Stephen Joel Coons|Chad Gwaltney|Ron D. Hays|J. Jason Lundy|Jeff A. Sloan|Dennis A. Revicki|William R. Lenderking|David Cella|Ethan Basch
Recommendations on Evidence Needed to Support Measurement Equivalence between Electronic and Paper-Based Patient-Reported Outcome (PRO) Measures: ISPOR ePRO Good Research Practices Task Force Report
University of Arizona
patientreported outcomes pros consequences disease andor treatment reported patient importance pro measures clinical trials new drugs biological agents devices underscored release us food drug administrations draft guidance industry titled patientreported outcome measures use medical product development support labeling claims intent guidance describe fda evaluate appropriateness adequacy pro measures used effectiveness end points clinical trials response expressed need ispor members clarification several aspects draft guidance ispors health science policy council created three task forces one charged addressing implications draft guidance collection pro data using electronic data capture modes administration epro objective report present recommendations ispors epro good research practices task force regarding evidence necessary support comparability measurement equivalence epros paperbased pro measures adaptedthe task force composed leadership team ispors epro working group members another group ie epro consensus development working group already begun develop recommendations regarding epro good research practices resulting task force membership reflected broad array backgrounds perspectives expertise enriched development report prior work became starting point task force report subset task force members became writing team prepared subsequent iterations report distributed full task force review feedback addition review beyond task force sought obtained along presentation discussion period ispor meeting draft version full report distributed roughly 220 members reviewer group reviewer group comprised individuals responded emailed invitation full membership ispor task force report reflects extensive internal external input received 16month good research practices development process resultsrecommendations epro questionnaire adapted paperbased questionnaire ought produce data equivalent superior eg higher reliability data produced original paper version measurement equivalence function comparability psychometric properties data obtained via original adapted administration mode comparability driven amount modification content format original paper pro questionnaire required migration process magnitude particular modification defined reference potential effect content meaning interpretation measures items andor scales based magnitude modification evidence measurement equivalence generated combinations following cognitive debriefingtesting usability testing equivalence testing substantial modifications made full psychometric testing long minor modifications made measure migration process substantial body existing evidence suggests psychometric properties original measure still hold epro version hence evaluation limited cognitive debriefing usability testing may sufficient however substantive changes migration process occurred confirming adaptation epro format introduce significant response bias two modes administration produce essentially equivalent results necessary recommendations regarding study designs statistical approaches assessing measurement equivalence providedthe electronic administration pro measures offers many advantages paper administration provide general framework decisions regarding level evidence needed support modifications made pro measures migrated paper epro devices key issues include 1 determination extent modification required administer pro epro device 2 selection implementation effective strategy testing measurement equivalence two modes administration hope good research practice recommendations provide path forward researchers interested migrating pro measures electronic data collection platforms