Evidence report/technology assessment最新文献

Objectives: The objectives are: (1) To assess diagnostic test characteristics of six alternative index tests compared with the selected reference standard-a standardized exercise challenge test (ECT) in patients with suspected exercise-induced bronchoconstriction or asthma (EIB/EIA); (2) to determine the efficacy of a single prophylactic dose of four pharmacologic and one nonpharmacologic interventions vs. placebo to attenuate EIB/EIA in patients with diagnosed EIB/EIA; and (3) to determine if regular daily treatment with short-acting or long-acting beta-agonists (SABA or LABA) causes patients with EIA to develop tachyphylaxis when additional prophylactic doses are used pre-exercise.

Data sources: A systematic and comprehensive literature search was conducted in 14 electronic databases (Diagnosis) and the Cochrane Airways Register (Therapy).

Review methods: Study selection, quality assessment, and data extraction were conducted independently by two reviewers. The primary outcome was the maximum percent fall in the post-exercise forced expiratory volume in 1 second (percent fall FEV1). The diagnostic threshold for a positive ECT was a percent fall FEV1 of 10% or more. Sensitivity (SN) and specificity (SP) were calculated. For therapy, mean differences (MD) in the percent fall FEV1 and 95% confidence intervals (CI) (random effects model) were calculated. A positive MD indicates the intervention works better than the control.

Results: For the diagnostic reviews, 5,318 citations yielded 28 relevant studies; for the therapy reviews, 1,634 citations yielded 109 relevant RCTs. Diagnostic test results versus ECT: self-reported history (2 studies) SN=36-8 percent; SP=85-86 percent; sport specific challenges (5 studies) SN=0-100 percent, SP=0-100 percent; eucapnic voluntary hyperpnea (7 studies) SN=25-90 percent, SP=0-71 percent; free running asthma screening test (3 studies) SN=60-67 percent, SP=47-67 percent; mannitol (3 studies) SN=58-96 percent, SP=65-78 percent. All SN and SP calculations indicated substantial heterogeneity that could not be explained by sensitivity or subgroup analyses. Therapy results: SABA offered greater protection than mast cell stabilizers (MCS) (12 studies); MD=6.8 (95 percent CI: 4.5, 9.2) but combining them offered no additional benefit; SABA versus MCS plus SABA (5 studies) MD=1.3 (95 percent CI: -6.3, 8.9). Leukotriene receptor antagonists (LTRA), MCS, ipratropium bromide, and interval warmup routines provided statistically significant attenuation of EIA when compared with placebo; inhaled corticosteroids (ICS) and other warmup routines did not. Single-dose intervention versus placebo results are: LTRA (9 studies) MD=8.9 (95 percent CI: 6.9, 11.0); MCS (nedocromil sodium) (17 studies) MD=15.6 (95 percent CI: 13.2, 18.2); interval warmup versus no warmup (4 studies) MD=10.6 (95 percent CI: 6.5, 14.7); ICS (4 studies) MD=5.0 (95 percent C

Objective: The objective of the report is to review the evidence on the impact of consumer health informatics (CHI) applications on health outcomes, to identify the knowledge gaps and to make recommendations for future research.

Data sources: We searched MEDLINE, EMBASE, The Cochrane Library, Scopus, and CINAHL databases, references in eligible articles and the table of contents of selected journals; and query of experts.

Methods: Paired reviewers reviewed citations to identify randomized controlled trials (RCTs) of the impact of CHI applications, and all studies that addressed barriers to use of CHI applications. All studies were independently assessed for quality. All data was abstracted, graded, and reviewed by 2 different reviewers.

Results: One hundred forty-six eligible articles were identified including 121 RCTs. Studies were very heterogeous and of variable quality. Four of five asthma care studies found significant positive impact of a CHI application on at least one healthcare process measure. In terms of the impact of CHI on intermediate health outcomes, significant positive impact was demonstrated in at least one intermediate health outcome of; all three identified breast cancer studies, 89 percent of 32 diet, exercise, physical activity, not obesity studies, all 7 alcohol abuse studies, 58 percent of 19 smoking cessation studies, 40 percent of 12 obesity studies, all 7 diabetes studies, 88 percent of 8 mental health studies, 25 percent of 4 asthma/COPD studies, and one of two menopause/HRT utilization studies. Thirteen additional single studies were identified and each found evidence of significant impact of a CHI application on one or more intermediate outcomes. Eight studies evaluated the effect of CHI on the doctor patient relationship. Five of these studies demonstrated significant positive impact of CHI on at least one aspect of the doctor patient relationship. In terms of the impact of CHI on clinical outcomes, significant positive impact was demonstrated in at least one clinical outcome of; one of three breast cancer studies, four of five diet, exercise, or physical activity studies, all seven mental health studies, all three identified diabetes studies. No studies included in this review found any evidence of consumer harm attributable to a CHI application. Evidence was insufficient to determine the economic impact of CHI applications.

