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Objectives: The study determined whether the results of recently completed systematic reviews evaluating the effectiveness of public health interventions were used in the development of new provincial policies for public health practice.
Methods: This telephone survey included all members from five review groups who updated the Ontario Mandatory Health Programs and Services guidelines for Public Health in 2000. Independent variables included characteristics of the systematic reviews, organization, and the individual. Outcomes included the use of the reviews in developing new policies and the extent to which the reviews led to new recommendations for practice. Descriptive summaries as well as multiple linear regression were conducted.
Results: Eighty-five percent of decision-makers agreed to participate in the study. Ninety-six percent of respondents reported that the systematic reviews played a part in developing the new guidelines, while 47 percent indicated that the reviews contributed a great deal to the development of new recommendations for practice. The multiple linear regression model explained 42 percent of the variation in use of the reviews for developing new recommendations for practice. Significant predictor variables included the importance of the reviews in comparison to other sources of information and relevance of the reviews to the policy decisions.
Conclusion: Public health decision-makers in Ontario have very positive perceptions of the usefulness of systematic reviews in policy development. Therefore, ongoing efforts to promote the usefulness and relevance of systematic reviews to public health decision-makers should remain a priority for health services researchers.
Objectives: The frequency and consequences of major bleeding associated with anticoagulant prophylaxis for prevention of venous thromboembolism is examined.
Methods: We conducted a systematic review and meta-analysis of controlled trials that reported rates of major bleeding after pharmaceutical thromboprophylaxis in patients undergoing major orthopedic surgery. Thromboprophylactic agents were divided into four groups:warfarin/other coumarin derivatives (WARF), unfractionated heparin (UFH), low molecular weight heparin (LMWH), and pentasaccharide (PS). Meta-analysis was conducted comparing LMWH with each of WARF, UFH, and PS. The frequency of re-operation due to major bleeding was reviewed and combined with published costs to estimate the mean cost of managing major bleeding events in these patients.
Results: Twenty-one studies including 20,523 patients met inclusion criteria for the meta-analysis. No evidence of significant between-trial heterogeneity in risk ratios was found. Combined (fixed effects) relative risks (RR) of major bleeding compared with LMWH were WARF – RR 0.59 (95 percent confidence interval [CI], 0.44–0.80); UFH – RR 1.52 (95 percent CI, 1.04–2.23); PS – RR 1.52 (95 percent CI, 1.11–2.09). Seventy-one studies including 32,433 patients were included in the review of consequences of major bleeding. We estimated that the average cost of major bleeding is $113 per patient receiving thromboprophylaxis.
Conclusions: LMWH results in fewer major bleeding episodes than UFH and PS but more than WARF. These events are costly and clinically important.
In A Theory of Justice, John Rawls demands from citizens who decide upon principles of justice and the rules derived from such principles that they abstract from all particularities that constitute their identity as unique individuals. This demand is unrealistic in policy settings where actual policy-makers convene to provide guidance, establish rules regarding public good, and enact legislation. In practice, I argue, policy-makers, legislators, and others involved in developing social rules that pertain to distributive justice formulate such rules as reasonably partial spectators. To illustrate, I show how clinical practice guidelines are established and mediated by a reasonably partial expert panel whose partial action is publicly justifiable, yet whose claims to impartiality are not.
Objectives: Promoting the adoption of clinical practice guidelines is a challenging task. Research shows that adopters' beliefs about guidelines and the process of their development are important predictors of guideline use. Our objective is to report on the development and refinement of an instrument designed to measure oncologists' assessments of guidelines in oncology.
Method: A theoretically derived instrument was drafted. Oncologists were asked to complete a questionnaire for each draft guideline they were asked to review. Factor analyses and multilevel modeling techniques were undertaken to explore the properties of the instrument and refine it.
Results: A total of 488 Ontario clinicians were sent 1,494 new questionnaires regarding 34 clinical practice guidelines produced between 1999 and 2002. A refined eighteen-item questionnaire with four stable factors that predicted 60 percent of the variance emerged. The factors are interpreted as guideline quality, applicability, acceptability, and comparative value. The four factors predicted oncologists' endorsements of draft guidelines and, with the exception of quality, predicted their intentions to use the guidelines. As expected, variation in the factor scores could be attributed more to the differences among the oncologist who completed the survey than to the differences among the guidelines themselves.
