Evidence report/technology assessment最新文献

Objectives: As part of the Closing the Quality Gap: Revisiting the State of the Science series of the Agency for Healthcare Research and Quality (AHRQ), this systematic review sought to identify completed and ongoing evaluations of the comprehensive patient-centered medical home (PCMH), summarize current evidence for this model, and identify evidence gaps.

Data sources: We searched PubMed®, CINAHL®, and the Cochrane Database of Systematic Reviews for published English-language studies, and a wide variety of databases and Web resources to identify ongoing or recently completed studies.

Review methods: Two investigators per study screened abstracts and full-text articles for inclusion, abstracted data, and performed quality ratings and evidence grading. Our functional definition of PCMH was based on the definition used by AHRQ. We included studies that explicitly claimed to be evaluating PCMH and those that did not but which met our functional definition.

Results: Seventeen studies with comparison groups evaluated the effects of PCMH (Key Question [KQ] 1). Older adults in the United States were the most commonly studied population (8 of 17 studies). PCMH interventions had a small positive impact on patient experiences (including patient-perceived care coordination) and small to moderate positive effects on preventive care services (moderate strength of evidence [SOE]). Staff experiences were also improved by a small to moderate degree (low SOE). There were too few studies to estimate effects on clinical or most economic outcomes. Twenty-one of 27 studies reported approaches that addressed all 7 major PCMH components (KQ 2), including team-based care, sustained partnership, reorganized care or structural changes to care, enhanced access, coordinated care, comprehensive care, and a systems-based approach to quality. A total of 51 strategies were used to address the 7 major PCMH components. Twenty-two of 27 studies reported information on financial systems used to implement PCMH, implementation strategies, and/or organizational learning strategies for implementing PCMH (KQ 3). The 31 studies identified in the horizon scan of ongoing PCMH studies (KQ 4) were broadly representative of the U.S. health care system, both in geography and in the complexity of private and public health care payers and delivery networks.

Conclusions: Published studies of PCMH interventions often have similar broad elements, but precise components of care varied widely. The PCMH holds promise for improving the experiences of patients and staff, and potentially for improving care processes. However, current evidence is insufficient to determine effects on clinical and most economic outcomes. Ongoing studies identified through the horizon scan have potential to greatly expand the evidence base relating to PCMH.

Objectives: The aim of this review is to identify, synthesize, and appraise the literature on the analytic validity, clinical validity, and clinical utility of commercially available single nucleotide polymorphism (SNP) panel tests for assessing the risk of prostate cancer.

Data sources: MEDLINE®, Cochrane CENTRAL, Cochrane Database of Systematic Reviews, and Embase, from the beginning of each database to October 2011. Search strategies used combinations of controlled vocabulary (medical subject headings, keywords) and text words. Grey literature was identified.

Review methods: Three Key Questions (KQs) encompassing broad aspects of the analytic validity, clinical validity, and clinical utility of SNP-based panels were developed with the input of a Technical Expert Panel assembled by the Evidence-based Practice Center and approved by the Agency for Healthcare Research and Quality. Standard systematic review methodology was applied, with eligibility criteria developed separately for each KQ.

Results: From 1,998 unique citations, 14 were retained for data abstraction and quality assessment following title and abstract screening and full text screening. All focused on clinical validity (KQ2), and evaluated 15 individual panels with two to 35 SNPs. All had poor discriminative ability for predicting risk of prostate cancer and/or distinguishing between aggressive and asymptomatic/latent disease. The risk of bias of the studies was determined to be moderate. None of the panels had been evaluated in routine clinical settings.

Conclusions: The evidence on currently available SNP panels does not permit meaningful assessment of analytic validity. The limited evidence on clinical validity is insufficient to conclude that the panels assessed would perform adequately as screening or risk stratification tests. No evidence is available on the clinical utility of current panels.

Objectives: The main objective of the report is to review the evidence on the impact of health information technology (IT) that supports patient-centered care (PCC) on: health care processes; clinical outcomes; intermediate outcomes (patient or provider satisfaction, health knowledge and behavior, and cost); responsiveness to needs and preferences of patients; shared decisionmaking and patient-clinician communication; and access to information. Additional objectives were to identify barriers and facilitators for using health IT to deliver PCC, and to identify gaps in evidence and information needed by patients, providers, payers, and policymakers.

