Development and Validation of ICD-10-CM-based Algorithms for Date of Last Menstrual Period, Pregnancy Outcomes, and Infant Outcomes.

INTRODUCTION AND OBJECTIVE: Validation studies of algorithms for pregnancy outcomes based on International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) codes are important for conducting drug safety research using administrative claims databases. To facilitate the conduct of pregnancy safety studies, this exploratory study aimed to develop and validate ICD-10-CM-based claims algorithms for date of last menstrual period (LMP) and pregnancy outcomes using medical records. METHODS: Using a mother-infant-linked claims database, the study included women with a pregnancy between 2016-2017 and their infants. Claims-based algorithms for LMP date utilized codes for gestational age (Z3A codes). The primary outcomes were major congenital malformations (MCMs) and spontaneous abortion; additional secondary outcomes were also evaluated. Each pregnancy outcome was identified using a claims-based simple algorithm, defined as presence of ≥ 1 claim for the outcome. Positive predictive values (PPV) and 95% confidence intervals (CI) were calculated. RESULTS: Overall, 586 medical records were sought and 365 (62.3%) were adjudicated, including 125 records each for MCMs and spontaneous abortion. Last menstrual period date was validated among maternal charts procured for pregnancy outcomes and fewer charts were adjudicated for the secondary outcomes. The median difference in days between LMP date based on Z3A codes and adjudicated LMP date was 4.0 (interquartile range: 2.0-10.0). The PPV of the simple algorithm for spontaneous abortion was 84.7% (95% CI 78.3, 91.2). The PPV for the MCM algorithm was < 70%. The algorithms for the secondary outcomes pre-eclampsia, premature delivery, and low birthweight performed well, with PPVs > 70%. CONCLUSIONS: The ICD-10-CM claims-based algorithm for spontaneous abortion performed well and may be used in pregnancy studies. Further algorithm refinement for MCMs is needed. The algorithms for LMP date and the secondary outcomes would benefit from additional validation in a larger sample.

Inpatient Constipation Among Migraine Patients Prescribed Anti-calcitonin Gene-Related Peptide Monoclonal Antibodies and Standard of Care Antiepileptic Drugs: A Retrospective Cohort Study in a United States Electronic Health Record Database.

INTRODUCTION: Erenumab, an anti-calcitonin gene-related peptide (CGRP) receptor monoclonal antibody (mAb), was approved by the US Food and Drug Administration in May 2018. Constipation with serious complications was added to the Warning and Precautions section in the erenumab Prescribing Information in October 2019 after events were observed during post-marketing surveillance. We aimed to assess and compare the risk of inpatient constipation, and, separately, inpatient constipation with serious complications, among patients with migraine treated with CGRP mAbs and standard of care antiepileptic drugs (AEDs). METHODS: Within Optum's Electronic Health Record Research Database, patients with migraine who initiated erenumab, other CGRP mAbs, and AEDs were identified from May 2018 through March 2020. Erenumab initiators were propensity score-matched separately to initiators of other CGRP mAbs and AEDs. Incident inpatient constipation events, and serious complications, were identified using multiple risk windows for outcome assessment (30-, 60-, 90-day risk windows, and all available follow-up). Odds ratios (ORs) were calculated comparing inpatient constipation risk among matched erenumab initiators relative to comparators. RESULTS: We identified 17,902 erenumab, 13,404 other CGRP mAb, and 49,497 AED initiators who met study criteria. Among matched initiators, the risk of inpatient constipation was 0.46% (95% confidence interval (CI) 0.35-0.60) for erenumab and 0.44% (95% CI 0.33-0.58) for other CGRP mAbs within the 90-day risk window, with a corresponding OR of 1.06 (95% CI 0.72-1.55). Among matched erenumab and AED initiators, inpatient constipation risk was 0.53% (95% CI 0.42-0.66) and 0.76% (95% CI 0.62-0.92), respectively, and the OR was 0.69 (95% CI 0.51-0.94). Few serious complications were observed. CONCLUSION: Patients initiating erenumab had similar risk of inpatient constipation within 90 days of treatment initiation versus patients initiating other CGRP mAbs, and lower risk versus patients initiating AEDs. These findings provide context to events observed during post-marketing surveillance.

