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Eszopiclone for insomnia.

OBJECTIVE: To review the pharmacology, pharmacokinetics, efficacy data, and adverse effects of eszopiclone in the treatment of transient and chronic insomnia in adult and geriatric patients. DATA SOURCES: A MEDLINE literature search (1966-May 2005) was conducted to retrieve articles and abstracts involving eszopiclone. The manufacturer of the drug provided a general summary of clinical data and abstracts of unpublished Phase III clinical trials. STUDY SELECTION AND DATA EXTRACTION: All articles identified from the data sources were reviewed, and information deemed relevant was included for this review. DATA SYNTHESIS: Food and Drug Administration approval of eszopiclone was based on 6 double-blind, placebo-controlled trials. Five trials published in abstract or study form were reviewed. The sixth trial was not available for evaluation. An open-label continuation trial was also reviewed. All studies showed statistically significant improvements in sleep parameters in adult and elderly patients treated for insomnia with eszopiclone. CONCLUSIONS: The results of the 5 available double-blind, placebo-controlled studies (and 1 open-label, 6-month extension) showed that eszopiclone was safe and effective in the treatment of transient and chronic insomnia in adult and geriatric patients. Tolerance with long-term exposure (6 mo) and rebound insomnia were not observed. The results of the 6-month, open-label extension trial demonstrated that improvements in sleep parameters were sustained. Future studies comparing eszopiclone with other non benzodiazepine sedative-hypnotics (eg, zolpidem, zaleplon) are needed with cost data to clearly define the role of eszopiclone in the pharmacotherapy of chronic insomnia.

Azabicyclo Compounds↗

Coronary artery stents.

CONTEXT: Intracoronary stents are now used for the majority of patients undergoing percutaneous coronary revascularization, and the body of scientific knowledge about stents has expanded rapidly in the last several years. OBJECTIVE: To review the evidence supporting the widespread use of intracoronary stents. DATA SOURCES: The MEDLINE database was searched for articles from 1990 through January 2000 using the indexing terms stents, coronary artery disease, and angioplasty. Additional data sources included bibliographies of articles identified on MEDLINE, bibliographies in textbooks on percutaneous coronary interventions, and preliminary data presented at recent national and international cardiology conferences. STUDY SELECTION: We selected for review studies that assessed the effects of stenting on the immediate and long-term outcome of patients undergoing percutaneous coronary revascularization. If data from randomized controlled trials were not available for specific patient subsets or lesion characteristics, observational studies were included. DATA EXTRACTION: The methodologic characteristics of studies in coronary stenting were extracted and summarized according to key components of research design, including lesion type, location, and adjunctive therapy used. Studies were classified according to the strength of the available data into proven and unproven indications for stent use. DATA SYNTHESIS: Coronary artery stents increase the safety of interventional procedures, increase procedure success rates, and decrease the need for emergency coronary artery bypass graft surgery. CONCLUSIONS: Intracoronary stents have become an essential component of the catheter-based treatment of coronary artery disease. The evidence indicates that elective stenting, rather than provisional stenting or balloon angioplasty alone, improves clinical outcomes in the months following percutaneous coronary revascularization in a wide variety of clinical settings and lesion types. JAMA. 2000;284:1828-1836.

Angioplasty, Balloon, Coronary↗

Comparison of alternative sources of data on health service encounters.

OBJECTIVES: Due to the paucity and incompleteness of routine databases, many areas of health services research rely on the accuracy of individuals' recollections of health service encounters. The objective of this study is to explore differences between patient and physician recall of health care resource use by employing data from two randomized controlled trials. METHODS: Data on the frequency of use of community-based health services were reported by both patients and their general practitioners (GPs) at three-month intervals for the first year after randomization. Analysis compared the completeness of data collected, the level of agreement between GPs and patients and differences in the estimated cost of community services. Further analysis assessed the impact of patient characteristics on reporting. RESULTS: Data provided by GPs were less likely to be complete than patient data. There were significant differences between GPs and patients in their reported use of certain community services, particularly in relation to GP-patient contacts. However, this did not lead to significant differences in estimates of costs. Patient characteristics influenced the level of agreement with GPs, but not the proportion of forms completed. CONCLUSIONS: In research in which the use of community resources is a major component of costs, differential estimates of resource use may influence study results. Further research is required to identify optimal data collection methods for health service encounters. Where possible, studies should incorporate estimates of resource use from a variety of sources and conduct sensitivity analyses to assess the robustness of the results.

