scholarly journals Using a web-based method to achieve stakeholder consensus about core outcomes for clinical trials is a viable option in the face of pandemic-related movement restrictions: Qualitative methods study (Preprint)

2021 ◽  
Author(s):  
Roulla Katiri ◽  
Deborah A. Hall ◽  
Derek J. Hoare ◽  
Kathryn Fackrell ◽  
Adele Horobin ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Core Outcome Set ◽  
Consensus Meeting ◽  
Core Outcome ◽  
Web Based ◽  
Face To Face ◽  
Outcome Set ◽  
Study Team ◽  
The Face ◽  
Single Sided Deafness

BACKGROUND Clinical trials that assess the benefits and harms of an intervention do so by measuring and reporting outcomes. Inconsistent selection and diversity in the choice of outcomes makes it challenging to directly compare interventions. To achieve an agreed core set of outcomes, a consensus methodology is recommended comprising a web-based Delphi survey and a face-to-face consensus meeting. However, UK-government regulations to control the pandemic prohibited plans for a face-to-face consensus meeting as part of the Core Rehabilitation Outcome Set for Single-Sided Deafness (CROSSSD) study. OBJECTIVE This article describes and evaluates the modifications taken by the CROSSSD study team to achieve consensus using web-based methods, but with minimal deviation from the original study protocol. METHODS The study team worked with healthcare users and professionals to translate the planned face-to-face consensus meeting in a web-based format, preserving key elements of the nominal group technique. A follow-up survey gathered evaluation feedback on the experience of the 22 participating members. Feedback covered (i) pre-meeting preparation, (ii) process of facilitated discussions and voting, (iii) ability to contribute, and (iv) perceived fairness of the outcome. RESULTS On balance, the web-based meeting achieved its original goals of open discussion, debate, and voting to agree a core outcome set for single-sided deafness. Hearing-impaired participants were fully engaged, but there were some methodological challenges. For the participants, challenges included building rapport, understanding, and delivering the tasks in hand. For the study team, challenges included the need for thorough preparation and managing the unpredictability of tasks on the day. CONCLUSIONS Sharing our experiences and lessons learned can benefit future core outcome set developers. Overcoming the challenges of delivering a web-based consensus exercise in the face of the pandemic can be applied more generally to maximise inclusiveness, enhance geographical access, as well as to reduce research costs. CLINICALTRIAL N/A

scholarly journals Core outcome set measurement for future clinical trials in acute myeloid leukemia: the HARMONY study protocol using a multi-stakeholder consensus-based Delphi process and a final consensus meeting

2020 ◽  
Author(s):  
Katharina M Lang ◽  
Kathryn L. Harrison ◽  
Paula R. Williamson ◽  
Brian J.P. Huntly ◽  
Gert Ossenkoppele ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Acute Myeloid Leukemia ◽  
Myeloid Leukemia ◽  
Core Outcome Set ◽  
Core Outcome ◽  
Face To Face ◽  
Outcome Set ◽  
Multi Stakeholder ◽  
Stakeholder Consensus ◽  
Acute Myeloid

Abstract Background Acute myeloid leukemia is the most common acute leukemia in adults with an unacceptably low cure rate. In recent years a number of new treatment strategies and compounds were developed for the treatment of acute myeloid leukemia. There were several randomized, controlled clinical trials with the objective to improve patients’ management and patients’ outcome in acute myeloid leukemia. Unfortunately, these trials are not always directly comparable, as they do not measure the same outcomes and currently there are no core outcome sets that can be utilized to guide outcome selection and harmonization in this disease area. The HARMONY Alliance is a public-private European Network established in 2017, which currently includes 53 partners and 32 associated members from 22 countries. Amongst many other goals of the HARMONY Alliance, Work Package 2 focuses on defining outcomes that are relevant to each hematological malignancy. In accordance, a pilot study will be performed to define core outcome set in acute myeloid leukemia. Methods The pilot study will use a three-round Delphi survey and a final consensus meeting to define a core outcome set. Participants will be recruited from different stakeholder groups, including patients, clinicians, regulators and members of the European Federation of Pharmaceutical Industries and Associations (EFPIA). At the pre-Delphi stage a literature research was conducted followed by several semi-structured interviews of clinical public and private key opinion leaders. Subsequently the preliminary outcome list was discussed in several multi-stakeholder face-to-face meetings. The Delphi survey will reduce the preliminary outcome list to essential core outcomes. After completing the last Delphi round a final face-to-face meeting is planned to achieve consensus about core outcome set in acute myeloid leukemia. Discussion The pilot Delphi as part of HARMONY Alliance aims to define a core outcome set in acute myeloid leukemia based on a multi-stakeholder consensus. Such a core outcome set will help to allow consistent comparison of future clinical trials and real world evidence research and ensures that appropriate outcomes valued by a range of stakeholders are measured within future trials.

