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Article ; Online: Using behavioral science to increase core outcome set use in trials.

Matvienko-Sikar, Karen / Hussey, Shannen / Mellor, Katie / Byrne, Molly / Clarke, Mike / Kirkham, Jamie J / Kottner, Jan / Quirke, Fiona / Saldanha, Ian J / Smith, Valerie / Toomey, Elaine / Williamson, Paula R

Journal of clinical epidemiology

2024 Volume 168, Page(s) 111285

Abstract: Objectives: Core outcome sets (COS) are agreed sets of outcomes for use in clinical trials, which can increase standardization and reduce heterogeneity of outcomes in research. Using a COS, or not, is a behavior that can potentially be increased using ... ...

Abstract	Objectives: Core outcome sets (COS) are agreed sets of outcomes for use in clinical trials, which can increase standardization and reduce heterogeneity of outcomes in research. Using a COS, or not, is a behavior that can potentially be increased using behavioral strategies. The aim of this study was to identify behavioral intervention components to potentially increase use of COS in trials. Methods: This project was informed by the Behavior Change Wheel framework. Two reviewers extracted barriers and facilitators to COS use from four recently published studies examining COS use in trials. Barriers and facilitators were coded to the Capability, Opportunity, Motivation-Behavior (COM-B) model, which forms part of the Behavior Change Wheel. COM-B findings were mapped to intervention functions by two reviewers, and then mapped to behavior change techniques (BCTs). Full-team Affordability, Practicability, Effectiveness/Cost-effectiveness, Acceptability, Side effects/Safety, Equity ratings were used to reach consensus on intervention functions and BCTs. BCTs were operationalized using examples of tangible potential applications and were categorized based on similarity. Results: Barriers and facilitators were identified for all capability, opportunity and motivation aspects of the COM-B model. Five intervention functions (education, training, enablement, persuasion, and modeling) and 15 BCTs were identified. Thirty-six BCT examples were developed, including providing information on benefits of COS for health research, and information choosing COS. BCT examples are categorized by approaches related to "workshops," "guidance," "audio/visual resources," and "other resources." Conclusion: Study findings represent diverse ways to potentially increase COS use in trials. Future work is needed to examine effects of these behavioral intervention components on COS use. If effective, increased use of COS can improve outcome reporting and minimize outcome heterogeneity and research waste.
MeSH term(s)	Humans ; Behavior Therapy ; Motivation ; Behavioral Sciences ; Consensus ; Outcome Assessment, Health Care
Language	English
Publishing date	2024-02-19
Publishing country	United States
Document type	Journal Article
ZDB-ID	639306-8
ISSN	1878-5921 ; 0895-4356
ISSN (online)	1878-5921
ISSN	0895-4356
DOI	10.1016/j.jclinepi.2024.111285
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Article ; Online: Using behavioural science to enhance use of core outcome sets in trials: protocol.

Matvienko-Sikar, Karen / Byrne, Molly / Clarke, Mike / Kirkham, Jamie / Kottner, Jan / Mellor, Katie / Quirke, Fiona / J Saldanha, Ian / Smith, Valerie / Toomey, Elaine / Williamson, Paula

HRB open research

2023 Volume 5, Page(s) 23

Abstract: Background: Core outcome sets (COS) represent agreed-upon sets of outcomes, which are the minimum that should be measured and reported in all trials in specific health areas. Use of COS can reduce outcome heterogeneity, selective outcome reporting, and ... ...

Abstract	Background: Core outcome sets (COS) represent agreed-upon sets of outcomes, which are the minimum that should be measured and reported in all trials in specific health areas. Use of COS can reduce outcome heterogeneity, selective outcome reporting, and research waste, and can facilitate evidence syntheses. Despite benefits of using COS, current use of COS in trials is low. COS use can be understood as a behaviour, in that it is something trialists do, or not do, adequately. The aim of this study is to identify strategies, informed by behaviour change theory, to increase COS use in trials. Methods: The project will be conducted in two stages, informed by the behaviour change wheel (BCW). The BCW is a theoretically based framework that can be used to classify, identify, and develop behaviour change strategies. In Stage 1, barriers and enablers to COS use will be extracted from published studies that examined trialist's use of COS. Barriers and facilitators will be mapped to the components of COM-B model (capability, opportunity, and motivation), which forms part of the BCW framework. Stage 2 will build on Stage 1 findings to identify and select intervention functions and behaviour change techniques to enhance COS use in trials. Discussion: The findings of this study will provide an understanding of the behavioural factors that influence COS use in trials and what strategies might be used to target these factors to increase COS use in trials.
Language	English
Publishing date	2023-11-20
Publishing country	Ireland
Document type	Journal Article
ISSN	2515-4826
ISSN (online)	2515-4826
DOI	10.12688/hrbopenres.13510.2
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Article ; Online: Optimising research for neonates with encephalopathy: the role of core outcome sets.

