Charles D. MacLean

The Single Item Literacy Screener: Evaluation of a brief instrument to identify limited reading ability

BackgroundReading skills are important for accessing health information, using health care services, managing ones health and achieving desirable health outcomes. Our objective was to assess the diagnostic accuracy of the Single Item Literacy Screener (SILS) to identify limited reading ability, one component of health literacy, as measured by the S-TOFHLA.MethodsCross-sectional interview with 999 adults with diabetes residing in Vermont and bordering states. Participants were randomly recruited from Primary Care practices in the Vermont Diabetes Information System June 2003 – December 2004. The main outcome was limited reading ability. The primary predictor was the SILS.ResultsOf the 999 persons screened, 169 (17%) had limited reading ability. The sensitivity of the SILS in detecting limited reading ability was 54% [95% CI: 47%, 61%] and the specificity was 83% [95% CI: 81%, 86%] with an area under the Receiver Operating Characteristics Curve (ROC) of 0.73 [95% CI: 0.69, 0.78]. Seven hundred seventy (77%) screened negative on the SILS and 692 of these subjects had adequate reading skills (negative predictive value = 0.90 [95% CI: 0.88, 0.92]). Of the 229 who scored positive on the SILS, 92 had limited reading ability (positive predictive value = 0.4 [95% CI: 0.34, 0.47]).ConclusionThe SILS is a simple instrument designed to identify patients with limited reading ability who need help reading health-related materials. The SILS performs moderately well at ruling out limited reading ability in adults and allows providers to target additional assessment of health literacy skills to those most in need. Further study of the use of the SILS in clinical settings and with more diverse populations is warranted.

Patient Preference for Physician Discussion and Practice of Spirituality

OBJECTIVE: To determine patient preferences for addressing religion and spirituality in the medical encounter.DESIGN: Multicenter survey verbally administered by trained research assistants. Survey items included questions on demographics, health status, health care utilization, functional status, spiritual well-being, and patient preference for religious/spiritual involvement in their own medical encounters and in hypothetical medical situations.SETTING: Primary care clinics of 6 academic medical centers in 3 states (NC, Fla, Vt).PATIENTS/PARTICIPANTS: Patients 18 years of age and older who were systematically selected from the waiting rooms of their primary care physicians.MEASUREMENTS AND MAIN RESULTS: Four hundred fifty-six patients participated in the study. One third of patients wanted to be asked about their religious beliefs during a routine office visit. Two thirds felt that physicians should be aware of their religious or spiritual beliefs. Patient agreement with physician spiritual interaction increased strongly with the severity of the illness setting, with 19% patient agreement with physician prayer in a routine office visit, 29% agreement in a hospitalized setting, and 50% agreement in a near-death scenario (P<.001). Patient interest in religious or spiritual interaction decreased when the intensity of the interaction moved from a simple discussion of spiritual issues (33% agree) to physician silent prayer (28% agree) to physician prayer with a patient (19% agree; P<.001). Ten percent of patients were willing to give up time spent on medical issues in an office visit setting to discuss religious/spiritual issues with their physician. After controlling for age, gender, marital status, education, spirituality score, and health care utilization, African-American subjects were more likely to accept this time trade-off (odds ratio, 4.9; confidence interval, 2.1 to 11.7).CONCLUSION: Physicians should be aware that a substantial minority of patients desire spiritual interaction in routine office visits. When asked about specific prayer behaviors across a range of clinical scenarios, patient desire for spiritual interaction increased with increasing severity of illness setting and decreased when referring to more-intense spiritual interactions. For most patients, the routine office visit may not be the optimal setting for a physician-patient spiritual dialog.