Trends in COVID-19 patient characteristics in a large electronic health record database in the United States: A cohort study.

BACKGROUND: Electronic health record (EHR) databases provide an opportunity to facilitate characterization and trends in patients with COVID-19. METHODS: Patients with COVID-19 were identified based on an ICD-10 diagnosis code for COVID-19 (U07.1) and/or a positive SARS-CoV-2 viral lab result from January 2020 to November 2020. Patients were characterized in terms of demographics, healthcare utilization, clinical comorbidities, therapies, laboratory results, and procedures/care received, including critical care, intubation/ventilation, and occurrence of death were described, overall and by month. RESULTS: There were 393,773 patients with COVID-19 and 56,996 with a COVID-19 associated hospitalization. A greater percentage of patients hospitalized with COVID-19 relative to all COVID-19 cases were older, male, African American, and lived in the Northeast and South. The most common comorbidities before admission/infection date were hypertension (40.8%), diabetes (29.5%), and obesity (23.8%), and the most common diagnoses during hospitalization were pneumonia (59.6%), acute respiratory failure (44.8%), and dyspnea (28.0%). A total of 85.7% of patients hospitalized with COVID-19 had CRP values > 10 mg/L, 75.5% had fibrinogen values > 400 mg/dL, and 76.8% had D-dimer values > 250 ng/mL. Median values for platelets, CRP, lactate dehydrogenase, D-dimer, and fibrinogen tended to decrease from January-March to November. The use of chloroquine/hydroxychloroquine during hospitalization peaked by March (71.2%) and was used rarely by May (5.1%) and less than 1% afterwards, while the use of remdesivir had increased by May (10.0%) followed by dexamethasone by June (27.7%). All-cause mortality was 3.2% overall and 15.0% among those hospitalized; 21.0% received critical care and 16.0% received intubation/ventilation/ECMO. CONCLUSIONS: This study characterizes US patients with COVID-19 and their management during hospitalization over the first eleven months of this disease pandemic.

Predictors of critical care, mechanical ventilation, and mortality among hospitalized patients with COVID-19 in an electronic health record database.

BACKGROUND: There are limited data on risk factors for serious outcomes and death from COVID-19 among patients representative of the U.S. POPULATION: The objective of this study was to determine risk factors for critical care, ventilation, and death among hospitalized patients with COVID-19. METHODS: This was a cohort study using data from Optum's longitudinal COVID-19 electronic health record database derived from a network of healthcare provider organizations across the US. The study included patients with confirmed COVID-19 (presence of ICD-10-CM code U07.1 and/or positive SARS-CoV-2 test) between January 2020 and November 2020. Patient characteristics and clinical variables at start of hospitalization were evaluated for their association with subsequent serious outcomes (critical care, mechanical ventilation, and death) using odds ratios (OR) and 95% confidence intervals (CI) from logistic regression, adjusted for demographic variables. RESULTS: Among 56,996 hospitalized COVID-19 patients (49.5% male and 72.4% ≥ 50 years), 11,967 received critical care, 9136 received mechanical ventilation, and 8526 died. The median duration of hospitalization was 6 days (IQR: 4, 11), and this was longer among patients that experienced an outcome: 11 days (IQR: 6, 19) for critical care, 15 days (IQR: 8, 24) for mechanical ventilation, and 10 days (IQR: 5, 17) for death. Dyspnea and hypoxemia were the most prevalent symptoms and both were associated with serious outcomes in adjusted models. Additionally, temperature, C-reactive protein, ferritin, lactate dehydrogenase, D-dimer, and oxygen saturation measured during hospitalization were predictors of serious outcomes as were several in-hospital diagnoses. The strongest associations were observed for acute respiratory failure (critical care: OR, 6.30; 95% CI, 5.99-6.63; ventilation: OR, 8.55; 95% CI, 8.02-9.11; death: OR, 3.36; 95% CI, 3.17-3.55) and sepsis (critical care: OR, 4.59; 95% CI, 4.39-4.81; ventilation: OR, 5.26; 95% CI, 5.00-5.53; death: OR, 4.14; 95% CI, 3.92-4.38). Treatment with angiotensin-converting enzyme inhibitors/angiotensin receptor blockers during hospitalization were inversely associated with death (OR, 0.57; 95% CI, 0.54-0.61). CONCLUSIONS: We identified several clinical characteristics associated with receipt of critical care, mechanical ventilation, and death among COVID-19 patients. Future studies into the mechanisms that lead to severe COVID-19 disease are warranted.