Pediatric research

2024 Volume 95, Issue 4, Page(s) 869–870

MeSH term(s)	Infant, Newborn ; Humans ; Brain Diseases/therapy ; Hypothermia, Induced ; Outcome Assessment, Health Care ; Hypoxia-Ischemia, Brain/therapy ; Retrospective Studies
Language	English
Publishing date	2024-01-09
Publishing country	United States
Document type	Journal Article
ZDB-ID	4411-8
ISSN	1530-0447 ; 0031-3998
ISSN (online)	1530-0447
ISSN	0031-3998
DOI	10.1038/s41390-023-03006-1
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Article ; Online: Protocol for the development of a core outcome set for neonatal sepsis (NESCOS).

Taneri, Petek Eylul / Kirkham, Jamie J / Molloy, Eleanor J / Biesty, Linda / Polin, Richard A / Wynn, James L / Stoll, Barbara J / Kissoon, Niranjan / Kawaza, Kondwani / Daly, Mandy / Branagan, Aoife / Bonnard, Lívia Nagy / Giannoni, Eric / Strunk, Tobias / Ohaja, Magdalena / Mugabe, Kenneth / Suguitani, Denise / Quirke, Fiona / Devane, Declan

PloS one

2023 Volume 18, Issue 12, Page(s) e0295325

Abstract: Neonatal sepsis is a serious public health problem; however, there is substantial heterogeneity in the outcomes measured and reported in research evaluating the effectiveness of the treatments. Therefore, we aim to develop a Core Outcome Set (COS) for ... ...

Abstract	Neonatal sepsis is a serious public health problem; however, there is substantial heterogeneity in the outcomes measured and reported in research evaluating the effectiveness of the treatments. Therefore, we aim to develop a Core Outcome Set (COS) for studies evaluating the effectiveness of treatments for neonatal sepsis. Since a systematic review of key outcomes from randomised trials of therapeutic interventions in neonatal sepsis was published recently, we will complement this with a qualitative systematic review of the key outcomes of neonatal sepsis identified by parents, other family members, parent representatives, healthcare providers, policymakers, and researchers. We will interpret the outcomes of both studies using a previously established framework. Stakeholders across three different groups i.e., (1) researchers, (2) healthcare providers, and (3) patients' parents/family members and parent representatives will rate the importance of the outcomes in an online Real-Time Delphi Survey. Afterwards, consensus meetings will be held to agree on the final COS through online discussions with key stakeholders. This COS is expected to minimize outcome heterogeneity in measurements and publications, improve comparability and synthesis, and decrease research waste.
MeSH term(s)	Infant, Newborn ; Humans ; Neonatal Sepsis/therapy ; Research Design ; Delphi Technique ; Consensus ; Outcome Assessment, Health Care/methods ; Treatment Outcome ; Systematic Reviews as Topic
Language	English
Publishing date	2023-12-05
Publishing country	United States
Document type	Journal Article
ZDB-ID	2267670-3
ISSN	1932-6203 ; 1932-6203
ISSN (online)	1932-6203
ISSN	1932-6203
DOI	10.1371/journal.pone.0295325
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Article ; Online: COHESION: core outcomes in neonatal encephalopathy (protocol).

Quirke, Fiona A / Healy, Patricia / Bhraonáin, Elaine Ní / Daly, Mandy / Biesty, Linda / Hurley, Tim / Walker, Karen / Meher, Shireen / Haas, David M / Bloomfield, Frank H / Kirkham, Jamie J / Molloy, Eleanor J / Devane, Declan

Trials

2021 Volume 22, Issue 1, Page(s) 125

Abstract: Background: Neonatal encephalopathy is a complex syndrome in infants that predominantly affects the brain and other organs. The leading cause is a lack of oxygen in the blood reaching the brain. Neonatal encephalopathy can result in mortality or ... ...

