Evidence report/technology assessment最新文献

Objectives: Despite the broad range of continuing medical education (CME) offerings aimed at educating practicing physicians through the provision of up-to-date clinical information, physicians commonly overuse, under-use, and misuse therapeutic and diagnostic interventions. It has been suggested that the ineffective nature of CME either accounts for the discrepancy between evidence and practice or at a minimum contributes to this gap. Understanding what CME tools and techniques are most effective in disseminating and retaining medical knowledge is critical to improving CME and thus diminishing the gap between evidence and practice. The purpose of this review was to comprehensively and systematically synthesize evidence regarding the effectiveness of CME and differing instructional designs in terms of knowledge, attitudes, skills, practice behavior, and clinical practice outcomes.

Review methods: We formulated specific questions with input from external experts and representatives of the Agency for Healthcare Research and Quality (AHRQ) and the American College of Chest Physicians (ACCP) which nominated this topic. We systematically searched the literature using specific eligibility criteria, hand searching of selected journals, and electronic databases including: MEDLINE, EMBASE, the Cochrane Database of Systematic Reviews, The Cochrane Central Register of Controlled Trials (CENTRAL), the Cochrane Database of Abstracts of Reviews of Effects (DARE), PsycINFO, and the Educational Resource Information Center (ERIC). Two independent reviewers conducted title scans, abstract reviews, and then full article reviews to identify eligible articles. Each eligible article underwent double review for data abstraction and assessment of study quality.

Results: Of the 68,000 citations identified by literature searching, 136 articles and 9 systematic reviews ultimately met our eligibility criteria. The overall quality of the literature was low and consequently firm conclusions were not possible. Despite this, the literature overall supported the concept that CME was effective, at least to some degree, in achieving and maintaining the objectives studied, including knowledge (22 of 28 studies), attitudes (22 of 26), skills (12 of 15), practice behavior (61 of 105), and clinical practice outcomes (14 of 33). Common themes included that live media was more effective than print, multimedia was more effective than single media interventions, and multiple exposures were more effective than a single exposure. The number of articles that addressed internal and/or external characteristics of CME activities was too small and the studies too heterogeneous to determine if any of these are crucial for CME success. Evidence was limited on the reliability and validity of the tools that have been used to assess CME effectiveness. Based on previous reviews, the evidence indicates that simulation methods in medical

Objectives: To assess the evidence for using heparin in the treatment of burn injury or the complications of burn injury in adults and children.

Data sources: The following databases were searched: MEDLINE (1966-current), EMBASE (1980-current), Cumulative Index to Nursing & Allied Health (CINAHL) (1982-current), The Cochrane Central Database of Controlled Trials (1995-current), Web of Science (1976-current), and BIOSIS (1976-current). Additional data sources included the U.S. and European Patent Offices, technical experts, the partner organization, and reference lists.

Review methods: Studies identified from the data sources went through two levels of title and abstract screening. Passing studies advanced to full text screening. Studies that met the full text screening criteria were abstracted. Criteria for abstraction included publication in any language, human patients of any age, and burns of any type, grade, or total body surface area. All formulations of heparin, and all application methods (e.g., topical, subcutaneous), were eligible for inclusion in the report. Abstracted studies required a comparison group. Outcomes of interest included mortality, pain, length of stay in hospital, thrombosis and emboli, psychiatric adjustment, and adverse effects (e.g., bleeding).

Results: Nineteen articles from 18 unique studies were abstracted and included in this report. In these articles, there were multiple uses of heparin to treat burns (e.g., wound healing, inhalation injury, sepsis, pain). However, the overall quality of the articles was weak. Examples of weakness included unclear or inappropriate treatment allocation, no blinding, no control of confounding, poorly defined burn characteristics (e.g., thickness), unclear duration of treatment, incomplete description of heparin treatment, and use of inadequately described or invalid outcome measures. Overall, the evidence from these weak articles was insufficient to determine whether the effectiveness of heparin to treat burn injury was different from the effectiveness of other treatments, or whether treatment effectiveness varied according to (a) the method of applying heparin to (b) burn etiology. Four studies mentioned contraindications to using heparin to treat burns. These contraindications were bleeding diathesis, bleeding history, active bleeding or associated trauma with potential bleeding, active intestinal ulcer, thrombocytopenia, liver disease, renal disorders, or allergy to heparin.

Conclusions: There is no strong evidence in the 19 abstracted articles to suggest that heparin should be used in the treatment of burn injury on account of its non-anticoagulant properties.

