WHICH ePRO MODALITY IS APPROPRIATE FOR YOUR STUDY?
Jennifer Ross (MS, M.Phil.Ed.), Eric Ross (BA), & Graham Nicholls (MSc)
OBJECTIVES
EVALUATION
To provide guidance in the decision-making process of selecting the most suitable
electronic patient reported outcome (ePRO) modality to collect diary data in a trial.
Table 1. Logistical Factors for Evaluation
Factors
IVRS
IWRS
To show how specific ePRO modalities can be more appropriate than others for
particular studies given the study’s characteristics.
Shipping
NA – not required.
NA – not required.
To provide illustration on this decision-making process through three distinct
scenarios of study / diary requirements and selection of the appropriate modality.
No concern – most patients have a home phone.
To emphasize how making appropriate modality choices can minimize patient
burden (thus resulting in increased compliance) and reduce costs.
Access / Reliability
(Home-based diary)
Access / Reliability
(Site-based diary)
Possible concern – home internet and computer access can
vary by country; reliability of country’s internet access.
No concern – most clinical sites have internet access.
To establish that appropriate modality choice result in enhanced patient
experience, compliance, and overall quality of the data.
Costs
(implementation related)
Low concern – no hardware required; incremental cost of
adding ePRO to IVRS functionality.
Note: this poster concentrates on the most commonly used ePRO modalities
(IVRS, IWRS, Handheld Device); other ePRO modalities exist aside from those
covered here.
METHODS
Based on experience/expertise, three study scenarios are provided that illustrate
the evaluation of ePRO modalities given individual study’s characteristics and
appropriate ePRO modality choice.
In each study scenario, patients are required to record their Patient Reported
Outcome (PRO) data electronically.
Low concern – clinical sites have phone access.
Study Scenario One
Location: Global.
Therapeutic Area: Flu vaccine.
Target Enrollment: 10,000 patients.
Diary: 8 questions reporting symptoms, 4 response options.
Diary Setting: Home-based.
Diary Frequency / Duration: Once daily for 2 weeks.
Constraints: Fast start-up for each country, as the system would have to
be ready to enroll patients as soon as the flu epidemic reaches that
country.
Study characteristics (location, therapeutic area, target enrollment) and situations
(relevant diary factors—description, setting, design, length, frequency, etc.; any
known or possible constraints) are defined for each scenario (see below).
For each scenario, the available ePRO modalities options to choose include:
Interactive Voice Response System (IVRS - phone), Handheld Device and
Interactive Web Response System (IWRS - internet).
Evaluation included study characteristics, diary and logistical factors.
Note that each scenario provided is illustrative and not based on actual clinical
studies.
EVALUATION
Factors for Evaluation:
Choosing the appropriate ePRO modality should be based on a number of different
factors, which have been summarized in the three categorizations below:
1) Study characteristics: Sample size, study population, therapeutic area,
demographics, conditions of target population that may impact the way a diary
can be administered (e.g., hearing impairment, visual impairment, mobility, etc.).
2) Diary factors: Length of study, frequency of diary, diary duration, length of diary,
number of response options, number of questions, diary design, visual
requirements, setting (location of where diary is conducted – home-based or
site-based).
3) Logistical factors: Location of study, shipping requirements, access (phone,
internet, equipment), costs, timelines, study budget, etc. (See Table 1).
CONCLUSIONS
Recommendations:
Handheld Device
Potential concern – time to ship, delays due to customs regulations of
certain countries.
Possible concern – if patient needs to obtain replacement Handheld Device
from site; reliability of data transmission from the docked device to the server.
Low concern – sites often will have replacement Handheld Devices
available at site; reliability of data transmission to server if no server exists at
site.
Low concern – no hardware required; incremental cost of adding High concern – costs of purchasing or renting equipment; shipping costs.
ePRO to IVRS functionality.
Study Scenario Two
Location: North America and Europe.
Therapeutic Area: Oncology pain.
Target Enrollment: 500 patients.
Diary: Branching diary up to 40 questions based on symptom presence (if
“yes” to symptom, then it branches to further questions). Base questions
have 2 response options, branched have 7 responses.
Diary Setting: Home-based.
Diary Frequency / Duration: Once daily for 1 month.
Constraints: The client is cost sensitive.
Study Scenario Three
Location: United States only.
Therapeutic Area: Gastrointestinal.
Target Enrollment: 50 patients.
Diary: Patients are asked to record episodic symptom data daily for 1 year
on a PRO containing a Visual Analogue Scale (VAS).
Diary Setting: Home-based.
Diary Frequency / Duration: Required to respond once daily, and
whenever symptoms are present throughout the day for 1 year.
Constraints: Choice of modality to deliver VAS.
