Allan V. Prochazka

The Assessment of Refill Compliance Using Pharmacy Records: Methods, Validity, and Applications

The refill records of computerized pharmacy systems are used increasingly as a source of compliance information. We reviewed the English-language literature to develop a typology of methods for assessing refill compliance (RC), to describe the epidemiology of compliance in obtaining medications, to identify studies that attempted to validate RC measures, to describe clinical features that predicted RC, and to describe the uses of RC measures in epidemiologic and health services research. In most of the 41 studies reviewed, patients obtained less medication than prescribed; gaps in treatment were common. Of the studies that assessed the validity of RC measures, most found significant associations between RC and other compliance measures, as well as measures of drug presence (e.g., serum drug levels) or physiologic drug effects. Refill compliance was generally not correlated with demographic characteristics of study populations, was higher among drugs with fewer daily doses, and was inconsistently associated with the total number of drugs prescribed. We conclude that, though some methodologic problems require further study, RC measures can be a useful source of compliance information in population-based studies when direct measurement of medication consumption is not feasible.

The Safety of Transdermal Nicotine as an Aid to Smoking Cessation in Patients with Cardiac Disease

BACKGROUND Transdermal nicotine therapy is widely used to aid smoking cessation, but there is uncertainty about its safety in patients with cardiac disease. METHODS In a randomized, double-blind, placebo-controlled trial at 10 Veterans Affairs medical centers, we randomly assigned 584 outpatients (of whom 576 were men) with at least one diagnosis of cardiovascular disease to a 10-week course of transdermal nicotine or placebo as an aid to smoking cessation. The subjects were monitored for a total of 14 weeks for the primary end points of the study (death, myocardial infarction, cardiac arrest, and admission to the hospital due to increased severity of angina, arrhythmia, or congestive heart failure); the secondary end points (admission to the hospital for other reasons and outpatient visits necessitated by increased severity of heart disease); any side effects of therapy; and abstinence from smoking. RESULTS There were 48 primary and 78 secondary end points noted in a total of 95 subjects. At least one of the primary end points was reached by 5.4 percent of the subjects in the nicotine group and 7.9 percent of the subjects in the placebo group (difference, 2.5 percent; 95 percent confidence interval, -1.6 to 6.5 percent; P=0.23). In the nicotine group, 11.9 percent of the subjects had at least one of the secondary end points, as compared with 9.7 percent in the placebo group (difference, 2.2 percent; 95 percent confidence interval, -2.2 to 7.4 percent; P= 0.37). After 14 weeks the rate of abstinence from smoking was 21 percent in the nicotine group, as compared with 9 percent in the placebo group (P=0.001), but after 24 weeks the abstinence rates were not significantly different (14 percent vs. 11 percent, P= 0.67). CONCLUSIONS Transdermal nicotine does not cause a significant increase in cardiovascular events in high-risk outpatients with cardiac disease. However, the efficacy of transdermal nicotine as an aid to smoking cessation in such patients is limited and may not be sustained over time.

Informed consent for clinical treatment

Although informed consent for clinical treatment has become a vital part of contemporary medical practice, it means different things in different contexts ([Figure 1][1]), is variably practised and rarely achieves the theoretical ideal. In this review, we focus on the clinical practice of informed

Predictors of persistent burnout in internal medicine residents: a prospective cohort study.

Purpose Resident burnout continues to be a major problem despite work hours restrictions. The authors conducted a longitudinal study to determine whether burnout in internal medicine residents is persistent and what factors predispose residents to persistent burnout. Method The authors mailed a survey to internal medicine residents at the University of Colorado Denver Health Science Center each May, from 2003 through 2008. The survey measures included the Maslach Burnout Inventory organized into three subscales: emotional exhaustion (EE), depersonalization (DP), and personal accomplishment. The authors defined burned-out residents as having a high EE or DP score and persistent burnout as being burned out during all three years of residency. Results Of the 179 eligible residents, 86 (48%) responded to the survey during all three years of their residency. Sixty-seven residents (78%) were burned out at least once: 58 residents (67%) were burned out during their internship, 58 (67%) during their second year, and 50 (58%) during their third year (P < .08). Of the 58 burned-out interns, 42 (72%) continued to be burned out through their three years of training. Persistent burnout was more likely to occur in men (OR = 3.31, P < .01) and was associated with screening positive for depression as an intern (OR = 4.4, P < .002). Conclusions Once present, burnout tends to persist through residency. Men and residents who screened positive for depression as interns are at the highest risk for persistent burnout. Interventions to prevent burnout during internship may significantly decrease burnout throughout residency.

