Association of Sleep With Risk of Alzheimer’s Disease Mortality: NIH-AARP Diet and Health Study

Objectives: Alzheimer’s disease (AD) and related dementias contribute to one in three senior deaths. Lifestyle factors, including sleep, may contribute to AD risk and mortality; however, current evidence on sleep and AD mortality is mixed. Methods: We used data from the NIH-AARP Diet and Health Study. Sleep duration and napping were self-reported and AD death were ascertained via linkage to the National Death Index. Results: Long sleep and napping were both associated with increased AD mortality. Specifically, 9+ hr of sleep was associated with 50% increase (hazard ratio = 1.50, 95% CI = [1.17, 1.92]) in AD mortality when compared 7 to 8 hr, while napping for 1+ hr was associated with 29% increase (1.29 [1.08, 1.55]) when compared with no napping. Results appeared to be stronger in men and remained after removing AD deaths within first 5 years after baseline. Discussion: Long sleep and napping may predict higher AD mortality in the older population.

Validation of a Mortality Composite Score in the Real-World Setting: Overcoming Source-Specific Disparities and Biases

PURPOSE This study tested whether a composite mortality score could overcome gaps and potential biases in individual real-world mortality data sources. Complete and accurate mortality data are necessary to calculate important outcomes in oncology, including overall survival. However, in the United States, there is not a single complete and broadly applicable mortality data source. It is further likely that available data sources are biased in their coverage of sex, race, age, and socioeconomic status (SES). METHODS Six individual real-world data sources were combined to develop a high-quality composite mortality score. The composite score was benchmarked against the gold standard for mortality data, the National Death Index. Subgroup analyses were then conducted to evaluate the completeness and accuracy by sex, race, age, and SES. RESULTS The composite mortality score achieved a sensitivity of 94.9% and specificity of 92.8% compared with the National Death Index, with concordance within 1 day of 98.6%. Although some individual data sources show significant coverage gaps related to sex, race, age, and SES, the composite score maintains high sensitivity (84.6%-96.1%) and specificity (77.9%-99.2%) across subgroups. CONCLUSION A composite score leveraging multiple scalable sources for mortality in the real-world setting maintained strong sensitivity, specificity, and concordance, including across sex, race, age, and SES subgroups.

Long-term outcomes of right ventricle-to-pulmonary artery conduit insertion in adults with congenital heart disease: survival analysis by National Death Index

OBJECTIVES The aim of this study was to investigate the long-term outcomes following right ventricle-to-pulmonary artery (RV-to-PA) conduit insertion of Medtronic Freestyle® porcine valve (MFV) or pulmonary allograft valve (PAV) in adult patients with congenital heart disease. METHODS Retrospective medical record review of consecutive RV-to-PA conduit insertion, using either PAV or MFV from 1991 to 2017. Perioperative data and clinic reports were collected. Cause and date of death were obtained from the Australian National Death Index to obtain survival function. RESULTS In total, 232 patients (median age 31.5 years, interquartile range 25–41 years) underwent RV-to-PA conduit insertion (PAV = 84 and MFV = 148) and were eligible for inclusion [63.8% tetralogy of Fallot (TOF); 11.6% congenital pulmonary stenosis (PS); 24.6% other diagnoses]. The overall median follow-up time was 9.1 years (interquartile range 5.3–12.6 years). The mean gradient was 11.8 ± 7.1 mmHg in PAV and 16.6 ± 9.6 mmHg in MFV patients. Congenital PS patients had 100% survival at 20 years, TOF patients at 5, 10, 15 and 20 years had 99%, 97%, 96% and 96% survival, respectively. Patients with other primary diagnoses at 5, 10, 15 and 20 years had 93%, 91%, 87% and 87% respectively. Freedom from reintervention did not differ significantly at 5 and 10 years between pulmonary allograft (98.6%, 98.6%) and Freestyle® porcine bioprosthesis (97.5%, 93%). CONCLUSIONS Both valves perform equally well with regard to patients’ freedom from reoperation, although transvalvular gradient was higher for Freestyle® patients. Congenital PS and TOF patients had better survival than patients with other primary diagnoses.

