We surveyed 319 clinicians at 12 sites within an integrated VA Healthcare System located in Southern California. Clinicians included attending-level physicians, nurse practitioners and physician assistants. The questionnaire, developed and tested locally, assessed extent of and comfort with CPRS. Questions assessed how CPRS in general, and clinician order entry and drug interaction alerts in particular, have affected clinician efficiency and patient care. Additionally, we assessed general knowledge about 21 common drug-drug and drug-disease interactions. This abstract reports the results of the first 63 (20%) respondents in this abstract. The survey period is expected to end in January 2001, with an anticipated response rate of 65% to 70%. RESULTS: In this preliminary analysis respondents were 71% male, 87% full-time employees and 72% Internists. Participants averaged 48 years of age, practiced 2.5 days per week in outpatient clinics and wrote 53 prescriptions per week. A majority of clinicians (range: 70% to 86%) preferred using CPRS to conventional written methods for entering patient notes, requesting consults, ordering radiological procedures, ordering laboratory tests, and prescribing medications. Overall, clinicians reported that CPRS improved the safety and quality of patient care but reduced clinician efficiency. For example, 81% of clinicians felt that drug interaction alerts increased the potential for prescribing safely but 70% perceived that clinician order entry increased the time required to write prescriptions. Also, while 71% felt that clinician order entry reduced errors in ordering laboratory tests, 68% reported that doing so required extra time. Clinicians recognized a median of 53% (range: 17% to 89%) of 21 common drug interactions. Eighty five percent (85%) of clinicians reported that they would have felt more confident about their answers had they had drug alerts to identify these interactions. In practice, however, respondents reported that they would be more likely to change a patient's medication based on personal interaction with a pharmacist (58%) rather than depend on a CPRS drug interaction alert (4%). Thirty-eight percent were equally likely to change medications based on an alert from either source. Clinicians reported the greatest barriers to effective use of drug alerts included non-relevant alerts (72%), system slowdowns and shutdowns (65%), and lack of time to review alerts (57%). CONCLUSION: Early analysis of an on-going survey suggests that clinicians perceive that CPRS improves the quality and safety of patient care but decreases their efficiency. Clinicians favor the CPRS drug alert system as a means to improve their recognition of drug interactions, an issue that needs to be further addressed based on our data, but note several implementation problems that impede effective utility. PURPOSE: Clinical practice guidelines (CPGs) are being implemented in many large health care systems; yet, little is known about clinician reaction. We evaluated clinician response to a hypertension (HTN) guideline implementation at a large, geographically-diverse VA medical center. METHODS: In the context of a facility-wide implementation of 10 CPGs, the HTN guideline was implemented with 36 attending physicians and nurse practitioners in a randomized trial comparing a general intervention (educational components and a list of the patient's antihypertensive drugs delivered to clinicians at each primary care clinic visit) with an individualized intervention (the general intervention plus patient-specific recommendations about drug therapy delivered to clinicians during primary care clinic visits). For the 4500 hypertensive patients of these study clinicians meeting study criteria, the individualized intervention improved guideline concordance of drug therapy (Med Dec Mkg 2000; 20:488) . At the end of the study period, two physicians, previously unaffiliated with the study, conducted structured interviews with 32 (89%) study clinicians. RESULTS: 31 (97%) clinicians were aware of CPG implementation at the facility and 28 (88%) were specifically aware of the HTN CPG. 29 (91%) and 28 (88%) clinicians, respectively, reported that they use CPGs and that CPGs help with patient care. 16 of 18 (89%) clinicians in the individualized group agreed with the recommendations, but only 3 (17%) reported that seeing the recommendations affected their management of patients. Barriers to following the recommendations included patient reluctance to change medication; concern about need for additional clinic visits and laboratory monitoring of recommended medications; previously demonstrated patient intolerance of the guideline drugs. Time constraints were mentioned frequently. CONCLUSION: Clinicians had a