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.

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.

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: 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 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 aim of this study was to examine potential associations between the professional background and experience of expert clinicians and their opinions about the clinical utility of interventional procedures.

Methods: A retrospective survey of expert clinician characteristics and their opinions was conducted. Information was collected on expert clinical adviser self-declared “operator,” “researcher,” and conflict of interest status. Associations were sought between expert clinical adviser characteristics and their opinions on whether procedures were “established,” “efficacious,” and “safe.” The setting was the Interventional Procedures Programme of the UK's National Institute for Health and Clinical Excellence (NICE). A total of 598 expert clinician questionnaires relating to 182 different interventional procedures were analyzed.

Results: Expert clinical advisers with operative experience of procedures were significantly more likely to consider them as established (odds ratio [OR] 3.93; 95 percent confidence interval [CI], 2.43 to 6.36; p < .001), efficacious (OR 1.76; 95 percent CI, 1.00 to 3.08; p = .049), and safe (OR 2.28; 95 percent CI, 1.43 to 3.65; p = .001). Once adjusted for other characteristics, there was no association between either researcher or conflict of interest status and opinions about the clinical utility of procedures.

Conclusions: Expert clinical advisers are an important source of information for decision makers producing guidance about the use of procedures, especially when published evidence is sparse or of poor quality. This study suggests that those who are operators, but not those who are researchers or declare a conflict of interest, are more likely to have a favorable opinion of a procedure's clinical utility. Use of expert clinical advisers with a variety of experience and backgrounds seems a reasonable approach to obtaining authoritative opinions about interventional procedures, to supplement and help interpret evidence from published data.

Objectives: The aim of this study was to provide a comprehensive summary and interpretation of the current evidence on the use and validity of statistical methods to conduct indirect comparisons of treatment effects.

Methods: A narrative review was conducted.

Results: Well-conducted methodological studies provide good evidence that adjusted indirect comparisons can lead to results similar to those from direct comparisons. The internal validity of several statistical methods to conduct indirect comparisons, therefore, has been established. Meta-regression, logistic regression, or adjusted indirect comparisons should be the methods of first choice. Unadjusted indirect comparisons are always unacceptable. Deciding whether to combine direct and indirect evidence will be a matter of informed judgment based on the similarities and dissimilarities of populations and interventions. Unverifiable assumptions with respect to the similarity of compared studies and low power are serious limitations of indirect comparisons.

Conclusions: In the absence of sufficient head-to-head evidence, adjusted indirect comparisons can be viewed as additional analytical tools to determine the comparative efficacy and effectiveness of competing interventions. Researchers who use indirect comparisons need to keep the limitations in mind.

Background: Hyperbaric oxygen therapy (HBOT) has been proposed as an adjunct to standard methods of care for diabetic foot ulcers (DFU). Its use may decrease the risk of infection and lower extremity amputations (LEAs). As part of a Canadian assessment, we estimated the cost-effectiveness and budget impact of HBOT in this application.

Methods: We developed a decision model comparing adjunctive HBOT with standard care alone. The population was a 65-year-old cohort with DFU. The time horizon was 12 years taken from a Ministry of Health perspective. The health states were a healed wound with or without a minor LEA, an unhealed wound with no related surgery, and a major LEA. Efficacy data were based on outcomes reported in studies included in a literature review. Cost and capacity needs for treating DFU patients in Canada were estimated using prevalence data from the literature, and cost and utilization data from government records.

Results: The 12-year cost for patients receiving HBOT was CND$40,695 compared with CND$49,786 for standard care alone. Outcomes were 3.64 quality-adjusted life-years (QALYs) for those receiving HBOT and 3.01 QALYs for controls. Estimated cost to treat all prevalent DFU cases in Canada was CND$14.4–19.7 million/year over 4 years. If seven-person HBOT chambers were used, a further nineteen to thirty-five machines would be required nationally.

Conclusions: Adjunctive HBOT for DFU is cost-effective compared with standard care. Additional HBOT capacity would be needed if it were to be adopted as the standard of care throughout Canada.

Objectives: The aim of this study was to summarize the current evidence for the cost-effectiveness of primarily human papillomavirus (HPV) -based cervical cancer screening in settings with already established Papanicolaou test (Pap) programs. Emphasis was placed on the German situation with annual Pap screening.