Validity and Relative Validity of Alternative Methods of Assessing Physical Activity in Epidemiologic Studies: Findings From the Men's Lifestyle Validation Study.

In the Men's Lifestyle Validation Study (2011-2013), we examined the validity and relative validity of a physical activity questionnaire (PAQ), a Web-based 24-hour recall (Activities Completed Over Time in 24 Hours (ACT24)), and an accelerometer by multiple comparison methods. Over the course of 1 year, 609 men completed 2 PAQs, two 7-day accelerometer measurements, at least 1 doubly labeled water (DLW) physical activity level (PAL) measurement (n = 100 with repeat measurements), and 4 ACT24s; they also measured their resting pulse rate. A subset (n = 197) underwent dual-energy x-ray absorptiometry (n = 99 with repeated measurements). The method of triads was used to estimate correlations with true activity using DLW PAL, accelerometry, and the PAQ or ACT24 as alternative comparison measures. Estimated correlations of the PAQ with true activity were 0.60 (95% confidence interval (95% CI): 0.52, 0.68) for total activity, 0.69 (95% CI: 0.61, 0.79) for moderate-to-vigorous physical activity (MVPA), and 0.76 (95% CI: 0.62, 0.93) for vigorous activity. Corresponding correlations for total activity were 0.53 (95% CI: 0.45, 0.63) for the average of 4 ACT24s and 0.68 (95% CI: 0.61, 0.75) for accelerometry. Total activity and MVPA measured by PAQ, ACT24, and accelerometry were all significantly correlated with body fat percentage and resting pulse rate, which are physiological indicators of physical activity. Using a combination of comparison methods, we found the PAQ and accelerometry to have moderate validity for assessing physical activity, especially MVPA, in epidemiologic studies.

Reproducibility, Validity, and Relative Validity of Self-Report Methods for Assessing Physical Activity in Epidemiologic Studies: Findings From the Women's Lifestyle Validation Study.

Among 683 participants in the Women's Lifestyle Validation Study (2010-2012), we evaluated the performance of a self-administered physical activity questionnaire (PAQ) and Web-based 24-hour recalls (Activities Completed Over Time in 24 Hours (ACT24)) using multiple comparison methods. Two PAQs, 4 ACT24s, two 7-day accelerometer measurements, 1 doubly labeled water (DLW) physical activity level (PAL) measure (repeated; n = 90), and 4 resting pulse rate measurements were collected over 15 months. The deattenuated correlation between the PAQ and DLW PAL was 0.41 (95% confidence interval (CI): 0.33, 0.49) for total physical activity (PA) and 0.40 (95% CI: 0.31, 0.48) for moderate-to-vigorous PA (MVPA). These correlations were similar when using accelerometry as the comparison method. Single and averaged ACT24 measurements had lower correlations with DLW and accelerometry as comparison methods. The PAQ showed inverse correlations with DLW body fat percentage and resting pulse rate. Using the method of triads, the estimated correlation of the PAQ with true total PA was 0.54 (95% CI: 0.47, 0.62) and that with true MVPA was 0.60 (95% CI: 0.52, 0.69). For averaged ACT24, the estimated correlations were 0.50 (95% CI: 0.43, 0.59) for total PA and 0.47 (95% CI: 0.39, 0.58) for MVPA, and for averaged accelerometry, these estimated correlations were 0.72 (95% CI: 0.64, 0.81) and 0.62 (95% CI: 0.53, 0.71), respectively. The PAQ provided reasonable validity for total PA and MVPA.

Elementary School Personnel and Cultural Factors Affecting Health Education Implementation in the High-Stakes Testing Era.

