Statin Use for the Primary Prevention of Cardiovascular Disease in Adults: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force.

Importance: A 2016 review for the US Preventive Services Task Force (USPSTF) found use of statins for primary prevention of cardiovascular disease (CVD) was associated with reduced mortality and cardiovascular outcomes. Objective: To update the 2016 review on statins for primary prevention of CVD to inform the USPSTF. Data Sources: Ovid MEDLINE, Cochrane Central Register of Controlled Trials, and Cochrane Database of Systematic Reviews (to November 2021); surveillance through May 20, 2022. Study Selection: Randomized clinical trials on statins vs placebo or no statin and statin intensity in adults without prior cardiovascular events; large cohort studies on harms. Data Extraction and Synthesis: One investigator abstracted data; a second checked accuracy. Two investigators independently rated study quality. Main Outcomes and Measures: All-cause and cardiovascular mortality, myocardial infarction, stroke, composite cardiovascular outcomes, and adverse events. Results: Twenty-six studies were included: 22 trials (N = 90 624) with 6 months to 6 years of follow-up compared statins vs placebo or no statin, 1 trial (n = 5144) compared statin intensities, and 3 observational studies (n = 417 523) reported harms. Statins were significantly associated with decreased risk of all-cause mortality (risk ratio [RR], 0.92 [95% CI, 0.87 to 0.98]; absolute risk difference [ARD], -0.35% [95% CI, -0.57% to -0.14%]), stroke (RR, 0.78 [95% CI, 0.68 to 0.90]; ARD, -0.39% [95% CI, -0.54% to -0.25%]), myocardial infarction (RR, 0.67 [95% CI, 0.60 to 0.75]; ARD, -0.85% [95% CI, -1.22% to -0.47%]), and composite cardiovascular outcomes (RR, 0.72 [95% CI, 0.64 to 0.81]; ARD, -1.28% [95% CI, -1.61% to -0.95%]); the association with cardiovascular mortality was not statistically significant (RR, 0.91 [95% CI, 0.81 to 1.02]; ARD, -0.13%). Relative benefits were consistent in groups defined by demographic and clinical characteristics, although data for persons older than 75 years were sparse. Statin therapy was not significantly associated with increased risk of serious adverse events (RR, 0.97 [95% CI, 0.93 to 1.01]), myalgias (RR, 0.98 [95% CI, 0.86 to 1.11]), or elevated alanine aminotransferase level (RR, 0.94 [95% CI, 0.78 to 1.13]). Statin therapy was not significantly associated with increased diabetes risk overall (RR, 1.04 [95% CI, 0.92 to 1.19]), although 1 trial found high-intensity statin therapy was significantly associated with increased risk (RR, 1.25 [95% CI, 1.05 to 1.49]). Otherwise, there were no clear differences in outcomes based on statin intensity. Conclusions and Relevance: In adults at increased CVD risk but without prior CVD events, statin therapy for primary prevention of CVD was associated with reduced risk of all-cause mortality and CVD events. Benefits of statin therapy appear to be present across diverse demographic and clinical populations, with consistent relative benefits in groups defined by demographic and clinical characteristics.

Telehealth Strategies for the Delivery of Maternal Health Care : A Rapid Review.

BACKGROUND: Telehealth strategies to supplement or replace in-person maternity care may affect maternal health outcomes. PURPOSE: To conduct a rapid review of the effectiveness and harms of telehealth strategies for maternal health care given the recent expansion of telehealth arising from the COVID-19 pandemic, and to produce an evidence map. DATA SOURCES: Systematic searches of MEDLINE, the Cochrane Library, CINAHL, Embase, and Scopus for English-language studies (January 2015 to April 2022). STUDY SELECTION: Randomized controlled trials (RCTs) and observational studies of maternal care telehealth strategies versus usual care. DATA EXTRACTION: Dual data extraction and risk-of-bias assessment of studies, with disagreements resolved through consensus. DATA SYNTHESIS: 28 RCTs and 14 observational studies (n = 44 894) were included. Maternal telehealth interventions supplemented in-person care for most studies of mental health and diabetes during pregnancy, primarily resulting in similar, and sometimes better, clinical and patient-reported outcomes versus usual care. Supplementing in-person mental health care with phone- or web-based platforms or mobile applications resulted in similar or better mental health outcomes versus in-person care. A reduced-visit prenatal care schedule using telehealth to replace in-person general maternity care for low-risk pregnancies resulted in similar clinical outcomes and higher patient satisfaction versus usual care. Overall, telehealth strategies were heterogeneous and resulted in similar obstetric and patient satisfaction outcomes. Few studies addressed disparities, health equity, or harms. LIMITATIONS: Interventions varied, and evidence was inadequate for some clinical outcomes. CONCLUSION: Replacing or supplementing in-person maternal care with telehealth generally results in similar, and sometimes better, clinical outcomes and patient satisfaction compared with in-person care. The effect on access to care, health equity, and harms is unclear. PRIMARY FUNDING SOURCE: Patient-Centered Outcomes Research Institute. (PROSPERO: CRD42021276347).

