Development and validation of the chronic hepatitis C virus treatment satisfaction (HCVTSat) instrument.

BACKGROUND: While current medications used to treat patients with chronic hepatitis C virus (HCV) effectively produce sustained viral response (SVR), postponement of therapy is often times attributed to patient perceptions of unfavourable outcomes. However, an instrument to assess patient perceptions of therapy (i.e. treatment satisfaction) has not been developed. AIM: To describe the development and validation the chronic Hepatitis C Virus Treatment Satisfaction (HCVTSat) instrument. METHODS: Focus groups, expert review and cognitive debriefing were used to develop a draft 37-item instrument (scale: 1 = not important at all; 5 = extremely important). The preliminary instrument was administered to a pre-test sample of 145 patients through Mayo Clinic, Rochester, MN. A refined HCVTSat was administered to a main sample of 333 participants with a chronic HCV diagnosis through Harris Interactive. RESULTS: The HCVTSat was completed by 333 participants with an average age of 51 (s.d. = 12.1) years, 55% male, current or previous HCV treatment experience, and a diagnosis of HCV for approximately 12 (s.d. = 8.9) years. Twelve items for the 3 dimensions, Treatment Experience (TE), Side Effects (SE) and Social Aspects (SA), were internally consistent (Cronbach's α range: 0.70-0.90), responsive and valid. Confirmatory factor analysis (goodness-of-fit indexes: χ(2) = 20.9, df = 23, P = 0.59; CFI = 1.00, GFI = 0.99, TFI = 1.00, RMSEA = 0.001) revealed a better fit with 9 items. All path coefficients were significant (P < 0.05). SE and SA were strong predictors of TE, while TE was positively associated with the 1-item global measure of TS (path coefficient = 0.12). CONCLUSIONS: The 10-item HCVTSat demonstrated valid psychometric properties and assessed patient satisfaction with HCV therapies. However, additional studies are needed to validate the HCVTSat in conjunction with SVR and in patients in underrepresented populations.

Precision and accuracy of commercial laboratories' ability to classify positive and/or negative allergen-specific IgE results.

BACKGROUND: Accurate and reliable evaluation of the presence or absence of allergen-specific IgE is important in the differential diagnosis of allergic disease. A variety of different commercial tests are available for this purpose. There are few data available to judge how the results of these different tests compare with one another in everyday use. OBJECTIVE: To examine prospectively the extent of comparability among specific IgE results from different laboratories. METHODS: Six diagnostic laboratories employing five different methods to assay specific IgE were selected. Aliquots from 26 serum samples that contained variable levels of IgE specific to 17 common aeroallergens were sent in triplicate to each study laboratory during a 6-week time period. Results were reported numerically and by class scores and then compared by examining their concordance using Kendall's W nonparametric statistical test. In addition, cut-off values were compared by a best agreement analysis using reported results. Reproducibility was determined using precision profiles based upon the coefficient of variation among triplicates for each allergen across the range of reported results. RESULTS: In all, 7,813 tests were analyzed. Concordance among different assays in commercial use with one exception was not good. This was particularly true around the cut-off region where most assays demonstrated high imprecision. The Pharmacia CAP System used by two different laboratories demonstrated highly comparable results with good precision. Some assays were reproducible but not accurate. Others were neither reproducible nor accurate. CONCLUSIONS: The results of this study indicate that not all commercial laboratories/assays for specific IgE provide reproducible and accurate data. Significant potential for misdiagnosis was detected for some reported results. Methods were identified that do give sensitive, accurate, and reproducible results.

Analytic precision and accuracy of commercial immunoassays for specific IgE: establishing a standard.

