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.

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.

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.

This study deals with the question of how to model health effects after the cessation of a randomized controlled trial (RCT). By using clinical trial data on severe congestive heart failure patients, we illustrate how survival beyond the cessation of an RCT can be predicted based on parametric survival models. In the analysis, we compare predicted survival and the resulting incremental cost-effectiveness ratio (ICER) of different survival models with actual survival/ICER. Our main finding is that the results are sensitive to the choice of survival model and that an extensive sensitivity analysis in the CE analysis is required.We thank John Kjekshus for providing us with data from the consensus and a ten-year follow-up study. Comments from Magnus Johannesson on a previous version of the article are also highly appreciated.

Objectives: Several studies have sought to analyze the cost-effectiveness of advanced home care and home rehabilitation. However, the costs of informal care are rarely included in economic appraisals of home care. This study estimates the cost of informal care for patients treated in advanced home care and analyses some patient characteristics that influence informal care costs.

Methods: During one week in October 1995, data were collected on all 451 patients in advanced home care in the Swedish county of Östergötland. Costs were calculated by using two models: one including leisure time, and one excluding leisure time. Multiple regression analysis was used to analyze factors associated with costs of informal care.

Results: Seventy percent of the patients in the study had informal care around the clock during the week investigated. The patients had, on average, five formal care visits per week, each of which lasted for almost half an hour. Thus, the cost of informal care constituted a considerable part of the cost of advanced home care. When the cost of leisure time was included, the cost of informal care was estimated at SEK 5,880 per week per patient, or twice as high as total formal caregiver costs. When leisure time was excluded, the cost of informal care was estimated at SEK 3,410 per week per patient, which is still 1.2 times higher than formal caregiver costs (estimated at SEK 2,810 per week per patient). Informal care costs were higher among patients who were men, who were younger, who had their own housing, and who were diagnosed with cancer.

Conclusions: Studies of advanced home care that exclude the cost of informal care substantially underestimate the costs to society, regardless of whether or not the leisure time of the caregiver is included in the calculations.

Objectives: To determine the need for and implement health technology assessment (HTA) to inform decision making and policy within a regional health care system in Calgary (Alberta, Canada).

Methods: Published literature and organizational materials for the Calgary Health Region (CHR) and HTA units worldwide were reviewed. Key individuals within the provincial health ministry (Alberta Health and Wellness), CHR, the University of Calgary (U of C), funding agencies, and HTA organizations were consulted in a structured fashion. A structure for a regional HTA program was developed, taking into account relationships between these organizations.

Results: A locally focused HTA and implementation unit was deemed desirable. The Calgary Health Technology Implementation Unit (CaHTIU) was established. The CaHTIU was designed to efficiently integrate with CHR planning as well as undertake independent research activities. HTA activities focus primarily on CHR needs and are managed by a Health Technology Advisory Committee (HTAC) that consists of CHR management and other key individuals. Working groups contribute to and coordinate HTAs and implementation under the leadership of the unit Director, and include content as well as management individuals. The unit cooperates where appropriate with extant Canadian HTA organizations.

Conclusions: The Calgary HTA unit is unique in Canada, because it functions within a regional health care system as well as a research institution. Advantages include a local focus in terms of applied HTAs, a systematic process for implementation of recommendations, and a collaborative atmosphere for research within the U of C.This work was supported by the Calgary Health Technology Implementation Unit. The authors thank Dr. Lloyd Sutherland of the University of Calgary and Dr. Dev Menon of the Institute of Health Economics for their important roles in the formation of the Calgary Health Technology Implementation Unit.

Objectives: This study compared the relative cost-effectiveness of daily recombinant human deoxyribonuclease (rhDNase), with alternate day rhDNase and hypertonic saline (HS) for treating children with cystic fibrosis (CF).

Methods: A randomized controlled trial with a crossover design allocated 40 CF children consecutively to 12 weeks of daily rhDNase, alternate day rhDNase, or HS. The primary outcome measure was forced expiratory volume in 1 second (FEV1), a measure of lung function. All health resource use was prospectively documented for each patient and multiplied by unit costs to give a total health service cost for each 12-week treatment period. The nonparametric bootstrap method was used to present cost-effectiveness acceptability curves and net benefit statistics for each treatment comparison, for various hypothetical levels of the decision maker's ceiling ratio.