Data sources: MEDLINE®, Embase®, Cochrane Library, Scopus, Cumulative Index to Nursing and Allied Health Literature, PsycINFO, INSPEC, and Compendex databases through July 31, 2010.

Methods: Paired members of our team reviewed citations to identify randomized controlled trials of PCC-related health IT interventions and studies that addressed barriers and facilitators for health IT for delivery of PCC. Independent assessors rated studies for quality. Paired reviewers abstracted data.

Results: The search identified 327 eligible articles, including 184 articles on the impact of health IT applications implemented to support PCC and 206 articles addressing barriers or facilitators for such health IT applications. Sixty-three articles addressed both questions. The study results suggested positive effects of PCC-related health IT interventions on health care process outcomes, disease-specific clinical outcomes (for diabetes mellitus, heart disease, cancer, and other health conditions), intermediate outcomes, responsiveness to the needs and preferences of patients, shared decisionmaking, patient-clinician communication, and access to medical information. Studies reported a number of barriers and facilitators for using health IT applications to enable PCC. Barriers included: lack of usability; problems with access to the health IT application due to older age, low income, education, cognitive impairment, and other factors; low computer literacy in patients and clinicians; insufficient basic formal training in health IT applications; physicians' concerns about more work; workflow issues; problems related to new system implementation, including concerns about confidentiality of patient information; depersonalization; incompatibility with current health care practices; lack of standardization; and problems with reimbursement. Facilitators for the utilization of health IT included ease of use, perceived usefulness, efficiency of use, availability of support, comfort in use, and site location.

Conclusions: Despite marked heterogeneity in study characteristics and quality, substantial evidence exists confirming that health IT applications with PCC-related components have a positive effect on health care outc

Objectives: This systematic review sought to identify the best available evidence regarding strategies for allocating scarce resources during mass casualty events (MCEs). Specifically, the review addresses the following questions: (1) What strategies are available to policymakers to optimize the allocation of scarce resources during MCEs? (2) What strategies are available to providers to optimize the allocation of scarce resources during MCEs? (3) What are the public's key perceptions and concerns regarding the implementation of strategies to allocate scarce resources during MCEs? (4) What methods are available to engage providers in discussions regarding the development and implementation of strategies to allocate scarce resources during MCEs?

Data sources: We searched Medline, Scopus, Embase, CINAHL (Cumulative Index to Nursing and Allied Health Literature), Global Health, Web of Science®, and the Cochrane Database of Systematic Reviews from 1990 through 2011. To identify relevant non-peer-reviewed reports, we searched the New York Academy of Medicine's Grey Literature Report. We also reviewed relevant State and Federal plans, peer-reviewed reports and papers by nongovernmental organizations, and consensus statements published by professional societies. We included both English- and foreign-language studies.

Review methods: Our review included studies that evaluated tested strategies in real-world MCEs as well as strategies tested in drills, exercises, or computer simulations, all of which included a comparison group. We reviewed separately studies that lacked a comparison group but nonetheless evaluated promising strategies. We also identified consensus recommendations developed by professional societies or government panels. We reviewed existing State plans to examine the current state of planning for scarce resource allocation during MCEs. Two investigators independently reviewed each article, abstracted data, and assessed study quality.

Results: We considered 5,716 reports for this comparative effectiveness review (CER); we ultimately included 170 in the review. Twenty-seven studies focus on strategies for policymakers. Among this group were studies that examined various ways to distribute biological countermeasures more efficiently during a bioterror attack or influenza pandemic. They provided modest evidence that the way these systems are organized influences the speed of distribution. The review includes 119 studies that address strategies for providers. A number of these studies provided evidence suggesting that commonly used triage systems do not perform consistently in actual MCEs. The number of high-quality studies addressing other specific strategies was insufficient to support firm conclusions about their effectiveness. Only 10 studies included strategies that consider the public's perspective. However, these studies were consistent in their fi

Objectives: To catalogue study designs used to assess the clinical effectiveness of CDSSs and KMSs, to identify features that impact the success of CDSSs/KMSs, to document the impact of CDSSs/KMSs on outcomes, and to identify knowledge types that can be integrated into CDSSs/KMSs.

Data sources: MEDLINE(®), CINAHL(®), PsycINFO(®), and Web of Science(®).