Cannabis-Based Products for Chronic Pain : A Systematic Review.

BACKGROUND: Contemporary data are needed about the utility of cannabinoids in chronic pain. PURPOSE: To evaluate the benefits and harms of cannabinoids for chronic pain. DATA SOURCES: Ovid MEDLINE, PsycINFO, EMBASE, the Cochrane Library, and Scopus to January 2022. STUDY SELECTION: English-language, randomized, placebo-controlled trials and cohort studies (≥1 month duration) of cannabinoids for chronic pain. DATA EXTRACTION: Data abstraction, risk of bias, and strength of evidence assessments were dually reviewed. Cannabinoids were categorized by THC-to-CBD ratio (high, comparable, or low) and source (synthetic, extract or purified, or whole plant). DATA SYNTHESIS: Eighteen randomized, placebo-controlled trials (n = 1740) and 7 cohort studies (n = 13 095) assessed cannabinoids. Studies were primarily short term (1 to 6 months); 56% enrolled patients with neuropathic pain, with 3% to 89% female patients. Synthetic products with high THC-to-CBD ratios (>98% THC) may be associated with moderate improvement in pain severity and response (≥30% improvement) and an increased risk for sedation and are probably associated with a large increased risk for dizziness. Extracted products with high THC-to-CBD ratios (range, 3:1 to 47:1) may be associated with large increased risk for study withdrawal due to adverse events and dizziness. Sublingual spray with comparable THC-to-CBD ratio (1.1:1) probably is associated with small improvement in pain severity and overall function and may be associated with large increased risk for dizziness and sedation and moderate increased risk for nausea. Evidence for other products and outcomes, including longer-term harms, were not reported or were insufficient. LIMITATION: Variation in interventions; lack of study details, including unclear availability in the United States; and inadequate evidence for some products. CONCLUSION: Oral, synthetic cannabis products with high THC-to-CBD ratios and sublingual, extracted cannabis products with comparable THC-to-CBD ratios may be associated with short-term improvements in chronic pain and increased risk for dizziness and sedation. Studies are needed on long-term outcomes and further evaluation of product formulation effects. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services. (PROSPERO: CRD42021229579).

Effectiveness of Patient Navigation to Increase Cancer Screening in Populations Adversely Affected by Health Disparities: a Meta-analysis.

BACKGROUND: This study evaluates the effectiveness of patient navigation to increase screening for colorectal, breast, and cervical cancer in populations adversely affected by health care disparities. METHODS: Eligible studies were identified through English-language searches of Ovid® MEDLINE®, PsycINFO®, SocINDEX, and Veterans Affairs Health Services database (January 1, 1996, to July 5, 2019) and manual review of reference lists. Randomized trials and observational studies of relevant populations that evaluated the effectiveness of patient navigation on screening rates for colorectal, breast, or cervical cancer compared with usual or alternative care comparison groups were included. Two investigators independently abstracted study data and assessed study quality and applicability using criteria adapted from the U.S. Preventive Services Task Force. Discrepancies were resolved by consensus with a third reviewer. Results were combined using profile likelihood random effects models. RESULTS: Thirty-seven studies met inclusion criteria (28 colorectal, 11 breast, 4 cervical cancers including 3 trials with multiple cancer types). Screening rates were higher with patient navigation for colorectal cancer overall (risk ratio [RR] 1.64; 95% confidence interval [CI] 1.42 to 1.92; I2 = 93.7%; 22 trials) and by type of test (fecal occult blood or immunohistochemistry testing [RR 1.69; 95% CI 1.33 to 2.15; I2 = 80.5%; 6 trials]; colonoscopy/endoscopy [RR 2.08; 95% CI 1.08 to 4.56; I2 = 94.6%; 6 trials]). Screening was also higher with navigation for breast cancer (RR 1.50; 95% CI 1.22 to 1.91; I2 = 98.6%; 10 trials) and cervical cancer (RR 1.11; 95% CI 1.05 to 1.19; based on the largest trial). The high heterogeneity of cervical cancer studies prohibited meta-analysis. Results were similar for colorectal and breast cancer regardless of prior adherence to screening guidelines, follow-up time, and study quality. CONCLUSIONS: In populations adversely affected by disparities, colorectal, breast, and cervical cancer screening rates were higher in patients provided navigation services. Registration: PROSPERO: CRD42018109263.