Objectives: The objectives of this report are to determine the following: (1) the effectiveness of the toilet training methods, (2) which factors modify the effectiveness of toilet training, (3) if the toilet training methods are risk factor for adverse outcomes, and (4) the optimal toilet training method for achieving bowel and bladder control among patients with special needs.

Data sources: MEDLINE, Ovid MEDLINE In-Process & Other Non-Indexed Citations, Ovid OLDMEDLINE, Cochrane Central Register of Controlled Trials, EMBASE, CINAHL, PsycINFO, ERIC, EBM Reviews, HealthSTAR, AMED, Web of Science, Biological Abstracts, Sociological Abstracts, OCLC ProceedingsFirst, OCLC PapersFirst, Dissertation Abstracts, Index to Theses, National Research Register's Projects Database, and trials registers.

Review methods: Two reviewers assessed the studies for inclusion. Studies were included if they met the following criteria:

Study design: RCT, CCT, prospective or retrospective cohort, case-control, cross-sectional or case-series;

Population: infants, toddlers, or children with or without co-morbidities, neuromuscular, cognitive, or behavioral handicaps disabilities;

Intervention: at least one toilet training method; and

Outcome: bladder and/or bowel control, successes, failures, adverse outcomes. Methodological quality was assessed independently by two reviewers. Data were extracted by one reviewer and a second checked for accuracy and completeness. Due to substantial heterogeneity, meta-analysis was not possible.

Results: Twenty-six observational studies and eight controlled trials were included. Approximately half of the studies examined healthy children while the remaining studies assessed toilet training of mentally or physically handicapped children. For healthy children, the Azrin and Foxx method performed better than the Spock method, while child-oriented combined with negative term avoidance proved better than without. For mentally handicapped children, individual training was superior to group methods; relaxation techniques proved more efficacious than standard methods; operant conditioning was better than conventional treatment, and the Azrin and Foxx and a behavior modification method fared better than no training. The child-oriented approach was not assessed among mentally handicapped children. For children with Hirschsprung's disease or anal atresia, a multi-disciplinary behavior treatment was more efficacious than no treatment.

Conclusions: Both the Azrin and Foxx method and the child-oriented approach resulted in quick, successful toilet training, but there was limited information about the sustainability of the training. The two methods were not directly compared, thus it is difficult to draw definitive conclusions regarding the superiority of

Objectives: To assess the evidence that the use of genomic tests for ovarian cancer screening, diagnosis, and treatment leads to improved outcomes.

Data sources: PubMed and reference lists of recent reviews.

Review methods: We evaluated tests for: (a) single gene products; (b) genetic variations affecting risk of ovarian cancer; (c) gene expression; and (d) proteomics. For tests covered in recent evidence reports (cancer antigen 125 [CA-125] and breast cancer genes 1 and 2 [BRCA1/2]), we added studies published subsequent to the reports. We sought evidence on: (a) the analytic performance of tests in clinical laboratories; (b) the sensitivity and specificity of tests in different patient populations; (c) the clinical impact of testing in asymptomatic women, women with suspected ovarian cancer, and women with diagnosed ovarian cancer; (d) the harms of genomic testing; and (e) the impact of direct-to-consumer and direct-to-physician advertising on appropriate use of tests. We also constructed a computer simulation model to test the impact of different assumptions about ovarian cancer natural history on the relative effectiveness of different strategies.

Results: There are reasonable data on the clinical laboratory performance of most radioimmunoassays, but the majority of the data on other genomic tests comes from research laboratories. Genomic test sensitivity/specificity estimates are limited by small sample sizes, spectrum bias, and unrealistically large prevalences of ovarian cancer; in particular, estimates of positive predictive values derived from most of the studies are substantially higher than would be expected in most screening or diagnostic settings. We found no evidence relevant to the question of the impact of genomic tests on health outcomes in asymptomatic women. Although there is a relatively large literature on the association of test results and various clinical outcomes, the clinical utility of changing management based on these results has not been evaluated. We found no evidence that genomic tests for ovarian cancer have unique harms beyond those common to other tests for genetic susceptibility or other tests used in screening, diagnosis, and management of ovarian cancer. Studies of a direct-to-consumer campaign for BRCA1/2 testing suggest increased utilization, but the effect on "appropriateness" was unclear. Model simulations suggest that annual screening, even with a highly sensitive test, will not reduce ovarian cancer mortality by more than 50 percent; frequent screening has a very low positive predictive value, even with a highly specific test.

Conclusions: Although research remains promising, adaptation of genomic tests into clinical practice must await appropriately designed and powered studies in relevant clinical settings.