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 Core outcome set measurement for future clinical trials in acute myeloid leukemia: the HARMONY study protocol using a multi-stakeholder consensus-based Delphi process and a final consensus meeting

2019 ◽  
Author(s):  
Katharina M Lang ◽  
Kathryn L. Harrison ◽  
Paula R. Williamson ◽  
Brian J.P. Huntly ◽  
Gert Ossenkoppele ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Acute Myeloid Leukemia ◽  
Myeloid Leukemia ◽  
Core Outcome Set ◽  
Core Outcome ◽  
Face To Face ◽  
Outcome Set ◽  
Multi Stakeholder ◽  
Stakeholder Consensus ◽  
Acute Myeloid

Abstract Background Acute myeloid leukemia is the most common acute leukemia in adults with an unacceptably low cure rate. In recent years a number of new treatment strategies and compounds were developed for the treatment of acute myeloid leukemia. There were several randomized, controlled clinical trials with the objective to improve patients’ management and patients’ outcome in acute myeloid leukemia. Unfortunately, these trials are not always directly comparable, as they do not measure the same outcomes and currently there are no core outcome sets that can be utilized to guide outcome selection and harmonization in this disease area. The HARMONY Alliance is a public-private European Network established in 2017, which currently includes 53 partners and 32 associated members from 22 countries. Amongst many other goals of the HARMONY Alliance, Work Package 2 focuses on defining outcomes that are relevant to each hematological malignancy. In accordance, a pilot study will be performed to define core outcome set in acute myeloid leukemia. Methods The pilot study will use a three-round Delphi survey and a final consensus meeting to define a core outcome set. Participants will be recruited from different stakeholder groups, including patients, clinicians, regulators and members of the European Federation of Pharmaceutical Industries and Associations (EFPIA). At the pre-Delphi stage a literature research was conducted followed by several semi-structured interviews of clinical public and private key opinion leaders. Subsequently the preliminary outcome list was discussed in several multi-stakeholder face-to-face meetings. The Delphi survey will reduce the preliminary outcome list to essential core outcomes. After completing the last Delphi round a final face-to-face meeting is planned to achieve consensus about core outcome set in acute myeloid leukemia. Discussion The pilot Delphi as part of HARMONY Alliance aims to define a core outcome set in acute myeloid leukemia based on a multi-stakeholder consensus. Such a core outcome set will help to allow consistent comparison of future clinical trials and real world evidence research and ensures that appropriate outcomes valued by a range of stakeholders are measured within future trials.

scholarly journals Developing a core outcome set for children with protracted bacterial bronchitis

2020 ◽  
Vol 6 (1) ◽  
pp. 00344-2019
Author(s):  
Francis J. Gilchrist ◽  
Imran Ali ◽  
Malcolm Brodlie ◽  
Will D. Carroll ◽  
Bridget Kemball ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Core Outcome Set ◽  
Consensus Meeting ◽  
Delphi Survey ◽  
Respiratory Pathogen ◽  
Core Outcome ◽  
Potential Core ◽  
Outcome Set ◽  
Protracted Bacterial Bronchitis ◽  
Wet Cough

BackgroundProtracted bacterial bronchitis (PBB) is a chronic endobrochial infection and a leading cause of chronic wet cough in children. There is an urgent need for a randomised controlled trial to investigate the optimal treatment but there is no core outcome set (COS) to inform choice of outcomes. A COS is a standardised set of outcomes representing the minimum that should be measured and reported in clinical trials of a specific condition. We have developed a COS for PBB.MethodsPotential core outcomes were collated from a systematic review, interviews with parents and a clinician survey. A two-round Delphi survey of healthcare professionals identified which outcomes had consensus for inclusion. The final COS was agreed at a consensus meeting of parent representatives and clinicians.Results20 outcomes were identified for the Delphi survey. After two rounds, 10 reached consensus. These were combined and edited at the consensus meeting into the final six: 1) Resolution of cough assessed using a cough score/diary recorded daily by parent(s) during treatment; 2) relapse of chronic wet cough and/or cumulative antibiotic treatment during ≥12 months follow-up; 3) change in child's quality of life (parent-proxy reporting for young children); 4) emergence of antibiotic resistance; 5) development of bronchiectasis diagnosed on clinically indicated computed tomography scans; and 6) microbiological clearance of identified respiratory pathogen if samples readily available.ConclusionsWe have developed a COS for PBB which will reduce the outcome heterogeneity and bias of future clinical trials, as well as promoting comparison between studies.

