Siamak Noorbaloochi

Validation of Screening Questions for Limited Health Literacy in a Large VA Outpatient Population

ObjectivesPrevious studies have shown that a single question may identify individuals with inadequate health literacy. We evaluated and compared the performance of 3 health literacy screening questions for detecting patients with inadequate or marginal health literacy in a large VA population.MethodsWe conducted in-person interviews among a random sample of patients from 4 VA medical centers that included 3 health literacy screening questions and 2 validated health literacy measures. Patients were classified as having inadequate, marginal, or adequate health literacy based on the Short Test of Functional Health Literacy in Adults (S-TOFHLA) and the Rapid Estimate of Adult Literacy in Medicine (REALM). We evaluated the ability of each of 3 questions to detect: 1) inadequate and the combination of “inadequate or marginal” health literacy based on the S-TOFHLA and 2) inadequate and the combination of “inadequate or marginal” health literacy based on the REALM.Measurements and Main ResultsOf 4,384 patients, 1,796 (41%) completed interviews. The prevalences of inadequate health literacy were 6.8% and 4.2%, based on the S-TOHFLA and REALM, respectively. Comparable prevalences for marginal health literacy were 7.4% and 17%, respectively. For detecting inadequate health literacy, “How confident are you filling out medical forms by yourself?” had the largest area under the Receiver Operating Characteristic Curve (AUROC) of 0.74 (95% CI: 0.69–0.79) and 0.84 (95% CI: 0.79–0.89) based on the S-TOFHLA and REALM, respectively. AUROCs were lower for detecting “inadequate or marginal” health literacy than for detecting inadequate health literacy for each of the 3 questions.ConclusionA single question may be useful for detecting patients with inadequate health literacy in a VA population.

Validation of Self-Reported Colorectal Cancer Screening Behavior from a Mixed-Mode Survey of Veterans

Objective: The aim of the study was to validate self-reported colorectal cancer (CRC) screening using the National Cancer Institute Colorectal Cancer Screening questionnaire. Materials and Methods: 890 patients, ages 50 to 75 years, from the Minneapolis Veterans Affairs (VA) Medical Center were surveyed by mail. Phone administration was attempted with mail nonresponders. VA and non-VA records were combined for the reference standard. Sensitivity, specificity, concordance, and report-to-records ratio (R2R) were estimated for overall and test-specific CRC adherence among respondents providing complete medical records. Secondary analyses examined variation in estimates by patient characteristics, treatment of missing and uncertain responses, and whether a strict or liberal time interval was used for assessing concordance. Results: Complete medical records were available for 345 of the 686 survey responders. For overall adherence, sensitivity was 0.98, specificity was 0.59, concordance was 0.88, and R2R was 1.14. Sensitivity was 0.82 for fecal occult blood test (FOBT), 0.75 for sigmoidoscopy, 0.97 for colonoscopy, and 0.63 for double-contrast barium enema (DCBE). Specificity was 0.89 for FOBT, 0.76 for sigmoidoscopy, 0.72 for colonoscopy, and 0.85 for DCBE. Concordance was >0.80 for all tests other than sigmoidoscopy (0.76). R2R was 1.31 for FOBT, 1.33 for sigmoidoscopy, 1.42 for colonoscopy, and 6.13 for DCBE. The R2R was lower for a combined sigmoidoscopy and colonoscopy measure. Overreporting was more pronounced for older, less-educated individuals with no family history of CRC. Sensitivity and R2R improved using a liberal interval and treating uncertain responses as nonadherent (versus missing), but differences were not statistically significant. Conclusions: Self-reported CRC screening validity is generally acceptable and robust across definitional decisions, but varies by screening test and patient characteristics. (Cancer Epidemiol Biomarkers Prev 2008;17(4):768–76)

The Effect of Perceived Racial Discrimination on Bodily Pain among Older African American Men

OBJECTIVES We examined the extent to which experiences of racial discrimination are associated with bodily pain reported by African American men. METHODS The study sample consisted of 393 African American male veterans who responded to a national survey of patients aged 50-75 who received care from the Veterans Health Administration (VHA). Veterans were surveyed by mail, with a telephone follow-up. The response rate for African Americans in the sample was 60.5%. Pain (assessed using the bodily pain subscale of the 36-item short-form health survey), experiences of discrimination, employment, education, and income were obtained through the survey. Age, race, and mental health comorbidities were obtained from VA administrative data. Multiple regression analysis adjusting for item non-response (via imputation) and unit non-response (via propensity scores and weighting) was used to assess the association between racial discrimination and likelihood of experiencing moderate or severe pain over the past 4 weeks. RESULTS Experiences of racial discrimination were associated with greater bodily pain (beta = -0.25, P < 0.0001), even after controlling for socioeconomic and health-related characteristics. CONCLUSION Perceived racial discrimination was associated with greater pain among a sample of older African American male patients in the VA. Additional research is needed to replicate this finding among other populations of African Americans.

