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 the International 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).

Objectives: Progression-free survival (PFS) has not been validated as a surrogate endpoint for overall survival (OS) for anthracycline (A) and taxane-based (T) chemotherapy in advanced breast cancer (ABC). Using trial-level, meta-analytic approaches, we evaluated PFS as a surrogate endpoint.

Methods: A literature review identified randomized, controlled A and T trials for ABC. Progression-based endpoints were classified by prospective definitions. Treatment effects were derived as hazard ratios for PFS (HRPFS) and OS (HROS). Kappa statistic assessed overall agreement. A fixed-effects regression model was used to predict HROS from observed HRPFS. Cross-validation was performed. Sensitivity and subgroup analyses were performed for PFS definition, year of last patient recruitment, line of treatment, and constant rate assumption.

Results: Sixteen A and fifteen T trials met inclusion criteria, producing seventeen A (n = 4,323) and seventeen T (n = 5,893) trial-arm pairs. Agreement (kappa statistic) between the direction of HROS and HRPFS was 0.71 for A (p = .0029) and 0.75 for T (p = .0028). While HRPFS was a statistically significant predictor of HROS for both A (p = .0019) and T (p = .012), the explained variances were 0.49 (A) and 0.35 (T). In cross-validation, 97 percent of the 95 percent prediction intervals crossed the equivalence line, and the direction of predicted HROS agreed with observed HROS in 82 percent (A) and 76 percent (T). Results were robust in sensitivity and subgroup analyses.

Conclusions: This meta-analysis suggests that the trial-level treatment effect on PFS is significantly associated with the trial-level treatment effect on OS. However, prediction of OS based on PFS is surrounded with uncertainty.

Objectives: This review assessed current practice in the preparation of rapid reviews by health technology assessment (HTA) organizations, both internationally and in the Australian context, and evaluated the available peer-reviewed literature pertaining to the methodology used in the preparation of these reviews.

Methods: A survey tool was developed and distributed to a total of fifty International Network of Agencies for Health Technology Assessment (INAHTA) members and other selected HTA organizations. Data on a broad range of themes related to the conduct of rapid reviews were collated, discussed narratively, and subjected to simple statistical analysis where appropriate. Systematic searches of the Cochrane Library, EMBASE, MEDLINE, and the Australian Medical Index were undertaken in March 2007 to identify literature pertaining to rapid review methodology. Comparative studies, guidelines, program evaluations, methods studies, commentaries, and surveys were considered for inclusion.

Results: Twenty-three surveys were returned (46 percent), with eighteen agencies reporting on thirty-six rapid review products. Axiomatic trends were identified, but there was little cohesion between organizations regarding the contents, methods, and definition of a rapid review. The twelve studies identified by the systematic literature search did not specifically address the methodology underpinning rapid review; rather, many highlighted the complexity of the area. Authors suggested restricted research questions and truncated search strategies as methods to limit the time taken to complete a review.

Conclusions: Rather than developing a formalized methodology by which to conduct rapid reviews, agencies should work toward increasing the transparency of the methods used for each review. It is perhaps the appropriate use, not the appropriate methodology, of a rapid review that requires future consideration.

Objectives: Many existing healthcare interventions diffused before modern evidence-based standards of clinical- and cost-effectiveness. Disinvestment from ineffective or inappropriately applied practices is growing as a priority for international health policy, both for improved quality of care and sustainability of resource allocation. Australian policy stakeholders were canvassed to assess their perspectives on the challenges and the nature of disinvestment.

Methods: Senior health policy stakeholders from Australia were criterion and snow-ball sampled (to identify opinion leaders). Participants were primed with a potential disinvestment case study and took part in individual semistructured interviews that focused on mechanisms and challenges within health policy to support disinvestment. Interviews were taped and transcribed for thematic analysis. Participant comments were de-identified.

