Comparison of Intravesical Therapy and Surgery as Treatment Options for Bladder Cancer 2

The primary outcome of patient-reported financial toxicity is measured by the COST measure. The questionnaire consists of 11 items, each scored on a 5-point Likert scale from zero to four. After reversing some items as indicated in the scoring manual (by reversing the sign on the original zero to four score and adding four), all item response scores are summed into a single financial toxicity score ranging from 0 to 44, with higher scores indicating less financial toxicity. Item nonresponse is accounted for by summing the items answered, multiplying by the total number of items in the scale, and then dividing by the number of items that were actually answered.

Patient-reported financial toxicity is measured by the COST measure. The questionnaire consists of 11 items, each scored on a 5-point Likert scale from zero to four. After reversing some items as indicated in the scoring manual (by reversing the sign on the original zero to four score and adding four), all item response scores are summed into a single financial toxicity score ranging from 0 to 44, with higher scores indicating less financial toxicity. Item nonresponse is accounted for by summing the items answered, multiplying by the total number of items in the scale, and then dividing by the number of items that were actually answered.

Caregiver-reported financial toxicity is measured by the COST measure. The questionnaire consists of 12 items, each scored on a 5-point Likert scale from zero to four. After reversing some items as indicated in the scoring manual (by reversing the sign on the original zero to four score and adding four), all item response scores are summed into a single financial toxicity score ranging from 0 to 44, with higher scores indicating less financial toxicity. Item nonresponse is accounted for by summing the items answered, multiplying by the total number of items in the scale, and then dividing by the number of items that were actually answered.

Patient-reported financial well-being is measured by the CFPB financial well-being scale. The scale consists of 10 items plus 2 questions to assist with scoring. Total response values are converted into an overall financial well-being score between 0 to 100, with higher scores indicating better financial wellness. The financial well-being scores vary based on age and how the questionnaire was administered.

Caregiver-reported financial well-being is measured by the CFPB financial well-being scale. The scale consists of 10 items plus 2 questions to assist with scoring. Total response values are converted into an overall financial well-being score between 0 to 100, with higher scores indicating better financial wellness. The financial well-being scores vary based on age and how the questionnaire was administered.

Caregiver-reported quality of life is measured by the CarGOQol questionnaire. The CarGOQol consists of 29 items, with 5-point Likert response scales, covering 10 domains. The scores for each domain are obtained by calculating the average item score for that domain. The overall score is calculated as the average of the domain scores. A domain score is calculated when more than half of the questions are answered. All domain scores and the overall score are linearly transformed and moralized using a scale of 0 to 100. Higher scores indicate better quality of life for the caregiver.

Patient-reported quality of life is measured by the EORTC QLQ-C30 Physical Function scale. The scale ranges in score from 0 to 100, with higher function scores indicating better health. Scale score is calculated by transforming individual item scores into a 0 to 1 scale, taking the mean, and multiplying by 100. Each scale requires responses for at least 50% of the items to be calculated.

Patient-reported urinary health is measured by the Bladder Cancer Index (BCI). The BCI consists of 36 items, with 4- or 5-point Likert response scales, covering 3 primary domains: urinary, bowel, and sexual. For each domain a summary score is constructed from the items used to calculate the two subscale scores (function and bother). Scores are calculated by transforming item responses into a 0 to 100 scale and calculating the mean of the standardized items. Higher scores indicate better health status. To calculate a score, a minimum of 80% completed items is required.

Patient-reported anxiety is measured by the PROMIS Short Form v1.0 - Anxiety 4a. Scores range from 0 to 100, with higher scores indicating greater symptoms. Scores are normalized to a mean of 50 and standard deviation of 10.

Patient-reported depression is measured by the PROMIS Short Form v1.0 - Depression 4a. Scores range from 0 to 100, with higher scores indicating greater symptoms. Scores are normalized to a mean of 50 and standard deviation of 10.

Caregiver-reported anxiety is measured by the PROMIS Short Form v1.0 - Anxiety 4a. Scores range from 0 to 100, with higher scores indicating greater symptoms. Scores are normalized to a mean of 50 and standard deviation of 10.

Caregiver-reported depression is measured by the PROMIS Short Form v1.0 - Depression 4a. Scores range from 0 to 100, with higher scores indicating greater symptoms. Scores are normalized to a mean of 50 and standard deviation of 10.

Patient-reported generic quality of life is measured by the EQ-5D. Scores range from 0 to 1, with higher scores indicating better health.

Caregiver-reported generic quality of life is measured by the EQ-5D. Scores range from 0 to 1, with higher scores indicating better health.

The evaluation of the effect of treatment choice on progression-free survival. Survival times are calculated from the date of diagnosis of recurrent high-grade non-muscle invasive bladder cancer to the event (metastasis or death). A progression is defined as any subsequent episode of muscle-invasive (T2-T4) disease in the bladder or elsewhere in the urinary tract AND/OR locoregional (true pelvic/common iliac) nodal disease (N+) AND/OR distant metastasis (M+) (for cystectomy arm this includes findings at cystectomy). Censoring occurs at the last electronic health record review or death.

The evaluation of the effect of treatment choice on bladder cancer-specific survival. Survival times are calculated from the date of diagnosis of recurrent high-grade non-muscle invasive bladder cancer to the event (death from bladder cancer). Censoring occurs at the last electronic health record review or date of death from bladder cancer.