Two-stage reimplantation in periprosthetic knee infection.

OBJECTIVE: The increasing number of total knee arthroplasties performed yearly worldwide has resulted in a concomitant rise in bacterial infections. Two-stage reimplantation has been reported as the most successful method of treating periprosthetic knee infections. The purpose of this study was to describe all the phases of the two-stage reimplantation and to review the literature regarding the topic. MATERIALS AND METHODS: Most significant and recent papers about the management of periprosthetic knee infection through a two-stage reimplantation protocol were carefully analysed and reviewed. Our personal experience, previously published, with two-stage-reimplantation protocol was also briefly reported. RESULTS: Two-stage reimplantation has been reported as the most successful method of treating periprosthetic knee infections. The strategy of using an antibiotic-loaded cement spacer and intravenous antibiotics with delayed exchange arthroplasty is actually considered the state-of-the-art, with a reported success rate of 88-96%. The two-stage protocol has been reported as a viable option also for patients with a periprosthetic knee infection by multidrug-resistant organisms. On the other hand, open debridement with polyethylene exchange and single-stage reimplantation have been reported effective only in selective case series involving acute infections by low-virulence organisms. CONCLUSIONS: The strategy that involves the use of cement spacer, intravenous antibiotic therapy, and successive revision total knee implantation is nowadays considered the gold standard for the management of the periprosthetic knee infection. This treatment is actually considered the first choice not only for chronic but also for acute infections, especially in the presence of resistant bacteria.

LARS™ in ACL reconstruction: evaluation of 60 cases with 5-year minimum follow-up.

PURPOSE: The injury of anterior cruciate ligament (ACL) causes joint instability and, in the absence of adequate treatment, progressive joint deterioration, meniscal lesions and development of post-traumatic osteoarthritis. METHODS: The purpose of this study was to evaluate the clinical, functional and radiographic outcomes and complications in a consecutive case series of 60 patients with minimum follow-up of 5 years who underwent an arthroscopic surgery for ACL reconstruction using LARS™ ligament. Patients with concomitant meniscal or chondral lesions in the same knee were excluded. RESULTS: The subjective evaluation of the patients involved in the study (Lysholm score, IKDC score and Tegner activity level scale) shows good/excellent results. The range of movement is optimal in most patients, and pain symptoms are considered mild. A total of 31.25% of the patients did not change their lifestyle that they had before the injury. None of the patients underwent resurgery in the same knee. In 85.4% of cases, X-ray images showed no signs of osteoarthritis after ACL reconstruction. CONCLUSIONS: Comparable with other series showed in the literature, this study assesses that the use of LARS™ in reconstruction of ACL is an excellent option for treating >40-year-old patients requesting rapid return to daily activities/sports also at the first surgery. By restoring knee stability, articular degeneration at short and medium follow-up was avoided.

Biphasic bioresorbable scaffold (TruFit®) in knee osteochondral defects: 3-T MRI evaluation of osteointegration in patients with a 5-year minimum follow-up.

PURPOSE: The aim of this study is to follow morphological imaging characteristics and osteointegration of TruFit® bone graft substitute (BGS) plugs in cases of chondral and osteochondral defects of the articular surface of the knee joint, using high-quality cartilage-sensitive 3-T magnetic resonance imaging (MRI), linked to clinical outcomes. METHODS: The MRI was used to assess osteointegration and biological evolution of the TruFit® BGS plugs in cases with minimum 5-year follow-up: The TruFit® plug was used in 46 patients for a total of 47 cases with mean age of 57.89 (range 32-80). In this study, we reviewed only the cases with minimum follow-up of 5 years: 5 patients with mean age 64.4 years (minimum 38, maximum 80). The mean follow-up was 71 months (range 63-77). Patients were evaluated clinically, with Lysholm Knee Scoring Scale and MOCART Scale. RESULTS: 3-T MRI, which is preferable to 1.5 T for the better signal-to-noise ratio, contrast and the ability to acquire morphological images at higher spatial resolution, shows a satisfactory integration of bone scaffolds in studied cases for more than 5 years and a satisfactory restoration of the articular cartilage, with the exception of a case of which we still have to consider the factors age, type of lesion and the relationship between the plugs implanted. CONCLUSION: Clinical and radiological results significantly improve in a longer follow-up time.

