The Clinimetric Properties of Instruments Measuring Home Hazards for Older People at Risk of Falling: A Systematic Review.

PubMed

Romli, Muhammad Hibatullah; Mackenzie, Lynette; Lovarini, Meryl; Tan, Maw Pin; Clemson, Lindy

2018-03-01

Home hazards are associated with falls among older people living in the community. However, evaluating home hazards is a complex process as environmental factors vary according to geography, culture, and architectural design. As a result, many health practitioners commonly use nonstandardized assessment methods that may lead to inaccurate findings. Thus, the aim of this systematic review was to identify standardized instruments for evaluating home hazards related to falls and evaluate the clinimetric properties of these instruments for use by health practitioners. A systematic search was conducted in the Medline, CINAHL, AgeLine, Web of Science databases, and the University of Sydney Library CrossSearch Engine. Study screening, assessment, and quality ratings were conducted independently. Thirty-six studies were identified describing 19 instruments and three assessment techniques. The clinimetric properties varied between instruments. The Home Falls and Accidents Screening Tool, Home Safety Self-Assessment Tool, In-Home Occupational Performance Evaluation, and Westmead Home Safety Assessment were the instruments with high potential for evaluating home hazards associated with falls. Health practitioners can choose the most appropriate instruments for their practice, as a range of standardized instruments with established clinimetric properties are available.

Autograft versus Allograft for Cervical Spinal Fusion: A Systematic Review.

PubMed

Tuchman, Alexander; Brodke, Darrel S; Youssef, Jim A; Meisel, Hans-Jörg; Dettori, Joseph R; Park, Jong-Beom; Yoon, S Tim; Wang, Jeffrey C

2017-02-01

Systematic review. To compare the effectiveness and safety between iliac crest bone graft (ICBG), non-ICBG autologous bone, and allograft in cervical spine fusion. To avoid problems at the donor site, various allograft materials have been used as a substitute for autograft. However, there are still questions as to the comparative effectiveness and safety of cadaver allograft compared with autologous ICBG. A systematic search of multiple major medical reference databases was conducted to identify studies evaluating spinal fusion in patients with cervical degenerative disk disease using ICBG compared with non-ICBG autograft or allograft or non-ICBG autograft compared with allograft in the cervical spine. Radiographic fusion, patient-reported outcomes, and functional outcomes were the primary outcomes of interest. Adverse events were evaluated for safety. The search identified 13 comparative studies that met our inclusion criteria: 2 prospective cohort studies and 11 retrospective cohort studies. Twelve cohort studies compared allograft with ICBG autograft during anterior cervical fusion and demonstrated with a low evidence level of support that there are no differences in fusion percentages, pain scores, or functional results. There was insufficient evidence comparing patients receiving allograft with non-ICBG autograft for fusion, pain, revision, and functional and safety outcomes. No publications directly comparing non-ICBG autograft with ICBG were found. Although the available literature suggests ICBG and allograft may have similar effectiveness in terms of fusion rates, pain scores, and functional outcomes following anterior cervical fusion, there are too many limitations in the available literature to draw any significant conclusions. No individual study provided greater than class III evidence, and when evaluating the overall body of literature, no conclusion had better than low evidence support. A prospective randomized trial with adequate sample size to compare fusion rates, efficacy measures, costs, and safety is warranted.

[Clinical orientation and thought on several problems in post-marketed reassessment of traditional Chinese medicine].

PubMed

Wang, Xin; Su, Xia; Yu, Jie; Xie, Yanming; Wang, Yongyan

2011-10-01

The post-marketed reassessment is an important link to ensure the safety and effectiveness of traditional chinese medicine. It is also the expansion and stretch of new drug evaluation. Through the systematic, standard, rigorous post-marketed reassessment, the enterprise can full access to drugs after listing the efficacy and safety information, evaluate the interests and risk of the drug and provide the scientific basis for the drug use. It can also provide timely, scientific technology basis for government health decisions, the enterprise marketing decision and public health security. This paper mainly discussed the thought on clinical orientation of traditional chinese medicine in the post-marketed reassessment and how to reach the goal through systematic consideration and overall plan.

The outcomes of recent patient safety education interventions for trainee physicians and medical students: a systematic review

PubMed Central

Kirkman, Matthew A; Sevdalis, Nick; Arora, Sonal; Baker, Paul; Vincent, Charles; Ahmed, Maria

2015-01-01

Objective To systematically review the latest evidence for patient safety education for physicians in training and medical students, updating, extending and improving on a previous systematic review on this topic. Design A systematic review. Data sources Embase, Ovid Medline and PsycINFO databases. Study selection Studies including an evaluation of patient safety training interventions delivered to trainees/residents and medical students published between January 2009 and May 2014. Data extraction The review was performed using a structured data capture tool. Thematic analysis also identified factors influencing successful implementation of interventions. Results We identified 26 studies reporting patient safety interventions: 11 involving students and 15 involving trainees/residents. Common educational content included a general overview of patient safety, root cause/systems-based analysis, communication and teamwork skills, and quality improvement principles and methodologies. The majority of courses were well received by learners, and improved patient safety knowledge, skills and attitudes. Moreover, some interventions were shown to result in positive behaviours, notably subsequent engagement in quality improvement projects. No studies demonstrated patient benefit. Availability of expert faculty, competing curricular/service demands and institutional culture were important factors affecting implementation. Conclusions There is an increasing trend for developing educational interventions in patient safety delivered to trainees/residents and medical students. However, significant methodological shortcomings remain and additional evidence of impact on patient outcomes is needed. While there is some evidence of enhanced efforts to promote sustainability of such interventions, further work is needed to encourage their wider adoption and spread. PMID:25995240

Improvements in safety testing of lithium cells

NASA Astrophysics Data System (ADS)

Stinebring, R. C.; Krehl, P.

1985-07-01

A systematic approach was developed for evaluating the basic safety parameters of high power lithium soluble cathode cells. This approach consists of performing a series of tests on each cell model during the design, prototype and production phases. Abusive testing is performed in a facility where maximum protection is given to test personnel.

Improvements in safety testing of lithium cells

NASA Technical Reports Server (NTRS)

Stinebring, R. C.; Krehl, P.

1985-01-01

A systematic approach was developed for evaluating the basic safety parameters of high power lithium soluble cathode cells. This approach consists of performing a series of tests on each cell model during the design, prototype and production phases. Abusive testing is performed in a facility where maximum protection is given to test personnel.

Methodology to assess clinical liver safety data.

PubMed

Merz, Michael; Lee, Kwan R; Kullak-Ublick, Gerd A; Brueckner, Andreas; Watkins, Paul B

2014-11-01

Analysis of liver safety data has to be multivariate by nature and needs to take into account time dependency of observations. Current standard tools for liver safety assessment such as summary tables, individual data listings, and narratives address these requirements to a limited extent only. Using graphics in the context of a systematic workflow including predefined graph templates is a valuable addition to standard instruments, helping to ensure completeness of evaluation, and supporting both hypothesis generation and testing. Employing graphical workflows interactively allows analysis in a team-based setting and facilitates identification of the most suitable graphics for publishing and regulatory reporting. Another important tool is statistical outlier detection, accounting for the fact that for assessment of Drug-Induced Liver Injury, identification and thorough evaluation of extreme values has much more relevance than measures of central tendency in the data. Taken together, systematical graphical data exploration and statistical outlier detection may have the potential to significantly improve assessment and interpretation of clinical liver safety data. A workshop was convened to discuss best practices for the assessment of drug-induced liver injury (DILI) in clinical trials.

[A systematic review of the effectiveness of workplace safety interventions].

PubMed

Baldasseroni, A; Olimpi, Nadia; Bonaccorsi, G

2009-01-01

The authors carried out a systematic review of the effectiveness of workplace safety interventions, as a part of a wider project funded by CCM, Centre for Disease Control. Several electronic bibliographic databases were checked, using a standardized string selection. The string contained the following four items: the intervention; job features; type of injury; efficacy/effectiveness. Of the various databases consulted, Web of Science was the most efficient. Overall 5531 articles were selected. After reading the title and abstract, 4695 were excluded and eventually 35 systematic reviews were selected, which synthesized 769 original articles. The main topics of the selected systematic reviews were: certain sectors (building industry, agriculture, health care); personal protective equipment; work organization and prevention management at plant level; evaluation of prevention policies by national and regional authorities. A clear need for multiple bibliographical data-base search emerged at the end of this study.

Reporting of meta-analyses of randomized controlled trials with a focus on drug safety: an empirical assessment.

PubMed

Hammad, Tarek A; Neyarapally, George A; Pinheiro, Simone P; Iyasu, Solomon; Rochester, George; Dal Pan, Gerald

2013-01-01

Due to the sparse nature of serious drug-related adverse events (AEs), meta-analyses combining data from several randomized controlled trials (RCTs) to evaluate drug safety issues are increasingly being conducted and published, influencing clinical and regulatory decision making. Evaluation of meta-analyses involves the assessment of both the individual constituent trials and the approaches used to combine them. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) reporting framework is designed to enhance the reporting of systematic reviews and meta-analyses. However, PRISMA may not cover all critical elements useful in the evaluation of meta-analyses with a focus on drug safety particularly in the regulatory-public health setting. This work was conducted to (1) evaluate the adherence of a sample of published drug safety-focused meta-analyses to the PRISMA reporting framework, (2) identify gaps in this framework based on key aspects pertinent to drug safety, and (3) stimulate the development and validation of a more comprehensive reporting tool that incorporates elements unique to drug safety evaluation. We selected a sample of meta-analyses of RCTs based on review of abstracts from high-impact journals as well as top medical specialty journals between 2009 and 2011. We developed a preliminary reporting framework based on PRISMA with specific additional reporting elements critical for the evaluation of drug safety meta-analyses of RCTs. The reporting of pertinent elements in each meta-analysis was reviewed independently by two authors; discrepancies in the independent evaluations were resolved through discussions between the two authors. A total of 27 meta-analyses, 12 from highest impact journals, 13 from specialty medical journals, and 2 from Cochrane reviews, were identified and evaluated. The great majority (>85%) of PRISMA elements were addressed in more than half of the meta-analyses reviewed. However, the majority of meta-analyses (>60%) did not address most (>80%) of the additional reporting elements critical for the evaluation of drug safety. Some of these elements were not addressed in any of the reviewed meta-analyses. This review included a sample of meta-analyses, with a focus on drug safety, recently published in high-impact journals; therefore, we may have underestimated the extent of the reporting problem across all meta-analyses of drug safety. Furthermore, temporal trends in reporting could not be evaluated in this review because of the short time interval selected. While the majority of PRISMA elements were addressed by most studies reviewed, the majority of studies did not address most of the additional safety-related elements. These findings highlight the need for the development and validation of a drug safety reporting framework and the importance of the current initiative by the Council for International Organizations of Medical Sciences (CIOMS) to create a guidance document for drug safety information synthesis/meta-analysis, which may improve reporting, conduct, and evaluation of meta-analyses of drug safety and inform clinical and regulatory decision making.

The economic burden of patient safety targets in acute care: a systematic review

PubMed Central

Mittmann, Nicole; Koo, Marika; Daneman, Nick; McDonald, Andrew; Baker, Michael; Matlow, Anne; Krahn, Murray; Shojania, Kaveh G; Etchells, Edward

2012-01-01

Background Our objective was to determine the quality of literature in costing of the economic burden of patient safety. Methods We selected 15 types of patient safety targets for our systematic review. We searched the literature published between 2000 and 2010 using the following terms: “costs and cost analysis,” “cost-effectiveness,” “cost,” and “financial management, hospital.” We appraised the methodologic quality of potentially relevant studies using standard economic methods. We recorded results in the original currency, adjusted for inflation, and then converted to 2010 US dollars for comparative purposes (2010 US$1.00 = 2010 €0.76). The quality of each costing study per patient safety target was also evaluated. Results We screened 1948 abstracts, and identified 158 potentially eligible studies, of which only 61 (39%) reported any costing methodology. In these 61 studies, we found wide estimates of the attributable costs of patient safety events ranging from $2830 to $10,074. In general hospital populations, the cost per case of hospital-acquired infection ranged from $2132 to $15,018. Nosocomial bloodstream infection was associated with costs ranging from $2604 to $22,414. Conclusion There are wide variations in the estimates of economic burden due to differences in study methods and methodologic quality. Greater attention to methodologic standards for economic evaluations in patient safety is needed. PMID:23097615

A systematic review of occupational health and safety interventions with economic analyses.

PubMed

Tompa, Emile; Dolinschi, Roman; de Oliveira, Claire; Irvin, Emma

2009-09-01

We reviewed the occupational health and safety intervention literature to synthesize evidence on financial merits of such interventions. A literature search included journal databases, existing systematic reviews, and studies identified by content experts. Studies meeting inclusion criteria were assessed for quality. Evidence was synthesized within industry-intervention type clusters. We found strong evidence that ergonomic and other musculoskeletal injury prevention interventions in manufacturing and warehousing are worth undertaking in terms of their financial merits. We also found strong evidence that multisector disability management interventions are worth undertaking. While the economic evaluation of interventions in this literature warrants further expansion, we found a sufficient number of studies to identify strong, moderate, and limited evidence in certain industry-intervention clusters. The review also provided insights into how the methodological quality of economic evaluations in this literature could be improved.

[Definition of "Safety and Hygiene Packages" as a management model for the Hospital Hygiene Service (HHS)].

PubMed

Raponi, Matteo; Damiani, Gianfranco; Vincenti, Sara; Wachocka, Malgorzata; Boninti, Federica; Bruno, Stefania; Quaranta, Gianluigi; Moscato, Umberto; Boccia, Stefania; Ficarra, Maria Giovanna; Specchia, Maria Lucia; Posteraro, Brunella; Berloco, Filippo; Celani, Fabrizio; Ricciardi, Walter; Laurenti, Patrizia

2014-01-01

The purpose of this research is to identify and formalize the Hospital Hygiene Service activities and products, evaluating them in a cost accounting management view. The ultimate aim, is to evaluate the financial adverse events prevention impact, in an Hospital Hygiene Service management. A three step methodology based on affinity grouping activities, was employed. This methodology led us to identify 4 action areas, with 23 related productive processes, and 86 available safety packages. Owing to this new methodology, we was able to implement a systematic evaluation of the furnished services.

Assessing safety climate in acute hospital settings: a systematic review of the adequacy of the psychometric properties of survey measurement tools.

PubMed

Alsalem, Gheed; Bowie, Paul; Morrison, Jillian

2018-05-10

The perceived importance of safety culture in improving patient safety and its impact on patient outcomes has led to a growing interest in the assessment of safety climate in healthcare organizations; however, the rigour with which safety climate tools were developed and psychometrically tested was shown to be variable. This paper aims to identify and review questionnaire studies designed to measure safety climate in acute hospital settings, in order to assess the adequacy of reported psychometric properties of identified tools. A systematic review of published empirical literature was undertaken to examine sample characteristics and instrument details including safety climate dimensions, origin and theoretical basis, and extent of psychometric evaluation (content validity, criterion validity, construct validity and internal reliability). Five questionnaire tools, designed for general evaluation of safety climate in acute hospital settings, were included. Detailed inspection revealed ambiguity around concepts of safety culture and climate, safety climate dimensions and the methodological rigour associated with the design of these measures. Standard reporting of the psychometric properties of developed questionnaires was variable, although evidence of an improving trend in the quality of the reported psychometric properties of studies was noted. Evidence of the theoretical underpinnings of climate tools was limited, while a lack of clarity in the relationship between safety culture and patient outcome measures still exists. Evidence of the adequacy of the psychometric development of safety climate questionnaire tools is still limited. Research is necessary to resolve the controversies in the definitions and dimensions of safety culture and climate in healthcare and identify related inconsistencies. More importance should be given to the appropriate validation of safety climate questionnaires before extending their usage in healthcare contexts different from those in which they were originally developed. Mixed methods research to understand why psychometric assessment and measurement reporting practices can be inadequate and lacking in a theoretical basis is also necessary.

Evaluating the safety and dosing of drugs in patients with liver cirrhosis by literature review and expert opinion

PubMed Central

Weersink, Rianne A; Bouma, Margriet; Burger, David M; Drenth, Joost P H; Hunfeld, Nicole G M; Kranenborg, Minke; Monster-Simons, Margje H; van Putten, Sandra A W; Metselaar, Herold J; Taxis, Katja; Borgsteede, Sander D

2016-01-01

Introduction Liver cirrhosis can have a major impact on drug pharmacokinetics and pharmacodynamics. Patients with cirrhosis often suffer from potentially preventable adverse drug reactions. Guidelines on safe prescribing for these patients are lacking. The aim of this study is to develop a systematic method for evaluating the safety and optimal dosage of drugs in patients with liver cirrhosis. Methods and analysis For each drug, a six-step evaluation process will be followed. (1) Available evidence on the pharmacokinetics and safety of a drug in patients with liver cirrhosis will be collected from the Summary of Product Characteristics (SmPC) and a systematic literature review will be performed. (2) Data regarding two outcomes, namely pharmacokinetics and safety, will be extracted and presented in a standardised assessment report. (3) A safety classification and dosage suggestion will be proposed for each drug. (4) An expert panel will discuss the validity and clinical relevance of this suggested advice. (5) Advices will be implemented in all relevant Clinical Decision Support Systems in the Netherlands and published on a website for patients and healthcare professionals. (6) The continuity of the advices will be guaranteed by a yearly check of new literature and comments on the advices. This protocol will be applied in the evaluation of a selection of drugs: (A) drugs used to treat (complications of) liver cirrhosis, and (B) drugs frequently prescribed to the general population. Ethics and dissemination Since this study does not directly involve human participants, it does not require ethical clearance. Besides implementation on a website and in clinical decision support systems, we aim to publish the generated advices of one or two drug classes in a peer-reviewed journal and at conference meetings. PMID:27733414

Amitriptyline for the treatment of fibromyalgia: a comprehensive review.

PubMed

Rico-Villademoros, Fernando; Slim, Mahmoud; Calandre, Elena P

2015-10-01

Fibromyalgia is characterized by chronic generalized pain accompanied by a wide range of clinical manifestations. Most clinical practice guidelines recommend multidisciplinary treatment using a combination of pharmacological and non-pharmacological therapies. The tricyclic antidepressant amitriptyline has been most thoroughly studied in fibromyalgia. Amitriptyline has been evaluated in placebo-controlled studies, and it has served as an active comparator to other therapeutic interventions in the treatment of fibromyalgia. In addition, several systematic reviews and meta-analyses have evaluated its efficacy and safety for the treatment of fibromyalgia. Data from individual studies as well as from systematic reviews indicate that low doses (10-75 mg/day) of amitriptyline are effective for the treatment of fibromyalgia and, despite the limited quality of the data, they do not seem to be associated with relevant tolerability or safety issues. Consistent with some clinical guidelines, we believe amitriptyline in low doses should be considered a first-line drug for the treatment of fibromyalgia.

Electroacupuncture for women with stress urinary incontinence: Protocol for a systematic review and meta-analysis.

PubMed

Huang, Weixin; Li, Xiaohui; Wang, Yuanping; Yan, Xia; Wu, Siping

2017-12-01

Stress urinary incontinence (SUI) is a widespread complaint in the adult women. Electroacupuncture has been widely applied in the treatment of SUI. But its efficacy has not been evaluated scientifically and systematically. Therefore, we provide a protocol of systematic evaluation to assess the effectiveness and safety of electroacupuncture treatment on women with SUI. The retrieved databases include 3 English literature databases, namely PubMed, Embase, and Cochrane Library, and 3 Chinese literature databases, namely Chinese Biomedical Literature Database (CBM), China National Knowledge Infrastructure (CNKI), and Wanfang Database. The randomized controlled trials (RCTs) of the electroacupuncture treatment on women with SUI will be searched in the above-mentioned databases from the time when the respective databases were established to December 2017. The change from baseline in the amount of urine leakage measured by the 1-hour pad test will be accepted as the primary outcomes. We will use RevMan V.5.3 software as well to compute the data synthesis carefully when a meta-analysis is allowed. This study will provide a high-quality synthesis to assess the effectiveness and safety of electroacupuncture treatment on women with SUI. The conclusion of our systematic review will provide evidence to judge whether electroacupuncture is an effective intervention for women with SUI. PROSPERO CRD42017070947.

Inadequate safety reporting in pre-eclampsia trials: a systematic evaluation.

PubMed

Duffy, Jmn; Hirsch, M; Pealing, L; Showell, M; Khan, K S; Ziebland, S; McManus, R J

2018-06-01

Randomised trials and their syntheses in meta-analyses offer a unique opportunity to assess the frequency and severity of adverse reactions. To assess safety reporting in pre-eclampsia trials. Systematic search using bibliographic databases, including Cochrane Central Register of Controlled Trials, Embase, and MEDLINE, from inception to August 2017. Randomised trials evaluating anticonvulsant or antihypertensive medication for pre-eclampsia. Descriptive statistics appraising the adequacy of adverse reaction and toxicity reporting. We included 60 randomised trials. Six trials (10%) were registered with the International Clinical Trials Registry Platform, two registry records referred to adverse reactions, stating 'safety and toleration' and 'possible side effects' would be collected. Twenty-six trials (43%) stated the frequency of withdrawals within each study arm, and five trials (8%) adequately reported these withdrawals. Adverse reactions were inconsistently reported across eligible trials: 24 (40%) reported no serious adverse reactions and 36 (60%) reported no mild adverse reactions. The methods of definition or measurement of adverse reactions were infrequently reported within published trial reports. Pre-eclampsia trials regularly omit critical information related to safety. Despite the paucity of reporting, randomised trials collect an enormous amount of safety data. Developing and implementing a minimum data set could help to improve safety reporting, permitting a more balanced assessment of interventions by considering the trade-off between the benefits and harms. National Institute for Health Research (DRF-2014-07-051), UK; Maternity Forum, Royal Society of Medicine, UK. Developing @coreoutcomes could help to improve safety reporting in #preeclampsia trials. @NIHR_DC. © 2017 Royal College of Obstetricians and Gynaecologists.

Integrated Approaches to Occupational Health and Safety: A Systematic Review.

PubMed

Cooklin, A; Joss, N; Husser, E; Oldenburg, B

2017-09-01

The study objective was to conduct a systematic review of the effectiveness of integrated workplace interventions that combine health promotion with occupational health and safety. Electronic databases (n = 8), including PsychInfo and MEDLINE, were systematically searched. Studies included were those that reported on workplace interventions that met the consensus definition of an "integrated approach," published in English, in the scientific literature since 1990. Data extracted were occupation, worksite, country, sample size, intervention targets, follow-up period, and results reported. Quality was assessed according to American College of Occupational and Environmental Medicine Practice Guidelines. Heterogeneity precluded formal meta-analyses. Results were classified according to the outcome(s) assessed into five categories (health promotion, injury prevention, occupational health and safety management, psychosocial, and return-on-investment). Narrative synthesis of outcomes was performed. A total of 31 eligible studies were identified; 23 (74%) were (quasi-)experimental trials. Effective interventions were most of those aimed at improving employee physical or mental health. Less consistent results were reported from integrated interventions targeting occupational health and safety management, injury prevention, or organizational cost savings. Integrated approaches have been posed as comprehensive solutions to complex issues. Empirical evidence, while still emerging, provides some support for this. Continuing investment in, and evaluation of, integrated approaches are worthwhile.

Use of patient safety culture instruments in operating rooms: A systematic literature review.

PubMed

Zhao, Pujng; Li, Yaqin; Li, Zhi; Jia, Pengli; Zhang, Longhao; Zhang, Mingming

2017-05-01

To identify and qualitatively describe, in a literature review, how the instruments were used to evaluate patient safety culture in the operating rooms of published studies. Systematic searches of the literature were conducted using the major database including MEDLINE, EMbase, The Cochrane Library, and four Chinese databases including Chinese Biomedical Literature Database (CBM), Wanfang Data, Chinese Scientific Journal Database (VIP), and Chinese Journals Full-text Database (CNKI) for studies published up to March 2016. We summarized and analyzed the country scope, the instrument utilized in the study, the year when the instrument was used, and fields of operating rooms. Study populations, study settings, and the time span between baseline and follow-up phase were evaluated according to the study design. We identified 1025 references, of which 99 were obtained for full-text assessment; 47 of these studies were deemed relevant and included in the literature review. Most of the studies were from the USA. The most commonly used patient safety culture instrument was Safety Attitude Questionnaire. All identified instruments were used after 2002 and across many fields. Most included studies on patient safety culture were conducted in teaching hospitals or university hospitals. The study population in the cross-sectional studies was much more than that in the before-after studies. The time span between baseline and follow-up phase of before-after studies were almost over three months. Although patient safety culture is considered important in health care and patient safety, the number of studies in which patient safety culture has been estimated using the instruments in operating rooms, is fairly small. © 2017 Chinese Cochrane Center, West China Hospital of Sichuan University and John Wiley & Sons Australia, Ltd.

Improving the health and safety of 911 emergency call centre agents: an evaluability assessment of a knowledge transfer strategy.

PubMed

Dagenais, Christian; Plouffe, Laurence; Gagné, Charles; Toulouse, Georges; Breault, Andrée-Anne; Dupont, Didier

2017-03-01

A knowledge transfer (KT) strategy was implemented by the IRSST, an occupational health and safety research institute established in Québec (Canada), to improve the prevention of psychological and musculoskeletal problems among 911 emergency call centre agents. An evaluability assessment was conducted in which each aspect of the KT approach was documented systematically to determine whether the strategy had the potential to be evaluated in terms of its impact on the targeted population. A review of the literature on KT in occupational health and safety and on the evaluation of such KT programmes, along with the development of a logic model based on documentary analysis and semi-structured interviews with key stakeholders, indicated that the KT strategy was likely to have had a positive impact in the 911 emergency call centre sector. Implications for future research are discussed.

Occupational injury among migrant workers in China: a systematic review.

PubMed

Fitzgerald, Simon; Chen, Xin; Qu, Hui; Sheff, Mira Grice

2013-10-01

This review considers the state of occupational injury surveillance and prevention among migrant workers in China and suggests areas of focus for future research on the topic. Bibliographic databases were searched for qualitative and quantitative studies on surveillance of and interventions to prevent occupational injury among migrant workers in mainland China. Additional abstracts were identified from the citations of relevant articles from the database search. Studies fitting the inclusion criteria were evaluated, and findings were extracted and summarised. The search uncovered 726 studies in the English-language databases searched, and 3109 in the Chinese database. This article analyses a total of 19 research articles that fit the inclusion criteria with qualitative or quantitative data on occupational injury surveillance and prevention of migrant workers in China. Despite evidence of the vulnerability of migrant workers in the workplace, there is little systematic surveillance of occupational injury and few evaluated interventions. Migrant workers account for a disproportionate burden of occupational injury morbidity and mortality in China. However, data are inconsistent and inadequate to detail injury incidence or to evaluate interventions. The following are suggestions to decrease injury incidence among migrants: strengthen the national system of occupational injury surveillance; focus surveillance and interventions on high-risk occupations employing migrants such as construction, manufacturing and small mining operations; improve occupational safety training and access to appropriate safety equipment; evaluate recent changes in occupational health and safety and evaluate outcome of multi-party interventions to reduce occupational injury among migrant workers.

Occupational injury among migrant workers in China: a systematic review

PubMed Central

Fitzgerald, Simon; Chen, Xin; Qu, Hui; Sheff, Mira Grice

2017-01-01

Objectives This review considers the state of occupational injury surveillance and prevention among migrant workers in China and suggests areas of focus for future research on the topic. Methods Bibliographic databases were searched for qualitative and quantitative studies on surveillance of and interventions to prevent occupational injury among migrant workers in mainland China. Additional abstracts were identified from the citations of relevant articles from the database search. Studies fitting the inclusion criteria were evaluated, and findings were extracted and summarised. Results The search uncovered 726 studies in the English-language databases searched, and 3109 in the Chinese database. This article analyses a total of 19 research articles that fit the inclusion criteria with qualitative or quantitative data on occupational injury surveillance and prevention of migrant workers in China. Despite evidence of the vulnerability of migrant workers in the workplace, there is little systematic surveillance of occupational injury and few evaluated interventions. Conclusions Migrant workers account for a disproportionate burden of occupational injury morbidity and mortality in China. However, data are inconsistent and inadequate to detail injury incidence or to evaluate interventions. The following are suggestions to decrease injury incidence among migrants: strengthen the national system of occupational injury surveillance; focus surveillance and interventions on high-risk occupations employing migrants such as construction, manufacturing and small mining operations; improve occupational safety training and access to appropriate safety equipment; evaluate recent changes in occupational health and safety and evaluate outcome of multi-party interventions to reduce occupational injury among migrant workers. PMID:23710065

Safety analysis and review system (SARS) assessment report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Browne, E.T.

1981-03-01

Under DOE Order 5481.1, Safety Analysis and Review System for DOE Operations, safety analyses are required for DOE projects in order to ensure that: (1) potential hazards are systematically identified; (2) potential impacts are analyzed; (3) reasonable measures have been taken to eliminate, control, or mitigate the hazards; and (4) there is documented management authorization of the DOE operation based on an objective assessment of the adequacy of the safety analysis. This report is intended to provide the DOE Office of Plans and Technology Assessment (OPTA) with an independent evaluation of the adequacy of the ongoing safety analysis effort. Asmore » part of this effort, a number of site visits and interviews were conducted, and FE SARS documents were reviewed. The latter included SARS Implementation Plans for a number of FE field offices, as well as safety analysis reports completed for certain FE operations. This report summarizes SARS related efforts at the DOE field offices visited and evaluates the extent to which they fulfill the requirements of DOE 5481.1.« less

The Traditional Chinese Medicine and Relevant Treatment for the Efficacy and Safety of Atopic Dermatitis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

PubMed Central

Shi, Zhao-feng; Song, Tie-bing; Xie, Juan; Yan, Yi-quan

2017-01-01

Background Atopic dermatitis (AD) has become a common skin disease that requires systematic and comprehensive treatment to achieve adequate clinical control. Traditional Chinese medicines and related treatments have shown clinical effects for AD in many studies. But the systematic reviews and meta-analyses for them are lacking. Objective The systematic review and meta-analysis based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement were conducted to evaluate the efficacy and safety of traditional Chinese medicines and related treatments for AD treatment. Methods Randomized controlled trials (RCTs) were searched based on standardized searching rules in eight medical databases from the inception up to December 2016 and a total of 24 articles with 1,618 patients were enrolled in this meta-analysis. Results The results revealed that traditional Chinese medicines and related treatments did not show statistical differences in clinical effectiveness, SCORAD amelioration, and SSRI amelioration for AD treatment compared with control group. However, EASI amelioration of traditional Chinese medicines and related treatments for AD was superior to control group. Conclusion We need to make conclusion cautiously for the efficacy and safety of traditional Chinese medicine and related treatment on AD therapy. More standard, multicenter, double-blind randomized controlled trials (RCTs) of traditional Chinese medicine and related treatment for AD were required to be conducted for more clinical evidences providing in the future. PMID:28713436

Efficacy and safety of statins and exercise combination therapy compared to statin monotherapy in patients with dyslipidaemia: A systematic review and meta-analysis.

PubMed

Gui, Ya-Jun; Liao, Cai-Xiu; Liu, Qiong; Guo, Yuan; Yang, Tao; Chen, Jing-Yuan; Wang, Ya-Ting; Hu, Jia-Hui; Xu, Dan-Yan

2017-06-01

Background Statin treatment in association with physical exercise can substantially reduce mortality in dyslipidaemic individuals. However, the available data to compare the efficacy and safety of statins and exercise combination therapy with statin monotherapy are limited. Design Systematic review and meta-analysis. Methods We systematically searched PubMed, Embase and the Cochrane Library from database inception until December 2016. We included randomised and non-randomised studies that compared the efficacy and safety of statins and exercise combination therapy with statin monotherapy in patients with dyslipidaemia. Standardised mean differences were calculated and pooled by means of fixed effects models. The risk of bias and heterogeneity among trials was also assessed. Seven articles were assessed in terms of the efficacy of therapy and 13 from the viewpoint of therapeutic safety. Results In terms of efficacy, statins and exercise combination decreased the incidence of diabetes mellitus, improved insulin sensitivity and inflammation, but caused no change in lipid profile compared to statins alone. In terms of safety, statins and exercise combination increased peak oxygen uptake (standardised mean difference 1.01, 95% confidence interval 0.46 to 1.57) compared to statins alone. In contrast to statin-induced myopathy, chronic exercise training prior to statin treatment could counteract statin-induced adverse effects in skeletal muscle. Conclusion Statins and exercise combination therapy is more effective than statin monotherapy in terms of insulin sensitivity, inflammation and exercise capacity. The small number of studies warrants the need for more randomised controlled trials evaluating the efficacy and safety of combination therapy.

Herbal medicine for idiopathic central precocious puberty: A protocol for a systematic review of controlled trials.

PubMed

Lee, Hye Lim; Lee, Yoo Been; Choi, Jun-Yong; Lee, Ju Ah

2018-03-01

Herbal medicine is widely used in East Asia to treat idiopathic central precocious puberty (ICPP). Most of the available clinical trials that investigated herbal medicine for ICPP have been included in this review. This systematic review will assess the efficacy and safety of herbal medicine for ICPP. Eleven databases, including Asian databases, will be searched for studies conducted through 2018. We will include randomized controlled trials assessing herbal medicine for ICPP. The risk of bias will be evaluated using the Cochrane risk of bias assessment tool, and confidence in the cumulative evidence will be evaluated using the Grading of Recommendations Assessment, Development, and Evaluation instrument. This systematic review will be published in a peer-reviewed journal and disseminated both electronically and in print. The review will be updated to inform and guide health care practices. PROSPER 2018 CRD42018087988.

Preventing and controlling foodborne disease in commercial and institutional food service settings: a systematic review of published intervention studies.

PubMed

Viator, Catherine; Blitstein, Jonathan; Brophy, Jenna E; Fraser, Angela

2015-02-01

This study reviews the current literature on behavioral and environmental food safety interventions conducted in commercial and institutional food service settings. A systematic search of the published literature yielded 268 candidate articles, from which a set of 23 articles reporting intervention outcomes was retained for evaluation. A categorization of measured outcomes is reported; studies addressed multiple outcomes ranging from knowledge, attitudes, and behavior of personal hygiene and food safety to management practices and disease rates and outbreaks. This study also investigates the quality of reported research methods used to evaluate the effectiveness of the interventions, using a nine-point quality index adapted by the authors. The observed scores suggest that there are opportunities to improve the design and reporting of research in the field of foodborne disease prevention as it applies to food safety interventions that target the food service industry. The aim is to aid researchers in this area to design higher quality studies and to produce clearer and more useful reports of their research. In turn, this can help to create a more complete evidence base that can be used to continually improve interventions in this domain.

A systematic review and meta-analysis of the safety, feasibility and effect of exercise in women with stage II+ breast cancer.

PubMed

Singh, Ben; Spence, Rosalind R; Steele, Megan L; Sandler, Carolina X; Peake, Jonathan M; Hayes, Sandra C

2018-05-03

To systematically evaluate the safety, feasibility and effect of exercise among women with stage II+ breast cancer. CINAHL, Cochrane, Ebscohost, MEDLINE, Pubmed, ProQuest Health and Medical Complete, ProQuest Nursing and Allied Health Source, Science Direct and SPORTDiscus were searched for articles published prior to March 1, 2017. Randomised, controlled, exercise trials involving at least 50% of women diagnosed with stage II+ breast cancer were included. Risk of bias was assessed and adverse event severity was classified using the Common Terminology Criteria. Feasibility was evaluated by computing median (range) recruitment, withdrawal and adherence rates. Meta-analyses were performed to evaluate exercise safety and effects on health outcomes only. The influence of intervention characteristics (mode, supervision, duration and timing) on exercise outcomes were also explored. There were no differences in adverse events between exercise and usual care (risk difference: <0.01 [95% CI: -0.01, 0.01]), p=0.38). Median recruitment rate was 56% (1%-96%), withdrawal rate was 10% (0%-41%) and adherence rate was 82% (44%-99%). Safety and feasibility outcomes were similar, irrespective of exercise mode, supervision, duration, or timing. Effects of exercise for quality of life, fitness, fatigue, strength, anxiety, depression, body mass index and waist circumference compared with usual care were significant (standardised mean difference range: 0.17-0.77, p<0.05). The findings support the safety, feasibility and effects of exercise for those with stage II+ breast cancer, suggesting that national and international exercise guidelines appear generalizable to women with local, regional and distant breast cancer. Copyright © 2018. Published by Elsevier Inc.

Autograft versus Allograft for Cervical Spinal Fusion

PubMed Central

Brodke, Darrel S.; Youssef, Jim A.; Meisel, Hans-Jörg; Dettori, Joseph R.; Park, Jong-Beom; Yoon, S. Tim; Wang, Jeffrey C.

2017-01-01

Study Design Systematic review. Objective To compare the effectiveness and safety between iliac crest bone graft (ICBG), non-ICBG autologous bone, and allograft in cervical spine fusion. To avoid problems at the donor site, various allograft materials have been used as a substitute for autograft. However, there are still questions as to the comparative effectiveness and safety of cadaver allograft compared with autologous ICBG. Methods A systematic search of multiple major medical reference databases was conducted to identify studies evaluating spinal fusion in patients with cervical degenerative disk disease using ICBG compared with non-ICBG autograft or allograft or non-ICBG autograft compared with allograft in the cervical spine. Radiographic fusion, patient-reported outcomes, and functional outcomes were the primary outcomes of interest. Adverse events were evaluated for safety. Results The search identified 13 comparative studies that met our inclusion criteria: 2 prospective cohort studies and 11 retrospective cohort studies. Twelve cohort studies compared allograft with ICBG autograft during anterior cervical fusion and demonstrated with a low evidence level of support that there are no differences in fusion percentages, pain scores, or functional results. There was insufficient evidence comparing patients receiving allograft with non-ICBG autograft for fusion, pain, revision, and functional and safety outcomes. No publications directly comparing non-ICBG autograft with ICBG were found. Conclusion Although the available literature suggests ICBG and allograft may have similar effectiveness in terms of fusion rates, pain scores, and functional outcomes following anterior cervical fusion, there are too many limitations in the available literature to draw any significant conclusions. No individual study provided greater than class III evidence, and when evaluating the overall body of literature, no conclusion had better than low evidence support. A prospective randomized trial with adequate sample size to compare fusion rates, efficacy measures, costs, and safety is warranted. PMID:28451511

The safety of St John's wort (Hypericum perforatum) in pregnancy and lactation: A systematic review of rodent studies.

PubMed

Avila, Catharine; Whitten, Dawn; Evans, Sue

2018-04-30

Herbal products are popular among women during the perinatal period. St John's wort (SJW), Hypericum perforatum, is a common remedy for mild depression, a problem prevalent in this population. Although the safety of herbal products must be investigated, ethical issues constrain intervention studies in humans. Hence, animal studies often inform clinical decisions. The objective of this study is to systematically review rodent studies assessing the safety of SJW during the perinatal period. A literature search to November 10, 2017, identified 10 rodent studies that met a priori inclusion criteria. Study quality was evaluated according to both the Systematic Review Centre for Laboratory animal Experimentation tool for assessing bias and recommendations for appropriate reporting of herbal medicine research. Significant methodological limitations were found in each of the studies reviewed. These limitations include the lack of botanical verification and omission of extract characterization, inadequate explanation of dosage rationale, and absence of bias limiting protocols. Critical appraisal with contemporary tools indicates that each of the reviewed studies lacks appropriate rigour, rendering the results unreliable. Despite this, these papers are used in the rationale for recommending or contraindicating SJW during pregnancy and lactation. Copyright © 2018 John Wiley & Sons, Ltd.

Efficacy and safety of laxatives for chronic constipation in long-term care settings: A systematic review.

PubMed

Alsalimy, N; Madi, L; Awaisu, A

2018-06-09

Constipation is a common disorder among long-term care (LTC) patients due to several factors. However, there are no systematic reviews investigating the use of laxatives for chronic constipation in LTC settings. This study aims to explore the safety and efficacy of laxatives in LTC patients. A systematic review of randomized controlled trials (RCTs) describing the efficacy and safety of laxatives for chronic constipation in LTC patients was conducted using the following databases and search engines: MEDLINE, Cochrane Database of Systematic Reviews, ScienceDirect, ProQuest and Google Scholar. Two of the investigators independently performed the searches, and the data were extracted using a standardized data abstraction tool. Seven RCTs involving 444 patients were included in the review. These studies included senna (with or without fibre, ie Plantago ovata), lactulose, sodium picosulphate, docusate sodium, docusate calcium, isotonic and hypotonic polyethylene glycol and Chinese herbal medicine. Senna and lactulose were the most studied laxatives in LTC patients, and senna was found to be superior to or as effective as other laxatives. Generally, the frequency and severity of adverse drug reactions (ADRs) were similar between the arms of the studies, and no serious ADRs were reported. Considering the short duration of the trials, the lack of trials including newer laxatives and the low quality of some of the included trials, the long-term efficacy and safety of these laxatives are not conclusive. There is a need to conduct more robust RCTs that include newer agents to evaluate long-term outcomes. © 2018 John Wiley & Sons Ltd.

Development and Evaluation of an ADME-informed High Throughput Exposure Estimation Tool

EPA Science Inventory

EPA’s Chemical Safety for Sustainability (CSS) research program has been developing new ways to prioritize chemicals used in consumer products and articles. Using a risk-based methodology to account for both toxicity and exposure offers a comprehensive and systematic approa...

Acute effects of electromagnetic stimulation of the brain on cortical activity, cortical blood flow, blood pressure and heart rate in the cat: an evaluation of safety.

PubMed Central

Eyre, J A; Flecknell, P A; Kenyon, B R; Koh, T H; Miller, S

1990-01-01

The influence of repeated high intensity electromagnetic stimulation of the brain on cortical activity, cortical blood flow, blood pressure and heart rate has been investigated in the cat, to evaluate the safety of the method. The observations have been made in preparations under propofol anaesthesia before, during and after periods of anoxia. Electromagnetic stimulation of the brain evoked activity in descending motor pathways and was recorded by activity in the median nerve and by muscle twitches. Following repeated series of high intensity stimulation there were no systematic changes in somatosensory evoked potentials or background EEG, nor were there signs of epileptogenic activity during electromagnetic stimulation, before, during or after periods of anoxia. No systematic changes in cortical blood flow, blood pressure or heart rate were observed during electromagnetic stimulation, before or after periods of anoxia. In conclusion, no acute adverse consequences following electromagnetic stimulation in the normal and anoxic cat brain were demonstrated. PMID:2380732

Linking Environmental Sustainability, Health, and Safety Data in Health Care: A Research Roadmap.

PubMed

Kaplan, Susan B; Forst, Linda

2017-08-01

Limited but growing evidence demonstrates that environmental sustainability in the health-care sector can improve worker and patient health and safety. Yet these connections are not appreciated or understood by decision makers in health-care organizations or oversight agencies. Several studies demonstrate improvements in quality of care, staff satisfaction, and work productivity related to environmental improvements in the health-care sector. A pilot study conducted by the authors found that already-collected data could be used to evaluate impacts of environmental sustainability initiatives on worker and patient health and safety, yet few hospitals do so. Future research should include a policy analysis of laws that could drive efforts to integrate these areas, elucidation of organizational models that promote sharing of environmental and health and safety data, and development of tools and methods to enable systematic linkage and evaluation of these data to expand the evidence base and improve the hospital environment.

Evaluating the Safety Profile of Non-Active Implantable Medical Devices Compared with Medicines.

PubMed

Pane, Josep; Coloma, Preciosa M; Verhamme, Katia M C; Sturkenboom, Miriam C J M; Rebollo, Irene

2017-01-01

Recent safety issues involving non-active implantable medical devices (NAIMDs) have highlighted the need for better pre-market and post-market evaluation. Some stakeholders have argued that certain features of medicine safety evaluation should also be applied to medical devices. Our objectives were to compare the current processes and methodologies for the assessment of NAIMD safety profiles with those for medicines, identify potential gaps, and make recommendations for the adoption of new methodologies for the ongoing benefit-risk monitoring of these devices throughout their entire life cycle. A literature review served to examine the current tools for the safety evaluation of NAIMDs and those for medicines. We searched MEDLINE using these two categories. We supplemented this search with Google searches using the same key terms used in the MEDLINE search. Using a comparative approach, we summarized the new product design, development cycle (preclinical and clinical phases), and post-market phases for NAIMDs and drugs. We also evaluated and compared the respective processes to integrate and assess safety data during the life cycle of the products, including signal detection, signal management, and subsequent potential regulatory actions. The search identified a gap in NAIMD safety signal generation: no global program exists that collects and analyzes adverse events and product quality issues. Data sources in real-world settings, such as electronic health records, need to be effectively identified and explored as additional sources of safety information, particularly in some areas such as the EU and USA where there are plans to implement the unique device identifier (UDI). The UDI and other initiatives will enable more robust follow-up and assessment of long-term patient outcomes. The safety evaluation system for NAIMDs differs in many ways from those for drugs, but both systems face analogous challenges with respect to monitoring real-world usage. Certain features of the drug safety evaluation process could, if adopted and adapted for NAIMDs, lead to better and more systematic evaluations of the latter.

Evaluating the safety and dosing of drugs in patients with liver cirrhosis by literature review and expert opinion.

PubMed

Weersink, Rianne A; Bouma, Margriet; Burger, David M; Drenth, Joost P H; Hunfeld, Nicole G M; Kranenborg, Minke; Monster-Simons, Margje H; van Putten, Sandra A W; Metselaar, Herold J; Taxis, Katja; Borgsteede, Sander D

2016-10-12

Liver cirrhosis can have a major impact on drug pharmacokinetics and pharmacodynamics. Patients with cirrhosis often suffer from potentially preventable adverse drug reactions. Guidelines on safe prescribing for these patients are lacking. The aim of this study is to develop a systematic method for evaluating the safety and optimal dosage of drugs in patients with liver cirrhosis. For each drug, a six-step evaluation process will be followed. (1) Available evidence on the pharmacokinetics and safety of a drug in patients with liver cirrhosis will be collected from the Summary of Product Characteristics (SmPC) and a systematic literature review will be performed. (2) Data regarding two outcomes, namely pharmacokinetics and safety, will be extracted and presented in a standardised assessment report. (3) A safety classification and dosage suggestion will be proposed for each drug. (4) An expert panel will discuss the validity and clinical relevance of this suggested advice. (5) Advices will be implemented in all relevant Clinical Decision Support Systems in the Netherlands and published on a website for patients and healthcare professionals. (6) The continuity of the advices will be guaranteed by a yearly check of new literature and comments on the advices. This protocol will be applied in the evaluation of a selection of drugs: (A) drugs used to treat (complications of) liver cirrhosis, and (B) drugs frequently prescribed to the general population. Since this study does not directly involve human participants, it does not require ethical clearance. Besides implementation on a website and in clinical decision support systems, we aim to publish the generated advices of one or two drug classes in a peer-reviewed journal and at conference meetings. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

The patient safety culture: a systematic review by characteristics of Hospital Survey on Patient Safety Culture dimensions.

PubMed

Reis, Cláudia Tartaglia; Paiva, Sofia Guerra; Sousa, Paulo

2018-05-08

To learn the weaknesses and strengths of safety culture as expressed by the dimensions measured by the Hospital Survey on Patient Safety Culture (HSOPSC) at hospitals in the various cultural contexts. The aim of this study was to identify studies that have used the HSOPSC to collect data on safety culture at hospitals; to survey their findings in the safety culture dimensions and possible contributions to improving the quality and safety of hospital care. Medline (via PubMed), Web of Science and Scopus were searched from 2005 to July 2016 in English, Portuguese and Spanish. Studies were identified using specific search terms and inclusion criteria. A total of 33 articles, reporting on 21 countries, was included. Scores were extracted by patient safety culture dimensions assessed by the HSOPSC. The quality of the studies was evaluated by the STROBE Statement. The dimensions that proved strongest were 'Teamwork within units' and 'Organisational learning-continuous improvement'. Particularly weak dimensions were 'Non-punitive response to error', 'Staffing', 'Handoffs and transitions' and 'Teamwork across units'. The studies revealed a predominance of hospital organisational cultures that were underdeveloped or weak as regards patient safety. For them to be effective, safety culture evaluation should be tied to strategies designed to develop safety culture hospital-wide.

Safety Profile of Biologic Drugs in the Therapy of Ulcerative Colitis: A Systematic Review and Network Meta-Analysis.

PubMed

Moćko, Paweł; Kawalec, Paweł; Pilc, Andrzej

2016-08-01

We compared the safety profile of biologic drugs in patients with moderately to severely active ulcerative colitis (UC). A systematic literature search was performed using Medline (PubMed), Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) databases through February 9, 2016. We included randomized controlled trials (RCTs) that compared the safety of biologic drugs (infliximab, adalimumab, golimumab, and vedolizumab) with one another or with placebo in patients with UC. Two reviewers independently conducted the search and selection of studies and rated the risk of bias in each trial. The network meta-analysis (NMA) was conducted for an induction phase (6-8 weeks) and maintenance phase (52-54 weeks) with a Bayesian hierarchical random effects model in Aggregate Data Drug Information System (ADDIS) software. The PROSPERO registration number was CRD42016032607. Seven RCTs were included in the systematic review with NMA. In the case of the induction phase, the NMA could be conducted for the assessment of the relative safety profile of adalimumab, golimumab, and vedolizumab, and in the case of the maintenance phase of infliximab, adalimumab, golimumab, and vedolizumab. The methodological quality of the included RCTs was evaluated as low risk of bias, but high risk of bias in the case of attrition bias (incomplete outcome data) according to the Cochrane criteria. No significant differences were found in the rate of adverse events in patients treated with the reviewed biologics. Vedolizumab was most likely to have the most favorable safety profile in the induction phase as was infliximab for the maintenance phase. The assessment of the relative safety profile revealed no significant differences between the biologic drugs. Further studies are needed to confirm our findings including head-to-head comparisons between the analyzed biologics. © 2016 Pharmacotherapy Publications, Inc.

The likelihood of achieving quantified road safety targets: a binary logistic regression model for possible factors.

PubMed

Sze, N N; Wong, S C; Lee, C Y

2014-12-01

In past several decades, many countries have set quantified road safety targets to motivate transport authorities to develop systematic road safety strategies and measures and facilitate the achievement of continuous road safety improvement. Studies have been conducted to evaluate the association between the setting of quantified road safety targets and road fatality reduction, in both the short and long run, by comparing road fatalities before and after the implementation of a quantified road safety target. However, not much work has been done to evaluate whether the quantified road safety targets are actually achieved. In this study, we used a binary logistic regression model to examine the factors - including vehicle ownership, fatality rate, and national income, in addition to level of ambition and duration of target - that contribute to a target's success. We analyzed 55 quantified road safety targets set by 29 countries from 1981 to 2009, and the results indicate that targets that are in progress and with lower level of ambitions had a higher likelihood of eventually being achieved. Moreover, possible interaction effects on the association between level of ambition and the likelihood of success are also revealed. Copyright © 2014 Elsevier Ltd. All rights reserved.

Promoting a Culture of Safety as a Patient Safety Strategy

PubMed Central

Weaver, Sallie J.; Lubomksi, Lisa H.; Wilson, Renee F.; Pfoh, Elizabeth R.; Martinez, Kathryn A.; Dy, Sydney M.

2015-01-01

Developing a culture of safety is a core element of many efforts to improve patient safety and care quality. This systematic review identifies and assesses interventions used to promote safety culture or climate in acute care settings. The authors searched MEDLINE, CINAHL, PsycINFO, Cochrane, and EMBASE to identify relevant English-language studies published from January 2000 to October 2012. They selected studies that targeted health care workers practicing in inpatient settings and included data about change in patient safety culture or climate after a targeted intervention. Two raters independently screened 3679 abstracts (which yielded 33 eligible studies in 35 articles), extracted study data, and rated study quality and strength of evidence. Eight studies included executive walk rounds or interdisciplinary rounds; 8 evaluated multicomponent, unit-based interventions; and 20 included team training or communication initiatives. Twenty-nine studies reported some improvement in safety culture or patient outcomes, but measured outcomes were highly heterogeneous. Strength of evidence was low, and most studies were pre–post evaluations of low to moderate quality. Within these limits, evidence suggests that interventions can improve perceptions of safety culture and potentially reduce patient harm. PMID:23460092

Effects of auditing patient safety in hospital care: design of a mixed-method evaluation

PubMed Central

2013-01-01

Background Auditing of patient safety aims at early detection of risks of adverse events and is intended to encourage the continuous improvement of patient safety. The auditing should be an independent, objective assurance and consulting system. Auditing helps an organisation accomplish its objectives by bringing a systematic, disciplined approach to evaluating and improving the effectiveness of risk management, control, and governance. Audits are broadly conducted in hospitals, but little is known about their effects on the behaviour of healthcare professionals and patient safety outcomes. This study was initiated to evaluate the effects of patient safety auditing in hospital care and to explore the processes and mechanisms underlying these effects. Methods and design Our study aims to evaluate an audit system to monitor and improve patient safety in a hospital setting. We are using a mixed-method evaluation with a before-and-after study design in eight departments of one university hospital in the period October 2011–July 2014. We measure several outcomes 3 months before the audit and 15 months after the audit. The primary outcomes are adverse events and complications. The secondary outcomes are experiences of patients, the standardised mortality ratio, prolonged hospital stay, patient safety culture, and team climate. We use medical record reviews, questionnaires, hospital administrative data, and observations to assess the outcomes. A process evaluation will be used to find out which components of internal auditing determine the effects. Discussion We report a study protocol of an effect and process evaluation to determine whether auditing improves patient safety in hospital care. Because auditing is a complex intervention targeted on several levels, we are using a combination of methods to collect qualitative and quantitative data about patient safety at the patient, professional, and department levels. This study is relevant for hospitals that want to early detect unsafe care and improve patient safety continuously. Trial registration Netherlands Trial Register (NTR): NTR3343 PMID:23800253

Effects of auditing patient safety in hospital care: design of a mixed-method evaluation.

PubMed

Hanskamp-Sebregts, Mirelle; Zegers, Marieke; Boeijen, Wilma; Westert, Gert P; van Gurp, Petra J; Wollersheim, Hub

2013-06-22

Auditing of patient safety aims at early detection of risks of adverse events and is intended to encourage the continuous improvement of patient safety. The auditing should be an independent, objective assurance and consulting system. Auditing helps an organisation accomplish its objectives by bringing a systematic, disciplined approach to evaluating and improving the effectiveness of risk management, control, and governance. Audits are broadly conducted in hospitals, but little is known about their effects on the behaviour of healthcare professionals and patient safety outcomes. This study was initiated to evaluate the effects of patient safety auditing in hospital care and to explore the processes and mechanisms underlying these effects. Our study aims to evaluate an audit system to monitor and improve patient safety in a hospital setting. We are using a mixed-method evaluation with a before-and-after study design in eight departments of one university hospital in the period October 2011-July 2014. We measure several outcomes 3 months before the audit and 15 months after the audit. The primary outcomes are adverse events and complications. The secondary outcomes are experiences of patients, the standardised mortality ratio, prolonged hospital stay, patient safety culture, and team climate. We use medical record reviews, questionnaires, hospital administrative data, and observations to assess the outcomes. A process evaluation will be used to find out which components of internal auditing determine the effects. We report a study protocol of an effect and process evaluation to determine whether auditing improves patient safety in hospital care. Because auditing is a complex intervention targeted on several levels, we are using a combination of methods to collect qualitative and quantitative data about patient safety at the patient, professional, and department levels. This study is relevant for hospitals that want to early detect unsafe care and improve patient safety continuously. Netherlands Trial Register (NTR): NTR3343.

Creating a Culture of Safety Around Bar-Code Medication Administration: An Evidence-Based Evaluation Framework.

PubMed

Kelly, Kandace; Harrington, Linda; Matos, Pat; Turner, Barbara; Johnson, Constance

2016-01-01

Bar-code medication administration (BCMA) effectiveness is contingent upon compliance with best-practice protocols. We developed a 4-phased BCMA evaluation program to evaluate the degree of integration of current evidence into BCMA policies, procedures, and practices; identify barriers to best-practice BCMA use; and modify BCMA practice in concert with changes to the practice environment. This program provides an infrastructure for frontline nurses to partner with hospital leaders to continually evaluate and improve BCMA using a systematic process.

Systematic Evaluation Program (SEP) at Rocky Flats Plant: An overview of practical management issues for evaluation of natural phenomena hazards

DOE Office of Scientific and Technical Information (OSTI.GOV)

Badwan, F.M.; Herring, K.S.

1993-08-01

Many of the buildings at the Rocky Flats Plant were designed and built before modern standards were developed, including standards for protection against extreme natural phenomenon such as tornadoes, earthquakes, and floods. The purpose of the SEP is to establish an integrated approach to assessing the design adequacy of specific high and moderate hazard Rocky Flats facilities from a safety perspective and to establish a basis for defining any needed facility improvements. The SEP is to be carried out in three Phases. In Phase 1, topics to be evaluated and an evaluation plan for each topic were developed. Any differencesmore » between Current Design Requirements (CDR) or acceptance criteria and the design of existing facilities, will be identified during Phase 2 and assessed using an integrated systematic approach during Phase 3. The integrated assessment performed during Phase 3 provides a process for evaluating the differences between existing facility design and CDRs so that decisions on corrective actions can be made on the basis of relative risk reduction and cost effectiveness. These efforts will ensure that a balanced and integrated level of safety is achieved for long-term operation of these buildings. Through appropriate selection of topics and identification of the structures, systems, and components to be evaluated, the SEP will address outstanding design issues related to the prevention and mitigation of design basis accidents, including those arising from natural phenomena. The objective of the SEP is not to bring these buildings into strict compliance with current requirements, but rather to ensure that an adequate level of safety is achieved in an economical fashion.« less

The risk of elevated prolactin levels in pediatric patients exposed to antipsychotics for the treatment of schizophrenia and schizophrenia spectrum disorders: protocol for a systematic review and meta-analysis

PubMed Central

2014-01-01

Background Antipsychotic medications, particularly second-generation antipsychotics, are increasingly being used to alleviate the symptoms of schizophrenia and other severe mental disorders in the pediatric population. While evidence-based approaches examining efficacy and safety outcomes have been reported, no review has evaluated prolactin-based adverse events for antipsychotic treatments in schizophrenia and schizophrenia spectrum disorders. Methods/design Searches involving MEDLINE, EMBASE, CENTRAL, PsycINFO, and clinical trial registries (ClinicalTrials.gov, Drug Industry Document Archive [DIDA], International Clinical Trials Registry Platform [ICTRP]) will be used to identify relevant studies. Two reviewers will independently screen abstracts and relevant full-text articles of the papers identified by the initial search according to the prospectively defined eligibility criteria. Data extraction will be conducted in duplicate independently. Pairwise random effects meta-analyses and network meta-analyses will be conducted on individual drug and class effects where appropriate. Discussion This systematic review will evaluate prolactin-based adverse events of first- and second-generation antipsychotics in the pediatric population with schizophrenia and schizophrenia spectrum disorders. It will also seek to strengthen the evidence base of the safety of antipsychotics by incorporating both randomized controlled trials and observational studies. Systematic review registration PROSPERO CRD42014009506 PMID:25312992

Safety of Patient Mobilization and Rehabilitation in the Intensive Care Unit. Systematic Review with Meta-Analysis.

PubMed

Nydahl, Peter; Sricharoenchai, Thiti; Chandra, Saurabh; Kundt, Firuzan Sari; Huang, Minxuan; Fischill, Magdalena; Needham, Dale M

2017-05-01

Early mobilization and rehabilitation of patients in intensive care units (ICUs) may improve physical function, and reduce the duration of delirium, mechanical ventilation, and ICU length of stay. However, safety concerns are an important barrier to widespread implementation. To synthesize safety data regarding patient mobilization and rehabilitation in the ICU, including falls, removal of endotracheal tubes, removal or dysfunction of intravascular catheters, removal of other catheters/tubes, cardiac arrest, hemodynamic changes, and desaturation. Systematic literature review, including searches of five databases. Eligible studies evaluated patients who received mobilization-related interventions in the ICU. Exclusion criteria included: (1) case series with fewer than 10 patients; (2) majority of patients under 18 years of age; and (3) data not reported to permit calculation of incidence of safety events. Number of patients, mobilization/rehabilitation sessions, potential safety events, and events with negative consequences (e.g., requiring intervention or additional therapy). Heterogeneity was assessed by I 2 statistics, and bias assessed by the Newcastle-Ottawa Scale and Cochrane risk of bias assessment. The literature search identified 20,660 titles. There were 48 eligible publications evaluating 7,546 patients, with 583 potential safety events occurring in 22,351 mobilization/rehabilitation sessions. There was a total of 583 (2.6%) potential safety events with heterogeneity in the definitions for these events. For the safety event types that could be meta-analyzed, pooled incidences per 1,000 mobilization/rehabilitation sessions (95% confidence interval), were: hemodynamic changes, 3.8 (1.3-11.4), and desaturation, 1.9 (0.9-4.3). A total of 24 studies of 3,404 patients reported on any consequences of potential safety events (e.g., needing to increase dose of vasopressor due to mobility-related hypotension), with a frequency of 0.6% in 14,398 mobilization/rehabilitation sessions. Patient mobilization and physical rehabilitation in the ICU appears safe, with a low incidence of potential safety events, and only rare events having any consequences for patient management. Heterogeneity in the definition of safety events across studies emphasizes the importance of implementing existing consensus-based definitions.

Canadian Association of Gastroenterology consensus guidelines on safety and quality indicators in endoscopy

PubMed Central

Armstrong, David; Barkun, Alan; Bridges, Ron; Carter, Rose; de Gara, Chris; Dubé, Catherine; Enns, Robert; Hollingworth, Roger; MacIntosh, Donald; Borgaonkar, Mark; Forget, Sylviane; Leontiadis, Grigorios; Meddings, Jonathan; Cotton, Peter; Kuipers, Ernst J; Valori, Roland

2012-01-01

BACKGROUND: Increasing use of gastrointestinal endoscopy, particularly for colorectal cancer screening, and increasing emphasis on health care quality, highlight the need for clearly defined, evidence-based processes to support quality improvement in endoscopy. OBJECTIVE: To identify processes and indicators of quality and safety relevant to high-quality endoscopy service delivery. METHODS: A multidisciplinary group of 35 voting participants developed recommendation statements and performance indicators. Systematic literature searches generated 50 initial statements that were revised iteratively following a modified Delphi approach using a web-based evaluation and voting tool. Statement development and evidence evaluation followed the AGREE (Appraisal of Guidelines, REsearch and Evaluation) and GRADE (Grading of Recommendations, Assessment, Development and Evaluation) guidelines. At the consensus conference, participants voted anonymously on all statements using a 6-point scale. Subsequent web-based voting evaluated recommendations for specific, individual quality indicators, safety indicators and mandatory endoscopy reporting fields. Consensus was defined a priori as agreement by 80% of participants. RESULTS: Consensus was reached on 23 recommendation statements addressing the following: ethics (statement 1: agreement 100%), facility standards and policies (statements 2 to 9: 90% to 100%), quality assurance (statements 10 to 13: 94% to 100%), training, education, competency and privileges (statements 14 to 19: 97% to 100%), endoscopy reporting standards (statements 20 and 21: 97% to 100%) and patient perceptions (statements 22 and 23: 100%). Additionally, 18 quality indicators (agreement 83% to 100%), 20 safety indicators (agreement 77% to 100%) and 23 recommended endoscopy-reporting elements (agreement 91% to 100%) were identified. DISCUSSION: The consensus process identified a clear need for high-quality clinical and outcomes research to support quality improvement in the delivery of endoscopy services. CONCLUSIONS: The guidelines support quality improvement in endoscopy by providing explicit recommendations on systematic monitoring, assessment and modification of endoscopy service delivery to yield benefits for all patients affected by the practice of gastrointestinal endoscopy. PMID:22308578

Evaluating the evidence for non-monotonic dose-response relationships: A systematic literature review and (re-)analysis of in vivo toxicity data in the area of food safety.

PubMed

Varret, C; Beronius, A; Bodin, L; Bokkers, B G H; Boon, P E; Burger, M; De Wit-Bos, L; Fischer, A; Hanberg, A; Litens-Karlsson, S; Slob, W; Wolterink, G; Zilliacus, J; Beausoleil, C; Rousselle, C

2018-01-15

This study aims to evaluate the evidence for the existence of non-monotonic dose-responses (NMDRs) of substances in the area of food safety. This review was performed following the systematic review methodology with the aim to identify in vivo studies published between January 2002 and February 2015 containing evidence for potential NMDRs. Inclusion and reliability criteria were defined and used to select relevant and reliable studies. A set of six checkpoints was developed to establish the likelihood that the data retrieved contained evidence for NMDR. In this review, 49 in vivo studies were identified as relevant and reliable, of which 42 were used for dose-response analysis. These studies contained 179 in vivo dose-response datasets with at least five dose groups (and a control group) as fewer doses cannot provide evidence for NMDR. These datasets were extracted and analyzed using the PROAST software package. The resulting dose-response relationships were evaluated for possible evidence of NMDRs by applying the six checkpoints. In total, 10 out of the 179 in vivo datasets fulfilled all six checkpoints. While these datasets could be considered as providing evidence for NMDR, replicated studies would still be needed to check if the results can be reproduced to rule out that the non-monotonicity was caused by incidental anomalies in that specific study. This approach, combining a systematic review with a set of checkpoints, is new and appears useful for future evaluations of the dose response datasets regarding evidence of non-monotonicity. Published by Elsevier Inc.

Efficacy and safety of rituximab in pemphigus: experience of the German Registry of Autoimmune Diseases.

PubMed

Kasperkiewicz, Michael; Eming, Rüdiger; Behzad, Melika; Hunzelmann, Nicolas; Meurer, Michael; Schulze-Koops, Hendrik; von Wussow, Peter; Hertl, Michael; Zillikens, Detlef; Freivogel, Klaus; Dörner, Thomas; Schmidt, Enno

2012-10-01

Rituximab has been reported to be effective in various small case series of patients with severe and/or refractory pemphigus. However, no systematic evaluation is available to corroborate this observation. The aim of this study was to systematically determine efficacy and safety of rituximab in treatment-resistant pemphigus. Multicenter retrospective, observational study of 36 patients with severe pemphigus vulgaris (n = 33) and pemphigus foliaceus (n = 3) treated with rituximab before August 31(st) , 2008 and enrolled in a national observational registery between December 2008 and June 2009. Within a mean period of observation of 11 (1-37) months, 21 (58 %) pemphigus patients showed complete, 13 (36 %) partial, and 2 (6 %) no response to rituximab treatment. This correlates with a mean improvement of the visual analog scale for well-being of 34 (20-60) at baseline to 75 (40-95) at the last control visit. In 4 (11 %) patients, severe adverse events were recorded including 1 (3 %) serious infection. Data collected in this systematic registry indicate that rituximab is an effective and relatively safe adjuvant treatment option for refractory pemphigus. To further extend our knowledge on efficacy and safety of this drug, controlled prospective trials are required. © The Authors • Journal compilation © Blackwell Verlag GmbH, Berlin.

Performance Evaluation and Analysis of Rural Drinking Water Safety Project——A Case Study in Jiangsu, China

NASA Astrophysics Data System (ADS)

Du, Xiaorong

2017-04-01

Water is the basic condition for human survival and development. As China is the most populous country, rural drinking water safety problems are most conspicuous. Therefore, the Chinese government keeps increasing investment and has built a large number of rural drinking water safety projects. Scientific evaluation of project performance is of great significance to promote the sustainable operation of the project and the sustainable development of rural economy. Previous studies mainly focus on the economic benefits of the project, while ignoring the fact that the rural drinking water safety project is quasi-public goods, which has economic, social and ecological benefits. This paper establishes a comprehensive evaluation model for rural drinking water safety performance, which adapts the rules of "5E" (economy, efficiency, effectiveness, equity and environment) as the value orientation, and selects a rural drinking water safety project as object in case study at K District, which is in the north of Jiangsu Province, China. The results shows: 1) the comprehensive performance of K project is in good condition; 2) The performance of every part shows that the scores of criteria "efficiency", "environment" and "effect" are higher than the mean performance, while the "economy" is slightly lower than the mean and the "equity" is the lowest. 3) The performance of indicator layer shows that: the planned completion rate of project, the reduction rate of project cost and the penetration rate of water-use population are significantly lower than other indicators. Based on the achievements of previous studies and the characteristics of rural drinking water safety project, this study integrates the evaluation dimensions of equity and environment, which can contribute to a more comprehensive and systematic assessment of project performance and provide empirical data for performance evaluation and management of rural drinking water safety project. Key Words: Rural drinking water safety project; Performance evaluation; 5E rules; Comprehensive evaluation model

Systematic review and meta-analysis of the efficacy and safety of alendronate and zoledronate for the treatment of postmenopausal osteoporosis.

PubMed

Serrano, Ana Julissa; Begoña, Leire; Anitua, Eduardo; Cobos, Raquel; Orive, Gorka

2013-12-01

The aim of this meta-analysis was to evaluate the efficacy and safety of two bisphosphonates (alendronate and zoledronate) in the treatment of postmenopausal osteoporosis. The incidence of fractures was considered as primary endpoint. Only randomized trials with a follow-up period of 1 year or more were included in this systematic review and meta-analysis. We excluded studies that included patients with secondary osteoporosis especially in relation to therapy with corticosteroids or other drugs or diseases known to affect bone mineral density. Studies published as subgroup analysis, extension studies, economic evaluations, and comparisons with active control were excluded. The methodological quality of controlled clinical trials that met these inclusion criteria was evaluated. No studies were excluded from analysis due to lack of quality. The risk ratio of hip, vertebral and wrist fractures for alendronate were 0.61 [95% confidence interval (CI) 0.40-0.93], 0.54 (95% CI 0.44-0.66) and 0.65 (95% CI 0.33-1.25), respectively. Zoledronate risk ratio was 0.62 (95% CI 0.46-0.82) and 0.38 (95% CI 0.22-0.67) for hip and vertebral fractures, respectively.

Patient safety, quality of care, and knowledge translation in the intensive care unit.

PubMed

Needham, Dale M

2010-07-01

A large gap exists between the completion of clinical research demonstrating the benefit of new treatment interventions and improved patient outcomes resulting from implementation of these interventions as part of routine clinical practice. This gap clearly affects patient safety and quality of care. Knowledge translation is important for addressing this gap, but evaluation of the most appropriate and effective knowledge translation methods is still ongoing. Through describing one model for knowledge translation and an example of its implementation, insights can be gained into systematic methods for advancing the implementation of evidence-based interventions to improve safety, quality, and patient outcomes.

First, keep it safe: Integration of a complementary medicine service within a hospital.

PubMed

Schiff, Elad; Levy, Ilana; Arnon, Zahi; Ben-Arye, Eran; Attias, Samuel

2018-05-01

This paper sought to explore risk/safety considerations associated with the integration of a complementary medicine (CM) service within a public academic medical centre in Israel. We reviewed various sources pertaining to the CM service (interviews with CM staff, patients' electronic charts, service guidelines, correspondence with hospital administration) and conducted a thematic analysis to evaluate safety-related incidents during the 7 years of operation. In addition, we systematically assessed the charts for reports of treatment-associated adverse effects, which were documented in an obligatory field on treatment reports. After reviewing transcripts of interviews with 12 CM practitioners and with the director and vice-director of the CM service as well as transcripts of 8560 consultations that included 7383 treatments, we categorised 3 major domains of CM safety management: (i) prevention of safety-related incidents by appropriate selection of CM practitioners and modalities, (ii) actual adverse incidents and (iii) prevention of their recurrence using both hospital and CM service safety protocols. CM staff reported 5 categories of adverse incidents, most of which were minor. Twenty-nine adverse incidents were documented in the 7383 treatment sessions (0.4%). Safety management needs to be addressed both before introducing CM services in hospitals and throughout their integration. Important considerations for the safe integration of CM practices in the hospital include communication between CM and conventional practitioners, adherence to hospital safety rules, implementing a systematic approach for detecting and reporting safety-related incidents and continuous adaptation of the CM service safety protocols. © 2018 John Wiley & Sons Ltd.

Prospective safety performance evaluation on construction sites.

PubMed

Wu, Xianguo; Liu, Qian; Zhang, Limao; Skibniewski, Miroslaw J; Wang, Yanhong

2015-05-01

This paper presents a systematic Structural Equation Modeling (SEM) based approach for Prospective Safety Performance Evaluation (PSPE) on construction sites, with causal relationships and interactions between enablers and the goals of PSPE taken into account. According to a sample of 450 valid questionnaire surveys from 30 Chinese construction enterprises, a SEM model with 26 items included for PSPE in the context of Chinese construction industry is established and then verified through the goodness-of-fit test. Three typical types of construction enterprises, namely the state-owned enterprise, private enterprise and Sino-foreign joint venture, are selected as samples to measure the level of safety performance given the enterprise scale, ownership and business strategy are different. Results provide a full understanding of safety performance practice in the construction industry, and indicate that the level of overall safety performance situation on working sites is rated at least a level of III (Fair) or above. This phenomenon can be explained that the construction industry has gradually matured with the norms, and construction enterprises should improve the level of safety performance as not to be eliminated from the government-led construction industry. The differences existing in the safety performance practice regarding different construction enterprise categories are compared and analyzed according to evaluation results. This research provides insights into cause-effect relationships among safety performance factors and goals, which, in turn, can facilitate the improvement of high safety performance in the construction industry. Copyright © 2015 Elsevier Ltd. All rights reserved.

Kombucha: a systematic review of the clinical evidence.

PubMed

Ernst, E

2003-04-01

Kombucha has become a popular complementary remedy. The aim of this systematic review was to critically evaluate the evidence related to its efficacy and safety. Computerised literature searches were carried out to locate all human medical investigations of kombucha regardless of study design. Data were extracted and validated by the present author and are reported in narrative form. No clinical studies were found relating to the efficacy of this remedy. Several case reports and case series raise doubts about the safety of kombucha. They include suspected liver damage, metabolic acidosis and cutaneous anthrax infections. One fatality is on record. On the basis of these data it was concluded that the largely undetermined benefits do not outweigh the documented risks of kombucha. It can therefore not be recommended for therapeutic use. Copyright 2003 S. Karger GmbH, Freiburg

Towards a better reliability of risk assessment: development of a qualitative & quantitative risk evaluation model (Q2REM) for different trades of construction works in Hong Kong.

PubMed

Fung, Ivan W H; Lo, Tommy Y; Tung, Karen C F

2012-09-01

Since the safety professionals are the key decision makers dealing with project safety and risk assessment in the construction industry, their perceptions of safety risk would directly affect the reliability of risk assessment. The safety professionals generally tend to heavily rely on their own past experiences to make subjective decisions on risk assessment without systematic decision making. Indeed, understanding of the underlying principles of risk assessment is significant. In this study, the qualitative analysis on the safety professionals' beliefs of risk assessment and their perceptions towards risk assessment, including their recognitions of possible accident causes, the degree of differentiations on their perceptions of risk levels of different trades of works, recognitions of the occurrence of different types of accidents, and their inter-relationships with safety performance in terms of accident rates will be explored in the Stage 1. At the second stage, the deficiencies of the current general practice for risk assessment can be sorted out firstly. Based on the findings from Stage 1 and the historical accident data from 15 large-scaled construction projects in 3-year average, a risk evaluation model prioritizing the risk levels of different trades of works and which cause different types of site accident due to various accident causes will be developed quantitatively. With the suggested systematic accident recording techniques, this model can be implemented in the construction industry at both project level and organizational level. The model (Q(2)REM) not only act as a useful supplementary guideline of risk assessment for the construction safety professionals, but also assists them to pinpoint the potential risks on site for the construction workers under respective trades of works through safety trainings and education. It, in turn, arouses their awareness on safety risk. As the Q(2)REM can clearly show the potential accident causes leading to different types of accident by trade of works, it helps the concerned safety professionals and parties to plan effective accident prevention measures with reference to the priority of the risk levels. Copyright © 2011 Elsevier Ltd. All rights reserved.

Tranexamic acid in epistaxis: a systematic review.

PubMed

Kamhieh, Y; Fox, H

2016-12-01

The role of tranexamic acid in the management of epistaxis remains unclear. There is uncertainty about its safety and about the contraindications for its use. We performed a systematic review of the use of systemic and topical tranexamic acid in epistaxis and a comparative review of its use in other specialties. This review assesses and summarises the existing evidence for the efficacy and safety of tranexamic acid in the management of epistaxis. Systematic review. MEDLINE and EMBASE were searched for 'epistaxis' and equivalent MESH terms, combined with the Boolean operator 'OR' and 'tranexamic acid'. The Cochrane library and society guidelines were reviewed for evidence regarding the use of tranexamic acid in other specialties. All five relevant RCTs were included in the review and were evaluated according to the recommendations of the Cochrane Handbook for Systematic Reviews. Three RCTS pertained to spontaneous epistaxis; of these, one trial found no benefit of oral tranexamic acid in acute epistaxis, one trial found no significant benefit of topical tranexamic acid, but the largest of the trials showed significant benefit of topical tranexamic acid in acute epistaxis management. Two RCTs examined oral tranexamic acid for prophylaxis of recurrent epistaxes in patients with hereditary haemorrhagic telangiectasia; both showed significant reduction in severity and frequency. Tranexamic acid, as a WHO 'essential medicine', is a powerful, readily available tool, the use of which in epistaxis has been limited by uncertainty over its efficacy and its safety profile. This systematic review summarises the existing evidence and extrapolates from the wealth of data for other specialties to address the clinical question - does TXA have a role in epistaxis management? © 2016 John Wiley & Sons Ltd.

[Monitoring evaluation system for high-specialty hospitals].

PubMed

Fajardo Dolci, Germán; Aguirre Gas, Héctor G; Robledo Galván, Héctor

2011-01-01

Hospital evaluation is a fundamental process to identify medical units' objective compliance, to analyze efficiency of resource use and allocation, institutional values and mission alignment, patient safety and quality standards, contributions to research and medical education, and the degree of coordination among medical units and the health system as a whole. We propose an evaluation system for highly specialized regional hospitals through the monitoring of performance indicators. The following are established as base thematic elements in the construction of indicators: safe facilities and equipment, financial situation, human resources management, policy management, organizational climate, clinical activity, quality and patient safety, continuity of care, patients' and providers' rights and obligations, teaching, research, social responsibility, coordination mechanisms. Monitoring refers to the planned and systematic evaluation of valid and reliable indicators, aimed at identifying problems and opportunity areas. Moreover, evaluation is a powerful tool to strengthen decision-making and accountability in medical units.

You can't improve what you don't measure: Safety climate measures available in the German-speaking countries to support safety culture development in healthcare.

