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      A systematic review assessing the quality of patient reported outcomes measures in dry eye diseases

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          Abstract

          Background

          Patient-reported outcome measures (PROMs) can provide valuable insights on the impact of a disease or treatment on a patient’s health-related quality of life. In ophthalmology, particularly in dry eye disease (DED) and ocular surface disease (OSD), it is unclear whether the available PROMs were developed using comprehensive guidelines. To address this, we evaluated the methodological quality of studies assessing the psychometric properties of PROMs in DED and OSD [PROSPERO registration number CRD42019142328].

          Methods

          Four databases were searched; reference list and citation searching of included studies was also conducted. The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist was used to appraise the quality of the studies evaluating the psychometric properties of PROMs used in DED and OSD.

          Results

          The search strategy ( S3 Table) retrieved 5,761 records, 573 duplicates were removed, 5,188 abstracts were screened and 127 full-text articles were retrieved for further review. Of these, 118 full-text articles did not meet the eligibility criteria and were excluded. Reference list and citation searching, identified an additional 8 articles bringing the total numbers of papers reviewed to 17. In general, psychometric properties such as content validity, measurement error and structural validity were not assessed by the studies included in this review. Studies reviewing The Impact of Dry Eye on Everyday Life (IDEEL) presented with the highest quality scores together with the Ocular Surface Disease Index (OSDI) questionnaire.

          Conclusions

          The quality of studies evaluating PROMs in DED and OSD was considered using the COSMIN standards. The majority of the studies evaluating PROMs included in this review did not meet the recommended COSMIN criteria and the quality of the PROMs evaluated is not assured. Further evaluation of their psychometric properties is required if these are going to be used in clinical practice or research.

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          Most cited references50

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          Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 statement

          David Moher, Larissa Shamseer, Mike Clarke … (2017)
          Systematic reviews should build on a protocol that describes the rationale, hypothesis, and planned methods of the review; few reviews report whether a protocol exists. Detailed, well-described protocols can facilitate the understanding and appraisal of the review methods, as well as the detection of modifications to methods and selective reporting in completed reviews. We describe the development of a reporting guideline, the Preferred Reporting Items for Systematic reviews and Meta-Analyses for Protocols 2015 (PRISMA-P 2015). PRISMA-P consists of a 17-item checklist intended to facilitate the preparation and reporting of a robust protocol for the systematic review. Funders and those commissioning reviews might consider mandating the use of the checklist to facilitate the submission of relevant protocol information in funding applications. Similarly, peer reviewers and editors can use the guidance to gauge the completeness and transparency of a systematic review protocol submitted for publication in a journal or other medium.
          Article 0 comments Cited 6296 times – based on 0 reviews     Review now
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            The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: explanation and elaboration

            Alessandro Liberati, Douglas G. Altman, Jennifer Tetzlaff … (2010)
            Systematic reviews and meta-analyses are essential to summarise evidence relating to efficacy and safety of healthcare interventions accurately and reliably. The clarity and transparency of these reports, however, are not optimal. Poor reporting of systematic reviews diminishes their value to clinicians, policy makers, and other users. Since the development of the QUOROM (quality of reporting of meta-analysis) statement—a reporting guideline published in 1999—there have been several conceptual, methodological, and practical advances regarding the conduct and reporting of systematic reviews and meta-analyses. Also, reviews of published systematic reviews have found that key information about these studies is often poorly reported. Realising these issues, an international group that included experienced authors and methodologists developed PRISMA (preferred reporting items for systematic reviews and meta-analyses) as an evolution of the original QUOROM guideline for systematic reviews and meta-analyses of evaluations of health care interventions. The PRISMA statement consists of a 27-item checklist and a four-phase flow diagram. The checklist includes items deemed essential for transparent reporting of a systematic review. In this explanation and elaboration document, we explain the meaning and rationale for each checklist item. For each item, we include an example of good reporting and, where possible, references to relevant empirical studies and methodological literature. The PRISMA statement, this document, and the associated website (www.prisma-statement.org/) should be helpful resources to improve reporting of systematic reviews and meta-analyses.
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              Quality criteria were proposed for measurement properties of health status questionnaires.

