Association between the prevalence of obstructive lung disease and the use of aspirin in a diabetic population.

Background: Many diabetic patients take a daily low-dose of aspirin because they are two to three times more likely to suffer from heart attacks and strokes, but its role in obstructive lung diseases is less clear. Methods: A total of 1,003 subjects in community practice settings were interviewed at home. Patients self-reported their personal and clinical characteristics, including any history of obstructive lung disease (including COPD or asthma). Current medications were obtained by the direct observation of medication containers. We performed a cross-sectional analysis of the interviewed subjects to assess for a possible association between obstructive lung disease history and the use of aspirin. Results: In a multivariate logistic regression model, a history of obstructive lung disease was significantly associated with the use of aspirin even after correcting for potential confounders, including gender, low income (

Association between prevalence of obstructive lung disease and obesity: results from The Vermont Diabetes Information System.

BACKGROUND: The association of obesity with the development of obstructive lung disease, namely asthma and/or chronic obstructive pulmonary disease, has been found to be significant in general population studies, and weight loss in the obese has proven beneficial in disease control. Obese patients seem to present with a specific obstructive lung disease phenotype including a reduced response to corticosteroids. Obesity is increasingly recognized as an important factor to document in obstructive lung disease patients and a critical comorbidity to report in diabetic patients, as it may influence disease management. This report presents data that contributes to establishing the relationship between obstructive lung disease in a diabetic cohort, a population highly susceptible to obesity. METHODS: A total of 1003 subjects in community practice settings were interviewed at home at the time of enrolment into the Vermont Diabetes Information System, a clinical decision support program. Patients self-reported their personal and clinical characteristics, including any history of obstructive lung disease. Laboratory data were obtained directly from the clinical laboratory, and current medications were obtained by direct observation of medication containers. We performed a cross-sectional analysis of the interviewed subjects to assess a possible association between obstructive lung disease history and obesity. RESULTS: In a multivariate logistic regression model, a history of obstructive lung disease was significantly associated with obesity (body mass index ≥30) even after correcting for potential confounders including gender, low income (<$30,000/year), number of comorbidities, number of prescription medications, cigarette smoking, and alcohol problems (adjusted odds ratio (OR) = 1.58, P = 0.03, 95% confidence interval (CI) = 1.05, 2.37). This association was particularly strong and significant among female patients (OR = 2.18, P = < 0.01, CI = 1.27, 3.72) but not in male patients (OR = 0.97, P = 0.93, CI = 0.51, 1.83). CONCLUSION: These data suggest an association between obesity and obstructive lung disease prevalence in patients with diabetes, with women exhibiting a stronger association. Future studies are needed to identify the mechanism by which women disproportionately develop obstructive lung disease in this population.

Potential enhanced association between obstructive lung disease and history of depression in patients with diabetes.

BACKGROUND: Depression is one of the most common comorbidities of chronic diseases including diabetes and obstructive lung diseases (emphysema, chronic bronchitis, and asthma). Obstructive lung diseases and depression have few symptoms in common. However, they are both common in adults and associated with chronic inflammation. It is not clear if their coappearance in diabetic patients is coincidental or associated beyond that expected by chance. METHODS: A total of 1,003 adults with diabetes in community practice settings were interviewed at home at the time of their enrolment into the Vermont Diabetes Information System, a clinical decision support program. Patients self-reported their personal and clinical characteristics, including any obstructive lung disease. Laboratory data were obtained directly from the clinical laboratory, and current medications were obtained by direct observation of medication containers. We performed a cross-sectional analysis of the interviewed subjects to assess a possible association between the prevalence of obstructive lung disease and depression. RESULTS: In a multivariate logistic regression model, obstructive lung disease was significantly associated with depression even after correcting for gender, obesity (≥30 kg/m2), high comorbidities (>2), low annual income (<$30,000/ year), cigarette smoking, alcohol problems, and education level (odds ratio=1.83; 95% confidence interval 1.27, 2.62; P <0.01). CONCLUSION: These data suggest a potential enhanced association between obstructive lung disease and depression in patients with diabetes. Future studies are needed to identify if inflammation is implicated in this association as a common denominator.

Patients' Experience With Opioid Pain Medication After Discharge From Surgery: A Mixed-Methods Study.

