Gregory P. Samsa

A method for assessing drug therapy appropriateness

This study evaluated the reliability of a new medication appropriateness index. Using the index, independent assessments were made of chronic medications taken by 10 ambulatory, elderly male patients by a clinical pharmacist and an internist-geriatrician. Their overall inter-rater agreement for medication appropriateness (ppos) was 0.88, and for medication inappropriateness (pneg) was 0.95; the overall kappa was 0.83. Their intra-rater agreement for ppos was 0.94 overall, for pneg was 0.98 overall while the overall kappa was 0.92. The chronic medications taken by 10 different ambulatory elderly male patients were independently evaluated by two different clinical pharmacists. Their overall inter-rater agreement for ppos was 0.76, and for pneg was 0.93, while the overall kappa was 0.59. This new index provides a reliable method to assess drug therapy appropriateness. Its use may be applicable as a quality of care outcome measure in health services research and in institutional quality assurance programs.

Society for Ambulatory Anesthesia Guidelines for the Management of Postoperative Nausea and Vomiting

The present guidelines were compiled by a multidisciplinary international panel of individuals with interest and expertise in postoperative nausea and vomiting (PONV) under the auspices of The Society of Ambulatory Anesthesia. The panel critically evaluated the current medical literature on PONV to provide an evidence-based reference tool for the management of adults and children who are undergoing surgery and are at increased risk for PONV. In brief, these guidelines identify risk factors for PONV in adults and children; recommend approaches for reducing baseline risks for PONV; identify the most effective antiemetic monotherapy and combination therapy regimens for PONV prophylaxis; recommend approaches for treatment of PONV when it occurs; and provide an algorithm for the management of individuals at increased risk for PONV.

Effects of the Amount of Exercise on Body Weight, Body Composition, and Measures of Central Obesity STRRIDE—A Randomized Controlled Study

Background Obesity is a major health problem due, in part, to physical inactivity. The amount of activity needed to prevent weight gain is unknown. Objective To determine the effects of different amounts and intensities of exercise training. Design Randomized controlled trial (February 1999–July 2002). Setting and Participants Sedentary, overweight men and women (aged 40-65 years) with mild to moderate dyslipidemia were recruited from Durham, NC, and surrounding communities. Interventions Eight-month exercise program with 3 groups: (1) high amount/vigorous intensity (calorically equivalent to approximately 20 miles [32.0 km] of jogging per week at 65%-80% peak oxygen consumption); (2) low amount/vigorous intensity (equivalent to approximately 12 miles [19.2 km] of jogging per week at 65%-80%), and (3) low amount/moderate intensity (equivalent to approximately 12 miles [19.2 km] of walking per week at 40%-55%). Subjects were counseled not to change their diet and were encouraged to maintain body weight. Main Outcome Measures Body weight, body composition (via skinfolds), and waist circumference. Results Of 302 subjects screened, 182 met criteria and were randomized and 120 completed the study. There was a significant ( P Conclusions In nondieting, overweight subjects, the controls gained weight, both low-amount exercise groups lost weight and fat, and the high-amount group lost more of each in a dose-response manner. These findings strongly suggest that, absent changes in diet, a higher amount of activity is necessary for weight maintenance and that the positive caloric imbalance observed in the overweight controls is small and can be reversed by a modest amount of exercise. Most individuals can accomplish this by walking 30 minutes every day.

A randomized, controlled trial of a clinical pharmacist intervention to improve inappropriate prescribing in elderly outpatients with polypharmacy

PURPOSE To evaluate the effect of sustained clinical pharmacist interventions involving elderly outpatients with polypharmacy and their primary physicians. PATIENTS AND METHODS Randomized, controlled trial of 208 patients aged 65 years or older with polypharmacy (> or = 5 chronic medications) from a general medicine clinic of a Veterans Affairs Medical Center. A clinical pharmacist met with intervention group patients during all scheduled visits to evaluate their drug regimens and make recommendations to them and their physicians. Outcome measures were prescribing appropriateness, health-related quality of life, adverse drug events, medication compliance and knowledge, number of medications, patient satisfaction, and physician receptivity. RESULTS Inappropriate prescribing scores declined significantly more in the intervention group than in the control group by 3 months (decrease 24% versus 6%, respectively; P = 0.0006) and was sustained at 12 months (decrease 28% versus 5%, respectively; P = 0.0002). There was no difference between groups at closeout in health-related quality of life (P = 0.99). Fewer intervention than control patients (30.2%) versus 40.0%; P = 0.19) experienced adverse drug events. Measures for most other outcomes remained unchanged in both groups. Physicians were receptive to the intervention and enacted changes recommended by the clinical pharmacist more frequently than they enacted changes independently for control patients (55.1% versus 19.8%; P <0.001). CONCLUSIONS This study demonstrates that a clinical pharmacist providing pharmaceutical care for elderly primary care patients can reduce inappropriate prescribing and possibly adverse drug effects without adversely affecting health-related quality of life.

