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

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          Abstract

          Personalized health care can be optimized by including patient-reported outcomes. Standardized and disease-specific questionnaires have been developed and are routinely used. These patient-reported outcome questionnaires can be simple paper forms given to the patient to fill out with a pen or embedded in digital devices. Regardless of the format used, they provide a snapshot of the patient’s feelings and indicate when therapies need to be adjusted. The advantage of digitizing these questionnaires is that they can be automatically analyzed, and patients can be monitored independently of doctor visits. Although the questions of most clinical patient-reported outcome questionnaires follow defined standards and are evaluated by clinical trials, these standards do not exist for data processing. Interoperable data formats and structures would benefit multilingual and cross-study data exchange. Linking questionnaires to standardized terminologies such as the Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT) and Logical Observation Identifiers, Names, and Codes (LOINC) would improve this interoperability. However, linking clinically validated patient-reported outcome questionnaires to clinical terms available in SNOMED CT or LOINC is not as straightforward as it sounds. Here, we report our approach to link patient-reported outcomes from health applications to SNOMED CT or LOINC codes. We highlight current difficulties in this process and outline ways to minimize them.

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          Most cited references47

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          The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005-2008.

          Patient-reported outcomes (PROs) are essential when evaluating many new treatments in health care; yet, current measures have been limited by a lack of precision, standardization, and comparability of scores across studies and diseases. The Patient-Reported Outcomes Measurement Information System (PROMIS) provides item banks that offer the potential for efficient (minimizes item number without compromising reliability), flexible (enables optional use of interchangeable items), and precise (has minimal error in estimate) measurement of commonly studied PROs. We report results from the first large-scale testing of PROMIS items. Fourteen item pools were tested in the U.S. general population and clinical groups using an online panel and clinic recruitment. A scale-setting subsample was created reflecting demographics proportional to the 2000 U.S. census. Using item-response theory (graded response model), 11 item banks were calibrated on a sample of 21,133, measuring components of self-reported physical, mental, and social health, along with a 10-item Global Health Scale. Short forms from each bank were developed and compared with the overall bank and with other well-validated and widely accepted ("legacy") measures. All item banks demonstrated good reliability across most of the score distributions. Construct validity was supported by moderate to strong correlations with legacy measures. PROMIS item banks and their short forms provide evidence that they are reliable and precise measures of generic symptoms and functional reports comparable to legacy instruments. Further testing will continue to validate and test PROMIS items and banks in diverse clinical populations. Copyright © 2010 Elsevier Inc. All rights reserved.
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            The European Organization for Research and Treatment of Cancer QLQ-C30: A Quality-of-Life Instrument for Use in International Clinical Trials in Oncology

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              Development of the National Cancer Institute's patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE).

              The standard approach for documenting symptomatic adverse events (AEs) in cancer clinical trials involves investigator reporting using the National Cancer Institute's (NCI's) Common Terminology Criteria for Adverse Events (CTCAE). Because this approach underdetects symptomatic AEs, the NCI issued two contracts to create a patient-reported outcome (PRO) measurement system as a companion to the CTCAE, called the PRO-CTCAE. This Commentary describes development of the PRO-CTCAE by a group of multidisciplinary investigators and patient representatives and provides an overview of qualitative and quantitative studies of its measurement properties. A systematic evaluation of all 790 AEs listed in the CTCAE identified 78 appropriate for patient self-reporting. For each of these, a PRO-CTCAE plain language term in English and one to three items characterizing the frequency, severity, and/or activity interference of the AE were created, rendering a library of 124 PRO-CTCAE items. These items were refined in a cognitive interviewing study among patients on active cancer treatment with diverse educational, racial, and geographic backgrounds. Favorable measurement properties of the items, including construct validity, reliability, responsiveness, and between-mode equivalence, were determined prospectively in a demographically diverse population of patients receiving treatments for many different tumor types. A software platform was built to administer PRO-CTCAE items to clinical trial participants via the internet or telephone interactive voice response and was refined through usability testing. Work is ongoing to translate the PRO-CTCAE into multiple languages and to determine the optimal approach for integrating the PRO-CTCAE into clinical trial workflow and AE analyses. It is envisioned that the PRO-CTCAE will enhance the precision and patient-centeredness of adverse event reporting in cancer clinical research.
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                Author and article information

                Contributors
                Journal
                JMIR Med Inform
                JMIR Med Inform
                JMI
                JMIR Medical Informatics
                JMIR Publications (Toronto, Canada )
                2291-9694
                2023
                22 December 2023
                : 11
                : e49301
                Affiliations
                [1 ] Ulm University Ulm Germany
                [2 ] University Hospital Ulm Ulm Germany
                Author notes
                Corresponding Author: Hans A Kestler hans.kestler@ 123456uni-ulm.de
                Author information
                https://orcid.org/0000-0002-3050-0618
                https://orcid.org/0000-0002-5153-0269
                https://orcid.org/0000-0003-4592-1519
                https://orcid.org/0009-0004-2666-4136
                https://orcid.org/0000-0003-3781-0843
                https://orcid.org/0000-0002-4759-5254
                Article
                v11i1e49301
                10.2196/49301
                10770786
                38133917
                dd16dafe-0334-43d9-91dc-791600c7049d
                ©Julian D Schwab, Silke D Werle, Rolf Hühne, Hannah Spohn, Udo X Kaisers, Hans A Kestler. Originally published in JMIR Medical Informatics (https://medinform.jmir.org), 22.12.2023.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Medical Informatics, is properly cited. The complete bibliographic information, a link to the original publication on https://medinform.jmir.org/, as well as this copyright and license information must be included.

                History
                : 24 May 2023
                : 7 August 2023
                : 27 September 2023
                : 12 November 2023
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                semantic terminology,semantic,terminology,terminologies,data linkage,interoperability,data exchange,snomed ct,loinc,ehealth,patient-reported outcome questionnaires,requirement for standards,standard,standards,pro,prom,patient reported

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