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)

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

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
I. A. El Karim ◽  
H. F. Duncan ◽  
S. Cushley ◽  
V. Nagendrababu ◽  
L. L. 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 Background The 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 the 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. Methods To 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 patient 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 the identification of a COS, we will proceed to identify how and when these outcomes are measured. Discussion Using 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. Trial registration COMET 1879. 21 May 2021.

scholarly journals Development of ‘Core Outcome Sets’ for meningioma in clinical studies: The COSMIC project

2021 ◽  
Vol 23 (Supplement_4) ◽  
pp. iv22-iv22
Author(s):  
Christopher Millward ◽  
Sumirat Keshwara ◽  
Abdurrahman Islim ◽  
Nisaharan Srikandarajah ◽  
Tony Marson ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Studies ◽  
Healthcare Professionals ◽  
Clinical Effectiveness ◽  
Core Outcome ◽  
Core Outcome Sets ◽  
Stakeholder Groups ◽  
Patient Reported ◽  
Effectiveness Trials ◽  
Clinical Trial Activity

Abstract Aims To date, meningioma clinical trial activity has been limited, but a number of high-quality studies are underway, with more in development. There is heterogeneity in the outcomes reported in meningioma clinical trials. The COSMIC Project will develop two ‘Core Outcome Sets’ (COS) through comprehensive, transparent, consensus methodology; to ensure outcomes relevant to key stakeholders are reported within and across future meningioma clinical studies. The first will be for use in clinical effectiveness trials (COSMIC: Intervention), the second will be for use in clinical studies of incidental meningioma (COSMIC: Observation). Method Three systematic literature reviews will be performed to generate a long-list of outcomes potentially relevant to meningioma patients, healthcare professionals, researchers, and other stakeholder groups. The first systematic review will present the outcomes reported in published and ongoing meningioma clinical effectiveness trials. The second systematic review will present patient-reported outcomes (PRO) from the measurement tools utilised in meningioma PRO studies. The third systematic review will present the outcomes reported in published and ongoing clinical studies of untreated meningioma. Outcomes will be deduplicated, unique outcomes categorised according to the taxonomy presented by COMET, and the lists combined. The long-list of outcomes will be prioritised through two, 2-round, modified eDelphi surveys including meningioma patients, healthcare professionals, researchers, and other stakeholder groups. Undecided outcomes from both eDelphi surveys will be ratified at two, one-day consensus meeting, with representation from all key stakeholder groups. Results We have formed a study advisory group with international representation from key organisations. The project already has confirmed support from the International Consortium on Meningioma (ICOM), the European Association of Neuro-Oncology (EANO), the Response Assessment in Neuro-Oncology Patient-Reported Outcome group (RANO-PRO), the Society for Neuro-Oncology (SNO), British Neuro-Oncology Society (BNOS), Society of British Neurological Surgeons (SBNS), The Brain Tumour Charity (TBTC), and Brainstrust. Conclusion Standardising minimum outcome reporting in meningioma clinical effectiveness trials and meningioma clinical studies, through the development of these two COS will ensure outcomes reported are relevant to key stakeholder groups, including patients, whilst reducing research waste for a disease with increasing clinical trial activity. We seek to raise awareness of this project and invite participation from a wide range of stakeholders to ensure that the final COS reflects the opinion of the neuro-oncology community. Registration will take place via the study website www.thecosmicproject.org between June-August 2021.

Facilitating International Participation in Core Outcome Set Development: A Proposed Approach for Multi-language Delphi Surveys, a Review of Current Practice and Issues to Consider

2020 ◽  
Author(s):  
Bilal Alkhaffaf ◽  
Paula Williamson ◽  
Jane M Blazeby ◽  
Anne-Marie Glenny ◽  
Ademola Adeyeye ◽  
...  
Keyword(s):  
Current Practice ◽  
Stakeholder Participation ◽  
Core Outcome Set ◽  
Core Outcome ◽  
Core Outcome Sets ◽  
Key Stakeholders ◽  
Outcome Set ◽  
International Participation ◽  
Methodological Approaches ◽  
Improve Planning

Abstract Background Core outcome sets (COS) should be relevant to key stakeholders and widely applicable so that researchers are willing to use them when designing trials. Many COS developers have utilised online Delphi surveys which enable wider international stakeholder participation. Despite broader participation, most international COS projects have restricted Delphi surveys to a single language potentially excluding important opinion from those who are not fluent in the survey language.Methods A structured review of current approaches to translating Delphi surveys for COS development was undertaken. We present a proposed methodology adapted from international guidance. Results Four studies were identified from our structured review. Wide variation exists in the methodological approaches to translating Delphi surveys for the developing of COS. Issues which arise when developing multi-language Delphi surveys include establishing translation groups, timelines, financial implications, strategies to maximise recruitment and regulatory approvals.Conclusion Consideration of the issues described will improve planning by other COS developers and can be used to widen international participation from both patients and healthcare professionals.

