Evidence report/technology assessment最新文献

Objectives: To update a prior systematic review on the effects of omega-3 fatty acids (n-3 FA) on maternal and child health and to assess the evidence for their effects on, and associations with, additional outcomes.

Data sources: MEDLINE®, Embase®, the Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and Centre for Agriculture and Biosciences (CAB) Abstracts from 2000 to August 2015; eligible studies from the original report; and relevant systematic reviews.

Review methods: We included randomized controlled trials (RCTs) of any defined dose of n-3 FA (or combination) compared to placebo, any other n-3 FA, or alternative dose with an outcome of interest conducted in pregnant or breastfeeding women or neonates (preterm or term). We also included prospective observational studies that analyzed the association between baseline n-3 FA intake or biomarker level and followup outcomes. Postnatal interventions began within a week of birth for term infants and within a week of beginning enteral or oral feeding for preterm infants. Standard methods were used for data abstraction and analysis, according to the Evidence-based Practice Center Methods Guide.

Results: We identified 4,275 potentially relevant titles from our searches, of which 95 RCTs and 48 observational studies met the inclusion criteria. Risk of bias was a concern with both RCTs and observational studies. Outcomes for which evidence was sufficient to draw a conclusion are summarized here with the Strength of Evidence (SoE). (Outcomes for which the evidence was insufficient to draw a conclusion are summarized in Appendix G of the report.).

Maternal Exposures and Outcomes: Gestational length and risk for preterm birth: Prenatal algal docosahexaenoic acid (DHA) or DHA-enriched fish oil supplementation had a small positive effect on length of gestation (moderate SoE), but no effect on risk for preterm birth (low SoE). Prenatal EPA (eicosapentaenoic acid) plus DHA-containing fish oil supplementation has no effect on length of gestation (low SoE). Supplementation with DHA, or EPA plus DHA-, or DHA-enriched fish oil does not decreaserisk for preterm birth (low SoE).

Birth weight and risk for low birth weight: Changes in maternal n-3 FA biomarkers were significantly associated with birth weight. Prenatal algal DHA or DHA-enriched fish oil supplementation had a positive effect on birth weight among healthy term infants (moderate SoE), but prenatal DHA supplementation had no effect on risk for low birth weight (low SoE). Prenatal EPA plus DHA or alpha-linolenic acid (ALA) supplementation had no effect on birth weight (low SoE).

Risk for peripartum depression: Maternal n-3 FA biomarkers had no association with risk for peripartum depression. Maternal DHA, EPA, or DHA-enriched fish oil supplementation had no effect on risk for peripartum depression (l

Objectives: Linking national, State, and community data systems, such as those used for medical service billing, to existing data from suicide prevention efforts could facilitate the assessment of longer term outcomes. Our objective was to identify and describe data systems that can be linked to data from studies of youth suicide prevention interventions and to identify analytic approaches to advance youth suicide prevention research.

Data sources: We conducted a systematic review to identify studies of suicide prevention interventions and three types of searches to identify data systems providing suicide-related outcomes: (1) a literature search, (2) an environmental scan of gray literature, and (3) a targeted search, through contact with relevant individuals, in six States, two cities, and one tribal community.

Review methods: Two independent reviewers screened all results. Studies and data systems had to be based in the United States; include individuals between 0 and 25 years of age; and include suicide, suicide attempt, or suicide ideation as an outcome.

Results: Of the 47 studies (described in 59 articles) of suicide prevention interventions identified in our systematic review, only 6 studied outcomes by linking to external data systems and only 12 explored treatment heterogeneity through the effects of moderators such as gender or race/ethnicity. We identified 153 unique and potentially linkable external data systems, 66 of which we classified as "fairly accessible" with data dictionaries available.

Conclusions: There is potential for linking existing data systems with suicide prevention efforts to assess the broader and extended impact of suicide prevention interventions. However, sparse availability of data dictionaries and lack of adherence to standard data elements limit the potential utility of linking prevention efforts with data systems.

Background: The effect and association of omega-3 fatty acids (n-3 FA) intake and biomarker levels with cardiovascular (CV) clinical and intermediate outcomes remains controversial. We update prior Evidence Reports of n-3 FA and clinical and intermediate CV disease (CVD) outcomes.

Objectives: Evaluate the effect of n-3 FA on clinical and selected intermediate CV outcomes and the association of n-3 FA intake and biomarkers with CV outcomes. The n-3 FA under review include eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), docosapentaenoic acid (DPA), stearidonic acid (SDA), and alphalinolenic acid (ALA).

