Correction: The Effect of Question Order on Outcomes in the Core Outcome Set for Brief Alcohol Interventions Among Online Help-Seekers: Protocol for a Factorial Randomized Trial (Preprint)

BACKGROUND A core outcome set (COS) for trials and evaluations of the effectiveness and efficacy of alcohol brief interventions (ABIs) has recently been established through international consensus to address the variability of outcomes evaluated. OBJECTIVE This is a protocol for studies to assess if there are order effects among the questions included in the COS. METHODS The 10 items of the COS are organized into 4 clusters. A factorial design will be used with 24 arms, where each arm represents 1 order of the 4 clusters. Individuals searching online for help will be asked to complete a questionnaire, and consenting participants will be randomized to 1 of the 24 arms (double-blind with equal allocation). Participants will be included if they are 18 years or older. The primary analyses will (1) estimate how the order of the clusters of outcomes affects how participants respond and (2) investigate patterns of abandonment of the questionnaire. RESULTS Data collection is expected to commence in November 2020. A Bayesian group sequential design will be used with interim analyses planned for every 50 participants completing the questionnaire. Data collection will end no more than 24 months after commencement, and the results are expected to be published no later than December 2023. CONCLUSIONS Homogenizing the outcomes evaluated in studies of ABIs is important to support synthesis, and the COS is an important step toward this goal. Determining whether there may be issues with the COS question order may improve confidence in using it and speed up its dissemination in the research community. We encourage others to adopt the protocol as a study within their trial as they adopt the ORBITAL (Outcome Reporting in Brief Intervention Trials: Alcohol) COS to build a worldwide repository and provide materials to support such analysis. CLINICALTRIAL ISRCTN Registry ISRCTN17954645; http://www.isrctn.com/ISRCTN17954645 INTERNATIONAL REGISTERED REPORT PRR1-10.2196/24175

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The Effect of Question Order on Outcomes in the Core Outcome Set for Brief Alcohol Interventions Among Online Help-Seekers: Protocol for a Factorial Randomized Trial

JMIR Research Protocols ◽

10.2196/24175 ◽

2020 ◽

Vol 9 (11) ◽

pp. e24175

Author(s):

Marcus Bendtsen ◽

Claire Garnett ◽

Paul Toner ◽

Gillian W Shorter

Keyword(s):

Data Collection ◽

Core Outcome Set ◽

Order Effects ◽

Core Outcome ◽

Group Sequential Design ◽

Online Help ◽

International Consensus ◽

Double Blind ◽

Outcome Set ◽

Question Order

Background A core outcome set (COS) for trials and evaluations of the effectiveness and efficacy of alcohol brief interventions (ABIs) has recently been established through international consensus to address the variability of outcomes evaluated. Objective This is a protocol for studies to assess if there are order effects among the questions included in the COS. Methods The 10 items of the COS are organized into 4 clusters. A factorial design will be used with 24 arms, where each arm represents 1 order of the 4 clusters. Individuals searching online for help will be asked to complete a questionnaire, and consenting participants will be randomized to 1 of the 24 arms (double-blind with equal allocation). Participants will be included if they are 18 years or older. The primary analyses will (1) estimate how the order of the clusters of outcomes affects how participants respond and (2) investigate patterns of abandonment of the questionnaire. Results Data collection is expected to commence in November 2020. A Bayesian group sequential design will be used with interim analyses planned for every 50 participants completing the questionnaire. Data collection will end no more than 24 months after commencement, and the results are expected to be published no later than December 2023. Conclusions Homogenizing the outcomes evaluated in studies of ABIs is important to support synthesis, and the COS is an important step toward this goal. Determining whether there may be issues with the COS question order may improve confidence in using it and speed up its dissemination in the research community. We encourage others to adopt the protocol as a study within their trial as they adopt the ORBITAL (Outcome Reporting in Brief Intervention Trials: Alcohol) COS to build a worldwide repository and provide materials to support such analysis. Trial Registration ISRCTN Registry ISRCTN17954645; http://www.isrctn.com/ISRCTN17954645 International Registered Report Identifier (IRRID) PRR1-10.2196/24175

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Correction: The Effect of Question Order on Outcomes in the Core Outcome Set for Brief Alcohol Interventions Among Online Help-Seekers: Protocol for a Factorial Randomized Trial

JMIR Research Protocols ◽

10.2196/26578 ◽

2021 ◽

Vol 10 (2) ◽

pp. e26578

Author(s):

Marcus Bendtsen ◽

Claire Garnett ◽

Paul Toner ◽

Gillian W Shorter

Keyword(s):

Randomized Trial ◽

Core Outcome Set ◽

Core Outcome ◽

Online Help ◽

The Core ◽

Alcohol Interventions ◽

Outcome Set ◽

Question Order

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The effect of question order on the outcomes in the core outcome set for brief alcohol interventions among online help-seekers

http://isrctn.com/ ◽

10.1186/isrctn17954645 ◽

2020 ◽

Author(s):

Marcus Bendtsen

Keyword(s):

Core Outcome Set ◽

Core Outcome ◽

Online Help ◽

The Core ◽

Alcohol Interventions ◽

Outcome Set ◽

Question Order

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A core outcome set for hyperemesis gravidarum research: an international consensus study

BJOG An International Journal of Obstetrics & Gynaecology ◽

10.1111/1471-0528.16172 ◽

2020 ◽

Vol 127 (8) ◽

pp. 983-992 ◽

Cited By ~ 9

Author(s):

LAW Jansen ◽

MH Koot ◽

J van‘t Hooft ◽

CR Dean ◽

JMN Duffy ◽

...

