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Methods of Documentation VII: EMR01:30

Methods of Documentation VII: EMR

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Ideally, the people who observe and record the children’s behavior are unaware of who was assigned to the experimental or control group, in order to control for experimenter bias. Experimenter bias refers to the possibility that a researcher’s expectations might skew the results of the study. Remember, conducting an experiment requires a lot of planning, and the people involved in the research project have a vested interest in supporting their hypotheses. If the observers knew which...
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Related Experiment Video

Updated: Jul 16, 2025

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Study within a trial of electronic versus paper-based Patient-Reported oUtcomes CollEction (SPRUCE): study protocol

Lara Philipps1, Stephanie Foster1, Deborah Gardiner1

  • 1Clinical Trials and Statistics Unit (ICR-CTSU), The Institute of Cancer Research, London, UK.

BMJ Open
|September 21, 2023
PubMed
Summary

This study evaluates electronic patient-reported outcomes (ePRO) versus paper questionnaires in cancer trials. ePRO collection is being assessed for its acceptability and data completeness in oncology clinical trials.

Keywords:
adult oncologypatient reported outcome measuresquality of life

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Area of Science:

  • Oncology clinical trials
  • Patient-reported outcomes
  • Health informatics

Background:

  • Patient-reported outcomes (PRO) are crucial in clinical trials.
  • Currently, PRO data is collected via paper questionnaires by ICR-CTSU.
  • Electronic PRO (ePRO) collection may enhance data quality and patient experience.

Purpose of the Study:

  • To investigate the acceptability of ePRO in oncology clinical trials.
  • To compare the data collection efficiency of ePRO versus paper PROs.
  • To assess patient and data completeness using ePRO.

Main Methods:

  • The SPRUCE protocol (Study within a trial of electronic versus paper-based Patient-Reported oUtcomes CollEction) was developed with patient input.
  • A partially randomised patient preference design allows participants to choose or be randomised to ePRO or paper PROs.
  • The primary objective is to compare return rates (compliance) between ePRO and paper PROs in the randomised group, with 244 participants required for statistical power.

Main Results:

  • The study aims to determine if ePRO is acceptable to participants in ICR-CTSU oncology trials.
  • It will establish whether ePRO can capture complete PRO data comparable to paper PROs.
  • Compliance rates for paper PROs are expected to be 90%.

Conclusions:

  • The SPRUCE trial will provide valuable insights into the implementation of ePRO in cancer research.
  • Findings will inform future strategies for streamlining PRO data collection in clinical trials.
  • The study will assess the feasibility and patient acceptance of digital health tools in oncology settings.