Data sources: MEDLINE®, Embase®, the Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and CAB Abstracts from 2000 or 2002 to June 8, 2015, and eligible studies from the original reports and relevant existing systematic reviews.

Review methods: We included randomized controlled trials (RCTs) of any n-3 FA intake compared to no, lower, or other n-3 FA intake with an outcome of interest conducted in healthy adults, those at risk for CVD, or those with CVD. We also included prospective observational studies of the association between baseline n-3 FA intake or biomarker level and followup outcomes. We required 1 year or more of followup for clinical outcomes and 4 weeks for intermediate outcomes (blood pressure [BP] and lipids).

Results: From 11,440 citations (from electronic literature searches and existing systematic reviews), 829 abstracts met basic eligibility criteria; 61 RCTs and 37 longitudinal observational studies (in 147 articles) were included. Most RCTs and observational studies had few risk-of-bias concerns.

Total n-3 FA: There is low strength of evidence (SoE) of no association between total n-3 FA intake and stroke death or myocardial infarction. There is insufficient evidence for other outcomes.

Marine oils, total: There is moderate to high SoE that higher marine oil intake lowers triglycerides (Tg), raises high density lipoprotein cholesterol (HDL-c), and lowers the ratio of total cholesterol to HDL-c but raises low density lipoprotein cholesterol (LDL-c); also that higher marine oil intake does not affect major adverse CV events, all-cause death, total stroke, sudden cardiac death, coronary revascularization, atrial fibrillation, or BP. There is low SoE of associations between higher marine oil intake and decreased risk of CVD death, coronary heart disease (CHD), myocardial infarction, ischemic stroke, and congestive heart failure (CHF). There is low SoE of no association with CHD death or hemorrhagic stroke. There is insufficient evidence for other outcomes.

Marine oil FA individually: There is low SoE of no associations between EPA or DHA intake (separately) and CHD, and between EPA or DPA and atrial fibrillation. There is low SoE of no association be

Objectives: This review sought to systematically review the available literature on health information exchange (HIE), the electronic sharing of clinical information across the boundaries of health care organizations. HIE has been promoted as an important application of technology in medicine that can improve the efficiency, cost-effectiveness, quality, and safety of health care delivery. However, HIE also requires considerable investment by sponsors, which have included governments as well as health care organizations. This review aims to synthesize the currently available research addressing HIE effectiveness, use, usability, barriers and facilitators to actual use, implementation, and sustainability, and to present this information as a foundation on which future implementation, expansion, and research can be based.

Data sources: A research librarian designed and conducted searches of electronic databases, including MEDLINE® (1990 to February 2015), PsycINFO® (1990 to February 2015), CINAHL® (1990 through February 2015), the Cochrane Central Register of Controlled Trials (through January 2015), the Cochrane Database of Systematic Reviews (through January 2015), the Database of Abstracts of Reviews of Effects (through the first quarter of 2015), and the National Health Sciences Economic Evaluation Database (through the first quarter of 2015). The searches were supplemented by reviewing reference lists and the table of contents of journals not indexed in the databases we searched.

Review methods: Two investigators reviewed abstracts and the selected full-text articles for inclusion based on predefined criteria. Discrepancies were resolved through discussion and consensus, with a third investigator making the final decision as needed. Data were abstracted from each included article by one person and verified by another. All analyses were qualitative, and they were customized according to the topic.

Results: We included 136 studies overall, with 34 on effectiveness, 26 of which reported intermediate clinical, economic, or patient outcomes, and 8 that reported on clinical perceptions of HIE. We also found 58 studies on the use of HIE, 22 on usability and other facilitators and barriers to actual use of HIE, 45 on facilitators or barriers to HIE implementation, and 17 on factors related to sustainability of HIE.

No studies of HIE effectiveness reported impact on primary clinical outcomes (e.g., mortality and morbidity) or identified harms. Low-quality evidence somewhat supports the value of HIE for reducing duplicative laboratory and radiology test ordering, lowering emergency department costs, reducing hospital admissions (less so for readmissions), improving public health reporting, increasing ambulatory quality of care, and improving disability claims processing. In studies of clinician perceptions of HIE, most respondents attributed positive changes

Objectives: This systematic review summarizes research on methods of diagnosing myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and benefits and harms of multiple medical and nonmedical treatments. It identifies evidence gaps and limitations to inform future research.

