[Evidence-based interventions to treat chronic low back pain: treatment selection for a personalized medicine approach : German version]. / Evidenzbasierte Interventionen zur Behandlung von chronischem Schmerz im unteren Rücken ­ Therapieauswahl für einen personalisierten Behandlungsansatz : Deutsche Fassung.

INTRODUCTION: Chronic low back pain (cLBP) is highly prevalent in the United States and globally, resulting in functional impairment and lowered quality of life. While many treatments are available for cLBP, clinicians have little information about which specific treatment(s) will work best for individual patients or subgroups of patients. The Back Pain Research Consortium, part of the National Institutes of Health Helping to End Addiction Long-termSM (HEAL) Initiative, will conduct a collaborative clinical trial, which seeks to develop a personalized medicine algorithm to optimize patient and provider treatment selection for patients with cLBP. OBJECTIVE: The primary objective of this article is to provide an update on evidence-based cLBP interventions and describe the process of reviewing and selecting interventions for inclusion in the clinical trial. METHODS: A working group of cLBP experts reviewed and selected interventions for inclusion in the clinical trial. The primary evaluation measures were strength of evidence and magnitude of treatment effect. When available in the literature, duration of effect, onset time, carryover effect, multimodal efficacy, responder subgroups, and evidence for the mechanism of treatment effect or biomarkers were considered. CONCLUSION: The working group selected 4 leading, evidence-based treatments for cLBP to be tested in the clinical trial and for use in routine clinical treatment. These treatments include (1) duloxetine, (2) acceptance and commitment therapy, (3) a classification-based exercise and manual therapy intervention, and (4) a self-management approach. These interventions each had a moderate to high level of evidence to support a therapeutic effect and were from different therapeutic classes.

Post-acute Ambulatory Care Service Use Among Patients Discharged Home After Stroke or TIA: The Cluster-randomized COMPASS Study.

BACKGROUND AND OBJECTIVES: We examined transitional care management within 90 days and 1 year following discharge home among acute stroke and transient ischemic attack patients from the Comprehensive Post-Acute Stroke Services (COMPASS) Study, a cluster-randomized pragmatic trial of early supported discharge conducted in 41 hospitals (40 hospital units) in North Carolina, United States. METHODS: Data for 2262 of the total 6024 (37.6%; 1069 intervention and 1193 usual care) COMPASS patients were linked with the Centers for Medicare and Medicaid Services fee-for-service Medicare claims. Time to the first ambulatory care visit was examined using Cox proportional hazard models adjusted for patient characteristics not included in the randomization protocol. RESULTS: Only 6% of the patients [mean (SD) age 74.9 (10.2) years, 52.1% women, 80.3% White)] did not have an ambulatory care visit within 90 days postdischarge. Mean time (SD) to first ambulatory care visit was 12.0 (26.0) and 16.3 (35.1) days in intervention and usual care arms, respectively, with the majority of visits in both study arms to primary care providers. The COMPASS intervention resulted in a 27% greater use of ambulatory care services within 1 year postdischarge, relative to usual care [HR=1.27 (95% CI: 1.14-1.41)]. The use of transitional care billing codes was significantly greater in the intervention arm as compared with usual care [OR=1.87 (95% CI: 1.54-2.27)]. DISCUSSION: The COMPASS intervention, which was aimed at improving stroke post-acute care, was associated with an increase in the use of ambulatory care services by stroke and transient ischemic attack patients discharged home and an increased use of transitional care billing codes by ambulatory providers.

Familial caregiving following stroke: findings from the comprehensive post-acute stroke services (COMPASS) pragmatic cluster-randomized transitional care study.