Conclusions: Despite study heterogeneity, quality variability, and some data paucity, available literature suggests that select CHI applications may effectively engage consumers, enhance traditional clinical interventions, and improve both intermediate and clinical health outcomes.

Objectives: Systematic synthesis of the published evidence about incidence, risk factors, and management options for women with ductal carcinoma in situ (DCIS) of the breast.

Data sources: Original epidemiologic studies were sought from several databases to identity articles published in English between 1970 and January 31, 2009.

Review methods: Incidence of DCIS in the general population and among women at greater risk of breast cancer and patient outcomes after diagnostic magnetic resonance imaging (MRI) or sentinel lymph node biopsy (SLNB) were abstracted into the developed standardized form. Patient outcomes after breast conserving surgery with or without adjuvant radio- or chemotherapy or after mastectomy were compared from randomized controlled clinical trials (RCTs) and observational studies.

Results: Three hundred seventy-four publications were eligible for the review. Rarely diagnosed before 1980, the incidence of DCIS increased by 270 percent since 1987 to 37.5 per 100,000 women in 2001, partially due to increased use of mammography with no good evidence of overdiagnosis (63 publications). Incidence was higher with increasing age, breast density, and family history and lower among physically active women and aspirin users (29 publications). Tamoxifen did not prevent DCIS at longer followup in women at high risk of breast cancer (two RCTs). No good evidence was identified around the optimal use of MRI for treatment planning (64 publications). Case-series from academic centers reported that around 5 percent of women with final histological diagnosis of DCIS had positive sentinel nodes and 1 percent were upgraded to metastatic cancer with no significant differences in outcomes (50 publications). Good evidence from five RCTs (ten publications) suggested that breast conserving surgery with adjuvant radiation reduced ipsilateral (the same breast) tumors by 53 percent with no differences in mortality or contralateral (the second breast) cancer. One RCT demonstrated that adjuvant chemotherapy reduced ipsilateral and contralateral cancer. Ten-year post diagnostic survival was more than 98 percent, while the rates of ipsilateral cancer were around 10 percent (133 publications of 64 observational studies). Major risk factors for ipsilateral cancer were younger age, larger tumor size, comedo necrosis, and positive surgical margins. Limited evidence of worse incidence and advanced outcomes in racial subgroups varied across the studies. Inconsistent evidence suggested that Her2 receptor and negative estrogen receptor status were associated with worse outcomes. No good evidence was found that adjuvant chemotherapy or mastectomy can improve outcomes and there was no evidence on natural history of DCIS or on quality of life among women treated for DCIS.

Conclusions: Incidence of DCIS continued to increase with no evidence of overdiagnosis or e

Objectives: The Vanderbilt Evidence-based Practice Center systematically reviewed evidence on treatment of overactive bladder (OAB), urge urinary incontinence, and related symptoms. We focused on prevalence and incidence, treatment outcomes, comparisons of treatments, modifiers of outcomes, and costs.

Data: We searched PubMed, MEDLINE, EMBASE, and CINAHL.

Review methods: We included studies published in English from January 1966 to October 2008. We excluded studies with fewer than 50 participants, fewer than 75 percent women, or lack of relevance to OAB. Of 232 included publications, 20 were good quality, 145 were fair, and 67 poor. We calculated weighted averages of outcome effects and conducted a mixed-effects meta-analysis to investigate outcomes of pharmacologic treatments across studies.

