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The impact of HTA reports on health policy: a systematic review.

Research Question The objective of health technology assessment (HTA) is to support decision-making in the health sector by assessing health technologies systematically under medical, economic, social, and ethical aspects. The present study aims at identifying ways of enabling the impact of HTA on decision-making processes in the German health sector. The authors formulate three research questions: (1) Can methods be identified that allow a valid assessment of the impact of HTA reports on the decision-making processes? (2) Has been shown an impact of HTA reports on decision-making processes in the health sector? (3) Which are the factors responsible for a high or a low impact of HTA? Methods The authors include studies that present a methodology to assess the impact of HTA, that investigate the impact of HTA on decision-making processes, or study the factors that might enhance or hinder the impact of HTA. Medical and social science electronic databases, lists of publications and projects of the European, North American, Canadian, and Australian HTA agencies, as well as the bibliography of the identified articles and documents are looked through. The writers do a handsearch of the International Journal of Technology Assessment in Health Care and contact 64 HTA agencies by a letter, requesting information on investigations that might not have been published. Results Abstracts from about 5,000 articles are read. 57 articles are ordered as full-text, 43 are finally included and 14 excluded. (1) In eight studies interviews with decision-makers are used to elicit the information, in three studies document analysis is employed, and in six surveys the results rely only on the observations and interpretations of the authors. One study analyses service data and in nine examinations more than one of the methods listed above are employed. Only in two studies pre-defined indicators were used and only in one clinical trial a prospective design is chosen. (2) In nine studies the impact of a population of HTA reports is analysed: Among these, seven find that more than 70% of the reports have an impact on the decision-making process, in one study 50% of the reports have none or only a minimal impact. In one study on the impact of 50 short HTA reports, it is found that they contribute valuable information but do not influence decisions. However, because of methodological flaws the evidence base for these results is rather limited. Most of the conclusions presented in the publications are based on the appraisal of the authors who are often related to the program of which the impact has been "evaluated". (3) The writers divide the factors that are identified as modifying the degree of impact of the HTA reports in two groups: context factors and factors that are connected to the developing process, the subject, the format, the content, or the quality of the reports. However, the relevance of these factors has to be assessed with caution: none of the publications has the relevance for a primary research question and in none of the studies is the relevance of the factors investigated in a prospective and systematic manner. Conclusion There is little experience with study designs or methods that allow a valid assessment of the impact of HTA reports on the decision-making process in the health sector. However, some approaches, such as the use of pre-defined indicators, were identified that should be pursued and elaborated in further studies. Due to the lack of a developed methodology only limited conclusions related to the impact of HTA reports can be drawn. Among the studies that show a relevant impact, most are methodological. However, results from qualitative studies caution against assuming a causal relationship where a mere coincidence between the recommendations of an HTA report and health policy is identified. In order to produce evidence-based conclusions regarding the impact of HTA reports, validated indicators should be used. Study design should also aim at controlling for other influencing factors. None of the studies explicitly aim at examining the role of the factors that might be responsible for a low or high impact of the HTA reports. The non-systematic retrospective analyses do not allow reliable conclusions regarding the relevance of these factors. Therefore the factors identified here should only serve for hypothesis formation. On the basis of these studies it is not possible to give evidence-based recommendations on the way how to increase the impact of HTA on decision-making in Germany. Instead a concept for evaluation should be developed that combines quantitative and qualitative methods and considers the following questions: (1) What kind of impact should be measured? (2) Which are the target groups and at which level of the health system are they located? (3) Which are the outcome parameters and how can they be measured? (4) Which are the potential impact enhancing or limiting factors?


