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Related Concept Videos

Assessment of the Gastrointestinal System I: Subjective Data01:17

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Assessing the gastrointestinal (GI) system is a complex process that begins with collecting subjective data. This data, collected through patient interviews, provides crucial insights into the patient's health history, perception patterns, and lifestyle habits, all contributing significantly to GI health.
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Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

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Related Experiment Video

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Patient-Reported Outcome Measures in Liver and Gastrointestinal Cancer Randomized Controlled Trials.

Carolin Winkelmann1,2, Anna Mezentseva1, Bodo Vogt1,2,3

  • 1Chair in Empirical Economics, Otto-von-Guericke-University Magdeburg, Universitätsplatz 2, 39106 Magdeburg, Germany.

International Journal of Environmental Research and Public Health
|July 14, 2023
PubMed
Summary

Patient-reported outcome measures (PROMs) are increasingly important in cancer trials. However, randomized controlled trials (RCTs) for liver and gastrointestinal cancers often lack comprehensive quality-of-life assessments, limiting a holistic patient view.

Keywords:
RCTgastrointestinal cancerhealth-related quality of life (HRQoL)liver cancerpatient-reported outcome (PRO)patient-reported outcome measures (PROMs)quality of life (QoL)randomized controlled trial

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Area of Science:

  • Oncology
  • Clinical Trials
  • Health Outcomes Research

Background:

  • Historically, oncological treatment effectiveness was evaluated using mortality and morbidity metrics.
  • Patient-reported outcome measures (PROMs) have shifted the focus to a broader concept of health and life satisfaction.
  • This study examines the use of PROMs in liver and gastrointestinal randomized controlled trials (RCTs).

Purpose of the Study:

  • To assess the integration and utilization of PROMs in liver and gastrointestinal cancer RCTs.
  • To identify commonly used PROMs in this specific trial population.
  • To evaluate the comprehensiveness and weighting of quality-of-life measures in cancer RCTs.

Main Methods:

  • A systematic review of 43 randomized controlled trials (RCTs) for liver or gastrointestinal cancer interventions was conducted.
  • Studies were included if they reported health-related quality of life measures as primary or secondary outcomes.
  • The frequency and type of PROMs used were analyzed.

Main Results:

  • The European Organization for Research and Treatment of Cancer Quality of Life questionnaire (EORTC QLQ-C30) was the most frequently used PROM.
  • Specific PROMs like EORTC QLQ-STO22 (gastrointestinal) and Short Form 36/EORTC QLQ-HCC18 (liver) were also common.
  • Quality-of-life measures were often secondary outcomes and not comprehensively integrated.

Conclusions:

  • Randomized controlled trials (RCTs) in liver and gastrointestinal oncology frequently lack thorough quality-of-life assessments.
  • Patient-reported outcomes are often relegated to secondary status, hindering a complete patient perspective.
  • Enhanced integration and prioritization of PROMs are crucial for a holistic evaluation of cancer treatments.