Review methods: We included studies published in English from January 1976 through December 2010. After screening titles and abstracts, full-text versions of articles were reviewed by two independent reviewers. Included articles were abstracted to evidence tables by two reviewers. Meta-analyses were performed for seven domains in which sufficient studies with common outcomes were included.

Results: We identified 15,176 articles, from which 323 articles describing 311 unique studies including 160 reports on 148 randomized control trials (RCTs) were selected for inclusion. RCTs comprised 47.5 percent of the comparative studies on CDSSs/KMSs. Both commercially and locally developed CDSSs effectively improved health care process measures related to performing preventive services (n = 25; OR 1.42, 95% confidence interval [CI] 1.27 to 1.58), ordering clinical studies (n = 20; OR 1.72, 95% CI 1.47 to 2.00), and prescribing therapies (n = 46; OR 1.57, 95% CI 1.35 to 1.82). Fourteen CDSS/KMS features were assessed for correlation with success of CDSSs/KMSs across all endpoints. Meta-analyses identified six new success features: Integration with charting or order entry system. Promotion of action rather than inaction. No need for additional clinician data entry. Justification of decision support via research evidence. Local user involvement. Provision of decision support results to patients as well as providers. Three previously identified success features were confirmed: Automatic provision of decision support as part of clinician workflow. Provision of decision support at time and location of decisionmaking. Provision of a recommendation, not just an assessment. Only 29 (19.6%) RCTs assessed the impact of CDSSs on clinical outcomes, 22 (14.9%) assessed costs, and 3 assessed KMSs on any outcomes. The primary source of knowledge used in CDSSs was derived from structured care protocols.

Conclusions: Strong evidence shows that CDSSs/KMSs are effective in improving health care process measures across diverse settings using both commercially and locally developed systems. Evidence for the effectiveness of CDSSs on clinical outcomes and costs and KMSs on any outcomes is minimal. Nine features of CDSSs/KMSs that correlate with a successful impact of clinical decision support have been newly identified or confirmed.

Objectives: To review the evidence for diagnostic accuracy of screening for serious bacterial illness (SBI) and invasive herpes simplex virus (HSV) infection in febrile infants 3 months or younger; ascertain harms and benefits of various management strategies; compare prevalence of SBI and HSV between different clinical settings; determine how well the presence of viral infection predicts against SBI; and review evidence on parental compliance to return for followup assessments (infants less than 6 months).

Data sources: MEDLINE, CINAHL, Embase, Cochrane Central Register of Controlled Trials, the Cochrane Database of Systematic Reviews, abstracts, and unpublished materials.

Review methods: Two independent reviewers screened the literature and extracted data on population characteristics, index/diagnostic test characteristics. Diagnostic test accuracy studies were assessed using Quality Assessment of Diagnostic Accuracy Studies.

Results: Eighty-four original studies were included. The combined clinical and laboratory criteria (Rochester, Philadelphia, Boston, and Milwaukee) demonstrated similar overall accuracy (sensitivity: 84.4 percent to 100.0 percent; specificity: 26.6 percent to 69.0 percent; negative predictive value: 93.7 percent to 100.0 percent; and positive predictive value: 3.3 percent to 48.6 percent) for identifying infants with SBI. The criteria based on history of recent immunization or rapid influenza test demonstrated higher sensitivity but lower specificity compared with criteria based on age, gender, and the degree of fever. The overall accuracy of C-reactive protein was greater than that for absolute neutrophil count and absolute band counts , white blood cell, and procalcitonin. For correctly identifying infants with and without SBI (or bacteremia), the Boston, Philadelphia, and Milwaukee criteria/protocol showed better overall accuracy when applied to older infants versus neonates. The Rochester criteria were more accurate in neonates than in older infants. Evidence on HSV was scarce. Most of the criteria/protocols demonstrated high negative predictive values and low positive predictive values for correctly predicting the absence or presence of SBI. In studies reporting outcomes of delayed treatment for infants with SBI initially classified as low risk, all infants recovered uneventfully. The reported adverse events following immediate antibiotic therapy were limited to drug related rash and infiltration of intravenous line. There was a higher prevalence of SBI in infants without viral infection or clinical bronchiolitis compared to infants with viral infection or bronchiolitis. The prevalence of SBI tended to be higher in the emergency departments versus primary care setting offices. The parental compliance to followup for return visits/reassessment of infants after initial examination across four studies ranged from 77.4 percent to 99.8

Background: Radical prostatectomy and radiation therapy for prostate cancer have side effects and unclear survival benefits for early stage and low-risk disease. Prostate cancer often has an indolent natural history, making observational management strategies potentially appealing.

