A Primary Care-Based Cognitive Behavioral Therapy Intervention for Long-Term Opioid Users With Chronic Pain : A Randomized Pragmatic Trial.

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.

Health plan-based mailed fecal testing for colorectal cancer screening among dual-eligible Medicaid/Medicare enrollees: Outcomes of 2 program models.

BACKGROUND: Health insurance plans are increasingly offering mailed fecal immunochemical test (FIT) programs for colorectal cancer (CRC) screening, but few studies have compared the outcomes of different program models (eg, invitation strategies). METHODS: This study compares the outcomes of 2 health plan-based mailed FIT program models. In the first program (2016), FIT kits were mailed to all eligible enrollees; in the second program (2018), FIT kits were mailed only to enrollees who opted in after an outreach phone call. Participants in this observational study included dual-eligible Medicaid/Medicare enrollees who were aged 50 to 75 years and were due for CRC screening (1799 in 2016 and 1906 in 2018). Six-month FIT completion rates, implementation outcomes (eg, mailed FITs sent and reminders attempted), and program-related health plan costs for each program are described. RESULTS: All 1799 individuals in 2016 were sent an introductory letter and a FIT kit. In 2018, all 1906 were sent an introductory letter, and 1905 received at least 1 opt-in call attempt, with 410 (21.5%) sent a FIT. The FIT completion rate was 16.2% (292 of 1799 [95% CI, 14.5%-17.9%]) in 2016 and 14.6% (278 of 1906 [95% CI, 13.0%-16.2%]) in 2018 (P = .36). The overall implementation costs were higher in 2016 ($40,156) than 2018 ($34,899), with the cost per completed FIT slightly higher in 2016 ($138) than 2018 ($126). CONCLUSIONS: An opt-in mailed FIT program achieved FIT completion rates similar to those of a program mailing to all dual-eligible Medicaid/Medicare enrollees. LAY SUMMARY: Health insurance plans can use different program models to successfully mail fecal test kits for colorectal cancer screening to dual-eligible Medicaid/Medicare enrollees, with nearly 1 in 6 enrollees completing fecal testing.

Economic Evaluation: A Randomized Pragmatic Trial of a Primary Care-based Cognitive Behavioral Intervention for Adults Receiving Long-term Opioids for Chronic Pain.

BACKGROUND: Chronic pain is prevalent and costly; cost-effective nonpharmacological approaches that reduce pain and improve patient functioning are needed. OBJECTIVE: Report the incremental cost-effectiveness ratio (ICER), compared with usual care, of cognitive behavioral therapy aimed at improving functioning and pain among patients with chronic pain on long-term opioid treatment. DESIGN: Economic evaluation conducted alongside a pragmatic cluster randomized trial. SUBJECTS: Adults with chronic pain on long-term opioid treatment (N=814). INTERVENTION: A cognitive behavioral therapy intervention teaching pain self-management skills in 12 weekly, 90-minute groups delivered by an interdisciplinary team (behaviorists, nurses) with additional support from physical therapists, and pharmacists. OUTCOME MEASURES: Cost per quality adjusted life year (QALY) gained, and cost per additional responder (≥30% improvement on standard scale assessment of Pain, Enjoyment, General Activity, and Sleep). Costs were estimated as-delivered, and replication. RESULTS: Per patient intervention replication costs were $2145 ($2574 as-delivered). Those costs were completely offset by lower medical care costs; inclusive of the intervention, total medical care over follow-up was $1841 lower for intervention patients. Intervention group patients also had greater QALY and responder gains than did controls. Supplemental analyses using pain-related medical care costs revealed ICERs of $35,000, and $53,000 per QALY (for replication, and as-delivered intervention costs, respectively); the ICER when excluding patients with outlier follow-up costs was $106,000. LIMITATIONS: Limited to 1-year follow-up; identification of pain-related utilization potentially incomplete. CONCLUSION: The intervention was the optimal choice at commonly accepted levels of willingness-to-pay for QALY gains; this finding was robust to sensitivity analyses.

Restricted spirometry and cardiometabolic comorbidities: results from the international population based BOLD study.

