scholarly journals Core Outcome Measures in Effectiveness Trials (COMET) initiative: protocol for an international Delphi study to achieve consensus on how to select outcome measurement instruments for outcomes included in a ‘core outcome set’

Trials ◽  
2014 ◽  
Vol 15 (1) ◽  
Author(s):  
Cecilia A C Prinsen ◽  
Sunita Vohra ◽  
Michael R Rose ◽  
Susanne King-Jones ◽  
Sana Ishaque ◽  
...  
Keyword(s):  
Outcome Measures ◽  
Delphi Study ◽  
Outcome Measurement ◽  
Core Outcome Set ◽  
Core Outcome ◽  
Measurement Instruments ◽  
Outcome Set ◽  
Core Outcome Measures ◽  
Effectiveness Trials

scholarly journals Study protocol to develop a core outcome set for thyroid dysfunction to bridge the unmet needs of patient-centred care

BMJ Open ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. e050231
Author(s):  
Cheow Peng Ooi ◽  
Abdul Hanif Khan Yusof Khan ◽  
Rosliza Abdul Manaf ◽  
Norlaila Mustafa ◽  
Norlela Sukor ◽  
...  
Keyword(s):  
Outcome Measures ◽  
Clinical Care ◽  
Core Outcome Set ◽  
Ethics Committee ◽  
Quality Data ◽  
Evidence Based ◽  
Core Outcome ◽  
Outcome Set ◽  
Core Outcome Measures ◽  
Effectiveness Trials

AbstractIntroductionThyroid dysfunctions (TD) are common medical conditions affecting all global populations. Improved healthcare leading to increasing survival rates and delayed diagnosis rendered significant burden of the disease in the increasing number of patients with TD with comorbid illnesses. Therefore, reducing the burden of TD and improving the quality of care are crucial. Existing poor-quality data that guide evidence-based decisions only provide a fragmented picture of clinical care. The different outcomes across studies assessing the effectiveness of treatments impede our ability to synthesise results for determining the most efficient treatments. This project aims to produce a core outcome set (COS), which embeds the multiple complex dimensions of routine clinical care for the effectiveness studies and clinical care of adult patients with TD.Methods and analysisThis mixed-method project has two phases. In phase 1, we will identify a list of patient-reported and clinical outcomes through qualitative research and systematic reviews. In phase 2, we will categorise the identified outcomes using the Core Outcome Measures in Effectiveness Trials taxonomy of core domains and the International Classification of Functioning, Disability and Health. We will develop questionnaires from the list of outcomes identified from each domain for the two-round online Delphi exercise, aiming to reach a consensus on the COS. The Delphi process will include patients, carers, researchers and healthcare participants. We will hold an online consensus meeting involving representatives of all key stakeholders to establish the final COS.Ethics and disseminationThe study has been reviewed and approved by the Ethics Committee for Research Involving Human Subjects, Universiti Putra Malaysia and the Research Ethics Committee, National University of Malaysia. This proposed COS in TD will improve the value of data, facilitate high-quality evidence synthesis and evidence-based decision-making. Furthermore, we will present the results to participants, in peer-reviewed academic journals and conferences.Registration detailsCore Outcome Measures in Effectiveness Trials (COMET) Initiative database registration: http://www.comet-initiative.org/studies/details/1371

scholarly journals Protocol for the development of a core outcome set for lateral elbow tendinopathy (COS-LET)

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Marcus Bateman ◽  
Jonathan P. Evans ◽  
Viana Vuvan ◽  
Val Jones ◽  
Adam C. Watts ◽  
...  
Keyword(s):  
Outcome Measures ◽  
Health Care Professionals ◽  
Delphi Study ◽  
Evidence Synthesis ◽  
Core Outcome Set ◽  
Outcome Evaluation ◽  
Core Outcome ◽  
Outcome Set ◽  
Lateral Elbow ◽  
Lateral Elbow Tendinopathy

