Showing papers in "International Journal of Technology Assessment in Health Care in 2003"

Interrupted time series designs in health technology assessment: lessons from two systematic reviews of behavior change strategies.

Abstract: Objectives: In an interrupted time series (ITS) design, data are collected at multiple instances over time before and after an intervention to detect whether the intervention has an effect significantly greater than the underlying secular trend. We critically reviewed the methodological quality of ITS designs using studies included in two systematic reviews (a review of mass media interventions and a review of guideline dissemination and implementation strategies). Methods: Quality criteria were developed, and data were abstracted from each study. If the primary study analyzed the ITS design inappropriately, we reanalyzed the results by using time series regression. Results: Twenty mass media studies and thirty-eight guideline studies were included. A total of 66% of ITS studies did not rule out the threat that another event could have occurred at the point of intervention. Thirty-three studies were reanalyzed, of which eight had significant preintervention trends. All of the studies were considered “effective” in the original report, but approximately half of the reanalyzed studies showed no statistically significant differences. Conclusions: We demonstrated that ITS designs are often analyzed inappropriately, underpowered, and poorly reported in implementation research. We have illustrated a framework for appraising ITS designs, and more widespread adoption of this framework would strengthen reviews that use ITS designs.

Literature searching for randomized controlled trials used in cochrane reviews: rapid versus exhaustive searches

Abstract: Objectives: To analyze sources searched in Cochrane reviews, to determine the proportion of trials included in reviews that are indexed in major databases, and to compare the quality of these trials with those from other sources.Methods: All new systematic reviews in the Cochrane Library, Issue1 2001, that were restricted to randomized controlled trials (RCTs) or quasi-RCTs were selected. The sources searched in the reviews were recorded, and the trials included were checked to see whether they were indexed in four major databases. Trials not indexed were checked to determine how they could be identified. The quality of trials found in major databases was compared with those found from other sources.Results: The range in the number of databases searched per review ranged between one and twenty-seven. The proportion of the trials in the four databases were Cochrane Controlled Trials Register=78.5%, MEDLINE=68.8%, Embase=65.0%, and Science/Social Sciences Citation Index=60.7%. Searching another twenty-six databases after Cochrane Controlled Trials Register (CCTR), MEDLINE, and Embase only found 2.4% additional trials. There was no significant difference between trials found in the CCTR, MEDLINE, and Embase compared with other trials, with respect to adequate allocation concealment or sample size.Conclusions: There was a large variation between reviews in the exhaustiveness of the literature searches. CCTR was the single best source of RCTs. Additional database searching retrieved only a small percentage of extra trials. Contacting authors and manufacturers to find unpublished trials appeared to be a more effective method of obtaining the additional better quality trials.

Characteristics of high-quality guidelines: evaluation of 86 clinical guidelines developed in ten European countries and Canada.

Abstract: Objectives: To identify predictors of high-quality clinical practice guidelines.Methods: A total of 86 guidelines from 11 countries were assessed by four independent appraisers per guideline using the AGREE instrument (23 items). Six aspects of guideline development were considered to explain the variation in quality scores: care level (primary/secondary care), scope (diagnosis/treatment), type of guideline (new/update), year of publication, type of agency (governmental/professional), and whether the guideline was produced within a structured and coordinated program.Results: Guidelines produced within a guideline program and by governmental agencies had higher scores than their counterparts. Differences in the applicability of the guidelines could not be explained by the variables studied.Conclusions: To ensure high quality, clinical guidelines should be produced within a structured and coordinated program. Professional organizations or specialist societies that aim to develop guidelines may adopt quality criteria from leading guideline agencies.

Cost-effectiveness analysis: can we reduce variability in costing methods?

Abstract: Objectives: The need for consistency and standardization of methods for economic appraisals has been recognized for some time and has led to the development of several sets of guidelines for economic evaluations and for costs. Despite this, considerable diversity is still apparent in applied studies. Some of these diversities might be defensible, and some might not. The objectives of this study are to explore sources of variations in the methods used in applied studies and to discuss the nature of these variations and the possibility of reducing some of them. Methods: We first use a systematic approach to identify the major sources of variation in costing methods used in applied economic evaluations. We then compare the methods used with the recommendations made in available guidelines. Results: Four possible sources of variation are identified. The first is where guidelines do not agree in their recommendations; therefore, it is not surprising that applied studies use different methods. The second is where guidelines agree in principle but provide little detail on how to comply with their recommendations; and the third is where a particular methodological issue is not discussed in guidelines. The fourth reason is simply lack of compliance with accepted guidelines. Conclusions: Variability in costing methods used in applied studies raises questions about the validity of their results and makes it difficult to compare the results of different studies. We discuss the implications for the transferability and generalizability of results and suggest ways to minimize the variability in the methods so that the results of costing studies and economic evaluations can be of more value to policy-makers.