Purpose: To systematically review the role of active surveillance for triggers to begin curative treatment in men with low-risk prostate cancer. Key Questions address changes in prostate cancer characteristics over time, definitions of active surveillance and other observational strategies, factors affecting the offer of, acceptance of, and adherence to active surveillance, the comparative effectiveness of active surveillance with curative treatments, and research gaps.

Data sources: MEDLINE(®), Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and existing systematic reviews, evidence reports, and economic evaluations.

Study selection: Randomized controlled trials and nonrandomized comparative studies of treatments, multivariable association studies, and studies of temporal trends in prostate cancer natural history. Only published, peer-reviewed, English-language articles were selected based on predetermined eligibility criteria.

Data extraction: A standardized protocol was used to extract details on design, diagnoses, interventions, predictive factors, outcomes, and study validity.

Data synthesis: In total, 80 studies provided information on epidemiologic trends; 56 on definitions of active surveillance; 42 on factors affecting the offer of, acceptance of, or adherence to observational management strategies; and 26 on comparative effectiveness. Increased diagnosis of early-stage prostate cancer due to prostate-specific antigen (PSA) testing, led to an increase in prostate cancer incidence from the mid-1980s to the mid-1990s. The prostate cancer-specific mortality rate decreased for all age groups from the early-1990s to 1999. Currently, patients are diagnosed with earlier stage and lower risk prostate cancers compared to the pre-PSA era. Over time, a lower proportion of men received observational management versus active treatment, even among those with low-risk disease. There was no standardized definition of active surveillance. Sixteen cohorts used different monitoring protocols, all with different combinations of periodic digital rectal examination, PSA testing, rebiopsy, and/or imaging findings. Predictors that a patient received no initial active treatment generally included older age, presence of comorbidities, lower Gleason score, lower tumor stage, lower diagnostic PSA, and lower disease progression risk group. No trial provided results comparing men with localized disease on active surveillance with surgery or radiation therapy.

Limitations: Because of the nonstan

Objectives: To review the available published literature to assess whether evidence supports a beneficial role for coordinated transition of care services for the postacute care of patients hospitalized with first or recurrent stroke or myocardial infarction (MI). This review was framed around five areas of investigation: (1) key components of transition of care services, (2) evidence for improvement in functional outcomes, morbidity, mortality, and quality of life, (3) associated risks or potential harms, (4) evidence for improvement in systems of care, and (5) evidence that benefits and harms vary by patient-based or system-based characteristics.

Data sources: MEDLINE(®), CINAHL(®), Cochrane Database of Systematic Reviews, and Embase(®).

Review methods: We included studies published in English from 2000 to 2011 that specified postacute hospitalization transition of care services as well as prevention of recurrent stroke or MI.

Results: A total of 62 articles representing 44 studies were included for data abstraction. Transition of care interventions were grouped into four categories: (1) hospital -initiated support for discharge was the initial stage in the transition of care process, (2) patient and family education interventions were started during hospitalization but were continued at the community level, (3) community-based models of support followed hospital discharge, and (4) chronic disease management models of care assumed the responsibility for long-term care. Early supported discharge after stroke was associated with reduced total hospital length of stay without adverse effects on functional recovery, and specialty care after MI was associated with reduced mortality. Because of several methodological shortcomings, most studies did not consistently demonstrate that any specific intervention resulted in improved patient-or system -based outcomes. Some studies included more than one intervention, which made it difficult to determine the effect of individual components on clinical outcomes. There was inconsistency in the definition of what constituted a component of transition of care compared to "standard care." Standard care was poorly defined, and nearly all studies were underpowered to demonstrate a statistical benefit. The endpoints varied greatly from study to study. Nearly all the studies were single-site based, and most (26 of 44) were conducted in countries with national health care systems quite different from that of the U.S., therefore limiting their generalizability.

Conclusions: Although a basis for the definition of transition of care exists, more consensus is needed on the definition of the interventions and the outcomes appropriate to those interventions. There was limited evidence that two components of hospital-initiated support for discharge (early supported discharge after stroke and specialty care followup

Objectives: The objective of the report was to review the evidence on the impact of health information technology (IT) on all phases of the medication management process (prescribing and ordering, order communication, dispensing, administration and monitoring as well as education and reconciliation), to identify the gaps in the literature and to make recommendations for future research.

