Health information technology: an updated systematic review with a focus on meaningful use.

BACKGROUND: Incentives offered by the U.S. government have spurred marked increases in use of health information technology (IT). PURPOSE: To update previous reviews and examine recent evidence that relates health IT functionalities prescribed in meaningful use regulations to key aspects of health care. DATA SOURCES: English-language articles in PubMed from January 2010 to August 2013. STUDY SELECTION: 236 studies, including pre-post and time-series designs and clinical trials that related the use of health IT to quality, safety, or efficiency. DATA EXTRACTION: Two independent reviewers extracted data on functionality, study outcomes, and context. DATA SYNTHESIS: Fifty-seven percent of the 236 studies evaluated clinical decision support and computerized provider order entry, whereas other meaningful use functionalities were rarely evaluated. Fifty-six percent of studies reported uniformly positive results, and an additional 21% reported mixed-positive effects. Reporting of context and implementation details was poor, and 61% of studies did not report any contextual details beyond basic information. LIMITATION: Potential for publication bias, and evaluated health IT systems and outcomes were heterogeneous and incompletely described. CONCLUSION: Strong evidence supports the use of clinical decision support and computerized provider order entry. However, insufficient reporting of implementation and context of use makes it impossible to determine why some health IT implementations are successful and others are not. The most important improvement that can be made in health IT evaluations is increased reporting of the effects of implementation and context. PRIMARY FUNDING SOURCE: Office of the National Coordinator.

Reporting of context and implementation in studies of global health interventions: a pilot study.

BACKGROUND: There is an increasing push for 'evidence-based' decision making in global health policy circles. However, at present there are no agreed upon standards or guidelines for how to evaluate evidence in global health. Recent evaluations of existing evidence frameworks that could serve such a purpose have identified details of program context and project implementation as missing components needed to inform policy. We performed a pilot study to assess the current state of reporting of context and implementation in studies of global health interventions. METHODS: We identified three existing criteria sets for implementation reporting and selected from them 10 criteria potentially relevant to the needs of policy makers in global health contexts. We applied these 10 criteria to 15 articles included in the evidence base for three global health interventions chosen to represent a diverse set of advocated global health programs or interventions: household water chlorination, prevention of mother-to-child transmission of HIV, and lay community health workers to reduce child mortality. We used a good-fair-poor/none scale for the ratings. RESULTS: The proportion of criteria for which reporting was poor/none ranged from 11% to 54% with an average of 30%. Eight articles had 'good' or 'fair' documentation for greater than 75% of criteria, while five articles had 'poor or none' documentation for 50% of criteria or more. Examples of good reporting were identified. CONCLUSIONS: Reporting of context and implementation information in studies of global health interventions is mostly fair or poor, and highly variable. The idiosyncratic variability in reporting indicates that global health investigators need more guidance about what aspects of context and implementation to measure and how to report them. This lack of context and implementation information is a major gap in the evidence needed by global health policy makers to reach decisions.

Safety of Vaccines Used for Routine Immunization in the United States.

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 individuals with demonstrated immunodeficiencies. There is moderate SOE that vaccines against rotavirus are associated with intussusception in children; risk was estimated as 1 to 5 cases per 100,000 vaccine doses, depending on brand. Moderate-strength evidence exists regarding human papillomavirus vaccine and a lack of association with onset of juvenile rheumatoid arthritis, type 1 diabetes, and GBS. Moderate-strength evidence shows no association between inactivated influenza vaccine and serious AEs in pregnant women.Evidence was insufficient to make conclusions regarding whether several routinely recommended vaccines are associated with serious conditions such as multiple sclerosis, transverse myelitis, and acute disseminated encephalomyelitis. CONCLUSIONS: There is evidence that some vaccines are associated with serious adverse events; however, these events are extremely rare and must be weighed against the protective benefits that vaccines provide. Careful consideration should be given to the investigation of research gaps, including patient risk factors that may be associated with AEs; however, important factors must be taken into account when determining whether studies are warranted, including the severity and frequency of the AE being studied and the challenges of conducting sufficiently powered studies when investigating rare events.

Safety of vaccines used for routine immunization of U.S. children: a systematic review.