Results: Compared with HS, there was a 14% improvement in FEV1 for daily rhDNase (95% CI, 5% to 23%), and a 12% improvement (95% CI, 2% to 22%) for alternate day rhDNase. For a ceiling ratio of £200 per 1% gain in FEV1, the mean net benefits of daily and alternate day rhDNase compared with HS were £1,158 (95% CI, −£621 to 2,842) and £1,188 (95% CI, −847 to 3,343), respectively; the mean net benefit of daily compared with alternate day rhDNase was *minus;£30 (95% CI, −£2,091 to 1,576).

Conclusions: If decision makers are prepared to pay £200 for a 1% gain in FEV1 over a 12-week period, then on average either rhDNase strategy is cost-effective.

Objectives: To examine the growing evidence and the consensus in the medical community concerning the efficacy and cost-effectiveness of hyperbaric oxygen therapy (HBO2T) and to suggest future research areas to ensure the appropriate use of this technology.

Methods: A literature search of articles published between 1985 and 2000 was conducted using PubMed to describe the growth of HBO2T-related articles published over the past fifteen years. In addition, articles involving the qualitative synthesis of the efficacy and cost-effectiveness of HBO2T in thirteen major application areas were identified and compared with the changing view of the medical community toward the evidence of HBO2T.

Results: The total number of HBO2T-related articles published annually has steadily increased over the past fifteen years. This increase has gradually contributed to a consensus in the medical community concerning the evidence of efficacy in its major application areas. However, information regarding the cost-effectiveness of HBO2T is still extremely limited.

Conclusions: Although evidence concerning the efficacy of HBO2T has been growing in the past, more evidence is still needed for some of its major application areas. Moreover, there is an urgent need to shift part of the research focus on HBO2T to its cost-effectiveness to provide decision makers with relevant information to evaluate this technology objectively.

Objectives: Examine the validity of using a self-completed Stated Preference Discrete Choice Modeling (SPDCM) questionnaire to measure parents' preferences for vaccinating their children against varicella.

Methods: A qualitative approach was used to assess the way parents understood the technical information in the questionnaire and the factors they considered to be important to the immunization decision. After completion of the SPDCM questionnaire, thirty-four participants completed a semistructured interview by telephone. Interview transcripts were analyzed by using content analysis. Comparisons were then made with the SPDCM questionnaire results.

Results: The technical information used to describe the program attributes appeared to be used appropriately by participants, although their explanations indicated that their understanding did not always come from the questionnaire information. Only one participant appeared to misunderstand the stated preference task, and a small number thought that the complexity and length should be reduced. The results of analysis of the questionnaire data were supported by the qualitative study, with the notable features of the model being reflected in the views commonly expressed about the immunization decision. Several additional factors were identified as important to the choice, including beliefs about vaccination generally and perceptions of the seriousness of varicella.

Conclusions: Although more research is required to investigate the validity of SPDCM for the measurement of preferences in health care, this study supports the validity of its use in childhood immunization where parents are familiar with the decision context.

Objectives: Most studies typically measure health preferences excluding health states perceived as worse than death. The objective of this study is to test the impact of including (versus excluding) health states perceived to be worse than death on utility measurementusing standard gamble (SG) and visual analogue scale (VAS) methods.

Methods: By means of a cross-sectional descriptive study design, women were asked to rate the utility of three hypothetical breast cancer health states: cure, treatment, and recurrence (n=119). Preference weights were estimated, allowing for negative utilities with death (perfect health) scaled at zero (1.0).

Results: Unpaired t-test analysis showed significantly greater change in SG and VAS weights for individuals perceiving cancer recurrence as worse than death than those perceiving death as least desirable state. Excluding negative utilities from the study resulted in significantly smaller changes in utility. Study results show that preference elicitation methods can be successfully adapted to acquire negative utilities.

Conclusions: Changes in utility were greater when negative preferences were permitted. Addressing negative preference scores could significantly affect quality adjusted life year estimates in economic analyses.

Objectives: To systematically assess the evidence for effectiveness of hyperbaric oxygen therapy in the treatment of conditions of significance in the West Midlands region and to determine whether there is a case for establishing a hyperbaric oxygen unit in the region.

Methods: Systematic review of the literature assessing randomized controlled trials from 1968 onward.

Results: A total of 154 full-text articles was obtained of which 13 relevant randomized control trials were identified. There was little consistency in the studies. Treatment protocols, study groups, time to treatment, and other characteristics and outcomes measured all varied considerably. No convincing evidence of effectiveness was identified.