BACKGROUND: Despite proven health and learning benefits, health education implementation in elementary schools is not optimal. This study investigated learning environment, leadership, and training factors that may influence elementary-level health education implementation in the current standardized testing-saturated environment. METHODS: Survey data were collected from principals of 8 Michigan elementary schools and, via focus groups, 30 teachers in their schools. Teacher groups were separated into 2 categories based on principals' understanding of state health education policies. Grounded theory analysis was used. RESULTS: Despite all 30 teachers' positive attitudes toward health education, numerous consistent implementation barriers were identified; competition for instructional time with tested subjects was most critical. Teachers with principals who indicated a greater understanding of state policies reported more: consistent instruction; availability of resources, and encouragement to teach select topics, especially mental health. CONCLUSION: That these findings were produced in a state with strong CSHE polices, proven curricula, and expansive support systems are disheartening and accentuate the profound impact of standardized testing on elementary-level health education implementation. More promising, principals' understanding of applicable state-level policies appeared to generate stronger health education implementation. Future research should focus on the possible impact of time devoted to health instruction on standardized test scores.

Method used to identify adenomyosis and potentially undiagnosed adenomyosis in a large, U.S. electronic health record database.

BACKGROUND: The prevalence of adenomyosis is underestimated due to lack of a specific diagnostic code and diagnostic delays given most diagnoses occur at hysterectomy. OBJECTIVES: To identify women with adenomyosis using indicators derived from natural language processing (NLP) of clinical notes in the Optum Electronic Health Record database (2014-2018), and to estimate the prevalence of potentially undiagnosed adenomyosis. METHODS: An NLP algorithm identified mentions of adenomyosis in clinical notes that were highly likely to represent a diagnosis. The anchor date was date of first affirmed adenomyosis mention; baseline characteristics were assessed in the 12 months prior to this date. Characteristics common to adenomyosis cases were used to select a suitable pool of women from the underlying population, among whom undiagnosed adenomyosis might exist. A random sample of this pool was selected to form the comparator cohort. Logistic regression was used to compare adenomyosis cases to comparators; the predictive probability (PP) of being an adenomyosis case was assessed. Comparators having a PP ≥ 0.1 were considered potentially undiagnosed adenomyosis and were used to calculate the prevalence of potentially undiagnosed adenomyosis in the underlying population. RESULTS: Among 11 456 347 women aged 18-55 years in the underlying population, 19 503 were adenomyosis cases. Among 332 583 comparators, 22 696 women were potentially undiagnosed adenomyosis cases. The prevalence of adenomyosis and potentially undiagnosed adenomyosis was 1.70 and 19.1 per 1000 women aged 18-55 years, respectively. CONCLUSIONS: Considering potentially undiagnosed adenomyosis, the prevalence of adenomyosis may be 10x higher than prior estimates based on histologically confirmed adenomyosis cases only.

Time Spent Sitting as an Independent Risk Factor for Cardiovascular Disease.

Sedentary behavior is highly prevalent despite growing evidence of adverse effects on the cardiovascular and metabolic system that are independent of the level of recreational physical activity (PA). We present results for the association between sitting time and cardiovascular disease (CVD) from selected cohort and cross-sectional studies published in or after the year 2010 according to the domains where sitting time is accumulated during the day. These include TV viewing, occupational sitting, and sitting during transportation as well as overall sitting. The outcomes considered in this review are total CVD, coronary heart disease, and stroke as well as CVD risk factors-namely, hypertension, hypercholesterolemia, and type 2 diabetes and their associated biomarkers. Finally, several current issues with regard to studying the effects of sitting time on CVD are discussed, including how sedentary behavior is assessed, isotemporal substitution modeling, examination of joint associations for sitting and PA, and benefits of breaks in sitting time. Overall, the scientific evidence supports public health recommendations that encourage adults to limit their sedentary time in order to improve their cardiovascular health.

The association of depression stigma with barriers to seeking mental health care: a cross-sectional analysis.