high level of awareness of the CPG implementation and a generally positive attitude toward CPGs. In the context of the randomized trial evidence of the impact of the guideline implementation, the small percent of clinicians who reported that the recommendations affected their management of patients suggests that clinicians may not be aware of the impact of guideline implementation. PURPOSE: Patient adherence to antiretroviral therapy (ART) is critical to effective treatment of HIV and may depend partly on health professionals' practices. However, little is known about providers' knowledge, practices, and barriers in promoting ART adherence. We sought to assess adherence counseling practices among the physicians (MD), pharmacists (PH), and case managers (CM) caring for HIV+ patients in NC and to identify barriers they faced in facilitating adherence. METHODS: In February 2000, using NC AIDS Drug Assistance Program records and commercial prescription records, we identified and surveyed, by mail, the 1,301 MDs, PHs, and CMs caring for HIV+ patients in NC. After 4 mailings, 440 (77%) of the PHs, 94 (85%) of the CMs, and 380 (63%) of the MDs responded. Among the responding MDs, only the 190 reporting having prescribed a protease inhibitor in the last year were included in the analytic sample. RESULTS: 31% of the MDs were general internists, 24% family practitioners, and 22% infectious disease specialists; half cared for < 10 HIV+ patients. 66% of PHs worked in chain pharmacies, 28% in independents and only 2% in hospitals; half cared for < 4 HIV+ patients. On average, CMs cared for 34 HIV+ patients. Regarding the average number of minutes counseling a patient on a new 3-drug ART regimen, PHs spent 7, MDs 13 and CMs 21. MDs seeing a higher volume of HIV+ patients spent no more time counseling but were more likely to: advise patients of side effects (SE), tailor the regimen, explain intake requirements, and provide a pill box (p < .01 for each). Over 90% of MDs explained dosing, asked for patients' questions and discussed drug resistance most or all of the time; < 60% discussed SE management, handling missed doses, ways to remember doses, or planning dose times. Over 70% of PHs explained dosing instructions and asked for questions but < 50% discussed SE management, handling missed doses, drug interactions or storage requirements. The most common CM adherence counseling behaviors were: praising adherent clients (84%), discussing nonadherence repercussions (74%), asking about clients' treatment concerns (74%) side effects (65%), and if medications were taken on time (71%). The vast majority of MDs, PHs, and CMs reported strong interest in doing adherence counseling and had positive attitudes toward ART, ART counseling, and HIV+ patients. The primary barriers reported were lack of space, time, and reimbursement for counseling. MDs viewed CMs' doing adherence counseling as acceptable but were dissatisfied with HIV CM availability. Both MDs and CMs indicated a high interest in improving collaborations with each other in the care of HIV+ patients. CONCLUSION: Innovative practice arrangements between all three provider groups may be needed and feasible to facilitate adherence counseling and address the multifaceted problem of antiretroviral adherence. Practice guidelines for sore throat, nasal congestion and cough illness developed by the Colorado Clinical Guidelines Collaborative were mailed to all primary care physicians belonging to the Colorado Medical Society in November 1999.`P rofiled physicians'' (having at least 10 office visit claims for adults with acute bronchitis in 1998) (n = 352) also received antibiotic prescribing profiles based on aggregated office visit and pharmacy claims from 7 HMOs participating in the Colorado Medical Society Joint Data Project; and``non-profiled'' physicians (n = 514) received summary data based on the entire cohort of patient visits. The office visit was the primary unit of analysis. Multivariate mixed effects models included patient age, physician specialty, HMO and time segments (baseline period = 1/98 ± 10/99; study period = 11/99 ± 2/00) as fixed effects, and unique physicians as random effects. Units of time were measured in months. RESULTS: There were 12,993 and 2,899 adult office visits for acute bronchitis in the baseline and study periods, respectively. The majority of patients were 18 ± 44 years old and treated by family physicians. Prescription rates for family physicians were about 5% greater than for internists (p = 0.006), and were positively associated with increased patient age. Adjusted monthly antibiotic prescription rates for acute bronchitis were stable during the baseline period for both physician groups (profiled: 65% to 63%, p = 0.10; non-profiled: 64% to 