Jan Douglass
Randomised controlled trials are still held as the pinnacle of 'evidence' for health interventions of all kinds. But really they are only suited to observing a cause and effect relationship in large drug trials on people who are very much the same as each other. Nothing about interventions for chronic conditions such as lymphoedema resembles anything like a big homogenous group of people all receiving exactly the same dose of something.
Chronic oedema and lymphatic disorders present in unique ways among individuals who have few similarities with each other. Many suffer from other co-morbidities which increase their overall inflammatory load or impact on the oedema in some way. Yet we still try to force them into the RCT model as if that is the only way to determine if our treatments are effective.
Systematic reviews which exclude any other kind of evidence compound the problem by missing vital opportunities to inform us on how we can tailor our treatment plans to most effectively serve the bespoke needs of our clients.
And yet we persist in trying to force the irregular shape of lymphatic disorders into the regular tube of the clinical trial process. Along the way we lose a plethora of observations made by therapists and their clients, on the basis that these observations were not made within the narrow pipeline of the RCT and SR sausage factory.
And so we end up with disappointing, repetitive and uninformative reviews on women with arm lymphoedema after breast cancer, as this is the closest thing to a homogenous group that we've got. I have written on this previously, read more.
The lack of real-life research is a big problem in all complex syndromes and chronic diseases.
So what's the answer?
Study designs and outcome measures which lend themselves to investigations on lymphoedema management include
N=1 studies
Case series and single case reports
Qualitative studies on patient experience
Cohort studies on self-reported-symptoms rather than simply focussing on limb volume
Factors affecting self-care adherence
Effect of tailored lymphoedema-care on the full spectrum of daily life such as employment, independence, relationships, social inclusion, and self-agency.
We also need a paradigm shift away from depending on research generated by institutions and sponsors that inherently rely on commercialisation of results, and look to the therapists who problem solve and strive to find new ways to help their clients, and the people affected who must manage their condition on a daily basis.
In other words we need a research paradigm that views people as individuals not numbers and averages.
I encourage every health professional who works with people affected by chronic diseases to consider publishing their case reports on what works and does not work for individual clients. These descriptive reports can be synthesised into a narrative review once we have enough of them to elucidate useful patterns in the data.
There are 10 steps to preparing and reporting a case study.
Define the study population and the problem you will address
Define the study aims, objectives and study period
Define the outcome measures and data collection intervals
Participant selection and informed consent
Record relevant demographics and medical history
Record baseline measures
Record treatments given and follow-up measures
Interpret your results to inform other therapists
Note the limitations to your study
Submit your observations for publication
I am developing an online course at #MovingLymphOnline.
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