PubMed

Manser, Tanja; Brösterhaus, Mareen; Hammer, Antje

2016-01-01

Safety climate measurement is a key input into safety culture development. The aim of this review is to provide an overview of the safety climate measures that have been evaluated for their psychometric properties in a German-speaking country and to make recommendations on how to use them in quality and patient safety improvement. A systematic search strategy was implemented to obtain relevant articles. PubMed and Web of Science databases were searched, and 128 abstracts were identified. After application of limits, 33 full texts were retrieved for subsequent evaluation. Studies were included on the basis of predetermined inclusion criteria and independent assessment by two reviewers. Publications were reviewed concerning healthcare setting, target group, safety culture dimensions covered and results of their psychometric evaluation. This review identified 11 instruments for safety climate assessment in different healthcare settings (i. e. hospitals, nursing homes, primary care, dental care and community pharmacy) for which acceptable to good internal consistency was reported. We observed wide variability concerning the number of dimensions (1 to 14; in some cases including outcome dimensions) and items (9 to 128) that the instruments were comprised of. Nevertheless, consistency with regard to the thematic areas covered was rather high. While there is clear evidence that we can assess safety climate in healthcare, the application of safety climate measures by quality and patient safety practitioners has so far been rather limited. This review bridges this gap between research and improvement practice by highlighting the central role of safety climate assessment in a mixed methods approach to inform safety culture development. Copyright © 2016. Published by Elsevier GmbH.

Patient Safety Learning Systems: A Systematic Review and Qualitative Synthesis.

PubMed

2017-01-01

A patient safety learning system (sometimes called a critical incident reporting system) refers to structured reporting, collation, and analysis of critical incidents. To inform a provincial working group's recommendations for an Ontario Patient Safety Event Learning System, a systematic review was undertaken to determine design features that would optimize its adoption into the health care system and would inform implementation strategies. The objective of this review was to address two research questions: (a) what are the barriers to and facilitators of successful adoption of a patient safety learning system reported by health professionals and (b) what design components maximize successful adoption and implementation? To answer the first question, we used a published systematic review. To answer the second question, we used scoping study methodology. Common barriers reported in the literature by health care professionals included fear of blame, legal penalties, the perception that incident reporting does not improve patient safety, lack of organizational support, inadequate feedback, lack of knowledge about incident reporting systems, and lack of understanding about what constitutes an error. Common facilitators included a non-accusatory environment, the perception that incident reporting improves safety, clarification of the route of reporting and of how the system uses reports, enhanced feedback, role models (such as managers) using and promoting reporting, legislated protection of those who report, ability to report anonymously, education and training opportunities, and clear guidelines on what to report. Components of a patient safety learning system that increased successful adoption and implementation were emphasis on a blame-free culture that encourages reporting and learning, clear guidelines on how and what to report, making sure the system is user-friendly, organizational development support for data analysis to generate meaningful learning outcomes, and multiple mechanisms to provide feedback through routes to reporters and the wider community (local meetings, email alerts, bulletins, paper contributions, etc.). The design of a patient safety learning system can be optimized by an awareness of the barriers to and facilitators of successful adoption and implementation identified by health care professionals. Evaluation of the effectiveness of a patient safety learning system is needed to refine its design.

Innovative Training for Occupational Health and Infection Control Workplace Assessment in Health Care

ERIC Educational Resources Information Center

O'Hara, Lyndsay; Bryce, Elizabeth Ann; Scharf, Sydney; Yassi, Annalee

2012-01-01

A user-friendly, high quality workplace assessment field guide and an accompanying worksheet are invaluable tools for recognizing hazards in the hospital environment. These tools ensure that both front line workers as well as health and safety and infection control professionals can systematically evaluate hazards and formulate recommendations.…

Influence of organizational factors on safety

DOE Office of Scientific and Technical Information (OSTI.GOV)

Haber, S.B.; Metlay, D.S.; Crouch, D.A.

There is a need for a better understanding of exactly how organizational management factors at a nuclear power plant (NPP) affect plant safety performance, either directly or indirectly, and how these factors might be observed, measured, and evaluated. The purpose of this research project is to respond to that need by developing a general methodology for characterizing these organizational and management factors, systematically collecting information on their status and integrating that information into various types of evaluative activities. Research to date has included the development of the Nuclear Organization and Management Analysis Concept (NOMAC) of a NPP, the identification ofmore » key organizational and management factors, and the identification of the methods for systematically measuring and analyzing the influence of these factors on performance. Most recently, two field studies, one at a fossil fuel plant and the other at a NPP, were conducted using the developed methodology. Results are presented from both studies highlighting the acceptability, practicality, and usefulness of the methods used to assess the influence of various organizational and management factors including culture, communication, decision-making, standardization, and oversight. 6 refs., 3 figs., 1 tab.« less

Effects of health information technology on patient outcomes: a systematic review.

PubMed

Brenner, Samantha K; Kaushal, Rainu; Grinspan, Zachary; Joyce, Christine; Kim, Inho; Allard, Rhonda J; Delgado, Diana; Abramson, Erika L

2016-09-01

To systematically review studies assessing the effects of health information technology (health IT) on patient safety outcomes. The authors employed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement methods. MEDLINE, Cumulative Index to Nursing Allied Health (CINAHL), EMBASE, and Cochrane Library databases, from 2001 to June 2012, were searched. Descriptive and comparative studies were included that involved use of health IT in a clinical setting and measured effects on patient safety outcomes. Data on setting, subjects, information technology implemented, and type of patient safety outcomes were all abstracted. The quality of the studies was evaluated by 2 independent reviewers (scored from 0 to 10). A total of 69 studies met inclusion criteria. Quality scores ranged from 1 to 9. There were 25 (36%) studies that found benefit of health IT on direct patient safety outcomes for the primary outcome measured, 43 (62%) studies that either had non-significant or mixed findings, and 1 (1%) study for which health IT had a detrimental effect. Neither the quality of the studies nor the rate of randomized control trials performed changed over time. Most studies that demonstrated a positive benefit of health IT on direct patient safety outcomes were inpatient, single-center, and either cohort or observational trials studying clinical decision support or computerized provider order entry. Many areas of health IT application remain understudied and the majority of studies have non-significant or mixed findings. Our study suggests that larger, higher quality studies need to be conducted, particularly in the long-term care and ambulatory care settings. © The Author 2015. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Systematic impact of institutional pressures on safety climate in the construction industry.

PubMed

He, Qinghua; Dong, Shuang; Rose, Timothy; Li, Heng; Yin, Qin; Cao, Dongping

2016-08-01

This paper explores how three types of institutional pressure (i.e., coercive, mimetic and normative pressures) systematically impact on the safety climate of construction projects. These impacts are empirically tested by survey data collected from 186 questionnaires of construction companies operating in Shanghai, China. The results, obtained by partial least squares analysis, show that organizational management commitment to safety and employee involvement is positively related to all three institutional pressures, while the perception of responsibility for safety and health is significantly influenced by coercive and mimetic pressure. However, coercive and normative pressures have no significant effect on the applicability of safety rules and work practices, revealing the importance of external organizational pressures in improving project safety climate from a systematic view. The findings also provide insights into the use of institutional forces to facilitate the improvement of safety climate in the construction industry. Copyright © 2015 Elsevier Ltd. All rights reserved.

Systematic drug safety evaluation based on public genomic expression (Connectivity Map) data: Myocardial and infectious adverse reactions as application cases

DOE Office of Scientific and Technical Information (OSTI.GOV)

Wang, Kejian, E-mail: kejian.wang.bio@gmail.com; Weng, Zuquan; Sun, Liya

Adverse drug reaction (ADR) is of great importance to both regulatory agencies and the pharmaceutical industry. Various techniques, such as quantitative structure–activity relationship (QSAR) and animal toxicology, are widely used to identify potential risks during the preclinical stage of drug development. Despite these efforts, drugs with safety liabilities can still pass through safety checkpoints and enter the market. This situation raises the concern that conventional chemical structure analysis and phenotypic screening are not sufficient to avoid all clinical adverse events. Genomic expression data following in vitro drug treatments characterize drug actions and thus have become widely used in drug repositioning. Inmore » the present study, we explored prediction of ADRs based on the drug-induced gene-expression profiles from cultured human cells in the Connectivity Map (CMap) database. The results showed that drugs inducing comparable ADRs generally lead to similar CMap expression profiles. Based on such ADR-gene expression association, we established prediction models for various ADRs, including severe myocardial and infectious events. Drugs with FDA boxed warnings of safety liability were effectively identified. We therefore suggest that drug-induced gene expression change, in combination with effective computational methods, may provide a new dimension of information to facilitate systematic drug safety evaluation. - Highlights: • Drugs causing common toxicity lead to similar in vitro gene expression changes. • We built a model to predict drug toxicity with drug-specific expression profiles. • Drugs with FDA black box warnings were effectively identified by our model. • In vitro assay can detect severe toxicity in the early stage of drug development.« less

DOE Office of Scientific and Technical Information (OSTI.GOV)

Ohi, J.

Supporting analysis and assessments can provide a sound analytic foundation and focus for program planning, evaluation, and coordination, particularly if issues of hydrogen production, distribution, storage, safety, and infrastructure can be analyzed in a comprehensive and systematic manner. The overall purpose of this activity is to coordinate all key analytic tasks-such as technology and market status, opportunities, and trends; environmental costs and benefits; and regulatory constraints and opportunities-within a long-term and systematic analytic foundation for program planning and evaluation. Within this context, the purpose of the project is to help develop and evaluate programmatic pathway options that incorporate near andmore » mid-term strategies to achieve the long-term goals of the Hydrogen Program. In FY 95, NREL will develop a comprehensive effort with industry, state and local agencies, and other federal agencies to identify and evaluate programmatic pathway options to achieve the long-term goals of the Program. Activity to date is reported.« less

Interventions to reduce medication errors in neonatal care: a systematic review

PubMed Central

Nguyen, Minh-Nha Rhylie; Mosel, Cassandra

2017-01-01

Background: Medication errors represent a significant but often preventable cause of morbidity and mortality in neonates. The objective of this systematic review was to determine the effectiveness of interventions to reduce neonatal medication errors. Methods: A systematic review was undertaken of all comparative and noncomparative studies published in any language, identified from searches of PubMed and EMBASE and reference-list checking. Eligible studies were those investigating the impact of any medication safety interventions aimed at reducing medication errors in neonates in the hospital setting. Results: A total of 102 studies were identified that met the inclusion criteria, including 86 comparative and 16 noncomparative studies. Medication safety interventions were classified into six themes: technology (n = 38; e.g. electronic prescribing), organizational (n = 16; e.g. guidelines, policies, and procedures), personnel (n = 13; e.g. staff education), pharmacy (n = 9; e.g. clinical pharmacy service), hazard and risk analysis (n = 8; e.g. error detection tools), and multifactorial (n = 18; e.g. any combination of previous interventions). Significant variability was evident across all included studies, with differences in intervention strategies, trial methods, types of medication errors evaluated, and how medication errors were identified and evaluated. Most studies demonstrated an appreciable risk of bias. The vast majority of studies (>90%) demonstrated a reduction in medication errors. A similar median reduction of 50–70% in medication errors was evident across studies included within each of the identified themes, but findings varied considerably from a 16% increase in medication errors to a 100% reduction in medication errors. Conclusion: While neonatal medication errors can be reduced through multiple interventions aimed at improving the medication use process, no single intervention appeared clearly superior. Further research is required to evaluate the relative cost-effectiveness of the various medication safety interventions to facilitate decisions regarding uptake and implementation into clinical practice. PMID:29387337

Efficacy and Safety of Remifentanil as an Alternative Labor Analgesic

PubMed Central

Devabhakthuni, Sandeep

2013-01-01

The objective of this review was to evaluate the clinical efficacy and safety of remifentanil in the management of labor pain. Although neuraxial analgesia is the best option during labor, alternative analgesic options are needed for patients with contraindications. Using a systematic literature search, clinical outcomes of remifentanil for labor pain have been summarized. Also, comparisons of remifentanil to other options including meperidine, epidural analgesia, fentanyl, and nitrous oxide are provided. Based on the literature review, remifentanil is associated with high overall maternal satisfaction and favorable side-effect profile. However, due to the low reporting of adverse events, large, randomized controlled trials are needed to evaluate maternal and neonatal safety adequately and determine the optimal dosing needed to provide effective analgesia. While remifentanil is a feasible alternative for patients who cannot or do not want to receive epidural analgesia, administration should be monitored closely for potential adverse effects. PMID:24665213

Health, safety, and environmental management system operation in contracting companies: A case study.

PubMed

Nassiri, Parvin; Yarahmadi, Rasoul; Gholami, Pari Shafaei; Hamidi, Abdolamir; Mirkazemi, Roksana

2016-05-03

Systematic and cooperative interactions among parent industry and contractors are necessary for a successful health, safety, and environmental management system (HSE-MS). This study was conducted to evaluate the HSE-MS performance in contracting companies in one of the petrochemical industries in Iran during 2013. Managers of parent and contracting companies participated in this study. The data collection forms included 7 elements of an integrated HSE-MS (leadership and commitment; policy and strategic objectives; organization, resources, and documentation; evaluation and risk management; planning; implementation and monitoring; auditing and reviewing). The results showed that mean percentage of the total scores in seven elements of HSE-MS was 85.7% and 87.0% based on self-report and report of parent company, respectively. In conclusion, this study showed that HSE-MS was desirably functioning; however, improvement to ensure health and safety of workers is still required.

Danshen injection as adjuvant treatment for unstable angina pectoris: A systematic review and meta-analysis.

PubMed

Wu, Jia-Rui; Liu, Shi; Zhang, Xiao-Meng; Zhang, Bing

2017-04-01

To systematically evaluate the clinical effectiveness and safety of Danshen Injection (, DS) as one adjuvant treatment for conventional therapy with Western medicine (WM) for unstable angina pectoris (UAP). Using literature databases, a thorough and systematic retrieval of randomized controlled trials (RCTs) comparing DS plus WM with WM was conducted from inception to April 2015. The extracted data from included studies was analyzed by Review Manager 5.2 software. The Cochrane risk of bias tool was used to assess the quality of included studies, and Begg's and Egger's tests conducted by Stata 12.0 were used to evaluate the potential presence of publication bias. A total of 17 RCTs, which involving 1,433 participants, were identified and reviewed. The meta-analysis indicated that the combined use of DS and WM was significantly superior to WM alone for UAP in terms of the total effectiveness rate of angina pectoris [risk ratio (RR) =1.23, 95% confidence interval (CI): 1.17, 1.29, P<0.01] and the total effectiveness rate of electrocardiogram (ECG) [RR=1.18, 95%CI: 1.06, 1.30, P=0.001]. Additionally, DS could also further reduce the content of fibrinogen, adjust blood lipid level, correct T wave inversion, and so on. Fifteen adverse drug reactions were reported in two studies, Four of which appeared in the experimental group. Based on the systematic review, the combined use of DS and WM was more effective than WM alone, it can be further widely used in clinic, however, there was no exact conclusion for its safety.

A systematic checklist approach to immunosuppression risk management: An audit of practice at two clinical neuroimmunology centers.

PubMed

Mori, Amelia M; Agarwal, Smriti; Lee, Monique W M; Rafferty, Martina; Hardy, Todd A; Coles, Alasdair; Reddel, Stephen W; Riminton, D Sean

2017-11-15

There is no consensus approach to safety screening for immune intervention in clinical neuroimmunology. An immunosuppression risk evaluation checklist was used as an audit tool to assess real-world immunosuppression risk management and formulate recommendations for quality improvements in patient safety. Ninety-nine patients from two centres with 27 non-MS diagnoses were included. An average of 1.9 comorbidities with the potential to adversely impact morbidity and mortality associated with immunosuppression were identified. Diabetes and smoking were the most common, however a range of rarer but potentially life-threatening co-morbid disorders in the context of immunosuppression were identified. Inadequate documentation of risk mitigation tasks was common at 40.1% of total tasks across both cohorts. A routine, systematic immunosuppression checklist approach should be considered to improve immunosuppression risk management in clinical neuroimmunology practice. Copyright © 2017 Elsevier B.V. All rights reserved.

Biodegradable stents for the treatment of refractory or recurrent benign esophageal stenosis.

PubMed

Imaz-Iglesia, Iñaki; García-Pérez, Sonia; Nachtnebel, Anna; Martín-Águeda, Belén; Sánchez-Piedra, Carlos; Karadayi, Bilgehan; Demirbaş, Ali Rıza

2016-06-01

Esophageal stents are used for the treatment of refractory and recurrent dyphagias. In 2007, esophageal biodegradable stents (EBS) were authorised as an alternative to existing metal and plastic stents in Europe. The advantages claimed for EBS are fewer complications concerning tissue ingrowth, stent migration and stent removal. We performed a systematic review to evaluate the efficacy and safety of EBS compared to fully-covered self-expanding metal stents, self-expanding plastic stents, and esophageal dilation for the treatment of refractory or recurrent benign esophageal stenosis. Three comparative studies (one randomized controlled trial and two cohort studies) were assessed. The studies used different inclusion criteria, had a very small (sample) size and the quality of the evidence was very low. Expert commentary: The current evidence is insufficient to determine the relative efficacy or safety of esophageal biodegradable stents. The results of this systematic review should be updated once new evidence is available.

Accident analysis and control options in support of the sludge water system safety analysis

DOE Office of Scientific and Technical Information (OSTI.GOV)

HEY, B.E.

A hazards analysis was initiated for the SWS in July 2001 (SNF-8626, K Basin Sludge and Water System Preliminary Hazard Analysis) and updated in December 2001 (SNF-10020 Rev. 0, Hazard Evaluation for KE Sludge and Water System - Project A16) based on conceptual design information for the Sludge Retrieval System (SRS) and 60% design information for the cask and container. SNF-10020 was again revised in September 2002 to incorporate new hazards identified from final design information and from a What-if/Checklist evaluation of operational steps. The process hazards, controls, and qualitative consequence and frequency estimates taken from these efforts have beenmore » incorporated into Revision 5 of HNF-3960, K Basins Hazards Analysis. The hazards identification process documented in the above referenced reports utilized standard industrial safety techniques (AIChE 1992, Guidelines for Hazard Evaluation Procedures) to systematically guide several interdisciplinary teams through the system using a pre-established set of process parameters (e.g., flow, temperature, pressure) and guide words (e.g., high, low, more, less). The teams generally included representation from the U.S. Department of Energy (DOE), K Basins Nuclear Safety, T Plant Nuclear Safety, K Basin Industrial Safety, fire protection, project engineering, operations, and facility engineering.« less

Occupational safety and health as an element of a complex compensation system evaluation within an organization.

PubMed

Beck-Krala, Ewa; Klimkiewicz, Katarzyna

2016-12-01

Occupational safety and health (OSH) plays a significant role in today's organizations, because it helps in attracting and retaining employees as well as molding their attitudes and behaviors at work. This is why the issue of OSH is stressed in a comprehensive approach to employee rewards: the total reward concept. This article explains how OSH may be included in a complex evaluation process of the compensation system. Although the literature on the effectiveness of employee compensation refers mainly to financial and non-financial components, there is a need for inclusion of working conditions in such analyses. An evaluation of the compensation system that incorporates OSH can drive many benefits for both the organization and employees. Obtaining such benefits, however, requires systematic evaluation of the reward system, including OSH. Incorporation of OSH issue within the comprehensive analysis of compensation systems promotes responsible behavior of all stakeholders.

The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: explanation and elaboration

PubMed Central

Liberati, Alessandro; Altman, Douglas G; Tetzlaff, Jennifer; Mulrow, Cynthia; Gøtzsche, Peter C; Ioannidis, John P A; Clarke, Mike; Devereaux, P J; Kleijnen, Jos; Moher, David

2009-01-01

Systematic reviews and meta-analyses are essential to summarise evidence relating to efficacy and safety of healthcare interventions accurately and reliably. The clarity and transparency of these reports, however, are not optimal. Poor reporting of systematic reviews diminishes their value to clinicians, policy makers, and other users. Since the development of the QUOROM (quality of reporting of meta-analysis) statement—a reporting guideline published in 1999—there have been several conceptual, methodological, and practical advances regarding the conduct and reporting of systematic reviews and meta-analyses. Also, reviews of published systematic reviews have found that key information about these studies is often poorly reported. Realising these issues, an international group that included experienced authors and methodologists developed PRISMA (preferred reporting items for systematic reviews and meta-analyses) as an evolution of the original QUOROM guideline for systematic reviews and meta-analyses of evaluations of health care interventions. The PRISMA statement consists of a 27-item checklist and a four-phase flow diagram. The checklist includes items deemed essential for transparent reporting of a systematic review. In this explanation and elaboration document, we explain the meaning and rationale for each checklist item. For each item, we include an example of good reporting and, where possible, references to relevant empirical studies and methodological literature. The PRISMA statement, this document, and the associated website (www.prisma-statement.org/) should be helpful resources to improve reporting of systematic reviews and meta-analyses. PMID:19622552

Efficacy and safety of miconazole for oral candidiasis: a systematic review and meta-analysis.

PubMed

Zhang, L-W; Fu, J-Y; Hua, H; Yan, Z-M

2016-04-01

The objective of this study is to assess the efficacy and safety of miconazole for treating oral candidiasis. Twelve electronic databases were searched for randomized controlled trials evaluating treatments for oral candidiasis and complemented by hand searching. The clinical and mycological outcomes, as well as adverse effects, were set as the primary outcome criteria. Seventeen trials were included in this review. Most studies were considered to have a high or moderate level of bias. Miconazole was more effective than nystatin for thrush. For HIV-infected patients, there was no significant difference in the efficacy between miconazole and other antifungals. For denture wearers, microwave therapy was significantly better than miconazole. No significant difference was found in the safety evaluation between miconazole and other treatments. The relapse rate of miconazole oral gel may be lower than that of other formulations. This systematic review and meta-analysis indicated that miconazole may be an optional choice for thrush. Microwave therapy could be an effective adjunct treatment for denture stomatitis. Miconazole oral gel may be more effective than other formulations with regard to long-term results. However, future studies that are adequately powered, large-scale, and well-designed are needed to provide higher-quality evidence for the management of oral candidiasis. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Application of patient safety indicators internationally: a pilot study among seven countries.

PubMed

Drösler, Saskia E; Klazinga, Niek S; Romano, Patrick S; Tancredi, Daniel J; Gogorcena Aoiz, Maria A; Hewitt, Moira C; Scobie, Sarah; Soop, Michael; Wen, Eugene; Quan, Hude; Ghali, William A; Mattke, Soeren; Kelley, Edward

2009-08-01

To explore the potential for international comparison of patient safety as part of the Health Care Quality Indicators project of the Organization for Economic Co-operation and Development (OECD) by evaluating patient safety indicators originally published by the US Agency for Healthcare Research and Quality (AHRQ). A retrospective cross-sectional study. Acute care hospitals in the USA, UK, Sweden, Spain, Germany, Canada and Australia in 2004 and 2005/2006. Routine hospitalization-related administrative data from seven countries were analyzed. Using algorithms adapted to the diagnosis and procedure coding systems in place in each country, authorities in each of the participating countries reported summaries of the distribution of hospital-level and overall (national) rates for each AHRQ Patient Safety Indicator to the OECD project secretariat. Each country's vector of national indicator rates and the vector of American patient safety indicators rates published by AHRQ (and re-estimated as part of this study) were highly correlated (0.821-0.966). However, there was substantial systematic variation in rates across countries. This pilot study reveals that AHRQ Patient Safety Indicators can be applied to international hospital data. However, the analyses suggest that certain indicators (e.g. 'birth trauma', 'complications of anesthesia') may be too unreliable for international comparisons. Data quality varies across countries; undercoding may be a systematic problem in some countries. Efforts at international harmonization of hospital discharge data sets as well as improved accuracy of documentation should facilitate future comparative analyses of routine databases.

Paracetamol (acetaminophen) poisoning.

PubMed

Park, B Kevin; Dear, James W; Antoine, Daniel J

2015-10-19

Paracetamol directly causes around 150 deaths per year in UK. We conducted a systematic overview, aiming to answer the following clinical question: What are the effects of treatments for acute paracetamol poisoning? We searched: Medline, Embase, The Cochrane Library, and other important databases up to October 2014 (Clinical Evidence overviews are updated periodically; please check our website for the most up-to-date version of this overview). At this update, searching of electronic databases retrieved 127 studies. After deduplication and removal of conference abstracts, 64 records were screened for inclusion in the overview. Appraisal of titles and abstracts led to the exclusion of 46 studies and the further review of 18 full publications. Of the 18 full articles evaluated, one systematic review was updated and one RCT was added at this update. In addition, two systematic reviews and three RCTs not meeting our inclusion criteria were added to the Comment sections. We performed a GRADE evaluation for three PICO combinations. In this systematic overview we categorised the efficacy for six interventions, based on information about the effectiveness and safety of activated charcoal (single or multiple dose), gastric lavage, haemodialysis, liver transplant, methionine, and acetylcysteine.

Safety monitoring of ophthalmic biologics: a systematic review of pre- and postmarketing safety data.

PubMed

Penedones, Ana; Mendes, Diogo; Alves, Carlos; Batel Marques, Francisco

2014-11-01

The present study evaluates the safety of the biologics approved for the treatment of ocular diseases. The European medicines agency Website was searched to identify biologics with approved ophthalmologic therapeutic indications. A systematic search was performed using MEDLINE, the Cochrane Central Register of Controlled Trials (CENTRAL) and the International Clinical Trials Registry Platform up to December 2013. Pre-marketing, phase III randomized controlled trials (RCT), postmarketing clinical trials, observational longitudinal studies, and case reports involving adverse events (AE) were included. Methodological quality was assessed by Downs & Black checklist. All European spontaneous reports of AE included in the Eudravigilance up to December 2013 were also considered. AE were classified as ocular (related and non-related with the injection procedure) and non-ocular (related or non-related with vascular endothelial growth factor inhibition). Incidences of all reported AEs were estimated. Pegaptanib, ranibizumab, and aflibercept were identified as ophthalmic biologics. Fourteen premarketing RCT, 7 postmarketing clinical trials, 31 observational studies, along with 31 case reports and 7,720 spontaneous reports were identified and included in this study. Both in pre- and postmarketing settings, ocular AEs were more frequent than non-ocular AEs. Premarketing safety data inform the most common AEs. Postmarketing studies suggest an increased number of events such as retinal pigmented epithelium tears (0.6%-24%), thromboembolic events (0.8%-5%), and mortality (2.8%-4%). This study highlights the need to properly evaluate the risk for rare, serious, and long-term AEs, such as thromboembolic events, since they can lead to imbalances in the benefit-risk ratio of biologics in ophthalmology.

Measuring Health Information Dissemination and Identifying Target Interest Communities on Twitter: Methods Development and Case Study of the @SafetyMD Network.

PubMed

Kandadai, Venk; Yang, Haodong; Jiang, Ling; Yang, Christopher C; Fleisher, Linda; Winston, Flaura Koplin

2016-05-05

Little is known about the ability of individual stakeholder groups to achieve health information dissemination goals through Twitter. This study aimed to develop and apply methods for the systematic evaluation and optimization of health information dissemination by stakeholders through Twitter. Tweet content from 1790 followers of @SafetyMD (July-November 2012) was examined. User emphasis, a new indicator of Twitter information dissemination, was defined and applied to retweets across two levels of retweeters originating from @SafetyMD. User interest clusters were identified based on principal component analysis (PCA) and hierarchical cluster analysis (HCA) of a random sample of 170 followers. User emphasis of keywords remained across levels but decreased by 9.5 percentage points. PCA and HCA identified 12 statistically unique clusters of followers within the @SafetyMD Twitter network. This study is one of the first to develop methods for use by stakeholders to evaluate and optimize their use of Twitter to disseminate health information. Our new methods provide preliminary evidence that individual stakeholders can evaluate the effectiveness of health information dissemination and create content-specific clusters for more specific targeted messaging.

Evaluation of a community-wide incentive program to promote safety restraint use.

PubMed

Foss, R D

1989-03-01

A program was designed and evaluated to determine the feasibility of implementing an incentive campaign to promote safety restraint use, primarily among children up to age 13. During a five-month period, community residents were eligible to win monthly prizes and a grand prize by buckling up all automobile occupants when driving. Systematic monitoring of traffic and a telephone survey indicate that the program was minimally effective, reaching the attention of only about half the families with children in the community despite extensive advertising. Effects of the program on seat belt use closely paralleled airing of radio announcements, appear to have been confined primarily to children under age four, and tailed off somewhat after the initial response.

A Systematic Review of Community Interventions to Improve Aboriginal Child Passenger Safety

PubMed Central

Oudie, Eugenia; Desapriya, Ediriweera; Turcotte, Kate; Pike, Ian

2014-01-01

We evaluated evidence of community interventions to improve Aboriginal child passenger safety (CPS) in terms of its scientific merit and cultural relevance. We included studies if they reported interventions to improve CPS in Aboriginal communities, compared at least pre- and postintervention conditions, and evaluated rates and severity of child passenger injuries, child restraint use, or knowledge of CPS. We also appraised quality and cultural relevance of studies. Study quality was associated with community participation and cultural relevance. Strong evidence showed that multicomponent interventions tailored to each community improves CPS. Interventions in Aboriginal communities should incorporate Aboriginal views of health, involve the community, and be multicomponent and tailored to the community’s circumstances and culture. PMID:24754652

Training and action for patient safety: embedding interprofessional education for patient safety within an improvement methodology.

PubMed

Slater, Beverley L; Lawton, Rebecca; Armitage, Gerry; Bibby, John; Wright, John

2012-01-01

Despite an explosion of interest in improving safety and reducing error in health care, one important aspect of patient safety that has received little attention is a systematic approach to education and training for the whole health care workforce. This article describes an evaluation of an innovative multiprofessional, team-based training program that embeds patient safety within quality improvement methods. Kirkpatrick's "levels of evaluation" model was adopted to evaluate the program in health organizations across one city in the north of England. Questionnaires were used to assess reaction of participants to the program (Level 1). Improvements in patient safety knowledge and patient safety culture (Level 2) were assessed using a 12-item multiple-choice questionnaire and a culture questionnaire. Interviews and project-specific quantitative measurements were used to assess changes in professional practice and patient outcomes (Levels 3 and 4). All aspects of the program were positively received by participants. Few participants completed the MCQ at both time points, but those who did showed improvement in knowledge. There were some small but significant improvements in patient safety culture. Interviews revealed a number of additional benefits beyond the specific problems addressed. Most importantly, 8 of the 11 teams showed improvements in patient safety practices and/or outcomes. This program is an example of interprofessional education in practice and demonstrates that team-based learning using quality improvement methods is feasible and can be effective in improving patient safety, but requires time and space for participants. Alignment with continuing education arrangements could support mainstream adoption of this approach within organizations. Copyright © 2012 The Alliance for Continuing Education in the Health Professions, the Society for Academic Continuing Medical Education, and the Council on CME, Association for Hospital Medical Education.

Systematic review to evaluate the safety, efficacy and economical outcomes of the Vibrant Soundbridge for the treatment of sensorineural hearing loss.

PubMed

Bruchhage, Karl-Ludwig; Leichtle, Anke; Schönweiler, Rainer; Todt, Ingo; Baumgartner, Wolf-Dieter; Frenzel, Henning; Wollenberg, Barbara

2017-04-01

Introduced in the late 90s, the active middle ear implant Vibrant Soundbridge (VSB) is nowadays used for hearing rehabilitation in patients with mild to severe sensorineural hearing loss (SNHL) unable to tolerate conventional hearing aids. In experienced hands, the surgical implantation is fast done, safe and highly standardized. Here, we present a systematic review, after more than 15 years of application, to determine the efficacy/effectiveness and cost-effectiveness, as well as patient satisfaction with the VSB active middle ear implant in the treatment of mild to severe SNHL. A systematic search of electronic databases, investigating the safety and effectiveness of the VSB in SNHL plus medical condition resulted in a total of 1640 papers. After removing duplicates, unrelated articles, screening against inclusion criteria and after in-depth screening, the number decreased to 37 articles. 13 articles were further excluded due to insufficient outcome data. 24 studies remained to be systematically reviewed. Data was searched on safety, efficacy and economical outcomes with the VSB. Safety-oriented outcomes included complication/adverse event rates, damage to the middle/inner ear, revision surgery/explant rate/device failure and mortality. Efficacy outcomes were divided into audiological outcomes, including hearing thresholds, functional gain, speech perception in quiet and noise, speech recognition thresholds, real ear insertion gain and subjective outcomes determined by questionnaires and patient-oriented scales. Data related to quality of life (QALY, ICER) were considered under economical outcomes. The VSB turns out to be a highly reliable and a safe device which significantly improves perception of speech in noisy situations with a high sound quality. In addition, the subjective benefit of the VSB was found to be mostly significant in all studies. Finally, implantation with the VSB proved to be a cost-effective and justified health care intervention.

Efficacy, safety, and economics of bracing after spine surgery: a systematic review of the literature.

PubMed

Zhu, Mary P; Tetreault, Lindsay A; Sorefan-Mangou, Fatimah; Garwood, Philip; Wilson, Jefferson R

2018-01-31

Bracing is often used after spinal surgery to immobilize the spine, improve fusion, and relieve pain. However, controversy exists regarding the efficacy, necessity, and safety of various bracing techniques in the postsurgical setting. In this systematic review, we aimed to compare the effectiveness, safety, and cost-effectiveness of postoperative bracing versus no postoperative bracing after spinal surgery in patients with several common operative spinal pathologies. A systematic review was carried out to compare postoperative bracing and no postoperative bracing. A systematic search was conducted of MEDLINE, Embase, and the Cochrane Collaboration Library from 1970 to May 2017, supplemented by manual searching of the reference list of relevant studies and previously published reviews. Studies were included if they compared disability, quality of life, functional impairment, radiographic outcomes, cost-effectiveness, or complications between patients treated with postoperative bracing and patients not receiving any postoperative bracing. Each article was critically appraised independently by two reviewers, and the overall body of evidence was rated using guidelines outlined by the Grading of Recommendation Assessment, Development and Evaluation (GRADE) Working Group. Of the 858 retrieved citations, 5 studies met the inclusion criteria and were included in this review, consisting of 4 randomized controlled trials and 1 prospective cohort study. Low to moderate evidence suggests that there are no significant differences in most measures of disability, pain, quality of life, functional impairment, radiographic outcomes, and safety between groups. Isolated studies reported statistically significant and inconsistent differences between groups with respect to Neck Disability Index at 6 weeks postoperatively or Short Form-36 Physical Component Score at 1.5, 3, 6, and 12 months postoperatively. Based on limited evidence, postoperative bracing does not result in improved outcomes after spinal surgery. Future high-quality randomized trials will be required to confirm these findings. Copyright © 2018 Elsevier Inc. All rights reserved.

Systematic control of nonmetallic materials for improved fire safety

NASA Technical Reports Server (NTRS)

1972-01-01

The elements of a systematic fire safety program are summarized and consist of fire safety criteria, design considerations, testing of materials, development of nonmetallic materials, nonmetallic materials information systems, design reviews, and change control. The system described in this report was developed for the Apollo spacecraft. The system can, however, be tailored to many industrial, commercial, and military activities.

Fibrin Sealants in Dura Sealing: A Systematic Literature Review

PubMed Central

2016-01-01

Background Fibrin sealants are widely used in neurosurgery to seal the suture line, provide watertight closure, and prevent cerebrospinal fluid leaks. The aim of this systematic review is to summarize the current efficacy and safety literature of fibrin sealants in dura sealing and the prevention/treatment of cerebrospinal fluid leaks. Methods A comprehensive electronic literature search was run in the following databases: Cochrane Database of Systematic Reviews, Cochrane Central Resister of Controlled Trials, clinicaltrials.gov, MEDLINE/PubMed, and EMBASE. Titles and abstracts of potential articles of interest were reviewed independently by 3 of the authors. Results A total of 1006 database records and additional records were identified. After screening for duplicates and relevance, a total of 78 articles were assessed by the investigators for eligibility. Thirty-eight were excluded and the full-text of 40 articles were included in the qualitative synthesis. Seven of these included only safety data and were included in the safety assessment. The remaining 33 articles included findings from 32 studies that enrolled a total of 2935 patients who were exposed to fibrin sealant. Among these 33 studies there were only 3 randomized controlled trials, with the remaining being prospective cohort analysis, case controlled studies, prospective or retrospective case series. One randomized controlled trial, with 89 patients exposed to fibrin sealant, found a greater rate of intraoperative watertight dura closure in the fibrin sealant group than the control group (92.1% versus 38.0%, p<0.001); however, post-operative cerebrospinal fluid leakage occurred in more fibrin sealant than control patients (6.7% versus 2.0%, p>0.05). Other clinical trials evaluated the effect of fibrin sealant in the postoperative prevention of cerebrospinal fluid leaks. These were generally lower level evidence studies (ie, not prospective, randomized, controlled trials) that were not designed or powered to demonstrate a significant advantage to fibrin sealant use. Two small case series studies evaluated the effect of fibrin sealants in persistent cerebrospinal fluid leak treatment, but did not establish firm efficacy conclusions. Specific adverse reports where fibrin sealants were used for dura sealing were limited, with only 8 cases reported in neurosurgical procedures since 1987 and most reporting only a speculative relationship/association with fibrin sealant exposure. Conclusions A major finding of this systematic literature review is that there is a paucity of randomized studies that have evaluated the effectiveness and safety of fibrin sealants in providing intraoperative watertight dura closure and post-operative cerebrospinal fluid leakage. Among the limited studies available, evidence from a single randomized, controlled trial indicates that fibrin sealants provide a higher rate of intraoperative watertight closure of the dura suture line than control, albeit with a higher rate of postoperative cerebrospinal fluid leakage. Evidence from non-randomized, controlled trials suggests that fibrin sealants may be effective in preventing cerebrospinal fluid leaks with an acceptable safety profile. There is a substantial need for randomized, controlled clinical trials or well-designed prospective observational trials where the conduct of a randomized trial is not feasible to fully assess the impact of fibrin sealant utilization on the rates of intraoperative dura closure, postoperative cerebrospinal leakage, and safety. PMID:27119993

Fibrin Sealants in Dura Sealing: A Systematic Literature Review.

PubMed

Esposito, Felice; Angileri, Filippo Flavio; Kruse, Peter; Cavallo, Luigi Maria; Solari, Domenico; Esposito, Vincenzo; Tomasello, Francesco; Cappabianca, Paolo

2016-01-01

Fibrin sealants are widely used in neurosurgery to seal the suture line, provide watertight closure, and prevent cerebrospinal fluid leaks. The aim of this systematic review is to summarize the current efficacy and safety literature of fibrin sealants in dura sealing and the prevention/treatment of cerebrospinal fluid leaks. A comprehensive electronic literature search was run in the following databases: Cochrane Database of Systematic Reviews, Cochrane Central Resister of Controlled Trials, clinicaltrials.gov, MEDLINE/PubMed, and EMBASE. Titles and abstracts of potential articles of interest were reviewed independently by 3 of the authors. A total of 1006 database records and additional records were identified. After screening for duplicates and relevance, a total of 78 articles were assessed by the investigators for eligibility. Thirty-eight were excluded and the full-text of 40 articles were included in the qualitative synthesis. Seven of these included only safety data and were included in the safety assessment. The remaining 33 articles included findings from 32 studies that enrolled a total of 2935 patients who were exposed to fibrin sealant. Among these 33 studies there were only 3 randomized controlled trials, with the remaining being prospective cohort analysis, case controlled studies, prospective or retrospective case series. One randomized controlled trial, with 89 patients exposed to fibrin sealant, found a greater rate of intraoperative watertight dura closure in the fibrin sealant group than the control group (92.1% versus 38.0%, p<0.001); however, post-operative cerebrospinal fluid leakage occurred in more fibrin sealant than control patients (6.7% versus 2.0%, p>0.05). Other clinical trials evaluated the effect of fibrin sealant in the postoperative prevention of cerebrospinal fluid leaks. These were generally lower level evidence studies (ie, not prospective, randomized, controlled trials) that were not designed or powered to demonstrate a significant advantage to fibrin sealant use. Two small case series studies evaluated the effect of fibrin sealants in persistent cerebrospinal fluid leak treatment, but did not establish firm efficacy conclusions. Specific adverse reports where fibrin sealants were used for dura sealing were limited, with only 8 cases reported in neurosurgical procedures since 1987 and most reporting only a speculative relationship/association with fibrin sealant exposure. A major finding of this systematic literature review is that there is a paucity of randomized studies that have evaluated the effectiveness and safety of fibrin sealants in providing intraoperative watertight dura closure and post-operative cerebrospinal fluid leakage. Among the limited studies available, evidence from a single randomized, controlled trial indicates that fibrin sealants provide a higher rate of intraoperative watertight closure of the dura suture line than control, albeit with a higher rate of postoperative cerebrospinal fluid leakage. Evidence from non-randomized, controlled trials suggests that fibrin sealants may be effective in preventing cerebrospinal fluid leaks with an acceptable safety profile. There is a substantial need for randomized, controlled clinical trials or well-designed prospective observational trials where the conduct of a randomized trial is not feasible to fully assess the impact of fibrin sealant utilization on the rates of intraoperative dura closure, postoperative cerebrospinal leakage, and safety.

Measuring the impact of medicines regulatory interventions – Systematic review and methodological considerations

PubMed Central

Morales, Daniel R.; Pacurariu, Alexandra; Kurz, Xavier

2017-01-01

Aims Evaluating the public health impact of regulatory interventions is important but there is currently no common methodological approach to guide this evaluation. This systematic review provides a descriptive overview of the analytical methods for impact research. Methods We searched MEDLINE and EMBASE for articles with an empirical analysis evaluating the impact of European Union or non‐European Union regulatory actions to safeguard public health published until March 2017. References from systematic reviews and articles from other known sources were added. Regulatory interventions, data sources, outcomes of interest, methodology and key findings were extracted. Results From 1246 screened articles, 229 were eligible for full‐text review and 153 articles in English language were included in the descriptive analysis. Over a third of articles studied analgesics and antidepressants. Interventions most frequently evaluated are regulatory safety communications (28.8%), black box warnings (23.5%) and direct healthcare professional communications (10.5%); 55% of studies measured changes in drug utilization patterns, 27% evaluated health outcomes, and 18% targeted knowledge, behaviour or changes in clinical practice. Unintended consequences like switching therapies or spill‐over effects were rarely evaluated. Two‐thirds used before–after time series and 15.7% before–after cross‐sectional study designs. Various analytical approaches were applied including interrupted time series regression (31.4%), simple descriptive analysis (28.8%) and descriptive analysis with significance tests (23.5%). Conclusion Whilst impact evaluation of pharmacovigilance and product‐specific regulatory interventions is increasing, the marked heterogeneity in study conduct and reporting highlights the need for scientific guidance to ensure robust methodologies are applied and systematic dissemination of results occurs. PMID:29105853

Banxia Xiexin tang for gastro-oesophageal reflux disease: A protocol for a systematic review of controlled trials.

PubMed

Kang, Bohyung; Lee, Haesol; Choi, Youkyung; Jeon, Chanyong; Lee, Ju Ah

2018-04-01

Gastrooesophageal reflux disease (GORD) is one of the most common gastrointestinal diseases encountered in clinical practice. The aim of the present study is thus to systematically review the literature, including Asian studies, to assess the efficacy and safety of Banxia Xiexin tang (BXT) for the treatment of GORD. Eleven databases will be searched for studies conducted through March 2018. We will include randomized controlled trials (RCTs) of BXT as a treatment for GORD. All RCTs on BXT or related formulations will be included. The risk of bias will be assessed using the Cochrane Risk of Bias Assessment Tool, while confidence in the cumulative evidence will be evaluated using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) tool. This systematic review will be published in a peer-reviewed journal and will also be disseminated electronically and in print. The review will be updated to inform and guide healthcare practices. CRD42018087056.

Certification of highly complex safety-related systems.

PubMed

Reinert, D; Schaefer, M

1999-01-01

The BIA has now 15 years of experience with the certification of complex electronic systems for safety-related applications in the machinery sector. Using the example of machining centres this presentation will show the systematic procedure for verifying and validating control systems using Application Specific Integrated Circuits (ASICs) and microcomputers for safety functions. One section will describe the control structure of machining centres with control systems using "integrated safety." A diverse redundant architecture combined with crossmonitoring and forced dynamization is explained. In the main section the steps of the systematic certification procedure are explained showing some results of the certification of drilling machines. Specification reviews, design reviews with test case specification, statistical analysis, and walk-throughs are the analytical measures in the testing process. Systematic tests based on the test case specification, Electro Magnetic Interference (EMI), and environmental testing, and site acceptance tests on the machines are the testing measures for validation. A complex software driven system is always undergoing modification. Most of the changes are not safety-relevant but this has to be proven. A systematic procedure for certifying software modifications is presented in the last section of the paper.

Towards Measurement of Confidence in Safety Cases

NASA Technical Reports Server (NTRS)

Denney, Ewen; Paim Ganesh J.; Habli, Ibrahim

2011-01-01

Arguments in safety cases are predominantly qualitative. This is partly attributed to the lack of sufficient design and operational data necessary to measure the achievement of high-dependability targets, particularly for safety-critical functions implemented in software. The subjective nature of many forms of evidence, such as expert judgment and process maturity, also contributes to the overwhelming dependence on qualitative arguments. However, where data for quantitative measurements is systematically collected, quantitative arguments provide far more benefits over qualitative arguments, in assessing confidence in the safety case. In this paper, we propose a basis for developing and evaluating integrated qualitative and quantitative safety arguments based on the Goal Structuring Notation (GSN) and Bayesian Networks (BN). The approach we propose identifies structures within GSN-based arguments where uncertainties can be quantified. BN are then used to provide a means to reason about confidence in a probabilistic way. We illustrate our approach using a fragment of a safety case for an unmanned aerial system and conclude with some preliminary observations

Review and meta-analysis of prospective randomized controlled trials (RCTs) comparing laparo-endoscopic single site and multiport laparoscopy in gynecologic operative procedures.

PubMed

Pontis, Alessandro; Sedda, Federica; Mereu, Liliana; Podda, Mauro; Melis, Gian Benedetto; Pisanu, Adolfo; Angioni, Stefano

2016-09-01

To critically appraise published randomized controlled trials (RCTs) comparing laparo-endoscopic single site (LESS) and multi-port laparoscopic (MPL) in gynecologic operative surgery; the aim was to assess feasibility, safety, and potential benefits of LESS in comparison to MPL. A systematic review and meta-analysis of eleven RCTs. Women undergoing operative LESS and MPL gynecologic procedure (hysterectomy, cystectomy, salpingectomy, salpingo-oophorectomy, myomectomy). Outcomes evaluated were as follows: postoperative overall morbidity, postoperative pain evaluation at 6, 12, 24 and 48 h, cosmetic patient satisfaction, conversion rate, body mass index (BMI), operative time, blood loss, hemoglobin drop, postoperative hospital stay. Eleven RCTs comprising 956 women with gynecologic surgical disease randomized to either LESS (477) or MPL procedures (479) were analyzed systematically. The LESS approach is a surgical procedure with longer operative and better cosmetic results time than MPL but without statistical significance. Operative outcomes, postoperative recovery, postoperative morbidity and patient satisfaction are similar in LESS and MPL. LESS may be considered an alternative to MPL with comparable feasibility and safety in gynecologic operative procedures. However, it does not offer the expected advantages in terms of postoperative pain and cosmetic satisfaction.

The PRISMA Statement for Reporting Systematic Reviews and Meta-Analyses of Studies That Evaluate Health Care Interventions: Explanation and Elaboration

PubMed Central

Liberati, Alessandro; Altman, Douglas G.; Tetzlaff, Jennifer; Mulrow, Cynthia; Gøtzsche, Peter C.; Ioannidis, John P. A.; Clarke, Mike; Devereaux, P. J.; Kleijnen, Jos; Moher, David

2009-01-01

Systematic reviews and meta-analyses are essential to summarize evidence relating to efficacy and safety of health care interventions accurately and reliably. The clarity and transparency of these reports, however, is not optimal. Poor reporting of systematic reviews diminishes their value to clinicians, policy makers, and other users. Since the development of the QUOROM (QUality Of Reporting Of Meta-analysis) Statement—a reporting guideline published in 1999—there have been several conceptual, methodological, and practical advances regarding the conduct and reporting of systematic reviews and meta-analyses. Also, reviews of published systematic reviews have found that key information about these studies is often poorly reported. Realizing these issues, an international group that included experienced authors and methodologists developed PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses) as an evolution of the original QUOROM guideline for systematic reviews and meta-analyses of evaluations of health care interventions. The PRISMA Statement consists of a 27-item checklist and a four-phase flow diagram. The checklist includes items deemed essential for transparent reporting of a systematic review. In this Explanation and Elaboration document, we explain the meaning and rationale for each checklist item. For each item, we include an example of good reporting and, where possible, references to relevant empirical studies and methodological literature. The PRISMA Statement, this document, and the associated Web site (http://www.prisma-statement.org/) should be helpful resources to improve reporting of systematic reviews and meta-analyses. PMID:19621070

A review of evidence for safe abortion care.

PubMed

Kapp, Nathalie; Whyte, Patti; Tang, Jennifer; Jackson, Emily; Brahmi, Dalia

2013-09-01

The provision of safe abortion services to women who need them has the potential to drastically reduce or eliminate maternal deaths due to unsafe abortion. The World Health Organization recently updated its evidence-based guidance for safe and effective clinical practices using data from systematic reviews of the literature. Systematic reviews pertaining to the evidence for safe abortion services, from pre-abortion care, medical and surgical methods of abortion and post-abortion care were evaluated for relevant outcomes, primarily those relating to safety, effectiveness and women's preference. Sixteen systematic reviews were identified and evaluated. The available evidence does not support the use of pre-abortion ultrasound to increase safety. Routine use of cervical preparation with osmotic dilators, mifepristone or misoprostol after 14 weeks gestation reduces complications; at early gestational ages, surgical abortions have very few complications. Prophylactic antibiotics result in lower rates of post-surgical abortion infection. Pain medication such as non-steroidal anti-inflammatories should be offered to women undergoing abortion procedures; acetaminophen, however, is not effective in reducing pain. Women who are eligible should be offered a choice between surgical (vacuum aspiration or dilation and evacuation) and medical methods (mifepristone and misoprostol) of abortion when possible. Modern methods of contraception can be safely initiated immediately following abortion procedures. Evidence-based guidelines assist health care providers and policymakers to utilize the best data available to provide safe abortion care and prevent the millions of deaths and disabilities that result from unsafe abortion. Copyright © 2013 Elsevier Inc. All rights reserved.

Efficacy and safety of Suanzaoren decoction for primary insomnia: a systematic review of randomized controlled trials

PubMed Central

2013-01-01

Background Insomnia is a widespread human health problem, but there currently are the limitations of conventional therapies available. Suanzaoren decoction (SZRD) is a well known classic Chinese herbal prescription for insomnia and has been treating people’s insomnia for more than thousand years. The objective of this study was to evaluate the efficacy and safety of SZRD for insomnia. Methods A systematic literature search was performed for 6 databases up to July of 2012 to identify randomized control trials (RCTs) involving SZRD for insomniac patients. The methodological quality of RCTs was assessed independently using the Cochrane Handbook for Systematic Reviews of Interventions. Results Twelve RCTs with total of 1376 adult participants were identified. The methodological quality of all included trials are no more than 3/8 score. Majority of the RCTs concluded that SZRD was more significantly effective than benzodiazepines for treating insomnia. Despite these positive outcomes, there were many methodological shortcomings in the studies reviewed, including insufficient information about randomization generation and absence of allocation concealment, lack of blinding and no placebo control, absence of intention-to-treat analysis and lack of follow-ups, selective publishing and reporting, and small number of sample sizes. A number of clinical heterogeneity such as diagnosis, intervention, control, and outcome measures were also reviewed. Only 3 trials reported adverse events, whereas the other 9 trials did not provide the safety information. Conclusions Despite the apparent reported positive findings, there is insufficient evidence to support efficacy of SZRD for insomnia due to the poor methodological quality and the small number of trials of the included studies. SZRD seems generally safe, but is insufficient evidence to make conclusions on the safety because fewer studies reported the adverse events. Further large sample-size and well-designed RCTs are needed. PMID:23336848

Biological Response Modifiers in Rheumatoid Arthritis: Systematic Review and Meta-analysis of Safety

PubMed Central

Tank, Nitishkumar D.; Karelia, Bharti N.; Vegada, Bhavisha N.

2017-01-01

Objective: To analyze available evidence on the safety of different biological response modifiers which are used for a treatment of rheumatoid arthritis (RA). Materials and Methods: We searched systematically for randomized controlled clinical trials on treatment of RA with different biological response modifiers, followed by a systematic review with meta-analysis. Trials were searched from MEDLINE and Cochrane Library databases. The following safety parameters reported in the selected trials were analyzed: number of patients suffering any adverse event (AE), withdrawal due to AEs, serious AE (SAEs), infections, serious infections, infusion reactions, injection site reactions, malignancies, and overall mortality. Undesired effects were estimated using combined relative risks (RR) and number needed to harm (NNH). Heterogeneity was evaluated by Cochrane's Q and I2 statistics. Results: According to inclusion criteria, a total of 43 trials (20,504 patients) were included in this study. A total number of AEs were found more with abatacept (RR: 1.05, NNH: 21.93). Withdrawal due to AEs was found with all biologicals, highest with anakinra (RR: 3.48, NNH: 15.70). Patients receiving newer tumor necrosis factor-alpha inhibitors, golimumab, were more likely to develop SAEs (RR: 2.44, NNH: 12.72) and infection (RR: 1.25, NNH: 10.09), and in certolizumab, serious infections (RR: 2.95, NNH: 37.31) were found more. Infusion reaction develops more with rituximab (RR: 1.52, NNH: 8.47). Etanercept showed the highest risk to develop infusion site reaction (RR: 5.33, NNH: 4.65). Biologicals showed no difference to their control counterparts in malignancy and mortality risk. Conclusion: This meta-analysis helps to clarify some frequently encountered and unanswered safety questions of different biological response modifiers, a new class of drugs, in the clinical care of RA patients. PMID:29081616

Probiotic and synbiotic safety in infants under two years of age.

PubMed

van den Nieuwboer, M; Claassen, E; Morelli, L; Guarner, F; Brummer, R J

2014-03-01

In this study, we systematically evaluated safety aspects in clinical trials with probiotics and synbiotics in young infants (0-2 years of age). This study is an update of earlier reports and covers the recent literature from 2008-2013. The safety evaluation is performed along the Common Terminology Clinical Adverse Events (CTCAE) version 4.0 scale, hereby also providing guidance for future studies. Safety aspects are represented and related to number of participants per probiotic strain/culture, study duration, dosage, clinical condition and selected afflictions. The results show a deficiency in the precise reporting and classification of adverse events in most studies. Analysis of 57 clinical trials with probiotics and synbiotics in combination with eight follow-up studies indicate that probiotic administration to infants between 0 and 24 months is safe with regard to the evaluated strains in infants with a particular health status or susceptibility. Most adverse events and serious adverse events were considered unrelated to the study product, and there were no major safety concerns. Almost all studies concluded that none of the adverse effects were related to the study product; the study products are generally well tolerated. Finally, inconsistent, imprecise and potentially incomplete reporting as well as the variation in probiotic strains, dosages, administration regimes, study populations and reported outcomes, greatly limit the generalizability of conclusions and argue convincingly for obligatory and standardised behaviour on adverse events (CTCAE) reporting in 'food' studies.

Systematic review of economic analyses in patient safety: a protocol designed to measure development in the scope and quality of evidence

PubMed Central

Carter, Alexander W; Mandavia, Rishi; Mayer, Erik; Marti, Joachim; Mossialos, Elias; Darzi, Ara

2017-01-01

Introduction Recent avoidable failures in patient care highlight the ongoing need for evidence to support improvements in patient safety. According to the most recent reviews, there is a dearth of economic evidence related to patient safety. These reviews characterise an evidence gap in terms of the scope and quality of evidence available to support resource allocation decisions. This protocol is designed to update and improve on the reviews previously conducted to determine the extent of methodological progress in economic analyses in patient safety. Methods and analysis A broad search strategy with two core themes for original research (excluding opinion pieces and systematic reviews) in ‘patient safety’ and ‘economic analyses’ has been developed. Medline, Econlit and National Health Service Economic Evaluation Database bibliographic databases will be searched from January 2007 using a combination of medical subject headings terms and research-derived search terms (see table 1). The method is informed by previous reviews on this topic, published in 2012. Screening, risk of bias assessment (using the Cochrane collaboration tool) and economic evaluation quality assessment (using the Drummond checklist) will be conducted by two independent reviewers, with arbitration by a third reviewer as needed. Studies with a low risk of bias will be assessed using the Drummond checklist. High-quality economic evaluations are those that score >20/35. A qualitative synthesis of evidence will be performed using a data collection tool to capture the study design(s) employed, population(s), setting(s), disease area(s), intervention(s) and outcome(s) studied. Methodological quality scores will be compared with previous reviews where possible. Effect size(s) and estimate uncertainty will be captured and used in a quantitative synthesis of high-quality evidence, where possible. Ethics and dissemination Formal ethical approval is not required as primary data will not be collected. The results will be disseminated through a peer-reviewed publication, presentations and social media. Trial registration number CRD42017057853. PMID:28821527

Effects of napping on sleepiness and sleep-related performance deficits in night-shift workers: a systematic review.

PubMed

Ruggiero, Jeanne S; Redeker, Nancy S

2014-04-01

Night-shift workers are prone to sleep deprivation, misalignment of circadian rhythms, and subsequent sleepiness and sleep-related performance deficits. The purpose of this narrative systematic review is to critically review and synthesize the scientific literature regarding improvements in sleepiness and sleep-related performance deficits following planned naps taken during work-shift hours by night workers and to recommend directions for future research and practice. We conducted a literature search using the Medline, PsychInfo, CINAHL, Cochrane Library, and Health and Safety Science Abstracts databases and included English-language quasi-experimental and experimental studies that evaluated the effects of a nighttime nap taken during a simulated or actual night-work shift. We identified 13 relevant studies, which consisted primarily of small samples and mixed designs. Most investigators found that, despite short periods of sleep inertia immediately following naps, night-shift napping led to decreased sleepiness and improved sleep-related performance. None of the studies examined the effects of naps on safety outcomes in the workplace. Larger-scale randomized clinical trials of night-shift napping and direct safety outcomes are needed prior to wider implementation.

Reducing RF-related heating of cardiac pacemaker leads in MRI: implementation and experimental verification of practical design changes.

PubMed

Nordbeck, Peter; Fidler, Florian; Friedrich, Michael T; Weiss, Ingo; Warmuth, Marcus; Gensler, Daniel; Herold, Volker; Geistert, Wolfgang; Jakob, Peter M; Ertl, Georg; Ritter, Oliver; Ladd, Mark E; Bauer, Wolfgang R; Quick, Harald H

2012-12-01

There are serious concerns regarding safety when performing magnetic resonance imaging in patients with implanted conductive medical devices, such as cardiac pacemakers, and associated leads, as severe incidents have occurred in the past. In this study, several approaches for altering an implant's lead design were systematically developed and evaluated to enhance the safety of implanted medical devices in a magnetic resonance imaging environment. The individual impact of each design change on radiofrequency heating was then systematically investigated in functional lead prototypes at 1.5 T. Radiofrequency-induced heating could be successfully reduced by three basic changes in conventional pacemaker lead design: (1) increasing the lead tip area, (2) increasing the lead conductor resistance, and (3) increasing outer lead insulation conductivity. The findings show that radiofrequency energy pickup in magnetic resonance imaging can be reduced and, therefore, patient safety can be improved with dedicated construction changes according to a "safe by design" strategy. Incorporation of the described alterations into implantable medical devices such as pacemaker leads can be used to help achieve favorable risk-benefit-ratios when performing magnetic resonance imaging in the respective patient group. Copyright © 2012 Wiley Periodicals, Inc.

Patient Safety and Quality Improvement in Otolaryngology Education: A Systematic Review.

PubMed

Gettelfinger, John D; Paulk, P Barrett; Schmalbach, Cecelia E

2017-06-01

Objective The breadth and depth of patient safety/quality improvement (PS/QI) research dedicated to otolaryngology-head and neck surgery (OHNS) education remains unknown. This systematic review aims to define this scope and to identify knowledge gaps as well as potential areas of future study to improved PS/QI education and training in OHNS. Data Sources A computerized Ovid/Medline database search was conducted (January 1, 1965, to May 15, 2015). Similar computerized searches were conducted using Cochrane Database, PubMed, and Google Scholar. Review Methods The study protocol was developed a priori using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). Articles were classified by year, subspecialty, Institute of Medicine (IOM) Crossing the Chasm categories, and World Health Organization (WHO) subclass. Results Computerized searches yielded 8743 eligible articles, 267 (3.4%) of which met otolaryngology PS/QI inclusion criteria; 51 (19%) were dedicated to resident/fellow education and training. Simulation studies (39%) and performance/competency evaluation (23.5%) were the most common focus. Most projects involved general otolaryngology (47%), rhinology (18%), and otology (16%). Classification by the IOM included effective care (45%), safety/effective care (41%), and effective and efficient care (7.8%). Most research fell into the WHO category of "identifying solutions" (61%). Conclusion Nineteen percent of OHNS PS/QI articles are dedicated to education, the majority of which are simulation and focus on effective care. Knowledges gaps for future research include facial plastics PS/QI and the WHO category of "studies translating evidence into safer care."

Benzodiazepine use in seizure emergencies: A systematic review.

PubMed

Haut, Sheryl R; Seinfeld, Syndi; Pellock, John

2016-10-01

The aim of this review was to systematically examine safety and efficacy outcomes, as well as patient/caregiver satisfaction, from clinical studies in pediatric and adult patients treated with benzodiazepines (BZDs) through various administration routes in response to seizure emergencies. A literature search was conducted to identify articles describing the use of various routes of administration (RoAs) of BZDs for the treatment of seizure emergencies through April 21, 2015, using Embase™ and PubMed®. Eligible studies included (a) randomized controlled trials or (b) controlled nonrandomized clinical trials, either retrospective or prospective. Outcome assessments reviewed were 1) time to administration, 2) time to seizure termination, 3) rate of treatment failure, 4) prevention of seizure recurrence, 5) patient and caregiver treatment satisfaction, 6) adverse events related to BDZ treatment or RoA, and 7) respiratory adverse events. Seventy-five studies evaluated safety and efficacy using individual or comparator BDZs of various RoAs for treating seizure emergencies in all-aged patients with epilepsy. Buccal, intranasal (IN), or intramuscular (IM) BZDs were often more rapidly administered compared with rectal and intravenous (IV) formulations. Time to seizure termination, seizure recurrence rates, and adverse events were generally similar among RoAs, whereas nonrectal RoAs resulted in greater patient and caregiver satisfaction compared with rectal RoA. Results of this systematic literature review suggest that nonrectal and non-IV BZD formulations provide equal or improved efficacy and safety outcomes compared with rectal and IV formulations for the treatment of seizure emergencies. Copyright © 2016. Published by Elsevier Inc.

Systematic review of economic analyses in patient safety: a protocol designed to measure development in the scope and quality of evidence.

PubMed

Carter, Alexander W; Mandavia, Rishi; Mayer, Erik; Marti, Joachim; Mossialos, Elias; Darzi, Ara

2017-08-18

Recent avoidable failures in patient care highlight the ongoing need for evidence to support improvements in patient safety. According to the most recent reviews, there is a dearth of economic evidence related to patient safety. These reviews characterise an evidence gap in terms of the scope and quality of evidence available to support resource allocation decisions. This protocol is designed to update and improve on the reviews previously conducted to determine the extent of methodological progress in economic analyses in patient safety. A broad search strategy with two core themes for original research (excluding opinion pieces and systematic reviews) in 'patient safety' and 'economic analyses' has been developed. Medline, Econlit and National Health Service Economic Evaluation Database bibliographic databases will be searched from January 2007 using a combination of medical subject headings terms and research-derived search terms (see table 1). The method is informed by previous reviews on this topic, published in 2012. Screening, risk of bias assessment (using the Cochrane collaboration tool) and economic evaluation quality assessment (using the Drummond checklist) will be conducted by two independent reviewers, with arbitration by a third reviewer as needed. Studies with a low risk of bias will be assessed using the Drummond checklist. High-quality economic evaluations are those that score >20/35. A qualitative synthesis of evidence will be performed using a data collection tool to capture the study design(s) employed, population(s), setting(s), disease area(s), intervention(s) and outcome(s) studied. Methodological quality scores will be compared with previous reviews where possible. Effect size(s) and estimate uncertainty will be captured and used in a quantitative synthesis of high-quality evidence, where possible. Formal ethical approval is not required as primary data will not be collected. The results will be disseminated through a peer-reviewed publication, presentations and social media. CRD42017057853. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Systematic Analysis of Icotinib Treatment for Patients with Non-Small Cell Lung Cancer.

PubMed

Shi, Bing; Zhang, Xiu-Bing; Xu, Jian; Huang, Xin-En

2015-01-01

This analysis was conducted to evaluate the efficacy and safety of icotinib based regimens in treating patients with non-small cell lung cancer (NSCLC). Clinical studies evaluating the efficacy and safety of icotinib-based regimens with regard to response and safety for patients with NSCLC were identified using a predefined search strategy. Pooled response rates of treatment were calculated. With icotinib-based regimens, 7 clinical studies which including 5,985 Chinese patients with NSCLC were considered eligible for inclusion. The pooled analysis suggested that, in all patients, the positive reponse rate was 30.1% (1,803/5,985) with icotinib-based regimens. Mild skin itching, rashes and diarrhea were the main side effects. No grade III or IV renal or liver toxicity was observed. No treatment-related death occurred in patients treated with icotinib-based regimens. This evidence based analysis suggests that icotinib based regimens are associated with mild response rate and acceptable toxicity for treating Chinese patients with NSCLC.

The Impact of System Factors on Quality and Safety in Arterial Surgery: A Systematic Review.

PubMed

Lear, R; Godfrey, A D; Riga, C; Norton, C; Vincent, C; Bicknell, C D

2017-07-01

A systems approach to patient safety proposes that a wide range of factors contribute to surgical outcome, yet the impact of team, work environment, and organisational factors, is not fully understood in arterial surgery. The aim of this systematic review is to summarize and discuss what is already known about the impact of system factors on quality and safety in arterial surgery. A systematic review of original research papers in English using MEDLINE, Embase, PsycINFO, and Cochrane databases, was performed according to PRISMA guidelines. Independent reviewers selected papers according to strict inclusion and exclusion criteria, and using predefined data fields, extracted relevant data on team, work environment, and organisational factors, and measures of quality and/or safety, in arterial procedures. Twelve papers met the selection criteria. Study endpoints were not consistent between papers, and most failed to report their clinical significance. A variety of tools were used to measure team skills in five papers; only one paper measured the relationship between team factors and patient outcomes. Two papers reported that equipment failures were common and had a significant impact on operating room efficiency. The influence of hospital characteristics on failure-to-rescue rates was tested in one large study, although their conclusions were limited to the American Medicare population. Five papers implemented changes in the patient pathway, but most studies failed to account for potential confounding variables. A small number of heterogenous studies have evaluated the relationship between system factors and quality or safety in arterial surgery. There is some evidence of an association between system factors and patient outcomes, but there is more work to be done to fully understand this relationship. Future research would benefit from consistency in definitions, the use of validated assessment tools, measurement of clinically relevant endpoints, and adherence to national reporting guidelines. Crown Copyright © 2017. Published by Elsevier Ltd. All rights reserved.

Evaluation of a patient centered e-nursing and caring system.

PubMed

Tsai, Lai-Yin; Shan, Huang; Mei-Bei, Lin

2006-01-01

This study aims to develop an electronic nursing and caring system to manage patients' information and provide patients with safe and efficient services. By transmitting data among wireless cards, optical network, and mainframe computer, nursing care will be delivered more systematically and patients' safety centered caring will be delivered more efficiently and effectively. With this system, manual record keeping time was cut down, and relevant nursing and caring information was linked up. With the development of an electronic nursing system, nurses were able to make the best use of the Internet resources, integrate information management systematically and improve quality of nursing and caring service.

The practice of pre-marketing safety assessment in drug development.

PubMed

Chuang-Stein, Christy; Xia, H Amy

2013-01-01

The last 15 years have seen a substantial increase in efforts devoted to safety assessment by statisticians in the pharmaceutical industry. While some of these efforts were driven by regulations and public demand for safer products, much of the motivation came from the realization that there is a strong need for a systematic approach to safety planning, evaluation, and reporting at the program level throughout the drug development life cycle. An efficient process can help us identify safety signals early and afford us the opportunity to develop effective risk minimization plan early in the development cycle. This awareness has led many pharmaceutical sponsors to set up internal systems and structures to effectively conduct safety assessment at all levels (patient, study, and program). In addition to process, tools have emerged that are designed to enhance data review and pattern recognition. In this paper, we describe advancements in the practice of safety assessment during the premarketing phase of drug development. In particular, we share examples of safety assessment practice at our respective companies, some of which are based on recommendations from industry-initiated working groups on best practice in recent years.

A probabilistic bridge safety evaluation against floods.

PubMed

Liao, Kuo-Wei; Muto, Yasunori; Chen, Wei-Lun; Wu, Bang-Ho

2016-01-01

To further capture the influences of uncertain factors on river bridge safety evaluation, a probabilistic approach is adopted. Because this is a systematic and nonlinear problem, MPP-based reliability analyses are not suitable. A sampling approach such as a Monte Carlo simulation (MCS) or importance sampling is often adopted. To enhance the efficiency of the sampling approach, this study utilizes Bayesian least squares support vector machines to construct a response surface followed by an MCS, providing a more precise safety index. Although there are several factors impacting the flood-resistant reliability of a bridge, previous experiences and studies show that the reliability of the bridge itself plays a key role. Thus, the goal of this study is to analyze the system reliability of a selected bridge that includes five limit states. The random variables considered here include the water surface elevation, water velocity, local scour depth, soil property and wind load. Because the first three variables are deeply affected by river hydraulics, a probabilistic HEC-RAS-based simulation is performed to capture the uncertainties in those random variables. The accuracy and variation of our solutions are confirmed by a direct MCS to ensure the applicability of the proposed approach. The results of a numerical example indicate that the proposed approach can efficiently provide an accurate bridge safety evaluation and maintain satisfactory variation.

Improving patient safety by instructional systems design

PubMed Central

Battles, J B

2006-01-01

Education and training are important elements in patient safety, both as a potential contributing factor to risks and hazards of healthcare associated injury or harm and as an intervention to be used in eliminating or preventing such harm. All too often we have relied on training as the only interventions for patient safety without examining other alternatives or realizing that, in some cases, the training systems themselves are part of the problem. One way to ensure safety by design is to apply established design principles to education and training. Instructional systems design (ISD) is a systematic method of development of education and training programs for improved learner performance. The ISD process involves five integrated steps: analysis, development, design, implementation, and evaluation (ADDIE). The application of ISD using the ADDIE approach can eliminate or prevent education and training from being a contributing factor of health associated injury or harm, and can also be effective in preventing injury or harm. PMID:17142604

Design Standards for Engineered Tissues

PubMed Central

Nawroth, Janna C.; Parker, Kevin Kit

2013-01-01

Traditional technologies are required to meet specific, quantitative standards of safety and performance. In tissue engineering, similar standards will have to be developed to enable routine clinical use and customized tissue fabrication. In this essay, we discuss a framework of concepts leading towards general design standards for tissue-engineering, focusing in particular on systematic design strategies, control of cell behavior, physiological scaling, fabrication modes and functional evaluation. PMID:23267860

OPPE, FPPE, QPS, and why the alphabet soup of physician assessment is essential for safer patient care.

PubMed

Loftus, Michael L

Creating a successful quality and patient safety program requires a multifaceted approach that systematically reviews overall systems and processes, but also creates a standardized framework for evaluating individual practitioner performance on a routine basis. There are two required elements of competency assessment that are typically tied to the hospital credentialing process: ongoing professional practice evaluation (OPPE) and focused professional practice evaluation (FPPE). Each of these processes are mandated by the Joint Commission, and form an important cornerstone for ensuring adequate physician performance and knowledge base. Copyright © 2017. Published by Elsevier Inc.

Efficacy and Safety of Medicinal Plants or Related Natural Products for Fibromyalgia: A Systematic Review

PubMed Central

de Souza Nascimento, Simone; DeSantana, Josimari Melo; Ribeiro, Êurica Adélia Nogueira; da Silva, Daniel Lira; Araújo-Júnior, João Xavier; da Silva Almeida, Jackson Roberto Guedes; Bonjardim, Leonardo Rigoldi; de Souza Araújo, Adriano Antunes; Quintans-Júnior, Lucindo José

2013-01-01

To assess the effects of medicinal plants (MPs) or related natural products (RNPs) on fibromyalgia (FM) patients, we evaluate the possible benefits and advantages of MP or RNP for the treatment of FM based on eight randomized placebo-controlled trials (RCTs) involving 475 patients. The methodological quality of all studies included was determined according to JADAD and “Risk of Bias” with the criteria in the Cochrane Handbook for Systematic Reviews of Interventions 5.1.0. Evidence suggests significant benefits of MP or RNP in sleep disruption, pain, depression, joint stiffness, anxiety, physical function, and quality of life. Our results demonstrated that MP or RNP had significant effects on improving the symptoms of FM compared to conventional drug or placebo; longer tests are required to determine the duration of the treatment and characterize the long-term safety of using MP, thus suggesting effective alternative therapies in the treatment of pain with minimized side effects. PMID:23861696

The efficacy and safety of estriol to treat vulvovaginal atrophy in postmenopausal women: a systematic literature review.

PubMed

Rueda, C; Osorio, A M; Avellaneda, A C; Pinzón, C E; Restrepo, O I

2017-08-01

To evaluate the efficacy and safety of estriol for the treatment of vulvovaginal atrophy in postmenopausal women. A systematic literature review was performed. We searched the following electronic databases: Medline, Cochrane, Embase, Lilacs, CINHAL and Google Scholar. The studies selected included controlled clinical trials and quasi-experimental studies. Selections were made in pairs and independently, first by title and abstract and then complete texts. We identified 188 studies, 22 of which met the inclusion criteria; 13 were controlled clinical trials and nine were quasi-experimental, and 1217 women were included. These studies confirmed the efficacy of local estrogens to treat symptoms of vulvovaginal atrophy with few adverse effects reported. Following treatment, serum estriol levels rose, peaking at 1 h. At the 6-month follow-up, there was no increase in serum estriol in treated women. The available evidence (of low and moderate quality) shows that, when administered vaginally, estriol preparations appear to be safe for women who have risk factors related to systemic estrogen therapy.

Efficacy and Safety of Oral and Transdermal Opioid Analgesics for Musculoskeletal Pain in Older Adults: A Systematic Review of Randomized, Placebo-Controlled Trials.

PubMed

Megale, Rodrigo Z; Deveza, Leticia A; Blyth, Fiona M; Naganathan, Vasi; Ferreira, Paulo H; McLachlan, Andrew J; Ferreira, Manuela L

2018-05-01

This systematic review with meta-analysis was performed to evaluate the efficacy and safety of using opioid analgesics in older adults with musculoskeletal pain. We searched Cochrane Library, MEDLINE, EMBASE, Web of Science, AMED, CINAHL, and LILACS for randomized controlled trials with mean population age of 60 years or older, comparing the efficacy and safety of opioid analgesics with placebo for musculoskeletal pain conditions. Reviewers extracted data, assessed risk of bias, and evaluated the quality of evidence using the Grading of Recommendations Assessment, Development and Evaluation approach. Random effects models were used to calculate standardized mean differences (when different scales were used across trials), mean differences and odds ratios with respective 95% confidence intervals (CIs). Meta-regressions were carried out to assess the influence of opioid analgesic daily dose and treatment duration on our main outcomes. We included 23 randomized placebo-controlled trials in the meta-analysis. Opioid analgesics had a small effect on decreasing pain intensity (standardized mean difference = -.27; 95% CI = -.33 to -.20) and improving function (standardized mean difference = -.27, 95% CI = -.36 to -.18), which was not associated with daily dose or treatment duration. The odds of adverse events were 3 times higher (odds ratio = 2.94; 95% CI = 2.33-3.72) and the odds of treatment discontinuation due to adverse events 4 times higher (odds ratio = 4.04; 95% CI = 3.10-5.25) in patients treated with opioid analgesics. The results show that in older adults suffering from musculoskeletal pain, using opioid analgesics had only a small effect on pain and function at the cost of a higher odds of adverse events and treatment discontinuation. For this specific population, the opioid-related risks may outweigh the benefits. The systematic review shows that, in older adults suffering from musculoskeletal conditions, opioid analgesics have only a small effect on pain and disability. Conversely, this population is at higher risk of adverse events. The results may reflect age-related physiological changes in pain processing, pharmacokinetics, and pharmacodynamics. Copyright © 2017 The American Pain Society. Published by Elsevier Inc. All rights reserved.

The Impact of eHealth on the Quality and Safety of Healthcare

NASA Astrophysics Data System (ADS)

Majeed, Azeem; Black, Ashly; Car, Josip; Anandan, Chantelle; Cresswell, Kathrin; McKinstry, Brian; Pagliari, Claudia; Procter, Rob; Sheikh, Aziz

There is considerable interest in using information technology (IT) to enhance the quality and safety of healthcare. We undertook a systematic literature review to assess the impact of eHealth applications on the quality and safety of healthcare. We retrieved 46,349 potentially relevant publications, from which we selected 67 relevant systematic reviews for inclusion. The literature was found to be poorly collated and of variable quality in its methodology, reporting and utility. We categorised eHealth applications into three main areas: i). storing, managing and transmission of data; ii). supporting clinical decision-making; and iii). facilitating care from a distance. We found that relative to the potential benefits noted within the literature, little empirical evidence exists in support of these applications. Of the few studies revealing the clearest evidence of benefits, many are from academic clinical centres where developers of new applications have also been directly associated with their evaluation. It is therefore unclear how effective these applications would be if deployed outside the environment in which they were developed. Our review of the impact of eHealth applications on quality and safety of healthcare demonstrated a vast gap between the postulated and empirically demonstrated benefits. In addition, there is a lack of robust research on risks and costs. Consequently, the cost-effectiveness of these interventions has yet to be demonstrated.

Measuring the impact of medicines regulatory interventions - Systematic review and methodological considerations.