BACKGROUND: Stroke patients discharged home often require prolonged assistance from caregivers. Little is known about the real-world effectiveness of a comprehensive stroke transitional care intervention on relieving caregiver strain. OBJECTIVES: To describe the effect of the COMPASS transitional care (COMPASS-TC) intervention on caregiver strain and characterize the types, duration, and intensity of caregiving. METHODS: The cluster-randomized COMPASS pragmatic trial evaluated the effectiveness of COMPASS-TC versus usual care with patients with mild stroke and TIA at 40 hospitals in North Carolina, USA. Of 5882 patients enrolled, 4208 (71%) identified a familial caregiver. A follow-up Caregiver Questionnaire, including the Modified Caregiver Strain Index, was administered at approximately three months post-discharge. Demographics and frequency, duration, and intensity of caregiving were compared between groups. RESULTS: 1228 caregivers (29%) completed the questionnaire. Completion was positively associated with older patient age, white race, and spousal relationship. One-third of the caregivers provided ≥30 hours of care per week and 889 (79%) provided care ≥9 weeks. Average standardized caregiver strain was 21.9 (0-100), increasing with stroke severity and comorbidity burden. Women caregivers reported higher strain than men. Treatment allocation was not associated with caregiver strain. CONCLUSIONS: This sample of mild stroke and TIA survivors received significant assistance from familial caregivers. However, caregiver strain was relatively low. Findings support the importance of familial caregiving in stroke, the continued disproportionate burden on women within the family, and the need for future research on caregiver support.

Evidence-based interventions to treat chronic low back pain: treatment selection for a personalized medicine approach.

Introduction: Chronic low back pain (cLBP) is highly prevalent in the United States and globally, resulting in functional impairment and lowered quality of life. While many treatments are available for cLBP, clinicians have little information about which specific treatment(s) will work best for individual patients or subgroups of patients. The Back Pain Research Consortium, part of the National Institutes of Health Helping to End Addiction Long-termSM (HEAL) Initiative, will conduct a collaborative clinical trial, which seeks to develop a personalized medicine algorithm to optimize patient and provider treatment selection for patients with cLBP. Objective: The primary objective of this article is to provide an update on evidence-based cLBP interventions and describe the process of reviewing and selecting interventions for inclusion in the clinical trial. Methods: A working group of cLBP experts reviewed and selected interventions for inclusion in the clinical trial. The primary evaluation measures were strength of evidence and magnitude of treatment effect. When available in the literature, duration of effect, onset time, carryover effect, multimodal efficacy, responder subgroups, and evidence for the mechanism of treatment effect or biomarkers were considered. Conclusion: The working group selected 4 leading, evidence-based treatments for cLBP to be tested in the clinical trial and for use in routine clinical treatment. These treatments include (1) duloxetine, (2) acceptance and commitment therapy, (3) a classification-based exercise and manual therapy intervention, and (4) a self-management approach. These interventions each had a moderate to high level of evidence to support a therapeutic effect and were from different therapeutic classes.

Skilled Nursing and Inpatient Rehabilitation Facility Use by Medicare Fee-for-Service Beneficiaries Discharged Home After a Stroke: Findings From the COMPASS Trial.

OBJECTIVES: To examine the effect of a comprehensive transitional care model on the use of skilled nursing facility (SNF) and inpatient rehabilitation facility (IRF) care in the 12 months after acute care discharge home following stroke; and to identify predictors of experiencing a SNF or IRF admission following discharge home after stroke. DESIGN: Cluster randomized pragmatic trial SETTING: Forty-one acute care hospitals in North Carolina. PARTICIPANTS: 2262 Medicare fee-for-service beneficiaries with transient ischemic attack or stroke discharged home. The sample was 80.3% White and 52.1% female, with a mean (SD) age of 74.9 (10.2) years and a mean ± SD National Institutes of Health stroke scale score of 2.3 (3.7). INTERVENTION: Comprehensive transitional care model (COMPASS-TC), which consisted of a 2-day follow-up phone call from the postacute care coordinator and 14-day in-person visit with the postacute care coordinator and advanced practice provider. MAIN OUTCOME MEASURES: Time to first SNF or IRF and SNF or IRF admission (yes/no) in the 12 months following discharge home. All analyses utilized multivariable mixed models including a hospital-specific random effect to account for the non-independence of measures within hospital. Intent to treat analyses using Cox proportional hazards regression assessed the effect of COMPASS-TC on time to SNF/IRF admission. Logistic regression was used to identify clinical and non-clinical predictors of SNF/IRF admission. RESULTS: Only 34% of patients in the intervention arm received COMPASS-TC per protocol. COMPASS-TC was not associated with a reduced hazard of a SNF/ IRF admission in the 12 months post-discharge (hazard ratio, 1.20, with a range of 0.95-1.52) compared to usual care. This estimate was robust to additional covariate adjustment (hazard ratio, 1.23) (0.93-1.64). Both clinical and non-clinical factors (ie, insurance, geography) were predictors of SNF/IRF use. CONCLUSIONS: COMPASS-TC was not consistently incorporated into real-world clinical practice. The use of a comprehensive transitional care model for patients discharged home after stroke was not associated with SNF or IRF admissions in a 12-month follow-up period. Non-clinical factors predictive of SNF/IRF use suggest potential issues with access to this type of care.