BACKGROUND: Decreasing the number of prescription opioids has been a leading strategy in combating the opioid epidemic. In Vermont, statewide and institutional policies have affected prescribing practices, resulting in a 40% decrease in postoperative opioid prescribing. The optimal approach to postoperative opioid prescribing remains unknown. In this study, we describe patients' experience with pain control 1 wk after discharge from surgery. MATERIALS AND METHODS: We assessed patients' experience using a telephone questionnaire, 1-wk after discharge after undergoing common surgical procedures between 2017 and 2019 at an academic medical center (n = 1027). Scaled responses regarding pain control, opioids prescribed, and opioids used (response rate 96%) were analyzed using a mixed-methods approach; open-ended patient responses to questions regarding whether the number of opioids prescribed was "correct" were analyzed using qualitative content analysis. RESULTS: One week after discharge, 96% of patients reported that their pain was well controlled. When asked whether they received the correct number of opioid pills postoperatively, qualitative analysis of patient responses yielded the following six themes: (1) I had more than I needed, but not more than I wanted; (2) Rationed medication; (3) Medication was not effective; (4) Caution regarding risks of opioids; (5) Awareness of the public health concerns; and (6) Used opioids from a prior prescription. CONCLUSIONS: Patient-reported pain control after common surgical procedures was excellent. However, patients are supportive of receiving more pain medications than they actually use, and they fear that further restrictions may prevent them or others from managing pain adequately. Understanding the patients' perspective is important for surgical education and improving discharge protocols.

Risk factors for cancer-associated venous thromboembolism: The venous thromboembolism prevention in the ambulatory cancer clinic (VTE-PACC) study.

BACKGROUND: The Khorana Score is a validated risk score for predicting 6-month incidence of cancer-associated venous thromboembolism (CAT) among patients starting chemotherapy. Venous thromboembolism (VTE) risk factors important in the general population, including age, sex, prior VTE, and hospitalization, are not included in this score, their association with VTE in cancer patients is unknown. OBJECTIVE: To examine risk factors for CAT and the impact of incorporating longitudinal hospitalization into risk assessment. METHODS: Risk factors were recorded among patients starting chemotherapy at a single institution from 2012-14. Hospitalization and time-periods after hospitalization were assessed as time-varying covariates. Logistic regression was used to determine factors related to 6-month CAT risk (the Khorana Score endpoint). Proportional hazard models were used for risk factor identification throughout the 3-year observation period. RESULTS: Among 1,583 patients starting chemotherapy (mean age 60, 48% male), 187 developed CAT (11.8%) with 129 (69%) cases occurring within 6 months of starting chemotherapy. In the 6-month analysis, no additional risk factors were associated with CAT. In the 3-year analysis, male sex (HR 1.57, 95%CI 1.21, 2.07), prior VTE (HR 2.12, 95%CI 1.41, 3.18), and hospitalization (HR 2.69, 95%CI 1.92, 3.75) were associated with increased hazard of CAT, adjusting for risk factors in the Khorana score. CONCLUSIONS: When time-to-event data were incorporated into CAT risk assessment, male sex, prior VTE, and hospitalization were important risk factors. These data highlight the need to consider dynamic methods for assessing VTE risk in cancer patients, with particular attention to the period around hospitalizations.

Impact of Policy Interventions on Postoperative Opioid Prescribing.

OBJECTIVE: To assess postoperative opioid prescribing in response to state and organizational policy changes. METHODS: We used an observational study design at an academic medical center in the Northeast United States over a time during which there were two important influences: 1) implementation of state rules regarding opioid prescribing and 2) changes in organization policies reflecting evolving standards of care. Results were summarized at the surgical specialty and procedure level and compared between baseline (July-December 2016) and postrule (July-December 2017) periods. RESULTS: We analyzed data from 17,937 procedures from July 2016 to December 2017, two-thirds of which were outpatient. Schedule II opioids were prescribed in 61% of cases and no opioids at all in 28%. The median morphine milligram equivalent (MME) prescribed at discharge decreased 40%, from 113 MME in the baseline period to 68 MME in the postrule period. Decreases were seen across all the surgical specialties. CONCLUSIONS: Postoperative opioid prescribing at the time of hospital discharge decreased between 2016 and 2017 in the setting of targeted and replicable state and health care organizational policies. POLICY IMPLICATIONS: Policies governing the use of opioids are an effective and adoptable approach to reducing opioid prescribing following surgery.