BACKGROUND: Concerns about vaccine safety have led some parents to decline recommended vaccination of their children, leading to the resurgence of diseases. Reassurance of vaccine safety remains critical for population health. This study systematically reviewed the literature on the safety of routine vaccines recommended for children in the United States. METHODS: Data sources included PubMed, Advisory Committee on Immunization Practices statements, package inserts, existing reviews, manufacturer information packets, and the 2011 Institute of Medicine consensus report on vaccine safety. We augmented the Institute of Medicine report with more recent studies and increased the scope to include more vaccines. Only studies that used active surveillance and had a control mechanism were included. Formulations not used in the United States were excluded. Adverse events and patient and vaccine characteristics were abstracted. Adverse event collection and reporting was evaluated by using the McHarm scale. We were unable to pool results. Strength of evidence was rated as high, moderate, low, or insufficient. RESULTS: Of 20 478 titles identified, 67 were included. Strength of evidence was high for measles/mumps/rubella (MMR) vaccine and febrile seizures; the varicella vaccine was associated with complications in immunodeficient individuals. There is strong evidence that MMR vaccine is not associated with autism. There is moderate evidence that rotavirus vaccines are associated with intussusception. Limitations of the study include that the majority of studies did not investigate or identify risk factors for AEs; and the severity of AEs was inconsistently reported. CONCLUSIONS: We found evidence that some vaccines are associated with serious AEs; however, these events are extremely rare and must be weighed against the protective benefits that vaccines provide.

Vitamin D and Calcium: A Systematic Review of Health Outcomes (Update).

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 bone health; breast, colorectal, and prostate cancer; cardiovascular disease and mortality; immune function; and pregnancy-related outcomes. Few studies assessed pancreatic cancer and birth outcomes. One new systematic review of observational studies found that circulating 25(OH)D was generally inversely associated with risk for cardiovascular disease. Methods used to assay serum 25(OH)D in studies reporting on key outcomes diverged widely. The current report also identified one new systematic review published since the original report that addressed whether a dose response relationship exists between dietary and supplemental vitamin D intake and serum 25(OH)D concentrations. The systematic review, based on 76 RCTs, reported widely varying increases in serum concentrations of 25(OH)D for similar doses of vitamin D, with a general increase in serum concentration with dietary intake. The RCTs identified for the current report found increases in serum 25(OH)D with supplementation; however, the findings varied by age group and health status of participants, baseline vitamin D status, dose, duration, and assay used to assess serum 25(OH)D. LIMITATIONS: Studies on vitamin D and calcium were not specifically targeted at life stages (except for pregnant and postmenopausal women) specified for the determination of DRI and were often underpowered for their intended outcomes. Studies vary widely in methodological quality and in the assays used to measure vitamin D status. CONCLUSIONS: In solid agreement with the findings of the original report, the majority of the findings concerning vitamin D, alone or in combination with calcium, on the health outcomes of interest were inconsistent. Associations observed in prospective cohort and nested case-control studies were inconsistent, or when consistent, were rarely supported by the results of randomized controlled trials. Clear dose-response relationships between intakes of vitamin D and health outcomes were rarely observed. Although a large number of new studies (and longer followups to older studies) were identified, particularly for cardiovascular outcomes, all-cause mortality, several types of cancer, and intermediate outcomes for bone health, no firm conclusions can be drawn. Studies identified for the current report suggest a possible U-shaped association between serum 25(OH)D concentrations and both all-cause mortality and hypertension and also suggest that the level of supplemental vitamin D and calcium administered in the Women's Health Initiative Calcium-Vitamin D Trial are not associated with an increased risk for cardiovascular disease or cancer among postmenopausal women who are not taking additional supplemental vitamin D and calcium. Studies suggest the method used to assay 25(OH)D may influence the outcomes of dose-response assessments. Beyond these observations, it is difficult to make any substantive statements on the basis of the available evidence concerning the association of either serum 25(OH)D concentration, vitamin D supplementation, calcium intake, or the combination of both nutrients, with the various health outcomes because most of the findings were inconsistent.

Allocation of scarce resources during mass casualty events.

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 findings. In particular, the public believes that resource allocation guidelines should be simple and consistent across health care facilities but should allow facilities some flexibility to make allocation decisions based on the specific demand and supply situation. The public also believes that a successful allocation system should balance the goals of ensuring the functioning of society, saving the greatest number of people, protecting the most vulnerable people, reducing deaths and hospitalizations, and treating people fairly and equitably. The remaining 14 studies provided strategies for engaging providers in discussions about allocating and managing scarce medical resources. These studies did not identify one engagement approach as clearly superior; however, they consistently noted the importance of a broad, inclusive, and systematic engagement process. CONCLUSIONS: Scientific research to identify the most effective adaptive strategies to implement during MCEs is an emerging area. While it remains unclear which of the many options available to policymakers and providers will be most effective, ongoing efforts to develop a focused, well-organized program of applied research should help to identify the optimal methods, techniques, and technologies to strengthen our nation's capacity to respond to MCEs.

Safety of probiotics used to reduce risk and prevent or treat disease.

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 equipped to answer questions on the safety of probiotic interventions with confidence.