William F. Miser

Screening Questions to Predict Limited Health Literacy: A Cross-Sectional Study of Patients With Diabetes Mellitus

PURPOSE Limited health literacy is increasingly recognized as a barrier to receiving adequate health care. Identifying patients at risk of poor health outcomes secondary to limited health literacy is currently the responsibility of clinicians. Our objective was to identify which screening questions and demographics independently predict limited health literacy and could thus help clinicians individualize their patient education. METHODS Between August 2006 and July 2007, we asked 225 patients being treated for diabetes at an academic primary care office several questions regarding their reading ability as part of a larger study (57% response rate). We built a logistic regression model predicting limited health literacy to determine the independent predictive properties of these questions and demographic variables. Patients were classified as having limited health literacy if they had a Short Test of Functional Health Literacy in Adults (S-TOFHLA) score of less than 23. The potential predictors evaluated were self-rated reading ability, highest education level attained, Single-Item Literacy Screener (SILS) result, patients’ reading enjoyment, age, sex, and race. RESULTS Overall, 15.1% of the patients had limited health literacy. In the final model, 5 of the potential predictors were independently associated with increased odds of having limited health literacy. Specifically, patients were more likely to have limited health literacy if they had a poorer self-rated reading ability (odds ratio [OR] per point increase in the model = 3.37; 95% confidence interval [CI], 1.71–6.63), more frequently needed help reading written health materials (assessed by the SILS) (OR = 2.03; 95% CI, 1.26–3.26), had a lower education level (OR = 1.89; 95% CI, 1.12–3.18), were male (OR = 4.46; 95% CI, 1.53–12.99), and were of nonwhite race (OR = 3.73; 95% CI, 1.04–13.40). These associations were not confounded by age. The area under the receiver operating characteristic curve was 0.9212. CONCLUSIONS Self-rated reading ability, SILS result, highest education level attained, sex, and race independently predict whether a patient has limited health literacy. Clinicians should be aware of these associations and ask questions to identify patients at risk. We propose an “SOS” mnemonic based on these findings to help clinicians wishing to individualize patient education.

Critical Appraisal of the Literature

Case 1 A 47-year-old perimenopausal woman, in your office for a well-woman examination, has a newspaper clipping given to her by a friend. The clipping reviews a recent article published in a well-known national medical journal that warns against the use of hormonal replacement therapy (HRT) because of an increased risk of breast cancer. 1 Although she is at low risk for this cancer, and findings of her breast examination are normal, she resists your recommendation to begin HRT. When you discuss with her the results of an article showing that postmenopausal use of estrogen reduces the risk of severe coronary heart disease, 2 she counters with another article from the same issue that concludes that cardiovascular mortality is increased in estrogen users. 3 As you review these studies, you fail to recognize that all have serious flaws. Also, you do not have available articles that are more methodologically sound that show the overwhelming benefit of HRT 4-6 with no increased risk in breast cancer 7-9 She leaves triumphantly from your office without a prescription, and you feel confused about the overall benefit of HRT. After you make a mental note to read more about HRT, you see your next patient, a 28-year-old man with allergic rhinitis. He hands you a study he obtained from the Internet, which concludes that the latest antihistamine is far superior in efficacy to all of the other antihistamines currently available on the market. He asks you for this new prescription, realizing that his health insurance company will not approve it unless you justifY to them why he should take this particular antihistamine. You promise to review the article and call him later in the week with his prescription. The mother of your next patient, a 12-year-old boy, requests a test that you have never heard of She hands you yet another article, which suggests that physicians who do not offer this test are guilty of negligence. As you

Randomized, open-label, parallel-group evaluations of basal-bolus therapy versus insulin lispro premixed therapy in patients with type 2 diabetes mellitus failing to achieve control with starter insulin treatment and continuing oral antihyperglycemic drugs: A noninferiority intensification substudy of the DURABLE trial