Hospital Readmissions and Mortality Among Fee-for-Service Medicare Patients With Minor Stroke or Transient Ischemic Attack: Findings From the COMPASS Cluster-Randomized Pragmatic Trial.

Background Mortality and hospital readmission rates may reflect the quality of acute and postacute stroke care. Our aim was to investigate if, compared with usual care (UC), the COMPASS-TC (Comprehensive Post-Acute Stroke Services Transitional Care) intervention (INV) resulted in lower all-cause and stroke-specific readmissions and mortality among patients with minor stroke and transient ischemic attack discharged from 40 diverse North Carolina hospitals from 2016 to 2018. Methods and Results Using Medicare fee-for-service claims linked with COMPASS cluster-randomized trial data, we performed intention-to-treat analyses for 30-day, 90-day, and 1-year unplanned all-cause and stroke-specific readmissions and all-cause mortality between INV and UC groups, with 90-day unplanned all-cause readmissions as the primary outcome. Effect estimates were determined via mixed logistic or Cox proportional hazards regression models adjusted for age, sex, race, stroke severity, stroke diagnosis, and documented history of stroke. The final analysis cohort included 1069 INV and 1193 UC patients (median age 74 years, 80% White, 52% women, 40% with transient ischemic attack) with median length of hospital stay of 2 days. The risk of unplanned all-cause readmission was similar between INV versus UC at 30 (9.9% versus 8.7%) and 90 days (19.9% versus 18.9%), respectively. No significant differences between randomization groups were seen in 1-year all-cause readmissions, stroke-specific readmissions, or mortality. Conclusions In this pragmatic trial of patients with complex minor stroke/transient ischemic attack, there was no difference in the risk of readmission or mortality with COMPASS-TC relative to UC. Our study could not conclusively determine the reason for the lack of effectiveness of the INV. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT02588664.

Methodological Challenges and Statistical Approaches in the COMprehensive Post-Acute Stroke Services Study.

BACKGROUND: The COMprehensive Post-Acute Stroke Services study was a cluster-randomized pragmatic trial designed to evaluate a comprehensive care transitions model versus usual care. The data collected during this trial were complex and analysis methodology was required that could simultaneously account for the cluster-randomized design, missing patient-level covariates, outcome nonresponse, and substantial nonadherence to the intervention. OBJECTIVE: The objective of this study was to discuss an array of complementary statistical methods to evaluate treatment effectiveness that appropriately addressed the challenges presented by the complex data arising from this pragmatic trial. METHODS: We utilized multiple imputation combined with inverse probability weighting to account for missing covariate and outcome data in the estimation of intention-to-treat effects (ITT). The ITT estimand reflects the effectiveness of assignment to the COMprehensive Post-Acute Stroke Services intervention compared with usual care (ie, it does not take into account intervention adherence). Per-protocol analyses provide complementary information about the effect of treatment, and therefore are relevant for patients to inform their decision-making. We describe estimation of the complier average causal effect using an instrumental variables approach through 2-stage least squares estimation. For all preplanned analyses, we also discuss additional sensitivity analyses. DISCUSSION: Pragmatic trials are well suited to inform clinical practice. Care should be taken to proactively identify the appropriate balance between control and pragmatism in trial design. Valid estimation of ITT and per-protocol effects in the presence of complex data requires application of appropriate statistical methods and concerted efforts to ensure high-quality data are collected.

Movement Matters, and So Does Context: Lessons Learned From Multisite Implementation of the Movement Matters Activity Program for Stroke in the Comprehensive Postacute Stroke Services Study.

