scholarly journals Polymyalgia Rheumatica (PMR) Special Interest Group at OMERACT 11: Outcomes of Importance for Patients with PMR

2014 ◽  
Vol 41 (4) ◽  
pp. 819-823 ◽  
Author(s):  
Sarah L. Mackie ◽  
Seher Arat ◽  
Jose da Silva ◽  
Catia Duarte ◽  
Sue Halliday ◽  
...  
Keyword(s):  
Focus Group ◽  
Observational Study ◽  
Outcome Measures ◽  
Polymyalgia Rheumatica ◽  
Symptom Severity ◽  
Core Outcome Set ◽  
Effect Sizes ◽  
Core Outcome ◽  
Outcome Set ◽  
Standardized Effect Sizes

We worked toward developing a core outcome set for clinical research studies in polymyalgia rheumatica (PMR) by conducting (1) patient consultations using modified nominal group technique; (2) a systematic literature review of outcome measures in PMR; (3) a pilot observational study of patients presenting with untreated PMR, and further discussion with patient research partners; and (4) a qualitative focus group study of patients with PMR on the meaning of stiffness, using thematic analysis. (1) Consultations included 104 patients at 4 centers. Symptoms of PMR included pain, stiffness, fatigue, and sleep disturbance. Function, anxiety, and depression were also often mentioned. Participants expressed concerns about diagnostic delay, adverse effects of glucocorticoids, and fear of relapse. (2) In the systematic review, outcome measures previously used for PMR include pain visual analog scores (VAS), morning stiffness, blood markers, function, and quality of life; standardized effect sizes posttreatment were large. (3) Findings from the observational study indicated that asking about symptom severity at 7 AM, or “on waking,” appeared more relevant to disease activity than asking about symptom severity “now” (which depended on the time of assessment). (4) Preliminary results were presented from the focus group qualitative study, encompassing broad themes of stiffness, pain, and the effect of PMR on patients’ lives. It was concluded that further validation work is required before a core outcome set in PMR can be recommended. Nevertheless, the large standardized effect sizes suggest that pain VAS is likely to be satisfactory as a primary outcome measure for assessing response to initial therapy of PMR. Dissection of between-patient heterogeneity in the subsequent treatment course may require attention to comorbidity as a potential confounding factor.

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.

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 Development of a working core outcome set for cutaneous lupus erythematosus: a practical approach to an urgent unmet need

2021 ◽  
Vol 8 (1) ◽  
pp. e000529
Author(s):  
Lisa N Guo ◽  
Lourdes M Perez-Chada ◽  
Robert Borucki ◽  
Vinod E Nambudiri ◽  
Victoria P Werth ◽  
...  
Keyword(s):  
Disease Activity ◽  
Outcome Measures ◽  
Lupus Erythematosus ◽  
Global Assessment ◽  
Core Outcome Set ◽  
Cutaneous Lupus Erythematosus ◽  
Core Outcome ◽  
Outcome Set ◽  
Starting Point ◽  
Cutaneous Lupus

ObjectiveThe lack of standardised outcomes and outcome measures for cutaneous lupus erythematosus (CLE) represents a substantial barrier to clinical trial design, comparative analysis and approval of novel investigative treatments. We aimed to develop a working core outcome set (COS) for CLE randomised controlled trials and longitudinal observational studies.MethodsWe conducted a multistage literature review of CLE and SLE studies to generate candidate domains and outcome measures. Domains were narrowed to a working core domain set. Outcome measures for core domains were identified and examined.ResultsProposed core domains include skin-specific disease activity and damage, investigator global assessment (IGA) of disease activity, symptoms (encompassing itch, pain and photosensitivity), health-related quality of life (HRQoL) and patient global assessment (PtGA) of disease activity. Recommended physician-reported outcome measures include the Cutaneous Lupus Erythematous Disease Area and Severity Index (CLASI) and Cutaneous Lupus Activity IGA (CLA-IGA). For the domains of symptoms, HRQoL and PtGA of disease activity, we were unable to recommend one clearly superior instrument.ConclusionThis work represents a starting point for further refinement pending formal consensus activities and more rigorous evaluations of outcome measure quality. In the interim, the proposed working COS can serve as a much-needed guide for upcoming CLE clinical trials.

