Health Care Technology Assessment Research Articles

Development of health technology assessment in Lithuania

To describe how Lithuania is attempting to develop health technology assessment (HTA) structures. The case study of the history of development of HTA in Lithuania is presented. Historical steps of HTA development are as follows: in 1993, a few conferences on HTA; eight people were trained in Sweden at SBU; the book First Steps of HTA in Lithuania (5) was issued together with SBU in 1993; participation in the International Society of Technology Assessment in Health Care (ISTAHC) conferences; participation in development of training courses and European networks of HTA; new people in HTA were trained in health accreditation service, Sickness Fund, and Ministry of Health. The major step was establishment of an evidence-based medicine library. In 1994, Article 54 in the Health Care System Law, which declares that the use of healthcare technologies that have not been assessed or approved shall be prohibited, except in cases provided by law, was passed. The procedure of healthcare technologies assessment and approval was to be established by the Ministry of Health Care. A policy of HTA was approved with the program for HTA in 1999 in the Ministry of Health. Currently, enthusiasts of HTA fully realize that technology assessment is a developing frontier for creative and constructive thinking from all disciplinary view points. Unfortunately, in this country, there is still a very small demand for HTA reports from the decision-maker's side. Hopefully joining the network of European Union Network for Health Technology Assessment (EUnetHTA) will give a new challenge for further policy development.

History of health technology assessment: A commentary

I have long felt the need for documentation on the global development—I could probably pin it to the moment I was visiting health technology assessment (HTA) institutions in the United States in 1995, and was looking forward to a trip to the Office of Technology Assessment, only to be told it had just been shut. Instead, I visited the Office of Health Technology Assessment in Washington. In addition, I have observed that some regular attendees of annual meetings of International Society of Technology Assessment in Health Care (ISTAHC) and then Health Technology Assessment International (HTAi), have been slowly dropping out, so that a lot of the history as well as their valuable experiences and expertise have been lost. To be fair, studies have been written about specific HTA institutions, programs, countries, and even regions. Attempts have also been made to chart the history of HTA, but these have, however, fizzled out. Why is this important? Going back to my personal experience, when I first set out to establish HTA in Malaysia, I was plagued with several questions—apart from the obvious one about what HTA really meant, there were others like what organization structure should it have, what should be the work process, how could HTA be used, to name a few. I needed to know what the options were, for example, in coming up with an organizational structure, and to understand these options I would need to look at organizational models in other countries—should it be a national office with regional offices like the Canadian model, or a fully public agency but not within the department of health, like the Swedish model, or an almost independent agency like the Catalan agency in Barcelona. In the absence of a detailed account with the information I sought, I actually had to physically visit various agencies to study their organizational structure, work process, and application, to hear of the challenges they faced, and to learn from their experiences of what could work and what may not.

Health technology assessment

Health technology assessment (HTA) (1), also known as healthcare technology assessment or medical technology assessment, is a form of policy research that systematically examines short- and long-term consequences of the application of a health technology, a set of related technologies, or an issue related to technology. The goal of HTA is to provide input to decision making in policy and practice. The essential properties of HTA are this orientation to decision making and its multidisciplinary and comprehensive nature.

