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 Contacting authors and manufacturers to find unpublished trials appeared to be a more effective method of obtaining the additional better quality trials.

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.

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.

Objectives: To examine the cost-effectiveness of Doppler ultrasonography in high-risk pregnancies.

Methods: An analysis was made of the cost-effectiveness of Doppler ultrasonography in high-risk pregnancies in relation to different organizational models. National costs of Doppler ultrasonography for singleton pregnancies with intrauterine growth retardation were estimated for three models. The cost-effectiveness analysis was based on results from a meta-analysis on clinical effects, patient costs, immediate health care costs, and costs per “saved” perinatal death.

Results: In the decentralized model (the current situation in Denmark), incremental health care costs were estimated to be 13.5 million DKK, with patient costs set at zero. In the regional and centralized models, the estimated costs were 9.3 million/0.9 million DKK and 3.4 million/2.6 million DKK, respectively. The incremental costs were more than outweighed by the savings made from significant reductions in obstetric interventions. The centralized model dominated the other two models in the cost-effective analysis. In the decentralized model, the costs of avoiding one perinatal death were estimated to be 1 million DKK. The sensitivity analysis suggested that the cost-effectiveness ratio differed considerably, depending on the assumptions used, although the rank order of the three models did not change.

Conclusions: The cost-effectiveness analysis showed that a centralized model with five obstetric centers offering Doppler ultrasonography dominates the regional and decentralized models. However, even with the decentralized model (which reflects the current situation in Denmark), the costs of avoiding one perinatal death would seem to be reasonable. In view of the paucity of available cost and effects data and the sensitivity of the results to changes in the assumptions made, more reliable information is needed before a decision can be made regarding the organization of Doppler ultrasonography for high-risk pregnancies.

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 €15,300 in respective cohorts. Considering the HCV screening strategy, the additional cost would be of €4,933 and €240,250 per additional year of life saved, respectively. In the intravenous drug user (IDU) population, the “two EIA” screening strategy was the more cost-effective alternative, with an additional cost of €3,825 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.

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: 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: 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: 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: The overall aim of this study is to discern whether and to what degree vaccination sites exhibit constant returns to scale.

Methods: Data Envelopment Analysis is used to compare all the facilities in the sample in terms of input costs used to produce multiple outputs. The application considers the Expanded Program on Immunization (EPI), which operated in Dhaka City, Bangladesh, during 1999.

Results: A preponderance of EPI sites were determined to be operating at increasing returns to scale.

Conclusions: Our findings question the applicability of cost-effectiveness analyses that assume constant returns to scale.

Objectives: Recently, we developed a diagnostic rule for the diagnosis and treatment of children with meningeal signs. This rule may provide the physician with a rationale to decide on the use of diagnostic and treatment procedures in these children and to improve their care. In this study, we estimated cost savings of the rule compared with current practice.

Methods: Routine care data of 360 children visiting the emergency department of the Sophia Children's Hospital with meningeal signs between 1988 and 1998 were used. Costs of diagnostic tests and treatment were estimated by using financial accounts of an academic and a general pediatric hospital. The number of procedures actually performed and the resulting cost estimates (i.e. unit costs×volume) were compared with the estimated figures after application of the decision rule.

Results: The population of children with meningeal signs comprised 99 with bacterial meningitis (27%), 36 with another serious bacterial infection (10%), and 225 with a self-limiting disease (63%). Application of the rule would reduce lumbar punctures by 12% and hospitalizations for empirical treatment by 15% with the same diagnostic accuracy as current practice. Cost savings were estimated at €292 per patient (relative reduction 10%) and were mainly achieved in the treatment course (€259).

Conclusions: A diagnostic decision rule for children with meningeal signs has the potential to improve the appropriate use of medical resources, to be cost-effective, and to ascertain the absence of bacterial meningitis earlier.

Objectives: To improve processes of ambulatory care for patients with type 2 diabetes in a nationwide program.

Methods: Interrupted time-series analysis with audits of practice. To implement selected recommendations of national guidelines, educational outreach visits (office visits or phone discussions) were offered to all French physicians who diagnosed one case of type 2 diabetes during a six-month intervention period. Outcome measures were the number of HBA1c measurements recorded monthly in the medical insurance computer database and the proportion of diabetic patients for whom one test had been reimbursed during the previous six months (HBA1c, fasting blood glucose) or previous twelve months (serum cholesterol, serum creatinine, urine microalbumin, electrocardiogram, ophthalmologic examination).