Conclusions: Although hyperbaric oxygen therapy is clearly appropriate in the treatment of decompression sickness and air/gas embolism, there is no convincing evidence of effectiveness for the conditions reviewed, despite its widespread use. Although this review has found no evidence to support the establishment of a unit in the West Midlands, there is a physiological case for an effect in conditions involving hypoxia and, given the limited volume (and in some cases quality) of published research, a case for a national research program.I thank the staff of the West Midlands Development and Evaluation Service Systematic Reviews Course (Dr. Amanda Burls, Dr. Chris Hyde, and Ms. Jackie Young), who reviewed the report.

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.

Objectives: To study the effects of health financing systems on patient care-seeking behavior in rural China.

Methods: A multistage sampling method was used to select county, township, and village health facilities. A total of 1,232 outpatients was interviewed during two weeks.

Results: Health-financing systems appeared to influence patient behavior. In the insured group, the proportion of patients being hospitalized was higher than that in the uninsured group. Among the different insurance schemes, the private insurance group had the highest proportion of self-medication, but the cooperative insurance group had the lowest; the government insurance group had the most delay days, but the cooperative insurance group had the fewest. A logistic regression analysis suggested that only “out-of-pocket” payment might decrease the access to hospitalization.

Conclusions: The empirical data suggest that health-financing systems appear to influence patient behavior for prescription and access to health care, especially some costly health care, that is, hospitalization. The data also suggest that China needs to increase the coverage of health insurance, especially in rural areas to improve the access to health care.This article resulted from a collaborative research project between IHCAR, Karolinska Institutet and School of Public Health, Fudan University (former Shanghai Medical University)-Health care financing in transitional society-financially supported by the Swedish International Development Cooperation Agency (Sida). Many thanks to Vinod Diwan, Lennart Bogg, and Göran Tomson at IHCAR and Clas Rehnberg at the Stockholm School of Economics for their assistance in the preparation of the article.

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.

Objectives: Do utility scores based on patient preferences and scores based on community preferences agree? The purpose is to assess agreement between directly measured standard gamble (SG) utility scores and utility scores from the Health Utilities Index Mark 2 (HUI2) and Mark 3 (HUI3) systems.

Methods: Patients were assessed repeatedly throughout the process of waiting to see a surgeon, waiting for surgery, and recovery after total hip arthroplasty (THA). Group mean scores are compared using paired t-tests. Agreement is assessed using the intraclass correlation coefficient (ICC).

Results: The mean SG, HUI2, and HUI3 (SD) scores at assessment 1 are 0.62 (0.31), 0.62 (0.19), and 0.52 (0.21); n=103. At assessment 2, the means are 0.67 (0.30), 0.68 (0.30), and 0.58 (0.22); n=84. There are no statistically significant differences between group mean SG and HUI2 scores. Mean SG and HUI3 scores are significantly different. ICCs are low.

Conclusions: At the mean level for the group, SG and HUI2 scores match closely. At the individual level, agreement is poor. HUI2 scores were greater than HUI3 scores. HUI2 and HUI3 are appropriate for group level analyses relying on community preferences but are not a good substitute for directly measured utility scores at the individual leve.

Objectives: To review the economic evaluations (EEs) done in Italy by Italian authors, following a common scheme to allow some comparisons of the studies selected and with the international reviews.

Methods: We selected all the original studies published by Italian authors (in Italian or English) in national and international journals. The period considered was January 1994 to December 2001. Both full and partial economic evaluations were included. Three international databases were interrogated: MEDLINE, Embase, and HealthStar; further articles were added from the internal database of our center (CESAV), which also classifies Italian local publications and journals specialized in health economics.

Results: A total of ninety-nine studies were reviewed. More than half of the fifty-seven full EEs focused on drugs as type of intervention (n=38), followed by diagnostic screening (n=7). The NHS viewpoint was the most used (n=55 studies), followed by that of society (n=27) and hospitals (n=12). Sixty-eight studies only analyzed direct costs and twenty-nine included both direct and indirect costs. Twenty-five of the thirty-eight pharmacoeconomic full EEs were sponsored by companies. In sixteen of the twenty-five sponsored studies, the sponsor's products were the dominant alternative.