Objectives: The purpose of this systematic review was to evaluate BNP and NT-proBNP to: (a) identify determinants, (b) establish their diagnostic performance in heart failure (HF) patients, (c) determine their predictive ability with respect to mortality and other cardiac endpoints, and (d) determine their value in monitoring HF treatment.

Data sources: MEDLINE, EMBASE, CINAHL, Cochrane Central, and AMED from 1989 to February 2005 were searched for primary studies.

Review methods: Standard systematic review methodology, including meta-analysis, was employed. All study designs were included. Eligibility criteria included English-only studies and restricted the number of test methods to maximize generalizability. Outcomes for prognosis were limited to mortality and specific cardiac events. Further specific criteria were developed for each research question.

Results: Determinants: There were 103 determinants identified including age, gender, disease, treatment, as well as biochemical and physiological measures. Few studies reported independent associations and of those that did age, female gender and creatinine levels were positively associated with BNP and NT-proBNP.

Diagnosis: Pooled sensitivity and specificity values were 94 and 66 percent for BNP and 92 and 65 percent for NT-proBNP; there was minimal difference among settings (emergency, specialized clinics, and primary care). B-type natriuretic peptides also added independent diagnostic information above traditional measures for HF.

Prognosis: Both BNP and NT-proBNP were found to be independent predictors of mortality and other cardiac composite endpoints in patients with risk of coronary artery disease (CAD) (risk estimate range = 1.10 to 5.40), diagnosed CAD (risk estimate range = 1.50 to 3.00), and diagnosed HF patients (risk estimate range = 2.11 to 9.35). With respect to screening, the AUC values (range = 0.57 to 0.88) suggested poor performance. Monitoring Treatment: Studies showed therapy reduced BNP and NT-proBNP, however, relationship to outcome was limited and not consistent.

Conclusions: Determinants: The importance of the identified determinants for clinical use is not clear.

Diagnosis: In all settings both BNP and NT-proBNP show good diagnostic properties as a rule out test for HF.

Prognosis: BNP and NT-proBNP are consistent independent predictors of mortality and other cardiac composite endpoints for populations with risk of CAD, diagnosed CAD, and diagnosed HF. There is insufficient evidence to determine the value of B-type natriuretic peptides for screening of HF. Monitoring Treatment: There is insufficient evidence to demonstrate that BNP and NT-proBNP levels show change in response to therapies to manage stable chronic HF patients.

Objectives: To systematically review the literature about children with anthrax to describe their clinical course, treatment responses, and the predictors of disease progression and mortality.

Data sources: MEDLINE (1966-2005), 14 selected journal indexes (1900-1966) and bibliographies of all retrieved articles.

Review methods: We sought case reports of pediatric anthrax published between 1900 and 2005 meeting predefined criteria. We abstracted three types of data from the English-language reports: (1) Patient information (e.g., age, gender, nationality), (2) symptom and disease progression information (e.g., whether the patient developed meningitis); (3) treatment information (e.g., treatments received, year of treatment). We compared the clinical symptoms and disease progression variables for the pediatric cases with data on adult anthrax cases reviewed previously.

Results: We identified 246 titles of potentially relevant articles from our MEDLINE(R) search and 2253 additional references from our manual search of the bibliographies of retrieved articles and the indexes of the 14 selected journals. We included 62 case reports of pediatric anthrax including two inhalational cases, 20 gastrointestinal cases, 37 cutaneous cases, and three atypical cases. Anthrax is a relatively common and historically well-recognized disease and yet rarely reported among children, suggesting the possibility of significant under-diagnosis, underreporting, and/or publication bias. Children with anthrax present with a wide range of clinical signs and symptoms, which differ somewhat from the presenting features of adults with anthrax. Like adults, children with gastrointestinal anthrax have two distinct clinical presentations: Upper tract disease characterized by dysphagia and oropharyngeal findings and lower tract disease characterized by fever, abdominal pain, and nausea and vomiting. Additionally, children with inhalational disease may have "atypical" presentations including primary meningoencephalitis. Children with inhalational anthrax have abnormal chest roentgenograms; however, children with other forms of anthrax usually have normal roentgenograms. Nineteen of the 30 children (63%) who received penicillin-based antibiotics survived; whereas nine of 11 children (82%) who received anthrax antiserum survived.

Conclusions: There is a broad spectrum of clinical signs and symptoms associated with pediatric anthrax. The limited data available regarding disease progression and treatment responses for children infected with anthrax suggest some differences from adult populations. Preparedness planning efforts should specifically address the needs of pediatric victims.

Objectives: Evaluate treatment options for nonruptured abdominal aortic aneurysms (AAA); the relationship of hospital and physician volume to outcomes for endovascular repair (EVAR); affect of patient and AAA factors on outcomes; cost-benefits of treatments.

