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6 results for “Core outcome set”
Core outcome set for burn care research: Delphi survey data
<p><strong>Background:</strong> Collated evidence from systematic reviews supports clinicians in identifying optimal treatment for patients. Evidence is created from outcomes that, in burn care, include survival, function, cosmesis, pain, and psychological well-being. Currently, this is limited because of variation in outcomes reported across trials. Improved selection and reporting of outcomes in primary research in burn care could improve treatment globally by improving data synthesis and the quality of evidence. The availability of a Core Outcome Set (COS), a minimum set of the most important outcomes to be reported in all trials of a medical condition, would resolve this issue. The aim of this study is to develop a COS for international burn care research.</p> <p><strong>Methods and findings</strong>: Candidate outcomes were identified from systematic reviews and stakeholder interviews. Through two rounds of a Delphi survey, international multi-disciplinary clinicians, researchers, and UK patients and carers prioritised the outcomes. Anonymised feedback aimed to achieve consensus. Pre-defined criteria for retaining and dropping outcomes were agreed upon. A consensus meeting with voting was held to finalise the COS.</p> <p>Examination of all data sources identified 1,021 unique outcomes grouped into 88 candidate outcomes. Stakeholders included 668 health professionals from 77 countries and 126 UK patients/carers; 25% of clinical participants were from low- or low-middle-income countries. After Round 1, one outcome was discarded, and 13 new outcomes were added. After Round 2, 69 items were discarded, leaving 31 outcomes for the consensus meeting.<em> </em>Discussion and voting agreed on seven core outcomes: death, specified complications, ability to do daily tasks, time to wound healing, neuropathic pain and itch, psychological well-being, and time to return to school/work.</p> <p><strong>Conclusions</strong>: This is the first COS for international burn care research. Implementation is now needed to improve data synthesis, and support evidence-based clinical decision-making in global burn care. It is recommended that future trials include measures of these seven outcomes.</p>
Core outcome set for burn care research: Delphi survey data
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Core Outcome Set for Head, Neck and Respiratory Disease in Mucopolysaccharidosis II
ClinicalTrials.gov study NCT06022380. IPD Sharing: Not stated. Countries: 1. Publications: 0.
Core Outcome Set for Pharmacist-led Interventions in CKD
ClinicalTrials.gov study NCT05987280. IPD Sharing: Not stated. Countries: 1. Publications: 0.
Defining Core Outcome Sets in Trigeminal Neuralgia
ClinicalTrials.gov study NCT04272385. IPD Sharing: NO. Countries: 1. Publications: 0.
The Italian midwifery core outcome set (M-COS) for healthy childbearing women and newborns: Development and initial validation study
<p>Maga G, Brigante L, Del Bo E, Cappadona R, Daniele MAS, Arrigoni C, Caruso R, Magon A. The Italian midwifery core outcome set (M-COS) for healthy childbearing women and newborns: Development and initial validation study. Midwifery. 2022 May;108:103292. doi: 10.1016/j.midw.2022.103292. Epub 2022 Feb 23. PMID: 35235891.</p> <p><strong>Abstract</strong></p> <p><strong>Objective: </strong>This study aimed to develop and validate a midwifery core outcome set (M-COS) for Italian settings based on a salutogenic framework of maternity care.</p> <p><strong>Design: </strong>A multi-phase and multi-method study was performed. In phase one, we conducted a literature review to identify a preliminary set of outcomes sensitive to midwifery care. In phase two, the qualitative and quantitative content validity of the M-COS was tested. Finally, in the third phase, construct validity was explored through a cross-sectional study to assess the psychometric properties of the M-COS through exploratory and confirmative factor analysis. This study was conducted from December 2019 to April 2020 in Italy.</p> <p><strong>Participants: </strong>Three main groups of experts/midwives were involved. Group One (n = 10) was involved in the content validity phase, while the other two groups (Group Two and Group Three) were involved in the construct validity phase (n = 300).</p> <p><strong>Results: </strong>The M-COS includes six outcome domains and thirty-one core outcomes perceived as sensitive to midwifery care, namely: mortality and morbidity (n = 6 outcomes), childbirth (n = 3), postnatal period (n = 6), maternal health (n = 11), maternal-infant bonding (n = 3), and maternal self-care (n = 2). All domains showed good evidence of internal consistency.</p> <p><strong>Conclusion: </strong>The Italian M-COS is a novel tool that will facilitate the consistent measurement of core outcomes sensitive to midwifery care from the antenatal to the postnatal period in Italian settings. This initial work will be followed by further studies, including validation by service users.</p> <p><strong>Implications for practice: </strong>The use of the M-COS in clinical practice would facilitate evidence-based data collection and thus contribute to promoting high-quality maternity care.</p>
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International Brain Laboratory public data
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OpenNeuro
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