PubMed

Goedecke, Thomas; Morales, Daniel R; Pacurariu, Alexandra; Kurz, Xavier

2018-03-01

Evaluating the public health impact of regulatory interventions is important but there is currently no common methodological approach to guide this evaluation. This systematic review provides a descriptive overview of the analytical methods for impact research. We searched MEDLINE and EMBASE for articles with an empirical analysis evaluating the impact of European Union or non-European Union regulatory actions to safeguard public health published until March 2017. References from systematic reviews and articles from other known sources were added. Regulatory interventions, data sources, outcomes of interest, methodology and key findings were extracted. From 1246 screened articles, 229 were eligible for full-text review and 153 articles in English language were included in the descriptive analysis. Over a third of articles studied analgesics and antidepressants. Interventions most frequently evaluated are regulatory safety communications (28.8%), black box warnings (23.5%) and direct healthcare professional communications (10.5%); 55% of studies measured changes in drug utilization patterns, 27% evaluated health outcomes, and 18% targeted knowledge, behaviour or changes in clinical practice. Unintended consequences like switching therapies or spill-over effects were rarely evaluated. Two-thirds used before-after time series and 15.7% before-after cross-sectional study designs. Various analytical approaches were applied including interrupted time series regression (31.4%), simple descriptive analysis (28.8%) and descriptive analysis with significance tests (23.5%). Whilst impact evaluation of pharmacovigilance and product-specific regulatory interventions is increasing, the marked heterogeneity in study conduct and reporting highlights the need for scientific guidance to ensure robust methodologies are applied and systematic dissemination of results occurs. © 2017 The Authors. British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society.

Evaluation of airfield pavement evenness

NASA Astrophysics Data System (ADS)

Pietruszewski, Paweł; Poświata, Adam; Wesołowski, Mariusz

2018-05-01

The evenness of airfield pavements is one of the basic operating parameters, which characterize them. The evenness determines not only comfort of traffic along an airfield pavement, but also influences the size of dynamic effect on the pavement, hence, the safety of air operations. In addition, the evenness condition changing as a result of dynamic loads, adverse weather conditions or inappropriate airfield pavement construction technology, lead to deviations from the desired condition in the form of longitudinal and transverse unevenness. As a result, systematic and correct performance of tests is a very significant and required factor impacting the improvement of traffic safety on airfield pavements. If the data obtained through the measurements are not sufficiently reliable, they may consequently lead to making incorrect decisions, which can ultimately impact the safety of air operations.

Classification of antecedents towards safety use of health information technology: A systematic review.

PubMed

Salahuddin, Lizawati; Ismail, Zuraini

2015-11-01

This paper provides a systematic review of safety use of health information technology (IT). The first objective is to identify the antecedents towards safety use of health IT by conducting systematic literature review (SLR). The second objective is to classify the identified antecedents based on the work system in Systems Engineering Initiative for Patient Safety (SEIPS) model and an extension of DeLone and McLean (D&M) information system (IS) success model. A systematic literature review (SLR) was conducted from peer-reviewed scholarly publications between January 2000 and July 2014. SLR was carried out and reported based on the preferred reporting items for systematic reviews and meta-analyses (PRISMA) statement. The related articles were identified by searching the articles published in Science Direct, Medline, EMBASE, and CINAHL databases. Data extracted from the resultant studies included are to be analysed based on the work system in Systems Engineering Initiative for Patient Safety (SEIPS) model, and also from the extended DeLone and McLean (D&M) information system (IS) success model. 55 articles delineated to be antecedents that influenced the safety use of health IT were included for review. Antecedents were identified and then classified into five key categories. The categories are (1) person, (2) technology, (3) tasks, (4) organization, and (5) environment. Specifically, person is attributed by competence while technology is associated to system quality, information quality, and service quality. Tasks are attributed by task-related stressor. Organisation is related to training, organisation resources, and teamwork. Lastly, environment is attributed by physical layout, and noise. This review provides evidence that the antecedents for safety use of health IT originated from both social and technical aspects. However, inappropriate health IT usage potentially increases the incidence of errors and produces new safety risks. The review cautions future implementation and adoption of health IT to carefully consider the complex interactions between social and technical elements propound in healthcare settings. Copyright © 2015. Published by Elsevier Ireland Ltd.

Flightdeck Automation Problems (FLAP) Model for Safety Technology Portfolio Assessment

NASA Technical Reports Server (NTRS)

Ancel, Ersin; Shih, Ann T.

2014-01-01

NASA's Aviation Safety Program (AvSP) develops and advances methodologies and technologies to improve air transportation safety. The Safety Analysis and Integration Team (SAIT) conducts a safety technology portfolio assessment (PA) to analyze the program content, to examine the benefits and risks of products with respect to program goals, and to support programmatic decision making. The PA process includes systematic identification of current and future safety risks as well as tracking several quantitative and qualitative metrics to ensure the program goals are addressing prominent safety risks accurately and effectively. One of the metrics within the PA process involves using quantitative aviation safety models to gauge the impact of the safety products. This paper demonstrates the role of aviation safety modeling by providing model outputs and evaluating a sample of portfolio elements using the Flightdeck Automation Problems (FLAP) model. The model enables not only ranking of the quantitative relative risk reduction impact of all portfolio elements, but also highlighting the areas with high potential impact via sensitivity and gap analyses in support of the program office. Although the model outputs are preliminary and products are notional, the process shown in this paper is essential to a comprehensive PA of NASA's safety products in the current program and future programs/projects.

Bayesian-network-based safety risk assessment for steel construction projects.

PubMed

Leu, Sou-Sen; Chang, Ching-Miao

2013-05-01

There are four primary accident types at steel building construction (SC) projects: falls (tumbles), object falls, object collapse, and electrocution. Several systematic safety risk assessment approaches, such as fault tree analysis (FTA) and failure mode and effect criticality analysis (FMECA), have been used to evaluate safety risks at SC projects. However, these traditional methods ineffectively address dependencies among safety factors at various levels that fail to provide early warnings to prevent occupational accidents. To overcome the limitations of traditional approaches, this study addresses the development of a safety risk-assessment model for SC projects by establishing the Bayesian networks (BN) based on fault tree (FT) transformation. The BN-based safety risk-assessment model was validated against the safety inspection records of six SC building projects and nine projects in which site accidents occurred. The ranks of posterior probabilities from the BN model were highly consistent with the accidents that occurred at each project site. The model accurately provides site safety-management abilities by calculating the probabilities of safety risks and further analyzing the causes of accidents based on their relationships in BNs. In practice, based on the analysis of accident risks and significant safety factors, proper preventive safety management strategies can be established to reduce the occurrence of accidents on SC sites. Copyright © 2013 Elsevier Ltd. All rights reserved.

Herbal medications for surgical patients: a systematic review protocol.

PubMed

Arruda, Ana Paula Nappi; Ayala, Ana Patricia; Lopes, Luciane C; Bergamaschi, Cristiane C; Guimarães, Caio; Grossi, Mariana Del; Righesso, Leonardo A R; Agarwal, Arnav; El Dib, Regina

2017-07-26

Postoperative nausea and vomiting (PONV) affect approximately 80% of surgical patients and is associated with increased length of hospital stay and systemic costs. Preoperative and postoperative pain, anxiety and depression are also commonly reported. Recent evidence regarding their safety and effectiveness has not been synthesised. The aim of this systematic review is to evaluate the efficacy and safety of herbal medications for the treatment and prevention of anxiety, depression, pain and PONV in patients undergoing laparoscopic, obstetrical/gynaecological and cardiovascular surgical procedures. The following electronic databases will be searched up to 1 October 2016 without language or publication status restrictions: CENTRAL, MEDLINE, EMBASE, CINAHL, Web of Science and LILACS. Randomised clinical trials enrolling adult surgical patients undergoing laparoscopic, obstetrical/gynaecological and cardiovascular surgeries and managed with herbal medication versus a control group (placebo, no intervention or active control) prophylactically or therapeutically will be considered eligible. Outcomes of interest will include the following: anxiety, depression, pain, nausea and vomiting. A team of reviewers will complete title and abstract screening and full-text screening for identified hits independently and in duplicate. Data extraction, risk of bias assessments and evaluation of the overall quality of evidence for each relevant outcome reported will be conducted independently and in duplicate using the Grading of Recommendations Assessment Development and Evaluation classification system. Dichotomous data will be summarised as risk ratios; continuous data will be summarised as standard average differences with 95% CIs. This is one of the first efforts to systematically summarise existing evidence evaluating the use of herbal medications in laparoscopic, obstetrical/gynaecological and cardiovascular surgical patients. The findings of this review will be disseminated through peer-reviewed publications and conference presentations. PROSPERO CRD42016042838. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Introduction of structural health and safety monitoring warning systems for Shenzhen-Hong Kong Western Corridor Shenzhen Bay Bridge

NASA Astrophysics Data System (ADS)

Li, N.; Zhang, X. Y.; Zhou, X. T.; Leng, J.; Liang, Z.; Zheng, C.; Sun, X. F.

2008-03-01

Though the brief introduction of the completed structural health and safety monitoring warning systems for Shenzhen-Hongkong western corridor Shenzhen bay highway bridge (SZBHMS), the self-developed system frame, hardware and software scheme of this practical research project are systematically discussed in this paper. The data acquisition and transmission hardware and the basic software based on the NI (National Instruments) Company virtual instruments technology were selected in this system, which adopted GPS time service receiver technology and so on. The objectives are to establish the structural safety monitoring and status evaluation system to monitor the structural responses and working conditions in real time and to analyze the structural working statue using information obtained from the measured data. It will be also provided the scientific decision-making bases for the bridge management and maintenance. Potential technical approaches to the structural safety warning systems, status identification and evaluation method are presented. The result indicated that the performance of the system has achieved the desired objectives, ensure the longterm high reliability, real time concurrence and advanced technology of SZBHMS. The innovate achievement which is the first time to implement in domestic, provide the reference for long-span bridge structural health and safety monitoring warning systems design.

Stories or statistics? Farmers' attitudes toward messages in an agricultural safety campaign.

PubMed

Morgan, S E; Cole, H P; Struttmann, T; Piercy, L

2002-05-01

Farming is the second most hazardous occupation in the U.S. The high mortality rate is due in large part to farm equipment hazards, particularly tractor overturns. Injuries and deaths associated with tractor overturns could be prevented with the use of a rollover protective structure (ROPS). In spite of the known dangers associated with overturn incidents, farmers are reluctant to retrofit ROPS on older tractors. Few agricultural safety campaigns target the issue of ROPS retrofits, and none have been evaluated systematically. This article reports a study that examines a set of messages that were central to the Community Partners for Healthy Farming project. This study indicates that narrative-based messages and messages incorporating fear appeals are more favorably evaluated by farmers than messages that simply inform farmers or messages that rely on statistics.

Identifying traffic safety needs - a systematic approach : [technical summary].

DOT National Transportation Integrated Search

2011-01-01

The Indiana Department of Transportation (INDOT) manages road safety in Indiana through safety emphasis areas, identification of safety needs within these areas, and development and implementation of transportation interventions that address the safe...

Review of the Methods to Obtain Paediatric Drug Safety Information: Spontaneous Reporting and Healthcare Databases, Active Surveillance Programmes, Systematic Reviews and Meta-analyses

PubMed

Gentili, Marta; Pozzi, Marco; Peeters, Gabrielle; Radice, Sonia; Carnovale, Carla

2018-02-06

Knowledge of drugs safety collected during the pre-marketing phase is inevitably limited because the randomized clinical trials (RCTs) are rarely designed to evaluate safety. The small and selective groups of enrolled individuals and the limited duration of trials may hamper the ability to characterize fully the safety profiles of drugs. Additionally, information about rare adverse drug reactions (ADRs) in special groups is often incomplete or not available for most of the drugs commonly used in the daily clinical practice. In the paediatric setting several highimpact safety issues have emerged. Hence, in recent years, there has been a call for improved post-marketing pharmacoepidemiological studies, in which cohorts of patients are monitored for sufficient time in order to determine the precise risk-benefit ratio. In this review, we discuss the current available strategies enhancing the post-marketing monitoring activities of the drugs in the paediatric setting and define criteria whereby they can provide valuable information to improve the management of therapy in daily clinical practice including both safety and efficacy aspects. The strategies we cover include the signal detection using international pharmacovigilance and/or healthcare databases, the promotion of active surveillance initiatives which can generate complete, informative data sets for the signal detection and systematic review/meta-analysis. Together, these methods provide a comprehensive picture of causality and risk improving the management of therapy in a paediatric setting and they should be considered as a unique tool to be integrated with post-marketing activities. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Consensus categorization of cheese based on water activity and pH-A rational approach to systemizing cheese diversity.

PubMed

Trmčić, A; Ralyea, R; Meunier-Goddik, L; Donnelly, C; Glass, K; D'Amico, D; Meredith, E; Kehler, M; Tranchina, N; McCue, C; Wiedmann, M

2017-01-01

Development of science-based interventions in raw milk cheese production is challenging due to the large diversity of production procedures and final products. Without an agreed upon categorization scheme, science-based food safety evaluations and validation of preventive controls would have to be completed separately on each individual cheese product, which is not feasible considering the large diversity of products and the typically small scale of production. Thus, a need exists to systematically group raw milk cheeses into logically agreed upon categories to be used for food safety evaluations. This paper proposes and outlines one such categorization scheme that provides for 30 general categories of cheese. As a base for this systematization and categorization of raw milk cheese, we used Table B of the US Food and Drug Administration's 2013 Food Code, which represents the interaction of pH and water activity for control of vegetative cells and spores in non-heat-treated food. Building on this table, we defined a set of more granular pH and water activity categories to better represent the pH and water activity range of different raw milk cheeses. The resulting categorization scheme was effectively validated using pH and water activity values determined for 273 different cheese samples collected in the marketplace throughout New York State, indicating the distribution of commercially available cheeses among the categories proposed here. This consensus categorization of cheese provides a foundation for a feasible approach to developing science-based solutions to assure compliance of the cheese processors with food safety regulations, such as those required by the US Food Safety Modernization Act. The key purpose of the cheese categorization proposed here is to facilitate product assessment for food safety risks and provide scientifically validated guidance on effective interventions for general cheese categories. Once preventive controls for a given category have been defined, these categories would represent safe havens for cheesemakers, which would allow cheesemakers to safely and legally produce raw milk cheeses that meet appropriate science-based safety requirements (e.g., risk to human health equivalent to pasteurized milk cheeses). Copyright © 2017 American Dairy Science Association. Published by Elsevier Inc. All rights reserved.

Huangqi injection (a traditional Chinese patent medicine) for chronic heart failure: a systematic review.

PubMed

Fu, Shufei; Zhang, Junhua; Menniti-Ippolito, Francesca; Gao, Xiumei; Galeotti, Francesca; Massari, Marco; Hu, Limin; Zhang, Boli; Ferrelli, Rita; Fauci, Alice; Firenzuoli, Fabio; Shang, Hongcai; Guerra, Ranieri; Raschetti, Roberto

2011-05-06

Chronic heart failure (CHF) is a global public health problem. Therefore, novel and effective drugs that show few side-effects are needed. Early literature studies indicated that Huangqi injection is one of the most commonly used traditional Chinese patent medicines for CHF in China. As a large number of clinical studies has been carried out and published, it is essential to evaluate the effectiveness and safety of Huangqi injection. Therefore, we carried out this systematic review under the support of the framework of the Joint Sino-Italian Laboratory (JoSIL). To evaluate the efficacy and safety of Huangqi injection for CHF according to the available scientific knowledge. An extensive search including PubMed, EMBASE, CBM, the Cochrane Library and Chinese literature databases was performed up to July 2008. Clinical trials regarding Huangqi injection for the treatment of CHF were searched for, irrespective of languages. The quality of each trial was assessed according to the Cochrane Reviewers' Handbook 5.0, and RevMan 5.0 provided by the Cochrane Collaboration and STATA 9.2 were used for data analysis. After selection of 1,205 articles, 62 RCTs and quasi-RCTs conducted in China and published in Chinese journals were included in the review. The methodological quality of the trials was low. In most trials inclusion and exclusion criteria were not specified. Furthermore, only one study evaluated the outcomes for drug efficacy after an adequate period of time. For these reasons and because of the different baseline characteristics we did not conduct a meta-analysis. Although available studies are not adequate to draw a conclusion on the efficacy and safety of Huangqi injection (a traditional Chinese patent medicine), we hope that our work could provide useful experience on further studies on Huangqi injections. The overall level of TCM clinical research needs to be improved so that the efficacy of TCM can be evaluated by the international community and possibly some TCM can enter into the international market.

Near-misses are an opportunity to improve patient safety: adapting strategies of high reliability organizations to healthcare.

PubMed

Van Spall, Harriette; Kassam, Alisha; Tollefson, Travis T

2015-08-01

Near-miss investigations in high reliability organizations (HROs) aim to mitigate risk and improve system safety. Healthcare settings have a higher rate of near-misses and subsequent adverse events than most high-risk industries, but near-misses are not systematically reported or analyzed. In this review, we will describe the strategies for near-miss analysis that have facilitated a culture of safety and continuous quality improvement in HROs. Near-miss analysis is routine and systematic in HROs such as aviation. Strategies implemented in aviation include the Commercial Aviation Safety Team, which undertakes systematic analyses of near-misses, so that findings can be incorporated into Standard Operating Procedures (SOPs). Other strategies resulting from incident analyses include Crew Resource Management (CRM) for enhanced communication, situational awareness training, adoption of checklists during operations, and built-in redundancy within systems. Health care organizations should consider near-misses as opportunities for quality improvement. The systematic reporting and analysis of near-misses, commonplace in HROs, can be adapted to health care settings to prevent adverse events and improve clinical outcomes.

Development of instruction in hospital electrical safety for medical education.

PubMed

Yoo, J H; Broderick, W A

1978-01-01

Although hospital electrical safety is receiving increased attention in the literature of engineers, it is not, at present, reflected in the curricula of medical schools. A possible reason for this omission is that biomedical and/or clinical engineers knowledgeable in electrical safety are not usually trained to teach. One remedy for this problem is to combine the knowledge of engineers with that of instructional developers to design a systematic curriculum for a course in hospital electrical safety. This paper describes such an effort at the University of Texas Health Science Center at San Antonio (UTHSCSA). A biomedical engineer and an instructional developer designed an instructional module in hospital electrical safety; the engineer taught the module, and both evaluated the results. The process and outcome of their collaboration are described. This model was effectively applied in the classroom as a four-hour segment in hospital electrical safety for first-year medical students at UTHSCSA. It is hoped that an additional benefit of this system will be that it offers an opportunity for continuing improvement in this kind of instruction at other medical schools and hospitals.

Steps to Ensure a Successful Implementation of Occupational Health and Safety Interventions at an Organizational Level

PubMed Central

Herrera-Sánchez, Isabel M.; León-Pérez, José M.; León-Rubio, José M.

2017-01-01

There is increasing meta-analytic evidence that addresses the positive impact of evidence-based occupational health and safety interventions on employee health and well-being. However, such evidence is less clear when interventions are approached at an organizational level and are aimed at changing organizational policies and processes. Given that occupational health and safety interventions are usually tailored to specific organizational contexts, generalizing and transferring such interventions to other organizations is a complex endeavor. In response, several authors have argued that an evaluation of the implementation process is crucial for assessing the intervention’s effectiveness and for understanding how and why the intervention has been (un)successful. Thus, this paper focuses on the implementation process and attempts to move this field forward by identifying the main factors that contribute toward ensuring a greater success of occupational health and safety interventions conducted at the organizational level. In doing so, we propose some steps that can guide a successful implementation. These implementation steps are illustrated using examples of evidence-based best practices reported in the literature that have described and systematically evaluated the implementation process behind their interventions during the last decade. PMID:29375413

Salvianolate injection in the treatment of unstable angina pectoris

PubMed Central

Zhang, Dan; Wu, Jiarui; Liu, Shi; Zhang, Xiaomeng; Zhang, Bing

2016-01-01

Abstract Background: To systematically evaluate the clinical efficacy and safety of Salvianolate injection in the treatment of unstable angina pectoris (UAP). Methods: Using literature databases, we conducted a thorough and systematic retrieval of randomized controlled trials (RCTs) that using Salvianolate injection for treating UAP. The Cochrane Risk of Bias Assessment Tool was used to evaluate the methodological quality of the RCTs, and then the data were extracted and meta-analyzed by RevMan5.2 software. Results: A total of 22 RCTs with 2050 participants were included. The meta-analysis indicated that the combined use of Salvianolate injection and western medicine (WM) in the treatment of UAP can achieve a superior effect in angina pectoris total effective rate (risk ratio [RR] = 1.22, 95% confidence interval [CI] (1.17, 1.27), Z = 10.15, P < 0.00001], and the total effectiveness rate of electrocardiogram [RR = 1.26, 95% CI (1.19,1.34), Z = 7.77, P < 0.00001]. In addition, Salvianolate injection can improve the nitroglycerin withdrawal rate and the serum level of NO, decrease high-sensitivity C-reactive protein. Adverse drug reactions (ADRs) or adverse drug events (ADEs) were reported in 6 RCTs involving 15 cases; however, there were no serious ADRs/ADEs. Conclusion: Based on the systematic review, the combined use of Salvianolate injection and WM in the treatment of UAP can achieve a better effect; however, there was no definitive conclusion about its safety. More the large-sample and multicenter RCTs are needed to support its clinical usage. PMID:28002341

Blood-letting therapy for the common cold: A protocol for a systematic review of controlled trials.

PubMed

Lee, Ju Ah; Hong, Minna; Lee, Myeong Soo; Yoon, Seong Hoon; Choi, Jun-Yong

2017-12-01

Many people experience the common cold, but there is currently no special treatment. For this reason, complementary and alternative medicine (CAM) therapies are used to improve the symptoms of the common cold. Blood-letting therapy (BL) is a CAM therapy that has been used for over 2000 years to treat various diseases. However, few studies have provided evidence for the efficacy and safety of BL for the common cold. This study aims to assess the effectiveness and safety of BL for the common cold. A total of 11 databases will be searched for studies conducted through June 2017. We will include randomized controlled trials assessing BL for the common cold. All randomized controlled trials on BL or related interventions will be included. Risk of bias will be assessed using the Cochrane Risk of Bias Assessment Tool, while confidence in the accumulated evidence will be evaluated using the Grading of Recommendations Assessment, Development and Evaluation instrument. This systematic review will be published in a peer-reviewed journal and will also be disseminated electronically and in print. The review will be updated to inform and guide healthcare practices. Copyright © 2017 The Authors. Published by Wolters Kluwer Health, Inc. All rights reserved.

Athlete's foot: oral antifungals

PubMed Central

2015-01-01

Introduction Around 15% to 30% of people are likely to have athlete's foot at any one time. The infection can spread to other parts of the body and to other people. Methods and outcomes We conducted a systematic overview, aiming to answer the following clinical question: What are the effects of oral treatments for athlete's foot? We searched: Medline, Embase, The Cochrane Library, and other important databases up to September 2014 (BMJ Clinical Evidence overviews are updated periodically; please check our website for the most up-to-date version of this overview). Results At this update, searching of electronic databases retrieved 335 studies. After deduplication and removal of conference abstracts, 210 records were screened for inclusion in the overview. Appraisal of titles and abstracts led to the exclusion of 162 studies and the further review of 48 full publications. Of the 48 full articles evaluated, one systematic review was included. We performed a GRADE evaluation for six PICO combinations. Conclusions In this systematic overview, we categorised the efficacy for one intervention based on information relating to the effectiveness and safety of oral antifungals versus placebo and different oral antifungals versus each other.

Helicobacter pylori eradication: gastric cancer prevention.

PubMed

Leontiadis, Grigorios I; Ford, Alexander Charles

2015-12-01

The principal effect of Helicobacter pylori infection is lifelong chronic gastritis, affecting up to 20% of younger adults but 50% to 80% of adults born in resource-rich countries before 1950. We conducted a systematic overview, aiming to answer the following clinical question: What are the effects of H pylori eradication treatment on the risk of developing gastric cancer? We searched: Medline, Embase, The Cochrane Library, and other important databases up to July 2014 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). At this update, searching of electronic databases retrieved 208 studies. After deduplication and removal of conference abstracts, 166 records were screened for inclusion in the overview. Appraisal of titles and abstracts led to the exclusion of 124 studies and the further review of 42 full publications. Of the 42 full articles evaluated, one systematic review was added at this update. We performed a GRADE evaluation for two PICO combinations. In this systematic overview, we categorised the efficacy for one intervention based on information about the effectiveness and safety of H pylori eradication treatment for the prevention of gastric cancer.

Burning mouth syndrome

PubMed Central

2016-01-01

Introduction Burning mouth syndrome mainly affects women, particularly after the menopause, when its prevalence may be 18% to 33%. Methods and outcomes We conducted a systematic overview, aiming to answer the following clinical question: What are the effects of selected treatments for burning mouth syndrome? We searched: Medline, Embase, The Cochrane Library, and other important databases up to January 2015 (BMJ Clinical Evidence overviews are updated periodically; please check our website for the most up-to-date version of this overview). Results At this update, searching of electronic databases retrieved 70 studies. After deduplication and removal of conference abstracts, 45 records were screened for inclusion in the overview. Appraisal of titles and abstracts led to the exclusion of 25 studies and the further review of 20 full publications. Of the 20 full articles evaluated, one systematic review and nine RCTs were added at this update. We performed a GRADE evaluation for five PICO combinations. Conclusions In this systematic overview, we categorised the efficacy for six interventions based on information about the effectiveness and safety of alphalipoic acid, benzodiazepines, benzydamine hydrochloride, cognitive behavioural therapy (CBT), selective serotonin re-uptake inhibitors (SSRIs), and tricyclic antidepressants. PMID:26745781

Integrative Review of the Intersection of Green Space and Neighborhood Violence.

PubMed

Mancus, Gibran C; Campbell, Jacquelyn

2018-03-01

To systematically analyze evidence about the impact of green space on the perception and actual safety of residents of urban neighborhoods. Systematic review of green space and violence based on Broome review criteria. One landmark study prompted the initial hand search and identification of search terms. Twenty-three quantitative, five qualitative, and two mixed-methods studies were found in the urban planning, public health, medical, and psychological literature that met the following criteria: analyzed green space and violence as factors in the perception of safety as an outcome measure, including action taken by being outside for recreation, exercise, or self-report in the survey. Findings were inconsistent regarding the direct relationship between perception of safety and green space when using recreation and exercise as a proxy for perception of safety. Findings regarding perception of safety in surveys were limited but indicated a positive correlation with green space. There is sufficient evidence to conclude that the perception of safety is supported by quality, accessibility, and aesthetic dimensions of neighborhood green space, and the perception of safety is often unrelated to actual crime rates. The science for understanding mechanisms between green space and violence as part of environmental health has been insufficiently developed and requires further study. Environmental health, including green space, is central to health promotion, and understanding is key to preventing the epidemic of violence. This article provides a summary of research related to green space, violence in communities, perception of safety, and violent crime in those communities. It identifies gaps in our knowledge where future research is needed. Nurses have the opportunity to lead the development, implementation, and evaluation of evidence-based interventions and policies addressing the inequality of quality and quantity of green space in the built and natural environment and related co-benefits. © 2018 Sigma Theta Tau International.

Prevention of all-terrain vehicle injuries: A systematic review from The Eastern Association for the Surgery of Trauma.

PubMed

Rattan, Rishi; Joseph, D'Andrea K; Dente, Christopher J; Klein, Eric N; Kimbrough, Mary K; Nguyen, Jonathan; Simmons, Jon D; O'Keeffe, Terence; Crandall, Marie

2018-06-01

Despite increasing usage since their introduction, there exist no evidence-based guidelines on all-terrain vehicles (ATVs) and injury prevention. While the power and speed of these vehicles has increased over time, advancements in ATV safety have been rare. A priori questions about ATV injury pattern and the effect of helmet and safety equipment use and legislation mandating use were developed. A query of MEDLINE, PubMed, Cochrane Library, and Embase for all-terrain vehicle injury was performed. Letters to the editor, case reports, book chapters, and review articles were excluded. Grading of Recommendations Assessment, Development, and Evaluation methodology was used to perform a systematic review and create recommendations. Twenty-eight studies were included. Helmet use reduced traumatic brain injury (TBI). However, studies examining whether legislation mandating helmet use reduced TBI had mixed results. When ATV safety legislation was enforced, overall injury rates and mortality decreased. However, enforcement varied widely and lack of enforcement led to decreased compliance with legislation and mixed results. There was not enough evidence to determine the effectiveness of non-helmet-protective equipment. Helmet use when riding an ATV reduced the rate of TBI. ATV safety legislation, when enforced, also reduced morbidity and mortality. Compliance with laws is often low, however, possibly due to poor enforcement. We recommend helmet use when riding on an ATV to reduce TBI. We conditionally recommend implementing ATV safety legislation as a means to reduce ATV injuries, noting that enforcement must go hand in hand with enactment to ensure compliance.

Application of an engineering problem-solving methodology to address persistent problems in patient safety: a case study on retained surgical sponges after surgery.

PubMed

Anderson, Devon E; Watts, Bradley V

2013-09-01

Despite innumerable attempts to eliminate the postoperative retention of surgical sponges, the medical error persists in operating rooms worldwide and places significant burden on patient safety, quality of care, financial resources, and hospital/physician reputation. The failure of countless solutions, from new sponge counting methods to radio labeled sponges, to truly eliminate the event in the operating room requires that the emerging field of health-care delivery science find innovative ways to approach the problem. Accordingly, the VA National Center for Patient Safety formed a unique collaboration with a team at the Thayer School of Engineering at Dartmouth College to evaluate the retention of surgical sponges after surgery and find a solution. The team used an engineering problem solving methodology to develop the best solution. To make the operating room a safe environment for patients, the team identified a need to make the sponge itself safe for use as opposed to resolving the relatively innocuous counting methods. In evaluation of this case study, the need for systematic engineering evaluation to resolve problems in health-care delivery becomes clear.

Cryosurgery would be An Effective Option for Clinically Localized Prostate Cancer: A Meta-analysis and Systematic Review

PubMed Central

Gao, Liang; Yang, Lu; Qian, Shengqiang; Tang, Zhuang; Qin, Feng; Wei, Qiang; Han, Ping; Yuan, Jiuhong

2016-01-01

Cryosurgery (CS) has been used on patients with clinically localized PCa for more than 10 years. However, clinical studies evaluating its effectiveness and safety have reported conflicting results. This systematic assessment was performed to obtain comprehensive evidence regarding the potential benefits and safety of CS compared with those of radiotherapy (RT) and radical prostatectomy (RP), respectively. All controlled trials comparing CS with RT or RP and single-arm studies reporting results of CS therapy were identified through comprehensive searches of PubMed, the Cochrane Library and Embase. Ten publications from seven trials, with totally 1252 patients, were included in the meta-analysis, which revealed no significant differences in comparisons of CS vs RT and CS vs RP for overall survival and disease specific survival. However, a significantly lower disease-free survival could be observed for CS than RP. Moreover, a systematic review of literature focusing on comparative data of databases and materials of single-arm trials revealed satisfactory survival results in both primary and salvage CS. Our results showed that cryosurgery would be a relatively effective method for clinically localized prostate cancer with survival results comparable to radiotherapy and radical prostatectomy. However, the large percentage of complications caused by cryosurgery should be carefully monitored. PMID:27271239

Identifying traffic safety needs - a systematic approach : research report and user manual.

DOT National Transportation Integrated Search

2012-01-01

The Indiana Department of Transportation (INDOT) manages road safety in Indiana through safety emphasis areas, identification of : safety needs within these areas, and development and implementation of transportation interventions that address the sa...

Structural precaution: the application of premarket approval schemes in EU food legislation.

PubMed

van der Meulen, Bernd M J; Bremmers, Harry J; Wijnands, Jo H M; Poppe, Krijn J

2012-01-01

Structural precaution refers to legal requirements by which food products (whether as ingredients, additives, genetically modified or innovative in some other form) are only admitted to the market after authorization by public authorities and till then are presumed unsafe. In the EU such authorization is granted after provision of conclusive scientific evidence of the product's safety by the applicant. The objective of this article is to critically evaluate structural precaution in the EU against the general principles of European and international law. Moreover, it addresses the positive and negative side-effects of structural precaution for food businesses. The methods which are applied are legal-systematic and empirical. Legal-systematic research shows that the European system of structural precaution may come into conflict with the principles of free trade. Empirical research on the effects of structural precaution shows that the barriers to market access impede food innovations, negatively impact competitiveness, and induce opportunistic strategic responses by food businesses. Among the opportunistic strategic responses that were identified are window-dressing, trespassing and circumventing. These may have adverse effects on food safety. This is remarkable since food safety is the key driving force behind the application of structural precaution. The article advocates an overhaul of the present European risk prevention framework. It argues that the newly proposed European legal framework for innovative foods only partly addresses the identified problems with which the food industry is confronted. Supplementary to legal-systematic overhaul, authorities should invest in accessibility and transparency of the legal framework and provide compliance assistance to reduce regulatory burdens.

The efficacy and safety of probiotics for prevention of chemoradiotherapy-induced diarrhea in people with abdominal and pelvic cancer: a systematic review and meta-analysis.

PubMed

Wang, Y-H; Yao, N; Wei, K-K; Jiang, L; Hanif, S; Wang, Z-X; Pei, C-X

2016-11-01

A systematic review and meta-analysis were designed to evaluate the efficacy and safety of probiotics for prevention of chemoradiotherapy-induced diarrhea in people with abdominal and pelvic cancer. We searched the Cochrane Library, PubMed, EMBASE and Web of Science up to November 2015. We also hand searched the citation lists of included studies and previously identified systematic reviews to identify further relevant trials. Odds ratio (OR) was used to compare efficacy, and the pooled OR was estimated using a random effects model; heterogeneity was assessed with Cochran's Q and the Higgins' I 2 -test. Two reviewers assessed trial quality and extracted data independently. Analysis and bias for each included study were performed using Review Manager 5.2. Nine randomized and placebo-controlled studies (N=1265 participants) were included for assessing efficacy, of which seven were about radiotherapy and two about chemotherapy. Probiotic groups were compared with control groups with respect to the the incidence of diarrhea, OR=0.47 (95% confidence interval 0.28-0.76; P=0.002). Eleven studies, including 1612 people (873 consuming probiotics and 739 not consuming probiotics), were used for the analysis of safety of probiotics. Of the 11 studies, seven studies had no adverse events (AEs) caused by probiotics, whereas four studies reported varying degrees of AEs in their treatment. Probiotics may have a beneficial effect in prevention of chemoradiotherapy-induced diarrhea generally, especially for Grade⩾2 diarrhea. Probiotics may rarely cause AEs.

Conbercept for patients with age-related macular degeneration: a systematic review.

PubMed

Zhang, Jiaxing; Liang, Yi; Xie, Juan; Li, Dong; Hu, Qian; Li, Xiaosi; Zheng, Wenyi; He, Rui

2018-06-15

Conbercept is a novel vascular endothelial growth factor (VEGF) inhibitor for the treatment of wet age-related macular degeneration (AMD). This systematic review aims to assess the efficacy and safety of conbercept in the treatment of wet AMD. PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure, VIP database, and Wanfang database were searched from their earliest records to June 2017. We included randomized controlled trials (RCTs) evaluating the efficacy and safety of conbercept in wet AMD patients. Outcomes included the mean changes from baseline in best-corrected visual acuity (BCVA) score (primary outcome), central retinal thickness (CRT), plasma level of vascular endothelial growth factor (VEGF) over time, and the incidence of adverse events (AEs). Eighteen RCTs (1285 participants) were included in this systematic review. Conbercept might improve BCVA compared to triamcinolone acetonide [MD = 0.11, 95% CI (0.08, 0.15)], and reduce CRT compared to the other four therapies (conservative treatment, ranibizumab, transpupillary thermotherapy, and triamcinolone acetonide). The incidence of AEs in patients receiving conbercept was significantly lower than those receiving triamcinolone acetonide [RR = 0.25, 95% CI (0.09-0.72)], but was similar to the other therapies. Conbercept seemed to be more effective than ranibizumab in lowering the plasma level of VEGF [MD = - 15.86, 95% CI (- 23.17, - 8.55)]. Current evidence shows that conbercept is a promising option for the treatment of wet AMD. Nevertheless, further studies are required to compare the efficacy, long-term safety and cost-effectiveness between conbercept and other anti-VEGF agents in different populations.

The provision and impact of online patient access to their electronic health records (EHR) and transactional services on the quality and safety of health care: systematic review protocol.

PubMed

Mold, Freda; Ellis, Beverley; de Lusignan, Simon; Sheikh, Aziz; Wyatt, Jeremy C; Cavill, Mary; Michalakidis, Georgios; Barker, Fiona; Majeed, Azeem; Quinn, Tom; Koczan, Phil; Avanitis, Theo; Gronlund, Toto Anne; Franco, Christina; McCarthy, Mary; Renton, Zoë; Chauhan, Umesh; Blakey, Hannah; Kataria, Neha; Jones, Simon; Rafi, Imran

2012-01-01

Innovators have piloted improvements in communication, changed patterns of practice and patient empowerment from online access to electronic health records (EHR). International studies of online services, such as prescription ordering, online appointment booking and secure communications with primary care, show good uptake of email consultations, accessing test results and booking appointments; when technologies and business process are in place. Online access and transactional services are due to be rolled out across England by 2015; this review seeks to explore the impact of online access to health records and other online services on the quality and safety of primary health care. To assess the factors that may affect the provision of online patient access to their EHR and transactional services, and the impact of such access on the quality and safety of health care. Two reviewers independently searched 11 international databases during the period 1999-2012. A range of papers including descriptive studies using qualitative or quantitative methods, hypothesis-testing studies and systematic reviews were included. A detailed eligibility criterion will be used to shape study inclusion. A team of experts will review these papers for eligibility, extract data using a customised extraction form and use the Grading of Recommendations Assessment, Development and Evaluation (GRADE) instrument to determine the quality of the evidence and the strengths of any recommendation. Data will then be descriptively summarised and thematically synthesised. Where feasible, we will perform a quantitative meta-analysis. Prospero (International Prospective Register of Systematic Reviews) registration number: crd42012003091.

Response Time Analysis and Test of Protection System Instrument Channels for APR1400 and OPR1000

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lee, Chang Jae; Han, Seung; Yun, Jae Hee

2015-07-01

Safety limits are required to maintain the integrity of physical barriers designed to prevent the uncontrolled release of radioactive materials in nuclear power plants. The safety analysis establishes two critical constraints that include an analytical limit in terms of a measured or calculated variable, and a specific time after the analytical limit is reached to begin protective action. Keeping with the nuclear regulations and industry standards, satisfying these two requirements will ensure that the safety limit will not be exceeded during the design basis event, either an anticipated operational occurrence or a postulated accident. Various studies on the setpoint determinationmore » methodology for the safety-related instrumentation have been actively performed to ensure that the requirement of the analytical limit is satisfied. In particular, the protection setpoint methodology for the advanced power reactor 1400 (APP1400) and the optimized power reactor 1000 (OPR1000) has been recently developed to cover both the design basis event and the beyond design basis event. The developed setpoint methodology has also been quantitatively validated using specific computer programs and setpoint calculations. However, the safety of nuclear power plants cannot be fully guaranteed by satisfying the requirement of the analytical limit. In spite of the response time verification requirements of nuclear regulations and industry standards, it is hard to find the studies on the systematically integrated methodology regarding the response time evaluation. In cases of APR1400 and OPR1000, the response time analysis for the plant protection system is partially included in the setpoint calculation and the response time test is separately performed via the specific plant procedure. The test technique has a drawback which is the difficulty to demonstrate completeness of timing test. The analysis technique has also a demerit of resulting in extreme times that not actually possible. Thus, the establishment of the systematic response time evaluation methodology is needed to justify the conformance to the response time requirement used in the safety analysis. This paper proposes the response time evaluation methodology for APR1400 and OPR1000 using the combined analysis and test technique to confirm that the plant protection system can meet the analytical response time assumed in the safety analysis. In addition, the results of the quantitative evaluation performed for APR1400 and OPR1000 are presented in this paper. The proposed response time analysis technique consists of defining the response time requirement, determining the critical signal path for the trip parameter, allocating individual response time to each component on the signal path, and analyzing the total response time for the trip parameter, and demonstrates that the total analyzed response time does not exceed the response time requirement. The proposed response time test technique is composed of defining the response time requirement, determining the critical signal path for the trip parameter, determining the test method for each component on the signal path, performing the response time test, and demonstrates that the total test result does not exceed the response time requirement. The total response time should be tested in a single test that covers from the sensor to the final actuation device on the instrument channel. When the total channel is not tested in a single test, separate tests on groups of components or single components including the total instrument channel shall be combined to verify the total channel response. For APR1400 and OPR1000, the ramp test technique is used for the pressure and differential pressure transmitters and the step function testing technique is applied to the signal processing equipment and final actuation device. As a result, it can be demonstrated that the response time requirement is satisfied by the combined analysis and test technique. Therefore, the proposed methodology in this paper plays a crucial role in guaranteeing the safety of the nuclear power plants systematically satisfying one of two critical requirements from the safety analysis. (authors)« less

Research and guidelines for implementing Fatigue Risk Management Systems for the French regional airlines.

PubMed

Cabon, Philippe; Deharvengt, Stephane; Grau, Jean Yves; Maille, Nicolas; Berechet, Ion; Mollard, Régis

2012-03-01

This paper describes research that aims to provide the overall scientific basis for implementation of a Fatigue Risk Management System (FRMS) for French regional airlines. The current research has evaluated the use of different tools and indicators that would be relevant candidates for integration into the FRMS. For the Fatigue Risk Management component, results show that biomathematical models of fatigue are useful tools to help an airline to prevent fatigue related to roster design and for the management of aircrew planning. The Fatigue Safety assurance includes two monitoring processes that have been evaluated during this research: systematic monitoring and focused monitoring. Systematic monitoring consists of the analysis of existing safety indicators such as Air Safety Reports (ASR) and Flight Data Monitoring (FDM). Results show a significant relationship between the hours of work and the frequency of ASR. Results for the FDM analysis show that some events are significantly related to the fatigue risk associated with the hours of works. Focused monitoring includes a website survey and specific in-flight observations and data collection. Sleep and fatigue measurements have been collected from 115 aircrews over 12-day periods (including rest periods). Before morning duties, results show a significant sleep reduction of up to 40% of the aircrews' usual sleep needs leading to a clear increase of fatigue during flights. From these results, specific guidelines are developed to help the airlines to implement the FRMS and for the airworthiness to oversight the implementation of the FRMS process. Copyright © 2011 Elsevier Ltd. All rights reserved.

Meta-analysis of food safety training on hand hygiene knowledge and attitudes among food handlers.

PubMed

Soon, Jan Mei; Baines, Richard; Seaman, Phillip

2012-04-01

Research has shown that traditional food safety training programs and strategies to promote hand hygiene increases knowledge of the subject. However, very few studies have been conducted to evaluate the impact of food safety training on food handlers' attitudes about good hand hygiene practices. The objective of this meta-analytical study was to assess the extent to which food safety training or intervention strategies increased knowledge of and attitudes about hand hygiene. A systematic review of food safety training articles was conducted. Additional studies were identified from abstracts from food safety conferences and food science education conferences. Search terms included combinations of "food safety," "food hygiene," "training," "education," "hand washing," "hand hygiene," "knowledge," "attitudes," "practices," "behavior," and "food handlers." Only before- and after-training approaches and cohort studies with training (intervention group) and without training (control group) in hand hygiene knowledge and including attitudes in food handlers were evaluated. All pooled analyses were based on a random effects model. Meta-analysis values for nine food safety training and intervention studies on hand hygiene knowledge among food handlers were significantly higher than those of the control (without training), with an effect size (Hedges' g) of 1.284 (95% confidence interval [CI] ∼ 0.830 to 1.738). Meta-analysis of five food safety training and intervention studies in which hand hygiene attitudes and self-reported practices were monitored produced a summary effect size of 0.683 (95% CI ∼ 0.523 to 0.843). Food safety training increased knowledge and improved attitudes about hand hygiene practices. Refresher training and long-term reinforcement of good food handling behaviors may also be beneficial for sustaining good hand washing practices.

A systematic review of the uses of fluoroscopy in dentistry.

PubMed

Uzbelger Feldman, Daniel; Yang, Jie; Susin, Cristiano

2010-01-01

To determine the quality of the evidence for the uses of fluoroscopy in dentistry. A systematic review using Ovid and MEDLINE was conducted to identify papers showing the uses of fluoroscopy in dentistry published between 1953 and September 2009. Human, animal and phantom/skull/mannequin studies on fluoroscopy with regard to its diagnostic value, research performance, and clinical and safety applications in dentistry were included in this analysis. Studies that were not in English, as well as those that employed fluoroscopy in dentistry without the use of image intensification, were excluded. Articles were evaluated, classified and graded by levels of evidence. Fifty-five out of 139 papers fulfilled the inclusion criteria. Amongst them, 19 were related to diagnosis, 15 to research, 12 to clinical and nine to safety applications. Fluoroscopy has contributed to nine different areas of dentistry. Also, it was used on 895 dental patients, 37 animals and 17 phantoms/skulls/mannequins. Two randomised controlled trials, two cohort studies, two case controls, 48 case reports and one expert opinion were found. Fluoroscopy with image intensification has been a useful, but not consistently used tool in dentistry for over 50 years. Several lines of evidence have shown fluoroscopy's diagnostic potential, research use, and clinical and safety applications in dentistry.

Supplement use by women during pregnancy: data from the Massachusetts General Hospital National Pregnancy Registry for Atypical Antipsychotics.

PubMed

Freeman, Marlene P; Sosinsky, Alexandra Z; Moustafa, Danna; Viguera, Adele C; Cohen, Lee S

2016-06-01

Women of reproductive age commonly use integrative treatments. However, the reproductive safety for most complementary products lacks systematic study. We aimed to study the use of supplements by women in a prospective pregnancy registry. The Massachusetts General Hospital National Pregnancy Registry for Atypical Antipsychotics was established to evaluate the reproductive safety of atypical antipsychotics. Exposed and control participants were systematically queried about the use of vitamins and supplements. Slightly greater than half (53.2 %) of the participants eligible for analysis (N = 534) were using at least one vitamin or supplement at the time of enrollment, not including prenatal vitamins or folic acid. The most common supplements used were omega-3 fatty acids (38.0 %), vitamin D (11.0 %), calcium (8.2 %), and iron (4.7 %). Probiotics and melatonin were used by 2.6 and 0.9 %, respectively. In this prospective pregnancy registry, we found that over half of the participants were taking supplements or vitamins other than prenatal vitamins and folic acid. These findings underscore the need for active query on the part of health care providers about the use of supplements during pregnancy, and the need to obtain rigorous reproductive safety and efficacy data for supplements used by pregnant women and reproductive aged women.

Human Reliability Program Workshop

DOE Office of Scientific and Technical Information (OSTI.GOV)

Landers, John; Rogers, Erin; Gerke, Gretchen

A Human Reliability Program (HRP) is designed to protect national security as well as worker and public safety by continuously evaluating the reliability of those who have access to sensitive materials, facilities, and programs. Some elements of a site HRP include systematic (1) supervisory reviews, (2) medical and psychological assessments, (3) management evaluations, (4) personnel security reviews, and (4) training of HRP staff and critical positions. Over the years of implementing an HRP, the Department of Energy (DOE) has faced various challenges and overcome obstacles. During this 4-day activity, participants will examine programs that mitigate threats to nuclear security andmore » the insider threat to include HRP, Nuclear Security Culture (NSC) Enhancement, and Employee Assistance Programs. The focus will be to develop an understanding of the need for a systematic HRP and to discuss challenges and best practices associated with mitigating the insider threat.« less

Evaluation of the neighborhood environment walkability scale in Nigeria.

PubMed

Oyeyemi, Adewale L; Sallis, James F; Deforche, Benedicte; Oyeyemi, Adetoyeje Y; De Bourdeaudhuij, Ilse; Van Dyck, Delfien

2013-03-21

The development of reliable and culturally sensitive measures of attributes of the built and social environment is necessary for accurate analysis of environmental correlates of physical activity in low-income countries, that can inform international evidence-based policies and interventions in the worldwide prevention of physical inactivity epidemics. This study systematically adapted the Neighborhood Environment Walkability Scale (NEWS) for Nigeria and evaluated aspects of reliability and validity of the adapted version among Nigerian adults. The adaptation of the NEWS was conducted by African and international experts, and final items were selected for NEWS-Nigeria after a cross-validation of the confirmatory factor analysis structure of the original NEWS. Participants (N = 386; female = 47.2%) from two cities in Nigeria completed the adapted NEWS surveys regarding perceived residential density, land use mix - diversity, land use mix - access, street connectivity, infrastructure and safety for walking and cycling, aesthetics, traffic safety, and safety from crime. Self-reported activity for leisure, walking for different purposes, and overall physical activity were assessed with the validated International Physical Activity Questionnaire (long version). The adapted NEWS subscales had moderate to high test-retest reliability (ICC range 0.59 -0.91). Construct validity was good, with residents of high-walkable neighborhoods reporting significantly higher residential density, more land use mix diversity, higher street connectivity, more traffic safety and more safety from crime, but lower infrastructure and safety for walking/cycling and aesthetics than residents of low-walkable neighborhoods. Concurrent validity correlations were low to moderate (r = 0.10 -0.31) with residential density, land use mix diversity, and traffic safety significantly associated with most physical activity outcomes. The NEWS-Nigeria demonstrated acceptable measurement properties among Nigerian adults and may be useful for evaluation of the built environment in Nigeria. Further adaptation and evaluation in other African countries is needed to create a version that could be used throughout the African region.

Safety of Traditional Arab Herbal Medicine

PubMed Central

Saad, Bashar; Azaizeh, Hassan; Abu-Hijleh, Ghassan; Said, Omar

2006-01-01

Herbal remedies are widely used for the treatment and prevention of various diseases and often contain highly active pharmacological compounds. Many medicinal herbs and pharmaceutical drugs are therapeutic at one dose and toxic at another. Toxicity related to traditional medicines is becoming more widely recognized as these remedies become popular in the Mediterranean region as well as worldwide. Most reports concerning the toxic effects of herbal medicines are associated with hepatotoxicity although reports of other toxic effects including kidney, nervous system, blood, cardiovascular and dermatologic effects, mutagenicity and carcinogenicity have also been published in the medical literature. This article presents a systematic review on safety of traditional Arab medicine and the contribution of Arab scholars to toxicology. Use of modern cell biological, biochemical, in vitro and in vivo techniques for the evaluation of medicinal plants safety is also discussed. PMID:17173106

Safety and immunogenicity of prepandemic H5N1 influenza vaccines: a systematic review of the literature.

PubMed

Prieto-Lara, Elisa; Llanos-Méndez, Aurora

2010-06-11

A systematic review was performed to assess the safety and immunogenicity of the prepandemic H5N1 influenza vaccines licensed so far. A bibliographic search according to the COSI protocol was carried out and 8 of 235 potentially relevant publications were selected. Quality assessment was defined with both CASP and Jadad checklists. Taken together, the results from the present systematic review suggest that the inactivated split-virion formulation that includes a low antigen dose (3.8 microg) and an oil-in-water emulsion-based adjuvant, represents the best option in the case of a pandemic, due to its antigen-sparing capacity and its favorable safety profile. (c) 2010 Elsevier Ltd. All rights reserved.

Validation of a Preclinical Spinal Safety Model: Effects of Intrathecal Morphine in the Neonatal Rat

PubMed Central

Westin, B. David; Walker, Suellen M.; Deumens, Ronald; Grafe, Marjorie; Yaksh, Tony L.

2010-01-01

Background Preclinical studies demonstrate increased neuroapoptosis after general anesthesia in early life. Neuraxial techniques may minimize potential risks, but there has been no systematic evaluation of spinal analgesic safety in developmental models. We aimed to validate a preclinical model for evaluating dose-dependent efficacy, spinal cord toxicity, and long term function following intrathecal morphine in the neonatal rat. Methods Lumbar intrathecal injections were performed in anesthetized rats aged postnatal day (P)3, 10 and 21. The relationship between injectate volume and segmental spread was assessed post mortem and by in-vivo imaging. To determine the antinociceptive dose, mechanical withdrawal thresholds were measured at baseline and 30 minutes following intrathecal morphine. To evaluate toxicity, doses up to the maximum tolerated were administered, and spinal cord histopathology, apoptosis and glial response were evaluated 1 and 7 days following P3 or P21 injection. Sensory thresholds and gait analysis were evaluated at P35. Results Intrathecal injection can be reliably performed at all postnatal ages and injectate volume influences segmental spread. Intrathecal morphine produced spinally-mediated analgesia at all ages with lower dose requirements in younger pups. High dose intrathecal morphine did not produce signs of spinal cord toxicity or alter long-term function. Conclusions The therapeutic ratio for intrathecal morphine (toxic dose / antinociceptive dose) was at least 300 at P3, and at least 20 at P21 (latter doses limited by side effects). This data provides relative efficacy and safety data for comparison with other analgesic preparations and contributes supporting evidence for the validity of this preclinical neonatal safety model. PMID:20526189

Validation of a preclinical spinal safety model: effects of intrathecal morphine in the neonatal rat.

PubMed

Westin, B David; Walker, Suellen M; Deumens, Ronald; Grafe, Marjorie; Yaksh, Tony L

2010-07-01

Preclinical studies demonstrate increased neuroapoptosis after general anesthesia in early life. Neuraxial techniques may minimize potential risks, but there has been no systematic evaluation of spinal analgesic safety in developmental models. We aimed to validate a preclinical model for evaluating dose-dependent efficacy, spinal cord toxicity, and long-term function after intrathecal morphine in the neonatal rat. Lumbar intrathecal injections were performed in anesthetized rats aged postnatal day (P) 3, 10, and 21. The relationship between injectate volume and segmental spread was assessed postmortem and by in vivo imaging. To determine the antinociceptive dose, mechanical withdrawal thresholds were measured at baseline and 30 min after intrathecal morphine. To evaluate toxicity, doses up to the maximum tolerated were administered, and spinal cord histopathology, apoptosis, and glial response were evaluated 1 and 7 days after P3 or P21 injection. Sensory thresholds and gait analysis were evaluated at P35. Intrathecal injection can be reliably performed at all postnatal ages and injectate volume influences segmental spread. Intrathecal morphine produced spinally mediated analgesia at all ages with lower dose requirements in younger pups. High-dose intrathecal morphine did not produce signs of spinal cord toxicity or alter long-term function. The therapeutic ratio for intrathecal morphine (toxic dose/antinociceptive dose) was at least 300 at P3 and at least 20 at P21 (latter doses limited by side effects). These data provide relative efficacy and safety for comparison with other analgesic preparations and contribute supporting evidence for the validity of this preclinical neonatal safety model.

Proposal of a risk-factor-based analytical approach for integrating occupational health and safety into project risk evaluation.

PubMed

Badri, Adel; Nadeau, Sylvie; Gbodossou, André

2012-09-01

Excluding occupational health and safety (OHS) from project management is no longer acceptable. Numerous industrial accidents have exposed the ineffectiveness of conventional risk evaluation methods as well as negligence of risk factors having major impact on the health and safety of workers and nearby residents. Lack of reliable and complete evaluations from the beginning of a project generates bad decisions that could end up threatening the very existence of an organization. This article supports a systematic approach to the evaluation of OHS risks and proposes a new procedure based on the number of risk factors identified and their relative significance. A new concept called risk factor concentration along with weighting of risk factor categories as contributors to undesirable events are used in the analytical hierarchy process multi-criteria comparison model with Expert Choice(©) software. A case study is used to illustrate the various steps of the risk evaluation approach and the quick and simple integration of OHS at an early stage of a project. The approach allows continual reassessment of criteria over the course of the project or when new data are acquired. It was thus possible to differentiate the OHS risks from the risk of drop in quality in the case of the factory expansion project. Copyright © 2011 Elsevier Ltd. All rights reserved.

Occupational safety beliefs among Latino residential roofing workers.

PubMed

Arcury, Thomas A; Summers, Phillip; Carrillo, Lourdes; Grzywacz, Joseph G; Quandt, Sara A; Mills, Thomas H

2014-06-01

This analysis describes beliefs about work safety and personal protective equipment (PPE) among Latino roofing workers, it delineates their perceptions of work environment characteristics that affect work safety and PPE use, and it describes how they experience work injuries and the consequences of these injuries. In-depth interviews were completed with 10 current and former Latino residential roofers. Interview transcripts were subjected to systematic qualitative analysis. Participants' valued productivity over safety, and this had a negative influence on their safety behavior and reduced their PPE use. They understood that roofing was hazardous. They limited use of PPE when they felt it reduced productivity and when it was uncomfortable. Work environment characteristics that affected safety included company size, the physical demands of the job, lack of training, the need for work, general life stress, and distractions at work. An injury had to result in lost work time to be considered significant. Access to health care is limited by employers not providing Workers' compensation. Future research is needed to substantiate these descriptive results and to delineate factors that are associated with safety behavior and use of PPE. Interventions, based on a lay health educator model, are needed to improve safety in this population. Safety regulations need to be evaluated and their enforcement needs to be improved. © 2013 Wiley Periodicals, Inc.

Teamwork Assessment Tools in Obstetric Emergencies: A Systematic Review.

PubMed

Onwochei, Desire N; Halpern, Stephen; Balki, Mrinalini

2017-06-01

Team-based training and simulation can improve patient safety, by improving communication, decision making, and performance of team members. Currently, there is no general consensus on whether or not a specific assessment tool is better adapted to evaluate teamwork in obstetric emergencies. The purpose of this qualitative systematic review was to find the tools available to assess team effectiveness in obstetric emergencies. We searched Embase, Medline, PubMed, Web of Science, PsycINFO, CINAHL, and Google Scholar for prospective studies that evaluated nontechnical skills in multidisciplinary teams involving obstetric emergencies. The search included studies from 1944 until January 11, 2016. Data on reliability and validity measures were collected and used for interpretation. A descriptive analysis was performed on the data. Thirteen studies were included in the final qualitative synthesis. All the studies assessed teams in the context of obstetric simulation scenarios, but only six included anesthetists in the simulations. One study evaluated their teamwork tool using just validity measures, five using just reliability measures, and one used both. The most reliable tools identified were the Clinical Teamwork Scale, the Global Assessment of Obstetric Team Performance, and the Global Rating Scale of performance. However, they were still lacking in terms of quality and validity. More work needs to be conducted to establish the validity of teamwork tools for nontechnical skills, and the development of an ideal tool is warranted. Further studies are required to assess how outcomes, such as performance and patient safety, are influenced when using these tools.

Air Travel Safety in Postoperative Breast Cancer Patients: A Systematic Review.

PubMed

Co, Michael; Ng, Judy; Kwong, Ava

2018-05-17

Air travel has long been a dilemma in post-breast cancer surgery patients. Anecdotal reports have described adverse outcomes on surgical wound, implants, and lymphedema during air travel. This review aims to evaluate the best evidence from the literature concerning the air travel safety in breast cancer patients. A comprehensive review was performed of the Medline, Embase, CINAHL, and Cochrane databases using a predefined strategy. Retrieved studies were independently screened and rated for relevance. Data were extracted by 2 researchers. We reviewed the best evidence on air travel safety in postoperative breast cancer patients. Evidence was limited in the current literature to suggest adverse effects on postoperative mastectomy wounds and drains by high-altitude travel. Similarly, adverse effects on breast implants were limited to case reports and ex vivo experiments. A systematic review of 12 studies concluded that air travel is not associated with upper limb lymphedema after breast cancer surgery. Deep-vein thrombosis (DVT) is a known complication after air travel; in addition, malignancy itself is a known risk factor for DVT. Evidence of safety to continue tamoxifen during the period of air travel is lacking in the literature. Evidence to support the use of systemic DVT prophylaxis in general postoperative breast cancer patients is also limited. Best evidence from a large retrospective study suggested that mechanical antiembolism devices and early mobilization are the only measures required. Air travel is generally safe in patients after breast cancer surgery. Copyright © 2018. Published by Elsevier Inc.

A systematic review and meta-analysis assessing adverse event profile and tolerability of nicergoline.

PubMed

Fioravanti, Mario; Nakashima, Taku; Xu, Jun; Garg, Amit

2014-07-30

To evaluate the safety profile of nicergoline compared with placebo and other active agents from published randomised controlled trials. Systematic review and meta-analysis of nicergoline compared with placebo and other active agents across various indications. MEDLINE, Medline-in-process, Cochrane, EMBASE, EMBASE alerts, Cochrane Central Register of Controlled Trials (CENTRAL), Cochrane Database of Systematic Reviews (CDSR) and Cochrane Methodology Register (CMR) for all the randomised controlled trials, open-label or blinded, in adults treated with nicergoline. Studies published until August 2013 were included. 29 studies were included for data extraction. The studies included in this review were majorly from European countries and mostly in cerebrovascular disease (n=15) and dementia (n=8). The treatment withdrawals were comparatively lower in the nicergoline group as compared with the placebo group (RR=0.92; 95% CI 0.7 to 1.21) and other active comparators (RR=0.45; 95% CI 0.10 to 1.95), but the difference was non-significant. Incidence of any adverse events (AEs) was slightly higher (RR=1.05; 95% CI 0.93 to 1.2) while incidence of serious AEs was lower (RR=0.85; 95% CI 0.50 to 1.45) in the nicergoline compared with placebo group. Frequency of anxiety was significantly lower in nicergoline as compared with placebo (p=0.01). Other AEs including diarrhoea, gastric upset, dizziness and drowsiness were less frequent in the nicergoline group when compared with placebo/active drugs, but the difference was non-significant. Frequency of hypotension and hot flushes was slightly higher in the nicergoline group but the difference was non-significant. None of the studies reported any incidence of fibrosis or ergotism with nicergoline treatment. Nicergoline is an ergot derivative, but its safety profile is better than other ergot derivatives like ergotamine and ergotoxine. This systematic review and meta-analysis suggests that nicergoline has a good safety profile. None of the studies included in this systematic review reported any incidence of fibrosis or ergotism with nicergoline. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

A systematic review and meta-analysis assessing adverse event profile and tolerability of nicergoline

PubMed Central

Fioravanti, Mario; Nakashima, Taku; Xu, Jun; Garg, Amit

2014-01-01

Objective To evaluate the safety profile of nicergoline compared with placebo and other active agents from published randomised controlled trials. Design Systematic review and meta-analysis of nicergoline compared with placebo and other active agents across various indications. Data sources MEDLINE, Medline-in-process, Cochrane, EMBASE, EMBASE alerts, Cochrane Central Register of Controlled Trials (CENTRAL), Cochrane Database of Systematic Reviews (CDSR) and Cochrane Methodology Register (CMR) for all the randomised controlled trials, open-label or blinded, in adults treated with nicergoline. Studies published until August 2013 were included. Review method 29 studies were included for data extraction. The studies included in this review were majorly from European countries and mostly in cerebrovascular disease (n=15) and dementia (n=8). Results The treatment withdrawals were comparatively lower in the nicergoline group as compared with the placebo group (RR=0.92; 95% CI 0.7 to 1.21) and other active comparators (RR=0.45; 95% CI 0.10 to 1.95), but the difference was non-significant. Incidence of any adverse events (AEs) was slightly higher (RR=1.05; 95% CI 0.93 to 1.2) while incidence of serious AEs was lower (RR=0.85; 95% CI 0.50 to 1.45) in the nicergoline compared with placebo group. Frequency of anxiety was significantly lower in nicergoline as compared with placebo (p=0.01). Other AEs including diarrhoea, gastric upset, dizziness and drowsiness were less frequent in the nicergoline group when compared with placebo/active drugs, but the difference was non-significant. Frequency of hypotension and hot flushes was slightly higher in the nicergoline group but the difference was non-significant. None of the studies reported any incidence of fibrosis or ergotism with nicergoline treatment. Conclusions Nicergoline is an ergot derivative, but its safety profile is better than other ergot derivatives like ergotamine and ergotoxine. This systematic review and meta-analysis suggests that nicergoline has a good safety profile. None of the studies included in this systematic review reported any incidence of fibrosis or ergotism with nicergoline. PMID:25079927

ICMR-DBT guidelines for evaluation of probiotics in food.

PubMed

2011-07-01

There has been an increased influx of probiotic products in the Indian market during the last decade. However, there has been no systematic approach for evaluation of probiotics in food to ensure their safety and efficacy. An initiative was, therefore, taken by the Indian Council of Medical Research (ICMR) along with the Department of Biotechnology (DBT) to formulate guidelines for regulation of probiotic products in the country. These guidelines define a set of parameters required for a product/strain to be termed as 'probiotic'. These include identification of the strain, in vitro screening for probiotic characteristics, animal studies to establish safety and in vivo animal and human studies to establish efficacy. The guidelines also include requirements for labeling of the probiotic products with strain specification, viable numbers at the end of shelf life, storage conditions, etc., which would be helpful to the consumers to safeguard their own interest.

Preterm birth: Case definition & guidelines for data collection, analysis, and presentation of immunisation safety data.

PubMed

Quinn, Julie-Anne; Munoz, Flor M; Gonik, Bernard; Frau, Lourdes; Cutland, Clare; Mallett-Moore, Tamala; Kissou, Aimee; Wittke, Frederick; Das, Manoj; Nunes, Tony; Pye, Savia; Watson, Wendy; Ramos, Ana-Maria Alguacil; Cordero, Jose F; Huang, Wan-Ting; Kochhar, Sonali; Buttery, Jim

2016-12-01

Preterm birth is commonly defined as any birth before 37 weeks completed weeks of gestation. An estimated 15 million infants are born preterm globally, disproportionately affecting low and middle income countries (LMIC). It contributes directly to estimated one million neonatal deaths annually and is a significant contributor to childhood morbidity. However, in many clinical settings, the information available to calculate completed weeks of gestation varies widely. Accurate dating of the last menstrual period (LMP), as well as access to clinical and ultrasonographic evaluation are important components of gestational age assessment antenatally. This case definition assign levels of confidence to categorisation of births as preterm, utilising assessment modalities which may be available across different settings. These are designed to enable systematic safety evaluation of vaccine clinical trials and post-implementation programmes of immunisations in pregnancy. Copyright © 2016. Published by Elsevier Ltd.

ICMR-DBT Guidelines for Evaluation of Probiotics in Food

PubMed Central

Ganguly, N.K.; Bhattacharya, S.K.; Sesikeran, B.; Nair, G.B; Ramakrishna, B.S.; Sachdev, H.P.S.; Batish, V.K.; Kanagasabapathy, A.S.; Muthuswamy, Vasantha; Kathuria, S.C; Katoch, V.M.; Satyanarayana, K.; Toteja, G.S; Rahi, Manju; Rao, Spriha; Bhan, M.K; Kapur, Rajesh; Hemalatha, R

2011-01-01

There has been an increased influx of probiotic products in the Indian market during the last decade. However, there has been no systematic approach for evaluation of probiotics in food to ensure their safety and efficacy. An initiative was, therefore, taken by the Indian Council of Medical Research (ICMR) along with the Department of Biotechnology (DBT) to formulate guidelines for regulation of probiotic products in the country. These guidelines define a set of parameters required for a product/strain to be termed as ‘probiotic’. These include identification of the strain, in vitro screening for probiotic characteristics, animal studies to establish safety and in vivo animal and human studies to establish efficacy. The guidelines also include requirements for labeling of the probiotic products with strain specification, viable numbers at the end of shelf life, storage conditions, etc., which would be helpful to the consumers to safeguard their own interest. PMID:21808130

Developing a Framework for Evaluating the Patient Engagement, Quality, and Safety of Mobile Health Applications.

PubMed

Singh, Karandeep; Drouin, Kaitlin; Newmark, Lisa P; Rozenblum, Ronen; Lee, Jaeho; Landman, Adam; Pabo, Erika; Klinger, Elissa V; Bates, David W

2016-02-01

Rising ownership of smartphones and tablets across social and demographic groups has made mobile applications, or apps, a potentially promising tool for engaging patients in their health care, particularly those with high health care needs. Through a systematic search of iOS (Apple) and Android app stores and an analysis of apps targeting individuals with chronic illnesses, we assessed the degree to which apps are likely to be useful in patient engagement efforts. Usefulness was determined based on the following criteria: description of engagement, relevance to the targeted patient population, consumer ratings and reviews, and most recent app update. Among the 1,046 health care-related, patient-facing applications identified by our search, 43 percent of iOS apps and 27 percent of Android apps appeared likely to be useful. We also developed criteria for evaluating the patient engagement, quality, and safety of mobile apps.

What effects have resident work-hour changes had on education, quality of life, and safety? A systematic review.

PubMed

Harris, Joshua D; Staheli, Greg; LeClere, Lance; Andersone, Diana; McCormick, Frank

2015-05-01

More than 15 years ago, the Institute of Medicine (IOM) identified medical error as a problem worthy of greater attention; in the wake of the IOM report, numerous changes were made to regulations to limit residents' duty hours. However, the effect of resident work-hour changes remains controversial within the field of orthopaedics. We performed a systematic review to determine whether work-hour restrictions have measurably influenced quality-of-life measures, operative and technical skill development, resident surgical education, patient care outcomes (including mortality, morbidity, adverse events, sentinel events, complications), and surgeon and resident attitudes (such as perceived effect on learning and training experiences, personal benefit, direct clinical experience, clinical preparedness). We performed a systematic review of PubMed, Scopus, CINAHL (Cumulative Index to Nursing and Allied Health Literature), and Google Scholar using PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Inclusion criteria were any English language peer-reviewed articles that analyzed the effect(s) of orthopaedic surgery resident work-hour restrictions on patient safety, resident education, resident/surgeon quality of life, resident technical operative skill development, and resident surgeon attitudes toward work-hour restrictions. Eleven studies met study inclusion criteria. One study was a prospective analysis, whereas 10 studies were of level IV evidence (review of surgical case logs) or survey results. Within our identified studies, there was some support for improved resident quality of life, improved resident sleep and less fatigue, a perceived negative impact on surgical operative and technical skill, and conflicting evidence on the topic of resident education, patient outcomes, and variable attitudes toward the work-hour changes. There is a paucity of high-level or clear evidence evaluating the effect of the changes to resident work hours. Future research in this area should focus on objective measures that include patient safety as a primary outcome.

The benefits of health information exchange: an updated systematic review.

PubMed

Menachemi, Nir; Rahurkar, Saurabh; Harle, Christopher A; Vest, Joshua R

2018-04-28

Widespread health information exchange (HIE) is a national objective motivated by the promise of improved care and a reduction in costs. Previous reviews have found little rigorous evidence that HIE positively affects these anticipated benefits. However, early studies of HIE were methodologically limited. The purpose of the current study is to review the recent literature on the impact of HIE. We used the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines to conduct our systematic review. PubMed and Scopus databases were used to identify empirical articles that evaluated HIE in the context of a health care outcome. Our search strategy identified 24 articles that included 63 individual analyses. The majority of the studies were from the United States representing 9 states; and about 40% of the included analyses occurred in a handful of HIEs from the state of New York. Seven of the 24 studies used designs suitable for causal inference and all reported some beneficial effect from HIE; none reported adverse effects. The current systematic review found that studies with more rigorous designs all reported benefits from HIE. Such benefits include fewer duplicated procedures, reduced imaging, lower costs, and improved patient safety. We also found that studies evaluating community HIEs were more likely to find benefits than studies that evaluated enterprise HIEs or vendor-mediated exchanges. Overall, these finding bode well for the HIEs ability to deliver on anticipated improvements in care delivery and reduction in costs.

Efficacy, acceptability and safety of guided imagery/hypnosis in fibromyalgia - A systematic review and meta-analysis of randomized controlled trials.

PubMed

Zech, N; Hansen, E; Bernardy, K; Häuser, W

2017-02-01

This systematic review aimed at evaluating the efficacy, acceptability and safety of guided imagery/hypnosis (GI/H) in fibromyalgia. Cochrane Library, MEDLINE, PsycINFO and SCOPUS were screened through February 2016. Randomized controlled trials (RCTs) comparing GI/H with controls were analysed. Primary outcomes were ≥50% pain relief, ≥20% improvement of health-related quality of life, psychological distress, disability, acceptability and safety at end of therapy and 3-month follow-up. Effects were summarized by a random effects model using risk differences (RD) or standardized mean differences (SMD) with 95% confidence intervals (CI).Seven RCTs with 387 subjects were included into a comparison of GI/H versus controls. There was a clinically relevant benefit of GI/H compared to controls on ≥50% pain relief [RD 0.18 (95% CI 0.02, 0.35)] and psychological distress [SMD -0.40 (95% CI -0.70, -0.11)] at the end of therapy. Acceptability at the end of treatment for GI/H was not significantly different to the control. Two RCTs with 95 subjects were included in the comparison of hypnosis combined with cognitive behavioural therapy (CBT) versus CBT alone. Combined therapy was superior to CBT alone in reducing psychological distress at the end of therapy [SMD -0.50 (95% CI -0.91, -0.09)]. There were no statistically significant differences between combined therapy and CBT alone in other primary outcomes at the end of treatment and follow-up. No study reported on safety. GI/H hold promise in a multicomponent management of fibromyalgia. We provide a systematic review with meta-analysis on guided imagery and hypnosis for fibromyalgia. Current analyses endorse the efficacy and tolerability of guided imagery/hypnosis and of the combination of hypnosis with cognitive-behavioural therapy in reducing key symptoms of fibromyalgia. © 2016 European Pain Federation - EFIC®.

The use of tramadol "on-demand" for premature ejaculation: a systematic review.

PubMed

Wong, Billy L K; Malde, Sachin

2013-01-01

To determine the efficacy and safety of tramadol in the treatment of premature ejaculation (PE) by systematically reviewing the results of randomized controlled trials. All studies evaluating the efficacy of tramadol for the treatment of PE published in peer reviewed medical journals between 2006 and March 2012 were identified by searching for the keywords "premature ejaculation" and "tramadol" in the PubMed database. Only randomized controlled trials published in the English language were included. A total of 5 articles, comprising 823 patients, met the inclusion criteria for further analysis. Overall, tramadol on-demand results in a significant improvement in mean intravaginal ejaculatory latency time and symptom scores compared with placebo and in an improvement in partner sexual satisfaction scores. The rate of short-term adverse effects is low. Tramadol is an effective treatment for patients with PE and represents a promising alternative to the currently used oral pharmacologic agents. Longer-term safety studies, and those comparing tramadol with the selective serotonin receptor inhibitors, are essential to determine the place of tramadol in the treatment of this distressing condition. Copyright © 2013 Elsevier Inc. All rights reserved.

Clinical and cost-effectiveness of non-medical prescribing: A systematic review of randomised controlled trials

PubMed Central

Marriott, John; Graham-Clarke, Emma; Shirley, Debra; Rushton, Alison

2018-01-01

Objective To evaluate the clinical and cost-effectiveness of non-medical prescribing (NMP). Design Systematic review. Two reviewers independently completed searches, eligibility assessment and assessment of risk of bias. Data sources Pre-defined search terms/combinations were utilised to search electronic databases. In addition, hand searches of reference lists, key journals and grey literature were employed alongside consultation with authors/experts. Eligibility criteria for included studies Randomised controlled trials (RCTs) evaluating clinical or cost-effectiveness of NMP. Measurements reported on one or more outcome(s) of: pain, function, disability, health, social impact, patient-safety, costs-analysis, quality adjusted life years (QALYs), patient satisfaction, clinician perception of clinical and functional outcomes. Results Three RCTs from two countries were included (n = 932 participants) across primary and tertiary care settings. One RCT was assessed as low risk of bias, one as high risk of bias and one as unclear risk of bias. All RCTs evaluated clinical effectiveness with one also evaluating cost-effectiveness. Clinical effectiveness was evaluated using a range of safety and patient-reported outcome measures. Participants demonstrated significant improvement in outcomes when receiving NMP compared to treatment as usual (TAU) in all RCTs. An associated cost analysis showed NMP to be more expensive than TAU (regression coefficient p = 0.0000), however experimental groups generated increased QALYs compared to TAU. Conclusion Limited evidence with overall unclear risk of bias exists evaluating clinical and cost-effectiveness of NMP across all professions and clinical settings. GRADE assessment revealed moderate quality evidence. Evidence suggests that NMP is safe and can provide beneficial clinical outcomes. Benefits to the health economy remain unclear, with the cost-effectiveness of NMP assessed by a single pilot RCT of low risk of bias. Adequately powered low risk of bias RCTs evaluating clinical and cost effectiveness are required to evaluate NMP across clinical specialities, professions and settings. Registration PROSPERO (CRD42015017212). PMID:29509763

Development of a Universal Safety Behavior Management System for Coal Mine Workers

PubMed Central

LI, Jizu; LI, Yuejiao; LIU, Xiaoguang

2015-01-01

Background: In China, over 80% of all work-related deaths in the mining industry occur in coal mines and human factors constitute 85% of the direct causes of coal mine accidents, which indicates that significant shortcomings currently exist in the safety behavior management of Chinese coal mine workers. We aimed to verify the impact of human psychological behavior in coal mine accidents systematically through experimental study, theoretical analysis and management application. Methods: Four test instruments (Sensory and cognitive capacity test, Sixteen-Personal Factor Questionnaire, Symptom Checklist 90 Questionnaire and the supervisors’ evaluation) were employed from November 2013 to June 2014 to identify unsafe behavior factors, the self-established Questionnaire of Safety Behavior Norms (QSBN) was also used to propose the safety behavior countermeasures of coal mine employees. Results: The mental health of most coal mine workers’ is relatively poor. The sensory and cognitive capacity of those in different work posts varies greatly, as does the sense of responsibility. Workers are susceptible to external influences, and score low in site management. When the 16-PF and SCL-90 sensory and cognitive assessments were combined, the psychological index predictive power was greatest for estimating sense of efficiency and degree of satisfaction in internal evaluations, while at the same time lowest for estimating control of introversion-extroversion and stress character. Conclusion: The psychological indicators can predict part of employee safety behavior, and assist a coal mine enterprise to recruit staff, develop occupational safety norms and improve the working environment. PMID:26258088

Safety of probiotics and synbiotics in children under 18 years of age.

PubMed

van den Nieuwboer, M; Brummer, R J; Guarner, F; Morelli, L; Cabana, M; Claassen, E

2015-01-01

This study aimed to systematically evaluate safety of probiotics and synbiotics in children ageing 0-18 years. This study is the third and final part in a safety trilogy and an update is provided using the most recent available clinical data (2008-2013) by means of the Common Terminology Clinical Adverse Events (CTCAE version 4.0) classification. Safety aspects are represented and related to number of participants per probiotic strain/culture, study duration, dosage, clinical condition and selected afflictions. Analysis of 74 clinical studies indicated that probiotic and/or synbiotic administration in children is safe with regard to the specific evaluated strains, dosages and duration. The population of children include healthy, immune compromised and obese subjects, as well as subjects with intestinal disorders, infections and inflammatory disorders. This study revealed no major safety concerns, as the adverse events (AEs) were unrelated, or not suspected to be related, to the probiotic or synbiotic product. In general the study products were well tolerated. Overall, AEs occurred more frequent in the control arm compared to children receiving probiotics and/or synbiotics. Furthermore, the results indicate inadequate reporting and classification of AEs in the majority of the studies. In addition, generalizability of conclusions are greatly limited by the inconsistent, imprecise and potentially incomplete reporting as well as the variation in probiotic strains, dosages, administration regimes, study populations and reported outcomes.