Beyond Medline: reducing bias through extended systematic review search.

Abstract: Objective: To evaluate the sensitivity and precision of various extended search methods in identifying randomized controlled trials (RCTs) for systematic reviews.Method: Prospective analysis of extended search methods (specialized databases or trial registries, reference lists, hand-searching, personal communication, and Internet) used in two systematic reviews of RCTs. The gold standard was the total number of RCTs identified by major databases (MEDLINE, EMBASE, etc.) and extended search strategies combined. Sensitivity was the proportion of all known RCTs identified by any extended search method. Precision reflected the proportion of all items uncovered by any extended search method that actually were RCTs.Results: The extended search identified 94 additional RCTs for the systematic reviews beyond those identified with the major databases. Specialized databases and trial registries had the highest sensitivity and precision for the lipid-lowering project (13.6% and 52.7%, respectively; p < .05) followed by scanning of reference lists (7.2% sensitivity and 41.9% precision; p < .05). Hand-searching was more effective than personal communication and Internet searching (1.7% sensitivity and 12.2% precision; p < .05). The acupuncture project had slightly different results, with the specialized databases and trial registries tied with the review of reference lists for highest sensitivity (14.2%). The precision followed the same trend as the lipid-lowering project (17.6% specialized databases; 8.3% reference lists; p < .05). A post-hoc analysis showed that 75 of the 94 RCTs were indexed in the major databases but missed by the major database search.Conclusions: Extended searching identified additional RCTs for the systematic reviews beyond those found in major databases. Specialized databases and trial registries were most effective. An important number of RCTs were missed by the major database search. Timing and accuracy of indexing may explain this finding. The definitive measure, whether there is an association between the method used to uncover RCTs, the quality of the items uncovered and their impact on systematic review results, is yet to be determined.

Development of explicit criteria for total knee replacement.

Abstract: Objectives: To develop and test an appropriateness of indications tool for total knee replacement (TKR) in patients with osteoarthritis.Methods: Criteria were developed using a modified Delphi panel judgment. Another panel rated the same indications, and the results were compared with the main panel. Test-retest of the main panel was performed. Regression models were used to assess the contribution of each algorithm variable. A classification tree was developed.Results: The procedure was considered appropriate in 167 (26.8%) scenarios, and there was agreement on 112 (67.1%) of them. When the rates of the main panel were compared with those of a second panel, the result was a kappa statistic of 0.75. The test-retest kappa for the main panel was 0.78. Neither in the first case nor in the second was there an instance in which a scenario classified as appropriate shifted to inappropriate or vice versa. The regression models showed that symptomatology and radiology were the variables that explained most of the variability of appropriateness as determined by panelists. In the classification tree performed, the probability of misclassification was 3.8% with 150 scenarios, of the 156 analyzed and classified correctly.Conclusions: The previous parameters tested showed acceptable results for an evaluation tool. These results support the use of this algorithm as an aid in formulating clinical practice guidelines and to promote the appropriateness of TKR.

Biomedical research productivity: factors across the countries.

Abstract: Objective The objective of this study was to elicit the factors related to worldwide variation in biomedical research productivity. Methods Biomedical research articles published in 1990-2000 were accessed through the MEDLINE database. The number of articles (journal articles) originating from each of the countries of the world was elicited and normalized to publication per million population per year. Results In a multiple regression model, where publication per million population was the dependent variable and 10 social and economic indicators were independent variables, gross national product (GNP) per capita and research and development (R&D) expenditure emerged as significant factors. In separate simple linear regression analyses, all but two independent variables were found significant. Conclusions To increase biomedical research output, GNP per capita and R&D expenditure are the most important factors to address.

Publication bias and meta-analyses - A practical example

Abstract: Objectives: Publication bias is widely appreciated, but considerable time and effort are needed to locate and obtain data from unpublished randomized controlled trials (RCTs), those published in non-English language journals or those reported in the gray literature; for this publication, we will call this collection of trials the “gray+ literature.” However, excluding such trials from systematic reviews could introduce bias and give rise to misleading conclusions.Methods: We aimed to explore and quantify the impact of inclusion of gray+ literature on the results of all completed individual patient data (IPD) reviews coordinated by our group (13 meta-analyses). For each IPD review, results were calculated for RCTs fully published in English language journals and RCTs fully published in English language journals and the gray+ literature.Results: The IPD meta-analyses based only on RCTs that were fully published in English language journals tended to give more favorable results than those that included RCTs from the gray+ literature. Although in most cases the addition of gray+ data gave less encouraging results, moving the estimated treatment effect toward a null result, the direction of effect was not always predictable.Conclusions: We recommend that all systematic reviews should at least attempt to identify trials reported in the gray+thinsp;literature and, where possible, obtain data from them.