The purpose of this Special Communication is to discuss the rationale and design of the Movement Matters Activity Program for Stroke (MMAP) and explore implementation successes and challenges in home health and outpatient therapy practices across the stroke belt state of North Carolina. MMAP is an interventional component of the Comprehensive Postacute Stroke Services Study, a randomized multicenter pragmatic trial of stroke transitional care. MMAP was designed to maximize survivor health, recovery, and functional independence in the community and to promote evidence-based rehabilitative care. MMAP provided training, tools, and resources to enable rehabilitation providers to (1) prescribe physical activity and exercise according to evidence-based guidelines and programs, (2) match service setting and parameters with survivor function and benefit coverage, and (3) align treatment with quality metric reporting to demonstrate value-based care. MMAP implementation strategies were aligned with the Expert Recommendations for Implementing Change project, and MMAP site champion and facilitator survey feedback were thematically organized into the Consolidated Framework for Implementation Research domains. MMAP implementation was challenging, required modification and was affected by provider- and system-level factors. Program and study participation were limited and affected by practice priorities, productivity standards, and stroke patient volume. Sites with successful implementation appeared to have empowered MMAP champions in vertically integrated systems that embraced innovation. Findings from this broad evaluation can serve as a road map for the design and implementation of other comprehensive, complex interventions that aim to bridge the currently disconnected realms of acute care, postacute care, and community resources.

Randomized Pragmatic Trial of Stroke Transitional Care: The COMPASS Study.

Background The objectives of this study were to develop and test in real-world clinical practice the effectiveness of a comprehensive postacute stroke transitional care (TC) management program. Methods and Results The COMPASS study (Comprehensive Post-Acute Stroke Services) was a pragmatic cluster-randomized trial where the hospital was the unit of randomization. The intervention (COMPASS-TC) was initiated at 20 hospitals, and 20 hospitals provided their usual care. Hospital staff enrolled 6024 adult stroke and transient ischemic attack patients discharged home between 2016 and 2018. COMPASS-TC was patient-centered and assessed social and functional determinates of health to inform individualized care plans. Ninety-day outcomes were evaluated by blinded telephone interviewers. The primary outcome was functional status (Stroke Impact Scale-16); secondary outcomes were mortality, disability, medication adherence, depression, cognition, self-rated health, fatigue, care satisfaction, home blood pressure monitoring, and falls. The primary analysis was intention to treat. Of intervention hospitals, 58% had uninterrupted intervention delivery. Thirty-five percent of patients at intervention hospitals attended a COMPASS clinic visit. The primary outcome was measured for 59% of patients and was not significantly influenced by the intervention. Mean Stroke Impact Scale-16 (±SD) was 80.6±21.1 in TC versus 79.9±21.4 in usual care. Home blood pressure monitoring was self-reported by 72% of intervention patients versus 64% of usual care patients (adjusted odds ratio, 1.43 [95% CI, 1.21-1.70]). No other secondary outcomes differed. Conclusions Although designed according to the best available evidence with input from various stakeholders and consistent with Centers for Medicare and Medicaid Services TC policies, the COMPASS model of TC was not consistently incorporated into real-world health care. We found no significant effect of the intervention on functional status at 90 days post-discharge. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT02588664.

Implementation of a billable transitional care model for stroke patients: the COMPASS study.