scholarly journals P121 The development of Core Outcome Sets and Common Data Elements in clinical neurosciences: a scoping review

BJS Open ◽  
2021 ◽  
Vol 5 (Supplement_1) ◽  
Author(s):  
Soham Bandyopadhyay ◽  
Hugo Layard Horsfall ◽  
Aswin Chari ◽  
Angelos G Kolias ◽  
Soham Bandyopadhyay
Keyword(s):  
International Development ◽  
Scoping Review ◽  
Meta Analysis ◽  
Primary Objective ◽  
Research Field ◽  
Core Outcome ◽  
International Consensus ◽  
Common Data Elements ◽  
Core Outcome Sets ◽  
Data Elements

Abstract Background Core Outcome Sets (COS) are a consensus-based agreed minimum set of outcomes that should be measured and reported in all studies within a research field. Common Data Elements (CDEs) are the minimum data points that should be collected regarding the characteristics of population, condition and intervention. The use of COS and CDEs minimises research wastage by increasing the cross-comparison and meta-analysis of study findings. Objective The primary objective was to collate and describe the current process of developing core outcome sets and common data elements in published research pertaining to clinical neurosciences. The secondary objective was to identify the clinical neuroscience subspecialties that have developed COS and CDEs, the countries of origin of authors, and the process through which COS and CDEs were developed. Design A search between 2000-2020 of the top 40 Impact Factor neurosurgical and neurological journals was conducted. A scoping review was performed in accordance with the PRISMA-ScR Checklist. Results Our search returned 169 papers, of which 35 were eligible for inclusion in the present study. The USA published the majority of papers (20/35). The papers mostly related to neurosurgery (30/35), with the most common neurosurgical sub-specialty being traumatic brain injury (14/35) and subarachnoid haemorrhage (10/35). There is an increasing publication trend over time, with 12 papers published in 2019. COS and CDE development is an international collaborative process, with authors from a number of different countries. Five papers were systematic reviews conducting with the intention of COS/CDE development. 27 papers reported CDE development and 2 papers reported COS development (aphasia and non-specific low back pain). The COS development papers utilised international consensus meetings and adhered to international development statements. Conclusions COS and CDEs are an essential research tool to reduce research wastage and ultimately improve patient outcomes through homogenous outcome reporting, aligned with patient-derived outcomes. COS and CDEs are increasingly being developed within clinical neurosciences.

scholarly journals Representation of published core outcome sets for research in regulatory guidance: protocol

2021 ◽  
Vol 4 ◽  
pp. 45
Author(s):  
Susanna Dodd ◽  
Rebecca Fish ◽  
Sarah Gorst ◽  
Deborah Hall ◽  
Pamela Jacobsen ◽  
...  
Keyword(s):  
Patient Involvement ◽  
European Medicines Agency ◽  
Core Outcome ◽  
Core Outcome Sets ◽  
Regulatory Guidance ◽  
The Core ◽  
Key Stakeholders ◽  
Regulatory Guidelines ◽  
Core Outcomes ◽  
Guidance Documents

Background: The COMET Initiative promotes the development and use of ‘core outcome sets’ (COS), agreed standardised sets of outcomes that should be measured and reported in all studies in a particular clinical condition. COS are determined by consensus amongst key stakeholders, including health professionals, policymakers and patients, ensuring that the priorities and expertise of these representatives inform the choice of the most important outcomes to measure for a given condition. There is increased recognition of the need to integrate COS across the healthcare system and with existing regulatory apparatus, to ensure that outcomes being recorded are those of key relevance to important stakeholders. The aim of this study is to assess the degree of concordance between outcomes recommended in COS for research and in guidance provided by two key regulators: US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Methods: COS for research published during 2015-2019 with patient involvement and covering drug or device interventions will be compared against relevant regulatory guidelines, matched by condition. Guidance documents which match in scope (relating to intervention and population) to a COS for research will be scrutinised to identify all suggested outcomes for comparison against the core outcomes in the corresponding COS. Discussion: This study will identify variation between outcomes suggested in EMA and FDA regulatory guidance relative to outcomes included in published COS for research, thus demonstrating the degree of representation of COS in regulatory guidance and vice versa. If the findings of this study reveal a lack of concordance between COS and regulatory guidance overall or for particular disease areas, we will invite feedback from FDA and EMA and will seek to highlight where findings support the recommendations towards using well-developed COS or will make recommendations to COS developers on outcomes of importance to these key regulators.