BACKGROUND: Whether restricted spirometry, i.e. low Forced Vital Capacity (FVC), predicts chronic cardiometabolic disease is not definitely known. In this international population-based study, we assessed the relationship between restricted spirometry and cardiometabolic comorbidities. METHODS: A total of 23,623 subjects (47.5% males, 19.0% current smokers, age: 55.1 ± 10.8 years) from five continents (33 sites in 29 countries) participating in the Burden of Obstructive Lung Disease (BOLD) study were included. Restricted spirometry was defined as post-bronchodilator FVC < 5th percentile of reference values. Self-reports of physician-diagnosed cardiovascular disease (CVD; heart disease or stroke), hypertension, and diabetes were obtained through questionnaires. RESULTS: Overall 31.7% of participants had restricted spirometry. However, prevalence of restricted spirometry varied approximately ten-fold, and was lowest (8.5%) in Vancouver (Canada) and highest in Sri Lanka (81.3%). Crude odds ratios for the association with restricted spirometry were 1.60 (95% CI 1.37-1.86) for CVD, 1.53 (95% CI 1.40-1.66) for hypertension, and 1.98 (95% CI 1.71-2.29) for diabetes. After adjustment for age, sex, education, Body Mass Index (BMI) and smoking, the odds ratios were 1.54 (95% CI 1.33-1.79) for CVD, 1.50 (95% CI 1.39-1.63) for hypertension, and 1.86 (95% CI 1.59-2.17) for diabetes. CONCLUSION: In this population-based, international, multi-site study, restricted spirometry associates with cardiometabolic diseases. The magnitude of these associations appears unattenuated when cardiometabolic risk factors are taken into account.

Evaluating the Implementation of a Digital Diabetes Prevention Program in an Integrated Health Care Delivery System Among Older Adults: Results of a Natural Experiment.

The purpose of this natural experiment study was to assess the effectiveness of a 12-month digital Diabetes Prevention Program (DPP) for adults aged 65-75 years with prediabetes and obesity within a large, integrated health care system. Adjusting for propensity scores and covariates, patients who enrolled and participated in the digital DPP had a mean weight loss of 8.6 lb over 12 months and 5.7 lb by 24 months, compared with a steady, minimal weight loss of 1.3 lb over 12 months and 2.8 lb by 24 months among patients not enrolled. There was a significant difference in mean change in A1C between enrolled and nonenrolled patients over 12 months (-0.10%), but not by 24 months (-0.06%). Digital DPP appears to be an effective weight loss option and potential diabetes prevention intervention for older adults at high risk for type 2 diabetes.

Direct-to-member mailed colorectal cancer screening outreach for Medicaid and Medicare enrollees: Implementation and effectiveness outcomes from the BeneFIT study.

BACKGROUND: Colorectal cancer screening uptake is low, particularly among individuals enrolled in Medicaid. To the authors' knowledge, little is known regarding the effectiveness of direct-to-member outreach by Medicaid health insurance plans to raise colorectal cancer screening use, nor how best to deliver such outreach. METHODS: BeneFIT is a hybrid implementation-effectiveness study of 2 program models that health plans developed for a mailed fecal immunochemical test (FIT) intervention. The programs differed with regard to whether they used a centralized approach (Health Plan Washington) or collaborated with health centers (Health Plan Oregon). The primary implementation outcome of the current study was the percentage of eligible enrollees to whom the plans delivered each intervention component. The primary effectiveness outcome was the rate of FIT completion within 6 months of mailing of the introductory letter. RESULTS: The health plans identified 12,000 eligible enrollees (8551 in Health Plan Washington and 3449 in Health Plan Oregon). Health Plan Washington mailed an introductory letter and FIT kit to 8551 enrollees (100%) and delivered a reminder call to 839 (10.3% of the 8132 attempted). Health Plan Oregon mailed an introductory letter, and a letter and FIT kit plus a reminder postcard to 2812 enrollees (81.5%) and 2650 enrollees (76.8%), respectively. FIT completion rates were 18.2% (1557 of 8551 enrollees) in Health Plan Washington. In Health Plan Oregon, completion rates were 17.4% (488 of 2812 enrollees) among enrollees who were mailed an introductory letter and 18.3% (484 of 2650 enrollees) among enrollees who also were mailed a FIT kit plus reminder postcard. CONCLUSIONS: The implementation of mailed FIT outreach by health plans may be effective and could reach many individuals at risk of developing colorectal cancer.