Health Technology Assessment in Health-Care Decisions in the United States

Health technology assessment (HTA) is a form of policy research that examines shortand long-term consequences of the application of a health-care technology. Properties assessed include evidence of safety, efficacy, patient-reported outcomes, real-world effectiveness, cost, and cost-effectiveness as well as social, legal, ethical, and political impacts [1]. At least five distinct activities define a formal health technology assessment process: 1) horizon scanning; 2) topic determination and queuing; 3) collection and assessment of evidence; 4) appraisal; and 5) funding and policy implementation. Horizon scanning involves the early examination and active monitoring of emerging technology to determine, in part, potential evidence requirements, and budgetary implications. Topic determination and queuing activities focus on setting priorities and sequencing of emerging and previously considered technologies for assessment or reassessment. The assessment function entails the process of collecting, evaluating, and systematically reviewing all available evidence for the technology under consideration. Appraisal is the decision-making function and is often distinguished by an external body (e.g., a pharmacy and therapeutics committee in the United States) that considers and weighs the summarized evidence in order to render a recommendation to the payer. Funding and policy implementation are the final steps in the HTA process. The explicit objective of organizations that operate formal HTA programs is to carefully consider a full range of clinical and economic evidence in order to render decisions as to the acceptance, modification, or rejection of technologies on a rational basis [2]. The UK National Health Service National Coordinating Center for HTA suggests that HTA programs directly consider the following attributes of health technology as they undertake their mission: When compared with existing alternatives, does the technology work, in whom does the technology work, and what is the cost impact? [3]. The funding for and use of health technology assessment programs in the United States has a long and storied history, is fragmented and uncoordinated, and includes both public and private sector initiatives. Some readers will be surprised to learn that a number of US HTA programs predate the development of well-known international efforts in Australia (Pharmaceutical Benefits Advisory Committee), Canada (Canadian Agency for Drugs and Technologies in Health), Sweden (Swedish Council on Technology Assessment in Health Care) and the United Kingdom (National Institute for Health and Clinical Excellence [NICE]). Regrettably, a number of these early US initiatives have been discontinued or have been substantially altered in large part because of political, financial and commercial pressures. In this article, we consider the changing landscape for systematic health technology assessment in the United States and what it means for health-care payers. In Section I, we start with a description of the many public and private agencies supplying and using health technology assessment reports to make coverage and reimbursement decisions. In Section II, against a backdrop of escalating costs and few restrictions on the pricing and use of health-care technology, we discuss the factors that are shaping and challenging private and public sector HTA programs. Finally, in Section III, we offer commentary on the potential role that a more formal approach to HTA can play in health care in the United States.

How guidance on the use of interventional procedures is produced in different countries: An international survey

Technology assessment systems for interventional procedures (including surgical operations, minimally invasive procedures, and others) have lagged behind those for pharmaceutical treatments. Such systems have been introduced in some countries during the past decade amid debate about how they should be organized, but there is no collated information about where they exist or how they work. This study was designed to provide hitherto unavailable information about the existence, organization, methods, and outputs of systems aimed at influencing the use of interventional procedures in different countries. Data were gathered from a questionnaire survey of key informers associated with healthcare technology assessment (HTA) organizations in different countries. Responses were received from key informers working for twenty-eight HTA organizations in twenty-five countries (response rate 83 percent). Information about a national system for assessing interventional procedures was obtained for fifteen countries. There was substantial variability in the type and funding of these organizations, the systems used for the selection of procedures, the types and sources of evidence used, the personnel involved in the appraisal of the evidence, the arrangements for consultation on the draft assessment, the format of assessment recommendations, the status of the guidance, and the use of guidance from other countries. Guidance on interventional procedures is produced variably in different countries--and not at all in some. Greater international collaboration in the assessment of new interventional procedures could help to optimize the efficiency of existing systems as well as the quality of the assessments, by capitalizing on the outputs from scarce (international) resources and expertise.

The challenge of selection bias and confounding in palliative care research.

The early successes of hospital- and community-based hospice and palliative care programs have led to rapid growth of these services over the past several decades.1,2 This widespread adoption is generally seen as a positive addition to the care of patients with complex illness. However, the growth in palliative care and hospice programs creates challenges for research, especially in the use of randomized controlled trial (RCT) designs, which are deemed the gold standard of research methods because of their ability to control for biases in the estimates of treatment effects. As Carlson and Morrison3 noted in their introduction to this research methods series, sometimes RCTs can be impossible to conduct due to inherent challenges in recruiting seriously ill participants, or may not be ethically appropriate in the absence of clinical equipoise. To date, observational studies have provided much of the evidence demonstrating the effectiveness of palliative care interventions on outcomes including pain and symptom management,4–9 communication between clinicians, patients, and families,10–13 patient and family satisfaction with care,8,14 and on reducing the costs of care while maintaining or improving quality.8,15–20 Observational studies have been criticized for their methodological weaknesses, yet it would be a mistake to dismiss their use as they have and will continue to offer important insights into the real world of hospice and palliative care.