Methods: Medical, economic, and health technology assessment (HTA) databases were systematically searched for cost-effectiveness studies comparing HPV to Pap screening. Study data were extracted, standardized, and summarized in cost-effectiveness plots contrasting HPV strategies to Pap screening with 1-, 2-, 3-, and 5-years interval. For each Pap setting, the likelihood of cost-effective HPV screening was assessed depending on willingness-to-pay.

Results: We reviewed twelve decision-analytic cost-effectiveness models. Study results showed wide variation due to methodical heterogeneity. Data synthesis revealed that the cost-effectiveness of HPV screening depends on the interval of the established Pap screening strategy. In comparison with Pap screening every 2 years, only 25 percent of the HPV-based screening strategies were cost-effective. However, in comparison with Pap screening every 1, 3, or 5 years, 83 percent, 55 percent, and 92 percent of HPV screening strategies were cost-effective, respectively. Results for settings with annual Pap screening are based on models assuming 100 percent screening coverage.

Conclusions: The introduction of HPV-based screening programs is cost-effective if the screening interval of the established Pap program exceeds 2 years. In settings with biennial Pap screening, introduction of HPV-based screening is unlikely to be cost-effective. Results also suggest cost-effectiveness of HPV-based screening in settings with annual Pap screening; however, this finding should be confirmed under realistic screening adherence assumptions.

Objectives: Multidisciplinary and multifactorial interventions seem to be effective in preventing falls. We aimed to assess the cost-effectiveness of a multidisciplinary fall prevention program compared with usual Dutch healthcare in community-dwelling people 65 years of age or older who experienced a fall.

Methods: Cost-effectiveness and cost-utility analysis were performed from a societal perspective. Falls and healthcare utilization were continuously measured for 12 months. Daily functioning and quality of life were measured at baseline, after 4 and 12 months. Bootstrap analyses were performed to estimate uncertainty of the findings and sensitivity analysis to assess the generalizability of assumptions made.

Results: One hundred sixty-six participants were randomly allocated to the experimental group and 167 to the control group. The overall response rate was 74 percent. Healthcare and patient and family costs of both groups were comparable. Our analyses showed no effect of the intervention program on falls, daily functioning, or quality of life measures.

Conclusions: The multidisciplinary intervention program to prevent falls was not cost-effective compared with usual care in the Netherlands. Notwithstanding our findings, however, falls still have an important impact on society and individuals in terms of costs and effects. Economic evaluations studying promising interventions to prevent falls, therefore, remain necessary.

Objectives: The aim of this study was to assess the cost-effectiveness of screening for open-angle glaucoma (OAG) in the United Kingdom, given that OAG is an important cause of blindness worldwide.

Methods: A Markov model was developed to estimate lifetime costs and benefits of a cohort of patients facing, alternatively, screening or current opportunistic case finding strategies. Strategies, varying in how screening would be organized (e.g., invitation for assessment by a glaucoma-trained optometrist [GO] or for simple test assessment by a technician) were developed, and allowed for the progression of OAG and treatment effects. Data inputs were obtained from systematic reviews. Deterministic and probabilistic sensitivity analyses were performed.

Results: Screening was more likely to be cost-effective as prevalence increased, for 40 year olds compared with 60 or 75 year olds, when the re-screening interval was greater (10 years), and for the technician strategy compared with the GO strategy. For each age cohort and at prevalence levels of ≤1 percent, the likelihood that either screening strategy would be more cost-effective than current practice was small. For those 40 years of age, “technician screening” compared with current practice has an incremental cost-effectiveness ratio (ICER) that society might be willing to pay when prevalence is 6 percent to 10 percent and at over 10 percent for 60 year olds. In the United Kingdom, the age specific prevalence of OAG is much lower. Screening by GO, at any age or prevalence level, was not associated with an ICER < £30,000.

Conclusions: Population screening for OAG is unlikely to be cost-effective but could be for specific subgroups at higher risk.

Objectives: Positron emission tomography (PET) is an innovative imaging tool. Associated with computed tomography (CT), it allows a better definition for the tumor volume for radiotherapy, compared with CT only. The aim of this study was to assess the effects of PET on resource allocation (costs and savings) and on the choice of the following treatment in radiotherapy.