Factors Affecting Adherence in a Pragmatic Trial of Annual Fecal Immunochemical Testing for Colorectal Cancer.

BACKGROUND: Colorectal cancer screening by fecal immunochemical test (FIT) reduces the burden of colorectal cancer. However, effectiveness relies on annual adherence, which presents challenges for clinic staff and patients. OBJECTIVE: Describe FIT return rates and identify factors associated with FIT adherence over 2 years in a mailed FIT outreach program in federally qualified health centers. DESIGN: Observational study nested in the Strategies and Opportunities to Stop Colon Cancer in Priority Populations (STOP CRC) trial. Five thousand one hundred ninety-five patients had an initial FIT order and were followed for ≥ 2 years (3574 also had a FIT order in the second year). MAIN MEASURES: FIT return percent in each year and patient- and neighborhood-level characteristics associated with FIT adherence. KEY RESULTS: Overall, the proportion of FIT orders that were completed was 46% in the patients' first year and 41% in the patients' second year. Of the 5195 patients with a FIT order in year 1, 3574 (69%) also had a FIT order in year 2 (71% of year 1 adherers and 67% of year 1 non-adherers, p = 0.009). Among those with a FIT order in the second year, the FIT return rate was about twice as high among those who were adherent in the first year (952/1674, or 57%) as among those who were not (531/1900, or 28%, p < 0.0001). Patient-level characteristics associated with higher odds of FIT return were a history of FIT screening at baseline, age over 65 (vs 50-65), no current tobacco use, recent receipt of a mammogram or flu vaccine, Asian ancestry (compared to non-Hispanic white), and non-English preference. The only neighborhood factor associated with lower FIT return rate was patient's larger residential city size. CONCLUSION: Our findings can inform the customization of programs to promote FIT return among patients who receive care at federally qualified health centers. TRIAL REGISTRATION: http://www.clinicaltrials.gov.

Airflow Obstruction and Cardio-metabolic Comorbidities.

Chronic obstructive pulmonary disease (COPD) is characterized by airflow obstruction and often co-exists with cardiovascular disease (CVD), hypertension and diabetes. This international study assessed the association between airflow obstruction and these comorbidities. 23,623 participants (47.5% males, 19.0% current smokers, age: 55.1 ± 10.8 years) in 33 centers in the Burden of Obstructive Lung Disease (BOLD) initiative were included. 10.4% of subjects had airflow obstruction. Self-reports of physician-diagnosed CVD (heart disease or stroke), hypertension and diabetes were regressed against airflow obstruction (post-bronchodilator FEV1/FVC < 5th percentile of reference values), adjusting for age, sex, smoking (including pack-years), body mass index and education. Analyses were undertaken within center and meta-analyzed across centers checking heterogeneity using the I2-statistic. Crude odds ratios for the association with airflow obstruction were 1.42 (95% CI: 1.20-1.69) for CVD, 1.24 (1.02-1.51) for hypertension, and 0.93 (0.76-1.15) for diabetes. After adjustment these were 1.00 (0.86-1.16) (I2:6%) for CVD, 1.14 (0.99-1.31) (I2:53%) for hypertension, and 0.76 (0.64-0.89) (I2:1%) for diabetes with similar results for men and women, smokers and nonsmokers, in richer and poorer centers. Alternatively defining airflow obstruction by FEV1/FVC < 2.5th percentile or 0.70, did not yield significant other results. In conclusion, the associations of CVD and hypertension with airflow obstruction in the general population are largely explained by age and smoking habits. The adjusted risk for diabetes is lower in subjects with airflow obstruction. These findings emphasize the role of common risk factors in explaining the coexistence of cardio-metabolic comorbidities and COPD.

Comparative Effectiveness of Usual Care With or Without Chiropractic Care in Patients with Recurrent Musculoskeletal Back and Neck Pain.