TOWARD TRANSPARENCY IN HEALTH TECHNOLOGY ASSESSMENT A Checklist for HTA Reports

Abstract: Objectives: As an initiative of the International Network of Agencies for Health Technology Assessment (INAHTA), a checklist for assessment reports was developed as a means of improving transparency and consistency in HTA. Methods: Preparation of a summary of key elements in HTA reports, drawing on experience in preparation of such documents, information from guidelines for HTA, and individual assessments. Review by INAHTA agencies and modification of the summary to reflect the consensus. Results: The resulting checklist includes 17 questions, with supporting detail. General areas covered include preliminary information, why and how the assessment has been prepared, the results of the assessment, implications of the results, and conclusions. Conclusions: The checklist is intended to be considered by those preparing or using an HTA report. It reflects the views of INAHTA members and is seen as a mechanism to improve the standard of HTA reports, being complementary to the more detailed guidelines on how to conduct assessments.

Prioritizing patients for elective surgery: a prospective study of clinical priority assessment criteria in New Zealand.

Abstract: OBJECTIVES: Many hospitals in New Zealand have been using clinical priority assessment criteria (CPAC) to select and prioritize patients for access to publicly funded elective surgery. CPAC usually consist of clinical, patient-experienced, and social measures. The objective of this study was to determine how robust patient rankings were and the extent to which the patients selected were those who benefited the most from surgery. METHODS: Patients prioritized for cataract (n = 101), prostate (n = 103), and hip or knee joint replacement (n = 137) surgery according to CPAC were assessed using the EQ-5D, SF-12, and condition-related patient-experienced health status measures before and after treatment. Correlations between the rankings of patients on the CPACs and the alternative instruments were explored. RESULTS: For each surgery group, the CPAC ranking of patients was not strongly correlated with rankings obtained using their before-treatment EQ-5D (valued) profiles or the SF-12, although there was some correlation with rankings according to the condition-related measures. Improvements in the health status of patients who were operated on, as measured by the change in their EQ-5D values, were poorly correlated with equivalent changes on the SF-12 and condition-related measures. Patients' baseline health status according to the CPAC, the EQ-5D, and the SF-12 patient-experienced measures was only slightly related to the magnitude of benefit following surgery. The strongest predictors of improvement in health status were the baseline condition-related measures. CONCLUSIONS: The current method of prioritizing patients in New Zealand requires reconsideration, although a gold standard method for prioritization is not immediately apparent from these results.

EU and member state medical devices regulation.

Abstract: This article examines European Union (EU) and member state regulation of medical devices, particularly: a) the similarities and differences between medical devices and prescription drugs, including the respective industries, market authorization pathways, and boundary issues between the two sectors; b) the political background, current nature, and future prospects for EU medical device regulation; and c) regulatory responsibilities of the member states. Included are definitions of medical devices and in vitro diagnostics, and a brief history of their treatment by European law. The erosion of boundaries between exclusive and shared responsibilities of the EU and member states will be addressed, especially as it affects market approval of medical devices, clinical investigations, labeling and instructions for use, price setting and reimbursement, and evidence-based medicine and healthcare technology assessment. Finally, the article discusses medical device reporting and surveillance systems, which may be the weakest link in the EU integrative process. If patient safety is as important to the EU regulatory scheme as free movement and competitiveness, then both Brussels and member states will require additional resources, as well as measures to overcome obstacles to implementation, evaluation, and accountability.

Paper standard gamble: a paper-based measure of standard gamble utility for current health.

Abstract: Objectives To develop and validate a paper-based instrument that is simple to administer and produces a reliable estimate of patient standard gamble (SG) utilities for current health status. Methods A 1-page paper questionnaire instrument, paper standard gamble (PSG), was designed to estimate SG utilities. We performed two studies to assess the validity of PSG. First we compared PSG and SG utilities for current health in patients with prostate cancer. They randomly received either PSG followed by SG or vice versa, always with an intervening SF-12. In the second validity study, we assessed the test-retest reliability of PSG by administering it to prostate cancer patients twice, at least 2 weeks apart. Results In the first study, utilities were assessed in 64 men (32 per SG/PSG order group). A paired-comparison t test suggested no difference between SG and PSG (mean difference = -0.007; 95% confidence interval (Cl), -0.022 to 0.008). The concordance correlation coefficient was 0.92 (95% Cl, 0.79 to 0.99). In the second study, test and retest PSGs were available for 184 patients. The concordance correlation coefficient was 0.88 (95% Cl, 0.73 to 0.94). Conclusions These data suggest that PSG may serve as a reliable substitute for SG when current health utility is of interest. PSG may have particular advantages for acquisition of health-related quality-of-life data in longitudinal studies.