Prevention and assessment of infectious diseases among children and adult migrants arriving to the European Union/European Economic Association: a protocol for a suite of systematic reviews for public health and health systems

PubMed Central

Mayhew, Alain D; Morton, Rachael L; Greenaway, Christina; Akl, Elie A; Rahman, Prinon; Zenner, Dominik; Pareek, Manish; Tugwell, Peter; Welch, Vivian; Meerpohl, Joerg; Alonso-Coello, Pablo; Hui, Charles; Biggs, Beverley-Ann; Requena-Méndez, Ana; Agbata, Eric; Noori, Teymur; Schünemann, Holger J

2017-01-01

Introduction The European Centre for Disease Prevention and Control is developing evidence-based guidance for voluntary screening, treatment and vaccine prevention of infectious diseases for newly arriving migrants to the European Union/European Economic Area. The objective of this systematic review protocol is to guide the identification, appraisal and synthesis of the best available evidence on prevention and assessment of the following priority infectious diseases: tuberculosis, HIV, hepatitis B, hepatitis C, measles, mumps, rubella, diphtheria, tetanus, pertussis, poliomyelitis (polio), Haemophilus influenza disease, strongyloidiasis and schistosomiasis. Methods and analysis The search strategy will identify evidence from existing systematic reviews and then update the effectiveness and cost-effectiveness evidence using prospective trials, economic evaluations and/or recently published systematic reviews. Interdisciplinary teams have designed logic models to help define study inclusion and exclusion criteria, guiding the search strategy and identifying relevant outcomes. We will assess the certainty of evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Ethics and dissemination There are no ethical or safety issues. We anticipate disseminating the findings through open-access publications, conference abstracts and presentations. We plan to publish technical syntheses as GRADEpro evidence summaries and the systematic reviews as part of a special edition open-access publication on refugee health. We are following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Protocols reporting guideline. This protocol is registered in PROSPERO: CRD42016045798. PMID:28893741

Safety Evaluation of a Novel Strain of Bacteroides fragilis.

PubMed

Wang, Ye; Deng, Huimin; Li, Zhengchao; Tan, Yafang; Han, Yanping; Wang, Xiaoyi; Du, Zongmin; Liu, Yangyang; Yang, Ruifu; Bai, Yang; Bi, Yujing; Zhi, Fachao

2017-01-01

Commensal non-toxigenic Bacteroides fragilis confers powerful health benefits to the host, and has recently been identified as a promising probiotic candidate. We previously isolated B. fragilis strain ZY-312 and identified it as a novel strain based on 16S rRNA sequencing and morphological analyses. We also determined that ZY-312 displayed desirable probiotic properties, including tolerance to simulated digestive fluid, adherence, and in vitro safety. In this study, we aim to investigate whether ZY-312 meets the safety criteria required for probiotic bacteria through comprehensive and systematic evaluation. Consequently, the fatty acid profile, metabolite production, and biochemical activity of strain ZY-312 were found to closely resemble descriptions of B. fragilis in Bergey's manual. Taxonomic identification of strain ZY-312 based on whole genome sequencing indicated that ZY-312 and ATCC 25285 showed 99.99% similarity. The 33 putative virulence-associated factors identified in ZY-312 mainly encoded structural proteins and proteins with physiological activity, while the lack of bft indicated that ZY-312 was non-toxigenic. In vivo safety was proven in both normal and immune-deficient mice. The 11 identified antibiotic resistance genes were located on the chromosome rather than on a plasmid, ruling out the risk of plasmid-mediated transfer of antibiotic resistance. In vitro , ZY-312 showed resistance to cefepime, kanamycin, and streptomycin. Finally, and notably, ZY-312 exhibited high genetic stability after 100 passages in vitro . This study supplements the foundation work on the safety evaluation of ZY-312, and contributes to the development of the first probiotic representative from the dominant Bacteroidetes phylum.

Safety Evaluation of a Novel Strain of Bacteroides fragilis

PubMed Central

Deng, Huimin; Li, Zhengchao; Tan, Yafang; Han, Yanping; Wang, Xiaoyi; Du, Zongmin; Liu, Yangyang; Yang, Ruifu; Bai, Yang; Bi, Yujing; Zhi, Fachao

2017-01-01

Commensal non-toxigenic Bacteroides fragilis confers powerful health benefits to the host, and has recently been identified as a promising probiotic candidate. We previously isolated B. fragilis strain ZY-312 and identified it as a novel strain based on 16S rRNA sequencing and morphological analyses. We also determined that ZY-312 displayed desirable probiotic properties, including tolerance to simulated digestive fluid, adherence, and in vitro safety. In this study, we aim to investigate whether ZY-312 meets the safety criteria required for probiotic bacteria through comprehensive and systematic evaluation. Consequently, the fatty acid profile, metabolite production, and biochemical activity of strain ZY-312 were found to closely resemble descriptions of B. fragilis in Bergey’s manual. Taxonomic identification of strain ZY-312 based on whole genome sequencing indicated that ZY-312 and ATCC 25285 showed 99.99% similarity. The 33 putative virulence-associated factors identified in ZY-312 mainly encoded structural proteins and proteins with physiological activity, while the lack of bft indicated that ZY-312 was non-toxigenic. In vivo safety was proven in both normal and immune-deficient mice. The 11 identified antibiotic resistance genes were located on the chromosome rather than on a plasmid, ruling out the risk of plasmid-mediated transfer of antibiotic resistance. In vitro, ZY-312 showed resistance to cefepime, kanamycin, and streptomycin. Finally, and notably, ZY-312 exhibited high genetic stability after 100 passages in vitro. This study supplements the foundation work on the safety evaluation of ZY-312, and contributes to the development of the first probiotic representative from the dominant Bacteroidetes phylum. PMID:28367145

[Should we establish patient safety leadership walkrounds? A systematic review].

PubMed

Girerd-Genessay, I; Michel, P

2015-10-01

Used for over a decade, patient safety leadership walkrounds (PSLWs) is a managerial method designed to enhance the implementation of safety measures in hospitals. In order to determine the effect of PSLWs in French hospitals, we reviewed the literature on participant perceptions and the impact of PSLW on the overall culture of safety. We conducted a systematic review of articles assessing the impact of PSLWs on the culture of safety (comparative studies) or the perceptions of caregivers and managers (qualitative studies). Five studies investigating safety culture and three studies investigating participant perception were identified. PSLWs were associated with an improvement in safety culture and the overall safety climate. The presence of caregivers during the PSLWs was important to achieve improvement. PSLWs improved the dialogue between caregivers and managers, and improved knowledge on care safety. Some problems concerning managerial PSLW attendance and counter-productive attitudes have occasionally been reported. PSLWs improve safety culture. Their effectiveness depends on the way they are implemented. They should initially be tested in France to ensure their feasibility and acceptability in our healthcare system. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

Secondary use of data from hospital electronic prescribing and pharmacy systems to support the quality and safety of antimicrobial use: a systematic review.

PubMed

Micallef, Christianne; Chaudhry, Navila T; Holmes, Alison H; Hopkins, Susan; Benn, Jonathan; Franklin, Bryony Dean

2017-07-01

Electronic prescribing (EP) and electronic hospital pharmacy (EHP) systems are increasingly common. A potential benefit is the extensive data in these systems that could be used to support antimicrobial stewardship, but there is little information on how such data are currently used to support the quality and safety of antimicrobial use. To summarize the literature on secondary use of data (SuD) from EP and EHP systems to support quality and safety of antimicrobial use, to describe any barriers to secondary use and to make recommendations for future work in this field. We conducted a systematic search within four databases; we included original research studies that were (1) based on SuD from hospital EP or EHP systems and (2) reported outcomes relating to quality and/or safety of antimicrobial use and/or qualitative findings relating to SuD in this context. Ninety-four full-text articles were obtained; 14 met our inclusion criteria. Only two described interventions based on SuD; seven described SuD to evaluate other antimicrobial stewardship interventions and five described descriptive or exploratory studies of potential applications of SuD. Types of data used were quantitative antibiotic usage data ( n  =   9 studies), dose administration data ( n  =   4) and user log data from an electronic dashboard ( n  = 1). Barriers included data access, data accuracy and completeness, and complexity when using data from multiple systems or hospital sites. The literature suggests that SuD from EP and EHP systems is potentially useful to support or evaluate antimicrobial stewardship activities; greater system functionality would help to realize these benefits. © The Author 2017. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

A systematic review and meta-analysis on the safety of newly adjuvanted vaccines among children.

PubMed

Stassijns, Jorgen; Bollaerts, Kaatje; Baay, Marc; Verstraeten, Thomas

2016-02-03

New adjuvants such as the AS- or the MF59-adjuvants improve vaccine efficacy and facilitate dose-sparing. Their use in influenza and malaria vaccines has resulted in a large body of evidence on their clinical safety in children. We carried out a systematic search for safety data from published clinical trials on newly adjuvanted vaccines in children ≤10 years of age. Serious adverse events (SAEs), solicited AEs, unsolicited AEs and AEs of special interest were evaluated for four new adjuvants: the immuno-stimulants containing adjuvant systems AS01 and AS02, and the squalene containing oil-in-water emulsions AS03 and MF59. Relative risks (RR) were calculated, comparing children receiving newly adjuvanted vaccines to children receiving other vaccines with a variety of antigens, both adjuvanted and unadjuvanted. Twenty-nine trials were included in the meta-analysis, encompassing 25,056 children who received at least one dose of the newly adjuvanted vaccines. SAEs did not occur more frequently in adjuvanted groups (RR 0.85, 95%CI 0.75-0.96). Our meta-analyses showed higher reactogenicity following administration of newly adjuvanted vaccines, however, no consistent pattern of solicited AEs was observed across adjuvant systems. Pain was the most prevalent AE, but often mild and of short duration. No increased risks were found for unsolicited AEs, febrile convulsions, potential immune mediated diseases and new onset of chronic diseases. Our meta-analysis did not show any safety concerns in clinical trials of the newly adjuvanted vaccines in children ≤10 years of age. An unexplained increase of meningitis in one Phase III AS01-adjuvanted malaria trial and the link between narcolepsy and the AS03-adjuvanted pandemic vaccine illustrate that continued safety monitoring is warranted. Copyright © 2015 Elsevier Ltd. All rights reserved.

Safety and efficacy of autologous cell therapy in critical limb ischemia: a systematic review.

PubMed

Benoit, Eric; O'Donnell, Thomas F; Patel, Amit N

2013-01-01

Researchers have accumulated a decade of experience with autologous cell therapy in the treatment of critical limb ischemia (CLI). We conducted a systematic review of clinical trials in the literature to determine the safety and efficacy of cell therapy in CLI. We searched the literature for clinical trials of autologous cell therapy in CLI, including observational series of five or more patients to accrue a large pool of patients for safety analysis. Safety analysis included evaluation of death, cancer, unregulated angiogenesis, and procedural adverse events such as bleeding. Efficacy analysis included the clinical endpoints amputation and death as well as functional and surrogate endpoints. We identified 45 clinical trials, including seven RCTs, and 1,272 patients who received cell therapy. The overall adverse event rate was low (4.2%). Cell therapy patients did not have a higher mortality rate than control patients and demonstrated no increase in cancer incidence when analyzed against population rates. With regard to efficacy, cell therapy patients had a significantly lower amputation rate than control patients (OR 0.36, p = 0.0004). Cell therapy also demonstrated efficacy in a variety of functional and surrogate outcomes. Clinical trials differed in the proportion of patients with risk factors for clinical outcomes, and these influenced rates of amputation and death. Cell therapy presents a favorable safety profile with a low adverse event rate and no increase in severe events such as mortality and cancer and treatment with cell therapy decreases the risk of amputation. Cell therapy has a positive benefit-to-risk ratio in CLI and may be a valuable treatment option, particularly for those challenging patients who cannot undergo arterial reconstruction.

Safety Risk Knowledge Elicitation in Support of Aeronautical R and D Portfolio Management: A Case Study

NASA Technical Reports Server (NTRS)

Shih, Ann T.; Ancel, Ersin; Jones, Sharon Monica; Reveley, Mary S.; Luxhoj, James T.

2012-01-01

Aviation is a problem domain characterized by a high level of system complexity and uncertainty. Safety risk analysis in such a domain is especially challenging given the multitude of operations and diverse stakeholders. The Federal Aviation Administration (FAA) projects that by 2025 air traffic will increase by more than 50 percent with 1.1 billion passengers a year and more than 85,000 flights every 24 hours contributing to further delays and congestion in the sky (Circelli, 2011). This increased system complexity necessitates the application of structured safety risk analysis methods to understand and eliminate where possible, reduce, and/or mitigate risk factors. The use of expert judgments for probabilistic safety analysis in such a complex domain is necessary especially when evaluating the projected impact of future technologies, capabilities, and procedures for which current operational data may be scarce. Management of an R&D product portfolio in such a dynamic domain needs a systematic process to elicit these expert judgments, process modeling results, perform sensitivity analyses, and efficiently communicate the modeling results to decision makers. In this paper a case study focusing on the application of an R&D portfolio of aeronautical products intended to mitigate aircraft Loss of Control (LOC) accidents is presented. In particular, the knowledge elicitation process with three subject matter experts who contributed to the safety risk model is emphasized. The application and refinement of a verbal-numerical scale for conditional probability elicitation in a Bayesian Belief Network (BBN) is discussed. The preliminary findings from this initial step of a three-part elicitation are important to project management practitioners as they illustrate the vital contribution of systematic knowledge elicitation in complex domains.

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

PubMed

Maglione, Margaret A; Das, Lopamudra; Raaen, Laura; Smith, Alexandria; Chari, Ramya; Newberry, Sydne; Shanman, Roberta; Perry, Tanja; Goetz, Matthew Bidwell; Gidengil, Courtney

2014-08-01

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. 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. 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. 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. Copyright © 2014 by the American Academy of Pediatrics.

How Does Medical Device Regulation Perform in the United States and the European Union? A Systematic Review

PubMed Central

Kramer, Daniel B.; Xu, Shuai; Kesselheim, Aaron S.

2012-01-01

Background Policymakers and regulators in the United States (US) and the European Union (EU) are weighing reforms to their medical device approval and post-market surveillance systems. Data may be available that identify strengths and weakness of the approaches to medical device regulation in these settings. Methods and Findings We performed a systematic review to find empirical studies evaluating medical device regulation in the US or EU. We searched Medline using two nested categories that included medical devices and glossary terms attributable to the US Food and Drug Administration and the EU, following PRISMA guidelines for systematic reviews. We supplemented this search with a review of the US Government Accountability Office online database for reports on US Food and Drug Administration device regulation, consultations with local experts in the field, manual reference mining of selected articles, and Google searches using the same key terms used in the Medline search. We found studies of premarket evaluation and timing (n = 9), studies of device recalls (n = 8), and surveys of device manufacturers (n = 3). These studies provide evidence of quality problems in pre-market submissions in the US, provide conflicting views of device safety based largely on recall data, and relay perceptions of some industry leaders from self-surveys. Conclusions Few studies have quantitatively assessed medical device regulation in either the US or EU. Existing studies of US and EU device approval and post-market evaluation performance suggest that policy reforms are necessary for both systems, including improving classification of devices in the US and promoting transparency and post-market oversight in the EU. Assessment of regulatory performance in both settings is limited by lack of data on post-approval safety outcomes. Changes to these device approval and post-marketing systems must be accompanied by ongoing research to ensure that there is better assessment of what works in either setting. Please see later in the article for the Editors' Summary. PMID:22912563

A systematic review protocol on the effectiveness of therapeutic exercises utilised by physiotherapists to improve function in patients with burns.

PubMed

Mudawarima, Tapfuma; Chiwaridzo, Matthew; Jelsma, Jennifer; Grimmer, Karen; Muchemwa, Faith Chengetayi

2017-10-23

Therapeutic exercises play a crucial role in the management of burn injuries. The broad objective of this review is to systematically evaluate the effectiveness, safety and applicability to low-income countries of therapeutic exercises utilised by physiotherapists to improve function in patients with burns. Population = adults and children/adolescents with burns of any aspect of their bodies. Interventions = any aerobic and/or strength exercises delivered as part of a rehabilitation programme by anyone (e.g. physiotherapists, occupational therapists, nurses, doctors, community workers and patients themselves). Comparators = any comparator. Outcomes = any measure of outcome (e.g. quality of life, pain, muscle strength, range of movement, fear or quality of movement). Settings = any setting in any country. A systematic review will be conducted by two blinded independent reviewers who will search articles on PubMed, CiNAHL, Cochrane library, Medline, Pedro, OTseeker, EMBASE, PsychINFO and EBSCOhost using predefined criteria. Studies of human participants of any age suffering from burns will be eligible, and there will be no restrictions on total body surface area. Only randomised controlled trials will be considered for this review, and the methodological quality of studies meeting the selection criteria will be evaluated using the Cochrane Collaboration tool for assessing risk of bias. The PRISMA reporting standards will be used to write the review. A narrative analysis of the findings will be done, but if pooling is possible, meta-analysis will be considered. Burns may have a long-lasting impact on both psychological and physical functioning and thus it is important to identify and evaluate the effects of current and past aerobic and strength exercises on patients with burns. By identifying the characteristics of effective exercise programmes, guidelines can be suggested for developing intervention programmes aimed at improving the function of patients with burns. The safety and precautions of exercise regimes and the optimal frequency, duration, time and intensity will also be examined to inform further intervention. PROSPERO CDR42016048370 .

The effectiveness of assertiveness communication training programs for healthcare professionals and students: A systematic review.

PubMed

Omura, Mieko; Maguire, Jane; Levett-Jones, Tracy; Stone, Teresa Elizabeth

2017-11-01

Communication errors have a negative impact on patient safety. It is therefore essential that healthcare professionals have the skills and confidence to speak up assertively when patient safety is at risk. Although the facilitators to and barriers of assertive communication have been the subject of previous reviews, evidence regarding the effectiveness of interventions designed to enhance assertive communication is lacking. Thus, this paper reports the findings from a systematic review of the effectiveness of assertiveness communication training programs for healthcare professionals and students. The objective of this review is to identify, appraise and synthesise the best available quantitative evidence in relation to the effectiveness of assertiveness communication training programs for healthcare professionals and students on levels of assertiveness, communication competence and impact on clinicians' behaviours and patient safety. The databases included: CINAHL, Cochrane library, EMBASE, Informit health collection, MEDLINE, ProQuest nursing and allied health, PsycINFO, Scopus and Web of Science. The search for unpublished studies included: MedNar, ProQuest Dissertations & Theses A&I. Studies published in English from 2001 until 2016 inclusive were considered. The review included original quantitative research that evaluated (a) any type of independent assertiveness communication training program; and (b) programs with assertiveness training included as a core component of team skills or communication training for healthcare professionals and students, regardless of healthcare setting and level of qualification of participants. Studies selected based on eligibility criteria were assessed for methodological quality and the data were extracted by two independent researchers using the Joanna Briggs Institute critical appraisal and data extraction tools. Eleven papers were critically appraised using the Joanna Briggs Institute critical appraisal checklists. Eight papers from the USA, Australia, Ireland, and Taiwan were included in the review. Interventions to improve assertive communication were reported to be effective to some degree with all targeted groups except experienced anaesthesiologists. Face-to-face and multimethod programs, support from leaders, teamwork skills training and communication techniques adapted from the aviation industry were identified as appropriate approaches for optimising the effectiveness of assertiveness communication training programs. Behavioural change as the result of assertiveness interventions was evaluated by observer-based rating scales during simulation, whilst self-perceived knowledge and attitudes were evaluated using validated scales. Future research should consider evaluation of sustained effect on behaviour change and patient safety. Copyright © 2017 Elsevier Ltd. All rights reserved.

A Systematic Review of the Effects of Resident Duty Hour Restrictions in Surgery

PubMed Central

Devitt, Katharine S.; Keshet, Itay; Spicer, Jonathan; Imrie, Kevin; Feldman, Liane; Cools-Lartigue, Jonathan; Kayssi, Ahmed; Lipsman, Nir; Elmi, Maryam; Kulkarni, Abhaya V.; Parshuram, Chris; Mainprize, Todd; Warren, Richard J.; Fata, Paola; Gorman, M. Sean; Feinberg, Stan; Rutka, James

2014-01-01

Background: In 2003, the Accreditation Council for Graduate Medical Education (ACGME) mandated 80-hour resident duty limits. In 2011 the ACGME mandated 16-hour duty maximums for PGY1 (post graduate year) residents. The stated goals were to improve patient safety, resident well-being, and education. A systematic review and meta-analysis were performed to evaluate the impact of resident duty hours (RDH) on clinical and educational outcomes in surgery. Methods: A systematic review (1980–2013) was executed on CINAHL, Cochrane Database, Embase, Medline, and Scopus. Quality of articles was assessed using the GRADE guidelines. Sixteen-hour shifts and night float systems were analyzed separately. Articles that examined mortality data were combined in a random-effects meta-analysis to evaluate the impact of RDH on patient mortality. Results: A total of 135 articles met the inclusion criteria. Among these, 42% (N = 57) were considered moderate-high quality. There was no overall improvement in patient outcomes as a result of RDH; however, some studies suggest increased complication rates in high-acuity patients. There was no improvement in education related to RDH restrictions, and performance on certification examinations has declined in some specialties. Survey studies revealed a perception of worsened education and patient safety. There were improvements in resident wellness after the 80-hour workweek, but there was little improvement or negative effects on wellness after 16-hour duty maximums were implemented. Conclusions: Recent RDH changes are not consistently associated with improvements in resident well-being, and have negative impacts on patient outcomes and performance on certification examinations. Greater flexibility to accommodate resident training needs is required. Further erosion of training time should be considered with great caution. PMID:24662409

Safety and efficacy of encapsulated fecal microbiota transplantation for recurrent Clostridium difficile infection: a systematic review.

PubMed

Iqbal, Umair; Anwar, Hafsa; Karim, Muhammad A

2018-07-01

Fecal microbial transplantation (FMT) has been shown to be effective for the treatment of recurrent clostridium difficile infection (CDI). The efficacy and safety of freeze-dried encapsulated FMT for the treatment of recurrent CDI is unclear. We performed a systematic review to evaluate and analyze the current evidence in this respect. A systematic literature search was performed using the PubMed, Embase, and Medline databases until December 2017 to identify all original studies that investigated the role of administration of encapsulated FMT in recurrent CDI. The study included patients of all ages. Two independent reviewers extracted data and assessed the quality of publications; a third investigator resolved any discrepancies. A total of six studies, five case series and one randomized-controlled trial, were included in this review. Overall, 341 patients completed treatment with encapsulated FMT. Only three major adverse events were reported and no deaths occurred directly related to FMT. In all, 285 patients responded to the first treatment, with no recurrence during the specified follow-up period set to meet the primary endpoint. Forty-two patients underwent a second treatment, with resolution of symptoms in 28 patients. At least five patients were reported to undergo a third treatment, with resolution in three of them. Only one patient was reported to have received four treatments without long-term resolution of symptoms. Low-quality to moderate-quality evidence showed that encapsulated FMT is safe and cost-effective for the treatment and prevention of recurrent CDI. Its efficacy is not inferior to FMT performed through the nonoral route. Randomized-controlled trials are necessary to compare its efficacy with oral antimicrobial drugs and also to evaluate the potential adverse effects associated with the treatment.

[Evidence-based Chinese medicine：theory and practice].

PubMed

Zhang, Jun-Hua; Li, You-Ping; Zhang, Bo-Li

2018-01-01

The introduction and popularization of evidence-based medicine has opened up a new research field of clinical efficacy evaluation of traditional Chinese medicine(TCM), produced new research ideas and methods, and promoted the progress of clinical research of TCM. After about 20 years assiduous study and earnest practice, the evidence based evaluation method and technique, which conforms to the characteristics of TCM theory and practice, has been developing continuously. Evidence-based Chinese medicine (EBCM) has gradually formed and become an important branch of evidence-based medicine. The basic concept of evidence-based Chinese medicine: EBCM is an applied discipline, following the theory and methodology of evidence-based medicine, to collect, evaluate, produce, transform the evidence of effectiveness, safety and economy of TCM, to reveal the feature and regular pattern of TCM taking effect, and to guide the development of clinical guidelines, clinical pathways and health decisions. The effects and achievements of EBCM development: secondary studies mainly based on systematic review/Meta-analysis were extensively carried out; clinical efficacy studies mainly relying on randomized controlled trials grew rapidly; clinical safety evaluations based on real world study have been conducted; methodological researches mainly focused on study quality control deepened gradually; internationalization researches mainly on report specifications have got some breakthroughs; standardization researches based on treatment specification were strengthened gradually; the research team and talents with the characteristics of inter-disciplinary have been steadily increased. A number of high-quality research findings have been published at international well-known journals; the clinical efficacy and safety evidence of TCM has been increased; the level of clinical rational use of TCM has been improved; a large number of Chinese patent medicines with big market have been cultured. The future missions of EBCM mainly consist of four categories (scientific research, methodology and standard, platform construction and personnel training) with nine tasks. ①Carry out systematic reviews to systematically collect clinical trial reports of TCM and establish database of clinical evidence of TCM; ②Carry out evidence transformation research to lay the foundation for the development of clinical diagnosis and treatment guidelines, clinical pathways of TCM, and for the screening of basic drug list and medical insurance list, and for the policy-making relevant to TCM; ③Conduct researches to evaluate the advantages and effective regular patterns of TCM and form the evidence chain of TCM efficacy; ④Carry out researches for the safety evaluation of TCM, and provide evidence supporting the rational and safe use of TCM in clinical practice; ⑤Conduct researches on methodology of EBCM and provide method for developing high quality evidence; ⑥Carry out researches to develop standards and norms of TCM, and to form methods, standards, specifications and technical systems; ⑦Establish data management platform for evidence-based evaluation of TCM, and promote data sharing; ⑧Build international academic exchange platform to promote international cooperation and mutual recognition of EBCM research; ⑨Carry out education and popularization activities of evidence-based evaluation methods, and train undergraduate students, graduate students, clinical healthcare providers and practitioners of TCM. The development of EBCM, as it was, not only promoted the transformation of clinical research and decision-making mode of TCM, contributed to the modernization and internationalization of TCM, but also enriched the connotation of Evidence-based Medicine. Copyright© by the Chinese Pharmaceutical Association.

Development and application of a safety assessment methodology for waste disposals

DOE Office of Scientific and Technical Information (OSTI.GOV)

Little, R.H.; Torres, C.; Schaller, K.H.

1996-12-31

As part of a European Commission funded research programme, QuantiSci (formerly the Environmental Division of Intera Information Technologies) and Instituto de Medio Ambiente of the Centro de Investigaciones Energeticas Medioambientales y Tecnologicas (IMA/CIEMAT) have developed and applied a comprehensive, yet practicable, assessment methodology for post-disposal safety assessment of land-based disposal facilities. This Safety Assessment Comparison (SACO) Methodology employs a systematic approach to the collection, evaluation and use of waste and disposal system data. It can be used to assess engineered barrier performance, the attenuating properties of host geological formations, and the long term impacts of a facility on the environmentmore » and human health, as well as allowing the comparison of different disposal options for radioactive, mixed and non-radioactive wastes. This paper describes the development of the methodology and illustrates its use.« less

Appropriateness of oral drugs for long-term treatment of lower urinary tract symptoms in older persons: results of a systematic literature review and international consensus validation process (LUTS-FORTA 2014).

PubMed

Oelke, Matthias; Becher, Klaus; Castro-Diaz, David; Chartier-Kastler, Emmanuel; Kirby, Mike; Wagg, Adrian; Wehling, Martin

2015-09-01

we aimed to systematically review drugs to treat lower urinary tract symptoms (LUTS) regularly used in older persons to classify appropriate and inappropriate drugs based on efficacy, safety and tolerability by using the Fit fOR The Aged (FORTA) classification. to evaluate the efficacy, safety and tolerability of drugs used for treatment of LUTS in older persons, a systematic review was performed. Papers on clinical trials and summaries of individual product characteristics were analysed regarding efficacy and safety in older persons (≥65 years). The most frequently used drugs were selected based on current prescription data. An interdisciplinary international expert panel assessed the drugs in a Delphi process. for the 16 drugs included here, a total of 896 citations were identified; of those, only 25 reported clinical trials with explicit data on, or solely performed in older people, underlining the lack of evidence in older people for drug treatment of LUTS. No drug was rated at the FORTA-A-level (indispensable). Only three were assigned to FORTA B (beneficial): dutasteride, fesoterodine and finasteride. The majority was rated FORTA C (questionable): darifenacin, mirabegron, extended release oxybutynin, silodosin, solifenacin, tadalafil, tamsulosin, tolterodine and trospium. FORTA D (avoid) was assigned to alfuzosin, doxazosin, immediate release oxybutynin, propiverine and terazosin. dutasteride, fesoterodine and finasteride were classified as beneficial in older persons or frail elderly people (FORTA B). For most drugs, in particular those from the group of α-blockers and antimuscarinics, use in this group seems questionable (FORTA C) or should be avoided (FORTA D). © The Author 2015. Published by Oxford University Press on behalf of the British Geriatrics Society. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Safety of gelatin solutions for the priming of cardiopulmonary bypass in cardiac surgery: a systematic review and meta-analysis.

PubMed

Ghijselings, Idris; Himpe, Dirk; Rex, Steffen

2017-07-01

This systematic review and meta-analysis was conducted to evaluate the safety of gelatin versus hydroxyethyl starches (HES) and crystalloids when used for cardiopulmonary bypass (CPB)-priming in cardiac surgery. MEDLINE (Pubmed), Embase and CENTRAL were searched. We included only randomized, controlled trials comparing CPB-priming with gelatin with either crystalloids or HES-solutions of the newest generation. The primary endpoint was the blood loss during the first 24 hours. Secondary outcomes included perioperative transfusion requirements, postoperative kidney function, postoperative ventilation times and length of stay on the intensive care unit. Sixteen studies were identified, of which only ten met the inclusion criteria, representing a total of 824 adult patients: 4 studies compared gelatin with crystalloid, and 6 studies gelatin with HES priming. Only 2 of the studies comparing HES and gelatin reported postoperative blood loss after 24 hours. No significant difference in postoperative blood loss was found when results of both studies were pooled (SMD -0.12; 95% CI: -0.49, 0.25; P=0.52). Likewise, the pooled results of 3 studies comparing gelatin and crystalloids as a priming solution could not demonstrate significant differences in postoperative bleeding after 24 hours (SMD -0.07; 95% CI: -0.40, 0.26; P=0.68). No differences regarding any of the secondary outcomes could be identified. This systematic review suggests gelatins to have a safety profile which is non-inferior to modern-generation tetrastarches or crystalloids. However, the grade of evidence is rated low owing to the poor methodological quality of the included studies, due to inconsistent outcome reporting and lack of uniform endpoint definitions.

Shift and night work and long working hours--a systematic review of safety implications.

PubMed

Wagstaff, Anthony Sverre; Sigstad Lie, Jenny-Anne

2011-05-01

In order to devise effective preventive strategies, it is important to study workplace stressors that might increase the risk of workplace accidents - both affecting workers themselves as well as causing harm to third-parties. The aim of this report is to provide a systematic, updated overview and scientific review of empirical research regarding accidents in relation to long work hours and shift work, primarily based on epidemiological studies. The search for articles was part of a large review study on the effects of work hours on various health outcomes, safety, and performance. The search strategy included 5 international scientific databases, and nearly 7000 articles were initially identified using our search string. Following the application of inclusion and exclusion criteria, 443 publications were found and evaluated using a pre-defined scoring system. Of these, 43 concerned safety and accidents but only 14 were considered to be of high quality (total score 2 or 3 on a scale from 0-3) and therefore used for this study. Both shift work and long working hours present a substantial and well-documented detrimental effect on safety - all the studies that are included in this review have one or more significant findings in this respect. The trends are quite coherent although the increases in accident rates are mostly from 50% to 100%. In epidemiological terms, this may be seen as rather small differences. The use of such data is therefore only of importance if the accident incidence is high or if accidents may have large effects. The findings are most relevant to safety-critical activities such as the transport and health sectors. Work periods >8 hours carry an increased risk of accidents that cumulates, so that the increased risk of accidents at around 12 hours is twice the risk at 8 hours. Shift work including nights carries a substantial increased risk of accidents, whereas "pure" night work may bring some protection against this effect due to resynchronization. The evaluated studies give no clear indications of any age or gender being specifically susceptible or protected against the effects of work times scheduling on accident risk.

GEDOS-SECOT consensus on the care process of patients with knee osteoarthritis and arthoplasty.

PubMed

Ruiz Iban, M A; Tejedor, A; Gil Garay, E; Revenga, C; Hermosa, J C; Montfort, J; Peña, M J; López Millán, J M; Montero Matamala, A; Capa Grasa, A; Navarro, M J; Gobbo, M; Loza, E

To develop recommendations on the evaluation and management procedure in patients undergoing total knee replacement based on best evidence and the experience of a panel of experts. A multidisciplinary group of 12 experts was selected that defined the scope, users and the document parts. Three systematic reviews were performed in patients undergoing knee replacement: (i)efficacy and safety of fast-tracks; (ii)efficacy and safety of cognitive interventions in patients with catastrophic pain, and (iii) efficacy and safety of acute post-surgical pain management on post-surgical outcomes. A narrative review was conducted on the evaluation and management of pain sensitization, and about the efficacy and safety of pre-surgical physiotherapy. The experts generated the recommendations and explicative text. The level of agreement was evaluated in a multidisciplinary group of 85 experts with the Delphi technique. The level of evidence was established as well for each recommendation. A total of 20 recommendations were produced. An agreement higher than 80% was reached in all of them. We found the highest agreement on the need for a full discharge report, on providing proper information about the process and on following available guidelines. There is consensus among professionals involved in the management of patients undergoing total knee replacement, in that it is important to protocolize the replacement process, performing a proper, integrated and coordinated patient evaluation and follow-up, paying special attention to the surgical procedure and postoperative period. Copyright © 2017 SECOT. Publicado por Elsevier España, S.L.U. All rights reserved.

Post-market drug evaluation research training capacity in Canada: an environmental scan of Canadian educational institutions.

PubMed

Wiens, Matthew O; Soon, Judith A; MacLeod, Stuart M; Sharma, Sunaina; Patel, Anik

2014-01-01

Ongoing efforts by Health Canada intended to modernize the legislation and regulation of pharmaceuticals will help improve the safety and effectiveness of drug products. It will be imperative to ensure that comprehensive and specialized training sites are available to train researchers to support the regulation of therapeutic products. The objective of this educational institution inventory was to conduct an environmental scan of educational institutions in Canada able to train students in areas of post-market drug evaluation research. A systematic web-based environmental scan of Canadian institutions was conducted. The website of each university was examined for potential academic programs. Six core programmatic areas were determined a priori as necessary to train competent post-market drug evaluation researchers. These included biostatistics, epidemiology, pharmacoepidemiology, health economics or pharmacoeconomics, pharmacogenetics or pharmacogenomics and patient safety/pharmacovigilance. Twenty-three academic institutions were identified that had the potential to train students in post-market drug evaluation research. Overall, 23 institutions taught courses in epidemiology, 22 in biostatistics, 17 in health economics/pharmacoeconomics, 5 in pharmacoepidemiology, 5 in pharmacogenetics/pharmacogenomics, and 3 in patient safety/pharmacovigilance. Of the 23 institutions, only the University of Ottawa offered six core courses. Two institutions offered five, seven offered four and the remaining 14 offered three or fewer. It is clear that some institutions may offer programs not entirely reflected in the nomenclature used for this review. As Heath Canada moves towards a more progressive licensing framework, augmented training to increase research capacity and expertise in drug safety and effectiveness is timely and necessary.

Workplace training for senior trainees: a systematic review and narrative synthesis of current approaches to promote patient safety.

PubMed

Walton, Merrilyn; Harrison, Reema; Burgess, Annette; Foster, Kirsty

2015-10-01

Preventable harm is one of the top six health problems in the developed world. Developing patient safety skills and knowledge among advanced trainee doctors is critical. Clinical supervision is the main form of training for advanced trainees. The use of supervision to develop patient safety competence has not been established. To establish the use of clinical supervision and other workplace training to develop non-technical patient safety competency in advanced trainee doctors. Keywords, synonyms and subject headings were used to search eight electronic databases in addition to hand-searching of relevant journals up to 1 March 2014. Titles and abstracts of retrieved publications were screened by two reviewers and checked by a third. Full-text articles were screened against the eligibility criteria. Data on design, methods and key findings were extracted. Clinical supervision documents were assessed against components common to established patient safety frameworks. Findings from the reviewed articles and document analysis were collated in a narrative synthesis. Clinical supervision is not identified as an avenue for embedding patient safety skills in the workplace and is consequently not evaluated as a method to teach trainees these skills. Workplace training in non-technical patient safety skills is limited, but one-off training courses are sometimes used. Clinical supervision is the primary avenue for learning in postgraduate medical education but the most overlooked in the context of patient safety learning. The widespread implementation of short courses is not matched by evidence of rigorous evaluation. Supporting supervisors to identify teaching moments during supervision and to give weight to non-technical skills and technical skills equally is critical. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Neutropenia as an Adverse Event following Vaccination: Results from Randomized Clinical Trials in Healthy Adults and Systematic Review

PubMed Central

Muturi-Kioi, Vincent; Lewis, David; Launay, Odile; Leroux-Roels, Geert; Anemona, Alessandra; Loulergue, Pierre; Bodinham, Caroline L.; Aerssens, Annelies; Groth, Nicola; Saul, Allan; Podda, Audino

2016-01-01

Background In the context of early vaccine trials aimed at evaluating the safety profile of novel vaccines, abnormal haematological values, such as neutropenia, are often reported. It is therefore important to evaluate how these trials should be planned not to miss potentially important safety signals, but also to understand the implications and the clinical relevance. Methodology We report and discuss the results from five clinical trials (two with a new Shigella vaccine in the early stage of clinical development and three with licensed vaccines) where the absolute neutrophil counts (ANC) were evaluated before and after vaccination. Additionally, we have performed a systematic review of the literature on cases of neutropenia reported during vaccine trials to discuss our results in a more general context. Principal Findings Both in our clinical trials and in the literature review, several cases of neutropenia have been reported, in the first two weeks after vaccination. However, neutropenia was generally transient and had a benign clinical outcome, after vaccination with either multiple novel candidates or well-known licensed vaccines. Additionally, the vaccine recipients with neutropenia frequently had lower baseline ANC than non-neutropenic vaccinees. In many instances neutropenia occurred in subjects of African descent, known to have lower ANC compared to western populations. Conclusions It is important to include ANC and other haematological tests in early vaccine trials to identify potential safety signals. Post-vaccination neutropenia is not uncommon, generally transient and clinically benign, but many vaccine trials do not have a sampling schedule that allows its detection. Given ethnic variability in the level of circulating neutrophils, normal ranges taking into account ethnicity should be used for determination of trial inclusion/exclusion criteria and classification of neutropenia related adverse events. Trial registration ClinicalTrials.gov NCT02017899, NCT02034500, NCT01771367, NCT01765413, NCT02523287 PMID:27490698

Outcomes of a Failure Mode and Effects Analysis for medication errors in pediatric anesthesia.

PubMed

Martin, Lizabeth D; Grigg, Eliot B; Verma, Shilpa; Latham, Gregory J; Rampersad, Sally E; Martin, Lynn D

2017-06-01

The Institute of Medicine has called for development of strategies to prevent medication errors, which are one important cause of preventable harm. Although the field of anesthesiology is considered a leader in patient safety, recent data suggest high medication error rates in anesthesia practice. Unfortunately, few error prevention strategies for anesthesia providers have been implemented. Using Toyota Production System quality improvement methodology, a multidisciplinary team observed 133 h of medication practice in the operating room at a tertiary care freestanding children's hospital. A failure mode and effects analysis was conducted to systematically deconstruct and evaluate each medication handling process step and score possible failure modes to quantify areas of risk. A bundle of five targeted countermeasures were identified and implemented over 12 months. Improvements in syringe labeling (73 to 96%), standardization of medication organization in the anesthesia workspace (0 to 100%), and two-provider infusion checks (23 to 59%) were observed. Medication error reporting improved during the project and was subsequently maintained. After intervention, the median medication error rate decreased from 1.56 to 0.95 per 1000 anesthetics. The frequency of medication error harm events reaching the patient also decreased. Systematic evaluation and standardization of medication handling processes by anesthesia providers in the operating room can decrease medication errors and improve patient safety. © 2017 John Wiley & Sons Ltd.

Use of Shuttle Heritage Hardware in Space Launch System (SLS) Application-Structural Assessment

NASA Technical Reports Server (NTRS)

Aggarwal, Pravin; Booker, James N.

2018-01-01

NASA is moving forward with the development of the next generation system of human spaceflight to meet the Nation's goals of human space exploration. To meet these goals, NASA is aggressively pursuing the development of an integrated architecture and capabilities for safe crewed and cargo missions beyond low-Earth orbit. Two important tenets critical to the achievement of NASA's strategic objectives are Affordability and Safety. The Space Launch System (SLS) is a heavy-lift launch vehicle being designed/developed to meet these goals. The SLS Block 1 configuration (Figure 1) will be used for the first Exploration Mission (EM-1). It utilizes existing hardware from the Space Shuttle inventory, as much as possible, to save cost and expedite the schedule. SLS Block 1 Elements include the Core Stage, "Heritage" Boosters, Heritage Engines, and the Integrated Spacecraft and Payload Element (ISPE) consisting of the Launch Vehicle Stage Adapter (LVSA), the Multi-Purpose Crew Vehicle (MPCV) Stage Adapter (MSA), and an Interim Cryogenic Propulsion Stage (ICPS) for Earth orbit escape and beyond-Earth orbit in-space propulsive maneuvers. When heritage hardware is used in a new application, it requires a systematic evaluation of its qualification. In addition, there are previously-documented Lessons Learned (Table -1) in this area cautioning the need of a rigorous evaluation in any new application. This paper will exemplify the systematic qualification/assessment efforts made to qualify the application of Heritage Solid Rocket Booster (SRB) hardware in SLS. This paper describes the testing and structural assessment performed to ensure the application is acceptable for intended use without having any adverse impact to Safety. It will further address elements such as Loads, Material Properties and Manufacturing, Testing, Analysis, Failure Criterion and Factor of Safety (FS) considerations made to reach the conclusion and recommendation.

Anti-angiogenic Therapy in Patients with Advanced Gastric and Gastroesophageal Junction Cancer: A Systematic Review

PubMed Central

Chen, Li-Tzong; Oh, Do-Youn; Ryu, Min-Hee; Yeh, Kun-Huei; Yeo, Winnie; Carlesi, Roberto; Cheng, Rebecca; Kim, Jongseok; Orlando, Mauro; Kang, Yoon-Koo

2017-01-01

Despite advancements in therapy for advanced gastric and gastroesophageal junction cancers, their prognosis remains dismal. Tumor angiogenesis plays a key role in cancer growth and metastasis, and recent studies indicate that pharmacologic blockade of angiogenesis is a promising approach to therapy. In this systematic review, we summarize current literature on the clinical benefit of anti-angiogenic agents in advanced gastric cancer. We conducted a systematic search of PubMed and conference proceedings including the American Society of Clinical Oncology, the European Society for Medical Oncology, and the European Cancer Congress. Included studies aimed to prospectively evaluate the efficacy and safety of anti-angiogenic agents in advanced gastric or gastroesophageal junction cancer. Each trial investigated at least one of the following endpoints: overall survival, progression-free survival/time to progression, and/or objective response rate. Our search yielded 139 publications. Forty-two met the predefined inclusion criteria. Included studies reported outcomes with apatinib, axitinib, bevacizumab, orantinib, pazopanib, ramucirumab, regorafenib, sorafenib, sunitinib, telatinib, and vandetanib. Second-line therapy with ramucirumab and third-line therapy with apatinib are the only anti-angiogenic agents so far shown to significantly improve survival of patients with advanced gastric cancer. Overall, agents that specifically target the vascular endothelial growth factor ligand or receptor have better safety profile compared to multi-target tyrosine kinase inhibitors. PMID:28052652

Anti-angiogenic Therapy in Patients with Advanced Gastric and Gastroesophageal Junction Cancer: A Systematic Review.

PubMed

Chen, Li-Tzong; Oh, Do-Youn; Ryu, Min-Hee; Yeh, Kun-Huei; Yeo, Winnie; Carlesi, Roberto; Cheng, Rebecca; Kim, Jongseok; Orlando, Mauro; Kang, Yoon-Koo

2017-10-01

Despite advancements in therapy for advanced gastric and gastroesophageal junction cancers, their prognosis remains dismal. Tumor angiogenesis plays a key role in cancer growth and metastasis, and recent studies indicate that pharmacologic blockade of angiogenesis is a promising approach to therapy. In this systematic review, we summarize current literature on the clinical benefit of anti-angiogenic agents in advanced gastric cancer. We conducted a systematic search of PubMed and conference proceedings including the American Society of Clinical Oncology, the European Society for Medical Oncology, and the European Cancer Congress. Included studies aimed to prospectively evaluate the efficacy and safety of anti-angiogenic agents in advanced gastric or gastroesophageal junction cancer. Each trial investigated at least one of the following endpoints: overall survival, progression-free survival/time to progression, and/or objective response rate. Our search yielded 139 publications. Forty-two met the predefined inclusion criteria. Included studies reported outcomes with apatinib, axitinib, bevacizumab, orantinib, pazopanib, ramucirumab, regorafenib, sorafenib, sunitinib, telatinib, and vandetanib. Second-line therapy with ramucirumab and third-line therapy with apatinib are the only anti-angiogenic agents so far shown to significantly improve survival of patients with advanced gastric cancer. Overall, agents that specifically target the vascular endothelial growth factor ligand or receptor have better safety profile compared to multi-target tyrosine kinase inhibitors.

Effectiveness and safety of cryotherapy after arthroscopic anterior cruciate ligament reconstruction. A systematic review of the literature.

PubMed

Martimbianco, Ana Luiza Cabrera; Gomes da Silva, Brenda Nazaré; de Carvalho, Alan Pedrosa Viegas; Silva, Valter; Torloni, Maria Regina; Peccin, Maria Stella

2014-11-01

Cryotherapy is widely used in rehabilitation; however, its effectiveness after anterior cruciate ligament (ACL) reconstruction remains uncertain. To investigate the effectiveness and safety of cryotherapy following ACL reconstruction through a systematic review, randomized and quasi-randomized clinical trials were searched in the databases: MEDLINE, EMBASE, CENTRAL, PEDro, SportDiscus, CINAHL, LILACS (June 2013). The primary outcomes measures were pain, edema and adverse events; the secondary outcomes were knee function, analgesic medication use, range of motion, blood loss, hospital stay, quality of life and patient satisfaction. The methodological quality of studies was evaluated using the Cochrane Collaboration risk-of-bias tool. Ten trials (a total of 573 patients) were included. Results of meta-analysis showed that the use of cold compression devices produced a significant reduction in pain scores 48 h after surgery (p < 0.00001), compared to no cryotherapy. The risk for adverse events did not differ between patients receiving cryotherapy versus no treatment (p = 1.00). The limited evidence currently available is insufficient to draw definitive conclusions on the effectiveness of cryotherapy for other outcomes. There is a need for well designed, good quality randomized trials to answer other questions related to this intervention and increase the precision of future systematic reviews. Copyright © 2014 Elsevier Ltd. All rights reserved.

The quality, safety and governance of telephone triage and advice services - an overview of evidence from systematic reviews.

PubMed

Lake, Rebecca; Georgiou, Andrew; Li, Julie; Li, Ling; Byrne, Mary; Robinson, Maureen; Westbrook, Johanna I

2017-08-30

Telephone triage and advice services (TTAS) are increasingly being implemented around the world. These services allow people to speak to a nurse or general practitioner over the telephone and receive assessment and healthcare advice. There is an existing body of research on the topic of TTAS, however the diffuseness of the evidence base makes it difficult to identify key lessons that are consistent across the literature. Systematic reviews represent the highest level of evidence synthesis. We aimed to undertake an overview of such reviews to determine the scope, consistency and generalisability of findings in relation to the governance, safety and quality of TTAS. We searched PubMed, MEDLINE, EMBASE, CINAHL, Web of Science and the Cochrane Library for English language systematic reviews focused on key governance, quality and safety findings related to telephone based triage and advice services, published since 1990. The search was undertaken by three researchers who reached consensus on all included systematic reviews. An appraisal of the methodological quality of the systematic reviews was independently undertaken by two researchers using A Measurement Tool to Assess Systematic Reviews. Ten systematic reviews from a potential 291 results were selected for inclusion. TTAS was examined either alone, or as part of a primary care service model or intervention designed to improve primary care. Evidence of TTAS performance was reported across nine key indicators - access, appropriateness, compliance, patient satisfaction, cost, safety, health service utilisation, physician workload and clinical outcomes. Patient satisfaction with TTAS was generally high and there is some consistency of evidence of the ability of TTAS to reduce clinical workload. Measures of the safety of TTAS tended to show that there is no major difference between TTAS and traditional care. Taken as a whole, current evidence does not provide definitive answers to questions about the quality of care provided, access and equity of the service, its costs and outcomes. The available evidence also suggests that there are many interactional factors (e.g., relationship with other health service providers) which can impact on measures of performance, and also affect the external validity of the research findings.

Systematic Approach to Food Safety Education on the Farm

ERIC Educational Resources Information Center

Shaw, Angela; Strohbehn, Catherine; Naeve, Linda; Domoto, Paul; Wilson, Lester

2015-01-01

Food safety education from farm to end user is essential in the mitigation of food safety concerns associated with fresh produce. Iowa State University developed a multi-disciplinary three-level sequential program ("Know," "Show," "Go") to provide a holistic approach to food safety education. This program provides…

Do Studies Evaluating QT/QTc Interval Prolongation with Dietary Supplements Meet FDA Standards: A Systematic Review.

PubMed

Nguyen, Tinh An; Kurian, Amy; Leong, Jessica; Patel, Umang M; Shah, Sachin A

2017-07-04

Dietary supplement use is continuously increasing, but the safety evaluation of these products remains partial. While dietary supplements have no mandate for assessing cardiovascular safety, all new drug entities (NDE) are required to undergo a thorough QT/corrected QT (QTc) assessment to determine their propensity to impact cardiac repolarization. Independent investigators and manufacturers of dietary supplements voluntarily initiate safety studies; however, the quality of these studies is controversial. We sought to compare studies evaluating the QT/QTc effects of dietary supplements based on the International Conference of Harmonization (ICH)-E14 recommendations for NDE. Twenty-six published dietary supplement studies assessed QT/QTc interval prolongation. Sample sizes ranged from nine subjects to 206 among the 15 crossover studies, six parallel design studies, and five observational studies. A plan to account for electrocardiogram (ECG) morphological abnormalities was included in 10 studies, and two studies reported cardiovascular adverse events. Eight studies found a significant change in QT/QTc intervals. The majority of studies included in this review contained many of the critical elements recommended by the ICH E14, which includes the U.S. Food and Drug Administration guidance document for QT/QTc interval assessment. Compared with the thorough QT (TQT) standards, studies are typically well performed but can be bolstered by some study design changes. More than 30% of the included studies showed some degree of ECG changes, suggesting the need for continued cardiovascular safety assessment of dietary supplements.

Using heuristic evaluations to assess the safety of health information systems.

PubMed

Carvalho, Christopher J; Borycki, Elizabeth M; Kushniruk, Andre W

2009-01-01

Health information systems (HISs) are typically seen as a mechanism for reducing medical errors. There is, however, evidence to prove that technology may actually be the cause of errors. As a result, it is crucial to fully test any system prior to its implementation. At present, evidence-based evaluation heuristics do not exist for assessing aspects of interface design that lead to medical errors. A three phase study was conducted to develop evidence-based heuristics for evaluating interfaces. Phase 1 consisted of a systematic review of the literature. In Phase 2 a comprehensive list of 33 evaluation heuristics was developed based on the review that could be used to test for potential technology induced errors. Phase 3 involved applying these healthcare specific heuristics to evaluate a HIS.

Do safety checklists improve teamwork and communication in the operating room? A systematic review.

PubMed

Russ, Stephanie; Rout, Shantanu; Sevdalis, Nick; Moorthy, Krishna; Darzi, Ara; Vincent, Charles

2013-12-01

The aim of this systematic review was to assess the impact of surgical safety checklists on the quality of teamwork and communication in the operating room (OR). Safety checklists have been shown to impact positively on patient morbidity and mortality following surgery, but it is unclear whether this clinical improvement is related to an improvement in OR teamwork and communication. A systematic search strategy of MEDLINE, EMBASE, PsycINFO, Google Scholar, and the Cochrane Database for Systematic Reviews was undertaken to obtain relevant articles. After de-duplication and the addition of limits, 315 articles were screened for inclusion by 2 researchers and all articles meeting a set of prespecified inclusion criteria were retained. Information regarding the type of checklist, study design, assessment tools used, outcomes, and study limitations was extracted. Twenty articles formed the basis of this systematic review. All articles described an empirical study relating to a case-specific safety checklist for surgery as the primary intervention, with some measure of change/improvement in teamwork and/or communication relating to its use. The methods for assessing teamwork and communication varied greatly, including surveys, observations, interviews, and 360° assessments. The evidence suggests that safety checklists improve the perceived quality of OR teamwork and communication and reduce observable errors relating to poor team skills. This is likely to function through establishing an open platform for communication at the start of a procedure: encouraging the sharing of critical case-related information, promoting team coordination and decision making, flagging knowledge gaps, and enhancing team cohesion. However, the evidence would also suggest that when used suboptimally or when individuals have not bought in to the process, checklists may conversely have a negative impact on the function of the team. Safety checklists are beneficial for OR teamwork and communication and this may be one mechanism through which patient outcomes are improved. Future research should aim to further elucidate the relationship between how safety checklists are used and team skills in the OR using more consistent methodological approaches and utilizing validated measures of teamwork such that best practice guidelines can be established.

Evaluating Patient-Centered Outcomes in Clinical Trials of Procedural Sedation, Part 2 Safety: Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research Recommendations.

PubMed

Ward, Denham S; Williams, Mark R; Berkenbosch, John W; Bhatt, Maala; Carlson, Douglas; Chappell, Phillip; Clark, Randall M; Constant, Isabelle; Conway, Aaron; Cravero, Joseph; Dahan, Albert; Dexter, Franklin; Dionne, Raymond; Dworkin, Robert H; Gan, Tong J; Gozal, David; Green, Steven; Irwin, Michael G; Karan, Suzanne; Kochman, Michael; Lerman, Jerrold; Lightdale, Jenifer R; Litman, Ronald S; Mason, Keira P; Miner, James; O'Connor, Robert E; Pandharipande, Pratik; Riker, Richard R; Roback, Mark G; Sessler, Daniel I; Sexton, Anne; Tobin, Joseph R; Turk, Dennis C; Twersky, Rebecca S; Urman, Richard D; Weiss, Mark; Wunsch, Hannah; Zhao-Wong, Anna

2018-05-17

The Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research, established by the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks, a public-private partnership with the US Food and Drug Administration, convened a second meeting of sedation experts from a variety of clinical specialties and research backgrounds to develop recommendations for procedural sedation research. The previous meeting addressed efficacy and patient- and/or family-centered outcomes. This meeting addressed issues of safety, which was defined as "the avoidance of physical or psychological harm." A literature review identified 133 articles addressing safety measures in procedural sedation clinical trials. After basic reporting of vital signs, the most commonly measured safety parameter was oxygen saturation. Adverse events were inconsistently defined throughout the studies. Only 6 of the 133 studies used a previously validated measure of safety. The meeting identified methodological problems associated with measuring infrequent adverse events. With a consensus discussion, a set of core and supplemental measures were recommended to code for safety in future procedural clinical trials. When adopted, these measures should improve the integration of safety data across studies and facilitate comparisons in systematic reviews and meta-analyses.

Melasma: systematic review of the systemic treatments.

PubMed

Zhou, Linghong Linda; Baibergenova, Akerke

2017-09-01

Currently available treatment options for melasma include prevention of UV radiation, topical lightening agents, chemical peels, and light-based and laser therapies. However, none have shown effective and sustained results, with incomplete clearance and frequent recurrences. There has been increasing interest recently in oral medications and dietary supplements in improving melasma. We sought to evaluate the efficacy and safety/tolerability of oral medications and dietary supplements for the treatment of melasma. Multiple databases were systematically searched for randomized clinical trials (RCTs) evaluating the use of oral medication for treatment of melasma alone or in combination with other treatments. A total of eight RCTs met inclusion criteria. Oral medications and dietary supplements evaluated include tranexamic acid, Polypodium leucotomos extract, beta-carotenoid, melatonin, and procyanidin. These agents appear to have a beneficial effect on melasma improvement. In conclusion, oral medications have a role in melasma treatment and have been shown to be efficacious and tolerable with a minimal number and severity of adverse events. Therefore, dermatologists should keep oral medications and dietary supplements in their armamentarium for the treatment of melasma. © 2017 The International Society of Dermatology.

Safety of Tamsulosin: A Systematic Review of Randomized Trials with a Focus on Women and Children.

PubMed

Kaplan, Steven A; Chughtai, Bilal I

2018-05-08

Although tamsulosin is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH), it has also been assessed in clinical studies for other conditions/symptoms and in other populations such as women and children. In this systematic review of randomized studies, the overall safety of tamsulosin was assessed, focusing on these understudied populations. Literature searches were conducted using Embase, Medline, and PubMed (inception-December 2015). A study was included if patients were randomized to receive treatment with any dose of tamsulosin capsules, tablets, or an oral controlled absorption system and numerical safety results were reported. Overall, 160 articles involving 46,072 participants met the inclusion criteria. Of these, four studies included women only and three included children. The mean [standard deviation (SD)] age ranged from 7.3 (4.2) to 76.8 (7.1) years. The studies (n; %) evaluated healthy subjects (18; 11%) or patients with lower urinary tract symptoms/BPH (90; 56%), ureteral stones/renal colic (42; 26%), prostatitis (4; 3%), or other conditions (6; 4%). Patients discontinued tamsulosin primarily because of adverse events (AEs) or insufficient response. AEs in women and children were abdominal pain, asthenia, constipation, dizziness, dry mouth, drowsiness, dyspepsia, headache, incontinence, nasal congestion, nausea, orthostatic hypotension, and somnolence. Due to heterogeneity across studies, statistical analysis could not be conducted. No unexpected AEs were observed in an all-comers population treated with tamsulosin for various conditions/symptoms. The overall safety profile in women and children seemed to be generally consistent with the profile in men, the indicated population.

How effective is drug testing as a workplace safety strategy? A systematic review of the evidence.

PubMed

Pidd, Ken; Roche, Ann M

2014-10-01

The growing prevalence of workplace drug testing and the narrow scope of previous reviews of the evidence base necessitate a comprehensive review of research concerning the efficacy of drug testing as a workplace strategy. A systematic qualitative review of relevant research published between January 1990 and January 2013 was undertaken. Inclusion criteria were studies that evaluated the effectiveness of drug testing in deterring employee drug use or reducing workplace accident or injury rates. Methodological adequacy was assessed using a published assessment tool specifically designed to assess the quality of intervention studies. A total of 23 studies were reviewed and assessed, six of which reported on the effectiveness of testing in reducing employee drug use and 17 which reported on occupational accident or injury rates. No studies involved randomised control trials. Only one study was assessed as demonstrating strong methodological rigour. That study found random alcohol testing reduced fatal accidents in the transport industry. The majority of studies reviewed contained methodological weaknesses including; inappropriate study design, limited sample representativeness, the use of ecological data to evaluate individual behaviour change and failure to adequately control for potentially confounding variables. This latter finding is consistent with previous reviews and indicates the evidence base for the effectiveness of testing in improving workplace safety is at best tenuous. Better dissemination of the current evidence in relation to workplace drug testing is required to support evidence-informed policy and practice. There is also a pressing need for more methodologically rigorous research to evaluate the efficacy and utility of drug testing. Copyright © 2014 Elsevier Ltd. All rights reserved.

Non-vitamin K antagonist oral anticoagulants have better efficacy and equivalent safety compared to warfarin in elderly patients with atrial fibrillation: A systematic review and meta-analysis.

PubMed

Kim, In-Soo; Kim, Hyun-Jung; Kim, Tae-Hoon; Uhm, Jae-Sun; Joung, Boyoung; Lee, Moon-Hyoung; Pak, Hui-Nam

2018-08-01

To evaluate the efficacy and safety of non-vitamin K antagonist oral anticoagulants (NOACs) in elderly patients (aged ≥75 years) with atrial fibrillation (AF), depending on dose and/or renal function. After systematically searching the databases (Medline, EMBASE, CENTRAL, SCOPUS, and Web of Science), 5 phase III randomized controlled trials and reported data according to subgroups of elderly/non-elderly AF patients, comparing any NOACs and warfarin were included. The primary efficacy and safety outcomes were stroke/systemic thromboembolism and major bleeding. (1) NOACs showed better efficacy than warfarin in elderly patients [RR 0.83 (0.69-1.00), p=0.04, I 2 =55%], but equivalent efficacy in non-elderly patients. (2) NOACs reduced major bleeding compared to warfarin in non-elderly (p<0.001) and had comparable safety to warfarin in elderly patients. (3) Even in elderly patients with moderately impaired renal function, NOACs had a safety profile comparable to that of warfarin for major bleeding if dose reduction was reached appropriately [pooled RR 0.82 (0.35-1.88), p=0.63, I 2 =63%]. (4) All-cause mortality was lower with NOACs in non-elderly patients [RR 0.89 (0.83-0.95), p=0.001, I 2 =0%], and with standard-dose NOAC group of elderly patients [RR 0.93 (0.86-1.00), p=0.04, I 2 =0%] compared to warfarin. For elderly patients (aged ≥75 years), NOACs showed better efficacy and equivalent safety compared to warfarin even in those with moderately impaired renal function. All-cause mortality was lower with standard-dose NOACs compared to warfarin in the elderly patient group. The protocol of this meta-analysis was registered on PROSPERO under CRD42016047922 (https://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42016047922). Copyright © 2018 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.

Vertebroplasty and kyphoplasty: a systematic review of 69 clinical studies.

PubMed

Hulme, Paul A; Krebs, Jörg; Ferguson, Stephen J; Berlemann, Ulrich

2006-08-01

Systematic literature review. To evaluate the safety and efficacy of vertebroplasty and kyphoplasty using the data presented in published clinical studies, with respect to patient pain relief, restoration of mobility and vertebral body height, complication rate, and incidence of new adjacent vertebral fractures. Vertebroplasty and kyphoplasty have been gaining popularity for treating vertebral fractures. Current reviews provide an overview of the procedures but are not comprehensive and tend to rely heavily on personal experience. This article aimed to compile all available data and evaluate the clinical outcome of the 2 procedures. This is a systematic review of all the available data presented in peer-reviewed published clinical trials. The methodological quality of included studies was evaluated, and data were collected targeting specific standard measurements. Where possible, a quantitative aggregation of the data was performed. A large proportion of subjects had some pain relief, including 87% with vertebroplasty and 92% with kyphoplasty. Vertebral height restoration was possible using kyphoplasty (average 6.6 degrees ) and for a subset of patients using vertebroplasty (average 6.6 degrees ). Cement leaks occurred for 41% and 9% of treated vertebrae for vertebroplasty and kyphoplasty, respectively. New fractures of adjacent vertebrae occurred for both procedures at rates that are higher than the general osteoporotic population but approximately equivalent to the general osteoporotic population that had a previous vertebral fracture. The problem with stating definitely that vertebroplasty and kyphoplasty are safe and effective procedures is the lack of comparative, blinded, randomized clinical trials. Standardized evaluative methods should be adopted.

Corticosteroid Administration to Prevent Complications of Anterior Cervical Spine Fusion: A Systematic Review

PubMed Central

Zadegan, Shayan Abdollah; Jazayeri, Seyed Behnam; Abedi, Aidin; Bonaki, Hirbod Nasiri; Vaccaro, Alexander R.; Rahimi-Movaghar, Vafa

2017-01-01

Study Design: Systematic review. Objectives: Anterior cervical approach is associated with complications such as dysphagia and airway compromise. In this study, we aimed to systematically review the literature on the efficacy and safety of corticosteroid administration as a preventive measure of such complications in anterior cervical spine surgery with fusion. Methods: Following a systematic literature search of MEDLINE, Embase, and Cochrane databases in July 2016, all comparative human studies that evaluated the effect of steroids for prevention of complications in anterior cervical spine surgery with fusion were included, irrespective of number of levels and language. Risk of bias was assessed using MINORS (Methodological Index for Non-Randomized Studies) checklist and Cochrane Back and Neck group recommendations, for nonrandomized and randomized studies, respectively. Results: Our search yielded 556 articles, of which 9 studies (7 randomized controlled trials and 2 non–randomized controlled trials) were included in the final review. Dysphagia was the most commonly evaluated complication, and in most studies, its severity or incidence was significantly lower in the steroid group. Although prevertebral soft tissue swelling was less commonly assessed, the results were generally in favor of steroid use. The evidence for airway compromise and length of hospitalization was inconclusive. Steroid-related complications were rare, and in both studies that evaluated the fusion rate, it was comparable between steroid and control groups in long-term follow-up. Conclusions: Current literature supports the use of steroids for prevention of complications in anterior cervical spine surgery with fusion. However, evidence is limited by substantial risk of bias and small number of studies reporting key outcomes. PMID:29796378

Systematic review: cardiovascular safety profile of 5-HT(4) agonists developed for gastrointestinal disorders.

PubMed

Tack, J; Camilleri, M; Chang, L; Chey, W D; Galligan, J J; Lacy, B E; Müller-Lissner, S; Quigley, E M M; Schuurkes, J; De Maeyer, J H; Stanghellini, V

2012-04-01

The nonselective 5-HT(4) receptor agonists, cisapride and tegaserod have been associated with cardiovascular adverse events (AEs). To perform a systematic review of the safety profile, particularly cardiovascular, of 5-HT(4) agonists developed for gastrointestinal disorders, and a nonsystematic summary of their pharmacology and clinical efficacy. Articles reporting data on cisapride, clebopride, prucalopride, mosapride, renzapride, tegaserod, TD-5108 (velusetrag) and ATI-7505 (naronapride) were identified through a systematic search of the Cochrane Library, Medline, Embase and Toxfile. Abstracts from UEGW 2006-2008 and DDW 2008-2010 were searched for these drug names, and pharmaceutical companies approached to provide unpublished data. Retrieved articles on pharmacokinetics, human pharmacodynamics and clinical data with these 5-HT(4) agonists, are reviewed and summarised nonsystematically. Articles relating to cardiac safety and tolerability of these agents, including any relevant case reports, are reported systematically. Two nonselective 5-HT(4) agonists had reports of cardiovascular AEs: cisapride (QT prolongation) and tegaserod (ischaemia). Interactions with, respectively, the hERG cardiac potassium channel and 5-HT(1) receptor subtypes have been suggested to account for these effects. No cardiovascular safety concerns were reported for the newer, selective 5-HT(4) agonists prucalopride, velusetrag, naronapride, or for nonselective 5-HT(4) agonists with no hERG or 5-HT(1) affinity (renzapride, clebopride, mosapride). 5-HT(4) agonists for GI disorders differ in chemical structure and selectivity for 5-HT(4) receptors. Selectivity for 5-HT(4) over non-5-HT(4) receptors may influence the agent's safety and overall risk-benefit profile. Based on available evidence, highly selective 5-HT(4) agonists may offer improved safety to treat patients with impaired GI motility. © 2012 Blackwell Publishing Ltd.

Systematic review: cardiovascular safety profile of 5-HT4 agonists developed for gastrointestinal disorders

PubMed Central

Tack, J; Camilleri, M; Chang, L; Chey, W D; Galligan, J J; Lacy, B E; Müller-Lissner, S; Quigley, E M M; Schuurkes, J; Maeyer, J H; Stanghellini, V

2012-01-01

Summary Background The nonselective 5-HT4 receptor agonists, cisapride and tegaserod have been associated with cardiovascular adverse events (AEs). Aim To perform a systematic review of the safety profile, particularly cardiovascular, of 5-HT4 agonists developed for gastrointestinal disorders, and a nonsystematic summary of their pharmacology and clinical efficacy. Methods Articles reporting data on cisapride, clebopride, prucalopride, mosapride, renzapride, tegaserod, TD-5108 (velusetrag) and ATI-7505 (naronapride) were identified through a systematic search of the Cochrane Library, Medline, Embase and Toxfile. Abstracts from UEGW 2006–2008 and DDW 2008–2010 were searched for these drug names, and pharmaceutical companies approached to provide unpublished data. Results Retrieved articles on pharmacokinetics, human pharmacodynamics and clinical data with these 5-HT4 agonists, are reviewed and summarised nonsystematically. Articles relating to cardiac safety and tolerability of these agents, including any relevant case reports, are reported systematically. Two nonselective 5-HT4 agonists had reports of cardiovascular AEs: cisapride (QT prolongation) and tegaserod (ischaemia). Interactions with, respectively, the hERG cardiac potassium channel and 5-HT1 receptor subtypes have been suggested to account for these effects. No cardiovascular safety concerns were reported for the newer, selective 5-HT4 agonists prucalopride, velusetrag, naronapride, or for nonselective 5-HT4 agonists with no hERG or 5-HT1 affinity (renzapride, clebopride, mosapride). Conclusions 5-HT4 agonists for GI disorders differ in chemical structure and selectivity for 5-HT4 receptors. Selectivity for 5-HT4 over non-5-HT4 receptors may influence the agent's safety and overall risk–benefit profile. Based on available evidence, highly selective 5-HT4 agonists may offer improved safety to treat patients with impaired GI motility. PMID:22356640

[Road safety measures and their effects on traffic injuries: a systematic review].

PubMed

Aguilera, Sandra Lúcia Vieira Ulinski; Moysés, Simone Tetú; Moysés, Samuel Jorge

2014-10-01

To identify and summarize the findings of studies describing interventions aimed at reducing road traffic injuries. An integrative systematic review without meta-analysis was performed. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) were used to synthesize the findings of the articles reviewed. The keywords "traffic accidents", "review" and "public policy" were used in isolation or combined with boolean operator "And" to search PubMed, Web of Science, SciELO, and LILACS for the period between 2006 and 2011 RESULTS: Twenty-two studies were included in the systematic review. Of these, two described engineering strategies, two described other road safety policies, three described education strategies, and 15 described law enforcement policies. Law enforcement had the most effective immediate results. Engineering strategies proved important to promote a safe environment. Finally, education strategies had an informative role and served to support other strategies, but did not seem sufficient to promote cultural changes regarding road safety. Law enforcement seems to be the most effective strategy to change the behavior of drivers, especially regarding speed limits and drinking and driving.

[Kagocel in the therapy of influenza and acute respiratory viral infections: Data analysis and systematization from the results of preclinical and clinical trials].

PubMed

Sologub, T V; Tsvetkov, V V

The article provides the summarized data of clinical trials evaluating the efficacy and safety of kagocel used to prevent and treat influenza and acute respiratory viral infections of different etiologies. The results of numerous preclinical and clinical trials suggest that the kagocel substance is highly safe and that it is appropriate to use the drug for the treatment and prevention of influenza and acute respiratory viral infections of another etiology.

Academic-practice collaboration in nursing education: service-learning for injury prevention.

PubMed

Alexander, Gina K; Canclini, Sharon B; Krauser, Debbie L

2014-01-01

Teams of senior-level baccalaureate nursing students at a private, urban university complete a population-focused public health nursing practicum through service-learning partnerships. Recently, students collaborated with local service agencies for Safe Communities America, a program of the National Safety Council in affiliation with the World Health Organization. This article describes the student-led process of community assessment, followed by systematic planning, implementation, and evaluation of evidence-based interventions to advance prescription drug overdose/poisoning prevention efforts in the community.

Eunkyosan for treatment of the common cold: A protocol for the systematic review of controlled trials.

PubMed

Lee, Hesol; Kang, Bohyung; Choi, Jun-Yong; Park, Sunju; Lee, Myeong Soo; Lee, Ju Ah

2018-05-01

Eunkyosan (EKS) is widely used for common colds in East Asian countries. Many clinical trials assessing the efficacy and safety of EKS formula for the treatment of common colds have been reported. This review will assess the clinical evidence for and against the use of EKS formula as a treatment for common colds. Fourteen databases will be searched from inception until March 2018. We will include randomized controlled trials (RCTs) assessing EKS decoctions for any type of common cold. All RCTs of decoctions or modified decoctions will be included. The methodological qualities of the RCTs will be assessed using the Cochrane Collaboration tool for assessing risk of bias, while confidence in the cumulative evidence will be evaluated using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) instrument. This systematic review will be published in a peer-reviewed journal and will also be disseminated electronically and in print. The review will be updated to inform and guide healthcare practices.Registration number: CRD42018087694.

Knowledge, attitudes, beliefs, values, preferences, and feasibility in relation to the use of injection safety devices in healthcare settings: a systematic review.

PubMed

Tarabay, Rami; El Rassi, Rola; Dakik, Abeer; Harb, Alain; Ballout, Rami A; Diab, Batoul; Khamassi, Selma; Akl, Elie A

2016-07-13

Adopting technologies such as injection safety devices in healthcare settings can enhance injection safety. Developing guidelines for appropriate adoption of such technologies need to consider factors beyond evidence for their health effects. The objective of this study is to systematically review the published literature for evidence among healthcare workers and patients about knowledge, attitudes, beliefs, values, preferences, and feasibility in relation to the use of injection safety devices in healthcare settings. We included both qualitative and quantitative studies conducted with the general public, patients, and healthcare workers, administrators, or policy makers. We searched MEDLINE, EMBASE, CINHAL and CENTRAL. We used a duplicate and independent approach to title and abstract screening, full text screening, data abstraction and risk of bias assessment. Out of a total of 6568 identified citations, we judged fourteen studies as eligible for this systematic review. All these studies were surveys, conducted with healthcare workers in high-income countries. We did not identify any qualitative study, or a study of the general public, patients, healthcare administrators or policy makers. We did not identify any study assessing knowledge, or values assigned to outcomes relevant to injection safety devices. Each of the included studies suffered from methodological limitations, which lowers our confidence in their findings. Based on the findings of six studies, the injection safety devices were generally perceived as easy to use and as an improvement compared with conventional syringes. Some of these studies reported few technical problems while using the devices. In three studies assessing perceived safety, the majority of participants judged the devices as safe. Two studies reported positive perceptions of healthcare workers regarding patient tolerance of these injection safety devices. One study found that less than half the nurses felt comfortable using the insulin pens. Findings from four studies assessing preference and satisfaction were not consistent. This systematic review identified evidence that injection safety devices are generally perceived as easy to use, safe, and tolerated by patients. There were few reports of technical problems while using the devices and some discomfort by nurses using the insulin pens.

Safety and Health Hazard Observations in Hmong Farming Operations

PubMed Central

Neitzel, R. L.; Krenz, J.; de Castro, A. B.

2014-01-01

Agricultural workers have a high risk of occupational injuries, illnesses, and fatalities. However, there are very few standardized tools available to assess safety and health in agricultural operations. Additionally, there are a number of groups of agricultural workers, including Hmong refugees and immigrants, for which virtually no information on safety and health conditions is available. This study developed an observation-based methodology for systematically evaluating occupational health and safety hazards in agriculture, and pilot-tested this on several small-scale Hmong farming operations. Each observation assessed of range of safety and health hazards (e.g., musculoskeletal hazards, dust and pollen, noise, and mechanical hazards), as well as on factors such as type of work area, presence of personal protective equipment, and weather conditions. Thirty-six observations were collected on nine farms. The most common hazards observed were bending at the back and lifting <50 pounds. Use of sharp tools without adequate guarding mechanisms, awkward postures, repetitive hand motions, and lifting >50 pounds were also common. The farming activities observed involved almost no power equipment, and no pesticide or chemical handling was observed. The use of personal protective equipment was uncommon. The results of this assessment agreed well with a parallel study of perceived safety and health hazards among Hmong agricultural workers. This study suggests that small-scale Hmong farming operations involve a variety of hazards, and that occupational health interventions may be warranted in this community. The study also demonstrates the utility of standardized assessment tools and mixed-method approaches to hazard evaluation. PMID:24911689

Systematic review of safety and tolerability of a complex micronutrient formula used in mental health.

PubMed

Simpson, J Steven A; Crawford, Susan G; Goldstein, Estelle T; Field, Catherine; Burgess, Ellen; Kaplan, Bonnie J

2011-04-18

Theoretically, consumption of complex, multinutrient formulations of vitamins and minerals should be safe, as most preparations contain primarily the nutrients that have been in the human diet for millennia, and at safe levels as defined by the Dietary Reference Intakes. However, the safety profile of commercial formulae may differ from foods because of the amounts and combinations of nutrients they contain. As these complex formulae are being studied and used clinically with increasing frequency, there is a need for direct evaluation of safety and tolerability. All known safety and tolerability data collected on one complex nutrient formula was compiled and evaluated. Data were assembled from all the known published and unpublished studies for the complex formula with the largest amount of published research in mental health. Biological safety data from 144 children and adults were available from six sources: there were no occurrences of clinically meaningful negative outcomes/effects or abnormal blood tests that could be attributed to toxicity. Adverse event (AE) information from 157 children and adults was available from six studies employing the current version of this formula, and only minor, transitory reports of headache and nausea emerged. Only one of the studies permitted a direct comparison between micronutrient treatment and medication: none of the 88 pediatric and adult participants had any clinically meaningful abnormal laboratory values, but tolerability data in the group treated with micronutrients revealed significantly fewer AEs and less weight gain. This compilation of safety and tolerability data is reassuring with respect to the broad spectrum approach that employs complex nutrient formulae as a primary treatment.

Current concepts in simulation-based trauma education.