Conclusions:An instrument composed of four stable and theoretically relevant factors emerged. The findings support the hypothesis that beliefs about guideline attributes and development attributes relate to oncologists' endorsement of and intentions to use guidelines. Our next step is to link the responses of the survey with actual clinical behavior.
Objectives: This study aimed to investigate whether evidence-based clinical practice in health care improves outcomes for patients, personnel, and/or organizations.
Methods: A systematic review of studies was conducted with various quantitative and qualitative methods up to the Spring of 2002. Protocols were used in quality assessment. Data synthesis is descriptive in a narrative form.
Results: Of 305 assessed articles, eight studies were included. The outcomes in the included studies were related to the experiences of patients and personnel and to organization concerning changed patient care and resource utilization. Because the included studies are heterogeneous in design, focus of research area, and scientific quality, the scientific foundation for the findings is weak. There is some support that evidence-based clinical practice guidelines, when put to use, improve outcomes (i) for patients—less likelihood of showing worsening of skin condition and disruption of skin condition improves more rapidly for infants; (ii) for personnel—support in daily work situation; and (iii) for organizations—decreased admission rates and length of stay, less resource utilization and reduced costs.
Conclusions: There is a need for further research as the findings are based on a rather limited number of studies. There is a tendency toward support for the idea that outcomes improve for patients, personnel, or organizations if clinical practice in health care is evidence-based, that is, if evidence-based clinical practice guidelines are used, although these findings could be specific to the settings and context of the studies reported in this systematic review.
Objectives: Clinical trials have demonstrated that fecal occult blood screening for colorectal cancer can significantly reduce mortality. However, to be deemed a priority from a public health policy perspective, any new program must prove itself to be cost-effective. The objective of this study was to assess the cost-effectiveness of screening for colorectal cancer using a fecal occult blood screening test, the Hemoccult-II, in a cohort of 100,000 asymptomatic individuals 50–74 years of age.
Methods: A decision analysis model using a Markov approach simulates the trajectory of the cohort allocated either to screening or no screening over a 20-year period through several health states. Clinical and economic data used in the model came from the Burgundy trial, French population-based studies, and Registry data.
Results: Modeling biennial screening versus the absence of screening over a 20-year period resulted in a 17.7 percent mortality reduction and a discounted incremental cost-effectiveness ratio of 3,357 € per life-year gained among individuals 50–74 years of age. Sensitivity analyses performed on epidemiological and economic data showed the strong impact on the results of colonoscopy cost, of compliance to screening, and of specificity of the screening test.
Conclusions: Cost-effectiveness estimates and sensitivity analyses suggest that biennial screening for colorectal cancer with fecal occult blood test could be recommended from the age of 50 until 74. Our findings support the attempts to introduce large-scale population screening programs.
Objective: To study the costs and effects of incorporating ultrasonography in the triple assessment of palpable breast masses.
Methods: A decision analytic model was designed to compare a conventional strategy of performing fine-needle aspiration cytology after clinical examination and mammography, with three different experimental strategies of preceding ultrasonography. Empirical data were used from a prospective study in 522 breasts in 492 patients with a palpable mass, including 93 malignancies. In strategy 1, cases with probably benign, suspect malignant, and malignant ultrasonography results were referred for fine-needle aspiration cytology; in strategy 2, benign cases were also referred for fine-needle aspiration cytology; and in strategy 3, ultrasonography was only performed in patients with benign results on clinical examination and mammography, whereas immediate fine-needle aspiration cytology was performed in patients with suspicious lesions. Outcome variables included the total costs and the expected number of life years. Sensitivity analysis was performed on all parameters in the model.
Results: All strategies reported a similar life expectancy of 31.0 years. Cost-minimization demonstrated that experimental strategy 3 was the least expensive strategy (€ 3,013). Experimental strategy 2 was the most costly one (€ 3,512). Compared with the conventional strategy of immediate fine-needle aspiration cytology (€ 3,087), both ultrasonography strategies 1 and −3 were preferred.
