A Mixed Methods Study of Resources Available for the Professional Development of Mid-Career Faculty.

OBJECTIVE: To determine what resources are available and useful for the professional development of mid-career faculty (MCF) in pharmacy education to foster career advancement. METHODS: A 37-question survey was sent to 7236 members of the American Association of Colleges of Pharmacy, an estimated 4640 of whom represented the target population of associate professors, full professors, and administrators. Semi-structured focus groups involving these 3 groups of faculty were held to provide additional insight. RESULTS: Of 4640 targeted pharmacy faculty, 825 completed the survey (18% response rate). At least one response was received from 98% of colleges and schools of pharmacy. Over 75% of MCF indicated a goal to advance to full professor, of whom only 55% were very or extremely confident they would be promoted. Clarity in expectations for advancement was identified as the most important factor for advancement; however, only 57% of MCF respondents agreed that their department/division has clearly delineated expectations for promotion. Protected time for research/scholarship was perceived by MCF as another important factor for advancement but was not provided as a resource to 61% of faculty. Thematic analysis of 7 focus groups including 31 faculty revealed 10 themes reinforcing the survey results. CONCLUSION: This study identified misalignment between the needs of MCF and the resources available to facilitate development/advancement.

A Call to Action for the Professional Development of Mid-Career Faculty.

Despite taking on heavier teaching and service loads, an expanding research program, and serving as mentors to junior faculty, mid-career faculty often feel unsupported. Providing a solid foundation through resource allocation and sharing between and within institutions can facilitate establishment or improvement of faculty development initiatives, workload equity, transparent policies, routine performance evaluation, a process for faculty recognition, and a system of mentoring to create an environment where this essential group of faculty can continue to grow. The following discussion, which includes suggested methods to achieve these goals with a focus on mid-career faculty, serves as a call to action for pharmacy school administrators to assess the state of mid-career faculty at their institution, and if indicated, implement systems that promote success among this group.

Challenges to Implementation of the Co-Curriculum in Accredited Pharmacy Programs.

Objective. To determine areas of concern, and challenges to implementing and assessing the co-curriculum in accredited Doctor of Pharmacy programs, along with how confident programs are in their ability to meet the co-curriculum requirement as mandated by the Accreditation Council for Pharmacy Education (ACPE).Methods. A survey was administered to all ACPE-accredited pharmacy programs to collect information regarding areas of concern, challenges, and confidence in their ability to meet the co-curriculum requirement. The frequency of responses to items are presented along with comparisons based on characteristics, including institution type, cohort size, most recent ACPE accreditation review, and supporting offices.Results. The most common concerns centered on the documentation and assessment process. The most commonly reported challenges were lack of enthusiasm or buy-in from faculty, staff, and students; lack of a clear definition of co-curriculum; and faculty time and insufficient staff. Overall, programs had a high level of confidence in their ability to meet the requirements for co-curriculum. The only differences found were related to supporting offices and cohort size.Conclusion. The results suggest that having supporting offices may reduce the co-curriculum burden. Similarly, student cohort size may have an impact on the challenges for some programs, particularly those with moderate-sized cohorts reporting challenges related to faculty and staff. Further research is needed to determine how programs address these critical issues, and to explore whether programs report differently on these areas after completing an accreditation review. The study results may be useful to members of the Academy when evaluating co-curriculum.

Increasing Reach of the Diabetes Prevention Program in African American Churches: Project FIT Lessons Learned in Using an Interprofessional Student Service-Learning Approach.