BACKGROUND Insulin glargine and lispro mix 75/25 (75% insulin lispro protamine suspension and 25% insulin lispro injection [LM75/25]) represent 2 common starter insulin regimen classes: basal and premixed. After initiation of starter insulin therapy, if patients with type 2 diabetes mellitus (DM) are unable to achieve a glycosylated hemoglobin (HbA1c) level <7.0%, insulin intensification may be indicated. The DURABLE (Assessing Durability of Basal Versus Lispro Mix 75/25 Insulin Efficacy) trial was designed to compare initiating insulin therapy with analogue basal insulin versus premixed analogue insulin in patients unable to achieve good glycemic control while taking multiple oral antihyperglycemic drugs (OADs). OBJECTIVE To provide objective information about insulin intensification, the DURABLE trial also included a substudy evaluating a systematic approach to advancing insulin therapy in those patients who did not achieve glycemic control with their initial insulin regimen. This substudy, the results of which are reported here, tested the hypothesis that advancing insulin therapy with premixed insulin is noninferior to basal-bolus therapy (BBT) in patients with type 2 DM unable to achieve an HbA1c level < or = 7.0% after 6 months of starter insulin therapy. METHODS In the main DURABLE study, 2091 patients (age range, 30-80 years) with type 2 DM and HbA1c values >7.0% receiving > or = 2 OADs were randomized to receive insulin glargine (n = 1046) or LM75/25 (n = 1045), both in combination with prestudy OADs. After 6 months, patients with HbA1c levels >7.0% could enter this intensification substudy; OADs except sulfonylureas were continued. Patients originally receiving insulin glargine were enrolled in intensification arm A and were randomized to receive BBT (insulin glargine once daily plus mealtime insulin lispro TID) or LM75/25 BID. Patients originally receiving LM75/25 were enrolled in intensification arm B and randomized to receive BBT or mealtime 50% insulin lispro protamine suspension and 50% insulin lispro injection (LM50/50) TID. Insulin doses were adjusted based on preprandial plasma glucose levels. The primary end point was noninferiority of premixed therapy versus BBT with respect to end-point HbA1c. Secondary end points included change in HbA1c and weight, percentage of patients reaching HbA1c target levels, total daily insulin dose, and rates of hypoglycemia. The safety profile was also assessed. RESULTS Of the 475 patients in the insulin glargine + OAD arm of the main study who had HbA1c levels >7.0% at 6 months, 399 (84%) entered intensification arm A. The mean age was 57 years, 53% of the patients were male, and mean (SD) HbA1c was 8.0% (1.0%) at baseline. Of those patients, 199 were randomly assigned to receive BBT and 200 were assigned to receive LM75/25. Of the 411 patients in the LM75/25 + OAD arm of the main study who had an HbA1c level >7.0% at 6 months, 345 (84%) entered intensification arm B. The mean age was 55 years, 51% of the patients were male, and mean (SD) HbA1c was 8.0% (0.9%) at baseline. Of those patients, 171 were randomly assigned to receive BBT and 174 were assigned to receive LM50/50. At end point, noninferiority of LM75/25 or LM50/50 to BBT was supported, with a 95% CI of -0.10 to 0.37 and -0.25 to 0.25, respectively. At 6 months, HbA1c did not differ significantly from baseline in any group. Regardless of treatment group, <20% of patients achieved an HbA1c level <7.0%. There were no significant differences between groups in total daily insulin dose, weight gain, incidence or rate of hypoglycemia, or incidence of serious adverse events. CONCLUSIONS No group had significant improvement from baseline in HbA1c. Our study results suggest that premixed therapy, dosed 2 times per day (LM75/25) or 3 times per day (LM50/50), was noninferior to BBT (4 injections/d) in this population of adult patients with type 2 DM previously uncontrolled with OADs plus basal insulin or twice-daily premixed insulin. Clinical-Trials.gov identifier: NCT00279201.

Comparison of Ultrasound Examination with Bone Scintiscan in the Diagnosis of Stress Fractures

