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Practical suggestions for harms reporting in exercise oncology: the Exercise Harms Reporting Method (ExHaRM)
Rosalind R Spence1,2, Carolina X Sandler2,3, Tamara L Jones2,4
1Menzies Institute of Health Queensland, Griffith University, Brisbane, Queensland, Australia r.spence@griffith.edu.au.
BMJ Open
|January 4, 2023
Summary
This study introduces the Exercise Harms Reporting Method (ExHaRM) to systematically track and report adverse outcomes in cancer exercise programs. ExHaRM ensures better understanding of exercise risks for cancer survivors, improving clinical guidance.
Area of Science:
- Exercise Oncology
- Clinical Trial Methodology
- Cancer Rehabilitation
Background:
- Growing evidence supports exercise benefits for cancer survivors.
- Potential harms of exercise in this population are understudied, creating uncertainty for clinicians and patients.
- Lack of standardized practical guidance for reporting exercise-related harms in oncology trials.
Purpose of the Study:
- To present a novel harms reporting protocol, the Exercise Harms Reporting Method (ExHaRM), for exercise oncology trials.
- To adapt existing clinical trial harms reporting guidelines for exercise interventions.
- To facilitate comprehensive assessment and reporting of adverse outcomes in cancer patients undergoing exercise interventions.
Main Methods:
- Development of ExHaRM informed by national/international guidelines and adapted for exercise.
- Iterative refinement of the protocol through implementation in diverse exercise oncology trials (various cancers, stages, intervention types).
- Inclusion of specific terminology (e.g., 'adverse outcomes') to capture physical, psychological, social, and economic harms.
- Four-step process: systematic/non-systematic surveillance, assessment/recording, expert causality review, and analysis/reporting of outcomes.
Main Results:
- ExHaRM provides a structured 4-step approach to monitor, assess, review, and report adverse outcomes.
- The protocol accommodates varied cancer diagnoses, stages, and exercise intervention characteristics (delivery mode, supervision).
- Established a framework for immediate improvement in harms assessment quality and reporting.
Conclusions:
- ExHaRM offers immediate improvements in the quality of harms assessment and reporting in exercise oncology.
- Provides a foundational framework for future refinements and standardization of exercise-specific nomenclature and causality assessment.
- Aims to clarify the risk-benefit profile of exercise for cancer survivors.
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