The Diabetes Prevention Program (DPP) is an evidence-based lifestyle intervention proven to reduce/delay diabetes onset with diet change, physical activity, and modest weight loss. However, access to the program is limited in low-resource communities. Having health profession students facilitate DPP groups as a service learning course-credit opportunity may benefit their interprofessional training while also expanding DPP access in underserved communities. We sought to use student reflections to identify themes to assist with program evaluation and to inform program refinements. Students (N=95) from the University of Missouri-Kansas City (UMKC) medical, physician assistant, and pharmacy programs led DPP groups in urban Kansas City African American churches alongside church health liaisons as part of an interprofessional service-learning course. Students reported creating satisfying, ongoing relationships with participants; developing a deeper understanding of obstacles to weight loss; and learning the role of other health professionals in the care of patients. They also identified obstacles to successful program implementation, such as needing less time in training and having equal participation from students across their interprofessional teams. Students learned important lessons by leading the DPP, but interprofessional service-learning courses have multiple obstacles to successful delivery. Still, this approach has great potential to increase access to the DPP in African American communities and promote skill development in health profession students.

Co-Curriculum Implementation and Assessment in Accredited Doctor of Pharmacy Programs.

Objective. To determine how accredited Doctor of Pharmacy programs implement and evaluate the co-curriculum requirement as mandated by the Accreditation Council for Pharmacy Education (ACPE). Methods. A survey was administered to all ACPE-accredited pharmacy programs to collect information regarding how co-curriculum models were being implemented, including types of activities, structure, learning outcomes, oversight, and assessment. The frequency of responses to items were presented to describe the general features of co-curriculum models. Results. The types of co-curricular activities reported by programs were generally consistent, with the majority of programs categorizing these activities and allowing students to choose which they would engage in. Most respondents reported that the program mapped co-curricular activities to learning outcomes, primarily ACPE Standards 1-4. The structural oversight of the co-curriculum typically included a co-curriculum committee, subcommittee, or task force, and supporting offices. The most common offices/departments involved in the co-curriculum were assessment, student affairs/services, experiential education, and academic/curricular affairs. The most common assessments were reflections, self-assessment surveys, and checklists. Conclusion. In most programs, implementation of the co-curriculum was a joint effort among various individuals, committees, and offices. Given the developing nature of programs, descriptive studies should be repeated to identify how programs develop and enhance co-curriculum models. The study results may be useful to members of the Academy when evaluating the current state of co-curriculum implementation and potential areas for program development.

Community pharmacy patient perceptions of a pharmacy-initiated mobile technology app to improve adherence.

OBJECTIVES: To determine patient perceptions of using a demonstration application (app) of mobile technology to improve medication adherence and to identify desired features to assist in the management of medications. METHODS: A qualitative study using key informant interviews was conducted in a community pharmacy chain for patients aged 50 and older, on statin therapy and owning a smart device. KEY FINDINGS: Three main themes emerged from 24 interviews at four pharmacy locations, which included benefits, barriers and desired features of the app. Benefits such as accessibility, privacy, pros of appearance and beneficiaries were more likely to lead to usage of the app. Barriers that might prevent usage of the app were related to concerns of appearance, the burden it might cause for others, cost, privacy, motivation and reliability. Specific features patients desired were categorized under appearance, customization, communication, functionality, input and the app platform. CONCLUSIONS: Patients provided opinions about using a mobile app to improve medication adherence and assist with managing medications. Patients envisioned the app within their lifestyle and expressed important considerations, identifying benefits to using this technology and voicing relevant concerns. App developers can use patient perceptions to guide development of a mobile app addressing patient medication-related needs.

Preparation of faculty members and students to be citizen leaders and pharmacy advocates.

To identify characteristics and quality indicators of best practices for leadership and advocacy development in pharmacy education, a national task force on leadership development in pharmacy invited colleges and schools to complete a phone survey to characterize the courses, processes, and noteworthy practices for leadership and advocacy development at their institution. The literature was consulted to corroborate survey findings and identify additional best practices. Recommendations were derived from the survey results and literature review, as well as from the experience and expertise of task force members. Fifty-four institutions provided information about lecture-based and experiential curricular and noncurricular components of leadership and advocacy development. Successful programs have a supportive institutional culture, faculty and alumni role models, administrative and/or financial support, and a cocurricular thread of activities. Leadership and advocacy development for student pharmacists is increasingly important. The recommendations and suggestions provided can facilitate leadership and advocacy development at other colleges and schools of pharmacy.