Data sources: Searches of electronic databases included MEDLINE® (1988 to September 2014), PsycINFO® (1988 to September 2014), and the Cochrane Library (through the third quarter of 2014). The searches were supplemented by reviewing reference lists, seeking suggestions from reviewers, and requesting scientific information from drug and device manufacturers.

Review methods: Two investigators reviewed abstracts and full-text articles for inclusion based on predefined criteria. Discrepancies were resolved through discussion and consensus, with a third investigator making the final decision.

Results: A total of 6,175 potentially relevant articles were identified, 1,069 were selected for full-text review, and 71 studies in 81 publications were included (36 observational studies on diagnosis and 35 trials of treatments). Eight case definitions have been used to define ME/CFS; those for ME, requiring the presence of postexertional malaise, represent a more symptomatic subset of the broader ME/CFS population. Researchers are unable to determine differences in accuracy between case definitions because there is no universally accepted reference standard for diagnosing ME/CFS. The Oxford criteria are the least restrictive and include patients who would not otherwise meet criteria for ME/CFS. Self-reported symptom scales may differentiate ME/CFS patients from healthy controls but have not been adequately evaluated to determine validity and generalizability in large populations with diagnostic uncertainty. Fourteen studies reported the consequences of diagnosis, including perceived stigma and the burden of misdiagnosis, as well as feelings of legitimacy upon receiving the diagnosis of ME/CFS.

Of the 35 trials of treatment, rintatolimod compared with placebo improved measures of exercise performance; counseling therapies and graded exercise treatment (GET) compared with no treatment, relaxation, or support improved fatigue, function, and quality of life, and counseling therapies also improved employment outcomes. Other treatments either provided no benefit or results were insufficient to draw conclusions. GET was associated with higher numbers of reported adverse events compared with counseling therapies or controls. Harms were generally inadequately reported across trials.

Limitations: Diagnostic methods were studied only in highly selected patient populations. Treatment trials were limited in number and had small sample sizes and methodological shortcomings.

Conclusions: None of the current diagnostic methods have been adequately tested to i

Background: In 2009, the Institute of Medicine/Food and Nutrition Board constituted a Dietary Reference Intakes (DRI) committee to undertake a review of the evidence that had emerged (since the 1997 DRI report) on the relationship of vitamin D and calcium, both individually and combined, to a wide range of health outcomes, and potential revision of the DRI values for these nutrients. To support that review, several United States and Canadian Federal Government agencies commissioned a systematic review of the scientific literature for use during the deliberations by the committee. The intent was to support a transparent literature review process and provide a foundation for subsequent reviews of the nutrients. The committee used the resulting literature review in their revision of the DRIs.

In 2013, in preparation for a project the National Institutes of Health Office of Dietary Supplements (NIH/ODS) was undertaking related to evidence-based decisionmaking for vitamin D in primary care, based on the updated DRI report, the ODS and AHRQ requested an update to the 2009 systematic review to incorporate the findings of studies conducted since the 2009 evidence review on the relationship between vitamin D alone or vitamin D plus calcium to selected health outcomes and to report on the methods used to assay vitamin D in the included trials.

Purpose: To systematically summarize the evidence on the relationship between vitamin D alone or in combination with calcium on selected health outcomes included in the earlier review: primarily those related to bone health, cardiovascular health, cancer, immune function, pregnancy, all-cause mortality, and vitamin D status; and to identify the vitamin D assay methods and procedures used for the interventional studies that aimed to assess the effect of vitamin D administration on serum 25(OH)D concentrations, and to stratify key outcomes by methods used to assay serum 25(OH)D concentrations.

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

Study selection: Primary interventional or prospective observational studies that reported outcomes of interest in human subjects in relation to vitamin D alone or in combination with calcium, as well as systematic reviews that met the inclusion and exclusion criteria.

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 154 newly identified primary articles and two new systematic reviews that incorporated more than 93 additional primary articles. Available evidence focused mainly on bone health, cardiovascular diseases, or cancer outcomes. Findings were inconsistent across studies for

Objectives: Chronic pain is common and use of long-term opioid therapy for chronic pain has increased dramatically. This report reviews the current evidence on effectiveness and harms of opioid therapy for chronic pain, focusing on long-term (≥1 year) outcomes.

