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Background: Chronic pain is common, disabling, and costly. Few clinical trials have examined cognitive behavioral therapy (CBT) interventions embedded in primary care settings to improve chronic pain among those receiving long-term opioid therapy.Objective: To determine the effectiveness of a group-based CBT intervention for chronic pain.Design: Pragmatic, cluster randomized controlled trial. (ClinicalTrials.gov: NCT02113592).Setting: Kaiser Permanente health care systems in Georgia, Hawaii, and the Northwest.Participants: Adults (aged ≥18 years) with mixed chronic pain conditions receiving long-term opioid therapy.Intervention: A CBT intervention teaching pain self-management skills in 12 weekly, 90-minute groups delivered by an interdisciplinary team (behaviorist, nurse, physical therapist, and pharmacist) versus usual care.Measurements: Self-reported pain impact (primary outcome, as measured by the PEGS scale [pain intensity and interference with enjoyment of life, general activity, and sleep]) was assessed quarterly over 12 months. Pain-related disability, satisfaction with care, and opioid and benzodiazepine use based on electronic health care data were secondary outcomes.Results: A total of 850 patients participated, representing 106 clusters of primary care providers (mean age, 60.3 years; 67.4% women); 816 (96.0%) completed follow-up assessments. Intervention patients sustained larger reductions on all self-reported outcomes from baseline to 12-month follow-up; the change in PEGS score was -0.434 point (95% CI, -0.690 to -0.178 point) for pain impact, and the change in pain-related disability was -0.060 point (CI, -0.084 to -0.035 point). At 6 months, intervention patients reported higher satisfaction with primary care (difference, 0.230 point [CI, 0.053 to 0.406 point]) and pain services (difference, 0.336 point [CI, 0.129 to 0.543 point]). Benzodiazepine use decreased more in the intervention group (absolute risk difference, -0.055 [CI, -0.099 to -0.011]), but opioid use did not differ significantly between groups.Limitation: The inclusion of only patients with insurance in large integrated health care systems limited generalizability, and the clinical effect of change in scores is unclear.Conclusion: Primary care-based CBT, using frontline clinicians, produced modest but sustained reductions in measures of pain and pain-related disability compared with usual care but did not reduce use of opioid medication.Primary Funding Source: National Institutes of Health. [ABSTRACT FROM AUTHOR]

The role of food reactions in asthma has not been well described The objectives of this study were to evaluate the types of self-reported reactions to foods in asthmatic patients, [...]

Objective: To examine changes in children's albuterol use and out-of-pocket (OOP) costs in response to increased copayments after the Food and Drug Administration banned inhalers with chlorofluorocarbon (CFC) propellants.Setting: Four health maintenance organizations (HMOs), two that increased copayments for albuterol inhalers that went from generic CFC-containing to branded CFC-free versions, and two that retained generic copayments for CFC-free inhalers (controls). We included children with asthma aged 4-17 years with commercial coverage from 2007 to 2010.Design: Interrupted time series with comparison series.Data: We obtained enrollee and plan characteristics from enrollment files, and utilization data from pharmacy and medical claims; OOP expenditures were extracted from pharmacy claims for two HMOs with cost data available.Findings: There were no significant differences in albuterol use between the group with increased cost-sharing and controls with respect to changes after the policy change. There was a postpolicy increase of $6.11 OOP per month per child using albuterol among those with increased cost-sharing versus $0.36 in controls; the difference between groups was significant (p < .01).Conclusions: Increased copayments for brand-name CFC-free albuterol after the CFC ban did not lead to a decrease in children's albuterol use, but it led to a modest increase in OOP costs. [ABSTRACT FROM AUTHOR]