Abstract	Background: Neonatal encephalopathy is a complex syndrome in infants that predominantly affects the brain and other organs. The leading cause is a lack of oxygen in the blood reaching the brain. Neonatal encephalopathy can result in mortality or complications later in life, including seizures, movement disorders and cerebral palsy. Treatment options for neonatal encephalopathy are limited mainly to therapeutic hypothermia, although other potential treatments are emerging. However, evaluations of the effectiveness of treatments are challenging because of heterogeneity and inconsistency in outcomes measured and reported between trials. In this paper, we detail how we will develop a core outcome set to standardise outcomes measured and reported upon for interventions for the treatment of neonatal encephalopathy. Methods: We will systematically review the literature to identify outcomes reported previously in randomised trials and systematic reviews of randomised trials. We will identify outcomes important to parents or caregivers of infants diagnosed with and who have received treatment for neonatal encephalopathy. We will do this by conducting in person or by video teleconferencing interviews with parents or caregivers in high-income and low- to middle-income countries. Stakeholders with expertise in neonatal encephalopathy (parents/caregivers, healthcare providers and researchers) will rate the importance of identified outcomes in an online Delphi survey using either a three-round Delphi survey or a "Real-Time" Delphi survey to which stakeholders will be allocated at random. Consensus meetings will take place by video conference to allow for an international group of stakeholder representatives to discuss and vote on the outcomes to include in the final core outcome set (COS). Discussion: More research is needed on treatments for neonatal encephalopathy. Standardising outcomes measured and reported in evaluations of the effectiveness of interventions for the treatment of neonatal encephalopathy will improve evidence synthesis and improve results reported in systematic reviews and meta-analysis in this area. Overall, this COS will allow for improved treatments to be identified, heterogeneity in research to be reduced, and overall patient care to be enhanced. Trial registration: This study is registered in the Core Outcome Measures for Effectiveness (COMET) database http://www.comet-initiative.org/Studies/Details/1270 .
MeSH term(s)	Brain Diseases/therapy ; Delphi Technique ; Humans ; Infant, Newborn ; Meta-Analysis as Topic ; Outcome Assessment, Health Care ; Research Design ; Systematic Reviews as Topic ; Treatment Outcome
Language	English
Publishing date	2021-02-08
Publishing country	England
Document type	Journal Article
ZDB-ID	2040523-6
ISSN	1745-6215 ; 1468-6694 ; 1468-6708
ISSN (online)	1745-6215 ; 1468-6694
ISSN	1468-6708
DOI	10.1186/s13063-021-05030-0
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Article ; Online: Multi-Round versus Real-Time Delphi survey approach for achieving consensus in the COHESION core outcome set: a randomised trial.

Trials

2023 Volume 24, Issue 1, Page(s) 461

Abstract: Background: Delphi surveys are commonly used to prioritise critical outcomes in core outcome set (COS) development. This trial aims to compare a three-round (Multi-Round) Delphi (MRD) with a Real-Time Delphi (RTD) in the prioritisation of outcomes for ... ...

Abstract	Background: Delphi surveys are commonly used to prioritise critical outcomes in core outcome set (COS) development. This trial aims to compare a three-round (Multi-Round) Delphi (MRD) with a Real-Time Delphi (RTD) in the prioritisation of outcomes for inclusion in a COS for neonatal encephalopathy treatments and explore whether 'feedback', 'iteration', and 'initial condition' effects may occur in the two survey methods. Methods: We recruited 269 participants (parents/caregivers, healthcare providers and researchers/academics) of which 222 were randomised to either the MRD or the RTD. We investigated the outcomes prioritised in each survey and the 'feedback', 'iteration', and 'initial condition' effects to identify differences between the two survey methods. Results: In the RTD, n = 92 participants (83%) fully completed the survey. In the MRD, n = 60 participants (54%) completed all three rounds. Of the 92 outcomes presented, 26 (28%) were prioritised differently between the RTD and MRD. Significantly fewer participants amended their scores when shown stakeholder responses in the RTD compared to the MRD ('feedback effect'). The 'iteration effect' analysis found most experts appeared satisfied with their initial ratings in the RTD and did not amend their scores following stakeholder response feedback. Where they did amend their scores, ratings were amended substantially, suggesting greater convergence. Variance in scores reduced with subsequent rounds of the MRD ('iteration effect'). Whilst most participants did not change their initial scores in the RTD, of those that did, later recruits tended to align their final score more closely to the group mean final score than earlier recruits (an 'initial condition' effect). Conclusion: The feedback effect differed between the two Delphi methods but the magnitude of this difference was small and likely due to the large number of observations rather than because of a meaningfully large difference. It did not appear to be advantageous to require participants to engage in three rounds of a survey due to the low change in scores. Larger drop-out through successive rounds in the MRD, together with a lesser convergence of scores and longer time to completion, indicate considerable benefits of the RTD approach. Trial registration: NCT04471103. Registered on 14 July 2020.
MeSH term(s)	Infant, Newborn ; Humans ; Consensus ; Delphi Technique ; Health Personnel ; Research Design ; Outcome Assessment, Health Care/methods ; Treatment Outcome
Language	English
Publishing date	2023-07-19
Publishing country	England
Document type	Randomized Controlled Trial ; Journal Article
ZDB-ID	2040523-6
ISSN	1745-6215 ; 1468-6694 ; 1745-6215
ISSN (online)	1745-6215
ISSN	1468-6694 ; 1745-6215
DOI	10.1186/s13063-023-07388-9
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Article ; Online: Multi-Round compared to Real-Time Delphi for consensus in core outcome set (COS) development: a randomised trial.