PubMed

Cherry, Robert A; Ali, Jameel

2008-11-01

The use of simulation-based technology in trauma education has focused on providing a safe and effective alternative to the more traditional methods that are used to teach technical skills and critical concepts in trauma resuscitation. Trauma team training using simulation-based technology is also being used to develop skills in leadership, team-information sharing, communication, and decision-making. The integration of simulators into medical student curriculum, residency training, and continuing medical education has been strongly recommended by the American College of Surgeons as an innovative means of enhancing patient safety, reducing medical errors, and performing a systematic evaluation of various competencies. Advanced human patient simulators are increasingly being used in trauma as an evaluation tool to assess clinical performance and to teach and reinforce essential knowledge, skills, and abilities. A number of specialty simulators in trauma and critical care have also been designed to meet these educational objectives. Ongoing educational research is still needed to validate long-term retention of knowledge and skills, provide reliable methods to evaluate teaching effectiveness and performance, and to demonstrate improvement in patient safety and overall quality of care.

Systematic strategies for the third industrial accident prevention plan in Korea.

PubMed

Kang, Young-sig; Yang, Sung-hwan; Kim, Tae-gu; Kim, Day-sung

2012-01-01

To minimize industrial accidents, it's critical to evaluate a firm's priorities for prevention factors and strategies since such evaluation provides decisive information for preventing industrial accidents and maintaining safety management. Therefore, this paper proposes the evaluation of priorities through statistical testing of prevention factors with a cause analysis in a cause and effect model. A priority matrix criterion is proposed to apply the ranking and for the objectivity of questionnaire results. This paper used regression method (RA), exponential smoothing method (ESM), double exponential smoothing method (DESM), autoregressive integrated moving average (ARIMA) model and proposed analytical function method (PAFM) to analyze trends of accident data that will lead to an accurate prediction. This paper standardized the questionnaire results of workers and managers in manufacturing and construction companies with less than 300 employees, located in the central Korean metropolitan areas where fatal accidents have occurred. Finally, a strategy was provided to construct safety management for the third industrial accident prevention plan and a forecasting method for occupational accident rates and fatality rates for occupational accidents per 10,000 people.

Systematic Heuristic Evaluation of Computerized Consultation Order Templates: Clinicians' and Human Factors Engineers' Perspectives.

PubMed

Savoy, April; Patel, Himalaya; Flanagan, Mindy E; Weiner, Michael; Russ, Alissa L

2017-08-01

We assessed the usability of consultation order templates and identified problems to prioritize in design efforts for improving referral communication. With a sample of 26 consultation order templates, three evaluators performed a usability heuristic evaluation. The evaluation used 14 domain-independent heuristics and the following three supplemental references: 1 new domain-specific heuristic, 6 usability goals, and coded clinicians' statements regarding ease of use for 10 sampled templates. Evaluators found 201 violations, a mean of 7.7 violations per template. Minor violations outnumbered major violations almost twofold, 115 (57%) to 62 (31%). Approximately 68% of violations were linked to 5 heuristics: aesthetic and minimalist design (17%), error prevention (16%), consistency and standards (14%), recognition rather than recall (11%), and meet referrers' information needs (10%). Severe violations were attributed mostly to meet referrers' information needs and recognition rather than recall. Recorded violations yielded potential negative consequences for efficiency, effectiveness, safety, learnability, and utility. Evaluators and clinicians demonstrated 80% agreement in usability assessment. Based on frequency and severity of usability heuristic violations, the consultation order templates reviewed may impede clinical efficiency and risk patient safety. Results support the following design considerations: communicate consultants' requirements, facilitate information seeking, and support communication. While the most frequent heuristic violations involved interaction design and presentation, the most severe violations lacked information desired by referring clinicians. Violations related to templates' inability to support referring clinicians' information needs had the greatest potential negative impact on efficiency and safety usability goals. Heuristics should be prioritized in future design efforts.

Implants for orthodontic anchorage

PubMed Central

Zheng, Xiaowen; Sun, Yannan; Zhang, Yimei; Cai, Ting; Sun, Feng; Lin, Jiuxiang

2018-01-01

Abstract Implantanchorage continues to receive much attention as an important orthodontic anchorage. Since the development of orthodontic implants, the scope of applications has continued to increase. Although multiple reviews detailing implants have been published, no comprehensive evaluations have been performed. Thus, the purpose of this study was to comprehensively evaluate the effects of implants based on data published in review articles. An electronic search of the Cochrane Library, Medline, Embase, Ebsco and Sicencedirect for reviews with “orthodontic” and “systematic review or meta analysis” in the title, abstract, keywords, or full text was performed. A subsequent manual search was then performed to identify reviews concerning orthodontic implants. A manual search of the orthodontic journals American Journal of Orthodontics and Dentofacial Orthopedics (AJODO), European Journal of Orthodontics (EJO), and Angle Othodontist was also performed. Such systematic reviews that evaluated the efficacy and safety of orthodontic implants were used to indicate success rates and molar movements. A total of 23 reviews were included in the analysis. The quality of each review was assessed using a measurement tool for Assessment of Multiple Systematic Reviews (AMSTAR), and the review chosen to summarize outcomes had a quality score of >6. Most reviews were less than moderate quality. Success rates of implants ranged in a broad scope, and movement of the maxillary first molar was superior with implants compared with traditional anchorage. PMID:29595673

Prevention and assessment of infectious diseases among children and adult migrants arriving to the European Union/European Economic Association: a protocol for a suite of systematic reviews for public health and health systems.

PubMed

Pottie, Kevin; Mayhew, Alain D; Morton, Rachael L; Greenaway, Christina; Akl, Elie A; Rahman, Prinon; Zenner, Dominik; Pareek, Manish; Tugwell, Peter; Welch, Vivian; Meerpohl, Joerg; Alonso-Coello, Pablo; Hui, Charles; Biggs, Beverley-Ann; Requena-Méndez, Ana; Agbata, Eric; Noori, Teymur; Schünemann, Holger J

2017-09-11

The European Centre for Disease Prevention and Control is developing evidence-based guidance for voluntary screening, treatment and vaccine prevention of infectious diseases for newly arriving migrants to the European Union/European Economic Area. The objective of this systematic review protocol is to guide the identification, appraisal and synthesis of the best available evidence on prevention and assessment of the following priority infectious diseases: tuberculosis, HIV, hepatitis B, hepatitis C, measles, mumps, rubella, diphtheria, tetanus, pertussis, poliomyelitis (polio), Haemophilus influenza disease, strongyloidiasis and schistosomiasis. The search strategy will identify evidence from existing systematic reviews and then update the effectiveness and cost-effectiveness evidence using prospective trials, economic evaluations and/or recently published systematic reviews. Interdisciplinary teams have designed logic models to help define study inclusion and exclusion criteria, guiding the search strategy and identifying relevant outcomes. We will assess the certainty of evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. There are no ethical or safety issues. We anticipate disseminating the findings through open-access publications, conference abstracts and presentations. We plan to publish technical syntheses as GRADEpro evidence summaries and the systematic reviews as part of a special edition open-access publication on refugee health. We are following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Protocols reporting guideline. This protocol is registered in PROSPERO: CRD42016045798. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Cutaneous lichen planus: A systematic review of treatments.

PubMed

Fazel, Nasim

2015-06-01

Various treatment modalities are available for cutaneous lichen planus. Pubmed, EMBASE, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, Database of Abstracts of Reviews of Effects, and Health Technology Assessment Database were searched for all the systematic reviews and randomized controlled trials related to cutaneous lichen planus. Two systematic reviews and nine relevant randomized controlled trials were identified. Acitretin, griseofulvin, hydroxychloroquine and narrow band ultraviolet B are demonstrated to be effective in the treatment of cutaneous lichen planus. Sulfasalazine is effective, but has an unfavorable safety profile. KH1060, a vitamin D analogue, is not beneficial in the management of cutaneous lichen planus. Evidence from large scale randomized trials demonstrating the safety and efficacy for many other treatment modalities used to treat cutaneous lichen planus is simply not available.

Food Safety at Farmers' Markets: A Knowledge Synthesis of Published Research.

PubMed

Young, Ian; Thaivalappil, Abhinand; Reimer, Danielle; Greig, Judy

2017-12-01

Farmers' markets are increasingly popular venues in North America for the sale of fresh produce and other foods. However, the nature of their operation can present possible food safety issues, challenges, and risks to consumers. A knowledge synthesis was conducted to identify, characterize, and summarize published research on the microbial food safety issues and implications associated with farmers' markets. A scoping review was conducted using the following steps: comprehensive search strategy, relevance screening of abstracts, and characterization of relevant articles. Two subsets of data were prioritized for more detailed systematic review (data extraction and risk-of-bias assessment) and meta-analysis: (i) studies comparing the microbial safety of foods from farmers' markets versus other sources and (ii) studies evaluating the use of food safety practices at farmers' markets. Overall, 83 relevant studies were identified. The majority of studies were published as journal articles (64%), used a cross-sectional design (81%), and were conducted in the United States (78%). Most studies (39%; n = 32) investigated stakeholder, mostly consumer (n = 22), attitudes toward food safety at farmers' markets. Limited but heterogeneous evidence indicated a higher prevalence of Campylobacter and Salmonella in chicken meat from farmers' markets versus other retail sources, but there was no difference in the microbial contamination of fresh produce. Studies evaluating the use of food safety practices at farmers' markets identified some gaps; for example, the average prevalence of vendor hand washing was 4% (95% confidence interval: 0 to 11%; I 2 = 27%; n = 5 studies). Twelve foodborne outbreaks and case reports were identified, resulting in a total of 411 illnesses, 38 hospitalizations, and two deaths from 1994 to 2016. Only five intervention studies were identified. Key knowledge gaps and areas warranting future research, training, and education are highlighted and discussed.

Evaluating the Impact of Radio Frequency Identification Retained Surgical Instruments Tracking on Patient Safety: Literature Review.

PubMed

Schnock, Kumiko O; Biggs, Bonnie; Fladger, Anne; Bates, David W; Rozenblum, Ronen

2017-02-22

Retained surgical instruments (RSI) are one of the most serious preventable complications in operating room settings, potentially leading to profound adverse effects for patients, as well as costly legal and financial consequences for hospitals. Safety measures to eliminate RSIs have been widely adopted in the United States and abroad, but despite widespread efforts, medical errors with RSI have not been eliminated. Through a systematic review of recent studies, we aimed to identify the impact of radio frequency identification (RFID) technology on reducing RSI errors and improving patient safety. A literature search on the effects of RFID technology on RSI error reduction was conducted in PubMed and CINAHL (2000-2016). Relevant articles were selected and reviewed by 4 researchers. After the literature search, 385 articles were identified and the full texts of the 88 articles were assessed for eligibility. Of these, 5 articles were included to evaluate the benefits and drawbacks of using RFID for preventing RSI-related errors. The use of RFID resulted in rapid detection of RSI through body tissue with high accuracy rates, reducing risk of counting errors and improving workflow. Based on the existing literature, RFID technology seems to have the potential to substantially improve patient safety by reducing RSI errors, although the body of evidence is currently limited. Better designed research studies are needed to get a clear understanding of this domain and to find new opportunities to use this technology and improve patient safety.

Survey of Cancer Patient Safety Culture: A Comparison of Chemotherapy and Oncology Departments of Teaching Hospitals of Tehran

PubMed Central

Raeissi, Pouran; Sharifi, Marziye; Khosravizadeh, Omid; Heidari, Mohammad

2017-01-01

Background: Patient safety culture plays an important role in healthcare systems, especially in chemotherapy and oncology departments (CODs), and its assessment can help to improve quality of services and hospital care. Objective: This study aimed to evaluate and compare items and dimensions of patient safety culture in the CODs of selected teaching hospitals of Iran and Tehran University of Medical Sciences. Materials and Methods: This descriptive-analytical cross-sectional survey was conducted during a six-month period on 270 people from chemotherapy and oncology departments selected through a cluster sampling method. All participants answered the standard questionnaire for “Hospital Survey of Patient Safety Culture” (HSOPSC). Statistical analyses were performed using SPSS/18 software. Results: The average score for patient safety culture was three for the majority of the studied CODs. Statistically significant differences were observed for supervisor actions, teamwork within various units, feedback and communications about errors, and the level of hospital management support. (p<0.05). Relationships between studied hospitals and patient safety culture were not statistically significant (p>0.05). Conclusion: Our results showed that the overall status of patient safety culture is not good in the studied CODs. In particular, teamwork across different units and organizational learning with continuous improvement were the only two properly operating items among 12 dimensions of patient safety culture. Therefore, systematic interventions are strongly required to promote communication. PMID:29072411

Whole blood pathogen reduction technology and blood safety in sub-Saharan Africa: A systematic review with regional discussion

PubMed Central

Agbor, Gabriel; Asongalem, Emmanuel; Tagny, Claude; Asonganyi, Tazoacha

2016-01-01

Background Despite vast improvements in transfusion services in sub-Saharan Africa over the last decade, there remain serious concerns on the safety and adequacy of the blood supply across the region. Objective This review paper ascertains the role of pathogen reduction technology (PRT) in improving blood safety and supply adequacy in the region. Method The state of blood safety in sub-Saharan Africa was reviewed. Meetings, seminars and correspondence were undertaken with key clinicians, scientists and professional bodies in the region, including the World Health Organization’s Regional Office for Africa, to examine the suitability of PRT for improving the safety of whole blood transfusion, a prevalent transfusion format in the region. Results Existing literature suggests that combining PRT with current blood safety measures (such as serology) would improve the safety and adequacy of the blood supply for transfusions in sub-Saharan Africa. This was echoed by the findings of the stakeholder meetings. Conclusion Following a detailed appraisal of two leading PRT systems, the Mirasol® PRT System and the Cerus S-303 System, we suggest that companies conduct comprehensive toxicological evaluation of the agents used for PRT and publish this in the scientific literature. We also recommend that the safety and efficacy of these technologies should be established in a randomised clinical trial conducted in sub-Saharan Africa. PMID:28879109

A systematic review on the effectiveness of school and community-based injury prevention programmes on risk behaviour and injury risk in 8-12 year old children.

PubMed

Nauta, Joske; van Mechelen, Willem; Otten, René H J; Verhagen, Evert A L M

2014-03-01

To review existing literature on the effectiveness of community-based and school-based physical activity related injury prevention programmes implemented to increase safety behaviour and decrease injury risk in 8-12 year old children, considering the methodological quality of the studies. A systematic review with quality assessment. A systematic search was performed using the CINAHL, Cochrane, EMBASE, PubMed and Sportdiscus databases. Inclusion criteria included the following: children aged 8-12 years; school- or community-based injury prevention programmes; an outcome defined as number of injuries, injury incidence or safety behaviour; published in an English language journal. Methodological quality was assessed for all included studies. The search yielded 5377 records, of which 11 were included in the review; four studies were considered as being of high quality. The focus of studies that were included was on the use of safety devices (8), pedestrian safety (2) and physical activity-related injury prevention (1). For safety device use, short term effects of school- and community-based interventions are promising for 8-12 year olds. Results regarding sustainability of the effect are inconsistent. A mediating effect on the distribution of safety devices was observed. Both financial and non-financial barriers seemed to prevent participants from purchasing a safety device. The short term effects for school- and community-based interventions using safety devices for 8-12 year olds are promising. More high quality research is, however warranted, preferably shifting focus from safety behaviour change to actual physical activity injury reduction. Copyright © 2013 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

Athlete's foot.

PubMed

Crawford, Fay

2006-11-01

Around 15-25% of people are likely to have athlete's foot at any one time. The infection can spread to other parts of the body and to other people. We conducted a systematic review and aimed to answer the following clinical question: What are the effects of topical treatments for athlete's foot? We searched: Medline, Embase, The Cochrane Library and other important databases up to April 2006 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA). We found 11 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions. In this systematic review we present information relating to the effectiveness and safety of the following interventions: improved foot hygiene, including socks, and hosiery; topical allylamines (naftifine, terbinafine); topical azoles; and topical ciclopirox olamine.

Ankle sprain.

PubMed

Struijs, Peter Aa; Kerkhoffs, Gino Mmj

2010-05-13

Injury of the lateral ligament complex of the ankle joint occurs in about one in 10,000 people a day, accounting for a quarter of all sports injuries. We conducted a systematic review and aimed to answer the following clinical question: What are the effects of treatment strategies for acute ankle ligament ruptures? We searched: Medline, Embase, The Cochrane Library, and other important databases up to November 2009 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA). We found 38 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions. In this systematic review we present information relating to the effectiveness and safety of the following interventions: cold treatment, diathermy, functional treatment, homeopathic ointment, immobilisation, physiotherapy, surgery, and ultrasound.

Ankle sprain

PubMed Central

2010-01-01

Introduction Injury of the lateral ligament complex of the ankle joint occurs in about one in 10,000 people a day, accounting for a quarter of all sports injuries. Methods and outcomes We conducted a systematic review and aimed to answer the following clinical question: What are the effects of treatment strategies for acute ankle ligament ruptures? We searched: Medline, Embase, The Cochrane Library, and other important databases up to November 2009 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA). Results We found 38 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions. Conclusions In this systematic review we present information relating to the effectiveness and safety of the following interventions: cold treatment, diathermy, functional treatment, homeopathic ointment, immobilisation, physiotherapy, surgery, and ultrasound. PMID:21718566

Systematic review and meta-analysis of electrocautery versus scalpel for surgical skin incisions.

PubMed

Aird, Lisa N F; Brown, Carl J

2012-08-01

The creation of surgical skin incisions has historically been performed using a cold scalpel. The use of electrocautery for this purpose has been controversial with respect to patient safety and surgical efficacy. A systematic review and meta-analysis of randomized controlled trials (RCTs) was conducted to compare skin incisions made by electrocautery and a scalpel. A systematic electronic literature search was performed using 2 electronic databases (MEDLINE and PubMed), and the methodological quality of included publications was evaluated. Six RCTs were identified comparing electrocautery (n = 606) and a scalpel (n = 628) for skin incisions. No significant difference in wound infection rates or scar cosmesis was identified between the treatment groups. Electrocautery significantly reduced the incision time and postoperative wound pain. A trend toward less incisional blood loss from skin incisions made with electrocautery was noted. Electrocautery is a safe and effective method for performing surgical skin incisions. Copyright © 2012 Elsevier Inc. All rights reserved.

Burning mouth syndrome

PubMed Central

2008-01-01

Introduction Burning mouth syndrome mainly affects women, particularly after the menopause, when its prevalence may be 18-33%. Methods and outcomes We conducted a systematic review and aimed to answer the following clinical question: What are the effects of treatments for burning mouth syndrome? We searched: Medline, Embase, The Cochrane Library, and other important databases up to February 2007 (BMJ Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA). Results We found 12 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions. Conclusions In this systematic review we present information relating to the effectiveness and safety of the following interventions: anaesthetics (local), antidepressants, benzodiazepines (topical clonazepam), benzydamine hydrochloride, cognitive behavioural therapy (CBT), dietary supplements, and hormone replacement therapy (HRT) in postmenopausal women. PMID:19450321

Revealed Preference Methods for Studying Bicycle Route Choice-A Systematic Review.

PubMed

Pritchard, Ray

2018-03-07

One fundamental aspect of promoting utilitarian bicycle use involves making modifications to the built environment to improve the safety, efficiency and enjoyability of cycling. Revealed preference data on bicycle route choice can assist greatly in understanding the actual behaviour of a highly heterogeneous group of users, which in turn assists the prioritisation of infrastructure or other built environment initiatives. This systematic review seeks to compare the relative strengths and weaknesses of the empirical approaches for evaluating whole journey route choices of bicyclists. Two electronic databases were systematically searched for a selection of keywords pertaining to bicycle and route choice. In total seven families of methods are identified: GPS devices, smartphone applications, crowdsourcing, participant-recalled routes, accompanied journeys, egocentric cameras and virtual reality. The study illustrates a trade-off in the quality of data obtainable and the average number of participants. Future additional methods could include dockless bikeshare, multiple camera solutions using computer vision and immersive bicycle simulator environments.

Revealed Preference Methods for Studying Bicycle Route Choice—A Systematic Review

PubMed Central

2018-01-01

One fundamental aspect of promoting utilitarian bicycle use involves making modifications to the built environment to improve the safety, efficiency and enjoyability of cycling. Revealed preference data on bicycle route choice can assist greatly in understanding the actual behaviour of a highly heterogeneous group of users, which in turn assists the prioritisation of infrastructure or other built environment initiatives. This systematic review seeks to compare the relative strengths and weaknesses of the empirical approaches for evaluating whole journey route choices of bicyclists. Two electronic databases were systematically searched for a selection of keywords pertaining to bicycle and route choice. In total seven families of methods are identified: GPS devices, smartphone applications, crowdsourcing, participant-recalled routes, accompanied journeys, egocentric cameras and virtual reality. The study illustrates a trade-off in the quality of data obtainable and the average number of participants. Future additional methods could include dockless bikeshare, multiple camera solutions using computer vision and immersive bicycle simulator environments. PMID:29518991

Physical Activity and Safety From Crime Among Adults: A Systematic Review.

PubMed

da Silva, Inacio C; Payne, Valerie L; Hino, Adriano Akira; Varela, Andrea Ramirez; Reis, Rodrigo S; Ekelund, Ulf; Hallal, Pedro C

2016-06-01

The aim of this study was to review the evidence to date on the association between physical activity and safety from crime. Articles with adult populations of 500+ participants investigating the association between physical activity and safety from crime were included. A methodological quality assessment was conducted using an adapted version of the Downs and Black checklist. The literature search identified 15,864 articles. After assessment of titles, abstracts and full-texts, 89 articles were included. Most articles (84.3%) were derived from high-income countries and only 3 prospective articles were identified. Articles presented high methodological quality. In 38 articles (42.7%), at least one statistically significant association in the expected direction was reported (ie, safety from crime was positively associated with physical activity). Nine articles (10.1%) found an association in the unexpected direction and 42 (47.2%) did not find statistically significant associations. The results did not change when we analyzed articles separately by sex, age, type of measurement, or domains of physical activity evaluated. The current evidence, mostly based on cross-sectional studies, suggests a lack of association between physical activity and safety from crime. Prospective studies and natural experiments are needed, particularly in areas with wide crime variability.

Edible safety requirements and assessment standards for agricultural genetically modified organisms.

PubMed

Deng, Pingjian; Zhou, Xiangyang; Zhou, Peng; Du, Zhong; Hou, Hongli; Yang, Dongyan; Tan, Jianjun; Wu, Xiaojin; Zhang, Jinzhou; Yang, Yongcun; Liu, Jin; Liu, Guihua; Li, Yonghong; Liu, Jianjun; Yu, Lei; Fang, Shisong; Yang, Xiaoke

2008-05-01

This paper describes the background, principles, concepts and methods of framing the technical regulation for edible safety requirement and assessment of agricultural genetically modified organisms (agri-GMOs) for Shenzhen Special Economic Zone in the People's Republic of China. It provides a set of systematic criteria for edible safety requirements and the assessment process for agri-GMOs. First, focusing on the degree of risk and impact of different agri-GMOs, we developed hazard grades for toxicity, allergenicity, anti-nutrition effects, and unintended effects and standards for the impact type of genetic manipulation. Second, for assessing edible safety, we developed indexes and standards for different hazard grades of recipient organisms, for the influence of types of genetic manipulation and hazard grades of agri-GMOs. To evaluate the applicability of these criteria and their congruency with other safety assessment systems for GMOs applied by related organizations all over the world, we selected some agri-GMOs (soybean, maize, potato, capsicum and yeast) as cases to put through our new assessment system, and compared our results with the previous assessments. It turned out that the result of each of the cases was congruent with the original assessment.

Safety of licensed vaccines in HIV-infected persons: a systematic review protocol

PubMed Central

2014-01-01

Background Safety of vaccines remains a cornerstone of building public trust on the use of these cost-effective and life-saving public health interventions. In some settings, particularly Sub-Saharan Africa, there is a high prevalence of HIV infection and a high burden of vaccine-preventable diseases. There is evidence suggesting that the immunity induced by some commonly used vaccines is not durable in HIV-infected persons, and therefore, repeated vaccination may be considered to ensure optimal vaccine-induced immunity in this population. However, some vaccines, particularly the live vaccines, may be unsafe in HIV-infected persons. There is lack of evidence on the safety profile of commonly used vaccines among HIV-infected persons. We are therefore conducting a systematic review to assess the safety profile of routine vaccines administered to HIV-infected persons. Methods/Design We will select studies conducted in any setting where licensed and effective vaccines were administered to HIV-infected persons. We will search for eligible studies in PubMed, Web of Science, Cochrane Central Register of Controlled Trials (CENTRAL), Scopus, Africa-Wide, PDQ-Evidence and CINAHL as well as reference lists of relevant publications. We will screen search outputs, select studies and extract data in duplicate, resolving discrepancies by discussion and consensus. Discussion Globally, immunisation is a major public health strategy to mitigate morbidity and mortality caused by various infectious disease-causing agents. In general, there are efforts to increase vaccination coverage worldwide, and for these efforts to be successful, safety of the vaccines is paramount, even among people living with HIV, who in some situations may require repeated vaccination. Results from this systematic review will be discussed in the context of the safety of routine vaccines among HIV-infected persons. From the safety perspective, we will also discuss whether repeat vaccination strategies may be feasible among HIV-infected persons. Systematic review registration PROSPERO CRD42014009794. PMID:25212760

A systematic review of patient safety in mental health: a protocol based on the inpatient setting.

PubMed

D'Lima, Danielle; Archer, Stephanie; Thibaut, Bethan Ines; Ramtale, Sonny Christian; Dewa, Lindsay H; Darzi, Ara

2016-11-29

Despite the growing international interest in patient safety as a discipline, there has been a lack of exploration of its application to mental health. It cannot be assumed that findings based upon physical health in acute care hospitals can be applied to mental health patients, disorders and settings. To the authors' knowledge, there has only been one review of the literature that focuses on patient safety research in mental health settings, conducted in Canada in 2008. We have identified a need to update this review and develop the methodology in order to strengthen the findings and disseminate internationally for advancement in the field. This systematic review will explore the existing research base on patient safety in mental health within the inpatient setting. To conduct this systematic review, a thorough search across multiple databases will be undertaken, based upon four search facets ("mental health", "patient safety", "research" and "inpatient setting"). The search strategy has been developed based upon the Canadian review accompanied with input from the National Reporting and Learning System (NRLS) taxonomy of patient safety incidents and the Diagnostic and Statistical Manual of Mental Disorders (fifth edition). The screening process will involve perspectives from at least two researchers at all stages with a third researcher invited to review when discrepancies require resolution. Initial inclusion and exclusion criteria have been developed and will be refined iteratively throughout the process. Quality assessment and data extraction of included articles will be conducted by at least two researchers. A data extraction form will be developed, piloted and iterated as necessary in accordance with the research question. Extracted information will be analysed thematically. We believe that this systematic review will make a significant contribution to the advancement of patient safety in mental health inpatient settings. The findings will enable the development and implementation of interventions to improve the quality of care experienced by patients and support the identification of future research priorities. PROSPERO CRD42016034057.

The effectiveness of acupuncture research across components of the trauma spectrum response (tsr): a systematic review of reviews

PubMed Central

2012-01-01

Background Co-morbid symptoms (for example, chronic pain, depression, anxiety, and fatigue) are particularly common in military fighters returning from the current conflicts, who have experienced physical and/or psychological trauma. These overlapping conditions cut across the boundaries of mind, brain and body, resulting in a common symptomatic and functional spectrum of physical, cognitive, psychological and behavioral effects referred to as the ‘Trauma Spectrum Response’ (TSR). While acupuncture has been shown to treat some of these components effectively, the current literature is often difficult to interpret, inconsistent or of variable quality. Thus, to gauge comprehensively the effectiveness of acupuncture across TSR components, a systematic review of reviews was conducted using the Samueli Institute’s Rapid Evidence Assessment of the Literature (REAL©) methodology. Methods PubMed/MEDLINE, the Cochrane Database of Systematic Reviews, EMBASE, CINAHL, and PsycInfo were searched from inception to September 2011 for systematic reviews/meta-analyses. Quality assessment was rigorously performed using the Scottish Intercollegiate Guidelines Network (SIGN 50) checklist and the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) methodology. Adherence to the Standards for Reporting Interventions in Clinical Trials in Acupuncture (STRICTA) criteria was also assessed. Results Of the 1,480 citations identified by our searches, 52 systematic reviews/meta-analyses, all high quality except for one, met inclusion criteria for each TSR component except post-traumatic stress disorder (PTSD) and sexual function. The majority of reviews addressed most STRICTA components, but did not describe safety. Conclusions Based on the results of our review, acupuncture appears to be effective for treating headaches and, although more research is needed, seems to be a promising treatment option for anxiety, sleep disturbances, depression and chronic pain. It does not, however, demonstrate any substantial treatment benefit for substance abuse. Because there were no reviews on PTSD or sexual function that met our pre-defined inclusion criteria, we cannot comment on acupuncture’s effectiveness in treating these conditions. More quality data are also needed to determine whether acupuncture is appropriate for treating fatigue or cognitive difficulties. Further, while acupuncture has been shown to be generally safe, safety was not described in the majority of studies, making it difficult to provide any strong recommendations. Future research should address safety reporting in detail in order to increase our confidence in acupuncture’s efficacy across the identified TSR components. PMID:23067573

Ozone therapy in postgraduate theses in Egypt: systematic review.

PubMed

AlBedah, Abdullah M N; Khalil, Mohamed K M; Elolemy, Ahmed T; Alrasheid, Mohamed H S; Al Mudaiheem, Abdullah; Elolemy, Tawfik M B

2013-08-01

Systematic reviews of the studies published in the major medical data bases have not shown solid support for the use of ozone therapy. Unpublished or grey literature, including postgraduate theses, may solve this controversy. To review the postgraduate theses published in Egypt in order to assess the clinical safety and effectiveness of ozone therapy in specific medical conditions. The databases of the Egyptian Universities' Library Consortium and the databases of each university were searched for postgraduate theses that evaluated ozone therapy as an intervention for any disease or condition in any age group, compared with any or no other intervention and published before September 2010. A total of 28 quasi trials were included. The theses did not report any safety issues in terms of ozone therapy. With respect to its effectiveness, the studies suggested some benefits of ozone in the treatment of dental infection and recovery, musculoskeletal disorders, diabetes mellitus, chronic diseases, and obstetrics and gynaecology. However, the number of studies included was small and they were of limited quality. There is insufficient evidence to recommend the use of ozone in the treatment of dental infections, in facilitating faster dental recovery after extraction or implantation, in diabetes mellitus, musculoskeletal disorders, or obstetrics and gynaecology.

RELAP-7 Code Assessment Plan and Requirement Traceability Matrix

DOE Office of Scientific and Technical Information (OSTI.GOV)

Yoo, Junsoo; Choi, Yong-joon; Smith, Curtis L.

2016-10-01

The RELAP-7, a safety analysis code for nuclear reactor system, is under development at Idaho National Laboratory (INL). Overall, the code development is directed towards leveraging the advancements in computer science technology, numerical solution methods and physical models over the last decades. Recently, INL has also been putting an effort to establish the code assessment plan, which aims to ensure an improved final product quality through the RELAP-7 development process. The ultimate goal of this plan is to propose a suitable way to systematically assess the wide range of software requirements for RELAP-7, including the software design, user interface, andmore » technical requirements, etc. To this end, we first survey the literature (i.e., international/domestic reports, research articles) addressing the desirable features generally required for advanced nuclear system safety analysis codes. In addition, the V&V (verification and validation) efforts as well as the legacy issues of several recently-developed codes (e.g., RELAP5-3D, TRACE V5.0) are investigated. Lastly, this paper outlines the Requirement Traceability Matrix (RTM) for RELAP-7 which can be used to systematically evaluate and identify the code development process and its present capability.« less

Barbiturates for the treatment of alcohol withdrawal syndrome: A systematic review of clinical trials.

PubMed

Mo, Yoonsun; Thomas, Michael C; Karras, George E

2016-04-01

To perform a systematic review of the clinical trials concerning the use of barbiturates for the treatment of acute alcohol withdrawal syndrome (AWS). A literature search of MEDLINE, EMBASE, and the Cochrane Library, together with a manual citation review was conducted. We selected English-language clinical trials (controlled and observational studies) evaluating the efficacy and safety of barbiturates compared with benzodiazepine (BZD) therapy for the treatment of AWS in the acute care setting. Data extracted from the included trials were duration of delirium, number of seizures, length of intensive care unit and hospital stay, cumulated doses of barbiturates and BZDs, and respiratory or cardiac complications. Seven studies consisting of 4 prospective controlled and 3 retrospective trials were identified. Results from all the included studies suggest that barbiturates alone or in combination with BZDs are at least as effective as BZDs in the treatment of AWS. Furthermore, barbiturates appear to have acceptable tolerability and safety profiles, which were similar to those of BZDs in patients with AWS. Although the evidence is limited, based on our findings, adding phenobarbital to a BZD-based regimen is a reasonable option, particularly in patients with BZD-refractory AWS. Copyright © 2015 Elsevier Inc. All rights reserved.

[Algorithms for early mobilization in intensive care units].

PubMed

Nydahl, P; Dubb, R; Filipovic, S; Hermes, C; Jüttner, F; Kaltwasser, A; Klarmann, S; Mende, H; Nessizius, S; Rottensteiner, C

2017-03-01

Immobility of patients in intensive care units (ICU) can lead to long-lasting physical and cognitive decline. During the last few years, bundles for rehabilitation were developed, including early mobilization. The German guideline for positioning therapy and mobilization, in general, recommends the development of ICU-specific protocols. The aim of this narrative review is to provide guidance when developing a best practice protocol in one's own field of work. It is recommended to a) implement early mobilization as part of a bundle, including screening and management of patient's awareness, pain, anxiety, stress, delirium and family's presence, b) develop a traffic-light system of specific in- and exclusion criteria in an interprofessional process, c) use checklists to assess risks and preparation of mobilization, d) use the ICU Mobility Scale for targeting and documentation of mobilization, e) use relative safety criteria for hemodynamic and respiratory changes, and Borg Scale for subjective evaluation, f) document and evaluate systematically mobilization levels, barriers, unwanted safety events and other parameters.

Potassium Dehydroandrographolide Succinate Injection for the treatment of child epidemic parotitis: A systematic review and meta-analysis.

PubMed

Wu, Jia-rui; Zhang, Xiao-meng; Zhang, Bing

2015-11-01

To systematically evaluate the clinical efficacy and safety of Potassium Dehydroandrographolide Succinate Injection (PDSI) in the treatment of child epidemic parotitis (EP). Randomized controlled trials (RCTs) regarding PDSI in the treatment of child EP were searched in China National Knowledge Infrastructure, Wanfang Database, Chinese Biomedical Literature Database, PubMed, and Cochrane Library from inception to July 30, 2013. Two reviewers independently retrieved RCTs and extracted information. The Cochrane risk of bias method was used to assess the quality of included studies, and a meta-analysis was conducted with RevMan 5.2 software. A total of 11 studies with 818 participants were included. The quality of the studies was generally low, among which only one study mentioned the random method. The meta-analysis indicated that PDSI was more effective than the conventional therapy with Western medicine for EP in the outcomes of the total effective rate [relative risk (RR)=1.23, 95% confidence interval (CI) [1.14, 1.33], P<0.01], the time of temperature return to normal, the time of detumescence [mean difference (MD)=-2.10, 95% CI [-2.78,-1.41], P<0.01], and the incidence of complications (RR=0.14, 95% CI [0.03, 0.72], P=0.02). There were 6 adverse drug reactions (ADRs) in this systematic review, 2 of which were mainly represented rash and diarrhea in the experiment group, while another 4 ADRs occurred in the control group. Based on the systematic review, PDSI was effectiveness and relatively safety in the treatment of child EP. But further rigorously designed trials are warranted to determine its effectiveness.

Efficacy and safety of haloperidol for in-hospital delirium prevention and treatment: A systematic review of current evidence.

PubMed

Schrijver, E J M; de Graaf, K; de Vries, O J; Maier, A B; Nanayakkara, P W B

2016-01-01

Haloperidol is generally considered the drug of choice for in-hospital delirium management. We conducted a systematic review to evaluate the evidence for the efficacy and safety of haloperidol for the prevention and treatment of delirium in hospitalized patients. PubMed, Embase, Cumulative Index to Nursing and Allied Health (CINAHL), PsycINFO, and the Cochrane Library were systematically searched up to April 21, 2015. We included English full-text randomized controlled trials using haloperidol for the prevention or treatment of delirium in adult hospitalized patients reporting on delirium incidence, duration, or severity as primary outcome. Quality of evidence was graded. Meta-analysis was not conducted because of between-study heterogeneity. Twelve studies met our inclusion criteria, four prevention and eight treatment trials. Methodological limitations decreased the graded quality of included studies. Results from placebo-controlled prevention studies suggest a haloperidol-induced protective effect for delirium in older patients scheduled for surgery: two studies reported a significant reduction in ICU delirium incidence and one study found a significant reduction in delirium severity and duration. Although placebo-controlled trials are missing, pharmacological treatment of established delirium reduced symptom severity. Haloperidol administration was not associated with treatment-limiting side-effects, but few studies used a systematic approach to identify adverse events. Although results on haloperidol for delirium management seem promising, current prevention trials lack external validity and treatment trials did not include a placebo arm on top of standard nonpharmacological care. We therefore conclude that the current use of haloperidol for in-hospital delirium is not based on robust and generalizable evidence. Copyright © 2015 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.

History of safe use as applied to the safety assessment of novel foods and foods derived from genetically modified organisms.

PubMed

Constable, A; Jonas, D; Cockburn, A; Davi, A; Edwards, G; Hepburn, P; Herouet-Guicheney, C; Knowles, M; Moseley, B; Oberdörfer, R; Samuels, F

2007-12-01

Very few traditional foods that are consumed have been subjected to systematic toxicological and nutritional assessment, yet because of their long history and customary preparation and use and absence of evidence of harm, they are generally regarded as safe to eat. This 'history of safe use' of traditional foods forms the benchmark for the comparative safety assessment of novel foods, and of foods derived from genetically modified organisms. However, the concept is hard to define, since it relates to an existing body of information which describes the safety profile of a food, rather than a precise checklist of criteria. The term should be regarded as a working concept used to assist the safety assessment of a food product. Important factors in establishing a history of safe use include: the period over which the traditional food has been consumed; the way in which it has been prepared and used and at what intake levels; its composition and the results of animal studies and observations from human exposure. This paper is aimed to assist food safety professionals in the safety evaluation and regulation of novel foods and foods derived from genetically modified organisms, by describing the practical application and use of the concept of 'history of safe use'.

[Evaluation of the effectiveness of occupational safety and health inspections of construction sites in the Piedmont region from 2001 to 2005].

PubMed

Bruno, Santina; Bena, Antonella; Debernardi, Maria Luisa; Nava, S; Pastore, Raffaella; Proietti, C; Quarta, D

2009-01-01

To assess the effectiveness of safety inspections in the construction industry in Piedmont in terms of exposure to risk and injuries. We conducted a retrospective analysis of the surveillance activities carried out in Piedmont between 2001 and 2005: to this purpose, we used a logical framework and we identified indicators to evaluate the process and its impact on exposure and injuries. fixed standards involving the number of safety inspections and the type of constructions under control were respected; there was always sufficient diversity among the public works under control, although local health units used different working methods. Impact on exposure and injuries: injury rates in the construction industry in Piedmont showed a decreasing trend and systematically lower values compared to national rates. Injury rates in the "roads and railways" sector showed an increasing trend owing to the great number of public works under construction. In this case, the effect of preventive measures seems less noticeable, but this mainly depends on methodological limits, such as mismatch between numerator and denominator, difficulties in estimating the number of workers actually present on the sites, underreporting of minor events. Despite the limitations of a retrospective analysis, the Piedmont safety inspection programme for the construction industry showed coherence with the objectives and had a positive impact on injury rates.

Following the (Clinical Decision) Rules: Opportunities for Improving Safety and Resource Utilization With the Bacterial Meningitis Score.

PubMed

Hagedorn, Philip A; Shah, Samir S; Kirkendall, Eric S

2016-05-01

The Bacterial Meningitis Score accurately classifies children with cerebrospinal fluid (CSF) pleocytosis at very low risk (VLR) versus not very low risk (non-VLR) for bacterial meningitis. Most children with CSF pleocytosis detected during emergency department evaluation are hospitalized despite the high accuracy of this prediction rule and the decreasing incidence of bacterial meningitis. The lack of widespread use of this rule may contribute to unnecessary risk exposure and costs. This cross-sectional study included 1049 patients who, between January 2010 and May 2013, had suspicion for meningitis and underwent both a complete blood cell count and CSF studies during their emergency department evaluation. We then examined their hospitalizations to characterize exposure to drugs, radiologic studies, and the costs associated with their care to determine the safety and value repercussions of these VLR admissions. Primary outcomes include duration of antibiotics, exposure to drugs and radiology studies, safety events, and costs incurred during these VLR admissions. Twenty patients classified as VLR were admitted to the hospital. On average they received 35 hours of antibiotic therapy. There was 1 adverse drug event and 1 safety event. The VLR patients admitted to the hospital were exposed to risk and costs despite their low risk stratification. Systematic application of the Bacterial Meningitis Score could prevent these exposures and costs. Copyright © 2016 by the American Academy of Pediatrics

Evaluation of Patient and Family Engagement Strategies to Improve Medication Safety.

PubMed

Kim, Julia M; Suarez-Cuervo, Catalina; Berger, Zackary; Lee, Joy; Gayleard, Jessica; Rosenberg, Carol; Nagy, Natalia; Weeks, Kristina; Dy, Sydney

2018-04-01

Patient and family engagement (PFE) is critical for patient safety. We systematically reviewed types of PFE strategies implemented and their impact on medication safety. We searched MEDLINE, EMBASE, reference lists and websites to August 2016. Two investigators independently reviewed all abstracts and articles, and articles were additionally reviewed by two senior investigators for selection. One investigator abstracted data and two investigators reviewed the data for accuracy. Study quality was determined by consensus. Investigators developed a framework for defining the level of patient engagement: informing patients about medications (Level 1), informing about engagement with health care providers (Level 2), empowering patients with communication tools and skills (Level 3), partnering with patients in their care (Level 4), and integrating patients as full care team members (Level 5). We included 19 studies that mostly targeted older adults taking multiple medications. The median level of engagement was 2, ranging from 2-4. We identified no level 5 studies. Key themes for patient engagement strategies impacting medication safety were patient education and medication reconciliation, with a subtheme of patient portals. Most studies (84%) reported implementation outcomes. The most commonly reported medication safety outcomes were medication errors, including near misses and discrepancies (47%), and medication safety knowledge (37%). Most studies (63%) were of medium to low quality, and risk of bias was generally moderate. Among the 11 studies with control groups, 55% (n = 6) reported statistically significant improvement on at least one medication safety outcome. Further synthesis of medication safety measures was limited due to intervention and outcome heterogeneity. Key strategies for engaging patients in medication safety are education and medication reconciliation. Patient engagement levels were generally low, as defined by a novel framework for determining levels of patient engagement. As more patient engagement studies are conducted, this framework should be evaluated for associations with patient outcomes.

Methodological guidelines for developing accident modification functions.

PubMed

Elvik, Rune

2015-07-01

This paper proposes methodological guidelines for developing accident modification functions. An accident modification function is a mathematical function describing systematic variation in the effects of road safety measures. The paper describes ten guidelines. An example is given of how to use the guidelines. The importance of exploratory analysis and an iterative approach in developing accident modification functions is stressed. The example shows that strict compliance with all the guidelines may be difficult, but represents a level of stringency that should be strived for. Currently the main limitations in developing accident modification functions are the small number of good evaluation studies and the often huge variation in estimates of effect. It is therefore still not possible to develop accident modification functions for very many road safety measures. Copyright © 2015 Elsevier Ltd. All rights reserved.

Efficacy and Safety of Oral Beclomethasone Dipropionate in Ulcerative Colitis: A Systematic Review and Meta-Analysis.

PubMed

Manguso, Francesco; Bennato, Raffaele; Lombardi, Giovanni; Riccio, Elisabetta; Costantino, Giuseppe; Fries, Walter

2016-01-01

We performed a systematic review and meta-analysis of all the available evidence comparing efficacy and safety of oral prolonged released beclomethasone dipropionate (BDP) to active oral controls in patients with mild-to-moderate ulcerative colitis (UC). A subgroup-analysis compared the effectiveness of BDP and 5-ASA. Literature research was performed in different databases, as well as manual search to identify abstracts from international meetings with data not included in extensive publications. Experts in the field and companies involved in BDP development and manufacture were contacted to identify unpublished studies used for registration purposes. Dichotomous data were pooled to obtain odds ratio meta-analysis. Five randomized controlled trials that compared oral BDP 5mg/day vs. all oral active controls in treating UC were identified as eligible. Efficacy and safety have been addressed after 4-week treatment period. One study evaluated efficacy and safety of BDP vs. prednisone and 4 of BDP vs. 5-ASA. Treatment with oral BDP 5 mg/day induces a significant better clinical response compared to oral 5-ASA (OR 1.86, 95% CI = 1.23-2.82, P = 0.003). The effect is detectable even when the comparison to prednisone is added (OR 1.41, 95% CI = 1.03-1.93, P = 0.03). Data on remission indicate that the potential clinical efficacy of BDP may be better than 5-ASA (OR 1.55, 95% CI = 1.00-2.40, P = 0.05). This difference is lost when the comparison with prednisone is added (OR 1.30, 95% CI = 0.76-2.23, P = 0.34). The safety analysis showed no differences between BDP and 5-ASA (OR 0.55, 95% CI = 0.24-1.27, P = 0.16). The lack of difference is maintained even when the study with prednisone is added (OR 0.67, 95% CI = 0.44-1.01, P = 0.06). However, the trend of difference is clear and indicates a more favourable safety profile of BDP compared to 5-ASA and PD. Oral prolonged release BDP showed a superior efficacy vs. oral 5-ASA in inducing clinical improvement of mild-to-moderate UC with a similar safety profile.

The Efficacy and Safety of Mainstream Medications for Patients With cDMARD-Naïve Rheumatoid Arthritis: A Network Meta-Analysis.

PubMed

Cai, Weiyan; Gu, Youyi; Cui, Huanqin; Cao, Yinyin; Wang, Xiaoliang; Yao, Yi; Wang, Mingyu

2018-01-01

Background: The mainstream medications for rheumatoid arthritis (RA) include conventional disease-modifying antirheumatic drugs (cDMARDs), which mostly are methotrexate (MTX), and biologic agents such as adalimumab (ADA), certolizumab (CZP), etanercept (ETN), golimumab (GOL), infliximab (IFX), and tocilizumab (TCZ). This network meta-analysis was aimed at evaluating the efficacy and safety of the medications above and interventions combining cDMARDs and biologic agents for patients with RA. Methods: PubMed, EMBASE, Cochrane Library, and ClinicalTrials.gov were searched systematically for eligible randomized controlled trials (RCTs). Outcomes concerning efficacy and safety were evaluated utilizing odds ratios (ORs) and 95% credible intervals ( CrI ). The outcomes of efficacy would be evaluated through remission and American College of Rheumatology (ACR) scores. The surface under the cumulative ranking curve (SUCRA) was calculated to rank each treatment on each index. Results: A total of 20 RCTs with 9,047 patients were included, and the efficacy and safety of the concerning interventions for RA were evaluated. Compared with cDMARDs alone, TCZ+MTX, ETN+MTX, IFX+MTX, TCZ, and ADA+MTX showed significant statistical advantage on ACR20, ACR50, and ACR70. Apart from that, as for remission, TCZ+MTX, IFX+MTX, TCZ, and CZP+MTX performed better compared to cDMARDs alone. The SUCRA ranking also indicated that TCZ+MTX was the intervention with best ranking in the entire four efficacy indexes followed by ETX+MTX and IFX+MTX. However, there was no obvious difference among these medications compared with cDMARDs when it comes to safety, which need more specific studies on that. Conclusion: TCZ+MTX was potentially the most recommended combination of medications for RA due to its good performance in all outcomes of efficacy. ETX+MTX and IFX+MTX, which also performed well, could be introduced as alternative treatments. However, considering the adverse events, the treatments concerning should be introduced with caution.

Evaluation of the suitability of root cause analysis frameworks for the investigation of community-acquired pressure ulcers: a systematic review and documentary analysis.

PubMed

McGraw, Caroline; Drennan, Vari M

2015-02-01

To evaluate the suitability of root cause analysis frameworks for the investigation of community-acquired pressure ulcers. The objective was to identify the extent to which these frameworks take account of the setting where the ulcer originated as being the person's home rather than a hospital setting. Pressure ulcers involving full-thickness skin loss are increasingly being regarded as indicators of nursing patient safety failure, requiring investigation using root cause analysis frameworks. Evidence suggests that root cause analysis frameworks developed in hospital settings ignore the unique dimensions of risk in home healthcare settings. A systematic literature review and documentary analysis of frameworks used to investigate community-acquired grade three and four pressure ulcers by home nursing services in England. No published papers were identified for inclusion in the review. Fifteen patient safety investigative frameworks were collected and analysed. Twelve of the retrieved frameworks were intended for the investigation of community-acquired pressure ulcers; seven of which took account of the setting where the ulcer originated as being the patient's home. This study provides evidence to suggest that many of the root cause analysis frameworks used to investigate community-acquired pressure ulcers in England are unsuitable for this purpose. This study provides researchers and practitioners with evidence of the need to develop appropriate home nursing root cause analysis frameworks to investigate community-acquired pressure ulcers. © 2014 John Wiley & Sons Ltd.

Vedolizumab for induction and maintenance of remission in ulcerative colitis: a Cochrane systematic review and meta-analysis.

PubMed

Mosli, Mahmoud H; MacDonald, John K; Bickston, Stephen J; Behm, Brian W; Tsoulis, David J; Cheng, Jianfeng; Khanna, Reena; Feagan, Brian G

2015-05-01

We performed a systematic review to evaluate the efficacy and safety of vedolizumab for induction and maintenance of remission in ulcerative colitis. A literature search to June 2014 identified all applicable randomized trials. Outcome measures were clinical and endoscopic remission, clinical and endoscopic response, quality of life, and adverse events. The risk ratio (RR) and 95% confidence intervals (CI) were estimated for each outcome. Study quality was evaluated using the Cochrane risk of bias tool. The GRADE criteria were used to assess the quality of the evidence. Four studies (606 patients) were included. The risk of bias was low. Pooled analyses indicated that vedolizumab was significantly superior to placebo for induction of remission (RR = 0.86, 95% CI, 0.80-0.91), clinical response (RR = 0.82, 95% CI, 0.75-0.91), endoscopic remission (RR = 0.82, 95% CI, 0.75-0.91), and for achieving remission at 52 weeks in week 6 responders (RR = 2.73, 95% CI, 1.78-4.18). GRADE analyses suggested that the overall quality of the evidence was high for induction of remission and moderate for maintenance therapy (due to sparse data consisting of 246 events). No statistically significant difference was observed in the incidence of adverse events between vedolizumab and placebo. Vedolizumab is superior to placebo as induction and maintenance therapy for ulcerative colitis. Future studies are needed to define long-term efficacy and safety of this agent.

Medicinal plants for primary dysmenorrhoea: A systematic review.

PubMed

Pellow, Janice; Nienhuis, Chantelle

2018-04-01

Primary dysmenorrhoea is a common complaint experienced by many females in their reproductive years. The use of medicinal plants in the treatment of various gynaecological conditions is on the increase, despite the limited evidence available regarding efficacy and safety of their use. The aim of this systematic review was to synthesise the most recent evidence relating to the treatment of primary dysmenorrhoea with medicinal plants. A thorough database search was conducted using defined search terms, and randomised controlled trials (RCTs) published in English between 2008 and 2016, pertaining to the use of medicinal plants (single use) for the treatment of primary dysmenorrhoea, were assessed. Studies evaluating dysmenorrhoeal pain and associated symptoms as a primary or secondary outcome were considered and assessed by two reviewers independently of each other, using the JADAD scale and the Cochrane risk of bias tool,. 22 RCTs were included in the review; 9 were placebo-controlled trials and 13 were comparative studies to pharmacological treatment or nutritional supplements. Most of the evaluated medicinal plants showed evidence of efficacy in relieving menstrual pain in at least one RCT. The low or unclear quality of the majority of these studies however warrants caution in interpreting these results. This review adds to the knowledge-base on the use of these medicinal plants in the treatment of primary dysmenorrhoea. Further research is needed before definitive conclusions can be made regarding the efficacy and safety of the use of these medicinal plants. Copyright © 2018 Elsevier Ltd. All rights reserved.

Efficacy and safety of pharmacological agents in the treatment of erythema migrans in early Lyme borreliosis-systematic review protocol.

PubMed

Torbahn, Gabriel; Hofmann, Heidelore; Allert, Roman; Freitag, Michael H; Dersch, Rick; Fingerle, Volker; Sommer, Harriet; Motschall, Edith; Meerpohl, Jörg J; Schmucker, Christine

2016-05-03

Erythema migrans represents an early cutaneous and most common manifestation of Lyme borreliosis. Recommendations regarding pharmacological agents, dose and duration of treatment are subject of intense debate. This review aims to explore differences in efficacy and safety between pharmacological treatments and control treatment. To identify relevant studies, we will conduct a systematic literature search. We will include randomised controlled trials (RCTs) and non-RCTs. Eligible comparative studies need to (1) consider patients with a diagnosis of erythema migrans resulting from Lyme borreliosis and (2) compare different pharmacological agents against each other, against any other non-pharmacological treatment, placebo or no treatment. Two review authors will independently assess included studies for risk of bias according to the methods of the Cochrane Handbook for Systematic Reviews of Interventions and related to specific study designs. We will address patient-relevant outcomes including clinical remission of cutaneous symptoms, any treatment-related adverse events, quality of life and progressive symptoms such as neuroborreliosis or Lyme carditis and flu-like symptoms. Provided that the identified trials are comparable in terms of clinical issues, combined estimates will be provided. Estimations of treatment effects will be calculated based on a random effects model. Heterogeneity will be evaluated based on I (2) and chi-square test. In case of significant heterogeneity, a pooled estimate will not be provided, but heterogeneity will be investigated on the basis of methodological and clinical study aspects. We plan subgroup analysis to reveal potential differences in the effect estimates between patient populations and treatment specifications. We will consider risk of bias using sensitivity analyses to decide whether to rely on the pooled estimates. The quality of a body of evidence for individual outcomes will be assessed using the GRADE approach. Benefits and harms of pharmacological treatment in erythema migrans have not yet been adequately assessed. This systematic review will evaluate and summarise available evidence addressing benefits and harms of different pharmacological treatments. In addition, this summary of clinical evidence will inform decision-making between clinicians and patients and will play an important part in patient care. CRD42016037932.

The Association Between Professional Burnout and Engagement With Patient Safety Culture and Outcomes: A Systematic Review.

PubMed

Mossburg, Sarah E; Dennison Himmelfarb, Cheryl

2018-06-25

In the last 20 years, there have been numerous successful efforts to improve patient safety, although recent research still shows a significant gap. Researchers have begun exploring the impact of individual level factors on patient safety culture and safety outcomes. This review examines the state of the science exploring the impact of professional burnout and engagement on patient safety culture and safety outcomes. A systematic search was conducted in CINAHL, PubMed, and Embase. Studies included reported on the relationships among burnout or engagement and safety culture or safety outcomes. Twenty-two studies met inclusion criteria. Ten studies showed a relationship between both safety culture and clinical errors with burnout. Two of 3 studies reported an association between burnout and patient outcomes. Fewer studies focused on engagement. Most studies exploring engagement and safety culture found a moderately strong positive association. The limited evidence on the relationship between engagement and errors depicts inconsistent findings. Only one study explored engagement and patient outcomes, which failed to find a relationship. The burnout/safety literature should be expanded to a multidisciplinary focus. Mixed results of the relationship between burnout and errors could be due to a disparate relationship with perceived versus observed errors. The engagement/safety literature is immature, although high engagement seems to be associated with high safety culture. Extending this science into safety outcomes would be meaningful, especially in light of the recent focus on an abundance-based approach to safety.

Adverse drug reactions due to drug-drug interactions with proton pump inhibitors: assessment of systematic reviews with AMSTAR method.

PubMed

Yucel, Emre; Sancar, Mesut; Yucel, Aylin; Okuyan, Betul

2016-01-01

Many systematic reviews resulted in claims on drug-drug interactions (DDIs) with proton pump inhibitors (PPIs). Such a large number begs for consensus on the clinical significance of findings. We critically evaluated the safety of PPI use with respect to DDIs with a meta-review of systematic reviews published between 1978 and 2015. We assessed the evidence by their reliability, repeatability, transparency, and objectivity according to the Assessment of Multiple Systematic Reviews (AMSTAR) criteria. Clinicians must assess risks for each PPI for certain comorbid conditions. DDIs don't substantiate class effect for PPIs; each PPI could induce unique DDIs. Concomitant use of PPIs with thienopyridines (e.g. clopidogrel) could be justified in patients without strong affinity to cytochrome CYP2C19 and with high risk of bleeding (e.g. patients with prior upper gastrointestinal bleeding, Helicobacter pylori infection, advanced age, steroid treatment, and nonsteroidal anti-inflammatory drug use). DDIs could occur in an AIDS subpopulation treated with highly active antiretroviral therapy (HAART). DDIs exist for cancer patients undergoing targeted therapy. Hypomagnesemia could increase in the setting of advanced age and polypharmacy. Omeprazole poses high risks owing to its pharmacokinetic DDI profile. Future systematic reviews should incorporate these additional risks for better clinical guidance.

Healthcare Staff Wellbeing, Burnout, and Patient Safety: A Systematic Review

PubMed Central

Hall, Louise H.; Johnson, Judith; Watt, Ian; Tsipa, Anastasia; O’Connor, Daryl B.

2016-01-01

Objective To determine whether there is an association between healthcare professionals’ wellbeing and burnout, with patient safety. Design Systematic research review. Data Sources PsychInfo (1806 to July 2015), Medline (1946 to July 2015), Embase (1947 to July 2015) and Scopus (1823 to July 2015) were searched, along with reference lists of eligible articles. Eligibility Criteria for Selecting Studies Quantitative, empirical studies that included i) either a measure of wellbeing or burnout, and ii) patient safety, in healthcare staff populations. Results Forty-six studies were identified. Sixteen out of the 27 studies that measured wellbeing found a significant correlation between poor wellbeing and worse patient safety, with six additional studies finding an association with some but not all scales used, and one study finding a significant association but in the opposite direction to the majority of studies. Twenty-one out of the 30 studies that measured burnout found a significant association between burnout and patient safety, whilst a further four studies found an association between one or more (but not all) subscales of the burnout measures employed, and patient safety. Conclusions Poor wellbeing and moderate to high levels of burnout are associated, in the majority of studies reviewed, with poor patient safety outcomes such as medical errors, however the lack of prospective studies reduces the ability to determine causality. Further prospective studies, research in primary care, conducted within the UK, and a clearer definition of healthcare staff wellbeing are needed. Implications This review illustrates the need for healthcare organisations to consider improving employees’ mental health as well as creating safer work environments when planning interventions to improve patient safety. Systematic Review Registration PROSPERO registration number: CRD42015023340. PMID:27391946

Outdoor workers' sun-related knowledge, attitudes and protective behaviours: a systematic review of cross-sectional and interventional studies.

PubMed

Reinau, D; Weiss, M; Meier, C R; Diepgen, T L; Surber, C

2013-05-01

Sun protection is a major concern for outdoor workers as they are particularly exposed to solar ultraviolet radiation and therefore at increased risk of developing some forms of skin cancer, cataract and ocular neoplasm. In order to provide an overview of outdoor workers' sun-related knowledge, attitudes and protective behaviours as reported in the literature and to evaluate the effectiveness of sun-safety education programmes in outdoor occupational settings, we conducted a systematic review of the literature by searching three electronic databases (PubMed, Embase, PsycINFO) from their inception up to 25 April 2012. An extensive hand search complemented the database searches. We identified 34 relevant articles on descriptive studies and 18 articles on interventional studies. Considerable numbers of outdoor workers were found to have sun-sensitive skin types; sunburn rates per season ranged from 50% to 80%. Data concerning outdoor workers' sun-related knowledge and attitudes were scarce and controversial. The reported sun-protective behaviours were largely inadequate, with many workers stating that they never or only rarely wore a long-sleeved shirt (50-80%), sun-protective headgear (30-80%) and sunscreen (30-100%) while working in the sun. However, there is growing evidence that occupational sun-safety education is effective in increasing outdoor workers' sun-protection habits and presumably in decreasing sunburn rates. Occupational sun-safety education programmes offer great potential for improving outdoor workers' largely insufficient sun-protective behaviours. It is hoped that, in the future, committed support from healthcare authorities, cancer foundations, employers and dermatologists will open the way for rapid and uncomplicated implementation of sun-safety education programmes. © 2012 The Authors. BJD © 2012 British Association of Dermatologists.

Treatment effect, adherence, and safety of high fluid intake for the prevention of incident and recurrent kidney stones: a systematic review and meta-analysis.

PubMed

Cheungpasitporn, Wisit; Rossetti, Sandro; Friend, Keith; Erickson, Stephen B; Lieske, John C

2016-04-01

The objective of this systematic review and meta-analysis were to evaluate the effectiveness of high fluid intake for the prevention of incident and recurrent kidney stones, as well as its adherence and safety. A literature search was performed encompassing 1980 through July 2014. Studies that reported relative risks, odds ratios, or hazard ratios comparing the risk of kidney stone events in patients with high vs inadequate fluid intake were included. Pooled risk ratios (RRs) and 95 % confidence intervals (CIs) were calculated using a random-effect, generic inverse variance method. Nine studies [2 randomized controlled trials (RCTs) with 269 patients; 7 observational studies with 273,685 individuals] were included in the meta-analysis. Pooled RRs of kidney stones in individuals with high-fluid intake were 0.40 (95 % CI 0.20-0.79) and 0.49 (0.34-0.71) in RCTs and observational studies, respectively. High fluid intake was significantly associated with reduced risk of recurrent kidney stones: RRs 0.40 (95 % CI 0.20-0.79) and 0.20 (0.09-0.44) in RCTs and observational studies, respectively. Adherence and safety data on high fluid intake treatment were limited; 1 RCT reported no withdrawals due to adverse events. This analysis demonstrated a significantly reduced risk of incident kidney stones among individuals with high fluid consumption. High fluid consumption also reduced the risk of recurrent kidney stones. Furthermore, the magnitude of risk reduction was high. Although increased water intake appears to be safe, future studies on its safety in patients with high risk of volume overload or hyponatremia may be indicated.

Safety of High Speed Magnetic Levitation Transportation Systems - Comparison of U.S. and Foreign Safety Requirements for Application to U.S. Maglev Systems

DOT National Transportation Integrated Search

1993-09-01

This report presents the results of a systematic review of the safety requirements selected for the German Transrapid : electromagnetic (EMS) type maglev system to determine their applicability and completeness with respect to the : construction and ...

Herbal Medicine for Hot Flushes Induced by Endocrine Therapy in Women with Breast Cancer: A Systematic Review and Meta-Analysis.

PubMed

Li, Yuanqing; Zhu, Xiaoshu; Bensussan, Alan; Li, Pingping; Moylan, Eugene; Delaney, Geoff; McPherson, Luke

2016-01-01

Objective. This systematic review was conducted to evaluate the clinical effectiveness and safety of herbal medicine (HM) as an alternative management for hot flushes induced by endocrine therapy in breast cancer patients. Methods. Key English and Chinese language databases were searched from inception to July 2015. Randomized Controlled Trials (RCTs) evaluating the effects of HM on hot flushes induced by endocrine therapy in women with breast cancer were retrieved. We conducted data collection and analysis in accordance with the Cochrane Handbook for Systematic Reviews of Interventions. Statistical analysis was performed with the software (Review Manager 5.3). Results. 19 articles were selected from the articles retrieved, and 5 articles met the inclusion criteria for analysis. Some included individual studies showed that HM can relieve hot flushes as well as other menopausal symptoms induced by endocrine therapy among women with breast cancer and improve the quality of life. There are minor side effects related to HM which are well tolerated. Conclusion. Given the small number of included studies and relatively poor methodological quality, there is insufficient evidence to draw positive conclusions regarding the objective benefit of HM. Additional high quality studies are needed with more rigorous methodological approach to answer this question.

Herbal Supplements for Prostate Enlargement: Current State of the Evidence.

PubMed

Nabavizadeh, Reza; Zangi, Mahdi; Kim, Michelle M; Yavari Bejestani, Maryam; Tabatabaei, Shahin

2018-02-01

To provide a comprehensive review of the current state of herbal supplement market for lower urinary tract symptoms (LUTS) and correlate the ingredients of each product with available scientific evidence. Twenty-seven products from Amazon.com that were advertised as herbal supplements for LUTS and had listed their active ingredients were selected. Active ingredients were reviewed on Google Scholar. Product price, warranty, and consumer review information were also collected. A total of 58 unique active ingredients were identified. The mean number of ingredients was 8.26 (standard deviation 5.25). Whereas 17 (63%) products had an ingredient with a systematic review to support their use, 20 (74%) had an ingredient with conflicting evidence based on systematic reviews. Out of the supplements that contained ingredients supported by literature, all (100%) products simultaneously had other ingredients with no, conflicting, or refuting evidence. There was no (0%) product that contained only scientifically proven ingredients. There is no scientific study to evaluate these supplements as a whole. Despite the widespread use of herbal supplements for LUTS, there is scant scientific evidence to support their safety and efficacy. Lack of adequate regulation and government support for research and development are some of the factors that disincentivize researchers to study safety and efficacy of these products. We encourage physicians to warn their patients on the lack of adequate evidence to support the safety and efficacy of many of these supplements. Copyright © 2017 Elsevier Inc. All rights reserved.

Systematic Review: Rectal Therapies for the Treatment of Distal Forms of Ulcerative Colitis.

PubMed

Cohen, Russell D; Dalal, Sushila R

2015-07-01

Many therapeutic options are available for patients with distal forms of ulcerative colitis (UC). Rectal therapies (e.g., suppositories, foams, gels, and enemas) may be recommended either alone or in combination with oral treatment. Compared with oral therapies, rectal therapies are underused in patients with distal forms of UC, although rectal therapies have favorable efficacy and safety profiles. This systematic review identified 48 articles for inclusion after a comprehensive PubMed search and the identification of additional relevant articles through other sources. Inclusion criteria were clinical studies examining efficacy and safety of 5-aminosalicylic acid, corticosteroid, and non-5-aminosalicylic acid rectal therapies (suppositories, foams, gels, and enemas) that induce or maintain remission in patients with ulcerative proctitis, ulcerative proctosigmoiditis, or left-sided colitis (i.e., distal forms of UC). The quality of the evidence presented was evaluated using the GRADE system. Overall, a greater percentage of patients with distal forms of UC receiving 5-aminosalicylic acids or corticosteroid rectal formulations derived greater therapeutic benefit after treatment compared with patients receiving placebo. Furthermore, most uncontrolled studies of rectal therapies reported that patients with distal forms of UC had marked improvement from baseline after treatment. The overall safety profile of rectal therapies was favorable. Treatment with second-generation corticosteroids, such as budesonide and beclomethasone dipropionate, did not increase the incidence of steroid-related adverse effects. The current literature supports the use of rectal therapies for both induction and maintenance of remission in patients with distal forms of UC.

Barcode medication administration work-arounds: a systematic review and implications for nurse executives.

PubMed

Voshall, Barbara; Piscotty, Ronald; Lawrence, Jeanette; Targosz, Mary

2013-10-01

Safe medication administration is necessary to ensure quality healthcare. Barcode medication administration systems were developed to reduce drug administration errors and the related costs and improve patient safety. Work-arounds created by nurses in the execution of the required processes can lead to unintended consequences, including errors. This article provides a systematic review of the literature associated with barcoded medication administration and work-arounds and suggests interventions that should be adopted by nurse executives to ensure medication safety.

Pregnancy outcomes in women with inflammatory bowel disease following exposure to thiopurines and antitumor necrosis factor drugs: a systematic review with meta-analysis.

PubMed

Mozaffari, S; Abdolghaffari, A H; Nikfar, S; Abdollahi, M

2015-05-01

Several studies have indicated the harmful effect of flare-up periods in pregnant women with inflammatory bowel disease (IBD) on their newborns. Therefore, an effective and safe medical treatment during pregnancy is of great concern in IBD patients. The aim of this study was to perform a meta-analysis on the outcomes of thiopurines use and a systematic review of antitumor necrosis factor (anti-TNF) drugs used during pregnancy in women with IBD. The results of cohorts evaluating the safety of anti-TNF drugs during pregnancy up to July 2013 were collected and analyzed. In the meta-analysis, a total of 312 pregnant women with IBD who used thiopurines were compared with 1149 controls (women with IBD who were not treated with any medication and women who were exposed to drugs other than thiopurines) to evaluate the drug effect on different pregnancy outcomes, including prematurity, low birth weight, congenital abnormalities, spontaneous abortion, and neonatal adverse outcomes. Results of statistical analysis demonstrated that congenital abnormalities were increased significantly in thiopurine-exposed group in comparison with control group who did not receive any medicine for IBD treatment. The summary odds ratio was 2.95 with 95% confidence interval = 1.03-8.43 (p = 0.04). We observed no significant differences in occurrence of other adverse pregnancy outcomes between compared groups. The results of cohorts evaluated the safety of anti-TNF drugs during pregnancy demonstrated no increase in occurrence of adverse pregnancy outcomes in comparison with controls except for the significant decrease in gestational age of newborns of drug-exposed mothers in one trial. In conclusion, a benefit-risk ratio should be considered in prescribing or continuing medicinal therapy during pregnancy of IBD patients. © The Author(s) 2014.

Comparison between herbal medicine and fluoxetine for depression: a systematic review of randomized controlled trials.

PubMed

Ren, Yi; Zhu, Chenjun; Wu, Jianjun; Zheng, Ruwen; Cao, Huijaun

2015-10-01

To evaluate the effectiveness and safety of Chinese herbal medicine (CHM) versus fluoxetine on depression. A systematic review of randomized controlled trials (RCTs). RCT with two parallel groups that compared CHM and fluoxetine on treatment of depression with reported decreased Hamilton Depression Scale (HAMD) and adverse events during treatment were included after searching through six electric-databases. The methodological quality of RCTs was assessed according to the Cochrane risk of bias tool. Meta-analysis was conducted using RevMan 5.3 software with pooled mean difference (MD) or risk ratio (RR) and their 95% confidence interval (CI) if no significant heterogeneity was detected. A SOF table was generated using GRADEPro software to evaluate the overall quality of the evidence. Twenty-six trials with 3294 participants were included in the review. Most of them had high risk of bias during conducting and reporting. The results achieved weak evidence which showed CHM had similar effect to fluoxetine (20mg/day) on relieving depression according to HAMD assessment (for primary depression: MD=-0.08, 95%CI -0.98-0.82; for secondary depression: MD=-0.36, 95%CI -1.55-0.83), but fewer incidences of adverse events than the drug (for primary depression: RR=0.31, 95%CI 0.17-0.59; for post-stroke depression: RR=0.04, 95%CI 0.00-0.25). No serious adverse event was found in neither CHM nor fluoxetine group. Due to the poor quality of included trials and the potential publication bias of this review, no confirmed conclusion could be draw to evaluate the effectiveness and safety of CHM for depression compared with fluoxetine. Copyright © 2015 Elsevier Ltd. All rights reserved.

Sickle cell disease

PubMed Central

2016-01-01

Introduction Sickle cell disease causes chronic haemolytic anaemia, dactylitis, and painful acute crises. It also increases the risk of stroke, organ damage, bacterial infections, and complications of blood transfusion. In sub-Saharan Africa, up to one third of adults are carriers of the defective sickle cell gene, and 1% to 2% of babies are born with the disease. Methods and outcomes We conducted a systematic overview, aiming to answer the following clinical question: What are the effects of pharmaceutical interventions to prevent sickle cell crisis and other acute complications in people with sickle cell disease? We searched: Medline, Embase, The Cochrane Library, and other important databases up to January 2015 (BMJ Clinical Evidence overviews are updated periodically; please check our website for the most up-to-date version of this overview). Results At this update, searching of electronic databases retrieved 369 studies. After deduplication and removal of conference abstracts, 136 records were screened for inclusion in the overview. Appraisal of titles and abstracts led to the exclusion of 99 studies and the further review of 37 full publications. Of the 37 full articles evaluated, three already included systematic reviews were updated, two systematic reviews, two RCTs, and one subsequent RCT were added at this update. We performed a GRADE evaluation for 12 PICO combinations. Conclusions In this systematic overview, we categorised the efficacy for five interventions based on information about the effectiveness and safety of antibiotic prophylaxis in children aged under 5 years, antibiotic prophylaxis in children aged 5 years or older, hydroxyurea, malaria chemoprophylaxis, and pneumococcal vaccines. PMID:26808098

Lacosamide in status epilepticus: Systematic review of current evidence.

PubMed

Strzelczyk, Adam; Zöllner, Johann Philipp; Willems, Laurent M; Jost, Julie; Paule, Esther; Schubert-Bast, Susanne; Rosenow, Felix; Bauer, Sebastian

2017-06-01

The intravenous formulation of lacosamide (LCM) and its good overall tolerability and safety favor the use in status epilepticus (SE). The aim of this systematic review was to identify and evaluate studies reporting on the use of LCM in SE. We performed a systematic literature search of electronic databases using a combined search strategy from 2008 until October 2016. Using a standardized assessment form, information on the study design, methodologic framework, data sources, efficacy, and adverse events attributed to LCM were extracted from each publication and systematically reported. In total, 522 SE episodes (51.7% female) in 486 adults and 36 children and adolescents were evaluated with an overall LCM efficacy of 57%. Efficacy was comparable between use in nonconvulsive (57%; 82/145) and generalized-convulsive (61%; 30/49; p = 0.68) SE, whereas overall success rate was better in focal motor SE (92%; 34/39, p = 0.013; p < 0.001). The efficacy with later positioning of LCM decreased from 100% to 20%. The main adverse events during treatment of SE are dizziness, abnormal vision, diplopia, and ataxia. Overall, lacosamide is well tolerated and has no clinically relevant drug-drug interactions. The available data regarding the use of LCM in SE are promising, with a success rate of 57%. The strength of LCM is the lack of interaction potential and the option for intravenous use in emergency situations requiring rapid uptitration. Wiley Periodicals, Inc. © 2017 International League Against Epilepsy.

Infliximab-Related Infusion Reactions: Systematic Review

PubMed Central

Ron, Yulia; Kivity, Shmuel; Ben-Horin, Shomron; Israeli, Eran; Fraser, Gerald M.; Dotan, Iris; Chowers, Yehuda; Confino-Cohen, Ronit; Weiss, Batia

2015-01-01

Objective: Administration of infliximab is associated with a well-recognised risk of infusion reactions. Lack of a mechanism-based rationale for their prevention, and absence of adequate and well-controlled studies, has led to the use of diverse empirical administration protocols. The aim of this study is to perform a systematic review of the evidence behind the strategies for preventing infusion reactions to infliximab, and for controlling the reactions once they occur. Methods: We conducted extensive search of electronic databases of MEDLINE [PubMed] for reports that communicate various aspects of infusion reactions to infliximab in IBD patients. Results: We examined full texts of 105 potentially eligible articles. No randomised controlled trials that pre-defined infusion reaction as a primary outcome were found. Three RCTs evaluated infusion reactions as a secondary outcome; another four RCTs included infusion reactions in the safety evaluation analysis; and 62 additional studies focused on various aspects of mechanism/s, risk, primary and secondary preventive measures, and management algorithms. Seven studies were added by a manual search of reference lists of the relevant articles. A total of 76 original studies were included in quantitative analysis of the existing strategies. Conclusions: There is still paucity of systematic and controlled data on the risk, prevention, and management of infusion reactions to infliximab. We present working algorithms based on systematic and extensive review of the available data. More randomised controlled trials are needed in order to investigate the efficacy of the proposed preventive and management algorithms. PMID:26092578

Patient safety content and delivery in pre-registration nursing curricula: A national cross-sectional survey study.

PubMed

Usher, Kim; Woods, Cindy; Conway, Jane; Lea, Jackie; Parker, Vicki; Barrett, Fiona; O'Shea, Eilish; Jackson, Debra

2018-07-01

Patient safety is a core principle of health professional practice and as such requires significant attention within undergraduate curricula. However, patient safety practice is complex requiring a broad range of skills and behaviours including the application of sound clinical knowledge within a range of health care contexts and cultures. There is very little research that explores how this is taught within Australian nursing curricula. To examine how Australian nursing curricula address patient safety; identify where and how patient safety learning occurs; and describe who is responsible for facilitating this learning. A cross-sectional study. Eighteen universities across seven Australian States and Territories. The sample consisted of 18 nursing course coordinators or those responsible for the inclusion of patient safety content within a Bachelor of Nursing course at Australian universities. An online survey was conducted to evaluate the patient safety content included and teaching methods used in Australian pre-registration nursing curricula. Approaches to teaching patient safety vary considerably between universities where patient safety tended to be integrated within undergraduate nursing course subjects rather than explicitly taught in separate, stand-alone subjects. Three-quarters of the surveyed staff believed patient safety was currently being adequately covered in their undergraduate nursing curricula. Although there is consensus in relation to the importance of patient safety across universities, and similarity in views about what knowledge, skills and attitudes should be taught, there were differences in: the amount of time allocated, who was responsible for the teaching and learning, and in which setting the learning occurred and was assessed. There was little indication of the existence of a systematic approach to learning patient safety, with most participants reporting emphasis on learning applied to infection control and medication safety. Copyright © 2018. Published by Elsevier Ltd.

Implementing local agency safety management

DOT National Transportation Integrated Search

2003-12-17

For local agencies to mount a successful effort toward reducing motor vehicle collisions and their costs, an effective systematic approach must be taken. A Safety Management System (SMS) has two basic components: a collaborative information exchange ...

Effects of digital countdown timer on intersection safety and efficiency: A systematic review.

PubMed

Fu, Chuanyun; Zhang, Yaping; Qi, Weiwei; Cheng, Shaowu

2016-01-01

To investigate the available evidence referring to the effectiveness of digital countdown timers (DCTs) in improving the safety and operational efficiency of signalized intersection. A systematic review was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) statement guidelines. Relevant literature was searched from electronic databases using key terms. Based on study selection and methodological quality assessment, 14 studies were included in the review. Findings of the studies were synthesized in a narrative analysis. Three types of DCT had different effects on intersection safety and operational efficiency. Green signal countdown timers (GSCTs) reduced red light violations, type I dilemma zone distributions, and rear-end collision likelihood but increased crossing after yellow onset and had mixed impacts on type II dilemma zone distributions and intersection capacity. In contrast, red signal countdown timers (RSCTs) increased intersection capacity, although their effectiveness in reducing red light violations dissipated over time. Likewise, continuous countdown timers (CCTs) significantly enhanced intersection capacity but had mixed influences on red light violations and crossing after yellow onset. Due to the limited and inconsistent evidence regarding DCTs' effects on intersection safety and efficiency, it is not sufficient to recommend any type of DCT to be installed at signalized intersections to improve safety and operational efficiency. Nevertheless, it is apparent that both RSCTs and CCTs enhance intersection capacity, though their impacts on intersection safety are unclear. Future studies need to further verify those anticipated safe and operational benefits of DCTs with enriched field observation data.

