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Data collection methods for patient-reported outcome measures in cancer randomised controlled trials: a protocol for a rapid scoping review

  • 0University Hospital of Psychiatry II, Medical University of Innsbruck, Innsbruck, Austria jens.lehmann@i-med.ac.at.
Bmj Open +

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September 11, 2024

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September 11, 2024

View abstract on PubMed

Summary

This summary is machine-generated.

This scoping review examines how patient-reported outcomes (PROs) are assessed in cancer clinical trials. It analyzes the modes of assessment (MOA) and reporting quality to improve PRO data collection in oncology research.

Area Of Science

  • Oncology
  • Clinical Trials Methodology
  • Health Outcomes Research

Background

  • Patient-reported outcomes (PROs) are crucial in clinical trials, but systematic information on their assessment modes (MOA) in cancer trials is limited.
  • Understanding how PROs are assessed and managed is essential for reliable data in oncology research.
  • Current practices in PRO assessment within cancer clinical trials require detailed examination.

Purpose Of The Study

  • To conduct a scoping review on the modes of assessment (MOA) and data management of PROs in cancer randomized controlled trials (RCTs).
  • To evaluate the reporting quality of PRO assessments in cancer RCTs according to established guidelines.
  • To inform guidance for improving the measurement of PROs in clinical trials.

Main Methods

  • The review protocol adheres to PRISMA guidelines, searching PubMed for cancer RCTs with PRO endpoints published between January 2019 and November 2023.
  • Two independent reviewers will screen abstracts and full texts, extracting data from trial publications and protocols.
  • Data will be summarized descriptively, focusing on MOA frequencies and reporting quality related to SPIRIT and CONSORT guidelines.

Main Results

  • This section is to be populated upon completion of the review.
  • The review will provide a descriptive analysis of PRO assessment modes and their frequencies.
  • Reporting quality concerning PRO assessment within SPIRIT and CONSORT guidelines will be evaluated.

Conclusions

  • The findings will contribute to a better understanding of PRO assessment practices in cancer RCTs.
  • This review will support ongoing projects on electronic data capture and inform guidance for PRO measurement.
  • Ultimately, the study aims to enhance the (electronic) measurement of PROs in clinical trials.

Keywords:

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