BACKGROUND: Different laboratory assays are used to detect and measure specific IgE antibodies. No standard exists to assess their analytic performance. OBJECTIVE: We sought to analyze reported specific IgE results from different laboratories on the same serum samples for their accuracy and precision. METHODS: Blinded serum samples (26) containing variable levels of specific IgE to 17 common aeroallergens were sent on 3 different occasions through normal channels to 6 laboratories that used 5 different test procedures. Six samples were presented as a dilution series. Laboratory-assay performance was assessed by analyzing the reported results (n = 12, 708) by using ordinary least squares regression with slope coefficients, the t statistic, SEs, confidence intervals, and R (2) values. These were compared with a theoretic ideal assay as the reference. RESULTS: Analysis revealed that one system used in two different laboratories performed nearly as well as the ideal standard, with an overall average slope (0.97; range, 0.91-1.01), SE (0.05; range, 0.02-0.16), R (2) value (93%; range, 0.64-0.99), and coefficient of variation (10.3%; range, 6%-14%). Extensive variability was observed in the other 4 laboratory-assay systems with respect to overall average slope (0.76; range, 0.11-1.24), SE (0.19; range, 0.03-0.95), R (2) value (53%; range, 0.00-0.98), and coefficient of variation (19%; range, 5%-49%). For some specific allergens, some laboratories-assays were not able to detect serial dilutions of the same sample. CONCLUSIONS: One commercial system used in two different laboratories performed nearly as well as the ideal standard. Four of the laboratories-assays for specific IgE antibodies demonstrated substandard overall performance with multiple instances of poor precision and accuracy, particularly for certain allergens, such as weeds and molds.

Pharmacy and herbal medicine in the US.

Herbal medicine is increasing in popularity in the United States. The market continues to grow, with a presence being established for commercially-prepared herbal products in community pharmacies throughout the nation. This survey was conducted to describe that presence in pharmacies and to describe pharmacists' perceptions of this product class. A response rate of 26.3% (n = 512) was achieved for a five-page mail survey sent to a geographically stratified random sample of community pharmacies in the United States. Approximately 73% of pharmacists responding indicated that their pharmacy carried commercially-prepared herbal products. Attitudinal items were included to measure pharmacists' perceptions toward these products, as those perceptions have the potential to influence attitudes and subsequently behavior (such as clinical involvement with patients wishing to integrate herbal products into an existing regimen). Pharmacists, on average, did not believe that herbal products are well standardized, or that the products are well accepted by the Food and Drug Administration or the National Association of Boards of Pharmacy. Much potential exists for pharmacists to fill a role as information provider to patients who self-medicate with herbal medicines; must their perceptions of the product class be changed first?

A systems-based disease management model: achieving optimal health care outcomes.

In this article, the "disease management system model" is presented, which is applicable to health care providers practicing in community, hospital, and long-term care settings. The core service of patient information for diabetic care is used to demonstrate how the model integrates individual system components involved in health care delivery.

Creating a managed care service network.

As health care services in general and pharmacy services specifically become more important, health care administrators may wish to consider focus strategies that include service differentiation in specific or narrow target markets. The type of strategy, whether cost, differentiation, or focus, will provide the mission and establish the organizational goals for health care providers.

Image development for health care firms.

This article addresses image development and how patients, organizational members, and society formulate a particular image of an organization that provides health care services. A framework is presented that describes how corporate image is shaped by the marketplace, the corporation, and professionalism. Also described are some suggestions for identifying corporations that have the image of community leaders and how other companies can strategically position themselves to improve their corporate image.

Modeling physicians' prescribing decisions for patients with panic disorder.

The authors asked general and family practitioners to rate the importance of several items relating to the prescribing of drug products for patients with panic disorder. Physicians preferred to use benzodiazepines alone and in combination with antidepressants for treatment, regardless of the presence or absence of phobic avoidance. Adverse drug events, efficacy, and patient characteristics were found to be important considerations when physicians prescribe medication. Educational and promotional strategies for pharmaceutical manufacturers and marketers are discussed.

Formularies: the role of pharmacy-and-therapeutics (P&T) committees.

Pharmacy-and-therapeutics (P&T) committees have been established by most hospitals and serve as the primary formal communications link between pharmacy and the medical staff. The P&T committee is responsible for all matters related to the use of medications in the institution, including the development and maintenance of the formulary (the continually revised compilation of drug products available to the medical staff). The basic objectives of a P&T committee are to specify drugs of choice and alternatives, based on safety and efficacy; to minimize therapeutic redundancies; and to maximize cost-effectiveness. Procedures necessary to strengthen the role of P&T committees and improve their decision-making processes are discussed. The increasing concern with controlling health care costs will support the continued expansion of P&T committees, formularies, and the formulary system.

Matrix management in hospital pharmacy departments.

