February 4, 2022
Digital health platforms: Considerations for study design and the IRB
Clinical Trials & Research
February 22, 2022
One in every five adults experiences chronic pain, often associated with back injuries, headaches, and joint pain. A staggering 8% of adults experience high-impact chronic pain, which is pain that inhibits a person’s ability to complete daily life or work activities. In addition, pain is “one of the most common and distressing symptoms reported by adolescents with cancer”. This incredible prevalence of chronic pain highlights the need for a comprehensive pain assessment tool.
There are two major types of pain assessment: pain scales and body maps. Pain scales, which can be numerical, visual analogue, or categorical, evaluate the intensity and category of pain. Body maps provide added value in that they evaluate the location of pain. Pain location was first included in the Fibromyalgia Survey Criteria in 2011, so there has been heightened interest in this form of pain measurement over the past decade. Incorporating location beyond the clinical setting into research studies has been a particular area of focus, as quantifying and analyzing data collected through a body map has not been standardized and presents a challenge for researchers.
The Brief Pain Inventory (BPI), a commonly used medical questionnaire developed by the Pain Research Group of the WHO Collaborating Centre for Symptom Evaluation in Cancer Care, employs a simple version of the body map that requires shading the areas where a patient feels pain. There are no pre-identified locations to choose from, so it is widely applicable to a variety of disciplines but difficult to quantify. The Widespread Pain Index (WPI), which was used in the 2011 Fibromyalgia Survey Criteria, allows for quantification of pain location by establishing 19 body areas from which patients can choose. However, this index was developed for areas specifically associated with fibromyalgia, resulting in limited applicability across disciplines.
The Michigan Body Map (MBM) combines the advantages of the BPI’s body map and the WPI resulting in a self-report mechanism to identify where participants experience chronic pain and to quantify the degree of that pain. The MBM provides 16 additional areas from which participants can select when compared to the WPI, increasing its applicability across disciplines while maintaining the quantifiable aspect that facilitates research.
In a validation study that compares the paper forms of the MBM, WPI, and BPI body map, Drs. Brummett, Hassett, and Moser and their teams at the University of Michigan found that, compared to the WPI, participants preferred the MBM and it was better at depicting pain areas. While their scripted interviews of participant preferences found no significant differences in participant experience between the MBM and BPI body map, the MBM lends itself more easily to data analysis. When combined with its rapid administration (39-44 seconds) and straightforward scoring system, the MBM has emerged as an important tool for clinical research.
The recent acceleration towards digital clinical research has prompted a need for an electronic body map to facilitate pain research. To meet that need, the Michigan team – the Michigan Opioid Prescribing Engagement Network (OPEN) – created and validated an electronic form of the MBM (eMBM). Participants experiencing chronic pain were given both the paper and electronic versions of the MBM and researchers understood their preferences through scripted interviews. Through this direct comparison, the teams demonstrated that there was no significant difference between the paper and digital administration of the map, thereby providing initial validation of its use in clinical research. Then, as part of Precision Health at the University of Michigan, they partnered with CareEvolution to implement the eMBM on the MyDataHelps™ digital clinical trial and research platform. Utilizing MyDataHelps™ has enabled them to investigate factors that impact long-term opioid use with the ultimate goal of understanding when to pursue alternative pain management strategies for patients undergoing surgery.
Interested in gathering body pain data for your own study? The eMBM is available in the MyDataHelps™ Survey Store, which is a feature that allows you to import standard surveys that others have created and publicly shared. Learn more about how MyDataHelps™ provides an easy way to implement the eMBM in any clinical research study along with a number of other powerful tools, including eConsent, digital endpoints, ePROs, and EHR/EMR.
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Dahlhamer, J., Lucas, J., Zelaya, C., Nahin, R., Mackey, S., DeBar, L., Kerns, R., von Korff, M., Porter, L., & Helmick, C. (2018). Prevalence of Chronic Pain and High-Impact Chronic Pain Among Adults — United States, 2016. Morbidity and Mortality Weekly Report, 67(36), 1001–1006. https://doi.org/10.15585/mmwr.mm6736a2
Hassett, A. L., Pierce, J., Goesling, J., Fritsch, L., Bakshi, R. R., Kohns, D. J., & Brummett, C. M. (2019). Initial validation of the electronic form of the Michigan Body Map. Regional Anesthesia & Pain Medicine, 45(2), 145–150. https://doi.org/10.1136/rapm-2019-101084
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Wolfe, F., Clauw, D. J., Fitzcharles, M. A., Goldenberg, D. L., Hauser, W., Katz, R. S., Mease, P., Russell, A. S., Russell, I. J., & Winfield, J. B. (2011). Fibromyalgia Criteria and Severity Scales for Clinical and Epidemiological Studies: A Modification of the ACR Preliminary Diagnostic Criteria for Fibromyalgia. The Journal of Rheumatology, 38(6), 1113–1122. https://doi.org/10.3899/jrheum.100594