Objectives:To compare the six-year outcome of a multidisciplinary rehabilitation program with continued care within primary care in terms of health-related quality of life and cost-effectiveness. Furthermore, predictors of total costs to society were examined.

Methods:A prospective, matched, controlled, six-year follow-up was designed. The study included 236 patients (42 men, 194 women) nineteen to sixty-one years of age with prolonged musculoskeletal disorders. The intervention comprised a four-week multidisciplinary rehabilitation and an active one-year follow-up based on a bio-psycho-social approach. The control group received continued care within primary care. The main outcome measures were quality of life measured using the Nottingham Health Profile, motivation identified by an interview and patient-specific total costs to society. Differences in mean costs between groups and cost-effectiveness were evaluated by applying nonparametric bootstrapping techniques.

Results: Total costs per treated patient in the rehabilitation group and the control group were £43,464 (SD=31,093) and £44,123 (SD=33,333), respectively (p=.896). Multidisciplinary rehabilitation improved quality of life somewhat more cost-effectively. Motivation was revealed as a predictor of total costs.

Conclusion: In the long-run, the evaluated multidisciplinary rehabilitation improved the highly motivated patients' quality of life most cost-effectively. The latently motivated patients may require rehabilitation, which is less intensive and with a longer duration, to improve their health in a whole-person perspective. The burden of prolonged musculoskeletal disorders to society was reaffirmed. Motivation could be a predictor of total costs, a factor which has to be taken into account in the examination procedure.

Objectives: Whether cost-effectiveness of secondary health care can be measured in a simple, yet commensurate way was studied.

Methods: Approximately 4,900 patients' health-related quality of life scores before and after treatment were measured. Used were a combination of quality of life data with diagnostic and financial indicators routinely collected in the hospital.

Results: Seventy percent of patients returned the first questionnaire and the informed written consent to participate. Of these patients, 80 percent also returned the second questionnaire sent out 3 to 12 months after treatment, depending on clinical specialty and diagnostic category. The routine of sending out questionnaires could be automated in such a way that data collection required only a limited amount of extra work. Patients were generally satisfied with the fact that the hospital was interested in their well-being also after treatment. No physician offered the chance to participate refused data collection in the patient group he or she was responsible for. The attitudes of the nursing staff were generally positive toward data collection, although it caused some extra work for some of them. The possibility of relating already routinely collected financial performance indicators with a relevant measure of treatment effectiveness, opened prospects for refined analysis of cost-effectiveness of secondary health care.

Conclusions: Routine collection of health-related quality of life data as an indicator of treatment effectiveness is feasible, requires only a small amount of extra work, and is potentially very useful when combined with existing measures of hospital performance.

The study by Hutton, Trueman, and Henshall provides a thoughtful and helpful set of observations about the potential benefits of linking reimbursement to requirements for further clinical research (coverage with evidence development—CED), as well as the likely challenges and obstacles to implementation. In this commentary, we will expand upon several of the key points made in their study and offer some additional suggestions for moving this policy discussion forward

Objectives: The history of health technology assessment (HTA) in Mexico is examined, starting with the efforts to incorporate this topic into the policy agenda and culminating with the recent creation of a specialized public agency.

Methods: Information was gathered through a bibliographic search and interviews with actors involved in HTA in Mexico.

Results: HTA efforts were developed in Mexico since the mid-1980s with the participation both of academics and of policy makers, a relationship that eventually led to the creation of the Center for Technological Excellence within the Ministry of Health.

Conclusions: Institutionalization of HTA in resource-constrained settings requires the development of a critical mass of researchers involved in this field, the implementation of information efforts, and the establishment of strong relationships between HTA experts and policy makers.

The greatest problem concerning health care technology for developing countries is that they are dependent upon the industrialized world for technology. The only short-term solution to this problem is to improve the choices that are available to them. This goal will require changes in the structure and processes of policy making. A particular difficulty for these countries is the lack of trained personnel in fields related to technology assessment.