Results: OAB affects more than 10 to 15 percent of adult women, with 5 to 10 percent experiencing urge urinary incontinence (UUI) monthly or more often. Six available medications are effective in short term studies: estimates from meta-analysis models suggest extended release forms (taken once a day) reduce UUI by 1.78 (95 percent confidence interval (CI): 1.61, 1.94) episodes per day, and voids by 2.24 (95 percent CI: 2.03, 2.46) per day. Immediate release forms (taken twice or more a day) reduce UUI by 1.46 (95 percent CI: 1.28, 1.64), and voids by 2.17 (95 percent CI: 1.81, 2.54). As context, placebo reduces UUI episodes by 1.08 (95 percent CI: 0.86, 1.30), and voids by 1.48 (95 percent CI: 1.19, 1.71) per day. No one drug was definitively superior to others, including comparison of newer more selective agents to older antimuscarinics. Current evidence is insufficient to guide choice of other therapies including sacral neuromodulation, instillation of oxybutynin, and injections of botulinum toxin. Acupuncture was the sole complementary and alternative medicine treatment, among reflexology and hypnosis, with early evidence of benefit. The strength of the evidence is insufficient to fully inform choice of these treatments. Select behavioral interventions were associated with symptom improvements comparable to medications. Limited evidence suggests no clear benefit from adding behavioral interventions at the time of initiation of pharmacologic treatment.

Conclusions: OAB and associated symptoms are common. Treatment effects are modest. Quality of life and treatment satisfaction measures suggest such improvements can be important to women. The amount of high quality literature available is meager for helping guide women's choices. Gaps include weak or absent data about long-term followup, poorly characterized and potentially concerning harms, information about best choices to minimize side effects, and study of how combinations of approaches may best be used. This is problematic since the condition is chronic and a single treatment modality is unlik

Objectives: This systematic review aimed to evaluate, within unselected populations: Question 1 (Q1) key elements of family history (FH) which usefully predict subsequent disease; Question 2 (Q2) the accuracy of reporting FH; Question 3 (Q3) the impact of FH-based risk information on the uptake of preventive interventions; Question 4 (Q4) the potential for harms associated with collecting cancer FH; Question 5 (Q5) factors that facilitate or hinder the collection of family history; and, Question 6 (Q6) future directions.

Data sources: MEDLINE, EMBASE, CINAHL, Cochrane Controlled Trial Register (CCTR), and PsycINFO were searched from 1995 to March 2, 2009 inclusive.

Review methods: Standard systematic review methodology was employed. Eligibility criteria varied by question, but overall, specified studies reported in English, excluded qualitative designs, and limited populations to those unselected for pre-existing risk (except for Q2). Study designs and outcomes varied by research question.

Results: One hundred and thirty-seven publications were eligible in total for this review. Q1: Key elements of FH: Eighty-nine studies were eligible for this question of which 59 reported FH and data on subsequent or current disease in subjects. The varied definitions of positive FH were consistently associated with elevated relative risks, but their value in predicting future risk or detecting current disease was difficult to assess without considering further information on other risk factors or the available preventive interventions. Q2: Accuracy of FH Reporting. Thirty-seven studies evaluated accuracy and showed relatively high specificity and low sensitivity across all disease categories. Q3: Uptake of preventive interventions. Two studies evaluated the impact of FH-based risk and the evidence was insufficient to establish any effect on change in clinical preventive behavior or uptake of interventions. Q4: Harms of FH taking. Three studies evaluated the impact of FH-based risk information on psychological outcomes and indicated no evidence of significant harm.Q5: Factors affecting FH collection: The evidence base for addressing Q5 is heterogeneous and limited to six studies exploring the association between various factors and family history reporting, documentation and discussion.

Conclusions: Our review indicates: (Q1) Many FH definitions showed low discriminatory accuracy in predicting disease risk in individuals but further research is warranted; (Q2) accuracy of reporting is higher for relatives without, than those affected by, a given disease; (Q3) there is insufficient evidence to assess the effect of FH-based risk assessment on preventive behaviors; (Q4) there is limited evidence to assess whether the provision of FH-based personalized risk assessment results in adverse outcomes; (Q5) there is little evidence on factors affecting FH repor

Background: Since the 1997 Dietary Reference Intake (DRI) values for vitamin D and calcium were established new data have become available on their relationship, both individually and combined, to a wide range of health outcomes. The Institute of Medicine/Food and Nutrition Board has constituted a DRI committee to undertake a review of the evidence and potential revision of the current DRI values for these nutrients. To support this review, several US and Canadian federal government agencies commissioned a systematic review of the scientific literature for use during the deliberations by the committee. The intent of providing a systematic review to the committee is to support transparency of the literature review process and provide a foundation for subsequent reviews of the nutrients.