Editorial

In 1982 we began discussions about the need for a new journal devoted to exploring the impact of technology on health care, and in 1984 we signed on with Cambridge University Press to launch theInternational Journal of Technology Assessment in Health Care. The first issue appeared in 1985 in connection to the inaugural meeting that year of the International Society for Technology Assessment in Health Care (ISTAHC), which has held annual meetings for 18 years starting in Washington DC in 1986. The Society was later reformed as Health Technology Assessment International (HTAi) in 2003. The Journal has served as the official scientific publication of both ISTAHC and HTAi for 24 years, and its mission remains as it was stated in the introduction to the first issue: to serve as an international forum to explore the effects of health care technology, and to provide “a channel of communication among the diverse and world-wide audience of scholars, practitioners, policy makers, and administrators concerned with this issue. . .to nurture the discipline of technology assessment” (1).

Rapid reviews versus full systematic reviews: An inventory of current methods and practice in health technology assessment: Corrigendum

In the article entitled “Rapid reviews versus full systematic reviews: An inventory of current methods and practice in health technology assessment,” by Watt et al. in volume 24 number 2 (Spring 2008) ofInternational Journal of Technology Assessment in Health Care, the affiliation of Stephen Blamey is incorrectly listed as Department of Health & Ageing. Dr. Blamey is the current Chair of the Medical Services Advisory Committee (MSAC). MSAC is an independent scientific committee comprising individuals with expertise in clinical medicine, health economics, and consumer matters. The Department of Health & Ageing administers funding and operations for MSAC. However, members of MSAC act independently of the Department. As Chair of MSAC, Dr. Blamey can be contacted through the Department. Dr. Blamey is not affiliated with the Department of Health and Ageing and his contribution to the above-mentioned article does not reflect its policy. Dr. Blamey wishes to apologize for this misunderstanding.

Treatment and assessment of neglect after stroke – from a physiotherapy perspective: A systematic review

The aim of the review was to determine, from a physiotherapeutic perspective, existing tools that assess neglect and whether there was support for the positive effect of physiotherapeutic interventions on neglect after stroke. The review was based on publicized randomized controlled studies and reviews about neglect and stroke. The databases PubMed (Medline), Ahmed, Cinahl, PeDRO and PsycINFO were queried from 1980 until March 2007. A checklist from the Swedish Council on Technology Assessment in Health Care (SBU) was used to evaluate the quality of randomized controlled studies; a model for analysis of systematic reviews from SBU was used for reviews. Specific training for the neglect syndrome was recommended. There was moderate evidence for spatio-motor cueing and scanning training towards the effected side. The literature also indicated that trunk rotation or repeated neck muscle vibrations when associated with an extensive training programme, mental imagery training, video feedback training and prism adaptation could be recommended for the rehabilitation of stroke patients with neglect. Treatment with Constraint-Induced Movement Therapy (CIMT) has shown some promising results. None of the tools designed to assess neglect evaluated physical performance. From a physiotherapeutic point of view, there is limited evidence for treatment of patients with neglect after stroke and the way neglect should be assessed. Scanning training and activation of the affected hemisphere with spatio-motor cueing can be effectual. Several assessment tools in combination are recommended. Further randomized controlled trials with larger samples concerning physiotherapeutic interventions are warranted, in order to evaluate new techniques targeting cognitive processes contributing to clinical manifestations of neglect.

Using the literature to quantify the learning curve: A case study

In the first paragraph in the “Description of Studies” subsection and the sole paragraph of the “Procedure Time” subsection of the “RESULTS” section on page 257 of Volume 23 Number 2 ofInternational Journal of Technology Assessment in Health Care, two tables are listed as “published on the Web site.” However, no link was provided.