Conclusions: The review showed that, in Italy, like elsewhere, there is a gap between theory and practice in EEs, and sponsors can considerably affect the results of EEs.

Objectives: To expand care for chronic haemodialysis (HD) patients throughout England and Wales by studying two aspects of service delivery that are important: to identify relative performance of haemodialysis satellite units (HDSUs), and understand the factors that influence the performance. As a first step toward these aspects, this work reports a study of apparent comparative efficiency in the delivery of HDSUs and demonstrates the potential of data envelopment analysis (DEA).

Methods: DEA was applied to data obtained from a national survey of the organizational structures and processes of delivering care at HDSUs in England and Wales.

Results: DEA was found to be a judicious approach for performance assessment of HDSUs, although valid results depend on appropriate model specification and quality of data available. The available data were not of sufficient comprehensiveness or quality to produce definitive results but suggested that overall efficiency could improve; these data suggested by as much as 10% overall (mean efficiency score 90%) and variably within the sample (46 [65%] that HDSUs were potentially inefficient, the lowest unit scoring 38%).

Conclusions: Addressing questions raised by comparative inefficiency could help plans to improve capacity to deal with the growing demand for HD delivered in HDSUs. The application was an important start and needs to be followed by further research to establish model validity and obtain authoritative results.The authors thank HDSU staff who participated in the national satellite survey and colleagues contributing to the main project “An evaluation of the costs and effectiveness of and quality of care of renal replacement therapy provision in renal satellite units in England and Wales.” Particular thanks to Alison Armitage, Tricia Nicholson, and Joy Townsend. Funding was provided by the NHS Research and Development Health Technology Assessment Programme and South East NHS Executive Research and Development Directorate. The opinions and any errors made are the authors' responsibility alone.

Objective: To evaluate the long-term impact of an intervention designed to reduce the ordering of three tumor markers frequently prescribed for gastroenterologic diseases (carcinoembryonic antigen, alpha-fetoprotein, carbohydrate antigen 19-9).

Methods: A prospective study with time series analysis in a teaching hospital. Local clinical guidelines were developed and implemented through a new order form, designed as a reminder to the physician, restricting the ordering of laboratory tests. Ratios between the number of markers ordered and number of admissions were recorded during a 3-month period before and after intervention in the whole hospital and monthly on a 4-year period in two wards of the hospital (Department of Gastroenterology and Department of Internal Medicine). To evaluate the appropriateness of tumor marker orders, audits were performed on a sample of order forms, before and after (1 month and 2 years after) the implementation of the new order form.

Results: The analysis of covariance showed a significant effect of the intervention in the hospital (p < .01), and in the Departments of Gastroenterology (p < .01) and Internal Medicine (p < .007). The decrease of tumor marker orders ranged from 25% (Internal Medicine Department) to 55% (whole hospital). A similar decrease was observed for the three studied markers. The appropriateness of prescriptions increased from 54.6% before to 73.6% after the implementation of the new order form, but decreased to 52.9% 2 years after intervention.

Conclusions: Providing a reminder to clinicians through a specific order form represents an inexpensive and easy way to implement guidelines on use of laboratory tests.

Objectives: To conduct a systematic review of the evidence for the effectiveness of five visual electrodiagnostic tests to inform the Medical Services Advisory Committee (MSAC) of the Department of Health and Ageing (Australia) in its decision in allocating public funding for new technologies.

Methods: We searched the biomedical literature to identify English-language articles published from 1966 to September 2000. We assessed validity of methodology of included studies against the following criteria: investigators (i) compared test with an appropriate reference test; (ii) tested an appropriate spectrum of patients; (iii) masked assessment of study and reference tests; (iv) measured the study test independently of clinical information; and (v) measured the reference test before any interventions.

Results: Sixty-one articles met inclusion criteria for critical appraisal: nineteen were cross-sectional studies that compared a study test with another test, thirty-four were case-control studies that compared a test in a group of patients with an eye disease to a group of subjects without eye disease, and eight studies were case series. None of the included studies met all of the validity criteria. Only four studies provided enough information to calculate diagnostic characteristics but were flawed due to inclusion of patients already diagnosed with disease or lack of an appropriate reference test and, thus, overestimated test accuracy.

Conclusions: Identified studies did not provide sufficient valid evidence of the clinical value of the five visual tests in diagnosing diseases of the retina or optic nerve. Thus, MSAC recommended that the tests not be supported by public funding.