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The Successful Aging after Elective Surgery (SAGES) Study: Cohort Description and Data Quality Procedures.

ABSTRACT: BACKGROUND/OBJECTIVES:Delirium is the most common complication of major elective surgery in older patients. The Successful Aging after Elective Surgery (SAGES) study was designed to examine novel risk factors and long-term outcomes associated with delirium. This report describes the cohort, quality assurance procedures, and results. DESIGN:Long-term prospective cohort study. SETTING:Three academic medical centers. PARTICIPANTS:A total of 566 patients age 70 and older without recognized dementia scheduled for elective major surgery. MEASUREMENTS:Participants were assessed preoperatively, daily during hospitalization, and at variable monthly intervals for up to 36 months post-discharge. Delirium was assessed in hospital by trained study staff. Study outcomes included cognitive and physical function. Novel risk factors for delirium were assessed including genetic and plasma biomarkers, neuroimaging markers, and cognitive reserve markers. Interrater reliability (kappa and weighted kappa) was assessed for key variables in 119 of the patient interviews. RESULTS:Participants were an average of 77 years old and 58% were female. The majority of patients (81%) were undergoing orthopedic surgery and 24% developed delirium post-operatively. Over 95% of eligible patients were followed for 18 months. There was >99% capture of key study outcomes (cognitive and functional status) at every study interview and interrater reliability was high (weighted kappas for delirium = 0.92 and for overall cognitive and functional outcomes = 0.94 -1.0). Completion rates for plasma biomarkers (4 timepoints) were 95%-99% and for neuroimaging (one year follow-up) was 86%. CONCLUSION:The SAGES study will contribute to the understanding of novel risk factors, pathophysiology and long-term outcomes of delirium. This manuscript describes the cohort and data quality procedures, and will serve as a reference source for future studies based on SAGES.

SUBMITTER: Schmitt EM

PROVIDER: S-EPMC4688907 | biostudies-literature | 2015 Dec

REPOSITORIES: biostudies-literature

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The Successful Aging after Elective Surgery (SAGES) Study: Cohort Description and Data Quality Procedures.

Schmitt Eva M EM Saczynski Jane S JS Kosar Cyrus M CM Jones Richard N RN Alsop David C DC Fong Tamara G TG Metzger Eran E Cooper Zara Z Marcantonio Edward R ER Travison Thomas T Inouye Sharon K SK

Journal of the American Geriatrics Society 20151214 12

<h4>Background/objectives</h4>Delirium is the most common complication of major elective surgery in older patients. The Successful Aging after Elective Surgery (SAGES) study was designed to examine novel risk factors and long-term outcomes associated with delirium. This report describes the cohort, quality assurance procedures, and results.<h4>Design</h4>Long-term prospective cohort study.<h4>Setting</h4>Three academic medical centers.<h4>Participants</h4>A total of 566 patients age 70 and older ...[more]

PMID: 26662213

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Project description:ObjectiveTo develop a nationally applicable tool for assessing the quality of informed consent documents for elective procedures.DesignMixed qualitative-quantitative approach.SettingConvened seven meetings with stakeholders to obtain input and feedback on the tool.ParticipantsTeam of physician investigators, measure development experts, and a working group of nine patients and patient advocates (caregivers, advocates for vulnerable populations and patient safety experts) from different regions of the country.InterventionsWith stakeholder input, we identified elements of high-quality informed consent documents, aggregated into three domains: content, presentation and timing. Based on this comprehensive taxonomy of key elements, we convened the working group to offer input on the development of an abstraction tool to assess the quality of informed consent documents in three phases: (1) selecting the highest-priority elements to be operationalised as items in the tool; (2) iteratively refining and testing the tool using a sample of qualifying informed consent documents from eight hospitals; and (3) developing a scoring approach for the tool. Finally, we tested the reliability of the tool in a subsample of 250 informed consent documents from 25 additional hospitals.OutcomesAbstraction tool to evaluate the quality of informed consent documents.ResultsWe identified 53 elements of informed consent quality; of these, 15 were selected as highest priority for inclusion in the abstraction tool and 8 were feasible to measure. After seven cycles of iterative development and testing of survey items, and development and refinement of a training manual, two trained raters achieved high item-level agreement, ranging from 92% to 100%.ConclusionsWe identified key quality elements of an informed consent document and operationalised the highest-priority elements to define a minimum standard for informed consent documents. This tool is a starting point that can enable hospitals and other providers to evaluate and improve the quality of informed consent.

Dataset Information

The Successful Aging after Elective Surgery (SAGES) Study: Cohort Description and Data Quality Procedures.

Publications

The Successful Aging after Elective Surgery (SAGES) Study: Cohort Description and Data Quality Procedures.

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