Trials

2021 Volume 22, Issue 1, Page(s) 142

Abstract: Background: The Delphi method is used in a wide variety of settings as a method of building consensus on important issues. Traditionally, the Delphi method uses multiple rounds of a survey to allow for feedback of other participants' survey responses in ...

Abstract	Background: The Delphi method is used in a wide variety of settings as a method of building consensus on important issues. Traditionally, the Delphi method uses multiple rounds of a survey to allow for feedback of other participants' survey responses in between rounds. By informing participants about how others answer a question or prioritise specific topics, it allows for diverse opinions to inform the consensus process. For this reason, the Delphi method is popular as a consensus building approach in developing core outcome sets (COS), i.e. the minimum agreed set of standardised outcomes that should be measured and reported in studies on a specific health condition. In a COS setting, participants prioritise the importance of outcomes for inclusion in a COS. This usually involves participating in multiple rounds of a survey that can span several weeks or months. Challenges with participant retention have been highlighted in previous COS. We will compare a three-round with a Real-Time Delphi approach on prioritised outcomes. This trial is embedded within the COHESION study which is developing a COS for interventions treating neonatal encephalopathy. Methods: One hundred and eighty stakeholders (parents/caregivers of infants diagnosed and treated with neonatal encephalopathy, healthcare providers and researchers) will be randomised using stratified randomisation to take part in either the Multi-Round or Real-Time Delphi. Stakeholders will rate the importance of the same set of outcomes in both arms. We will compare the prioritised outcomes at the end of both surveys as well as other parameters such as feedback, initial condition and iteration effects. Discussion: This trial will provide evidence to inform decisions on the use of Multi-Round compared to Real-Time Delphi survey methods. Trial registration: NCT04471103 . Registered on 14 July 2020.
MeSH term(s)	Consensus ; Delphi Technique ; Health Personnel ; Humans ; Infant, Newborn ; Outcome Assessment, Health Care ; Research Design ; Treatment Outcome
Language	English
Publishing date	2021-02-15
Publishing country	England
Document type	Journal Article ; Randomized Controlled Trial
ZDB-ID	2040523-6
ISSN	1745-6215 ; 1468-6694 ; 1468-6708
ISSN (online)	1745-6215 ; 1468-6694
ISSN	1468-6708
DOI	10.1186/s13063-021-05074-2
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Article ; Online: COHESION: a core outcome set for the treatment of neonatal encephalopathy.

Pediatric research

2023 Volume 95, Issue 4, Page(s) 922–930

Abstract: Background: Heterogeneity in outcomes reported in trials of interventions for the treatment of neonatal encephalopathy (NE) makes evaluating the effectiveness of treatments difficult. Developing a core outcome set for NE treatment would enable ... ...

Abstract	Background: Heterogeneity in outcomes reported in trials of interventions for the treatment of neonatal encephalopathy (NE) makes evaluating the effectiveness of treatments difficult. Developing a core outcome set for NE treatment would enable researchers to measure and report the same outcomes in future trials. This would minimise waste, ensure relevant outcomes are measured and enable evidence synthesis. Therefore, we aimed to develop a core outcome set for treating NE. Methods: Outcomes identified from a systematic review of the literature and interviews with parents were prioritised by stakeholders (n = 99 parents/caregivers, n = 101 healthcare providers, and n = 22 researchers/ academics) in online Delphi surveys. Agreement on the outcomes was achieved at online consensus meetings attended by n = 10 parents, n = 18 healthcare providers, and n = 13 researchers/ academics. Results: Seven outcomes were included in the final core outcome set: survival; brain injury on imaging; neurological status at discharge; cerebral palsy; general cognitive ability; quality of life of the child, and adverse events related to treatment. Conclusion: We developed a core outcome set for the treatment of NE. This will allow future trials to measure and report the same outcomes and ensure results can be compared. Future work should identify how best to measure the COS. Impact: We have identified seven outcomes that should be measured and reported in all studies for the treatment of neonatal encephalopathy. Previously, a core outcome set for neonatal encephalopathy treatments did not exist. This will help to reduce heterogeneity in outcomes reported in clinical trials and other studies, and help researchers identify the best treatments for neonatal encephalopathy.
MeSH term(s)	Infant, Newborn ; Child ; Humans ; Quality of Life ; Research Design ; Cerebral Palsy ; Consensus ; Outcome Assessment, Health Care/methods ; Treatment Outcome
Language	English
Publishing date	2023-12-22
Publishing country	United States
Document type	Review ; Journal Article
ZDB-ID	4411-8
ISSN	1530-0447 ; 0031-3998
ISSN (online)	1530-0447
ISSN	0031-3998
DOI	10.1038/s41390-023-02938-y
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Article ; Online: Core outcomes in neonatal encephalopathy: a qualitative study with parents.

