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Identification and assessment of ongoing trials in health technology assessment reviews.

OBJECTIVES: To assess the importance of ongoing trials in health technology assessment reviews (HTARs) for the National Institute for Clinical Excellence and to provide practical recommendations for identifying ongoing trials and assessing their possible impact. DATA SOURCES: Electronic databases. REVIEW METHODS: Ongoing trials (or trials in progress) were defined as any trials that have started but where the results are not yet available or only interim results are available for HTARs. This methodological review included: (1) an assessment of ongoing trials in HTARs completed by the end of August 2002, (2) a survey and assessment of trial registers and other sources of ongoing trials and (3) a summary and assessment of available methods for assessing the possible impacts of ongoing trials. RESULTS: The identification of ongoing trials is a common phenomenon in reviews of health technology assessment. Twenty-three of the 32 HTARs identified one or more ongoing trials and in eight of these the information on identified ongoing trials was not considered in the evidence synthesis and research recommendations. All but one HTAR that considered the potential impact of ongoing trials adopted a narrative approach. Trial registers and grey literature are important sources of information on ongoing trials. All 32 HTARs explicitly or implicitly searched for unpublished studies, and/or ongoing trials and/or grey literature and trial registers. The assessment of six commonly used trial registers suggested that most registers provided sufficient information for reviewers to decide the relevance of identified ongoing trials. However, it is sometimes extremely difficult to know whether ongoing trials identified from different sources (registers) are the same trials or belong to the same multicentre trials. The ISRCTN (the International Standard Randomised Controlled Trial Number) is the most reliable system but it has not been widely adopted. The qualitative assessment of ongoing trials compared major features of completed and ongoing trials, providing information about the possible impact of ongoing trials in terms of relevance, validity, reliability and generalisability. Quantitative methods to assess the impact of ongoing trials include cumulative meta-analysis related methods, fail-safe N, Bayesian data monitoring, and Bayesian interim predictions. The most useful method may be the Bayesian predictive probability, which estimates predictive probabilities for any possible values of treatment effect. A case study indicated that the appropriate use of quantitative methods would strengthen findings from narrative assessment of possible impact of ongoing trials. CONCLUSIONS: Identification of ongoing trials is common in HTARs. Searching for ongoing trials in effectiveness reviews should be more thorough and explicit. Conversely, primary researchers, in particular those working with in multicentre trials, should label ongoing trials more clearly, preferably by ISRCTN. Qualitative assessment of identified ongoing trials is crucial and informative. Available quantitative methods could be used to strengthen findings from narrative assessment, although further research and more empirical examples are required. Information from ongoing trials may contribute to syntheses of results, conclusions and recommendations for future research. Future research is suggested into the identification and assessment of ongoing trials in other systematic reviews of effectiveness of health care interventions; existing and new methods for incorporating information on ongoing trials; comparing estimated impacts with the actual results of ongoing trials; and to incorporate findings from the assessment of ongoing trials into decision models.

Bayes Theorem↗

The Impact of Chatbot Type and Normative Messaging on Chatbot Usage Intention Based on the Health Technology Acceptance Model: Randomized Controlled Trial.

BACKGROUND: Digital health tools, such as health chatbots, may improve access to scalable health support, but adoption remains inconsistent. Existing models do not fully integrate technology acceptance factors with health motivation factors relevant to digital health use. OBJECTIVE: This study proposed and tested the health technology acceptance model and examined whether normative message framing and chatbot type were associated with health motivation, technology acceptance, and intention to use a health chatbot. METHODS: In October 2025, we conducted a 4 &#xd7; 2 between-participants online experiment with 1000 US adults recruited from a nationally representative YouGov panel. Participants were randomized to 1 of 8 conditions varying norm message type (self-oriented, peer-oriented, expert-oriented, or family-oriented) and chatbot type (AI-powered or rule-based) in a cancer prevention and genetic risk information scenario. Outcomes included descriptive norms, injunctive norms, perceived susceptibility, perceived severity, perceived benefits, self-efficacy, perceived ease of use, trust, privacy concerns, and usage intention. Data were analyzed using a multivariate ANOVA with Bonferroni-adjusted post hoc tests and multiple linear regression. RESULTS: Peer-oriented and family-oriented messages produced higher usage intention than expert-oriented messages, and peer-oriented messages also increased descriptive norms, injunctive norms, self-efficacy, and trust. AI-powered chatbots were associated with higher usage intention (P=.02) and greater trust (P=.008) than rule-based chatbots. In regression analyses, the model explained 50.8% of the variance in usage intention. Usage intention was positively associated with descriptive norms (&#x3b2;=0.087; P=.003), injunctive norms (&#x3b2;=0.078; P=.009), perceived susceptibility (&#x3b2;=0.051; P=.03), perceived benefits (&#x3b2;=0.253; P<.001), and trust (&#x3b2;=0.33; P<.001), and negatively associated with perceived severity (&#x3b2;=-0.047; P=.049) and privacy concerns (&#x3b2;=-0.11; P<.001). Perceived ease of use and self-efficacy were not significant predictors. CONCLUSIONS: The health technology acceptance model was a useful framework for explaining the intention to use a health chatbot by combining technology acceptance and health motivation constructs. Both social design features and chatbot design features shaped adoption-related beliefs, with peer-oriented and family-oriented framing and AI-powered chatbots showing particular promise. Trust and privacy concerns remained central determinants of intended use.

