminished the association of UI and risk of death (mild to moderate UI, HR = 1.20, 95% CI = 0.85-1.68; severe UI, HR = 0.91, 95% CI = 0.59-1.39). DISCUSSION: The relationship between UI and mortality in older adults can largely be understood on the basis of increased frailty in incontinent individuals.

Activities of Daily Living↗
PubMed1996

The silent ones: a review of sampling issues and biases pertinent to the area of pediatric oncology procedural pain.

Pain related to procedures for pediatric oncology patients is a salient topic. Although these procedures can cause much distress, this area has been neglected in research. Previous research has suffered from serious sampling problems, such as using small, nonrepresentative, biased samples. In addition, little is known about the influence of sociocultural factors on the phenomena of pain in children. This article presents the results of a review of the past 10 years of pertinent literature, argues that sociocultural influences on pain need to be studied, and offers suggestions for improving sampling designs.

Child↗
PubMed2003

The use of advance directives in a population of Asian Indian Hindus.

Advance directives are a way to communicate the kind of care that people desire at the end of life. Recent research shows that ethnic minorities have been found to complete advance directives significantly less often than Caucasians, and no information was available regarding advance directives in the Asian Indian population. To address this shortcoming, this descriptive exploratory design sampled a community sample of 45 Asian Indian Hindus. Being female and having an individualistic decision-making style were significantly positively correlated with advance directive completion. Having strong religious affiliation and a family decision-making style were significantly negatively correlated with advance directive completion. The results of this study provide needed information regarding the Asian Indian population and how Hinduism affects advance directives.

Adult↗
PubMed1986

Consumer preference for personal drug information source: relationship to perceived importance of drug class.

The purposes of this study were to: (1) determine consumer preferences for personal drug information sources, and (2) determine if preference for information source is affected by perceived drug importance. A telephone survey of 204 metropolitan subjects was conducted using a systematic sampling design. Pharmacists and physicians were preferred over lay sources for all drug categories. Pharmacists and physicians were preferred equally for drugs perceived of low to moderate importance, but not for drugs perceived of highest importance. Perceived drug importance, which has not been examined previously, appears to be an important factor in consumers' preference for personal drug information sources.

Community Participation↗
PubMed1993

Vigabatrin.

OBJECTIVE: To introduce the reader to the use of a new agent, vigabatrin, in the treatment of refractory complex partial seizures. Clinical trials and pharmacokinetic data are reviewed, as well as neuropathology, adverse effects, drug interactions, and dosage guidelines. DATA SOURCES: A MEDLINE search through March 1992 was used to identify pertinent English-language literature, including clinical trials, reviews, abstracts, and conference proceedings. Indexing terms included vigabatrin and anticonvulsants. STUDY SELECTIONS: All clinical trials (total of 21) were reviewed, as were all pharmacokinetic studies (total of 8). Selected studies highlighting chemistry, pharmacology, neuropathology, and adverse effects were also reviewed. DATA EXTRACTION: Performed subjectively by the author. Trials were assessed by design, sample size, types of seizures of the subjects, and clinical response. DATA SYNTHESIS: Vigabatrin represents the first of a new class of antiepileptic drugs (AEDs)--the gamma-aminobutyric acid transaminase (GABA-T) inhibitors. Vigabatrin works by selective, irreversible inhibition of GABA-T, thus preventing the breakdown of GABA. It has been shown to produce dose-dependent increases in cerebrospinal fluid GABA concentrations, and decreases in GABA-T activity. Vigabatrin may also cause a decrease in excitation-related amino acids. It is well absorbed, is not protein bound, and is eliminated by glomerular filtration. However, even with a short half-life (5-7 h), vigabatrin may be given once or twice daily because of its mechanism of action. Few drug interactions have been reported with this agent, although decreases in phenytoin concentration may reach clinical significance. Concern over neuropathologic findings (microvacuolization of white matter) in animals caused trials of vigabatrin to be halted in 1983, but trials have now resumed as there is no evidence of toxicity in humans. Clinical efficacy of vigabatrin has been evaluated in controlled trials and appears to be most effective in complex partial seizures, producing a 50 percent or greater reduction in seizure frequency in approximately 50 percent of the adult patients studied. Efficacy in children with partial seizures also appears promising, and one uncontrolled study suggests that further study of vigabatrin in infantile spasms may be warranted. CONCLUSIONS: Vigabatrin appears to be effective in treating refractory complex partial seizures in adults and refractory partial seizures in children. Its relatively benign adverse-effect profile and few known drug interactions may given this agent an advantage over existing anticonvulsants. However, definitive conclusions about the role of vigabatrin in epilepsy treatment should await the completion of ongoing Phase II and Phase III trials.