Results: Ten stakeholders were interviewed before saturation was reached. Three primary themes were identified. (i) The current focus on assessment of new and emerging health technologies/practices and lack of attention toward existing practices is due to resource limitations and methodological complexity. Participants considered a parallel model to that of Australia's current assessment process for new medical technologies is best-positioned to facilitate disinvestment. (ii) To advance the disinvestment agenda requires an explicit focus on the potential for cost-savings coupled with improved quality of care. (iii) Support (financial and collaborative) is needed for research advancement in the methodological underpinnings associated with health technology assessment and for disinvestment specifically.

Conclusions: In this exploratory study, stakeholders support the notion that systematic policy approaches to disinvestment will improve equity, efficiency, quality, and safety of health care, as well as sustainability of resource allocation.

Objectives: A vaccine to prevent diseases due to human papillomavirus (HPV) types 6, 11, 16, and 18 is now available in France. The objective of this study was to assess the health and economic impact in France of implementing a quadrivalent HPV vaccine alongside existing screening practices versus screening alone.

Methods: A Markov model of the natural history of HPV infection incorporating screening and vaccination, was adapted to the French context. A vaccine that would prevent 100 percent of HPV 6, 11, 16, and 18-associated diseases, with lifetime duration and 80 percent coverage, given to girls at age 14 in conjunction with current screening was compared with screening alone. Results were analyzed from both a direct healthcare cost perspective (DCP) and a third-party payer perspective (TPP). Indirect costs such as productivity loss were not taken into account in this analysis.

Results: The incremental cost per life-year gained from vaccination was €12,429 (TPP) and €20,455 (DCP). The incremental cost per quality-adjusted life-year (QALY) for the introduction of HPV vaccination alongside the French cervical cancer screening program was €8,408 (TPP) and €13,809 (DCP). Sensitivity analyses demonstrated that cost-effectiveness was stable, but was most sensitive to the discount rate used for costs and benefits.

Conclusions: Considering the commonly accepted threshold of €50,000 per QALY, these analyses support the fact that adding a quadrivalent HPV vaccine to the current screening program in France is a cost-effective strategy for reducing the burden of cervical cancer, precancerous lesions, and genital warts caused by HPV types 6, 11, 16, and 18.

Pharmaceutical regulators and healthcare reimbursement authorities operate in different intellectual paradigms and adopt very different decision rules. As a result, drugs that have been licensed are often not available to all patients who could benefit because reimbursement authorities judge that the cost of therapies is greater than the health produced. This finding creates uncertainty for pharmaceutical companies planning their research and development investment, as licensing is no longer a guarantee of market access. In this study, we propose that it would be consistent with the objectives of pharmaceutical regulators to use the Net Benefit Framework of reimbursement authorities to identify those therapies that should be subject to priority review, that it is feasible to do so and that this would have several positive effects for patients, industry, and healthcare systems.

Objectives: Due to the aging baby boom population, utilization rates of diagnostic imaging (i.e., X-ray, CT, and MRI scanning) have risen rapidly relative to other health services. The aim of this study is to investigate the utilization patterns of outpatient diagnostic imaging services (X-ray, CT, and MRI) across the late life course (65 years and older).

Methods: A population-based retrospective cohort study was conducted for the period April 1, 2005, to March 31, 2006. All Ontario residents aged 65+ and eligible for government health insurance were included in the analysis.

Results: Utilization of diagnostic imaging followed an inverted U-pattern: increasing with advancing age, peaking in the 80–84 age group for CT scans and in the 70–74 age group for MRI and X-rays, and then declining in the later years. Overall, females received significantly more X-rays than males (p < .01), but males received significantly more CT and MRI scans (p < .01). A small proportion of high-users of radiology services accounted for a large proportion of overall utilization. Finally, our analysis revealed that a disproportionately large proportion of high-users of MRI services were in the highest SES quintile. No SES differences were observed for X-ray or CT scans.

Conclusions: Population aging will lead to increased demand for healthcare services. Utilization of outpatient diagnostic imaging services is associated with age, gender, and SES. Given the increasing demand and the limited resources available, there may be a need for programs to target underserved populations to reduce remediable inequities. Whereas patient-level decisions regarding the use of diagnostic imaging are rightfully determined on the basis of clinical factors, allocation decisions should also be informed by the ethical principles of equity and fairness.