Background: Stigma is one of several barriers to seeking mental health care. However, few studies have examined how stigma relates to other common barriers (e.g. attitudes about treatment, cost, time).Aims: This study investigated whether depression stigma (internalized or perceived) was related to other treatment-seeking barriers (attitudinal, structural) and whether depression severity influenced the strength of the association.Methods: We used multivariable-adjusted linear regression to model barrier outcomes as a function of internalized and perceived stigma in an undergraduate population (N = 2551). We evaluated potential effect modification by depression severity using likelihood-ratio tests.Results: Internalized stigma displayed a stronger association with overall barriers to care (including perceived need, negative treatment expectations, and structural barriers) than did perceived stigma. Higher internalized stigma predicted a stronger emphasis on each barrier to treatment measured. Sub-components of internalized stigma (e.g. alienation, stereotype endorsement) uniquely predicted a greater emphasis on distinct barriers.Conclusions: Internalized stigma is strongly linked to greater perception of barriers to mental health care. It may be necessary to address stigma and barriers concurrently rather than independently.

Objective and Self-Reported Measures of Physical Activity and Sex Hormones: Women's Lifestyle Validation Study.

Background: The relationship between specific characteristics of physical activity (PA) (eg, intensity, type, frequency) with sex hormones is uncertain. The authors evaluated the association between characteristics of PA and circulating sex hormones. Methods: This was a cross-sectional analysis of the Women's Lifestyle Validation Study (n = 493). Total PA, light-intensity PA (LPA), and moderate- to vigorous-intensity PA (MVPA) were assessed by accelerometry (a) and self-report (sr). Self-report was used to assess PA type (ie, aerobic, weight training) and exercise frequency. Dehydroepiandrosterone sulfate, testosterone, and sex hormone-binding globulin (SHBG) were assayed among all women; estradiol was assayed in postmenopausal women not currently on hormone therapy. Results: Estradiol was inversely associated and SHBG positively associated with MVPA and LPA (estradiol: ß = -0.15 per SD increase, P ≤ .01 for a-MVPA and a-LPA; SHBG: a-MVPA ß = 0.20 per SD increase, P ≤ .01, a-LPA ß = 0.15, P < .01). By type, aerobic activity and weight training were each independently associated with estradiol and SHBG. Controlling for body mass index attenuated all associations for estradiol, and to a lesser extent SHBG. PA was not associated with testosterone levels. Conclusions: Multiple aspects of PA were independently associated with sex hormones; associations varied some by activity intensity and type, and were attenuated after accounting for body mass index.

They Shall Be One: Sexual Satisfaction Among Men and Women Married in the LDS Faith.

Sexual satisfaction is understudied among highly religious communities, such as the Church of Jesus Christ of Latter-day Saints (LDS). Through an Internet-based self-report survey, this study (N = 266) examined potential predictors of sexual satisfaction among adults living in Utah who had married in the LDS faith, regardless of current faith practice. Both men and women reported their perceived partner satisfaction as the top contributing factor to their own overall sexual satisfaction. These findings have implications for clinicians, educators, and researchers evaluating the sexual lives, including sexual satisfaction, of men and women who have married in the LDS faith.

Differentiating Between Walking and Stair Climbing Using Raw Accelerometry Data.

Wearable accelerometers provide an objective measure of human physical activity. They record high frequency unlabeled three-dimensional time series data. We extract meaningful features from the raw accelerometry data and based on them develop and evaluate a classification method for the detection of walking and its sub-classes, i.e. level walking, descending stairs and ascending stairs. Our methodology is tested on a sample of 32 middle-aged subjects for whom we extracted features based on the Fourier and wavelet transforms. We build subject-specific and group-level classification models utilizing a tree-based methodology. We evaluate the effects of sensor location and tuning parameters on the classification accuracy of the tree models. In the group-level classification setting, we propose a robust feature inter-subject normalization and evaluate its performance compared to unnormalized data. The overall classification accuracy for the three activities at the subject-specific level was on average 87.6%, with the ankle-worn accelerometers showing the best performance with an average accuracy 90.5%. At the group-level, the average overall classification accuracy for the three activities using the normalized features was 80.2% compared to 72.3% for the unnormalized features. In summary, a framework is provided for better use and feature extraction from raw accelerometry data to differentiate among different walking modalities as well as considerations for study design.