BACKGROUND: Chiropractic care is a popular alternative for back and neck pain, with efficacy comparable to usual care in randomized trials. However, the effectiveness of chiropractic care as delivered through conventional care settings remains largely unexplored. OBJECTIVE: To evaluate the comparative effectiveness of usual care with or without chiropractic care for patients with chronic recurrent musculoskeletal back and neck pain. STUDY DESIGN: Prospective cohort study using propensity score-matched controls. PARTICIPANTS: Using retrospective electronic health record data, we developed a propensity score model predicting likelihood of chiropractic referral. Eligible patients with back or neck pain were then contacted upon referral for chiropractic care and enrolled in a prospective study. For each referred patient, two propensity score-matched non-referred patients were contacted and enrolled. We followed the participants prospectively for 6 months. MAIN MEASURES: Main outcomes included pain severity, interference, and symptom bothersomeness. Secondary outcomes included expenditures for pain-related health care. KEY RESULTS: Both groups' (N = 70 referred, 139 non-referred) pain scores improved significantly over the first 3 months, with less change between months 3 and 6. No significant between-group difference was observed. (severity - 0.10 (95% CI - 0.30, 0.10), interference - 0.07 (- 0.31, 0.16), bothersomeness - 0.1 (- 0.39, 0.19)). After controlling for variances in baseline costs, total costs during the 6-month post-enrollment follow-up were significantly higher on average in the non-referred versus referred group ($1996 [SD = 3874] vs $1086 [SD = 1212], p = .034). Adjusting for differences in age, gender, and Charlson comorbidity index attenuated this finding, which was no longer statistically significant (p = .072). CONCLUSIONS: We found no statistically significant difference between the two groups in either patient-reported or economic outcomes. As clinical outcomes were similar, and the provision of chiropractic care did not increase costs, making chiropractic services available provided an additional viable option for patients who prefer this type of care, at no additional expense.

Effect of Reminding Patients to Complete Fecal Immunochemical Testing: A Comparative Effectiveness Study of Automated and Live Approaches.

BACKGROUND: The Community Preventive Services Task Force recommends multi-component interventions, including patient reminders, to improve uptake of colorectal cancer screening. OBJECTIVE: We sought to compare the effectiveness of different forms of reminders for a direct-mail fecal immunochemical test (FIT) program. DESIGN: Patient-randomized controlled trial. PARTICIPANTS: 2772 adults aged 50-75, not up to date with colorectal cancer screening recommendations, with a clinic visit in the previous year at any of four participating health center clinics. INTERVENTION: Participants were mailed an introductory letter and FIT. Those who did not complete their FIT within 3 weeks were randomized to receive (1) a reminder letter, (2) two automated phone calls, (3) two text messages, (4) a live phone call, (5) a reminder letter and a live phone call, (6) two automated phone calls and a live phone call, or (7) two text messages and a live phone call. Patients with a patient portal account were sent two email reminders, but were not randomized. MAIN MEASURES: FIT return rates for each group, 6 months following randomization. KEY RESULTS: A total of 255 (10%) participants returned their FIT within 3 weeks of the mailing. Among randomized participants (n = 2010), an additional 25.5% returned their FITs after reminders were delivered (estimated overall return rate = 32.7%). In intention-to-treat analysis, compared to the group allocated to receive a reminder letter, return rates were higher for the group assigned to receive the live phone call (OR = 1.51 [1.03-2.21]) and lower for the group assigned to receive text messages (OR = 0.66 [0.43-0.99]). Reminder effectiveness differed by language preference. CONCLUSIONS: Our data suggest that FIT reminders that included a live call were more effective than reminders that relied solely on written communication (a text message or letter). TRIAL REGISTRATION: ClinicalTrials.gov/ctc2/show/NCT01742065 .

Predictors of Colorectal Cancer Screening Prior to Implementation of a Large Pragmatic Trial in Federally Qualified Health Centers.

Colorectal cancer screening can prevent cancer deaths. Federally qualified health centers serve a unique patient population that often is not screened. Knowing who in this environment is getting screened via fecal testing and via colonoscopy can assist in tailoring intervention to raise rates of colorectal cancer screening. We examined patient-level and neighborhood-level characteristics associated with being up to date with colorectal cancer screening guidelines. We also examined associations between these factors and being screened with a fecal test. We observed an increase in colorectal cancer screening rates from 2010 to 2015. Adjusted analyses revealed that the following factors were significantly associated with colorectal cancer screening: aged 65 or older, having any type of insurance, previous outpatient visits, and current or other preventive screenings. Among adults aged 50-75 who were up to date with colorectal cancer screening, factors associated with use of fecal testing, as opposed to colonoscopy, were: being younger, speaking a non-English language, being uninsured, having prior office visits, and having had a flu shot in past year. Our findings may inform clinic-based effort to raise rates of colorectal cancer screening, especially in the community clinic setting. TRIAL REGISTRATION: ClinicalTrials.gov , NCT01742065.