Abstract Background Lateral elbow tendinopathy (LET) is a common condition that can cause significant disability and associated socioeconomic cost. Although it has been widely researched, outcome measures are highly variable which restricts evidence synthesis across studies. In 2019, a working group of international experts, health care professionals and patients, in the field of tendinopathy (International Scientific Tendinopathy Symposium Consensus (ICON) Group), published the results of a consensus exercise defining the nine core domains that should be measured in tendinopathy research. The aim of this study is to develop a core outcome set (COS) for LET mapping to these core domains. The primary output will provide a template for future outcome evaluation of LET. In this protocol, we detail the methodological approach to the COS-LET development. Methods This study will employ a three-phase approach. (1) A systematic review of studies investigating LET will produce a comprehensive list of all instruments currently employed to quantify the treatment effect or outcome. (2) Instruments will be matched to the list of nine core tendinopathy outcome domains by a Steering Committee of clinicians and researchers with a specialist interest in LET resulting in a set of candidate instruments. (3) An international three-stage Delphi study will be conducted involving experienced clinicians, researchers and patients. Within this Delphi study, candidate instruments will be selected based upon screening using the Outcome Measures in Rheumatology (OMERACT) truth, feasibility and discrimination filters with a threshold of 70% agreement set for consensus. Conclusions There is currently no COS for the measurement or monitoring of LET in trials or clinical practice. The output from this project will be a minimum COS recommended for use in all future English language studies related to LET. The findings will be published in a high-quality journal and disseminated widely using professional networks, social media and via presentation at international conferences. Trial registration Registered with the Core Outcome Measures in Effectiveness Trials (COMET) database, November 2019. https://www.comet-initiative.org/Studies/Details/1497.

scholarly journals A Core Outcome Set for Nonpharmacological Community-Based Interventions for People Living With Dementia at Home: A Systematic Review of Outcome Measurement Instruments

2020 ◽  
Author(s):  
Andrew J E Harding ◽  
Hazel Morbey ◽  
Faraz Ahmed ◽  
Carol Opdebeeck ◽  
Ruth Elvish ◽  
...  
Keyword(s):  
Outcome Measurement ◽  
Core Outcome Set ◽  
Face Validity ◽  
Core Outcome ◽  
Measurement Instruments ◽  
Community Based Interventions ◽  
Community Based ◽  
Key Stakeholders ◽  
Outcome Set ◽  
Dementia Research

Abstract Background and Objectives It is questionable whether existing outcome measurement instruments (OMIs) in dementia research reflect what key stakeholders’ value. We attained consensus from more than 300 key stakeholders, including people living with dementia, and identified 13 core outcome items for use in nonpharmacological and community-based interventions for people with dementia living at home. In this systematic review, we review OMIs that have previously been used in dementia care research to determine how, or even if, the 13 core outcome items can be measured. Research Design and Methods We extracted self-reported OMIs from trials, reviews, and reports of instrument development. Searches were undertaken in the ALOIS database, MEDLINE, PsycINFO, CINAHL, SocINDEX, and COSMIN databases. We aimed to assess the psychometric properties of OMI items for face validity with the core outcome items, content validity, internal consistency, and responsiveness. We held a coresearch workshop involving people living with dementia and care partners in order to ratify the findings. Results In total 347 OMIs were located from 354 sources. Of these, 76 OMIs met the inclusion criteria. No OMIs were deemed to have sufficient face validity for the core outcome set (COS) items, and no OMIs proceeded to further assessment. The “best” available OMI is the Engagement and Independence in Dementia Questionnaire. Discussion and Implications This study provides a practical resource for those designing dementia research trials. Being able to measure the COS items would herald a paradigm shift for dementia research, be responsive to what key stakeholders value and enhance the ability to make comparisons.

scholarly journals OMERACT Filter 2.1: Elaboration of the Conceptual Framework for Outcome Measurement in Health Intervention Studies

2019 ◽  
Vol 46 (8) ◽  
pp. 1021-1027 ◽  
Author(s):  
Maarten Boers ◽  
Dorcas E. Beaton ◽  
Beverley J. Shea ◽  
Lara J. Maxwell ◽  
Susan J. Bartlett ◽  
...  
Keyword(s):  
Conceptual Framework ◽  
Outcome Measures ◽  
Intervention Studies ◽  
Outcome Measurement ◽  
Core Outcome Set ◽  
Health Intervention ◽  
Health Conditions ◽  
Core Outcome ◽  
Outcome Set ◽  
Core Set