Impact of wellness coaching and monitoring services provided in a community pharmacy.

OBJECTIVE: To assess the clinical and patient-centered outcomes of health coaching provided in the workplace by community pharmacists. DESIGN: Prospective interventional cohort study. SETTING: 11 independent community pharmacy chain locations in northwest and central Missouri, from January 2010 to January 2011. PARTICIPANTS: 81 benefit-eligible patients and 23 community pharmacy coaches employed by the self-insured pharmacy chain. INTERVENTION: Patients were stratified into monitoring groups according to baseline screening values for cholesterol, blood pressure, fasting blood glucose (FBG), body mass index (BMI), and waist circumference. Patients selected their pharmacist coach. Follow-up appointments occurred monthly to quarterly. Appointments consisted of education, goal setting, and monitoring through evaluation of treatment goals and physical assessment. MAIN OUTCOME MEASURES: Change from baseline in mean total cholesterol, serum triglycerides, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, systolic blood pressure (SBP), diastolic blood pressure (DBP), FBG, weight, BMI, waist circumference, health-related quality of life (HRQoL), and patient satisfaction. RESULTS: Patients' total cholesterol, LDL cholesterol, HDL cholesterol, DBP, and FBG were reduced significantly. Mean changes in triglycerides, SBP, weight, BMI, and waist circumference were not statistically significant. The 36-Item Short-Form Health Survey version 2.0 showed improvements in both the Physical and Mental Component Summaries but did not reach statistical significance. More than 90% of patients were satisfied with the service and the care they received. CONCLUSION: Wellness coaching by a pharmacist provided in a community pharmacy can result in significant improvements in cardiovascular risk factors, with a trend toward improved HRQoL. In addition, patients were satisfied with the wellness program from the start of the project.

Use of online modules to enhance knowledge and skills application during an introductory pharmacy practice experience.

OBJECTIVES: To implement and assess the effectiveness of online instructional modules to increase the consistency of learning outcomes related to students' patient-care practice knowledge and their skills application and confidence across introductory pharmacy practice experience (IPPE) sites. DESIGN: Twenty online modules were created to provide uniform delivery of instructional content that complemented classroom instruction and to introduce students to common pharmacy-practice skills in the patient-care arena. ASSESSMENT: Quantitative data were collected by means of a survey and pre- and post-module quizzes, which were completed by students to assess knowledge. More than 85% of students applied the IPPE skills. During the course, students' confidence increased significantly in all areas. For all but 1 of the 13 competencies, more than 70% of students agreed or strongly agreed that the competencies were met. CONCLUSIONS: Online instructional modules in patient care can effectively increase students' knowledge, skills application, and confidence, and improve the consistency of achieving outcomes for instructional content and activities across diverse practice settings.

Relative efficacy of antilipemic agents in non­high-density lipoprotein cholesterol reduction.

The investigators sought to summarize the percentage reduction in non­high-density lipoprotein cholesterol (non-HDL-C) achieved with various antilipemic regimens and to determine whether certain antilipemic regimens have been proven more effective in lowering non-HDL-C. A search of MEDLINE, International Pharmaceutical Abstracts, and Iowa Drug Information Service Database from 1970 to May 2011 was performed. Criteria were used to exclude studies not published in English, studies with methodology limitations, and studies with variables that may affect efficacy beyond the antilipemic agent administered. Only randomized, controlled trials comparing medications approved by the Food and Drug Administration were reviewed to determine whether significant differences in percentage reduction in non-HDL-C had been observed between different medication regimens. A total of 51 trials reported data that could be used to determine the range of percentage reduction in non-HDL-C achieved by select antilipemic regimens. Of these 51 trials, 38 provided head-to-head comparisons of antilipemic regimens. Rosuvastatin and atorvastatin are the most potent 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (statins) in lowering non-HDL-C. Adding ezetimibe, fibric acid derivatives, and omega-3 fatty acids to antilipemic monotherapy may result in further reduction in non-HDL-C. Subjects with certain characteristics (eg, nonwhite) were not prevalent in these studies.

