scholarly journals Finalizing the international core domain set for peripheral vascular malformations: the OVAMA project

2019 ◽  
Vol 181 (5) ◽  
pp. 1076-1078 ◽  
Author(s):  
M.M. Lokhorst ◽  
S.E.R. Horbach ◽  
C.M.A.M. Horst ◽  
P.I. Spuls ◽  
Keyword(s):  
Vascular Malformations ◽  
Peripheral Vascular ◽  
Core Domain ◽  
Core Domain Set

Achieving Consensus on Total Joint Replacement Trial Outcome Reporting Using the OMERACT Filter: Endorsement of the Final Core Domain Set for Total Hip and Total Knee Replacement Trials for Endstage Arthritis

2017 ◽  
Vol 44 (11) ◽  
pp. 1723-1726 ◽  
Author(s):  
Jasvinder A. Singh ◽  
Michelle M. Dowsey ◽  
Michael Dohm ◽  
Susan M. Goodman ◽  
Amye L. Leong ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Total Knee Replacement ◽  
Knee Replacement ◽  
Joint Replacement ◽  
Working Group ◽  
Total Joint Replacement ◽  
Core Domain ◽  
Total Knee ◽  
Core Domain Set

Objective.Discussion and endorsement of the OMERACT total joint replacement (TJR) core domain set for total hip replacement (THR) and total knee replacement (TKR) for endstage arthritis; and next steps for selection of instruments.Methods.The OMERACT TJR working group met at the 2016 meeting at Whistler, British Columbia, Canada. We summarized the previous systematic reviews, the preliminary OMERACT TJR core domain set and results from previous surveys. We discussed preliminary core domains for TJR clinical trials, made modifications, and identified challenges with domain measurement.Results.Working group participants (n = 26) reviewed, clarified, and endorsed each of the inner and middle circle domains and added a range of motion domain to the research agenda. TJR were limited to THR and TKR but included all endstage hip and knee arthritis refractory to medical treatment. Participants overwhelmingly endorsed identification and evaluation of top instruments mapping to the core domains (100%) and use of subscales of validated multidimensional instruments to measure core domains for the TJR clinical trial core measurement set (92%).Conclusion.An OMERACT core domain set for hip/knee TJR trials has been defined and we are selecting instruments to develop the TJR clinical trial core measurement set to serve as a common foundation for harmonizing measures in TJR clinical trials.

scholarly journals Co-producing a multi-stakeholder Core Outcome Set for distal Tibia and Ankle fractures (COSTA): a study protocol

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Nathan A. Pearson ◽  
Elizabeth Tutton ◽  
Alexander Joeris ◽  
Stephen Gwilym ◽  
Richard Grant ◽  
...  
Keyword(s):  
Core Outcome Set ◽  
Distal Tibia ◽  
Ankle Fractures ◽  
Core Outcome ◽  
Core Domain ◽  
Outcome Reporting ◽  
The Core ◽  
Outcome Set ◽  
Multi Stakeholder ◽  
Core Domain Set

Abstract Background Ankle fracture is a common injury with a strong evidence base focused on effectiveness of treatments. However, there are no reporting guidelines on distal tibia and ankle fractures. This has led to heterogeneity in outcome reporting and consequently, restricted the contribution of evidence syntheses. Over the past decade, core outcome sets have been developed to address this issue and are available for several common fractures, including those of the hip, distal radius, and open tibial fractures. This protocol describes the process to co-produce—with patient partners and other key stakeholders—a multi-stakeholder derived Core Outcome Set for distal Tibia and Ankle fractures (COSTA). The scope of COSTA will be for clinical trials. Methods The study will have five-stages which will include the following: (i) systematic reviews of existing qualitative studies and outcome reporting in randomised controlled trial studies to inform a developing list of potential outcome domains; (ii) qualitative interviews (including secondary data) and focus groups with patients and healthcare professionals to explore the impact of ankle fracture and the outcomes that really matter; (iii) generation of meaningful outcome statements with the study team, international advisory group and patient partners; (iv) a multi-round, international e-Delphi study to achieve consensus on the core domain set; and (v) an evidence-based consensus on a core measurement set will be achieved through a structured group consensus meeting, recommending best assessment approaches for each of the domains in the core domain set. Discussion Development of COSTA will provide internationally endorsed outcome assessment guidance for clinical trials for distal tibia and ankle fractures. This will enhance comparative reviews of interventions, potentially reducing reporting bias and research waste.