Health-related quality of life measure based on the minimum data set.

Abstract: Objectives: To introduce a health-related quality of life measure for home care and institutional long-term care settings based on the Minimum Data Set (MDS) and the Health Utilities Index Mark 2 (HUI2).Methods: Health attributes of Health Related Quality of Life (HRQOL) were identified, and suitable constructs were determined. Items from the MDS were mapped to the HUI2. Scores for the Minimum Data Set Health Status Index (MDS-HSI) were calculated using the HUI2 scoring function. Measurement properties are examined and reported. HRQOL scores were compared across study populations and to an external reference population. Random samples were drawn from long-term care clients in private households (n=377), supportive housing apartments (n=80), two residential care facilities (n=166), and a chronic care hospital (n=274) in Ontario, Canada. All sampled residents were assessed for health-related items using the MDS.Results: The MDS-HSI results provide preliminary evidence of good validity. Institutional populations had lower overall HRQOL scores than community populations. Comparisons to existing Canadian national data support construct validity.Conclusions: The MDS-HSI provides a summary outcome measure and an indicator of health status in the six supporting attributes. Longitudinal research is required to assess the sensitivity of the measure to changes over time. Further research is also required to establish the consistency between the preference weights used in this application of the HUI2 and those that would be derived from a frail elderly population.This research was supported by the Seniors Independence Program (grant 4687-06-93-458) and the Providence Centre Foundation. Thanks to Copernicus Lodge, Providence Centre, and the Red Cross Homemaker Program for participating in this study. Also thanks to Roger Roberge and Dan Dekoker from Statistics Canada for their help in obtaining and analyzing the NPHS data. International copyright for the MDS-NH and MDS-HC is held by interRAI. International copyright for HUI2 and HUI3 materials are held by Health Utilities, Inc.

Efficacy and safety of viscosupplementation with Hylan G-F 20 for the treatment of knee osteoarthritis: a systematic review.

Abstract: Objectives To review the scientific evidence on the efficacy, effectiveness, and safety of intra-articular injections of Hylan G-F 20 for the treatment of knee osteoarthritis. Methods Systematic review of experimental and observational studies performed in humans up to December 1999. Qualitative and quantitative (meta-analytic) techniques were used for data synthesis. Results A single course of intra-articular Hylan G-F 20 provides a statistically significant and clinically relevant short-term decrease of the painful symptomatology of knee osteoarthritis and improves joint function. It also seems to delay the need for knee replacement, if results observed in noncontrolled studies are confirmed. Hylan G-F 20 has a comparable efficacy to that of oral NSAID, and a smaller risk of gastrointestinal adverse effects. It seems to be well tolerated and safe, but the short follow-up in most studies limits any extrapolation of the effectiveness and safety over the longer term. There is also scarce evidence on the effect of multiple courses of Hylan G-F 20, and the scientific rigor of both experimental and nonexperimental studies reviewed is somewhat limited. Conclusions Whereas there is good quality scientific evidence showing that Hylan G-F 20 is a safe and well-tolerated therapy providing a short-term decrease of the pain symptoms while improving joint function, the delay of the need for knee replacement as well as the durability of the effect over the longer term have only been demonstrated in noncontrolled clinical series. The available evidence is not sufficient to reach firm conclusions on the effect of multiple courses of intra-articular injections of Hylan G-F 20 on health outcomes.

Doing the right thing and doing it right: toward a framework for assessing the policy relevance of health services research

Abstract: Objectives: Health services research is a typical instance of applied research, meaning that its research findings should contribute to a more evidence-based health policy. A basic assumption for the usefulness of policy research is that it is of good scientific quality, but evaluation of health services research would be incomplete without an assessment of its societal relevance. However, there is no generally accepted framework in which criteria to assess societal relevance are defined. Methods: In this study, we made an effort to specify criteria and indicators for policy relevance. Results and Conclusions: In general, we concluded that it is important to define from the start of a research project, what kind of answers are being sought to the questions at hand, who the intended users of these answers will be, and how they can be reached. Furthermore, a productive dialogue between researchers and policy makers is indispensable for remaining in tune with policy thinking. In addition, we specified domains and a list of potential criteria for assessing policy relevance. For the purpose of quality assurance, these criteria have to be integrated into a quality improvement cycle. This means that the societal output of health services research should be related to the aims and missions at the level of projects, programs, and institutes. Furthermore, it is important that consensus is reached about (the weighting of) relevant indicators and that routines are developed for collecting information on these indicators.

Confronting the "gray zones" of technology assessment: evaluating genetic testing services for public insurance coverage in Canada.

