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

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 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.

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

2019 ◽  
Vol 46 (8) ◽  
pp. 1041-1046 ◽  
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.

scholarly journals Development of a Core Outcome Set for clinical trials aimed at improving antimicrobial stewardship in care homes

2021 ◽  
Vol 29 (Supplement_1) ◽  
pp. i15-i16
Author(s):  
H Q Nguyen ◽  
D T Bradley ◽  
M M Tunney ◽  
C M Hughes
Keyword(s):  
Clinical Trials ◽  
Older People ◽  
Antimicrobial Stewardship ◽  
Healthcare Professionals ◽  
Care Home ◽  
Core Outcome Set ◽  
Care Homes ◽  
Core Outcome ◽  
Delphi Consensus ◽  
Outcome Set

Abstract Introduction Diverse outcomes reported in clinical trials to improve antimicrobial stewardship (AMS) in care homes has hindered evidence synthesis [1]. We previously reported that a number of outcomes for care home AMS which may be important to healthcare professionals and relatives of care home residents had not been measured in previous trials [2]. It is essential to generate a set of important outcomes (a core outcome set – COS) for future studies of AMS interventions in care homes. Aim To develop a COS for use in clinical trials aimed at improving AMS in care homes. Methods A refined inventory of outcomes for AMS interventions in care homes, compiled from a previous study [2], was presented in a three-round international Delphi consensus survey, followed by an online consensus exercise. Stakeholders engaged in AMS in care homes (e.g. healthcare professionals, representatives of care home residents) were invited to participate, having been identified through the research team’s contacts and knowledge of relevant organisations. A 9-point Likert scale was used during the consensus procedures and an outcome was included in the COS if 80% or more of participants scored between 7 and 9, and 15% or less scored between 1 and 3. Less stringent criteria for inclusion were also applied if the final COS comprised fewer than three outcomes. Subsequently, a suitable outcome measurement instrument (OMI) was selected for each outcome in the COS using the following steps: finding existing OMIs in the literature and consulting with experts, assessing the quality of OMIs, and selecting one OMI for each core outcome via a two-round international Delphi consensus exercise. Consent was obtained from all participants taking part in all consensus procedures. Results The initial inventory of 14 outcomes was presented to 82 international Delphi panellists from 17 countries in the first round who also suggested three additional outcomes. These 17 outcomes were rated again in two further rounds, with consensus achieved for ten outcomes. A subsequent online consensus exercise with twelve participants from Northern Ireland, including the research team, reached consensus to include five outcomes in the COS (Table 1). Regarding selection of OMIs for the COS, 17 OMIs were identified through literature searches and experts’ suggestions. Based on quality assessment, three OMIs - ‘Number of antimicrobial courses started per 1000 resident-days’, ‘Rate of antimicrobial days of therapy per 1000 resident-days’, and ‘Van Buul algorithms to evaluate appropriateness of initiating or withholding antibiotics’ - were selected for a two-round Delphi exercise with 59 participants from 16 countries. Consensus was reached to select two OMIs for the COS, as presented in Table 1. Conclusion This is the first study to develop a COS for use in clinical trials aimed at improving AMS in care homes. Although we recruited few representatives from advocacy groups for older people, care home staff and managers, there was common agreement for inclusion of a number of outcomes. This COS represents the minimum that should be used in research and trialists may consider exploring other outcomes as reported in previous studies. References 1. Nguyen HQ, Tunney MM, Hughes CM. Interventions to Improve Antimicrobial Stewardship for Older People in Care Homes: A Systematic Review. Drugs and Aging. 2019;36(4):355–69. 2. Nguyen HQ, Bradley DT, Tunney MM, Hughes CM. Antimicrobial Stewardship in Care Homes: Outcomes of Importance to Stakeholders. J Hosp Infect. 2020 Jan 27;104(4):582–91.

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.

Developing core outcome set for vitiligo clinical trials: international e-Delphi consensus

2015 ◽  
Vol 28 (3) ◽  
pp. 363-369 ◽  
Author(s):  
Viktoria Eleftheriadou ◽  
Kim Thomas ◽  
Nanja van Geel ◽  
Iltefat Hamzavi ◽  
Henry Lim ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Core Outcome Set ◽  
Core Outcome ◽  
Delphi Consensus ◽  
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.

Sign in / Sign up

Export Citation Format

Share Document