Military to civilian questionnaire: A measure of postdeployment community reintegration difficulty among veterans using Department of Veterans Affairs medical care

The primary objective of this study was to describe the development, reliability, and construct validity of scores on the Military to Civilian Questionnaire (M2C-Q), a 16-item self-report measure of postdeployment community reintegration difficulty. We surveyed a national, stratified sample of 1,226 Iraq and Afghanistan veterans who used U.S. Department of Veterans Affairs (VA) medical care; 745 completed the M2C-Q and validated mental health screening measures. All analyses were based on weighted estimates. The internal consistency of the M2C-Q was .95 in this sample. Factor analyses indicated a single total score was the best-fitting model. Total scores were associated with measures theoretically related to reintegration difficulties including perception of overall difficulty readjusting back into civilian life (R(2) = .49), probable PTSD (d = 1.07), probable problem drug or alcohol use (d = 0.34), and overall mental health (r = -.83). Subgroup analyses revealed a similar pattern of findings in those who screened negative for PTSD. Nonwhite and unemployed veterans reported greater community reintegration difficulty (d = 0.20 and 0.45, respectively). Findings offer preliminary support for the reliability and construct validity of M2C-Q scores.

Intra-articular botulinum toxin A for refractory shoulder pain: a randomized, double-blinded, placebo-controlled trial

We compared the short-term efficacy and safety of intra-articular (IA) botulinum toxin A (BoNT/A) to IA-placebo in patients with chronic, refractory shoulder joint pain. Forty-three shoulder joints in patients with moderate-to-severe shoulder arthritis pain were randomized to receive (1) 100 units IA-BoNT/A + lidocaine or (2) IA-saline + lidocaine. The following outcomes were compared using analysis of covariance: (1) primary: change in pain severity on a visual analog scale at 1 month (VAS, 0 cm to 10 cm); (2) secondary: Shoulder Pain and Disability Index (SPADI) disability subscale, quality of life on short-form (SF)-36 subscales, percent of patients who achieved at least a 30% decrease or a 2-point reduction in VAS pain (clinically meaningful pain relief), and safety. Both BoNT/A (n = 21) and placebo (n = 22) groups were comparable at baseline. At 1 month post-injection, the VAS pain reduction was significantly more in the BoNT/A group versus the placebo group (-2.4 vs -0.8; P-value = 0.014). When comparing BoNT/A with the placebo group at 1 month, it was observed that 5 SF-36 subscale scores improved significantly (P </= 0.035), and the SPADI disability improved more with a trend toward significance (51.5 +/- 4.4 vs 64.9 +/- 3.9; P = 0.083). In addition, clinically meaningful pain relief occurred in 61% versus 36% patients (P = 0.22). The total number of adverse events was similar, which included 50 events in the BoNT/A group versus 46 events in the placebo group. A single injection of BoNT/A produced statistically significant and clinically meaningful pain relief and improvement in quality of life in patients with chronic refractory moderate/severe shoulder arthritis pain at 1 month. These data provide evidence to support the efficacy of this novel neurotoxin therapy that needs to be confirmed in a multicenter, randomized trial.

Effect of Opioid vs Nonopioid Medications on Pain-Related Function in Patients With Chronic Back Pain or Hip or Knee Osteoarthritis Pain: The SPACE Randomized Clinical Trial