Postinflammatory hyperpigmentation: protocol for development of a core outcome set for clinical trials

2021 ◽  
Author(s):  
Bianca Y. Kang ◽  
Sarah A. Ibrahim ◽  
Divya Shokeen ◽  
Daniel I. Schlessinger ◽  
Jamie J. Kirkham ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Core Outcome Set ◽  
Core Outcome ◽  
Outcome Set ◽  
Postinflammatory Hyperpigmentation

A multi-stakeholder Delphi consensus core outcome set for clinical trials in moderate-to-severe asthma (coreASTHMA)

2021 ◽  
Author(s):  
Vickram Tejwani ◽  
Hsing-Yuan Chang ◽  
Annie P. Tran ◽  
Jennifer Al Naber ◽  
Florian S. Gutzwiller ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Severe Asthma ◽  
Core Outcome Set ◽  
Core Outcome ◽  
Delphi Consensus ◽  
Outcome Set ◽  
Multi Stakeholder

Identifying Outcomes in Clinical Trials of Fistulizing Crohn’s Disease for the Development of a Core Outcome Set

2019 ◽  
Vol 17 (9) ◽  
pp. 1904-1908 ◽  
Author(s):  
Christopher Ma ◽  
Claire E. Parker ◽  
Tran M. Nguyen ◽  
Reena Khanna ◽  
Brian G. Feagan ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Core Outcome Set ◽  
Core Outcome ◽  
Outcome Set

scholarly journals Acute severe paediatric asthma: study protocol for the development of a core outcome set, a Pediatric Emergency Networks (PERN) study

2019 ◽  
Author(s):  
Simon Craig ◽  
Franz E Babl ◽  
Stuart R Dalziel ◽  
Charmaine Gray ◽  
Colin Powell ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Severe Asthma ◽  
Working Group ◽  
Core Outcome Set ◽  
Asthma Severity ◽  
Core Outcome ◽  
Acute Severe Asthma ◽  
Paediatric Asthma ◽  
Future Studies ◽  
Outcome Set

Abstract Background. Acute severe childhood asthma is an infrequent, but potentially life-threatening emergency presentation. There is a wide range of different approaches to this condition, with very little supporting evidence, leading to significant variation in practice. To improve knowledge in this area, there must first be consensus on how to conduct clinical trials, so that valid comparisons can be made between future studies. We have formed an international working group comprising paediatricians and emergency physicians from North America, Europe, Asia, the Middle East, Africa, South America, Central America, Australasia and the United Kingdom. Methods / design. A five-stage approach will be used: (1) A comprehensive list of outcomes relevant to stakeholders will be compiled through systematic reviews and qualitative interviews with patients, families, and clinicians; (2) A Delphi methodology will be applied to reduce the comprehensive list to a core outcome set; (3) We will review current clinical practice guidelines, existing clinical trials, and literature regarding bedside assessment of asthma severity. We will then identify practice differences in clinical assessment of asthma severity, and determine whether further prospective work is needed to achieve agreement on inclusion criteria for clinical trials on acute paediatric asthma in the emergency department setting; (4) A retrospective chart review in Australia and New Zealand will identify the incidence of serious clinical complications in children hospitalized with acute severe asthma, such as intubation, ICU admission, and death. Understanding the incidence of such outcomes will allow us to understand how common (and therefore how feasible) particular outcomes are in an asthma ED population; (5) Finally, a meeting of the PERN asthma working group will be held, with invitation of other clinicians interested in acute asthma research, and patients / families. The group will be asked to achieve consensus on a core set of outcomes and to make recommendations for the conduct of clinical trials on acute severe asthma. If this is not possible, the group will agree on a series of prioritized steps to achieve this aim. Discussion The development of an international consensus on core outcomes is an important first step towards the development of consensus guidelines and standardised protocols for RCTs in this population. This will enable us to better interpret and compare future studies, reduce risks of study heterogeneity and outcome reporting bias, and improve the evidence base for the management of this important condition.

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