scholarly journals Detecting changes in quality‐of‐life over time in patients with peripheral vascular malformations: the OVAMA project

2020 ◽  
Vol 182 (6) ◽  
Author(s):  
M.M. Lokhorst ◽  
S.E.R. Horbach ◽  
M. Waner ◽  
T.M. O ◽  
C.J.M. Vleuten ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Vascular Malformations ◽  
Peripheral Vascular ◽  
Over Time

scholarly journals 3T MRI of Peripheral Vascular Malformations: Characteristics and Comparison of Two Fat-Saturated sequences: Short Tau Inversion Recovery Versus Three-Dimensional High-Resolution Volume Interpolated Gradient Recalled Echo

2020 ◽  
Author(s):  
Florentine Höhn ◽  
Simone Hammer ◽  
Claudia Fellner ◽  
Florian Zeman ◽  
Wibke Uller ◽  
...  
Keyword(s):  
Magnetic Resonance ◽  
High Resolution ◽  
Vascular Malformations ◽  
Three Dimensional ◽  
High Flow ◽  
Low Flow ◽  
Peripheral Vascular ◽  
Contrast Enhanced ◽  
Hemodynamic Characteristics ◽  
Short Tau Inversion Recovery

Purpose To assess morphological and hemodynamic characteristics of peripheral vascular malformations on 3 T magnetic resonance imaging (MRI) including qualitative comparison of two fat-saturated sequences: short tau inversion recovery (STIR) and three-dimensional high-resolution volume interpolated gradient recalled echo (GRE). Materials and Methods During 9 months, 100 patients with suspected or known vascular malformations were prospectively assessed on a 3 T scanner using T2-weighted STIR and turbo spin echo (TSE), T1-weighted TSE, time-resolved contrast-enhanced magnetic resonance angiography (MRA) with interleaved stochastic trajectories (TWIST) and T1-weighted volume interpolated breath-hold examination (VIBE) after contrast enhancement. The analysis included signal behavior and morphologic and hemodynamic characteristics. Additionally, the image quality of the fat-saturated sequences was evaluated by 2 radiologists. Results 86 patients (14 dropouts; 57 female, 29 male; mean age 26.8 years, age range 1–56) were analyzed. 22 had high-flow and 64 low-flow malformations, including 14 with a lymphatic component. In 21 of 22 patients with high-flow malformations, typical characteristics (flow voids, hyperdynamic arteriovenous fistula, dilated main/feeder-arteries and draining veins) were documented. Patients with low-flow malformations had phleboliths in 35 cases, fluid-fluid levels in 47 and dilated draining veins in 23. Lymphatic malformations showed peripheral contrast enhancement of cyst walls in the volume interpolated GRE. The comparison of fat-saturated sequences showed significantly better results of the volume interpolated GRE in all categories except the presence of artifacts which were significantly reduced in the STIR (p < 0.05). Conclusion 3 T MRI with MRA provides detailed morphological and hemodynamic information of different types of peripheral vascular malformations. Contrast-enhanced high-resolution volume interpolated GRE proved superior to STIR in differentiating morphologic features and to be diagnostic in the differentiation of lymphatic parts and joint involvement. Key Points:  Citation Format

scholarly journals Identifying flares in rheumatoid arthritis: reliability and construct validation of the OMERACT RA Flare Core Domain Set