Adverse drug events in high risk older outpatients.

OBJECTIVE: To describe the prevalence, types, and consequences of adverse drug events (ADEs) in older outpatients with polypharmacy.

Effect of Clinical Decision-Support Systems: A Systematic Review

BACKGROUND Despite increasing emphasis on the role of clinical decision-support systems (CDSSs) for improving care and reducing costs, evidence to support widespread use is lacking. PURPOSE To evaluate the effect of CDSSs on clinical outcomes, health care processes, workload and efficiency, patient satisfaction, cost, and provider use and implementation. DATA SOURCES MEDLINE, CINAHL, PsycINFO, and Web of Science through January 2011. STUDY SELECTION Investigators independently screened reports to identify randomized trials published in English of electronic CDSSs that were implemented in clinical settings; used by providers to aid decision making at the point of care; and reported clinical, health care process, workload, relationship-centered, economic, or provider use outcomes. DATA EXTRACTION Investigators extracted data about study design, participant characteristics, interventions, outcomes, and quality. DATA SYNTHESIS 148 randomized, controlled trials were included. A total of 128 (86%) assessed health care process measures, 29 (20%) assessed clinical outcomes, and 22 (15%) measured costs. Both commercially and locally developed CDSSs improved health care process measures related to performing preventive services (n= 25; odds ratio [OR], 1.42 [95% CI, 1.27 to 1.58]), ordering clinical studies (n= 20; OR, 1.72 [CI, 1.47 to 2.00]), and prescribing therapies (n= 46; OR, 1.57 [CI, 1.35 to 1.82]). Few studies measured potential unintended consequences or adverse effects. LIMITATIONS Studies were heterogeneous in interventions, populations, settings, and outcomes. Publication bias and selective reporting cannot be excluded. CONCLUSION Both commercially and locally developed CDSSs are effective at improving health care process measures across diverse settings, but evidence for clinical, economic, workload, and efficiency outcomes remains sparse. This review expands knowledge in the field by demonstrating the benefits of CDSSs outside of experienced academic centers. PRIMARY FUNDING SOURCE Agency for Healthcare Research and Quality.

Reliability of the National Institutes of Health Stroke Scale: Extension to Non-Neurologists in the Context of a Clinical Trial

BACKGROUND AND PURPOSE The reliability of the National Institutes of Health Stroke Scale (NIHSS) has been established through testing its use in live and videotaped patients. This reliability testing has primarily focused on the use of the scale by neurologists. We sought to determine the reliability of the NIHSS as used by non-neurologists in the context of a clinical trial. METHODS In anticipation of the initiation of a randomized trial of a new therapy for patients with acute ischemic stroke, 30 physician investigators (30% of whom were not neurologists) and 29 non-physician study coordinators were trained in the use of the NIHSS at an informational and training conference using standardized videotaped patient examinations. A series of 4 patients were rated initially. After 3 months, the same 4 patients were rerated, providing a measure of intraobserver reliability. An additional series of 4 new patients were also rated after 3 months and, with the initial 4 ratings, provided data for assessment of interobserver reliability. RESULTS Overall, 28% of the raters had previous experience with the NIHSS, and 22% had previously used the videotapes as used in the present trial. The coefficients of determination (r2) were each greater than .95 when the means of the two ratings of the same 4 cases were compared between (1) neurologists and other types of physicians, (2) physicians and study coordinators, (3) raters who had prior experience with the NIHSS and those without prior experience, and (4) raters who had used the videotapes in the past and those who had never viewed the tapes. The calculated r2s were greater than .98 for the initial rating of the first 4 cases and for the later rating of the 4 new cases. The slopes of the regression lines were all near 1, indicating that the raters were similarly calibrated. The intraclass correlation coefficients were .93 and .95, reflecting high levels of intraobserver and interobserver reliability. CONCLUSIONS These data extend the previously demonstrated reliability of the NIHSS to non-neurologists and show that both a variety of physician investigators and nurse study coordinators can be rapidly trained to reliably apply the scale in the context of an actual clinical trial.