63%, p = 0.78), and declined significantly during the study period among profiled physicians (63% to 54%; p = 0.0005), but not among non-profiled physicians. The rate of decline in antibiotic prescription rates during the study period did not differ by patient age (p = 0.09) or physician specialty (p = 0.87). CONCLUSION: This study demonstrates that antibiotic treatment of adults diagnosed with acute bronchitis by physicians in private practice can be reduced using a combination of educational physician profiling and practice guideline dissemination. , 1994 ± 1998 . R. Gonzales 1 , J. Maselli 1 ; 1 University of Colorado Health Sciences Center, Denver, CO PURPOSE: Rising rates of S. pneumoniae resistant to penicillin and other antibiotics have been publicized in the US since 1994, and have led to numerous calls to limit excess antibiotic use in ambulatory practice. This study evaluates whether changes in antibiotic treatment of acute respiratory infections (ARIs) between 1994 and 1998 have occurred, and whether these changes are associated with specific patient and physician characteristics. METHODS: The National Ambulatory Medical Care Survey data files for years 1994 ± 98 were obtained from the National Center for Health Statistics web site. Office visits with a principal diagnosis of otitis media, sinusitis, pharyngitis, bronchitis and upper respiratory tract infections (URIs)/common cold were identified, and further limited to visits to a general or family practitioner (GFP), internist (IM) or pediatrician (PED). Antimicrobial treatment was assigned to the visit only if it was entered as the principal medication entry (out of 6 possible). Multivariate logistic regression analysis was used to evaluate independent associations between antibiotic treatment for ARIs and time (year); patient age, race and diagnosis; and physician specialty and practice location. To determine if a change in antibiotic prescription rates during this period were associated with one of the other variables, interaction terms were utilized. RESULTS: Overall, annual antibiotic prescription rates for ARIs declined between 1994 and 1998 (65%, 64%, 60%, 62% and 55%, respectively; p = 0.0001). This equates to 7 million fewer antibiotic prescriptions for ARIs dispensed by primary care physicians in 1998 compared to 1995 (the peak year). Independent of specific diagnosis and time, antibiotic treatment was less likely for patients age > 45 years (vs. children age < 5 years) (OR = 0.62, 95% CI = 0.51 ± 0.76), and of non-white race (OR = 0.75, 95% CI 0.65 ± 0.88). Because of a significant interaction between time and physician specialty, we stratified further analyses by specialty. Between 1994 and 1998, time was associated with a decrease in adjusted annual antibiotic prescription rates among PED and IM, but not among GFP (relative rate change = À8.9%; p = 0.0001; À9.3%; p = 0.043; and À4.5%; p = 0.17, respectively). Antibiotic prescription rates for specific diagnoses declined variably across specialties: sinusitis: no declines for any specialty; otitis media: PED; pharyngitis: PED; bronchitis: GFP; URIs/colds: IM decline > PED > GFP. CONCLUSION: Primary care physicians are heeding the call to limit antibiotic prescribing in ambulatory practice, although there remains much room for improvement. Changes in prescribing need to be correlated with trends in antibiotic-resistance rates. PURPOSE: Antibiotic treatment of the common cold and upper respiratory tract infections (URIs) by US primary care physicians declined between 1994 and 1998. This study evaluates the amount of public and professional media exposure provided to the topics of antibiotic-resistance and overuse of antibiotics, and the correlation between media exposure and changes in antibiotic treament of colds and URIs during this period. METHODS: Treatment related to primary care physician (general and family practitioner, internist or pediatrician) office visits with a principal diagnosis of the common cold or URI were analyzed using the National Ambulatory Medical Care Survey (years 1994 ± 98) . Key word searches relating to excess antibiotic use and antibiotic resistance were performed on all databases, and final tallies confirmed by manual review. Lexis-Nexis was used to identify US news stories from large-circulation newspapers corresponding to the northeast (NY Times), midwest (Chicago Sun-Times), south (Atlanta Journal-Constitution) and west (LA Times), and one national newspaper (USA Today). The Vanderbilt Television News Archive was used to identify evening news stories on ABC, CBS, NBC, and CNN. Articles from medical journals represented in the Abridged Index Medicus were identified using MEDLINE.