Outcome prevalence is reported while also accounting for the attrition rate over the course of the study. Between wave 1 and wave 2 of TILDA, 46 of 407 participants (11.3%) were no longer participating in the study owing to death (n = 21), loss to follow-up (n = 2), refusal to answer questions as part of the study (n = 22), or withdrawal from the study (n = 1). Between wave 2 and wave 3, 109 of 407 participants (26.8%) were no longer participating in the study. Ascertainment of the reasons for this attrition at wave 3 is currently still ongoing at the time of writing.
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Sexton DJ, Canney M, O’Connell MDL, et al. Injurious Falls and Syncope in Older Community-Dwelling Adults Meeting Inclusion Criteria for SPRINT. JAMA Intern Med. 2017;177(9):1385–1387. doi:10.1001/jamainternmed.2017.2924
The Systolic Blood Pressure Intervention Trial (SPRINT) demonstrated that treating adults 75 years of age or older with hypertension to reach a systolic blood pressure target of less than 120 mm Hg compared with a systolic blood pressure target of less than 140 mm Hg reduced the numbers of cardiovascular events and death without a significant increase in the number of injurious falls or syncope.1 However, prior to the adoption of an intensive strategy to lower systolic blood pressure in the oldest segment of the population, it is prudent to determine if individuals meeting inclusion criteria for SPRINT outside the clinical trial context are similar to trial participants, especially with regard to risk for adverse outcomes. We used The Irish Longitudinal Study on Ageing2,3 (TILDA) to compare baseline rates of injurious falls and syncope in community-dwelling older adults with the rates in the standard care group of SPRINT.
The Irish Longitudinal Study on Ageing is a nationally representative prospective cohort study of community-dwelling adults 50 years of age or older in the Republic of Ireland.2,3 Random sampling of geographical clusters was used to select households. Data collection involved an in-home interview, a self-completed questionnaire (N = 8175), and a comprehensive health assessment (N = 5751). Mean follow-up for TILDA was 3.4 years, compared with a median of 3.4 years in SPRINT. Our study used data from wave 1 of TILDA (completed July 31, 2011) to retrospectively identify participants meeting final inclusion criteria for SPRINT. Outcomes were then reported at wave 2 (February 1, 2012-March 31, 2013) and wave 3 (March 1, 2014-December 31, 2015) follow-up. Ethical approval for TILDA was obtained from the Faculty of Health Sciences Research Ethics Committee at Trinity College Dublin. All participants provided written informed consent.
We used the SPRINT eligibility criteria to identify TILDA participants who would be eligible for the trial.1,4; all SPRINT eligibility parameters apart from degree of proteinuria were available for TILDA participants. Falls and syncope were assessed either by self-report or proxy at each wave. Participants were asked if they had fallen since their last interview and, if so, if they injured themselves seriously enough to need medical treatment. These questions were repeated for syncope. All analyses were performed using R statistical software (R Foundation for Statistical Computing) and Stata, version 14.1 (StataCorp), incorporating inverse probability weighting to account for complex survey designs. P < .05 was considered significant.
The Table5 displays a comparison of characteristics between TILDA participants meeting inclusion criteria for the subgroup of SPRINT participants who were 75 years of age or older and those of participants in the standard care arm of SPRINT.1 All 407 participants in TILDA were white, as opposed to participants in SPRINT (987 of 1319 [74.8%]). Orthostatic hypotension at baseline was more common in TILDA participants than SPRINT (50 of 407 [12.3%] vs 124 of 1319 [9.4%]).2,3 History of cardiovascular disease (309 of 1319 [23.4%] vs 72 of 407 [17.7%]), as well as rates of aspirin (765 of 1319 [58.0%] vs 160 of 407 [39.3%]) and statin use (697 of 1319 [52.8%] vs 159 of 407 [39.1%]), were higher in SPRINT participants, suggesting a higher cardiovascular risk profile. While the 407 TILDA participants were undergoing standard care in the community for a similar duration of follow-up, 111 (27.3%) reported an injurious fall and 54 (13.3%) reported syncope. In SPRINT, 73 of 1319 participants (5.5%) reported injurious falls and 32 of 1319 (2.4%) reported syncope (Figure).
In a community-based prospective cohort with contemporaneous follow-up of comparable duration (TILDA), participants 75 years of age or older who met inclusion criteria for SPRINT had rates of injurious falls and syncope approximately 5-fold higher than the standard care group in SPRINT. Given the high baseline rates of falls and syncope, any increase in these rates due to intensive treatment of hypertension could result in harm.
Corresponding Author: Donal J. Sexton, BSc, MD, The Irish Longitudinal Study on Ageing, Trinity College Dublin, Dublin, Ireland (email@example.com).
Accepted for Publication: May 14, 2017.
Published Online: July 17, 2017. doi:10.1001/jamainternmed.2017.2924
Author Contributions: Dr Sexton had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Sexton, Canney, Moore, Little, O’Seaghdha, Kenny.
Acquisition, analysis, or interpretation of data: Sexton, Canney, O’Connell, O’Seaghdha, Kenny.
Drafting of the manuscript: Sexton, Canney.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Sexton, Canney, O’Connell, Little.
Obtained funding: Kenny.
Administrative, technical, or material support: Sexton, Moore.
Study supervision: Sexton, Little, O’Seaghdha, Kenny.
Conflict of Interest Disclosures: None reported.
Funding/Support: This study was funded by grant HPF-2013-455 from the Health Research Board of Ireland (Dr Sexton). Dr O’Connell is supported by an Ageing Research Leadership Fellowship awarded from the Centre for Ageing Research and Development in Ireland, which became the Ageing Research and Development Division within the Institute of Public Health in Ireland in September 2015, sponsored by the American Federation for Aging Research Paul B. Beeson Career Development Awards in Aging Research for the Island of Ireland. The Irish Longitudinal Study on Ageing (TILDA) is funded by the Irish Department of Health, Irish Life, and the Atlantic Philanthropies.
Role of the Funder/Sponsor: The funding sources had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
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