Postoperative opioid prescribing patterns and use after vascular surgery.

The aim of this study was to assess postoperative opioid prescribing patterns, usage, and pain control after common vascular surgery procedures in order to develop patient centered best-practice guidelines. We performed a prospective review of opioid prescribing after seven common vascular surgeries at a rural, academic medical center from December 2016 to July 2017. A standardized telephone questionnaire was prospectively administered to patients ( n = 110) about opioid use and pain management perceptions. For comparison we retrospectively assessed opioid prescribing patterns ( n = 939) from July 2014 to June 2016 normalized into morphine milligram equivalents (MME). Prescribers were surveyed regarding opioid prescription attitudes, perceptions, and practices. Opioids were prescribed for 78% of procedures, and 70% of patients reported using opioid analgesia. In the prospective group, the median MMEs prescribed were: VEIN (31, n = 16), CEA (40, n = 14), DIAL (60, n = 17), EVAR (108, n = 8), INFRA (160, n = 16), FEM TEA (200, n = 11), and OA (273, n = 4). The median proportion of opioids used by patients across all procedures was only 30% of the amount prescribed across all procedures (range 14-64%). Patients rated the opioid prescribed as appropriate (59%), insufficient (16%), and overprescribed (25%), and pain as very well controlled (47%), well controlled (47%), poorly controlled (4%), and very poorly controlled (2%). In conclusion, we observed significant variability in opioid prescribing after vascular procedures. The overall opioid use was substantially lower than the amount prescribed. These data enabled us to develop guidelines for opioid prescribing practice for our patients.

Post-Discharge Opioid Prescribing and Use after Common Surgical Procedure.

BACKGROUND: The number of deaths from prescription opioids in the US continues to increase and remains a major public health concern. Opioid-related deaths parallel prescribing trends, and postoperative opioids are a significant source of opioids in the community. Our objective was to identify opioid prescribing and use patterns after surgery to inform evidence-based practices. STUDY DESIGN: Data from a 340-bed academic medical institution and its affiliated outpatient surgical facility included retrospective medical record data and prospective telephone questionnaire and medical record data. Retrospective data included patients discharged after 1 of 19 procedure types, from July 2015 to June 2016 (n = 10,112). Prospective data included a consecutive sample of general and orthopaedic surgery and urology patients undergoing 1 of 13 procedures, from July 2016 to February 2017 (n = 539). Primary outcomes were the quantity of opioid prescribed and used in morphine milligram equivalents (MME), and the proportion of patients receiving instructions on disposal and nonopioid strategies. RESULTS: In the retrospective dataset, 76% of patients received an opioid after surgery, and 87% of prescriptions were prescribed by residents or advanced practice providers. Median prescription size ranged from 0 to 503 MME, with wide interquartile ranges (IQR) for most procedures. In the prospective dataset, there were 359 participants (67% participation rate). Of these, 92% of patients received an opioid and the median proportion used was 27%, or 24 MME (IQR 0 to 96). Only 18% of patients received disposal instructions, while 84% of all patients received instructions on nonopioid strategies. CONCLUSIONS: Median opioid use after surgery was 27% of the total prescribed, and only 18% of patients reported receiving disposal instructions. Significant variability in opioid prescribing and use after surgery warrants investigation into contributing factors.

Primary Care Providers' Beliefs and Recommendations and Use of Screening Mammography by their Patients.