Development of an evidence-based framework of factors contributing to patient safety incidents in hospital settings: a systematic review

PubMed Central

McEachan, Rosemary R C; Giles, Sally J; Sirriyeh, Reema; Watt, Ian S; Wright, John

2012-01-01

Objective The aim of this systematic review was to develop a ‘contributory factors framework’ from a synthesis of empirical work which summarises factors contributing to patient safety incidents in hospital settings. Design A mixed-methods systematic review of the literature was conducted. Data sources Electronic databases (Medline, PsycInfo, ISI Web of knowledge, CINAHL and EMBASE), article reference lists, patient safety websites, registered study databases and author contacts. Eligibility criteria Studies were included that reported data from primary research in secondary care aiming to identify the contributory factors to error or threats to patient safety. Results 1502 potential articles were identified. 95 papers (representing 83 studies) which met the inclusion criteria were included, and 1676 contributory factors extracted. Initial coding of contributory factors by two independent reviewers resulted in 20 domains (eg, team factors, supervision and leadership). Each contributory factor was then coded by two reviewers to one of these 20 domains. The majority of studies identified active failures (errors and violations) as factors contributing to patient safety incidents. Individual factors, communication, and equipment and supplies were the other most frequently reported factors within the existing evidence base. Conclusions This review has culminated in an empirically based framework of the factors contributing to patient safety incidents. This framework has the potential to be applied across hospital settings to improve the identification and prevention of factors that cause harm to patients. PMID:22421911

Colic in infants.

PubMed

Lucassen, Peter

2010-02-05

Colic in infants causes one in six families (17%) with children to consult a health professional. One systematic review of 15 community-based studies found a wide variation in prevalence, which depended on study design and method of recording. We conducted a systematic review and aimed to answer the following clinical question: What are the effects of treatments for colic in infants? We searched: Medline, Embase, The Cochrane Library, and other important databases up to September 2009 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA). We found 27 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions. In this systematic review we present information relating to the effectiveness and safety of the following interventions: advice to increase carrying, advice to reduce stimulation, casein hydrolysate milk, cranial osteopathy, crib vibrator device, focused counselling, gripe water, infant massage, low-lactose milk, simethicone, soya-based infant feeds, spinal manipulation, and whey hydrolysate milk.

Colic in infants

PubMed Central

2010-01-01

Introduction Colic in infants causes one in six families (17%) with children to consult a health professional. One systematic review of 15 community-based studies found a wide variation in prevalence, which depended on study design and method of recording. Methods and outcomes We conducted a systematic review and aimed to answer the following clinical question: What are the effects of treatments for colic in infants? We searched: Medline, Embase, The Cochrane Library, and other important databases up to September 2009 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA). Results We found 27 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions. Conclusions In this systematic review we present information relating to the effectiveness and safety of the following interventions: advice to increase carrying, advice to reduce stimulation, casein hydrolysate milk, cranial osteopathy, crib vibrator device, focused counselling, gripe water, infant massage, low-lactose milk, simethicone, soya-based infant feeds, spinal manipulation, and whey hydrolysate milk. PMID:21729336

Evaluation Studies of Robotic Rollators by the User Perspective: A Systematic Review.

PubMed

Werner, Christian; Ullrich, Phoebe; Geravand, Milad; Peer, Angelika; Hauer, Klaus

2016-01-01

Robotic rollators enhance the basic functions of established devices by technically advanced physical, cognitive, or sensory support to increase autonomy in persons with severe impairment. In the evaluation of such ambient assisted living solutions, both the technical and user perspectives are important to prove usability, effectiveness and safety, and to ensure adequate device application. The aim of this systematic review is to summarize the methodology of studies evaluating robotic rollators with focus on the user perspective and to give recommendations for future evaluation studies. A systematic literature search up to December 31, 2014, was conducted based on the Cochrane Review methodology using the electronic databases PubMed and IEEE Xplore. Articles were selected according to the following inclusion criteria: evaluation studies of robotic rollators documenting human-robot interaction, no case reports, published in English language. Twenty-eight studies were identified that met the predefined inclusion criteria. Large heterogeneity in the definitions of the target user group, study populations, study designs and assessment methods was found across the included studies. No generic methodology to evaluate robotic rollators could be identified. We found major methodological shortcomings related to insufficient sample descriptions and sample sizes, and lack of appropriate, standardized and validated assessment methods. Long-term use in habitual environment was also not evaluated. Apart from the heterogeneity, methodological deficits in most of the identified studies became apparent. Recommendations for future evaluation studies include: clear definition of target user group, adequate selection of subjects, inclusion of other assistive mobility devices for comparison, evaluation of the habitual use of advanced prototypes, adequate assessment strategy with established, standardized and validated methods, and statistical analysis of study results. Assessment strategies may additionally focus on specific functionalities of the robotic rollators allowing an individually tailored assessment of innovative features to document their added value. © 2016 S. Karger AG, Basel.

Systematic review of safety and tolerability of a complex micronutrient formula used in mental health

PubMed Central

2011-01-01

Background Theoretically, consumption of complex, multinutrient formulations of vitamins and minerals should be safe, as most preparations contain primarily the nutrients that have been in the human diet for millennia, and at safe levels as defined by the Dietary Reference Intakes. However, the safety profile of commercial formulae may differ from foods because of the amounts and combinations of nutrients they contain. As these complex formulae are being studied and used clinically with increasing frequency, there is a need for direct evaluation of safety and tolerability. Methods All known safety and tolerability data collected on one complex nutrient formula was compiled and evaluated. Results Data were assembled from all the known published and unpublished studies for the complex formula with the largest amount of published research in mental health. Biological safety data from 144 children and adults were available from six sources: there were no occurrences of clinically meaningful negative outcomes/effects or abnormal blood tests that could be attributed to toxicity. Adverse event (AE) information from 157 children and adults was available from six studies employing the current version of this formula, and only minor, transitory reports of headache and nausea emerged. Only one of the studies permitted a direct comparison between micronutrient treatment and medication: none of the 88 pediatric and adult participants had any clinically meaningful abnormal laboratory values, but tolerability data in the group treated with micronutrients revealed significantly fewer AEs and less weight gain. Conclusions This compilation of safety and tolerability data is reassuring with respect to the broad spectrum approach that employs complex nutrient formulae as a primary treatment. PMID:21501484

[Drug safety warnings in psychiatry: adverse drug reactions' signaling from 2002 to 2014].

PubMed

Prisco, Vincenzo; Iannaccone, Teresa; Tusciano, Adriano; Boccardi, Mariangela; Perris, Francesco; Capuano, Annalisa; Catapano, Francesco; Fabrazzo, Michele

2016-01-01

Monitoring drug-related side effects in psychiatric patients is highly recommended. In fact, frequent exposure to long-term polipharmacotherapy, poor compliance to pharmachological treatment and comorbidity with organic illnesses requiring the prescription of other drugs are causes of pharmacokinetic/pharmacodynamic interactions. These vulnerability factors result in a certain increase in adverse drug reactions (ADRs). This study performes an analysis of Italian Medicine Agency data, in the section "signal analysis", to attempt an assessment of the safety warnings among the different psychotropic drug classes, belonging to the ATC class: N03 (antiepileptics), N05 (antipsychotics), N06 (psycho-analectic drugs). Then we analysed, in a descriptive way, the different association between the drug and the related ADR, evaluating the different safety profiles, in relation to experimental studies, supporting the importance of the signal. In the last years, among the new 25 ADRs, 10 were related to antidepressant drugs (8 SSRI, 1 mirtazapine, 1 agomelatine). In relation to antipsychotic drugs, 6 new correlations were found between drug and ADR onset, mainly among atypical antispychotics. Other correlations (6 above all) were found among antiepileptic drugs. Among benzodiazepines, a signal linked to rabdomylysis onset was found. It is also recommended an evaluation of safety profile in relation to zolpidem prescription. The results of our systematic review are a motivational input, considering the continuous increase of safety warnings, to attentively monitor drug's prescription. Spontaneous ADRs' signaling is a classical system to provide the required attention in relation to a potential risk. The clinician in charge must report this because he is the key figure in the drugs' safety process. In psychiatry, in which a long-term pharmachological therapy is frequent, clinicians are requested to find and signal ADRs to the competent authority.

Is vehicle automation enough to prevent crashes? Role of traffic operations in automated driving environments for traffic safety.

PubMed

Jeong, Eunbi; Oh, Cheol; Lee, Seolyoung

2017-07-01

Automated driving systems (ADSs) are expected to prevent traffic accidents caused by driver carelessness on freeways. There is no doubt regarding this safety benefit if all vehicles in the transportation system were equipped with ADSs; however, it is implausible to expect that ADSs will reach 100% market penetration rate (MPR) in the near future. Therefore, the following question arises: 'Can ADSs, which consider only situations in the vicinity of an equipped vehicle, really contribute to a significant reduction in traffic accidents?' To address this issue, the interactions between equipped and unequipped vehicles must be investigated, which is the purpose of this study. This study evaluated traffic safety at different MPRs based on a proposed index to represent the overall rear-end crash risk of the traffic stream. Two approaches were evaluated for adjusting longitudinal vehicle maneuvers: vehicle safety-based maneuvering (VSM), which considers the crash risk of an equipped vehicle and its neighboring vehicles, and traffic safety-based maneuvering (TSM), which considers the overall crash risk in the traffic stream. TSM assumes that traffic operational agencies are able to monitor all the vehicles and to intervene in vehicle maneuvering. An optimization process, which attempts to obtain vehicle maneuvering control parameters to minimize the overall crash risk, is integrated into the proposed evaluation framework. The main purpose of employing the optimization process for vehicle maneuvering in this study is to identify opportunities to improve traffic safety through effective traffic management rather than developing a vehicle control algorithm that can be implemented in practice. The microscopic traffic simulator VISSIM was used to simulate the freeway traffic stream and to conduct systematic evaluations based on the proposed methodology. Both TSM and VSM achieved significant reductions in the potential for rear-end crashes. However, TSM obtained much greater reductions when the MPR was greater than 50%. This study should inspire transportation researchers and engineers to develop effective traffic operations strategies for automated driving environments. Copyright © 2017. Published by Elsevier Ltd.

Assuring the safety of genetically modified (GM) foods: the importance of an holistic, integrative approach.

PubMed

Cockburn, Andrew

2002-09-11

Genes change continuously by natural mutation and recombination enabling man to select and breed crops having the most desirable traits such as yield or flavour. Genetic modification (GM) is a recent development which allows specific genes to be identified, isolated, copied and inserted into other plants with a high level of specificity. The food safety considerations for GM crops are basically the same as those arising from conventionally bred crops, very few of which have been subject to any testing yet are generally regarded as being safe to eat. In contrast a rigorous safety testing paradigm has been developed for GM crops, which utilises a systematic, stepwise and holistic approach. The resultant science based process, focuses on a classical evaluation of the toxic potential of the introduced novel trait and the wholesomeness of the transformed crop. In addition, detailed consideration is given to the history and safe use of the parent crop as well as that of the gene donor. The overall safety evaluation is conducted under the concept known as substantial equivalence which is enshrined in all international crop biotechnology guidelines. This provides the framework for a comparative approach to identify the similarities and differences between the GM product and its comparator which has a known history of safe use. By building a detailed profile on each step in the transformation process, from parent to new crop, and by thoroughly evaluating the significance from a safety perspective, of any differences that may be detected, a very comprehensive matrix of information is constructed which enables the conclusion as to whether the GM crop, derived food or feed is as safe as its traditional counterpart. Using this approach in the evaluation of more than 50 GM crops which have been approved worldwide, the conclusion has been that foods and feeds derived from genetically modified crops are as safe and nutritious as those derived from traditional crops. The lack of any adverse effects resulting from the production and consumption of GM crops grown on more than 300 million cumulative acres over the last 5 years supports these safety conclusions.

The quality of systematic reviews about interventions for refractive error can be improved: a review of systematic reviews.

PubMed

Mayo-Wilson, Evan; Ng, Sueko Matsumura; Chuck, Roy S; Li, Tianjing

2017-09-05

Systematic reviews should inform American Academy of Ophthalmology (AAO) Preferred Practice Pattern® (PPP) guidelines. The quality of systematic reviews related to the forthcoming Preferred Practice Pattern® guideline (PPP) Refractive Errors & Refractive Surgery is unknown. We sought to identify reliable systematic reviews to assist the AAO Refractive Errors & Refractive Surgery PPP. Systematic reviews were eligible if they evaluated the effectiveness or safety of interventions included in the 2012 PPP Refractive Errors & Refractive Surgery. To identify potentially eligible systematic reviews, we searched the Cochrane Eyes and Vision United States Satellite database of systematic reviews. Two authors identified eligible reviews and abstracted information about the characteristics and quality of the reviews independently using the Systematic Review Data Repository. We classified systematic reviews as "reliable" when they (1) defined criteria for the selection of studies, (2) conducted comprehensive literature searches for eligible studies, (3) assessed the methodological quality (risk of bias) of the included studies, (4) used appropriate methods for meta-analyses (which we assessed only when meta-analyses were reported), (5) presented conclusions that were supported by the evidence provided in the review. We identified 124 systematic reviews related to refractive error; 39 met our eligibility criteria, of which we classified 11 to be reliable. Systematic reviews classified as unreliable did not define the criteria for selecting studies (5; 13%), did not assess methodological rigor (10; 26%), did not conduct comprehensive searches (17; 44%), or used inappropriate quantitative methods (3; 8%). The 11 reliable reviews were published between 2002 and 2016. They included 0 to 23 studies (median = 9) and analyzed 0 to 4696 participants (median = 666). Seven reliable reviews (64%) assessed surgical interventions. Most systematic reviews of interventions for refractive error are low methodological quality. Following widely accepted guidance, such as Cochrane or Institute of Medicine standards for conducting systematic reviews, would contribute to improved patient care and inform future research.

Flexible endoscopic evaluation of swallowing (FEES) for neurogenic dysphagia: training curriculum of the German Society of Neurology and the German stroke society.

PubMed

Dziewas, Rainer; Glahn, Jörg; Helfer, Christine; Ickenstein, Guntram; Keller, Jochen; Ledl, Christian; Lindner-Pfleghar, Beate; G Nabavi, Darius; Prosiegel, Mario; Riecker, Axel; Lapa, Sriramya; Stanschus, Sönke; Warnecke, Tobias; Busse, Otto

2016-02-25

Neurogenic dysphagia is one of the most frequent and prognostically relevant neurological deficits in a variety of disorders, such as stroke, parkinsonism and advanced neuromuscular diseases. Flexible endoscopic evaluation of swallowing (FEES) is now probably the most frequently used tool for objective dysphagia assessment in Germany. It allows evaluation of the efficacy and safety of swallowing, determination of appropriate feeding strategies and assessment of the efficacy of different swallowing manoeuvres. The literature furthermore indicates that FEES is a safe and well-tolerated procedure. In spite of the huge demand for qualified dysphagia diagnostics in neurology, a systematic FEES education has not yet been established. The structured training curriculum presented in this article aims to close this gap and intends to enforce a robust and qualified FEES service. As management of neurogenic dysphagia is not confined to neurologists, this educational programme is applicable to other clinicians and speech-language therapists with expertise in dysphagia as well. The systematic education in carrying out FEES across a variety of different professions proposed by this curriculum will help to spread this instrumental approach and to improve dysphagia management.

Determining the causal relationships among balanced scorecard perspectives on school safety performance: case of Saudi Arabia.

PubMed

Alolah, Turki; Stewart, Rodney A; Panuwatwanich, Kriengsak; Mohamed, Sherif

2014-07-01

In the public schools of many developing countries, numerous accidents and incidents occur because of poor safety regulations and management systems. To improve the educational environment in Saudi Arabia, the Ministry of Education seeks novel approaches to measure school safety performance in order to decrease incidents and accidents. The main objective of this research was to develop a systematic approach for measuring Saudi school safety performance using the balanced scorecard framework philosophy. The evolved third generation balanced scorecard framework is considered to be a suitable and robust framework that captures the system-wide leading and lagging indicators of business performance. The balanced scorecard architecture is ideal for adaptation to complex areas such as safety management where a holistic system evaluation is more effective than traditional compartmentalised approaches. In developing the safety performance balanced scorecard for Saudi schools, the conceptual framework was first developed and peer-reviewed by eighteen Saudi education experts. Next, 200 participants, including teachers, school executives, and Ministry of Education officers, were recruited to rate both the importance and the performance of 79 measurement items used in the framework. Exploratory factor analysis, followed by the confirmatory partial least squares method, was then conducted in order to operationalise the safety performance balanced scorecard, which encapsulates the following five salient perspectives: safety management and leadership; safety learning and training; safety policy, procedures and processes; workforce safety culture; and safety performance. Partial least squares based structural equation modelling was then conducted to reveal five significant relationships between perspectives, namely, safety management and leadership had a significant effect on safety learning and training and safety policy, procedures and processes, both safety learning and training and safety policy, procedures and processes had significant effects on workforce safety culture, and workforce safety culture had a significant effect on safety performance. Copyright © 2014 Elsevier Ltd. All rights reserved.

Explaining the food safety behaviours of food handlers using theories of behaviour change: a systematic review.

PubMed

Young, Ian; Thaivalappil, Abhinand; Greig, Judy; Meldrum, Richard; Waddell, Lisa

2018-06-01

Theories of behaviour change can explain the factors affecting food handlers' use of food safety practices. A systematic review was conducted on this topic to identify which theories have been applied in this area and to determine which theories are the most consistent predictors of food handlers' behaviours. Standard systematic review procedures were followed: comprehensive search strategy; relevance screening of abstracts; article characterization; data extraction; risk-of-bias assessment; and descriptive analysis. Among 19 relevant studies, the most commonly investigated theories were the Theory of Planned Behaviour (n = 9 studies) and Health Belief Model (n = 5). All investigated theories were useful to explain food handlers' behavioural intentions and behaviours related to food safety across different settings, and could serve as useful frameworks for future research and practice. However, there was wide variability in the predictive ability of the theories and their specific constructs, indicating theories should be adapted to the local context of application.

The relationship between resident burnout and safety-related and acceptability-related quality of healthcare: a systematic literature review.

PubMed

Dewa, Carolyn S; Loong, Desmond; Bonato, Sarah; Trojanowski, Lucy; Rea, Margaret

2017-11-09

There has been increasing interest in examining the relationship between physician wellbeing and quality of patient care. However, few reviews have specifically focused on resident burnout and quality of patient care. The purpose of this systematic literature review of the current scientific literature is to address the question, "How does resident burnout affect the quality of healthcare related to the dimensions of acceptability and safety?" This systematic literature review uses a multi-step screening process of publicly available peer-reviewed studies from five electronic databases: (1) Medline Current, (2) Medline In-process, (3) PsycINFO, (4) Embase, and (5) Web of Science. The electronic literature search resulted in the identification of 4638 unique citations. Of these, 10 articles were included in the review. Studies were assessed for risk of bias. Of the 10 studies that met the inclusion criteria, eight were conducted in the US, one in The Netherlands, and one in Mexico. Eight of the 10 studies focused on patient safety. The results of these included studies suggest there is moderate evidence that burnout is associated with patient safety (i.e., resident self-perceived medical errors and sub-optimal care). There is less evidence that specific dimensions of burnout are related to acceptability (i.e., quality of care, communication with patients). The results of this systematic literature review suggest a relationship between patient safety and burnout. These results potentially have important implications for the medical training milieu because residents are still in training and at the same time are asked to teach students. The results also indicate a need for more evidence-based interventions that support continued research examining quality of care measures, especially as they relate to acceptability.

Biosimilarity and Interchangeability: Principles and Evidence: A Systematic Review.

PubMed

McKinnon, Ross A; Cook, Matthew; Liauw, Winston; Marabani, Mona; Marschner, Ian C; Packer, Nicolle H; Prins, Johannes B

2018-02-01

The efficacy, safety and immunogenicity risk of switching between an originator biologic and a biosimilar or from one biosimilar to another are of potential concern. The aim was to conduct a systematic literature review of the outcomes of switching between biologics and their biosimilars and identify any evidence gaps. A systematic literature search was conducted in PubMed, EMBASE and Cochrane Library from inception to June 2017. Relevant societal meetings were also checked. Peer-reviewed studies reporting efficacy and/or safety data on switching between originator and biosimilar products or from one biosimilar to another were selected. Studies with fewer than 20 switched patients were excluded. Data were extracted on interventions, study population, reason for treatment switching, efficacy outcomes, safety and anti-drug antibodies. The systematic literature search identified 63 primary publications covering 57 switching studies. The reason for switching was reported as non-medical in 50 studies (23 clinical, 27 observational). Seven studies (all observational) did not report whether the reasons for switching were medical or non-medical. In 38 of the 57 studies, fewer than 100 patients were switched. Follow-up after switching went beyond 1 year in eight of the 57 studies. Of the 57 studies, 33 included statistical analysis of disease activity or patient outcomes; the majority of these studies found no statistically significant differences between groups for main efficacy parameters (based on P < 0.05 or predefined acceptance ranges), although some studies observed changes for some parameters. Most studies reported similar safety profiles between groups. There are important evidence gaps around the safety of switching between biologics and their biosimilars. Sufficiently powered and appropriately statistically analysed clinical trials and pharmacovigilance studies, with long-term follow-ups and multiple switches, are needed to support decision-making around biosimilar switching.

Perioperative Lidocaine Infusions for the Prevention of Chronic Post-Surgical Pain: A Systematic Review and Meta-Analysis of Efficacy and Safety.

PubMed

Bailey, Martin; Corcoran, Tomas; Schug, Stephan; Toner, Andrew

2018-05-11

Chronic post-surgical pain (CPSP) occurs in 12% of surgical populations and is a high priority for perioperative research. Systemic lidocaine may modulate several of the pathophysiological processes linked to CPSP. This systematic review aims to identify and synthesize the evidence linking lidocaine infusions and CPSP.The authors conducted a systematic literature search of the major medical databases from inception until October 2017. Trials that randomized adults without baseline pain to perioperative lidocaine infusion or placebo were included if they reported on CPSP. The primary outcome was the presence of procedure-related pain at three months or longer after surgery. The secondary outcomes of pain intensity, adverse safety events and local anesthetic toxicity were also assessed.Six trials from four countries (n=420) were identified. CPSP incidence was consistent with existing epidemiological data. Perioperative lidocaine infusions significantly reduced the primary outcome (odds ratio, 0.29; 95% CI, 0.18 to 0.48), although the difference in intensity of CPSP assessed by the short form McGill pain questionnaire (four trials) was not statistically significant (weighted mean difference, -1.55; 95% CI, -3.16 to 0.06). Publication and other bias were highly apparent, as were limitations in trial design. Each study included a statement reporting no adverse events attributable to lidocaine, but systematic safety surveillance strategies were absent.Current limited clinical trial data and biological plausibility support lidocaine infusions use to reduce the development of CPSP without full assurances as to its safety. This hypothesis should be addressed in future definitive clinical trials with comprehensive safety assessment and reporting.

The administration of probiotics and synbiotics in immune compromised adults: is it safe?

PubMed

Van den Nieuwboer, M; Brummer, R J; Guarner, F; Morelli, L; Cabana, M; Claasen, E

2015-03-01

This study aimed to systematically evaluate safety of probiotics and synbiotics in immune compromised adults (≥18 years). Safety was analysed using the Common Terminology Clinical Adverse Events (CTCAE version 4.0) classification, thereby providing an update on previous reports using the most recent available clinical data (2008-2013). Safety aspects are represented and related to number of participants per probiotic strain/culture, study duration, dosage, clinical condition and selected afflictions. Analysis of 57 clinical studies indicates that probiotic and/or synbiotic administration in immune compromised adults is safe with regard to the current evaluated probiotic strains, dosages and duration. Individuals were considered immune compromised if HIV-infected, critically ill, underwent surgery or had an organ- or an autoimmune disease. There were no major safety concerns in the study, as none of the serious adverse events (AE)s were related, or suspected to be related, to the probiotic or synbiotic product and the study products were well tolerated. Overall, AEs occurred less frequent in immune compromised subjects receiving probiotics and/or synbiotics compared to the control group. In addition, the results demonstrated a flaw in precise reporting and classification of AE in most studies. Furthermore, generalisability of conclusions are greatly limited by the inconsistent, imprecise and potentially incomplete reporting as well as the variation in probiotic strains, dosages, administration regimes, study populations and reported outcomes. We argue that standardised reporting on adverse events (CTCAE) in 'food' studies should be obligatory, thereby improving reliability of data and re-enforcing the safety profile of probiotics.

Economics of Mass Media Health Campaigns with Health-Related Product Distribution: A Community Guide Systematic Review

PubMed Central

Jacob, Verughese; Chattopadhyay, Sajal K.; Elder, Randy W.; Robinson, Maren N.; Tansil, Kristin A.; Soler, Robin E.; Labre, Magdala P.; Mercer, Shawna L.

2015-01-01

Context The objective of this systematic review was to determine the costs, benefits, and overall economic value of communication campaigns that included mass media and distribution of specified health-related products at reduced price or free of charge. Evidence Acquisition Economic evaluation studies from a literature search from January 1980–December 2009 were screened and abstracted following systematic economic review methods developed by The Community Guide. Data were analyzed in 2011. Evidence Synthesis The economic evidence was grouped and assessed by type of product distributed and health risk addressed. A total of 15 evaluation studies were included in the economic review, involving campaigns promoting the use of child car seats or booster seats, pedometers, condoms, recreational safety helmets, and nicotine replacement therapy (NRT). Conclusion Economic merits of the intervention could not be determined for health communication campaigns associated with use of recreational helmets, child car seats, and pedometers, primarily because available economic information and analyses were incomplete. There is some evidence that campaigns with free condom distribution to promote safer sex practices were cost-effective among high-risk populations and the cost per quit achieved in campaigns promoting tobacco cessation with NRT products may translate to a cost per quality-adjusted life year (QALY) less than $50,000. Many interventions were publicly funded trials or programs, and the failure to properly evaluate their economic cost and benefit is a serious gap in the science and practice of public health. PMID:25145619

Validation of a common data model for active safety surveillance research

PubMed Central

Ryan, Patrick B; Reich, Christian G; Hartzema, Abraham G; Stang, Paul E

2011-01-01

Objective Systematic analysis of observational medical databases for active safety surveillance is hindered by the variation in data models and coding systems. Data analysts often find robust clinical data models difficult to understand and ill suited to support their analytic approaches. Further, some models do not facilitate the computations required for systematic analysis across many interventions and outcomes for large datasets. Translating the data from these idiosyncratic data models to a common data model (CDM) could facilitate both the analysts' understanding and the suitability for large-scale systematic analysis. In addition to facilitating analysis, a suitable CDM has to faithfully represent the source observational database. Before beginning to use the Observational Medical Outcomes Partnership (OMOP) CDM and a related dictionary of standardized terminologies for a study of large-scale systematic active safety surveillance, the authors validated the model's suitability for this use by example. Validation by example To validate the OMOP CDM, the model was instantiated into a relational database, data from 10 different observational healthcare databases were loaded into separate instances, a comprehensive array of analytic methods that operate on the data model was created, and these methods were executed against the databases to measure performance. Conclusion There was acceptable representation of the data from 10 observational databases in the OMOP CDM using the standardized terminologies selected, and a range of analytic methods was developed and executed with sufficient performance to be useful for active safety surveillance. PMID:22037893

A Systematic Review of the Use of Social Media for Food Safety Risk Communication.

PubMed

Overbey, Katie N; Jaykus, Lee-Ann; Chapman, Benjamin J

2017-09-01

This article covers the current published literature related to the use of social media in food safety and infectious disease communication. The aim was to analyze literature recommendations and draw conclusions about how best to utilize social media for food safety risk communication going forward. A systematic literature review was conducted, and 24 articles were included for analysis. The inclusion criteria were (i) original peer-reviewed articles and (ii) primary focus on communication through social media about food safety and/or infectious diseases. Studies were coded for themes about social media applications, benefits, limitations, and best practices. Trust and personal beliefs were important drivers of social media use. The wide reach, immediacy, and information gathering capacities of social media were frequently cited benefits. Suggestions for social media best practices were inconsistent among studies, and study designs were highly variable. More evidence-based suggestions are needed to better establish guidelines for social media use in food safety and infectious disease risk communication. The information gleaned from this review can be used to create effective messages for shaping food safety behaviors.

A systematic review of human factors and ergonomics (HFE)-based healthcare system redesign for quality of care and patient safety.

PubMed

Xie, Anping; Carayon, Pascale

2015-01-01

Healthcare systems need to be redesigned to provide care that is safe, effective and efficient, and meets the multiple needs of patients. This systematic review examines how human factors and ergonomics (HFE) is applied to redesign healthcare work systems and processes and improve quality and safety of care. We identified 12 projects representing 23 studies and addressing different physical, cognitive and organisational HFE issues in a variety of healthcare systems and care settings. Some evidence exists for the effectiveness of HFE-based healthcare system redesign in improving process and outcome measures of quality and safety of care. We assessed risk of bias in 16 studies reporting the impact of HFE-based healthcare system redesign and found varying quality across studies. Future research should further assess the impact of HFE on quality and safety of care, and clearly define the mechanisms by which HFE-based system redesign can improve quality and safety of care.

Validity of the Agency for Health Care Research and Quality Patient Safety Indicators and the Centers for Medicare and Medicaid Hospital-acquired Conditions: A Systematic Review and Meta-Analysis.

PubMed

Winters, Bradford D; Bharmal, Aamir; Wilson, Renee F; Zhang, Allen; Engineer, Lilly; Defoe, Deidre; Bass, Eric B; Dy, Sydney; Pronovost, Peter J

2016-12-01

The Agency for Health Care Research and Quality Patient Safety Indicators (PSIs) and Centers for Medicare and Medicaid Services Hospital-acquired Conditions (HACs) are increasingly being used for pay-for-performance and public reporting despite concerns over their validity. Given the potential for these measures to misinform patients, misclassify hospitals, and misapply financial and reputational harm to hospitals, these need to be rigorously evaluated. We performed a systematic review and meta-analysis to assess PSI and HAC measure validity. We searched MEDLINE and the gray literature from January 1, 1990 through January 14, 2015 for studies that addressed the validity of the HAC measures and PSIs. Secondary outcomes included the effects of present on admission (POA) modifiers, and the most common reasons for discrepancies. We developed pooled results for measures evaluated by ≥3 studies. We propose a threshold of 80% for positive predictive value or sensitivity for pay-for-performance and public reporting suitability. Only 5 measures, Iatrogenic Pneumothorax (PSI 6/HAC 17), Central Line-associated Bloodstream Infections (PSI 7), Postoperative hemorrhage/hematoma (PSI 9), Postoperative deep vein thrombosis/pulmonary embolus (PSI 12), and Accidental Puncture/Laceration (PSI 15), had sufficient data for pooled meta-analysis. Only PSI 15 (Accidental Puncture and Laceration) met our proposed threshold for validity (positive predictive value only) but this result was weakened by considerable heterogeneity. Coding errors were the most common reasons for discrepancies between medical record review and administrative databases. POA modifiers may improve the validity of some measures. This systematic review finds that there is limited validity for the PSI and HAC measures when measured against the reference standard of a medical chart review. Their use, as they currently exist, for public reporting and pay-for-performance, should be publicly reevaluated in light of these findings.

Rivaroxaban Versus Dabigatran or Warfarin in Real-World Studies of Stroke Prevention in Atrial Fibrillation: Systematic Review and Meta-Analysis.

PubMed

Bai, Ying; Deng, Hai; Shantsila, Alena; Lip, Gregory Y H

2017-04-01

This study was designed to evaluate the effectiveness and safety of rivaroxaban in real-world practice compared with effectiveness and safety of dabigatran or warfarin for stroke prevention in atrial fibrillation through meta-analyzing observational studies. Seventeen studies were included after searching in PubMed for studies reporting the comparative effectiveness and safety of rivaroxaban versus dabigatran (n=3), rivaroxaban versus Warfarin (n=11), or both (n=3) for stroke prevention in atrial fibrillation. Overall, the risks of stroke/systematic thromboembolism with rivaroxaban were similar when compared with those with dabigatran (stroke/thromboembolism: hazard ratio, 1.02; 95% confidence interval, 0.91-1.13; I 2 =70.2%, N=5), but were significantly reduced when compared with those with warfarin (hazard ratio, 0.75; 95% confidence interval, 0.64-0.85; I 2 =45.1%, N=9). Major bleeding risk was significantly higher with rivaroxaban than with dabigatran (hazard ratio, 1.38; 95% confidence interval, 1.27-1.49; I 2 =26.1%, N=5), but similar to that with warfarin (hazard ratio, 0.99; 95% confidence interval, 0.91-1.07; I 2 =0.0%, N=6). Rivaroxaban was associated with increased all-cause mortality and gastrointestinal bleeding, but similar risk of acute myocardial infarction and intracranial hemorrhage when compared with dabigatran. When compared with warfarin, rivaroxaban was associated with similar risk of any bleeding, mortality, and acute myocardial infarction, but a higher risk of gastrointestinal bleeding and lower risk of intracranial hemorrhage. In this systematic review and meta-analysis, rivaroxaban was as effective as dabigatran, but was more effective than warfarin for the prevention of stroke/thromboembolism in atrial fibrillation patients. Major bleeding risk was significantly higher with rivaroxaban than with dabigatran, as was all-cause mortality and gastrointestinal bleeding. Rivaroxaban was comparable to warfarin for major bleeding, with an increased risk in gastrointestinal bleeding and decreased risk of intracranial hemorrhage. © 2017 American Heart Association, Inc.

Psychological Treatment of Depression in People Aged 65 Years and Over: A Systematic Review of Efficacy, Safety, and Cost-Effectiveness

PubMed Central

Jonsson, Ulf; Bertilsson, Göran; Gyllensvärd, Harald; Söderlund, Anne; Tham, Anne; Andersson, Gerhard

2016-01-01

Objectives Depression in elderly people is a major public health concern. As response to antidepressants is often unsatisfactory in this age group, there is a need for evidence-based non-pharmacological treatment options. Our objectives were twofold: firstly, to synthesize published trials evaluating efficacy, safety and cost-effectiveness of psychological treatment of depression in the elderly and secondly, to assess the quality of evidence. Method The electronic databases PubMed, EMBASE, Cochrane Library, CINAL, Scopus, and PsycINFO were searched up to 23 May 2016 for randomized controlled trials (RCTs) of psychological treatment for depressive disorders or depressive symptoms in people aged 65 years and over. Two reviewers independently assessed relevant studies for risk of bias. Where appropriate, the results were synthesized in meta-analyses. The quality of the evidence was graded according to GRADE (Grading of Recommendations Assessment, Development and Evaluation). Results Twenty-two relevant RCTs were identified, eight of which were excluded from the synthesis due to a high risk of bias. Of the remaining trials, six evaluated problem-solving therapy (PST), five evaluated other forms of cognitive behavioural therapy (CBT), and three evaluated life review/reminiscence therapy. In frail elderly with depressive symptoms, the evidence supported the efficacy of PST, with large but heterogeneous effect sizes compared with treatment as usual. The results for life-review/reminiscence therapy and CBT were also promising, but because of the limited number of trials the quality of evidence was rated as very low. Safety data were not reported in any included trial. The only identified cost-effectiveness study estimated an incremental cost per additional point reduction in Beck Depression Inventory II score for CBT compared with talking control and treatment as usual. Conclusion Psychological treatment is a feasible option for frail elderly with depressive symptoms. However, important questions about efficacy, generalizability, safety and cost-effectiveness remain. PMID:27537217

Innovations for the future of pharmacovigilance.

PubMed

Almenoff, June S

2007-01-01

Post-marketing pharmacovigilance involves the review and management of safety information from many sources. Among these sources, spontaneous adverse event reporting systems are among the most challenging and resource-intensive to manage. Traditionally, efforts to monitor spontaneous adverse event reporting systems have focused on review of individual case reports. The science of pharmacovigilance could be enhanced with the availability of systems-based tools that facilitate analysis of aggregate data for purposes of signal detection, signal evaluation and knowledge management. GlaxoSmithKline (GSK) recently implemented Online Signal Management (OSM) as a data-driven framework for managing the pharmacovigilance of marketed products. This pioneering work builds upon the strong history GSK has of innovation in this area. OSM is a software application co-developed by GSK and Lincoln Technologies that integrates traditional pharmacovigilance methods with modern quantitative statistical methods and data visualisation tools. OSM enables the rapid identification of trends from the individual adverse event reports received by GSK. OSM also provides knowledge-management tools to ensure the successful tracking of emerging safety issues. GSK has developed standard procedures and 'best practices' around the use of OSM to ensure the systematic evaluation of complex safety datasets. In summary, the implementation of OSM provides new tools and efficient processes to advance the science of pharmacovigilance.

Methodological quality of systematic reviews on influenza vaccination.

PubMed

Remschmidt, Cornelius; Wichmann, Ole; Harder, Thomas

2014-03-26

There is a growing body of evidence on the risks and benefits of influenza vaccination in various target groups. Systematic reviews are of particular importance for policy decisions. However, their methodological quality can vary considerably. To investigate the methodological quality of systematic reviews on influenza vaccination (efficacy, effectiveness, safety) and to identify influencing factors. A systematic literature search on systematic reviews on influenza vaccination was performed, using MEDLINE, EMBASE and three additional databases (1990-2013). Review characteristics were extracted and the methodological quality of the reviews was evaluated using the assessment of multiple systematic reviews (AMSTAR) tool. U-test, Kruskal-Wallis test, chi-square test, and multivariable linear regression analysis were used to assess the influence of review characteristics on AMSTAR-score. Fourty-six systematic reviews fulfilled the inclusion criteria. Average methodological quality was high (median AMSTAR-score: 8), but variability was large (AMSTAR range: 0-11). Quality did not differ significantly according to vaccination target group. Cochrane reviews had higher methodological quality than non-Cochrane reviews (p=0.001). Detailed analysis showed that this was due to better study selection and data extraction, inclusion of unpublished studies, and better reporting of study characteristics (all p<0.05). In the adjusted analysis, no other factor, including industry sponsorship or journal impact factor had an influence on AMSTAR score. Systematic reviews on influenza vaccination showed large differences regarding their methodological quality. Reviews conducted by the Cochrane collaboration were of higher quality than others. When using systematic reviews to guide the development of vaccination recommendations, the methodological quality of a review in addition to its content should be considered. Copyright © 2014 Elsevier Ltd. All rights reserved.

Efficacy and safety of selective glucocorticoid receptor modulators in comparison to glucocorticoids in arthritis, a systematic review.

PubMed

Safy, M; de Hair, M J H; Jacobs, J W G; Buttgereit, F; Kraan, M C; van Laar, J M

2017-01-01

Long-term treatment with glucocorticoids (GCs) plays an important role in the management of arthritis patients, although the efficacy/safety balance is unfavorable. Alternatives with less (severe) adverse effects but with good efficacy are needed. Selective GC receptor modulators (SGRMs) are designed to engage the GC receptor with dissociative characteristics: transactivation of genes, which is mainly responsible for unwanted effects, is less strong while trans-repression of genes, reducing inflammation, is maintained. It is expected that SGRMs thus have a better efficacy/safety balance than GCs. A systematic review providing an overview of the evidence in arthritis is lacking. To systematically review the current literature on efficacy and safety of oral SGRMs in comparison to GCs in arthritis. A search was performed in Medline, Embase and the Cochrane Library, from inception dates of databases until May 2017. Experimental studies involving animal arthritis models or human material of arthritis patients, as well as clinical studies in arthritis patients were included, provided they reported original data. All types of arthritis were included. Data was extracted on the SGRM studied and on the GC used as reference standard; the design or setting of the study was extracted as well as the efficacy and safety results. A total of 207 articles was retrieved of which 17 articles were eligible for our analysis. Two studies concerned randomized controlled trials (RCT), five studies were pre-clinical studies using human material, and 10 studies involved pre-clinical animal models (acute and/or chronic arthritis induced in mice or rats). PF-04171327, the only compound investigated in a clinical trial setting, had a better efficacy/safety balance compared to GCs: better clinical anti-inflammatory efficacy and similar safety. Studies assessing both efficacy and safety of SGRMs are scarce. There is limited evidence for dissociation of anti-inflammatory and metabolic effects of the SGRMs studied. Development of many SGRMs is haltered in a preclinical phase. One SGRM showed a better clinical efficacy/safety balance.

Economic evaluation of pharmacist-led medication reviews in residential aged care facilities.

PubMed

Hasan, Syed Shahzad; Thiruchelvam, Kaeshaelya; Kow, Chia Siang; Ghori, Muhammad Usman; Babar, Zaheer-Ud-Din

2017-10-01

Medication reviews is a widely accepted approach known to have a substantial impact on patients' pharmacotherapy and safety. Numerous options to optimise pharmacotherapy in older people have been reported in literature and they include medication reviews, computerised decision support systems, management teams, and educational approaches. Pharmacist-led medication reviews are increasingly being conducted, aimed at attaining patient safety and medication optimisation. Cost effectiveness is an essential aspect of a medication review evaluation. Areas covered: A systematic searching of articles that examined the cost-effectiveness of medication reviews conducted in aged care facilities was performed using the relevant databases. Pharmacist-led medication reviews confer many benefits such as attainment of biomarker targets for improved clinical outcomes, and other clinical parameters, as well as depict concrete financial advantages in terms of decrement in total medication costs and associated cost savings. Expert commentary: The cost-effectiveness of medication reviews are more consequential than ever before. A critical evaluation of pharmacist-led medication reviews in residential aged care facilities from an economical aspect is crucial in determining if the time, effort, and direct and indirect costs involved in the review rationalise the significance of conducting medication reviews for older people in aged care facilities.

Effectiveness of assistive technology in improving the safety of people with dementia: a systematic review and meta-analysis.

PubMed

Brims, Lucy; Oliver, Kathryn

2018-04-10

Assistive technology (AT) may enable people with dementia to live safely at home for longer, preventing care home admission. This systematic review assesses the effectiveness of AT in improving the safety of people with dementia living in the domestic setting, by searching for randomised controlled trials, non-randomised controlled trials and controlled before-after studies which compared safety AT with treatment as usual. Measures of safety include care home admission; risky behaviours, accidents and falls at home; and numbers of deaths. The review updates the safety aspect of Fleming and Sum's 2014 systematic review. Seven bibliographic databases, the Social Care Institute for Excellence website and the Alzheimer's Society website were searched for published and unpublished literature between 2011-2016. Search terms related to AT, dementia and older people. Common outcomes were meta-analysed. Three randomised controlled trials were identified, including 245 people with dementia. No significant differences were found between intervention and control groups in care home admission (risk ratio 0.85 95% CI [0.37, 1.97]; Z = 0.37; p = 0.71). The probability of a fall occurring was 50% lower in the intervention group (risk ratio 0.50 95% CI [0.32, 0.78]; Z = 3.03; p = 0.002). One included study found that a home safety package containing AT significantly reduced risky behaviour and accidents (F(45) = 4.504, p < 0.001). Limitations include the few studies found and the inclusion of studies in English only. AT's effectiveness in decreasing care home admission is inconclusive. However, the AT items and packages tested improved safety through reducing falls risk, accidents and other risky behaviour.

Application of demographic analysis to pedestrian safety : final report.

DOT National Transportation Integrated Search

2017-04-01

In recent years, many departments of transportation in the US have invested additional resources to enhance : pedestrian safety. However, there is still a need to effectively and systematically address the pedestrian experience : in low-income areas....

Safety effectiveness of pedestrian crossing enhancements : final report.

DOT National Transportation Integrated Search

2017-02-01

Over the last decade, the Oregon DOT and other agencies have systematically implemented many pedestrian crossing enhancements (PCEs) across the state. This study explored the safety performance of these enhanced crossing in Oregon. Detailed data were...

Data collection and analysis for local roadway safety assessment.

DOT National Transportation Integrated Search

2014-11-01

The project Data Analysis for Local Roadway : Assessment conducted systematic road-safety : assessment and identified major risks that can be el : iminated or reduced by pr : actical road-improvement : measures. Specifically, the primary task o...

Public availability of results of observational studies evaluating an intervention registered at ClinicalTrials.gov.

PubMed

Baudart, Marie; Ravaud, Philippe; Baron, Gabriel; Dechartres, Agnes; Haneef, Romana; Boutron, Isabelle

2016-01-28

Observational studies are essential for assessing safety. The aims of this study were to evaluate whether results of observational studies evaluating an intervention with safety outcome(s) registered at ClinicalTrials.gov were published and, if not, whether they were available through posting on ClinicalTrials.gov or the sponsor website. We identified a cohort of observational studies with safety outcome(s) registered on ClinicalTrials.gov after October 1, 2007, and completed between October 1, 2007, and December 31, 2011. We systematically searched PubMed for a publication, as well as ClinicalTrials.gov and the sponsor website for results. The main outcomes were the time to the first publication in journals and to the first public availability of the study results (i.e. published or posted on ClinicalTrials.gov or the sponsor website). For all studies with results publicly available, we evaluated the completeness of reporting (i.e. reported with the number of events per arm) of safety outcomes. We identified 489 studies; 334 (68%) were partially or completely funded by industry. Results for only 189 (39%, i.e. 65% of the total target number of participants) were published at least 30 months after the study completion. When searching other data sources, we obtained the results for 53% (n = 158; i.e. 93% of the total target number of participants) of unpublished studies; 31% (n = 94) were posted on ClinicalTrials.gov and 21% (n = 64) on the sponsor website. As compared with non-industry-funded studies, industry-funded study results were less likely to be published but not less likely to be publicly available. Of the 242 studies with a primary outcome recorded as a safety issue, all these outcomes were adequately reported in 86% (114/133) when available in a publication, 91% (62/68) when available on ClinicalTrials.gov, and 80% (33/41) when available on the sponsor website. Only 39% of observational studies evaluating an intervention with safety outcome(s) registered at ClinicalTrials.gov had their results published at least 30 months after study completion. The registration of these observational studies allowed searching other sources (results posted at ClinicalTrials.gov and sponsor website) and obtaining results for half of unpublished studies and 93% of the total target number of participants.

Interventions that facilitate sustainable jobs and have a positive impact on workers' health: an overview of systematic reviews.

PubMed

Haby, Michelle M; Chapman, Evelina; Clark, Rachel; Galvão, Luiz A C

2016-11-01

To identify interventions that facilitate sustainable jobs and have a positive impact on the health of workers in health sector workplaces. This overview utilized systematic review methods to synthesize evidence from multiple systematic reviews and economic evaluations. A comprehensive search was conducted based on a predefined protocol, including specific inclusion criteria. To be classified as "sustainable," interventions needed to aim (explicitly or implicitly) to 1) have a positive impact on at least two key dimensions of the integrated framework for sustainable development and 2) include measures of health impact. Only interventions conducted in, or applicable to, health sector workplaces were included. Fourteen systematic reviews and no economic evaluations met the inclusion criteria for the overview. The interventions that had a positive impact on health included 1) enforcement of occupational health and safety regulations; 2) use of the "degree of experience rating" feature of workers' compensation; 3) provision of flexible working arrangements that increase worker control and choice; 4) implementation of certain organizational changes to shift work schedules; and 5) use of some employee participation schemes. Interventions with negative impacts on health included 1) downsizing/restructuring; 2) temporary and insecure work arrangements; 3) outsourcing/home-based work arrangements; and 4) some forms of task restructuring. What is needed now is careful implementation, in health sector workplaces, of interventions likely to have positive impacts, but with careful evaluation of their effects including possible adverse impacts. Well-evaluated implementation of the interventions (including those at the pilot-study stage) will contribute to the evidence base and inform future action. Interventions with negative health impacts should be withdrawn from practice (through regulation, where possible). If use of these interventions is necessary, for other reasons, considerable care should be taken to ensure an appropriate balance between business needs and human health and well-being.

Instruments for Assessing Risk of Bias and Other Methodological Criteria of Published Animal Studies: A Systematic Review

PubMed Central

Krauth, David; Woodruff, Tracey J.

2013-01-01

Background: Results from animal toxicology studies are critical to evaluating the potential harm from exposure to environmental chemicals or the safety of drugs prior to human testing. However, there is significant debate about how to evaluate the methodology and potential biases of the animal studies. There is no agreed-upon approach, and a systematic evaluation of current best practices is lacking. Objective: We performed a systematic review to identify and evaluate instruments for assessing the risk of bias and/or other methodological criteria of animal studies. Method: We searched Medline (January 1966–November 2011) to identify all relevant articles. We extracted data on risk of bias criteria (e.g., randomization, blinding, allocation concealment) and other study design features included in each assessment instrument. Discussion: Thirty distinct instruments were identified, with the total number of assessed risk of bias, methodological, and/or reporting criteria ranging from 2 to 25. The most common criteria assessed were randomization (25/30, 83%), investigator blinding (23/30, 77%), and sample size calculation (18/30, 60%). In general, authors failed to empirically justify why these or other criteria were included. Nearly all (28/30, 93%) of the instruments have not been rigorously tested for validity or reliability. Conclusion: Our review highlights a number of risk of bias assessment criteria that have been empirically tested for animal research, including randomization, concealment of allocation, blinding, and accounting for all animals. In addition, there is a need for empirically testing additional methodological criteria and assessing the validity and reliability of a standard risk of bias assessment instrument. Citation: Krauth D, Woodruff TJ, Bero L. 2013. Instruments for assessing risk of bias and other methodological criteria of published animal studies: a systematic review. Environ Health Perspect 121:985–992 (2013); http://dx.doi.org/10.1289/ehp.1206389 PMID:23771496

Organization, quality and cost of oncological home-hospitalization: A systematic review.

PubMed

Cool, Lieselot; Vandijck, Dominique; Debruyne, Philip; Desmedt, Melissa; Lefebvre, Tessa; Lycke, Michelle; De Jonghe, Pieter Jan; Pottel, Hans; Foulon, Veerle; Van Eygen, Koen

2018-06-01

Home-hospitalization might be a patient-centred approach facing the increasing burden of cancer on societies. This systematic review assessed how oncological home-hospitalization has been organized and to what extent its quality and costs were evaluated. Twenty-four papers describing parenteral cancer drug administration to adult patients in their homes were included. Most papers concluded oncological home-hospitalization had no significant effect on patient-reported quality of life (7/8 = 88%), but large majority of patients were satisfied (12/13, 92%) and preferred home treatment (7/8, 88%). No safety risks were associated with home-hospitalization (10/10, 100%). The cost of home-hospitalization was found beneficial in five trials (5/9, 56%); others reported no financial impact (2/9, 22%) or additional costs (2/9, 22%). Despite heterogeneity, majority of reported models for oncological home-hospitalization demonstrated that this is a safe, equivalent and acceptable alternative to ambulatory hospital care. More well-designed trials are needed to evaluate its economic impact. Copyright © 2018 Elsevier B.V. All rights reserved.

Systematic reviews of workplace injury interventions: what are we missing?

PubMed

Lipscomb, Hester J; Pompeii, Lisa A; Myers, D J; Schoenfisch, Ashley L; Dement, J M

2009-01-01

There are pitfalls associated with applying a biomedical model with its emphasis on experimental designs to the evaluation of workplace injury interventions. Evaluation over enough time is essential in occupational safety when interventions are expected to have a latent effect as well as to assess sustained effects. Controlled trials are not well-suited to this task and are not even possible in circumstances where a policy change, such as legislative action, affects a population of workers simultaneously. Social context influences occupational injury interventions, their evaluation and the wider generalization of findings but is lost in the pooling of data for meta-analyses. Some of these issues can be addressed through recognition of the contribution of diverse observational methodologies in intervention evaluation, improvement and maintenance of robust surveillance systems, and inclusion of qualitative methodologies not typically embraced by epidemiologists or medical researchers. Through consideration of an evaluation of a legislative effort to prevent falls from height in construction, we demonstrate lack of flexibility in current methods used for evaluating time series analyses in systematic reviews of occupational injury intervention effectiveness. These include the manner in which downward change in slope is assessed and the call to demonstrate a significant initial downward change in level. We illustrate essential contextual detail regarding this intervention that is lost in the pooling of data from multiple studies into a combined measure of effect. This reduction of occupational injury intervention evaluation to one of pure statistical significance is ill-conceived, irresponsible, and should be stopped.

[ISMP-Spain questionnaire and strategy for improving good medication practices in the Andalusian health system].

PubMed

Padilla-Marín, V; Corral-Baena, S; Domínguez-Guerrero, F; Santos-Rubio, M D; Santana-López, V; Moreno-Campoy, E

2012-01-01

To describe the strategy employed by Andalusian public health service hospitals to foster safe medication use. The self-evaluation questionnaire on drug system safety in hospitals, adapted by the Spanish Institute for Safe Medication Practices was used as a fundamental tool to that end. The strategy is developed in several phases. We analyse the report evaluating drug system safety in Andalusian public hospitals published by the Spanish Ministry of Health and Consumption in 2008 and establish a grading system to assess safe medication practices in Andalusian hospitals and prioritise areas needing improvement. We developed a catalogue of best practices available in the web environment belonging to the Andalusian health care quality agency's patient safety observatory. We publicised the strategy through training seminars and implemented a system allowing hospitals to evaluate the degree of compliance for each of the best practices, and based on that system, we were able to draw up a map of centres of reference. We found areas for improvement among several of the questionnaire's fundamental criteria. These areas for improvement were related to normal medication procedures in daily clinical practice. We therefore wrote 7 best practice guides that provide a cross-section of the assessment components of the questionnaire related to the clinical process needing improvement. The self-evaluation questionnaire adapted by ISMP-Spain is a good tool for designing a systematic, rational intervention to promote safe medication practices and intended for a group of hospitals that share the same values. Copyright © 2011 SEFH. Published by Elsevier Espana. All rights reserved.

Imatinib discontinuation in chronic myeloid leukaemia patients with undetectable BCR-ABL transcript level: A systematic review and a meta-analysis.

PubMed

Campiotti, Leonardo; Suter, Matteo Basilio; Guasti, Luigina; Piazza, Rocco; Gambacorti-Passerini, Carlo; Grandi, Anna Maria; Squizzato, Alessandro

2017-05-01

Tyrosine kinase inhibitors (TKIs) are the cornerstones of treatment for patients with chronic myeloid leukaemia (CML). In recent years, several studies were conducted to evaluate the safety of TKIs discontinuation. We performed a systematic review of the literature to determine the incidence of CML relapse, to identify possible factors relapse rates and to evaluate the long-term safety in CML patients with stable undetectable BCR-ABL transcript level who discontinued TKIs. Studies evaluating TKIs discontinuation in CML patients with undetectable BCR-ABL transcript level were identified by electronic search of MEDLINE and EMBASE database until May 2015. Weighted mean proportion and 95% confidence intervals (CIs) of CML relapse was calculated using a fixed-effects and a random-effects model. Statistical heterogeneity was evaluated using the I 2 statistic. Fifteen cohort studies, for a total of 509 patients, were included. Nine studies were at low-risk of bias. All 15 studies included only patients on imatinib. Overall weighted mean molecular relapse rate of CML was 51% (95% CI 44-58%; I 2  = 55). Weighted mean molecular relapse rate at 6-month follow-up was 41% (95% CI 32-51%; I 2  = 78). Eighty percent of molecular relapses occurred in the first 6 months. All 509 patients were alive at 2-year follow-up and only one patient (0.8%, 95% CI 0.2-1.8%; I 2  = 0) has progressed to a blastic crisis. Our findings suggest that imatinib discontinuation is feasible for the majority of CML patients with stable undetectable BCR-ABL transcript level. Approximately 50% of patients remain therapy-free after imatinib discontinuation. Restarting TKIs therapy was followed by a very high rate of molecular response, with no deaths 2 years after discontinuation. Copyright © 2017 Elsevier Ltd. All rights reserved.

How Safe Is Ginger Rhizome for Decreasing Nausea and Vomiting in Women during Early Pregnancy?

PubMed Central

Stanisiere, Julien; Mousset, Pierre-Yves; Lafay, Sophie

2018-01-01

Ginger, Zingiber officinale Roscoe, is increasingly consumed as a food or in food supplements. It is also recognized as a popular nonpharmacological treatment for nausea and vomiting of pregnancy (NVP). However, its consumption is not recommended by all countries for pregnant women. Study results are heterogeneous and conclusions are not persuasive enough to permit heath care professionals to recommend ginger safely. Some drugs are also contraindicated, leaving pregnant women with NVP with few solutions. We conducted a review to assess effectiveness and safety of ginger consumption during early pregnancy. Systematic literature searches were conducted on Medline (via Pubmed) until the end of December 2017. For the evaluation of efficacy, only double-blind, randomized, controlled trials were included. For the evaluation of the safety, controlled, uncontrolled, and pre-clinical studies were included in the review. Concerning toxicity, none can be extrapolated to humans from in vitro results. In vivo studies do not identify any major toxicities. Concerning efficacy and safety, a total of 15 studies and 3 prospective clinical studies have been studied. For 1 g of fresh ginger root per day for four days, results show a significant decrease in nausea and vomiting and no risk for the mother or her future baby. The available evidence suggests that ginger is a safe and effective treatment for NVP. However, beyond the ginger quantity needed to be effective, ginger quality is important from the perspective of safety. PMID:29614764

[Employees in high-reliability organizations: systematic selection of personnel as a final criterion].

PubMed

Oubaid, V; Anheuser, P

2014-05-01

Employees represent an important safety factor in high-reliability organizations. The combination of clear organizational structures, a nonpunitive safety culture, and psychological personnel selection guarantee a high level of safety. The cockpit personnel selection process of a major German airline is presented in order to demonstrate a possible transferability into medicine and urology.

Are there any differences in the efficacy and safety of different formulations of Oral 5-ASA used for induction and maintenance of remission in ulcerative colitis? evidence from cochrane reviews.

PubMed

Feagan, Brian G; Chande, Nilesh; MacDonald, John K

2013-08-01

We systematically reviewed and compared the efficacy and safety of oral mesalamine formulations (sustained release, delayed release, and prodrugs) used for induction and maintenance of remission in ulcerative colitis. The main objective of this review was to determine if there are any differences in efficacy or safety among the oral 5-ASA drugs. A literature search in February 2013 identified all applicable randomized trials. Study quality was evaluated using the Cochrane risk of bias tool. The Grading of Recommendations Assessment, Development and Evaluation criteria were used to assess the overall quality of the evidence. Studies were subgrouped by common mesalamine comparators for meta-analysis. Studies were pooled for analysis if they compared equimolar doses of oral 5-ASA. Seventeen studies that evaluated 2925 patients were identified. The risk of bias was low for most factors, although 1 study was single blind and 3 were open label. No difference was observed between oral 5-ASA and comparator 5-ASA formulations in the proportion of patients with clinical remission (relative risk, 0.94; 95% confidence interval, 0.86-1.02), clinical improvement (relative risk, 0.89; 95% confidence interval, 0.77-1.01), or relapse at 12 months (relative risk, 1.01; 95% confidence interval, 0.80-1.28). Subgroup analyses showed no important differences in efficacy. No significant difference was demonstrated in rates of adverse events or withdrawal due to adverse events. There does not seem to be any difference in efficacy or safety among the various formulations of oral 5-ASA. Oral mesalamine is an effective and safe treatment of mild-to-moderate or quiescent ulcerative colitis regardless of the chosen formulation.

Screening of repeated dose toxicity data present in SCC(NF)P/SCCS safety evaluations of cosmetic ingredients.

PubMed

Vinken, Mathieu; Pauwels, Marleen; Ates, Gamze; Vivier, Manon; Vanhaecke, Tamara; Rogiers, Vera

2012-03-01

Alternative methods, replacing animal testing, are urgently needed in view of the European regulatory changes in the field of cosmetic products and their ingredients. In this context, a joint research initiative called SEURAT was recently raised by the European Commission and COLIPA, representing the European cosmetics industry, with the overall goal of developing an animal-free repeated dose toxicity testing strategy for human safety assessment purposes. Although cosmetic ingredients are usually harmless for the consumer, one of the initial tasks of this research consortium included the identification of organs that could potentially be affected by cosmetic ingredients upon systemic exposure. The strategy that was followed hereof is described in the present paper and relies on the systematic evaluation, by using a self-generated electronic databank, of published reports issued by the scientific committee of DG SANCO responsible for the safety of cosmetic ingredients. By screening of the repeated dose toxicity studies present in these reports, it was found that the liver is potentially the most frequently targeted organ by cosmetic ingredients when orally administered to experimental animals, followed by the kidney and the spleen. Combined listing of altered morphological, histopathological, and biochemical parameters subsequently indicated the possible occurrence of hepatotoxicity, including steatosis and cholestasis, triggered by a limited number of cosmetic compounds. These findings are not only of relevance for the in vitro modeling efforts and choice of compounds to be tested in the SEURAT project cluster, but also demonstrate the importance of using previously generated toxicological data through an electronic databank for addressing specific questions regarding the safety evaluation of cosmetic ingredients.

Efficacy and safety of icotinib in treating non-small cell lung cancer: a systematic evaluation and meta-analysis based on 15 studies.

PubMed

Biaoxue, Rong; Hua, Liu; Wenlong, Gao; Shuanying, Yang

2016-12-27

Icotinib is a new epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) that developed and used in China; this work was to evaluate its efficacy and safety in treating non-small cell lung cancer (NSCLC). Clinical studies evaluating the efficacy and safety of icotinib in treating NSCLC were identified from the databases of Medline, Web of Science, Embase and Cochrance Library. Pooled efficacy and safety of icotinib were calculated through a series of predefined search strategies. A total of 15 studies with 2,304 patients were involved in this study. The overall response rate (ORR) and disease control rate (DCR) of icotinib were 40.99% (95% CI: 33.77% to 48.22%) and 77.16% (95% CI: 51.43% to 82.31%). The pooled progression-free survival (PFS) and overall survival (OS) were 7.34 months (95% CI: 5.60 to 9.07) and 14.98 months (95% CI: 9.78 to 20.18). Patients with EGFR mutations exhibited better ORR (OR = 3.67, p < 0.001), DCR (OR = 1.39, p = 0.001) and PFS (11.0 ± 0.76 vs. 1.97 ± 0.82 months). Moreover, patients with rash had a higher ORR (OR = 2.14, p = 0.001) than those without rash. The common adverse effects (AEs) included skin rash (31.4%), diarrhea (14.2%), pruritus (6.7%) and hepatic toxicity (3.8%) and most of them were well tolerated. In conclusion, Icotinib is an effective and well tolerated regimen for Chinese patients with advanced NSCLC. Further randomized trials with large population are required to provide stronger evidence for icotinib in treating NSCLC.

Efficacy and safety of icotinib in treating non-small cell lung cancer: a systematic evaluation and meta-analysis based on 15 studies

PubMed Central

Biaoxue, Rong; Hua, Liu; Wenlong, Gao; Shuanying, Yang

2016-01-01

Icotinib is a new epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) that developed and used in China; this work was to evaluate its efficacy and safety in treating non-small cell lung cancer (NSCLC). Clinical studies evaluating the efficacy and safety of icotinib in treating NSCLC were identified from the databases of Medline, Web of Science, Embase and Cochrance Library. Pooled efficacy and safety of icotinib were calculated through a series of predefined search strategies. A total of 15 studies with 2,304 patients were involved in this study. The overall response rate (ORR) and disease control rate (DCR) of icotinib were 40.99% (95% CI: 33.77% to 48.22%) and 77.16% (95% CI: 51.43% to 82.31%). The pooled progression-free survival (PFS) and overall survival (OS) were 7.34 months (95% CI: 5.60 to 9.07) and 14.98 months (95% CI: 9.78 to 20.18). Patients with EGFR mutations exhibited better ORR (OR = 3.67, p < 0.001), DCR (OR = 1.39, p = 0.001) and PFS (11.0 ± 0.76 vs. 1.97 ± 0.82 months). Moreover, patients with rash had a higher ORR (OR = 2.14, p = 0.001) than those without rash. The common adverse effects (AEs) included skin rash (31.4%), diarrhea (14.2%), pruritus (6.7%) and hepatic toxicity (3.8%) and most of them were well tolerated. In conclusion, Icotinib is an effective and well tolerated regimen for Chinese patients with advanced NSCLC. Further randomized trials with large population are required to provide stronger evidence for icotinib in treating NSCLC. PMID:27893423

Athlete's foot

PubMed Central

2009-01-01

Introduction Around 15% to 25% of people are likely to have athlete's foot at any one time. The infection can spread to other parts of the body and to other people. Methods and outcomes We conducted a systematic review and aimed to answer the following clinical question: What are the effects of topical treatments for athlete's foot? We searched: Medline, Embase, The Cochrane Library, and other important databases up to July 2008 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA). Results We found 14 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions. Conclusions In this systematic review we present information relating to the effectiveness and safety of the following interventions: improved foot hygiene, including socks and hosiery; topical allylamines (naftifine and terbinafine); topical azoles (bifonazole, clotrimazole, econazole nitrate, miconazole nitrate, sulconazole nitrate, and tioconazole); and topical ciclopirox olamine. PMID:21696646

Athlete's foot.

PubMed

Crawford, Fay

2009-07-20

Around 15% to 25% of people are likely to have athlete's foot at any one time. The infection can spread to other parts of the body and to other people. We conducted a systematic review and aimed to answer the following clinical question: What are the effects of topical treatments for athlete's foot? We searched: Medline, Embase, The Cochrane Library, and other important databases up to July 2008 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA). We found 14 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions. In this systematic review we present information relating to the effectiveness and safety of the following interventions: improved foot hygiene, including socks and hosiery; topical allylamines (naftifine and terbinafine); topical azoles (bifonazole, clotrimazole, econazole nitrate, miconazole nitrate, sulconazole nitrate, and tioconazole); and topical ciclopirox olamine.

Halitosis

PubMed Central

2008-01-01

Introduction Halitosis can be caused by oral disease, or by respiratory tract conditions such as sinusitis, tonsillitis, and bronchiectasis, but an estimated 40% of affected individuals have no underlying organic disease. Methods and outcomes We conducted a systematic review and aimed to answer the following clinical question: What are the effects of treatments in people with physiological halitosis? We searched: Medline, Embase, The Cochrane Library, and other important databases up to July 2008 (Clinical evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA). Results We found five systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions. Conclusions In this systematic review we present information relating to the effectiveness and safety of the following interventions: artificial saliva; cleaning, brushing, or scraping the tongue; diet modification; regular or single use of mouthwash; sugar-free chewing gums; and zinc toothpastes. PMID:19445739

PCOS.

PubMed

Cahill, David

2009-01-15

Polycystic ovary syndrome (PCOS) is diagnosed in up to 10% of women attending gynaecology clinics, but the prevalence in the population as a whole is unclear. PCOS has been associated with hirsutism, infertility, acne, weight gain, type 2 diabetes, cardiovascular disease (CVD), and endometrial hyperplasia. We conducted a systematic review and aimed to answer the following clinical question: What are the effects of treatments? We searched: Medline, Embase, The Cochrane Library, and other important databases up to December 2007 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA). We found 24 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions. In this systematic review we present information relating to the effectiveness and safety of the following interventions: finasteride, flutamide, metformin, spironolactone, cyproterone acetate-ethinylestradiol (co-cyprindiol), interventions to achieve weight loss, ketoconazole, and mechanical hair removal.

Amoebic dysentery.

PubMed

Marie, Chelsea; Petri, William Arthur

2013-08-30

Amoebic dysentery is caused by the protozoan parasite Entamoeba histolytica. It is transmitted in areas where poor sanitation allows contamination of drinking water and food with faeces. In these areas, up to 40% of people with diarrhoea may have amoebic dysentery. We conducted a systematic review and aimed to answer the following clinical question: What are the effects of drug treatments for amoebic dysentery in endemic areas? We searched: Medline, Embase, The Cochrane Library, and other important databases up to June 2013 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA). We found 6 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions. In this systematic review, we present information relating to the effectiveness and safety of the following interventions: diiodohydroxyquinoline (iodoquinol), diloxanide, emetine, metronidazole, nitazoxanide, ornidazole, paromomycin, secnidazole, and tinidazole.

Viability of dental implants in head and neck irradiated patients: A systematic review.

PubMed

Zen Filho, Edson Virgílio; Tolentino, Elen de Souza; Santos, Paulo Sérgio Silva

2016-04-01

The purpose of this systematic review was to evaluate the safety of dental implants placed in irradiated bone and to discuss their viability when placed post-radiotherapy (RT). A systematic review was performed to answer the questions: "Are dental implants in irradiated bone viable?" and "What are the main factors that influence the loss of implants in irradiated patients?" The search strategy resulted in 8 publications. A total of 331 patients received 1237 implants, with an overall failure rate of 9.53%. The osseointegration success rates ranged between 62.5% and 100%. The optimal time interval between irradiation and dental implantation varied from 6 to 15 months. The interval time between RT and implant placement and the radiation doses are not associated with significant implant failure rates. The placement of implants in irradiated bone is viable, and head and neck RT should not be considered as a contraindication for dental rehabilitation with implants. © 2015 Wiley Periodicals, Inc. Head Neck 38: E2229-E2240, 2016. © 2015 Wiley Periodicals, Inc.

Opioids in people with cancer-related pain

PubMed Central

2008-01-01

Introduction Up to 80% of people with cancer experience pain at some time during their illness, and most will need opioid analgesics. This review assesses how different opioid analgesics compare, in terms of both pain control and adverse effects, in people with cancer. Methods and outcomes We conducted a systematic review and aimed to answer the following clinical question: what are the effects of opioids in treating cancer-related pain? We searched: Medline, Embase, The Cochrane Library, and other important databases up to July 2007 (BMJ Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA). Results We found 22 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions. Conclusions In this systematic review, we present information relating to the effectiveness and safety of the following interventions: codeine, dihydrocodeine, transdermal fentanyl, hydromorphone, methadone, morphine, oxycodone, and tramadol. PMID:19445735

Iliac Crest Bone Graft versus Local Autograft or Allograft for Lumbar Spinal Fusion: A Systematic Review.

PubMed

Tuchman, Alexander; Brodke, Darrel S; Youssef, Jim A; Meisel, Hans-Jörg; Dettori, Joseph R; Park, Jong-Beom; Yoon, S Tim; Wang, Jeffrey C

2016-09-01

Systematic review. To compare the effectiveness and safety between iliac crest bone graft (ICBG) and local autologous bone and allograft in the lumbar spine. A systematic search of multiple major medical reference databases identified studies evaluating spinal fusion in patients with degenerative joint disease using ICBG, local autograft, or allograft in the thoracolumbar spine. Six comparative studies met our inclusion criteria. A "low" strength of the overall body of evidence suggested no difference in fusion percentages in the lumbar spine between local autograft and ICBG. We found no difference in fusion percentages based on low evidence comparing allograft with ICBG autograft. There were no differences in pain or functional results comparing local autograft or allograft with ICBG autograft. Donor site pain and hematoma/seroma occurred more frequently in ICBG autograft group for lumbar fusion procedures. There was low evidence around the estimate of patients with donor site pain following ICBG harvesting, ranging from 16.7 to 20%. With respect to revision, low evidence demonstrated no difference between allograft and ICBG autograft. There was no evidence comparing patients receiving allograft with local autograft for fusion, pain, functional, and safety outcomes. In the lumbar spine, ICBG, local autograft, and allograft have similar effectiveness in terms of fusion rates, pain scores, and functional outcomes. However, ICBG is associated with an increased risk for donor site-related complications. Significant limitations exist in the available literature when comparing ICBG, local autograft, and allograft for lumbar fusion, and thus ICBG versus other fusion methods necessitates further investigation.

Measurement of patient safety: a systematic review of the reliability and validity of adverse event detection with record review

PubMed Central

Hanskamp-Sebregts, Mirelle; Zegers, Marieke; Vincent, Charles; van Gurp, Petra J; de Vet, Henrica C W; Wollersheim, Hub

2016-01-01

Objectives Record review is the most used method to quantify patient safety. We systematically reviewed the reliability and validity of adverse event detection with record review. Design A systematic review of the literature. Methods We searched PubMed, EMBASE, CINAHL, PsycINFO and the Cochrane Library and from their inception through February 2015. We included all studies that aimed to describe the reliability and/or validity of record review. Two reviewers conducted data extraction. We pooled κ values (κ) and analysed the differences in subgroups according to number of reviewers, reviewer experience and training level, adjusted for the prevalence of adverse events. Results In 25 studies, the psychometric data of the Global Trigger Tool (GTT) and the Harvard Medical Practice Study (HMPS) were reported and 24 studies were included for statistical pooling. The inter-rater reliability of the GTT and HMPS showed a pooled κ of 0.65 and 0.55, respectively. The inter-rater agreement was statistically significantly higher when the group of reviewers within a study consisted of a maximum five reviewers. We found no studies reporting on the validity of the GTT and HMPS. Conclusions The reliability of record review is moderate to substantial and improved when a small group of reviewers carried out record review. The validity of the record review method has never been evaluated, while clinical data registries, autopsy or direct observations of patient care are potential reference methods that can be used to test concurrent validity. PMID:27550650

Acupuncture for chronic prostatitis: A systematic review and meta-analysis protocol.

PubMed

Peng, Tianzhong; Cheng, Ying; Jin, Yuhao; Xu, Na; Guo, Taipin

2018-04-01

Chronic prostatitis (CP) is a prevalent genitourinary condition. Considering its safety profile, acupuncture can be an option treating CP symptoms. The aim of this review is to undertake a systematic review to estimate the effectiveness and safety of acupuncture on CP. We will search all randomized controlled trials for CP in August 2018 in the databases of MEDLINE, Cochrane Library, Web of Science, EMBASE, Springer, WHO International Clinical Trials Registry Platform (ICTRP), China National Knowledge Infrastructure (CNKI), Wan fang, Chinese Biomedical Literature Database (CBM), PsycInfo, Chinese Scientific Journal Database (VIP), and other available resources. Languages are limited as English and Chinese. Search terms used are will "acupuncture," and "chronic prostatitis," "non-bacterial prostatitis," "abacterial prostatitis." And duplicates will be screened. The primary outcomes consisted of improvement rate and pain relief evaluated by The National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) index. Secondary outcomes include the recurrence rate and side effects, such as pneumothorax, discomforts, and infection. This study will demonstrate an evidence-based review of acupuncture for chronic prostatitis. The study will provide clear evidence to assess the effectiveness and side effects of acupuncture for chronic prostatitis. There is no requirement of ethical approval and it will be in print or disseminated by electronic copies. CRD42018088834.

Antihistamines and birth defects: a systematic review of the literature.

PubMed

Gilboa, Suzanne M; Ailes, Elizabeth C; Rai, Ramona P; Anderson, Jaynia A; Honein, Margaret A

2014-12-01

Approximately 10 - 15% of women reportedly take an antihistamine during pregnancy for the relief of nausea and vomiting, allergy and asthma symptoms, or indigestion. Antihistamines include histamine H1-receptor and H2-receptor antagonists. This is a systematic evaluation of the peer-reviewed epidemiologic literature published through February 2014 on the association between prenatal exposure to antihistamines and birth defects. Papers addressing histamine H1- or H2-receptor antagonists are included. Papers addressing pyridoxine plus doxylamine (Bendectin in the United States, Debendox in the United Kingdom, Diclectin in Canada, Lenotan and Merbental in other countries) prior to the year 2001 were excluded post hoc because of several previously published meta-analyses and commentaries on this medication. The literature on the safety of antihistamine use during pregnancy with respect to birth defects is generally reassuring though the positive findings from a few large studies warrant corroboration in other populations. The findings in the literature are considered in light of three critical methodological issues: i) selection of appropriate study population; ii) ascertainment of antihistamine exposures; and iii) ascertainment of birth defect outcomes. Selected antihistamines have been very well studied (e.g., loratadine); others, especially H2-receptor antagonists, require additional study before an assessment of safety with respect to birth defect risk could be made.

Tai chi for health benefits in patients with multiple sclerosis: A systematic review

PubMed Central

Wang, Huiru; Xiao, ZhongJun; Fang, Qun; Zhang, Mark; Li, Ting; Du, Geng; Liu, Yang

2017-01-01

The aim of this systematic review was to evaluate the existing evidence on the effectiveness and safety of Tai chi, which is critical to provide guidelines for clinicians to improve symptomatic management in patients with multiple sclerosis (MS). After performing electronic and manual searches of many sources, ten relevant peer-reviewed studies that met the inclusion criteria were retrieved. The existing evidence supports the effectiveness of Tai chi on improving quality of life (QOL) and functional balance in MS patients. A small number of these studies also reported the positive effect of Tai chi on flexibility, leg strength, gait, and pain. The effect of Tai chi on fatigue is inconsistent across studies. Although the findings demonstrate beneficial effects on improving outcome measures, especially for functional balance and QOL improvements, a conclusive claim should be made carefully for reasons such as methodological flaws, small sample size, lack of specific-disease instruments, unclear description of Tai chi protocol, unreported safety of Tai chi, and insufficient follow-up as documented by the existing literature. Future research should recruit a larger number of participants and utilize the experimental design with a long-term follow-up to ascertain the benefits of Tai chi for MS patients. PMID:28182629

The Role of Mifepristone in Meningiomas Management: A Systematic Review of the Literature.

PubMed

Cossu, Giulia; Levivier, Marc; Daniel, Roy Thomas; Messerer, Mahmoud

2015-01-01

We performed a systematic literature review to analyze the clinical application and the safety of mifepristone, a prominent antiprogesterone agent, in meningioma patients. A systematic search was performed through Medline, Cochrane, and clinicaltrials.gov databases from 1960 to 2014. Study Selection. Studies were selected through a PICO approach. Population was meningioma patients, meningioma cells cultures, and animal models. Intervention was mifepristone administration. Control was placebo administration or any other drug tested. Outcomes were clinical and radiological responsiveness, safety profile, and cell growth inhibition. A total of 7 preclinical and 6 clinical studies and one abstract were included. Encouraging results were found in preclinical studies. Concerning clinical studies, the response rate to mifepristone in terms of radiological regression and symptomatic improvement/stability in patients with inoperable meningioma was low. In meningiomatosis, favorable preliminary results were recorded. The safety profile was good. Limitations were as follows. The tumoral expression of progesterone receptors was not analyzed systematically in every study considered. No clear evidence exists to recommend mifepristone in inoperable meningiomas. Preliminary encouraging results were found in diffuse meningiomatosis. Mifepristone is a well-tolerated treatment. Patients' selection and hormonal profile analysis in meningiomas are fundamental for a better understanding of its benefit. Multicenter placebo-controlled trials are required.