Importance Limited evidence is available regarding long-term outcomes of opioids compared with nonopioid medications for chronic pain. Objective To compare opioid vs nonopioid medications over 12 months on pain-related function, pain intensity, and adverse effects. Design, Setting, and Participants Pragmatic, 12-month, randomized trial with masked outcome assessment. Patients were recruited from Veterans Affairs primary care clinics from June 2013 through December 2015; follow-up was completed December 2016. Eligible patients had moderate to severe chronic back pain or hip or knee osteoarthritis pain despite analgesic use. Of 265 patients enrolled, 25 withdrew prior to randomization and 240 were randomized. Interventions Both interventions (opioid and nonopioid medication therapy) followed a treat-to-target strategy aiming for improved pain and function. Each intervention had its own prescribing strategy that included multiple medication options in 3 steps. In the opioid group, the first step was immediate-release morphine, oxycodone, or hydrocodone/acetaminophen. For the nonopioid group, the first step was acetaminophen (paracetamol) or a nonsteroidal anti-inflammatory drug. Medications were changed, added, or adjusted within the assigned treatment group according to individual patient response. Main Outcomes and Measures The primary outcome was pain-related function (Brief Pain Inventory [BPI] interference scale) over 12 months and the main secondary outcome was pain intensity (BPI severity scale). For both BPI scales (range, 0-10; higher scores = worse function or pain intensity), a 1-point improvement was clinically important. The primary adverse outcome was medication-related symptoms (patient-reported checklist; range, 0-19). Results Among 240 randomized patients (mean age, 58.3 years; women, 32 [13.0%]), 234 (97.5%) completed the trial. Groups did not significantly differ on pain-related function over 12 months (overall P = .58); mean 12-month BPI interference was 3.4 for the opioid group and 3.3 for the nonopioid group (difference, 0.1 [95% CI, −0.5 to 0.7]). Pain intensity was significantly better in the nonopioid group over 12 months (overall P = .03); mean 12-month BPI severity was 4.0 for the opioid group and 3.5 for the nonopioid group (difference, 0.5 [95% CI, 0.0 to 1.0]). Adverse medication-related symptoms were significantly more common in the opioid group over 12 months (overall P = .03); mean medication-related symptoms at 12 months were 1.8 in the opioid group and 0.9 in the nonopioid group (difference, 0.9 [95% CI, 0.3 to 1.5]). Conclusions and Relevance Treatment with opioids was not superior to treatment with nonopioid medications for improving pain-related function over 12 months. Results do not support initiation of opioid therapy for moderate to severe chronic back pain or hip or knee osteoarthritis pain. Trial Registration clinicaltrials.gov Identifier: NCT01583985

Proactive tobacco treatment and population-level cessation a pragmatic randomized clinical trial

IMPORTANCE Current tobacco use treatment approaches require smokers to request treatment or depend on the provider to initiate smoking cessation care and are therefore reactive. Most smokers do not receive evidence-based treatments for tobacco use that include both behavioral counseling and pharmacotherapy. OBJECTIVE To assess the effect of a proactive, population-based tobacco cessation care model on use of evidence-based tobacco cessation treatments and on population-level smoking cessation rates (ie, abstinence among all smokers including those who use and do not use treatment) compared with usual care among a diverse population of current smokers. DESIGN, SETTING, AND PARTICIPANTS The Veterans Victory Over Tobacco Study, a pragmatic randomized clinical trial involving a population-based registry of current smokers aged 18 to 80 years. A total of 6400 current smokers, identified using the Department of Veterans Affairs (VA) electronic medical record, were randomized prior to contact to evaluate both the reach and effectiveness of the proactive care intervention. INTERVENTIONS Current smokers were randomized to usual care or proactive care. Proactive care combined (1) proactive outreach and (2) offer of choice of smoking cessation services (telephone or in-person). Proactive outreach included mailed invitations followed by telephone outreach to motivate smokers to seek treatment with choice of services. MAIN OUTCOMES AND MEASURES The primary outcome was 6-month prolonged smoking abstinence at 1 year and was assessed by a follow-up survey among all current smokers regardless of interest in quitting or treatment utilization. RESULTS A total of 5123 participants were included in the primary analysis. The follow-up survey response rate was 66%. The population-level, 6-month prolonged smoking abstinence rate at 1 year was 13.5% for proactive care compared with 10.9% for usual care (P = .02). Logistic regression mixed model analysis showed a significant effect of the proactive care intervention on 6-month prolonged abstinence (odds ratio [OR], 1.27 [95% CI, 1.03-1.57]). In analyses accounting for nonresponse using likelihood-based not-missing-at-random models, the effect of proactive care on 6-month prolonged abstinence persisted (OR, 1.33 [95% CI, 1.17-1.51]). CONCLUSIONS AND RELEVANCE Proactive, population-based tobacco cessation care using proactive outreach to connect smokers to evidence-based telephone or in-person smoking cessation services is effective for increasing long-term population-level cessation rates. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00608426.

Intraarticular Botulinum Toxin A for Refractory Painful Total Knee Arthroplasty: A Randomized Controlled Trial