Adult↗
PubMed1993

Nabumetone: a "nonacidic" nonsteroidal antiinflammatory drug.

OBJECTIVE: To review the pharmacology, pharmacokinetic disposition, dosage recommendations, adverse effects, drug interactions, and efficacy of nabumetone in patients with selected rheumatic disorders and soft-tissue injuries. DATA SOURCES: Data from scientific literature were extracted, evaluated, and summarized for presentation. A MEDLINE search was conducted using the following indexing terms: antiinflammatory agents, nonsteroidal, nabumetone, rheumatoid arthritis (RA), and osteoarthritis (OA). Studies evaluating nabumetone reported in articles, abstracts, or proceedings involving human subjects were considered for inclusion. STUDY SELECTION: Special consideration was given to clinical studies using double-blind, randomized, parallel, controlled designs. Studies comparing the effectiveness and safety of nabumetone with placebo and other nonsteroidal antiinflammatory drugs (NSAIDs) were included. DATA EXTRACTION: Data from human studies published in the English language were evaluated. Trials were assessed according to study design, sample size, and description of outcomes. DATA SYNTHESIS: Nabumetone is a nonacidic prodrug that is metabolized to an active nonsteroidal antiinflammatory moiety, 6-methoxy-2-naphthylacetic acid (6-MNA). 6-MNA is a structural analog of naproxen. Like naproxen and other NSAIDs, 6-MNA possesses analgesic, antipyretic, and antiinflammatory activity, 6-MNA has a prolonged elimination half-life, ranging from 17 to 74 hours, which allows for once-daily dosing. The efficacy of nabumetone for treating symptoms of RA and OA has been established in controlled clinical trials. Nabumetone also has been studied in ankylosing spondylitis and soft-tissue injuries. Adverse effects associated with nabumetone are similar to those associated with other NSAIDs. Gastrointestinal reactions occur most frequently in the form of abdominal pain or indigestion, nausea, or vomiting. Central nervous system adverse effects occur less frequently, and are followed in order of occurrence by rashes. CONCLUSIONS: Nabumetone is a prodrug metabolized to an active metabolite structurally related to naproxen. Studies have demonstrated the efficacy of nabumetone, but no advantages over the many other NSAIDs now available.

Anti-Inflammatory Agents, Non-Steroidal↗
PubMed1993

Paroxetine: a selective serotonin reuptake inhibiting antidepressant.

OBJECTIVE: To review the pharmacology, pharmacokinetics, clinical investigations, adverse effects, and dosing strategies of paroxetine as a treatment of major depression. DATA SOURCES: Specific paroxetine information was selected from a MEDLINE search using paroxetine as the search term. Other sources included manual searches of pertinent journal article references, meeting abstracts, and the manufacturer. STUDY SELECTION: Clinical investigations with a blind, controlled (placebo and/or active), randomized design were selected. With the exception of treatment-resistant depression, no short-term, open investigations were selected. DATA EXTRACTION: Clinical investigations were evaluated for design, sample size, diagnosis, duration, definition of response, and outcome. Data from all investigations were selected by one author and reviewed by both authors. DATA SYNTHESIS: Paroxetine is a selective serotonin reuptake inhibitor (SSRI) recently approved for the treatment of major depression. It is a potent and selective inhibitor of serotonin reuptake and has weak or no activity on the other monoamines; it is also weakly anticholinergic. Although pharmacokinetic parameters are variable, paroxetine is generally well absorbed, highly protein bound, hepatically cleared, and has no active metabolites. Clinical investigations support paroxetine's effectiveness as an antidepressant in an outpatient population with moderately severe depression. Its effectiveness is superior to that of placebo and is comparable to that of active controls. The majority of investigations have been six weeks in duration. Additional data are required to support paroxetine's promise for longer treatment periods (i.e., > or = 1 y), in the elderly, and for treatment-resistant depression. Adverse effects appear to be similar to those caused by the other SSRIs; some of the most common are nausea, diarrhea, insomnia, dry mouth, and nervousness. Significant drug interactions may occur with the monoamine oxidase inhibitors, phenobarbital, and phenytoin. CONCLUSIONS: Paroxetine is safe and effective for treatment of outpatients with moderately severe depression. Further clinical data and experience are necessary to determine this agent's place in the long-term treatment of major depression.