Methods: In 2004 and 2005, 209 patients were enrolled (97 patients with Hodgkin's disease and 112 with non-small cell lung cancer) in a national study conducted in eight hospitals. Two treatment decisions made on the basis of CT only or CT associated with PET, were compared in a prospective study where each subject was his/her own control. The direct medical cost of using PET was assessed by microcosting, using data collected from specific questionnaires. The costs of new tests and the costs and savings associated with changes in the chosen treatment were calculated on the basis of reimbursement rates.

Results: The mean cost of using PET was approximately €800 per patient (50 percent for the radionuclide 18F-FDG [2-[18F]fluoro-2-deoxy-D-glucose]). Radiotherapy treatments were modified for 10 percent of patients with Hodgkin's disease versus 40 percent of patients with lung cancer. Overall, the use of PET induced both increases and decreases in the mean cost per patient: the net effect was a €425 and €931 cost increase in lung cancer and Hodgkin's disease, respectively.

Conclusions: The use of PET for radiotherapy decision making seems more valuable for lung cancer than for Hodgkin's disease, both in terms of costs and changes in radiotherapy treatment. This result might help policy makers for prioritization.

Objectives: The aim of this prospective study was to perform a cost and outcome comparison between two alternative operative techniques (osteosynthesis and hemiarthroplasty) used in the treatment of elderly patients with unstable trochanteric hip fracture.

Materials and Methods: One hundred seventy-three trochanteric hip fracture patients were followed-up for 1 year after surgery. For each operative technique, hospital treatment's cost per patient was computed. Mortality and complication rate in-hospital and at specific time points after surgery were used as outcome measures. Patients' functional level before and after hip fracture was estimated according to their mobility and ability to perform basic and instrumental activities of daily living.

Results: The cost for patients undergoing osteosynthesis reached €1,931 per case, whereas for those treated with hemiarthroplasty reached €3,719 per case (2001 rates). There was no statistically significant difference regarding in-hospital mortality and complication rate, as well as mortality and complication rate 1 year after surgery, between the two patient groups.

Conclusions: The quite similar performance of the two operative techniques suggests that cost could be the key factor for choosing between them. However, it is critical that many more randomized studies, with larger sample sizes and wider follow-up time periods should be conducted.

Objectives: There are very few descriptions on how familial hypercholesterolemia (FH), a genetic disorder with an increased risk of coronary heart disease (CHD), affects older patients. The aim of this study was to analyze the health-related quality of life (HRQoL) of elderly patients with FH.

Methods: All FH patients with the same FH North Karelia-mutation aged 65 and over living in North Karelia province in Eastern Finland were asked to participate in the study in 2003. They were compared with age-standardized controls from the Finnish general population. A total of forty-three elderly FH patients were identified and thirty-seven of them (aged 65 to 84 years, M/F 10/27) agreed to participate. Most of them (27/37) had been diagnosed with CHD. All but one of these FH patients had been using statins for approximately 15 years. HRQoL was assessed with the RAND-36 (SF-36) and 15D instruments.

Results: Despite the clear cardiovascular morbidity and low socioeconomic status, these FH patients enjoyed a similar HRQoL as the age-standardized controls in the general population.

Conclusions: Lifelong hypercholesterolemia was not associated with poorer HRQoL in elderly survivors of FH. These elderly FH individuals were characterized by their healthy lifestyle and long-term statin treatment.

Objectives: The Turkish healthcare system is currently undergoing reform, and efficient use of resources has become a key factor in determining the allocation of resources. The objective of this study was to analyze strengths, weaknesses, opportunities, and threats (SWOT) in the development of a health technology assessment (HTA) program in Turkey.

Methods: A SWOT analysis was performed using a literature review and interviews with key people in the Turkish Ministry of Health and Ministry of Labor and Social Security.

Results: Regarding recent reforms in health care, investments for information network and databank are the strengths, but the traditional “expert-based” decision making, poor availability of data, and poor quality of data could be seen as some of the weaknesses. Another major weakness is lack of general awareness of HTA. Increasing demand for transparency in decision making, demand for evidence, and demand for credibility by decision makers are some of the opportunities, and current healthcare reforms, i.e., restructuring of healthcare and general health insurance, could also be seen as major opportunities. These opportunities unfortunately could be threatened by lack of funding, and resources are challenged by large, recent national investments.

Conclusions: There is a good opportunity for Turkey to use the skills in HTA currently being developed through activities in Europe and the Americas to assist in the development of a much more cost-effective and transparent healthcare system in Turkey.