Adult↗

Validity of self-reported hypertension in the National Health and Nutrition Examination Survey III, 1988-1991.

BACKGROUND: The National Health and Nutrition Examination Survey (NHANES) is the main data source for hypertension surveillance. However, because of a gap of almost 10 years between each NHANES, self-reported data from annual surveys need to be examined as an alternative data source. This study analyzes the validity of self-reported hypertension in a national sample of non-Hispanic whites, non-Hispanic blacks, and Mexican-Americans. METHODS: Sensitivity, specificity, and predictive values positive (PVP) and negative (PVN) of self-reported hypertension were calculated against two definitions of hypertension: the definition recommended by the Third Joint National Committee on Hypertension, JNC III (blood pressure > or = 140/90 and/or taking antihypertension medication) and a broader definition including control with lifestyle modifications. Data used come from the NHANES III, 1988-1991. RESULTS: Overall test characteristics using the JNC III definition are sensitivity 71%, specificity 90%, PVP 72%, and PVN 89%. Test characteristics were consistently higher for the broad than for the JNC III definition. Validity of self-reported hypertension is higher among women than among men and among persons with a medical visit during the past year than among those with no visits: validity was lowest among Mexican-American men. Due to the similarity between sensitivity and PVP, the prevalence of self-reported hypertension is nearly equal to the prevalence of JNC III-defined hypertension. CONCLUSIONS: Self-reported hypertension may be used for surveillance of hypertension trends, in the absence of measured blood pressure, among non-Hispanic whites and non-Hispanic black women and persons with a medical visit in the past year. Validation should be repeated with each NHANES.

Adult↗

Diabetes and atherosclerosis: epidemiology, pathophysiology, and management.

CONTEXT: Complications of atherosclerosis cause most morbidity and mortality in patients with diabetes mellitus. Despite the frequency and severity of disease, proven medical therapy remains incompletely understood and underused. OBJECTIVE: To review the epidemiology, pathophysiology, and medical and invasive treatment of atherosclerosis in patients with diabetes mellitus. DATA SOURCES: Using the index terms diabetes mellitus, myocardial infarction, peripheral vascular diseases, cerebrovascular accident, endothelium, vascular smooth muscle, platelets, thrombosis, cholesterol, hypertension, hyperglycemia, insulin, angioplasty, and coronary artery bypass, we searched the MEDLINE and EMBASE databases from 1976 to 2001. Additional data sources included bibliographies of identified articles and preliminary data presented at recent cardiology conferences. STUDY SELECTION: We selected original investigations and reviews of the epidemiology, pathophysiology, and therapy of atherosclerosis in diabetes. We selected randomized, double-blind, controlled studies, when available, to support therapeutic recommendations. Criteria for data inclusion (168 of 396) included publication in a peer-reviewed journal or presentation at a national cardiovascular society-sponsored meeting. DATA EXTRACTION: Data quality was determined by publication in peer-reviewed literature. Data extraction was performed by one of the authors. DATA SYNTHESIS: Diabetes mellitus markedly increases the risk of myocardial infarction, stroke, amputation, and death. The metabolic abnormalities caused by diabetes induce vascular dysfunction that predisposes this patient population to atherosclerosis. Blood pressure control, lipid-lowering therapy, angiotensin-converting enzyme inhibition, and antiplatelet drugs significantly reduce the risk of cardiovascular events. Although diabetic patients undergo revascularization procedures because of acute coronary syndromes or critical limb ischemia, the outcomes are less favorable than in nondiabetic cohorts. CONCLUSIONS: Since most patients with diabetes die from complications of atherosclerosis, they should receive intensive preventive interventions proven to reduce their cardiovascular risk.

