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T 48: Best Practices for Development or Migration of Patient-Reported Outcome Measures for use on Multiple Data Collection Modes

Poster Presenter

Mabel Crescioni

Director, Public Health & Outcomes Research
Hemophilia Federation of America
United States

Objectives

To describe best practices developed by the Critical Path Institute’s ePRO Consortium for instrument development and electronic migration of patient-reported outcome (PRO) measures to ensure data comparability across data collection platforms and enable use in the broadest range of clinical trials.

Method

The ePRO Consortium members collaborate pre-competitively to further eCOA (e.g., ePRO) science, including supporting/conducting research and defining best practices. These best practices focus on PRO instrument development and migration principles that consider the range of data collection modes.

Results

A number of considerations factor into the selection of data collection modes for PRO instruments, including functional limitations of target patient population, data collection setting (field-based or site-based), length of the instrument, and translatability. However, whether developing a new PRO instrument or migrating an existing one to an electronic data collection mode, there are specific considerations to ensure consistent implementation across a range of platforms. The following are examples of the considerations to be addressed. Instructions: Should be mode agnostic (unless using an interactive voice response [IVR] system), clear and succinct, with minimal changes to make sense on an electronic platform (e.g., ‘select' instead of ‘circle’). Items: The text should be concise and self-contained. All information that the respondent must consider when formulating a response (i.e., item text, recall period, definitions) should be included on a single screen. Response Options: Response scales require special consideration, particularly when designing an instrument for use on multiple electronic platforms. When designing for screen-based devices (e.g. handheld, tablets or Web), the hit spot for each response option should be the same size, the font size should be consitent regardless of text amount, and include an indicator that makes it clear that the anchor text on a numeric rating scale (NRS) refers to the ends of the scale. When using a verbal rating scale (VRS) on an IVR system, the response choice should be stated prior to the entry value and the cognitive load on the subject having to remember the item and the response scale should be considered. A visual analog scale (VAS) is not suitable for IVR due to its visual nature. If using a NRS on an IVR platform, ensure system is able to capture the maximum number of digits of the response choices, and consider repeating and confirming responses to ensure high quality data.

Conclusion

The assessment of PROs is an increasingly important means of evaluating the efficacy of new medical products. PRO measures should be used when assessing concepts best known by the patient or best measured from the patient’s perspective. Advances in technology have substantially expanded the data collection options for clinical trials. The movement from paper-based to electronic PRO data collection has enhanced the integrity and accuracy of clinical trial data and is encouraged by regulatory agencies. Hence, optimizing the use and usefulness of PRO measures on a variety of electronic data capture platforms is a worthy goal. The ePRO Consortium has developed best practice recommendations for the development of new PRO instruments to enable them to be more readily implemented on a variety of electronic data collection platforms. PRO instrument developers should consider these recommendations during the PRO instrument development process to prevent the need for significant modifications when the instrument is being operationalized electronically. In addition, the ePRO Consortium has developed best practice recommendations for the migration of existing PRO instruments to electronic platforms. Overlooking key considerations addressed by the recommendations can lead to avoidable challenges. Following the best practices outlined by the ePRO Consortium in this poster should enable more efficient PRO measure migration/implementation and deployment in clinical trials. Hence, optimizing the use and usefulness of PRO measures on a variety of electronic data capture platforms is an important goal. The following individuals collaborated to develop this abstract: Celeste Elash, ERT, Jennifer Ross, ALMAC; Bill Byrom, ICON Clinical Research, Paul O’Donohoe, CRF Health, Mabel Crescioni, Critical Path Institute.