Conclusions: Incorporating ultrasonography in the triple assessment of palpable breast masses can result in a reduction of the total costs for the diagnosis and treatment of breast cancer.
Objectives: The feasibility and accuracy of sentinel lymph node biopsy (SLNB) in the treatment of breast cancer is widely acknowledged today. The aim of our study was to compare the hospital-related costs of this strategy with those of conventional axillary lymph node dissection (ALND).
Methods: A retrospective study was carried out to determine the total direct medical costs for each of the two medical strategies. Two patient samples (n=43 for ALND; n=48 for SLNB) were selected at random among breast cancer patients at the Centre Léon Bérard, a comprehensive cancer treatment center in Lyon, France. Costs related to ALND carried out after SLNB (either immediately or at a later date) were included in SLNB costs (n=18 of 48 patients).
Results: Total direct medical costs were significantly different in the two groups (median 1,965.86€ versus 1,429.93€, p=0.0076, Mann-Whitney U-test). The total cost for SLNB decreased even further for patients who underwent SLNB alone (median, 1,301€). Despite the high cost of anatomic pathology examinations and nuclear medicine (both favorable to ALND), the difference in direct medical costs for the two strategies was primarily due to the length of hospitalization, which differs significantly depending on the technique used (9-day median for ALND versus 3 days for SLNB, p<0.0001).
Conclusions: A lower morbidity rate is favorable to the generalization of SLNB, when the patient's clinical state allows for it. From an economic point of view, SLNB also seems to be preferred, particularly because our results confirm those found in two published studies concerning the cost of SLNB.
Objectives: Stress urinary incontinence affects between 10 percent and 50 percent of women. Surgery is commonly recommended for troublesome incontinence that does not respond to nonsurgical management. Tension-free vaginal tape (TVT) is a newer, minimal access surgical sling procedure, which is being increasingly adopted worldwide. The cost-effectiveness of TVT in comparison with other surgical procedures, particularly open colposuspension, is assessed.
Methods: Effectiveness estimates came from a systematic review of TVT compared with other surgical procedures (open and laparoscopic colposuspension, traditional slings, and injectables). Deterministic and probabilistic analyses were used to assess the likelihood of TVT being cost-effective. Sensitivity analyses assessed the impact of changing assumptions about cure rates and costs for TVT, cure rates for retreatment open colposuspension, and proportions of women who choose retreatment.
Results: Reliable estimates of relative effectiveness were difficult to derive because the few randomized controlled comparisons had not been optimally analyzed or fully reported. Results of the economic model suggested that TVT dominates open colposuspension (lower cost and same quality of life years[QALYs]) within 5 years after surgery. Stochastic analysis indicated that the likelihood of TVT being cost-effective was 100 percent if decision-makers are unwilling to pay for additional QALYs. TVT's dominance depended on the assumption fact that retreatment open colposuspension has lower cure rates than a first colposuspension.
Conclusions: Analysis based on current short-term data indicates dominance of TVT over open colposuspension from approximately 5 years. There is a need for longer-term follow-up data from methodologically rigorous randomized trials to provide a sounder basis for estimating the relative benefits and cost implications.
Objectives: The cost-effectiveness of opportunistic nuchal translucency ultrasound screening in pregnancy was compared with alternative screening strategies for trisomy 21 in Australia.
Methods: A decision analytic model was used of various pregnancy screening strategies based on a systematic review of the literature on the effectiveness of nuchal translucency ultrasound and serum screening and costs based on current reimbursement fees. The model included the likelihood and cost of terminations after diagnostic testing and the associated risk of fetal loss. All prices are in 2001 Australian dollars.
Results: With a twenty percentage point difference in detection rate, the incremental cost for a combination of nuchal translucency and serum screening with age in the first trimester compared with maternal serum screening in the second trimester was $105,484 per extra case detected and $374,779 per live trisomy 21 birth avoided. Serum screening in the second trimester had an incremental cost per extra case detected of between $61,700 and $117,100 per extra live birth avoided when compared with no screening.
Conclusions: The cost-effectiveness of ultrasound screening for trisomy 21 would appear to be more attractive if it were done at the same time as current dating ultrasound. Any funding mechanism for screening should take this strategy into account by incorporating, as far as possible, provision of nuchal translucency screening into existing services provided in early pregnancy.