Health technology assessment (HTA) is a dynamic, rapidly evolving process, embracing different types of assessments that inform real-world decisions about the value (i.e., benefits, risks, and costs) of new and existing technologies. Historically, most HTA agencies have focused on producing high quality assessment reports that can be used by a range of decision makers. However, increasingly organizations are undertaking or commissioning HTAs to inform a particular resource allocation decision, such as listing a drug on a national or local formulary, defining the range of coverage under insurance plans, or issuing mandatory guidance on the use of health technologies in a particular healthcare system. A set of fifteen principles that can be used in assessing existing or establishing new HTA activities is proposed, providing examples from existing HTA programs. The principal focus is on those HTA activities that are linked to, or include, a particular resource allocation decision. In these HTAs, the consideration of both costs and benefits, in an economic evaluation, is critical. It is also important to consider the link between the HTA and the decision that will follow. The principles are organized into four sections: (i) “Structure” of HTA programs; (ii) “Methods” of HTA; (iii) “Processes for Conduct” of HTA; and (iv) “Use of HTAs in Decision Making.”

Objectives: In 2003, the National Institute for Health and Clinical Excellence (NICE) advised that liquid based cytology (LBC) should be adopted for cervical screening in England. The aim of this study was to explore the cost implications of implementing the NICE guidance in cytology laboratories. The ThinPrep® technology was used as the case study.

Methods: An optimization model was developed to analyze options for leasing alternative LBC processing machines with different capacities. Variables entered in the model included: the cost of the contract with the supplier, the laboratory labor cost, and inter-laboratory transport costs. All costs referred to the 2005–06 financial year. A simulation program calculated mileages within laboratory networks. Alternative strategies for contracting by laboratories acting independently and by Quality Assessment Regional Centres (QARC) were analyzed.

Results: Centralizing the processing of specimens in “hub and spoke” laboratory networks was the least costly strategy. Total annual costs for England using existing transport links were £14,807,000 for 5-year contracts. If all laboratories installed processors, the annual cost for 5-year contracts placed by QARCs was £14,941,000 compared with £16,359,000 if the laboratories placed their own contracts. Three-year contracts averaged an additional £1 million: £15,912,000 for networks and £17,304,000 for independent laboratory contracts.

Conclusions: Deciding on the mode of implementation of a NICE guidance can be challenging for decision makers. These cost minimization appraisal techniques are equally applicable to national screening programs in general and to other health technologies for which there are significant cost implications associated with innovative policy directives.

Background: Decision analytic models, as used in economic evaluations, require data on several clinical parameters. The gold standard approach is to conduct a systematic review of the relevant clinical literature, although reviews of economic evaluations indicate that this is rarely done. Technology appraisals for the National Institute for Health and Clinical Excellence (NICE), which are fully funded, represent the best case scenario for the close integration of economic evaluations and systematic reviews. The objective of this study was to assess the extent to which the systematic review of the clinical literature informs the economic evaluation in NICE technology appraisals.

Methods: All NICE technology assessment reports (TARs) published between January 2003 and July 2006 were considered. Data were abstracted on the TAR topics, the primary measure of clinical effectiveness, the approach to pooling in the clinical review, the measure of economic benefit and the use, or non-use, of the systematic review in the economic evaluation.

Results: Forty-one TARs were published in the period studied, all of which contained a systematic review. Most of the economic evaluations (85 percent) were cost-utility analyses, reflecting NICE's guidelines for economic evaluation. In seventeen cases, the clinical data were not pooled in the review, owing to heterogeneity in the clinical data or the limited number of studies. In these cases, the economists used alternative approaches for estimating the key effectiveness parameter in the model. The results of the review (when pooled) were always used when the primary clinical effectiveness measure corresponded with the measure of economic benefit (e.g., survival). However, because preference-based quality of life measures are rarely included in clinical trials, the results of the systematic review were never directly used in the cost-utility analyses. Nevertheless, the outputs of the systematic review were used when the data were useful in estimating components of the quality-adjusted life-year (QALY) (e.g., the life-years gained, or the frequencies of health states to which QALYs could be assigned). Problems occurred mainly when the clinical data were not pooled, or when the measure of clinical benefit could not be converted into health states to which QALYs could be assigned.

