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Electronic

Diary-Based Data Capture in a Pain Clinical Trial CDMS


Chanchai S. McDonald, Ph.D.1, Somchan Vuthipadadon, Ph.D.1, Mark E Sakauye, BS1, Emin Kuscu, ME1, Michelle Washington, PharmD.2, Leslie Rawlinson2, Candace Brown, PharmD.2, 3 4 1 David Foster, MD , Gloria Bachmann MD , & Ian M. Brooks Ph.D.
1. Oce of Biomedical InformaOcs, & 2. College of Pharmacy, The University of Tennessee Health Science Center, Memphis, TN, 38163; 3. University of Rochester Medical Center, School of Medicine and DenOstry, Rochester, NY 14642; 4. UMDNJ-RWJ Medical School, New Brunswick, NJ 08901

Introduction
Although chronic pain is recognized by the federal government as a public health problem, with direct and indirect costs of over $635 billion annually, evidence based research in this area is challenging due to lack of objecOve measures and the varying emoOonal, psychosocial, and cultural percepOons of pain. Certain pain condiOons, such as chronic vulvar pain (vulvodynia), have addiOonal adverse eects on women, impacOng not only everyday funcOon, but also aecOng sexuality, self esteem, and mental and emoOonal wellness. EmoOons and stress in turn play a role in how pain is perceived and coped with. To enhance objecOve capture of pain measures for an NIH vulvodynia clinical trial we created an online Daily Diary through the UTHSC Slim-Prim Biomedical InformaOcs data collecOon system. The Daily Diary allows subjects to electronically report their 24 hour pain intensity and describe provoked pain related to sexual intercourse and to tampon inserOon. The Daily Diary, is designed for simplicity, and uses standardized quesOons for vulvar pain (Foster, 2012). Incoming data are monitored by the biomedical informaOcs and research teams. Automated e-mails are sent to inform nurse coordinators if a subject misses 3 days of diary entry. Reports are regularly created for nurse coordinators to review and to communicate with subjects and the clinical team. We believe this data capture system is applicable in the clinical study of most pain condiOons.

Daily Diary: Subject Main Menu


Subject data entry is controlled via dropdown menus and checkboxes. Other tools within Slim-Prim enforce controlled vocabularies, for example ICD-9/10, CPT, and NDC.

Daily Diary: Medication Compliance


Each day, when they log in to complete their Diary, subjects are prompted to record the amount of study medicaOon taken that day (morning and evening doses). Slim-Prim compares this paOent self- report with the prescripOon records in the main study module. The system calculates medicaOon compliance, which is rendered graphically for PIs and coordinators to view.

Slim-Prim Data System: Daily Diary Tool


User log in Diary Tool Menu

Branching logic guides subjects through the quesOonnaire

Daily Diary: Subject Data Quickview


Scheduling funcOons remind subjects to perform the weekly tampon test a primary outcome measure of subject pain. If a subject skips the tampon text then email noOcaOons are sent to coordinators. In addiOon to graphical overviews of paOent compliance, InvesOgators can view a tabular snapshot of subject data. (One test paOent is shown here, but side-by-side comparisons of mulOple subjects/days is possible.) This Quickview is linked to the Slim-Prim data validaOon system; Diary data alone can be viewed within the administraOve area of the Daily Diary Tool, or a subjects enOre study record can be viewed from the ValidaOon taskbar of the main study module. Clicking the System ID link (far lem) jumps to that Dairy entry for direct review, data validaOon or curaOon.

Generate subject
From the Diary Menu invesOgators and sta are presented with a range of opOons: 1. Register a new subject subjects get a unique PIN to act as a password for their diary 2. View exisOng subjects if subjects forget their pin, its easily accessible to sta 3. Enter subject diary and enter data some subjects use paper diaries 4. View diary audit logs tables and graphical tools track subject compliance

Supported by funding from NICHD/ORWH to Drs. Brown, Bachmann & Foster (R01 HD065740-01A1). The BMI gratefully acknowledges the administraOve and technical assistance of Rae Schell & Emanuel Villa.

Support & Acknowledgments

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