Recruiting and retaining participants in e-Delphi surveys for core outcome set development: Evaluating the COMiT'ID study

Author(s): Deborah Ann Hall ¹ ^, ² ^, ³ ^, ^* , Harriet Smith ¹ ^, ² , Eithne Heffernan ¹ ^, ² , Kathryn Fackrell ¹ ^, ² , for the Core Outcome Measures in Tinnitus International Delphi (COMiT’ID) Research Steering Group

Editor(s): Bridget Young

Publication date (Electronic): 30 July 2018

Journal: PLoS ONE

Publisher: Public Library of Science

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Abstract

Background

A Core Outcome Set (COS) is an agreed list of outcomes that are measured and reported in all clinical trials for a particular health condition. An ‘e-Delphi’ is an increasingly popular method for developing a COS whereby stakeholders are consulted via a multi-round online survey to reach agreement regarding the most important outcomes. Many COS studies seek diverse, international input that includes professionals and healthcare users. However, the recruitment and retention of participants can be deterred by various factors (e.g. language barriers and iterative, time-consuming rounds). This report evaluates the effectiveness of recruitment and retention methods used in the Core Outcome Measures in Tinnitus International Delphi (COMiT’ID) study using participant feedback from healthcare users, healthcare practitioners, researchers, commercial representatives and funders.

Methods

A range of methods were applied to recruit participants to the study and maintain engagement over the three rounds. Feedback on recruitment and retention methods was collected using a twenty-item online questionnaire, with free text comments.

Results

A personalised email invitation was the most frequent recruitment route, and 719 professionals and healthcare users consented to take part. Retention of each stakeholder group ranged from 76 to 91% completing all three e-Delphi rounds. Feedback was given by 379 respondents. A majority of respondents were satisfied with the study methods that were implemented to promote retention. Over 55% indicated that their overall experience closely matched their expectations at the start of the study, and over 90% felt that their contribution was appreciated.

Conclusions

This report highlights study methods that worked well with respect to recruitment and retention, and those that did not. Findings provide a unique contribution to the growing evidence base of good practice in COS development by demonstrating the relative effectiveness of recruitment and retention methods for an e-Delphi survey.

Trial registration

This project was registered (November 2014) in the database of the Core Outcome Measures in Effectiveness Trials (COMET) initiative. The protocol is published in Trials (doi: 10.1186/s13063-017-2123-0).

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Most cited references 21

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Core outcome domains for clinical trials in non-specific low back pain.

Alessandro Chiarotto, Richard A Deyo, Caroline Terwee … (2015)

Inconsistent reporting of outcomes in clinical trials of patients with non-specific low back pain (NSLBP) hinders comparison of findings and the reliability of systematic reviews. A core outcome set (COS) can address this issue as it defines a minimum set of outcomes that should be reported in all clinical trials. In 1998, Deyo et al. recommended a standardized set of outcomes for LBP clinical research. The aim of this study was to update these recommendations by determining which outcome domains should be included in a COS for clinical trials in NSLBP.

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A proposal for case definitions and outcome measures in studies of infantile spasms and West syndrome: consensus statement of the West Delphi group.

Andrew Lux, Colin Osborne (2004)

To reach a broad consensus on case definitions, outcomes, and outcome measures that will ease future study design and facilitate comparison of data from different studies of infantile spasms and West syndrome. Persons who had recently presented or published first-author original research in this field were invited to participate in an e-mail Delphi process and to invite other investigators or clinicians who they thought might participate. The process consisted of six rounds, anonymous except to the facilitator. In total, responses were received from 46 participants. The final statement was approved by 31 participants from 15 countries. It concluded that the primary clinical outcome, cessation of spasms, should denote absence of witnessed spasms from within 14 days of commencement of treatment, and for > or =28 consecutive days from the last witnessed spasm. Primary electroclinical outcome denotes cessation of spasms with resolution of hypsarrhythmia. West syndrome should be a defined subset of the syndrome of infantile spasms. An infantile spasms single-spasm variant should be recognized. Ways are suggested of handling subtle spasms in the context of clinical studies. It proposes a standard for reporting modifying and atypical features of hypsarrhythmia, a minimal set of baseline characteristics and outcomes that should be reported in trials of infantile spasms, and suggests a standard definition of relapse. Consensus was not reached on a definition of hypsarrhythmia. We reached a clear consensus on many aspects of study design for the investigation of infantile spasms, although incomplete consensus was found on how to define EEG criteria.

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Systematic review of outcome domains and instruments used in clinical trials of tinnitus treatments in adults

Deborah A. Hall, Haúla Haider, Agnieszka J. Szczepek … (2016)