Historical overview of generic medication policy.

OBJECTIVE: To provide a historical perspective on controversies surrounding the use of generic drugs. DATA SOURCES: Articles were indexed initially using terms such as generic medications, generic drugs, multisource medications, and multisource drugs. These terms were used to search indexing services such as MEDLINE, International Pharmaceutical Abstracts, CINAHL (a database of nursing and allied health literature), Science Citation Index, Psychological Abstracts, and Wilson Indexes to Journal Articles. STUDY SELECTION: Performed by the authors, with preference given to events from 1951 to the present. DATA EXTRACTION: Not applicable. DATA SYNTHESIS: The history of generic drug use is a history of conflict from a variety of perspectives. The primary conflict is economic, in which manufacturers of brandname pharmaceuticals aggressively seek to protect their patents from a variety of groups (e.g., the federal government, managed care organizations, consumer groups) that want access to less expensive medications. Another conflict is professional, especially for the members of the pharmacy profession who view drug product selection as an important opportunity for pharmacists to use their professional judgment. The most confusing conflict is the scientific discussion of bioequivalence and product quality. The brand manufacturers suggest that not all products are bioequivalent and of the same quality. This position has been opposed by the pharmacy profession, generic drug manufacturers, health care institutions, and the Food and Drug Administration. CONCLUSION: Generic drug use has increased dramatically during the past 50 years and is an accepted part of health care. However, the economic consequences of generic drug use are sufficiently high for this activity to continue as a source of controversy in the future.

Economics and structure of the generic pharmaceutical industry.

OBJECTIVE: To review key economic trends of the generic medication market and analyze the changing structure of the generic medication industry. DATA SOURCES: Articles were indexed initially using terms such as generic medications, generic drugs, multisource medications, and multisource drugs. These terms were used to search indexing services such as MEDLINE, International Pharmaceutical Abstracts, CINAHL (a database of nursing and allied health literature), Science Citation Index, Psychological Abstracts, and Wilson Indexes to Journal Articles. STUDY SELECTION: Performed by the authors. DATA EXTRACTION: Not applicable. DATA SYNTHESIS: The generic pharmaceutical market has the potential to play an important role in containing drug costs, although the amount that could be saved through the use of generic medications is not easy to measure. If estimates for the future growth in the use of generic products prove correct, the proportion of pharmaceutical sales attributable to generic products will remain in the 9% to 10% range through the first decade of the 21st century. The generic pharmaceutical industry includes several categories of companies based on business strategies. Further consolidation is expected as more resources are needed to address patent challenges stimulated by the Drug Price Competition and Patent Restoration Act. Companies are also entering into partnerships with research manufacturers to share profits from proprietary products. Future growth of the generic market will require more than increased use of generic products. Therapeutic interchange, involving switching from single-source, patent-protected products to products within the therapeutic class for which there are generic equivalents, represents a major growth opportunity for generic drug manufacturers because the savings potential is more significant than that for straightforward substitution of generic for brandname products. CONCLUSION: As it responds to challenges and opportunities, the generic pharmaceutical industry will continue to be a major force shaping the economics of medication use.

An organizational tool to describe and evaluate group performance in the health care setting.

OBJECTIVE: To develop and test a tool for evaluating the performance of working groups in the institutional health care setting and to discuss its utility for pharmacists and other health care providers. DESIGN: A model for understanding how groups make decisions in health care settings was developed based on theories derived from organizational research. Our general group decision-making model was based on data collected from a national survey of members of hospital pharmacy and therapeutics (P&T) committees. Members were asked to describe how they interacted when making decisions regarding whether to add or delete drugs from their hospital's formulary. The relationships were examined using structural equation modeling. SETTING: Large teaching hospitals. PARTICIPANTS: Key members of P&T committees. MAIN OUTCOME MEASURES: Committee members' responses about committee structure, organizational environment, quality of their interactions with each other, and the committee's decision-making abilities. Individual responses were aggregated into group measures to improve reliability and validity. RESULTS: Responses were received from 114 of the 222 hospitals surveyed (51.3%), and analysis was conducted on 95 hospitals (42.8%) for which three or more group members responded. Positive interactions among group members had the greatest influence on the group's decision-making abilities (beta = 0.92). These interactions were facilitated by a well-designed group (gamma = 0.71) and the support of the environment within which the committee operates (gamma = 0.29). CONCLUSION: The general group decision-making model tested in this study may be useful in understanding how the internal processes of health care groups such as P&T committees influence group performance and, hence, group outputs. Health care providers who apply a systematic approach to assessing group performance will find this model useful because it provides a starting point for examining the process, a way to show interrelationships among various group activities, and a guide to which strategies may be most effective for improving the decision-making process.