              Caroline Terwee, Sandra D M Bot, Michael de Boer … (2007)
              Recently, an increasing number of systematic reviews have been published in which the measurement properties of health status questionnaires are compared. For a meaningful comparison, quality criteria for measurement properties are needed. Our aim was to develop quality criteria for design, methods, and outcomes of studies on the development and evaluation of health status questionnaires. Quality criteria for content validity, internal consistency, criterion validity, construct validity, reproducibility, longitudinal validity, responsiveness, floor and ceiling effects, and interpretability were derived from existing guidelines and consensus within our research group. For each measurement property a criterion was defined for a positive, negative, or indeterminate rating, depending on the design, methods, and outcomes of the validation study. Our criteria make a substantial contribution toward defining explicit quality criteria for measurement properties of health status questionnaires. Our criteria can be used in systematic reviews of health status questionnaires, to detect shortcomings and gaps in knowledge of measurement properties, and to design validation studies. The future challenge will be to refine and complete the criteria and to reach broad consensus, especially on quality criteria for good measurement properties.
              Article 0 comments Cited 1549 times – based on 0 reviews     Review now
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                Author and article information

                Contributors
                Alberto Recchioni:
                ORCID: https://orcid.org/0000-0002-9708-2588
                Role: ConceptualizationRole: Data curationRole: Formal analysisRole: InvestigationRole: MethodologyRole: ResourcesRole: Writing – original draftRole: Writing – review & editing
                Olalekan Lee Aiyegbusi:
                ORCID: https://orcid.org/0000-0001-9122-8251
                Role: ConceptualizationRole: Data curationRole: Formal analysisRole: InvestigationRole: MethodologyRole: Writing – original draftRole: Writing – review & editing
                Samantha Cruz-Rivera: Role: MethodologyRole: Validation
                Saaeha Rauz:
                ORCID: https://orcid.org/0000-0003-4627-3496
                Role: ConceptualizationRole: Funding acquisitionRole: Project administrationRole: ValidationRole: Writing – review & editing
                Anita Slade:
                ORCID: https://orcid.org/0000-0003-2827-7741
                Role: ConceptualizationRole: Funding acquisitionRole: MethodologyRole: ValidationRole: Writing – review & editing
                Peter M. ten Klooster: Role: Editor
                Journal
                Journal ID (nlm-ta): PLoS One
                Journal ID (iso-abbrev): PLoS One
                Journal ID (publisher-id): plos
                Title: PLoS ONE
                Publisher: Public Library of Science (San Francisco, CA USA )
                ISSN (Electronic): 1932-6203
                Publication date (Electronic): 9 August 2021
                Publication date Collection: 2021
                Volume: 16
                Issue: 8
                Electronic Location Identifier: e0253857
                Affiliations
                [1 ] Centre for Patient Reported Outcomes Research, Institute of Applied Health Research, University of Birmingham, Birmingham, United Kingdom
                [2 ] Academic Unit of Ophthalmology, Institute of Inflammation and Ageing, Birmingham and Midland Eye Centre, University of Birmingham, Birmingham, United Kingdom
                [3 ] Optometry & Vision Sciences Group, School of Life & Health Sciences, Aston University, Birmingham, United Kingdom
                [4 ] National Institute for Health Research (NIHR) Birmingham Biomedical Research Centre, University Hospitals Birmingham NHS Foundation Trust and the University of Birmingham, Birmingham, United Kingdom
                [5 ] National Institute for Health Research Surgical Reconstruction and Microbiology Research Centre, West Midlands, UK University, Birmingham, United Kingdom
                University of Twente, NETHERLANDS
                Author notes

                Competing Interests: OLA reports personal fees from Gilead outside the given work. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

