W-14: Common Symptom Terminology is Frequently Misunderstood
Poster Presenter
Rinah Yamamoto
Principal Scientist
Clinical ink United States
Objectives
To determine if common symptom terminology is understood by respondents who might participate in clinical trials.
Method
Up to 959 participants completed items in an online survey through a clinical trials recruiting website. As part of the survey, respondents were asked to identify whether two symptoms have the same or different meanings. Demographic data were also collected.
Results
Respondents were asked: “For each pair of words below, indicate if you think the words mean about the same thing (synonyms) or if you think they have different meanings?”
Mild Pain – Moderate Pain
Bloated – Distended
Fatigue – Tiredness
Coma – Loss of Consciousness
Insomnia – Narcolepsy
Worst Pain – Average Pain
34% of respondents indicated that Mild Pain and Moderate Pain meant the same thing. 29% incorrectly indicated that Bloating and Distended were different. 10% said Fatigue and Tiredness meant different things. 56% incorrectly said that Coma and Loss of Consciousness mean different things. 13% selected that Insomnia and Narcolepsy mean the same thing. Only 3% thought that Worst Pain and Average Pain had the same meaning.
A breakdown of responses by level of education shows that even among those with college and advanced degrees, just under 83% correctly selected that Mild Pain and Moderate Pain have different meanings. Only 78% correctly identified that Bloated and Distended meant the same thing. 89% correctly indicated that Fatigue and Tiredness meant the same thing. Less than 39% of those with college and advanced degrees correctly selected that Coma and Loss of Consciousness have the same meaning. 92% and 98% correctly identified the pairs of symptoms, Insomnia and Narcolepsy and Worst Pain and Average Pain as having different meanings, respectively.
Conclusion
Subjects in clinical trials may fail to understand the terminology for symptoms and signs commonly used to describe their disorder. This means they are unable to make accurate statements regarding their treatment experience which can impact patient reported outcome measures. The current data were elicited through a survey directed at potential subjects in clinical trials. These “potential” subjects demonstrated poor understanding of common symptom terminology. More than half of the respondents did not understand that the terms “Coma” and “Loss of Consciousness” mean the same thing and more than 60% of those with college and advanced degrees did not know this. Even more surprising was that over 17% of the well-educated respondents and 34% of all respondents, inclusive, did not know the difference between “Mild” and “Moderate” pain, yet this type of grading is routinely used in PRO scales, such as none, mild, moderate, and severe. It is easy to extrapolate from these data that if these people were participating in a clinical trial that included a patient reported outcome (PRO) measure on pain, the resulting data would be unreliable, since patients are not distinguishing between these terms
Subjects in clinical trials need to have an understanding of the terminology being used so that they can accurately report their experiences. Providing subject training on the symptom terminology would improve the reliability of the data and potentially the statistical results, as well.