Physical Activity and Incidence of Heart Failure in Postmenopausal Women.

OBJECTIVES: This study prospectively examined physical activity levels and the incidence of heart failure (HF) in 137,303 women, ages 50 to 79 years, and examined a subset of 35,272 women who, it was determined, had HF with preserved ejection fraction (HFpEF) and HF with reduced EF (HFrEF). BACKGROUND: The role of physical activity in HF risk among older women is unclear, particularly for incidence of HFpEF or HFrEF. METHODS: Women were free of HF and reported ability to walk at least 1 block without assistance at baseline. Recreational physical activity was self-reported. The study documented 2,523 cases of total HF, and 451 and 734 cases of HFrEF and HFpEF, respectively, during a mean 14-year follow-up. RESULTS: After controlling for age, race, education, income, smoking, alcohol, hormone therapy, and hysterectomy status, compared with women who reported no physical activity (reference group), inverse associations were observed across incremental tertiles of total physical activity for overall HF (hazard ratio [HR]: Tertile 1 = 0.89, Tertile 2 = 0.74, Tertile 3 = 0.65; trend p < 0.001), HFpEF (HR: 0.93, 0.70, 0.68; p < 0.001), and HFrEF (HR: 0.81, 0.59, 0.68; p = 0.01). Additional controlling for potential mediating factors included attenuated time-varying coronary heart disease (CHD) (nonfatal myocardial infarction, coronary revascularization) diagnosis but did not eliminate the inverse associations. Walking, the most common form of physical activity in older women, was also inversely associated with HF risks (overall: 1.00, 0.98, 0.93, 0.72; p < 0.001; HFpEF: 1.00, 0.98, 0.87, 0.67; p < 0.001; HFrEF: 1.00, 0.75, 0.78, 0.67; p = 0.01). Associations between total physical activity and HF were consistent across subgroups, defined by age, body mass index, diabetes, hypertension, physical function, and CHD diagnosis. Analysis of physical activity as a time-varying exposure yielded findings comparable to those of baseline physical activity. CONCLUSIONS: Higher levels of recreational physical activity, including walking, are associated with significantly reduced HF risk in community-dwelling older women.

Adolescent Weight and Electronic Vapor Product Use: Comparing BMI-Based With Perceived Weight Status.

INTRODUCTION: This study examined the associations of BMI-based and perceived body weight status with electronic vapor product use, cigarette smoking, and dual use among U.S. adolescents. METHODS: A cross-sectional analysis was conducted in 2017 on data from 15,129 adolescents in the National Youth Risk Behavior Survey, 2015. Multiple logistic regression analyses were used to examine the associations of BMI-based and perceived weight status with electronic vapor product use, cigarette smoking, and dual use, after adjusting for all other covariates. The regression models were stratified by gender. RESULTS: Overall, 25.5% of males used electronic vapor products, 11.6% smoked cigarettes, and 8.1% used both; percentages among females were 22.6%, 9.8%, and 6.8%, respectively. Females who perceived themselves as overweight were more likely than those who perceived themselves as normal weight to be current electronic vapor product users (AOR=1.09, 95% CI=1.01, 1.19) and dual users (AOR=1.23, 95% CI=1.01, 1.49). When compared with normal BMI-based category, males with obese BMI status were more likely to be current cigarette smokers (AOR=1.61, 95% CI=1.06, 2.44), however, only females with overweight BMI status were more likely to be current smokers (AOR=1.89, 95% CI=1.25, 2.86). CONCLUSIONS: Findings suggest that the influence of adolescents' body weight perceptions and BMI-based status should be accounted for when developing nicotine-containing product use prevention programs for adolescents. Specific strategies for influencing female adolescents who perceive themselves as overweight should be included to prevent emerging electronic vapor product and dual use.

Associations of Sedentary Time with Energy Expenditure and Anthropometric Measures.