Screening for Hepatitis C Virus Infection in Adolescents and Adults: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force.

IMPORTANCE: A 2013 review for the US Preventive Services Task Force (USPSTF) of hepatitis C virus (HCV) screening found interferon-based antiviral therapy associated with increased likelihood of sustained virologic response (SVR) and an association between achieving an SVR and improved clinical outcomes. New direct-acting antiviral (DAA) regimens are available. OBJECTIVE: To update the 2013 review on HCV screening to inform the USPSTF. DATA SOURCES: Ovid MEDLINE, the Cochrane Central Register of Controlled Trials, and the Cochrane Database of Systematic Reviews through February 2019, with surveillance through September 2019. STUDY SELECTION: Randomized clinical trials (RCTs) and nonrandomized treatment studies of HCV screening and DAA therapy; cohort studies on screening, antiviral therapy, and the association between an SVR after antiviral therapy and clinical outcomes. DATA EXTRACTION AND SYNTHESIS: One investigator abstracted data; a second checked accuracy. Two investigators independently rated study quality. MAIN OUTCOMES AND MEASURES: Mortality, morbidity, quality of life, screening and treatment harms, and screening diagnostic yield. RESULTS: Eight RCTs of DAA therapy vs placebo or an outdated antiviral regimen, 48 other treatment studies, and 33 cohort studies, with a total of 179 230 participants, were included. No study evaluated effects of HCV screening vs no screening. One new study since the 2013 review (n = 5917) found similar diagnostic yield of risk-based screening (sensitivity, 82%; number needed to screen to identify 1 HCV case, 15) and birth cohort screening (sensitivity, 76%; number needed to screen, 29), assuming perfect implementation. Ten open-label studies (n = 3292) reported small improvements in some quality-of-life and functional outcomes (eg, less than 3 points on the 0 to 100 36-Item Short Form Health Survey physical and mental component summary scales) after DAA treatment compared with before treatment. Two cohort studies (n = 24 686) found inconsistent associations of antiviral therapy vs no therapy with risk of hepatocellular carcinoma. Forty-nine treatment studies (n = 10 181) found DAA regimens associated with pooled SVR rates greater than 95% across genotypes, and low short-term rates of serious adverse events (1.9%) and withdrawal due to adverse events (0.4%). An SVR after antiviral therapy was associated with decreased adjusted risk of all-cause mortality (13 studies, n = 36 986; pooled hazard ratio [HR], 0.40 [95% CI, 0.28-0.56) and hepatocellular carcinoma (20 studies, n = 84 491; pooled HR, 0.29 [95% CI, 0.23 to 0.38]) vs no SVR. CONCLUSIONS AND RELEVANCE: Direct evidence on the effects of HCV screening on clinical outcomes remains unavailable, but DAA regimens were associated with SVR rates greater than 5% and few short-term harms relative to older antiviral therapies. An SVR after antiviral therapy was associated with improved clinical outcomes compared with no SVR.

Achieving Health Equity in Preventive Services: A Systematic Review for a National Institutes of Health Pathways to Prevention Workshop.

