The Equivalence of Remote Electronic and Paper Collection of Patient Reported Outcome Measures (PROMs): a Randomised Crossover Trial.
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Abstract
Background
The collection of pre- and post-operative Patient Reported Outcome Measures (PROMs) have traditionally been used to assess the benefit of medical and surgical interventions. More recently, individual patient level PROMs have been used in everyday clinical practice. Online website 'electronic' collection, so called remote ePROMs, provides a platform to collect scores at regular intervals and report results back to both patients and their clinicians in real-time.
Objective
The primary objective of this study was to assess whether scores collected via a website (ePROM) are equivalent to scores collected via the traditional pen and paper format (paper PROM).
Methods
A group of 47 patients, previously having undergone open hip debridement for femeroacetabular impingement, were allocated to one of two groups as part of a randomised crossover study. As per the 'International Society for Pharmacoeconomics and Outcomes Research ePRO Good Research Practices Task Force Report', this study was powered to rule out a difference between paper PROM and ePROM assessment of 0.3 standard deviations. Group 1 completed the online ePROM scores- Oxford, McCarthy, UCLA and HowRu score- followed by the paper PROM equivalents one week later, and Group 2 completed these in reverse order.
Results
The scores between Group 1 and Group 2 were not significantly different. Thus combining the two groups revealed an ePROM Oxford score of 32.8, 29.7 to 35.8 (mean, 95% CI) and a paper PROM score of 33.0, 29.9 to 36.1 (mean, 95% CI) (p = 0.99). The Intraclass Correlation Coefficient (ICC) for the Oxford score was 0.99, 0.98 to 0.99 (ICC, 95%CI) with the ICC for the other scores ranging between 0.95 and 0.97.
Conclusions
Remote online ePROM score collection using this website reveals excellent equivalence to paper PROM collection for group and individual applications. The system is therefore suitable for PROMs collection away from the outpatient clinic.
The collection of pre- and post-operative Patient Reported Outcome Measures (PROMs) have traditionally been used to assess the benefit of medical and surgical interventions. More recently, individual patient level PROMs have been used in everyday clinical practice. Online website 'electronic' collection, so called remote ePROMs, provides a platform to collect scores at regular intervals and report results back to both patients and their clinicians in real-time.
Objective
The primary objective of this study was to assess whether scores collected via a website (ePROM) are equivalent to scores collected via the traditional pen and paper format (paper PROM).
Methods
A group of 47 patients, previously having undergone open hip debridement for femeroacetabular impingement, were allocated to one of two groups as part of a randomised crossover study. As per the 'International Society for Pharmacoeconomics and Outcomes Research ePRO Good Research Practices Task Force Report', this study was powered to rule out a difference between paper PROM and ePROM assessment of 0.3 standard deviations. Group 1 completed the online ePROM scores- Oxford, McCarthy, UCLA and HowRu score- followed by the paper PROM equivalents one week later, and Group 2 completed these in reverse order.
Results
The scores between Group 1 and Group 2 were not significantly different. Thus combining the two groups revealed an ePROM Oxford score of 32.8, 29.7 to 35.8 (mean, 95% CI) and a paper PROM score of 33.0, 29.9 to 36.1 (mean, 95% CI) (p = 0.99). The Intraclass Correlation Coefficient (ICC) for the Oxford score was 0.99, 0.98 to 0.99 (ICC, 95%CI) with the ICC for the other scores ranging between 0.95 and 0.97.
Conclusions
Remote online ePROM score collection using this website reveals excellent equivalence to paper PROM collection for group and individual applications. The system is therefore suitable for PROMs collection away from the outpatient clinic.
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