``Sentinel articles'' were defined as receiving evening network news coverage by at least 1 network within 3 days of publication. Segmented time series analysis (logistic regression) was used to compare the change in 60-day (the smallest time unit providing adequate sample size) antibiotic prescription rates between time periods corresponding to increases in media exposure. RESULTS: From 1994 ± 98, there were 207 newspaper stories, 31 major network evening news stories, and 65 journal articles identified. The number of newspaper stories reported in 1994 ± 1996 was stable, but more than doubled in 1997, and remained high in 1998. Evening news stories doubled in 1996 and 1997 compared to the previous years, but reverted to baseline levels in 1998. In contrast, journal articles have increased linearly between 1994 and 1998. There were 6 sentinal publications during this period: June 94, January 95, August 95, January 96, September 97 and March 98. Inspection of 60-day antibiotic prescription rates for colds and URIs reveals only 2 major trends: 1) relatively stable rates between 1994 and 1996 (p = 0.73); and 2) declining prescription rates from 1996 through 1998 (parameter estimate = (À)0.036; p = 0.06). CONCLUSION: The change in antibiotic prescribing for colds and URIs that occurred in 1996 appears to be more strongly correlated with an increase in public media exposure than with medical journal publications. However, one can not rule out an impact of other forms of physician education (eg. local or national conferences) on prescribing behavior. PURPOSE: Home glucose monitoring is a common practice in diabetes (DM) treatment, but adds significantly to costs of care. Several studies have questioned the benefit of glucose monitoring in patients with type II DM. We examined the impact of glucose test strips on glycemic control in outpatient DM patients at four VA facilities. METHODS: All patients receiving outpatient DM medications during 1997 were evaluated at four VA hospitals in Pennsylvania. Administrative data identified demographic variables (age, sex, race, marital status), glycosylated hemoglobin (HBA1C), all medications and DM supplies, and type of clinician (resident, nurse practitioner, staff internist, endocrinologist, and other). We examined differences among patients who recieved glucose test strips (strip+) and those that did not (strip-). Simple descriptive statistics was performed comparing strip+ and strip-patients, and analysis of variance was done, including main effects (medication type [oral agents, insulin, and both oral agents and insulin], site of care, and physician type), interaction terms, and demographic variables. Chart review of a subset of patients examined Charlson comorbidity scores, and presence of diabetes complications (neuropathy, retinopathy, and nephropathy). RESULTS: There were 2912 strip+ patients, and 2221 strip-patients. Strips added an average of $22.56 each month to cost of diabetes care. Average HBA1C for strip+ patients was 7.92; for strip-patients, 7.34. There were significant differences for use of strips in patients for site (ranging from 26% to 73% strip+), race (favoring white race), and marital status (favoring married). Differences in HBA1C persisted after adjusting for type of medication, site, and demographic covariates. There was no difference in Charlson comorbidity scores between groups in the substudy, but there were more diabetic complications in the strip+ group (15% more had at least one diabetic complication). CONCLUSION: Glucose control was poorer in patients who received test strips. Differences persisted after controlling for important confounders. Thus, our study does not suggest benefit from home glucose monoitoring in terms of improved glycemic control, although presence of more DM complications in the strip+ group suggests that strips may be used more often in difficult to control patients. Because home glucose monitoring is costly, further study should evaluate the cost-effectiveness and clinical benefit of its use. used to exclude subjects who are likely to be non-adherent with therapy or to experience side effects. While this approach may increase the chances of finding a treatment effect by eliminating non-compliers and subjects likely to experience adverse events, it diminishes the generalizability of the results of the trial, as patients are less likely to be as adherent and more likely to experience side effects. This is especially so if measures such as the``Number Needed to Treat'' (NNT) are used, as the``true'' NNT is likely to be higher than that obtained in the trial if an appreciable number of patients are excluded during the run-in period. As run-in periods would seem to increase the chance of finding a positive result, we hypothesized that there might be an association between the use of run-in