Drug product selection: legal issues.

OBJECTIVE: To review the potential legal liability of the pharmacist in the drug product selection process. DATA SOURCES: Published articles identified through MEDLINE, published law reviews identified through InfoTrac, and appellate court decisions. Search terms used included pharmacist liability, drug product selection, and generic substitution. Additional articles, books, and appellate court decisions were identified from the bibliographies of retrieved articles and citations in appellate court decisions. DATA SYNTHESIS: Pharmacists engaging in drug product selection are civilly liable under three legal theories: negligence, express or implied warranties, and strict product liability. Potential criminal liability includes prosecution for insurance fraud, deceptive business practices, and violation of state drug product selection laws and regulation. CONCLUSION: Pharmacists increase their liability when engaging in drug product selection, but the increase is small. Still, the law continues to evolve as pharmacists seek expanded roles and responsibilities. When courts give closer examination to pharmacists' expanded role, it is likely that pharmacists' liability will increase.

Understanding the scientific issues embedded in the generic drug approval process.

OBJECTIVE: To review the major scientific issues embedded in the generic drug approval process. DATA SOURCES: Articles indexed initially under terms such as generic medications, generic drugs, bioequivalence, and bioinequivalence. These terms were used to search indexing services such as MEDLINE, International Pharmaceutical Abstracts, CINAHL (a database of nursing and allied health literature), and Science Citation Index. Additional data sources included the Code of Federal Regulations and regulatory guidances from the Food and Drug Administration (FDA) Center for Drug Evaluation and Research. STUDY SELECTION: Performed by the authors. DATA EXTRACTION: Not applicable. DATA SYNTHESIS: Despite the fact that regulations regarding bioequivalence have been in place for more than 20 years, controversies over bioequivalence continue to arise. Consensus on many of these issues is driving the development of new FDA guidances regarding bioequivalence. Still, despite the issuance of new guidance and consensus building among scientists, many clinicians and consumers remain uninformed regarding the scientific basis for establishing bioequivalence and the generic drug approval process in general. Although some have suggested that the generic drug approval process is flawed, overall, it appears that the process works. CONCLUSION: Understanding the generic drug approval process and the issues surrounding bioequivalence is of paramount importance to both clinicians and scientists.

Activities, functions, and structure of pharmacy and therapeutics committees in large teaching hospitals.

The results of a survey on the activities and functions of hospital-based pharmacy and therapeutics (P&T) committees are presented. Questionnaires were mailed to the pharmacy director or the person responsible for the pharmacy's drug information service at 267 teaching hospitals throughout the United States in 1994 and 1995. The survey questions covered P&T committee composition, functions, roles of members, policies and procedures, and formulary-maintenance activities. The overall response rate was 70%. The mean number of members on the P&T committees was 19.3, of whom 91% were allowed to vote. There was an average of 12.3 physicians on the committees. Each P&T committee had at least one pharmacist member, with an average of 3.2 pharmacist members; 69.5% of the institutions reported having a committee secretary, who was almost always a pharmacist. On almost all committees, pharmacists wrote the minutes, prepared the formulary review documents, and were responsible for monitoring formulary activities outside the meeting. The P&T committee functioned in a very formal manner. Most (87.7%) of the respondents reported that their institutions had a closed formulary. At all hospitals, the attending medical staff could request additions to the formulary, but at only 62.4% of the hospitals could pharmacy staff make a similar request. The committees were active in changing the formulary. P&T committees in large teaching hospitals are active in formulary management, are large and diverse, and consist mainly of physicians, although pharmacists play an important role in the meetings.

