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 Developing an OMERACT Core Outcome Set for Assessing Safety Components in Rheumatology Trials: The OMERACT Safety Working Group

2016 ◽  
Vol 44 (12) ◽  
pp. 1916-1919 ◽  
Author(s):  
Louise Klokker ◽  
Peter Tugwell ◽  
Daniel E. Furst ◽  
Dan Devoe ◽  
Paula Williamson ◽  
...  
Keyword(s):  
Working Group ◽  
Qualitative Data ◽  
Safety Issue ◽  
Core Outcome Set ◽  
Core Outcome ◽  
Core Outcome Sets ◽  
Randomized Controlled ◽  
Outcome Set ◽  
Rheumatic Conditions ◽  
Consistent Approach

Objective.Failure to report harmful outcomes in clinical research can introduce bias favoring a potentially harmful intervention. While core outcome sets (COS) are available for benefits in randomized controlled trials in many rheumatic conditions, less attention has been paid to safety in such COS. The Outcome Measures in Rheumatology (OMERACT) Filter 2.0 emphasizes the importance of measuring harms. The Safety Working Group was reestablished at the OMERACT 2016 with the objective to develop a COS for assessing safety components in trials across rheumatologic conditions.Methods.The safety issue has previously been discussed at OMERACT, but without a consistent approach to ensure harms were included in COS. Our methods include (1) identifying harmful outcomes in trials of interventions studied in patients with rheumatic diseases by a systematic literature review, (2) identifying components of safety that should be measured in such trials by use of a patient-driven approach including qualitative data collection and statistical organization of data, and (3) developing a COS through consensus processes including everyone involved.Results.Members of OMERACT including patients, clinicians, researchers, methodologists, and industry representatives reached consensus on the need to continue the efforts on developing a COS for safety in rheumatology trials. There was a general agreement about the need to identify safety-related outcomes that are meaningful to patients, framed in terms that patients consider relevant so that they will be able to make informed decisions.Conclusion.The OMERACT Safety Working Group will advance the work previously done within OMERACT using a new patient-driven approach.

scholarly journals Harmonizing heterogeneous endpoints in COVID-19 trials without loss of information –an essential step to facilitate decision making

2020 ◽  
Author(s):  
Maja von Cube ◽  
Marlon Grodd ◽  
Martin Wolkewitz ◽  
Derek Hazard ◽  
Jerome Lambert
Keyword(s):  
Decision Making ◽  
Treatment Effects ◽  
Core Outcome Set ◽  
Decision Makers ◽  
Global Network ◽  
Sufficient Information ◽  
Core Outcome ◽  
Multistate Model ◽  
Primary Analysis

AbstractBackgroundMany trials are now underway to inform decision-makers on potential effects of treatments for COVID-19. To provide sufficient information for all involved decision-makers (clinicians, public health authorities, drug regulatory agencies) a multiplicity of endpoints must be considered. It is a challenge to generate detailed high quality evidence from data while ensuring fast availability and evaluation of the results.MethodsWe reviewed all interventional COVID-19 trials on Remdesivir, Lopinavir/ritonavir and Hydroxychloroquine registered in the National Library of Medicine (NLM) at the National Institutes of Health (NIH) and summarized the endpoints used to assess treatment effects. We propose a multistate model that harmonizes heterogeneous endpoints and differing lengths of follow-up within and between trials.ResultsThere are currently, March 27, 2020, 23 registered interventional trials investigating the potential benefits of Remdesivir, Lopinavir/ritonavir and Hydroxychloroquine. The endpoints are highly heterogeneous. Follow-up for the primary endpoints ranges from four to 168 days.A detailed precisely defined endpoint has been proposed by the global network REMAP-CAP, which is specialized on community-acquired pneumonia. Their seven-category endpoint accounts for major clinical events informative for all decision-makers. Moreover, the Core Outcome Measures in Effectiveness Trials (COMET) Initiative is currently working on a core outcome set. We propose a multistate model that accommodates analysis of these recommended endpoints. The model allows for a detailed investigation of treatment effects for various endpoints over the course of time thereby harmonizing differing endpoints and lengths of follow-up.ConclusionMultistate model analysis is a powerful tool to study clinically heterogeneous endpoints (mortality, discharge) as well as endpoints influencing hospital capacities (duration of hospitalization and ventilation) simultaneously over time. Our proposed model extracts all information available in the data and is - by harmonizing endpoints within and between trials - a step towards faster decision making. All ongoing clinical trials, especially those with severe cases, should accommodate primary analysis with a stacked probability plot of the major events mechanical ventilation, discharge alive and death.