Background: While electronic health records (EHRs) play a key role in increasing colorectal cancer (CRC) screening by identifying individuals who are overdue, important shortfalls remain.Objectives: As part of the Strategies and Opportunities to STOP Colon Cancer (STOP CRC) study, we assessed the accuracy of EHR codes in identifying patients eligible for CRC screening.Methods: We selected a stratified random sample of 800 study participants from 26 participating clinics, in the Pacific Northwest region of the USA. We compared data obtained through codes in the EHR to conduct a manual chart audit. A trained chart abstractor completed the abstraction of eligible and ineligible patients.Results: Of 520 individuals in need of CRC screening, identified via the EHR, 459 were confirmed through chart review (positive predictive value = 88%). Of 280 individuals flagged as up-to-date in their screening per EHR data, 269 were confirmed through chart review (negative predictive value = 96%). Among the 61 patients incorrectly classified as eligible, 83.6% of disagreements were due to evidence of a prior colonoscopy or referral that was not captured in recognizable fields in the EHR.Conclusions: Our findings highlight importance of better capture of past screening events in the EHR. While the need for better population-based data is not unique to CRC screening, it provides an important example of the use of population-based data not only for tracking care, but also for delivering interventions. [ABSTRACT FROM AUTHOR]

Context: There is little research investigating whether health information technologies, such as interactive voice recognition, are effective ways to deliver information to individuals with lower health literacy.Objective: Determine the extent to which the impact of an interactive voice recognition-based intervention to improve medication adherence appeared to vary by participants’ health literacy level.Design: Promoting Adherence to Improve Effectiveness of Cardiovascular Disease Therapies (PATIENT) was a randomized clinical trial designed to test the impact, compared with usual care, of 2 technology-based interventions that leveraged interactive voice recognition to promote medication adherence. A 14% subset of participants was sent a survey that included questions on health literacy. This exploratory analysis was limited to the 833 individuals who responded to the survey and provided data on health literacy.Main Outcome Measures: Adherence to statins and/or angiotensin-converting enzyme inhibitors and/or angiotensin II receptor blockers.Results: Although intervention effects did not differ significantly by level of health literacy, the data were suggestive of differential intervention effects by health literacy level.Conclusions: The differences in intervention effects for high vs low health literacy in this exploratory analysis are consistent with the hypothesis that individuals with lower health literacy may derive greater benefit from this type of intervention compared with individuals with higher health literacy. Additional studies are needed to further explore this finding. [ABSTRACT FROM AUTHOR]

This study aimed to find the set of risk indicators best able to predict root caries (RC) incidence in caries-active adults utilizing data from the Xylitol for Adult Caries Trial (X-ACT). Five logistic regression models were compared with respect to their predictive performance for incident RC using data from placebo-control participants with exposed root surfaces at baseline and from two study centers with ancillary data collection (n = 155). Prediction performance was assessed from baseline variables and after including ancillary variables [smoking, diet, use of removable partial dentures (RPD), toothbrush use, income, education, and dental insurance]. A sensitivity analysis added treatment to the models for both the control and treatment participants (n = 301) to predict RC for the control participants. Forty-nine percent of the control participants had incident RC. The model including the number of follow-up years at risk, the number of root surfaces at risk, RC index, gender, race, age, and smoking resulted in the best prediction performance, having the highest AUC and lowest Brier score. The sensitivity analysis supported the primary analysis and gave slightly better performance summary measures. The set of risk indicators best able to predict RC incidence included an increased number of root surfaces at risk and increased RC index at baseline, followed by white race and nonsmoking, which were strong nonsignificant predictors. Gender, age, and increased number of follow-up years at risk, while included in the model, were also not statistically significant. The inclusion of health, diet, RPD use, toothbrush use, income, education, and dental insurance variables did not improve the prediction performance. [ABSTRACT FROM AUTHOR]

Objective: In the Weight Loss Maintenance (WLM) Trial, a personal contact (PC) intervention sustained greater weight loss relative to a self-directed (SD) group over 30 months. This study investigated the effects of continued intervention over an additional 30 months and overall weight change across the entire WLM Trial.Methods: WLM had 3 phases. Phase 1 was a 6-month weight loss program. In Phase 2, those who lost ≥4 kg were randomized to a 30-month maintenance trial. In Phase 3, PC participants (n = 196, three sites) were re-randomized to no further intervention (PC-Control) or continued intervention (PC-Active) for 30 more months; 218 SD participants were also followed.Results: During Phase 3, weight increased 1.0 kg in PC-Active and 0.5 kg in PC-Control (mean difference 0.6 kg; 95% CI:-1.4 to 2.7; P = 0.54). Mean weight change over the entire study was -3.2 kg in those originally assigned to PC (PC-Combined) and -1.6 kg in SD (mean difference -1.6 kg; 95% CI:-3.0 to -0.1; P = 0.04).Conclusions: After 30 months of the PC maintenance intervention, continuation for another 30 months provided no additional benefit. However, across the entire study, weight loss was slightly greater in those originally assigned to PC. [ABSTRACT FROM AUTHOR]