BMJ paediatrics open

2022 Volume 6, Issue 1

Abstract: Objective: To identify the outcomes considered important to parents or caregivers of infants diagnosed with neonatal encephalopathy, hypoxic ischaemic encephalopathy or birth asphyxia in high-income and low- to middle-income countries (LMiCs), as part ... ...

Abstract	Objective: To identify the outcomes considered important to parents or caregivers of infants diagnosed with neonatal encephalopathy, hypoxic ischaemic encephalopathy or birth asphyxia in high-income and low- to middle-income countries (LMiCs), as part of the outcome-identification process in developing a core outcome set (COS) for the treatment of neonatal encephalopathy. Design: A qualitative study involving 25 semistructured interviews with parents or other family members (caregivers) of infants who were diagnosed with, and treated for, neonatal encephalopathy, hypoxic ischaemic encephalopathy or birth asphyxia. Setting: Interviews were conducted in high-income countries (HiCs) (n=11) by Zoom video conferencing software and in LMiCs (n=14) by phone or face to face. Findings: Parents identified 54 outcomes overall, which mapped to 16 outcome domains. The domains identified were neurological outcomes, respiratory outcomes, gastrointestinal outcomes, cardiovascular outcomes, motor development, cognitive development, development (psychosocial), development (special senses), cognitive development, development (speech and social), other organ outcomes, survival/living outcomes, long-term disability, hospitalisation, parent-reported outcomes and adverse events. Conclusions: This study provides insight into the outcomes that parents of infants diagnosed with neonatal encephalopathy have identified as the most important, to be considered in the process of developing a COS for the treatment of neonatal encephalopathy. We also provide description of the processes employed to ensure the inclusion of participants from LMiCs as well as HiCs.
MeSH term(s)	Asphyxia ; Asphyxia Neonatorum/therapy ; Humans ; Hypoxia-Ischemia, Brain/therapy ; Infant ; Infant, Newborn ; Infant, Newborn, Diseases ; Outcome Assessment, Health Care ; Parents/psychology
Language	English
Publishing date	2022-07-25
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ISSN	2399-9772
ISSN (online)	2399-9772
DOI	10.1136/bmjpo-2022-001550
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Article ; Online: Neonatal encephalopathy and hypoxic-ischemic encephalopathy: moving from controversy to consensus definitions and subclassification.

Molloy, Eleanor J / Branagan, Aoife / Hurley, Tim / Quirke, Fiona / Devane, Declan / Taneri, Petek E / El-Dib, Mohamed / Bloomfield, Frank H / Maeso, Beccy / Pilon, Betsy / Bonifacio, Sonia L / Wusthoff, Courtney J / Chalak, Lina / Bearer, Cynthia / Murray, Deirdre M / Badawi, Nadia / Campbell, Suzann / Mulkey, Sarah / Gressens, Pierre /

Ferriero, Donna M / de Vries, Linda S / Walker, Karen / Kay, Sarah / Boylan, Geraldine / Gale, Chris / Robertson, Nicola J / D'Alton, Mary / Gunn, Alistair / Nelson, Karin B

Pediatric research

2023 Volume 94, Issue 6, Page(s) 1860–1863

MeSH term(s)	Infant, Newborn ; Humans ; Hypoxia-Ischemia, Brain/diagnosis ; Hypoxia-Ischemia, Brain/therapy ; Consensus ; Infant, Newborn, Diseases/diagnosis ; Infant, Newborn, Diseases/therapy
Language	English
Publishing date	2023-08-12
Publishing country	United States
Document type	Editorial
ZDB-ID	4411-8
ISSN	1530-0447 ; 0031-3998
ISSN (online)	1530-0447
ISSN	0031-3998
DOI	10.1038/s41390-023-02775-z
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