Sex Differences in Timeliness of Reperfusion in Young Patients With ST-Segment-Elevation Myocardial Infarction by Initial Electrocardiographic Characteristics

Background-Young women with ST-segment-elevation myocardial infarction experience reperfusion delays more frequently than men. Our aim was to determine the electrocardiographic correlates of delay in reperfusion in young patients with ST-segment-elevation myocardial infarction. Methods and Results-We examined sex differences in initial electrocardiographic characteristics among 1359 patients with ST-segment-elevation myocardial infarction in a prospective, observational, cohort study (2008-2012) of 3501 patients with acute myocardial infarction, 18 to 55 years of age, as part of the VIRGO (Variation in Recovery: Role of Gender on Outcomes of Young AMI Patients) study at 103 US and 24 Spanish hospitals enrolling in a 2:1 ratio for women/men. We created a multivariable logistic regression model to assess the relationship between reperfusion delay (door-to-balloon time >90 or >120 minutes for transfer or door-to-needle time >30 minutes) and electrocardiographic characteristics, adjusting for sex, sociodemographic characteristics, and clinical characteristics at presentation. In our study (834 women and 525 men), women were more likely to exceed reperfusion time guidelines than men (42.4\% versus 31.5\%; P<0.01). In multivariable analyses, female sex persisted as an important factor in exceeding reperfusion guidelines after adjusting for electrocardiographic characteristics (odds ratio, 1.57; 95\% CI, 1.15-2.15). Positive voltage criteria for left ventricular hypertrophy and absence of a prehospital ECG were positive predictors of reperfusion delay; and ST elevation in lateral leads was an inverse predictor of reperfusion delay. Conclusions-Sex disparities in timeliness to reperfusion in young patients with ST-segment-elevation myocardial infarction persisted, despite adjusting for initial electrocardiographic characteristics. Left ventricular hypertrophy by voltage criteria and absence of prehospital ECG are strongly positively correlated and ST elevation in lateral leads is negatively correlated with reperfusion delay.This work was supported by grants from the National Heart, Lung, and Blood Institute, National Institutes of Health, Department of Health and Human Services (R01 HL081153, F30HL120498 to EMB, and U01 HL105270 to the Center for Cardiovascular Outcomes Research at Yale University). Infarto de miocardio en la Mujer Joven (the Spanish component of VIRGO [Variation in Recovery: Role of Gender on Outcomes of Young AMI Patients]) is supported in Spain by the Fondo de Investigaciones Sanitarias del Instituto Carlos III, Ministry of Science and Technology (PI 081614) and additional funds from the Centro Nacional de Investigaciones Cardiovasculares. Gupta is supported by grant HL007854 from the National Institutes of Health. Spatz is supported by grant K12HS023000 from the Agency for Healthcare Research and Quality Patient-Centered Outcomes Research Institute Mentored Career Development Program.S

Gender differences in pre-event health status of young patients with acute myocardial infarction: a VIRGO study analysis

Aims: We assessed gender differences in pre-event health status (symptoms, functioning, quality of life) in young patients with acute myocardial infarction and whether or not this association persists following sequential adjustment for important covariates. We also evaluated the interaction between gender and prior coronary artery disease, given that aggressive symptom control is a cornerstone of care in those with known coronary disease. Methods and results: A total of 3501 acute myocardial infarction patients (2349 women) aged 18-55 years were enrolled from 103 US/24 Spanish hospitals (2008-2012). Clinical/health status information was obtained by medical record abstraction and patient interviews. Pre-event health status was measured by generic (Short Form-12, EuroQoL) and disease-specific (Seattle Angina Questionnaire) measures. T-test/chi-square and multivariable linear/logistic regression analysis was utilized, sequentially adjusting for covariates. Women had more co-morbidities and significantly lower generic mean health scores than men (Short Form-12 physical health = 43 +/- 12 vs. 46 +/- 11 and mental health = 44 +/- 13 vs. 48 +/- 11); EuroQoL utility index = 0.7 +/- 0.2 vs. 0.8 +/- 0.2 and visual analog scale = 63 +/- 22 vs. 67 +/- 20, P < 0.0001 for all. Their disease-specific health status was also worse, with more angina (Seattle Angina Questionnaire angina frequency = 83 +/- 22 vs. 87 +/- 18), worse physical function (physical limitation = 78 +/- 27 vs. 87 +/- 21) and poorer quality of life (55 +/- 25 vs. 60 +/- 22, P<0.0001 for all). In multivariable analysis, the association between female gender and worse generic physical/mental health persisted, as well as worse disease-specific physical limitation and quality of life. The interaction between gender and prior coronary artery disease was not significant in any of the health status outcomes. Conclusion: Young women have worse pre-event health status as compared with men, regardless of their coronary artery disease history. While future studies of gender differences should adjust for baseline health status, an opportunity may exist to better address the pre-event health status of women at risk for acute myocardial infarction

Protocol for serious fall injury adjudication in the Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) study.

