Mobile Application Vs. Paper Pictorial Blood Assessment Chart to Track Menses in Young Women: A Randomized Cross-over Design

Background

Heavy menstrual bleeding (HMB) is the most common symptom for women with bleeding disorders. Major barriers to performing research in this field are difficulties in quantifying and tracking changes in menstrual bleeding, particularly in adolescents. The Pictorial Blood Assessment Chart (PBAC) score is often used to quantify severity of menstrual bleeding¹. However, the traditional paper diary PBAC score is fraught with recall bias and compliance issues in adolescents.

Utilizing mobile applications (apps) has great potential for improving health by assisting with behavior modification and disease self-management. Additionally, mobile apps can serve as a valuable medical research tool by facilitating rapid reporting.

Objectives

We developed a mobile app version of the PBAC score to enable adolescents to report and quantify menstrual bleeding. We evaluated patient satisfaction and compliance with mobile app reporting as compared to paper reporting. We hypothesized that adolescents would be compliant with mobile app reporting and would prefer this method over paper reporting.

Methods

This study was a randomized cross-over study of 25 post-menarchal females ages 13-21 years seen in the Hematology Clinics at Nationwide Children's Hospital, Columbus, Ohio. Inclusion criteria included: history of regularly occurring menstrual cycle and possession of a mobile application capable device (smart phone) with continuous service expected. Non-English speaking patients and patients intending to start a hormonal agent that may fully suppress menstrual bleeding were excluded. Subjects agreed to track menstrual bleeding in two consecutive menstrual cycles and were randomized to using the PBAC paper diary or the PBAC mobile app format first. At the end of each cycle, a 10-point response scale satisfaction questionnaire and a system usability scale (mobile app only) assessed the acceptability of the format of the diary used. Weekly email reminders were sent in both groups. Mobile device notifications and reminders were used in the mobile app group. To compare the satisfaction survey results, the Hills and Armitage method for analyzing cross-over data was used which included evaluation of period effect, group effect, and their interaction using a series of independent t-tests.

Results

The 25 subjects enrolled had a median age of 15 years (range 13-21 years). Eleven (44%) had identified bleeding disorders. Twenty-two (88%) could use phones in school. Subjects' PBAC scores did not have significant variability between the paper diary (median PBAC=95) and the mobile app (median PBAC=114). There was a median number of 2 entry times per day in both groups. There was no significant difference in the number of app entries subjects reported to study staff and the actual number recorded in the app. For the mobile app, twenty subjects (80%) had high compliance for reporting bleeding symptoms (app entries for >80% of cycle duration). There were no subjects with low compliance (app entries for <50% of cycle duration). All paper diaries received by study staff met definition for high compliance. The most common reasons subjects listed for missing a daily entry were 1) forgetting to enter data or 2) app not working. Results of the cross-over analysis showed that subject satisfaction was significantly higher for mobile app (mean satisfaction score of 9.5/40 with 4/40 being most satisfied) than for the paper diary (mean satisfaction score of 17.8/40) (p <0.001). Twenty (80%) subjects preferred the mobile app over the paper diary. There was no significant period effect or group by period interaction.

Discussion

This study demonstrated that a PBAC mobile app as compared to the PBAC paper diary was the preferred method of recording menstrual bleeding in adolescents and demonstrated feasibility as a research data collection tool. The app received stronger satisfaction scores and overall compliance was high. A PBAC mobile app is unique compared to publicly available apps because it allows girls and women to quantify their heaviness of flow during menses. Most menstrual tracking apps only track length of cycles or use qualitative assessments of bleeding. In a clinical setting, data from the PBAC app can allow providers to see real-time bleeding symptoms allowing for adjustments in therapy.

¹Higham JM, O'Brien PM, Shaw RW. Assessment of menstrual blood loss using a pictorial chart. Br J Obstet Gynaecol 1990:97(8):734-739.