scholarly journals A review of the Cochrane COVID-19 Study Register reveals inconsistency in the choice and measurement of SARS-CoV-2 infection outcomes in prevention trials

F1000Research ◽  
2021 ◽  
Vol 10 ◽  
pp. 426
Author(s):  
Susanna Dodd ◽  
Sarah Gorst ◽  
Kerry Avery ◽  
Nicola Harman ◽  
Rhiannon Macefield ◽  
...  
Keyword(s):  
Outcome Measurement ◽  
Core Outcome Set ◽  
Multiple Infection ◽  
Safety Measures ◽  
Prophylactic Drugs ◽  
Early Phase Trials ◽  
Outcome Set ◽  
Prevention Interventions ◽  
Outcome Selection ◽  
Prevention Trials

Background: Multiple studies are evaluating how to prevent SARS-CoV-2 infection. Interventions are wide ranging and include vaccines, prophylactic drugs, public health safety measures, and behavioural interventions. Heterogeneity in the outcomes measured and reported is leading to research waste and inefficiency, slowing worldwide identification and implementation of effective methods to prevent infection. A core outcome set (COS) for studies of interventions to prevent SARS-CoV-2 infection has recently been developed, identifying infection as a critical outcome to measure. This paper examines how SARS-CoV-2 infection outcomes are measured in registered COVID-19 prevention trials and considers how this can be improved. Methods: We searched the Cochrane COVID-19 Study Register to identify and review SARS-CoV-2 infection outcomes in prevention trials, including the rationale for choice of outcome measurement. We included phase 3 and 4 trials of COVID-19 prevention interventions. Early phase trials and studies relating to the transmission, treatment or management of COVID-19 were excluded. Results: We identified 430 entries in the register, of which 199 unique prevention trials were included across eight settings and 12 intervention types. Fifteen (8%) trials did not include any SARS-CoV-2 infection outcomes. The remaining 184 (92%) studies included a total of 268 SARS-CoV-2 infection outcomes, of which 32 (17%) did not specify how infection would be measured. Testing (i.e. formal diagnostic test) as a standalone method for determining infection was used in 57 (31%) trials, whereas defining infection by symptoms alone was used in 16 (9%) trials. All other trials (n=79, 43%) included multiple infection outcomes, defined in different ways. Discussion: There is considerable variation in how SARS-CoV-2 infection is measured within and across different interventions and settings. Furthermore, few studies report the rationale for outcome selection and measurement. Better transparency and standardisation of SARS-CoV-2 infection measurement is needed for the findings from prevention trials to inform decision-making.

scholarly journals The importance of stakeholder selection in core outcome set development: how surveying different health professionals may influence outcome selection

Trials ◽  
2015 ◽  
Vol 16 (S2) ◽  
Author(s):  
Kerry Avery ◽  
Katy Chalmers ◽  
Katie Whale ◽  
Natalie Blencowe ◽  
Rhiannon Macefield ◽  
...  
Keyword(s):  
Health Professionals ◽  
Core Outcome Set ◽  
Core Outcome ◽  
Outcome Set ◽  
Outcome Selection

scholarly journals Diabetes after pregnancy prevention trials: Systematic review for core outcome set development

2020 ◽  
Vol 16 (3) ◽  
Author(s):  
Sharleen L. O'Reilly ◽  
Yvonne Leonard ◽  
Kaberi Dasgupta ◽  
Helle Terkildsen Maindal
Keyword(s):  
Systematic Review ◽  
Core Outcome Set ◽  
Pregnancy Prevention ◽  
Core Outcome ◽  
Outcome Set ◽  
Prevention Trials

Delphi procedure in core outcome set development: rating scale and consensus criteria determined outcome selection

2019 ◽  
Vol 111 ◽  
pp. 23-31 ◽  
Author(s):  
Dorien De Meyer ◽  
Jan Kottner ◽  
Hilde Beele ◽  
Jochen Schmitt ◽  
Toni Lange ◽  
...  
Keyword(s):  
Rating Scale ◽  
Core Outcome Set ◽  
Core Outcome ◽  
Outcome Set ◽  
Delphi Procedure ◽  
Outcome Selection

scholarly journals Development of a core outcome set for diabetes after pregnancy prevention interventions (COS-DAP): a study protocol

Trials ◽  
2018 ◽  
Vol 19 (1) ◽  
Author(s):  
Karoline Kragelund Nielsen ◽  
Sharleen O’Reilly ◽  
Nancy Wu ◽  
Kaberi Dasgupta ◽  
Helle Terkildsen Maindal
Keyword(s):  
Study Protocol ◽  
Core Outcome Set ◽  
Pregnancy Prevention ◽  
Core Outcome ◽  
Outcome Set ◽  
Prevention Interventions

scholarly journals Core outcomes in neonatology: development of a core outcome set for neonatal research

2019 ◽  
Vol 105 (4) ◽  
pp. 425-431 ◽  
Author(s):  
James William Harrison Webbe ◽  
James M N Duffy ◽  
Elsa Afonso ◽  
Iyad Al-Muzaffar ◽  
Ginny Brunton ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Core Outcome Set ◽  
Neonatal Care ◽  
Consensus Meeting ◽  
High Income ◽  
Core Outcome ◽  
Outcome Set ◽  
Outcome Selection ◽  
Survey Results ◽  
Meta Analyses