Arteriosclerosis↗

Should immunonutrition become routine in critically ill patients? A systematic review of the evidence.

CONTEXT: Several nutrients have been shown to influence immunologic and inflammatory responses in humans. Whether these effects translate into an improvement in clinical outcomes in critically ill patients remains unclear. OBJECTIVE: To examine the relationship between enteral nutrition supplemented with immune-enhancing nutrients and infectious complications and mortality rates in critically ill patients. DATA SOURCES: The databases of MEDLINE, EMBASE, Biosis, and CINAHL were searched for articles published from 1990 to 2000. Additional data sources included the Cochrane Controlled Trials Register from 1990 to 2000, personal files, abstract proceedings, and relevant reference lists of articles identified by database review. STUDY SELECTION: A total of 326 titles, abstracts, and articles were reviewed. Primary studies were included if they were randomized trials of critically ill or surgical patients that evaluated the effect of enteral nutrition supplemented with some combination of arginine, glutamine, nucleotides, and omega-3 fatty acids on infectious complication and mortality rates compared with standard enteral nutrition, and included clinically important outcomes, such as mortality. DATA EXTRACTION: Methodological quality of individual studies was scored and necessary data were abstracted in duplicate and independently. DATA SYNTHESIS: Twenty-two randomized trials with a total of 2419 patients compared the use of immunonutrition with standard enteral nutrition in surgical and critically ill patients. With respect to mortality, immunonutrition was associated with a pooled risk ratio (RR) of 1.10 (95% confidence interval [CI], 0.93-1.31). Immunonutrition was associated with lower infectious complications (RR, 0.66; 95% CI, 0.54-0.80). Since there was significant heterogeneity across studies, we examined several a priori subgroup analyses. We found that studies using commercial formulas with high arginine content were associated with a significant reduction in infectious complications and a trend toward a lower mortality rate compared with other immune-enhancing diets. Studies of surgical patients were associated with a significant reduction in infectious complication rates compared with studies of critically ill patients. In studies of critically ill patients, studies with a high-quality score were associated with increased mortality and a significant reduction in infectious complication rates compared with studies with a low-quality score. CONCLUSION: Immunonutrition may decrease infectious complication rates but it is not associated with an overall mortality advantage. However, the treatment effect varies depending on the intervention, the patient population, and the methodological quality of the study.

Arginine↗

Changing physician performance. A systematic review of the effect of continuing medical education strategies.

OBJECTIVE: To review the literature relating to the effectiveness of education strategies designed to change physician performance and health care outcomes. DATA SOURCES: We searched MEDLINE, ERIC, NTIS, the Research and Development Resource Base in Continuing Medical Education, and other relevant data sources from 1975 to 1994, using continuing medical education (CME) and related terms as keywords. We manually searched journals and the bibliographies of other review articles and called on the opinions of recognized experts. STUDY SELECTION: We reviewed studies that met the following criteria: randomized controlled trials of education strategies or interventions that objectively assessed physician performance and/or health care outcomes. These intervention strategies included (alone and in combination) educational materials, formal CME activities, outreach visits such as academic detailing, opinion leaders, patient-mediated strategies, audit with feedback, and reminders. Studies were selected only if more than 50% of the subjects were either practicing physicians or medical residents. DATA EXTRACTION: We extracted the specialty of the physicians targeted by the interventions and the clinical domain and setting of the trial. We also determined the details of the educational intervention, the extent to which needs or barriers to change had been ascertained prior to the intervention, and the main outcome measure(s). DATA SYNTHESIS: We found 99 trials, containing 160 interventions, that met our criteria. Almost two thirds of the interventions (101 of 160) displayed an improvement in at least one major outcome measure: 70% demonstrated a change in physician performance, and 48% of interventions aimed at health care outcomes produced a positive change. Effective change strategies included reminders, patient-mediated interventions, outreach visits, opinion leaders, and multifaceted activities. Audit with feedback and educational materials were less effective, and formal CME conferences or activities, without enabling or practice-reinforcing strategies, had relatively little impact. CONCLUSION: Widely used CME delivery methods such as conferences have little direct impact on improving professional practice. More effective methods such as systematic practice-based interventions and outreach visits are seldom used by CME providers.