PURPOSE: To investigate associations between accelerometer-determined sedentary time (ST) in prolonged (≥30 min) and nonprolonged (<30 min) bouts with physical activity energy expenditure (PAEE) from doubly labeled water. Additionally, associations between ST and body mass index (BMI) and waist circumference were examined. METHODS: Data from 736 women and 655 men age 43 to 82 yr were analyzed. Participants wore the Actigraph GT3X for 7 d on two occasions approximately 6 months apart, and the average of the measurements was used. Physical activity energy expenditure was estimated by subtracting resting metabolic rate and the thermic effect of food from doubly labeled water estimates of total daily energy expenditure. Cross-sectional associations were analyzed using isotemporal substitution modeling. RESULTS: Reallocation of prolonged ST to nonprolonged was not associated with increased PAEE and only significantly associated with lower BMI (ß = -0.57 kg·m; 95% confidence interval, -0.94 to -0.20) and waist circumference (ß = -1.61 cm; 95% confidence interval, -2.61 to -0.60) in men. Replacing either type of ST with light or moderate-to-vigorous physical activity was significantly associated with higher PAEE, and lower BMI and waist circumference in both women and men. CONCLUSIONS: Limiting time spent sedentary as well as decreasing ST accumulated in prolonged bouts may have beneficial effects on BMI and waist circumference. Replacing any type of ST with activities of light or higher intensity may also have a substantial impact on PAEE.

Balance- and Strength-Training Protocols to Improve Chronic Ankle Instability Deficits, Part I: Assessing Clinical Outcome Measures.

CONTEXT: Functional rehabilitation may improve the deficits associated with chronic ankle instability (CAI). OBJECTIVE: To determine if balance- and strength-training protocols improve the balance, strength, and functional performance deficits associated with CAI. DESIGN: Randomized controlled clinical trial. SETTING: Athletic training research laboratory. PATIENTS OR OTHER PARTICIPANTS: Participants were 39 volunteers with CAI, which was determined using the Identification of Functional Ankle Instability Questionnaire. They were randomly assigned to 1 of 3 groups: balance-training protocol (7 males, 6 females; age = 23.5 ± 6.5 years, height = 175.0 ± 8.5 cm, mass = 72.8 ± 10.9 kg), strength-training protocol (8 males, 5 females; age = 24.6 ± 7.7 years, height = 173.2 ± 9.0 cm, mass = 76.0 ± 16.2 kg), or control (6 males, 7 females; age = 24.8 ± 9.0 years, height = 175.5 ± 8.4 cm, mass = 79.1 ± 16.8 kg). INTERVENTION(S): Each group participated in a 20-minute session, 3 times per week, for 6 weeks. The control group completed a mild to moderately strenuous bicycle workout. MAIN OUTCOME MEASURE(S): Participants completed baseline testing of eccentric and concentric isokinetic strength in each ankle direction (inversion, eversion, plantar flexion, and dorsiflexion) and the Balance Error Scoring System (BESS), Star Excursion Balance Test (SEBT), and side-hop functional performance test. The same variables were tested again at 6 weeks after the intervention. Two multivariate repeated-measures analyses of variance with follow-up univariate analyses were conducted. The α level was set a priori at .05. RESULTS: We observed time-by-group interactions in concentric ( P = .02) and eccentric ( P = .01) inversion, eccentric eversion ( P = .01), concentric ( P = .001) and eccentric ( P = .03) plantar flexion, BESS ( P = .01), SEBT ( P = .02), and side hop ( P = .004). With pairwise comparisons, we found improvements in the balance- and strength-training protocol groups in concentric and eccentric inversion and concentric and eccentric plantar flexion and the BESS, SEBT, and side hop (all P values = .001). Only the strength-training protocol group improved in eccentric eversion. The control group did not improve in any dependent variable. CONCLUSIONS: Both training protocols improved strength, balance, and functional performance. More clinicians should incorporate hop-to-stabilization exercises into their rehabilitation protocols to improve the deficits associated with CAI.

Balance- and Strength-Training Protocols to Improve Chronic Ankle Instability Deficits, Part II: Assessing Patient-Reported Outcome Measures.