Adherence to antihyperlipidemic medication and lipid control in diabetic Veterans Affairs patients with psychotic disorders.

BACKGROUND: Medication adherence for chronic medical illnesses has been studied extensively, but there is limited data evaluating medication adherence for comorbid medical illnesses in a psychiatric population. Furthermore, only one study has evaluated both medication adherence and clinical outcomes between the two populations. Examining medication adherence rates and clinical outcomes are important as chronic medical illnesses occur commonly in psychiatric patients, can be drug-induced, and have negative long-term consequences. OBJECTIVES: To compare antihyperlipidemic medication adherence and lipid control between individuals with psychotic disorders and those without a psychiatric illness. METHODS: This was a retrospective medical record review of 124 subjects with hyperlipidemia and diabetes (62 subjects with schizophrenia or a related psychotic disorder and 62 randomly selected, age-matched individuals without a psychiatric illness) receiving medical and psychiatric care through the Veterans Affairs Medical Center during 2008. Cumulative mean gap ratio (CMGR) was used to determine adherence. Lipid values were utilized to compare lipid control between groups. RESULTS: A significant difference in CMGR was detected. Subjects with psychotic disorders were without antihyperlipidemic therapy for 44 days compared with 62 days for the nonpsychiatric comparison group (P = 0.034). Antipsychotic adherent subjects (≥80% adherent) were more likely to adhere to their antihyperlipidemic medication (P = 0.0007). There were no significant differences between the groups for lipid control. CONCLUSION: Antihyperlipidemic medication adherence differed with the psychotic disorder group having fewer days without drug therapy. However, there was no significant difference in lipid control between subjects with a psychotic disorder and those without a psychiatric illness.

Medication adherence and glycemic control in patients with psychotic disorders in the Veterans Affairs healthcare system / Cumplimiento de la medicación y control glucémico en pacientes con desordenes psicóticos en el sistema de salud de la Oficina de Veteranos

Objective: To compare antihyperglycemic medication adherence and glycemic control between individuals with schizophrenia and related psychotic disorders and a nonpsychiatric comparison group. Methods: This was a retrospective medical record review. A total of 124 subjects with diabetes (62 patients with schizophrenia or a related psychotic disorder and 62 randomly selected, age-matched patients without a psychiatric illness) receiving their medical and psychiatric care exclusively through the Kansas City Veterans Affairs healthcare system during 2008 were included in the study. Adherence to antihyperglycemic and antipsychotic medication was determined by refill records obtained through the computerized patient record system to calculate the cumulative mean gap ratio. Hemoglobin A1C values were utilized to compare glycemic control between groups and compared to glycemic goals established by diabetes treatment guidelines. Results: Antihyperglycemic medication adherence was poor for both groups as approximately 60% of the psychotic disorder group and 75% of the nonpsychiatric comparison group were without antihyperglycemic medication for greater than 30 days during the 12-month period but adherence did not differ between the groups (p=0.182). Antipsychotic adherent subjects (>=80% adherent) were more likely to be adherent to their antihyperglycemic medication (p=0.0003). There were no significant differences between groups in glycemic control (AU)