Decision Making↗

Promoting ethical and objective practice in the medicolegal arena of disability evaluation.

As providers of medical information and testimony, clinicians have ultimate responsibility for ethical conduct as it relates to this information. The authors offer the following recommendations for enhancing ethical relationships between expert clinicians and the courts. 1. Avoid or resist attorney efforts at enticement into joining the attorney-client team. Such compromises of scientific boundaries and ethical principles exist on a continuum ranging from standard attorney-client advocacy at the beginning of the expert consultation phase (e.g., promotional information at the forefront of retaining an expert, with either provision of selective or incomplete records or less than enthusiastic efforts to produce all records) and extending to completion of evaluation, when requests for changes in reports and documentation might be made. 2. Respect role boundaries and do not mix conflicting roles. Remember that the treating doctor possesses a bond with the patient but does not as a rule obtain complete preinjury and postinjury information in the context of assessing causality and apportionment. In contrast, the expert witness must conduct a thorough and multifaceted case analysis sans the physician-patient relationship in order to facilitate objectivity and allow optimum diagnostic formulations. Finally, the trial consultant's function in this adversarial process is to assist with critically scrutinizing and attacking positions of experts for the opposing side. These roles all represent inherently different interests, and mixing them can only reduce objectivity. 3. Insist on adequate time for thorough record review, evaluation, and report generation. Also insist on sufficient time and preparation for deposition and court appearances. 4. Work at building a reputation for general objectivity, reliance on multiple data sources, reaching opinions only after reviewing complete information from both sides, and completing the evaluation. 5. Spend a good amount of time actually treating the patient population being examined or being offered testimony about. This treatment should be current and should be of a similar frequency to treating practitioner specialists. Be able to discuss relevant research and scientific methodology issues competently and without notes. 6. Arrive at opinions only after reviewing all of the evidence from both sides of the adversarial fence, employing multiple data sources, completing the evaluation, and interpreting data within the full context of comprehensive historical, behavioral observation, and contextual information. Being otherwise favorable to retaining attorney interests suggests endorsement of "opinion prostitute," "scientific perjurer," or "hired gun" status. The only way a practitioner can reduce the likelihood of facing an "opinion prostitute" on the opposing side in future cases is to insist on establishing and maintaining a reputation for scientific objectivity. 7. Balance cases from plaintiff and defense attorneys. Predilection for one side or the other suggests bias and sets up predisposition to nonobjectivity. For example, a preponderance of plaintiff work suggests an overdiagnosis or uncritical sympathy bias, whereas a ratio that favors hiring by the defense suggests an underdiagnosis or skepticism bias. Perhaps Brodsky's suggested cut-off ratio of .8 for favorability findings would represent an initial cutoff for defense versus plaintiff ratio. That is, experts should do at least 20% work for the opposite side of the current case being represented. Further, it might be a reasonable expectation that data on these ratios be collected as an important method for ensuring objective opinions. 8. Ensure against excessive favorability to the side of the retaining attorney or firm. Objectivity demands that scientific opinions not be influenced by the position of the legal advocate. Importantly, Brodsky recommends using a ratio of .8 as a cut-off for detecting excessive bias. That is, practitioners should possess prerequisite objectivity to disagree with the referring attorney at least 20% of the time. We suggest that a more useful cut-off would be .75, where experts are expected to generate findings that do not support the referring attorney's position at least 25% of the time. 9. Never arrive at opinions that are inconsistent with plaintiff records, examination data, test data, behavioral presentation, and so forth, especially when such opinions are favorable to the side of the retaining attorney firm. Instead, use the following recommendations. (ABSTRACT TRUNCATED)

Disability Evaluation↗

Is exposure to income inequality a public health concern? Lagged effects of income inequality on individual and population health.

