Commentary on ‘Disability outcome measures in multiple sclerosis clinical trials’

2012 ◽  
Vol 18 (12) ◽  
pp. 1718-1720 ◽  
Author(s):  
J Gareth Noble ◽  
Lisa A Osborne ◽  
Kerina H Jones ◽  
Rod M Middleton ◽  
David V Ford
Keyword(s):  
Multiple Sclerosis ◽  
Clinical Trials ◽  
Outcome Measures ◽  
Well Being ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Health Technologies ◽  
Additional Information ◽  
Patient Reported ◽  
Disability Outcome

In order to fully understand and explore the effectiveness of any intervention for the management of multiple sclerosis (MS), it is important to have robust, valid, reliable, and universally applied measures. The recent article, ‘Disability outcome measures in multiple sclerosis clinical trials’ by Cohen, Reingold, Polman and Wolinsky (2012), explores this issue in regards to the effective measurement of MS-related disability, and the utilisation of patient-reported outcome measures, whilst highlighting the need for collaboration between the academic and clinical communities. Although it is important to examine disability measures, it is also equally important to recognise that physical function is only one aspect of a person’s experience; for example, quality of life and psychological well-being are also important aspects to assess. The application of e-health technologies and patient registers could be a useful method of gaining additional information, using patient-reported outcomes. This commentary explores these issues in relation to points raised by the Cohen et al. paper.

Patient-Reported Outcome Measures in Colorectal Surgery: Construction of Core Measures Using Open-Source Research Method

2021 ◽  
pp. 155335062199887
Author(s):  
Alaa El-Hussuna ◽  
Ines Rubio-Perez ◽  
Monica Millan ◽  
Gianluca Pellino ◽  
Ionut Negoi ◽  
...  
Keyword(s):  
Colorectal Surgery ◽  
Outcome Measures ◽  
Short Form ◽  
Wide Spectrum ◽  
Core Outcome Set ◽  
Well Being ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Patient Reported ◽  
Eortc Qlq

Purpose. The primary aim of the study was to review the existing literature about patient-reported outcome measures (PROMs) in colorectal cancer and IBD. The secondary aim was to present a road map to develop a core outcome set via opinion gathering using social media. Method. This study is the first step of a three-step project aimed at constructing simple, applicable PROMs in colorectal surgery. This article was written in a collaborative manner with authors invited both through Twitter via the #OpenSourceResearch hashtag. The 5 most used PROMs were presented and discussed as slides/images on Twitter. Inputs from a wide spectrum of participants including researchers, surgeons, physicians, nurses, patients, and patients’ organizations were collected and analyzed. The final draft was emailed to all contributors and 6 patients’ representatives for proofreading and approval. Results. Five PROM sets were identified and discussed: EORTC QLQ-CR29, IBDQ short health questionnaire, EORTC QLQ-C30, ED-Q5-5L, and Short Form-36. There were 315 tweets posted by 50 tweeters with 1458 retweets. Awareness about PROMs was generally limited. The general psycho-physical well-being score (GPP) was suggested and discussed, and then a survey was conducted in which more than 2/3 of voters agreed that GPP covers the most important aspects in PROMs. Conclusion. Despite the limitations of this exploratory study, it offered a new method to conduct clinical research with opportunity to engage patients. The general psycho-physical well-being score suggested as simple, applicable PROMs to be eventually combined procedure-specific, disease-specific, or symptom-specific PROMs if needed.

scholarly journals Enabling patient-reported outcome measures in clinical trials, exemplified by cardiovascular trials

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Theresa M. Coles ◽  
Adrian F. Hernandez ◽  
Bryce B. Reeve ◽  
Karon Cook ◽  
Michael C. Edwards ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Outcome Measures ◽  
Contextual Factors ◽  
The United States ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Think Tank ◽  
Level Of Evidence ◽  
Patient Reported ◽  
Evidentiary Standards

Abstract Objectives There has been limited success in achieving integration of patient-reported outcomes (PROs) in clinical trials. We describe how stakeholders envision a solution to this challenge. Methods Stakeholders from academia, industry, non-profits, insurers, clinicians, and the Food and Drug Administration convened at a Think Tank meeting funded by the Duke Clinical Research Institute to discuss the challenges of incorporating PROs into clinical trials and how to address those challenges. Using examples from cardiovascular trials, this article describes a potential path forward with a focus on applications in the United States. Results Think Tank members identified one key challenge: a common understanding of the level of evidence that is necessary to support patient-reported outcome measures (PROMs) in trials. Think Tank participants discussed the possibility of creating general evidentiary standards depending upon contextual factors, but such guidelines could not be feasibly developed because many contextual factors are at play. The attendees posited that a more informative approach to PROM evidentiary standards would be to develop validity arguments akin to courtroom briefs, which would emphasize a compelling rationale (interpretation/use argument) to support a PROM within a specific context. Participants envisioned a future in which validity arguments would be publicly available via a repository, which would be indexed by contextual factors, clinical populations, and types of claims. Conclusions A publicly available repository would help stakeholders better understand what a community believes constitutes compelling support for a specific PROM in a trial. Our proposed strategy is expected to facilitate the incorporation of PROMs into cardiovascular clinical trials and trials in general.

scholarly journals Multidisciplinary data infrastructures in multiple sclerosis: Why they are needed and can be done!