Data sources: A prior systematic review (searches through October 2008), electronic databases (Ovid MEDLINE, Scopus, and the Cochrane Libraries January 2008 to August 2014), reference lists, and clinical trials registries.

Review methods: Using predefined criteria, we selected randomized trials and comparative observational studies of patients with cancer or noncancer chronic pain being considered for or prescribed long-term opioid therapy that addressed effectiveness or harms versus placebo, no opioid use, or nonopioid therapies; different opioid dosing methods; or risk mitigation strategies. We also included uncontrolled studies ≥1 year that reported rates of abuse, addiction, or misuse, and studies on the accuracy of risk prediction instruments for predicting subsequent opioid abuse or misuse. The quality of included studies was assessed, data were extracted, and results were summarized qualitatively.

Results: Of the 4,209 citations identified at the title and abstract level, a total of 39 studies were included. For a number of Key Questions, we identified no studies meeting inclusion criteria. Where studies were available, the strength of evidence was rated no higher than low, due to imprecision and methodological shortcomings, with the exception of buccal or intranasal fentanyl for pain relief outcomes within 2 hours after dosing (strength of evidence: moderate). No study evaluated effects of long-term opioid therapy versus no opioid therapy. In 10 uncontrolled studies, rates of opioid abuse were 0.6 percent to 8 percent and rates of dependence were 3.1 percent to 26 percent in primary care settings, but studies varied in methods used to define and ascertain outcomes. Rates of aberrant drug-related behaviors ranged from 5.7 percent to 37.1 percent. Compared with nonuse, long-term opioid therapy was associated with increased risk of abuse (one cohort study), overdose (one cohort study), fracture (two observational studies), myocardial infarction (two observational studies), and markers of sexual dysfunction (one cross-sectional study), with several studies showing a dose-dependent association. One randomized trial found no difference between a more liberal opioid dose escalation strategy and maintenance of current dose in pain or function, but differences between groups in daily opioid doses at the end of the trial were small. One cohort study found methadone associated with lower risk of mortality than long-acting morphine in a Veterans Affairs population in a propensity adjusted analysis (adjusted HR 0.56, 95 percent CI 0.51 to 0.62). Estimates of diagnostic accuracy for the Opioid Risk Tool were

Objectives: To conduct a systematic review of the literature on the safety of vaccines recommended for routine immunization of children, adolescents, and adults in the United States as of 2011.

Data sources: We included placebo-controlled clinical trials and cohort studies comparing vaccinated and unvaccinated patients. We also included the following types of post-licensure analyses: case-control studies, self-controlled case series, and multivariate risk factor analyses. We conducted an electronic search of PubMed from inception through August 2013, and reviewed Advisory Committee for Immunization Practices statements, vaccine package inserts, and previously published reviews to identify studies. Scientific Information Packets were requested from vaccine manufacturers.

Review methods: We reviewed the methodology of the 2011 Institute of Medicine (IOM) consensus report "Adverse Effects of Vaccines: Evidence and Causality" and accepted their findings. We augmented their work with new studies and additional vaccines. For studies not included in the IOM report, we abstracted data on the presence or absence of adverse health outcomes, characteristics of patients, study design, and vaccine description, including brand, potency, dosage, timing, and formulation, where available. We excluded formulations not used in the United States. The McHarm instrument was used to evaluate the quality of adverse events collection and reporting in each study. We were unable to pool results; we rated the overall strength of evidence (SOE) as high, moderate, low, or insufficient by using guidance suggested by the Agency for Healthcare Research and Quality for its Effective Health Care Program.

Results: A total of 20,478 titles were identified; after title, abstract, and full-text review, 166 studies were accepted for abstraction. The vast majority of studies either did not investigate or could not identify risk factors for adverse events (AEs) associated with vaccination. Similarly, the severity of AEs was inconsistently reported, as was information that would make independent severity determination possible.

SOE was high for the following associations in nonpregnant adults: seasonal influenza vaccine and arthralgia, myalgia, malaise, fever, pain at injection site; 2009 monovalent H1N1 vaccine and Guillain-Barré syndrome (GBS); and a lack of association between influenza and pneumococcal vaccines and cardiovascular events in the elderly. Risk of GBS was estimated at 1.6 excess cases per million persons vaccinated. SOE was high for the following associations in children and adolescents: measles, mumps, rubella (MMR) vaccine and febrile seizures in children under age 5; lack of association between MMR vaccine and autism spectrum disorders; and varicella vaccine and disseminated Oka strain varicella zoster virus with associated complications (i.e., meningitis, encephalitis) in

Objectives: To evaluate the benefits and harms of pharmacological therapy for depression in women during pregnancy or the postpartum period.

