Therapeutic Area Solutions - ePRO Solutions
In each therapeutic area, there are conditions and indications where the patient experience cannot be objectively or independently measured (e.g. pain levels, breathlessness, stomach discomfort, health-related quality of life). ePRO solutions are ideally suited for collecting the subjective voice of the patient accurately and reliably, in order to understand symptom presence, severity and treatment effectiveness.
Pain
In pain studies, frequent sampling and timely responses are keys to demonstrating accurate changes in a patient's health status. The LogPad uses restricted time response windows and accurate timestamps to ensure the pain data you get from patients are reliable. Our electronic Visual Analog Scale (VAS) has been validated for use on 5-centimeter PDA screens (Jamison et al, Pain, 2002), and the eSource nature of the data eliminates manual measurement of the VAS, data entry and queries of the VAS entry.
Respiratory and Asthma
Wirelessly integrating a Peak Expiratory Flow (PEF) meter, such as the PHT eSense device, with an eDiary is quickly becoming the gold standard in global asthma studies, as it ensures subjects use the measurement device appropriately. As is the case with all LogPad data, subject PEF scores are available for real-time review, leading to enhanced safety monitoring and improved compliance. In order to offer sponsors the opportunity to collect HRQoL data electronically, PHT has worked with Prof. Elizabeth Juniper to design and validate electronic versions of her questionnaires. PHT is the only ePRO provider to offer validated electronic versions of the ACQ, AQLQ and RQLQ, all with Prof. Juniper's official approval.
Gastrointestinal
GI studies require patient to report on their symptoms and level of relief on a daily basis, when they experience an episode, or a combination of both. Diaries often include graphical ratings, including the Bristol Stool Scale, which PHT has successfully implemented. The LogPad also performs real-time calculations, which are important for screening scoring in questionnaires such as in the Chron's Disease Activity Index (CDAI). In addition, PHT participated in a validation study (Bushnell et al, Value in Health, 2006) of instruments that are often used in GI studies, including the IBS QoL.
Central Nervous System
Collecting precise and meaningful data on certain disorders of the CNS poses certain challenges due to the nature of the afflictions. Migraines, for example, last a variable duration, sometimes even for days, and can be accompanied by severe pain; it may be too burdensome for a patient to complete a diary of any kind during this time. Emerging ePRO designs, led by PHT's Barbara Marino, Ph.D., RN, address these issues with creative techniques such as combining evening and episodic diary reports, and using complex branching logic and behind-the-scenes edit checks to ensure clean data. A carefully and thoughtfully designed LogPad application makes it easier for subjects to respond and to provide better PRO migraine data.
Sexual Dysfunction
The LogPad is a personal device and features private access codes to keep patient responses strictly confidential. This has been shown to promote more honest responses regarding sensitive information. In a female sexual dysfunction pilot implemented by PHT, respondents using the LogPad reported 50% more sexual encounters than they did using paper diaries. Experts in the field of sexual dysfunction have suggested that subjects were less willing to report sexual experiences on paper due to fear that it could be found and read by their partner. Others may be embarrassed to review the information with their study coordinator. In either case, the LogPad's enhanced privacy increases subject reporting in sensitive trials.
Vaccines
ePRO is being increasingly used in vaccine trials due to the reliable timestamped data it provides, most notably for injection site reaction and reaction symptom data. Because many vaccine trials include children too young to respond to a diary on their own, PHT offers its unique Caregiver Module, which enables an authorized parent or guardian to respond on the child's behalf. PHT has implemented a number of vaccine trials, including fever prevention for pneumococcal, meningitis and the common cold, throughout the United States, the United Kingdom, Australia and parts of Europe.
Learn More about Therapeutic Areas
What level of experience does PHT have implementing solutions for my therapeutic area and condition? What are some of the best practices other trial sponsors have implemented when using ePRO in studies similar to mine? How would PHT approach my data collection needs? Contact PHT for answers to these questions or any others you may have.
References
Jamison RN, Gracely RH, Raymond SA, Levine JG, Marino B, Herrmann TJ, Daly M, Fram D, Katz NP. Comparative study of electronic vs. paper VAS ratings: A randomized, crossover trial using healthy volunteers. Pain 99 (2002) 341-347.
Donald M. Bushnell, MA, Margaret C. Reilly, MPH, Carmen Galani, MD, Mona L. Martin, RN, MPA, Jean-François Ricci, PhD, Donald L. Patrick, PhD, Christopher R. McBurney, PharmD. Validation of Electronic Data Capture of the Irritable Bowel Syndrome-Quality of Life Measure, the Work Productivity and Activity Impairment Questionnaire for Irritable Bowel Syndrome and the EuroQol. Value in Health, Volume 9, Number 2 (2006) 98-105.