Objetivo: Comparar la adherencia a la medicación antihiperglucémica y el control glucémico entre individuos con esquizofrenia y desordenes psicóticos relacionados y un grupo de comparación no psiquiátrico. Métodos: Esto fue una revisión retrospectiva de historiales clínicos. Se incluyeron en el estudio a un total de 124 individuos con diabetes (62 pacientes con esquizofrenia o desordenes psicóticos relacionados y 62 pacientes sin enfermedad psiquiátrica aleatoriamente seleccionados y emparejados por edades) que recibían su medicación y sus cuidados psiquiátricos exclusivamente a través del sistema sanitario de la Oficina de Veteranos de Kansas City durante 2008. La adherencia a la medicación antihiperglicemica y antipsicótica se determinó de los registros de recogida de medicación a través del sistema informático para calcular el porcentaje de discordancia medio acumulativo. Se utilizaron los valores de hemoglobina A1C para comparar el control glucémico entre los grupos y comparar con los objetivos glucémicos establecidos en las guias de tratamiento. esultados: La adherencia a la medicación antihiperglucémica fue pobre en ambos grupos, ya que aproximadamente el 60% del grupo de desordenes psicóticos y el 75% del grupo de comparación no psiquiátrico estuvieron sin medicación antihiperglucémica durante más de 30 días en el periodo de 12 meses pero la adherencia no fue diferente entre los grupos (p=0,182). Los individuos adherentes a los antipsicóticos (>=80% adherentes) eran más adherentes a sus antihiperglucémicos (p=0,0003). No hubo diferencias significativas entre los dos grupos en el control glucémico. Conclusión: La adherencia a la medicación antihiperglucémica y el control glucémico fue menos que óptimo en los dos grupos. No hubo diferencias significativas en la adherencia a la medicación antihiperglucémica y al control glucémico entre pacientes con un desorden psicótico y los que no tenían enfermedad psiquiátrica (AU)

Medication adherence and glycemic control in patients with psychotic disorders in the Veterans Affairs healthcare system.

OBJECTIVE: To compare antihyperglycemic medication adherence and glycemic control between individuals with schizophrenia and related psychotic disorders and a nonpsychiatric comparison group. METHODS: This was a retrospective medical record review. A total of 124 subjects with diabetes (62 patients with schizophrenia or a related psychotic disorder and 62 randomly selected, age-matched patients without a psychiatric illness) receiving their medical and psychiatric care exclusively through the Kansas City Veterans Affairs healthcare system during 2008 were included in the study. Adherence to antihyperglycemic and antipsychotic medication was determined by refill records obtained through the computerized patient record system to calculate the cumulative mean gap ratio. Hemoglobin A1C values were utilized to compare glycemic control between groups and compared to glycemic goals established by diabetes treatment guidelines. RESULTS: Antihyperglycemic medication adherence was poor for both groups as approximately 60% of the psychotic disorder group and 75% of the nonpsychiatric comparison group were without antihyperglycemic medication for greater than 30 days during the 12-month period but adherence did not differ between the groups (p=0.182). Antipsychotic adherent subjects (≥80% adherent) were more likely to be adherent to their antihyperglycemic medication (p=0.0003). There were no significant differences between groups in glycemic control. CONCLUSIONS: Antihyperglycemic medication adherence and glycemic control was less than optimal for both groups. There were no significant differences in antihyperglycemic medication adherence and glycemic control between patients with a psychotic disorder and those without a psychiatric illness.

Costs to physician offices of providing medications to medically indigent patients via pharmaceutical manufacturer prescription assistance programs.