BACKGROUND: The COMprehensive Post-Acute Stroke Services (COMPASS) pragmatic trial compared the effectiveness of comprehensive transitional care (COMPASS-TC) versus usual care among stroke and transient ischemic attack (TIA) patients discharged home from North Carolina hospitals. We evaluated implementation of COMPASS-TC in 20 hospitals randomized to the intervention using the RE-AIM framework. METHODS: We evaluated hospital-level Adoption of COMPASS-TC; patient Reach (meeting transitional care management requirements of timely telephone and face-to-face follow-up); Implementation using hospital quality measures (concurrent enrollment, two-day telephone follow-up, 14-day clinic visit scheduling); and hospital-level sustainability (Maintenance). Effectiveness compared 90-day physical function (Stroke Impact Scale-16), between patients receiving COMPASS-TC versus not. Associations between hospital and patient characteristics with Implementation and Reach measures were estimated with mixed logistic regression models. RESULTS: Adoption: Of 95 eligible hospitals, 41 (43%) participated in the trial. Of the 20 hospitals randomized to the intervention, 19 (95%) initiated COMPASS-TC. Reach: A total of 24% (656/2751) of patients enrolled received a billable TC intervention, ranging from 6 to 66% across hospitals. IMPLEMENTATION: Of eligible patients enrolled, 75.9% received two-day calls (or two attempts) and 77.5% were scheduled/offered clinic visits. Most completed visits (78% of 975) occurred within 14 days. Effectiveness: Physical function was better among patients who attended a 14-day visit versus those who did not (adjusted mean difference: 3.84, 95% CI 1.42-6.27, p = 0.002). Maintenance: Of the 19 adopting hospitals, 14 (74%) sustained COMPASS-TC. CONCLUSIONS: COMPASS-TC implementation varied widely. The greatest challenge was reaching patients because of system difficulties maintaining consistent delivery of follow-up visits and patient preferences to pursue alternate post-acute care. Receiving COMPASS-TC was associated with better functional status. TRIAL REGISTRATION: ClinicalTrials.gov number: NCT02588664. Registered 28 October 2015.

Meeting Medicare requirements for transitional care: Do stroke care and policy align?

OBJECTIVE: This study (1) describes transitional care for stroke patients discharged home from hospitals, (2) compares hospitals' standards of transitional care with core transitional care management (TCM) components recognized by Medicare, and (3) examines the association of policy and hospital specialty designations with TCM implementation. METHODS: Hospitals participating in the Comprehensive Post-Acute Stroke Services (COMPASS) Study provided data on their hospital, stroke patient population, and standards of transitional care. Hospital-reported transitional care strategies were compared with the federal TCM definition (2-day follow-up, 14-day visit, non-face-to-face services). We examined the associations of TCM billing, stroke center certification, and Magnet nursing excellence designation with TCM implementation. RESULTS: Transitional care varied widely among 41 hospitals in North Carolina and no one strategy was universally applied or provided across hospitals. One third of hospitals met the TCM definition (37% provided telephone follow-up, 76% provided face-to-face provider follow-up, all provided a type of non-face-to-face support). There were no differences between groups (TCM met/not met) in hospital characteristics or transitional care resources and processes. Stroke center certification, Magnet designation, and use of TCM billing codes were not different for hospitals that did and did not meet the TCM definition. CONCLUSIONS: There was substantial variation in the provision of strategies supporting stroke patients' transition home from the hospital. Supportive stroke care transitions are essential when more than 50% of stroke patients are discharged home and more than half experience moderate to severe strokes. More research is needed to identify drivers of TCM uptake. CLINICALTRIALSGOV IDENTIFIER: NCT02588664.

COMPASS-CP: An Electronic Application to Capture Patient-Reported Outcomes to Develop Actionable Stroke and Transient Ischemic Attack Care Plans.

Background Patient-reported outcomes (PROs) are clinical tools that measure patients' goals of care and assess patient-reported physical, mental, and social well-being. Despite their value in advancing patient-centered care, routine use of PROs in stroke management has lagged. As part of the pragmatic COMPASS (Comprehensive Post-Acute Stroke Services) trial, we developed COMPASS-Care Plan (CP), a clinician-facing application that captures and analyzes PROs for stroke and transient ischemic attack patients discharged home and immediately generates individualized electronic CP. In this report, we (1) present our methods for developing and implementing COMPASS-CP PROs, (2) provide examples of CP generated from COMPASS-CP, (3) describe key functional, social, and behavioral determinants of health captured by COMPASS-CP, and (4) report on clinician experience with using COMPASS-CP in routine clinical practice for care planning and engagement of stroke and transient ischemic attack patients discharged home. Methods and Results We report on the first 871 patients enrolled in 20 North Carolina hospitals randomized to the intervention arm of COMPASS between July 2016 and February 2018; these patients completed a COMPASS follow-up visit within 14 days of hospital discharge. We also report user satisfaction results from 56 clinicians who used COMPASS-CP during these visits. COMPASS-CP identified more cognitive and depression deficits than physical deficits. Within 14-day posthospitalization, less than half of patients could list the major risk factors for stroke, 36% did not recognize blood pressure as a stroke risk factor, and 19% of patients were nonadherent with prescribed medications. Three-fourths of clinicians reported that COMPASS-CP identifies important factors impacting patients' recovery that they otherwise may have missed, and two-thirds were highly satisfied with COMPASS-CP. Conclusions The COMPASS-CP application meets an immediate need to incorporate PROs into the clinical workflow to develop patient-centered CP for stroke patients and has high user satisfaction. Clinical Trial Registration URL: https://www.clinicaltrials.gov . Unique identifier: NCT02588664.