Aged↗
PubMed1993

Fluvoxamine-associated manic behavior: a case series.

OBJECTIVE: To report cases of manic-like behavior induced by fluvoxamine, a selective serotonin-reuptake inhibitor; to review pertinent literature; and to encourage replication of our findings in larger patient samples. DESIGN: Description of a case series of fluvoxamine-induced, manic-like behavior. PATIENTS: Eight patients with depression or obsessive features who developed manic-like behavior after initiation of fluvoxamine therapy. RESULTS: Manic symptomatology resolved in all eight patients following dosage reduction or withdrawal of fluvoxamine. Four patients still are maintained on low-dose fluvoxamine without recurrent manic symptoms. CONCLUSIONS: Our case series suggests that fluvoxamine may have the ability to induce or unmask manic behavior in depressed patients. Clinicians are alerted to monitor for this "switching" effect, especially in patients previously or currently treated with neuroleptics or lithium, and in those patients exhibiting characteristics of obsessive-compulsive disorder.

Adult↗
PubMed1995

Sulpiride: an antipsychotic with selective dopaminergic antagonist properties.

OBJECTIVE: To review the pharmacology, pharmacokinetics, clinical investigations, and adverse effects of sulpiride as a treatment for schizophrenia. DATA SOURCES: Information was selected from a MEDLINE search of English-language medical literature using "sulpiride" as the search term. Manual searches of pertinent journal article bibliographies also were performed. STUDY SELECTION: Clinical investigations with a blind, controlled, randomized design and treatment durations of at least 6 weeks were preferred. Formal assessment of a patient's schizophrenia was required. One clinical investigation using a 4-week treatment duration and 1 open investigation were included for purposes of adverse reaction assessment. DATA EXTRACTION: Clinical investigations were evaluated for design, sample size, diagnosis, duration, and outcome. Data from all investigations were selected by 1 author and reviewed by both authors. DATA SYNTHESIS: Sulpiride is a substituted benzamide with selective dopaminergic blocking activity. Early pharmacology reports hypothesized that sulpiride was selective for dopamine (D)2 receptors only, but sulpiride also blocks D3 and D4 receptors. Sulpiride does not block D1, adrenergic, cholinergic, gamma-aminobutyric acid-ergic, histaminergic, or serotonergic receptors to an appreciable extent. The oral bioavailability of sulpiride is poor, with estimates approximating 35%. Sulpiride does not appear to have an extensive first-pass metabolism, nor is it extensively protein-bound. There have been no identified active metabolites, and elimination appears to depend primarily on the kidneys. Clinical studies support sulpiride as being equally effective as active controls in the acute treatment of patients with schizophrenia. Daily doses permitted in these clinical investigations ranged from 100 to 3200 mg. Further investigation is required to determine the usefulness of sulpiride as a chronic treatment of schizophrenia and its effectiveness in treating the negative symptoms of schizophrenia. Sulpiride may cause extrapyramidal effects, autonomic effects, tardive dyskinesia, and the neuroleptic malignant syndrome. The incidence of these adverse reactions has not been established. CONCLUSIONS: Sulpiride is a safe and effective pharmacotherapeutic treatment for the acute management of schizophrenia. A unique pharmacology does not appear to provide sulpiride with a greater effectiveness than the standard antipsychotics, but may provide it with minor safety advantages.

Animals↗
PubMedDate not supplied

Fostering a culture of prevention in a residency program through a continuous quality improvement project.

This project explored the effect of a multifaceted quality improvement (QI) intervention at a university-based residency program clinic on the documented provision of preventive services. The intervention, based on the Put Prevention Into Practice program and standard QI techniques, consisted of patient self-administered Health Risk Profiles (HRPs) and a monthly educational curriculum for patients, staff, and providers. Documentation of preventive services in patient charts was measured using a repeated cross-sectional sampling design before and after the 1-year intervention period. Documentation of 8 of 19 preventive services under examination increased significantly (P < .05). Measurements of the intervention, including use of the HRPs and the educational curriculum, revealed little association with the observed improvements. Although the intervention was associated with improved documentation of clinical preventive services, specific elements of the intervention were underused. The authors postulate that the QI process fostered a culture change in the clinic that affected prevention activities. Whether the increased documentation of services reflected an increase in the actual provision of services and whether this increase is clinically significant require further study.

Adult↗