Objectives: The cost-effectiveness of the Swedish quitline, a nation-wide, free of charge service, is assessed.
Methods: The study was based on data of a sample of 1,131 callers enrolled from February 1, 2000 to November 30, 2001. Outcome was measured as cost per quitter and cost per year of life saved. Cost per quitter was based on a calculation of the total cost of the quitline divided by the number of individuals who reported abstinence after 12 months. The cost per life year saved (LYS) was calculated by the use of data from the literature on average life expectancy for smokers versus quitters, the total cost of the quitline, and the cost of pharmacological treatment.
Results: The number of smokers who used the quitline and reported abstinence after 1 year was 354 (31 percent). The accumulated number of life years saved in the study population was 2,400. The cost per quitter was 1,052–1,360 USD, and the cost per life year saved was 311–401 USD. A sensitivity analysis showed that, for outcomes down to an abstinence rate of 20 percent, the cost per LYS rose modestly, from 311 to 482 USD. Discounting the cost per LYS showed the cost to be 135 USD for 3 percent and 283 USD for 5 percent.
Conclusions: The Swedish quitline is a cost-effective public health intervention compared with other smoking cessation interventions.
Objectives: We assess the cost-effectiveness of smoking relapse prevention interventions designed to keep quitters from resuming the use of cigarettes. Because relapse prevention is complementary to smoking cessation efforts, the appropriate test of its cost-effectiveness is whether it reduces the incremental cost-effectiveness ratio (ICER) of smoking cessation. The major goal of the study is to carry out such a test.
Methods: Data from a randomized trial that ascertained the effectiveness of alternative modes of smoking relapse prevention are combined with ICER estimates of smoking cessation to assess whether relapse prevention is cost-effective.
Results: The trial produced convincing evidence that relapse prevention yields statistically significant reductions in the proportion of quitters who are smoking at 24 months postquit. The intervention effects are substantial enough to raise the denominator terms of the smoking cessation ICER and, thereby, offset the amount relapse prevention adds to cost numerator terms. In this sense, smoking relapse prevention tends to pay for itself.
Conclusions: Smoking relapse prevention is a highly cost-effective addition to current efforts to curb cigarette consumption. Complementary health interventions of this sort should be assessed by different methods than those commonly found in the cost-effectiveness literature.
Objectives: Reported is the importance of properly reflecting uncertainty associated with prognostic model estimates when calculating the survival benefit of a treatment or technology, using liver transplantation as an example.
Methods: Monte Carlo simulation techniques were used to account for the uncertainty of prognostic model estimates using the standard errors of the regression coefficients and their correlations. These methods were applied to patients with primary biliary cirrhosis undergoing liver transplantation using a prognostic model from a historic cohort who did not undergo transplantation. The survival gain over 4 years from transplantation was estimated.
Results: Ignoring the uncertainty in the prognostic model, the estimated survival benefit of liver transplantation was 16.7 months (95 percent confidence interval [CI], 13.5 to 20.1), and was statistically significant (p<.001). After adjusting for model uncertainty using the standard errors of the regression coefficients, the estimated survival benefit was 17.5 months (95 percent CI, −3.9 to 38.5) and was no longer statistically significant. An additional adjustment for the correlation between regression coefficients widened the 95 percent confidence interval slightly: the estimated survival benefit was 17.0 months (95 percent CI: −4.6 to 38.6).
Conclusions: It is important that the precision of regression coefficients is available for users of published prognostic models. Ignoring this additional information substantially underestimates uncertainty, which can then impact misleadingly on policy decisions.
Objectives: The observed posterior probability distributions regarding the benefits of surgery for otitis media with effusion (OME) with expected probability distributions, using Bayes' theorem are compared.
Methods: Postal questionnaires were used to assess prior and posterior probability distributions among ear-nose-throat (ENT) surgeons in the Netherlands.
Results: In their prior probability estimates, ENT surgeons were quite optimistic with respect to the effectiveness of tube insertion in the treatment of OME. The trial showed no meaningful benefit of tubes on hearing and language development. Posterior probabilities calculated on the basis of prior probability estimates and trial results differed widely from those, elicited empirically 1 year after completion of the trial and dissemination of the results.