Objective To describe the full range of behavior of the visible, noncavitated, early caries lesion in caries-active adults with substantial fluoride exposure, and to consider implications. Methods The data were from the Xylitol for Adult Caries Trial (X- ACT) collected annually for 33 months using condensed ICDAS caries threshold criteria. Individual tooth surfaces having a noncavitated caries lesion were included, and the patterns of transition to each subsequent annual clinical examination to sound, noncavitated or cavitated, filled or crowned were determined. The resulting sets of patterns for an individual tooth surface, looking forward from its first appearance as a noncavitated lesion, were combined into one of four behavior profiles classified as reversing, stable, oscillating, or continuously progressing, or were excluded if not part of the caries continuum. The distributions of profile types were assessed using the Rao-Scott chi-square test, which adjusts for clustering of tooth surfaces within teeth. Results Inter- and intra-examiner kappa scores demonstrated acceptable calibration at baseline and annually. 8084 tooth surfaces from 543 subjects were included. The distribution of profile types differed significantly between coronal and root surfaces. Overall, two-thirds of all coronal noncavitated lesions were first seen at baseline, half reversed, over a fifth were stable, 15% oscillated, and only 8.3% progressed to cavitation, filled, or crowned in 33 months or less (6.3% consistently Progressed plus 2.0% inconsistently, a subset of oscillating, which oscillated before progressing to cavitation). Approximal, smooth, and occlusal coronal surfaces each were significantly different in their individual distributions of profile types. Xylitol showed no significant and consistent effect on this distribution by tooth surface type. This was in keeping with the X- ACT's lack of effect of xylitol at the noncavitated plus cavitated lesion thresholds combined. Conclusions This study demonstrated the full dynamic range of early caries lesion behavior. The great majority were not progressive, and few (8.3%) became cavitated over 33 months in caries-active adults using fluorides. Important caries management implications favoring recorded longitudinal monitoring, prevention of active risks, and minimal restoration only after direct visual determination of cavitation are discussed. [ABSTRACT FROM AUTHOR]

Objectives To better understand the effectiveness of xylitol in caries prevention in adults and to attempt improved clinical trial efficiency. Methods As part of the Xylitol for Adult Caries Trial (X- ACT), non cavitated and cavitated caries lesions were assessed in subjects who were experiencing the disease. The trial was a test of the effectiveness of 5 g/day of xylitol, consumed by dissolving in the mouth five 1 g lozenges spaced across each day, compared with a sucralose placebo. For this analysis, seeking trial efficiency, 538 subjects aged 21-80, with complete data for four dental examinations, were selected from the 691 randomized into the 3-year trial, conducted at three sites. Acceptable inter- and intra-examiner reliability before and during the trial was quantified using the kappa statistic. Results The mean annualized noncavitated plus cavitated lesion transition scores in coronal and root surfaces, from sound to carious favoured xylitol over placebo, during the three cumulative periods of 12, 24, and 33 months, but these clinically and statistically nonsignificant differences declined in magnitude over time. Restricting the present assessment to those subjects with a higher baseline lifetime caries experience showed possible but inconsistent benefit. Conclusions There was no clear and clinically relevant preventive effect of xylitol on caries in adults with adequate fluoride exposure when non cavitated plus cavitated lesions were assessed. This conformed to the X- ACT trial result assessing cavitated lesions. Including non cavitated lesion assessment in this full-scale, placebo-controlled, multisite, randomized, double-blinded clinical trial in adults experiencing dental caries did not achieve added trial efficiency or demonstrate practical benefit of xylitol. Trial Registration: ClinicalTrials.Gov NCT00393055. [ABSTRACT FROM AUTHOR]