The results of a nationwide survey to determine the managerial structures of selected hospital departments are reported. A questionnaire was mailed in August 1990 to a random sample of 1792 hospital pharmacy directors. The survey included questions on hospital bed capacity and ownership and on the managerial structures used for several departments and services, including pharmacy, satellite pharmacy, home health care, and hospice care. Recipients were asked to indicate a centralized management structure if decisions were made by a single individual; decentralized if the responsibility was distributed down the hierarchy; functional if departments were grouped according to specialties, skills, and knowledge; and matrix if the vertical hierarchy was overlaid by lateral mechanisms of authority. A total of 567 usable responses were received, for a response rate of 31.6%. Across departments, the most frequently reported type of management was centralized. Functional systems and systems that included a combination of features were cited least often. Of the pharmacy departments, 24.5% had decentralized management. Matrix management was used for 11.8%, 9.7%, 7.0%, and 4.7% of the pharmacy, home health-care, hospice-care, and satellite pharmacy departments, respectively, and was used more often in large hospitals than small hospitals. Pharmacy departments in nonprofit hospitals tended to use decentralized management more often than those in for-profit institutions. Centralized management was used most frequently by pharmacy departments, followed by decentralized and matrix management structures. Few pharmacy directors reported plans to implement matrix management.

An examination of adverse drug event monitoring practices in U.S. hospitals.

Unfortunately, the reasons for respondents' negative attitudes and perceptions toward ADE monitoring are not entirely clear because they generally are not related to time or staff constraints. There was some indication that poor medical record documentation was a contributing factor; however, this problem can be addressed through education of physicians and nurses as to the importance of capturing and reporting ADE data. Other research has demonstrated that substantial effort and diligence are required on the part of all members of the health care team to capture ADEs consistently. Fortunately or unfortunately--depending on the perspective--the motivation and at least the initial energy to establish and maintain an effective ADE monitoring program have to come from the pharmacy department. The greatest fear is that many pharmacists simply will be apathetic to the issue and not devote the time and energy necessary to capture and process ADE information effectively.

An evaluation of interventions designed to stimulate physician reporting of adverse drug events.

A frequent complaint among health care professionals about ADE reporting programs is that they never know what happens to the information they took the time and effort to report. In the Mississippi ADE program, physicians appreciated the feedback they were provided--in letter form--indicating the ultimate disposition of the reported information. Also, a regular newsletter summarizing the number and types of reports and the drugs involved was well received. This vehicle was also used to educate physicians about new drugs on the market that warranted closer scrutiny. Reminder posters placed at strategic points around the hospital and periodic inservices on the program are effective in maintaining a level of awareness about the importance of ADE monitoring and its impact on the quality of care.

Adverse drug reaction monitoring in Mississippi home health care agencies.

A statewide survey of home health care agency directors in Mississippi was conducted to determine the extent of Adverse Drug Reaction (ADR) monitoring and reporting by health care professionals. A 24-item questionnaire was sent to agency directors eliciting responses on agency characteristics, rate of occurrence of ADRs, and attitudes toward responsibility for monitoring ADRs. A total of 77 questionnaires were returned yielding a response rate of 48%. The average program enrolled 104 patients with 3.5 ADRs reported by health care professionals per year (range 0-65). Agency directors reported that physicians, nurses, pharmacists, and members of the pharmacy and therapeutics committee should monitor ADRs. Results indicated a need for all health-care professional involved in home health care to increase their ADR monitoring and reporting activities.

Variables affecting pharmacists' willingness to accept third-party prescription contracts: a conjoint analysis.

Pharmacists were asked to rate their willingness to accept 12 hypothetical third-party prescription contracts offering different combinations of dispensing fees, average wholesale price levels for the ingredients, and payment lag times. Dispensing fee explained the most variance in the dependent variable of willingness to accept third-party contracts, followed by payment lag time and average wholesale price level.

Lawful uses of drugs purchased at preferential prices.

The issue of use of pharmaceuticals purchased at preferential prices by hospital pharmacies in competition with community pharmacies has received great attention in recent years. The U.S. Supreme Court has addressed such issues twice within the past 10 years. The statutory basis for the lawsuits is explained and the history and implications of the Supreme Court decisions are discussed, with emphasis on the various categories of permissible and impermissible uses under the court's decisions. Implications for the hospital pharmacy are described and discussed.