periods in the design of randomized trials and the presence of commercial sponsorship, particularly by the pharmaceutical industry. METHODS: We searched all randomized trials published in The New England Journal of Medicine, The Journal of the American Medical Association, The Lancet, and The BMJ, from January 1, 1998 through December 31, 2000 . We included trials that had at least one arm consisting of either PO, dietary, intranasal, or subcutaneous therapy administered by the study subjects, of at least 4 weeks duration. We excluded studies of treatments not administered by subjects (e.g., intravenous or intramuscular treatments) and studies of treatment of acute events (e.g., myocardial infarction or COPD exacerbations), in which setting a run-in period would not be feasible. However, studies of treatments following acute events that did not require acute treatment were included. Trials of treatments during pregnancy were also excluded. For the purpose of our study, we defined a run-in period as follows: Any period preceding randomization during which time subjects took active treatment, placebo, or a dietary intervention to which they might subsequently be randomized. Pre-randomization periods used to assess subjects' symptoms were not considered run-in periods, even if the authors of the studies designated them as such. This is because these screening or``baseline'' periods serve a very different function from the above defined run-in periods. Drug``wash-out'' periods were also not considered run-in periods in our analysis, for similar reasons. Sponsorship was determined based on stated funding source at the conclusion of the article. We considered a study to be industry sponsored if at least one of the funding sources was from a commercial entity (e.g., a pharmaceutical company). We did not consider the provision of medication or placebo to constitute commercial support. All studies were evaluated separately by two reviewers, and determination of the presence or absence, as well as type of run-in period was made while blinded to the source of funding. Likewise, ascertainment of funding source was made blinded to presence or absence of a run in period. Any disagreement regarding presence or type of run-in period was resolved by consensus among the three authors, while blinded to the funding source. RESULTS: There were 214 eligible trials. Of these, 138, or 65%, were industry sponsored. Runin periods as defined above were found in 39 of the trials. Twenty-eight of these were placebo runin, 3 were placebo and diet, 2 were treatment, 2 were diet alone, 2 were treatment and placebo, and in 2 reports the type of run-in was not stated. In only 12, or 31%, of the 39 trials was the number of subjects excluded because of non-compliance or adverse events included in the result. Of the 39 trials with run-in periods, 36, or 92%, were commercially funded. The odds that a trial with a run-in period was commercially funded was 12:1, compared to 1.4:1 for trials without run-in periods (OR = 8.6). CONCLUSION: Run-in periods in clinical trials appear to serve a commercial, rather than a scientific, purpose. As their presence limits the generalizability of the results of these trials, we question their use in the design of randomized clinical trials done for scientific purposes. . Despite demonstrated efficacy of medical therapy in clinical trials, effectiveness of CVD risk reduction in actual practice may be sub-optimal. Our goals were to: 1) determine patterns of hyperglycemia (HG), hypertension (HTN) and hyperlipidemia (HL) management among patients with DM2, and 2) assess whether effective HG management was associated with effective HTN and HL management. METHODS: 601 confirmed DM2 patients attending our outpatient clinics between 3/96 ± 8/ 97 were randomly selected; chart abstraction data were linked to laboratory testing results. We defined 3 components of effective CVD risk reduction: 1) risk marker testing for HbA1c, systolic blood pressure (SBP), and LDL cholesterol, 2) initiation of medical therapy if above goal, and 3) use of high dose therapy if above goal. To assess the relationship between HG, HTN, and HL management, we compared risk marker levels, testing frequency, and medication dose intensity, using linear and logistic regression. RESULTS: Cohort characteristics included: mean age 64.7, 58.4% male, median DM2 duration 6 years, with 73% HTN and 50% HL prevalence. Sub-optimal management effectiveness was greatest for HL compared to HG or HTN. Fewer patients were tested for LDL than HbA1c (Fisher's exact test, p < 0.0001), and among tested patients, significantly fewer were at LDL goal than HbA1c goal (p = 0.045) [Table] . Levels of HbA1c, SBP, and LDL were not significantly correlated after adjusting