Great variation exists in the health care delivery systems throughout Latin America and the Caribbean. In general, medical technology is concentrated in large cities at private hospitals that serve a small, elite segment of the population. What is missing in most of these countries is a clearly defined social policy guaranteeing distribution of medical technology to all segments of society. While data is scarce, it appears that political and economic concerns, rather than medical concerns, determine what and how much technology will be available to all segments of the society. Products are sometimes imported that compete with domestically produced ones. Moreover, transfers of technology often fail to include the necessary knowledge to make imported technology truly useful. However, current economic crises throughout the region are forcing changes in policies; as a result, there is a new emphasis on domestic production of technology over imports and the evaluation of medical technology for its appropriate use in Latin America and the Caribbean.

Objectives: We compared Polish and Scottish Health Technology Assessment (HTA) process in order to elicit recommendations for future development of HTA methodological guidelines in Poland.

Methods: We studied the differences between Polish and Scottish HTA methodological guidelines. HTA recommendations issued by Polish HTA agency (AHTAPol) in the period January 1 through December 31, 2008, were benchmarked to HTA guidance published by Scottish Medical Consortium (SMC) for the same drug technology.

Results: The Scottish HTA methodological guidelines were more instructive in terms of clinical and economic evaluations than Polish guidelines. SMC evaluated forty-eight of sixty-eight drug technologies appraised by AHTAPoL. There were thirty drug technologies that received similar guidance in both countries and eighteen with contradictory HTA recommendations. In Scotland, there were more positive HTA recommendations than there were in Poland. While comments about efficacy or safety were commonplace among reasons for negative recommendations in Poland, insufficient justification of treatment's cost in relation to benefits was the most often cited reason for rejection in Scotland. SMC tended to recommend restricted use to specific sub-populations for several drug technologies negatively appraised by AHTAPoL.

Conclusions: The comparison between SMC and AHTAPoL suggests that there is potential room of improvement of the Polish HTA methodological guidelines. Comparative effectiveness and safety, subgroup analysis, and adaptation of models to local settings were identified as key areas for further development of Polish HTA methodological guidelines.

Objectives: For medical devices, benefits other than direct clinical effects may have a large impact on the patients’ well-being, but a standardized method for measuring these benefits is unavailable. The objective was to explore potential patient benefits provided by medical devices, and to assess the relative preferences of these benefits in the general Swedish population.

Methods: To identify attributes of patient benefit, healthcare personnel within a wide range of disease areas were interviewed. The generalized attributes were then validated among healthcare personnel, patient organizations, and manufacturers; in two pilot studies in the general population; and in two rounds of cognitive interviews. The general population's preferences of the attributes were measured with a usability-tested questionnaire in a final responding sample of 3,802 individuals, representative of the Swedish population.

Results: Twenty attributes were identified, encompassing aspects of integrity, sense of security, social participation, and convenience. When measuring the relative preferences, the response rate was 37.0 percent, and the results showed that the attributes with the highest preferences concerned reliability, reduced need for assistance, and sense of control of the illness/disability.

Conclusions: A set of twenty attributes of patient benefit relevant to users of medical devices was identified and validated. A questionnaire for patient-reported assessment of the benefits provided by a medical device was developed, based on the attributes. The questionnaire, designated MedTech20, provides a generic measurement method for the evaluation of medical devices used in a wide range of diseases/disabilities.

Objectives: To describe the first hospital-based health technology assessment (HTA) program in a public hospital in Argentina, and report some clinical, educational, economic and organizational results after 10 years of its implementation.

Methods: A hospital-based HTA program was created in March 2001 at Hospital Garrahan (Buenos Aires, Argentina), a national pediatric facility with a self-managed budget. Its main goal is to promote a rational and evidence-based technologic development. The program consists of HTA reports for technology acquisition, clinical practice guidelines (CPG), capacity building in research and management, and technical support for health services research (HSR). The evaluation cycle comprises: prioritization, evidence synthesis, dissemination and monitoring. We report program performance, comment educational and organizational effects, and discuss unresolved issues and future challenges.