Data sources: We searched peer-reviewed electronic databases, grey literature, and performed hand searches. Databases searched included MEDLINE®, Embase, CINAHL (Cumulated Index to Nursing and Allied Health Literature), Cochrane Database of Systematic Reviews, International Pharmaceutical Abstracts, Compendex, Inspec (which includes IEEE Xplore), Library and Information Science Abstracts, E-Prints in Library and Information Science, PsycINFO, Sociological Abstracts, and Business Source Complete. Grey literature searching involved Internet searching, reviewing relevant Web sites, and searching electronic databases of grey literatures. AHRQ also provided all references in their e-Prescribing, bar coding, and CPOE knowledge libraries.

Methods: Paired reviewers looked at citations to identify studies on a range of health IT used to assist in the medication management process (MMIT) during multiple levels of screening (titles and abstracts, full text and final review for assignment of questions and data abstrction). Randomized controlled trials and cohort, case-control, and case series studies were independently assessed for quality. All data were abstracted by one reviewer and examined by one of two different reviewers with content and methods expertise.

Results: 40,582 articles were retrieved. After duplicates were removed, 32,785 articles were screened at the title and abstract phase. 4,578 full text articles were assessed and 789 articles were included in the final report. Of these, 361 met only content criteria and were listed without further abstraction. The final report included data from 428 articles across the seven key questions. Study quality varied according to phase of medication management. Substantially more studies, and studies with stronger comparative methods, evaluated prescribing and monitoring. Clinical decision support systems (CDSS) and computerized provider order entry (CPOE) systems were studied more than any other application of MMIT. Physicians were more often the subject of evaluation than other participants. Other health care professionals, patients, and families are important but not studied as thoroughly as physicians. These nonphysicians groups often value different aspects of MMIT, have diverse needs, and use systems differently. Hospitals and ambulatory clinics were well-represented in the literature with less emphasis placed on long-term care facilities, communities, homes, and nonhospital pharmacies. Most studies evaluated changes in process and

Objectives: To catalog what is known about the safety of interventions containing Lactobacillus, Bifidobacterium, Saccharomyces, Streptococcus, Enterococcus, and/or Bacillus strains used as probiotic agents in research to reduce the risk of, prevent, or treat disease.

Data sources: We searched 12 electronic databases, references of included studies, and pertinent reviews for studies addressing the safety of probiotics from database inception to August 2010 without language restriction.

Review methods: We identified intervention studies on probiotics that reported the presence or absence of adverse health outcomes in human participants, without restriction by study design, participant type, or clinical field. We investigated the quantity, quality, and nature of adverse events.

Results: The search identified 11,977 publications, of which 622 studies were included in the review. In 235 studies, only nonspecific safety statements were made ("well tolerated"); the remaining 387 studies reported the presence or absence of specific adverse events. Interventions and adverse events were poorly documented. A number of case studies described fungemia and some bacteremia potentially associated with administered probiotic organisms. Controlled trials did not monitor routinely for such infections and primarily reported on gastrointestinal adverse events. Based on reported adverse events, randomized controlled trials (RCTs) showed no statistically significantly increased relative risk (RR) of the overall number of experienced adverse events (RR 1.00; 95% confidence interval [CI]: 0.93, 1.07, p=0.999); gastrointestinal; infections; or other adverse events, including serious adverse events (RR 1.06; 95% CI: 0.97, 1.16; p=0.201), associated with short-term probiotic use compared to control group participants; long-term effects are largely unknown. Existing studies primarily examined Lactobacillus alone or in combination with other genera, often Bifidobacterium. Few studies directly compared the safety among different intervention or participant characteristics. Indirect comparisons indicated that effects of delivery vehicles (e.g., yogurt, dairy) should be investigated further. Case studies suggested that participants with compromised health are most likely to experience adverse events associated with probiotics. However, RCTs in medium-risk and critically ill participants did not report a statistically significantly increased risk of adverse events compared to control group participants.

Conclusions: There is a lack of assessment and systematic reporting of adverse events in probiotic intervention studies, and interventions are poorly documented. The available evidence in RCTs does not indicate an increased risk; however, rare adverse events are difficult to assess, and despite the substantial number of publications, the current literature is not well