Maria Shubina

Discontinuation of Statins in Routine Care Settings: A Cohort Study

BACKGROUND Systematic data on discontinuation of statins in routine practice of medicine are limited. OBJECTIVE To investigate the reasons for statin discontinuation and the role of statin-related events (clinical events or symptoms believed to have been caused by statins) in routine care settings. DESIGN A retrospective cohort study. SETTING Practices affiliated with Brigham and Womens Hospital and Massachusetts General Hospital in Boston. PATIENTS Adults who received a statin prescription between 1 January 2000 and 31 December 2008. MEASUREMENTS Information on reasons for statin discontinuations was obtained from a combination of structured electronic medical record entries and analysis of electronic provider notes by validated software. RESULTS Statins were discontinued at least temporarily for 57 292 of 107 835 patients. Statin-related events were documented for 18 778 (17.4%) patients. Of these, 11 124 had statins discontinued at least temporarily; 6579 were rechallenged with a statin over the subsequent 12 months. Most patients who were rechallenged (92.2%) were still taking a statin 12 months after the statin-related event. Among the 2721 patients who were rechallenged with the same statin to which they had a statin-related event, 1295 were receiving the same statin 12 months later, and 996 of them were receiving the same or a higher dose. LIMITATIONS Statin discontinuations and statin-related events were assessed in practices affiliated with 2 academic medical centers. Utilization of secondary data could have led to missing or misinterpreted data. Natural-language-processing tools used to compensate for the low (30%) proportion of reasons for statin discontinuation documented in structured electronic medical record fields are not perfectly accurate. CONCLUSION Statin-related events are commonly reported and often lead to statin discontinuation. However, most patients who are rechallenged can tolerate statins long-term. This suggests that many of the statin-related events may have other causes, are tolerable, or may be specific to individual statins rather than the entire drug class. PRIMARY FUNDING SOURCE National Library of Medicine, Diabetes Action Research and Education Foundation, and Chinese National Key Program of Clinical Science.

Hypoglycemia and clinical outcomes in patients with diabetes hospitalized in the general ward.

OBJECTIVE Hypoglycemia is associated with adverse outcomes in mixed populations of patients in intensive care units. It is not known whether the same risks exist for diabetic patients who are less severely ill. In this study, we aimed to determine whether hypoglycemic episodes are associated with higher mortality in diabetic patients hospitalized in the general ward. RESEARCH DESIGN AND METHODS This retrospective cohort study analyzed 4,368 admissions of 2,582 patients with diabetes hospitalized in the general ward of a teaching hospital between January 2003 and August 2004. The associations between the number and severity of hypoglycemic (≤50 mg/dl) episodes and inpatient mortality, length of stay (LOS), and mortality within 1 year after discharge were evaluated. RESULTS Hypoglycemia was observed in 7.7% of admissions. In multivariable analysis, each additional day with hypoglycemia was associated with an increase of 85.3% in the odds of inpatient death (P = 0.009) and 65.8% (P = 0.0003) in the odds of death within 1 year from discharge. The odds of inpatient death also rose threefold for every 10 mg/dl decrease in the lowest blood glucose during hospitalization (P = 0.0058). LOS increased by 2.5 days for each day with hypoglycemia (P < 0.0001). CONCLUSIONS Hypoglycemia is common in diabetic patients hospitalized in the general ward. Patients with hypoglycemia have increased LOS and higher mortality both during and after admission. Measures should be undertaken to decrease the frequency of hypoglycemia in this high-risk patient population.