Literacy and health outcomes: a cross-sectional study in 1002 adults with diabetes

BackgroundInconsistent findings reported in the literature contribute to the lack of complete understanding of the association of literacy with health outcomes. We evaluated the association between literacy, physiologic control and diabetes complications among adults with diabetes.MethodsA cross-sectional study of 1,002 English speaking adults with diabetes, randomly selected from the Vermont Diabetes Information System, a cluster-randomized trial of a diabetes decision support system in a region-wide sample of primary care practices was conducted between July 2003 and March 2005. Literacy was assessed by the Short-Test of Functional Health Literacy in Adults. Outcome measures included glycated hemoglobin, low density lipoprotein, blood pressure and self-reported complications.ResultsAfter adjusting for sociodemographic characteristics, duration of diabetes, diabetes education, depression, alcohol use, and medication use we did not find a significant association between literacy and glycemic control (beta coefficent,+ 0.001; 95% confidence interval [CI], -0.01 to +0.01; P = .88), systolic blood pressure (beta coefficent, +0.08; 95% CI, -0.10 to +0.26; P = .39), diastolic blood pressure (beta coefficent, -0.03; 95% CI, -0.12 to +0.07, P = .59), or low density lipoprotein (beta coefficent, +0.04; 95% CI, -0.27 to +0.36, P = .77. We found no association between literacy and report of diabetes complications.ConclusionThese findings suggest that literacy, as measured by the S-TOFHLA, is not associated with glycated hemoglobin, blood pressure, lipid levels or self-reported diabetes complications in a cross-sectional study of older adults with diabetes under relatively good glycemic control. Additional studies to examine the optimal measurement of health literacy and its relationship to health outcomes over time are needed.

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

BackgroundPeroxisome proliferator-activated receptors (PPARs) have emerged as important drug targets for diabetes. Drugs that activate PPARγ, such as the thiazolidinediones (TZDs), are widely used for treatment of Type 2 diabetes mellitus. PPARγ 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.MethodsA 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.ResultsIn 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).ConclusionThese data suggest an association between TZD use and cancer in patients with diabetes. Further studies are required to determine if this association is causal.

The use of adherence aids by adults with diabetes: A cross-sectional survey

BackgroundAdherence with medication taking is a major barrier to physiologic control in diabetes and many strategies for improving adherence are in use. We sought to describe the use of mnemonic devices and other adherence aids by adults with diabetes and to investigate their association with control of hyperglycemia, hyperlipidemia and hypertension.MethodsCross sectional survey of diabetic adults randomly selected from Primary Care practices in the Vermont Diabetes Information System. We used linear regression to examine the associations between the use of various aids and physiologic control among subjects who used oral agents for hyperglycemia, hypercholesterolemia, and hypertension.Results289 subjects (mean age 65.4 years; 51% female) used medications for all three conditions. Adherence aids were reported by 80%. The most popular were day-of-the-week pill boxes (50%), putting the pills in a special place (41%), and associating pill taking with a daily event such as a meal, TV show, or bedtime (11%). After adjusting for age, sex, marital status, income, and education, those who used a special place had better glycemic control (A1C -0.36%; P = .04) and systolic blood pressure (-5.9 mm Hg; P = .05) than those who used no aids. Those who used a daily event had better A1C (-0.56%; P = .01) than patients who used no aids.ConclusionAlthough adherence aids are in common use among adults with diabetes, there is little evidence that they are efficacious. In this study, we found a few statistically significant associations with adherence aids and better diabetes control. However, these findings could be attributed to multiple comparisons or unmeasured confounders. Until more rigorous evaluations are available, it seems reasonable to recommend keeping medicines in a special place for diabetic adults prescribed multiple medications.

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.

The Vermont Diabetes Information System: A Cluster Randomized Trial of a Population Based Decision Support System