RMD Open ◽  
2016 ◽  
Vol 2 (1) ◽  
pp. e000225 ◽  
Author(s):  
Vivian P Bykerk ◽  
Clifton O Bingham ◽  
Ernest H Choy ◽  
Daming Lin ◽  
Rieke Alten ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Construct Validation ◽  
Core Domain ◽  
Core Domain Set

scholarly journals Feasibility and Domain Validation of Rheumatoid Arthritis (RA) Flare Core Domain Set: Report of the OMERACT 2014 RA Flare Group Plenary

2015 ◽  
Vol 42 (11) ◽  
pp. 2185-2189 ◽  
Author(s):  
Susan J. Bartlett ◽  
Vivian P. Bykerk ◽  
Roxanne Cooksey ◽  
Ernest H. Choy ◽  
Rieke Alten ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Clinical Care ◽  
Joint Disease ◽  
Self Management ◽  
International Studies ◽  
Core Domain ◽  
Ongoing Work ◽  
Activity Measures ◽  
Core Domain Set

Objective.The Outcome Measures in Rheumatology (OMERACT) Rheumatoid Arthritis (RA) Flare Group was established to develop an approach to identify and measure RA flares. An overview of our OMERACT 2014 plenary is provided.Methods.Feasibility and validity of flare domains endorsed at OMERACT 11 (2012) were described based on initial data from 3 international studies collected using a common set of questions specific to RA flare. Mean flare frequency, severity, and duration data were presented, and domain scores were compared by flare status to examine known-groups validity. Breakout groups provided input for stiffness, self-management, contextual factors, and measurement considerations.Results.Flare data from 501 patients in an observational study indicated 39% were in flare, with mean (SD) severity of 6.0 (2.6) and 55% lasting > 14 days. Pain, physical function, fatigue, participation, and stiffness scores averaged ≥ 2 times higher (2 of 11 points) in flaring individuals. Correlations between flare domains and corresponding legacy instruments were obtained: r = 0.46 to 0.93. A combined definition (patient report of flare and 28-joint Disease Activity Score increase) was evaluated in 2 other trials, with similar results. Breakout groups debated specific measurement issues.Conclusion.These data contribute initial evidence of feasibility and content validation of the OMERACT RA Flare Core Domain Set. Our research agenda for OMERACT 2016 includes establishing duration/intensity criteria and developing criteria to identify RA flares using existing disease activity measures. Ongoing work will also address discordance between patient and physician ratings, facilitate application of flare criteria to clinical care, elucidate the role of self-management, and finalize recommendations for RA flare measurement.

scholarly journals Toward a Core Domain Set for Glucocorticoid Impact in Inflammatory Rheumatic Diseases: The OMERACT 2018 Glucocorticoid Impact Working Group

2019 ◽  
Vol 46 (9) ◽  
pp. 1179-1182 ◽  
Author(s):  
Jonathan T.L. Cheah ◽  
Rachel J. Black ◽  
Joanna C. Robson ◽  
Iris Y. Navarro-Millán ◽  
Sarah R. Young ◽  
...  
Keyword(s):  
Research Agenda ◽  
Patient Survey ◽  
Patient Reported Outcome ◽  
Inflammatory Rheumatic Diseases ◽  
Core Domain ◽  
Patient Reported ◽  
Literature Reviews ◽  
Rich Data ◽  
Validated Instrument ◽  
Core Domain Set

Objective.To understand the effects of glucocorticoids (GC), which are of importance to patients.Methods.The results of 2 literature reviews, a patient survey, and a qualitative study were presented.Results.No validated instrument exists to evaluate GC effect on patients. Survey data revealed skin thinning/bruising, sleep disturbance, and weight gain as the most frequent adverse effects. The qualitative research yielded rich data covering rapid benefits and physical and emotional consequences of GC.Conclusion.It was agreed that a patient-reported outcome to measure GC effect was required and a research agenda was developed for this goal.

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