Conclusions: Economic evaluations can benefit from systematic reviews of the clinical literature. However, such reviews are not a panacea for conducting a good economic evaluation. Much of the relevant data for estimating QALYs are not contained in such reviews and the chosen method for summarizing the clinical data may inhibit the assessment of economic benefit. Problems would be reduced if those undertaking the technology assessments discussed the data requirements for the economic model at an early stage.

Objectives: The aim of this study was to develop a methodology for calculating the need for positron emission tomography (PET) scanners in a country and illustrate this methodology for Belgium.

Methods: First, levels of evidence were assigned to PET in different indications according to a standard hierarchical classification system. The level reached depends on whether there is evidence on diagnostic accuracy, impact on diagnostic thinking, therapeutic impact, impact on patient outcomes, or cost-effectiveness. Second, the number of patients eligible for PET for each indication was derived from a registry of PET. Third, the number of PET scanners needed in Belgium was estimated for different baseline hypotheses about maximum annual capacity of a scanner and the minimally required level of evidence.

Results: The number of PET scanners needed crucially depends on the level of evidence considered acceptable for the implementation of PET: the higher the level of evidence required, the lower the number of PET scanners needed. Belgium needs at least three and at most ten PET scanners. This contrasts with the thirteen currently approved.

Conclusions: Scientific evidence and information on the eligible population for a specific procedure are crucial elements for policy makers who wish to make evidence-based decisions about programming and planning of heavy medical equipment.

Objectives: Investments in health research should lead to improvements in health and health care. This is also the remit of the main HTA program in the Netherlands. The aims of this study were to assess whether the results of this program have led to such improvements and to analyze how best to assess the impact from health research.

Methods: We assessed the impact of individual HTA projects by adapting the “payback framework” developed in the United Kingdom. We conducted dossier reviews and sent a survey to principal investigators of forty-three projects awarded between 2000 and 2003. We then provided an overview of documented output and outcome that was assessed by ten HTA experts using a scoring method. Finally, we conducted five case studies using information from additional dossier review and semistructured key informant interviews.

Results: The findings confirm that the payback framework is a useful approach to assess the impact of HTA projects. We identified over 101 peer reviewed papers, more than twenty-five PhDs, citations of research in guidelines (six projects), and implementation of new treatment strategies (eleven projects). The case studies provided greater depth and understanding about the levels of impact that arise and why and how they have been achieved.

Conclusions: It is generally too early to determine whether the HTA program led to actual changes in healthcare policy and practice. However, the results can be used as a baseline measurement for future evaluation and can help funding organizations or HTA agencies consider how to assess impact, possibly routinely. This, in turn, could help inform research strategies and justify expenditure for health research.

Objectives: Although the importance of economic evaluations is recognized, research suggests the ways in which studies are summarized may not be optimal for a busy decision maker with little training in economics methodology. Therefore, the objective of this study was to seek decision makers' views on different summary formats, including a score, short summary, and structured abstracts of different degrees of detail.

Methods: We contacted 2,400 people, of which 84 decision makers volunteered and were presented, cumulatively, with different formats and asked whether these provided sufficient detail on the methodology and results of an economic study.

Results: From the fifty decision makers who responded to the questionnaire, it was found that the preferred combination was a very short summary, plus a more detailed structured abstract. It was also found that decision makers with economics training preferred the most detailed format, partly reflecting their reasons for consulting economic evaluations.

Conclusions: Decision makers require both an initial screen of study content, plus more detail should they find the study relevant or interesting.

Objectives: The aim of this study was to analyze the current status of population screening for colon/rectum cancer in Europe to compare the different strategies, the coverage, the existence of pilot experiences, regional coverages, and the risk factors considered in each strategy.

