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从患者角度出发,改善治疗的获益-风险评估:OMERACT 会前会议达成关于随机对照试验核心数据集的共识。

Improving Benefit-harm Assessment of Therapies from the Patient Perspective: OMERACT Premeeting Toward Consensus on Core Sets for Randomized Controlled Trials.

机构信息

From the Department of Family Medicine, and Department of Medicine, McGill University, Montreal, Quebec; Institute for Work & Health, Toronto; OMERACT; Ottawa Hospital Research Institute, Ottawa Hospital; Division of Rheumatology, Department of Medicine, and School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa; Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa Cardiovascular Research Methods Centre, University of Ottawa Heart Institute, Ottawa, Ontario, Canada; Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen; Department of Rheumatology, Odense University Hospital, Odense, Denmark; Division of Rheumatology, Hospital for Special Surgery; Department of Medicine, Weill Cornell Medical School, New York, New York; Division of Rheumatology, Department of Medicine, Johns Hopkins University, Baltimore, Maryland; Division of Biostatistics, Department of Health Sciences Research, Mayo Clinic, Scottsdale, Arizona; Medicine Service, VA Medical Center; Department of Medicine, School of Medicine, University of Alabama at Birmingham; Division of Epidemiology, School of Public Health, University of Alabama at Birmingham, Birmingham, Alabama; Division of Immunology/Rheumatology, Stanford University, Palo Alto, California; SDG LLC, Cambridge, Massachusetts, USA; Sydney Medical School, and Sydney School of Public Health, University of Sydney; Centre for Kidney Research, The Children's Hospital at Westmead, Sydney; Institute of Bone and Joint Research, Kolling Institute, Northern Sydney Local Health District; Department of Rheumatology, Royal North Shore Hospital, Reserve Road, St Leonards; Centre for Health Policy, School of Population and Global Health, The University of Melbourne, Melbourne; Discipline of Medicine, University of Adelaide; Rheumatology Unit, The Queen Elizabeth Hospital, Woodville; Department of Rheumatology, Royal Prince Alfred Hospital, Camperdown, Australia; Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds; UK National Institute for Health Research (NIHR) Leeds Biomedical Research Centre, Leeds Teaching Hospitals National Health Service (NHS) Trust; NIHR-Leeds Musculoskeletal Biomedical Research Unit, University of Leeds, Leeds, UK; Hôpital Ambroise Paré, Rheumatology Department, Boulogne-Billancourt; INSERM U1173, Laboratoire d'Excellence INFLAMEX, UFR Simone Veil, Versailles-Saint-Quentin University, Saint-Quentin en Yvelines, France; Amsterdam University Medical Centre, Department of Medical Humanities, Amsterdam Public Health, Amsterdam, the Netherlands.