Purpose: To systematically summarize the evidence on the relationship between vitamin D, calcium, and a combination of both nutrients on a wide range of health outcomes as identified by the IOM, AHRQ and technical expert panel convened to support the project.

Data sources: MEDLINE; Cochrane Central; Cochrane Database of Systematic Reviews; and the Health Technology Assessments; search limited to English-language articles in humans.

Study selection: Primary interventional or observational studies that reported outcomes of interest in human subjects in relation to vitamin D and/or calcium, as well as systematic reviews that met the inclusion and exclusion criteria. Cross sectional and retrospective case-control studies were excluded.

Data extraction: A standardized protocol with predefined criteria was used to extract details on study design, interventions, outcomes, and study quality.

Data synthesis: We summarized 165 primary articles and 11 systematic reviews that incorporated over 200 additional primary articles. Available evidence focused mainly on bone health, cardiovascular diseases or cancer outcomes. For many outcomes, it was difficult to draw firm conclusions on the basis of the available literature concerning the association of either serum 25(OH)D concentration or calcium intake, or the combination of both nutrients. Findings were inconsistent across studies for colorectal and prostate cancer, and pregnancy-related outcomes including preeclampsia. There were few studies for pancreatic cancer and immune function. Among trials of hypertensive adults, calcium supplementation lowered systolic, but not diastolic, blood pressure by 2-4 mm Hg. For body weight, the trials were consistent in finding no significant effect of increased calcium intake on weight. For growth rates, a meta-analysis did not find a significant effect on weight or height gain attributable to calcium supplement in children. For bone health, one systematic review found that vitamin D plus calcium supplementation resulted in small increases in BMD of the spine

Objectives: To conduct a systematic review and synthesize the evidence for the effects of surgical treatments for subcapital and intertrochanteric/subtrochanteric hip fractures on patient-focused outcomes for elderly patients.

Data sources: MEDLINE, Cochrane databases, Scirus, and ClinicalTrials.gov, and expert consultants. We also manually searched reference lists from relevant systematic reviews.

Review methods: High quality quasi-experimental design studies were used to examine relationships between patient characteristics, type of fracture, and patient outcomes. Randomized controlled trials were used to examine relationships between type of surgical treatment and patient outcomes. Patient mortality was examined with Forest plots. Narrative analysis was used for pain, quality of life (QoL), and functional outcomes due to inconsistently measured and reported outcomes.

Results: Mortality does not appear to differ by device class, or by devices within a class. Nor, on the whole, do pain, functioning, and QoL. Some internal fixation devices may confer earlier return to functioning over others for some patients, but such gains are very short lived. Very limited results suggest that subcapital hip fracture patients with total hip replacements have improved patient outcomes over internal fixation, but it is unclear whether these results would continue to hold if the analyses included the full complement of relevant covariates. Age, gender, prefracture functioning, and cognitive impairment appear to be related to mortality and functional outcomes. Fracture type does not appear to be independently related to patient outcomes. Again, however, the observational literature does not include the full complement of potential covariates and it is uncertain if these results would hold.

Conclusions: Several factors limit our ability to definitively answer the key questions posed in this study using the existing literature. Limited perspectives lead to incomplete sets of independent variables included in analyses. Specific populations are poorly defined and separated for comparative study. Fractures with widely varying biomechanical problems are often lumped together. Outcome variables are inconsistently measured and reported, making it very difficult to aggregate or even compare results. If future high quality trials continue to support the evidence that differences in devices are short term at best, within the first few weeks to few months of recovery, policy implications involve establishing the value of a shorter recovery relative to the cost of the new device. As the literature generally focuses on community dwelling elderly patients, more attention needs to be directed toward understanding implications of surgical treatment choices for the nursing home population.

Objective: To address whether Factor V Leiden (FVL) testing alone, or in combination with prothrombin G20210A testing, leads to improved clinical outcomes in adults with a personal history of venous thromboembolism (VTE) or to improved clinical outcomes in adult family members of mutation-positive individuals.

Data sources: Searches of MEDLINE, EMBASE, The Cochrane Library, the Cumulative Index to Nursing and Allied Health Literature, and PsycInfo through December 2008.

