When it comes to evaluating patients who have a degenerative condition, it is never straight-forward to predict what the outcomes of any research or evaluation will be. With Parkinson’s disease, there are the ethical, moral and safety considerations that may greatly affect the data generated from an evaluation – especially in a human factors/usability study.
People with Parkinson’s disease require management due to the affect of their condition on their bodies – mentally and physically. They need management from a medication perspective as well as in a lifestyle manner if they are to have a quality of life. When it comes to evaluating a product with patients, then a continuation of care has to be paramount, alongside safety, to ensure the completion of the evaluation safely, ethically and morally. The participant in the evaluation has to be looked after from the time they leave their homes to when they return. This is the responsibility of the evaluation since it is the evaluation that is taking them out of a comfort zone and into an unknown situation.
Quite often we have seen patients – people with Parkinson’s disease in studies, research and evaluations where the condition affects their abilities to use medical products. We have had to really consider the ability of the participant who has Parkinson’s disease to complete the evaluation. They will often arrive at a test venue over-medicated, nervous and unsure of what they will be expected to do. As such, one of the first things we do is to talk to them – make them at ease, relaxed, more confident and less worried about their symptoms (and the effects of their symptoms). Once relaxed, less medicated and more confident, then they are in a state where good quality data will be gained. This sounds like a market research activity, but it can be used well in a human factors study, research or evaluation.
And that is the crux of any research, study or evaluation – gaining good quality data. If your participant is “not themselves”, then the data may be skewed. Over-medication in Parkinson’s disease can cause symptoms to be often worse than if under-medicated – dyskinesia being one commonly seen example, alongside quiet speech, bradykinesia and tremours. The remedy is to wait, postpone, relax the participant until they feel under control of their Parkinson’s disease symptoms, and of course symptoms of any other condition, injury or disease they may have. We have to ensure we act ethically, morally and safely, and this is sometimes a dilemma. Data is being paid for, yet sometimes, and not often, we have stopped an evaluation since the participant would be able to continue, but we have felt that it would be unethical and unsafe. With Parkinson’s disease, and with other degenerative diseases such as Alzheimer’s, COPD and Rheumatioid Arthritis, quick thinking of the research team is required to ensure the evaluation is completed safely – for all concerned.
If you have any questions on evaluating people with Parkinson’s disease, we are quite experienced at it and would love to hear from you.
The staff at THAY Medical