Results: During the first 10 years the program produced 18 HTA reports on drugs (6 = 33 percent), therapeutic (6 = 33 percent), preventive (2 = 11 percent) or diagnostic (2 = 11 percent) procedures and institutional programs (3 = 17 percent). The scope covered effectiveness (12 = 67 percent), safety (10 = 56 percent), budget impact (6 = 33 percent), cost-effectiveness (2 = 11 percent) and organizational impact (3 = 17 percent). Mean time from request to report was 10 months. Eleven pediatric CPGs were submitted to expert consensus and disseminated for full-text Web access. A 1-year course on research and management was completed by 225 professionals in 6 years, and twenty-two projects for HSR were coached.

Conclusions: Our experience shows that an HTA program is both feasible and useful in a public hospital of a developing country. Promotion of hospital-based HTA, professional integration in HTA activities and network collaboration to discuss unresolved issues with colleagues can multiply the benefits and optimize the use of hospital budgets.

Chorionic villus sampling (CVS), a new technique for prenatally diagnosing chromosomal and genetic disorders, may soon replace amniocentesis. This procedure, performed by inserting a catheter through the pregnant woman's cervix or through the abdomen and removing cells from the placenta, has the advantages of being available earlier in the pregnancy than amniocentesis (at 9 to 11 weeks gestational age) and of yielding results in a shorter time. Although the medical aspects of the procedure are being investigated, its psychosocial and policy implications have not been studied systematically. These issues include the subjective assessment of risk that prompts women to choose or to reject CVS, the implications of earlier diagnosis for feelings about abortion, the potential of negative findings (i.e., the absence of the designated disorder) for well-being during the remainder of the pregnancy, the ramifications of first trimester identification of fetal sex, equity of access to prenatal diagnosis, and the possible over- utilization of these procedures. Drawing on previous research regarding amniocentesis and more recent research concerning CVS, this article discusses the potential implications of CVS.

Objectives: To review the existing health economic literature on meningococcal disease vaccination.

Methods: A Medline search for economic evaluations of vaccination programs for meningococcal disease in developed countries was conducted. All identified studies were reviewed.

Results: Nine published studies were identified examining either mass vaccination during outbreaks or routine vaccination. Although net expenses were estimated in almost all studies, the resulting cost-effectiveness ratios varied widely. Vaccination of college-age students was found to be potentially cost-effective in Australia but not in the United States. With one exception, routine vaccination of children and adolescents in Europe was predicted to be cost-effective. Many simplifying assumptions were made, and important elements were often left out, in particular the potential for reduced transmission of disease.

Conclusions: The methods used and the vaccination strategies vary widely, and results do not provide strong grounds for making conclusions as to whether vaccination is cost-effective. Furthermore, in all instances, transmission of disease, changes in population carriage rates, and outbreaks are either ignored, dealt with using very broad simplifying assumptions, or are not necessarily generalizable to other settings. The analyses provide some insight into the potential cost-effectiveness of vaccination, but more importantly, they highlight areas requiring further study. Economic evaluations based on observed outcomes from recently implemented strategies would be helpful, as would more sophisticated health economic models. The choice of vaccination strategies cannot be based on the results of existing economic analyses.

The Republic of Singapore is an island city-state in Southeast Asia. Its population enjoys good health and the Singapore Ministry of Health's mission is to promote good health and reduce illness, ensure access to good and affordable health care, and pursue medical excellence. This is achieved through a healthcare system that includes both private and public sector elements. The financing philosophy of Singapore's healthcare delivery system is based on individual responsibility and community support. Health care in Singapore is financed by a combination of taxes, employee medical benefits, compulsory health savings, insurance, and out-of-pocket payment. The capability for health technology assessment in Singapore was developed concurrently with its medical device regulation system in the 1990s. The first formal unit with health technology assessment (HTA) functions was established in September 1995. Today, HTA features in decision making for the Standard Drug List, licensing of medical clinics, the Health Service Development Programme, healthcare subsidies, and policy development. The public sector healthcare delivery clusters have also recently started health services research units with HTA functions. Singapore is organizing the 6th Health Technology Assessment International (HTAi) Annual Meeting in June 2009. Bringing this prestigious international conference to Asia for the first time will help raise awareness of HTA in the region.