Background: Disadvantaged populations in the United States experience disparities in the use of preventive health services. Purpose: To examine effects of barriers that create health disparities in 10 recommended preventive services for adults, and to evaluate the effectiveness of interventions to reduce them. Data Sources: English-language searches of Ovid MEDLINE, PsycINFO, SocINDEX, and the Veterans Affairs Health Services database (1 January 1996 to 5 July 2019); reference lists. Study Selection: Trials, observational studies with comparison groups, and systematic reviews of populations adversely affected by disparities that reported effects of barriers on use of any of the 10 selected preventive services or that reported the effectiveness of interventions to reduce disparities in use of a preventive service by improving intermediate or clinical outcomes. Data Extraction: Dual extraction and assessment of study quality, strength of evidence, and evidence applicability. Data Synthesis: No studies reported effects of provider-specific barriers on preventive service use. Eighteen studies reporting effects of patient barriers, such as insurance coverage or lack of a regular provider, on preventive service use had mixed and inconclusive findings. Studies of patient-provider interventions (n = 12), health information technologies (n = 11), and health system interventions (n = 88) indicated higher cancer screening rates with patient navigation; telephone calls, prompts, and other outreach methods; reminders involving lay health workers; patient education; risk assessment, counseling, and decision aids; screening checklists; community engagement; and provider training. Single studies showed that clinician-delivered and technology-assisted interventions improved rates of smoking cessation and weight loss, respectively. Limitation: Insufficient or low strength of evidence and applicability for most interventions except patient navigation, telephone calls and prompts, and reminders involving lay health workers. Conclusion: In populations adversely affected by disparities, patient navigation, telephone calls and prompts, and reminders involving lay health workers increase cancer screening. Primary Funding Source: National Institutes of Health Office of Disease Prevention through an interagency agreement with the Agency for Healthcare Research and Quality. (PROSPERO: CRD42018109263).

Short-Term Acute Exercise Preconditioning Reduces Neurovascular Injury After Stroke Through Induced eNOS Activation.

Physical exercise is known to reduce cardiovascular risk but its role in ischemic stroke is not clear. It was previously shown that an acute single bout of exercise reduced increased eNOS activation in the heart and reduced myocardial infarction. However, the impact of a single bout or short-term exercise on eNOS-induced neuroprotection after stroke was not previously studied. Accordingly, this study was designed to test the hypothesis that short-term acute exercise can provide "immediate neuroprotection" and improve stroke outcomes through induced eNOS activation. Male Wistar rats (300 g) were subjected to HIIT treadmill exercise for 4 days (25 min/day), break for 2 days, and then one acute bout for 30 min. Exercised animals were subjected to thromboembolic stroke 1 h, 6 h, 24 h, or 72 h after the last exercise session. At 24 h after stroke, control (sedentary) and exercised rats were tested for neurological outcomes, infarct size, and edema. The expression of active eNOS (p-S1177-eNOS) and active AMPK (p-T172-AMPK) was measured in the brain, cerebral vessels, and aorta. In an additional cohort, animals were treated with the eNOS inhibitor, L-NIO (I.P, 20 mg/kg), and stroked 1 h after exercise and compared with non-exercise animals. Acute exercise significantly reduced infarct size, edema, and improved functional outcomes, and significantly increased the expression of peNOS and pAMPK in the brain, cerebral vessels, and aorta. eNOS inhibition abolished the exercise-induced improvement in outcomes. Short-term acute preconditioning exercise reduced the neurovascular injury and improved functional outcomes after stroke through eNOS activation.

Implementing Risk Stratification in Primary Care: Challenges and Strategies.

INTRODUCTION: Primary care risk stratification (RS) has been shown to help practices better understand their patient populations' needs and may improve health outcomes and reduce expenditures by targeting and tailoring care to high-need patients. This study aims to understand key considerations practices faced and practice experiences as they began to implement RS models. METHODS: We conducted semistructured interviews about experiences in RS with 34 stakeholders from 15 primary care practices in Oregon and Colorado and qualitatively analyzed the data. RESULTS: Three decisions were important in shaping practices' experiences with RS: choosing established versus self-created algorithms or heuristics, clinical intuition, or a combination; selecting mechanisms for assigning risk scores; determining how to integrate RS approaches into care delivery. Practices using clinical intuition found stratification time-consuming and difficult to incorporate into existing workflows, but trusted risk scores more than those using algorithms. Trust in risk scores was influenced by data extraction capabilities; practices often lacked sufficient data to calculate their perceived optimal risk score. Displaying the scores to the care team was a major issue. Finally, obtaining buy-in from care team members was challenging, requiring repeated cycles of improvement and workflow integration. DISCUSSION: Practices used iterative approaches to RS implementation. As a result, procedural and algorithmic changes were introduced and were influenced by practices' health IT, staffing, and resource capacities. Practices were most successful when able to make iterative changes to their approaches, incorporated both automation and human process in RS, educated staff on the importance of RS, and had readily accessible risk scores.