Methods: A comprehensive, systematic search was performed in the literature for documents addressing population screening for colon/rectum cancer in Europe. An ad hoc questionnaire was prepared including questions considered relevant. The questionnaire was reviewed by experts in the area. To identify key informants, colleague members of the International Network of Agencies for Health Technology Assessment (INAHTA), participants in the EUnetHTA project, or representatives of the ministries of health of the different European countries were contacted. The information provided by key informants was checked with information directly obtained from the ministries of health, gray literature, and research documents.

Results: An 88 percent response rate was obtained. In countries for which no questionnaire data were collected, information was directly retrieved from the Web sites of the corresponding ministries. Four countries were found to perform population screenings: Austria, France, Germany, and the United Kingdom. However, they used different strategies. Five countries had begun regional or local strategies: Denmark, Finland, Italy, Spain, and Switzerland, and two additional countries (the Netherlands and Norway) reported ongoing research studies intended to determine the best strategy to implement a population-based screening program. Differences were found in age range, procedure chosen, and follow-up period.

Conclusions: Even though the European Council recommended a wider implementation of population screening for colon/rectum cancer, our results suggest that this recommendation continues to be valid. The differences found in screening strategies (in terms of age range, procedures, risk factors considered, and follow-up periods) are not warranted by the results obtained in research studies or regional-national cancer registries.

Objectives: Although endoscopic ultrasound (EUS) staging of esophageal cancer is established in clinical practice, high-quality evidence about its impact on patient outcomes is not available. This study aims to determine the impact of EUS for esophageal cancer staging on patient management and survival.

Methods: A systematic review was conducted using Medline, PreMedline, Embase, and The Cochrane Library. Included studies were (i) comparative studies reporting survival following EUS esophageal cancer staging, (ii) therapeutic impact studies reporting change in patient management following EUS. The quality of included studies was critically appraised.

Results: One systematic review, five studies reporting therapeutic impact, and two studies reporting patient survival were identified. The design and quality of the therapeutic impact studies varied widely. Management changed in 24–29 percent of patients following EUS staging of esophageal cancer (two studies). No studies provided data on the avoidance of surgery for this indication. One retrospective cohort study with historical control found EUS staging of esophageal cancer improved patient survival; a second study with similar design limitations did not find a survival benefit for EUS staging in patients undergoing resection. These studies had a high potential for bias, limiting the value of these findings.

Conclusions: Two studies provided evidence of a change in patient management following EUS for staging esophageal cancer, a higher level of evidence for a clinical benefit than can be obtained from accuracy studies alone. This evidence contributed to a recommendation for public funding of EUS in staging esophageal cancer in Australia.

Objectives: The aim of this study was to elucidate, whether shift from first generation antipsychotics (FGA) to olanzapine can affect health-related quality of life (HRQoL) of residually symptomatic schizophrenic outpatients.

Methods: Patients were randomized to either olanzapine or to continuation on their FGA. The 15D-measured HRQoL at baseline and end-point (after 12 weeks) was compared.

Results: Patients (n = 21) randomized to olanzapine achieved better HRQoL than those (n = 21) who continued on their FGA. This difference on the 15D (0.048 on a 0–1 scale; p = .037) was clinically important and comparable to that resulting from common surgical interventions, for example, hip or knee replacement.

Conclusions: HRQoL of stable outpatients with residual symptoms or adverse effects may improve substantially after shift from FGAs to olanzapine.

Objectives: The aim of this study was to examine location of systematic reviews of test accuracy in five specialist review databases: York CRD's DARE and HTA databases, Medion (University of Maastricht), C-EBLM (International Federation of Clinical Chemistry), and the ARIF in-house database (University of Birmingham).

Methods: Searches were limited to the period 1996–2006. Test accuracy reviews were located using in-house diagnostic search filters and with help from database producers where databases were not confined to test accuracy reviews. References were coded according to disease area, review purpose, and test application. Ease of use, volume, overlap, and content of databases was noted.

Results: A large degree of overlap existed between databases. Medion contained the largest number (n = 672) and the largest number of unique (n = 328) test accuracy references. A combination of three databases identified only 76% of test reviews. All databases were rated as easy to search but varied with respect to timeliness and compatibility with reference management software. Most reviews evaluated test accuracy (85%) but the HTA database had a larger proportion of cost-effectiveness and screening reviews and C-EBLM more reviews addressing early test development. Most reviews were conducted in secondary care settings.