2018 ◽  
Vol 25 (4) ◽  
pp. 500-509 ◽  
Author(s):  
Liesbet M Peeters ◽  
Caspar EP van Munster ◽  
Bart Van Wijmeersch ◽  
Robin Bruyndonckx ◽  
Ilse Lamers ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Outcome Measures ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Personalized Treatment ◽  
Multidisciplinary Data ◽  
Patient Reported ◽  
Longitudinal Data Collection ◽  
Patient Profiling ◽  
Data Infrastructures

Personalized treatment is highly desirable in multiple sclerosis (MS). We believe that multidisciplinary measurements including clinical, functional and patient-reported outcome measures in combination with extensive patient profiling can enhance personalized treatment and rehabilitation strategies. We elaborate on four reasons behind this statement: (1) MS disease activity and progression are complex and multidimensional concepts in nature and thereby defy a one-size-fits-all description, (2) functioning, progression, treatment, and rehabilitation effects are interdependent and should be investigated together, (3) personalized healthcare is based on the dynamics of system biology and on technology that confirms a patient’s fundamental biology and (4) inclusion of patient-reported outcome measures can facilitate patient-relevant healthcare. We discuss currently available multidisciplinary MS data initiatives and introduce joint actions to further increase the overall success. With this topical review, we hope to drive the MS community to invest in expanding towards more multidisciplinary and longitudinal data collection.

Assessment of computer adaptive testing version of the Neuro-QOL for people with multiple sclerosis

2018 ◽  
Vol 25 (13) ◽  
pp. 1791-1799 ◽  
Author(s):  
Brian C Healy ◽  
Jonathan Zurawski ◽  
Cindy T Gonzalez ◽  
Tanuja Chitnis ◽  
Howard L Weiner ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Outcome Measures ◽  
Computerized Adaptive Testing ◽  
Short Form ◽  
Patient Reported Outcome Measures ◽  
Adaptive Testing ◽  
Patient Reported Outcome ◽  
Longitudinal Change ◽  
Sf 36 ◽  
Patient Reported

Background: To date, the computerized adaptive testing (CAT) version of the Neuro-quality of life (QOL) has not been assessed in a large sample of people with multiple sclerosis (MS). Objective: The aim of this study was to assess the associations between the CAT version of Neuro-QOL and other clinical and patient-reported outcome measures. Methods: Subjects ( n = 364) enrolled in SysteMS completed the CAT version of the Neuro-QOL and the 36-Item Short Form Survey (SF-36) within 4 weeks of a clinical exam that included the Multiple Sclerosis Functional Composite-4 (MSFC-4). The correlations between the Neuro-QOL domains and the MSFC-4 subscores and the SF-36 scores were calculated. The changes over time in the Neuro-QOL and other measures were also examined. Results: The lower extremity functioning score of the Neuro-QOL showed the highest correlations with MSFC-4 components including Timed 25-Foot Walk, 9-Hole Peg Test, and cognitive score. The expected domains of the Neuro-QOL showed high correlations with the SF-36 subscores, and some Neuro-QOL domains were associated with many SF-36 subscores. There was limited longitudinal change on the Neuro-QOL domains over 12 months, and the change was not associated with change on other measures. Conclusion: The CAT version of the Neuro-QOL shows many of the expected associations with clinical and patient-reported outcome measures.

scholarly journals Benefits and Disadvantages of Electronic Patient-reported Outcome Measures: Systematic Review

10.2196/15588 ◽  
2020 ◽  
Vol 3 (1) ◽  
pp. e15588 ◽  
Author(s):  
Jill Meirte ◽  
Nick Hellemans ◽  
Mieke Anthonissen ◽  
Lenie Denteneer ◽  
Koen Maertens ◽  
...  
Keyword(s):  
Systematic Review ◽  
Data Quality ◽  
Outcome Measures ◽  
Symptom Management ◽  
Completion Time ◽  
Clinical Decision Making ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Health Technologies ◽  
Patient Reported

Background Patient-reported outcome measures (PROMs) are important in clinical practice and research. The growth of electronic health technologies provides unprecedented opportunities to systematically collect information via PROMs. Objective The aim of this study was to provide an objective and comprehensive overview of the benefits, barriers, and disadvantages of the digital collection of qualitative electronic patient-reported outcome measures (ePROMs). Methods We performed a systematic review of articles retrieved from PubMED and Web of Science. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were followed during all stages. The search strategy yielded a total of 2333 records, from which 32 met the predefined inclusion and exclusion criteria. The relevant ePROM-related information was extracted from each study. Results Results were clustered as benefits and disadvantages. Reported benefits of ePROMs were greater patient preference and acceptability, lower costs, similar or faster completion time, higher data quality and response rates, and facilitated symptom management and patient-clinician communication. Tablets were the most used ePROM modality (14/32, 44%), and, as a platform, Web-based systems were used the most (26/32, 81%). Potential disadvantages of ePROMs include privacy protection, a possible large initial financial investment, and exclusion of certain populations or the “digital divide.” Conclusions In conclusion, ePROMs offer many advantages over paper-based collection of patient-reported outcomes. Overall, ePROMs are preferred over paper-based methods, improve data quality, result in similar or faster completion time, decrease costs, and facilitate clinical decision making and symptom management. Disadvantages regarding ePROMs have been outlined, and suggestions are provided to overcome the barriers. We provide a path forward for researchers and clinicians interested in implementing ePROMs. Trial Registration PROSPERO CRD42018094795; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=94795

scholarly journals International guidance on the selection of patient-reported outcome measures in clinical trials: a review

2020 ◽  
Author(s):  
Norah L. Crossnohere ◽  
Michael Brundage ◽  
Melanie J. Calvert ◽  
Madeleine King ◽  
Bryce B. Reeve ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Outcome Measures ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Patient Reported ◽  
Selection Of
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