Humans↗

Electronic fetal monitoring. Lessons from a formative case of health technology assessment.

OBJECTIVES: The assessment of electronic fetal monitoring (EFM) carried out by the authors in the late 1970s provides an early case of a systematic review of evidence in health technology assessment. This paper identifies lessons pertinent for the present day in this field. METHODS: We reviewed our own files for the description of our assessment and reactions to it. We also reviewed recent literature to evaluate our observations in relation to recent evidence. RESULTS: Our findings of insufficient evidence of efficacy and concerns about safety have been confirmed by subsequent research. Still, despite findings and recommendations of prominent professional and governmental bodies, EFM continues in widespread use in the United States and Europe and is spreading into developing countries around the world. Aggressive attacks on our assessment as well as our skills and integrity have been mirrored in recent years by criticism of other researchers in health technology assessment. CONCLUSIONS: The case of EFM points to the limitations of assessment without other actions to assure the implementation of results. Health technologies that are accepted by the majority of clinicians in a particular field may require extraordinary efforts to assure appropriate use of technology assessments.

Female↗

The use of societal criteria in priority setting for health technology assessment in The Netherlands. Initial experiences and future challenges.

Priority setting for the evaluation of health technologies in the Netherlands is exclusively based on the scientific merits of individual research proposals. This process has not resulted in satisfactory allocation of resources. Therefore, societal criteria for setting priorities for health technology assessment have been proposed as an adjunct to scientific criteria. These societal criteria include the burden of disease, uncertainty about the (cost-)effectiveness of the intervention at issue, the potential benefits of the research project, and its potential impact on health care. To realize the full potential of this model for priority setting, a number of methodological issues need to be addressed. Joint efforts of researchers and policy makers in this field are necessary for future progress.

Health Care Rationing↗

Doing mini-health technology assessments in hospitals: a new concept of decision support in health care?

OBJECTIVES: The purpose of this project was to evaluate local decision support tools used in the Danish hospital sector from a theoretical and an empirical point of view. METHODS: The use of local decision support was evaluated through questionnaires sent to all county health directors, all hospital managers, and all heads of clinical departments in cardiology, orthopedic surgery, and intensive care. In addition, respondents were asked to submit whatever decision support tools they were using (including mini-HTAs, other forms or checklists, and special procedures for decision making concerning new health technologies). A theoretical analysis of the decision support tools (decision theory) was performed as well as a comparison with the business case method used in private companies. Finally, the Danish mini-HTA was compared with foreign production and use of HTA and HTA-like assessments as local decision support. RESULTS: The response rate was high (87 percent, 94 percent, 85 percent, respectively). We collected sixty different forms (of which forty-nine were mini-HTAs) and twenty variants of written procedures. We found theoretical and empirical evidence that local involvement in the process of making the HTA could be important for the use of the results from the HTA and for the process of implementing the new technology. CONCLUSIONS: Doing mini-HTA in hospitals seems to balance the need for quality and depth with the limited time and resources for assessment.

Decision Support Techniques↗

SARS and population health technology.

The recent global outbreak of SARS (severe acute respiratory syndrome) provides an opportunity to study the use and impact of public health informatics and population health technology to detect and fight a global epidemic. Population health technology is the umbrella term for technology applications that have a population focus and the potential to improve public health. This includes the Internet, but also other technologies such as wireless devices, mobile phones, smart appliances, or smart homes. In the context of an outbreak or bioterrorism attack, such technologies may help to gather intelligence and detect diseases early, and communicate and exchange information electronically worldwide. Some of the technologies brought forward during the SARS epidemic may have been primarily motivated by marketing efforts, or were more directed towards reassuring people that "something is being done," ie, fighting an "epidemic of fear." To understand "fear epidemiology" is important because early warning systems monitoring data from a large number of people may not be able to discriminate between a biological epidemic and an epidemic of fear. The need for critical evaluation of all of these technologies is stressed.