Conclusions: Specialist review databases offer an essential addition to general bibliographic databases where application of diagnostic method filters can compromise search sensitivity. Important differences exist between databases in terms of ease of use and content. Our findings raise the question whether the current balance of research setting, in particular the predominance of research on tests used in secondary care, matches the needs of decision makers.

Objectives: The aim of this study was to investigate doctors' knowledge of the relative and absolute costs of diagnostic tests, medical consumables (e.g., syringes or intravenous tubing), and healthcare visits as well as to determine factors influencing awareness.

Methods: For this systematic review, we searched the Cochrane Library, EconoLit, EMBASE, and MEDLINE; reviewed reference lists; and had contact with authors. Studies were included if either doctors or trainees were surveyed, there were >10 survey respondents, costs of diagnostic or therapeutic items were estimated, results were expressed quantitatively, and a clear description was provided of how authors defined Accurate Estimates and determined True Cost. Two authors reviewed each article for eligibility and extracted data independently. Cost accuracy outcomes were summarized, but data were not combined due to extensive heterogeneity.

Results: Fourteen articles were included in the final analysis. Cost accuracy was low; 33 percent of estimates were within 20 percent or 25 percent of true cost and 50 percent were within 50 percent or in the 50–200 percent range of the true cost. Country, year of study, level of training, and specialty did not impact accuracy. The cost of items appears to have no impact on the accuracy (Fisher's exact test, p = .41) or pattern of estimation (binomial test, p = .92).

Conclusions: Doctors have a limited understanding of diagnostic and nondrug therapeutic costs, and we could not identify anything that impacts understanding of these costs. More focus is required in the education of physicians about costs and the access to cost information.

Objectives: The semiprivate health system in Iran has created an opportunity for unnecessary uses of advanced medical equipments including magnetic resonance imaging (MRI). This study aimed to evaluate the evidence for MRI overuse in private diagnostic imaging centers in Tehran, Iran. The objectives of this study were to determine the frequency of use of MRI scans for different complaints and to explore frequency of normal MRI findings as a function of unnecessary MRI use.

Methods: We conducted a survey among private MRI centers in Tehran, Iran, to study the proportion of MRI scans that may result in significant clinical finding. All MRI reports at a specific point in time at selected MRI centers were reviewed by a physician and the findings were recorded as normal, abnormal, or substantial changes.

Results: Of all the MRI reports, 17.2 percent had resulted in normal findings; 9.8 percent ordered for examination of headache, and 4.8 percent for lower back pain.

Conclusion: Unnecessary MRIs are most likely to result in normal finding; although not all the MRI with normal results could be identified as unnecessary. Negative findings from MRI scans may be reassuring to both clinicians and patients. The proportion of normal findings in MRI scans did not provide evidence of MRI overuse in Iran. The results of this study warrant formation of guidelines for the use of MRIs for headache and low back pain disorders.

Objectives: In the United States, medical devices represent an eighty-billion dollar a year market. The U.S. Food and Drug Administration rejects a significant number of applications of devices that reach the investigational stage. The prospects of improving patient condition, as well as firms' profits, are thus substantial, but fraught with uncertainties at the time when investments and design decisions are made. This study presents a quantitative model focused on the risk aspects of early technology assessment, designed to support the decisions of medical device firms in the investment and development stages.

Methods: The model is based on the engineering risk analysis method involving systems analysis and probability. It assumes use of all evidence available (both direct and indirect) and integrates the information through a linear formula of aggregation of probability distributions. The model is illustrated by a schematic version of the case of the AtrialShaper, a device for the reduction of stroke risk that is currently in the preprototype stage.

Results: The results of the modeling provide a more complete description of the evidence base available to support early-stage decisions, thus allowing comparison of alternative designs and management alternatives.

Conclusions: The model presented here provides early-stage decision-support to industry, but also benefits regulators and payers in their later assessment of new devices and associated procedures.