for BMI. Achieving goal HbA1c did not predict meeting either SBP or LDL goals. There were no significant correlations between HG medication dose intensity (oral HG agent or insulin U/Kg dose) and either HMG CoA reductase (statin) dose or number of HTN medications. To explore factors associated with physicians' decisions to use warfarin in patients with non-valvular atrial fibrillation (NVAF). METHODS: We mailed a self-administered questionnaire to a random sample of general internists, selected from the AMA Masterfile. The instrument included questions on physicians' demographic characteristics, prior experiences and beliefs about the natural history and treatment outcomes for patients with NVAF. Case scenarios described patients with varying degrees of risk of thromboembolism or hemorrhage. Respondents who were in the upper quartile of warfarin use, as defined by the proportion of cases in which they recommended warfarin, were``high-users''. Results were summarized as proportions; chi-square was used for comparisons with a significance level of 0.05. RESULTS: Surveys were returned by 120 of 427 eligible respondents. The mean age was 46 years (79% male; 38% academic). The median perceived risk for TIA and ischemic stroke (CVA) in a NVAF patient who was 76 year old (otherwise healthy, not receiving therapy) were 10% (Interquartile Range -(IQR): 5 ± 20%) and 7.5% (IQR: 5 ± 16%) per year, respectively. For NVAF patients on warfarin, the median risk estimates for TIA and ischemic stroke were 2% for TIA (IQR: 1 ± 5%) and 2% for CVA (IQR: 1 ± 5%); the median annual risk estimate of intracranial hemorrhage (ICH) for these patients was 3% (IQR: 1 ± 5%). Respondents indicated they would recommend warfarin for a median of 9 of the 14 cases (IQR: 7 ± 11 cases). Physician age, gender, perceived risk of ischemic stroke and estimated stroke risk reduction attributable to warfarin were not associated with warfarin use. However, respondents whose estimated risk of warfarin-associated ICH was in the highest quartile were significantly less likely to be high-users than those who provided lower estimates (6.9% vs. 30.8%; p = 0.01). Use of warfarin was also inversely related to the belief that an ICH was a``worse outcome'' than an ischemic strok for a NVAF patient or a``more regrettable'' outcome for their physician. CONCLUSION: There is substantial variability in beliefs about the natural history of NVAF and the risks and benefits of warfarin. Warfarin use was impacted more by estimated risk of intracranial hemorrhage and by the perceived severity and``regrettability'' of this complication than by the potential benefits. However, little is known about the recruitment and evaluation of potential subjects in published trials. We therefore performed a review of published randomized controlled trials (RCT's) to assess the rigor with which enrollment experience was reported, and to analyze the available data. METHODS: We selected all RCT's that were published in the Annals of Internal Medicine, The New England Journal of Medicine, Lancet, or JAMA between April 1, 1999 and March 31, 2000 . From each article, we abstracted the number of patients that were screened by the investigators to determine if they were eligible, the number who were eligible, and the number who were enrolled. Results were summarized as proportions; chi-square tests were used to compare groups with a significance level of 0.05. RESULTS: A total of 172 RCT's were reviewed; the median number of participants was 260 (range 18 to 54,654). Of these, 90 (52%) papers included an estimate of the number of patients that were screened by the investigators for eligibility. The number of patients who were eligible for participation was reported in 74 (43%) studies. Multicenter trials were significantly less likely to report the number of eligible patients (33.9%) than single center trials (58.7%; p = 0.002). Only 54 (31.4%) papers included information about both the number of patients screened and the number eligible. In these studies, the median proportion of screened patients who were eligible for participation was 58.8% (range 1.4% ± 100%); and the median proportion of eligible patients who enrolled was 91.8% (range 35.1 ± 100%). CONCLUSION: Many RCT's published in major medical journals provided incomplete information about their patient recruitment experience. In the papers that did include this information, there was marked variability in the proportion of patients who were eligible and the proportion that enrolled. Clinician-scientists should be encouraged to collect and report this information in order to allow readers to consider the external validity of their work. we considered the RR's to be discrepant when they were not both less than or greater than 1.0.