The evolution of instrument selection for inclusion in core outcome sets at OMERACT: Filter 2.2

2021 ◽  
Author(s):  
Lara J Maxwell ◽  
Dorcas E Beaton ◽  
Maarten Boers ◽  
Maria Antonietta D'Agostino ◽  
Philip G Conaghan ◽  
...  
Keyword(s):  
Core Outcome ◽  
Core Outcome Sets ◽  
Instrument Selection ◽  
Selection For

scholarly journals Outcome selection for tissue-agnostic drug trials for immune-mediated inflammatory diseases: a systematic review of core outcome sets and regulatory guidance

Trials ◽  
2022 ◽  
Vol 23 (1) ◽  
Author(s):  
Olalekan Lee Aiyegbusi ◽  
Lavinia Ferrante di Ruffano ◽  
Ameeta Retzer ◽  
Philip N. Newsome ◽  
Christopher D. Buckley ◽  
...  
Keyword(s):  
Systematic Review ◽  
Inflammatory Diseases ◽  
Core Outcome ◽  
Core Outcome Sets ◽  
Regulatory Guidance ◽  
Immune Mediated ◽  
Outcome Selection ◽  
Similarities And Differences ◽  
Selection For

Abstract Background Tissue-agnostic drug development provides a paradigm shift in precision medicine and requires innovative trial designs. However, outcome selection for such trials can prove challenging. The objectives of this review were to: Identify and map core outcome sets (COS), across 11 immune-mediated inflammatory diseases (IMIDs) in order to facilitate the selection of relevant outcomes across the conditions for innovative trials of tissue-agnostic drug therapies. Compare outcomes or endpoints recommended by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) to identify and highlight similarities and differences. Methods The Core Outcome Measures in Effectiveness Trials (COMET), International Consortium for Health Outcomes Measurement (ICHOM), FDA and EMA databases were searched from inception to 28th December 2019. Two reviewers independently screened titles and abstracts of retrieved entries and conducted the subsequent full text screening. Hand searching of the reference lists and citation searching of the selected publications was conducted. The methodological quality of the included peer-reviewed articles was independently assessed by the reviewers based on the items of the COS–Standards for Development recommendations (COS–STAD) checklist. Core outcomes from the included publications were extracted and mapped across studies and conditions. Regulatory guidance from FDA and EMA, where available for clinical trials for the IMIDs, were obtained from their databases and recommendations on outcomes to measure directly compared. Results Forty-four COS publications were included in the final analysis. Outcomes such as disease activity, pain, fatigue, quality of life, physical function, work limitation/productivity, steroid use and biomarkers were recommended across majority of the conditions. There were significant similarities and differences in FDA and EMA recommendations. The only instance where either regulatory body directly referenced a COS was for jSLE—both referenced the Paediatric Rheumatology International Trials Organization (PRINTO) COS. Conclusions The findings from this systematic review provide valuable information to inform outcome selection in tissue-agnostic trials for IMIDs. There is a need for increased collaboration between regulators and COS developers and inclusion of regulators as key stakeholders in COS development to enhance the quality of COS. Trial registration Not registered.

scholarly journals Engaging Stakeholders and Promoting Uptake of OMERACT Core Outcome Instrument Sets

2017 ◽  
Vol 44 (10) ◽  
pp. 1551-1559 ◽  
Author(s):  
Sean R. Tunis ◽  
Lara J. Maxwell ◽  
Ian D. Graham ◽  
Beverley J. Shea ◽  
Dorcas E. Beaton ◽  
...  
Keyword(s):  
Knowledge Translation ◽  
Core Outcome Set ◽  
Healthcare Providers ◽  
Stakeholder Involvement ◽  
Decision Makers ◽  
Core Outcome ◽  
Core Outcome Sets ◽  
Regulatory Decision ◽  
Outcome Instrument ◽  
Outcome Domain

Objective.While there has been substantial progress in the development of core outcomes sets, the degree to which these are used by researchers is variable. We convened a special workshop on knowledge translation at the Outcome Measures in Rheumatology (OMERACT) 2016 with 2 main goals. The first focused on the development of a formal knowledge translation framework and the second on promoting uptake of recommended core outcome domain and instrument sets.Methods.We invited all 189 OMERACT 2016 attendees to the workshop; 86 attended, representing patient research partners (n = 15), healthcare providers/clinician researchers (n = 52), industry (n = 4), regulatory agencies (n = 4), and OMERACT fellows (n = 11). Participants were given an introduction to knowledge translation and were asked to propose and discuss recommendations for the OMERACT community to (1) strengthen stakeholder involvement in the core outcome instrument set development process, and (2) promote uptake of core outcome sets with a specific focus on the potential role of post-regulatory decision makers.Results.We developed the novel “OMERACT integrated knowledge translation” framework, which formalizes OMERACT’s knowledge translation strategies. We produced strategies to improve stakeholder engagement throughout the process of core outcome set development and created a list of creative and innovative ways to promote the uptake of OMERACT’s core outcome sets.Conclusion.The guidance provided in this paper is preliminary and is based on the views of the participants. Future work will engage OMERACT groups, “post-regulatory decision makers,” and a broad range of different stakeholders to identify and evaluate the most useful methods and processes, and to revise guidance accordingly.

