# Outcome measures reported by cancer patients treated with tyrosine kinase inhibitors: a methodological study

## TL;DR

This study developed and validated a tool to measure outcomes for cancer patients undergoing tyrosine kinase inhibitor therapy.

## Contribution

A new patient-reported outcome instrument was validated for TKI-treated cancer patients using expert input and pilot testing.

## Key findings

- The instrument was refined from 16 to 20 items with strong content validity (CVI of 0.878).
- Pilot testing confirmed the instrument is understandable and suitable for the target population (CVI of 1.0).
- The PRO-CTCAE® Estudo PROM-TKI Brasil has evidence of validity for use during TKI therapy.

## Abstract

to validate the content of an outcome measurement instrument with expert judges and to assess the understandability and suitability of this validated instrument with cancer patients undergoing tyrosine kinase inhibitor (TKI) therapy.

a methodological study, which included the development of an instrument through integrative review, content validity, using the Delphi technique with expert judges, and pilot testing, to verify users’ understandability and suitability to the instrument.

literature review allowed constructing PRO-CTCAE® Estudo PROM-TKI Brasil, with 16 items, which was later submitted to validity using the Delphi technique. After the second round, the final instrument consisted of 20 items, with a Content Validity Index (CVI) of 0.878. The pilot test showed that the instrument is understandable and suitable for the target population (CVI of 1.0).

PRO-CTCAE® Estudo PROM-TKI Brasil obtained evidence of validity for use during TKI therapy.

validar o conteúdo de um instrumento de medidas de resultados com juízes especialistas e avaliar a compreensibilidade e adequabilidade deste instrumento validado com pacientes com câncer sob terapia com inibidores de tirosina-quinase (TKI).

estudo metodológico, que incluiu o desenvolvimento de um instrumento através de revisão integrativa, validação de conteúdo, com emprego de técnica Delphi com juízes especialistas, e teste piloto, para verificar compreensibilidade e adequabilidade dos usuários ao instrumento.

a revisão de literatura permitiu construir o PRO-CTCAE® Estudo PROM-TKI Brasil, com 16 itens, posteriormente submetido à validação pela técnica Delphi. Após a segunda rodada, o instrumento final foi composto por 20 itens, com Índice de Validade de Conteúdo (IVC) de 0,878. O teste piloto evidenciou que o instrumento é compreensível e adequado à população-alvo (IVC de 1,0).

o PRO-CTCAE® Estudo PROM-TKI Brasil obteve evidências de validação para ser utilizado na vigência de terapia com TKI.