BackgroundThis paper describes a protocol for determining the incidence of serious fall injuries for Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE), a large, multicenter pragmatic clinical trial with limited resources for event adjudication. We describe how administrative data (from participating health systems and Medicare claims) can be used to confirm participant-reported events, with more time- and resource-intensive full-text medical record data used only on an "as-needed" basis.MethodsSTRIDE is a pragmatic cluster-randomized controlled trial involving 5451 participants age ≥ 70 and at increased risk for falls, served by 86 primary care practices in 10 US health systems. The STRIDE intervention involves a nurse falls care manager who assesses a participant's underlying risks for falls, suggests interventions using motivational interviewing, and then creates, implements and longitudinally follows up on an individualized care plan with the participant (and caregiver when appropriate), in partnership with the participant's primary care provider. STRIDE's primary outcome is serious fall injuries, defined as a fall resulting in: (1) medical attention billable according to Medicare guidelines with a) fracture (excluding isolated thoracic vertebral and/or lumbar vertebral fracture), b) joint dislocation, or c) cut requiring closure; OR (2) overnight hospitalization with a) head injury, b) sprain or strain, c) bruising or swelling, or d) other injury determined to be "serious" (i.e., burn, rhabdomyolysis, or internal injury). Two sources of data are required to confirm a serious fall injury. The primary data source is the participant's self-report of a fall leading to medical attention, identified during telephone interview every 4 months, with the confirmatory source being (1) administrative data capturing encounters at the participating health systems or Medicare claims and/or (2) the full text of medical records requested only as needed.DiscussionAdjudication is ongoing, with over 1000 potentially qualifying events adjudicated to date. Administrative data can be successfully used for adjudication, as part of a hybrid approach that retrieves full-text medical records only when needed. With the continued refinement and availability of administrative data sources, future studies may be able to use administrative data completely in lieu of medical record review to maximize the quality of adjudication with finite resources.Trial registrationClinicalTrials.gov (NCT02475850)

Insurance and prehospital delay in patients ≤55 years with acute myocardial infarction

This prospective study assessed whether gender differences in health insurance help explain gender differences in delay in seeking care for US patients with acute myocardial infarction (AMI). We also assessed gender differences in such prehospital delay for AMI in Spain, a country with universal insurance. We used data from 2,951 US and 496 Spanish patients aged 18–55 years with AMI. US patients were grouped by insurance status: adequately insured, underinsured, or uninsured. For each country, we assessed the association between gender and prehospital delay (symptom onset to hospital arrival). For the US cohort, we modeled the relationship between insurance groups and delay of >12 hours. US women were less likely than men to be uninsured, but more likely to be underinsured and a larger proportion of women than men experienced delays of >12 hours (38% versus 29%). We found no association between insurance status and delays of >12 hours in men or women. Only 17.3% of Spanish patients had delays of >12 hours and there were no significant gender differences. In conclusion, women were more likely than men to delay, though it was not explained by differences in insurance status. The lack of gender differences in prehospital delays in Spain suggests that these differences may vary by health care system and culture. Keywords: Prehospital delay, acute myocardial infarction, health insurance, multinational stud

Protocol for serious fall injury adjudication in the Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) study

Abstract Background This paper describes a protocol for determining the incidence of serious fall injuries for Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE), a large, multicenter pragmatic clinical trial with limited resources for event adjudication. We describe how administrative data (from participating health systems and Medicare claims) can be used to confirm participant-reported events, with more time- and resource-intensive full-text medical record data used only on an “as-needed” basis. Methods STRIDE is a pragmatic cluster-randomized controlled trial involving 5451 participants age ≥ 70 and at increased risk for falls, served by 86 primary care practices in 10 US health systems. The STRIDE intervention involves a nurse falls care manager who assesses a participant’s underlying risks for falls, suggests interventions using motivational interviewing, and then creates, implements and longitudinally follows up on an individualized care plan with the participant (and caregiver when appropriate), in partnership with the participant’s primary care provider. STRIDE’s primary outcome is serious fall injuries, defined as a fall resulting in: (1) medical attention billable according to Medicare guidelines with a) fracture (excluding isolated thoracic vertebral and/or lumbar vertebral fracture), b) joint dislocation, or c) cut requiring closure; OR (2) overnight hospitalization with a) head injury, b) sprain or strain, c) bruising or swelling, or d) other injury determined to be “serious” (i.e., burn, rhabdomyolysis, or internal injury). Two sources of data are required to confirm a serious fall injury. The primary data source is the participant’s self-report of a fall leading to medical attention, identified during telephone interview every 4 months, with the confirmatory source being (1) administrative data capturing encounters at the participating health systems or Medicare claims and/or (2) the full text of medical records requested only as needed. Discussion Adjudication is ongoing, with over 1000 potentially qualifying events adjudicated to date. Administrative data can be successfully used for adjudication, as part of a hybrid approach that retrieves full-text medical records only when needed. With the continued refinement and availability of administrative data sources, future studies may be able to use administrative data completely in lieu of medical record review to maximize the quality of adjudication with finite resources. Trial registration ClinicalTrials.gov (NCT02475850)