Results
Abstracts from about 5,000 articles are read. 57 articles are ordered as full-text, 43 are finally included and 14 excluded.
(1) In eight studies interviews with decision-makers are used to elicit the information, in three studies document analysis is employed, and in six surveys the results rely only on the observations and interpretations of the authors. One study analyses service data and in nine examinations more than one of the methods listed above are employed. Only in two studies pre-defined indicators were used and only in one clinical trial a prospective design is chosen.
(2) In nine studies the impact of a population of HTA reports is analysed: Among these, seven find that more than 70% of the reports have an impact on the decision-making process, in one study 50% of the reports have none or only a minimal impact. In one study on the impact of 50 short HTA reports, it is found that they contribute valuable information but do not influence decisions. However, because of methodological flaws the evidence base for these results is rather limited. Most of the conclusions presented in the publications are based on the appraisal of the authors who are often related to the program of which the impact has been "evaluated".
(3) The writers divide the factors that are identified as modifying the degree of impact of the HTA reports in two groups: context factors and factors that are connected to the developing process, the subject, the format, the content, or the quality of the reports. However, the relevance of these factors has to be assessed with caution: none of the publications has the relevance for a primary research question and in none of the studies is the relevance of the factors investigated in a prospective and systematic manner.

Conclusion
1. There is little experience with study designs or methods that allow a valid assessment of the impact of HTA reports on the decisionmaking process in the health sector. However, some approaches, such as the use of pre-defined indicators, were identified that should be pursued and elaborated in further studies. 2. Due to the lack of a developed methodology only limited conclusions related to the impact of HTA reports can be drawn. Among the studies that show a relevant impact, most are methodological. However, results from qualitative studies caution against assuming a causal relationship where a mere coincidence between the recommendations of an HTA report and health policy is identified. In order to produce evidence-based conclusions regarding the impact of HTA reports, validated indicators should be used. Study design should also aim at controlling for other influencing factors. 3. None of the studies explicitly aim at examining the role of the factors that might be responsible for a low or high impact of the HTA reports. The non-systematic retrospective analyses do not allow reliable conclusions regarding the relevance of these factors. Therefore the factors identified here should only serve for hypothesis formation.
On the basis of these studies it is not possible to give evidence-based recommendations on the way how to increase the impact of HTA on decision-making in Germany. Instead a concept for evaluation should be developed that combines quantitative and qualitative methods and considers the following questions: (1) What kind of impact should be measured?
(2) Which are the target groups and at which level of the health system are they located?
(3) Which are the outcome parameters and how can they be measured?
(4) Which are the potential impact enhancing or limiting factors? Executive Summary

Research question
The aim of health technology assessment (HTA) is to support decision-making in the health sector by assessing health technologies systematically under medical, econom-ic, social, and ethical aspects. In order to do so, two preconditions have to be fulfilled: The reports have to meet qualitative standards and need to have an actual impact on the decision-making process. The present study aims at identifying ways of enabling the impact of HTA on decision-making processes in the German health sector. Therefore, three research questions are formulated: (1) Can methods be identified that allow a valid assessment of the impact of HTA reports on the decision-making processes?
(2) Has been shown an impact of HTA reports on decisionmaking processes in the health sector?
(3) Which are the factors responsible for a high or a low impact of HTA?

Methods
The authors include studies that present a methodology to assess the impact of HTA, that investigate the impact of HTA on decision-making processes, or study the factors that might enhance or hinder the impact. For the first research question the writers extract the data by using a rather open approach because they expect a limited degree of standardisation in methods investigating the impact of HTA. To answer the second question the authors extract the following parameters: the proportion of HTA reports that have an impact, the degree of impact, as well as its kind. From the qualitative studies that employ a holistic approach the position and the relative weight of HTA reports as compared to other factors are to be identified. To respond to the third question the factors that enhance or hindered the impact of HTA must have been drawn from the data and explicitly name by the authors. Also we assess the evidence for the second and third question.