BACKGROUND: Prescription assistance programs (PAPs) are offered by pharmaceutical manufacturers to provide medications at no out-of-pocket cost to various categories of medically indigent patients. some PAPs require only 1 application whereas others require as many as 4 applications per year per drug per patient, depending on the manufacturer's requirements. OBJECTIVE: to measure the costs incurred by a medical clinic that provides chronic prescription medications via PAPs. METHODS: this project was conducted in a free-standing, inner-city, Midwestern health clinic on the PAP application process for 1 representative drug for 32 pharmaceutical manufacturers that offered PAPs for drugs taken on a long-term basis for chronic conditions. time and motion studies were conducted using a medical assistant with the greatest amount of PAP experience. Assessment of time-to-access and time-to-complete forms was performed outside of normal clinic business hours to avoid interruptions. Personnel time costs also included receipt and delivery of drug to the patient (drug distribution time), which were assessed during normal business hours for actual medications received for 10 patients and included the time required to notify the patient of the arrival of the drug and to dispense the medication to the patient. supply costs for this PAP service included printing and copying costs. submission costs associated with mailing or faxing the documents were determined and calculated using the price of materials only. total application cost was calculated by adding the personnel time cost, supply cost, and submission cost. Annual PAP time was the time spent completing PAPs for 1 medication for 1 patient for 1 year. the time and resources required and the associated costs were aggregated separately for the pharmaceutical manufacturers that required 1, 2, or 4 applications per drug per patient per year. RESULTS: The total average application cost for all 32 companies was $25.18 [SD, $17.23]. Personnel time costs accounted for half or more of the total application cost, regardless of submission mode. the time to complete the form for any PAP was 0:06:20 [SD, 0:05:03] minutes with a range from 0:03:01 to 0:34:22 minutes. Printing costs were $0.20 [SD, $0.10] and copying costs were $1.96 [SD, $0.21]. Average supply costs were $2.16 [SD, $0.23]. Faxing versus mailing PAPs saved $17.90 per application. total annual clinic cost to assist patients in obtaining drugs through a PAP ranged from $10.42 per patient for a drug that requires 1 application per year (15 manufacturers, 47%) to $46.30 per patient for a drug in a PAP that requires 4 (re)applications per year (12 manufacturers, 38%). PAPs transmitted by mail required 0:49:18 [SD, 0:32:18] minutes, approximately 0:25:00 [SD, 0:21:00] minutes more than by fax (0:24:13 [SD, 0:11:32] minutes) or by Internet submissions (0:28:20 minutes), respectively. CONCLUSION: The number of PAP applications required per patient per medication annually has the greatest impact on clinic time and financial resources. Application submission method also influences the overall costs of providing this service in the clinical setting. Medical clinics should base their decision to provide a PAP application service to patients on the time and costs associated over the course of 1 year and not on the 1-time application cost.

Clinical efficacy, tolerability, and cost savings associated with the use of open-label metronidazole plus ceftriaxone once daily compared with ticarcillin/clavulanate every 6 hours as empiric treatment for diabetic lower-extremity infections in older males.

BACKGROUND: Patients with diabetes mellitus, particularly those with poor glucose control, commonly experience various medical complications related to the disease (eg, renal impairment, decreased peripheral vascular circulation, suppressed immune function). Infections of the lower extremities can range from superficial cellulitis to ulcerative, deep soft-tissue infections to osteomyelitis that necessitates some degree of amputation. OBJECTIVE: This study compared the efficacy, tolerability, and cost differences associated with the use of metronidazole plus ceftriaxone (MTZ/CTX) given once daily with those of ticarcillin/clavulanate potassium (T/C) given every 6 hours in hospitalized older males with diabetic lower-extremity infections. METHODS: This prospective, open-label study was conducted at a Veterans Affairs Medical Center. Male patients with diabetes and a lower-extremity infection were randomized to receive MTZ/CTX 1 g once daily or T/C 3.1 g every 6 hours. Treatment success was determined at 96 hours or on discontinuation of antibiotic. Success was measured in terms of body temperature <38.3 degrees C (100.6 degrees F), normalization of the finger-stick blood sugar concentration, improvement in wound staging, or a white blood cell count <10,000 cells/mm3. Medication acquisition costs per treatment arm were calculated and compared. RESULTS: Seventy patients were enrolled in the study (36 MTZ/CTX, 34 T/C). The study population had a mean (SD) age of 63.8 (10.8) years, a duration of diabetes of 12.4 (9.1) years, 0.5 (0.7) diabetes-related comorbidities, and an initial creatinine clearance of 67.1 (26.0) mL/min. There were no significant differences between groups at randomization. At 96 hours, treatment success was achieved in 31 (86%) patients in the MTZ/CTX group, compared with 28 (82%) patients in the T/C group (P=NS). Twenty-six patients were considered successfully treated on the final day of therapy in both the MTZ/CTX group (72%) and the T/C group (76%) (P=NS). There were no significant differences in primary or secondary measures of success between the 2 groups. No single or multiple baseline factors predicted treatment success or failure. No patient experienced adverse events considered related to study medication. MTZ/CTX was associated with savings of $61.06 per hospital admission, or $2198.05 for all patients who received this combination. CONCLUSION: In this population of older males, once-daily MTZ/CTX was as well tolerated and effective as T/C in the treatment of diabetic lower-extremity infections and was associated with reduced institutional costs.