Defining High Value Elements for Reducing Cost and Utilization in Patient-Centered Medical Homes for the TOPMED Trial.

INTRODUCTION: Like most patient-centered medical home (PCMH) models, Oregon's program, the Patient-Centered Primary Care Home (PCPCH), aims to improve care while reducing costs; however, previous work shows that PCMH models do not uniformly achieve desired outcomes. Our objective was to describe a process for refining PCMH models to identify high value elements (HVEs) that reduce cost and utilization. METHODS: We performed a targeted literature review of each PCPCH core attribute. Value-related concepts and their metrics were abstracted, and studies were assessed for relevance and strength of evidence. Focus groups were held with stakeholders and patients, and themes related to each attribute were identified; calculation of HVE attainment versus PCPCH criteria were completed on eight primary care clinics. Analyses consisted of descriptive statistics and criterion validity with stakeholder input. RESULTS: 2,126 abstracts were reviewed; 22 met inclusion criteria. From these articles and focus groups of stakeholders/experts (n = 49; 4 groups) and patients (n = 7; 1 group), 12 HVEs were identified that may reduce cost and utilization. At baseline, clinics achieved, on average, 31.3 percent HVE levels compared to an average of 87.9 percent of the 35 PCMH measures. DISCUSSION: A subset of measures from the PCPCH model were identified as "high value" in reducing cost and utilization. HVE performance was significantly lower than standard measures, and may better calibrate clinic ability to reduce costs. CONCLUSION: Through literature review and stakeholder engagement, we created a novel set of high value elements for advanced primary care likely to be more related to cost and utilization than other models.

Tailored treatment of patients with hepatocellular carcinoma with portal vein invasion: experience from a multidisciplinary hepatobiliary tumor program within a NCI comprehensive cancer center.

BACKGROUND: Hepatocellular carcinoma (HCC) with portal vein invasion (PVI) has a poor prognosis with limited treatment options. Intra-arterial brachytherapy (IAB) and transarterial chemoembolization (TACE) yield local control but risk accelerating liver dysfunction. The outcomes, survival, and safety of selective liver-directed treatment are reported. METHODS: Thirty-seven consecutive patients with HCC and PVI treated between 2009 and 2015 were reviewed from a prospectively collected database. Univariate analysis, Kaplan-Meier plots using the log-rank method, and multivariate analyses were performed. Statistical significance was defined as P<0.05. Overall survival was reported in months (median; 95% CI). RESULTS: Most patients (59%) had PVI identified at initial HCC diagnosis. The liver-directed therapy group (n=22) demonstrated a survival advantage versus the systemic/supportive care group (n=14) [23.6 (5.8, 30.9) vs. 6.0 (3.5, 8.8) months]. Patients indicated for liver directed therapy had unilateral liver involvement (100% vs. 43%, P<0.0001), lower median alkaline phosphatase (105.5 vs. 208.0, P=0.002), and lower mean Child-Turcotte-Pugh (CTP) score (5.9 vs. 7.2, P=0.04) and tolerated treatment without serious complications. CONCLUSIONS: In HCC patients presenting with PVI, liver-directed therapy was safely performed in patients with limited venous involvement and preserved liver function. Liver-directed therapy extended survival for these patients indicated for palliative chemotherapy by traditional guidelines.

Chronic Remote Ischemic Conditioning Is Cerebroprotective and Induces Vascular Remodeling in a VCID Model.