                Author information
                https://orcid.org/0000-0002-9708-2588
                https://orcid.org/0000-0001-9122-8251
                https://orcid.org/0000-0003-4627-3496
                https://orcid.org/0000-0003-2827-7741
                Article
                Publisher ID: PONE-D-20-39488
                DOI: 10.1371/journal.pone.0253857
                PMC ID: 8351938
                PubMed ID: 34370748
                SO-VID: d25a7e15-71c7-4231-b51f-de62d6840d25
                Copyright © © 2021 Recchioni et al
                License:

                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                Date received : 28 December 2020
                Date accepted : 14 June 2021
                Page count
                Figures: 0, Tables: 4, Pages: 23
                Funding
                Funded by: funder-id http://dx.doi.org/10.13039/501100009270, Invention for Innovation;
                Award ID: II-LA-1117-20001
                Award Recipient :
                ORCID: https://orcid.org/0000-0002-9708-2588
                Funded by: funder-id http://dx.doi.org/10.13039/501100009270, Invention for Innovation;
                Award ID: II-LA-1117-20001
                Award Recipient :
                ORCID: https://orcid.org/0000-0003-4627-3496
                Funded by: funder-id http://dx.doi.org/10.13039/501100009270, Invention for Innovation;
                Award ID: II-LA-1117-20001
                Award Recipient :
                ORCID: https://orcid.org/0000-0003-2827-7741
                Funded by: national institute for health research (nihr)
                Award Recipient :
                ORCID: https://orcid.org/0000-0001-9122-8251
                Funded by: national institute for health research (nihr)
                Award Recipient :
                ORCID: https://orcid.org/0000-0002-9708-2588
                Funded by: national institute for health research (nihr)
                Award Recipient :
                ORCID: https://orcid.org/0000-0003-4627-3496
                Funded by: funder-id http://dx.doi.org/10.13039/501100003141, Consejo Nacional de Ciencia y Tecnología;
                Award Recipient :
                Funded by: funder-id http://dx.doi.org/10.13039/501100000265, Medical Research Council;
                Award Recipient :
                ORCID: https://orcid.org/0000-0003-4627-3496
                Funded by: medical research council
                Award Recipient :
                ORCID: https://orcid.org/0000-0003-2827-7741
                Funded by: developmental pathway funding scheme (dpfs)
                Award Recipient :
                ORCID: https://orcid.org/0000-0003-4627-3496
                Funded by: funder-id http://dx.doi.org/10.13039/100002089, fight for sight;
                Award Recipient :
                ORCID: https://orcid.org/0000-0003-4627-3496
                Funded by: funder-id http://dx.doi.org/10.13039/100011327, sandwell and west birmingham hospitals nhs trust;
                Award Recipient :
                ORCID: https://orcid.org/0000-0003-4627-3496
                Funded by: british heart foundation
                Award Recipient :
                ORCID: https://orcid.org/0000-0003-2827-7741
                Funded by: national institute for health research medtech and invitro diagnostic co-operative – trauma management
                Award Recipient :
                ORCID: https://orcid.org/0000-0003-2827-7741
                Funded by: eye hope foundation
                Award Recipient :
                ORCID: https://orcid.org/0000-0003-2827-7741
                Funded by: association du syndrome de wolfram
                Award Recipient :
                ORCID: https://orcid.org/0000-0003-2827-7741
                Funded by: snow foundation
                Award Recipient :
                ORCID: https://orcid.org/0000-0003-2827-7741
                Funded by: funder-id http://dx.doi.org/10.13039/100014475, pfizer health research foundation;
                Award Recipient :
                ORCID: https://orcid.org/0000-0003-2827-7741
                Funded by: national institute for health research clinical research network
                Award Recipient :
                ORCID: https://orcid.org/0000-0003-2827-7741
                Funded by: birmingham biomedical research centre and national institute for health research surgical reconstruction and microbiology research centre
                Award Recipient :
                ORCID: https://orcid.org/0000-0003-2827-7741
                Funded by: university hospitals birmingham national health service foundation trust
                Award Recipient :
                ORCID: https://orcid.org/0000-0003-2827-7741
