Image-Based Documentation of Vulvodynia Pain Location

Abstract

Aims: Better documentation of vulvar pain is needed. We examined pain locations marked on general body and genital specific outlines among women with vulvodynia. Methods: 62 women (mean age 32.1 ± 9.5 years) with vulvodynia marked their pain on a digital genital specific outline (22 segments) and 59 of those women also marked their pain on a digital general body outline (48 segments). We used ImageJ software to determine body surface area (BSA) for each outline. Results: On the general body outline, 24/48 segments were marked; 22/22 segments were marked on the genital specific outline. There was a moderate correlation (r = 0.43; p = 0.001) between the BSA marked on the general body outline and the BSA marked on the genital area outline. Conclusions: Findings support concurrent validity of the BSA as a measure of pain location using either outline.

Lay abstract

Women with genital pain need to be able to show their healthcare provider where they have pain, and providers need to document where women have pain. In total, 62 women with vulvodynia used a computer tablet to mark their pain on a general body outline and a genital specific outline. We used computer software to document the location of women’s pain looking at percent body surface area. Women marked half of the segments on the general body outline and all the segments on the genital specific outline. Because women marked almost the same percent of body surface area on the general body outline as they did on the genital specific outline, percent body surface may be used to measure pain location.

Keywords::

• pain tool
• PAINReportIt
• tool development
• vulvar pain
• vulvodynia

Author contributions

DJ Wilkie and JM Schlaeger conceptualized this study. DJ Wilkie and Y Yao contributed to the design and plan for analysis. Acquisition of the data was completed by JM Schlaeger, G Telisnor and JE Glayzer. DJ Wilkie, Y Yao and R Garg developed the computer program. Analysis and interpretation of the data was performed by Y Yao and DJ Wilkie. The manuscript was drafted by G Telisnor, JE Glayzer, G-E Kiros, WH Kobak, DJ Wilkie and JM Schlaeger. All authors edited and revised the manuscript for content and also read and approved the final version of the manuscript accepted for publication.

Financial & competing interests disclosure

This research was made possible by grant numbers U54CA233396, U54CA233444, U54CA233465, R25CA214225, R01HD091210 and F31NR019529 from the National Institutes of Health (NIH), National Cancer Institute (NCI), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the National Institute for Nursing Research (NINR). Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the NCI or NICHD. The final peer-reviewed manuscript is subject to the National Institutes of Health Public Access Policy. This publication is co-sponsored by the Rockefeller University Heilbrunn Family Center for Research Nursing through the generosity of the Heilbrunn Family and the National Center for Advancing Translational Sciences, National Institutes of Health, through Rockefeller University, Grant Number UL1TR001866. DJ Wilkie is the founder and chairman of eNURSING LLC, a company without current ownership of the PAINReportIt software. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Ethical conduct of research

The authors state that they have obtained appropriate institutional review board approval or have followed the principles outlined in the Declaration of Helsinki for all human or animal experimental investigations. In addition, for investigations involving human subjects, informed consent has been obtained from the participants involved.

Data sharing statement

The authors certify that this manuscript reports original clinical trial data (NCT03364127). The datasets used and/or analyzed during the current study are available from the corresponding author after deidentification on reasonable request. Other documents available are the study protocol, statistical analysis plan and the analytical code. The data will be available beginning 9 months and up to 36 months following article publication. Data will be shared with researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. Proposals should be directed to [email protected]. Data requesters will need to sign a data use agreement.

Additional information

Funding

This research was made possible by grant numbers U54CA233396, U54CA233444, U54CA233465, R25CA214225, R01HD091210 and F31NR019529 from the National Institutes of Health (NIH), National Cancer Institute (NCI), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the National Institute for Nursing Research (NINR). Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the NCI or NICHD. The final peer-reviewed manuscript is subject to the National Institutes of Health Public Access Policy. This publication is co-sponsored by the Rockefeller University Heilbrunn Family Center for Research Nursing through the generosity of the Heilbrunn Family and the National Center for Advancing Translational Sciences, National Institutes of Health, through Rockefeller University, Grant Number UL1TR001866. DJ Wilkie is the founder and chairman of eNURSING LLC, a company without current ownership of the PAINReportIt software. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. No writing assistance was utilized in the production of this manuscript.