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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]

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]

Group-randomized trials are randomized studies that allocate intact groups of individuals to different comparison arms. A frequent practical limitation to adopting such research designs is that only a limited number of groups may be available, and therefore, simple randomization is unable to adequately balance multiple group-level covariates between arms. Therefore, covariate-based constrained randomization was proposed as an allocation technique to achieve balance. Constrained randomization involves generating a large number of possible allocation schemes, calculating a balance score that assesses covariate imbalance, limiting the randomization space to a prespecified percentage of candidate allocations, and randomly selecting one scheme to implement. When the outcome is binary, a number of statistical issues arise regarding the potential advantages of such designs in making inference. In particular, properties found for continuous outcomes may not directly apply, and additional variations on statistical tests are available. Motivated by two recent trials, we conduct a series of Monte Carlo simulations to evaluate the statistical properties of model-based and randomization-based tests under both simple and constrained randomization designs, with varying degrees of analysis-based covariate adjustment. Our results indicate that constrained randomization improves the power of the linearization F-test, the KC-corrected GEE t-test (Kauermann and Carroll, 2001, Journal of the American Statistical Association 96, 1387-1396), and two permutation tests when the prognostic group-level variables are controlled for in the analysis and the size of randomization space is reasonably small. We also demonstrate that constrained randomization reduces power loss from redundant analysis-based adjustment for non-prognostic covariates. Design considerations such as the choice of the balance metric and the size of randomization space are discussed. [ABSTRACT FROM AUTHOR]

Background: Propensity scores are typically applied in retrospective cohort studies. We describe the feasibility of matching on a propensity score derived from a retrospective cohort and subsequently applied in a prospective cohort study of patients with chronic musculoskeletal pain before the start of acupuncture or usual care treatment and enrollment in a comparative effectiveness study that required patient reported pain outcomes.Methods: We assembled a retrospective cohort study using data from 2010 to develop a propensity score for acupuncture versus usual care based on electronic healthcare record and administrative data (e.g., pharmacy) from an integrated health plan, Kaiser Permanente Northwest. The propensity score's probabilities allowed us to match acupuncture-referred and non-referred patients prospectively in 2013-14 after a routine outpatient visit for pain. Among the matched patients, we collected patient-reported pain before treatment and during follow-up to assess the comparative effectiveness of acupuncture. We assessed balance in patient characteristics with the post-matching c-statistic and standardized differences.Results: Based on the propensity score and other characteristics (e.g., patient-reported pain), we were able to match all 173 acupuncture-referred patients to 350 non-referred (usual care) patients. We observed a residual imbalance (based on the standardized differences) for some characteristics that contributed to the score; for example, age, -0.283, and the Charlson comorbidity score, -0.264, had the largest standardized differences. The overall balance of the propensity score appeared more favorable according to the post-matching c-statistic, 0.503.Conclusion: The propensity score matching was feasible statistically and logistically and allowed approximate balance on patient characteristics, some of which will require adjustment in the comparative effectiveness regression model. By transporting propensity scores to new patients, healthcare systems with electronic health records can conduct comparative effectiveness cohort studies that require prospective data collection, such as patient-reported outcomes, while approximately balancing numerous patient characteristics that might confound the benefit of an intervention. The approach offers a new study design option. [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]

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]

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]

Purpose: In 2009, the US Food and Drug Administration (FDA) mandated a label change for leukotriene inhibitors (LTIs) to include neuropsychiatric adverse events (eg, depression and suicidality) as a precaution. This study investigated how this label change affected the use of LTIs and other asthma controller medications, mental health visits, and suicide attempts. Methods: We analyzed data (2005-2010) from 5 large health plans in the US Population-Based Effectiveness in Asthma and Lung Diseases (PEAL) Network. The study cohort included children and adolescents (n = 30,000), young adults (n = 20,0), and adults (n = 90,000) with asthma. We used interrupted time series to examine changes in rates of LTI dispensings, non-LTI dispensings, mental health visits, and suicide attempts (using a validated algorithm based on a combination of diagnoses of injury or poisoning and psychiatric conditions). Findings: The label change was associated with abrupt reductions in LTI use among all age groups (relative reductions of 8.3%, 15.1%, and 6.0% among adolescents, young adults, and adults, respectively, compared with expected rates at 1 year after the warnings). Although we detected immediate offset increases in non-LTI asthma medication use, these increases were not sustained among adolescents and young adults. There were small increases in mental health visits among LTI users. Implications: The FDA label change for LTIs communicated possible risk of neuropsychiatric events. Communication and enhanced awareness may have increased reporting of mental health symptoms among young adults and adults. It is important to assess intended and unintended consequences of FDA warnings and label changes. [ABSTRACT FROM AUTHOR]