Sensitivity and Specificity of the National Death Index for Multiple Causes of Death in People With HIV

Objectives Inaccuracies in cause-of-death information in death certificates can reduce the validity of national death statistics and result in poor targeting of resources to reduce morbidity and mortality in people with HIV. Our objective was to measure the sensitivity, specificity, and agreement between multiple causes of deaths from death certificates obtained from the National Death Index (NDI) and causes determined by expert physician review. Methods Physician specialists determined the cause of death using information collected from the medical records of 50 randomly selected HIV-infected people who died in San Francisco from July 1, 2016, through May 31, 2017. Using expert review as the gold standard, we measured sensitivity, specificity, and agreement. Results The NDI had a sensitivity of 53.9% and a specificity of 66.7% for HIV deaths. The NDI had a moderate sensitivity for non–AIDS-related infectious diseases and non–AIDS-related cancers (70.6% and 75.0%, respectively) and high specificity for these causes (100.0% and 94.7%, respectively). The NDI had low sensitivity and high specificity for substance abuse (27.3% and 100.0%, respectively), heart disease (58.3% and 86.8%, respectively), hepatitis B/C (33.3% and 97.7%, respectively), and mental illness (50.0% and 97.8%, respectively). The measure of agreement between expert review and the NDI was lowest for HIV (κ = 0.20); moderate for heart disease (κ = 0.45) and hepatitis B/C (κ = 0.40); high for non–AIDS-related infectious diseases (κ = 0.76) and non–AIDS-related cancers (κ = 0.72); and low for all other causes of death (κ < 0.35). Conclusions Our findings support education and training of health care providers to improve the accuracy of cause-of-death information on death certificates.

Semi-supercentenarians in the United States

This chapter discusses in detail the procedure followed to identify a 1-in-10 sample of persons born between 1870 and 1899 who resided in the United States at the time of their death at ages 105–109 for men and 108 or 109 for women. We tabulate the characteristics of these “semi-supercentenarians” and offer some observations about the level of their mortality. The procedure for identifying semi-supercentenarians consists of (1) casting a net to find candidates and then (2) determining for which candidates can both date of birth and date of death be validated. The net used to find candidates in the United States is different from the nets typically used in other counties: in the United States we use the file of enrollments in the federal government’s Medicare health insurance program. Some of the information needed for the verification step comes from another administrative file – the Social Security Administration’s file of applications for a new or replacement social security card. Verification of the date of death is accomplished by querying the National Death Index. Dates of birth are verified by using online resources to access the records of several censuses conducted many decades earlier.

Psychological Distress and Alzheimer’s Disease Mortality in the United States: Results from the 1997–2014 National Health Interview Survey-National Death Index Record Linkage Study

Objective: This study examines the association between psychological distress and Alzheimer’s disease mortality among US adults aged ≥45. Methods: We analyzed the Kessler 6-item psychological distress scale as a risk factor for Alzheimer’s mortality using the pooled 1997–2014 National Health Interview Survey (NHIS)- National Death Index (NDI) database ( N = 265,089). Cox regression was used to model mortality as a function of psychological distress and sociodemographic and behavioral covariates. Results: The Alzheimer’s mortality risk was 97% higher (HR = 1.97; 95% confidence interval [CI] = 1.37, 2.84) in adults with serious psychological distress compared with those without psychological distress, controlling for sociodemographic covariates. The relative mortality risk remained statistically significant (HR = 1.49; 95% CI = 1.04, 2.13) after additional adjustment for smoking, alcohol consumption, health status, activity limitation, and body mass index. Discussion: US adults had significantly higher risks of Alzheimer’s disease mortality at higher psychological distress levels. These findings underscore the significance of addressing psychological well-being as a strategy for reducing Alzheimer’s disease mortality.

Assessing the relationship between institutional cancer and diabetes mortality rates using National Death Index data

Aim: To evaluate overall survival (OS), glycemic control in cancer patients with and without diabetes mellitus (DM). Patients & methods: Patients (2010–2015) with newly diagnosed prostate, breast, lung, colorectal and pancreatic cancers were identified in institutional cancer registry. Data linked to National Death Index for vital status. 5-year OS estimated; glucose and hemoglobin A1c assessed during year postdiagnosis. Results: We identified 1404 patients (non-DM, n = 936; DM, n = 468). DM cohort had 168 deaths (36%); non-DM, 267 (29%). 5-year OS estimated at 58% (95% CI: 53–64%) for DM and 67% (95% CI: 64–71%) for controls; for matched pairs, hazard ratio: 1.35 (95% CI: 1.02–1.79). Cancer did not harm glycemic control. Conclusion: OS among cancer patients with DM was lower than without DM.