CONTEXT: Assessing global, regional, and fear-of-reinjury outcomes in individuals with chronic ankle instability (CAI) is critical to understanding the effectiveness of clinical interventions. OBJECTIVE: To determine the improvement of patient-reported outcomes after balance- and strength-training and control protocols among participants with CAI. DESIGN: Randomized controlled clinical trial. SETTING: Athletic training research laboratory. PATIENTS OR OTHER PARTICIPANTS: Thirty-nine volunteers with CAI who scored 11 or greater on the Identification of Functional Ankle Instability questionnaire were randomly assigned to 1 of 3 groups: balance-training protocol (7 males, 6 females; age = 23.5 ± 6.5 years, height = 175.0 ± 8.5 cm, mass = 72.8 ± 10.9 kg), strength-training protocol (8 males, 5 females; age = 24.6 ± 7.7 years, height = 173.2 ± 9.0 cm, mass = 76.0 ± 16.2 kg), or control (6 males, 7 females; age = 24.8 ± 9.0 years, height = 175.5 ± 8.4 cm, mass = 79.1 ± 16.8 kg). INTERVENTION(S): Each group met for 20 minutes, 3 times each week, for 6 weeks. The control group completed a mild to moderately strenuous bicycle workout. MAIN OUTCOME MEASURE(S): Global patient-reported outcomes, regional ankle function, and perceived instability were measured using the Disablement in the Physically Active Scale, the Fear-Avoidance Beliefs Questionnaire, the Foot and Ankle Ability Measure, and a visual analog scale for perceived instability. Participants completed the questionnaires at pretest and 6 weeks posttest. A multivariate repeated-measures analysis of variance with follow-up univariate analysis was conducted. The α level was set a priori at .05. RESULTS: No time-by-group interaction was found ( P = .78, η2 = 0.09). However, we observed a main effect for time ( P = .001, η2 = 0.49). Follow-up univariate analyses revealed differences between the pretest and posttest for the Disablement in the Physically Active Scale ( P = .02, η2 = 0.15), Fear-Avoidance Beliefs Questionnaire ( P = .001, η2 = 0.27), Foot and Ankle Ability Measure-Activities of Daily Living subscale ( P = .003, η2 = 0.22), Foot and Ankle Ability Measure-Sport subscale ( P = .001, η2 = 0.36), and visual analog scale ( P = .008, η2 = 0.18). CONCLUSIONS: Statistically, after the 6-week intervention, all groups improved in global and regional health-related quality of life. Clinicians should compare patient-reported outcomes with clinical measures to have a better understanding of progression during rehabilitation.

Physical Activity and Incident Cardiovascular Disease in Women: Is the Relation Modified by Level of Global Cardiovascular Risk?

BACKGROUND: The inverse association between physical activity and cardiovascular disease (CVD) is well- established and has previously been shown in people with and without single CVD risk factors. We examined whether level of global cardiovascular risk, on the basis of the pooled cohort equation or Reynolds risk score, which include multiple risk factors, modified the physical activity-CVD association. METHODS AND RESULTS: Participants in the prospective WHS (Women's Health Study; n=27 536) reported their leisure-time physical activity at study entry (1992-1995) and during follow-up through 2013. Participants were divided into 10-year cardiovascular risk groups on the basis of the pooled cohort equation and Reynolds risk score. The primary outcome was incident total CVD. The CVD hazard ratio for active (≥500 kcal/wk of physical activity) compared with inactive (<500 kcal/wk) individuals was 0.73 (95% confidence interval, 0.66-0.80) in multivariable models. This association was not modified by level of cardiovascular risk; physical activity was inversely associated with CVD within all pooled cohort equation and Reynolds risk score groups (P=0.17 and P=0.66 for interaction, respectively). When the joint association of physical activity and level of cardiovascular risk was examined, women with higher risk on the basis of either the pooled cohort equation or Reynolds risk score had higher CVD rates compared with those at low risk, regardless of physical activity. However, among women at both high and low risk, being physically active was associated with lower risk of CVD events. CONCLUSIONS: In this large prospective cohort of women, level of global cardiovascular risk did not modify the inverse association between leisure-time physical activity and incident CVD. Thus, promoting physical activity is important in women at both low and high cardiovascular risk.