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Table 4 Direct implications of this study to BladderPath

From: Development and validation of a follow-up methodology for a randomised controlled trial, utilising routine clinical data as an alternative to traditional designs: a pilot study to assess the feasibility of use for the BladderPath trial

Outcome

Database

Implication from validation

Surgery to bladder

- Hospital Episode Statistics (HES)

- Historically high quality

- HES data alone sufficient

Chemotherapy regimens

- Hospital Episode Statistics (HES)

- Systemic Anti-Cancer Therapy (SACT)

- Historically high quality to detect regimens

- The exact date of administrations can additionally be found in the SACT data (and clinical noting if required)

- HES data alone sufficient

Radiotherapy regimens

- Hospital Episode Statistics (HES)

- National Radiotherapy Data set (RTDS)

- More recent high quality (since 2014) to detect regimens

- Due to the validation of the radiotherapy LINAC data, the RTDS will be used to supplement missing events

Cystoscopy

- Hospital Episode Statistics (HES)

- Diagnostic Imaging Data set (DID)

- Recent high quality (since 2016)

- Consistent high quality TURBT coding

- Historically lower quality of flexible cystoscopy coding

- Prior to trial data confidence, a database query process may be necessary (check flag = if no flexible cystoscopy is identified prior to TURBT)

- To confirm identification of subsequent surveillance flexible cystoscopy events, the DID will be used as a supplement

BCG regimens

- Hospital Episode Statistics (HES)

- Systemic Anti-Cancer Therapy (SACT)

- More recent high quality (since 2013)

- SACT data will supplement missing administration details

Censor

- Hospital Episode Statistics (HES)

- Data quality historically high, but reduced recently (post-2016)

- Therefore, upon query at site, the most recent event in the clinical noting should be confirmed