Why Are Outcomes Different for Registry Patients Enrolled Prospectively and Retrospectively? Insights from the Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF).

Background: Retrospective and prospective observational studies are designed to reflect real-world evidence on clinical practice, but can yield conflicting results. The GARFIELD-AF Registry includes both methods of enrolment and allows analysis of differences in patient characteristics and outcomes that may result. Methods and Results: Patients with atrial fibrillation (AF) and ≥1 risk factor for stroke at diagnosis of AF were recruited either retrospectively (n = 5069) or prospectively (n = 5501) from 19 countries and then followed prospectively. The retrospectively enrolled cohort comprised patients with established AF (for a least 6, and up to 24 months before enrolment), who were identified retrospectively (and baseline and partial follow-up data were collected from the emedical records) and then followed prospectively between 0-18 months (such that the total time of follow-up was 24 months; data collection Dec-2009 and Oct-2010). In the prospectively enrolled cohort, patients with newly diagnosed AF (≤6 weeks after diagnosis) were recruited between Mar-2010 and Oct-2011 and were followed for 24 months after enrolment. Differences between the cohorts were observed in clinical characteristics, including type of AF, stroke prevention strategies, and event rates. More patients in the retrospectively identified cohort received vitamin K antagonists (62.1% vs. 53.2%) and fewer received non-vitamin K oral anticoagulants (1.8% vs . 4.2%). All-cause mortality rates per 100 person-years during the prospective follow-up (starting the first study visit up to 1 year) were significantly lower in the retrospective than prospectively identified cohort (3.04 [95% CI 2.51 to 3.67] vs . 4.05 [95% CI 3.53 to 4.63]; p = 0.016). Conclusions: Interpretations of data from registries that aim to evaluate the characteristics and outcomes of patients with AF must take account of differences in registry design and the impact of recall bias and survivorship bias that is incurred with retrospective enrolment. Clinical Trial Registration: - URL: http://www.clinicaltrials.gov . Unique identifier for GARFIELD-AF (NCT01090362)

Risk profiles and one-year outcomes of patients with newly diagnosed atrial fibrillation in India: Insights from the GARFIELD-AF Registry.

BACKGROUND: The Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF) is an ongoing prospective noninterventional registry, which is providing important information on the baseline characteristics, treatment patterns, and 1-year outcomes in patients with newly diagnosed non-valvular atrial fibrillation (NVAF). This report describes data from Indian patients recruited in this registry. METHODS AND RESULTS: A total of 52,014 patients with newly diagnosed AF were enrolled globally; of these, 1388 patients were recruited from 26 sites within India (2012-2016). In India, the mean age was 65.8 years at diagnosis of NVAF. Hypertension was the most prevalent risk factor for AF, present in 68.5% of patients from India and in 76.3% of patients globally (P < 0.001). Diabetes and coronary artery disease (CAD) were prevalent in 36.2% and 28.1% of patients as compared with global prevalence of 22.2% and 21.6%, respectively (P < 0.001 for both). Antiplatelet therapy was the most common antithrombotic treatment in India. With increasing stroke risk, however, patients were more likely to receive oral anticoagulant therapy [mainly vitamin K antagonist (VKA)], but average international normalized ratio (INR) was lower among Indian patients [median INR value 1.6 (interquartile range {IQR}: 1.3-2.3) versus 2.3 (IQR 1.8-2.8) (P < 0.001)]. Compared with other countries, patients from India had markedly higher rates of all-cause mortality [7.68 per 100 person-years (95% confidence interval 6.32-9.35) vs 4.34 (4.16-4.53), P < 0.0001], while rates of stroke/systemic embolism and major bleeding were lower after 1 year of follow-up. CONCLUSION: Compared to previously published registries from India, the GARFIELD-AF registry describes clinical profiles and outcomes in Indian patients with AF of a different etiology. The registry data show that compared to the rest of the world, Indian AF patients are younger in age and have more diabetes and CAD. Patients with a higher stroke risk are more likely to receive anticoagulation therapy with VKA but are underdosed compared with the global average in the GARFIELD-AF. CLINICAL TRIAL REGISTRATION-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01090362

Relationships between social isolation, neighborhood poverty, and cancer mortality in a population-based study of US adults.