Effect of Board Certification on Antihypertensive Treatment Intensification in Patients With Diabetes Mellitus

Background— Regular recertification is mandatory to maintain board certification status in all specialties. However, the evidence that physicians’ performance decreases with time since initial certification is limited. We therefore carried out a study to determine whether the frequency of antihypertensive treatment intensification for diabetic patients changes with time since their physicians’ last board certification. Methods and Results— In this retrospective cohort study, we analyzed treatment of 8127 hypertensive patients with diabetes mellitus treated by 301 internists at primary care practices affiliated with 2 large academic hospitals. Patient visits with documented blood pressure ≥130/85 mm Hg between January 1, 2000, and August 31, 2005, were studied. The association between the number of years since the physician’s last board certification and the probability of pharmacological antihypertensive treatment intensification at a given visit was analyzed. Frequency of treatment intensification decreased from 26.7% for physicians who were board certified the previous year to 6.9% for physicians who were board certified 31 years before the visit. Treatment intensification rate was 22.5% for physicians certified ≤10 years ago versus 16.9% for physicians last certified >10 years ago (P<0.0001). Multivariable analysis adjusted for patient and visit characteristics and physician age showed that for every decade since the physician’s last board certification, the probability of treatment intensification decreased by 21.3% (P=0.0097). Conclusion— Physician intensification of pharmacological therapy for blood pressure levels above the recommended treatment goals decreases with time since the last board certification. This finding supports the current policy of mandatory recertification.

Encounter frequency and serum glucose level, blood pressure, and cholesterol level control in patients with diabetes mellitus.

BACKGROUND More frequent patient-provider encounters may lead to faster control of hemoglobin A1c level, blood pressure (BP), and low-density lipoprotein (LDL) cholesterol (LDL-C) level (hereafter referred to as hemoglobin A1c, BP, and LDL-C) and improve outcomes, but no guidelines exist for how frequently patients with diabetes mellitus (DM) should be seen. METHODS This retrospective cohort study analyzed 26,496 patients with diabetes and elevated hemoglobin A1c, BP, and/or LDL-C treated by primary care physicians at 2 teaching hospitals between January 1, 2000, and January 1, 2009. The relationship between provider encounter (defined as a note in the medical record) frequency and time to hemoglobin A1c, BP, and LDL-C control was assessed. RESULTS Comparing patients who had encounters with their physicians between 1 to 2 weeks vs 3 to 6 months, median time to hemoglobin A1c less than 7.0% was 4.4 vs 24.9 months (not receiving insulin) and 10.1 vs 52.8 months (receiving insulin); median time to BP lower than 130/85 mm Hg was 1.3 vs 13.9 months; and median time to LDL-C less than 100 mg/dL was 5.1 vs 32.8 months, respectively (P<.001 for all). In multivariable analysis, doubling the time between physician encounters led to an increase in median time to hemoglobin A1c (not receiving [35%] and receiving [17%] insulin), BP (87%), and LDL-C (27%) targets (P<.001 for all). Time to control decreased progressively as encounter frequency increased up to once every 2 weeks for most targets, consistent with the pharmacodynamics of the respective medication classes. CONCLUSIONS Primary care provider encounters every 2 weeks are associated with fastest achievement of hemoglobin A1c, BP, and LDL-C targets for patients with diabetes mellitus.

Optimal systolic blood pressure target, time to intensification, and time to follow-up in treatment of hypertension: population based retrospective cohort study.