A Person-Centered Approach to Poststroke Care: The COMprehensive Post-Acute Stroke Services Model.

Many individuals who have had a stroke leave the hospital without postacute care services in place. Despite high risks of complications and readmission, there is no standard in the United States for postacute stroke care after discharge home. We describe the rationale and methods for the development of the COMprehensive Post-Acute Stroke Services (COMPASS) care model and the structure and quality metrics used for implementation. COMPASS, an innovative, comprehensive extension of the TRAnsition Coaching for Stroke (TRACS) program, is a clinician-led quality improvement model providing early supported discharge and transitional care for individuals who have had a stroke and have been discharged home. The effectiveness of the COMPASS model is being assessed in a cluster-randomized pragmatic trial in 41 sites across North Carolina, with a recruitment goal of 6,000 participants. The COMPASS model is evidence based, person centered, and stakeholder driven. It involves identification and education of eligible individuals in the hospital; telephone follow-up 2, 30, and 60 days after discharge; and a clinic visit within 14 days conducted by a nurse and advanced practice provider. Patient and caregiver self-reported assessments of functional and social determinants of health are captured during the clinic visit using a web-based application. Embedded algorithms immediately construct an individualized care plan. The COMPASS model's pragmatic design and quality metrics may support measurable best practices for postacute stroke care.

Hospital recruitment for a pragmatic cluster-randomized clinical trial: Lessons learned from the COMPASS study.

BACKGROUND: Pragmatic randomized clinical trials are essential to determine the effectiveness of interventions in "real-world" clinical practice. These trials frequently use a cluster-randomized methodology, with randomization at the site level. Despite policymakers' increased interest in supporting pragmatic randomized clinical trials, no studies to date have reported on the unique recruitment challenges faced by cluster-randomized pragmatic trials. We investigated key challenges and successful strategies for hospital recruitment in the Comprehensive Post-Acute Stroke Services (COMPASS) study. METHODS: The COMPASS study is designed to compare the effectiveness of the COMPASS model versus usual care in improving functional outcomes, reducing the numbers of hospital readmissions, and reducing caregiver strain for patients discharged home after stroke or transient ischemic attack. This model integrates early supported discharge planning with transitional care management, including nurse-led follow-up phone calls after 2, 30, and 60 days and an in-person clinic visit at 7-14 days involving a functional assessment and neurological examination. We present descriptive statistics of the characteristics of successfully recruited hospitals compared with all eligible hospitals, reasons for non-participation, and effective recruitment strategies. RESULTS: We successfully recruited 41 (43%) of 95 eligible North Carolina hospitals. Leading, non-exclusive reasons for non-participation included: insufficient staff or financial resources (n = 33, 61%), lack of health system support (n = 16, 30%), and lack of support of individual decision-makers (n = 11, 20%). Successful recruitment strategies included: building and nurturing relationships, engaging team members and community partners with a diverse skill mix, identifying gatekeepers, finding mutually beneficial solutions, having a central institutional review board, sharing published pilot data, and integrating contracts and review board administrators. CONCLUSIONS: Although we incorporated strategies based on the best available evidence at the outset of the study, hospital recruitment required three times as much time and considerably more staff than anticipated. To reach our goal, we tailored strategies to individuals, hospitals, and health systems. Successful recruitment of a sufficient number and representative mix of hospitals requires considerable preparation, planning, and flexibility. Strategies presented here may assist future trial organizers in implementing cluster-randomized pragmatic trials. TRIAL REGISTRATION: Clinicaltrials.gov, NCT02588664 . Registered on 23 October 2015.

Average Temperature, Diurnal Temperature Variation, and Stroke Hospitalizations.