OBJECTIVE: To examine the health consequences of exposure to income inequality. DATA SOURCES: Secondary analysis employing data from several publicly available sources. Measures of individual health status and other individual characteristics are obtained from the March Current Population Survey (CPS). State-level income inequality is measured by the Gini coefficient based on family income, as reported by the U.S. Census Bureau and Al-Samarrie and Miller (1967). State-level mortality rates are from the Vital Statistics of the United States, other state-level characteristics are from U.S. census data as reported in the Statistical Abstract of the United States. STUDY DESIGN: We examine the effects of state-level income inequality lagged from 5 to 29 years on individual health by estimating probit models of poor/fair health status for samples of adults aged 25-74 in the 1995 through 1999 March CPS. We control for several individual characteristics, including educational attainment and household income, as well as regional fixed effects. We use multivariate regression to estimate the effects of income inequality lagged 10 and 20 years on state-level mortality rates for 1990, 1980, 1970, and 1960. PRINCIPAL FINDINGS: Lagged income inequality is not significantly associated with individual health status after controlling for regional fixed effects. Lagged income inequality is not associated with all cause mortality, but associated with reduced mortality from cardiovascular disease and malignant neoplasms, after controlling for state fixed-effects. CONCLUSIONS: In contrast to previous studies that fail to control for regional variations in health outcomes, we find little support for the contention that exposure to income inequality is detrimental to either individual or population health.

Adult↗

A checklist for retrospective database studies--report of the ISPOR Task Force on Retrospective Databases.

INTRODUCTION: Health-related retrospective databases, in particular claims databases, continue to be an important data source for outcomes research. However, retrospective databases pose a series of methodological challenges, some of which are unique to this data source. METHODS: In an effort to assist decision makers in evaluating the quality of published studies that use health-related retrospective databases, a checklist was developed that focuses on issues that are unique to database studies or are particularly problematic in database research. This checklist was developed primarily for the commonly used medical claims or encounter-based databases but could potentially be used to assess retrospective studies that employ other types of databases, such as disease registries and national survey data. RESULTS: Written in the form of 27 questions, the checklist can be used to guide decision makers as they consider the database, the study methodology, and the study conclusions. Checklist questions cover a wide range of issues, including relevance, reliability and validity, data linkages, eligibility determination, research design, treatment effects, sample selection, censoring, variable definitions, resource valuation, statistical analysis, generalizability, and data interpretation. CONCLUSIONS: For many of the questions, key references are provided as a resource for those who want to further examine a particular issue.

Data Interpretation, Statistical↗

Smallpox: clinical features, prevention, and management.

OBJECTIVE: To describe a general overview of smallpox, clinical presentation, diagnosis, adverse events, and management of both pre- and postexposure vaccination. DATA SOURCES: Literature was identified by search of MEDLINE (1966-June 2003) and International Pharmaceutical Abstracts (1966-May 2003) databases using the key terms smallpox, bioterrorism, biological warfare, and smallpox vaccine. STUDY SELECTION AND DATA EXTRACTION: Articles identified from data sources were evaluated, and relevant information was included in this review. DATA SYNTHESIS: Smallpox is spread by human-to-human contact with an infected host and therefore can be contagious. The mortality rate for smallpox is approximately 30%. While the disease was completely eradicated by 1980 with successful use of smallpox vaccine, concern has been raised that smallpox may emerge as a tool of bioterrorism. This concern, combined with the reality of current smallpox vaccination programs in the military and selected civilian populations, mandates a clear understanding of vaccination-related adverse events and contraindications by all healthcare professionals. The vaccine may cause moderate to severe adverse events such as eczema vaccinatum, progressive vaccinia, and generalized vaccinia. CONCLUSIONS: The balance between the risks and benefits of mass vaccination in prevention of an epidemic is not clear. The Centers for Disease Control and Prevention has established a guideline for appropriate use of smallpox vaccine in the civilian population.

Antiviral Agents↗

Estimation in regression models with externally estimated parameters.

In many regression applications, some of the model parameters are estimated from separate data sources. Typically, these estimates are plugged into the regression model and the remainder of the parameters is estimated from the primary data source. This situation arises frequently in compartment modeling when there is an external input function to the system. This paper provides asymptotic and bootstrap-based approaches for accounting for all sources of variability when computing standard errors for estimated regression model parameters. Examples and simulations are provided to motivate and illustrate the ideas.