Results: A total of 15,522 office visits and 9,062 telephone discussions were performed among 22,940 physicians. The increase in the monthly proportion of the number of HBA1c tests to the total number of laboratory tests was higher during the intervention period than during the preintervention (p value<.0001) and postintervention periods (p value<.001). Between the first audit (n=651,574) and the third audit (n=911,871), HBA1c measurements increased from 41.2% to 60.5% and blood glucose measurements performed alone decreased from 38.8% to 18.7%. Urine microalbumin measurements increased from 10.6% before to 15.3% after intervention. Only a slight increase was observed for other tests.

Conclusions: Physician to physician outreach visits can be an effective way to improve the processes of care for diabetes and to routinize nationwide use of practice guidelines.

Objectives: This study aims to assess the impact of articles with very high reprint orders (“high-reprint articles”) by measuring their citation in the subsequent literature as compared with a control group of articles.

Methods: The twenty-one articles (published in the Lancet in 1998) with reprint orders of over 10,000 were matched with a control set of twenty-one articles with smaller reprint orders. The Science Citation Index was used to obtain the number of citations for each of the forty-two articles.

Results: The twenty-one high-reprint articles were cited 2,548 times; the mean number of citations was 121 (range, 3 to 499 citations per article). Five of the twenty-one high-reprint articles had more than 200 citations, but seven (33%) were cited twenty-five times or fewer. The twenty-one control articles were cited 986 times; the mean number of citations was forty-seven (range, 1 to 165). Fifteen (71%) of the twenty-one control articles were cited twenty-five times or fewer. Thirteen of the high-reprint articles were reports of randomized trials with a mean of 163 citations. In the control articles, six were reports of randomized trials with a mean of eighty-eight citations.

Conclusions: Articles with a high-reprint order were cited more frequently than other articles. However, some high-reprint articles were cited infrequently. If the size of a reprint order is related to the importance of an article, those articles with very high reprint orders may, therefore, be perceived as more important. Further research is needed to explore other aspects of the relative importance and impact of high-reprint articles.

Objectives: A series of randomized controlled trials have demonstrated that screening for colorectal cancer (CRC) using the fecal occult blood (FOB) test can decrease mortality from this disease. These findings were used to develop an actuarial model to estimate the impact that a FOB screening program for colorectal cancer would have on the Canadian population.

Methods: The mortality experience of the year 2000 cohort of Canadians fifty to seventy-four years of age, with follow-up extending to 2010, was modelled according to three scenarios: no screening, annual screening, biennial screening. The primary screening tool was the FOB test using unrehydrated samples, with follow-up of positive test results using colonoscopy. The framework of the model was developed based on published findings from the relevant randomized controlled trials, available data, and a literature review that yielded parameter values for some model items.

Results: During the 10-year follow-up of the cohort, we estimated that 4,444 and 2,827 deaths would be averted with annual and biennial FOB screening, respectively. We estimated that for an annual FOB screening program, approximately 3,400 FOB tests would be required to prevent one death, whereas 2,700 tests would be required within a biennial program.

Conclusions: Our analysis documents the population health impact of using the FOB test to screen for CRC. Additional information on the natural history of the disease, and Canadian pilot data are needed to better model the effectiveness of population-based FOB screening programs.

Objectives: To assess the annual direct and indirect costs of skin diseases caused by ultraviolet radiation.

Methods: A model for cost-of-illness, including costs for hospital care, primary care, pharmaceuticals, mortality, and morbidity, for approximately 1.8 million inhabitants in Stockholm.

Results: The total annual discounted cost-of-illness in Stockholm was approximately 162 million SEK (MSEK; approximate 2002 exchange rate: 1 U.S. dollar=10 SEK). The indirect costs were predominant and constituted approximately 91 MSEK (56% of total costs), mainly due to an estimated cost of mortality for cutaneous malignant melanoma of 84 MSEK. The direct costs of these diseases, approximately 71 MSEK, were predominated by hospital ambulatory care costs of approximately 33 MSEK. The direct costs constituted approximately 0.4% of the overall health-care costs for hospital care and primary health care in the area.

Conclusions: Skin diseases caused by ultraviolet radiation result in moderate economic losses in the community. Therefore, it may not be easy to make successful prevention of these diseases economically beneficial.

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 $27,310, $5,166, and $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.