Developing a Standardized and Reusable Method to Link Distributed Health Plan Databases to the National Death Index: Methods Development Study Protocol

Background Certain medications may increase the risk of death or death from specific causes (eg, sudden cardiac death), but these risks may not be identified in premarket randomized trials. Having the capacity to examine death in postmarket safety surveillance activities is important to the US Food and Drug Administration’s (FDA) mission to protect public health. Distributed networks of electronic health plan databases used by the FDA to conduct multicenter research or medical product safety surveillance studies often do not systematically include death or cause-of-death information. Objective This study aims to develop reusable, generalizable methods for linking multiple health plan databases with the Centers for Disease Control and Prevention’s National Death Index Plus (NDI+) data. Methods We will develop efficient administrative workflows to facilitate multicenter institutional review board (IRB) review and approval within a distributed network of 6 health plans. The study will create a distributed NDI+ linkage process that avoids sharing of identifiable patient information between health plans or with a central coordinating center. We will develop standardized criteria for selecting and retaining NDI+ matches and methods for harmonizing linked information across multiple health plans. We will test our processes within a use case comprising users and nonusers of antiarrhythmic medications. Results We will use the linked health plan and NDI+ data sets to estimate the incidences and incidence rates of mortality and specific causes of death within the study use case and compare the results with reported estimates. These comparisons provide an opportunity to assess the performance of the developed NDI+ linkage approach and lessons for future studies requiring NDI+ linkage in distributed database settings. This study is approved by the IRB at Harvard Pilgrim Health Care in Boston, MA. Results will be presented to the FDA at academic conferences and published in peer-reviewed journals. Conclusions This study will develop and test a reusable distributed NDI+ linkage approach with the goal of providing tested NDI+ linkage methods for use in future studies within distributed data networks. Having standardized and reusable methods for systematically obtaining death and cause-of-death information from NDI+ would enhance the FDA’s ability to assess mortality-related safety questions in the postmarket, real-world setting. International Registered Report Identifier (IRRID) DERR1-10.2196/21811

Long-term outcomes following percutaneous coronary intervention for patients with rheumatoid arthritis

Background Rheumatoid arthritis (RA) is the most common inflammatory arthritis and is associated with increased risk of cardiovascular events and mortality. Despite this, data regarding long-term outcomes following percutaneous coronary intervention (PCI) are limited. Methods We identified 756 patients with RA from the Melbourne Interventional Group PCI registry (2005–2018) and compared outcomes to the remaining cohort (N=38,579). Cox regression analysis was performed to assess risk of adverse cardiac events including long-term mortality (derived from linkage with the National Death Index [NDI]). Results Patients with RA were older (68.9±10.0 vs. 64.6±12.0 years) and more often female (40% vs. 23%), with higher rates of hypertension (70% vs 67%), previous stroke (9% vs 6%), peripheral vascular disease (9% vs 6%), obstructive sleep apnoea (10% vs 5%), chronic lung disease (22% vs 12%), prior myocardial infarction (32% vs 27%), and impaired renal function (eGFR&lt;60 ml/min/1.73m2 in 31% vs 24%), while rates of current smoking were lower (20% vs. 25%), all p&lt;0.05. Lesions were more frequently complex (ACC/AHA type B2/C in 61% vs 57%), required longer stents (&gt;20mm in 39% vs 35%), and rates of no reflow were higher (5% vs 3%), all p&lt;0.05. 30-day mortality was higher (4.4% vs. 3.3%, p=0.04) mainly owing to higher non-cardiac mortality (1.6% vs. 0.8%, p=0.01). National Death Index-linked long-term mortality was 28% vs. 19% (p&lt;0.01) with mean follow-up 4.6 vs. 5.4 years. Risk of 30-day and long-term mortality (including by indication subgroup) are presented in the Table. Conclusions Patients with RA undergoing PCI have more comorbidities and longer, more complex coronary lesions. After adjustment, risk of short-term adverse outcomes are similar, while risk of long-term mortality is higher, particularly among patients with acute coronary syndromes. Funding Acknowledgement Type of funding source: None