BACKGROUNDOptimal care for patients with diabetes is difficult to achieve in clinical practice.OBJECTIVETo evaluate the impact of a registry and decision support system on processes of care, and physiologic control.PARTICIPANTSRandomized trial with clustering at the practice level, involving 7,412 adults with diabetes in 64 primary care practices in the Northeast.INTERVENTIONSProvider decision support (reminders for overdue diabetes tests, alerts regarding abnormal results, and quarterly population reports with peer comparisons) and patient decision support (reminders and alerts).MEASUREMENTS AND MAIN RESULTSProcess and physiologic outcomes were evaluated in all subjects. Functional status was evaluated in a random patient sample via questionnaire. We used multiple logistic regression to quantify the effect, adjusting for clustering and potential confounders. Intervention subjects were significantly more likely to receive guideline-appropriate testing for cholesterol (OR = 1.39; [95%CI 1.07, 1.80] P = 0.012), creatinine (OR = 1.40; [95%CI 1.06, 1.84] P = 0.018), and proteinuria (OR = 1.74; [95%CI 1.13, 1.69] P = 0.012), but not A1C (OR = 1.17; [95% CI 0.80, 1.72] P = 0.43). Rates of control of A1C and LDL cholesterol were similar in the two groups. There were no differences in blood pressure, body mass index, or functional status.CONCLUSIONSA chronic disease registry and decision support system based on easily obtainable laboratory data was feasible and acceptable to patients and providers. This system improved the process of laboratory monitoring in primary care, but not physiologic control.

The Vermont Diabetes Information System (VDIS): Study Design and Subject Recruitment for a Cluster Randomized Trial of a Decision Support System in a Regional Sample of Primary Care Practices

Background Despite evidence that optimal care for diabetes can result in reduced complications and improved economic outcomes, such care is often not achieved. The Vermont Diabetes Information System (VDIS) is a registry-based decision support and reminder system based on the Chronic Care Model and targeted to primary care physicians and their patients with diabetes. Purpose To develop and evaluate a regional decision support system for patients with diabetes. Methods Randomized trial of an information system with clustering at the practice level. Ten percent random subsample of patients selected for a home interview. Subject and setting includes 10 hospitals, 121 primary care providers, and 7348 patients in 55 Vermont and New York primary care practices. Results We report on the study design and baseline characteristics of the population. Patients have a mean age of 63 years and a mean glycosolated hemoglobin A1C of 7.1%. Sixty percent of the population has excellent glycemic control (A1C, 7%); 45% have excellent lipid control (serum LDL-cholesterol,100 mg /dL and serum triglycerides,400 mg/dL). Twenty-five percent have excellent blood pressure control (,130/80 mm Hg). These results compare favorably to recent national reports. However, only 8% are in optimal control for all three of hyperglycemia, lipids and blood pressure. Conclusions Our experience to date indicates that a low cost decision support and information system based on the Chronic Care Model is feasible in primary care practices that lack sophisticated electronic information systems. VDIS is well accepted by patients, providers and laboratory staff. If proven beneficial in a rigorous, randomized, controlled evaluation, the intervention could be widely disseminated to practices across America and the world with a substantial impact on the outcomes and costs of diabetes. It could also be adapted to other chronic conditions. We anticipate the results of the study will be available in 2006.

Intra-cluster correlation coefficients in adults with diabetes in primary care practices: the Vermont Diabetes Information System field survey

BackgroundProper estimation of sample size requirements for cluster-based studies requires estimates of the intra-cluster correlation coefficient (ICC) for the variables of interest.MethodsWe calculated the ICC for 112 variables measured as part of the Vermont Diabetes Information System, a cluster-randomized study of adults with diabetes from 73 primary care practices (the clusters) in Vermont and surrounding areas.ResultsICCs varied widely around a median value of 0.0185 (Inter-quartile range: 0.006, 0.037). Some characteristics (such as the proportion having a recent creatinine measurement) were highly associated with the practice (ICC = 0.288), while others (prevalence of some comorbidities and complications and certain aspects of quality of life) varied much more across patients with only small correlation within practices (ICC<0.001).ConclusionThe ICC values reported here may be useful in designing future studies that use clustered sampling from primary care practices.

Interactive Voice Response Technology Can Deliver Alcohol Screening and Brief Intervention in Primary Care

BACKGROUNDAlcohol 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.OBJECTIVETo develop IVR-based BI and pilot test it for feasibility and acceptability.DESIGNSingle-group pre-post feasibility study.PARTICIPANTSPrimary care patients presenting for an office visit.INTERVENTIONSIVR-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.MEASUREMENTSUtilization 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.RESULTSCall 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.CONCLUSIONSUsing IVR technology to deliver BI in a primary care setting is feasible and data suggest potential for efficacy in a larger trial.