Conclusions: ENT surgeons did not adjust their opinion about the benefits of surgical treatment of glue ears to the extent that they should have done according to Bayes' theorem. Users of the results of Bayesian analyses, notably policy-makers, should realize that Bayes' theorem is prescriptive and not necessarily descriptively correct. Health policy decisions should not be based on the untested assumption that health-care professionals use new evidence to adjust their subjective beliefs in a Bayesian manner.
Objectives: This study aims to describe a cycle of development leading to sustainable methods for involving consumers in the management of a program commissioning health technology assessment.
Methods: Staff time was dedicated to developing procedures for recruiting and briefing consumers to participate in prioritizing, commissioning, and reporting research. Resources and support were developed in light of early feedback from consumers and those working with them. These were piloted and amended before being used routinely.
Results: Over 4 years, procedures and resources have been developed to support six consumers attending seven to eight prioritization meetings a year; thirty to forty-five consumers each year commenting on research need for particular topics; thirty consumers a year commenting on research proposals, and twenty a year commenting on research reports. The procedures include clear job descriptions, induction and development days, clear briefing materials, payment for substantial tasks, and regularly seeking feedback to improve procedures.
Conclusions: Explicit, inclusive, and reproducible methods for supporting consumer involvement that satisfy National Health Service policy recommendations for involving consumers in research require dedicated staff time to support a cycle of organizational development.
Objectives: This study aims to examine the impact of European Union (EU) law relating to information technology (IT) on health systems.
Methods: The study identifies EU directives relating to IT, analyzes them in terms of their impact on the use of IT in health systems, and outlines their implications for health technology assessment (HTA). Analysis is based on a review of literature identified through relevant databases and Internet searches.
Results: Developments in IT have serious implications for EU health systems, presenting policy makers with new challenges. The European Commission has adopted a range of legal measures to protect consumers in the “information society” However, as few of them are health-specific, it is not evident that they have implications for health, health systems, or HTA, and they may not be effective in protecting consumers in the health sector.
Conclusions: In light of the growing importance of IT in the health sector, legal and nonlegal measures need to be further developed at EU and international level. Where possible, future initiatives should pay attention to the particular characteristics of health goods and services and health systems. Although definitions of HTA usually recognize the importance of evaluating both the indirect, unintended consequences of health technologies and the legal aspects of their application, it seems that, in practice, HTA often overlooks or underestimates legislative matters. Those involved in HTA should be aware of the legal implications of using IT to provide health goods and services and compile, store, transfer, and disseminate health information electronically.
Objectives: This study tested the reliability and validity of the Western Canada Waiting List Project priority criteria score (PCS) for prioritizing patients waiting for hip and knee arthroplasty.
Methods: Sixteen orthopedic surgeons assessed 233 consecutive patients at consultation for hip or knee arthroplasty. Measures included the PCS, a visual analogue scale of urgency (VAS urgency), and maximum acceptable waiting time (MAWT). Patients completed a VAS urgency, an MAWT, the Western Ontario McMaster Osteoarthritis Index (WOMAC), and the EQ-5D. Using correlational analysis, convergent and discriminant validity was assessed between similar constructs in the priority criteria and WOMAC. Median MAWTs were determined for five levels of urgency based on PCS percentiles. Internal consistency reliability was assessed with Cronbach's alpha.
Results: The sample of 233 patients (62 percent female) ranged in age from 18 to 89 years (mean, 66.3 years). A total of 45 percent were booked for hip and 55 percent for knee arthroplasty. Correlations were strong between the PCS and surgeon VAS urgency (r=.79) and weaker between patient and surgeon measures of VAS urgency (r=.24) and MAWT (r=.44). Correlation coefficients between similar constructs in the priority criteria and WOMAC ranged from 0.24 to 0.32 and were higher than those measuring dissimilar constructs. For decreasing levels of urgency, the median MAWT ranged from 10 to 12 weeks for surgeons and 4 to 12 weeks for patients. Cronbach's alpha was 0.79.
Conclusions: Results support the validity of the PCS as a measure of surgeon-rated urgency. Patients might be ranked differently with different prioritization measures.