Urinary incontinence: Evaluation of an information campaign directed towards the general public

To study and evaluate the effect of an information campaign in the form of a brochure on urinary incontinence (UI) directed towards the general public, concerning knowledge, individual health behaviour, self-reported healthcare utilization and how the information was perceived. Within a community in central Sweden a random sample of the population, in age groups from 18 years upwards, was selected from the population registry, resulting in a total sample of 3,658 people. The study group was sent the brochure "Treatment of urinary incontinence", produced by SBU (Swedish Council on Technology Assessment in Health Care) in March 2003 and a questionnaire 1-2 months after the brochure was received. The overall response rate was 47.5%. Eighty per cent of the responders stated UI as an important health problem in society and 66% that they had gained new knowledge on UI. Twenty-eight per cent of the responders reported a current or previous history of UI, of whom 49% felt that they had received useful information for self-treatment and 21% had begun self-treatment. This population-based study found that the distribution of a brochure on UI to the general public was well received and can be an efficient method to spread knowledge and encourage self-management.

Measuring the validity of early health technology assessment: Bibliometrics as a tool to indicate its scientific basis

The aim of this study was to assess whether publications of importance for improving the health system and its technologies are highly cited intrascientifically. Bibliometric assessment of the 596 publications used as sources in the fifty SBU Alerts from 2001 to 2004 from the Swedish Council on Technology Assessment in Health Care was carried out using the Thomson Scientific citation indexes. Normalized citation scores were calculated for all included studies. Additional factors such as the time and place of the research, subject categories, and journal source were analyzed. On average, the sources in SBU Alert have been cited eight times more than the world average consistently during the time period and across research areas. Articles used as its scientific basis are often published in a few, high impact, general medical journals. However, many of the articles are published in field-specific journals with low impact factors. Most articles used in SBU Alert are published by authors based in the United States or the United Kingdom. However, Swedish, Danish, and Dutch publications are overrepresented in its science base, whereas Japanese, Taiwanese, Indian, and Russian publications are underrepresented. Publications used as sources in a Swedish system for identification and early assessment of new methods in health care are also highly cited within the scientific community. This finding increases the appropriateness of using bibliometric indicators in evaluations of clinical research and suggests that decision makers through SBU Alert are getting scientifically sound advice.

Health care technology assessment and transfer

Health care technology assessment and transfer

Healthcare technology and technology assessment

Healthcare technology and technology assessment

Commentary on “Health economics and the value of therapy in Alzheimer’s disease.” Cost-effectiveness studies

The high prevalence of dementia has a great impact on the formal care systems as well as on the situation for informal caregivers. Thus the question of cost effectiveness is crucial. This paper is based on the health-economic portion of the dementia project of the Swedish Council on Technology Assessment in Healthcare. After a database search and quality judgment of papers, 35 papers were included (22 were pharmacoeconomic studies, and 13 focused on programs, such as daycare, caregiver support, and living arrangements). No empirical drug study was regarded as a complete health-economic study. Of the four prospective, randomized, controlled trials, three yielded a nonsignificant difference regarding costs (all for donepezil), whereas there was a significant cost reduction in the Memantine study (favoring Memantine treatment), mainly due to reduction in caregiver time. The majority of the complete pharmacoeconomic modeling studies showed a dominance for drug treatment, indicating cost effectiveness. In conclusion, as regards the cost effectiveness of treatment for Alzheimer’s disease, no evidence could be stated in terms of empirical studies, mainly because of a lack of studies. Although most models indicated cost effectiveness, the Swedish Council on Technology Assessment in Healthcare did not regard this as sufficient evidence of cost effectiveness. There is a need for larger and longer empirical studies, and for enlarged sensitivity analyses, in terms of model studies.

Healthcare technology and technology assessment.

New technology is one of the primary drivers for increased healthcare costs in the United States. Both physician and industry play important roles in the development, adoption, utilization and choice of new technologies. The Federal Drug Administration regulates new drugs and new medical devices, but healthcare technology assessment remains limited. Healthcare technology assessment originated in federal agencies; today it is decentralized with increasing private sector efforts. Innovation is left to free market forces, including direct to consumer marketing and consumer choice. But to be fair to the consumer, he/she must have free knowledge of all the risks and benefits of a new technology in order to make an informed choice. Physicians, institutions and industry need to work together by providing proven, safe, clinically effective and cost effective new technologies, which require valid pre-market clinical trials and post-market continued surveillance with national and international registries allowing full transparency of new products to the consumer--the patient.