Objectives To investigate the optimal systolic blood pressure goal above which new antihypertensive medications should be added or doses of existing medications increased (“systolic intensification threshold”) and to determine the relation between delays in medication intensification and follow-up and the risk of cardiovascular events or death. Design Retrospective cohort study. Setting Primary care practices in the United Kingdom, 1986-2010. Participants 88 756 adults with hypertension from The Health Improvement Network nationwide primary care research database. Main outcome measures Rates of acute cardiovascular events or death from any cause for patients with different hypertension treatment strategies (defined by systolic intensification threshold, time to intensification, and time to follow-up over the course of a 10 year treatment strategy assessment period) after adjustment for age, sex, smoking status, socioeconomic deprivation, history of diabetes, cardiovascular disease or chronic kidney disease, Charlson comorbidity index, body mass index, medication possession ratio, and baseline blood pressure. Results During a median follow-up of 37.4 months after the treatment strategy assessment period, 9985 (11.3%) participants had an acute cardiovascular event or died. No difference in risk of the outcome was seen between systolic intensification thresholds of 130-150 mm Hg, whereas systolic intensification thresholds greater than 150 mm Hg were associated with progressively greater risk (hazard ratio 1.21, 95% confidence interval 1.13 to 1.30; P<0.001 for intensification threshold of 160 mm Hg). Outcome risk increased progressively from the lowest (0-1.4 months) to the highest fifth of time to medication intensification (hazard ratio 1.12, 1.05 to 1.20; P=0.009 for intensification between 1.4 and 4.7 months after detection of elevated blood pressure). The highest fifth of time to follow-up (>2.7 months) was also associated with increased outcome risk (hazard ratio 1.18, 1.11 to 1.25; P<0.001). Conclusions Systolic intensification thresholds higher than 150 mm Hg, delays of greater than 1.4 months before medication intensification after systolic blood pressure elevation, and delays of greater than 2.7 months before blood pressure follow-up after antihypertensive medication intensification were associated with increased risk of an acute cardiovascular event or death. These findings support the importance of timely medical management and follow-up in the treatment of patients with hypertension.

An unintended consequence of electronic prescriptions: prevalence and impact of internal discrepancies

Many e-prescribing systems allow for both structured and free-text fields in prescriptions, making possible internal discrepancies. This study reviewed 2914 electronic prescriptions that contained free-text fields. Internal discrepancies were found in 16.1% of the prescriptions. Most (83.8%) of the discrepancies could potentially lead to adverse events and many (16.8%) to severe adverse events, involving a hospital admission or death. Discrepancies in doses, routes or complex regimens were most likely to have a potential for a severe event (p=0.0001). Discrepancies between structured and free-text fields in electronic prescriptions are common and can cause patient harm. Improvements in electronic medical record design are necessary to minimize the risk of discrepancies and resulting adverse events.

Encounter Frequency and Blood Pressure in Hypertensive Patients With Diabetes Mellitus

The relationship between encounter frequency (average number of provider-patient encounters over a period of time) and blood pressure for hypertensive patients is unknown. We tested the hypothesis that shorter encounter intervals are associated with faster blood pressure normalization. We performed a retrospective cohort study of 5042 hypertensive patients with diabetes mellitus treated at primary care practices affiliated with 2 academic hospitals between 2000 and 2005. Distinct periods of continuously elevated blood pressure (≥130/85 mm Hg) were studied. We evaluated the association of the average encounter interval with time to blood pressure normalization and rate of blood pressure decrease. Blood pressure of the patients with the average interval between encounters ≤1 month normalized after a median of 1.5 months at the rate of 28.7 mm Hg/month compared with 12.2 months at 2.6 mm Hg/month for the encounter interval >1 month (P<0.0001 for all). Median time to blood pressure normalization was 0.7 versus 1.9 months for the average encounter interval ≤2 weeks versus between 2 weeks and 1 month, respectively (P<0.0001). In proportional hazards analysis adjusted for patient demographics, initial blood pressure, and treatment intensification rate, a 1 month increase in the average encounter interval was associated with a hazard ratio of 0.764 for blood pressure normalization (P<0.0001). Shorter encounter intervals are associated with faster decrease in blood pressure and earlier blood pressure normalization. Greatest benefits were observed at encounter intervals (≤2 weeks) shorter than what is currently recommended.