Abstract: We describe an evaluation model to guide public coverage of new predictive genetic tests in Ontario, Canada. The model confronts common "gray zones" in evaluation and coverage policy for challenging new technologies. Analysis addresses three domains of the evaluation picture. The first specifies evaluative criteria (purpose, effectiveness, additional effects, unit cost, demand, cost-effectiveness). The second induces or deduces acceptable cutoffs for each criterion. The third domain addresses the need to make decisions under uncertainty and to respond to "gray" evaluations with conditional-coverage decisions. The evaluation criteria should be applied within sound decision-making processes.

CONSIDERATIONS IN DEFINING EVIDENCE FOR PUBLIC HEALTH The European Advisory Committee on Health Research ∗ World Health Organization Regional Office for Europe

Abstract: The issue of evidence for decision-making, including formal policy-making and public health policy, has increased rapidly in prominence during the past few years. The term “evidence-based” was first used in health care in 1992, when Sackett and others coined the term “evidence-based medicine” (42). More recently, many have asked if public health activities are based on evidence (2;8;13;19;30).

Cost-effectiveness of adjunctive hyperbaric oxygen in the treatment of diabetic ulcers.

Abstract: Objectives: This study estimates the cost-effectiveness (CE) of the adjunctive use of hyperbaric oxygen (HBO2) therapy in the treatment of diabetic ulcers based on the payer's and societal perspectives.Methods: The study population was a hypothetical cohort of 1,000 patients sixty years of age with severe diabetic foot ulcers. A decision tree model was constructed to estimate the CE of HBO2 therapy in the treatment of diabetic ulcers at years 1, 5, and 12. Scenario and one-way sensitivity analyses were also undertaken to identify parameters that may significantly influence the estimates.Results: The CE model estimated that the incremental cost per additional quality-adjusted life year (QALY) gained at years 1, 5, and 12, was $2,255, respectively.Conclusions: The study results indicate that HBO2 therapy in the treatment of diabetic ulcers is cost-effective, particularly based on a long-term perspective. However, the results are limited by the clinical studies that provide the basis of the CE estimation.

Health technology assessment: the contribution of qualitative research.

Abstract: The pragmatism in health care has made health technology assessment (HTA) restrict its scope to a particular set of problems, c.q. methods. The "multidisciplinary and comprehensive nature" of HTA, as the concept is presented in certain definitions, is lacking. Health care is also dominated by a positivistic-rationalistic approach of evaluation. In contrast, social studies of evaluations learn that a major difference has to be made between scientific research on (potential) impact of a technology and valuing these effects. In this contribution, we will discuss how the positivistic scientific bias of current HTA practice can be made up with other research traditions. More specifically, we focus on the question of how social scientists and particularly how qualitative research can contribute to HTA, complementary to positivistic studies of evidence and efficacy.

Keeping cancer guidelines current: results of a comprehensive prospective literature monitoring strategy for twenty clinical practice guidelines.

Abstract: Objectives: To describe a methodology used to keep practice guidelines up to date and to summarize data collected during the first year of implementing this plan with a cancer practice guidelines program.Methods: The updating strategy includes regular searches of peer-reviewed literature and meeting proceedings, review and interpretation of new evidence, review and revision of clinical recommendations, and notification to practitioners and policy makers about new evidence and its impact on recommendations.Results: Eighty pieces of new evidence were found relating to seventeen of the twenty guidelines included in this study. On average, four pieces of new evidence were found per guideline, but there was considerable variation across the guidelines. Of the eighty pieces, nineteen contributed to modifications of clinical recommendations in six practice guidelines, whereas the remaining evidence served to support the original recommendations. None of the modifications led to changes that advised against original recommendations. MEDLINE, the Cochrane Library, and meeting proceedings yielded many pieces of evidence, whereas CancerLit and HealthStar did not contribute significantly to the overall yield. Furthermore, key pieces of evidence that led to modifications to the recommendations were often identified by members of the disease site groups before appearing in electronic databases.Conclusions: The updating process is resource intensive but yields important findings. In response to this evaluation, the updating protocol has been revised such that literature searches are conducted quarterly and the scope of sources searched routinely is restricted to MEDLINE, the Cochrane Library, and meeting proceedings.

The great escape? Prospects for regulating access to technology through health technology assessment.