Background. Although caries is prevalent in adults, investigators have tested few preventive therapies in adult populations. In a randomized controlled trial, the authors evaluated the effectiveness of xylitol lozenges in preventing caries in adults at elevated risk of developing caries. Methods. The Xylitol for Adult Caries Trial (X-ACT) was a three-site placebo-controlled randomized trial. Participants (n = 691) aged 21 through 80 years consumed five 1.0-gram xylitol or placebo lozenges daily for 33 months. They underwent clinical examinations at baseline and at 12, 24 and 33 months. Results. Xylitol lozenges reduced the caries increment 10 percent. This reduction, which represented less than one-third of a surface per year, was not statistically significant. There was no indication of a dose-response effect. Conclusions. Daily use of xylitol lozenges did not result in a statistically or clinically significant reduction in 33-month caries increment among adults at an elevated risk of developing caries. Clinical Implications. These results suggest that xylitol used as a supplement in adults does not reduce their caries experience significantly. [ABSTRACT FROM AUTHOR]

Background: The Asthma Impact Survey (AIS-6) is a new six question asthma outcome tool for which information on validity has not been published.Objective: To provide validation for the AIS-6 as a brief asthma-specific quality of life tool.Methods: Surveys were sent to a random sample of members of a large managed care organization who were at least 35 years of age and in the two-year period preceding the survey had either (1) at least one documented asthma-related medical encounter, or (2) at least a 6 months supply of asthma medication dispensed. In addition to the AIS-6, the survey included a validated quality of life tool [the mini-Asthma Quality of Life Questionnaire (AQLQ)]; a validated asthma control questionnaire [the Asthma Therapy Assessment Questionnaire (ATAQ)]; a validated symptom severity scale (AOMS); and information regarding demographics, co-morbidities, asthma severity, and asthma management. The results of the AIS-6 were compared to the results of the other tools by means of correlation and factor analysis. Independent predictors of AIS-6 and AQLQ scores were determined by multiple stepwise linear regression analyses.Results: AIS-6 scores were significantly related to female sex, educational level, income, smoking, body mass index (BMI), COPD, steroid use, and hospitalization history in bivariate analyses. The AIS-6 score significantly correlated (r = - 0.84, p < 0.0001) with the AQLQ total score and loaded on the three factors (activity, symptoms, and concern/bother) reflected by the survey information and on which the AQLQ also loaded. Significant but somewhat smaller correlations were found between the AIS-6 and the ATAQ (r = 0.70, p < 0.0001) and the AOMS (r = 0.55, p < 0.0001). Independent predictors were the same for the AIS-6 and AQLQ and included oral steroid use, COPD history, BMI, female sex, educational level, and hospitalization in the past year.Conclusion: These data support the validity of the short six-question AIS-6 as an asthma-specific quality of life tool. [ABSTRACT FROM AUTHOR]

Objective: Preplanned economic analysis of a pragmatic trial using electronic-medical-record-linked interactive voice recognition (IVR) reminders for enhancing adherence to cardiovascular medications (i.e., statins, angiotensin-converting enzyme inhibitors [ACEIs], and angiotensin receptor blockers [ARBs]).Methods: Three groups, usual care (UC), IVR, and IVR plus educational materials (IVR+), with 21,752 suboptimally adherent patients underwent follow-up for 9.6 months on average. Costs to implement and deliver the intervention (from a payer perspective) were tracked during the trial. Medical care costs and outcomes were ascertained using electronic medical records.Results: Per-patient intervention costs ranged from $9 to $17 for IVR and from $36 to $47 for IVR+. For ACEI/ARB, the incremental cost-effectiveness ratio for each percent adherence increase was about 3 times higher with IVR+ than with IVR ($6 and $16 for IVR and IVR+, respectively). For statins, the incremental cost-effectiveness ratio for each percent adherence increase was about 7 times higher with IVR+ than with IVR ($6 and $43 for IVR and IVR+, respectively). Considering potential cost offsets from reduced cardiovascular events, the probability of breakeven was the highest for UC, but the IVR-based interventions had a higher probability of breakeven for subgroups with a baseline low-density lipoprotein (LDL) level of more than 100 mg/dl and those with two or more calls.Conclusions: We found that the use of an automated voice messaging system to promote adherence to ACEIs/ARBs and statins may be cost-effective, depending on a decision maker's willingness to pay for unit increase in adherence. When considering changes in LDL level and downstream medical care offsets, UC is the optimal strategy for the general population. However, IVR-based interventions may be the optimal choice for those with elevated LDL values at baseline. [ABSTRACT FROM AUTHOR]