Reduction of polypharmacy by feedback to clinicians

Objective:To determine whether two different educational interventions would reduce polypharmacy in outpatients receiving ten (10) or more active medications at the Denver Veterans Affairs Center.Design:292 patients were randomized into three (3) groups: Control (n=88); simple notification of primary care provider (n=102); intensive notification, provision of pharmacy profiles, compliance index, and chart review by senior clinician with recommendations (n=104).Setting:Veterans Affairs Medical Center affiliated with the University of Colorado Health Sciences Center.Patients/Participants:All patients receiving greater than ten (10) active medications who are followed by clinic staff at the Denver VAMC. The mean age was 62 years (range 26–88) and 96% were male.Interventions:The simple notification group received only a single letter recommending that the patient’s number of medications be reduced. The intensive notification group received more sophisticated intervention with a chart review, two letters with calculation of patient compliance, and individualized suggestions for reduction in polypharmacy. The control group received no intervention.Measurements and main results:Control patients had significantly less reduction in polypharmacy then either the simple or intensive intervention groups at four months (p=0.028). There was no significant difference between the intervention groups (p=0.189). By six months the difference was no longer significant.Conclusions:A simple intervention can result in a significant reduction in the number of medications prescribed to patients with polypharmacy. The authors were unable to show that a more complex intervention resulted in a further reduction in polypharmacy.

Predictors of Comprehension during Surgical informed Consent

BACKGROUND Patient comprehension during surgical informed consent remains problematic. Using data from our randomized trial of methods to improve informed consent comprehension, we performed an additional analysis to define independent factors associated with improved patient understanding. STUDY DESIGN Patients scheduled for 1 of 4 elective operations (total hip arthroplasty [n = 137], carotid endarterectomy [n = 178], laparoscopic cholecystectomy [n = 179], or radical prostatectomy [n = 81]) at 7 Department of Veterans Affairs (VA) medical centers were enrolled. All informed consent discussions were performed using iMedConsent (Dialog Medical), the VAs computerized informed consent platform. Using a unique module within iMedConsent, we randomized patients to repeat back (RB), requiring correct reiteration of procedure-specific facts, or standard (STD) iMedConsent. Patient comprehension was tested after the informed consent discussion using procedure-specific questionnaires. Time spent completing the informed consent process was measured using time stamps within iMedConsent. Multiple linear regression identified factors independently associated with improved comprehension. RESULTS We enrolled 575 patients (276 RB, 299 standard); 93% were male, 74% were Caucasian, and 89% had at least a high school education. Independent factors associated with improved comprehension included race (p < 0.01), ethnicity (p < 0.05), age (p < 0.02), operation type (p < 0.01), group assignment (+/- RB; p < 0.05), and total consent time (p < 0.0001). Patient comprehension was maximized when informed consent took between 15 and 30 minutes. RBs positive impact on patient comprehension was weaker in the analysis including consent time. CONCLUSIONS Comprehension during informed consent discussions may be limited in individuals with potential language difficulty due to ethnicity or education. Total consent time was the strongest predictor of patient comprehension. Affording adequate time for informed consent discussions and using informed consent adjuncts such as RB may enhance comprehension in such individuals.

Enhancement of Surgical Informed Consent by Addition of Repeat Back: A Multicenter, Randomized Controlled Clinical Trial

Objective:In this randomized, controlled, unblinded trial, we sought to test Repeat Backs (RB) effect on comprehension following informed consent discussions. Summary Background Data:RB has been suggested as a method to improve patient comprehension when obtaining informed consent. In this technique, patients are asked to recount what they have been told in the informed consent discussion. Despite preliminary data, this practice has not been evaluated in any large scale study. Methods:This study was conducted in 7 Veterans Health Administration Medical Centers where informed consent is obtained using iMedConsent, the VAs computer based platform. Patients scheduled for elective surgeries were randomized to RB (a module added to the iMedConsent package) or standard iMedConsent (no RB). Comprehension was tested after the informed consent using procedure-specific questionnaires. Time stamps in the iMedConsent program estimated the time spent completing the informed consent process. Provider and patient satisfaction were measured using 5-point Likert scales. Statistical comparisons of groups were performed using t-tests and &khgr;2 tests. Results:A total of 575 patients were enrolled. In the RB group, providers spent 2.6 minutes longer (P < 0.0001) obtaining informed consent. The mean comprehension score was significantly higher in the RB group (71.4%) versus the no RB group (68.2%, P = 0.03); the effect was greatest in carotid endarterectomy patients (RB = 73.4% vs. no RB = 67.7%, P = 0.02). Quality of decision making was rated similarly. Providers were neutral to slightly favorable regarding RB. Conclusions:RB implemented within an electronic informed consent system improved patient comprehension. The additional time required was acceptable to providers. RB should be considered as an enhancement to surgical informed consent. This clinical trial was registered at http://www.clinicaltrials.gov (Identifier NCT00288899).