BACKGROUND: Revised breast cancer screening guidelines have fueled debate about the effectiveness and frequency of screening mammography, encouraging discussion between women and their providers. OBJECTIVE: To examine whether primary care providers' (PCPs') beliefs about the effectiveness and frequency of screening mammography are associated with utilization by their patients. DESIGN: Cross-sectional survey data from PCPs (2014) from three primary care networks affiliated with the Population-based Research Optimizing Screening through Personalized Regimens (PROSPR) consortium, linked with data about their patients' mammography use (2011-2014). PARTICIPANTS: PCPs (n = 209) and their female patients age 40-89 years without breast cancer (n = 30,233). MAIN MEASURES: Outcomes included whether (1) women received a screening mammogram during a 2-year period; and (2) screened women had >1 mammogram during that period, reflecting annual screening. Principal independent variables were PCP beliefs about the effectiveness of mammography and their recommendations for screening frequency. KEY RESULTS: Overall 65.2% of women received >1 screening mammogram. For women 40-48 years, mammography use was modestly lower for those cared for by PCPs who believed that screening was ineffective compared with those who believed it was somewhat or very effective (59.1%, 62.3%, and 64.7%; p = 0.019 after controlling for patient characteristics). Of women with PCPs who reported they did not recommend screening before age 50, 48.1% were nonetheless screened. For women age 49-74 years, the vast majority were cared for by providers who believed that screening was effective. Provider recommendations were not associated with screening frequency. For women ≥75 years, those cared for by providers who were uncertain about effectiveness had higher screening use (50.7%) than those cared for by providers who believed it was somewhat effective (42.8%). Patients of providers who did not recommend screening were less likely to be screened than were those whose providers recommended annual screening, yet 37.1% of patients whose providers recommended against screening still received screening. CONCLUSIONS: PCP beliefs about mammography effectiveness and screening recommendations are only modestly associated with use, suggesting other likely influences on patient participation in mammography.

Inadequate Systems to Support Breast and Cervical Cancer Screening in Primary Care Practice.

BACKGROUND: Despite substantial resources devoted to cancer screening nationally, the availability of clinical practice-based systems to support screening guidelines is not known. OBJECTIVE: To characterize the prevalence and correlates of practice-based systems to support breast and cervical cancer screening, with a focus on the patient-centered medical home (PCMH). DESIGN: Web and mail survey of primary care providers conducted in 2014. The survey assessed provider (gender, training) and facility (size, specialty training, physician report of National Committee for Quality Assurance (NCQA) PCMH recognition, and practice affiliation) characteristics. A hierarchical multivariate analysis clustered by clinical practice was conducted to evaluate characteristics associated with the adoption of practice-based systems and technology to support guideline-adherent screening. PARTICIPANTS: Primary care physicians in family medicine, general internal medicine, and obstetrics and gynecology, and nurse practitioners or physician assistants from four clinical care networks affiliated with PROSPR (Population-based Research Optimizing Screening through Personalized Regimens) consortium research centers. MAIN MEASURES: The prevalence of routine breast cancer risk assessment, electronic health record (EHR) decision support, comparative performance reports, and panel reports of patients due for routine screening and follow-up. KEY RESULTS: There were 385 participants (57.6 % of eligible). Forty-seven percent (47.0 %) of providers reported NCQA recognition as a PCMH. Less than half reported EHR decision support for breast (48.8 %) or cervical cancer (46.2 %) screening. A minority received comparative performance reports for breast (26.2 %) or cervical (19.7 %) cancer screening, automated reports of patients overdue for breast (18.7 %) or cervical (16.4 %) cancer screening, or follow-up of abnormal breast (18.1 %) or cervical (17.6 %) cancer screening tests. In multivariate analysis, reported NCQA recognition as a PCMH was associated with greater use of comparative performance reports of guideline-adherent breast (OR 3.23, 95 % CI 1.58-6.61) or cervical (OR 2.56, 95 % CI 1.32-4.96) cancer screening and automated reports of patients overdue for breast (OR 2.19, 95 % CI 1.15-41.7) or cervical (OR. 2.56, 95 % CI 1.26-5.26) cancer screening. CONCLUSIONS: Providers lack systems to support breast and cervical cancer screening. Practice transformation toward a PCMH may support the adoption of systems to achieve guideline-adherent cancer screening in primary care settings.

Take the money and run? Redemption of a gift card incentive in a clinician survey.