scholarly journals Core outcome sets and systematic reviews

2016 ◽  
Vol 5 (1) ◽  
Author(s):  
Mike Clarke ◽  
Paula R. Williamson
Keyword(s):  
Systematic Reviews ◽  
Core Outcome ◽  
Core Outcome Sets

Video-Based Teaching in Patient and Instrument Selection for Operative Vaginal Deliveries

2018 ◽  
Vol 40 (9) ◽  
pp. 1162-1169.e3
Author(s):  
Aparna Sarangapani ◽  
Andrea N. Simpson ◽  
John Snelgrove ◽  
Mary Higgins ◽  
Rory Windrim ◽  
...  
Keyword(s):  
Instrument Selection ◽  
Vaginal Deliveries ◽  
Selection For

scholarly journals Core outcome sets in women's and newborn health: a systematic review

2017 ◽  
Vol 124 (10) ◽  
pp. 1481-1489 ◽  
Author(s):  
JMN Duffy ◽  
R Rolph ◽  
C Gale ◽  
M Hirsch ◽  
KS Khan ◽  
...  
Keyword(s):  
Systematic Review ◽  
Newborn Health ◽  
Core Outcome ◽  
Core Outcome Sets

scholarly journals A protocol for the Development of Core Outcome Sets for Endodontic Treatment modalities (COSET): an international consensus process

2021 ◽  
Author(s):  
Ikhlas El karim ◽  
Henry F Duncan ◽  
Siobhan Cushley ◽  
Venkatesh Nagendrababu ◽  
Lise-Lotte Kirkevang ◽  
...  
Keyword(s):  
Clinical Studies ◽  
Endodontic Treatment ◽  
Treatment Modalities ◽  
Core Outcome ◽  
Consensus Process ◽  
International Consensus ◽  
Core Outcome Sets ◽  
Key Stakeholders ◽  
Dental Practitioners ◽  
Patient Reported

Abstract BackgroundThe outcome of endodontic treatment is generally assessed using a range of patient and clinician-centred, non-standardised clinical and radiographic outcome measures. This makes it difficult to synthesise evidence for systematic analysis of the literature and the development of clinical guidelines. Core outcome sets (COS) represent a standardised list of outcomes that should be measured and reported in all clinical studies in a particular field. Recently, clinical researchers and guideline developers have focussed on the need for integration of a patient-reported COS with clinician-centred measures. This study aims to develop a COS that includes both patient reported outcomes and clinician centred measures for various endodontic treatment modalities to be used in clinical research and practice.MethodsTo identify reported outcomes (including when and how they are measured), systematic reviews and their included clinical studies, which focus on the outcome of endodontic treatment and were published between 1990 and 2020 will be screened. The COSs will be defined by a consensus process involving key stakeholders using semi-structured interviews and an online Delphi methodology followed by an interactive virtual consensus meeting. A heterogeneous group of key ‘stakeholders’ including patients, general dental practitioners, endodontists, endodontic teachers, clinical researchers, students and policy-makers will be invited to participate. Patients will establish, via interactive interviews, which outcomes they value and feel should be included in a COS. In the Delphi process, other stakeholders will be asked to prioritise outcomes identified from the literature and patients interviews, and will have the opportunity at the end of the first round to add outcomes that are not included, but which they consider relevant. Feedback will be provided in the second round, when participants will be asked to prioritise the list again. If consensus is reached, the remaining outcomes will be discussed at an online meeting and agreement established via defined consensus rules of outcome inclusion. If consensus is not reached after the second round, a third round will be conducted with feedback, followed by the online meeting. Following identification of a COS, we will proceed to identify how and when these outcomes are measured.DiscussionUsing a rigorous methodology, the proposed consensus process aims to develop a COS for endodontic treatment that will be relevant to stakeholders. The results of the study will be shared with participants and COS users. To increase COS uptake, it will also be actively shared with clinical guideline developers, research funders and the editors of general dental and endodontology journals.Study registrationThe study is registered in COMET (https://comet-initiative.org/Studies/Details/1879)

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