Vascular contributions to cognitive impairment and dementia (VCID) make up 50% of the cases of dementia. The purpose of this study was to determine the effect of chronic remote ischemic conditioning (C-RIC) on improving long-term (6 months) outcomes and cerebral blood flow (CBF) and collateral formation in a mouse model of VCID. Adult C57BL/6J male mice (10 weeks) were randomly assigned to four different groups: (1) sham-bilateral carotid artery stenosis (BCAS), (2) BCAS + sham RIC, (3) BCAS+C-RIC for 1 month (1MO), and (4) BCAS+C-RIC-4 months (4MO). CBF, cognitive impairment, and functional outcomes were performed up for 6 months after BCAS surgery. The expression of CD31, α-SMA, and myelin basic protein (MBP) was assessed by immunohistochemistry (IHC). Additional set of mice were randomized to sham, BCAS, and BCAS+C-RIC. The cerebrovascular angioarchitecture was studied with micro-CT. RIC therapy for either 1 or 4 months significantly improved CBF, new collateral formation, functional and cognitive outcomes, and prevented white matter damage. There was no difference between C-RIC for 1 or 4 months; IHC studies at 6 months showed an increase in brain CD31 and α-SMA expression indicating increased angiogenesis and MBP indicating preservation of white matter in animals receiving RIC. One month of daily RIC is as effective as 4 months of daily RIC in improving CBF, angiogenesis, and long-term functional outcomes (6 months) in a VCID model. This suggests that 1 month of RIC is sufficient to reduce cognitive impairment and induce beneficial cerebrovascular remodeling.

Perceptions of Risk Stratification Workflows in Primary Care.

Risk stratification (RS) in primary care is frequently used by policy-makers, payers, and health systems; the process requires risk assessment for adverse health outcomes across a population to assign patients into risk tiers and allow care management (CM) resources to be targeted effectively. Our objective was to understand the approach to and perception of RS in primary care practices. An online survey was developed, tested, and administered to 148 representatives of 37 primary care practices engaged in RS varying in size, location and ownership. The survey assessed practices' approach to, perception of, and confidence in RS, and its effect on subsequent CM activities. We examined psychometric properties of the survey to determine validity and conducted chi-square analyses to determine the association between practice characteristics and confidence and agreement with risk scores. The survey yielded a 68% response rate (100 respondents). Overall, participants felt moderately confident in their risk scores (range 41-53.8%), and moderately to highly confident in their subsequent CM workflows (range 46-68%). Respondents from small and independent practices were more likely to have higher confidence and agreement with their RS approaches and scores (p < 0.01). Confidence levels were highest, however, when practices incorporated human review into their RS processes (p < 0.05). This trend was not affected by respondents' professional roles. Additional work from a broad mixed-methods effort will add to our understanding of RS implementation processes and outcomes.

Comparison of EHR-based diagnosis documentation locations to a gold standard for risk stratification in patients with multiple chronic conditions.

OBJECTIVE: To measure variation among four different Electronic Health Record (EHR) system documentation locations versus 'gold standard' manual chart review for risk stratification in patients with multiple chronic illnesses. METHODS: Adults seen in primary care with EHR evidence of at least one of 13 conditions were included. EHRs were manually reviewed to determine presence of active diagnoses, and risk scores were calculated using three different methodologies and five EHR documentation locations. Claims data were used to assess cost and utilization for the following year. Descriptive and diagnostic statistics were calculated for each EHR location. Criterion validity testing compared the gold standard verified diagnoses versus other EHR locations and risk scores in predicting future cost and utilization. RESULTS: Nine hundred patients had 2,179 probable diagnoses. About 70% of the diagnoses from the EHR were verified by gold standard. For a subset of patients having baseline and prediction year data (n=750), modeling showed that the gold standard was the best predictor of outcomes on average for a subset of patients that had these data. However, combining all data sources together had nearly equivalent performance for prediction as the gold standard. CONCLUSIONS: EHR data locations were inaccurate 30% of the time, leading to improvement in overall modeling from a gold standard from chart review for individual diagnoses. However, the impact on identification of the highest risk patients was minor, and combining data from different EHR locations was equivalent to gold standard performance. The reviewer's ability to identify a diagnosis as correct was influenced by a variety of factors, including completeness, temporality, and perceived accuracy of chart data.

Effect of a Pragmatic, Cluster-randomized Controlled Trial on Patient Experience With Care: The Transforming Outcomes for Patients Through Medical Home Evaluation and reDesign (TOPMED) Study.