BACKGROUND:Social isolation is an important determinant of all-cause mortality, with evidence suggesting an association with cancer-specific mortality as well. In this study, we examined the associations between social isolation and neighborhood poverty (independently and jointly) on cancer mortality in a population-based sample of US adults. METHODS:Using data from the Third National Health and Nutrition Examination Survey (NHANES III; 1988-1994), NHANES III Linked Mortality File (through 2011) and 1990 Census, we estimated the relationship between social isolation and high neighborhood poverty and time-to-cancer death using multivariable-adjusted Cox proportional hazards models. We examined the associations of each factor independently and explored the multiplicative and additive interaction effects on cancer mortality risk and also analyzed these associations by sex. RESULTS:Among 16 044 US adults with 17-23 years of follow-up, there were 1133 cancer deaths. Social isolation (HR 1.25, 95% CI: 1.01-1.54) and high neighborhood poverty (HR 1.31, 95% CI: 1.08-1.60) were associated with increased risk of cancer mortality adjusting for age, sex, and race/ethnicity; in sex-specific estimates this increase in risk was evident among females only (HR 1.39, 95% CI: 1.04-1.86). These associations were attenuated upon further adjustment for socioeconomic status. There was no evidence of joint effects of social isolation and high neighborhood poverty on cancer mortality overall or in the sex-stratified models. CONCLUSIONS:These findings suggest that social isolation and higher neighborhood poverty are independently associated with increased risk of cancer mortality, although there is no evidence to support our a priori hypothesis of a joint effect

Inconsistent Surgical Implant Documentation: A Case Study in Total Knee and Hip Arthroplasty

Value-based care initiatives require accurate quantification of resource utilization. This study explores hospital resource documentation performance for total knee and hip arthroplasty (TKA, THA) implants and how this may differ between hospitals. This retrospective study utilized the Premier discharge database, years 2006 to 2020. TKA/THA cases were categorized into 5 tiers based upon the completeness of implant component documentation: Platinum, Gold, Silver, Bronze, Poor. Correlation between TKA and THA documentation performance (per-hospital percentage of Platinum cases) was assessed. Logistic regression analyses measured the association between hospital characteristics (region, teaching status, bed size, urban/rural) and satisfactory documentation. TKA/THA implant documentation performance was compared to documentation for endovascular stent procedures. Individual hospitals tended to have very complete (Platinum) or very incomplete (Poor) documentation for both TKA and THA. TKA and THA documentation performance were correlated (correlation coefficient = .70). Teaching hospitals were less likely to have satisfactory documentation for both TKA ( P  = .002) and THA ( P  = .029). Documentation for endovascular stent procedures was superior compared to TKA/THA. Hospitals’ TKA and THA-related implant documentation performance is generally either very proficient or very poor, in contrast with often well-documented endovascular stent procedures. Hospital characteristics, other than teaching status, do not appear to impact TKA/THA documentation completeness

Cox proportional regression models of the joint effects of and social network index and neighborhood poverty on cancer mortality (unweighted N = 13 499)

<p>Cox proportional regression models of the joint effects of and social network index and neighborhood poverty on cancer mortality (unweighted N = 13 499)</p

Relationships between social isolation, neighborhood poverty, and cancer mortality in a population-based study of US adults - Fig 1

<p>Sex-stratified hazard ratios (HR) of the effects of Social Network Index (A) and Neighborhood Poverty (B) on cancer mortality. In model 1, the HRs are unadjusted, in model 2 they are adjusted for race/ethnicity and age, and in model 3 they are adjusted for race/ethnicity, age, education, and poverty income ratio. The error bars represent the 95% confidence intervals around each HR.</p

Weighted demographics characteristics of the study population presented by neighborhood poverty and social network index, NHANES III, N = 16 044.

<p>Weighted demographics characteristics of the study population presented by neighborhood poverty and social network index, NHANES III, N = 16 044.</p

Cox proportional hazards models of the associations between social network index and neighborhood poverty with cancer mortality.

<p>Cox proportional hazards models of the associations between social network index and neighborhood poverty with cancer mortality.</p

Risk Profile and 1-Year Outcome of Newly Diagnosed Atrial Fibrillation in Japan - Insights From GARFIELD-AF -

Background: Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF) is an ongoing prospective non-interventional study of stroke prevention in patients with newly diagnosed non-valvular AF (NAVF) that is being conducted in 35 countries