Background: We wanted to compare an ultrasound examination with the bone scintiscan to diagnose stress fractures. Methods: Using the bone scintiscan as the reference standard, we conducted a prospective, double-blind study of 78 patients (87 percent were men, mean age 24 years) referred for bone scintiscan to rule out tibial stress fractures. After the participants were injected with radionuclide, we examined each tibia once using ultrasound adjusted for an active intensity of 2.0 W/cm2 and again with the wand turned off. The patient was blinded to the mode used. The patients response to the ultrasound was considered positive if the patient reported pain as the wand passed over the tibia. A bone scintiscan was considered positive according to the criteria of Zwas. One sonography technician performed all examinations; both he and the nuclear medicine department were blinded to the others findings. The final results were tabulated by a third, uninvolved party. A positive correlation between the scintiscan and ultrasound examination consisted of pain with active ultrasound and any degree of stress fracture in any part of the same tibia as found on the bone scintiscan. Results: Thirty-five stress fractures were found on bone scintiscan, whereas only 15 were detected by ultrasound examination (sensitivity 43 percent). With ultrasound testing there were 22 false positives (specificity 49 percent) and 20 false negatives. These findings resulted in a positive predictive value of 41 percent and a negative predictive value of 51 percent. Conclusion: Ultrasound is not reliable in the diagnosis of tibial stress fractures. Bone scintiscan remains the test of choice.

A Validation Study of the Spoken Knowledge in Low Literacy in Diabetes Scale (SKILLD)

In 2005 the Spoken Knowledge in Low Literacy in Diabetes scale (SKILLD) was introduced as a diabetes knowledge test. The SKILLD has not been validated since its introduction. To perform a validation analysis on the SKILLD. Cross-sectional observational study of 240 patients with diabetes at an academic family practice center. SKILLD’s correlation with an oral form of the Diabetes Knowledge Test (DKT) was used to assess criterion validity. A regression model tested construct validity, hypothesizing that SKILLD score was independently related to health literacy and education level. Content validity was tested using Cronbach’s Alpha for inter-item relatedness and by comparing SKILLD items with the content of a National Institutes of Health (NIH) diabetes education website. We assessed inter-rater reliability and bias using Spearman correlation coefficients and sign-rank tests between interviewers scoring the same interview. The SKILLD demonstrated fair correlation with the DKT (Pearson’s coefficient 0.54, 95% CI = 0.49 to 0.66, p < 0.001). Health literacy, education level, male gender, household income, and years with diabetes were independent predictors of SKILLD score in the regression model. Cronbach’s Alpha for inter-item relatedness was 0.54. There were some topics on the NIH website not addressed by the SKILLD. The inter-rater correlation coefficient was 0.79 (95% CI 0.56 to 0.91, p < 0.001). The SKILLD is an adequate diabetes knowledge test and is appropriate for people of all literacy levels. However, it should be expanded to more completely evaluate diabetes knowledge.ABSTRACTBACKGROUNDIn 2005 the Spoken Knowledge in Low Literacy in Diabetes scale (SKILLD) was introduced as a diabetes knowledge test. The SKILLD has not been validated since its introduction.OBJECTIVETo perform a validation analysis on the SKILLD.DESIGN AND PARTICIPANTSCross-sectional observational study of 240 patients with diabetes at an academic family practice center.MAIN MEASURESSKILLD’s correlation with an oral form of the Diabetes Knowledge Test (DKT) was used to assess criterion validity. A regression model tested construct validity, hypothesizing that SKILLD score was independently related to health literacy and education level. Content validity was tested using Cronbach’s Alpha for inter-item relatedness and by comparing SKILLD items with the content of a National Institutes of Health (NIH) diabetes education website. We assessed inter-rater reliability and bias using Spearman correlation coefficients and sign-rank tests between interviewers scoring the same interview.KEY RESULTSThe SKILLD demonstrated fair correlation with the DKT (Pearson’s coefficient 0.54, 95% CI = 0.49 to 0.66, p < 0.001). Health literacy, education level, male gender, household income, and years with diabetes were independent predictors of SKILLD score in the regression model. Cronbach’s Alpha for inter-item relatedness was 0.54. There were some topics on the NIH website not addressed by the SKILLD. The inter-rater correlation coefficient was 0.79 (95% CI 0.56 to 0.91, p < 0.001).CONCLUSIONSThe SKILLD is an adequate diabetes knowledge test and is appropriate for people of all literacy levels. However, it should be expanded to more completely evaluate diabetes knowledge.

Terminology Matters: Patient Understanding of “Opioids” and “Narcotics”

Background:  The terms “opioid” and “narcotic” are often used interchangeably by healthcare providers. The purpose of this study was to compare understanding “narcotics” vs. “opioids.”