The Successful Aging After Elective Surgery 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.

Alzheimer's-related cortical atrophy is associated with postoperative delirium severity in persons without dementia

“…The neuroimaging subset did not differ from the rest of the SAGES cohort on various relevant characteristics including age, sex, education, and surgery type. Details of the SAGES study including inclusion and exclusion criteria have been described previously (Cavallari et al, 2016; Schmitt et al, 2012; Schmitt et al, 2015). Inclusion criteria included age ≥70 years old, English speaking, and undergoing elective surgery at Beth Israel Deaconess Medical Center (BIDMC) or Brigham and Women’s Hospital (BWH).…”

“…The CAM was rated based on information from patient interviews performed once daily in the late morning or early afternoon at approximately the same time each day; these included a brief cognitive screen (orientation, short-term recall, sustained attention), the Delirium Symptom Interview (Albert et al, 1992), and information related to acute changes in mental status noted by nurses or family members (Schmitt et al, 2015). Study interviewers underwent intensive training and standardization (Inouye, 2003).…”

Derivation and Validation of a Severity Scoring Method for the 3‐Minute Diagnostic Interview for Confusion Assessment Method‐‐Defined Delirium

“…The study design and methods have been described in detail previously 15,16 . In brief, eligible participants were age 70 years and older, English speaking, scheduled to undergo elective surgery at two Harvard-affiliated academic medical centers and had an anticipated length of stay of at least 3 days.…”

Quantifying the Severity of a Delirium Episode Throughout Hospitalization: the Combined Importance of Intensity and Duration

“…Study interviewers underwent intensive training and standardization. 16,21 Delirium Episode Severity Measures Individual Measures: We chose to examine different types of measures based on evidence in the literature. For example, previous studies have examined delirium intensity, persistence or duration as severity indicators.…”

“…Among these patients, 318 declined an interview, 163 were ineligible (residing within 50 miles, evidence of dementia, rescheduled surgery, prior hospitalization, severe blindness or deafness), and 5 were eligible but refused participation, resulting in a final sample of 566 patients (eFigure 1). 16 Project Recovery enrolled patients aged ≥70 years, who were admitted to the medicine service at Yale-New Haven Hospital from March 1995 to March 1998. Sample inclusion and exclusion criteria have been reported.…”