Methodology of constructive technology assessment in health care

Technologies in health care are evolving quickly, with new findings in the area of biotechnological and genetic research being published regularly. A health technology assessment (HTA) is often used to answer the question of whether the new technology should be implemented into clinical practice. International evidence confirms that the results of HTA research sometimes have limited impact on practical implementation and on coverage decisions; the study design is commonly based on the paradigm of stability of both the technology and the environment, which is often not the case. Constructive technology assessment (CTA) was first described in the 1980s. In addition to the traditional HTA elements, this approach also takes into account the technology dynamics by emphasizing sociodynamic processes. With a CTA approach, comprehensive assessment can be combined with an intentional influence in a favorable direction to improve quality. In this study, the methodological aspects mainly concerning the diagnostic use of CTA are explained. The methodology will be illustrated using the controlled introduction of a new technology, called microarray analysis, into the clinical practice of breast cancer treatment as a case study. Attention is paid to the operationalization of the phases of development and implementation and the research methods most appropriate for CTA. In addition to HTA, CTA can be used as a complementary approach, especially in technologies that are introduced in an early stage of development in a controlled way.

Cost–effectiveness of treatments for Alzheimer’s dementia

Care of dementia is extremely resource demanding and has a great impact on both the formal care systems and the situation for informal carers. Thus, the question of cost–effectiveness is crucial. This presentation is, to a great extent, based on the dementia project by the Swedish council on technology assessment in health care. After the database search and quality judgment of papers, 22 papers of drug treatment were finally included. A summary of the situation as regards cost–effectiveness on drugs for Alzheimer’s disease showed that no evidence could be stated on empirical studies. Although most modeling studies indicate cost–effectiveness, this was not regarded as enough support for cost–effectiveness since the empirical studies were inconclusive. The need for larger empirical studies of high standards of quality and modeling studies including an enlarged sensitivity analysis, is evident.

Long-term Stability of Orthodontic Treatment and Patient Satisfaction

To evaluate morphologic stability and patient satisfaction at least 5 years after orthodontic treatment. Published literature was searched through the PubMed and Cochrane Library electronic databases from 1966 to January 2005. The search was performed by an information specialist at the Swedish Council on Technology Assessment in Health Care. The inclusion criteria consisted of a follow-up period of at least 5 years postretention; randomized clinical trials, prospective or retrospective clinical controlled studies, and cohort studies; and orthodontic treatment including fixed or removable appliances, selective grinding, or extractions. Two reviewers extracted the data independently and also assessed the quality of the studies. The search strategy resulted in 1004 abstracts or full-text articles, of which 38 met the inclusion criteria. Treatment of crowding resulted in successful dental alignment. However, the mandibular arch length and width gradually decreased, and crowding of the lower anterior teeth reoccurred postretention. This condition was unpredictable at the individual level (limited evidence). Treatment of Angle Class II division 1 malocclusion with Herbst appliance normalized the occlusion. Relapse occurred but could not be predicted at the individual level (limited evidence). The scientific evidence was insufficient for conclusions on treatment of cross-bite, Angle Class III, open bite, and various other malocclusions as well as on patient satisfaction in a long-term perspective. This review has exposed the difficulties in drawing meaningful evidence-based conclusions often because of the inherent problems of retrospective and uncontrolled study design.

Frederick Mosteller (1916–2006): Mentoring, A Memoir

Frederick Mosteller was born in Clarksburg, West Virginia, at the time of the birth of medical technology assessment (10). During a long academic career at Harvard, he, probably more than any other person, contributed to techniques of assessment of therapy and outcome (6;14;29). Much of his seminal writing was published in theInternational Journal of Technology Assessment in Health Care(1;3;8;12;16;17;19;21–23).