Evaluation of the Health and Research Outcomes of Technologies Licensed by the National Institutes of Health




НазваниеEvaluation of the Health and Research Outcomes of Technologies Licensed by the National Institutes of Health
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2.1 Overview of Approach


Step 1: Developing the framework for classifying products made using NIH technologies – The objective of this effort was to develop a framework to guide the classification of products made using NIH technologies and also to guide the literature review process.

Step 2: Review of the literature to identify potential methods and metrics – A thorough review of the literature was performed to identify potential methods and their advantages and disadvantages. Case studies were specifically excluded from the assessment as this method is not cost effective when applied to a large group of technologies. The focus was on key NIH technology groupings but the review also included those without large representation (e.g. rehabilitation) because there could be future technologies in this area. We performed a comprehensive assessment which can be narrowed in the future as appropriate. The findings from this effort are presented in this report.

Step 3: Interviews with experts and licensees to validate initial assumptions and proposed methods – These interviews played a key role in validating the preliminary recommendations based on the literature review

Step 4: Pilot test potential methods and metrics – This process allowed for the hands-on assessment of the implementation of the recommended methods and data sources.

Step 5: Finalize the process for evaluating technologies including new tools and metrics required to perform assessment- The final set of recommendations were derived based on the expert interviews and pilot studies. These recommendations will be presented to NIH and are also summarized in this report.

2.2 Measurement of Impact on Health Outcomes


Health outcomes are the final or “ultimate” outcomes. Final outcomes are mortality (e.g., all-cause or diagnosis-specific death rates), morbidity (e.g., severity of disease, comorbidities), and quality of life. Final health outcomes incorporate both positive and negative affects of the technology, that is, benefits and harms. In some instances, the intermediate outcomes may be all that can be measured directly or all that needs to be measured. In the case of research tools, the impact generally indirect because the measurable effects are on research processes. A diagrammatic representation of the direct and indirect impacts is presented in Figure 1. The final health outcomes at an individual patient level (e.g. increase in survival) can be quantifies at the population level to assess public health impacts.

Figure 1. Direct and Indirect Impacts on Health Outcomes

Drugs & Vaccines

Diagnostics

Medical Devices

Health (final) Outcomes

Intermediate Outcomes




Research Tools &

Reagents

Research Advancement

Process Optimization

Health (final) Outcomes




2.3 Literature Review Methodology


Given the enormous volume of literature on metrics, tools, and methods (including those that apply to specific disease areas and intervention), a systematic search of the literature will yield valuable information only if it is narrowly focused and the objectives are clearly defined. Therefore, we focused our initial search efforts to identify the overall framework that will be used to assess the products made using NIH technologies licensed by the Office of Technology Transfer (OTT). Based on this framework, we performed targeted searches to identify specific literature to assist in reviewing potential methods, tools and data sources. The literature review processes employed for developing the framework and for identifying methods and tools are described in detail in the sessions below.

2.3.1 Framework Development


We began with a critical search of the approaches used in the fields of technology transfer and technology assessment. The technology transfer literature review was targeted to identify studies on the effectiveness and impact of research tools, whereas the technology assessment literature was reviewed to guide the assessment of commercialized technologies. The goal was to review the literature in these fields to develop an overall framework that will (1) guide the development of metrics and tools and (2) address specific methodological challenges that will be faced in assessing the public health impacts of products made using NIH technologies. First, we searched for peer-reviewed manuscripts and review articles in MEDLINE. The search terms used included “technology transfer effectiveness,” “technology diffusion,” “technology transfer metrics/measures,” “technology assessment methods,” “health impact measurement,” and “health technology assessment.” We included both new and older publications (did not limit search by years) because we wanted to capture both the current and historic perspectives. Second, using the same search terminologies, we searched the gray literature using Internet search engines (yahoo and google). Third, we performed more targeted searches to identify publications related to technology transfer and technology assessment. These are described in detail below.

To identify methods to study the effectiveness of technology transfer, we searched the Journal of Technology Transfer, a journal that is devoted exclusively to the topic of technology transfer and also Policy Research which has a significant number of articles reviewing measurement and effectiveness of technology transfer. We also searched for relevant reports and other materials published by the Technology Transfer Society, Association of University Technology Managers (AUTM), state agencies/consortiums (Iowa, Georgia), and specific academic institutions (Massachusetts Institute of Technology [MIT] Enterprise Forum). Lastly, we also searched for relevant materials published by venture capital and equity research firms on assessing the impact of early stage technologies.

To identify materials relevant to health technology assessment, we acquired and examined relevant RTI internal documents and publications by technology assessment agencies (Agency for Healthcare Research and Quality’s [AHRQ] Center for Outcomes and Evidence; Institute of Medicine [IOM]). We also acquired publications from international organizations and agencies, including the Canadian Coordinating Office for Health Technology Assessment (CCOHTA), International Network of Agencies for Health Technology Assessment (INAHTA), National Institute of Clinical Excellence (NICE), and World Health Organization (WHO).

2.3.2 Methods, Metrics and Tools/Data Sources for Assessing Effectiveness

Methods


Our review to develop the framework identified several studies on the methods employed but we performed additional searches to ensure that a comprehensive review of all potential methods was undertaken. Because the literature pertaining to technology transfer outcomes research, pharmacoeconomics, public health assessment, program evaluation, and technology assessment of products and research tools is extremely large, we limited our searches to review articles or reports published in the recent past (1995 to the present) and used these as the basis of identifying appropriate methods and relevant articles. To improve the efficiency of our search process, we identified additional studies by hand-searching the bibliographies of articles and reports identified during the initial search. This approach allowed us to review the methodologies available in an efficient, reliable, and systematic manner.

Metrics


To identify a comprehensive set of intermediate and final health metrics we performed the following three steps:

STEP 1: Identified the key disease areas of relevance for products made using NIH technologies. The majority of the technologies were for cancer and HIV/AIDS and therefore we focused much of our effort on these two disease areas.

STEP 2: Searched MEDLINE, the Cochrane Library and the Database of Abstracts of Reviews of Effectiveness (DARE), to identify prior synthesis of the peer-reviewed literature through reviews and meta-analysis. We also acquired and examined relevant RTI internal documents and publications by technology assessment agencies and those from agencies that sponsor evaluations. We searched the Web sites of several agencies including AHRQ, CDC, CCOHTA, and WHO.

STEP 3: Reviewed the documents to identify both intermediate and final outcomes by disease area. Based on the publications, we also assessed the extent to which these metrics are quantifiable and linked with data sources available.

Tools/Data Sources


We selected seminal articles and publications to identify data sources based on RTI’s past project experience. We also supplemented this with targeted searches via Medline and review of reports from technology assessment agencies. We relied heavily on past expertise in assessing the tools and data sources to identify the potential limitations and “best approaches” to collecting high-quality data. We also updated and tailored RTI’s exhaustive Excel database listing of potential data sources which includes details related to obtaining the data, populations covered, type of data parameters available, and acquisition cost.

Overall, the search identified a large number of relevant manuscripts and reports. These were reviewed for relevant information pertaining to the overall framework for evaluating the products made using NIH technologies and for methods to be employed in developing effectiveness measures or metrics. The findings from the literature search are summarized in the relevant sessions in Sections that follow.
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