日本ヘルスケア歯科学会誌
Online ISSN : 2436-7311
Print ISSN : 2187-1760
ISSN-L : 2187-1760
<講演ノート>明確な患者利益の追求における臨床疫学の役割
フィリップ フジョー内藤 徹
著者情報
ジャーナル オープンアクセス

2001 年 3 巻 1 号 p. 33-49

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The goal in clinical decision-making is to obtain tangible patient benefits. The word tangible indicates that the end result of an intervention should be an outcome that patients can perceive. Such outcomes are referred to as clinically relevant outcomes or true endpoints. The clinically relevant outcomes in dentistry are saving teeth and improving dental related quality of life by improving esthetics, minimizing pain, or improving chewing function. In dentistry, there is almost no clinical research to assist clinicians in determining which clinical decisions are associated with tangible patients benefits. Dental clinical research has focused mostly on the study of intangible outcomes; outcomes that patients cannot perceive. Intangible outcomes measures are referred to as surrogate endpoints or measures of disease process. Examples of surrogate endpoints are changes in probing pocket depths, changes in Streptococcus mutans levels, or changes in cephalographic anatomical landmarks. It has been a common and pervasive assumption in dental research that the study of factors that influence clinically relevant outcomes was unnecessary. In the USA and Europe, billions of dollars have been spent on the study of intangible outcomes, and yet almost none of these resources were focused on the study of clinically relevant outcomes. Such a one-sided approach to clinical research can be dangerous; clinical interventions that influence intangible outcome measures do not necessary influence tangible outcome measures. Improvements in intangible outcome measures may result in real harm, or vice-versa. For instance, once widely used interventions that successfully lowered lipid levels, increased immune function, or normalized heart rhythms, have now been shown to increase mortality. In such instances, use of intangible outcome measures led to falsepositive results; conclusions that interventions had positive effects, while in fact the interventions were harmful. Similarly, interventions have been identified that had no impact on 'important' intangible outcomes measures, and yet provided real benefits. In such instances, intangible outcome measures led to false-negative results; conclusions that interventions were ineffective, while in fact the interventions were beneficial. If we want to stay true to our goal of providing tangible patient benefits, clinical epidemiology will have to start playing an increasingly important role in dental research. Clinical epidemiology is defined as the study of the factors that influence tangible patient outcomes. Clinical epidemiology can assist clinicians in providing reliable answers to important and controversial clinical questions related to etiology, diagnosis and treatment.
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© 2001 一般社団法人日本ヘルスケア歯科学会

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