Algorithms↗

[Incidence of insulin-dependent diabetes mellitus in Santiago, Chile (1990-1993)].

The aim of this study was to determine IDDM incidence in the Metropolitan Region of Chile, during the period 1990-1993 as part of the Multinational Project for Childhood Diabetes (WHO DIAMOND Project Group). The studied population was 1499.784 inhabitants. All children in whom the diagnosis was made between January 1, 1990 and December 31, 1993 were included. We used a retrospective and prospective search and confirmation method, using as data sources public and private hospitals and medical records of Pediatricians. The Juvenile Diabetes Foundation was used as a secondary data source. All cases had at least two confirmation sources. A total of 176 new cases (90 male) were diagnosed in the study period, with an annual incidence of 2.92/100,000 for females and 2.95 for males. The group of children from 10 to 14 years old had the highest incidence rate (4.9/100,000), specially in women (5.25/100,000). The yearly incidence was 1.31 in 1990, 2.71 in 1991, 2.93 in 1992 and 3.7/1000,000 in 1993. It is concluded that the Metropolitan Region has one of the lowest incidences of IDDM in Latin America, although it increased along the study years.

Adolescent↗

Pneumococcal resistance: the treatment challenge.

OBJECTIVE: To review in vitro and in vivo information dealing with pneumococcal antibiotic resistance and provide a review of the incidence, mechanisms, and controversies surrounding this growing problem. The review is also intended to provide clinicians with relevant recommendations on treatment and prevention of this organism. DATA SOURCES AND SELECTION: Primary and review articles were identified by MEDLINE search (1966-August 2000) and through secondary resources such as conference proceedings. All of the articles identified from the data sources were evaluated, and all information deemed relevant was included in this review. DATA SYNTHESIS: The growing incidence and reporting of pneumococcal isolates that are resistant to one or more classes of antibiotics have become a troubling trend that has resulted in significant shifts in treatment. Although clinicians have shifted to a new generation or class of antibiotics when faced with a resistance trend, data with resistant pneumococci show that this may not be necessary. By incorporating the pharmacokinetic and pharmacodynamic data of antimicrobials into the decision-making process, many of the drugs that we have become hesitant to use due to this resistance may still be appropriate if used correctly. CONCLUSIONS: Appropriate dosing of antimicrobials, combined with optimal use of pneumococcal vaccines, will not only prolong the longevity of some agents, but also hopefully slow resistance development.

Animals↗

Treatment of tick-borne diseases.

OBJECTIVE: To review the data regarding the pharmacotherapy of Lyme disease, Rocky Mountain spotted fever (RMSF), and the human ehrlichioses. DATA SOURCES: English-language literature was identified via MEDLINE (1966-January 2002) using the keywords Lyme disease, Rocky Mountain spotted fever, and ehrlichiosis. Textbooks and other pertinent resources were also reviewed. STUDY SELECTION AND DATA EXTRACTION: All articles identified through the data sources above were evaluated and reviewed if pertinent to the objective. DATA SYNTHESIS: Tick-borne diseases are the most common vector-transmitted diseases in North America. Each disease causes significant morbidity and, in the case of RMSF, mortality if patients go untreated. If the disease syndromes are recognized early and treatment is initiated, complications are greatly reduced. Doxycycline is active against each of the causative organisms, simplifying empiric treatment. CONCLUSIONS: Effective pharmacotherapy exists to treat each of these diseases, assuming diagnosis is made quickly. The beta-lactam and tetracycline antibiotics appear to be the most effective therapy for Lyme disease. The tetracyclines, but not the beta-lactams, are effective for RMSF and the human ehrlichioses. Since Borrelia burgdorferi and the human granulocytic ehrlichiosis agent are becoming more common coinfecting pathogens, tetracycline or doxycycline should be considered the drugs of choice for patients from endemic areas where exposure to both pathogens may have occurred. Doxycycline is the preferred agent because of decreased frequency of administration and adverse effects.