BACKGROUND: Clinician surveys provide critical information about many facets of health care, but are often challenging to implement. Our objective was to assess use by participants and non-participants of a prepaid gift card incentive that could be later reclaimed by the researchers if unused. METHODS: Clinicians were recruited to participate in a mailed or online survey as part of a study to characterize women's primary health care provider attitudes towards breast and cervical cancer screening guidelines and practices (n = 177). An up-front incentive of a $50 gift card to a popular online retailer was included with the study invitation. Clinicians were informed that the gift card would expire if it went unused after 4 months. Outcome measures included use of gift cards by participants and non-participants and comparison of hypothetical costs of different incentive strategies. RESULTS: 63.5% of clinicians who responded to the survey used the gift card, and only one provider who didn't participate used the gift card (1.6%). Many of those who participated did not redeem their gift cards (36.5% of respondents). The price of the incentives actually claimed totaled $3700, which was less than half of the initial outlay. Since some of the respondents did not redeem their gift cards, the cost of incentives was less than it might have been if we had provided a conditional incentive of $50 to responders after they had completed the survey. CONCLUSIONS: Redeemable online gift card codes may provide an effective way to motivate clinicians to participate in surveys.

Provider Attitudes and Screening Practices Following Changes in Breast and Cervical Cancer Screening Guidelines.

BACKGROUND: Changes to national guidelines for breast and cervical cancer screening have created confusion and controversy for women and their primary care providers. OBJECTIVE: To characterize women's primary health care provider attitudes towards screening and changes in practice in response to recent revisions in guidelines for breast and cervical cancer screening. DESIGN, SETTING, PARTICIPANTS: In 2014, we distributed a confidential web and mail survey to 668 women's health care providers affiliated with the four clinical care networks participating in the three PROSPR (Population-based Research Optimizing Screening through Personalized Regimens) consortium breast cancer research centers (385 respondents; response rate 57.6 %). MAIN MEASURES: We assessed self-reported attitudes toward breast and cervical cancer screening, as well as practice changes in response to the most recent revisions of the U.S. Preventive Services Task Force (USPSTF) recommendations. KEY RESULTS: The majority of providers believed that mammography screening was effective for reducing cancer mortality among women ages 40-74 years, and that Papanicolaou (Pap) testing was very effective for women ages 21-64 years. While the USPSTF breast and cervical cancer screening recommendations were widely perceived by the respondents as influential, 75.7 and 41.2 % of providers (for mammography and cervical cancer screening, respectively) reported screening practices in excess of those recommended by USPSTF. Provider-reported barriers to concordance with guideline recommendations included: patient concerns (74 and 36 % for breast and cervical, respectively), provider disagreement with the recommendations (50 and 14 %), health system measurement of a provider's screening practices that use conflicting measurement criteria (40 and 21 %), concern about malpractice risk (33 and 11 %), and lack of time to discuss the benefits and harms with their patients (17 and 8 %). CONCLUSIONS: Primary care providers do not consistently follow recent USPSTF breast and cervical cancer screening recommendations, despite noting that these guidelines are influential.

Feasibility of automated pre-screening for lifestyle and behavioral health risk factors in primary care.

BACKGROUND: Screening of primary care patients for unhealthy behaviors and mental health issues is recommended by numerous governing bodies internationally, yet evidence suggests that provider-initiated screening is not routine practice. The objective of this study was to implement systematic pre-screening of primary care patients for common preventive health issues on a large scale. METHODS: Patients registered for non-acute visits to one of 40 primary care providers from eight clinics in an Academic Medical Center health care network in the United States from May, 2012 to May, 2014 were contacted one- to three-days prior to their visit. Patients were invited to complete a questionnaire using an Interactive Voice Response (IVR) system. Six items assessed pain, smoking, alcohol use, physical activity, concern about weight, and mood. RESULTS: The acceptance rate among eligible patients reached by phone was 65.6 %, of which 95.5 % completed the IVR-Screen (N = 8,490; mean age 57; 57 % female). Sample demographics were representative of the overall primary care population from which participants were drawn on gender, race, and insurance status, but participants were slightly older and more likely to be married. Eighty-seven percent of patients screened positive on at least one item, and 59 % endorsed multiple problems. The majority of respondents (64.2 %) reported being never or only somewhat physically active. Weight concern was reported by 43.9 % of respondents, 36.4 % met criteria for unhealthy alcohol use, 23.4 % reported current pain, 19.6 % reported low mood, and 9.4 % reported smoking. CONCLUSIONS: The percent endorsement for each behavioral health concern was generally consistent with studies of screening using other methods, and contrasts starkly with the reported low rates of screening and intervention for such concerns in typical PC practice. Results support the feasibility of IVR-based, large-scale pre-appointment behavioral health/ lifestyle risk factor screening of primary care patients. Pre-screening in this population facilitated participation in a controlled trial of brief treatment for unhealthy drinking, and also could be valuable clinically because it allows for case identification and management during routine care.