scholarly journals Development of reporting guidance and core outcome sets for seamless, standardised evaluation of innovative surgical procedures and devices: a study protocol for content generation and a Delphi consensus process (COHESIVE study)

BMJ Open ◽  
2019 ◽  
Vol 9 (9) ◽  
pp. e029574 ◽  
Author(s):  
Kerry Avery ◽  
Jane Blazeby ◽  
Nicholas Wilson ◽  
Rhiannon Macefield ◽  
Sian Cousins ◽  
...  
Keyword(s):  
Qualitative Interviews ◽  
Core Outcome Set ◽  
Scientific Meeting ◽  
Routine Practice ◽  
Regulatory Body ◽  
Core Outcome ◽  
Delphi Consensus ◽  
Core Outcome Sets ◽  
North East ◽  
Key Stakeholders

IntroductionRigorous evaluation of innovative invasive procedures and medical devices is uncommon and lacks reporting standardisation. Devices may therefore enter routine practice without thorough evaluation, resulting in patient harm. Detailed guidance on how to select and report outcomes at each stage of evaluation is lacking. Development of reporting guidance and core outcome sets (COS) is one strategy to promote safe and transparent evaluation.Methods and analysisA COS, comprising outcome domains applicable to all phases of evaluation of procedure/device introduction and modification and, if necessary, supplementary domains relevant to specific phases or types of innovation (procedure or device), will be developed according to principles outlined by Core Outcome Measures in Effectiveness Trials (COMET) and Core Outcome Set-Standards for Development (COS-STAD) guidelines. Reporting guidance will be developed concurrently. The study will have the following three phases:1. Generation of a list of relevant outcome domains and reporting items identified from (a) published studies, (b) hospital policy documentation, (c) regulatory body documentation and (d) stakeholder qualitative interviews. Identified items/domains will be categorised using a conceptual framework and formatted into Delphi consensus survey questionnaire items.2. Key stakeholders, including 50 patients and 150 professionals (surgeons, researchers, device manufacturers, regulatory representatives, journal editors) sampled from multinational sources, will complete a Delphi survey to score the importance of each reporting item and outcome.3. A consensus meeting with key stakeholders will discuss and agree the final content of the reporting guidance and COS(s).Ethics and disseminationEthical approval has been granted by North East-Newcastle and North Tyneside 1 Health Research Authority Research Ethics Committee (18/NE/0378). Dissemination strategies include scientific meeting presentations, peer-reviewed journal publications, development of plain English summaries/materials, patient engagement events, development of a social media identity, workshops and other events.

scholarly journals Development of core outcome sets for effectiveness trials of interventions to prevent and/or treat delirium (Del-COrS): study protocol

BMJ Open ◽  
2017 ◽  
Vol 7 (9) ◽  
pp. e016371 ◽  
Author(s):  
Louise Rose ◽  
Meera Agar ◽  
Lisa D Burry ◽  
Noll Campbell ◽  
Mike Clarke ◽  
...  
Keyword(s):  
Local Governance ◽  
Core Outcome Set ◽  
Nominal Group Technique ◽  
Consensus Meeting ◽  
Nominal Group ◽  
Core Outcome ◽  
International Consensus ◽  
Core Outcome Sets ◽  
Hospitalised Patients ◽  
Wide Range

IntroductionDelirium is a common, serious and potentially preventable condition with devastating impact on the quality of life prompting a proliferation of interventional trials. Core outcome sets aim to standardise outcome reporting by identifying outcomes perceived fundamental for measurement in trials of a specific interest area. Our aim is to develop international consensus on two core outcome sets for trials of interventions to prevent and/or treat delirium, irrespective of study population. We aim to identify additional core outcomes specific to the critically ill, acutely hospitalised patients, palliative care and older adults.Methods and analysisWe will conduct a systematic review of published and ongoing delirium trials (1980 onwards) and one-on-one interviews of patients who have experienced delirium and family members. These data will inform Delphi round 1 of a two-stage consensus process. In round 2, we will provide participants their own response, summarised group responses and those of patient/family participants for rescoring. We will randomise participants to receive feedback as proportion scoring the outcome as critical or as group mean responses. We will hold a consensus meeting using nominal group technique to finalise outcomes for inclusion. We will repeat the Delphi process and consensus meeting to select measures for each core outcome. We will recruit 240 Delphi participants giving us 80% power to detect a 1.0–1.5 point (9-point scale) difference by feedback method between rounds. We will analyse differences for subsequent scores, magnitude of opinion change, items retained and level of agreement.Ethics and disseminationWe are obtaining research ethics approvals according to local governance. Participation will be voluntary and data deidentified. Support from three international delirium organisations will be instrumental in dissemination and core outcome set uptake. We will disseminate through peer-reviewed open access publications and present at conferences selected to reach a wide range of knowledge users.

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