Practical suggestions for harms reporting in exercise oncology: the Exercise Harms Reporting Method (ExHaRM), 2022, Spence et al

Practical suggestions for harms reporting in exercise oncology: the Exercise Harms Reporting Method (ExHaRM), BMJ Open 2022;12:e067998. doi: 10.1136/bmjopen-2022-067998
Spence RR, Sandler CX, Jones TL, et al
https://bmjopen.bmj.com/content/12/12/e067998

Abstract
The volume of high-quality evidence supporting exercise as beneficial to cancer survivors has grown exponentially; however, the potential harms of exercise remain understudied. Consequently, the trade-off between desirable and undesirable outcomes of engaging in exercise remains unclear to clinicians and people with cancer. Practical guidance on collecting and reporting harms in exercise oncology is lacking. We present a harms reporting protocol developed and refined through exercise oncology trials since 2015.

Development of the Exercise Harms Reporting Method (ExHaRM) was informed by national and international guidelines for harms reporting in clinical trials involving therapeutic goods or medical devices, with adaptations to enhance applicability to exercise. The protocol has been adjusted via an iterative process of implementation and adjustment through use in multiple exercise oncology trials involving varied cancer diagnoses (types: breast, brain, gynaecological; stages at diagnosis I–IV; primary/recurrent), and heterogeneous exercise intervention characteristics (face to face/telehealth delivery; supervised/unsupervised exercise). It has also involved the development of terms (such as, adverse outcomes, which capture all undesirable physical, psychological, social and economic outcomes) that facilitate the harms assessment process in exercise.

ExHaRM involves: step 1: Monitor occurrence of adverse outcomes through systematic and non-systematic surveillance; step 2: Assess and record adverse outcomes, including severity, causality, impact on intervention and type; step 3: Review of causality by harms panel (and revise as necessary); and step 4: Analyse and report frequencies, rates and clinically meaningful details of all-cause and exercise-related adverse outcomes.

ExHaRM provides guidance to improve the quality of harms assessment and reporting immediately, while concurrently providing a framework for future refinement. Future directions include, but are not limited to, standardising exercise-specific nomenclature and methods of assessing causality.

 

The presumption that there is any reliable evidence for exercise being useful after cancer is probably the first and biggest harm.

Harm will continue as long as researchers go in for this sort of pseudo methodology.

How do you document causality? Don't they know that you cannot do that for individual cases?

 

Ah, but all they said is that there's a lot of it. True. Just as true as exercise is commonly used to treat "chronic fatigue". Despite a complete lack of evidence, it has been used for several decades by now.

So there is pretty much the issue with evidence-based medicine: it's a placeholder that ends up squatting the place by merely existing. It's the asymmetry of bullshit, but turbocharged and abused to turn low-quality uninterpretable results into a vast quantity of low-quality uninterpretable results where all the details are removed.

I genuinely think that in time, the whole EBM paradigm will be seen as one of the worst mistakes ever done by any group of professionals. A premise that never made any sense: opinions, but with an arbitrary process where people pretend the sum of many opinions amounts to science. Which, ironically, is the old pre-science model.