The determinants of physician attitudes and subjective norms toward drug information sources: modification and test of the theory of reasoned action.

PURPOSE: To improve upon the theory of reasoned action and apply it to pharmaceutical research, we investigated the effects of relevant appraisals attributes, and past behavior of physicians on the use of drug information sources. We also examined the moderating effects of practice characteristics. METHODS: A mail questionnaire asked HMO physicians to evaluate seven common sources of drug information on general appraisals (degree of usefulness and ease of use), specific attributes (availability, quality of information on harmful effects and on drug efficacy), and past behavior when searching for information on a new, simulated H2 antagonist agent. Semantic differential scales were used to measure each appraisal, attribute and past behavior. Information was also collected on practice characteristics. RESULTS: Findings from 108/200 respondents indicated that appraisals and attributes were useful determinants of attitudes and subjective norms toward use. Degree of usefulness and quality of information on harmful effects were important predictors of attitudes toward use for several sources of information. Ease of use and degree of usefulness were important predictors of subjective norms toward use. In many cases, moderating effects of practice characteristics were in opposing directions. Past behavior had significant direct effects on attitudes toward the PDR. CONCLUSIONS: The findings suggest ways to improve the usefulness of the theory of reasoned action as a model of decision-making. We also propose practical guidelines that can be used to improve the types of drug information sources used by physicians.

Understanding how elderly patients process drug information: a test of a theory of information processing.

PURPOSE: The goal of this research was to apply a well-known model of consumer behavior, the Elaboration Likelihood Model (ELM), to "direct-to-consumer" advertising of prescription drugs aimed at elderly consumers. In particular, the specific aim was to determine whether the effect of promotional aspects of consumer drug advertising predicted by the ELM could by demonstrated on elderly consumers' product attitudes and perceptions of risk. METHODS: Subject reaction to a fictitious drug advertisement was assessed using a 2 x 2 x 2 factorial design based on the theoretical concepts of the ELM. the advertisement message varied in the expertise of the product endorser, the expected involvement or interest level of the study subject, and the content of the advertisement message. RESULTS: Analysis of variance revealed a three-way interaction effect between involvement, argument quality, and source credibility on subjects' attitudes toward the product [F(1, 123) = 4.77, p = 0.03] and perceptions of risk [F(1, 118) = 3.22, p = 0.08]. The information content of the ads had an impact on subject's attitudes under the low involvement/low credibility condition but not the low involvement/high credibility condition. Under high involvement conditions, the information content of the ad impacted attitudes under both the high and low credibility conditions. CONCLUSIONS: It appears that the ELM may be a useful model for determining when elderly individuals are more likely to be influenced by the information content or the promotional aspects of consumer advertisements for prescription drugs.

A reasoned action approach to physicians' utilization of drug information sources.

PURPOSE: The effects of attitude and subjective norm were investigated on physicians' intention to use seven drug information sources: the PDR, medical textbooks, medical journals/newsletters, pharmaceutical manufacturers' literature, pharmaceutical manufacturers' representatives, other physicians, and pharmacists. The effects of past behavior and practice characteristics were also examined. METHODS: An eight-page mail questionnaire queried health maintenance organization physicians on their intention to use, attitude (emotional response) and subjective norm (colleagues' approval/disapproval) toward use of each source when searching for drug information on a fictitious, new H2 antagonist agent. RESULTS: Responses were received from 54% (108) of the 200 physicians surveyed. Positive attitudes toward use had the greatest influence upon intention to use each of the sources (b > or = .40) (except for pharmacists, for which subjective norm was the most important predictor (b = .31)). Past behavior directly affected intention to use the PDR (b = .27), and pharmaceutical manufacturers' literature (b = .26). The effects of attitude and/or subjective norm on intention to use non-commercial sources of drug information were moderated by the practice characteristics. CONCLUSIONS: These findings suggest that physicians' use of drug information sources is strongly influenced by their attitudes toward use. In addition, the importance of situational contingencies should not be overlooked when investigating the use of drug information sources.

Ethics and animal issues in US medical education.