Abstract: Objective: Health technology assessment (HTA) can be used both to promote access to safe, efficacious, and cost-effective technologies, and to discourage access to undesirable ones. Yet HTA has had less success than might be hoped in pursuing the latter goal. This paper examines the scope of HTA as currently practiced to contribute to regulation of access to undesirable technologies. Design : The study design is a critical analysis of HTA's methods, based on an exposition of the normative issues involved in restriction of access to health technologies. The paper classifies technologies that might figure as potential candidates for exclusion into five categories and underscores the key social and ethical dilemmas associated with limiting their use. Results: For four of the five categories of technology outlined, limitation of access necessarily involves denial of benefit. Limitation of access thus inevitably raises difficult normative issues. We show that these are ill-addressed by the range of evidence typically considered in technology assessments, which centers predominantly on clinical and technical features such as efficacy, safety, and costs. Conclusions: If HTA is to enhance our ability to make reasonable decisions concerning the use and diffusion of health technologies, it must better integrate consideration of the social, political, and ethical dimensions of health technologies into the process of technology assessment. We suggest a framework within which to approach this goal.

Factors influencing adherence to guidelines in general practice.

Abstract: Objectives: To identify and assess the effects of general practitioner and patient characteristics on global adherence to pharmacotherapeutic guidelines. Methods: In a cross-sectional study in the northern Netherlands, a two-level multilevel model was applied to patients (n = 269,067) in 190 practices with a total of 251 general practitioners. The dependent variable was the global adherence to pharmacotherapeutic guidelines as a measure of good prescribing in a general practice setting. Results: The mean global adherence was 82%. Two general practice variables, organization form and degree of urbanization influenced the global adherence, whereas all patient variables (age and gender) and the patient-related prescription characteristics (costs, volume, different ATC-codes) were significant predictors for the global adherence. The total explained variance was 28%. Conclusions: Patient characteristics have a greater influence on prescribing behavior than general practitioner characteristics.

Dissemination and characteristics of acute care for elders (ACE) units in the United States.

Abstract: Objective The objective of this paper is to determine prevalence and characteristics of acute care for elders (ACE) units and hospital characteristics associated with the presence of an ACE unit. Methods Data on characteristics and prevalence of ACE units were obtained by surveying all established geriatric medical divisions across U.S. medical schools. Data on hospital characteristics such as number of beds, revenue, number of Medicare inpatients, and average length of stay were obtained from the 1999 American Hospital Association Annual Survey Data. Descriptive statistics and t test were used to analyze the characteristics of ACE units. Stepwise logistic regression was used to analyze the hospital characteristics associated with the presence of an ACE unit. Results The survey identified 16 geriatric divisions and programs with ACE units. Hospitals that have ACE units differ significantly with respect to number of beds and total revenue, compared with institutions that do not have an ACE unit. Stepwise logistic regression indicated total hospital revenue was the only factor significantly associated with the presence of an ACE unit. Conclusions ACE units are attractive interdisciplinary models to address the particular needs of the elderly during their hospital stay. Low presence of ACE units warrants further research as to reasons more hospitals have not included them, given the available evidence for clinical, functional, and economic benefits.

Impact of gene patents on the cost-effective delivery of care: the case of BRCA1 genetic testing.

Abstract: BACKGROUND: In 1994/95, two genes, BRCA1/2, associated with a predisposition to breast or ovarian cancer were identified. Genetic testing of deleterious BRCA1/2 mutations consequently can be proposed to individuals with a family history of breast or ovarian cancer to identify who is at risk. The granting of U.S. patents on BRCA1/2 to a privately owned company has led to the monopoly use of a unique technique (Direct Sequencing of the gene, DS) for BRCA1/2 testing in this country. Alternative strategies using prescreening techniques, however, have been experienced worldwide. METHODS: On the basis of data collected at three laboratories of French public hospitals, we carried out a cost-effectiveness study comparing DS to 19 alternative strategies with the number of deleterious BRCA1 mutations detected as the outcome. RESULTS: Results show that the DS strategy presents the highest average cost per mutation detected (9,882.5 Euro) and that there exist strategies using prescreening techniques that can reach similar effectiveness while reducing total costs. Moreover, other strategies can obtain a four- to sevenfold reduction in the average cost per mutation detected as soon as some rates of false negatives (2% to 13%) are deemed to be acceptable. CONCLUSIONS: Results suggest that gene patents with a very broad scope, covering all potential medical applications, may prevent health care systems from identifying and adopting the most efficient genetic testing strategies due to the monopoly granted for the exploitation of the gene. Policy implications for regulatory authorities, in the current context of the extension of BRCA1/2 patents in other countries, are discussed.