Objective.The Outcome Measures in Rheumatology (OMERACT) Filter 2.0 framework was developed in 2014 to aid core outcome set development by describing the full universe of “measurable aspects of health conditions” from which core domains can be selected. This paper provides elaborations and updated concepts (OMERACT Filter 2.1).Methods.At OMERACT 2018, we discussed challenges in the framework application caused by unclear or ambiguous wording and terms and incompletely developed concepts.Results.The updated OMERACT Filter 2.1 framework makes benefits and harms explicit, clarifies concepts, and improves naming of various terms.Conclusion.We expect that the Filter 2.1 framework will improve the process of core set development.

scholarly journals How to select outcome measurement instruments for outcomes included in a “Core Outcome Set” – a practical guideline

Trials ◽  
2016 ◽  
Vol 17 (1) ◽  
Author(s):  
Cecilia A. C. Prinsen ◽  
Sunita Vohra ◽  
Michael R. Rose ◽  
Maarten Boers ◽  
Peter Tugwell ◽  
...  
Keyword(s):  
Outcome Measurement ◽  
Core Outcome Set ◽  
Core Outcome ◽  
Measurement Instruments ◽  
Practical Guideline ◽  
Outcome Set

scholarly journals Developing a core outcome set for paediatric wrist fractures: a systematic review of prior outcomes

2020 ◽  
Vol 1 (5) ◽  
pp. 121-130
Author(s):  
Benjamin Thomas Crosby ◽  
Abolfazl Behbahani ◽  
Olivia Olujohungbe ◽  
Ben Cottam ◽  
Daniel Perry
Keyword(s):  
Outcome Measures ◽  
Core Outcome Set ◽  
Clinical Effectiveness ◽  
Wrist Fracture ◽  
Cochrane Library ◽  
Core Outcome ◽  
Measurement Instruments ◽  
Range Of Movement ◽  
Wrist Fractures ◽  
Outcome Set

Objectives This review aims to summarize the outcomes used to describe effectiveness of treatments for paediatric wrist fractures within existing literature. Method We searched the Cochrane Library, Scopus, and Ovid Medline for studies pertaining to paediatric wrist fractures. Three authors independently identified and reviewed eligible studies. This resulted in a list of outcome domains and outcomes measures used within clinical research. Outcomes were mapped onto domains defined by the COMET collaborative. Results Our search terms identified 4,262 different papers. Screening of titles excluded 2,975, leaving 1,287 papers to be assessed for eligibility. Of this 1,287, 30 studies were included for full analysis. Overall, five outcome domains, 16 outcome measures, and 28 measurement instruments were identified as outcomes within these studies. 24 studies used at least one measurement pertaining to the physiological/clinical outcome domain. The technical, life impact, and adverse effect domains were recorded in 23, 20, and 11 of the studies respectively. Within each domain it was common for different measurement instruments to be used to assess each outcome measure. The most commonly reported outcome measures were range of movement, a broad array of “radiological measures” and pain intensity, which were used in 24, 23, and 12 of the 30 studies. Conclusion This study highlights the heterogeneity in outcomes reported within clinical effectiveness studies of paediatric wrist fractures. We provided an overview of the types of outcomes reported in paediatric wrist fracture studies and identified a list of potentially relevant outcomes required for the development of a core outcome set.

scholarly journals Establishing a core outcome set for mucopolysaccharidoses (MPS) in children: study protocol for a rapid literature review, candidate outcomes survey, and Delphi surveys

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Alison H. Howie ◽  
Kylie Tingley ◽  
Michal Inbar-Feigenberg ◽  
John J. Mitchell ◽  
Nancy J. Butcher ◽  
...  
Keyword(s):  
Literature Review ◽  
Health Care Providers ◽  
Metabolic Diseases ◽  
Outcome Measurement ◽  
Core Outcome Set ◽  
Core Outcome ◽  
Care Providers ◽  
Measurement Instruments ◽  
Two Phase ◽  
Outcome Set

