Use of Patient-reported Outcome Measures and Patient-reported Experience Measures within Evaluation Studies of Telemedicine Applications: Systematic Review (Preprint)

BACKGROUND With the rise of digital health technologies and telemedicine services, the need for evidence-based evaluation is growing. Patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs) are recommended as an essential part of comprehensive and multidisciplinary evaluation studies on telemedicine applications. For the first time, a systematic review has been conducted investigating the use of PROMs and PREMs in evaluation studies of telemedicine applications covering all application types and medical purposes. OBJECTIVE Our review investigates the following research questions: • In which scenarios were PROMs and PREMs collected for evaluation purposes? • Which PROM/PREM outcome domains have been covered and how often? • Which outcome measurement instruments (OMIs) have been used and how often? • Did the selection and quantity of PROMs and PREMs differ between study types and application types? • Has the use of PROMs and PREMs in evaluation studies changed over time? METHODS We conducted a systematic literature search in the MEDLINE and EMBASE databases and included studies published from inception until April 2, 2020. We included studies evaluating telemedicine applications with patients as main users; these studies reported PROMs and PREMs within randomized controlled trials (RCT), controlled trials, non-controlled trials and feasibility trials in English and German. RESULTS Out of 2671 records identified, 303 studies were included with 22.1% (67/303) feasibility studies, 23.1% (70/303) non-controlled trials, 6.6% (20/303) controlled trials and 48.2% (146/303) RCTs. Health-related quality of life (HRQoL) (n=310, mean=1.02, SD=1.05), emotional function (n=244, mean=0.81, SD=1.18) and adherence (n=103, mean=0.34, SD=0.53) were the most frequently assessed outcome domains. Self-developed PROMs were used in 21.4% (65/303) of all studies, self-developed PREMs were used in 22.3% (68/303). PROMs (n=884) were assessed more frequently than PREMs (n=234). As the evidence level of the studies increased, the number of PROMs also increased (τ=-0.45) with the number of PREMs decreasing (τ=0.35) at the same time. Since 2000, not only has the number of evaluation studies using PROMs/PREMs increased - the level of evidence and the number of OMIs used have also increased, with the number of PREMs permanently remaining at a lower level compared to the number of PROMs. CONCLUSIONS There have been increasingly more studies, particularly high-evidence studies, which use PROMs and PREMs to evaluate telemedicine applications. PROMs have been used more frequently than PREMs. With an increasing maturity stage of the telemedicine applications and higher evidence level, the use of PROMs increased in line with the recommendations of evaluation guidelines. HRQoL and emotional function were measured in almost all studies. Simultaneously, health literacy as a precondition for using the application adequately - alongside proper training and guidance - was rarely reported. Further efforts should be pursued for the standardization of PROM and PREM collection in evaluation studies of telemedicine applications.