Topical testosterone for breast cancer patients with vaginal atrophy related to aromatase inhibitors: a phase I/II study.

PURPOSE: Controversy exists about whether vaginal estrogens interfere with the efficacy of aromatase inhibitors (AIs) in breast cancer patients. With the greater incidence of vaginal atrophy in patients on AIs, a safe and effective nonestrogen therapy is necessary. We hypothesized that vaginal testosterone cream could safely treat vaginal atrophy in women on AIs. METHODS: Twenty-one postmenopausal breast cancer patients on AIs with symptoms of vaginal atrophy were treated with testosterone cream applied to the vaginal epithelium daily for 28 days. Ten women received a dose of 300 µg, 10 received 150 µg, and one was not evaluable. Estradiol levels, testosterone levels, symptoms of vaginal atrophy, and gynecologic examinations with pH and vaginal cytology were compared before and after therapy. RESULTS: Estradiol levels remained suppressed after treatment to <8 pg/mL. Mean total symptom scores improved from 2.0 to 0.7 after treatment (p < .001) and remained improved 1 month thereafter (p = .003). Dyspareunia (p = .0014) and vaginal dryness (p <.001) improved. The median vaginal pH decreased from 5.5 to 5.0 (p = .028). The median maturation index rose from 20% to 40% (p < .001). Although improvement in total symptom score was similar for both doses (-1.3 for 300 µg, -0.8 for 150 µg; p = .37), only the 300-µg dose was associated with improved pH and maturation values. CONCLUSIONS: A 4-week course of vaginal testosterone was associated with improved signs and symptoms of vaginal atrophy related to AI therapy without increasing estradiol or testosterone levels. Longer-term trials are warranted.

Interactive voice response technology can deliver alcohol screening and brief intervention in primary care.

BACKGROUND: Alcohol screening and brief intervention (BI) is an effective primary care preventive service, but implementation rates are low. Automating BI using interactive voice response (IVR) may be an efficient way to expand patient access to needed information and advice. OBJECTIVE: To develop IVR-based BI and pilot test it for feasibility and acceptability. DESIGN: Single-group pre-post feasibility study. PARTICIPANTS: Primary care patients presenting for an office visit. INTERVENTIONS: IVR-BI structured to correspond to the provider BI method recommended by NIAAA: (1) Ask about use; (2) Assess problems; (3) Advise and Assist for change, and (4) Follow up for continued support. Advice was tailored to patient readiness and preferences. MEASUREMENTS: Utilization rate, call duration, and patients' subjective reports of usefulness, comfort and honesty with the IVR-BI. Pre-post evaluation of motivation to change and change in alcohol consumption as measured by Timeline Follow Back. RESULTS: Call duration ranged from 3-7 minutes. Subjective reactions were generally positive or neutral. About 40% of subjects indicated IVR-BI had motivated them to change. About half of the patients had discussed drinking with their provider at the visit. These tended to be heavier drinkers with greater concerns about drinking. Patients who reported a provider-delivered BI and called the IVR-BI endorsed greater comfort and honesty with the IVR-BI. On average, a 25% reduction in alcohol use was reported two weeks after the clinic visit. CONCLUSIONS: Using IVR technology to deliver BI in a primary care setting is feasible and data suggest potential for efficacy in a larger trial.

Association of angiotensin-converting enzyme inhibitor therapy and comorbidity in diabetes: results from the Vermont diabetes information system.