Abstract Background Mucopolysaccharidoses (MPS) are a group of inherited metabolic diseases characterized by chronic, progressive multi-system manifestations with varying degrees of severity. Disease-modifying therapies exist to treat some types of MPS; however, they are not curative, underscoring the need to identify and evaluate co-interventions that optimize functioning, participation in preferred activities, and quality of life. A Canadian pediatric MPS registry is under development and may serve as a platform to launch randomized controlled trials to evaluate such interventions. To promote the standardized collection of patient/family-reported and clinical outcomes considered important to patients/families, health care providers (HCPs), and policymakers, the choice of outcomes to include in the registry will be informed by a core outcome set (COS). We aim to establish a patient-oriented COS for pediatric MPS using a multi-stakeholder approach. Methods In step 1 of the six-step process to develop the COS, we will identify relevant outcomes through a rapid literature review and candidate outcomes survey. A two-phase screening approach will be implemented to identify eligible publications, followed by extraction of outcomes and other pre-specified data elements. Simultaneously, we will conduct a candidate outcomes survey with children with MPS and their families to identify outcomes most important to them. In step 2, HCPs experienced in treating patients with MPS will be invited to review the list of outcomes generated in step 1 and identify additional clinically relevant outcomes. We will then ask patients/families, HCPs, and policymakers to rate the outcomes in a set of Delphi Surveys (step 3), and to participate in a subsequent consensus meeting to finalize the COS (step 4). Step 5 involves establishing a set of outcome measurement instruments for the COS. Finally, we will disseminate the COS to knowledge users (step 6). Discussion The proposed COS will inform the choice of outcomes to include in the MPS registry and, more broadly, promote the standardized collection of patient-oriented outcomes for pediatric MPS research. By involving patients/families from the earliest stage of the research, we will ensure that the COS will be relevant to those who will ultimately benefit from the research. Trial registration PROSPERO CRD42021267531, COMET

scholarly journals Outcomes Measured in Polymyalgia Rheumatica and Measurement Properties of Instruments Considered for the OMERACT Core Outcome Set: A Systematic Review

2020 ◽  
pp. jrheum.200248 ◽  
Author(s):  
Helen Twohig ◽  
Claire Owen ◽  
Sara Muller ◽  
Christian D. Mallen ◽  
Caroline Mitchell ◽  
...  
Keyword(s):  
Physical Function ◽  
Outcome Measures ◽  
Polymyalgia Rheumatica ◽  
Outcome Measurement ◽  
Core Outcome Set ◽  
Full Range ◽  
Measurement Properties ◽  
Core Outcome ◽  
Health Measurement ◽  
Outcome Set

Objective To systematically identify the outcome measures and instruments used in clinical studies of polymyalgia rheumatica (PMR) and to evaluate evidence about their measurement properties. Methods Searches based on the MeSH term “polymyalgia rheumatica” were carried out in 5 databases. Two researchers were involved in screening, data extraction, and risk of bias assessment. Once outcomes and instruments used were identified and categorized, key instruments were selected for further review through a consensus process. Studies on measurement properties of these instruments were appraised against the COSMIN-OMERACT (COnsensus-based Standards for the selection of health Measurement Instruments–Outcome Measures in Rheumatology) checklist to determine the extent of evidence supporting their use in PMR. Results Forty-six studies were included. In decreasing order of frequency, the most common outcomes (and instruments) used were markers of systemic inflammation [erythrocyte sedimentation rate (ESR), C-reactive protein (CRP)], pain [visual analog scale (VAS)], stiffness (duration in minutes), and physical function (elevation of upper limbs). Instruments selected for further evaluation were ESR, CRP, pain VAS, morning stiffness duration, and the Health Assessment Questionnaire. Five studies evaluated measurement properties of these instruments, but none met all of the COSMIN-OMERACT checklist criteria. Conclusion Measurement of outcomes in studies of PMR lacks consistency. The critical patient-centered domain of physical function is poorly assessed. None of the candidate instruments considered for inclusion in the core outcome set had high-quality evidence, derived from populations with PMR, on their full range of measurement properties. Further studies are needed to determine whether these instruments are suitable for inclusion in a core outcome measurement set for PMR.

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