Background There is no evidence-based guidance to facilitate design decisions for confirmatory trials or systematic reviews investigating treatment efficacy for adults with tinnitus. This systematic review therefore seeks to ascertain the current status of trial designs by identifying and evaluating the reporting of outcome domains and instruments in the treatment of adults with tinnitus. Methods Records were identified by searching PubMed, EMBASE CINAHL, EBSCO, and CENTRAL clinical trial registries (ClinicalTrials.gov, ISRCTN, ICTRP) and the Cochrane Database of Systematic Reviews. Eligible records were those published from 1 July 2006 to 12 March 2015. Included studies were those reporting adults aged 18 years or older who reported tinnitus as a primary complaint, and who were enrolled into a randomised controlled trial, a before and after study, a non-randomised controlled trial, a case-controlled study or a cohort study, and written in English. Studies with fewer than 20 participants were excluded. Results Two hundred and twenty-eight studies were included. Thirty-five different primary outcome domains were identified spanning seven categories (tinnitus percept, impact of tinnitus, co-occurring complaints, quality of life, body structures and function, treatment-related outcomes and unclear or not specified). Over half the studies (55 %) did not clearly define the complaint of interest. Tinnitus loudness was the domain most often reported (14 %), followed by tinnitus distress (7 %). Seventy-eight different primary outcome instruments were identified. Instruments assessing multiple attributes of the impact of tinnitus were most common (34 %). Overall, 24 different patient-reported tools were used, predominantly the Tinnitus Handicap Inventory (15 %). Loudness was measured in diverse ways including a numerical rating scale (8 %), loudness matching (4 %), minimum masking level (1 %) and loudness discomfort level (1 %). Ten percent of studies did not clearly report the instrument used. Conclusions Our findings indicate poor appreciation of the basic principles of good trial design, particularly the importance of specifying what aspect of therapeutic benefit is the main outcome. No single outcome was reported in all studies and there was a broad diversity of outcome instruments. PROSPERO registration The systematic review protocol is registered on PROSPERO (International Prospective Register of Systematic Reviews): CRD42015017525. Registered on 12 March 2015 revised on 15 March 2016. Electronic supplementary material The online version of this article (doi:10.1186/s13063-016-1399-9) contains supplementary material, which is available to authorized users.

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Author and article information

Contributors

Deborah Ann Hall:

ORCID: http://orcid.org/0000-0002-3804-1452

Role: ConceptualizationRole: Data curationRole: Formal analysisRole: Funding acquisitionRole: InvestigationRole: MethodologyRole: Project administrationRole: ResourcesRole: SupervisionRole: ValidationRole: VisualizationRole: Writing – original draftRole: Writing – review & editing

Harriet Smith: Role: Formal analysisRole: InvestigationRole: MethodologyRole: Project administrationRole: ResourcesRole: SoftwareRole: Writing – original draftRole: Writing – review & editing

Eithne Heffernan: Role: Formal analysisRole: Writing – original draftRole: Writing – review & editing

Kathryn Fackrell:

ORCID: http://orcid.org/0000-0001-6529-8643

Role: Data curationRole: Funding acquisitionRole: InvestigationRole: MethodologyRole: Project administrationRole: ResourcesRole: SoftwareRole: Writing – review & editing

Bridget Young: Role: Editor

Journal

Journal ID (nlm-ta): PLoS One

Journal ID (iso-abbrev): PLoS ONE

Journal ID (publisher-id): plos

Journal ID (pmc): plosone

Title: PLoS ONE

Publisher: Public Library of Science (San Francisco, CA USA )

ISSN (Electronic): 1932-6203

Publication date (Electronic): 30 July 2018

Publication date Collection: 2018

Volume: 13

Issue: 7

Electronic Location Identifier: e0201378

Affiliations

[1 ] NIHR Nottingham Biomedical Research Centre, Nottingham, United Kingdom

[2 ] Hearing Sciences, Division of Clinical Neuroscience, School of Medicine, University of Nottingham, Nottingham, United Kingdom

[3 ] Nottingham University Hospitals NHS Trust, Queens Medical Centre, Nottingham, United Kingdom

University of Liverpool, UNITED KINGDOM

Author notes

Competing Interests: The authors have declared that no competing interests exist.

[¤]

Current address: University of Nottingham Malaysia campus, Jalan Broga, Selangor Darul Ehsan, Malaysia

¶ Membership of the Core Outcome Measures in Tinnitus International Delphi (COMiT’ID) Research Steering Group is provided in the Acknowledgments.

* E-mail: deborah.hall@ 123456nottingham.ac.uk

Author information

Deborah Ann Hall http://orcid.org/0000-0002-3804-1452

Kathryn Fackrell http://orcid.org/0000-0001-6529-8643

Article

Publisher ID: PONE-D-18-03804

DOI: 10.1371/journal.pone.0201378

PMC ID: 6066228

PubMed ID: 30059560

SO-VID: d16c50a7-5fb8-40ad-ba7a-719fb0f90294

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 : 9 February 2018

Date accepted : 13 June 2018

Page count

Figures: 3, Tables: 6, Pages: 22

Funding

Funded by: British Tinnitus Association

Award Recipient :

ORCID: http://orcid.org/0000-0001-6529-8643

Kathryn Fackrell

Funded by: funder-id http://dx.doi.org/10.13039/501100000272, National Institute for Health Research;

Award Recipient :

ORCID: http://orcid.org/0000-0002-3804-1452

Deborah Ann Hall

Funded by: funder-id http://dx.doi.org/10.13039/501100000703, Action on Hearing Loss;

Award Recipient :

ORCID: http://orcid.org/0000-0002-3804-1452

Deborah Ann Hall

This article presents independent research primarily funded by the National Institute for Health Research (NIHR) [NIHR Nottingham Biomedical Research Centre] (DAH). The views expressed in this article are those of the author(s) and not necessarily those of the NHS, the NIHR, or the Department of Health and Social Care. Small research grants were awarded by Action on Hearing Loss to purchase relevant software licenses and to create the Introduction video described in this article (DAH), and British Tinnitus Association to support Public Research Partner Involvement (KF). TINNET is supported by a European Cooperation in Science and Technology (COST) Action (BM1306). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

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Data Availability All relevant data are within the paper and its Supporting Information files (see " S5 Appendix").

Recruiting and retaining participants in e-Delphi surveys for core outcome set development: Evaluating the COMiT'ID study

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Abstract

Background

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Results

Conclusions

Trial registration

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PLOS Climate

Most cited references 21

Core outcome domains for clinical trials in non-specific low back pain.

A proposal for case definitions and outcome measures in studies of infantile spasms and West syndrome: consensus statement of the West Delphi group.

Systematic review of outcome domains and instruments used in clinical trials of tinnitus treatments in adults

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