Bartelmes Marc, Neumann Ulrike, Lühmann Dagmar, Schönermark Matthias P, Hagen Anja
Abteilung für Epidemiologie, Sozialmedizin und Gesundheitssystemforschung, Medizinische Hochschule Hannover, Hannover, Deutschland.
GMS Health Technol Assess. 2009 Nov 5;5:Doc15. doi: 10.3205/hta000077.
Conventional Health Technology Assessment (HTA) is usually conducted at a point in time at which the development of the respective technology may no longer be influenced. By this time developers and/or purchasers may have misinvested resources. Thus the demand for Technology Assessment (TA) which incorporates appropriate methods during early development stages of a technology becomes apparent. Against this health political background, the present report describes methods for a development-accompanying assessment of innovative medical technologies. Furthermore, international research programmes set out to identify or apply such methods will be outlined. A systematic literature search as well as an extensive manual literature search are carried out in order to obtain literature and information. The greatest units of the identified methods consist of assessment concepts, decision support methods, modelling approaches and methods focusing on users and their knowledge. Additionally, several general-purpose concepts have been identified. The identified research programmes INNO-HTA and MATCH (Multidisciplinary-Assessment-of-Technology-Centre-for-Healthcare) are to be seen as pilot projects which so far have not been able to generate final results. MATCH focuses almost entirely on the incorporation of the user-perspective regarding the development of non-pharmaceutical technologies, whereas INNO-HTA is basically concerned with the identification and possible advancement of methods for the early, socially-oriented technology assessment. Most references offer only very vague descriptions of the respective method and the application of greatly differing methods seldom exceeds the character of a pilot implementation. A standardisation much less an institutionalisation of development-accompanying assessment cannot be recognized. It must be noted that there is no singular method with which development-accompanying assessment should be carried out. Instead, a technology and evaluation specific method selection seem to be necessary as medical innovations are diverse and none of the methods are exhaustive. Because of a variety of issues (e. g. ideal time of evaluation, lack of data and uncertainty of data) a development-accompanying assessment should not replace a comprehensive HTA, but rather form a possible preceding step in a multi-staged HTA-process. A final appraisal of the methods for development-accompanying assessment cannot be made based on the available sources. However, the present review may serve as a starting point for further development and application of these methods as well as further examination of the concept of development-accompanying assessment. There is a substantial need for further research concerning the application, validation and comparison of the various methods for development-accompanying assessment.
传统的卫生技术评估（HTA）通常是在某个时间点进行的，此时相关技术的发展可能已无法受到影响。到这个时候，开发者和/或购买者可能已经错误地投入了资源。因此，在技术早期开发阶段纳入适当方法的技术评估（TA）需求就变得明显了。在这种卫生政策背景下，本报告描述了对创新医疗技术进行伴随开发评估的方法。此外，还将概述旨在识别或应用此类方法的国际研究项目。为了获取文献和信息，进行了系统的文献检索以及广泛的手工文献检索。所确定方法的最大单元包括评估概念、决策支持方法、建模方法以及关注用户及其知识的方法。此外，还确定了几个通用概念。已确定的研究项目“创新卫生技术评估”（INNO-HTA）和“技术多学科评估——医疗保健中心”（MATCH）应被视为试点项目，到目前为止尚未能够产生最终结果。MATCH几乎完全专注于在非制药技术开发中纳入用户视角，而INNO-HTA基本上关注早期、面向社会的技术评估方法的识别和可能改进。大多数参考文献对各自方法的描述非常模糊，而且很少有对大不相同方法的应用能超出试点实施的性质。无法看到伴随开发评估的标准化，更不用说制度化了。必须指出的是，不存在一种单一的方法来进行伴随开发评估。相反，由于医疗创新多种多样且没有一种方法是详尽无遗的，似乎有必要根据技术和评估选择特定的方法。由于各种问题（例如评估的理想时间、数据缺乏和数据不确定性），伴随开发评估不应取代全面的HTA，而应在多阶段HTA过程中形成一个可能的前期步骤。基于现有资料无法对伴随开发评估方法进行最终评价。然而，本综述可作为进一步开发和应用这些方法以及进一步审视伴随开发评估概念的起点。对于伴随开发评估的各种方法的应用、验证和比较，存在大量进一步研究的需求。