Anti-Infective Agents↗

Archival data in program evaluation and policy analysis.

Evaluators have typically avoided using existing data sets, choosing instead to collect their own information to maintain control over both the content and quality of the data. As demands on action researchers increase without provision for additional resources, primary data collection may become a luxury and the use of archival data may increase. Though archival data has practical and methodological advantages, there are limitations associated with the utilization of such information. The general problems with secondary data sources include the accuracy, acceptability and accessibility of the information. Following a discussion of these general problems, an example from the Civilian Health and Medical Program of the Uniformed Services (CHAMPUS) reimbursement data set is presented to illustrate specific difficulties with using archival data for evaluation research. Strategies are then presented for minimizing these difficulties, including determining the feasibility of utilization of such data sources, methods for assessing their accuracy and factors to consider in the data acquisition process.

Archives↗

HIV infection: point-of-care testing.

OBJECTIVE: To review the data regarding point-of-care testing for the diagnosis of HIV infection in the US. DATA SOURCES: English-language literature was identified via MEDLINE (1980-August 2003) using key words such as rapid HIV tests and HIV antibody testing. Textbooks and other pertinent resources were also reviewed. STUDY SELECTION AND DATA EXTRACTION: All articles identified through the data sources above were evaluated and reviewed if pertinent to the objective. DATA SYNTHESIS: The Centers for Disease Control and Prevention (CDC) has announced an effort to expand currently recommended strategies to prevent new infections with HIV. The cornerstone of this initiative is the availability of the new rapid test for antibodies to HIV (OraQuick Rapid HIV-1 Antibody Test, OraSure Technologies, Bethlehem, PA). The effectiveness, sensitivity, and specificity of this test have been evaluated in a number of cross-sectional studies using previously or simultaneously performed HIV enzyme immunoassays with Western blot confirmation as a reference standard. Although there are several limitations to consider, results of these studies suggest that this test has comparable ability to detect HIV antibodies to other commercially available tests. CONCLUSIONS: The OraQuick test is simple enough to be performed in many settings including those that facilitate achievement of the goals outlined by the CDC. Availability of this test should have a dramatic impact on HIV detection and prevention strategies.

AIDS Serodiagnosis↗

An update on evidence of clinical pharmacy services' impact on health-related quality of life.

OBJECTIVE: To describe and critique recent studies of clinical pharmacy services that have evaluated impact on health-related quality of life (HRQL) and to determine whether studies that lacked a control group were more likely to report a statistically significant impact on HRQL. DATA SOURCES: MEDLINE, EMBASE and International Pharmaceutical Abstracts were searched (March 1999-December 2004) using terms for HRQL and clinical pharmacy services. STUDY SELECTION AND DATA EXTRACTION: All original research articles in English identified from the data sources were examined. Abstracts were screened by 2 reviewers, and studies were included if a clinical pharmacy service was evaluated and pre-/post - HRQL outcomes were reported. DATA SYNTHESIS: Of 1152 citations identified by the literature search, 36 articles met the inclusion criteria. Twenty-two studies had a condition-specific focus. Fifteen studies incorporated a generic HRQL measure (primarily the short-form-36 items), 13 studies used a condition-specific measure, and 8 studies included both. Significant impact on one or more domains of HRQL was predominantly demonstrated in interventions relating to asthma, hypertension, and chronic heart failure. Statistically significant change in HRQL was reported in 8 of 21 studies that used a randomized controlled design (38%), in 2 of 5 studies with a nonrandomized design with control group (40%), and in 6 of 8 studies without a control group (75%; chi2 2.00; p = 0.16). CONCLUSIONS: Since 1999, the number of published studies of clinical pharmacy services that evaluated HRQL as an endpoint has more than tripled. Study designs have improved in terms of longer length of follow-up, and a wider breadth of clinical services has been evaluated. Certain pharmacy services, such as asthma management, appear to offer the most convincing evidence for the value of clinical pharmacy services in terms of measurable short-term HRQL benefit.

Health↗