Communicable Diseases↗

Investigating the structural reliability of a discrete choice experiment within health technology assessment.

This paper investigates the structural reliability of a discrete choice experiment within health technology assessment. Two versions of a discrete choice experiment, in the form of a self-completion questionnaire, were randomly administered to two samples of women who had recently given birth as part of an exercise to determine women's preferences for alternative modes of intrapartum care. In the first questionnaire, two of the attributes had only their highest and lowest levels included, while in the second questionnaire all three levels for these two attributes were included. The levels included for all other attributes remained the same throughout both questionnaires. The evidence relating to the structural reliability of the discrete choice experiment in this context was mixed. The results indicated that the relative importance of the two attributes in which the levels were varied increased as the number of levels for these attributes increased. However, the relative importance of the attributes in which the levels were not varied remained relatively stable throughout. The results provide evidence in support of a psychological effect whereby respondents place more importance upon specific attributes as the number of levels for these attributes increases. It is recommended that further research of both a qualitative and quantitative nature should be undertaken to assess the potential importance (or otherwise) of a psychological effect relating to the number of levels chosen for attributes within discrete choice experiments in health technology assessment.

Choice Behavior↗

Health technology assessment in Denmark.

The Danish healthcare services are mainly provided by public sector institutions. The system is highly decentralized. The state has little direct influence on the provision of healthcare services. State influence is exercised through legislation and budget allocations. The main task of the state is to initiate, coordinate, and advise. Counties, which run the hospitals, also decide on the placement of services. The hospital sector is controlled within the framework of legislation and global budgets. General practitioners occupy a central position in the Danish healthcare sector, acting as gatekeepers to the rest of the system. The system works well, and its structure has resulted in steady costs of health care for a long period. There is no regulatory mechanism in the Danish health services requiring use of health technology assessment (HTA) as a basis for policy decisions, planning, or administrative procedures. However, since the late 1970s a number of comprehensive assessments of health technology have formed the basis for national health policy decisions. In 1997, after years of public criticism of the quality of hospital care and health technologies, and on the basis of a previously developed national HTA strategy, a national institute for HTA (DIHTA) was established. There seems to be a growing awareness of evidence-based healthcare among health professionals and a general acceptance of health economic analyses as a basis for health policy decision making. This progress is coupled with growing regional HTA activity in the health services. HTA seems to have a bright future in Denmark.

Adolescent↗

Health technology assessment of three screening methods in Switzerland.

OBJECTIVE: To describe the level of health technology assessments for three screening methods in Switzerland. METHODS: Analysis of documents and expert opinions on mammography screening, ultrasound examinations during normal pregnancy, and screening for prostate-specific antigen (PSA) with a focus on services provided, recommendations, formal regulations, national papers, projects, and formal assessments. RESULTS: Preventive services are explicitly recommended by the Swiss federal law on health insurance. Two routine ultrasound examinations during normal pregnancy as well as PSA analysis for men over 40 years of age on medical indication are covered by basic health insurance. Mammography screening every 2 years has been covered since 1997 for women over 50 years. A systematic screening program for mammography exists in the western part of Switzerland, and a nationwide program is planned. However, a national program may not come into being until a quality assurance program for evaluation is established, and a nationwide fee for reimbursement-to include all costs of such a program-is accepted by providers and insurers. CONCLUSION: According to the Swiss health insurance law, the effectiveness of mammography screening and ultrasound examinations during normal pregnancy have to be proven. Systematic evaluation of these screening methods is in preparation. PSA is not part of current evaluation. It can be concluded that health technology assessment in Switzerland is now required by law for several medical services. However, limited financial and personnel resources as well as the lack of disease registers may hamper progress in the near future.

Adult↗

Assessing the accuracy of forecasting: applying standard diagnostic assessment tools to a health technology early warning system.