A comparison among four tract dilation methods of percutaneous nephrolithotomy: a systematic review and meta-analysis.

PubMed

Dehong, Cao; Liangren, Liu; Huawei, Liu; Qiang, Wei

2013-11-01

The purpose of this study was to evaluate the efficacy and safety of the Amplatz dilation (AD), metal telescopic dilation (MTD), balloon dilation (BD), and one-shot dilation (OSD) methods for tract dilation during percutaneous nephrolithotomy (PCNL). Relevant eligible studies were identified using three electronic databases (Medline, EMBASE, and Cochrane CENTRAL). Database acquisition and quality evaluation were independently performed by two reviewers. Efficacy (stone-free rate, surgical duration, and tract dilatation fluoroscopy time) and safety (transfusion rate and hemoglobin decrease) were evaluated using Review Manager 5.2. Four randomized controlled trials and eight clinical controlled trials involving 6,820 patients met the inclusion criteria. The pooled result from a meta-analysis showed statistically significant differences in tract dilatation fluoroscopy time and hemoglobin decrease between the OSD and MTD groups, which showed comparable stone-free and transfusion rates. Significant differences in transfusion rate were found between the BD and MTD groups. Among patients without previous open renal surgery, those who underwent BD exhibited a lower blood transfusion rate and a shorter surgical duration compared with those who underwent AD. The OSD technique is safer and more efficient than the MTD technique for tract dilation during PCNL, particularly in patients with previous open renal surgery, resulting in a shorter tract dilatation fluoroscopy time and a lesser decrease in hemoglobin. The efficacy and safety of BD are better than AD in patients without previous open renal surgery. The OSD technique should be considered for most patients who undergo PCNL therapy.

Impact of reduction in working hours for doctors in training on postgraduate medical education and patients' outcomes: systematic review.

PubMed

Moonesinghe, S R; Lowery, J; Shahi, N; Millen, A; Beard, J D

2011-03-22

To determine whether a reduction in working hours of doctors in postgraduate medical training has had an effect on objective measures of medical education and clinical outcome. Systematic review. Medline, Embase, ISI Web of Science, Google Scholar, ERIC, and SIGLE were searched without language restriction for articles published between 1990 and December 2010. Reference lists and citations of selected articles. Studies that assessed the impact of a change in duty hours using any objective measure of outcome related to postgraduate medical training, patient safety, or clinical outcome. Any study design was eligible for inclusion. 72 studies were eligible for inclusion: 38 reporting training outcomes, 31 reporting outcomes in patients, and three reporting both. A reduction in working hours from greater than 80 hours a week (in accordance with US recommendations) does not seem to have adversely affected patient safety and has had limited effect on postgraduate training. Reports on the impact of European legislation limiting working hours to less than 56 or 48 a week are of poor quality and have conflicting results, meaning that firm conclusions cannot be made. Reducing working hours to less than 80 a week has not adversely affected outcomes in patient or postgraduate training in the US. The impact of reducing hours to less than 56 or 48 a week in the UK has not yet been sufficiently evaluated in high quality studies. Further work is required, particularly in the European Union, using large multicentre evaluations of the impact of duty hours' legislation on objective educational and clinical outcomes.

Efficacy and safety of TNF antagonists in sarcoidosis: data from the Spanish registry of biologics BIOBADASER and a systematic review.

PubMed

Maneiro, Jose Ramon; Salgado, Eva; Gomez-Reino, Juan J; Carmona, Loreto

2012-08-01

To evaluate the safety, efficacy, and effectiveness of TNF antagonists in patients with sarcoidosis. A descriptive study of a case series registered in BIOBADASER and a systematic review was performed. The search strategy of articles published between 1998 and July 2011 in Medline, Embase, and the Cochrane Library included synonyms of sarcoidosis and synonyms of TNF antagonists. Seven patients treated with infliximab (IFX) and 1 with etanercept (ETN) switched to IFX for inefficacy were registered in BIOBADASER 2.0. In 3, treatment is still ongoing. Reasons for discontinuation were serious adverse events in 2 cases, inefficacy in 2 cases, and complete clinical response in 2 cases. Eight serious adverse events were reported. In the selected 69 of 2262 reports and 1 abstract of the review, 232 patients (89.9%) were treated with IFX and 26 (10.0%) were treated with ETN. In 2 randomized clinical trials, favorable response of the lung disease was reported with IFX. In other randomized clinical trials, no improvement of ocular manifestations was reported with ETN. In the cases series, results were diverse. Mean weighted rates of adverse events, infections, serious infections, and malignancy were 39.9, 22.1, 5.9, and 1.0 per 100 patient-years, respectively. There is insufficient evidence to ensure the efficacy of TNF antagonists in sarcoidosis. Nevertheless, IFX may be effective in selected manifestations of the disease. Before starting treatment of sarcoidosis with IFX, a careful evaluation of the benefit/risk ratio must be considered on an individual basis. Copyright © 2012 Elsevier Inc. All rights reserved.

Experimental validation of depletion calculations with VESTA 2.1.5 using JEFF-3.2

NASA Astrophysics Data System (ADS)

Haeck, Wim; Ichou, Raphaëlle

2017-09-01

The removal of decay heat is a significant safety concern in nuclear engineering for the operation of a nuclear reactor both in normal and accidental conditions and for intermediate and long term waste storage facilities. The correct evaluation of the decay heat produced by an irradiated material requires first of all the calculation of the composition of the irradiated material by depletion codes such as VESTA 2.1, currently under development at IRSN in France. A set of PWR assembly decay heat measurements performed by the Swedish Central Interim Storage Facility (CLAB) located in Oskarshamm (Sweden) have been calculated using different nuclear data libraries: ENDF/B-VII.0, JEFF-3.1, JEFF-3.2 and JEFF-3.3T1. Using these nuclear data libraries, VESTA 2.1 calculates the assembly decay heat for almost all cases within 4% of the measured decay heat. On average, the ENDF/B-VII.0 calculated decay heat values appear to give a systematic underestimation of only 0.5%. When using the JEFF-3.1 library, this results a systematic underestimation of about 2%. By switching to the JEFF-3.2 library, this systematic underestimation is improved slighty (up to 1.5%). The changes made in the JEFF-3.3T1 beta library appear to be overcorrecting, as the systematic underestimation is transformed into a systematic overestimation of about 1.5%.

Permissive or Trophic Enteral Nutrition and Full Enteral Nutrition Had Similar Effects on Clinical Outcomes in Intensive Care: A Systematic Review of Randomized Clinical Trials.

PubMed

Silva, Camila F A; de Vasconcelos, Simone G; da Silva, Thales A; Silva, Flávia M

2018-01-26

The aim of this study was to systematically review the effect of permissive underfeeding/trophic feeding on the clinical outcomes of critically ill patients. A systematic review of randomized clinical trials to evaluate the mortality, length of stay, and mechanical ventilation duration in patients randomized to either hypocaloric or full-energy enteral nutrition was performed. Data sources included PubMed and Scopus and the reference lists of the articles retrieved. Two independent reviewers participated in all phases of this systematic review as proposed by the Cochrane Handbook, and the review was reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. A total of 7 randomized clinical trials that included a total of 1,717 patients were reviewed. Intensive care unit length of stay and mechanical ventilation duration were not statistically different between the intervention and control groups in all randomized clinical trials, and mortality rate was also not different between the groups. In conclusion, hypocaloric enteral nutrition had no significantly different effects on morbidity and mortality in critically ill patients when compared with full-energy nutrition. It is still necessary to determine the safety of this intervention in this group of patients, the optimal amount of energy provided, and the duration of this therapy. © 2018 American Society for Parenteral and Enteral Nutrition.

Systematic Review of Chinese Medicine for Miscarriage during Early Pregnancy

PubMed Central

Leung, Ping Chung; Chung, Tony Kwok Hung; Wang, Chi Chiu

2014-01-01

Background. Miscarriage is a very common complication during early pregnancy. So far, clinical therapies have limitation in preventing the early pregnancy loss. Chinese Medicine, regarded as gentle, effective, and safe, has become popular and common as a complementary and alternative treatment for miscarriages. However, the evidence to support its therapeutic efficacy and safety is still very limited. Objectives and Methods. To summarize the clinical application of Chinese Medicine for pregnancy and provide scientific evidence on the efficacy and safety of Chinese medicines for miscarriage, we located all the relevant pieces of literature on the clinical applications of Chinese Medicine for miscarriage and worked out this systematic review. Results. 339,792 pieces of literature were identified, but no placebo was included and only few studies were selected for systematic review and conducted for meta-analysis. A combination of Chinese medicines and Western medicines was more effective than Chinese medicines alone. No specific safety problem was reported, but potential adverse events by certain medicines were identified. Conclusions. Studies vary considerably in design, interventions, and outcome measures; therefore conclusive results remain elusive. Large scales of randomized controlled trials and more scientific evidences are still necessary to confirm the efficacy and safety of Chinese medicines during early pregnancy. PMID:24648851

Validity and consistency assessment of accident analysis methods in the petroleum industry.

PubMed

Ahmadi, Omran; Mortazavi, Seyed Bagher; Khavanin, Ali; Mokarami, Hamidreza

2017-11-17

Accident analysis is the main aspect of accident investigation. It includes the method of connecting different causes in a procedural way. Therefore, it is important to use valid and reliable methods for the investigation of different causal factors of accidents, especially the noteworthy ones. This study aimed to prominently assess the accuracy (sensitivity index [SI]) and consistency of the six most commonly used accident analysis methods in the petroleum industry. In order to evaluate the methods of accident analysis, two real case studies (process safety and personal accident) from the petroleum industry were analyzed by 10 assessors. The accuracy and consistency of these methods were then evaluated. The assessors were trained in the workshop of accident analysis methods. The systematic cause analysis technique and bowtie methods gained the greatest SI scores for both personal and process safety accidents, respectively. The best average results of the consistency in a single method (based on 10 independent assessors) were in the region of 70%. This study confirmed that the application of methods with pre-defined causes and a logic tree could enhance the sensitivity and consistency of accident analysis.

Distracted Walking, Bicycling, and Driving: Systematic Review and Meta-Analysis of Mobile Technology and Youth Crash Risk.

PubMed

Stavrinos, Despina; Pope, Caitlin N; Shen, Jiabin; Schwebel, David C

2018-01-01

This article examined the impact of mobile technology on young pedestrians, bicyclists, and drivers. A systematic search yielded 41 articles meeting inclusion criteria: peer-reviewed, published before February 1, 2016, behavioral outcome related to pedestrian, bicycling, or driving in the presence of mobile technology use, youth sample. Eleven studies were meta-analyzed to evaluate increased risk for crash/near-crash while distracted. Risk of bias and quality of research were assessed. Across methodologies, developmental stages, and type of distracting task, mobile technology use impairs youth safety on the road. Quality of evidence was low (pedestrian) to moderate (driving). Findings are discussed from the perspective of cognitive and visual distractions. Policy and behavioral efforts should continue to reduce mobile technology use in transportation settings. © 2017 The Authors. Child Development © 2017 Society for Research in Child Development, Inc.

Endobronchial ultrasound-guided transbronchial needle aspiration of thyroid: Report of two cases and systematic review of literature

PubMed Central

Madan, Karan; Mittal, Saurabh; Hadda, Vijay; Jain, Deepali; Mohan, Anant; Guleria, Randeep

2016-01-01

Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is a minimally invasive and safe technique for a sampling of mediastinal lesions. Indications for EBUS-TBNA have gradually expanded since its introduction. The usual approach to cytological sampling of the thyroid gland is percutaneous ultrasound-guided fine needle aspiration (US-FNA) performed under local anesthesia. US-FNA may be risky or not feasible in intrathoracic/substernal thyroid location. Feasibility of aspirating thyroid lesions with EBUS-TBNA has been occasionally reported. We report two patients wherein EBUS-TBNA was utilized for thyroid lesion aspiration and definitive diagnosis. We highlight the utility and safety of EBUS-TBNA in the evaluation of intrathoracic thyroid lesions wherein image-guided percutaneous aspiration may be risky/sometimes impossible to perform. A systematic review of literature has also been performed summarizing and discussing the issues pertaining to EBUS-TBNA of the thyroid gland. PMID:27891005

Comparative Efficacy of the Air-Q Intubating Laryngeal Airway during General Anesthesia in Pediatric Patients: A Systematic Review and Meta-Analysis.

PubMed

Ahn, Eun Jin; Choi, Geun Joo; Kang, Hyun; Baek, Chong Wha; Jung, Yong Hun; Woo, Young Cheol; Bang, Si Ra

2016-01-01

Air-Q® (air-Q) is a supraglottic airway device which can be used as a guidance of intubation in pediatric as well as in adult patients. We evaluated the efficacy and safety of air-Q compared to other airway devices during general anesthesia in pediatric patients by conducting a systematic review and meta-analysis. A total of 10 studies including 789 patients were included in the final analysis. Compared with other supraglottic airway devices, air-Q showed no evidence for a difference in leakage pressure and insertion time. The ease of insertion was significantly lower than other supraglottic airway devices. The success rate of intubation was significantly lower than other airway devices. However, fiberoptic view was better through the air-Q than other supraglottic airway devices. Therefore, air-Q could be a safe substitute for other airway devices and may provide better fiberoptic bronchoscopic view.

Efficacy and Safety of Oseltamivir in Children: Systematic Review and Individual Patient Data Meta-analysis of Randomized Controlled Trials.

PubMed

Malosh, Ryan E; Martin, Emily T; Heikkinen, Terho; Brooks, W Abdullah; Whitley, Richard J; Monto, Arnold S

2018-05-02

Oseltamivir has been used to treat children with influenza for nearly 2 decades, with treatment currently approved for infants aged ≥2 weeks. However, efficacy and safety remain controversial. Newer randomized, placebo-controlled trials (RCTs), not included in previous meta-analyses, can add to the evidence base. We conducted a systematic review to identify RCTs of oseltamivir therapy in children. We obtained individual patient data and examined protocol-defined outcomes. We then conducted a 2-stage, random-effects meta-analysis to determine the efficacy of treatment in reducing the duration of illness, estimated using differences in restricted mean survival time (RMST) by treatment group. We also examined complications and safety. We identified 5 trials that included 2561 patients in the intention-to-treat (ITT) and 1598 in the intention-to-treat infected (ITTI) populations. Overall, oseltamivir treatment significantly reduced the duration of illness in the ITTI population (RMST difference, -17.6 hours; 95% confidence interval [CI], -34.7 to -0.62 hours). In trials that enrolled patients without asthma, the difference was larger (-29.9 hours; 95% CI, -53.9 to -5.8 hours). Risk of otitis media was 34% lower in the ITTI population. Vomiting was the only adverse event with a significantly higher risk in the treatment group. Despite substantial heterogeneity in pediatric trials, we found that treatment with oseltamivir significantly reduced the duration of illness in those with influenza and lowered the risk of developing otitis media. Alternative endpoints may be required to evaluate the efficacy of oseltamivir in pediatric patients with asthma.

Therapeutic efficacy of alternative primaquine regimens to standard treatment in preventing relapses by Plasmodium vivax: A systematic review and meta-analysis.

PubMed

Zuluaga-Idarraga, Lina Marcela; Tamayo Perez, María-Eulalia; Aguirre-Acevedo, Daniel Camilo

2015-12-30

To compare efficacy and safety of primaquine regimens currently used to prevent relapses by P. vivax. A systematic review was carried out to identify clinical trials evaluating efficacy and safety to prevent malaria recurrences by P. vivax of primaquine regimen 0.5 mg/kg/ day for 7 or 14 days compared to standard regimen of 0.25 mg/kg/day for 14 days. Efficacy of primaquine according to cumulative incidence of recurrences after 28 days was determined. The overall relative risk with fixed-effects meta-analysis was estimated. For the regimen 0.5 mg/kg/day/7 days were identified 7 studies, which showed an incidence of recurrence between 0% and 20% with follow-up 60-210 days; only 4 studies comparing with the standard regimen 0.25 mg/kg/day/14 days and no difference in recurrences between both regimens (RR= 0.977, 95% CI= 0.670 to 1.423) were found. 3 clinical trials using regimen 0.5 mg/kg/day/14 days with an incidence of recurrences between 1.8% and 18.0% during 330-365 days were identified; only one study comparing with the standard regimen (RR= 0.846, 95% CI= 0.484 to 1.477). High risk of bias and differences in handling of included studies were found. Available evidence is insufficient to determine whether currently PQ regimens used as alternative rather than standard treatment have better efficacy and safety in preventing relapse of P. vivax. Clinical trials are required to guide changes in treatment regimen of malaria vivax.

Comparison of self-report and objective measures of driving behavior and road safety: A systematic review.

PubMed

Kaye, Sherrie-Anne; Lewis, Ioni; Freeman, James

2018-06-01

This research systematically reviewed the existing literature in regards to studies which have used both self-report and objective measures of driving behavior. The objective of the current review was to evaluate disparities or similarities between self-report and objective measures of driving behavior. Searches were undertaken in the following electronic databases, PsycINFO, PubMed, and Scopus, for peer-reviewed full-text articles that (1) focused on road safety, and (2) compared both subjective and objective measures of driving performance or driver safety. A total of 22,728 articles were identified, with 19 articles, comprising 20 studies, included as part of the review. The research reported herein suggested that for some behaviors (e.g., driving in stressful situations) there were similarities between self-report and objective measures while for other behaviors (e.g., sleepiness and vigilance states) there were differences between these measurement techniques. In addition, findings from some studies suggested that in-vehicle devices may be a valid measurement tool to assess driving exposure in older drivers. Further research is needed to examine the correspondence between self-report and objective measures of driving behavior. In particular, there is a need to increase the number of studies which compare "like with like" as it is difficult to draw comparisons when there are variations in measurement tools used. Incorporating a range of objective and self-report measurements tools in research would help to ensure that the methods used offer the most reliable measures of assessing on-road behaviors. Crown Copyright © 2018. Published by Elsevier Ltd. All rights reserved.

Development of the Consumer Refrigerator Safety Questionnaire: A Measure of Consumer Perceptions and Practices.

PubMed

Cairnduff, Victoria; Dean, Moira; Koidis, Anastasios

2016-09-01

Food preparation and storage behaviors in the home deviating from the "best practice" food safety recommendations may result in foodborne illnesses. Currently, there are limited tools available to fully evaluate the consumer knowledge, perceptions, and behavior in the area of refrigerator safety. The current study aimed to develop a valid and reliable tool in the form of a questionnaire, the Consumer Refrigerator Safety Questionnaire (CRSQ), for assessing systematically all these aspects. Items relating to refrigerator safety knowledge (n =17), perceptions (n =46), and reported behavior (n =30) were developed and pilot tested by an expert reference group and various consumer groups to assess face and content validity (n =20), item difficulty and consistency (n =55), and construct validity (n =23). The findings showed that the CRSQ has acceptable face and content validity with acceptable levels of item difficulty. Item consistency was observed for 12 of 15 in refrigerator safety knowledge. Further, all 5 of the subscales of consumer perceptions of refrigerator safety practices relating to risk of developing foodborne disease showed acceptable internal consistency (Cronbach's α value > 0.8). Construct validity of the CRSQ was shown to be very good (P = 0.022). The CRSQ exhibited acceptable test-retest reliability at 14 days with the majority of knowledge items (93.3%) and reported behavior items (96.4%) having correlation coefficients of greater than 0.70. Overall, the CRSQ was deemed valid and reliable in assessing refrigerator safety knowledge and behavior; therefore, it has the potential for future use in identifying groups of individuals at increased risk of deviating from recommended refrigerator safety practices, as well as the assessment of refrigerator safety knowledge and behavior for use before and after an intervention.

49 CFR Appendix B to Part 222 - Alternative Safety Measures

Code of Federal Regulations, 2014 CFR

2014-10-01

... statistically valid baseline violation rate must be established through automated or systematic manual... enforcement, a program of public education and awareness directed at motor vehicle drivers, pedestrians and..., a statistically valid baseline violation rate must be established through automated or systematic...

49 CFR Appendix B to Part 222 - Alternative Safety Measures

Code of Federal Regulations, 2013 CFR

2013-10-01

... statistically valid baseline violation rate must be established through automated or systematic manual... enforcement, a program of public education and awareness directed at motor vehicle drivers, pedestrians and..., a statistically valid baseline violation rate must be established through automated or systematic...

Post-trial follow-up methodology in large randomized controlled trials: a systematic review protocol.

PubMed

Llewellyn-Bennett, Rebecca; Bowman, Louise; Bulbulia, Richard

2016-12-15

Clinical trials typically have a relatively short follow-up period, and may both underestimate potential benefits of treatments investigated, and fail to detect hazards, which can take much longer to emerge. Prolonged follow-up of trial participants after the end of the scheduled trial period can provide important information on both efficacy and safety outcomes. This protocol describes a systematic review to qualitatively compare methods of post-trial follow-up used in large randomized controlled trials. A systematic search of electronic databases and clinical trial registries will use a predefined search strategy. All large (more than 1000 adult participants) randomized controlled trials will be evaluated. Two reviewers will screen and extract data according to this protocol with the aim of 95% concordance of papers checked and discrepancies will be resolved by a third reviewer. Trial methods, participant retention rates and prevalence of missing data will be recorded and compared. The potential for bias will be evaluated using the Cochrane Risk of Bias tool (applied to the methods used during the in-trial period) with the aim of investigating whether the quality of the post-trial follow-up methodology might be predicted by the quality of the methods used for the original trial. Post-trial follow-up can provide valuable information about the long-term benefits and hazards of medical interventions. However, it can be logistically challenging and costly. The aim of this systematic review is to describe how trial participants have been followed-up post-trial in order to inform future post-trial follow-up designs. Not applicable for PROSPERO registration.

Frequency, Expected Effects, Obstacles, and Facilitators of Disclosure of Patient Safety Incidents: A Systematic Review

PubMed Central

2017-01-01

Objectives We performed a systematic review to assess and aggregate the available evidence on the frequency, expected effects, obstacles, and facilitators of disclosure of patient safety incidents (DPSI). Methods We used the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines for this systematic review and searched PubMed, Scopus, and the Cochrane Library for English articles published between 1990 and 2014. Two authors independently conducted the title screening and abstract review. Ninety-nine articles were selected for full-text reviews. One author extracted the data and another verified them. Results There was considerable variation in the reported frequency of DPSI among medical professionals. The main expected effects of DPSI were decreased intention of the general public to file medical lawsuits and punish medical professionals, increased credibility of medical professionals, increased intention of patients to revisit and recommend physicians or hospitals, higher ratings of quality of care, and alleviation of feelings of guilt among medical professionals. The obstacles to DPSI were fear of medical lawsuits and punishment, fear of a damaged professional reputation among colleagues and patients, diminished patient trust, the complexity of the situation, and the absence of a patient safety culture. However, the factors facilitating DPSI included the creation of a safe environment for reporting patient safety incidents, as well as guidelines and education for DPSI. Conclusions The reported frequency of the experience of the general public with DPSI was somewhat lower than the reported frequency of DPSI among medical professionals. Although we identified various expected effects of DPSI, more empirical evidence from real cases is required. PMID:28372351

Structural Integrity Evaluation of the Lear Fan 2100 Aircraft

NASA Technical Reports Server (NTRS)

Kan, H. P.; Dyer, T. A.

1996-01-01

An in-situ nondestructive inspection was conducted to detect manufacturing and assembly induced defects in the upper two wing surfaces (skin s) and upper fuselage skin of the Lear Fan 2100 aircraft E009. The effects of the defects, detected during the inspection, on the integrity of the structure was analytically evaluated. A systematic evaluation was also conducted to determine the damage tolerance capability of the upper wing skin against impact threats and assembly induced damage. The upper wing skin was divided into small regions for damage tolerance evaluations. Structural reliability, margin of safety, allowable strains, and allowable damage size were computed. The results indicated that the impact damage threat imposed on composite military aircraft structures is too severe for the Lear Fan 2100 upper wing skin. However, the structural integrity is not significantly degraded by the assembly induced damage for properly assembled structures, such as the E009 aircraft.

Challenges in evaluating cancer as a clinical outcome in postapproval studies of drug safety

PubMed Central

Pinheiro, Simone P.; Rivera, Donna R.; Graham, David J.; Freedman, Andrew N.; Major, Jacqueline M.; Penberthy, Lynne; Levenson, Mark; Bradley, Marie C.; Wong, Hui-Lee; Ouellet-Hellstrom, Rita

2017-01-01

Pharmaceuticals approved in the United States are largely not known human carcinogens. However, cancer signals associated with pharmaceuticals may be hypothesized or arise after product approval. There are many study designs that can be used to evaluate cancer as an outcome in the postapproval setting. Because prospective systematic collection of cancer outcomes from a large number of individuals may be lengthy, expensive, and challenging, leveraging data from large existing databases are an integral approach. Such studies have the capability to evaluate the clinical experience of a large number of individuals, yet there are unique methodological challenges involved in their use to evaluate cancer outcomes. To discuss methodological challenges and potential solutions, the Food and Drug Administration and the National Cancer Institute convened a two-day public meeting in 2014. This commentary summarizes the most salient issues discussed at the meeting. PMID:27663208

Challenges in evaluating cancer as a clinical outcome in postapproval studies of drug safety.

PubMed

Pinheiro, Simone P; Rivera, Donna R; Graham, David J; Freedman, Andrew N; Major, Jacqueline M; Penberthy, Lynne; Levenson, Mark; Bradley, Marie C; Wong, Hui-Lee; Ouellet-Hellstrom, Rita

2016-11-01

Pharmaceuticals approved in the United States are largely not known human carcinogens. However, cancer signals associated with pharmaceuticals may be hypothesized or arise after product approval. There are many study designs that can be used to evaluate cancer as an outcome in the postapproval setting. Because prospective systematic collection of cancer outcomes from a large number of individuals may be lengthy, expensive, and challenging, leveraging data from large existing databases are an integral approach. Such studies have the capability to evaluate the clinical experience of a large number of individuals, yet there are unique methodological challenges involved in their use to evaluate cancer outcomes. To discuss methodological challenges and potential solutions, the Food and Drug Administration and the National Cancer Institute convened a two-day public meeting in 2014. This commentary summarizes the most salient issues discussed at the meeting. Published by Elsevier Inc.

[Preventive measures for the prophylaxis of contractures in geriatric nursing. A systematic review].

PubMed

Scheffel, Sonja; Hantikainen, Virpi

2011-06-01

Contractures constitute a health problem in mobility-restricted geriatric patients. Contractures are clinically important due to their impact on functional outcome. Prophylactic interventions seem to be indispensable. We performed a systematic review studying the interventions used to prevent immobility-related contractures in the geriatric long-term care. The efficacy and safety of preventive methods was assessed. Electronic literature searches covered the databases PubMed, PEDro, CINAHL and the Cochrane Library (May 2010). Eligibility criteria for studies were: Investigation of an intervention aimed to prevent contractures, conducted in a geriatric and long-term care setting, inclusion of participants aged>65 years. The primary search focused on RCTs, systematic reviews und meta-analysis published between 1990 and May 2010 in English or German. The included studies were analysed and evaluated by one author while a second author checked the results. Methodological quality was critically evaluated using internationally accepted criteria. Eight studies met the inclusion criteria. Prophylactic interventions comprise mobility-encouraging and position-supportive interventions. Mobility-encouraging interventions aim to prevent contractures and immobility, for example offering range-of-motion exercises. Position-supportive interventions are transformations of motion and position, which are conducted with nurses' support. Due to limited methodological quality of these studies, the efficacy of certain measures remains unclear. Further studies on contracture prophylaxis investigating patient-relevant outcomes, interventions' adverse effects and costs are required.

Cross-continental comparison of the association between the physical environment and active transportation in children: a systematic review.

PubMed

D'Haese, Sara; Vanwolleghem, Griet; Hinckson, Erica; De Bourdeaudhuij, Ilse; Deforche, Benedicte; Van Dyck, Delfien; Cardon, Greet

2015-11-26

The purpose of this systematic review was to determine the relationship between a wide range of physical environmental characteristics and different contexts of active transportation in 6- to 12-year-old children across different continents. A systematic search was conducted in six databases (Pubmed, Web of Science, Cinahl, SportDiscus, TRIS and Cochrane) resulting in 65 papers, eligible for inclusion. The investigated physical environmental variables were grouped into six categories: walkability, accessibility, walk/cycle facilities, aesthetics, safety, recreation facilities. The majority of the studies were conducted in North America (n = 35), Europe (n = 17) and Australia (n = 11). Active transportation to school (walking or cycling) was positively associated with walkability. Walking to school was positively associated with walkability, density and accessibility. Evidence for a possible association was found for traffic safety and all forms of active transportation to school. No convincing evidence was found for associations between the physical environment and active transportation during leisure. General safety and traffic safety were associated with active transportation to school in North America and Australia but not associated with active transportation to school in Europe. The physical environment was mainly associated with active transportation to school. Continent specific associations were found, indicating that safety measures were most important in relation to active commuting to school in North America and Australia. There is a need for longitudinal studies and studies conducted in Asia, Africa and South-America and studies focusing specifically on active transportation during leisure.

Systematic Review of Breastfeeding and Herbs

PubMed Central

Budzynska, Katarzyna; Gardner, Zoë E.; Dugoua, Jean-Jacques; Low Dog, Tieraona

2012-01-01

Abstract Objectives Despite popular and historical use, there has been little modern research conducted to determine the safety and efficacy of herb use during breastfeeding. The purpose of this study was to systematically review the clinical literature on herbal medicine and lactation. Methods The databases PubMed, CAB Abstracts, Cochrane Central Register of Controlled Trials, HealthSTAR, Cumulative Index to Nursing and Allied Health Literature, and Reprotox were systematically searched for human trials from 1970 until 2010. Reference lists from relevant articles were hand-searched. Results Thirty-two studies met the inclusion criteria. Clinical studies were divided into three categories: survey studies (n=11), safety studies (n=8), and efficacy studies (n=13). Six studies were randomized controlled trials. The most common herbs studied were St. John's wort (Hypericum perforatum L.) (n=3), garlic (Allium sativum L.) extract (n=2), and senna (Cassia senna L.) (n=2). Studies were very heterogeneous with regard to study design, herbal intervention, and outcome measures. Overall, poor methodological quality predominated among the studies. Conclusions Our review concludes that further research is needed to assess the prevalence, efficacy, and safety of commonly used herbs during breastfeeding. PMID:22686865

The California corridor transportation system: A design summary

NASA Technical Reports Server (NTRS)

1990-01-01

A design group was assembled to find and research criteria relevent to the design of a California Corridor Transportation System. The efforts of this group included defining the problem, conducting a market analysis, formulation of a demand model, identification and evaluation of design drivers, and the systematic development of a solution. The problems of the current system were analyzed and used to determine design drivers, which were divided into the broad categories of cost, convenience, feasibility, environment, safety, and social impact. The relative importance of individual problems was addressed, resulting in a hierarchy of design drivers. Where possible, methods of evaluating the relative merit of proposed systems with respect to each driver were developed. Short takeoff vertical landing aircraft concepts are also discussed for supersonic fighters.

Asking Students about the Importance of Safety Skills Instruction: A Preliminary Analysis of What They Think Is Important

ERIC Educational Resources Information Center

Agran, Martin; Krupp, Michael; Spooner, Fred; Zakas, Tracie-Lynn

2012-01-01

Although the importance of safety skills instruction is well acknowledged and available data suggest individuals with varying disabilities sustain injuries from accidents at a rate that is comparable to or may exceed the normative population, many students do not receive systematic safety skills instruction. Findings on the extent to which…

Safety and efficacy of cranberry (vaccinium macrocarpon) during pregnancy and lactation.

PubMed

Dugoua, Jean-Jacques; Seely, Dugald; Perri, Daniel; Mills, Edward; Koren, Gideon

2008-01-01

There is a lack of basic knowledge on the part of both clinicians and patients as to the indications for use and safety of herbs used during pregnancy and lactation. This is one article in a series that systematically reviews the evidence for herbs commonly used during pregnancy and lactation. To systematically review the literature for evidence on the use, safety and pharmacology of cranberry, focusing on issues pertaining to pregnancy and lactation. We searched 7 electronic databases and compiled data according to the grade of evidence found. There is no direct evidence of safety or harm to the mother or fetus as a result of consuming cranberry during pregnancy. Indirectly, there is good scientific evidence that cranberry may be of minimal risk, where a survey of 400 pregnant women did not uncover any adverse events when cranberry was regularly consumed. In lactation, the safety or harm of cranberry is unknown. Women experience urinary tract infections with greater frequency during pregnancy. Given the evidence to support the use of cranberry for urinary tract infections (UTIs) and its safety profile, cranberry supplementation as fruit or fruit juice may be a valuable therapeutic choice in the treatment of UTIs during pregnancy.

Efficacy and Safety of Oral Beclomethasone Dipropionate in Ulcerative Colitis: A Systematic Review and Meta-Analysis

PubMed Central

Bennato, Raffaele; Lombardi, Giovanni; Riccio, Elisabetta; Costantino, Giuseppe; Fries, Walter

2016-01-01

Background and Aim We performed a systematic review and meta-analysis of all the available evidence comparing efficacy and safety of oral prolonged released beclomethasone dipropionate (BDP) to active oral controls in patients with mild-to-moderate ulcerative colitis (UC). A subgroup-analysis compared the effectiveness of BDP and 5-ASA. Methods Literature research was performed in different databases, as well as manual search to identify abstracts from international meetings with data not included in extensive publications. Experts in the field and companies involved in BDP development and manufacture were contacted to identify unpublished studies used for registration purposes. Dichotomous data were pooled to obtain odds ratio meta-analysis. Results Five randomized controlled trials that compared oral BDP 5mg/day vs. all oral active controls in treating UC were identified as eligible. Efficacy and safety have been addressed after 4-week treatment period. One study evaluated efficacy and safety of BDP vs. prednisone and 4 of BDP vs. 5-ASA. Treatment with oral BDP 5 mg/day induces a significant better clinical response compared to oral 5-ASA (OR 1.86, 95% CI = 1.23–2.82, P = 0.003). The effect is detectable even when the comparison to prednisone is added (OR 1.41, 95% CI = 1.03–1.93, P = 0.03). Data on remission indicate that the potential clinical efficacy of BDP may be better than 5-ASA (OR 1.55, 95% CI = 1.00–2.40, P = 0.05). This difference is lost when the comparison with prednisone is added (OR 1.30, 95% CI = 0.76–2.23, P = 0.34). The safety analysis showed no differences between BDP and 5-ASA (OR 0.55, 95% CI = 0.24–1.27, P = 0.16). The lack of difference is maintained even when the study with prednisone is added (OR 0.67, 95% CI = 0.44–1.01, P = 0.06). However, the trend of difference is clear and indicates a more favourable safety profile of BDP compared to 5-ASA and PD. Conclusions Oral prolonged release BDP showed a superior efficacy vs. oral 5-ASA in inducing clinical improvement of mild-to-moderate UC with a similar safety profile. PMID:27846307

A systematic review of Human Factors and Ergonomics (HFE)-based healthcare system redesign for quality of care and patient safety

PubMed Central

Xie, Anping; Carayon, Pascale

2014-01-01

Healthcare systems need to be redesigned to provide care that is safe, effective and efficient, and meets the multiple needs of patients. This systematic review examines how Human Factors and Ergonomics (HFE) is applied to redesign healthcare work systems and processes and improve quality and safety of care. We identified twelve projects representing 23 studies and addressing different physical, cognitive and organizational HFE issues in a variety of healthcare systems and care settings. Some evidence exists for the effectiveness of HFE-based healthcare system redesign in improving process and outcome measures of quality and safety of care. We assessed risk of bias in 16 studies reporting the impact of HFE-based healthcare system redesign and found varying quality across studies. Future research should further assess the impact of HFE on quality and safety of care, and clearly define the mechanisms by which HFE-based system redesign can improve quality and safety of care. Practitioner Summary Existing evidence shows that HFE-based healthcare system redesign has the potential to improve quality of care and patient safety. Healthcare organizations need to recognize the importance of HFE-based healthcare system redesign to quality of care and patient safety, and invest resources to integrate HFE in healthcare improvement activities. PMID:25323570

What is the Relationship between Risky Outdoor Play and Health in Children? A Systematic Review

PubMed Central

Brussoni, Mariana; Gibbons, Rebecca; Gray, Casey; Ishikawa, Takuro; Sandseter, Ellen Beate Hansen; Bienenstock, Adam; Chabot, Guylaine; Fuselli, Pamela; Herrington, Susan; Janssen, Ian; Pickett, William; Power, Marlene; Stanger, Nick; Sampson, Margaret; Tremblay, Mark S.

2015-01-01

Risky outdoor play has been associated with promoting children’s health and development, but also with injury and death. Risky outdoor play has diminished over time, concurrent with increasing concerns regarding child safety and emphasis on injury prevention. We sought to conduct a systematic review to examine the relationship between risky outdoor play and health in children, in order to inform the debate regarding its benefits and harms. We identified and evaluated 21 relevant papers for quality using the GRADE framework. Included articles addressed the effect on health indicators and behaviours from three types of risky play, as well as risky play supportive environments. The systematic review revealed overall positive effects of risky outdoor play on a variety of health indicators and behaviours, most commonly physical activity, but also social health and behaviours, injuries, and aggression. The review indicated the need for additional “good quality” studies; however, we note that even in the face of the generally exclusionary systematic review process, our findings support the promotion of risky outdoor play for healthy child development. These positive results with the marked reduction in risky outdoor play opportunities in recent generations indicate the need to encourage action to support children’s risky outdoor play opportunities. Policy and practice precedents and recommendations for action are discussed. PMID:26062038

What is the Relationship between Risky Outdoor Play and Health in Children? A Systematic Review.

PubMed

Brussoni, Mariana; Gibbons, Rebecca; Gray, Casey; Ishikawa, Takuro; Sandseter, Ellen Beate Hansen; Bienenstock, Adam; Chabot, Guylaine; Fuselli, Pamela; Herrington, Susan; Janssen, Ian; Pickett, William; Power, Marlene; Stanger, Nick; Sampson, Margaret; Tremblay, Mark S

2015-06-08

Risky outdoor play has been associated with promoting children's health and development, but also with injury and death. Risky outdoor play has diminished over time, concurrent with increasing concerns regarding child safety and emphasis on injury prevention. We sought to conduct a systematic review to examine the relationship between risky outdoor play and health in children, in order to inform the debate regarding its benefits and harms. We identified and evaluated 21 relevant papers for quality using the GRADE framework. Included articles addressed the effect on health indicators and behaviours from three types of risky play, as well as risky play supportive environments. The systematic review revealed overall positive effects of risky outdoor play on a variety of health indicators and behaviours, most commonly physical activity, but also social health and behaviours, injuries, and aggression. The review indicated the need for additional "good quality" studies; however, we note that even in the face of the generally exclusionary systematic review process, our findings support the promotion of risky outdoor play for healthy child development. These positive results with the marked reduction in risky outdoor play opportunities in recent generations indicate the need to encourage action to support children's risky outdoor play opportunities. Policy and practice precedents and recommendations for action are discussed.

Technology assessment in medicine. The role of the American Medical Association.

PubMed

McGivney, W T; Hendee, W R

1988-12-01

Public policy decisions about health care and decisions about an individual patient's care are only as sound as the data and information on which they are founded. The formal systematic evaluation of the safety, effectiveness, and cost-effectiveness of a medical technology provides such information and is essential to the appropriate application of technology in patient care. The American Medical Association (AMA) historically has recognized the need for the practicing medical community to develop and communicate accurate and balanced evaluative information to physicians and other health care professionals. In recent years, the association has established formal programs to accomplish this objective. This article describes the AMA's three major assessment programs, the Diagnostic and Therapeutic Technology Assessment program, the Council on Scientific Affairs, and AMA Drug Evaluations. The implications of these activities for patient care and public policy are discussed.

Environment, Safety and Health Self-Assessment Report Fiscal Year 2010

DOE Office of Scientific and Technical Information (OSTI.GOV)

Robinson, Scott

2011-03-23

The Lawrence Berkeley National Laboratory (LBNL) Environment, Safety, and Health (ES&H) Self-Assessment Program was established to ensure that Integrated Safety Management (ISM) is implemented institutionally and by all divisions. The ES&H Self-Assessment Program, managed by the Office of Contractor Assurance (OCA), provides for an internal evaluation of all ES&H programs and systems at LBNL. The primary objective of the program is to ensure that work is conducted safely and with minimal negative impact to workers, the public, and the environment. Self-assessment follows the five core functions and guiding principles of ISM. Self-assessment is the mechanism used to promote the continuousmore » improvement of the Laboratory's ES&H programs. The process is described in the Environment, Safety, and Health Assurance Plan (PUB-5344) and is composed of three types of self-assessments: Division ES&H Self-Assessment, ES&H Technical Assurance Program Assessment, and Division ES&H Peer Review. The Division ES&H Self-Assessment Manual (PUB-3105) provides the framework by which divisions conduct formal ES&H self-assessments to systematically identify program deficiencies. Issue-specific assessments are designed and implemented by the divisions and focus on areas of interest to division management. They may be conducted by teams and involve advance planning to ensure that appropriate resources are available. The ES&H Technical Assurance Program Manual (PUB-913E) provides the framework for systematic reviews of ES&H programs and processes. The ES&H Technical Assurance Program Assessment is designed to evaluate whether ES&H programs and processes are compliant with guiding regulations, are effective, and are properly implemented by LBNL divisions. The Division ES&H Peer Review Manual provides the framework by which division ISM systems are evaluated and improved. Peer Reviews are conducted by teams under the direction of senior division management and focus on higher-level management issues. Peer Review teams are selected on the basis of members knowledge and experience in the issues of interest to the division director. LBNL periodically requests in-depth independent assessments of selected ES&H programs. Such assessments augment LBNL's established assessment processes and provide an objective view of ES&H program effectiveness. Institutional Findings, Observations, and Noteworthy Practices identified during independent assessments are specifically intended to help LBNL identify opportunities for program improvement. This report includes the results of the Division ES&H Self-Assessment, ES&H Technical Assurance Program Assessment, and Division ES&H Peer Review, respectively.« less

Modeling and applications in microbial food safety

USDA-ARS?s Scientific Manuscript database

Mathematical modeling is a scientific and systematic approach to study and describe the recurrent events or phenomena with successful application track for decades. When models are properly developed and validated, their applications may save costs and time. For the microbial food safety concerns, ...

Predictive Microbiology and Food Safety Applications

USDA-ARS?s Scientific Manuscript database

Mathematical modeling is the science of systematic study of recurrent events or phenomena. When models are properly developed, their applications may save costs and time. For microbial food safety research and applications, predictive microbiology models may be developed based on the fact that most ...

[Improving patient safety through voluntary peer review].

PubMed

Kluge, S; Bause, H

2015-01-01

The intensive care unit (ICU) is one area of the hospital in which processes and communication are of primary importance. Errors in intensive care units can lead to serious adverse events with significant consequences for patients. Therefore quality and risk-management are important measures when treating critically ill patients. A pragmatic approach to support quality and safety in intensive care is peer review. This approach has gained significant acceptance over the past years. It consists of mutual visits by colleagues who conduct standardised peer reviews. These reviews focus on the systematic evaluation of the quality of an ICU's structure, its processes and outcome. Together with different associations, the State Chambers of Physicians and the German Medical Association have developed peer review as a standardized tool for quality improvement. The common goal of all stakeholders is the continuous and sustainable improvement in intensive care with peer reviews significantly increasing and improving communication between professions and disciplines. Peer reviews secure the sustainability of planned change processes and consequently lead the way to an improved culture of quality and safety.

Evolution of the central safety factor during stabilized sawtooth instabilities at KSTAR

NASA Astrophysics Data System (ADS)

Messmer, M. C. C.; Ko, J.; Chung, J.; Woo, M. H.; Lee, K.-D.; Jaspers, R. J. E.

2018-01-01

A motional Stark effect (MSE) diagnostic has recently been installed in the KSTAR tokamak. A difficulty faced at KSTAR and common to other MSE diagnostics is calibration of the system for absolute measurements. In this report we present our novel calibration routine and discuss first results, evaluating the evolution of the the central safety factor during sawtooth instabilities. The calibration scheme ensures that the bandpass filters typically used in MSE systems are aligned correctly and identifies and removes systematic offsets present in the measurement. This is verified by comparing the reconstructed safety factor profile against various discharges where the locations of rational q surfaces have been obtained from MHD markers. The calibration is applied to analyse the evolution of q 0 in a shot where the sawteeth are stabilized by neutral beam injection. Within the analysed sawtooth periods q 0 drops below unity during the quiescent phase and relaxes close to or slightly above unity at the sawtooth crash. This finding is in line with the classical Kadomtsev model of full magnetic reconnection and earlier findings at JET.

The safety of pharmacologic treatment for pediatric obesity.

PubMed

Chao, Ariana M; Wadden, Thomas A; Berkowitz, Robert I

2018-04-01

Pediatric obesity is a serious public health concern. Five medications have been approved by the Food and Drug Administration (FDA) for chronic weight management in adults with obesity, when used as an adjunct to lifestyle modification. Orlistat is the only FDA-approved medication for pediatric patients aged 12 years and above. Areas covered: This paper summarizes safety and efficacy data from clinical trials of weight loss medications conducted among pediatric samples. Relevant studies were identified through searches in PubMed. Expert opinion: Orlistat, as an adjunct to lifestyle modification, results in modest weight losses and may be beneficial for some pediatric patients with obesity. However, gastrointestinal side effects are common and may limit use. In adults taking orlistat, rare but severe adverse events, including liver and renal events, have been reported. Recent pediatric pharmacokinetic studies of liraglutide have demonstrated similar safety and tolerability profiles as found in adults, with gastrointestinal disorders being the most common adverse events. Clinical trials are needed of liraglutide, as well as other medications for obesity, that systematically evaluate their risks and benefits in pediatric patients.

The safety of hormonal contraceptives for women living with HIV and their sexual partners.

PubMed

Phillips, Sharon J; Polis, Chelsea B; Curtis, Kathryn M

2016-01-01

Hormonal contraceptives are important for the health and well-being of some women living with HIV, so evaluation of evidence regarding their safety vis-à-vis HIV-related risks is important. We updated two prior systematic reviews on the impact of hormonal contraception (HC) on HIV disease progression and female-to-male HIV transmission. One new study finds no increased risk for HIV disease progression or death associated with oral contraceptive use [adjusted (adj) hazard ratio (HR) 0.83, confidence interval [CI] 0.48-1.44] or injectables (adj HR 0.72, CI 0.53-0.98). Three new studies did not find significantly increased risks for measures of female-to-male HIV transmission with HC use. Hormonal contraceptive methods do not appear to accelerate HIV disease progression. More research is needed to clarify whether HC impacts HIV transmissibility. Copyright © 2016. Published by Elsevier Inc.

Scanning for safety: an integrated approach to improved bar-code medication administration.

PubMed

Early, Cynde; Riha, Chris; Martin, Jennifer; Lowdon, Karen W; Harvey, Ellen M

2011-03-01

This is a review of lessons learned in the postimplementation evaluation of a bar-code medication administration technology implemented at a major tertiary-care hospital in 2001. In 2006, with a bar-code medication administration scan compliance rate of 82%, a near-miss sentinel event prompted review of this technology as part of an institutional recommitment to a "culture of safety." Multifaceted problems with bar-code medication administration created an environment of circumventing safeguards as demonstrated by an increase in manual overrides to ensure timely medication administration. A multiprofessional team composed of nursing, pharmacy, human resources, quality, and technical services formalized. Each step in the bar-code medication administration process was reviewed. Technology, process, and educational solutions were identified and implemented systematically. Overall compliance with bar-code medication administration rose from 82% to 97%, which resulted in a calculated cost avoidance of more than $2.8 million during this time frame of the project.

120: THE CLINICAL EFFECTIVENESS AND COST-EFFECTIVENESS OF FRACTIONAL CO2 LASER IN ACNE SCARS AND SKIN REJUVENATION: A SYSTEMATIC REVIEW AND ECONOMIC EVALUATION

PubMed Central

Yaaghoobian, Barmak; Sadeghi-Ghyassi, Fatemeh; Hajebrahimi, Sakineh

2017-01-01

Background and aims Skin rejuvenation is one of high demand cosmetic interventions in Iran. Fractional CO2 Laser is a high power ablative laser which has variety of utilization in medicine including treatment of acne scars and rejuvenation. The aim of this study was to evaluate the safety, efficacy, and cost-effectiveness of Fractional CO2 Laser in comparison with other methods of rejuvenation and acne scar treatment. Methods A systematic database search including Medline (via OVID and PubMed), EMBASE, CINHAL, Cochrane Library, CRD, SCOPUS and Web of Science conducted. After screening search results, selected publications appraised by CASP and Cochrane Collaboration's tool for assessing risk of bias and eligible studies included in the systematic review. In economic evaluation, all costs and benefits analyzed from Iran ministry of health's perspective. Results From 2667 publications, two randomized control trials were eligible and included in the study. The affectivity and complications of Fractional CO2 laser were comparable with Er: YAG but Fractional CO2 laser was 14.7% (P=0.01) more effective than Q-Switched ND: YAG laser. Cost affectivity of this method was the same as other alternative lasers. Conclusions Fractional CO2 laser is an effective and safe method for curing several kinds of skin. Never the less there was not sufficient evidence to support its advantage. This device has equal or lower price in comparison to competent technologies except for the non- fractional ablative Co2 laser that has the same or lower price and comparable effects.

Systematic review of the evidence related to mandated nurse staffing ratios in acute hospitals.

PubMed

Olley, Richard; Edwards, Ian; Avery, Mark; Cooper, Helen

2018-04-17

Objective The purpose of this systematic review was to evaluate and summarise available research on nurse staffing methods and relate these to outcomes under three overarching themes of: (1) management of clinical risk, quality and safety; (2) development of a new or innovative staffing methodology; and (3) equity of nursing workload. Methods The PRISMA method was used. Relevant articles were located by searching via the Griffith University Library electronic catalogue, including articles on PubMed, Cumulative Index to Nursing and Allied Health Literature (CINAHL) and Medline. Only English language publications published between 1 January 2010 and 30 April 2016 focusing on methodologies in acute hospital in-patient units were included in the present review. Results Two of the four staffing methods were found to have evidenced-based articles from empirical studies within the parameters set for inclusion. Of the four staffing methodologies searched, supply and demand returned 10 studies and staffing ratios returned 11. Conclusions There is a need to develop an evidence-based nurse-sensitive outcomes measure upon which staffing for safety, quality and workplace equity, as well as an instrument that reliability and validly projects nurse staffing requirements in a variety of clinical settings. Nurse-sensitive indicators reflect elements of patient care that are directly affected by nursing practice In addition, these measures must take into account patient satisfaction, workload and staffing, clinical risks and other measures of the quality and safety of care and nurses' work satisfaction. i. What is known about the topic? Nurse staffing is a controversial topic that has significant patient safety, quality of care, human resources and financial implications. In acute care services, nursing accounts for approximately 70% of salaries and wages paid by health services budgets, and evidence as to the efficacy and effectiveness of any staffing methodology is required because it has workforce and industrial relations implications. Although there is significant literature available on the topic, there is a paucity of empirical evidence supporting claims of increased patient safety in the acute hospital setting, but some evidence exists relating to equity of workload for nurses. What does this paper add? This paper provides a contemporary qualitative analysis of empirical evidence using PRISMA methodology to conduct a systematic review of the available literature. It demonstrates a significant research gap to support claims of increased patient safety in the acute hospital setting. The paper calls for greatly improved datasets upon which research can be undertaken to determine any associations between mandated patient to nurse ratios and other staffing methodologies and patient safety and quality of care. What are the implications for practitioners? There is insufficient contemporary research to support staffing methodologies for appropriate staffing, balanced workloads and quality, safe care. Such research would include the establishment of nurse-sensitive patient outcomes measures, and more robust datasets are needed for empirical analysis to produce such evidence.

Medication safety programs in primary care: a scoping review.

PubMed

Khalil, Hanan; Shahid, Monica; Roughead, Libby

2017-10-01

Medication safety plays an essential role in all healthcare organizations; improving this area is paramount to quality and safety of any wider healthcare program. While several medication safety programs in the hospital setting have been described and the associated impact on patient safety evaluated, no systematic reviews have described the impact of medication safety programs in the primary care setting. A preliminary search of the literature demonstrated that no systematic reviews, meta-analysis or scoping reviews have reported on medication safety programs in primary care; instead they have focused on specific interventions such as medication reconciliation or computerized physician order entry. This scoping review sought to map the current medication safety programs used in primary care. The current scoping review sought to examine the characteristics of medication safety programs in the primary care setting and to map evidence on the outcome measures used to assess the effectiveness of medication safety programs in improving patient safety. The current review considered participants of any age and any condition using care obtained from any primary care services. We considered studies that focussed on the characteristics of medication safety programs and the outcome measures used to measure the effectiveness of these programs on patient safety in the primary care setting. The context of this review was primary care settings, primary healthcare organizations, general practitioner clinics, outpatient clinics and any other clinics that do not classify patients as inpatients. We considered all quantitative studied published in English. A three-step search strategy was utilized in this review. Data were extracted from the included studies to address the review question. The data extracted included type of medication safety program, author, country of origin, aims and purpose of the study, study population, method, comparator, context, main findings and outcome measures. The objectives, inclusion criteria and methods for this scoping review were specified in advance and documented in a protocol that was previously published. This scoping review included nine studies published over an eight-year period that investigated or described the effects of medication safety programs in primary care settings. We classified each of the nine included studies into three main sections according to whether they included an organizational, professional or patient component. The organizational component is aimed at changing the structure of the organization to implement the intervention, the professional component is aimed at the healthcare professionals involved in implementing the interventions, and the patient component is aimed at counseling and education of the patient. All of the included studies had different types of medication safety programs. The programs ranged from complex interventions including pharmacists and teams of healthcare professionals to educational packages for patients and computerized system interventions. The outcome measures described in the included studies were medication error incidence, adverse events and number of drug-related problems. Multi-faceted medication safety programs are likely to vary in characteristics. They include educational training, quality improvement tools, informatics, patient education and feedback provision. The most likely outcome measure for these programs is the incidence of medication errors and reported adverse events or drug-related problems.

Direct comparative effectiveness and safety between non-vitamin K antagonist oral anticoagulants for stroke prevention in nonvalvular atrial fibrillation: a systematic review and meta-analysis of observational studies.

PubMed

Li, Guowei; Lip, Gregory Y H; Holbrook, Anne; Chang, Yaping; Larsen, Torben B; Sun, Xin; Tang, Jie; Mbuagbaw, Lawrence; Witt, Daniel M; Crowther, Mark; Thabane, Lehana; Levine, Mitchell A H

2018-06-08

The non-vitamin K antagonist oral anticoagulants (NOACs) have been increasingly prescribed in clinical practice for stroke prevention in patients with nonvalvular atrial fibrillation (AF). Direct comparisons between NOACs in trials are lacking, leaving an important clinical decision-making gap. We aimed to perform a systematic review and meta-analysis to summarize the evidence of observational studies for direct comparative effectiveness and safety amongst NOACs in patients with AF. Conference proceedings and electronic databases including MEDLINE, CINAHL, EMBASE and PUBMED were systematically searched. We included observational studies directly comparing individual NOACs in patients with nonvalvular AF who were aged ≥ 18 years for stroke prevention. Primary outcome included effectiveness outcome (stroke or systemic embolism) and safety outcome (major bleeding). Data were extracted in duplicated by two reviewers independently. A random-effects meta-analysis was conducted to synthesize the data from included observational studies. We used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) to rate the overall quality of evidence for each outcome. Fifteen studies were included for qualitative synthesis, twelve studies for meta-analyses. It was found that rivaroxaban and dabigatran were similar with regard to risk of stroke or systemic embolism (Hazard ratio [HR] = 1.00, 95% CI 0.91-1.10; evidence quality: low), but rivaroxaban was associated with higher risk of major bleeding (HR = 1.39, 95% CI 1.28-1.50; evidence quality: moderate). Compared with apixaban, a significantly higher risk of major bleeding was observed with rivaroxaban (HR = 1.71, 95% CI 1.51-1.94; evidence quality: low). Apixaban was associated with lower risk of major bleeding, in comparison with dabigatran (HR = 0.80, 95% CI 0.68-0.95; evidence quality: low). No differences in risk of stroke or systemic embolism was observed between rivaroxaban versus apixaban, and apixaban versus dabigatran. In this study, apixaban was found to have the most favorable safety profile amongst the three NOACs. No significant difference was observed in risk of stroke or systemic embolism between the NOACs. Such findings may provide some decision-making support for physicians regarding their choices amongst NOACs in patients with AF.Registration PROSPERO (identifier: CRD42016052908).

Comparative safety of anti-epileptic drugs among infants and children exposed in utero or during breastfeeding: protocol for a systematic review and network meta-analysis.

PubMed

Tricco, Andrea C; Cogo, Elise; Angeliki, Veroniki A; Soobiah, Charlene; Hutton, Brian; Hemmelgarn, Brenda R; Moher, David; Finkelstein, Yaron; Straus, Sharon E

2014-06-25

Epilepsy affects about 1% of the general population. Anti-epileptic drugs (AEDs) prevent or terminate seizures in individuals with epilepsy. Pregnant women with epilepsy may continue taking AEDs. Many of these agents cross the placenta and increase the risk of major congenital malformations, early cognitive and developmental delays, and infant mortality. We aim to evaluate the comparative safety of AEDs approved for chronic use in Canada when administered to pregnant and breastfeeding women and the effects on their infants and children through a systematic review and network meta-analysis. Studies examining the effects of AEDs administered to pregnant and breastfeeding women regardless of indication (e.g., epilepsy, migraine, pain, psychiatric disorders) on their infants and children will be included. We will include randomized clinical trials (RCTs), quasi-RCTs, non-RCTs, controlled before-after, interrupted time series, cohort, registry, and case-control studies. The main literature search will be executed in MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials. We will seek unpublished literature through searches of trial protocol registries and conference abstracts. The literature search results screening, data abstraction, and risk of bias appraisal will be performed by two individuals, independently. Conflicts will be resolved through discussion. The risk of bias of experimental and quasi-experimental studies will be appraised using the Cochrane Effective Practice and Organization of Care Risk-of-Bias tool, methodological quality of observational studies will be appraised using the Newcastle-Ottawa Scale, and quality of reporting of safety outcomes will be conducted using the McMaster Quality Assessment Scale of Harms (McHarm) tool. If feasible and appropriate, we will conduct random effects meta-analysis. Network meta-analysis will be considered for outcomes that fulfill network meta-analysis assumptions.The primary outcome is major congenital malformations (overall and by specific types), while secondary outcomes include fetal loss/miscarriage, minor congenital malformations (overall and by specific types), cognitive development, psychomotor development, small for gestational age, preterm delivery, and neonatal seizures. Our systematic review will address safety concerns regarding the use of AEDs during pregnancy and breastfeeding. Our results will be useful to healthcare providers, policy-makers, and women of childbearing age who are taking anti-epileptic medications. PROSPERO CRD42014008925.

Characteristics and practices of National Immunisation Technical Advisory Groups in Europe and potential for collaboration, April 2014.

PubMed

Takla, A; Wichmann, O; Carrillo-Santisteve, P; Cotter, S; Levy-Bruhl, D; Paradowska-Stankiewicz, I; Valentiner-Branth, P; D'Ancona, F

2015-03-05

In many countries, national vaccination recommendations are developed by independent expert committees, so-called national immunisation technical advisory groups (NITAG). Since the evaluation of vaccines is complex and resource-demanding, collaboration between NITAGs that evaluate the same vaccines could be beneficial. We conducted a cross-sectional survey among 30 European countries in February 2014, to explore basic characteristics and current practices of European NITAGs and identify potential modes and barriers for collaboration. Of 28 responding countries, 26 reported to have a NITAG or an equivalent expert group. Of these, 20 apply a systematic approach in the vaccine decision-making process, e.g. by considering criteria such as country-specific disease epidemiology, vaccine efficacy/effectiveness/safety, health economics, programme implementation/logistics or country-specific values/preferences. However, applied frameworks and extent of evidence review differ widely. The use of systematic reviews is required for 15 of 26 NITAGs, while results from transmission modelling and health economic evaluations are routinely considered by 18 and 20 of 26 NITAGs, respectively. Twenty-five countries saw potential for NITAG-collaboration, but most often named structural concerns, e.g. different NITAG structures or countries’ healthcare systems. Our survey gathered information that can serve as an inventory on European NITAGs, allowing further exploration of options and structures for NITAG collaboration.

Fluconazole prophylaxis in preterm infants: a systematic review.

PubMed

Rios, Juliana Ferreira da Silva; Camargos, Paulo Augusto Moreira; Corrêa, Luísa Petri; Romanelli, Roberta Maia de Castro

This article aims to review the use of antifungal prophylaxis with intravenous fluconazole in premature newborns and the occurrence of Invasive Candidiasis. This is a systematic review with search at databases: PubMed, Capes Portal, Virtual Health Library (BVS - Biblioteca Virtual em Saúde)/Lilacs, Scopus and Cochrane. The keywords used were: "Antifungal", "Candida" "Fluconazole prophylaxis" and "Preterm infants". Invasive Candidiasis was evaluated in all the twelve items. In eleven of them, there was a statistically significant difference between the groups receiving prophylactic fluconazole, with lower frequency of Invasive Candidiasis, compared to placebo or no prophylaxis group. Colonization by Candida species was also evaluated in five studies; four of them presented statistically lower proportion of colonization in patients with Fluconazole prophylaxis, compared to placebo or no drugs. In one study, there was a significant difference, favoring the use of fluconazole, and reduction of death. Studies indicate the effectiveness of prophylaxis with fluconazole, with reduction in the incidence of colonization and invasive fungal disease. The benefits of prophylaxis should be evaluated considering the incidence of candidiasis in the unit, the mortality associated with candidiasis, the safety and toxicity of short and long-term medication, and the potential for development of resistant pathogens. Copyright © 2017 Sociedade Brasileira de Infectologia. Published by Elsevier Editora Ltda. All rights reserved.

The process of collecting and evaluating evidences for the development of Guidelines for the management of rheumatoid arthritis, Japan College of Rheumatology 2014: Utilization of GRADE approach.

PubMed

Kojima, Masayo; Nakayama, Takeo; Kawahito, Yutaka; Kaneko, Yuko; Kishimoto, Mitsumasa; Hirata, Shintaro; Seto, Yohei; Endo, Hirahito; Ito, Hiromu; Kojima, Toshihisa; Nishida, Keiichiro; Matsushita, Isao; Tsutani, Kiichiro; Igarashi, Ataru; Kamatani, Naoyuki; Hasegawa, Mieko; Miyasaka, Nobuyuki; Yamanaka, Hisashi

2016-01-01

To describe the process of collecting and evaluating evidence for treating rheumatoid arthritis (RA) for developing clinical practice guidelines (CPGs) for rheumatologists in Japan. The task force comprised rheumatologists, epidemiologists, health economists, and patients. First, the critical outcomes were determined according to a three-round Delphi method, and eight topics with 88 clinical questions (CQs) were formulated. A systematic review of CQs was conducted using the Cochran Database of Systematic Reviews, MEDLINE, and Japana Centra Revvo Medicina (2003-2012). A questionnaire survey and focus group interview were performed to capture the patients' values and preferences. Data from the National Health Insurance drug price list and product information provided by pharmaceutical companies were collected to evaluate drug cost and safety. The GRADE approach was used to describe the evidence quality and determine the strength of recommendations. Recommendations were developed using a modified Delphi method by a multidisciplinary panel including patients. Eight meetings and frequent e-mail communications were conducted to draft a quality assessment of evidence and recommendations. For 88 CQs, recommendation statements were determined. Using the GRADE approach, new CPGs successfully addressed important clinical issues for treating RA patients. Timely updating of recommendations should be routinely considered.

Using a quantitative risk register to promote learning from a patient safety reporting system.

PubMed

Mansfield, James G; Caplan, Robert A; Campos, John S; Dreis, David F; Furman, Cathie

2015-02-01

Patient safety reporting systems are now used in most health care delivery organizations. These systems, such as the one in use at Virginia Mason (Seattle) since 2002, can provide valuable reports of risk and harm from the front lines of patient care. In response to the challenge of how to quantify and prioritize safety opportunities, a risk register system was developed and implemented. Basic risk register concepts were refined to provide a systematic way to understand risks reported by staff. The risk register uses a comprehensive taxonomy of patient risk and algorithmically assigns each patient safety report to 1 of 27 risk categories in three major domains (Evaluation, Treatment, and Critical Interactions). For each category, a composite score was calculated on the basis of event rate, harm, and cost. The composite scores were used to identify the "top five" risk categories, and patient safety reports in these categories were analyzed in greater depth to find recurrent patterns of risk and associated opportunities for improvement. The top five categories of risk were easy to identify and had distinctive "profiles" of rate, harm, and cost. The ability to categorize and rank risks across multiple dimensions yielded insights not previously available. These results were shared with leadership and served as input for planning quality and safety initiatives. This approach provided actionable input for the strategic planning process, while at the same time strengthening the Virginia Mason culture of safety. The quantitative patient safety risk register serves as one solution to the challenge of extracting valuable safety lessons from large numbers of incident reports and could profitably be adopted by other organizations.

Safety and efficacy of low molecular weight heparins in children: a systematic review of the literature and meta-analysis of single-arm studies.

PubMed

Bidlingmaier, Christoph; Kenet, Gili; Kurnik, Karin; Mathew, Prasad; Manner, Daniela; Mitchell, Lesley; Krümpel, Anne; Nowak-Göttl, Ulrike

2011-10-01

Within the last two decades low molecular weight heparins (LMWH) have gained increasing widespread use as anticoagulants in children. The use of LMWH has been implemented into clinical care even though there is a lack of firm evidence on the efficacy and safety of LMWH in this population due to the absence of sufficiently powered randomized controlled trials. In the absence of clinical trials, we performed a meta-analysis of available single-arm studies using LMWH in children. A systematic search of electronic databases (Medline, EMBASE, OVID, Web of Science, The Cochrane Library) for studies published from 1980 to 2010 was conducted using keywords in combination both as MeSH terms and text words. Two authors independently screened citations and those meeting a priori defined inclusion criteria were retained. Data on year of publication, study design, country of origin, number of patients, ethnicity, venous thromboembolic events type, and frequency of recurrence and major bleedings were abstracted. Pooled incidence rates (IR) including 95% confidence intervals (95% CIs) on efficacy and safety data of LMWH administration on primary prophylaxis, as well as on secondary prophylaxis in children following symptomatic thromboembolism (TE) were shown. We included 2251 pediatric patients derived from 35 single-arm studies from 12 study countries who were eligible for analysis in the present systematic review. Pooled incidence rates (95% CI) to develop first TE on primary prophylaxis, further TE event on LMWH secondary prophylaxis, or a major bleeding event on LMWH were 0.047 (0.023 to 0.091), 0.052 (0.037 to 0.073) for efficacy, and 0.054 (0.039 to 0.074) for safety (treatment data only), respectively. Efficacy and safety data are comparable with adult data. The present systematic review suggests that use of LMWH in children as primary prophylaxis and in treatment of symptomatic thrombosis is effective and safe. However, properly designed randomized controlled trials are needed. © Thieme Medical Publishers.

A Systematic Review of Treatments for Anxiety in Youth with Autism Spectrum Disorders

ERIC Educational Resources Information Center

Vasa, Roma A.; Carroll, Laura M.; Nozzolillo, Alixandra A.; Mahajan, Rajneesh; Mazurek, Micah O.; Bennett, Amanda E.; Wink, Logan K.; Bernal, Maria Pilar

2014-01-01

This study systematically examined the efficacy and safety of psychopharmacological and non-psychopharmacological treatments for anxiety in youth with autism spectrum disorders (ASD). Four psychopharmacological, nine cognitive behavioral therapy (CBT), and two alternative treatment studies met inclusion criteria. Psychopharmacological studies were…

The Relationships Among Perceived Patients' Safety Culture, Intention to Report Errors, and Leader Coaching Behavior of Nurses in Korea: A Pilot Study.

PubMed

Ko, YuKyung; Yu, Soyoung

2017-09-01

This study was undertaken to explore the correlations among nurses' perceptions of patient safety culture, their intention to report errors, and leader coaching behaviors. The participants (N = 289) were nurses from 5 Korean hospitals with approximately 300 to 500 beds each. Sociodemographic variables, patient safety culture, intention to report errors, and coaching behavior were measured using self-report instruments. Data were analyzed using descriptive statistics, Pearson correlation coefficient, the t test, and the Mann-Whitney U test. Nurses' perceptions of patient safety culture and their intention to report errors showed significant differences between groups of nurses who rated their leaders as high-performing or low-performing coaches. Perceived coaching behavior showed a significant, positive correlation with patient safety culture and intention to report errors, i.e., as nurses' perceptions of coaching behaviors increased, so did their ratings of patient safety culture and error reporting. There is a need in health care settings for coaching by nurse managers to provide quality nursing care and thus improve patient safety. Programs that are systematically developed and implemented to enhance the coaching behaviors of nurse managers are crucial to the improvement of patient safety and nursing care. Moreover, a systematic analysis of the causes of malpractice, as opposed to a focus on the punitive consequences of errors, could increase error reporting and therefore promote a culture in which a higher level of patient safety can thrive.

NASA Software Safety Standard

NASA Technical Reports Server (NTRS)

Rosenberg, Linda

1997-01-01

If software is a critical element in a safety critical system, it is imperative to implement a systematic approach to software safety as an integral part of the overall system safety programs. The NASA-STD-8719.13A, "NASA Software Safety Standard", describes the activities necessary to ensure that safety is designed into software that is acquired or developed by NASA, and that safety is maintained throughout the software life cycle. A PDF version, is available on the WWW from Lewis. A Guidebook that will assist in the implementation of the requirements in the Safety Standard is under development at the Lewis Research Center (LeRC). After completion, it will also be available on the WWW from Lewis.

Adaptation and Evaluation of the Neighborhood Environment Walkability Scale in India (NEWS-India).

PubMed

Adlakha, Deepti; Hipp, J Aaron; Brownson, Ross C

2016-04-02

Physical inactivity is the fourth leading risk factor for global mortality, with most of these deaths occurring in low and middle-income countries (LMICs) like India. Research from developed countries has consistently demonstrated associations between built environment features and physical activity levels of populations. The development of culturally sensitive and reliable measures of the built environment is a necessary first step for accurate analysis of environmental correlates of physical activity in LMICs. This study systematically adapted the Neighborhood Environment Walkability Scale (NEWS) for India and evaluated aspects of test-retest reliability of the adapted version among Indian adults. Cultural adaptation of the NEWS was conducted by Indian and international experts. Semi-structured interviews were conducted with local residents and key informants in the city of Chennai, India. At baseline, participants (N = 370; female = 47.2%) from Chennai completed the adapted NEWS-India surveys on perceived residential density, land use mix-diversity, land use mix-access, street connectivity, infrastructure and safety for walking and cycling, aesthetics, traffic safety, and safety from crime. NEWS-India was administered for a second time to consenting participants (N = 62; female = 53.2%) with a gap of 2-3 weeks between successive administrations. Qualitative findings demonstrated that built environment barriers and constraints to active commuting and physical activity behaviors intersected with social ecological systems. The adapted NEWS subscales had moderate to high test-retest reliability (ICC range 0.48-0.99). The NEWS-India demonstrated acceptable measurement properties among Indian adults and may be a useful tool for evaluation of built environment attributes in India. Further adaptation and evaluation in rural and suburban settings in India is essential to create a version that could be used throughout India.

Adaptation and Evaluation of the Neighborhood Environment Walkability Scale in India (NEWS-India)

PubMed Central

Adlakha, Deepti; Hipp, J. Aaron; Brownson, Ross C.

2016-01-01

Physical inactivity is the fourth leading risk factor for global mortality, with most of these deaths occurring in low and middle-income countries (LMICs) like India. Research from developed countries has consistently demonstrated associations between built environment features and physical activity levels of populations. The development of culturally sensitive and reliable measures of the built environment is a necessary first step for accurate analysis of environmental correlates of physical activity in LMICs. This study systematically adapted the Neighborhood Environment Walkability Scale (NEWS) for India and evaluated aspects of test-retest reliability of the adapted version among Indian adults. Cultural adaptation of the NEWS was conducted by Indian and international experts. Semi-structured interviews were conducted with local residents and key informants in the city of Chennai, India. At baseline, participants (N = 370; female = 47.2%) from Chennai completed the adapted NEWS-India surveys on perceived residential density, land use mix-diversity, land use mix-access, street connectivity, infrastructure and safety for walking and cycling, aesthetics, traffic safety, and safety from crime. NEWS-India was administered for a second time to consenting participants (N = 62; female = 53.2%) with a gap of 2–3 weeks between successive administrations. Qualitative findings demonstrated that built environment barriers and constraints to active commuting and physical activity behaviors intersected with social ecological systems. The adapted NEWS subscales had moderate to high test-retest reliability (ICC range 0.48–0.99). The NEWS-India demonstrated acceptable measurement properties among Indian adults and may be a useful tool for evaluation of built environment attributes in India. Further adaptation and evaluation in rural and suburban settings in India is essential to create a version that could be used throughout India. PMID:27049394

Efficacy and safety of topical diquafosol ophthalmic solution for treatment of dry eye: a systematic review of randomized clinical trials.

PubMed

Wu, Di; Chen, Wang Qi; Li, Ryan; Wang, Yan

2015-06-01

To evaluate the efficacy and safety of topical diquafosol ophthalmic solution for treatment of dry eye. Randomized clinical trials (RCTs) from MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials (CENTRAL) were identified to evaluate the efficacy and safety of topical administration of diquafosol to patients with dry eyes. Data evaluation was based on endpoints including Schirmer test, tear film break-up time, ocular surface staining score, subjective symptom score, and adverse events. A total of 8 RCTs involving 1516 patients were selected based on the prespecified criteria. Significant improvement of Schirmer test values and tear film break-up time were reported in 40% (2 of 5) and 80% (4 of 5) studies, respectively. Ocular surface staining scores significantly decreased in 100% (fluorescein corneal staining, 6 of 6; Rose Bengal corneal and conjunctival staining, 4 of 4) RCTs. Symptoms significantly improved in 75% (6 of 8) RCTs in patients with dry eyes. No severe adverse events were reported with the concentration of diquafosol from 0.5% to 5%. Heterogeneity in study design prevented meta-analysis from statistical integration and summarization. Topical diquafosol seems to be a safe therapeutic option for the treatment of dry eye. The high variability of the selected RCTs compromised the strength of evidence and limits the determination of efficacy. However, the topical administration of diquafosol seems to be beneficial in improving the integrity of the epithelial cell layer of the ocular surface and mucin secretion in patients with dry eyes. This review indicates a need for standardized criteria and methods for evaluation to assess the efficacy of diquafosol in the future clinical trials.

[Post-marketing surveillance on Guizhi Fuling Jiaonang based on literature review].

PubMed

Wang, Gui-Qian; Gao, Yang; Liu, Fu-Mei; Wei, Rui-Li; Xie, Yan-Ming

2018-02-01

To systemically evaluate the post-marketing safety of Guizhi Fuling Jiaonang. Computer retrieval was conducted in Medline, EMbase, the Web of Science, Clinical Trials. Gov, the Cochrane Library, CNKI, VIP, WanFang Data and CBM to collect relevant information. The papers were then screened according to inclusion and exclusion criteria. A total of 234 papers were included in this study, including 164 randomized controlled trials, 7 quasi-randomized controlled trials, 8 non-randomized controls, 56 case series, and 1 cohort study. The patients were only treated with Guizhi Fuling Jiaonang in 56 studies, and Guizhi Fuling Jiaonang was combined with other drugs in 178 studies. The total ADRs/AEs incidence was 1.99% in single use of Guizhi Fuling Jiaonang, and 8.21% in combined use, but showing no severe adverse reactions. Gastrointestinal system damage was most common in mild ADRs. In this study, it was found that the overall safety of Guizhi Fuling Jiaonang was acceptable. The direct evidences of the drug's safety case reports were systematically analyzed in this study, but the mechanism study on the safety of the drug after marketing or the prospective long-term clinical observation study was not sufficient, so the further studies on the safety of drug use should be conducted in order to provide better guidance for clinical medication. Copyright© by the Chinese Pharmaceutical Association.

Efficacy and safety of prophylactic levetiracetam in supratentorial brain tumour surgery: a systematic review and meta‐analysis

PubMed Central

Tsaousi, Georgia; Apostolidou, Eirini; Karakoulas, Konstantinos; Kouvelas, Dimitrios; Amaniti, Ekaterini

2016-01-01

Aims The aim of this study was to perform an up‐to‐date systematic review and meta‐analysis on the efficacy and safety of prophylactic administration of levetiracetam in brain tumour patients. Method A systematic review of studies published until April 2015 was conducted using Scopus/Elsevier, EMBASE and MEDLINE. The search was limited to articles reporting results from adult patients, suffering from brain tumour, undergoing supratentorial craniotomy for tumour resection or biopsy and administered levetiracetam in the perioperative period for seizure prophylaxis. Outcomes included the efficacy and safety of levetiracetam, as well as the tolerability of the specific regimen, defined by the discontinuation of the treatment due to side effects. Results The systematic review included 1148 patients from 12 studies comparing levetiracetam with no treatment, phenytoin and valproate, while only 243 patients from three studies, comparing levetiracetam vs phenytoin efficacy and safety, were included in the meta‐analysis. The combined results from the meta‐analysis showed that levetiracetam administration was followed by significantly fewer seizures than treatment with phenytoin (OR = 0.12 [0.03–0.42]: χ2 = 1.76: I2 = 0%). Analysis also showed significantly fewer side effects in patients receiving levetiracetam, compared to other groups (P < 0.05). The combined results showed fewer side effects in the levetiracetam group compared to the phenytoin group (OR = 0.65 [0.14–2.99]: χ2 = 8.79: I2 = 77%). Conclusions The efficacy of prophylaxis with levetiracetam seems to be superior to that with phenytoin and valproate administration. Moreover, levetiracetam use demonstrates fewer side effects in brain tumour patients. Nevertheless, high risk of bias and moderate methodological quality must be taken into account when considering these results. PMID:26945547

Effectiveness and safety of moxibustion treatment for non-specific lower back pain: protocol for a systematic review.