Incidence and Occurrence of Total (First-Ever and Recurrent) Stroke

BACKGROUND AND PURPOSE It has recently been hypothesized that the figure of approximately half a million strokes substantially underestimates the actual annual stroke burden for the United States. The majority of previously reported studies on the epidemiology of stroke used relatively small and homogeneous population-based stroke registries. This study was designed to estimate the occurrence, incidence, and characteristics of total (first-ever and recurrent) stroke by using a large administrative claims database representative of all 1995 US inpatient discharges. METHODS We used the Nationwide Inpatient Sample of the Healthcare Cost and Utilization Project, release 4, which contains approximately 20% of all 1995 US inpatient discharges. Because the accuracy of International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) coding is suboptimal, we performed a literature review of ICD-9-CM 430 to 438 validation studies. The pooled results from the literature review were used to make appropriate adjustments in the analysis to correct for some of the inaccuracies of the diagnostic codes. RESULTS There were 682 000 occurrences of stroke with hospitalization (95% CI 660 000 to 704 000) and an estimated 68 000 occurrences of stroke without hospitalization. The overall incidence rate for occurrence of total stroke (first-ever and recurrent) was 259 per 100 000 population (age- and sex-adjusted to 1995 US population). Incidence rates increased exponentially with age and were consistently higher for males than for females. CONCLUSIONS We conservatively estimate that there were 750 000 first-ever or recurrent strokes in the United States during 1995. This new figure emphasizes the importance of preventive measures for a disease that has identifiable and modifiable risk factors and for the development of new and improved treatment strategies and infrastructures that can reduce the consequences of stroke.

Charlson Index comorbidity adjustment for ischemic Stroke outcome studies

Background and Purpose— The Charlson Index is commonly used in outcome studies to adjust for patient comorbid conditions, but has not been specifically validated for use in studies of ischemic stroke. The purpose of the present study was to determine whether outcomes of ischemic stroke patients varied on the basis of the Charlson Index. Methods— The Department of Veterans Affairs (VA) Stroke Study prospectively identified stroke patients admitted to 9 VA hospitals between April 1995 and March 1997. The Charlson Index was scored on the basis of discharge International Classification of Diseases, 9th Revision, Clinical Modification coding and dichotomized (low comorbidity 0 or 1 versus high ≥2) for analysis. Validity was assessed on the basis of modified Rankin score at hospital discharge (good outcome 0 or 1 versus poor ≥2 or dead) and 1-year mortality, adjusting for initial stroke severity. Results— Of the 960 enrolled ischemic stroke patients, 23% had a Charlson Index of 0, 34% 1, 22% 2, 12% 3, and 8% ≥4. Forty-eight percent of those with a low Charlson Index had a good outcome at discharge versus 37% of those with a high Charlson Index (P <0.001). For 1-year mortality, the proportions were 16% versus 26%, respectively (P <0.001). Logistic regression adjusting for initial stroke severity showed that those with a high Charlson Index had 36% increased odds of having a poor outcome at discharge (P =0.038) and 72% greater odds of death at 1 year (P =0.001). Every 1-point increase in Charlson Index was independently associated with a 15% increase in the odds of a poor outcome at discharge (P <0.005) and a 29% increase in the odds of death by 1 year (P <0.001). Conclusions— These data support the validity of the Charlson Index as a measure of comorbidity for use in ischemic stroke outcome studies.

Impact of air filtration on nosocomial aspergillus infections: Unique risk of bone marrow transplant recipients☆

Bone marrow transplant recipients were found to have a 10-fold greater incidence of nosocomial Aspergillus infection than other immunocompromised patient populations (p less than 0.001) when housed outside of a high-efficiency particulate air (HEPA) filtered environment. Multivariate analysis demonstrated that number of infections, age, and graft-versus-host disease severe enough to require treatment were independent risk factors for development of nosocomial Aspergillus infection in this group. The use of whole-wall HEPA filtration units with horizontal laminar flow in patient rooms reduced the number of Aspergillus organisms in the air to 0.009 colony-forming units/m3, which was significantly lower than in all other areas of the hospital (p less than or equal to 0.03). No cases of nosocomial Aspergillus infection developed in 39 bone marrow transplant recipients who resided in this environment throughout their transplantation period compared with 14 cases of nosocomial Aspergillus infection in 74 bone marrow transplant recipients who were housed elsewhere (p less than 0.001). Thus, although bone marrow transplant recipients had an order-of-magnitude greater risk of nosocomial Aspergillus infection than other immunocompromised hosts, this risk could be eliminated by using HEPA filters with horizontal laminar airflow.