A prospective, randomized, multicentered controlled trial to compare the annual glycemic and quality outcomes of patients with diabetes mellitus monitored with weekly fructosamine testing versus usual care.

Fructosamine is an indicator of overall glycemic control for a 10-14-day time frame, medium-term marker, versus the 90-day average indicated by the hemoglobin A1c (A1C) test. The utility of the home fructosamine test for management of persons with diabetes remains undefined. The primary objectives of this study were (1) to compare the annual A1C results of subjects monitoring weekly fructosamine with those receiving usual care, (2) to identify the number of subjects achieving goal A1C, and (3) to determine if the addition of a weekly fructosamine test changed a subject's quality of life. This was a prospective, randomized, multicenter, controlled trial. Subjects were recruited from three sites and randomly assigned to collect weekly fructosamine in addition to daily glucose (Group 1) or to receive usual care of daily glucose collection (Group 2). Follow-up occurred at 3-month intervals for a year. Baseline and quarterly A1C tests were collected. Quality of life assessment was conducted at baseline and at the final study visit. Seventy-two subjects were randomized. Demographic and whole blood assessments were similar between the two groups at baseline. The mean percent change of A1C from baseline to final study visit in Group 1 (-0.52 +/- 1.5) was not statistically different than Group 2 (-0.86 +/- 1.4) (P = 0.320). Seven subjects in each group achieved A1C of less than 7% (P = 0.532). No change in quality of life between or within the two groups was observed (P > 0.05) for each area of concern. Blood glucose monitoring alone was shown to be superior to the additional fructosamine testing after 1 year of treatment; however, weekly fructosamine testing demonstrated a decrease in A1C earlier and more consistently throughout the study. Despite glycemic improvement, the number of subjects attaining American Diabetes Association-defined A1C goals was not different between the treatment groups. Quality of life did not change with the addition of a weekly fructosamine test.

A clinical comparison of calculated versus direct measurement of low-density lipoprotein cholesterol level.

STUDY OBJECTIVES: To determine if, and to what extent, the low-density lipoprotein cholesterol (LDL) level is underestimated when it is calculated by the Friedewald formula compared with the LDL level measured by a direct method. A secondary objective was to determine and compare the percentages of patients meeting LDL goal using each of these two methods. DESIGN: Retrospective chart review. SETTING: Kansas City Veterans Affairs Medical Center. SUBJECTS: Patients aged 18 years or older and whose laboratory results reflected a complete lipid profile for 1 year. MEASUREMENT AND MAIN RESULTS: Calculated LDL level (C-LDL) was derived using the Friedewald formula and was compared with Wako method-derived direct LDL level (D-LDL) to ascertain whether a positive correlation existed. The absolute difference between the methods for each sample was determined and compared overall and for various subgroups. The number of patient samples achieving National Cholesterol Education Program-defined LDL goal was determined and compared for both methods. A total of 20,224 lipid profiles were generated and 19,343 were included in the analysis. A strong correlation was found between D-LDL and C-LDL (r = 0.94). The absolute difference between the two methods demonstrated an underestimation of C-LDL of 19.5 +/- 11.8 mg/dl. The degree of underestimation increased as the triglyceride level increased (p < 0.05). Age within the fifth and sixth decades resulted in significantly higher differences compared with age in the eighth decade or greater (p < 0.05). Female sex and elevated body mass index also resulted in increased discrepancies between the two methods (p < 0.05 for both). Seventy-six percent of the lipid profiles were derived from patients with coronary heart disease (CHD) or a CHD risk equivalent. Approximately one half of these patients met their LDL goal when LDL level was measured versus calculated (p < 0.0001). CONCLUSION: When compared with D-LDL, an underestimation of approximately 20 mg/dl was found with C-LDL, resulting in a loss of LDL goal attainment for half of the patients with CHD or a CHD risk equivalent.