OBJECTIVES: Early warning systems are an integral part of many health technology assessment programs. Despite this finding, to date, there have been no quantitative evaluations of the accuracy of predictions made by these systems. We report a study evaluating the accuracy of predictions made by the main United Kingdom early warning system. METHODS: As prediction of impact is analogous to diagnosis, a method normally applied to determine the accuracy of diagnostic tests was used. The sensitivity, specificity, and predictive values of the National Horizon Scanning Centre's prediction methods were estimated with reference to an (imperfect) gold standard, that is, expert opinion of impact 3 to 5 years after prediction. RESULTS: The sensitivity of predictions was 71 percent (95 percent confidence interval [CI], 0.36-0.92), and the specificity was 73 percent (95 percent CI, 0.64-0.8). The negative predictive value was 98 percent (95 percent CI, 0.92-0.99), and the positive predictive value was 14 percent (95 percent CI, 0.06-0.3). CONCLUSIONS: Forecasting is difficult, but the results suggest that this early warning system's predictions have an acceptable level of accuracy. However, there are caveats. The first is that early warning systems may themselves reduce the impact of a technology, as helping to control adoption and diffusion is their main purpose. The second is that the use of an imperfect gold standard may bias the results. As early warning systems are viewed as an increasingly important component of health technology assessment and decision making, their outcomes must be evaluated. The method used here should be investigated further and the accuracy of other early warning systems explored.

Diagnostic Techniques and Procedures↗

Economic evaluation and the rational diffusion and use of health technology.

In principle, economic evaluation provides a suitable framework for the assessment of the costs and benefits of health technologies. However, despite a rapid growth in the publication of cost-effectiveness and cost-benefit analysis in health care, there is little evidence that economic evaluation has yet become part of an integrated approach to technology assessment. This paper, based on the findings of a European Community project on economic appraisal of health technology, discusses how the design and conduct of economic evaluations can be improved so as to increase their relevance to health care decision making, and how policies on the diffusion and use of health technology can be devised so as to make fuller use of the economic evaluations that are carried out.

Communication↗

Health technology diffusion rates. Statins, coronary stents, and MRI in England.

OBJECTIVE: To analyze the rates and influences on the adoption of three selected health technologies: statins, coronary stents, and magnetic resonance imaging (MRI). METHODS: A retrospective diffusion study using primary care prescribing data and questionnaire responses from acute hospital trusts in the West Midlands region (population 5.3 million or 10% of England). RESULTS: The selected technologies had markedly different diffusion curves. Statins diffused rapidly soon after launch. Coronary stents were initially used 6 years after first availability, but within 2 years all responding hospitals reported using them. MRI scanners were initially purchased 6 years after first availability with a subsequently slow rate of diffusion, and are still absent from some hospitals. Influences on the adoption of each technology were different. Commercial marketing was reported as a major influence on the diffusion of statins but not at all on MRIs. Cost impact was a major negative influence on the diffusion of MRI scanners and statins, whereas enthusiastic individuals were key to the diffusion of stents. CONCLUSIONS: Influences on adoption and consequent diffusion rates are very different for different health technologies. It is not at all clear that such diffusion patterns relate well to an optimum timing rate. This has important implications for technology gatekeepers in health care.

Anticholesteremic Agents↗

Health technology assessment in Canada. A decade in review.

OBJECTIVES: Since 1988, four government-funded health technology assessment (HTA) agencies have been established in Canada. This paper is a descriptive review of reports issued by these organizations during the period from 1988 to 1998. METHODS: Publications from the national and three provincial HTA agencies in Canada were obtained and reviewed. Only the 117 assessment reports that were reported to have undergone external review were included in this analysis. Each report was classified on a standard abstraction form according to criteria such as technology type(s), assessment focus, whether a specific policy question was clearly stated and relevant decision maker(s) identified, description of search strategy and selection criteria, sources of data and assessment methods used, whether recommendations or conclusions were made, and duplication or overlap of reports. The trends in these qualities over the 10-year period were also examined. RESULTS: Therapeutic technologies have received the most attention from all four agencies, although the focus on devices, drugs, and procedures varied between agencies. The policy question under investigation was clearly identified in 82% of reports, and 71% clearly identified the decision maker toward whom the assessment was targeted. Efficacy or effectiveness was examined in 81% of reports, and costs were assessed in 65% of studies. These were the two most frequently examined aspects. Almost all assessments were descriptive literature reviews; 9% included meta-analyses and 32% had cost analyses or economic evaluations. Forty-four percent of reports had a clear description of the literature search strategy, and selection criteria were clearly specified in 38% of studies, but there was considerable variation among agencies in the level of description of these methods. Conclusions were clearly stated in 83% of the assessments' conclusions, and 13% had recommendations. When analyzed longitudinally, it is apparent that the quality of reports has improved markedly during the past decade. This was determined by examining the clarity of specifying the policy question(s) under investigation, the identification of the target audience of decision makers for the information, and by evaluating the thoroughness of the description of the methods used in the assessment. CONCLUSIONS: Canadian government agencies have contributed a considerable quantity of health technology assessments. There has been very little duplication of technologies evaluated, and the quality of the assessment reports has markedly improved during the past decade.