K.M. Andersen, MSc, Department of Family Medicine, McGill University, and Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital; J.T. Cheah, MBBS, Rheumatology Fellow, Division of Rheumatology, Hospital for Special Surgery, and Fellow in Medicine, Department of Medicine, Weill Cornell Medicine; L. March, MBBS, MSc, PhD, FRACP, FAFPHM, Sydney Medical School, University of Sydney, and Institute of Bone and Joint Research, Kolling Institute, Northern Sydney Local Health District, and Department of Rheumatology, Royal North Shore Hospital; S.J. Bartlett, PhD, Professor, Department of Medicine, McGill University, and Adjunct Professor, Department of Medicine, Johns Hopkins University; D. Beaton, BscOT, PhD, Senior Scientist, Institute for Work & Health; C.O. Bingham III, MD, Division of Rheumatology, Department of Medicine, Johns Hopkins University; P.M. Brooks, MD, Centre for Health Policy, School of Population and Global Health, The University of Melbourne; R. Christensen, MSc, PhD, Professor of Biostatistics and Clinical Epidemiology, Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, and Department of Rheumatology, Odense University Hospital; P.G. Conaghan, MBBS, PhD, Director, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and Deputy Director, NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust; M.A. D'Agostino, MD, PhD, APHP, Hôpital Ambroise Paré, Rheumatology Department, and INSERM U1173, Laboratoire d'Excellence INFLAMEX, UFR Simone Veil; M. de Wit, PhD, Amsterdam University Medical Centre, Department of Medical Humanities, Amsterdam Public Health; A. Dueck, PhD, Division of Biostatistics, Department of Health Sciences Research, Mayo Clinic; S.M. Goodman, MD, Professor of Clinical Medicine, Division of Rheumatology, Hospital for Special Surgery, and Professor of Clinical Medicine, Department of Medicine, Weill Cornell Medical School; S. Grosskleg, OMERACT, and University of Ottawa; C.L. Hill, MBBS, MSc, MD, FRACP, Professor, Discipline of Medicine, University of Adelaide & Rheumatology Unit, The Queen Elizabeth Hospital; M. Howell, PhD, Sydney School of Public Health, The University of Sydney, and Centre for Kidney Research, The Children's Hospital at Westmead; S.L. Mackie, MB BCh, PhD, MRCP, Associate Clinical Professor, NIHR-Leeds Musculoskeletal Biomedical Research Unit, University of Leeds; B. Richards, MBBS (Hons), MClinEpi, MSportsMed, FRACP, Department of Rheumatology, Royal Prince Alfred Hospital; B. Shea, PhD, Clinical Investigator, Ottawa Hospital Research Institute, Ottawa Hospital, and Adjunct Professor, Public Health, Faculty of Medicine, University of Ottawa; J.A. Singh, MBBS, MPH, Medicine Service, VA Medical Center, and Department of Medicine, School of Medicine, University of Alabama at Birmingham, and Division of Epidemiology, School of Public Health, University of Alabama at Birmingham; V. Strand, MD, Biopharmaceutical Consultant, Portola Valley, California, USA; P. Tugwell, MD, MSc, Division of Rheumatology, Department of Medicine, and School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa, and Clinical Epidemiology Program, Ottawa Hospital Research Institute; G.A. Wells, MSc, PhD, School of Epidemiology and Public Health, University of Ottawa, and Cardiovascular Research Methods Centre, University of Ottawa Heart Institute; L.S. Simon, MD, SDG LLC.

出版信息

J Rheumatol. 2019 Aug;46(8):1053-1058. doi: 10.3899/jrheum.181123. Epub 2019 Jan 15.

DOI:10.3899/jrheum.181123
PMID:30647191
Abstract

OBJECTIVE

Outcome Measures in Rheumatology (OMERACT) convened a premeeting in 2018 to bring together patients, regulators, researchers, clinicians, and consumers to build upon previous OMERACT drug safety work, with patients fully engaged throughout all phases.

METHODS

Day 1 included a brief introduction to the history of OMERACT and methodology, and an overview of current efforts within and outside OMERACT to identify patient-reported medication safety concerns. On Day 2, two working groups presented results; after each, breakout groups were assembled to discuss findings.

RESULTS

Five themes pertaining to drug safety measurement emerged.

CONCLUSION

Current approaches have failed to include data from the patient's perspective. A better understanding of how individuals with rheumatic diseases view potential benefits and harms of therapies is essential.

摘要

目的

风湿病疗效评价方法学会议(OMERACT)于 2018 年召开了一次会前会议,召集了患者、监管机构、研究人员、临床医生和消费者,以在之前的 OMERACT 药物安全工作的基础上再接再厉,整个过程都充分让患者参与其中。

方法

第一天包括对 OMERACT 的历史和方法的简要介绍,以及对当前 OMERACT 内外识别患者报告药物安全问题的努力的概述。第二天,两个工作组介绍了研究结果;在每次介绍之后,都成立了分组讨论小组来讨论研究结果。

结果

出现了五个与药物安全测量相关的主题。

结论

目前的方法未能纳入来自患者角度的数据。更好地了解患有风湿性疾病的个体如何看待治疗的潜在益处和危害是至关重要的。

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