Comparison of hospital costing methods in an economic evaluation of a multinational clinical trial

Abstract: Objectives To develop and evaluate strategies for estimating hospitalization costs in multinational clinical trials. Methods Hospital cost estimates for eleven diagnoses were collected from twelve countries participating in a trial of therapies for congestive heart failure. Estimates were combined with U.S.-based diagnosis-related group weights to compute country-specific unit cost estimates for all reasons for hospitalization. Variations of hospital costing methods were developed. The unit cost method assigns a country-specific unit cost estimate to each hospitalization. The other methods adjust for length of stay using a daily cost (DC) estimate for each diagnosis, based on either the mean length of stay (DC-mean method) or the median length of stay (DC-median method) for each diagnosis in each country. Additional modifications were explored through adjustment of the distribution of daily costs incurred during a hospital stay. Results The mean cost for all hospitalizations was dollars 10,242 (SD, 10,042) using the unit cost method, dollars 10,242 (SD, 12,760) using the standard DC-mean method, and dollars 13,967 (SD, 18,762) using the standard DC-median method. In comparisons of costs for all 5,486 hospitalizations incurred by a subset of 2,352 patients in the trial, the unit cost method provided 92% power to detect a dollars 1,000 cost difference. The standard DC-mean method provided 76% power, and the standard DC-median method provided 44% power. Conclusions Hospital costing methods that adjust for differences in length of stay require a significantly larger sample to attain comparable statistical power as methods that assign unadjusted unit cost estimates to hospitalization events.

Counseling versus antidepressant therapy for the treatment of mild to moderate depression in primary care: economic analysis.

Abstract: Objectives: To compare the cost-effectiveness of generic psychological therapy (counseling) with routinely prescribed antidepressant drugs in a naturalistic general practice setting for a follow-up period of 12 months.Methods: Economic analysis alongside a randomized clinical trial with patient preference arm. Comparison of depression-related health service costs at 12 months. Cost-effectiveness analysis of bootstrapped trial data using net monetary benefits and acceptability curves.Results: No significant difference between the mean observed costs of patients randomized to antidepressants or to counseling (£342 vs £302, p = .56 [t test]). If decision makers are not willing to pay more for additional benefits (value placed on extra patient with good outcome, denoted by K, is zero), then we find little difference between the treatment modalities in terms of cost-effectiveness. If decision makers do place value on additional benefit (K > £0), then the antidepressant group becomes more likely to be cost-effective. This likelihood is in excess of 90% where decision makers are prepared to pay an additional £2,000 or more per additional patient with a good global outcome. The mean values for incremental net monetary benefits (INMB) from antidepressants are substantial for higher values of K (INMB = £406 when K = £2,500).Conclusions: For a small proportion of patients, the counseling intervention (as specified in this trial) is a dominant cost-effective strategy. For a larger proportion of patients, the antidepressant intervention (as specified in this trial) is the dominant cost-effective strategy. For the remaining group of patients, cost-effectiveness depends on the value of K. Since we cannot observe K, acceptability curves are a useful way to inform decision makers.

Health care resource use and stroke outcome. Multinational comparisons within the GAIN International trial.

Abstract: Background and Purpose: Outcome in patients hospitalized for acute stroke varies considerably between populations. Within the framework of the GAIN International trial, a large multicenter trial of a neuroprotective agent (gavestinel, glycine antagonist), stroke outcome in relation to health care resource use has been compared in a large number of countries, allowing for differences in case mix. Methods: This substudy includes 1,422 patients in 19 countries grouped into 10 regions. Data on prognostic variables on admission to hospital, resource use, and outcome were analyzed by regression models. Results: All results were adjusted for differences in prognostic factors on admission (NIH Stroke Scale, age, comorbidity). There were threefold variations in the average number of days in hospital/institutional care (from 20 to 60 days). The proportion of patients who met with professional rehabilitation staff also varied greatly. Three-month case fatality ranged from 11% to 28%, and mean Barthel ADL score at three months varied between 64 and 73. There was no relationship between health care resource use and outcome in terms of survival and ADL function at three months. The proportion of patients living at home at three months did not show any relationship to ADL function across countries. Conclusions: There are wide variations in health care resource use between countries, unexplained by differences in case mix. Across countries, there is no obvious relationship between resource use and clinical outcome after stroke. Differences in health care traditions (treatment pathways) and social We thank the coinvestigators and research staff at the participating centers for their support. Glaxo Wellcome sponsored the GAIN International trial, supported the present analyses and reviewed the final draft of the article.

Cost-effectiveness of alternative approaches in the management of dyspepsia.