Objectives: The research question was whether training level of admitting physicians and referrals from practitioners in primary health care (PHC) are risk factors for emergency readmission within 30 days to internal medicine.
Methods: This report is a prospective multicenter study carried out during 1 month in 1997 in seven departments of internal medicine in the County of Stockholm, Sweden. Two of the units were at university hospitals, three at county hospitals and two in district hospitals. The study area is metropolitan–suburban with 1,762,924 residents. Data were analyzed by multiple logistic regression.
Results: A total of 5,131 admissions, thereby 408 unplanned readmissions (8 percent) were registered (69.8 percent of 7,348 true inpatient episodes). The risk of emergency readmission increased with patient's age and independently 1.40 times (95 percent confidence interval [CI], 1.13–1.74) when residents decided on hospitalization. Congestive heart failure as primary or comorbid condition was the main reason for unplanned readmission. Referrals from PHC were associated with risk decrease (odds ratio, 0.53; 95 percent CI, 0.38–0.73).
Conclusion: The causes of unplanned hospital readmissions are mixed. Patient contact with primary health care appears to reduce the recurrence. In addition to the diagnoses of cardiac failure, training level of admitting physicians in emergency departments was an independent risk factor for early readmission. Our conclusion is that it is cost-effective to have all decisions on admission to hospital care confirmed by senior doctors. Inappropriate selection of patients to inpatient care contributes to poor patient outcomes and reduces cost-effectiveness and quality of care.
Objectives: The purpose of this study is to describe the situation with the distribution and utilization of prenatal diagnosis technology in China, to identify some important barriers to prenatal diagnosis use, and to suggest changes to improve the present situation.
Methods: The study uses cross-sectional surveys to capture quantitative data from both providers and consumers. Qualitative information based on focus group discussions is also presented.
Results: A mail survey of the provincial Bureaus of Health (BOHs) reveals that sixteen provincial prenatal diagnosis centers and twelve city level centers were accredited by the BOHs by July of 2001. These centers were located in thirteen provinces, of thirty in all of China. Of 147 selected institutions surveyed separately, 90.5 ercent offer ultrasound examination, 72.1 percent provide pathogen tests (mainly Toxoplasma, rubella virus, cytomegalovirus, and herpes simplex or TORCH), 57.1 percent do biochemical tests, 21.8 percent have genetic counseling, 13.6 percent do karyotype testing, 7.5 percent do enzymology testing, and 5.4 percent carry out molecular genetic testing. Chromosome diseases, congenital diseases, and several gene diseases are the target diseases. According to qualitative data, macromanagement for prenatal diagnosis, supplier provision of tests, and population demand are the main influences on prenatal diagnosis use.
Conclusions: From the quantitative and qualitative analysis, it is clear that the technology of prenatal diagnosis is not diffusing well throughout China and is apparently not appropriately used. The situation of prenatal diagnosis has implications for policy-makers, including identification of priorities, regulation of prenatal diagnosis, strategic planning, development of guidelines based on health technology assessment, and consumer orientation.
Objectives: To describe the adoption and take up of thrombolytic agents for acute myocardial infarction since 1980 in England and compare use with the estimated ceiling of need.
Methods: Data on national sales and use of thrombolysis since 1980 (supplied by IMS Health) was used to draw an adoption and diffusion curve. The epidemiological ceiling of acute myocardial infarction, from hospital activity statistics, was modified to an estimated clinical need by accounting for diagnostic difficulty and contraindications using information from published surveys of thrombolysis use in the United Kingdom.
Results: There was a rapid uptake of thrombolytic agents in the first 2 years after availability in 1987, then a plateau, followed by a rise to a peak use in 1995. The shortfall in doses resulting from the difference between estimated ceiling of clinical need and doses purchased and provided in the 14 years since availability is estimated as 167,800 (95 percent confidence range 94,000 to 241,700).
Conclusions: Although there was a rapid initial uptake of thrombolysis in England, usage took 8 years to reach the ceiling of clinical need of 65 percent of patients with acute myocardial infarction, with many patients missing the opportunity to benefit. Monitoring of uptake of innovations known to be cost-effective is required to identify those developments that need additional stimulus for change to ensure that patients do not miss out on the opportunity to benefit.