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Leveraging Patient-Reported Outcome Measures for Optimal Dose Selection in Early Phase Cancer Trials

Leveraging Patient-Reported Outcome Measures for Optimal Dose Selection in Early Phase Cancer Trials

In later phase trials, there is typically enough understanding of the AE profile of the investigational treatment to enable a reliable preselection of items for measurement (eg, using a small subset of PRO-CTCAE items). The same is not true for first in human and other early phase trials.

Bill Byrom, Anthony Everhart, Paul Cordero, Chris Garratt, Tim Meyer

JMIR Cancer 2025;11:e64611

Testing an Electronic Patient-Reported Outcome Platform in the Context of Traumatic Brain Injury: PRiORiTy Usability Study

Testing an Electronic Patient-Reported Outcome Platform in the Context of Traumatic Brain Injury: PRiORiTy Usability Study

A total of 4 PRO measures were selected and programmed in Atom5. The results of the interviews show that most of the people living with the effects of a TBI who took part in the usability study were able to report their symptoms using the Atom5 platform. The number of errors were low (1 critical and 2 noncritical errors) and were due to incompatibility of a device, not knowing what to do after onboarding, or a missing question. Overall, the platform was found to be effective.

Christel McMullan, Grace Turner, Ameeta Retzer, Antonio Belli, Elin Haf Davies, Laura Nice, Luke Flavell, Jackie Flavell, Melanie Calvert

JMIR Form Res 2025;9:e58128

Digital Health Innovations to Catalyze the Transition to Value-Based Health Care

Digital Health Innovations to Catalyze the Transition to Value-Based Health Care

A patient-reported outcome (PRO) is “an outcome reported directly by patients themselves and not interpreted by an observer.” PROs bring the “patient’s voice” to the care journey and identify conditions or symptoms that matter the most to a patient’s daily life and quality of life [21]. To measure PROs, instruments known as patient-reported outcome measures (PROMs) have been developed.

Lan Zhang, Christopher Bullen, Jinsong Chen

JMIR Med Inform 2025;13:e57385

A Behavior-Based Model to Validate Electronic Systems Designed to Collect Patient-Reported Outcomes: Model Development and Application

A Behavior-Based Model to Validate Electronic Systems Designed to Collect Patient-Reported Outcomes: Model Development and Application

PRO measures (PROMs) are tools used to capture PRO in the form of questionnaires with different constructs and measurement schemes. PROMs have been increasingly used for service evaluation and quality measurement and have been embraced in routine clinical care [4]. The traditional administration method of PROMs in a paper format can be a burden on clinicians and researchers, which makes a remote and automated method of collection potentially beneficial [5].

Sultan Attamimi, Zoe Marshman, Christopher Deery, Stephen Radley, Fiona Gilchrist

JMIR Form Res 2024;8:e56370

Impact of Electronic Patient-Reported Outcomes on Unplanned Consultations and Hospitalizations in Patients With Cancer Undergoing Systemic Therapy: Results of a Patient-Reported Outcome Study Compared With Matched Retrospective Data

Impact of Electronic Patient-Reported Outcomes on Unplanned Consultations and Hospitalizations in Patients With Cancer Undergoing Systemic Therapy: Results of a Patient-Reported Outcome Study Compared With Matched Retrospective Data

In the PRO study (registered on Clinical Trials.gov; NCT03578731), the primary end point investigated the extent to which the self-assessment of the severity of undesirable outcomes between patients with cancer using the Consilium Care app for 90 days and the treating physicians was consistent [17,18]. The occurrence of unplanned (emergency) consultations and hospitalizations among patients with cancer was recorded by the investigators as a secondary end point.

Andreas Trojan, Christian Kühne, Michael Kiessling, Johannes Schumacher, Stefan Dröse, Christian Singer, Christian Jackisch, Christoph Thomssen, Gerd A Kullak-Ublick

JMIR Form Res 2024;8:e55917

The Necessity of Interoperability to Uncover the Full Potential of Digital Health Devices

The Necessity of Interoperability to Uncover the Full Potential of Digital Health Devices

Here, we have focused on the general applicability of semantic terminologies for PRO questionnaires in the 2 comprehensive terminology systems for clinical settings, SNOMED CT and LOINC, from an international perspective. However, we would also like to point out some other interesting terminologies that allow PRO mapping, such as the NCI Thesaurus or the Med DRA.

Julian D Schwab, Silke D Werle, Rolf Hühne, Hannah Spohn, Udo X Kaisers, Hans A Kestler

JMIR Med Inform 2023;11:e49301

Evaluating the Impact of an mHealth Platform for Managing Acute Postoperative Dental Pain: Randomized Controlled Trial

Evaluating the Impact of an mHealth Platform for Managing Acute Postoperative Dental Pain: Randomized Controlled Trial

Patient-reported outcomes (PROs) and PRO measures play a crucial role in this process. PROs refer to any report of the patient’s health status that comes directly from the patient, while patient-reported outcome measures are validated questionnaires that patients complete to self-assess their health status [13]. Patient self-reporting is a critical part of comprehensive pain assessment [14], given pain’s subjective and multidimensional nature.

Bunmi Tokede, Alfa Yansane, Ana Ibarra-Noriega, Joanna Mullins, Kristen Simmons, Nicholas Skourtes, Urvi Mehta, Sayali Tungare, David Holmes, Joel White, Muhammad Walji, Elsbeth Kalenderian

JMIR Mhealth Uhealth 2023;11:e49677

Co-created Mobile Apps for Palliative Care Using Community-Partnered Participatory Research: Development and Usability Study

Co-created Mobile Apps for Palliative Care Using Community-Partnered Participatory Research: Development and Usability Study

Efforts to integrate artificial intelligence into the design of PRO-collecting apps have resulted in improved cancer-related pain control and fewer pain-related hospital admissions [9]. To date, we are aware of no mobile apps focusing on the needs of patients diagnosed with cancer that have used community-partnered participatory research (CPPR) methods in their development.

Jafar Al-Mondhiry, Sarah D'Ambruoso, Christopher Pietras, Thomas Strouse, Dikla Benzeevi, Armen C Arevian, Kenneth B Wells

JMIR Form Res 2022;6(6):e33849

Evaluation of Self-care Activities and Quality of Life in Patients With Type 2 Diabetes Treated With Metformin Using the 2D Matrix Code of Outer Drug Packages as Patient Identifier: the DePRO Proof-of-Concept Observational Study

Evaluation of Self-care Activities and Quality of Life in Patients With Type 2 Diabetes Treated With Metformin Using the 2D Matrix Code of Outer Drug Packages as Patient Identifier: the DePRO Proof-of-Concept Observational Study

The study was conducted using the my e PRO app, a patient-reported outcome (PRO) data capture tool that can gather additional data based on individual study requirements (codeveloped by Institut Dr. Schauerte and Bayer and hosted by Institut Dr. Schauerte). The my e PRO app is not a self-care management tool supporting patients in their treatment of T2 DM. Adult patients who had been prescribed metformin-containing medications were eligible to participate.

Christian Mueller, Isabel Schauerte, Stephan Martin, Valeska Irrgang

JMIR Diabetes 2022;7(2):e31832