Data sources: Cochrane Database of Systematic Reviews, the Cochrane Central Register of Controlled Trials, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), MEDLINE, Scopus, ClinicalTrials.gov, and Scientific Information Packets from pharmaceutical manufacturers. Databases were searched from their inception to July 2013..

Review methods: We included studies comparing pharmacological treatments for depression during or after pregnancy with each other, with nonpharmacological treatments, or with usual care or no treatment. Outcomes included both maternal and infant or child benefits and harms. Dual review was used for study inclusion, data abstraction, and quality assessment. We assessed study quality using methods of the Drug Effectiveness Review Project. We graded the strength of the body of evidence according to the methods of the Effective Health Care Program. Direct evidence comprised studies that compared interventions of interest in the population of interest (i.e., depressed women) and measured the outcomes of interest. Studies comparing groups of depressed women with control groups with no evidence of depression were considered indirect.

Results: We included 15 observational studies that provided direct evidence on benefits and harms of antidepressants for depression during pregnancy. We included six randomized controlled trials and two observational studies of antidepressant treatment for depression in postpartum women. Studies of depressed pregnant women primarily compared antidepressant treatment with no treatment, and studies of postpartum women also compared antidepressants alone with combination antidepressant-nonpharmacological treatments. This evidence was insufficient to draw conclusions on the comparative benefits or harms of antidepressants for the outcomes of maternal depression symptoms, functional capacity, breastfeeding, mother-infant dyad interactions, and infant and child development for either pregnant or postpartum women with depression. Low-strength evidence suggests that neonates of women with depression taking selective serotonin reuptake inhibitors (SSRIs) during pregnancy had higher risk of respiratory distress than neonates of untreated women but that risk of preterm birth or neonatal convulsions does not differ between these groups. Direct evidence on the risk of major malformations and neonatal development with exposure to antidepressants in utero was insufficient to draw conclusions. For postpartum women with depression, evidence was insufficient to evaluate the full range of benefits and harms of treatment. Low-strength evidence was unable to show a benefit of adding brief psychotherapy or cognitive behavioral therapy to SSRIs.

To address gaps in the direc

Objectives: This review examined how to best communicate and disseminate evidence, including uncertain evidence, to inform health care decisions. The review focused on three primary objectives--comparing the effectiveness of: (1) communicating evidence in various contents and formats that increase the likelihood that target audiences will both understand and use the information (KQ 1); (2) a variety of approaches for disseminating evidence from those who develop it to those who are expected to use it (KQ 2); and (3) various ways of communicating uncertainty-associated health-related evidence to different target audiences (KQ 3). A secondary objective was to examine how the effectiveness of communication and dissemination strategies varies across target audiences, including evidence translators, health educators, patients, and clinicians.

Data sources: We searched MEDLINE®, the Cochrane Library, Cochrane Central Trials Registry, PsycINFO®, and the Web of Science. We used a variety of medical subject headings (MeSH terms) and major headings, and used free-text and title and abstract text-word searches. The search was limited to studies on humans published from 2000 to March 15, 2013, for communication and dissemination, given the prior systematic reviews, and from 1966 to March 15, 2013, for communicating uncertainty.

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

Results: The search identified 4,152 articles (after removing duplicates) for all three KQs. After dual review at the title/abstract stage and full-text review stage, we retained 61 articles that directly (i.e., head to head) compared strategies to communicate and disseminate evidence. Across the KQs, many of the comparisons yielded insufficient evidence to draw firm conclusions. For KQ 1, we found that investigators frequently blend more than one communication strategy in interventions. For KQ 2, we found that, compared with single dissemination strategies, multicomponent dissemination strategies are more effective at enhancing clinician behavior, particularly for guideline adherence. Key findings for KQ 3 indicate that evidence on communicating overall strength of recommendation and precision was insufficient, but certain ways of communicating directness and net benefit may be helpful in reducing uncertainty.

Conclusions: The lack of comparative research evidence to inform communication and dissemination of evidence, including uncertain evidence, impedes timely clinician, patient, and policymaker awareness, uptake, and use of evidence to improve the quality of care. Expanding investment in communication, dissemination, and implementation research is critical to the id