Patient and Population Health and Informatics Research, Swansea University, Swansea, UK.
United European Gastroenterol J. 2014 Dec;2(6):463-70. doi: 10.1177/2050640614558345.
Gastrointestinal illnesses cause physical, emotional and social impact on patients. Patient reported outcome measures (PROMs) are increasingly used in clinical decision-making, clinical research and approval of new therapies. In the last decade, there has been a rapid increase in the number of PROMs in gastroenterology and, therefore, the choice between which of these PROMs to use can be difficult. Not all PROM instruments currently used in research and clinical practice in gastroenterology have gone through a rigorous development methodology. New drugs and therapies will not have access to the market if the PROMs used in their clinical trials are not validated according to the guidelines of the international agencies. Therefore, it is important to know the required properties of PROMs when choosing or evaluating a drug or a clinical intervention. This paper reviews the current literature on how to assess the validity and reliability of PROMs. It summarises the required properties into a practical guide for gastroenterologists to use in assessing an instrument for use in clinical practice or research.
胃肠道疾病会对患者的身体、心理和社会造成影响。患者报告的结局指标(PROMs)越来越多地用于临床决策、临床研究和新疗法的审批。在过去十年中,胃肠病学中的 PROM 数量迅速增加,因此,选择使用哪些 PROM 可能会很困难。目前在胃肠病学研究和临床实践中使用的并非所有 PROM 工具都经过严格的开发方法。如果临床试验中使用的 PROM 不符合国际机构的指南进行验证,那么新的药物和疗法将无法进入市场。因此,在选择或评估药物或临床干预措施时,了解 PROM 的所需特性非常重要。本文综述了目前关于如何评估 PROM 的有效性和可靠性的文献。它将所需的特性总结为一个实用指南,供胃肠病学家在评估用于临床实践或研究的仪器时使用。
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