Lifestyle Counseling in Routine Care and Long-Term Glucose, Blood Pressure, and Cholesterol Control in Patients With Diabetes

OBJECTIVE In clinical trials, diet, exercise, and weight counseling led to short-term improvements in blood glucose, blood pressure, and cholesterol levels in patients with diabetes. However, little is known about the long-term effects of lifestyle counseling on patients with diabetes in routine clinical settings. RESEARCH DESIGN AND METHODS This retrospective cohort study of 30,897 patients with diabetes aimed to determine whether lifestyle counseling is associated with time to A1C, blood pressure, and LDL cholesterol control in patients with diabetes. Patients were included if they had at least 2 years of follow-up with primary care practices affiliated with two teaching hospitals in eastern Massachusetts between 1 January 2000 and 1 January 2010. RESULTS Comparing patients with face-to-face counseling rates of once or more per month versus less than once per 6 months, median time to A1C <7.0% was 3.5 versus 22.7 months, time to blood pressure <130/85 mmHg was 3.7 weeks versus 5.6 months, and time to LDL cholesterol <100 mg/dL was 3.5 versus 24.7 months, respectively (P < 0.0001 for all). In multivariable analysis, one additional monthly face-to-face lifestyle counseling episode was associated with hazard ratios of 1.7 for A1C control (P < 0.0001), 1.3 for blood pressure control (P < 0.0001), and 1.4 for LDL cholesterol control (P = 0.0013). CONCLUSIONS Lifestyle counseling in the primary care setting is strongly associated with faster achievement of A1C, blood pressure, and LDL cholesterol control. These results confirm that the findings of controlled clinical trials are applicable to the routine care setting and provide evidence to support current treatment guidelines.

Copy/Paste Documentation of Lifestyle Counseling and Glycemic Control in Patients With Diabetes: True to Form?

Electronic medical records (EMRs) can improve many aspects of patient care(1). Utilization of electronic medical records is increasing and is particularly encouraged by recent federal legislation(2). However EMRs are not always used optimally. Concerns have been raised about inappropriate copying and pasting of information between provider notes(3, 4). Up to 50% of the content of progress notes may be copied from older documents(5, 6) and copying frequently leads to errors in documentation(6). However, whether copied text generally reflects the care delivered is not known. Lifestyle counseling improves outcomes in patients with diabetes and is recommended by treatment guidelines(7). Narrative provider notes are the primary source of information on whether lifestyle counseling was provided. However, if copying and pasting of note fragments does not reflect treatment, the information contained in narrative electronic documents may not be reliable. We therefore performed a retrospective study of over 5,000 patients with diabetes to determine the relationship between copied lifestyle counseling and glucose control.

Performance of Primary Care Physicians and Other Providers on Key Process Measures in the Treatment of Diabetes

OBJECTIVE Studies have shown that patients without a consistent primary care provider have inferior outcomes. However, little is known about the mechanisms for these effects. This study aims to determine whether primary care physicians (PCPs) provide more frequent medication intensification, lifestyle counseling, and patient encounters than other providers in the primary care setting. RESEARCH DESIGN AND METHODS This retrospective cohort study included 584,587 encounters for 27,225 patients with diabetes and elevated A1C, blood pressure, and/or LDL cholesterol monitored for at least 2 years. Encounters occurred at primary care practices affiliated with two teaching hospitals in eastern Massachusetts. RESULTS Of the encounters documented, 83% were with PCPs, 13% were with covering physicians, and 5% were with midlevel providers. In multivariable analysis, the odds of medication intensification were 49% (P < 0.0001) and 26% (P < 0.0001) higher for PCPs than for covering physicians and midlevel providers, respectively, whereas the odds of lifestyle counseling were 91% (P < 0.0001) and 21% (P = 0.0015) higher. During visits with acute complaints, covering physicians were even less likely, by a further 52% (P < 0.0001), to intensify medications, and midlevel providers were even less likely, by a further 41% (P < 0.0001), to provide lifestyle counseling. Compared with PCPs, the hazard ratios for time to the next encounter after a visit without acute complaints were 1.11 for covering physicians and 1.19 for midlevel providers (P < 0.0001 for both). CONCLUSIONS PCPs provide better care through higher rates of medication intensification and lifestyle counseling. Covering physicians and midlevel providers may enable more frequent encounters when PCP resources are constrained.