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.

Minimum data and core outcomes for subacute rehabilitation: A scoping review

2021 ◽  
pp. 026921552110604
Author(s):  
Joshua R Lowe ◽  
Sarah J Wallace ◽  
Sonia Sam ◽  
Adrienne Young
Keyword(s):  
Core Outcome Set ◽  
Grey Literature ◽  
Minimum Data Set ◽  
Data Sets ◽  
Core Outcome ◽  
Data Set ◽  
Core Outcome Sets ◽  
Minimum Data ◽  
Global Quality ◽  
Global Quality Of Life

Objective In clinical practice and research, standardised sets of data and outcomes are routinely collected to facilitate data comparison, benchmarking and quality improvement. Most existing data sets are condition-specific and cannot be applied to all patients in a given clinical setting. This review aimed to determine whether the development of a minimum data set for subacute rehabilitation is feasible by collating and comparing existing rehabilitation minimum data sets and core outcome sets. Data sources Published literature was identified through database searches (Scopus, PubMed, EMBASE, CINAHL and the COMET Initiative) in September 2021. Additional data sets were identified through a grey literature search. Review methods This review was conducted in alignment with the PRISMA-ScR recommendations. Datasets were included if they were published in English, designed for adults, and intended for use in subacute rehabilitation. Data were extracted and taxonomically organised to identify commonalities. Items present in ≥50% of data sets were considered common. Results Twenty minimum data sets and seven core outcome sets were included. There were 29 common minimum data set domains, with 19 relating to Patient Information, seven relating to Outcomes, two relating to Service Delivery and one relating to Provider Demographics. Four common domains were identified within the Core Outcome Set analysis, which all related to Life Impact, specifically Physical Functioning (86%) , Emotional Functioning/Wellbeing (57%) , Social Functioning (86%) and Global Quality of Life (100%). Conclusion Common item domains in conditions requiring subacute rehabilitation have been identified, suggesting that development of a dataset for subacute rehabilitation may be feasible.

scholarly journals Core Outcome Sets in Clinical Research: What are They and How Can they Help Decision Makers?

2018 ◽  
Vol 21 ◽  
pp. S53
Author(s):  
RM Moloney ◽  
DA Messner ◽  
J Al Naber ◽  
SR Tunis
Keyword(s):  
Clinical Research ◽  
Decision Makers ◽  
Core Outcome ◽  
Core Outcome Sets

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 Barriers to uptake of the hip fracture core outcome set: An international survey of 80 hip fracture trialists

2020 ◽  
Vol 17 (6) ◽  
pp. 712-716
Author(s):  
Jessica Fletcher ◽  
Katie Jane Sheehan ◽  
Toby O Smith
Keyword(s):  
Hip Fracture ◽  
Outcome Measures ◽  
Research Training ◽  
Core Outcome Set ◽  
Core Outcome ◽  
Core Outcome Sets ◽  
Mean Values ◽  
Surgical Interventions ◽  
Outcome Set ◽  
Randomised Controlled

Background: Core outcome sets are an agreed recommendation to inform the selection of outcome measures in clinical trials. There has been low uptake of the 2014 hip fracture core outcome set. The reasons for this remain unclear. The aim of this study was to understand the reasons for the non-adoption and approaches to increase adoption of the hip fracture core outcome set. Methods: Randomised controlled trials from PubMed (2017–2019) and ClinicalTrials.gov (2015–2019) were identified. Corresponding authors for each identified trial (n = 302) were surveyed using five questions on awareness of the hip fracture core outcome set, reasons for non-adoption and approaches to increase adoption. Data were analysed descriptively using frequencies, mean values and standard deviations. Results: Fifty-four percent of the respondents (n = 43) were aware of the concept of core outcome set. Only 15% (n = 12) based the outcome measure selection on the 2014 hip fracture core outcome set. Key reasons for non-adoption included the following: authors being unaware and perceived inappropriateness to their trial design. Eighty-six percent (n = 69) of respondents agreed to the need for increased awareness of core outcome sets through research training, academic and clinical journal requirements, and funding or publication stipulations. Eighty-eight percent (n = 70) of respondents indicated the current core outcome set required revision to focus on trials investigating people with cognitive impairment, caregivers, rehabilitation, surgical interventions and anaesthetic trial designs. Conclusion: Barriers to the adoption of the hip fracture core outcome set centre on education, awareness of the core outcome sets and applicability to the breath of hip fracture trial designs. Further consideration should be made to address these, to improve the harmonisation of outcome measures across hip fracture trials.

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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