Abstract: Objectives: To assess the cost-effectiveness of alternative initial strategies in the management of uninvestigated dyspepsia in adult patients presenting to a primary care physician in Canada.Methods: Clinical decision-making was modeled based on outcomes data from the literature and expert opinion. Costs were obtained from official reimbursement lists, and a detailed microcosting analysis of a gastroscopy. Costs were analysed over a one-year period after initial presentation, including consideration of a single relapse of symptoms. The main outcome was a symptomatic cure. The seven management strategies based on different initial tests were endoscopy, double-contrast barium meal, empirical eradication therapy, empirical antisecretory treatment, urea breath test (UBT), laboratory serology, and sequential testing (laboratory serology followed, if Helicobacter pylori positive, by UBT).Results: In patients under age 45, endoscopy, double-contrast barium meal, and sequential testing were not cost-effective approaches. UBT was the most effective and most costly strategy costing $8,238 per additional patient cure compared with laboratory serology. In patients over age 45, UBT was again the most effective and most costly strategy, but endoscopy was the most reliable in detecting gastric cancers. Clinical variables that impacted these findings were the probability of symptomatic relapse in patients with nonulcer dyspepsia (NUD) after successful versus failed H. pylori eradication, the probability of finding a duodenal ulcer (DU) in a young dyspeptic patient, the specificity of UBT, and the prevalence of H. pylori in patients with DU.Conclusions: A “test-and-treat” approach was favored, with UBT being the most effective but most costly initial test in adult dyspeptics under age 45. The choice of the most cost-effective approach is dependent on the benefits of H. pylori eradication in patients with NUD. In patients over age 45, UBT is the most effective and most costly, but endoscopy results in the early detection of most gastric cancers.The authors are indebted to the other members of the UBTAN Group, including Drs. Phil Sherman, Alan Thomson, and Sander Veldhuyzen van Zanten. The authors also thank Paul Sinclair, Eileen Grace, and Lawrence Joseph for their much valued comments and opinions. AB and CAF are research scholars of the Fonds de la Recherche en Sante du Quebec. This work was supported in part by an “at arms length” grant from AstraZeneca Canada.

Prevention could be less cost-effective than cure: The case of hepatitis C screening policies in France

Abstract: OBJECTIVES To access the cost-effectiveness of French recommendations for hepatitis C virus (HCV) screening and the extent to which earlier identification of carriers may or not improve the cost-effectiveness of therapeutic strategies. METHODS Cost-effectiveness analysis were performed using decision-tree analysis and a Markov model. Four alternative strategies were compared: no screening and no treatment; initiation of HCV treatment after the diagnosis of cirrhosis; and two alternative strategies refer to the current French policies of HCV testing, i.e., two enzyme immunoblot assay (EIA) tests in series, or a polymerase chain reaction (PCR) analysis after the first positive EIA test. Costs were computed from the viewpoint of the health care system. The analysis has been applied to populations particularly at risk of infection, as well as the general population. RESULTS The "wait and treat cirrhosis" strategy was more cost-effective in the general population and in transfusion recipients. The incremental cost-effectiveness ratio of this strategy compared with baseline strategy was 3,476 of euros and Euro15,300 in respective cohorts. Considering the HCV screening strategy, the additional cost would be of Euro4,933 and Euro240,250 per additional year of life saved, respectively. In the intravenous drug user (IDU) population, the "two ElA" screening strategy was the more cost-effective alternative, with an additional cost of Euro3,825 per additional year of life saved. CONCLUSIONS HCV screening would be discarded for transfusion recipients but should be encouraged for IDUs and also for the general population, in which the additional cost of screening is an order of magnitude more acceptable.

Daily cost prediction model in neonatal intensive care.

Abstract: Objectives: One barrier to economic evaluation alongside neonatal randomized controlled trials is the expense of collecting detailed patient resource information. To reduce this data collection burden, we identified the key resource items that predict daily ancillary costs for extremely low birth weight infants. Methods: Participants were 385 infants enrolled in the Trial of Indomethacin Prophylaxis for Preterms in nine tertiary level neonatal intensive care units in Canada. Information on eighty-nine nonpersonnel resource items was abstracted from the hospital chart from admission to tertiary hospital discharge. Unit costs were derived from a provincially standardized cost accounting system. Using stepwise linear regression, models correlating total daily ancillary costs with key resource items were constructed for each of five periods of admission. Models were derived in a randomly split half of the total sample of patient days and validated against the remainder. Results:The 385 infants contributed resource information from 23,354 admission days. The regression model for weeks one to twelve included the covariates surfactant, chest radiograph, red blood cell transfusion, cranial ultrasound, abdominal radiograph, parenteral amino acid infusion, surgery, platelet transfusion, and echocardiogram and explained 91% of the variability in daily nonpersonnel costs (P <.0001). Models for other admission periods similarly included between four and eight covariates, were highly significant (P <.0001) and explained between 76% and 94% of daily ancillary cost variability. The regression equations showed excellent predictive power when applied to the second half of the patient data set. Conclusions: Daily nonpersonnel costs for extremely low birth weight infants are driven by a limited number of key resource variables. The ability to predict total ancillary costs with minimal data collection will facilitate inclusion of economic evaluations in neonatal trials.