A retrospective review of thiazolidinediones with development of a troglitazone conversion protocol.

The objective of this paper was (1) to assess compliance with the National Veterans Affairs Guidelines for the use of troglitazone and rosiglitazone and (2) to develop and implement a conversion protocol that allows effective management of patients receiving troglitazone. A retrospective chart review was conducted to assess adherence to guidelines for all patients receiving troglitazone and rosiglitazone at the medical center. Appropriateness of therapy through indication evaluation, safety through alanine aminotransferase (ALT) monitoring compliance, and efficacy through hemoglobin A1c (HbA1c) changes were used to assess adherence. According to National Veterans Affairs (VA) Guidelines, 68% of troglitazone and 63% of rosiglitazone patients had an appropriate indication for the use of these agents. Baseline ALT levels were obtained in 40% of troglitazone and 71% of rosiglitazone patients. Full compliance with continual ALT monitoring was seen in 6 and 54% of patients, respectively. Goal HbA1c was achieved in 57 and 29% of patients, respectively. Of the 33 patients receiving troglitazone, 19 were converted to rosiglitazone therapy; 11 were maintained on current regimens without troglitazone, and 3 were lost to follow up. Adherence to guidelines needs to be reinforced, in particular, compliance with ALT monitoring. However, there were no reported cases of hepatotoxicity in the patients reviewed. Many patients did not achieve a HbA1c < 8% on either agent. Development of the protocol allowed for efficient conversion of the patients" diabetes regimen while safely identifying those that should remain on this class of medication.

A prospective, randomized, multicentered controlled trial to compare the annual outcomes of patients with diabetes mellitus monitored with weekly fructosamine testing versus usual care: a 3-month interim analysis.

The recent introduction of a home monitoring system that measures whole blood glucose and whole blood fructosamine values by fingerstick blood drop adds a previously unavailable estimate of overall glycemic control via the fructosamine component. Fructosamine serves as an indicator of overall glycemic control for a 10-14-day time frame versus the 90-day average indicated by the hemoglobin A1c (A1C) test. The utilization of the fructosamine test for management of patients with diabetes mellitus remains unclear. The primary objectives of this study are to compare the quarterly A1C results of subjects monitoring weekly fructosamine with those receiving usual care, to identify the number of patients achieving goal A1C, and to determine if the addition of a weekly fructosamine test changes a patient's quality of life. Secondary objectives include determining if specific patient demographics predict success or difficulty in achieving improved A1C. This is a prospective, randomized, multicenter controlled trial. Patients were randomly assigned to collect weekly fructosamine in addition to daily glucose (Group 1) or usual care of daily glucose (Group 2) and had study visits every 3 months. Baseline and quarterly A1C tests were collected. Quality of life assessment was conducted at baseline and will be evaluated at the final study visit. Sixty subjects have been randomized into the study since May 2001 with enrollment ongoing. Baseline demographics, glucose, fructosamine, and A1C were similar between the two groups. The 3-month interim analysis demonstrated no statistically significant difference in fructosamine (p = 0.265) between Group 1 (293.00 +/- 111.22 micromol/L) and Group 2 (336.69 +/- 111.12 micromol/L), respectively. No statistical difference at 3 months (p = 0.676) in A1C values for Group 1 (7.921 +/- 1.848% vs. 7.755 +/- 1.408%) and Group 2 (7.800 +/- 1.505% vs. 7.971 +/- 1.797%) were noted when compared with baseline. The interim data suggest that the fructosamine group has had a net decrease in A1C over the 3-month time frame, whereas the control group has had a net increase in A1C values. Ongoing follow-up will determine if this trend continues and becomes statistically and clinically significant.