Frailty Assessments for Risk Assessment in Gynecologic Oncology Patients

Vascular death is defined as any death with a vascular cause and includes those deaths following a myocardial infarction, cardiac arrest, stroke, cardiac revascularization procedure (i.e., percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG] surgery), pulmonary embolus, hemorrhage, or deaths due to an unknown cause. Non-vascular death is defined as any death due to a clearly documented non-vascular cause (e.g., trauma, infection, malignancy).

PFS, defined as the time from treatment initiation to tumor progression or recurrence or death from any cause, or to the date of censoring at the last time the subject was known to be alive. Cancer progression/recurrence will be defined as a measurable progression/recurrence documented on imaging.

Cancer-specific death is death directly attributable to the primary gynecological cancer or directly related to its treatment, in the absence of other causes of death.

Disability status is determined using the 12-item World Health Organization Disability Assessment Schedule (WHODAS 2.0). New disability at any time point is based according to the following criteria that account for baseline disability scores:

1. For individuals with a disability score of <25% at baseline, new disability is defined as a disability score ≥25% at follow-up;
2. For individuals with a disability score ≥25%, new disability is defined an increase in disability score of ≥8%.

Definition of new disability at 28 days, 6 months, and 1 year after surgery will use as baseline disability score the WHODAS 2.0 score measured before surgery.

defined as a composite of vascular death, and non-fatal myocardial infarction (or myocardial injury for the 28-day time point), stroke, symptomatic proximal venous thromboembolism, and cardiac arrest

Infection is defined as a pathologic process caused by the invasion of normally sterile tissue or fluid or body cavity by pathogenic or potentially pathogenic organisms.

The Third International Consensus Definitions Task Force defines sepsis as a "life-threatening organ dysfunction due to a dysregulated host response to infection." Based on the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) criteria, sepsis will require a quick Sequential Organ Failure Assessment (qSOFA) Score ≥2 points due to infection. The qSOFA includes the following items and scoring system:

1. Altered mental status (1 point)
2. systolic blood pressure of 100 mm Hg or less (1 point), and
3. respiratory rate of 22 breaths/min or more (1 point).

Delirium during the first 3 days after surgery or before discharge from the hospital, based on Confusion Assessment Method (CAM). According to CAM, patients are diagnosed with delirium if they meet the first 2 criteria (acute onset with fluctuating course, AND attention deficit), and at least one of the second 2 criteria (disorganized thinking OR altered level of consciousness). Participants will be screened for postoperative delirium while in hospital, twice daily, during the first 3 days after surgery or until discharge (if before 3 days), by research personnel, using the 3D-CAM, or the CAM-ICU any time the participants are in the PACU or in ICU

BIMS is a bleeding meeting any of the following 3 criteria:

1. Leading to a postoperative hemoglobin <70 g/L
2. Requiring transfusion of one or more units of red blood cells
3. Judged to be the immediate cause of death

The definition of congestive heart failure requires at least one of the following clinical signs (i.e. any of the following signs: elevated jugular venous pressure, respiratory rales/crackles, crepitations, or presence of S3) and at least one of the following:

1. Radiographic findings (i.e., vascular redistribution, interstitial pulmonary edema, or frank alveolar pulmonary edema) OR
2. Heart failure treatment implemented with diuretics with documented clinical improvement.

admission to the ICU that was not planned

The definition of new clinically important atrial fibrillation requires the documentation of atrial fibrillation or atrial flutter of any duration on an ECG or rhythm strip, which results in angina congestive heart failure, symptomatic hypotension, or requires treatment with a rate controlling drug, antiarrhythmic drug, or electrical cardioversion.

time spent in hospital immediately after surgery

This will be measured at the end of any chemotherapy treatment when considered terminated:

Total dose received, defined as Relative Dose Intensity (RDI), as calculated as the percentage of the standard dose that was administered

This will be measured at the end of any chemotherapy treatment when considered terminated:

Time to completion of all chemotherapy cycles (number of days)

This will be measured at the end of any chemotherapy treatment when considered terminated:

Patient's decisional regret, defined as "distress or remorse after a (health care) decision," assessed using the Decisional Regret scale, a validated a 5-item scale

This will be measured at the end of any chemotherapy treatment when considered terminated:

Change in health-related function or well-being, defined as the difference in WHODAS 2.0 score after chemotherapy compared to before chemotherapy.

This will be measured at the end of any chemotherapy treatment when considered terminated:

Change in health-related quality of life, defined as the difference in FACT-G7 score after chemotherapy compared to before chemotherapy.