Collecting Electronic Clinical Outcome Assessments: Comparing the 5 Devices Used to Acquire Attributed Patient-Reported Data

By; Valdo Arnera MD, PHT Europe General Manager and Chris Hall, Senior Marketing Manager, PHT Corporation

The specialized industry of collecting electronic clinical outcome assessments (eCOAs) including patient-reported outcomes (PROs) is increasing exponentially. This is in part because global government regulators want to hear directly from the patient, and because electronic collection (versus paper collection) improves data quality and efficiencies for data analysis and trial management. 

The FDA Guidance for Industry – Patient-Reported Outcome Measures states that ‘The degree of respondent burden that is tolerable for instruments in clinical trials depends on the frequency and timing of PRO assessments in a protocol and on patient cognition, illness severity, or treatment toxicity. For example, if the questionnaire contains instructions to skip one or more questions based on response to a previous question, respondents may fail to understand what to do and make errors in responding or find the assessment too complicated to complete. Sponsors should consider missing data and the refusal rate as possible indications of inappropriate respondent burden or inappropriate items or response options.’ [i]

In other words, the FDA does not want sponsors to place undue burden on patients. eCOA Systems minimize respondent burden with features that make even complicated diaries and questionnaires simple for patient populations of all ages.

Globally, there are five proven ways to collect COA/PRO data – smartphone, phone, Internet, digital pen and tablet. The device or combination of devices most suitable depends entirely on the protocol requirements, including   

1)                   Where will the COA/PRO data be collected? 

a.        In transit, at the clinic, or both?

2)                   Will the COA/PRO data be collected using simple or complex questionnaires and/or diaries?

a.       Simple means short and brief questions that require dichotomous responses. 

b.       Complex means long diaries, many questions, questions using body graphics, and/or visual analog scales.

3)                   Will COA/PRO data be collected frequently, episodically, or infrequently? 

a.       Frequent refers to timed assessments, on a fixed schedule, daily, or several times a day. 

b.       Episodic refers to event-driven data collection. 

c.        Infrequent means periodically, seasonally or annually.[ii]

The following chart summarizes each of these five collection devices, recognizing that the ideal method of acquiring patient-reported data are further determined by each trial’s indication, size, complexity, length, locations, survey elements, patient population, budget and critical success factors.  These devices may be used alone or in a combination with others, depending upon study protocol requirements. 

eCOA Devices

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Advantages & Disadvantages

	eCOA Device	Advantages	Disadvantages
1	Smartphone electronic data capture on a mobile browser	·    Widely available ·    Easy-to-use ·    Collects frequent and/or episodic events ·    Enables patient reminders ·    Options for touch screen or stylus data entry ·    Enables efficient mid-study changes ·    Integrates with data from glucometers, PEF meters and actigraphs ·    Displays visuals and scales ·    Compares data instantly on-device for medicine, diary or activity prompts ·    Alerts site of extreme high or low patient dosages, irregular and infrequent diary entries and/or compliance issues ·    Alerts monitor of data out-of-range	·    Often provisioned to ensure availability and universal cognition
2	IVR (Interactive Voice Response): keypad or voice data capture	·    Widely available ·    Easy-to-use ·    Enables patient reminders ·    Enables efficient mid-study changes	·    Suitable only for short and simple diaries
3	Web Browser  electronic data capture on any device with Internet access	·    Becoming widely available ·    Accommodates complex and lengthy diaries and questionnaires ·    Enables efficient mid-study changes ·    Displays visuals and scales ·    Enables efficient mid-study changes ·    Compares data instantly on-device for medicine, diary or activity prompts ·    Alerts site of extreme high or low patient dosages, irregular and infrequent diary entries and/or compliance issues ·    Alerts monitor of data out-of-range	·    Patient reminders unavailable
4	Digital Pen captures data electronically	·    Easy-to-use ·    Uses images and visual scales	·   Requires special paper ·   Suitable only for short and simple diaries ·   Does not provide real-time data ·   Extensive back-end data quality checks required
5	Tablet electronic data capture on a tablet	·    Widely available, easy to use ·    Enables efficient mid-study changes ·    Options for touch screen or stylus data entry ·    Displays visuals and scales ·    Compares data instantly on-device for medicine, diary or activity prompts ·    Alerts site of extreme high or low patient dosages, irregular and infrequent diary entries and/or compliance issues ·    Alerts monitor of data out-of-range	·   Provisioning is cost-effective for site use, not individual diaries

Conclusion:

Each of the five types of eCOA devices have been used for successful data submission to regulatory agencies, and each has specific utility for protocol requirements.  Selecting the best device(s) for your next trial should be based upon protocol requirements.

Regardless of which device(s) is (are) used, eCOA devices are proven to collect attributable, legible, contemporaneous, original, accurate (ALCOA) data; the standard for evidence that is expected by regulatory authorities for accurate clinical outcome assessments.

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[i] FDA, Guidance for Industry. Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims, 2009, http://www.fda.gov/downloads/Drugs/Guidances/UCM193282.pdf (April  2013).

[ii] PHT provides a FREE online decision tool to assist with determining the most suitable device(s) for eCOA/ePRO collection.  Visit  http://bit.ly/15XiLcd