Prevalence and burden of chronic bronchitis symptoms: results from the BOLD study.

We studied the prevalence, burden and potential risk factors for chronic bronchitis symptoms in the Burden of Obstructive Lung Disease study.Representative population-based samples of adults aged ≥40 years were selected in participating sites. Participants completed questionnaires and spirometry. Chronic bronchitis symptoms were defined as chronic cough and phlegm on most days for ≥3 months each year for ≥2 years.Data from 24 855 subjects from 33 sites in 29 countries were analysed. There were significant differences in the prevalence of self-reported symptoms meeting our definition of chronic bronchitis across sites, from 10.8% in Lexington (KY, USA), to 0% in Ile-Ife (Nigeria) and Blantyre (Malawi). Older age, less education, current smoking, occupational exposure to fumes, self-reported diagnosis of asthma or lung cancer and family history of chronic lung disease were all associated with increased risk of chronic bronchitis. Chronic bronchitis symptoms were associated with worse lung function, more dyspnoea, increased risk of respiratory exacerbations and reduced quality of life, independent of the presence of other lung diseases.The prevalence of chronic bronchitis symptoms varied widely across the studied sites. Chronic bronchitis symptoms were associated with significant burden both in individuals with chronic airflow obstruction and those with normal lung function.

Unemployment in chronic airflow obstruction around the world: results from the BOLD study.

We aimed to examine associations between chronic airflow obstruction (CAO) and unemployment across the world.Cross-sectional data from 26 sites in the Burden of Obstructive Lung Disease (BOLD) study were used to analyse effects of CAO on unemployment. Odds ratios for unemployment in subjects aged 40-65 years were estimated using a multilevel mixed-effects generalised linear model with study site as random effect. Site-by-site heterogeneity was assessed using individual participant data meta-analyses.Out of 18 710 participants, 11.3% had CAO. The ratio of unemployed subjects with CAO divided by subjects without CAO showed large site discrepancies, although these were no longer significant after adjusting for age, sex, smoking and education. The site-adjusted odds ratio (95% CI) for unemployment was 1.79 (1.41-2.27) for CAO cases, decreasing to 1.43 (1.14-1.79) after adjusting for sociodemographic factors, comorbidities and forced vital capacity. Of other covariates that were associated with unemployment, age and education were important risk factors in high-income sites (4.02 (3.53-4.57) and 3.86 (2.80-5.30), respectively), while female sex was important in low- to middle-income sites (3.23 (2.66-3.91)).In the global BOLD study, CAO was associated with increased levels of unemployment, even after adjusting for sociodemographic factors, comorbidities and lung function.

Antipsychotic Use Among Adult Outpatients and Venous Thromboembolic Disease: A Retrospective Cohort Study.

BACKGROUND: Treatment with antipsychotic (AP) agents is associated with incident thromboembolic events. However, the underpinnings of this association remain unknown. We sought to evaluate the effect of AP agents-categorized by their metabolic/sedative and hyperprolactinemia adverse effect profile-on the risk of venous thromboembolic disease during long-term follow-up. METHODS: A retrospective cohort study of adult patients initiating AP treatment for the first time was conducted. Primary outcome was defined as the time to venous thromboembolism (VTE) (either deep venous thrombosis or acute pulmonary embolism). Antipsychotic agents were categorized by their risk (high vs low) of either drug-induced (a) sedation/metabolic adverse event or (b) hyperprolactinemia. We used a propensity score-adjusted Cox proportional hazards model to control for confounding. FINDINGS: One thousand eight patients (mean age, 72.4 y) were followed for a median of 36 months. Incident VTE occurred in 6.25% of patients, corresponding to an incidence rate of 184 cases per 10,000 person-years. We found no difference in the hazard of VTE during follow-up between high- and low-risk groups (hazard ratio, 1.23 [95% confidence interval, 0.74-2.04] for drug-induced sedation/metabolic adverse event risk categories, and hazard ratio 0.81 [95% confidence interval, 0.50-1.35] for high versus low hyperprolactinemia risk). CONCLUSIONS: These results suggest that the risk of thromboembolic events in older adults who started AP treatment for the first time does not seem to be related to these drugs' risk of either sedation/metabolic adverse events or hyperprolactinemia. However, VTE remains a common problem in this subgroup of patients.