BACKGROUND: Health reform programs like the patient-centered medical home are intended to improve the triple aim. Previous studies on patient-centered medical homes have shown mixed effects, but high value elements (HVEs) are expected to improve the triple aim. OBJECTIVE: The aim of this study is to understand whether focusing on HVEs would improve patient experience with care. METHODS: Eight clinics were cluster-randomized in a year-long trial. Both arms received practice facilitation, IT-based reporting, and financial incentives. Intervention practices were encouraged to choose HVEs for quality improvement goals. To assess patient experience, 1597 Consumer Assessment of Healthcare Providers and Systems surveys were sent pretrial and posttrial to a stratified random sample of patients. Difference-in-difference multivariate analysis was used to compare patient responses from intervention and control practices, adjusting for confounders. RESULTS: The response rate was 43% (n=686). Nonrespondent analysis showed no difference between arms, although differences were seen by risk status and age. The overall difference in difference was 2.8%, favoring the intervention. The intervention performed better in 9 of 11 composites. The intervention performed significantly better in follow-up on test results (P=0.091) and patients' rating of the provider (P=0.091), whereas the control performed better in access to care (P=0.093). Both arms also had decreases, including 4 of 11 composites for the intervention, and 8 of 11 for the control. DISCUSSION: Practices that targeted HVEs showed significantly more improvement in patient experience of care. However, contemporaneous trends may have affected results, leading to declines in patient experience in both arms.

Study protocol: transforming outcomes for patients through medical home evaluation and redesign: a cluster randomized controlled trial to test high value elements for patient-centered medical homes versus quality improvement.

BACKGROUND: Health care in the United States is in the midst of a near perfect storm: strong cost pressures, dramatic redesign efforts like patient-centered medical homes and accountable care organizations, and a broad series of payment and eligibility reforms. To date, alternative models of care intended to reduce costs and improve outcomes have shown mixed effects in the U.S., in part due to the difficulty of performing rigorous evaluation studies that control for the broader transformation while avoiding other biases, such as organizational or clinic effect on individual patient outcomes. Our objective is to test whether clinics assigned to achieve high value elements (HVEs) of practice redesign are more likely than controls to achieve improvements in patient health and satisfaction with care and reduction in costs. METHODS/DESIGN: To prepare, we interview stakeholders, align with health reform, and propose a pilot. Participants are primary care clinics engaged in reform. Study protocol requires that both arms receive monthly practice facilitation, IT-based milestone reporting, and small financial incentives based on self-determined quality improvement (QI) goals; intervention receives additional prompting to choose HVEs. Design is a cluster randomized controlled trial over 1 year with pre- and post-washout periods. Outcomes are unplanned utilization and costs, patient experience of care, quality, and team performance. Analysis is a multivariate difference-in-difference with adjustments for patient risk, intraclinic correlation, and other confounders. DISCUSSION: The TOPMED study is a cluster randomized controlled trial focused on learning how primary care practices can transform within health reform guidelines to achieve outcomes related to the Triple Aim. TRIAL REGISTRATION: ClinicalTrials.gov registration: NCT02106221.

Safety and outcomes following resection of colorectal liver metastases in the era of current perioperative chemotherapy.

BACKGROUND: Preoperative chemotherapy is increasingly utilized in the treatment of colorectal liver metastases (CRLM). Although this strategy may improve resectability, long-term advantages of preoperative chemotherapy for resectable CRLM are less clear. The objective of this study is to report safety and outcomes when perioperative chemotherapy is routinely added to surgery for CRLM. METHODS: A retrospective review of patients undergoing liver resections for CRLM during 2003-2011 in single academic oncology center. Demographic data, tumor characteristics, chemotherapy, surgical details, complications and survival were analyzed. RESULTS: The study included 157 patients that underwent 168 liver operations. One hundred eighteen patients (70 %) underwent preoperative chemotherapy (75 % oxaliplatin-based). Preoperative portal vein embolization was utilized in 16 (10.1 %) patients. Overall survival (OS) was 89, 57, and 27 % at 1, 3, and 5 years, respectively (median survival-42.8 months). Eleven (7 %) patients had repeat resections for liver recurrence. Thirty-day mortality was 1.26 %, morbidity-24 % (6 %-liver related). Complications were not significantly different in patients that had preoperative chemotherapy. On a multivariate analysis advanced age and >3 lesions predicted poor OS, while advanced age, lesions >5 cm, synchronous lesions, margin-positivity and resection less than hepatectomy were associated with decreased DFS. CONCLUSIONS: Our results suggest that even with chemotherapy and resection only a subset of patients remain disease-free after 5 years. However, even in a high-risk patient with multiple lesions, preoperative chemotherapy can be administered safely without apparent increase in postoperative complications. Perioperative chemotherapy should be considered particularly in patients with multifocal or large lesions, synchronous disease and short disease-free interval.