scholarly journals Outcomes reported on the management of COPD exacerbations: a systematic survey of randomised controlled trials

2019 ◽  
Vol 5 (2) ◽  
pp. 00072-2019 ◽  
Author(s):  
Alexander G. Mathioudakis ◽  
Mia Moberg ◽  
Julie Janner ◽  
Pablo Alonso-Coello ◽  
Jørgen Vestbo
Keyword(s):  
Outcome Measures ◽  
Systematic Reviews ◽  
Randomised Controlled Trials ◽  
Core Outcome Set ◽  
Controlled Trials ◽  
Significant Heterogeneity ◽  
Core Outcome ◽  
Copd Exacerbations ◽  
Outcome Set ◽  
Randomised Controlled

Randomised controlled trials (RCTs) evaluating the management of acute exacerbations of chronic obstructive pulmonary disease (COPD) report heterogeneous outcome measures, thus rendering their results incomparable, complicating their translation into clinical practice. As a first step in the development of a core outcome set that will aim to homogenise outcome measures in future RCTs, we assessed the outcomes reported in recent relevant RCTs and systematic reviews.We conducted a methodological systematic review (https://www.crd.york.ac.uk/prospero/ registration number CRD42016052437) of RCTs and systematic reviews on COPD exacerbation management indexed on Medline and PubMed during the last decade. We evaluated their methodology, specifically focusing on the reported outcome measures.Based on 123 RCTs and 38 systematic reviews, we found significant variability in the outcomes reported and in their definition. Mortality, which was assessed in 82% of the included trials, was the most frequently assessed outcome, followed by the rate of treatment success or failure (63%), adverse events (59%), health status, symptoms and quality of life (59%), lung function (47%), and duration of exacerbations (42%).The significant heterogeneity in the selection and definition of outcome measures in RCTs and systematic reviews limits the interpretability and comparability of their results, and warrants the development of a core outcome set for COPD exacerbations management.

scholarly journals Development of a core outcome set to use in the research and assessment of malignant bowel obstruction: protocol for the RAMBO study

BMJ Open ◽  
2020 ◽  
Vol 10 (6) ◽  
pp. e039154
Author(s):  
Elin Baddeley ◽  
Alison Bravington ◽  
Miriam Johnson ◽  
David C Currow ◽  
Fliss EM Murtagh ◽  
...  
Keyword(s):  
Outcome Measures ◽  
Bowel Obstruction ◽  
Core Outcome Set ◽  
Phase Iii ◽  
Rapid Review ◽  
Core Outcome ◽  
Malignant Bowel Obstruction ◽  
Open Access Journals ◽  
Outcome Set ◽  
Ethical Approval

IntroductionStudies regarding the management of malignant bowel obstruction (MBO) report conflicting findings. This is partly due to different outcome measures being used to evaluate severity of MBO and the response to treatments. Furthermore, current outcome measures focus mainly on measurable physiological parameters which may not correlate strongly with patient-defined quality of life. The development of core outcome sets allows a consistent approach to evaluating clinical conditions taking into consideration patient, healthcare professional and researcher viewpoints. It follows an internationally recognised standard methodology. We present a protocol for the development of a core outcome set for Research and Assessment of MBO (RAMBO).MethodsRAMBO is a multicentre study, comprising of four phases: a systematic review to examine current scope of outcome measures associated with MBO (phase I). Interviews with patients, companions and healthcare professionals will explore priorities and preferences for care and outcomes (phase II). An expert panel meeting will collate the findings into a set of outcomes (phase III), refined by consensus through a Delphi survey with key stakeholders (phase IV). The final set of outcomes will be ratified at a consensus meeting. Each step will actively include patient partners. Thematic analysis and descriptive statistics will be used to analyse qualitative and quantitative data, respectively.Ethics and disseminationEthical approval was obtained (Wales REC 5, REF: 19/LO/1876). Study participants and relevant stakeholders will be updated with newsletters and a lay summary at the end of the study. Abstracts will be submitted to national and international conferences, result papers will be submitted to peer-reviewed, open access journals.Trial and PROSPERO registration numbersCore Outcome Measures in Effectiveness Trials (1402); Systematic Literature Review (CRD42019150648); Rapid Review (CRD42020176393).

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 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.

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