ePRO and Asthma How electronic patient reported outcomes enable sponsors to secure data integrity

1. A Breath of Fresh Air
How ePRO improves Asthma and Rhinoconjunctivitis clinical studies
The Time is Now
Sponsors elect to use ePRO to capture data from asthma patients primarily because of the
importance of collecting timely and frequent assessments. The LogPad’s accurate time-
stamps ensure data are entered at appropriate times according to the protocl, while its
intuitive touchscreen interface, reminder alarms and branching logic reduce respondent
burden especially during periods of dense sampling. eSense device integration further
elevates the reliability of patient data to unprecedented heights.
Whether you are implementing a diary question about the degree of breathing difficulty,
or comparing PEF and FEV1scores to baseline, PHT’s LogPad System enables higher quality
data and safer clinical research worldwide.
Behind only disorders of the Central Nervous System, the majority of PHT’s market-leading
clinical trial experience is in the Respiratory therapeutic area, a significant percentage of
which are allergy and rhinoconjunctivitis studies*:
Clinical Trials 35
Subjects 14,000 (includes pediatrics) eSense Device Integration
Wirelessly integrated PEF meters,
Sites 2,100 pioneered by PHT, have become the
By Phase Phase II (30%) - Phase III (58%) - Phase IV (12%) gold standard in asthma research.
Subjects use the PEF meter throughout
Questionnaires Asthma Control Quesitonnaire (ACQ-5), Asthma Quality of the day, and all timestamped scores
Life Questionnaire (AQLQ), Rhinioconjunctivitis Quality of Life are sent automatically to the LogPad.
Questionnaire (RQLQ), St. George’s Respiratory Questionnaire This eliminates invented data, user
(SGRQ),Total Nasal Symptom Score (TNSS) error, and transcription error typical of
Countries Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, asthma and pediatric asthma trials.
Costa Rica, Colombia, Czech Republic, Denmark, France,
Germany, Hungary, Israel, Indonesia, Italy, Latvia, Mexico, PHT Client Case Study
Netherlands, New Zealand, Pakistan, Peru, Phillipines, Poland, One sponsor allowed subjects to use
Portugal, Puerto Rico, Russia, Singapore, Slovakia, South Africa, eSense integration or enter readings
South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, manually into the eDiary.
United Kingdom, United States
As presented in a poster at the 2008
Languages Afrikaans, Bulgarian, Chinese (China, Singapore, Taiwan), Czech,
AAAAI Annual Meeting, 86.5% of
Danish, Dutch, English (Australia, UK, US), Flemish, French
12,195 expected blows were sent to the
(Belgium, Canada, France), German, Hangul, Hebrew, Hindi,
LogPad via eSense, 12.5% were entered
Hungarian, Indonesian, Italian, Latvian, Malay, Polish, Portu-
manually, and only 1.0% were missed.
guese (Brazil, Portugal), Spanish (Argentina, Costa Rica, Puerto
Rico, Russian, Peru, Spain, US), Swedish, Tagalog, Thai, Urdu
These results demonstrate frequent
voluntary use of the eSense PiKo
* As of September, 2008
provides a significant increase in data
reliability over antiquated paper diaries
or disconnected eSource methods.
NDA Approval of SYBMICORT® by AstraZeneca
The FDA approved the use of SYBMICORT (budesonide/formoterol) in the United States based on primary efficacy
data captured in two LogPad trials with 1,076 patients. Data from seven LogPad studies were used to prove safety.

2. PHT Corporation
Asthma and Rhinoconjunctivitis
Sample Screen Shots
The LogPad System can display an infinite number of screen types and items. The following are samples of diaries used by clients in previous trials:
Number Spinner Edit Check Numeric Scale Keypad
Allows subjects to indicate dosage Enables subjects to confirm or Limits subjects to legible and Helps subjects enter multi-digit
of medication simply with a tap of clarify out-of-range responses. logically appropriate responses numerical data (e.g. a PEF score)
an arrow. Also provides custom instructions (e.g. they cannot enter invented in a familiar fashion. eSense
as necessary. values or write AEs in the margin). sends these data automatically.
Recommendations and Best Practices for Asthma Diary Design
The real value of the eDiary comes in its design - from work flows and branching logic to edit checks and calculations. PHT’s PROVision science
team has unrivaled experience and expertise in designing screens and diaries to meet the specific requirements of clients and patient populations.
General recommendations and best practices for asthma diary design:
• Ask subjects to complete two reports per day (morning and evening)
• Record Peak Expiratory Flow values during both reports
• Enable alerts on diaries based on specific threshold values (e.g. when a subject’s performance declines as compared to baseline)
• A simple message screen inside of a subject report asks subjects to clarify/confirm out-of-range responses (e.g. a
response of too many puffs of albuterol) and advise the subject to seek medical attention as necessary
• StudyWorks™ flags the data in real time for site personnel in online data summaries
• SafetyPRO™ email and phone alerts are sent instantly to site and medical personnel indicating that attention to, and
contact with, the subject is required
• Use questionnaires completed during a screening period as randomization criteria. The LogPad can retain information from previous
diaries and perform complex calculations integrating both past and present information. Suggested criteria include symptom
severity and diary compliance
• Include questionnaires under Qoltech copyrights (e.g. AQLQ, RQLQ) - they are the current benchmark for asthma questionnaires.
Ensure they are validated with Prof. Juniper’s official approval for the particular eDiary device you will use**
• Plan to study patients of all ages. PHT has found that children as young as six can use the LogPad effectively. For certain pediatric ages,
consider implementing a Caregiver Module, which allows an authorized parent or guardian to enter responses on the child’s behalf
• Employ eSense PiKo devices to transmit wireless PEF readings directly from the PiKo meter to the LogPad
Learn More about ePRO and Asthma
Trust your patient and questionnaire data again. Accurate timestamps and frequent sampling,
enhanced by eSense device integration and best practices for patient safety monitoring, are
taking asthma research to new heights. Contact PHT or review interactive product demos at the
award-winning www.phtcorp.com to learn how your upcoming asthma program can benefit
from improved data quality, real-time data access and more efficient trial management. PHT is
the leading provider of ePRO solutions used by 90 sponsors in 360 clinical trials worldwide.
** Juniper EF, Riis B, Juniper BA. Development and validation of an electronic version of the Rhinoconjunctivitis Quality of Life Questionnaire. Allergy 2007; 62:
1091-3
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