Estimated use of industrial chemicals in Connecticut.

BACKGROUND: Chemical exposures in the workplace are poorly documented and researched, yet appear to be widespread and with significant potential for impacting worker health. There are few reporting requirements for chemical usage on a national level. METHODS: Chemical usage reports and employment data from Massachusetts were categorized by manufacturing subsector. Connecticut employment was compared to Massachusetts data, with the employment fraction used to estimate chemical usage in Connecticut. RESULTS: The chemical manufacturing sector was estimated to use 620 million pounds of chemicals annually in Connecticut, and all other manufacturing sectors combined used an estimated 50 million pounds, with approximately half listed as carcinogens or reproductive hazards. Potential health effects are presented. CONCLUSION: Widespread chemicaluse underscores the need for the development and use of safer alternatives, as well as additional documentation of potential health effects. Physicians should be aware of potential chemical exposures for patients and provide preventive advice.

Recidivism rates among mentally ill inmates: impact of the Connecticut Offender Reentry Program.

This study compares data from the Connecticut Offender Reentry Program (CORP) and retrospective data for inmates who received standard treatment planning services from the Connecticut Department of Mental Health and Addictions Services (DMHAS). Analysis of DMHAS data investigated characteristics (demographic, psychiatric, and prison classification scores) and recidivism rates of 883 individuals. A program evaluation was later completed on a separate cohort of 88 individuals who participated in CORP. Comparison of the study results found that 14.1% of the CORP participants were rearrested within 6 months of discharge compared to 28.3% of the DMHAS group. This study concluded that younger age and having a co-occurring substance use disorder appear to be predictors of recidivism. A distinctly smaller percentage of CORP participants were recidivistic, indicating support for specialized reentry programs.

Closing the quality gap: revisiting the state of the science (vol. 5: public reporting as a quality improvement strategy).

OBJECTIVES: The goal of this review was to evaluate the effectiveness of public reporting of health care quality information as a quality improvement strategy. We sought to determine if public reporting results in improvements in health care delivery and patient outcomes. We also considered whether public reporting affects the behavior of patients or of health care providers. Finally we assessed whether the characteristics of the public reports and the context affect the impact of public reports. DATA SOURCES: Articles available between 1980 and 2011 were identified through searches of the following bibliographical databases: MEDLINE®, Embase, EconLit, PsychINFO, Business Source Premier, CINAHL, PAIS, Cochrane Database of Systematic Reviews, EPOC Register of Studies, DARE, NHS EED, HEED, NYAM Grey Literature Report database, and other sources (experts, reference lists, and gray literature). REVIEW METHODS: We screened citations based on inclusion and exclusion criteria developed based on our definition of public reporting. We initially did not exclude any studies based on study design. Of the 11,809 citations identified through title and abstract triage, we screened and reviewed 1,632 articles. A total of 97 quantitative and 101 qualitative studies were included, abstracted, entered into tables, and evaluated. The heterogeneity of outcomes as well as methods prohibited formal quantitative synthesis. Systematic reviews were used to identify studies, but their conclusions were not incorporated into this review. RESULTS: For most of the outcomes, the strength of the evidence available to assess the impact of public reporting was moderate. This was due in part to the methodological challenges researchers face in designing and conducting research on the impact of population-level interventions. Public reporting is associated with improvement in health care performance measures such as those included in Nursing Home Compare. Almost all identified studies found no evidence or only weak evidence that public reporting affects the selection of health care providers by patients or their representatives. Studies of health care providers' response to public reports suggest they engage in activities to improve quality when performance data are made public. Characteristics of public reports and the context, which are likely to be important when considering the diffusion of quality improvement activities, were rarely studied or even described. CONCLUSIONS: The heterogeneity of the outcomes and the moderate strength of evidence for most outcomes make it difficult to draw definitive conclusions. However, some observations were supported by existing research. Public reporting is more likely to be associated with changes in health care provider behaviors than with selection of health services providers by patients or families. Quality measures that are publicly reported improve over time. Although the potential for harms is frequently cited by commentators and critics of public reporting, the amount of research on harms is limited and most studies do not confirm the potential harm.