Clinimetric Criteria for Patient-Reported Outcome Measures,Psychotherapy and Psychosomatics

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Clinimetric Criteria for Patient-Reported Outcome Measures
Psychotherapy and Psychosomatics ( IF 22.8 ) Pub Date : 2021-05-26 , DOI: 10.1159/000516599
Danilo Carrozzino ₁ , Chiara Patierno ₁ , Jenny Guidi ₁ , Carmen Berrocal Montiel ₂ , Jianxin Cao ₃ , Mary E Charlson ₄ , Kaj Sparle Christensen ₅ , John Concato _{6,

7} , Carlos De Las Cuevas ₈ , Jose de Leon ₉ , Ajandek Eöry ₁₀ , Marcelo Pio Fleck ₁₁ , Toshi A Furukawa ₁₂ , Ralph I Horwitz ₁₃ , Andrew A Nierenberg _{14,

15} , Chiara Rafanelli ₁ , Hongxing Wang _{16,

17} , Thomas N Wise _{18,

19,

20} , Nicoletta Sonino _{21,

22} , Giovanni A Fava ₂₂

Affiliation

Department of Psychology Renzo Canestrari, University of Bologna, Bologna, Italy.
Department of Surgical, Medical and Molecular Pathology, and Critical Care Medicine, University of Pisa, Pisa, Italy.
Changzhou First People's Hospital and Psychosomatic Gastroenterology Institute, Soochow University, Changzhou, China.
Division of Clinical Epidemiology and Evaluative Sciences Research, Department of Medicine, Weill Cornell Medicine, New York, New York, USA.
Research Unit for General Practice, Department of Public Health, Aarhus University, Aarhus, Denmark.
Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
Department of Medicine, Yale University School of Medicine, New Haven, Connecticut, USA.
Department of Internal Medicine, Dermatology and Psychiatry, Universidad de La Laguna, Canary Islands, Spain.
University of Kentucky Mental Health Research Center at Eastern State Hospital, Lexington, Kentucky, USA.
Department of Family Medicine, Semmelweis University, Budapest, Hungary.
Department of Psychiatry, Universidade Federal do Rio Grande do Sul, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.
Department of Health Promotion and Human Behavior, Kyoto University Graduate School of Medicine/School of Public Health, Kyoto, Japan.
Lewis Katz School of Medicine, Temple University, Philadelphia, Pennsylvania, USA.
Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts, USA.
Harvard Medical School, Boston, Massachusetts, USA.
Division of Neuropsychiatry and Psychosomatics, Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.
Beijing Psychosomatic Disease Consultation Center, Xuanwu Hospital, Capital Medical University, Beijing, China.
Department of Psychiatry, Inova Health Systems, Falls Church, Virginia, USA.
Department of Psychiatry, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Department of Psychiatry and Behavioral Sciences, George Washington University School of Medicine, Washington, District of Columbia, USA.
Department of Statistical Sciences, University of Padova, Padova, Italy.
Department of Psychiatry, University at Buffalo, State University of New York, Buffalo, New York, USA.

Patient-reported outcome measures (PROMs) are self-rated scales and indices developed to improve the detection of the patients’ subjective experience. Given that a considerable number of PROMs are available, it is important to evaluate their validity and usefulness in a specific research or clinical setting. Published guidelines, based on psychometric criteria, do not fit in with the complexity of clinical challenges, because of their quest for homogeneity of components and inadequate attention to sensitivity. Psychometric theory has stifled the field and led to the routine use of scales widely accepted yet with a history of poor performance. Clinimetrics, the science of clinical measurements, may provide a more suitable conceptual and methodological framework. The aims of this paper are to outline the major limitations of the psychometric model and to provide criteria for clinimetric patient-reported outcome measures (CLIPROMs). The characteristics related to reliability, sensitivity, validity, and clinical utility of instruments are critically reviewed, with particular reference to the differences between clinimetric and psychometric approaches. Of note is the fact that PROMs, rating scales, and indices developed according to psychometric criteria may display relevant clinimetric properties. The present paper underpins the importance of the clinimetric methodology in choosing the appropriate PROMs. CLIPROM criteria may also guide the development of new indices and the validation of existing PROMs to be employed in clinical settings.
Psychother Psychosom

中文翻译：

患者报告结果测量的临床标准

患者报告的结果测量 (PROM) 是自评量表和指数，旨在改进对患者主观体验的检测。鉴于有大量 PROM 可用，重要的是在特定研究或临床环境中评估它们的有效性和有用性。基于心理测量标准的已发布指南不适合临床挑战的复杂性，因为它们寻求组件的同质性和对敏感性的关注不足。心理测量学理论扼杀了该领域，并导致了广泛接受但表现不佳的量表的常规使用。临床测量学，临床测量科学，可以提供更合适的概念和方法框架。本文的目的是概述心理测量模型的主要局限性，并为临床患者报告的结果测量 (CLIPROM) 提供标准。与仪器的可靠性、敏感性、有效性和临床效用相关的特征经过严格审查，特别是临床测量方法和心理测量方法之间的差异。值得注意的是，根据心理测量标准制定的 PROM、评分量表和指数可能会显示相关的临床特征。本文强调了临床方法在选择合适的 PROM 方面的重要性。CLIPROM 标准还可以指导新指标的开发和现有 PROM 的验证以用于临床环境。特别提到了临床测量方法和心理测量方法之间的差异。值得注意的是，根据心理测量标准制定的 PROM、评分量表和指数可能会显示相关的临床特征。本文强调了临床方法在选择合适的 PROM 方面的重要性。CLIPROM 标准还可以指导新指标的开发和现有 PROM 的验证以用于临床环境。特别提到了临床测量方法和心理测量方法之间的差异。值得注意的是，根据心理测量标准制定的 PROM、评分量表和指数可能会显示相关的临床特征。本文强调了临床方法在选择合适的 PROM 方面的重要性。CLIPROM 标准还可以指导新指标的开发和现有 PROM 的验证以用于临床环境。
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更新日期：2021-05-26

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