BACKGROUND: Studies assessing the relationship between meteorological factors and stroke incidence are inconsistent. We assessed the associations of average temperature and diurnal temperature fluctuations with ischemic stroke hospitalizations in a nationally representative sample of patients in the United States. METHODS: Hospitalizations were identified for adults aged 18 years or older in the 2009-2011 Nationwide Inpatient Sample and linked with county-level monthly average temperatures from the United States National Climatic Data Center. Logistic regression models assessed the relationships of 5°F increases in average temperature and diurnal temperature variation (difference between high- and low-daily temperatures) with the odds of ischemic stroke hospitalization (International Classification of Diseases, Ninth Revision, Clinical Modification codes 433, 434, and 436), adjusting for patient characteristics and dew point. Models were stratified by age (18-64, ≥65 years), season, and region, with analysis at the hospitalization level. RESULTS: Increased average temperature was associated with decreased odds of stroke hospitalization among both age groups and across seasons in the Northeast, and among the elderly in the West. Increased diurnal temperature variation was associated with increased odds of stroke hospitalization for nearly all regions in the spring to fall seasons; associations were most pronounced in the Northeast and strongest in the spring. CONCLUSIONS: Lower average temperature and larger diurnal temperature variations were associated with stroke hospitalizations. Associations were strongest in the Northeast and largely similar across seasons and age. Further research is needed to explore the mechanisms underlying these associations. Understanding these patterns may lead to targeted prevention strategies for vulnerable populations during periods of extreme weather conditions.

Midlife Alcohol Consumption and the Risk of Stroke in the Atherosclerosis Risk in Communities Study.

BACKGROUND AND PURPOSE: Alcohol consumption is common in the United States and may confer beneficial cardiovascular effects at light-to-moderate doses. The alcohol-stroke relationship remains debated. We estimated the relationship between midlife, self-reported alcohol consumption and ischemic stroke and intracerebral hemorrhage (ICH) in a biracial cohort. METHODS: We examined 12,433 never and current drinkers in the Atherosclerosis Risk in Communities study, aged 45 to 64 years at baseline. Participants self-reported usual drinks per week of beer, wine, and liquor at baseline. We used multivariate Cox proportional hazards regression to assess the association of current alcohol consumption relative to lifetime abstention with incident ischemic stroke and ICH and modification by sex-race group. We modeled alcohol intake with quadratic splines to further assess dose-response relationships. RESULTS: One third of participants self-reported abstention, 39% and 24%, respectively, consumed ≤3 and 4 to 17 drinks/wk, and only 5% reported heavier drinking. There were 773 ischemic strokes and 81 ICH over follow-up (median≈22.6 years). For ischemic stroke, light and moderate alcohol consumption were not associated with incidence (hazard ratios, 0.98; 95% CI, 0.79-1.21; 1.06, 0.84-1.34), whereas heavier drinking was associated with a 31% increased rate relative to abstention (hazard ratios, 1.31; 95% CI, 0.92-1.86). For ICH, moderate-to-heavy (hazard ratios, 1.99; 95% CI, 1.07-3.70), but not light, consumption increased incidence. CONCLUSIONS: Self-reported light-to-moderate alcohol consumption at midlife was not associated with reduced stroke risk compared with abstention over 20 years of follow-up in the Atherosclerosis Risk in Communities study. Heavier consumption increased the risk for both outcomes as did moderate intake for ICH.

Age and sex differences in inhospital complication rates and mortality after percutaneous coronary intervention procedures: evidence from the NCDR(®).

BACKGROUND: Older women experience higher complication rates and mortality after percutaneous coronary intervention (PCI) than men, but there is limited evidence about sex-based differences in outcomes among younger patients. We compared rates of complications and inhospital mortality by sex for younger and older PCI patients. METHODS: A total of 1,079,751 hospital admissions for PCI were identified in the CathPCI Registry(®) from 2005 to 2008. Complication rates (general, bleeding, bleeding with transfusion, and vascular) and inhospital mortality after PCI were compared by sex and age (<55 and ≥55 years). Analyses were adjusted for demographic and clinical factors and stratified by PCI type (elective, urgent, or emergency). RESULTS: Overall, 6% of patients experienced complications, and 1% died inhospital. Unadjusted complication rates were higher for women compared with men in both age groups. In risk-adjusted analyses, younger women (odds ratio 1.24, 95% CI 1.16-1.33) and older women (1.27, 1.09-1.47) were more likely to experience any complication than similarly aged men. The increased risk persisted across complication categories and PCI type. Within age groups, risk-adjusted mortality was marginally higher for young women (1.19, 1.00-1.41), but not for older women (1.03, 0.97-1.10). In analyses stratified by PCI type, young women had twice the mortality risk after an elective procedure as young men (2.04, 1.15-3.61). CONCLUSIONS: Women, regardless of age, experience more complications after PCI than men; young women are at increased mortality risk after an elective PCI. Identifying strategies to reduce adverse outcomes, particularly for women younger than 55 years, is important.