Objective. To assess short-term efficacy of single intraarticular botulinum toxin (IA-BoNT/A) injection in patients with chronically painful total knee arthroplasty (TKA) in a randomized, placebo-controlled, triple-blind study. Methods. Patients with chronic TKA pain (pain > 6 on 0–10 scale and > 6 months post-TKA) evaluated in and referred from orthopedic surgery clinics were recruited. The primary outcome, proportion of patients with clinically meaningful decrease of at least 2 points on 0–10 visual analog scale (VAS) for pain, was compared between treatment groups at 2 months using comparison of proportions test and for all efficacy timepoints (2, 3, and 4 months) using generalized estimating equations (GEE). Secondary outcomes of global assessment, function, and quality of life were compared using GEE, duration of pain relief by t-test, and adverse events by chi-square test. Results. In total, 54 patients with 60 painful TKA were randomized, with main analyses restricted to one TKA per patient (49 TKA in 49 patients). Mean age was 67 years, 84% were men, and mean duration of TKA pain was 4.5 years. A significantly greater proportion of patients (71%) in the IA-BoNT/A group compared to IA-placebo (35%) achieved clinically meaningful reduction in VAS pain at 2 months (p = 0.028) and at all efficacy timepoints (p = 0.019). Duration of meaningful pain relief was significantly greater after IA-BoNT/A, 39.6 days (SD 50.4) compared to IA-placebo, 15.7 days (SD 22.6; p = 0.045). Statistically significantly better scores were seen in IA-BoNT/A vs IA-placebo for all efficacy timepoints for the following outcomes: “very much improved” on physician global assessment of change (p = 0.003); Western Ontario McMaster Osteoarthritis Index physical function (p = 0.026), stiffness (p = 0.004), and total scores (p = 0.024); and Short-Form 36 pain subscale score (p = 0.049). Number of total and serious adverse events was similar between groups, with no patients in either group with new objective motor or sensory deficits during followup. Conclusion. In this single-center randomized trial, single IA-BoNT/A injection provided clinically meaningful short-term improvements in pain, global assessment, and function in patients with chronic painful TKA. A multicenter trial is needed to confirm these findings.

Long-term Outcomes of Disability Benefits in US Veterans With Posttraumatic Stress Disorder

CONTEXT Most studies examining the clinical impact of disability benefits have compared aid recipients with people who never applied for benefits. Such practices may bias findings against recipients because disability applicants tend to be much sicker than never-applicants. Furthermore, these studies ignore the outcomes of denied claimants. OBJECTIVE To examine long-term outcomes associated with receiving or not receiving Department of Veterans Affairs (VA) disability benefits for posttraumatic stress disorder (PTSD), the most common mental disorder for which veterans seek such benefits. DESIGN Comparison of outcomes between successful and unsuccessful applicants for VA disability payments. Because we could not randomize the receipt of benefits, we used exact matching by propensity scores to control for potential baseline differences. We examined clinical outcomes approximately 10 years later. SETTING AND PARTICIPANTS Stratified, nationally representative cohort of 3337 veterans who applied for VA PTSD disability benefits between January 1, 1994, and December 31, 1998. MAIN OUTCOME MEASURES Assessment on validated survey measures of PTSD; work, role, social, and physical functioning; employment; and poverty. We compared outcomes with earlier scores. Homelessness and mortality were assessed using administrative data. RESULTS Of still-living cohort members, 85.1% returned usable surveys. Symptoms of PTSD were elevated in both groups. After adjustment, awardees had more severe PTSD symptoms than denied claimants but were nonetheless more likely to have had a meaningful symptom reduction since their last assessment (-6.1 vs -4.4; SE, 0.1; P = .01). Both groups had meaningful improvements of similar magnitude in work, role, and social functioning (-0.15 vs -0.19; SE, 0.01; P = .94), but functioning remained poor nonetheless. Comparing awardees with denied claimants after adjustment, 13.2% vs 19.0% were employed (P = .11); 15.2% vs 44.8% reported poverty (P < .001); 12.0% vs 20.0% had been homeless (P = .02); and 10.4% vs 9.7% had died (P = .66). CONCLUSIONS Regardless of claim outcome, veterans who apply for PTSD disability benefits are highly impaired. However, receiving PTSD benefits was associated with clinically meaningful reductions in PTSD symptoms and less poverty and homelessness.

Variation in Estimates of Limited Health Literacy by Assessment Instruments and Non-Response Bias

ObjectivesThis paper compares estimates of poor health literacy using two widely used assessment tools and assesses the effect of non-response on these estimates.Study Design and SettingA total of 4,868 veterans receiving care at four VA medical facilities between 2004 and 2005 were stratified by age and facility and randomly selected for recruitment. Interviewers collected demographic information and conducted assessments of health literacy (both REALM and S-TOFHLA) from 1,796 participants. Prevalence estimates for each assessment were computed. Non-respondents received a brief proxy questionnaire with demographic and self-report literacy questions to assess non-response bias. Available administrative data for non-participants were also used to assess non-response bias.ResultsAmong the 1,796 patients assessed using the S-TOFHLA, 8% had inadequate and 7% had marginal skills. For the REALM, 4% were categorized with 6th grade skills and 17% with 7–8th grade skills. Adjusting for non-response bias increased the S-TOFHLA prevalence estimates for inadequate and marginal skills to 9.3% and 11.8%, respectively, and the REALM estimates for ≤6th and 7–8th grade skills to 5.4% and 33.8%, respectively.ConclusionsEstimates of poor health literacy varied by the assessment used, especially after adjusting for non-response bias. Researchers and clinicians should consider the possible limitations of each assessment when considering the most suitable tool for their purposes.