BackgroundNeonatal research evaluates many different outcomes using multiple measures. This can prevent synthesis of trial results in meta-analyses, and selected outcomes may not be relevant to former patients, parents and health professionals.ObjectiveTo define a core outcome set (COS) for research involving infants receiving neonatal care in a high-income setting.DesignOutcomes reported in neonatal trials and qualitative studies were systematically reviewed. Stakeholders were recruited for a three-round international Delphi survey. A consensus meeting was held to confirm the final COS, based on the survey results.ParticipantsFour hundred and fourteen former patients, parents, healthcare professionals and researchers took part in the eDelphi survey; 173 completed all three rounds. Sixteen stakeholders participated in the consensus meeting.ResultsThe literature reviews identified 104 outcomes; these were included in round 1. Participants proposed 10 additional outcomes; 114 outcomes were scored in rounds 2 and 3. Round 1 scores showed different stakeholder groups prioritised contrasting outcomes. Twelve outcomes were included in the final COS: survival, sepsis, necrotising enterocolitis, brain injury on imaging, general gross motor ability, general cognitive ability, quality of life, adverse events, visual impairment/blindness, hearing impairment/deafness, retinopathy of prematurity and chronic lung disease/bronchopulmonary dysplasia.Conclusions and relevanceA COS for clinical trials and other research studies involving infants receiving neonatal care in a high-income setting has been identified. This COS for neonatology will help standardise outcome selection in clinical trials and ensure these are relevant to those most affected by neonatal care.

scholarly journals Development of a core outcome set for the evaluation of interventions to enhance trial participation decisions on behalf of adults who lack capacity to consent: a mixed methods study (COnSiDER Study)

2021 ◽  
Author(s):  
Victoria Shepherd ◽  
Fiona Wood ◽  
Michael Robling ◽  
Elizabeth Randell ◽  
Kerenza Hood
Keyword(s):  
Outcome Measurement ◽  
Core Outcome Set ◽  
Consensus Meeting ◽  
Delphi Survey ◽  
Additional Patient ◽  
Trial Participation ◽  
Core Outcome ◽  
Capacity To Consent ◽  
Outcome Set ◽  
Participation Decisions

Abstract BackgroundTrials involving adults who lack capacity to provide consent for themselves rely on proxy or surrogate decision-makers, usually a family member, to make decisions about participation. Following decades of innovations to improve informed consent in trials, the first interventions to enhance proxy decisions about trial participation are now being developed. However, a lack of standardised outcome measurement in the evaluation of these novel interventions will impede comparisons between their effectiveness. The aim of this study was to establish an agreed standardised core outcome set (COS) for use when evaluating interventions to improve proxy decisions about trial participation on behalf of adults who lack capacity to consent.MethodsWe used established methods to develop the COS including a consensus study with key stakeholder groups comprising those who will use the COS in research (researchers and healthcare professionals) and patients or their representatives. Following a scoping review to identify candidate items, we used a modified two-round Delphi survey to achieve consensus on core outcomes, with equivocal items taken to a consensus meeting for discussion. The COS was finalised following an online consensus meeting in October 2020.ResultsA total of 28 UK stakeholders (5 researchers, 10 trialists, 3 patient/family representatives, 7 recruiters and 3 advisors/approvers) participated in the online Delphi survey to rank candidate items. Items were broadly grouped into three categories: how family members make decisions, their experiences of making decisions, and the personal aspects that influence the decision. Following the Delphi survey, 27 items were included and ten items exhibited no consensus which required discussion at the consensus meeting. Sixteen participants attended the meeting, including additional patient/family representatives invited to increase representation from this key group. We reached consensus for the inclusion of 28 outcome items, including one selected at the consensus meeting.ConclusionsThe study identified outcomes that should be measured as a minimum in all evaluations of interventions to enhance proxy decisions about trials. Further work is required to identify appropriate measures and timing of outcome measurement. Enhancing the quality of proxy decisions will help improve trial participation decisions for these vulnerable groups. Trial registration: The study is registered on the COMET database (https://www.comet-initiative.org/Studies/Details/1409)

scholarly journals A Core Outcome Set for Nonpharmacological Community-Based Interventions for People Living With Dementia at Home: A Systematic Review of Outcome Measurement Instruments

2020 ◽  
Author(s):  
Andrew J E Harding ◽  
Hazel Morbey ◽  
Faraz Ahmed ◽  
Carol Opdebeeck ◽  
Ruth Elvish ◽  
...  
Keyword(s):  
Outcome Measurement ◽  
Core Outcome Set ◽  
Face Validity ◽  
Core Outcome ◽  
Measurement Instruments ◽  
Community Based Interventions ◽  
Community Based ◽  
Key Stakeholders ◽  
Outcome Set ◽  
Dementia Research

Abstract Background and Objectives It is questionable whether existing outcome measurement instruments (OMIs) in dementia research reflect what key stakeholders’ value. We attained consensus from more than 300 key stakeholders, including people living with dementia, and identified 13 core outcome items for use in nonpharmacological and community-based interventions for people with dementia living at home. In this systematic review, we review OMIs that have previously been used in dementia care research to determine how, or even if, the 13 core outcome items can be measured. Research Design and Methods We extracted self-reported OMIs from trials, reviews, and reports of instrument development. Searches were undertaken in the ALOIS database, MEDLINE, PsycINFO, CINAHL, SocINDEX, and COSMIN databases. We aimed to assess the psychometric properties of OMI items for face validity with the core outcome items, content validity, internal consistency, and responsiveness. We held a coresearch workshop involving people living with dementia and care partners in order to ratify the findings. Results In total 347 OMIs were located from 354 sources. Of these, 76 OMIs met the inclusion criteria. No OMIs were deemed to have sufficient face validity for the core outcome set (COS) items, and no OMIs proceeded to further assessment. The “best” available OMI is the Engagement and Independence in Dementia Questionnaire. Discussion and Implications This study provides a practical resource for those designing dementia research trials. Being able to measure the COS items would herald a paradigm shift for dementia research, be responsive to what key stakeholders value and enhance the ability to make comparisons.

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