BACKGROUND: Angiotensin converting enzyme inhibitors (ACE inhibitors) reduce peripheral vascular resistance via blockage of angiotensin converting enzyme (ACE). ACE inhibitors are commonly used to treat congestive heart failure and high blood pressure, but other effects have been reported. In this study, we explored the association between ACE inhibitor therapy and the prevalence of comorbid conditions in adults with diabetes METHODS: We surveyed 1003 adults with diabetes randomly selected from community practices. Patients were interviewed at home and self-reported their personal and clinical characteristics including comorbidity. Current medications were obtained by direct observation of medication containers. We built logistic regression models with the history of comorbidities as the outcome variable and the current use of ACE inhibitors as the primary predictor variable. We adjusted for possible confounding by social (age, sex, alcohol drinking, cigarette smoking) and clinical factors (systolic blood pressure, body mass index (BMI), glycosolated hemoglobin (A1C), number of comorbid conditions, and number of prescription medications). RESULTS: ACE users reported a history of any cancer (except the non-life-threatening skin cancers) less frequently than non-users (10% vs. 15%; odd ratio = 0.59; 95% confidence interval [0.39, 0.89]; P = 0.01); and a history of stomach ulcers or peptic ulcer disease less frequently than non-users (12% vs. 16%, odd ratio = 0.70, [0.49, 1.01], P = 0.06). After correcting for potential confounders, ACE inhibitors remained significantly inversely associated with a personal history of cancer (odds ratio = 0.59, [0.39, 0.89]; P = 0.01) and peptic ulcer disease (odd ratio = 0.68, [0.46, 1.00], P = 0.05). CONCLUSION: ACE inhibitor use is associated with a lower likelihood of a history of cancer and peptic ulcers in patients with diabetes. These findings are limited by the cross sectional study design, self-report of comorbid diagnoses, and lack of information on the timing and duration of ACE inhibitor use. Further research is needed to confirm these associations and understand their mechanisms.

Association between cancer prevalence and use of thiazolidinediones: results from the Vermont Diabetes Information System.

BACKGROUND: Peroxisome proliferator-activated receptors (PPARs) have emerged as important drug targets for diabetes. Drugs that activate PPARgamma, such as the thiazolidinediones (TZDs), are widely used for treatment of Type 2 diabetes mellitus. PPARgamma signaling could also play an anti-neoplastic role in several in vitro models, although conflicting results are reported from in vivo models. The effects of TZDs on cancer risk in humans needs to be resolved as these drugs are prescribed for long periods of time in patients with diabetes. METHODS: A total of 1003 subjects in community practice settings were interviewed at home at the time of enrolment into the Vermont Diabetes Information System, a clinical decision support program. Patients self-reported their personal and clinical characteristics, including any history of malignancy. Laboratory data were obtained directly from the clinical laboratory and current medications were obtained by direct observation of medication containers. We performed a cross-sectional analysis of the interviewed subjects to assess a possible association between cancer diagnosis and the use of TZDs. RESULTS: In a multivariate logistic regression model, a diagnosis of cancer was significantly associated with TZD use, even after correcting for potential confounders including other oral anti-diabetic agents (sulfonylureas and biguanides), age, glycosylated hemoglobin A1C, body mass index, cigarette smoking, high comorbidity, and number of prescription medications (odds ratio = 1.59, P = 0.04). This association was particularly strong among patients using rosiglitazone (OR = 1.89, P = 0.02), and among women (OR = 2.07, P = 0.01). CONCLUSION: These data suggest an association between TZD use and cancer in patients with diabetes. Further studies are required to determine if this association is causal.

Adapting root cause analysis to chronic medical conditions.

BACKGROUND: Root cause analysis (RCA), used to study the conditions leading to acute accidents, was adapted to analyze adverse events in chronic medical conditions. METHODS: RCA was modified to investigate "trigger events"--markers of potential adverse events--in outpatient diabetes care. For 20 cases with the trigger event of hypoglycemia evidenced by an A1C of > or = 11%, a multidisciplinary team reviewed the findings of medical record abstractions, provider interviews, and patient interviews for each case. The RCA team identified active failures, error-producing conditions, latent conditions, and defenses leading to the trigger event in each case. RESULTS: The methodology identified potential root causes of persistent hyperglycemia. Latent conditions, error-producing conditions, and active failures occurred at the assessment, planning, and implementation phases of a diabetes visit. Recurring failure modes were identified within and across cases. CONCLUSION: RCA can be used to study trigger events in medical care for chronic conditions. Although the data collection occurs months after the event, this methodology can identify variations in chronic care and stimulate discussion about potential solutions.