Keyword(s):

Hyperemesis Gravidarum ◽

Core Outcome Set ◽

Core Outcome ◽

International Consensus ◽

Outcome Set

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Consensus Building in OMERACT: Recommendations for Use of the Delphi for Core Outcome Set Development

The Journal of Rheumatology ◽

10.3899/jrheum.181094 ◽

2019 ◽

Vol 46 (8) ◽

pp. 1041-1046 ◽

Cited By ~ 3

Author(s):

Susan Humphrey-Murto ◽

Richard Crew ◽

Beverley Shea ◽

Susan J. Bartlett ◽

Lyn March ◽

...

Keyword(s):

Clinical Trials ◽

Outcome Measures ◽

Core Outcome Set ◽

Delphi Process ◽

Consensus Building ◽

Core Outcome ◽

Delphi Consensus ◽

International Consensus ◽

Work In Progress ◽

Outcome Set

Objective.Developing international consensus on outcome measures for clinical trials is challenging. The following paper will review consensus building in Outcome Measures in Rheumatology (OMERACT), with a focus on the Delphi.Methods.Based on the literature and feedback from delegates at OMERACT 2018, a set of recommendations is provided in the form of the OMERACT Delphi Consensus Checklist.Results.The OMERACT delegates generally supported the use of the checklist as a guide. The checklist provides guidance for clearly outlining the multiple aspects of the Delphi process.Conclusion.OMERACT is deeply committed to consensus building and these recommendations should be considered a work in progress.

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A core outcome set for pre‐eclampsia research: an international consensus development study

BJOG An International Journal of Obstetrics & Gynaecology ◽

10.1111/1471-0528.16319 ◽

2020 ◽

Vol 127 (12) ◽

pp. 1516-1526 ◽

Cited By ~ 1

Author(s):

JMN Duffy ◽

AE Cairns ◽

D Richards‐Doran ◽

J 't Hooft ◽

C Gale ◽

...

Keyword(s):

Core Outcome Set ◽

Core Outcome ◽

Consensus Development ◽

International Consensus ◽

Development Study ◽

Outcome Set

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BJOG commentary for BJOG‐21‐0466 A core outcome set for the treatment of pregnant women with pregestational diabetes: an international consensus study

BJOG An International Journal of Obstetrics & Gynaecology ◽

10.1111/1471-0528.16823 ◽

2021 ◽

Author(s):

Sanne J Gordijn ◽

Wessel Ganzevoort

Keyword(s):

Pregnant Women ◽

Core Outcome Set ◽

Core Outcome ◽

Pregestational Diabetes ◽

International Consensus ◽

Outcome Set

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Development of a core outcome set for multimorbidity trials in low- and middle-income countries (COSMOS): Study Protocol

10.1101/2021.03.23.21253685 ◽

2021 ◽

Author(s):

Jan R. Boehnke ◽

Rusham Zahra Rana ◽

Jamie J. Kirkham ◽

Louise Rose ◽

Gina Agarwal ◽

...

Keyword(s):

Core Outcome Set ◽

Core Outcome ◽

International Consensus ◽

Long Term Conditions ◽

Middle Income ◽

Middle Income Countries ◽

Effective Interventions ◽

Outcome Set ◽

Wide Range ◽

Low And Middle Income

Introduction 'Multimorbidity' describes the presence of two or more long-term conditions, which can include communicable and non-communicable diseases, and mental disorders. The rising global burden from multimorbidity is well-documented, but trial evidence for effective interventions in low- and middle-income countries (LMICs) is limited. Selection of appropriate outcomes is fundamental to trial design to ensure cross-study comparability, but there is currently no agreement on a core outcome set (COS) to include in trials investigating multimorbidity specifically in LMIC. Our aim is to develop international consensus on two COS for trials of interventions to prevent and treat multimorbidity in LMIC settings. Methods and Analysis Following methods recommended by the Core Outcome Measures in Effectiveness Trials (COMET initiative), the development of these two COS will occur in three stages: (1) generation of a long list of potential outcomes for inclusion; (2) two-round online Delphi surveys; and (3) consensus meetings. First, to generate an initial list of outcomes, we will conduct a systematic review of multimorbidity intervention and prevention trials and interviews with people living with multimorbidity and their caregivers in LMICs. Outcomes will be classified using an outcome taxonomy. Two-round Delphi surveys will be used to elicit importance scores for these outcomes from people living with multimorbidity, caregivers, healthcare professionals, policy makers, and researchers in LMICs. Finally, consensus meetings will be held to discuss the Delphi survey results and agree outcomes for inclusion in the two COS. Ethics and dissemination The study has been approved by the Research Governance Committee of the Department of Health Sciences, University of York, UK [HSRGC/2020/409/D:COSMOS]. Each participating country/research group will obtain local ethics board approval. Informed consent will be obtained from all participants. We will disseminate findings through peer-reviewed open access publications, and presentations at global conferences selected to reach a wide range of LMIC stakeholders.

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