Data sources: PubMed, Cochrane Library, FDA, and other electronic websites until May 2006. Reference lists and content experts were used to identify additional reports.

Review methods: Randomized controlled trials (RCT) of open surgical repair (OSR), EVAR, or active surveillance, systematic reviews, nonrandomized U.S. trials, and national registries were used to assess clinical outcomes. Volume-outcome articles published after 2000 were reviewed if they reported the relationship between U.S. hospital or physician volume and outcomes, were population-based, and the analysis was adjusted for risk factors. Cost studies included at least 50 EVAR and provided data on costs or charges, and cost-effectiveness analyses.

Results: Initial or attained diameter is the strongest known predictor of rupture. The annual risk of rupture is below 1 percent for AAA <5.5 cm in diameter. Among medically ill patients unfit for OSR with AAA >/=5.5 cm, the risk of rupture may be as high as 10 percent per year. Early/immediate OSR of AAA <5.5 cm (two trials n=2,226) did not reduce all-cause mortality compared with surveillance and delayed OSR. Results did not differ according to age, gender, baseline AAA diameter or creatinine concentration. Two RCT with followup of at least 2 years compared EVAR to OSR for AAA >/=5.5 cm. EVAR reduced postoperative 30-day mortality compared to OSR (1.6 percent EVAR vs. 4.7 percent OSR, RR = 0.34 [0.17 to 0.65]). Early reduction in all-cause mortality with EVAR disappeared before 2 years. Post-operative complications and reinterventions were higher with EVAR. Quality of life differences were small and disappeared after 3-6 months. One RCT of patients with AAA >/=5.5 cm judged medically unfit for OSR (n=338), reported no difference in all-cause mortality or AAA mortality between EVAR and no intervention (HR = 1.21; 95 percent CI 0.87 to 1.69). Forty-eight nonrandomized reports evaluated EVAR. Patient, AAA characteristics, and outcomes were similar to RCT comparing EVAR to OSR. A volume outcome relationship has been shown for OSR, but there are no data adequate to estimate the effect of hospital or physician volume on EVAR outcomes or to identify a volume threshold for policymakers. Immediate OSR for AAA <5.5 cm costs more and does not improve long-term survival compared to active surveillance and delayed OSR. The cost effectiveness of EVAR relative to OSR is difficult to determine. However, compared to OSR for AAA >/=5.5 cm, EVAR has greater in-hospital costs primarily due to the cost of the prosthesis. EVAR has shorter length of stay, lower 30-day morbidity and mortality but does not improve quali

Objectives: This is a systematic review of evidence on issues in managing small cell lung cancer (SCLC). Key questions addressed are: the sequence, timing, and dosing characteristics of primary thoracic radiotherapy (TRTx) for limited-stage disease; primary TRTx for extensive-stage disease; effect of prophylactic cranial irradiation (PCI); positron emission tomography (PET) for staging; treatment of mixed histology tumors; surgery; and second- and subsequent-line treatment for relapsed/progressive disease.

Data sources: MEDLINE, EMBASE, and the Cochrane Register

Review methods: The review methods were defined prospectively in a written protocol. We sought randomized controlled trials that compared the interventions of interest. Where randomized trials were limited or nonexistent, we sought additional studies. We performed meta-analysis of studies that compared early and late TRTx.

Results: The strongest evidence available for this report is a patient-level meta-analysis showing that PCI improves survival of SCLC patients who achieved complete response following primary therapy from 15.3 percent to 20.7 percent (p=0.01). No other question yielded evidence so robust. The case for concurrent over sequential radiation delivery rests largely on a single multicenter trial. Support for early concurrent therapy comes from one multicenter trial, but two other multicenter trials found no advantage. Our meta-analysis did not find significant reductions in 2- and 3-year mortality for early TRTx. Favorable results from a single-center trial on TRTx for extensive stage disease need replication in a multicenter setting. For other questions (i.e., management of mixed histology disease; surgery for early limited SCLC), relevant comparative studies were nonexistent. PET may be more sensitive in detecting disease outside the brain than conventional staging modalities, but studies were of poor quality and reliable estimates of performance are not possible.

Conclusions: PCI improves survival among those with a complete response to primary therapy. A research agenda is needed to optimize the effectiveness of TRTx and its components. PET for staging may be useful, but its role awaits clarification by rigorous studies. No relevant evidence was available to address management of mixed histology disease or surgery for early limited SCLC.