Objectives: The association between type and amount of clinical evidence and type of National Institute for Health and Clinical Excellence recommendations for interventional procedures was examined.

Methods: The evidence about 736 studies (including 183,729 patients) relating to 130 different interventional procedures and about relevant recommendations was analyzed. Associations were examined between type of recommendation (“normal arrangements” or “cautionary guidance”) and evidence type, total number of treated patients, and mean follow-up length. Evidence type was categorized as (a) randomized, (b) nonrandomized controlled, and (c) case series/reports. The main outcome measures were frequency of evidence type, total number of patients treated, and mean follow-up length, by type of recommendation.

Results: “Normal arrangements” recommendations were made for 70 (54 percent) procedures and “cautionary guidance” was issued for 60 (46 percent) procedures. Procedures supported by at least one randomized study (34 percent, n = 44) were more likely to receive a “normal arrangements” recommendation (relative risk 1.38, p = .063). Overall, there were 85 (12 percent), 135 (18 percent), and 516 (70 percent) studies in categories a–c, respectively. The number of treated patients was significantly larger among procedures with “normal arrangements” (median, 605; range, 26–6,842) than among those with “cautionary guidance” (median, 240; range, 1–3,261; p < .001) recommendation. Mean follow-up length was longer in studies relating to procedures with “normal arrangements” recommendation (median, 16.7; range, 0–84 months) compared with those with “cautionary guidance” (median, 14.6; range, 0–67 months; p = .160).

Conclusions: Procedures supported by randomized studies, and with larger numbers of patients and longer follow-up length, were more likely to receive positive guidance. Future research and development on interventional procedures should aim to produce better and more relevant evidence to optimize the possibility of such procedures being accepted by policy makers.

From its inception in 1999, the National Institute for Health and Care Excellence (NICE) committed to including the expertise, experiences, and perspectives of lay people, patients and carers, and patient organizations in its health technology assessments (HTAs). This is our story of patient involvement in HTA: from early methods designed for use when assessing medicines, widening to address the different requirements of HTAs for interventional procedures, medical technologies, and diagnostic technologies. We also chart the evolution and development of all our patient involvement methods over the past 20 years through regular evaluation and by responding to external challenge. However, we know that processes and methods alone are not enough. Through case studies we demonstrate the value of patient involvement in HTA and highlight the unique perspectives and experiences that patients bring to HTA committees. Finally, we discuss the underpinning principles and commitments that have made NICE a world leader in delivering meaningful and legitimate patient involvement.

This paper considers the question of what ought to be valued in the context of measuring the outcomes of healthcare interventions. The answer is discrete health states in the case of the quality-adjusted life-year (QALY) model and an entire health profile in the case of the healthy-years equivalent (HYE) approach. How well the weighted average of values attached to the former approximates the overall value attached to the latter depends on the validity of the assumptions of the QALY model. The paper considers some of the empirical literature relating to them. One of the most important assumptions, which from the limited evidence available appears not to hold, is additive separability. However, it is argued that violation of this assumption does not in itself invalidate the QALY approach, since in some circumstances it might be more appropriate to elicit the value of a health state independently of the states that succeed it. Investigation into this issue is identified as one of the key areas where future research efforts should be directed.

Objectives: The aim of this study was to evaluate the universal newborn hearing screening (UNHS) and intervention program in Shanghai, China.