Preventable readmissions within 30 days of ischemic stroke among Medicare beneficiaries.

BACKGROUND AND PURPOSE: The Centers for Medicare and Medicaid Services proposes to use 30-day hospital readmissions after ischemic stroke as part of the Hospital Inpatient Quality Reporting Program for payment determination beginning in 2016. The proportion of poststroke readmissions that is potentially preventable is unknown. METHODS: Thirty-day readmissions for all Medicare fee-for-service beneficiaries aged≥65 years discharged alive with a primary diagnosis of ischemic stroke (International Classification of Diseases, Ninth Revision, Clinical Modification 433, 434, 436) between December 2005 and November 2006 were analyzed. Preventable readmissions were identified based on 14 Prevention Quality Indicators developed for use with administrative data by the US Agency for Healthcare Research and Quality. National, hospital-level, and regional preventable readmission rates were estimated. Random-effects logistic regression was also used to determine patient-level factors associated with preventable readmissions. RESULTS: Among 307 887 ischemic stroke discharges, 44 379 (14.4%) were readmitted within 30 days; 5322 (1.7% of all discharges) were the result of a preventable cause (eg, pneumonia), and 39 057 (12.7%) were for other reasons (eg, cancer). In multivariate analysis, older age and cardiovascular-related comorbid conditions were strong predictors of preventable readmissions. Preventable readmission rates were highest in the Southeast, Mid-Atlantic, and US territories and lowest in the Mountain and Pacific regions. CONCLUSIONS: On the basis of Agency for Healthcare Research and Quality Prevention Quality Indicators, we found that a small proportion of readmissions after ischemic stroke were classified as preventable. Although other causes of readmissions not reflected in the Agency for Healthcare Research and Quality measures could also be avoidable, hospital-level programs intended to reduce all-cause readmissions and costs should target high-risk patients.

Prevalence of traditional cardiac risk factors and secondary prevention among patients hospitalized for acute myocardial infarction (AMI): variation by age, sex, and race.

BACKGROUND: Modification of traditional cardiac risk factors is an important goal for patients after an acute myocardial infarction (AMI). Risk factor prevalence and secondary prevention efforts at discharge are well characterized among older patients; however, research is limited for younger and minority AMI populations, particularly among women. METHODS: Among 2369 AMI patients enrolled in a 19-center prospective study, we compared the prevalence and cumulative number of five cardiac risk factors (hypertension, hypercholesterolemia, current smoking, diabetes, obesity) by age, sex, and race. We also compared secondary prevention strategies at discharge for these risk factors, including prescription of antihypertensive or lipid-lowering medications and counseling on preventive behaviors (smoking cessation, diabetes management, diet/weight management). RESULTS: Approximately 93% of patients had ≥1 risk factor, 72% had ≥2 factors, and 40% had ≥3 factors. The prevalence of multiple risk factors was markedly higher for blacks than for whites within each age-sex group; black women had the greatest risk factor burden of any subgroup (60% of older black women and 54% of younger black women had ≥3 risk factors). Secondary prevention efforts for smoking cessation were less common for black compared with white patients, and younger black patients were less often prescribed antihypertensive and lipid-lowering medications compared with younger white patients. CONCLUSIONS: Multiple cardiac risk factors are highly prevalent in AMI patients, particularly among black women. Secondary prevention efforts, however, are less common for blacks compared to whites, especially among younger patients. Our findings highlight the need for improved risk factor modification efforts in these high-risk subgroups.