Review methods: We focused on the analytic validity, clinical validity, and clinical utility of these tests. Each included article underwent double review for data abstraction and assessment of study quality. We pooled the results of studies addressing the clinical validity of these tests when there were sufficient data. Other evidence was summarized in evidence tables. We graded the evidence by adapting a scheme recommended by the Grading of Recommendations Assessment, Development and Evaluation (GRADE) Working Group by assessing the limitations affecting individual study quality, the certainty regarding the directness of the observed effects in the studies, the precision and strength of the findings, and the availability (or lack) of data to answer the relevant key question. Evidence for each sub-question was graded as high, moderate, or low.

Results: We reviewed 7,777 titles and included 124 articles. No direct evidence addressed the primary objective. However, high-grade evidence supported the conclusion that tests for the detection of FVL and prothrombin G20210A have excellent analytic validity. Most clinical laboratories test for these mutations accurately. Heterozygosity [odds ratio (OR) =1.56 (95 percent confidence interval (CI) 1.14 to 2.12)] and homozygosity [OR=2.65 (95 percent C.I. 1.2 to 6.0)] for FVL in probands are predictive of recurrent VTE. Heterozygosity for FVL predicts VTE in family members [OR=3.5 (95 percent C.I. 2.5 to 5.0)] as does homozygosity for FVL [OR=18 (95 percent C.I. 7.8 to 40)]. Heterozygosity for prothrombin G20210A is not predictive of recurrence in probands [OR=1.45 (95 percent C.I. 0.96-2.2)]. Evidence is insufficient about heterozygosity for prothrombin G20210A in family members and insufficient about homozygosity for prothrombin G20210A. A single study supported the hypothesis that clinicians might change management based on test results. There was high-grade evidence that anticoagulation reduces recurrent events in probands with FVL or prothrombin G20210A, however, there was low-grade evidence that the relative reduction with treatment is comparable to that seen in individuals without mutations. There was moderate evidence to support the conclusion that neither harms nor benefits of testing have been demonstrated conclusively. Decision-analysis models suggest that testing may be cost-effective in select individuals.

Conclusions:

Objectives: To conduct a systematic review of the evidence on characteristics of community health workers (CHWs) and CHW interventions, outcomes of such interventions, costs and cost-effectiveness of CHW interventions, and characteristics of CHW training.

Data sources: We searched MEDLINE, Cochrane Collaboration resources, and the Cumulative Index to Nursing and Allied Health Literature for studies published in English from 1980 through November 2008.

Review methods: We used standard Evidence-based Practice Center methods of dual review of abstracts, full-text articles, abstractions, quality ratings, and strength of evidence grades. We resolved disagreements by consensus.

Results: We included 53 studies on characteristics and outcomes of CHW interventions, 6 on cost-effectiveness, and 9 on training. CHWs interacted with participants in a broad array of locations, using a spectrum of materials at varying levels of intensity. We classified 8 studies as low intensity, 18 as moderate intensity, and 27 as high intensity, based on the type and duration of interaction. Regarding outcomes, limited evidence (five studies) suggests that CHW interventions can improve participant knowledge when compared with alternative approaches such as no intervention, media, mail, or usual care plus pamphlets. We found mixed evidence for CHW effectiveness on participant behavior change (22 studies) and health outcomes (27 studies): some studies suggested that CHW interventions can result in greater improvements in participant behavior and health outcomes when compared with various alternatives, but other studies suggested that CHW interventions provide no statistically different benefits than alternatives. Low or moderate strength of evidence suggests that CHWs can increase appropriate health care utilization for some interventions (30 studies). The literature showed mixed results of effectiveness when analyzed by clinical context: CHW interventions had the greatest effectiveness relative to alternatives for some disease prevention, asthma management, cervical cancer screening, and mammography screening outcomes. CHW interventions were not significantly different from alternatives for clinical breast examination, breast self-examination, colorectal cancer screening, chronic disease management, or most maternal and child health interventions. Six studies with economic and cost information yielded insufficient data to evaluate the cost-effectiveness of CHW interventions relative to other community health interventions. Limited evidence described characteristics of CHW training; no studies examined the impact of CHW training on health outcomes.

Conclusions: CHWs can serve as a means of improving outcomes for underserved populations for some health conditions. The effectiveness of CHWs in numerous areas requires further research that addresses the methodological li