Methods: This study included the quantitative analyses of the UNHS-Shanghai database in 2002–12 and qualitative assessment of the program. The Otoacoustic Emissions and the Automated Auditory Brainstem Evoked Responses tests were conducted in screening. The costs and benefits were calculated based on the number of participants in each stage. The short-term and long-term periods were defined as from birth to 15 years of age or to death (82-year-olds), respectively. Sensitivity analyses were conducted.

Results: A total 1,574,380 newborns were included, representing 93.6 percent of all eligible babies in Shanghai during the study period. The prevalence of newborn hearing loss was 1.66‰. The short-term/long-term program costs were ¥488.5 million (US$75.52 million)/¥1.08 billion (US$167.12 million), and the short-term/long-term program benefit was ¥980.1 million (US$151.53 million)/¥8.13 billion (US$1.26 billion). The program benefit was greater than its cost if the proportion of hearing-loss children enrolled in regular schools was no less than 41.4 percent of all hearing impaired children, as well as if the wage growth rate ranged from 3 percent to 8 percent. Qualitative results also suggested that stakeholders strongly supported this program.

Conclusions: The universal newborn hearing screening and intervention program in Shanghai is justified in terms of the resource input in the long run, although there is still room for further improvement with respect to educational rehabilitation and a better infrastructure system.

Background: Most developing countries and resource-limited settings lack robust health technology assessment (HTA) systems. Because the development of locally relevant HTA is not immediately viable, and the extrapolation of external HTA is inappropriate, a new model for evaluating health technologies is required.

Objectives: The aim of this study was to describe the development and application of KNOW ESSENTIALS, a tool facilitating evidence-based decisions on health technologies by stakeholders in settings lacking formal HTA systems.

Methods: Current HTA methodology was examined through literature search. Additional issues relevant to resource-limited settings, but not adequately addressed in current methodology, were identified through further literature search, appraisal of contextually relevant issues, discussion with healthcare professionals familiar with the local context, and personal experience. A set of thirteen elements important for evidence-based decisions was identified, selected and combined into a tool with the mnemonic KNOW ESSENTIALS. Detailed definitions for each element, coding for the elements, and a system to evaluate a given health technology using the tool were developed.

Results and Conclusions: Developing countries and resource-limited settings face several challenges to informed decision making. Models that are relevant and applicable in high-income countries are unlikely in such settings. KNOW ESSENTIALS is an alternative that facilitates evidence-based decision making by stakeholders without formal expertise in HTA. The tool could be particularly useful, as an interim measure, in healthcare systems that are developing HTA capacity. It could also be useful anywhere when rapid evidence-based decisions on health technologies are required.

Objectives: The aim of this study was to obtain information on methods used to measure health technology assessment (HTA) influence, decisions that were influenced, and outcomes linked to HTA.

Methods: Electronic databases were used to locate studies in which HTA influence had been demonstrated. Inclusion criteria were studies that reliably reported consideration by decision makers of HTA findings; comparative studies of technology use before and after HTA; and details of changes in policy, health outcomes, or research that could be credibly linked to an HTA.

Results: Fifty-one studies were selected for review. Settings were national (24), regional (12), both national and regional (3) hospitals (9), and multinational (3). The most common approach to appraisal of influence was review of policy or administrative decisions following HTA recommendations (51 percent). Eighteen studies (35 percent) reported interview or survey findings, thirteen (26 percent) reviewed administrative data, and six considered the influence of primary studies. Of 142 decisions informed by HTA, the most common types were on routine clinical practice (67 percent of studies), coverage (63 percent), and program operation (37 percent). The most frequent indications of HTA influence were on decisions related to resource allocation (59 percent), change in practice pattern (31 percent), and incorporation of HTA details in reference material (18 percent). Few publications assessed the contribution of HTA to changing patient outcomes.

Conclusions: The literature on HTA influence remains limited, with little on longer term effects on practice and outcomes. The reviewed publications indicated how HTA is being used in different settings and approaches to measuring its influence that might be more widely applied, such as surveys and monitoring administrative data.