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      Key considerations to reduce or address respondent burden in patient-reported outcome (PRO) data collection

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          Abstract

          Patient-reported outcomes (PROs) are used in clinical trials to provide evidence of the benefits and risks of interventions from a patient perspective and to inform regulatory decisions and health policy. The collection of PROs in routine practice can facilitate monitoring of patient symptoms; identification of unmet needs; prioritisation and/or tailoring of treatment to the needs of individual patients and inform value-based healthcare initiatives. However, respondent burden needs to be carefully considered and addressed to avoid high rates of missing data and poor reporting of PRO results, which may lead to poor quality data for regulatory decision making and/or clinical care.

          Abstract

          The collection of patient-reported outcomes (PROs) may capture patients’ assessments of their health status. Here authors highlight PRO-specific issues that should be considered to minimise respondent burden in clinical trials and routine care.

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          World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects.

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            Reporting of patient-reported outcomes in randomized trials: the CONSORT PRO extension.

            Doug G. Altman, Jane Blazeby, Melanie Calvert … (2013)
            The CONSORT (Consolidated Standards of Reporting Trials) Statement aims to improve the reporting of randomized controlled trials (RCTs); however, it lacks guidance on the reporting of patient-reported outcomes (PROs), which are often inadequately reported in trials, thus limiting the value of these data. In this article, we describe the development of the CONSORT PRO extension based on the methodological framework for guideline development proposed by the Enhancing the Quality and Transparency of Health Research (EQUATOR) Network. Five CONSORT PRO checklist items are recommended for RCTs in which PROs are primary or important secondary end points. These recommendations urge that the PROs be identified as a primary or secondary outcome in the abstract, that a description of the hypothesis of the PROs and relevant domains be provided (ie, if a multidimensional PRO tool has been used), that evidence of the PRO instrument's validity and reliability be provided or cited, that the statistical approaches for dealing with missing data be explicitly stated, and that PRO-specific limitations of study findings and generalizability of results to other populations and clinical practice be discussed. Examples and an updated CONSORT flow diagram with PRO items are provided. It is recommended that the CONSORT PRO guidance supplement the standard CONSORT guidelines for reporting RCTs with PROs as primary or secondary outcomes. Improved reporting of PRO data should facilitate robust interpretation of the results from RCTs and inform patient care.
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              Response burden and questionnaire length: is shorter better? A review and meta-analysis.

              Sindre Rolstad, John Adler, Anna Rydén (2011)
              Response burden is often defined as the effort required by the patient to answer a questionnaire. A factor that has been proposed to affect the response burden is questionnaire length, and this burden is manifested in, for example, response rate. Even though response burden is frequently mentioned as a reason for abridging questionnaires, evidence to support the notion that shorter instruments are preferable is limited. This study aimed to accumulate, analyze, and discuss evidence regarding the association between response burden, as measured by response rate, and questionnaire length. A systematic literature review and meta-analysis of studies reporting response rates in relation to questionnaire length was performed. A Cochran-Mantel-Haenszel test stratified by study using the Breslow-Day test was undertaken to investigate homogeneity of the odds ratios. Thirty-two reports were identified, of which 20 were eligible for inclusion in the meta-analysis. Three studies used patient input as main outcome when evaluating response burden. In the meta-analysis, a general association between response rate and questionnaire length was found (P ≤ 0.0001). Response rates were lower for longer questionnaires, but because the P value for test of homogeneity was P = 0.03, this association should be interpreted with caution because it is impossible to separate the impact of content from length of the questionnaires. Given the inherently problematic nature of comparing questionnaires of various lengths, it is preferable to base decisions on use of instruments on the content rather than the length per se. Copyright © 2011 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.
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                Author and article information

                Contributors
                Olalekan Lee Aiyegbusi:
                ORCID: http://orcid.org/0000-0001-9122-8251
                O.L.Aiyegbusi@bham.ac.uk
                Journal
                Journal ID (nlm-ta): Nat Commun
                Journal ID (iso-abbrev): Nat Commun
                Title: Nature Communications
                Publisher: Nature Publishing Group UK (London )
                ISSN (Electronic): 2041-1723
                Publication date (Electronic): 12 October 2022
                Publication date PMC-release: 12 October 2022
                Publication date Collection: 2022
                Volume: 13
                Electronic Location Identifier: 6026
                Affiliations
                [1 ]GRID grid.6572.6, ISNI 0000 0004 1936 7486, Centre for Patient Reported Outcomes Research, Institute of Applied Health Research, , University of Birmingham, ; Birmingham, UK
                [2 ]GRID grid.6572.6, ISNI 0000 0004 1936 7486, National Institute for Health and Care Research (NIHR) Applied Research Collaboration West Midlands, , University of Birmingham, ; Birmingham, UK
                [3 ]GRID grid.412563.7, ISNI 0000 0004 0376 6589, NIHR Birmingham Biomedical Research Centre at University Hospitals Birmingham NHS Foundation Trust, ; Birmingham, UK
                [4 ]GRID grid.6572.6, ISNI 0000 0004 1936 7486, NIHR Birmingham-Oxford Blood and Transplant Research Unit (BTRU) in Precision Transplant and Cellular Therapeutics, , University of Birmingham, ; Birmingham, UK
                [5 ]Birmingham Health Partners Centre for Regulatory Science and Innovation, Birmingham, UK
                [6 ]GRID grid.1009.8, ISNI 0000 0004 1936 826X, Menzies Institute for Medical Research, , University of Tasmania, ; Hobart, TAS Australia
                [7 ]GRID grid.6572.6, ISNI 0000 0004 1936 7486, DEMAND Hub, , University of Birmingham, ; Birmingham, UK
                [8 ]GRID grid.39009.33, ISNI 0000 0001 0672 7022, EMD Serono Inc, , Healthcare Business of Merck KGaA, ; Darmstadt, Germany
                [9 ]LAIFE Reply GmbH, Frankfurt, Germany
                [10 ]GRID grid.6572.6, ISNI 0000 0004 1936 7486, Patient partner, Centre for Patient Reported Outcomes Research, Institute of Applied Health Research, , University of Birmingham, ; Birmingham, UK
                [11 ]GRID grid.6572.6, ISNI 0000 0004 1936 7486, National Institute for Health Research Surgical Reconstruction and Microbiology Research Centre, , University of Birmingham, ; Birmingham, UK
                [12 ]GRID grid.507332.0, ISNI 0000 0004 9548 940X, Health Data Research UK, ; London, UK
                [13 ]GRID grid.6572.6, ISNI 0000 0004 1936 7486, UK SPINE, , University of Birmingham, ; Birmingham, UK
                Author information
                http://orcid.org/0000-0001-9122-8251
                http://orcid.org/0000-0002-8025-5841
                http://orcid.org/0000-0002-1856-837X
                Article
                Publisher ID: 33826
                DOI: 10.1038/s41467-022-33826-4
                PMC ID: 9556436
                PubMed ID: 36224187
                SO-VID: e91b74e8-bfc7-4900-8d3b-e2be9e24a1a2
                Copyright © © The Author(s) 2022
                License:

                Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/.

                History
                Date received : 24 May 2022
                Date accepted : 5 October 2022
                Funding
                Funded by: Merck Healthcare KGaA, Darmstadt, Germany
                Categories
                Subject: Perspective
                Custom metadata
                issue-copyright-statement © The Author(s) 2022

                ScienceOpen disciplines: Uncategorized
                Keywords: quality of life,outcomes research,clinical trial design
                Data availability:
                ScienceOpen disciplines: Uncategorized
                Keywords: quality of life, outcomes research, clinical trial design

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