                This work was supported by funding from the II-LA-1117-20001 Programme Invention for Innovation (i4i) and it presents an independent research supported by the National Institute of Health Research Birmingham Biomedical Research Centre at the University Hospitals Birmingham National Health Service Foundation Trust and the University of Birmingham. The study funders did not have any role in the study design; the collection, analysis, and interpretation of the data; the writing of the report; or the decision to submit the article for publication. AR is supported by funding from the II-LA-1117-20001 Programme Invention for Innovation (i4i), National Institute for Health Research (NIHR). OLA is supported by the National Institute of Health Research (NIHR) Birmingham Biomedical Research Centre (BRC), West Midlands, Birmingham and reports funding by the Health Foundation and UCB Biopharma. He reports personal fees from Gilead Sciences Ltd. SCR is supported by the funding from Consejo Nacional de Ciencia y Tecnologia (CONACYT) (the National Council of Science and Technology CONACYT) of Mexico. SR is supported by National Institute for Health Research (NIHR) Programme Invention for Innovation (i4i), Medical Research Council (MRC) Developmental Pathway Funding Scheme (DPFS), Fight for Sight, Sandwell and West Birmingham Hospitals National Health Service Trust. AS is supported by funding from the II-LA-1117-20001 Programme Invention for Innovation (i4i) and reports funding by: British Heart Foundation, National Institute for Health Research Invention for Innovation, Medical Research Council, National Institute for Health Research MedTech and INvitro diagnostic Co-operative – Trauma management, Eye Hope Foundation, Association du Syndrome de Wolfram, Snow Foundation; Pfizer Health Research Foundation; National Institute for Health Research Clinical Research Network; National Institute For Health Research, Birmingham Biomedical Research Centre and National Institute For Health Research Surgical Reconstruction and Microbiology Research Centre at the University of Birmingham and University Hospitals Birmingham National Health Service Foundation Trust outside the submitted work.
                Categories
                Subject: Research Article
                Subject: Biology and Life Sciences
                Subject: Anatomy
                Subject: Head
                Subject: Eyes
                Subject: Medicine and Health Sciences
                Subject: Anatomy
                Subject: Head
                Subject: Eyes
                Subject: Biology and Life Sciences
                Subject: Anatomy
                Subject: Ocular System
                Subject: Eyes
                Subject: Medicine and Health Sciences
                Subject: Anatomy
                Subject: Ocular System
                Subject: Eyes
                Subject: Medicine and Health Sciences
                Subject: Ophthalmology
                Subject: Biology and Life Sciences
                Subject: Psychology
                Subject: Psychometrics
                Subject: Social Sciences
                Subject: Psychology
                Subject: Psychometrics
                Subject: Biology and Life Sciences
                Subject: Neuroscience
                Subject: Cognitive Science
                Subject: Cognitive Psychology
                Subject: Perception
                Subject: Sensory Perception
                Subject: Vision
                Subject: Biology and Life Sciences
                Subject: Psychology
                Subject: Cognitive Psychology
                Subject: Perception
                Subject: Sensory Perception
                Subject: Vision
                Subject: Social Sciences
                Subject: Psychology
                Subject: Cognitive Psychology
                Subject: Perception
                Subject: Sensory Perception
                Subject: Vision
                Subject: Biology and Life Sciences
                Subject: Neuroscience
                Subject: Sensory Perception
                Subject: Vision
                Subject: Medicine and Health Sciences
                Subject: Health Care
                Subject: Quality of Life
                Subject: Research and Analysis Methods
                Subject: Research Assessment
                Subject: Systematic Reviews
                Subject: Research and Analysis Methods
                Subject: Database and Informatics Methods
                Subject: Database Searching
                Subject: Research and Analysis Methods
                Subject: Research Design
                Subject: Survey Research
                Subject: Questionnaires
                Custom metadata
                Data Availability All relevant data are within the paper and its Supporting Information files.

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