Attending Rounds in the Current Era: What Is and Is Not Happening

IMPORTANCE General medicine rounds by attending physicians provide the foundation for patient care and education in teaching hospitals. However, the detailed activities of these rounds in the current era are not well characterized. OBJECTIVE To describe the characteristics of attending rounds for internal medicine inpatients in a large teaching hospital system. DESIGN A cross-sectional observational study of attending rounds in internal medicine. Rounds were observed directly by research assistants. SETTING Four teaching hospitals associated with a large public medical school. PARTICIPANTS Fifty-six attending physicians and 279 trainees treating 807 general medicine inpatients. MAIN OUTCOMES AND MEASURES Duration and location of rounds, composition of teams, and frequency of 19 potential activities during rounds. RESULTS We observed 90 days of rounds. A typical rounding day consisted of 1 attending with 3 trainees visiting a median of 9 (range, 2-18 [SD, 2.9]) patients for a median of 2.0 hours (range, 25-241 [SD, 2.7] minutes). On rounds, teams most frequently discussed the patient care plan (96.7% of patients), reviewed diagnostic studies (90.7%), communicated with patients (73.4%), and discussed the medication list (68.8%). Teams infrequently discussed invasive lines or tubes (9.3%) or nursing notes (6.2%) and rarely communicated with nurses (12.0%) or taught physical examination skills (14.6%), evidence-based medicine topics (7.2%), or learner-identified topics (3.2%). Many commonly performed activities occurred infrequently at the bedside. CONCLUSIONS AND RELEVANCE Most activities on attending rounds do not take place at the bedside. The teams discuss patient care plans and test results most of the time but fail to include many items that may be of significant value, including specific aspects of patient care, interprofessional communication, and learner-centered education. Future studies are needed to further assess the implications of these observations.

Brief report: The risk of overanticoagulation with antibiotic use in outpatients on stable warfarin regimens

AbstractBACKGROUND: Medication interactions account for a significant proportion of overanticoagulation in warfarin users. However, little is known about the incidence or degree of interaction with commonly used oral antibiotics. OBJECTIVE: To investigate the incidence and degree of overanticoagulation associated with commonly used oral antibiotics. DESIGN: Retrospective cohort study of patients using warfarin who initiated an antibiotic (azithromycin, levofloxacin, or trimethoprim/sulfamethoxazole (TMP/SMX)) or terazosin for clinical indications between January 1998 and December 2002. The incidence of international normalized ratio (INR) elevation and the degree of change and bleeding events after institution of either medication type was recorded. SUBJECTS: Patients at a university-affiliated Veteran’s Affairs Medical Center. RESULTS: The mean change in INR was −0.15 for terazosin, 0.51 for azithromycin, 0.85 for levofloxacin, and 1.76 for TMP/SMX. These mean INR changes in the antibiotic groups were all statistically different from the terazosin group. The incidence of supratherapeutic INR was 5% for terazosin, 31% for azithromycin, 33% for levofloxacin, and 69% for TMP/SMX. The incidence of absolute INR >4.0 was 0% for terazosin, 16% for azithromycin, 19% for levofloxacin, and 44% for TMP/SMX. CONCLUSIONS: Among acutely ill outpatients, oral antibiotics (azithromycin, levofloxacin, and TMP/SMX) increase the incidence and degree of overanticoagulation.

Home blood glucose monitoring: Effectiveness in a general population of patients who have non-insulin-dependent diabetes mellitus

AbstractObjective: To determine whether home blood glucose monitoring as used by non-insulin-dependent diabetes mellitus patients followed in primary care nonresearch clinics improves glycemic control or reduces utilization of the outpatient laboratory. Design: A retrospective chart reviewfor 229 patients receiving outpatient supplies for home testing of either blood or urine. Setting: A variety of nonresearch clinics at a Veterans Affairs Medical Center, a teaching hospital affiliated with an academic university medical center. Patients: Outpatient veterans followed in diabetes, primary care, internal medicine, or endocrine clinics. Interventions: None. Measurements and main results: The mean glycosylated hemoglobin for an unselected group monitoring glycemic control by urine testing only was 11.32% and for those using blood monitoring was 11.37%. Frequency and duration of monitoring had no apparent impact on glucose control. There was no decrease in the utilization of the laboratory among those patients practicing home blood glucose monitoring. Conclusions: For non-insulin-dependent diabetic patients followed in a nonresearch clinic setting, the benefits of home blood glucose monitoring remain to be proven.