Increasing public and regulatory agency concern about a variety of animal protection issues that affect the field of medicine have made these issues increasingly relevant to medical school curricula. The purpose of this study was to assess the availability and forms of medical school training relating to ethical, conceptual, and societal concerns in the use of animals within the field of medicine and the perceived need for such training. Questionnaire surveys were mailed to the Deans of the 125 accredited US medical schools, and completed by Deans or their designees within the same medical institution. Questionnaire recipients were informed that results would be compiled in a fashion that did not identify specific individuals or institutions. Survey responses were obtained from 84 medical institutions (67% response). Sixty respondents (71%) indicated that their medical school offered or sponsored some type of activity related to ethical and conceptual concerns in the use of animals in medical research and training. Most schools (43) offered informal discussions/seminars relating to these issues, but nine schools offered full formal courses with up to 15 lectures on these topics. Programme content and perceived need for additional instruction varied greatly amongst respondents. The results suggest a wide diversity amongst US medical schools in the availability and perceived importance of medical school training relating to ethical and conceptual concerns in the uses of animals in medicine. It is proposed that instruction in these areas be pursued with more concerted efforts to address the growing body of knowledge about non-human beings and the ethical implications of such knowledge.

Chronic hemodialysis patients. Part I: Characterization and drug-related problems.

OBJECTIVE: To describe medication use in hemodialysis patients and to characterize the potential drug-related problems that may occur in this population. DESIGN: All patients being dialyzed during the study period who were responsible for taking their own medications and who were able to provide an accurate medication history were included in this study. A pharmacist administered a structured medication history and drug therapy review protocol known as the Focused Drug Therapy Review Program to identify potential drug-related problems. This process was modified for a hemodialysis population. SETTING: Outpatient hemodialysis unit at a university-affiliated hospital. RESULTS: Thirty patients with endstage renal disease requiring hemodialysis were enrolled in the study. On average, 10 prescription and 2 prescribed nonprescription medications were used per patient. The incidence of potential adverse effects and medication allergies or intolerances averaged 5.5 and 2.2 per patient, respectively. Twenty patients (67 percent) reported missing an average of 3.4 (range 1-11) doses of medication per month. A total of 216 potential drug-related problems (encompassing both prescribing choices and patient behaviors) were identified by the pharmacist; the categories of drug selection and medication compliance contained the greatest number of potential problems (24 and 23 percent, respectively). CONCLUSIONS: Hemodialysis patients use a large number of medications, which increases the risk for adverse reactions and other drug-related problems. The types of potential drug-related problems identified are amenable to pharmacist input. Thus, such patients should be targeted for clinical pharmacy intervention.

Chronic hemodialysis patients. Part II: Reducing drug-related problems through application of the focused drug therapy review program.

OBJECTIVE: To test the value and measure the impact of a model of pharmacy practice called the Focused Drug Therapy Review Program (FDTRP) in patients with endstage renal disease on hemodialysis. DESIGN: A modified version of FDTRP, adapted for a hemodialysis population, was assessed for its impact on prescriber behavior. The impact was measured by examining the percentage of pharmacist therapeutic recommendations accepted and implemented by the prescriber. SETTING: Thirty patients at a university hospital-based outpatient hemodialysis unit participated in the study. Twenty-four patients completed the study through the implementation evaluation. RESULTS: The pharmacist generated 114 therapeutic recommendations and 85 informative comments regarding drug therapy. The prescriber accepted 76 percent and implemented 70 percent of the therapeutic recommendations. The prescriber considered the informative comments to be helpful, even if the information was known previously. CONCLUSIONS: The FDTRP has been shown to be useful in the care of chronic hemodialysis patients. In addition, the pharmacist was able to provide clinically important recommendations in a closely monitored patient population.

Gender differences in Piagetian visual-spatial representation of verticality and horizontality.

Visual-spatial representations of verticality and horizontality (V/H) were assessed by novel plumb-line and water-level tasks in a replication of Jamison and Signorella's (1980) study of sex role orientation differences in V/H performance. Comparisons between men and women classified as masculine, feminine, and androgynous revealed no significant effect for either sex role orientation or for interactions between orientation and sex on V/H performance. The main effect for sex was significant, favoring men.