Results
Abstracts from about 5,000 articles are read. 57 articles are ordered as full text, 43 are finally included and 14 excluded.
(1) In eight studies interviews with decision-makers are used to elicit the information, in three works document analysis is employed, and in six studies the results relies only on the observations and interpretations of the authors. One study analyses service data and in nine studies more than one of the methods listed above are employed. Only in two trials pre-defined indicators are used and only in one study a prospective design is chosen.
(2) In nine studies the impact on a population is analysed: Seven trials find that more than 70% of the reports have an impact on the decision-making process, in one study 50% of the reports have none or minimal impact and in one study on the impact of 50 short HTA reports it is found that they contribute valuable information but do not influence decisions. Studies that separate evaluations of the impact on health policy and on clinical practise patterns find less impact on clinical practise than on health policy. However, because of methodological flaws the evidence base for these results is rather limited. Most of the conclusions presented in the publications are based on the appraisal of the authors who are often related to the program of which impact has been "evaluated". There are also findings from qualitative in-depth studies that protect us against assuming always a causal relationship, when a coincidence between recommendations of a HTA report and health policy is found. No conclusions can be drawn regarding a possible relationship between the health system (tax-based/social insurance/others) and the degree of impact of HTA.
(3)The writers divide the factors that are identified as modifying the degree of impact of the HTA reports in two groups: a) environment or context factors which are not directly related to the HTA report and cannot be influenced by it and b) factors that are connected to the developing process, the subject, the format, the content, or the quality of the reports. a) Among the contextual factors that enhance the impact of HTA reports are a felt need for cost control in the health sector and a "culture" of consideration of evidence-based information in a health system. Among the restraining factors are a high degree of influence by partisan groups, a substantial leeway for making decisions at the operational level, a lack of competence in interpreting HTA reports under the decision-makers, rapidly changing political situations, changes of personnel in the HTA providing agency, and the absence of a central institution what gathers information.
b) In the second group the following factors are considered as promoting the impact of HTA: the HTA providing agency should have a reputation of being independent, neutral and scientifically proven, it is regionally embedded, decision-makers and other stakeholders are participating in the process of producing a HTA report, and a congruence of decision-makers and clients or decisionmakers and users of the technology. The probability of an impact is also higher for reports on new or cost-relevant technologies than for reports on established and little cost-relevant technologies. If a decision is related to an emotionally ambivalent topic the impact is expected to be low. If it is a fundamental decision in favour or against a technology the impact of an HTA-report is expected to be lower than if the decision is on mere procedural issues. Other factors are the timelines and the sufficient financing of the reports. Authors advise to consider and include the context (among other things ethical and social aspects) in the report. The adoption of the conclusions is also more likely if the report contains clear-cut recommendations and if guidance for the implementation of the recommendations is given. In one study a consensus conference seems to have contributed substantially to a better dissemination of the recommendations. In another study the compact format of short HTA reports is reported as useful by the recipients.

Conclusion
1. There is little experience with study designs or methods that allow a valid assessment of the impact of HTA reports on the decision-making process in the health sector. However, some approaches, such as the use of pre-defined indicators, are identified that should be pursued and elaborated in further studies. 2. Due to the lack of a developed methodology only limited conclusions related to the impact of HTA reports can be drawn. Among the studies that show a relevant impact are the methodologically more elaborated investigations. However, results from qualitative studies protect against assuming a causal relationship where a mere coincidence between the recommendations from an HTA report and health policy are identified. In order to produce evidence-based conclusions re-garding the impact of HTA reports, the use of validated indicators will be needed. Study design should also aim at looking for other influencing factors. 3. None of the studies explicitly aimed at examining the role of the factors that might be responsible for a low or high impact of the HTA reports. The non-systematic retrospective analyses do not allow for reliable conclusions regarding the relevance of these factors. Therefore the factors identified here should only serve for hypothesis formation. 4. On the basis of these studies it is not possible to give evidence-based recommendations on how to increase the impact of HTA on decision-making in Germany.
Instead a concept for evaluation should be developed that combines quantitative and qualitative methods and considers the following lead questions: (1) What kind of impact should be measured?
(2) Which are the target groups and at which level of the health system are they located?
(3) Which are the outcome parameters and how can they be measured? Bei der Einschätzung der Validität der genannten Faktoren ist zu berücksichtigen, dass ihre Bedeutung in keiner der Studien systematisch und prospektiv untersucht wird.