RESULTS
Study Scenario One
Modality Evaluation:
IVRS:
Deployment – can be deployed quickly in countries; once the system
is live then users can call into the IVRS.
Shipping – no shipping requirements to sites; patients will use the
IVRS global network from their own or any phone.
Handheld Device:
Deployment – logistically challenging to deploy 10,000 devices.
Costs – costly to rent or buy 10,000 devices and to ship them.
Timelines / delays – concern of timely shipping due to certain country’s
customs regulations.
IWRS:
Logistics – logistically feasible in large scale study (similar to IVRS).
Access – access to a computer / web in certain countries could be a
concern.
Most Appropriate ePRO Modality Choice:
IVRS – quick deployment; Sponsor would not have to
deal with shipping time and related issues; would not
have to worry about access issues; no hardware costs.
Study Scenario Two
Modality Evaluation:
IVRS:
Length of dairy – may be a long phone call with questions / responses
being read out.
Number of response options – patients may have trouble remembering
while waiting for 7 response options (branched questions) to be read.
Handheld Device:
Number of response options – smaller screen size may make
response options hard to read.
Costs – renting or buying large amount of devices and shipping.
Timelines / delays – concern of timely shipping due to certain country’s
customs regulations.
IWRS:
Length – long diaries fit well with IWRS due to visual aspect.
Number of response options – more than 5 response options fit well
with IWRS since the response options are visual.
Most Appropriate ePRO Modality Choice:
IWRS – quick deployment (like Scenario One);
no hardware or shipping costs; easy for patients
to visually see questions/responses.
Study Scenario Three
Modality Evaluation:
IVRS:
Diary Design – VAS are to be delivered visually (not orally); would
need to be converted to a numerical rating scale (NRS).
Handheld Device:
Diary Frequency / Duration – as patients have to record episodic daily
for a year, Handheld Device would be convenient (since they can carry
it with them throughout the day).
Diary Design – Handheld Device screen would be feasible for VAS;
controlled screen size would ensure VAS line size is viewed the same
by all patients (ensuring response reliability).
IWRS:
Diary Frequency / Duration – with episodic response it may be
challenging for the patient to find a computer during that episode.
Diary Design – VAS can be delivered via IWRS; but variable screen
sizes with different computers may be a possible issue regarding VAS
line size.
Most Appropriate ePRO Modality Choice:
Handheld Device – most convenient for patients;
standard Handheld Device screen size ensures response
reliability of VAS; costs are less of a concern with smaller sample size.
Making appropriate ePRO modality selections improves the quality
of data collection of patient reported outcomes in clinical trials.
Selecting an appropriate ePRO modality can enhance the patient’s
user experience by reducing burden, making responding to the
diary convenient, and making it easy for the patient to use.
Enhanced patient experience will result in higher patient
compliance to diary completion, and thus, overall high quality data.
Appropriate ePRO selection helps Sponsors reduce costs, avoid
implementation delays, and achieve high quality data in clinical
trials.
It is important to note that there is often overlap in deciding which
modality to use for a particular clinical study; as often, it would be
acceptable to use any of the available options for a study.
However, while it would be feasible to select any ePRO modality,
there is often one that is most suitable for each study given the
study’s characteristics.
Often, the driving factor for the decision may be costs; however,
cost should not be the only important factor when choosing a
modality – other factors should include what works best for the
patient population.
The key factors that will drive these decisions are timelines,
population, logistics, study budget, participating countries, scale to
be utilized, diary design and site / patient preference.
The ePRO selection should be considered prior to or during Phase
II, such that the optimal implementation approach is in place when
the product enters Phase III.
Planning is key for the successful implementation of ePRO –
which includes the appropriate training of sites and patients on the
practicalities of data entry.
Selected ePRO References:
Ross, J, (Session Chair), Teall, J, Udani, J, Deal, L, (2011). Electronic
Patient-Reported Outcomes (ePRO): How to Maximize PatientReported Information for Your Studies. Panel Session - presented at
the DIA 47th Annual Meeting, Chicago, IL June 19-23, 2011.
Ross J, O’Gorman, H, (2011). Addressing the Patient Factor in EPRO
to Improve Compliance. Journal For Patient Compliance: Strategies
to enhance Health Outcomes, 1 (1), 2011.
Ross J, (2010). Electronic Patient Reported Outcomes: The Future of
Patient-Centred Data in Global Clinical Trials. Journal for Clinical
Studies. July 2010, 50-52.
Disclosure Panels:
Author(s) of this presentation have the following to disclose concerning
possible financial or personal relationships with commercial entities that
may have a direct or indirect interest in the subject matter of this
presentation:
Jennifer Ross: Nothing to disclose
Eric Ross: Nothing to disclose
Graham Nicholls: Nothing to disclose