An evaluation of constrained randomization for the design and analysis of group-randomized trials with binary outcomes.

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.

The feasibility of matching on a propensity score for acupuncture in a prospective cohort study of patients with chronic pain.

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.

Severity of Airflow Obstruction in Chronic Obstructive Pulmonary Disease (COPD): Proposal for a New Classification.

Current classifications of Chronic Obstructive Pulmonary Disease (COPD) severity are complex and do not grade levels of obstruction. Obstruction is a simpler construct and independent of ethnicity. We constructed an index of obstruction severity based on the FEV1/FVC ratio, with cut-points dividing the Burden of Obstructive Lung Disease (BOLD) study population into four similarly sized strata to those created by the GOLD criteria that uses FEV1. We measured the agreement between classifications and the validity of the FEV1-based classification in identifying the level of obstruction as defined by the new groupings. We compared the strengths of association of each classification with quality of life (QoL), MRC dyspnoea score and the self-reported exacerbation rate. Agreement between classifications was only fair. FEV1-based criteria for moderate COPD identified only 79% of those with moderate obstruction and misclassified half of the participants with mild obstruction as having more severe COPD. Both scales were equally strongly associated with QoL, exertional dyspnoea and respiratory exacerbations. Severity assessed using the FEV1/FVC ratio is only in moderate agreement with the severity assessed using FEV1 but is equally strongly associated with other outcomes. Severity assessed using the FEV1/FVC ratio is likely to be independent of ethnicity.

Improving Adherence to Cardiovascular Therapies: An Economic Evaluation of a Randomized Pragmatic Trial.

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.

Statistical lessons learned for designing cluster randomized pragmatic clinical trials from the NIH Health Care Systems Collaboratory Biostatistics and Design Core.

BACKGROUND/AIMS: Pragmatic clinical trials embedded within health care systems provide an important opportunity to evaluate new interventions and treatments. Networks have recently been developed to support practical and efficient studies. Pragmatic trials will lead to improvements in how we deliver health care and promise to more rapidly translate research findings into practice. METHODS: The National Institutes of Health (NIH) Health Care Systems Collaboratory was formed to conduct pragmatic clinical trials and to cultivate collaboration across research areas and disciplines to develop best practices for future studies. Through a two-stage grant process including a pilot phase (UH2) and a main trial phase (UH3), investigators across the Collaboratory had the opportunity to work together to improve all aspects of these trials before they were launched and to address new issues that arose during implementation. Seven Cores were created to address the various considerations, including Electronic Health Records; Phenotypes, Data Standards, and Data Quality; Biostatistics and Design Core; Patient-Reported Outcomes; Health Care Systems Interactions; Regulatory/Ethics; and Stakeholder Engagement. The goal of this article is to summarize the Biostatistics and Design Core's lessons learned during the initial pilot phase with seven pragmatic clinical trials conducted between 2012 and 2014. RESULTS: Methodological issues arose from the five cluster-randomized trials, also called group-randomized trials, including consideration of crossover and stepped wedge designs. We outlined general themes and challenges and proposed solutions from the pilot phase including topics such as study design, unit of randomization, sample size, and statistical analysis. Our findings are applicable to other pragmatic clinical trials conducted within health care systems. CONCLUSION: Pragmatic clinical trials using the UH2/UH3 funding mechanism provide an opportunity to ensure that all relevant design issues have been fully considered in order to reliably and efficiently evaluate new interventions and treatments. The integrity and generalizability of trial results can only be ensured if rigorous designs and appropriate analysis choices are an essential part of their research protocols.

The validation of electronic health records in accurately identifying patients eligible for colorectal cancer screening in safety net clinics.

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.