Objectives: The RTI International-University of North Carolina at Chapel Hill Evidence-based Practice Center (RTI-UNC EPC) systematically reviewed the evidence on (a) the effectiveness of community- and population-based interventions to prevent tobacco use and to increase consumer demand for and implementation of effective cessation interventions; (b) the impacts of smokeless tobacco marketing on smoking, use of those products, and population harm; and (c) the directions for future research.

Data sources: We searched MEDLINE, Cumulative Index to Nursing and Applied Health (CINAHL), Cochrane libraries, Cochrane Clinical Trials Register, Psychological Abstracts, and Sociological Abstracts from January 1980 through June 10, 2005. We included English-language randomized controlled trials, other trials, and observational studies, with sample size and follow-up restrictions. We used 13 Cochrane Collaboration systematic reviews, 5 prior systematic reviews, and 2 meta-analyses as the foundation for this report.

Review methods: Trained reviewers abstracted detailed data from included articles into evidence tables and completed quality assessments; other senior reviewers confirmed accuracy and resolved disagreements.

Results: We identified 1,288 unique abstracts; 642 did not meet inclusion criteria, 156 overlapped with prior reviews, and 2 were not published articles. Of 488 full-text articles retrieved and reviewed, we excluded 298 for several reasons, marked 88 as background, and retained 102. Evidence (consistent with previous reviews) showed that (a) school-based prevention interventions have short-term (but not long-term) effects on adolescents; (b) multicomponent approaches, including telephone counseling, increase the number of users who attempt to quit; (c) self-help strategies alone are ineffective, but counseling and pharmacotherapy used either alone or in combination can improve success rates of quit attempts; and (d) provider training and academic detailing improve provider delivery of cessation treatments, but evidence is insufficient to show that these approaches yield higher quit rates. New evidence was insufficient to address the following: (a) effectiveness of population-based prevention interventions; (b) effectiveness of provider-based interventions to reduce tobacco initiation; (c) effectiveness of community- and provider-based interventions to increase use of proven cessation strategies; (d) effectiveness of marketing campaigns to switch tobacco users from smoking to smokeless tobacco products; and (e) effectiveness of interventions in populations with comorbidities and risk behaviors (e.g., depression, substance and alcohol abuse). No evidence was available on the way in which smokeless tobacco product marketing affects population harm.

Conclusions: The evidence base has notable gaps and numerous study deficiencies. We found

Objectives: To review and synthesize published literature on the efficacy of multivitamin/mineral supplements and certain single nutrient supplements in the primary prevention of chronic disease in the general adult population, and on the safety of multivitamin/mineral supplements and certain single nutrient supplements, likely to be included in multivitamin/mineral supplements, in the general population of adults and children.

Data sources: All articles published through February 28, 2006, on MEDLINE, EMBASE, and the Cochrane databases.

Review methods: Each article underwent double reviews on title, abstract, and inclusion eligibility. Two reviewers performed data abstraction and quality assessment. Differences in opinion were resolved through consensus adjudication.

Results: Few trials have addressed the efficacy of multivitamin/mineral supplement use in chronic disease prevention in the general population of the United States. One trial on poorly nourished Chinese showed supplementation with combined Beta-carotene, vitamin E and selenium reduced gastric cancer incidence and mortality, and overall cancer mortality. In a French trial, combined vitamin C, vitamin E, Beta-carotene, selenium, and zinc reduced cancer risk in men but not in women. No cardiovascular benefit was evident in both trials. Multivitamin/mineral supplement use had no benefit for preventing cataract. Zinc/antioxidants had benefits for preventing advanced age-related macular degeneration in persons at high risk for the disease. With few exceptions, neither Beta-carotene nor vitamin E had benefits for preventing cancer, cardiovascular disease, cataract, and age-related macular degeneration. Beta-carotene supplementation increased lung cancer risk in smokers and persons exposed to asbestos. Folic acid alone or combined with vitamin B12 and/or vitamin B6 had no significant effects on cognitive function. Selenium may confer benefit for cancer prevention but not cardiovascular disease prevention. Calcium may prevent bone mineral density loss in postmenopausal women, and may reduce vertebral fractures, but not non-vertebral fractures. The evidence suggests dose-dependent benefits of vitamin D with/without calcium for retaining bone mineral density and preventing hip fracture, non-vertebral fracture and falls. We found no consistent pattern of increased adverse effects of multivitamin/mineral supplements except for skin yellowing by Beta-carotene.

Conclusions: Multivitamin/mineral supplement use may prevent cancer in individuals with poor or suboptimal nutritional status. The heterogeneity in the study populations limits generalization to United States population. Multivitamin/mineral supplements conferred no benefit in preventing cardiovascular disease or cataract, and may prevent advanced age-related macular degeneration only in high-risk individuals. The overall quality