Canada↗

Perspectives on health technology assessment: response from the patient's perspective.

Health technology assessment (HTA) involves values and judgments, but there have been few attempts to seek the views of members of the public or to ensure that they have access to the results. Patients and citizens can make an important contribution to HTA by determining priorities for assessment, designing and conducting assessments and appraisals, receiving and using the findings, and engaging in debates about policy priorities and rationing. Those responsible for HTA should make greater efforts to involve the public and ensure that the findings are accessible to patients for use when making treatment choices.

Europe↗

Co-ordinating health technology assessment in Canada: a European perspective.

Health Technology Assessment (HTA) is well-established in Canada, with both a national co-ordinating office for HTA and several provincial HTA organisations. The success of and relationship between these agencies, may provide useful lessons for policy-makers considering how to facilitate increased co-operation and harmonisation of HTA activity across Europe. Interviews were conducted with a number of key individuals associated with HTA in Canada to identify achievements, examine the relationship between the provincial agencies and the national co-ordinating office, and detect barriers to the increased use of HTA knowledge in decision-making.

Canada↗

A taxonomy of model structures for economic evaluation of health technologies.

Models for the economic evaluation of health technologies provide valuable information to decision makers. The choice of model structure is rarely discussed in published studies and can affect the results produced. Many papers describe good modelling practice, but few describe how to choose from the many types of available models. This paper develops a new taxonomy of model structures. The horizontal axis of the taxonomy describes assumptions about the role of expected values, randomness, the heterogeneity of entities, and the degree of non-Markovian structure. Commonly used aggregate models, including decision trees and Markov models require large population numbers, homogeneous sub-groups and linear interactions. Individual models are more flexible, but may require replications with different random numbers to estimate expected values. The vertical axis of the taxonomy describes potential interactions between the individual actors, as well as how the interactions occur through time. Models using interactions, such as system dynamics, some Markov models, and discrete event simulation are fairly uncommon in the health economics but are necessary for modelling infectious diseases and systems with constrained resources. The paper provides guidance for choosing a model, based on key requirements, including output requirements, the population size, and system complexity.

Cost-Benefit Analysis↗

International collaboration in health technology assessment: a study of technologies used in management of osteoporosis.

A collaborative study was undertaken by members of the International Network of Agencies for Health Technology Assessment (INAHTA). The evidence of the effectiveness of bone density measurement and selected treatments in preventing fractures in later life was reviewed. There was fair evidence that bone density measurement can predict risk of fractures and that hormone replacement therapy and intranasal salmon calcitonin preserve bone mass and decrease the risk of fractures. However, it was estimated that only 1-7% of hip fractures would be prevented if these technologies were used in a screening program for menopausal women. Results of the assessment were endorsed by 13 INAHTA members, disseminated widely and provided input to policy and further work in this area. The project demonstrated the feasibility of international collaborative health technology assessment.

Bone Density↗

Health technology assessment in the ICU: noninvasive positive pressure ventilation for acute respiratory failure.

Critical care practitioners have a number of health-related technologies at our disposal to provide the best possible care for our critically ill patients. Although certain technologies may improve outcomes in the intensive care unit (ICU), many technologies are disseminated without rigorous evaluation. Health technology assessment (HTA) in critical care is a complex and dynamic process, which is a powerful tool to assess a health technology for its initial use or continued application in the ICU. This article applies an HTA framework to the use of noninvasive positive pressure ventilation (NPPV) for patients with acute respiratory failure (ARF). The strongest evidence to date supports the use of NPPV in patients with ARF caused by exacerbations of chronic obstructive pulmonary disease (COPD); the benefit for patients with acute nonhypercarbic, hypoxemic respiratory failure is less clear. The success of NPPV technology depends on operator education and experience. The cost effectiveness of NPPV has been evaluated in patients with ARF caused by COPD, and cost reduction is attributed to the prevention of ventilator-associated pneumonia by avoiding endotracheal intubation. An HTA framework can help health care practitioners make important decisions regarding the acquisition of new technologies and the evaluation of current technologies. Careful evaluation of health technologies in the ICU should be an ongoing priority.

Acute Disease↗