PubMed

Leem, Jungtae; Lee, Seunghoon; Park, Yeoncheol; Seo, Byung-Kwan; Cho, Yeeun; Kang, Jung Won; Lee, Yoon Jae; Ha, In-Hyuk; Lee, Hyun-Jong; Kim, Eun-Jung; Lee, Sanghoon; Nam, Dongwoo

2017-06-23

Many patients experience acute lower back pain that becomes chronic pain. The proportion of patients using complementary and alternative medicine to treat lower back is increasing. Even though several moxibustion clinical trials for lower back pain have been conducted, the effectiveness and safety of moxibustion intervention is controversial. The purpose of this study protocol for a systematic review is to evaluate the effectiveness and safety of moxibustion treatment for non-specific lower back pain patients. We will conduct an electronic search of several databases from their inception to May 2017, including Embase, PubMed, Cochrane Central Register of Controlled Trial, Allied and Complementary Medicine Database, Wanfang Database, Chongqing VIP Chinese Science and Technology Periodical Database, China National Knowledge Infrastructure Database, Korean Medical Database, Korean Studies Information Service System, National Discovery for Science Leaders, Oriental Medicine Advanced Searching Integrated System, the Korea Institute of Science and Technology, and KoreaMed. Randomised controlled trials investigating any type of moxibustion treatment will be included. The primary outcome will be pain intensity and functional status/disability due to lower back pain. The secondary outcome will be a global measurement of recovery or improvement, work-related outcomes, radiographic improvement of structure, quality of life, and adverse events (presence or absence). Risk ratio or mean differences with a 95% confidence interval will be used to show the effect of moxibustion therapy when it is possible to conduct a meta-analysis. This review will be published in a peer-reviewed journal and will be presented at an international academic conference for dissemination. Our results will provide current evidence of the effectiveness and safety of moxibustion treatment in non-specific lower back pain patients, and thus will be beneficial to patients, practitioners, and policymakers. CRD42016047468 in PROSPERO 2016. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Huperzine A for treatment of cognitive impairment in major depressive disorder: a systematic review of randomized controlled trials.

PubMed

Zheng, Wei; Xiang, Ying-Qiang; Ungvari, Gabor S; Chiu, F K Helen; H Ng, Chee; Wang, Ying; Xiang, Yu-Tao

2016-04-25

Acetylcholinesterase (AChE) inhibitors have been shown to be effective in treating cognitive impairment in animal models and in human subjects with major depressive disorder (MDD). Huperzine A (HupA), a Traditional Chinese Medicine derived from a genus of clubmosses known as Huperzineserrata, is a powerful AChE inhibitor that has been used as an adjunctive treatment for MDD, but no meta-analysis on HupA augmentation for MDD has yet been reported. Conduct a systematic review and meta-analysis of randomized controlled trials (RCTS) about HupA augmentation in the treatment of MDD to evaluate its efficacy and safety. Two evaluators independently searched nine English-language and Chinese-language databases, selected relevant studies that met pre-determined inclusion criteria, extracted data about outcome and safety, and conducted quality assessments and data synthesis. Three low-quality RCTs (pooled n=238) from China were identified that compared monotherapy antidepressant treatment for depression versus combined treatment with antidepressants and HupA. Participants in the studies ranged from 16 to 60 years of age. The average duration of adjunctive antidepressant and HupA treatment in the studies was only 6.7 weeks. All three studies were open label and non-blinded, so their overall quality was judged as poor. Meta-analysis of the pooled sample found no significant difference in the improvement in depressive symptoms between the two groups (weighted mean difference: -1.90 (95%CI: -4.23, 0.44), p=0.11). However, the adjunctive HupA group did have significantly greater improvement than the antidepressant only group in cognitive functioning (as assessed by the Wisconsin Card Sorting Test and the Wechsler Memory Scale-Revised) and in quality of life. There was no significant difference in the incidence of adverse drug reactions between groups. The data available on the effectiveness and safety of adjunctive treatment using HupA in patients with MDD who are receiving antidepressants is insufficient to arrive at a definitive conclusion about its efficacy and safety. Pooling of the data from three low-quality RCTs from China found no advantage of adjunctive HupA in the treatment of depressive symptoms, but adjunctive treatment with HupA was associated with a faster resolution of the cognitive symptoms that frequently accompany MDD.

Huperzine A for treatment of cognitive impairment in major depressive disorder: a systematic review of randomized controlled trials

PubMed Central

ZHENG, Wei; XIANG, Ying-Qiang; UNGVARI, Gabor S.; CHIU, F.K. Helen; H. NG, Chee; WANG, Ying; XIANG, Yu-Tao

2016-01-01

Background Acetylcholinesterase (AChE) inhibitors have been shown to be effective in treating cognitive impairment in animal models and in human subjects with major depressive disorder (MDD). Huperzine A (HupA), a Traditional Chinese Medicine derived from a genus of clubmosses known as Huperzineserrata, is a powerful AChE inhibitor that has been used as an adjunctive treatment for MDD, but no meta-analysis on HupA augmentation for MDD has yet been reported. Aim Conduct a systematic review and meta-analysis of randomized controlled trials (RCTS) about HupA augmentation in the treatment of MDD to evaluate its efficacy and safety. Methods Two evaluators independently searched nine English-language and Chinese-language databases, selected relevant studies that met pre-determined inclusion criteria, extracted data about outcome and safety, and conducted quality assessments and data synthesis. Results Three low-quality RCTs (pooled n=238) from China were identified that compared monotherapy antidepressant treatment for depression versus combined treatment with antidepressants and HupA. Participants in the studies ranged from 16 to 60 years of age. The average duration of adjunctive antidepressant and HupA treatment in the studies was only 6.7 weeks. All three studies were open label and non-blinded, so their overall quality was judged as poor. Meta-analysis of the pooled sample found no significant difference in the improvement in depressive symptoms between the two groups (weighted mean difference: -1.90 (95%CI: -4.23, 0.44), p=0.11). However, the adjunctive HupA group did have significantly greater improvement than the antidepressant only group in cognitive functioning (as assessed by the Wisconsin Card Sorting Test and the Wechsler Memory Scale-Revised) and in quality of life. There was no significant difference in the incidence of adverse drug reactions between groups. Conclusions The data available on the effectiveness and safety of adjunctive treatment using HupA in patients with MDD who are receiving antidepressants is insufficient to arrive at a definitive conclusion about its efficacy and safety. Pooling of the data from three low-quality RCTs from China found no advantage of adjunctive HupA in the treatment of depressive symptoms, but adjunctive treatment with HupA was associated with a faster resolution of the cognitive symptoms that frequently accompany MDD. PMID:27605862

A systematic review of safety data reporting in clinical trials of vaccines against malaria, tuberculosis, and human immunodeficiency virus.

PubMed

Tamminga, Cindy; Kavanaugh, Michael; Fedders, Charlotte; Maiolatesi, Santina; Abraham, Neethu; Bonhoeffer, Jan; Heininger, Ulrich; Vasquez, Carlos S; Moorthy, Vasee S; Epstein, Judith E; Richie, Thomas L

2013-08-02

Malaria, tuberculosis (TB) and human immunodeficiency virus (HIV) are diseases with devastating effects on global public health, especially in the developing world. Clinical trials of candidate vaccines for these diseases are being conducted at an accelerating rate, and require accurate and consistent methods for safety data collection and reporting. We performed a systematic review of publications describing the safety results from clinical trials of malaria, TB and HIV vaccines, to ascertain the nature and consistency of safety data collection and reporting. The target for the review was pre-licensure trials for malaria, TB and HIV vaccines published in English from 2000 to 2009. Search strategies were customized for each of the databases utilized (MEDLINE, EMBASE, the Cochrane Database of Systematic Reviews and the Database of Reviews and Effects). Data extracted included age of trial participants, vaccine platform, route and method of vaccine administration, duration of participant follow-up, reporting of laboratory abnormalities, and the type, case definitions, severity, reporting methods and internal reporting consistency of adverse events. Of 2278 publications screened, 124 were eligible for inclusion (malaria: 66, TB: 9, HIV: 49). Safety data reporting was found to be highly variable among publications and often incomplete: overall, 269 overlapping terms were used to describe specific adverse events. 17% of publications did not mention fever. Descriptions of severity or degree of relatedness to immunization of adverse events were frequently omitted. 26% (32/124) of publications failed to report data on serious adverse events. The review demonstrated lack of standardized safety data reporting in trials for vaccines against malaria, TB and HIV. Standardization of safety data collection and reporting should be encouraged to improve data quality and comparability. The search strategy missed studies published in languages other than English and excluded studies reporting on vaccine trials for diseases besides malaria, TB and HIV. Copyright © 2013 Elsevier Ltd. All rights reserved.

Safety and efficacy of blue cohosh (Caulophyllum thalictroides) during pregnancy and lactation.

PubMed

Dugoua, Jean-Jacques; Perri, Daniel; Seely, Dugald; Mills, Edward; Koren, Gideon

2008-01-01

There is a lack of basic knowledge on the part of both clinicians and patients as to the indications for use and safety of herbal medicines in pregnancy and lactation. This is one article in a series that systematically reviews the evidence for commonly used herbs during pregnancy and lactation. To systematically review the literature for evidence on the use, safety and pharmacology of blue cohosh, focusing on issues pertaining to pregnancy and lactation. We searched 7 electronic databases and compiled data according to the grade of evidence found. According to a survey of midwives in the United States, approximately 64% of midwives reported using blue cohosh as a labour-inducing aid. There are three case reports in the scientific literature that blue cohosh taken at the time of delivery may cause; 1) perinatal stroke, 2) acute myocardial infarction, profound congestive heart failure and shock and 3) severe multi-organ hypoxic injury. There is one case report that blue cohosh possesses abortifacient properties. There is in vitro evidence that blue cohosh may have teratogenic, embryotoxic and oxytoxic effects. In lactation, the safety of blue cohosh is unknown. Based on the available scientific information, blue cohosh should; 1) be used with extreme caution during pregnancy, 2) be used only under medical professional supervision and 3) not be available to the public as an over-the-counter product. There is an urgent need to conduct a retrospective or prospective cohort study of midwifes using blue cohosh in order to determine its safety. Key words: Blue cohosh, caulophyllum thalictroides, pregnancy, lactation, breastfeeding, systematic review.

Review of evaluations of educational approaches to promote safe storage of firearms

PubMed Central

McGee, K; Coyne-Beasley, T; Johnson, R

2003-01-01

Objective: To systematically review evaluation studies of educational interventions promoting safe firearm storage. Methods: Medline, ERIC, PsycINFO, Criminal Justice Periodicals Index, Cumulative Index of Nursing and Allied Health Literature, and Sociofile were searched. The references from each potentially eligible study were checked, and experts in the field were contacted for additional reports. In addition, an internet search was performed to identify programs not published in the conventional literature. Sources relevant to safe firearm storage promotion were selected and evaluated. Results: Seven studies met inclusion criteria: adult subjects, program description was included, and firearm storage outcomes were measured. One was a randomized controlled trial and the other six were one group pre-test and/or post-test. The studies were classified into the following categories based on the intervention strategies used: (1) counseling and firearm safety materials (n=3); (2) counseling/educational message (n=3); and (3) firearm safety materials distribution (n=1).The outcomes were safe firearms storage (firearms locked up and unloaded or removal from home) after intervention. Four studies, three using counseling and materials distribution, reported improved storage after the interventions. Conclusions: It is not yet clear what types of interventions, or which specific intervention components, prompt gun owners to securely store their weapons. Increased understanding of gun storage behaviors and stronger evaluation designs will aid further understanding of this important issue. PMID:12810734

A systematic review of dosing frequency with bone-targeted agents for patients with bone metastases from breast cancer

PubMed Central

Hutton, Brian; Addison, Christina L.; Campbell, Kaitryn; Fergusson, Dean; Mazarello, Sasha; Clemons, Mark

2013-01-01

Background Bone-targeted agents are usually administered to breast cancer patients with bone metastases every 3–4 weeks. Less frequent (‘de-escalated’) treatment may provide similar benefits with improved safety and reduced cost. Methods To systematically review randomised trials comparing de-escalated treatment with bone-targeted agents (i.e. every 12–16 weeks) to standard treatment (i.e. every 3–4 weeks), a formal systematic review of the literature was performed. Two individuals independently screened citations and full text articles. Random effects meta-analyses of clinically important outcomes were planned provided homogeneous studies were identified. Results Five relevant studies (n=1287 patients) were identified. Sample size ranged from 38 to 425. Information on outcomes including occurrence of SREs, bone pain, urinary N-telopeptide concentrations, serum C-telopeptide concentrations, pain medication use and safety outcomes was not consistently available. Two trials were non-inferiority studies, two dose-response evaluations and one was a pilot study. Bone-targeted agents use varied between studies, as did duration of prior therapy. Patient populations were considered heterogeneous in several ways, and thus no meta-analyses were performed. Observations from the included studies suggest there is potential that 3 month de-escalated treatment may provide similar benefits compared to 3–4 weekly treatment and that lower doses of zoledronic acid and denosumab might be equally effective. Conclusions Studies comparing standard and de-escalated treatment with bone-targeted agents in breast cancer are rare. The benefits of standard treatment compared to de-escalated therapy on important clinical outcomes remain unclear. Future pragmatic studies must be conducted to determine the merits of this approach. PMID:26909282

Iliac Crest Bone Graft versus Local Autograft or Allograft for Lumbar Spinal Fusion: A Systematic Review

PubMed Central

Tuchman, Alexander; Brodke, Darrel S.; Youssef, Jim A.; Meisel, Hans-Jörg; Dettori, Joseph R.; Park, Jong-Beom; Yoon, S. Tim; Wang, Jeffrey C.

2016-01-01

Study Design  Systematic review. Objective  To compare the effectiveness and safety between iliac crest bone graft (ICBG) and local autologous bone and allograft in the lumbar spine. Methods  A systematic search of multiple major medical reference databases identified studies evaluating spinal fusion in patients with degenerative joint disease using ICBG, local autograft, or allograft in the thoracolumbar spine. Results  Six comparative studies met our inclusion criteria. A “low” strength of the overall body of evidence suggested no difference in fusion percentages in the lumbar spine between local autograft and ICBG. We found no difference in fusion percentages based on low evidence comparing allograft with ICBG autograft. There were no differences in pain or functional results comparing local autograft or allograft with ICBG autograft. Donor site pain and hematoma/seroma occurred more frequently in ICBG autograft group for lumbar fusion procedures. There was low evidence around the estimate of patients with donor site pain following ICBG harvesting, ranging from 16.7 to 20%. With respect to revision, low evidence demonstrated no difference between allograft and ICBG autograft. There was no evidence comparing patients receiving allograft with local autograft for fusion, pain, functional, and safety outcomes. Conclusion  In the lumbar spine, ICBG, local autograft, and allograft have similar effectiveness in terms of fusion rates, pain scores, and functional outcomes. However, ICBG is associated with an increased risk for donor site-related complications. Significant limitations exist in the available literature when comparing ICBG, local autograft, and allograft for lumbar fusion, and thus ICBG versus other fusion methods necessitates further investigation. PMID:27556001

Portal imaging based definition of the planning target volume during pelvic irradiation for gynecological malignancies.

PubMed

Mock, U; Dieckmann, K; Wolff, U; Knocke, T H; Pötter, R

1999-08-01

Geometrical accuracy in patient positioning can vary substantially during external radiotherapy. This study estimated the set-up accuracy during pelvic irradiation for gynecological malignancies for determination of safety margins (planning target volume, PTV). Based on electronic portal imaging devices (EPID), 25 patients undergoing 4-field pelvic irradiation for gynecological malignancies were analyzed with regard to set-up accuracy during the treatment course. Regularly performed EPID images were used in order to systematically assess the systematic and random component of set-up displacements. Anatomical matching of verification and simulation images was followed by measuring corresponding distances between the central axis and anatomical features. Data analysis of set-up errors referred to the x-, y-,and z-axes. Additionally, cumulative frequencies were evaluated. A total of 50 simulation films and 313 verification images were analyzed. For the anterior-posterior (AP) beam direction mean deviations along the x- and z-axes were 1.5 mm and -1.9 mm, respectively. Moreover, random errors of 4.8 mm (x-axis) and 3.0 mm (z-axis) were determined. Concerning the latero-lateral treatment fields, the systematic errors along the two axes were calculated to 2.9 mm (y-axis) and -2.0 mm (z-axis) and random errors of 3.8 mm and 3.5 mm were found, respectively. The cumulative frequency of misalignments < or =5 mm showed values of 75% (AP fields) and 72% (latero-lateral fields). With regard to cumulative frequencies < or =10 mm quantification revealed values of 97% for both beam directions. During external pelvic irradiation therapy for gynecological malignancies, EPID images on a regular basis revealed acceptable set-up inaccuracies. Safety margins (PTV) of 1 cm appear to be sufficient, accounting for more than 95% of all deviations.

Effect and safety of early weight-bearing on the outcome after open-wedge high tibial osteotomy: a systematic review and meta-analysis.

PubMed

Lee, O-Sung; Ahn, Soyeon; Lee, Yong Seuk

2017-07-01

The purpose of this systematic review and meta-analysis was to evaluate the effectiveness and safety of early weight-bearing by comparing clinical and radiological outcomes between early and traditional delayed weight-bearing after OWHTO. A rigorous and systematic approach was used. The methodological quality was also assessed. Results that are possible to be compared in two or more than two articles were presented as forest plots. A 95% confidence interval was calculated for each effect size, and we calculated the I 2 statistic, which presents the percentage of total variation attributable to the heterogeneity among studies. The random-effects model was used to calculate the effect size. Six articles were included in the final analysis. All case groups were composed of early full weight-bearing within 2 weeks. All control groups were composed of late full weight-bearing between 6 weeks and 2 months. Pooled analysis was possible for the improvement in Lysholm score, but there was no statistically significant difference shown between groups. Other clinical results were also similar between groups. Four studies reported mechanical femorotibial angle (mFTA) and this result showed no statistically significant difference between groups in the pooled analysis. Furthermore, early weight-bearing showed more favorable results in some radiologic results (osseointegration and patellar height) and complications (thrombophlebitis and recurrence). Our analysis supports that early full weight-bearing after OWHTO using a locking plate leads to improvement in outcomes and was comparable to the delayed weight-bearing in terms of clinical and radiological outcomes. On the contrary, early weight-bearing was more favorable with respect to some radiologic parameters and complications compared with delayed weight-bearing.

The need for a standardized informed consent procedure in live donor nephrectomy: a systematic review.

PubMed

Kortram, Kirsten; Lafranca, Jeffrey A; IJzermans, Jan N M; Dor, Frank J M F

2014-12-15

Informed consent in live donor nephrectomy is a topic of great interest. Safety and transparency are key items increasingly getting more attention from media and healthcare inspection. Because live donors are not patients, but healthy individuals undergoing elective interventions, they justly insist on optimal conditions and guaranteed safety. Although transplant professionals agree that consent should be voluntary, free of coercion, and fully informed, there is no consensus on which information should be provided, and how the donors' comprehension should be ascertained. Comprehensive searches were conducted in Embase, Medline OvidSP, Web-of-Science, PubMed, CENTRAL (The Cochrane Library 2014, issue 1) and Google Scholar, evaluating the informed consent procedure for live kidney donation. The methodology was in accordance with the Cochrane Handbook for Interventional Systematic Reviews and written based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. The initial search yielded 1,009 hits from which 21 articles fell within the scope of this study. Procedures vary greatly between centers, and transplant professionals vary in the information they disclose. Although research has demonstrated that donors often make their decision based on moral reasoning rather than balancing risks and benefits, providing them with accurate, uniform information remains crucial because donors report feeling misinformed about or unprepared for donation. Although a standardized procedure may not provide the ultimate solution, it is vital to minimize differences in live donor education between transplant centers. There is a definite need for a guideline on how to provide information and obtain informed consent from live kidney donors to assist the transplant community in optimally preparing potential donors.

Patterns of use and impact of standardised MedDRA query analyses on the safety evaluation and review of new drug and biologics license applications.

PubMed

Chang, Lin-Chau; Mahmood, Riaz; Qureshi, Samina; Breder, Christopher D

2017-01-01

Standardised MedDRA Queries (SMQs) have been developed since the early 2000's and used by academia, industry, public health, and government sectors for detecting safety signals in adverse event safety databases. The purpose of the present study is to characterize how SMQs are used and the impact in safety analyses for New Drug Application (NDA) and Biologics License Application (BLA) submissions to the United States Food and Drug Administration (USFDA). We used the PharmaPendium database to capture SMQ use in Summary Basis of Approvals (SBoAs) of drugs and biologics approved by the USFDA. Characteristics of the drugs and the SMQ use were employed to evaluate the role of SMQ safety analyses in regulatory decisions and the veracity of signals they revealed. A comprehensive search of the SBoAs yielded 184 regulatory submissions approved from 2006 to 2015. Search strategies more frequently utilized restrictive searches with "narrow terms" to enhance specificity over strategies using "broad terms" to increase sensitivity, while some involved modification of search terms. A majority (59%) of 1290 searches used descriptive statistics, however inferential statistics were utilized in 35% of them. Commentary from reviewers and supervisory staff suggested that a small, yet notable percentage (18%) of 1290 searches supported regulatory decisions. The searches with regulatory impact were found in 73 submissions (40% of the submissions investigated). Most searches (75% of 227 searches) with regulatory implications described how the searches were confirmed, indicating prudence in the decision-making process. SMQs have an increasing role in the presentation and review of safety analysis for NDAs/BLAs and their regulatory reviews. This study suggests that SMQs are best used for screening process, with descriptive statistics, description of SMQ modifications, and systematic verification of cases which is crucial for drawing regulatory conclusions.

Patterns of use and impact of standardised MedDRA query analyses on the safety evaluation and review of new drug and biologics license applications

PubMed Central

Chang, Lin-Chau; Mahmood, Riaz; Qureshi, Samina

2017-01-01

Purpose Standardised MedDRA Queries (SMQs) have been developed since the early 2000’s and used by academia, industry, public health, and government sectors for detecting safety signals in adverse event safety databases. The purpose of the present study is to characterize how SMQs are used and the impact in safety analyses for New Drug Application (NDA) and Biologics License Application (BLA) submissions to the United States Food and Drug Administration (USFDA). Methods We used the PharmaPendium database to capture SMQ use in Summary Basis of Approvals (SBoAs) of drugs and biologics approved by the USFDA. Characteristics of the drugs and the SMQ use were employed to evaluate the role of SMQ safety analyses in regulatory decisions and the veracity of signals they revealed. Results A comprehensive search of the SBoAs yielded 184 regulatory submissions approved from 2006 to 2015. Search strategies more frequently utilized restrictive searches with “narrow terms” to enhance specificity over strategies using “broad terms” to increase sensitivity, while some involved modification of search terms. A majority (59%) of 1290 searches used descriptive statistics, however inferential statistics were utilized in 35% of them. Commentary from reviewers and supervisory staff suggested that a small, yet notable percentage (18%) of 1290 searches supported regulatory decisions. The searches with regulatory impact were found in 73 submissions (40% of the submissions investigated). Most searches (75% of 227 searches) with regulatory implications described how the searches were confirmed, indicating prudence in the decision-making process. Conclusions SMQs have an increasing role in the presentation and review of safety analysis for NDAs/BLAs and their regulatory reviews. This study suggests that SMQs are best used for screening process, with descriptive statistics, description of SMQ modifications, and systematic verification of cases which is crucial for drawing regulatory conclusions. PMID:28570569

Measurement properties and feasibility of clinical tests to assess sit-to-stand/stand-to-sit tasks in subjects with neurological disease: a systematic review

PubMed Central

Silva, Paula F. S.; Quintino, Ludmylla F.; Franco, Juliane; Faria, Christina D. C. M.

2014-01-01

Background Subjects with neurological disease (ND) usually show impaired performance during sit-to-stand and stand-to-sit tasks, with a consequent reduction in their mobility levels. Objective To determine the measurement properties and feasibility previously investigated for clinical tests that evaluate sit-to-stand and stand-to-sit in subjects with ND. Method A systematic literature review following the PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses) protocol was performed. Systematic literature searches of databases (MEDLINE/SCIELO/LILACS/PEDro) were performed to identify relevant studies. In all studies, the following inclusion criteria were assessed: investigation of any measurement property or the feasibility of clinical tests that evaluate sit-to-stand and stand-to-sit tasks in subjects with ND published in any language through December 2012. The COSMIN checklist was used to evaluate the methodological quality of the included studies. Results Eleven studies were included. The measurement properties/feasibility were most commonly investigated for the five-repetition sit-to-stand test, which showed good test-retest reliability (Intraclass Correlation Coefficient:ICC=0.94-0.99) for subjects with stroke, cerebral palsy and dementia. The ICC values were higher for this test than for the number of repetitions in the 30-s test. The five-repetition sit-to-stand test also showed good inter/intra-rater reliabilities (ICC=0.97-0.99) for stroke and inter-rater reliability (ICC=0.99) for subjects with Parkinson disease and incomplete spinal cord injury. For this test, the criterion-related validity for subjects with stroke, cerebral palsy and incomplete spinal cord injury was, in general, moderate (correlation=0.40-0.77), and the feasibility and safety were good for subjects with Alzheimer's disease. Conclusions The five-repetition sit-to-stand test was used more often in subjects with ND, and most of the measurement properties were investigated and showed adequate results. PMID:24839043

Safety and usability evaluation of a web-based insulin self-titration system for patients with type 2 diabetes mellitus.

PubMed

Simon, Airin C R; Holleman, Frits; Gude, Wouter T; Hoekstra, Joost B L; Peute, Linda W; Jaspers, Monique W M; Peek, Niels

2013-09-01

The rising incidence of type 2 diabetes mellitus (T2DM) induces severe challenges for the health care system. Our research group developed a web-based system named PANDIT that provides T2DM patients with insulin dosing advice using state of the art clinical decision support technology. The PANDIT interface resembles a glucose diary and provides advice through pop-up messages. Diabetes nurses (DNs) also have access to the system, allowing them to intervene when needed. The objective of this study was to establish whether T2DM patients can safely use PANDIT at home. To this end, we assessed whether patients experience usability problems with a high risk of compromising patient safety when interacting with the system, and whether PANDIT's insulin dosing advice are clinically safe. The study population consisted of patients with T2DM (aged 18-80) who used a once daily basal insulin as well as DNs from a university hospital. The usability evaluation consisted of think-aloud sessions with four patients and three DNs. Video data, audio data and verbal utterances were analyzed for usability problems encountered during PANDIT interactions. Usability problems were rated by a physician and a usability expert according to their potential impact on patient safety. The usability evaluation was followed by an implementation with a duration of four weeks. This implementation took place at the patients' homes with ten patients to evaluate clinical safety of PANDIT advice. PANDIT advice were systematically compared with DN advice. Deviating advice were evaluated with respect to patient safety by a panel of experienced physicians, which specialized in diabetes care. We detected seventeen unique usability problems, none of which was judged to have a high risk of compromising patient safety. Most usability problems concerned the lay-out of the diary, which did not clearly indicate which data entry fields had to be entered in order to obtain an advice. 27 out of 74 (36.5%) PANDIT advice differed from those provided by DNs. However, only one of these (1.4%) was considered unsafe by the panel. T2DM patients with no prior experience with the web-based self-management system were capable of consulting the system without encountering significant usability problems. Furthermore, the large majority of PANDIT advice were considered clinically safe according to the expert panel. One advice was considered unsafe. This could however easily be corrected by implementing a small modification to the system's knowledge base. Copyright © 2013 Elsevier B.V. All rights reserved.

Prevention of accidental exposure in radiotherapy: the risk matrix approach.

PubMed

Vilaragut, J J; Duménigo, C; Delgado, J M; Morales, J; McDonnell, J D; Ferro, R; Ortiz López, P; Ramírez, M L; Pérez Mulas, A; Papadopulos, S; Gonçalves, M; López Morones, R; Sánchez Cayuela, C; Cascajo Castresana, A; Somoano, F; Álvarez, C; Guillén, A; Rodríguez, M; Pereira, P P; Nader, A

2013-02-01

Knowledge and lessons from past accidental exposures in radiotherapy are very helpful in finding safety provisions to prevent recurrence. Disseminating lessons is necessary but not sufficient. There may be additional latent risks for other accidental exposures, which have not been reported or have not occurred, but are possible and may occur in the future if not identified, analyzed, and prevented by safety provisions. Proactive methods are available for anticipating and quantifying risk from potential event sequences. In this work, proactive methods, successfully used in industry, have been adapted and used in radiotherapy. Risk matrix is a tool that can be used in individual hospitals to classify event sequences in levels of risk. As with any anticipative method, the risk matrix involves a systematic search for potential risks; that is, any situation that can cause an accidental exposure. The method contributes new insights: The application of the risk matrix approach has identified that another group of less catastrophic but still severe single-patient events may have a higher probability, resulting in higher risk. The use of the risk matrix approach for safety assessment in individual hospitals would provide an opportunity for self-evaluation and managing the safety measures that are most suitable to the hospital's own conditions.

Adalimumab for treating childhood plaque psoriasis: a clinical trial evaluation.

PubMed

Di Lernia, Vito

2017-12-01

Most systemic therapies have not been systematically investigated in moderate to severe childhood plaque psoriasis. Evidence on the efficacy and safety of systemic treatments is limited and therapeutic guidelines are lacking. Recently adalimumab, a fully human monoclonal antibody that binds tumor necrosis factor (TNF)- alpha, was investigated in childhood psoriasis. Adalimumab is licensed for many inflammatory conditions including chronic plaque psoriasis in adults. Areas covered: A randomized phase III study published provided favourable efficacy and safety data of adalimumab in childhood psoriasis. The active comparator was methotrexate. After 16 weeks of treatment, a PASI 75 score was achieved in 58% of patients within the adalimumab 0.8 mg/kg group compared with 32% of patients within the methotrexate group. Safety data gave no evidence of drug-related serious adverse events and no organ toxicity. This is the first randomised controlled study of either adalimumab or methotrexate in children and adolescents with psoriasis. Expert opinion: The aforementioned trial was the first to provide clinical data on adalimumab's efficacy and safety in the short term when treating children and adolescents with psoriasis. Through the use of an active comparator, this study has opened the way for the future assessment of systemic therapies in children and adolescent with this condition.

A systematic review of occupational safety and health business cases.

PubMed

Verbeek, Jos; Pulliainen, Marjo; Kankaanpää, Eila

2009-12-01

Business cases are commonly developed as means to rationalize investment. We systematically reviewed 26 reported cases on occupational safety and health (OSH) interventions to assess if health and productivity arguments make a good business case. To be included in the review, studies had to analyze the costs and benefits, including productivity, of an OSH intervention at the enterprise level. We searched Medline and Embase for studies and used Google search in addition. Two reviewers independently selected studies and extracted data. The intervention profitability was calculated in euros (euro in 2008) as the first year's benefits minus the total intervention costs per worker. The payback period was calculated as the intervention costs divided by the first year's benefits. We found three ex-ante and 23 ex-post cases. In 20 cases, the study design was a before-after comparison without a control group. Generally a 100% reduction of injuries or sickness absence was assumed. In two cases, productivity and quality increases were very large. The main benefit was avoided sick leave. Depreciation or discounting was applied only in a minority of cases. The intervention profitability was negative in seven studies, up to euro 500 per employee in 12 studies and more than euro 500 per employee in seven studies. The payback period was less than half a year for 19 studies. Only a few studies included sensitivity analyses. Few ex-ante business cases for management decisions on OSH are reported. Guidelines for reporting and evaluation are needed. Business cases need more sound assumptions on the effectiveness of interventions and should incorporate greater uncertainty into their design. Ex-post evaluation should be based preferably on study designs that control for trends at a time different from that of the intervention.

Meta-analysis of the efficacy and safety of combined surgery in the management of eyes with coexisting cataract and open angle glaucoma.

PubMed

Jiang, Nan; Zhao, Gui-Qiu; Lin, Jing; Hu, Li-Ting; Che, Cheng-Ye; Wang, Qian; Xu, Qiang; Li, Cui; Zhang, Jie

2018-01-01

To conduct a systematic review and quantitative Meta-analysis of the efficacy and safety of combined surgery for the eyes with coexisting cataract and open angle glaucoma. We performed a systematic search of the related literature in the Cochrane Library, PubMed, EMBASE, Web of Science databases, CNKI, CBM and Wan Fang databases, with no limitations on language or publication date. The primary efficacy estimate was identified by weighted mean difference of the percentage of intraocular pressure reduction (IOPR%) from baseline to end-point, the percentage of number of glaucoma medications reduction from pre- to post-operation, and the secondary efficacy evaluations were performed by odds ratio (OR) and 95% confidence interval (CI) for complete and qualified success rate. Besides, ORs were applied to assess the tolerability of adverse incidents. Meta-analyses of fixed or random effect models were performed using RevMan software 5.2 to gather the consequences. Heterogeneity was evaluated by Chi 2 test and the I 2 measure. Ten studies enrolling 3108 patients were included. The combined consequences indicated that both glaucoma and combined cataract and glaucoma surgery significantly decreased IOP. For deep sclerectomy vs deep sclerectomy plus phacoemulsification and canaloplasty vs phaco-canaloplasty, the differences in IOPR% were not all statistically significant while trabeculotomy was detected to gain a quantitatively greater IOPR% compared with trabeculotomy plus phacoemulsification. Furthermore, there was no statistical significance in the complete and qualified success rate, and the rates of adverse incidents for trabeculotomy vs trabeculotomy plus phacoemulsification. Compared with trabeculotomy plus phacoemulsification, trabeculectomy alone is more effective in lowering IOP and the number of glaucoma medications, while the two surgeries can not demonstrate statistical differences in the complete success rate, qualified success rate, or incidence of adverse incidents.

Medication errors in paediatric care: a systematic review of epidemiology and an evaluation of evidence supporting reduction strategy recommendations

PubMed Central

Miller, Marlene R; Robinson, Karen A; Lubomski, Lisa H; Rinke, Michael L; Pronovost, Peter J

2007-01-01

Background Although children are at the greatest risk for medication errors, little is known about the overall epidemiology of these errors, where the gaps are in our knowledge, and to what extent national medication error reduction strategies focus on children. Objective To synthesise peer reviewed knowledge on children's medication errors and on recommendations to improve paediatric medication safety by a systematic literature review. Data sources PubMed, Embase and Cinahl from 1 January 2000 to 30 April 2005, and 11 national entities that have disseminated recommendations to improve medication safety. Study selection Inclusion criteria were peer reviewed original data in English language. Studies that did not separately report paediatric data were excluded. Data extraction Two reviewers screened articles for eligibility and for data extraction, and screened all national medication error reduction strategies for relevance to children. Data synthesis From 358 articles identified, 31 were included for data extraction. The definition of medication error was non‐uniform across the studies. Dispensing and administering errors were the most poorly and non‐uniformly evaluated. Overall, the distributional epidemiological estimates of the relative percentages of paediatric error types were: prescribing 3–37%, dispensing 5–58%, administering 72–75%, and documentation 17–21%. 26 unique recommendations for strategies to reduce medication errors were identified; none were based on paediatric evidence. Conclusions Medication errors occur across the entire spectrum of prescribing, dispensing, and administering, are common, and have a myriad of non‐evidence based potential reduction strategies. Further research in this area needs a firmer standardisation for items such as dose ranges and definitions of medication errors, broader scope beyond inpatient prescribing errors, and prioritisation of implementation of medication error reduction strategies. PMID:17403758

Occupational safety and health interventions to reduce musculoskeletal symptoms in the health care sector.

PubMed

Tullar, Jessica M; Brewer, Shelley; Amick, Benjamin C; Irvin, Emma; Mahood, Quenby; Pompeii, Lisa A; Wang, Anna; Van Eerd, Dwayne; Gimeno, David; Evanoff, Bradley

2010-06-01

Health care work is dangerous and multiple interventions have been tested to reduce the occupational hazards. A systematic review of the literature used a best evidence synthesis approach to address the general question "Do occupational safety and health interventions in health care settings have an effect on musculoskeletal health status?" This was followed by an evaluation of the effectiveness of specific interventions. The initial search identified 8,465 articles, for the period 1980-2006, which were reduced to 16 studies based on content and quality. A moderate level of evidence was observed for the general question. Moderate evidence was observed for: (1) exercise interventions and (2) multi-component patient handling interventions. An updated search for the period 2006-2009 added three studies and a moderate level of evidence now indicates: (1) patient handling training alone and (2) cognitive behavior training alone have no effect on musculoskeletal health. Few high quality studies were found that examined the effects of interventions in health care settings on musculoskeletal health. The findings here echo previous systematic reviews supporting exercise as providing positive health benefits and training alone as not being effective. Given the moderate level of evidence, exercise interventions and multi-component patient handling interventions (MCPHI) were recommended as practices to consider. A multi-component intervention includes a policy that defines an organizational commitment to reducing injuries associated with patient handling, purchase of appropriate lift or transfer equipment to reduce biomechanical hazards and a broad-based ergonomics training program that includes safe patient handling and/or equipment usage. The review demonstrates MCPHI can be evaluated if the term multi-component is clearly defined and consistently applied.

Intensive gestational glycemic management and childhood obesity: a systematic review and meta-analysis.

PubMed

Guillemette, L; Durksen, A; Rabbani, R; Zarychanski, R; Abou-Setta, A M; Duhamel, T A; McGavock, J M; Wicklow, B

2017-07-01

Hyperglycemia in pregnancy is associated with increased risk of offspring childhood obesity. Treatment reduces macrosomia; however, it is unclear if this effect translates into a reduced risk of childhood obesity. We performed a systematic review and meta-analysis of randomized controlled trials to evaluate the efficacy and safety of intensive glycemic management in pregnancy in preventing childhood obesity. We searched MEDLINE, EMBASE, CENTRAL and ClinicalTrials.gov up to February 2016 and conference abstracts from 2010 to 2015. Two reviewers independently identified randomized controlled trials evaluating intensive glycemic management interventions for hyperglycemia in pregnancy and included four of the 383 citations initially identified. Two reviewers independently extracted study data and evaluated internal validity of the studies using the Cochrane Collaboration's Risk of Bias tool. Data were pooled using random-effects models. Statistical heterogeneity was quantified using the I 2 test. The primary outcome was age- and sex-adjusted childhood obesity. Secondary outcomes included childhood weight and waist circumference and maternal hypoglycemia during the trial (safety outcome). The four eligible trials (n=767 children) similarly used lifestyle and insulin to manage gestational hyperglycemia, but only two measured offspring obesity and waist circumference and could be pooled for these outcomes. We found no association between intensive gestational glucose management and childhood obesity at 7-10 years of age (relative risk 0.89, 95% confidence interval (CI) 0.65 to 1.22; two trials; n=568 children). Waist circumference also did not differ between treatment and control arms (mean difference, -2.68 cm; 95% CI, -8.17 to 2.81 cm; two trials; n=568 children). Intensive gestational glycemic management is not associated with reduced childhood obesity in offspring, but randomized data is scarce. Long-term follow-up of trials should be prioritized and comprehensive measures of childhood metabolic risk should be considered as outcomes in future trials.

Chinese herbal medicine for the treatment of recurrent miscarriage: a systematic review of randomized clinical trials

PubMed Central

2013-01-01

Background Traditional Chinese medicine has been widely used for the treatment of recurrent miscarriage in China and other Asian countries for long time. We conducted this review to systematically summarize the evidences of Chinese herbal medicine (CHM) for the prevention and treatment of recurrent miscarriage in randomized trials, and evaluate the effectiveness and safety of CHM compared with placebo or conventional medicine. Methods We searched studies in PubMed, ClinicalTrials, the Cochrane Library, CNKI, SinoMed and VIP databases until December, 2012. Randomized trials on CHM alone or in combination with conventional medicine for recurrent miscarriage compared with placebo or conventional medicine were included. We evaluated the methodological quality of each included trials using the Cochrane risk of bias tool. Results A total of 41 RCTs (3660 participants) were included. The majority of trials had a high or unclear risk of bias. CHM used alone or plus progesterone-based treatment showed superior effect over progesterone-based treatment in improving live birth rate and embryonic developmental state (measured by B ultrasound). However, there is substantial heterogeneity within each subgroup analysis (I2 ranging from 35% to 71%). CHM plus progesterone and hCG-based treatment was superior to progesterone and hCG-based treatment in improving the embryonic developmental state, but not live birth rate. No severe adverse events were reported in relation to CHM. Conclusions Some Chinese herbal medicines or in combination with progesterone-based treatment demonstrated potentially beneficial effect in improving live birth rate and embryonic developmental state for women with recurrent miscarriage. However, due to the substantial heterogeneity among the herbal interventions and limitations of methodological quality of the included trials, it is not possible to recommend any specific CHMs for recurrent miscarriage. Further rigorous clinical trials are warranted to evaluate the efficacy and safety of CHM. PMID:24245671

Probiotics for the Treatment of Infantile Colic: A Systematic Review.

PubMed

Schreck Bird, Anna; Gregory, Philip J; Jalloh, Mohamed A; Risoldi Cochrane, Zara; Hein, Darren J

2017-06-01

To evaluate whether clinical data support the safety and efficacy of probiotics for the management of infantile colic. Probiotics have been suggested as a potential strategy for infantile colic, and the specific species that have been studied in healthy infants are considered to be safe. A systematic review was conducted to identify randomized controlled trials (RCTs) evaluating the use of probiotic supplementation in infants with colic. RCTs with a primary end point assessing crying or fussing time were selected. A meta-analysis comparing "responders" to "nonresponders" in infants receiving probiotic versus control was conducted. The quality of trials selected was assessed. Five RCTs assessing 2 different strains of the probiotic Lactobacillus reuteri in mostly breastfed infants were identified. Analysis of response rates showed that infants receiving probiotics had a 2.3-fold greater chance of having a 50% or greater decrease in crying/fussing time compared to controls ( P = .01). Probiotic supplementation was not associated with any adverse events. Supplementation with the probiotic L. reuteri in breastfed infants appears to be safe and effective for the management of infantile colic. Further research is needed to determine the role of probiotics in infants who are formula-fed.

Integrating legal liabilities in nanomanufacturing risk management.

PubMed

Mohan, Mayank; Trump, Benjamin D; Bates, Matthew E; Monica, John C; Linkov, Igor

2012-08-07

Among other things, the wide-scale development and use of nanomaterials is expected to produce costly regulatory and civil liabilities for nanomanufacturers due to lingering uncertainties, unanticipated effects, and potential toxicity. The life-cycle environmental, health, and safety (EHS) risks of nanomaterials are currently being studied, but the corresponding legal risks have not been systematically addressed. With the aid of a systematic approach that holistically evaluates and accounts for uncertainties about the inherent properties of nanomaterials, it is possible to provide an order of magnitude estimate of liability risks from regulatory and litigious sources based on current knowledge. In this work, we present a conceptual framework for integrating estimated legal liabilities with EHS risks across nanomaterial life-cycle stages using empirical knowledge in the field, scientific and legal judgment, probabilistic risk assessment, and multicriteria decision analysis. Such estimates will provide investors and operators with a basis to compare different technologies and practices and will also inform regulatory and legislative bodies in determining standards that balance risks with technical advancement. We illustrate the framework through the hypothetical case of a manufacturer of nanoscale titanium dioxide and use the resulting expected legal costs to evaluate alternative risk-management actions.

Photodynamic therapy for actinic cheilitis: a systematic review.

PubMed

Yazdani Abyaneh, Mohammad-Ali; Falto-Aizpurua, Leyre; Griffith, Robert D; Nouri, Keyvan

2015-02-01

Actinic cheilitis (AC) is a premalignant lesion of the lips that can progress to squamous cell carcinoma and metastasize. Actinic cheilitis is difficult to treat because surgical treatments have significant adverse effects whereas less invasive procedures have uncertain efficacy. Photodynamic therapy (PDT) may offer a noninvasive yet effective treatment option for AC. To systematically review the safety and efficacy of PDT for AC. The terms "photodynamic," "actinic," "solar," "cheilitis," and "cheilosis" were used in combinations to search the PubMed database. Studies were considered for inclusion based on eligibility criteria, and specific data were extracted from all studies. The authors identified 15 eligible case series encompassing a total of 242 treated subjects. Among studies that evaluated subjects for complete clinical response, 139 of 223 subjects (62%) showed complete response at final follow-ups ranging from 3 to 30 months. Among studies that evaluated subjects for histological outcome, 57 of 121 subjects (47%) demonstrated histological cure at final follow-ups ranging from 1.5 to 18 months. Cosmetic outcomes were good to excellent in the majority of subjects, and adverse events were well tolerated. Photodynamic therapy is safe and has the potential to clinically and histologically treat AC, with a need for future randomized controlled trials.

A systematic approach for the location of hand sanitizer dispensers in hospitals.

PubMed

Cure, Laila; Van Enk, Richard; Tiong, Ewing

2014-09-01

Compliance with hand hygiene practices is directly affected by the accessibility and availability of cleaning agents. Nevertheless, the decision of where to locate these dispensers is often not explicitly or fully addressed in the literature. In this paper, we study the problem of selecting the locations to install alcohol-based hand sanitizer dispensers throughout a hospital unit as an indirect approach to maximize compliance with hand hygiene practices. We investigate the relevant criteria in selecting dispenser locations that promote hand hygiene compliance, propose metrics for the evaluation of various location configurations, and formulate a dispenser location optimization model that systematically incorporates such criteria. A complete methodology to collect data and obtain the model parameters is described. We illustrate the proposed approach using data from a general care unit at a collaborating hospital. A cost analysis was performed to study the trade-offs between usability and cost. The proposed methodology can help in evaluating the current location configuration, determining the need for change, and establishing the best possible configuration. It can be adapted to incorporate alternative metrics, tailored to different institutions and updated as needed with new internal policies or safety regulation.

Effectiveness of Acupuncture for Primary Ovarian Insufficiency: A Systematic Review and Meta-Analysis.

PubMed

Jo, Junyoung; Lee, Yoon Jae; Lee, Hyangsook

2015-01-01

Objective. This systematic review aimed to assess current evidence from randomized controlled trials (RCTs) on the effects of acupuncture for patients with primary ovarian insufficiency (POI). Methods. We searched twelve databases to identify relevant studies published before July 2014. The outcomes were serum follicle-stimulating hormone (FSH) levels and resumption of menstruation. Two reviewers independently assessed the risk of bias using the Cochrane's tool, extracted the results, and evaluated the overall level of the evidence using Grading of Recommendations Assessment, Development, and Evaluation (GRADE) criteria. Results. Eight RCTs were selected. Acupuncture significantly lowered serum FSH levels and more women receiving acupuncture reported resumption of menses. However, the results should be interpreted with caution due to a small number of participants, high risk of bias for blinding, and likely publication bias. The level of evidence for FSH level and resumption of menses were assessed as "low" using GRADE. Conclusion. The current evidence on acupuncture for POI is insufficient to draw a firm conclusion due to scarcity of studies with a low risk of bias and likely publication bias. Further rigorously designed and conducted studies are needed to confirm the effectiveness and safety of acupuncture in patients with POI.

Heartburn in pregnancy.

PubMed

Vazquez, Juan C

2015-09-08

Heartburn is a common complaint during pregnancy; the incidence is reported to be between 17% and 45%. We conducted a systematic overview and aimed to answer the following clinical question: What are the effects of interventions to prevent or treat heartburn in pregnancy? We searched Medline, Embase, The Cochrane Library, and other important databases up to December 2014 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). At this update, searching of electronic databases retrieved 80 studies. After deduplication and removal of conference abstracts, 59 records were screened for inclusion in the review. Appraisal of titles and abstracts led to the exclusion of 58 studies and the further review of one full publication. The full article evaluated did not meet our reporting criteria, and thus no new evidence was added at this update. We performed a GRADE evaluation for two PICO combinations. In this systematic overview, we categorised the efficacy for six interventions, based on information about the effectiveness and safety of acid-suppressing drugs, antacids with or without alginates, raising the head of the bed, reducing caffeine intake, reducing intake of fatty foods, and reducing the size and frequency of meals.

Systematic review and meta-analysis of selected toxicities of approved ALK inhibitors in metastatic non-small cell lung cancer.

PubMed

Costa, Rubens Barros; Costa, Ricardo L B; Talamantes, Sarah M; Kaplan, Jason B; Bhave, Manali A; Rademaker, Alfred; Miller, Corinne; Carneiro, Benedito A; Mahalingam, Devalingam; Chae, Young Kwang

2018-04-24

Anaplastic lymphoma kinase ( ALK ) inhibitors are the mainstay treatment for patients with non-small cell lung carcinoma (NSCLC) harboring a rearrangement of the ALK gene or the ROS1 oncogenes. With the recent publication of pivotal trials leading to the approval of these compounds in different indications, their toxicity profile warrants an update. A systematic literature search was performed in July 2017. Studies evaluating US FDA approved doses of one of the following ALK inhibitors: Crizotinib, Ceritinib, Alectinib or Brigatinib as monotherapy were included. Data were analyzed using random effects meta-analysis for absolute risks (AR), study heterogeneity, publication bias and differences among treatments. Fifteen trials with a total of 2,005 patients with evaluable toxicity data were included in this report. There was significant heterogeneity amongst different studies. The pooled AR of death and severe adverse events were 0.5% and 34.5%, respectively. Grade 3/4 nausea, vomiting, diarrhea, and constipation were uncommon: 2.6%, 2.5%, 2.7%, 1.2%, respectively. ALK inhibitors have an acceptable safety profile with a low risk of treatment-related deaths. Important differences in toxicity profile were detected amongst the different drugs.

Developing patient safety in dentistry.

PubMed

Pemberton, M N

2014-10-01

Patient safety has always been important and is a source of public concern. Recent high profile scandals and subsequent reports, such as the Francis report into the failings at Mid Staffordshire, have raised those concerns even higher. Mortality and significant morbidity associated with the practice of medicine has led to many strategies to help improve patient safety, however, with its lack of associated mortality and lower associated morbidity, dentistry has been slower at systematically considering how patient safety can be improved. Recently, several organisations, researchers and clinicians have discussed the need for a patient safety culture in dentistry. Strategies are available to help improve patient safety in healthcare and deserve further consideration in dentistry.

Perioperative systemic steroid for rapid recovery in total knee and hip arthroplasty: a systematic review and meta-analysis of randomized trials.

PubMed

Yue, Chen; Wei, Rong; Liu, Youwen

2017-06-27

Perioperative systemic steroid administration for rapid recovery in total knee and hip arthroplasty (TKA/THA) is an important and controversial topic. We conducted this systematic review and meta-analysis to evaluate the overall benefits and harms of perioperative systemic steroid in patients undergoing TKA and THA. A comprehensive search was performed on PubMed, OVID, and Web of Science databases, and a systematic approach was carried out starting from the PRISMA recommendations. Relevant randomized controlled trials (RCTs) were selected. The risk of bias was evaluated according to the Cochrane Handbook for Systematic Reviews of Interventions version. Data were extracted and meta-analyzed or qualitatively synthesized for all the outcomes. Data were extracted from 11 trials involving 774 procedures. Meta-analysis showed that high-dose systemic steroid (dexamethasone > 0.1 mg/kg) rather than low dose is effective to reduce postoperative nausea and vomiting and postoperative acute pain (within 24 h). In addition, systemic steroid is associated within faster functional rehabilitation and greater inflammation control. On the other hand, systemic steroid is associated with a higher level of postoperative serum glucose on the operation day. The complications between groups are similarly low. Our study suggests that by providing lower incidence of postoperative nausea and vomiting and less postoperative acute pain, high-dose systemic steroid plays a critical role in rapid recovery to TKA and THA. The preliminary results also show the superior possibility of systemic steroid in functional rehabilitation and inflammation control. More large, high-quality studies that investigate the safety and dose-response relationship are necessary.

[Descemet's stripping automated endothelial keratoplasty (DEAEK). Systematic review of clinical-effectiveness and safety].

PubMed

Paz-Valiñas, L; de la Fuente-Cid, R; de Rojas-Silva, M V; López-Rodríguez, I; López-García, M

2015-04-01

To conduct a systematic review of the efficacy/effectiveness, safety and cost of Descemet's stripping automated endothelial keratoplasty (DSAEK) technique in patients with corneal endothelial failure. Comprehensive literature search conducted in the main biomedical databases from January-May 2012. Following a critical perusal of the total of 485 abstracts retrieved, 16 case series and one economic evaluation study were included. Corrected distance visual acuity and uncorrected distance visual acuity improved after treatment with DSAEK, attaining values of 0.6 to 0.8 and 0.5 respectively. The degree of post-DSAEK astigmatism was not significant with respect to baseline values. The main complications were graft dislocation-detachment (1.5-23%), primary failure (0-12%) and endothelial rejection (0.8-8.5%). In Fuchs' dystrophy and bullous keratopathy, data on the effectiveness of DSAEK indicate post-intervention improvement in uncorrected and corrected distance visual acuity. Astigmatism arising after DSAEK was not significant. The most significant post-DSAEK complications are linked to the viability of the graft, with the most frequent complications being dislocation-detachment and, to a lesser extent, endothelial rejection. The studies that assess DSAEK are case series, and for the most part retrospective. The quality of this type of studies is both low and limited. Copyright © 2012 Sociedad Española de Oftalmología. Published by Elsevier España, S.L.U. All rights reserved.

Antihistamines and Birth Defects: A Systematic Review of the Literature

PubMed Central

Gilboa, Suzanne M.; Ailes, Elizabeth C.; Rai, Ramona P.; Anderson, Jaynia A.; Honein, Margaret A.

2015-01-01

Introduction Approximately 10-15% of women reportedly take an antihistamine during pregnancy for the relief of nausea and vomiting, allergy and asthma symptoms, or indigestion. Antihistamines include histamine H1-receptor and H2-receptor antagonists. Areas covered This is a systematic evaluation of the peer-reviewed epidemiologic literature published through February 2014 on the association between prenatal exposure to antihistamines and birth defects. Papers addressing histamine H1- or H2-receptor antagonists are included. Papers addressing pyridoxine plus doxylamine (Bendectin in the United States, Debendox in the United Kingdom, Diclectin in Canada, Lenotan and Merbental in other countries) prior to the year 2001 were excluded post-hoc because of several previously published meta-analyses and commentaries on this medication. Expert opinion The literature on the safety of antihistamine use during pregnancy with respect to birth defects is generally reassuring though the positive findings from a few large studies warrant corroboration in other populations. The findings in the literature are considered in light of three critical methodological issues: (1) selection of appropriate study population; (2) ascertainment of antihistamine exposures; and (3) ascertainment of birth defects outcomes. Selected antihistamines have been very well-studied (e.g. loratadine); others, especially H2- receptor antagonists, require additional study before an assessment of safety with respect to birth defects risk could be made. PMID:25307228

Alveolar ridge and maxillary sinus augmentation using rhBMP-2: a systematic review.

PubMed

Freitas, Rubens Moreno de; Spin-Neto, Rubens; Marcantonio Junior, Elcio; Pereira, Luís Antônio Violin Dias; Wikesjö, Ulf M E; Susin, Cristiano

2015-01-01

The aim of this systematic review was to evaluate clinical and safety data for recombinant human bone morphogenetic protein-2 (rhBMP-2) in an absorbable collagen sponge (ACS) carrier when used for alveolar ridge/maxillary sinus augmentation in humans. Clinical studies/case series published 1980 through June 2012 using rhBMP-2/ACS were searched. Studies meeting the following criteria were considered eligible for inclusion: >10 subjects at baseline and maxillary sinus or alveolar ridge augmentation not concomitant with implant placement. Seven of 69 publications were eligible for review. rhBMP-2/ACS yielded clinically meaningful bone formation for maxillary sinus augmentation that would allow placement of regular dental implants without consistent differences between rhBMP-2 concentrations. Nevertheless, the statistical analysis showed that sinus augmentation following autogenous bone graft was significantly greater (mean bone height: 1.6 mm, 95% CI: 0.5-2.7 mm) than for rhBMP-2/ACS (rhBMP-2 at 1.5 mg/mL). In extraction sockets, rhBMP-2/ACS maintained alveolar ridge height while enhancing alveolar ridge width. Safety reports did not represent concerns for the proposed indications. rhBMP-2/ACS appears a promising alternative to autogenous bone grafts for alveolar ridge/maxillary sinus augmentation; dose and carrier optimization may expand its efficacy, use, and clinical application. © 2013 Wiley Periodicals, Inc.

Determination of the starting dose in the first-in-human clinical trials with monoclonal antibodies: a systematic review of papers published between 1990 and 2013.

PubMed

Suh, Hoon Young; Peck, Carl C; Yu, Kyung-Sang; Lee, Howard

2016-01-01

A systematic review was performed to evaluate how the maximum recommended starting dose (MRSD) was determined in first-in-human (FIH) studies with monoclonal antibodies (mAbs). Factors associated with the choice of each MRSD determination method were also identified. PubMed was searched for FIH studies with mAbs published in English between January 1, 1990 and December 31, 2013, and the following information was extracted: MRSD determination method, publication year, therapeutic area, antibody type, safety factor, safety assessment results after the first dose, and number of dose escalation steps. Seventy-nine FIH studies with mAbs were identified, 49 of which clearly reported the MRSD determination method. The no observed adverse effects level (NOAEL)-based approach was the most frequently used method, whereas the model-based approach was the least commonly used method (34.7% vs 16.3%). The minimal anticipated biological effect level (MABEL)- or minimum effective dose (MED)-based approach was used more frequently in 2011-2013 than in 1990-2007 (31.6% vs 6.3%, P =0.036), reflecting a slow, but steady acceptance of the European Medicines Agency's guidance on mitigating risks for FIH clinical trials (2007). The median safety factor was much lower for the MABEL- or MED-based approach than for the other MRSD determination methods (10 vs 32.2-53). The number of dose escalation steps was not significantly different among the different MRSD determination methods. The MABEL-based approach appears to be safer and as efficient as the other MRSD determination methods for achieving the objectives of FIH studies with mAbs faster.

The Feasibility and Oncological Safety of Axillary Reverse Mapping in Patients with Breast Cancer: A Systematic Review and Meta-Analysis of Prospective Studies

PubMed Central

Han, Chao; Yang, Ben; Zuo, Wen-Shu; Zheng, Gang; Yang, Li; Zheng, Mei-Zhu

2016-01-01

Objective The axillary reverse mapping (ARM) technique has recently been developed to prevent lymphedema by preserving the arm lymphatic drainage during sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND) procedures. The objective of this systematic review and meta-analysis was to evaluate the feasibility and oncological safety of ARM. Methods We searched Medline, Embase, Web of science, Scopus, and the Cochrane Library for relevant prospective studies. The identification rate of ARM nodes, the crossover rate of SLN-ARM nodes, the proportion of metastatic ARM nodes, and the incidence of complications were pooled into meta-analyses by the random-effects model. Results A total of 24 prospective studies were included into meta-analyses, of which 11 studies reported ARM during SLNB, and 18 studies reported ARM during SLNB. The overall identification rate of ARM nodes was 38.2% (95% CI 32.9%-43.8%) during SLNB and 82.8% (78.0%-86.6%) during ALND, respectively. The crossover rate of SLN-ARM nodes was 19.6% (95% CI 14.4%-26.1%). The metastatic rate of ARM nodes was 16.9% (95% CI 14.2%-20.1%). The pooled incidence of lymphedema was 4.1% (95% CI 2.9–5.9%) for patients undergoing ARM procedure. Conclusions The ARM procedure was feasible during ALND. Nevertheless, it was restricted by low identification rate of ARM nodes during SLNB. ARM was beneficial for preventing lymphedema. However, this technique should be performed with caution given the possibility of crossover SLN-ARM nodes and metastatic ARM nodes. ARM appeared to be unsuitable for patients with clinically positive breast cancer due to oncological safety concern. PMID:26919589

Short-term efficacy and safety of new biological agents targeting the interleukin-23-T helper 17 pathway for moderate-to-severe plaque psoriasis: a systematic review and network meta-analysis.

PubMed

Gómez-García, F; Epstein, D; Isla-Tejera, B; Lorente, A; Vélez García-Nieto, A; Ruano, J

2017-03-01

A new generation of biologics targeting the interleukin-23-T helper 17 pathway has been developed. This study aimed to assess the short-term effectiveness and safety of these new agents using a network meta-analysis. Twenty-seven randomized clinical trials (10 629 patients) were identified by a comprehensive systematic literature review (PROSPERO 2015: CRD42015025472). Quality of evidence was assessed following Cochrane-compliant rules and the Grading of Recommendations, Assessment, Development and Evaluations approach. Efficacy and safety outcomes at weeks 10-16 were compared using a random-effects network meta-analysis within a frequentist framework to estimate pooled odds ratios (ORs) of direct and indirect comparisons among the therapeutic options. There were six direct drug-to-drug comparisons in the network, with a high degree of consistency between the direct and indirect evidence. From the available evidence, infliximab 5 mg kg -1 every 8 weeks [OR 118·89, 95% confidence interval (CI) 60·91-232·04] and secukinumab 300 mg every 4 weeks (OR 87·07, 95% CI 55·01-137·82) are shown to be among the most effective short-term treatments, but are ranked as the biologics most likely to produce any adverse event or an infectious adverse event, respectively. Ustekinumab 90 mg every 12 weeks, the third most efficacious treatment (OR 73·67, 95% CI 46·97-115·56), was the only agent that did not show increased risk of adverse events compared with placebo. Treatment recommendations should also consider long-term outcomes and costs. © 2016 British Association of Dermatologists.

[Hyaluronate sodium treatment for internal derangement of temporomandibular joint: a systematic review based on randomized controlled trials].

PubMed

Li, Chunjie; Zhang, Yifan; Jia, Yuanyuan; Lü, Jun; Li, Longjiang; Shi, Zong-Dao

2011-10-01

To assess the efficacy and safety of hyaluronate sodium (HS) for internal derangement of temporomandibular joint by means of systematic review on relevant randomized controlled trials. After identifing the study question of the efficacy and safety of HS for internal derangement of temporomandibular joint, Medline, Cochrane Controlled Trials Register, EMBASE, OPEN SIGLE and CBM were searched electronically till October 3rd 2010. Hand-searching covering 19 dental journals in Chinese were also performed. Risk of bias assessment, with Cochrane Collaboration's tool, and data extraction of included studies were conducted by two reviewers in duplicate. Meta analysis was done with Revman 5.0.23 and the quality of evidence was evaluated by GRADE. 10 randomized controlled trials met the eligibility criteria and were included. All these studies had unclear risk of bias. When compared with negative control, HS showed a significant advantage on maximal mouth opening in short and long-term (P < 0.05), and clinical overall assessment in short-term (P < 0.05), but its effect on pain control and long-term effect on clinical overall assessment had no extra benefit (P > 0.05). Additionally, when compared with glucocorticoids, the participants who received HS injection would get a better clinical overall assessment in short-term and less adverse drug reactions (P < 0.05), but presented a similar temporomandibular joint pain relief and maximal mouth opening (P > 0.05). To a certain extent, HS had good efficacy and better safety than controls when treating internal derangement of temporomandibular joint. However, as the quality of some included studies were limited, more randomized controlled trials are needed to reinforce the conclusion.

46 CFR 116.340 - Alternate design considerations.

Code of Federal Regulations, 2010 CFR

2010-10-01

... ARRANGEMENT Hull Structure § 116.340 Alternate design considerations. The Commanding Officer, Marine Safety... does not meet the requirements of § 116.300, if it is shown by systematic analysis based on engineering principles that the vessel structure provides adequate safety and strength. An owner seeking approval of an...

46 CFR 116.340 - Alternate design considerations.

Code of Federal Regulations, 2011 CFR

2011-10-01

... ARRANGEMENT Hull Structure § 116.340 Alternate design considerations. The Commanding Officer, Marine Safety... does not meet the requirements of § 116.300, if it is shown by systematic analysis based on engineering principles that the vessel structure provides adequate safety and strength. An owner seeking approval of an...

46 CFR 116.340 - Alternate design considerations.

Code of Federal Regulations, 2013 CFR

2013-10-01

... ARRANGEMENT Hull Structure § 116.340 Alternate design considerations. The Commanding Officer, Marine Safety... does not meet the requirements of § 116.300, if it is shown by systematic analysis based on engineering principles that the vessel structure provides adequate safety and strength. An owner seeking approval of an...

Safety and efficacy of chastetree (Vitex agnus-castus) during pregnancy and lactation.

PubMed

Dugoua, Jean-Jacques; Seely, Dugald; Perri, Daniel; Koren, Gideon; Mills, Edward

2008-01-01

There is a lack of basic knowledge on the part of both clinicians and patients as to the indications for use and safety of herbs used during pregnancy and lactation. This is one article in a series that systematically reviews the evidence for herbs commonly used during pregnancy and lactation. To systematically review the literature for evidence on the use, safety and pharmacology of chastetree, focusing on issues pertaining to pregnancy and lactation. We searched 7 electronic databases and compiled data according to the grade of evidence found. RESULTS In pregnancy, there is poor evidence based on theoretical and expert opinion and in vitro studies that chastetree may have estrogenic and progesteronic activity, uterine stimulant activity, emmenagogue activity and prevent miscarriages. In lactation, theoretical and expert opinion conflict as to whether chastetree increases or decreases lactation. Given its relatively common use amongst women of childbearing age, it is likely that some women may consume chastetree while unknowingly pregnant. Complementary and alternative medicine, midwifery and medical practitioners should be aware of this fact when prescribing chastetree to women of childbearing age, particularly when the patient is planning a family. Key words: Chastetree, vitex agnus-castus, pregnancy, lactation, breastfeeding, systematic review.

Proposed Standardized Neurological Endpoints for Cardiovascular Clinical Trials: An Academic Research Consortium Initiative.

PubMed

Lansky, Alexandra J; Messé, Steven R; Brickman, Adam M; Dwyer, Michael; Bart van der Worp, H; Lazar, Ronald M; Pietras, Cody G; Abrams, Kevin J; McFadden, Eugene; Petersen, Nils H; Browndyke, Jeffrey; Prendergast, Bernard; Ng, Vivian G; Cutlip, Donald E; Kapadia, Samir; Krucoff, Mitchell W; Linke, Axel; Scala Moy, Claudia; Schofer, Joachim; van Es, Gerrit-Anne; Virmani, Renu; Popma, Jeffrey; Parides, Michael K; Kodali, Susheel; Bilello, Michel; Zivadinov, Robert; Akar, Joseph; Furie, Karen L; Gress, Daryl; Voros, Szilard; Moses, Jeffrey; Greer, David; Forrest, John K; Holmes, David; Kappetein, Arie P; Mack, Michael; Baumbach, Andreas

2018-05-14

Surgical and catheter-based cardiovascular procedures and adjunctive pharmacology have an inherent risk of neurological complications. The current diversity of neurological endpoint definitions and ascertainment methods in clinical trials has led to uncertainties in the neurological risk attributable to cardiovascular procedures and inconsistent evaluation of therapies intended to prevent or mitigate neurological injury. Benefit-risk assessment of such procedures should be on the basis of an evaluation of well-defined neurological outcomes that are ascertained with consistent methods and capture the full spectrum of neurovascular injury and its clinical effect. The Neurologic Academic Research Consortium is an international collaboration intended to establish consensus on the definition, classification, and assessment of neurological endpoints applicable to clinical trials of a broad range of cardiovascular interventions. Systematic application of the proposed definitions and assessments will improve our ability to evaluate the risks of cardiovascular procedures and the safety and effectiveness of preventive therapies.

Using logic models in a community-based agricultural injury prevention project.

PubMed

Helitzer, Deborah; Willging, Cathleen; Hathorn, Gary; Benally, Jeannie

2009-01-01

The National Institute for Occupational Safety and Health has long promoted the logic model as a useful tool in an evaluator's portfolio. Because a logic model supports a systematic approach to designing interventions, it is equally useful for program planners. Undertaken with community stakeholders, a logic model process articulates the underlying foundations of a particular programmatic effort and enhances program design and evaluation. Most often presented as sequenced diagrams or flow charts, logic models demonstrate relationships among the following components: statement of a problem, various causal and mitigating factors related to that problem, available resources to address the problem, theoretical foundations of the selected intervention, intervention goals and planned activities, and anticipated short- and long-term outcomes. This article describes a case example of how a logic model process was used to help community stakeholders on the Navajo Nation conceive, design, implement, and evaluate agricultural injury prevention projects.

Acne vulgaris

PubMed Central

2011-01-01

Introduction Acne vulgaris affects over 80% of teenagers, and persists beyond the age of 25 years in 3% of men and 12% of women. Typical lesions of acne include comedones, inflammatory papules, and pustules. Nodules and cysts occur in more severe acne and can cause scarring and psychological distress. Methods and outcomes We conducted a systematic review and aimed to answer the following clinical question: What are the effects of topical and oral treatments in people with acne vulgaris? We searched: Medline, Embase, The Cochrane Library, and other important databases up to February 2010 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA). Results We found 69 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions. Conclusions In this systematic review we present information relating to the effectiveness and safety of the following interventions: topical treatments (adapalene, azelaic acid, benzoyl peroxide, clindamycin, erythromycin [alone or plus zinc]; isotretinoin, tetracycline, tretinoin); and oral treatments (doxycycline, isotretinoin, lymecycline, minocycline, oxytetracycline, tetracycline). PMID:21477388

Acne vulgaris.

PubMed

Purdy, Sarah; de Berker, David

2011-01-05

Acne vulgaris affects over 80% of teenagers, and persists beyond the age of 25 years in 3% of men and 12% of women. Typical lesions of acne include comedones, inflammatory papules, and pustules. Nodules and cysts occur in more severe acne and can cause scarring and psychological distress. We conducted a systematic review and aimed to answer the following clinical question: What are the effects of topical and oral treatments in people with acne vulgaris? We searched: Medline, Embase, The Cochrane Library, and other important databases up to February 2010 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA). We found 69 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions. In this systematic review we present information relating to the effectiveness and safety of the following interventions: topical treatments (adapalene, azelaic acid, benzoyl peroxide, clindamycin, erythromycin [alone or plus zinc]; isotretinoin, tetracycline, tretinoin); and oral treatments (doxycycline, isotretinoin, lymecycline, minocycline, oxytetracycline, tetracycline).

Wrinkles

PubMed Central

2008-01-01

Introduction Skin disorders associated with photodamage from ultraviolet light include wrinkles, hyperpigmentation, tactile roughness, and telangiectasia, and are more common in people with white compared with other skin types. Wrinkles are also associated with ageing, hormonal status, smoking, and intercurrent disease. Methods and outcomes We conducted a systematic review and aimed to answer the following clinical question: What are the effects of interventions to prevent and treat skin wrinkles? We searched: Medline, Embase, The Cochrane Library, and other important databases up to April 2008 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA). Results We found 20 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions. Conclusions In this systematic review we present information relating to the effectiveness and safety of the following interventions: alpha and beta hydroxyl acids, carbon dioxide laser, chemical peel, dermabrasion, facelifts, isotretinoin, natural cartilage polysaccharides (oral or topical), retinyl esters, sunscreens, tazarotene, tretinoin, variable pulse erbium:YAG laser, and vitamin C or E (topical). PMID:19445782

Wrinkles.

PubMed

Manríquez, Juan Jorge; Majerson Gringberg, Daniela; Nicklas Diaz, Claudia

2008-12-16

Skin disorders associated with photodamage from ultraviolet light include wrinkles, hyperpigmentation, tactile roughness, and telangiectasia, and are more common in people with white compared with other skin types. Wrinkles are also associated with aging, hormonal status, smoking, and intercurrent disease. We conducted a systematic review and aimed to answer the following clinical question: What are the effects of interventions to prevent and treat skin wrinkles? We searched: Medline, Embase, The Cochrane Library, and other important databases up to April 2008 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA). We found 20 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions. In this systematic review we present information relating to the effectiveness and safety of the following interventions: carbon dioxide laser, chemical peel, dermabrasion, facelifts, glycolic acid, isotretinoin, lactic acid, natural cartilage polysaccharides (oral or topical), retinyl esters, sunscreens, tazarotene, tretinoin, variable pulse erbium:YAG laser, and vitamin C or E (topical).

A systematic review of microwave-based therapy for axillary hyperhidrosis.

PubMed

Hsu, Tzu-Herng; Chen, Yu-Tsung; Tu, Yu-Kang; Li, Chien-Nien

2017-10-01

To systematically analyse the literature on the use of the microwave-based device for subdermal thermolysis of the axilla and its efficacy for the treatment of axillary hyperhidrosis. A systematic review was conducted using PubMed, Embase, SCOPUS and Cochrane databases on 2 June 2016. The inclusion criteria including: (1) studies with human subjects, (2) full-text articles published in English, (3) a microwave-based device used to treat axillary hyperhidrosis and (4) trials that precisely evaluated axillary hyperhidrosis. Exclusion criteria were the following: (1) studies that did not fit the inclusion criteria mentioned above and (2) case reports and reviews. We reviewed five clinical trials and 189 patients, all of which were published between 2012 and 2016. There was one randomized controlled trial, one retrospective study and the remainder were prospective studies. Although all of the studies were conducted with a small sample size, the results indicated that microwave-based device treatment of axillary hyperhidrosis had long-term efficacy with mild adverse effects. In addition, most patients were satisfied with the outcomes in these studies. Microwave-based device treatment may be an effective alternative treatment for axillary hyperhidrosis. However, further investigation is necessary to determine its long-term efficacy and safety.

Seborrhoeic dermatitis.

PubMed

Naldi, Luigi

2010-12-07

Seborrhoeic dermatitis affects at least 10% of the population. Malassezia (Pityrosporum) ovale is thought to be the causative organism, and causes inflammation by still poorly defined mechanisms. Seborrhoeic dermatitis tends to relapse after treatment. We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of topical treatments for seborrhoeic dermatitis of the scalp in adults? What are the effects of topical treatments for seborrhoeic dermatitis of the face and body in adults? We searched: Medline, Embase, The Cochrane Library, and other important databases up to April 2010 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA). We found 12 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions. In this systematic review we present information relating to the effectiveness and safety of the following interventions: bifonazole, emollients, ketoconazole, lithium succinate, selenium sulphide, tar shampoo, terbinafine, and topical corticosteroids (betamethasone valerate, clobetasol propionate, clobetasone butyrate, hydrocortisone, mometasone furoate).

Prevention of MSD within OHSMS/IMS: a systematic review of risk assessment strategies.

PubMed

Yazdani, Amin; Wells, Richard

2012-01-01

The purpose of this systematic review was to identify and summarize the research evidence on prevention of Musculoskeletal Disorders (MSD) within Occupational Health and Safety Management Systems (OHSMS) and Integrated Management Systems (IMS). Databases in business, management, engineering and health and safety were systematically searched and relevant publications were synthesized. The number of papers that could address the research questions was small. However, the review revealed that many of the techniques to address MSD hazards require substantial background knowledge and training. This may limit employees' involvement in the technical aspects of the risk assessment process. Also these techniques did not usually fit into techniques used by companies to address other risk factors within their management systems. This could result in MSD prevention becoming a separate issue that cannot be managed with company-wide tools. In addition, this review also suggested that there is a research gap concerning the MSD prevention within companies' management systems.

Triage for action: Systematic assessment and dissemination of construction health and safety research.

PubMed

Baker, Robin; Chang, Charlotte; Bunting, Jessica; Betit, Eileen

2015-08-01

Research translation too often relies on passive methods that fail to reach those who can impact the workplace. The need for better research to practice (r2p) approaches is especially pressing in construction, where a disproportionate number of workers suffer serious injury illness. A triage process was designed and used to systematically review completed research, assess r2p readiness, establish priorities, and launch dissemination follow-up efforts. A mixed quantitative and qualitative approach was used. The process proved effective in ensuring that significant findings and evidence-based solutions are disseminated actively. Key factors emerged in the selection of follow-up priorities, including availability of partners able to reach end users, windows of opportunity, and cross-cutting approaches that can benefit multiple dissemination efforts. Use of a systematic triage process may have an important role to play in building r2p capacity in construction safety and health. © 2015 Wiley Periodicals, Inc.

Inhaled beclomethasone in pregnant asthmatic women--a systematic review.

PubMed

de Aguiar, M M; da Silva, H J; Rizzo, J Â; Leite, D F B; Silva Lima, M E P L; Sarinho, E S C

2014-01-01

The aim of this study was to systematically review the safety and efficacy of inhaled beclomethasone for asthma treatment in pregnant women. We performed a systematic review in Medline, LILACS and SciELO electronic databases in December 2012. A total of 3433 articles were found by using the keywords asthma, pregnancy and beclomethasone. Among these, 1666 were from Medline, via PubMed, and 1767 were from LILACS and SciELO. Nine of these articles were selected. Only one paper suggested an increased foetal risk for congenital malformations, and one other for offspring endocrine and metabolic disturbances. Data are mostly reassuring, supporting the use of glucocorticoid inhalants during pregnancy, and we found no evidence of inferiority in relation to efficacy and safety of beclomethasone compared to other drugs used in pregnant asthmatic women. Copyright © 2013 SEICAP. Published by Elsevier Espana. All rights reserved.

Indicators of safety compromise in gastrointestinal endoscopy.

PubMed

Borgaonkar, Mark Ram; Hookey, Lawrence; Hollingworth, Roger; Kuipers, Ernst J; Forster, Alan; Armstrong, David; Barkun, Alan; Bridges, Ron; Carter, Rose; de Gara, Chris; Dube, Catherine; Enns, Robert; Macintosh, Donald; Forget, Sylviane; Leontiadis, Grigorios; Meddings, Jonathan; Cotton, Peter; Valori, Roland

2012-02-01

The importance of quality indicators has become increasingly recognized in gastrointestinal endoscopy. Patient safety requires the identification and monitoring of occurrences associated with harm or the potential for harm. The identification of relevant indicators of safety compromise is, therefore, a critical element that is key to the effective implementation of endoscopy quality improvement programs. To identify key indicators of safety compromise in gastrointestinal endoscopy. The Canadian Association of Gastroenterology Safety and Quality Indicators in Endoscopy Consensus Group was formed to address issues of quality in endoscopy. A subcommittee was formed to identify key safety indicators. A systematic literature review was undertaken, and articles pertinent to safety in endoscopy were identified and reviewed. All complications and measures used to document safety were recorded. From this, a preliminary list of 16 indicators was compiled and presented to the 35-person consensus group during a three-day meeting. A revised list of 20 items was subsequently put to the consensus group for vote for inclusion on the final list of safety indicators. Items were retained only if the consensus group highly agreed on their importance. A total of 19 indicators of safety compromise were retained and grouped into the three following categories: medication-related - the need for CPR, use of reversal agents, hypoxia, hypotension, hypertension, sedation doses in patients older than 70 years of age, allergic reactions and laryngospasm⁄bronchospasm; procedure-related early - perforation, immediate postpolypectomy bleeding, need for hospital admission or transfer to emergency department from the gastroenterology unit, instrument impaction, severe persistent abdominal pain requiring evaluation proven to not be perforation; and procedure-related delayed - death within 30 days of procedure, 14-day unplanned hospitalization, 14-day unplanned contact with a health provider, gastrointestinal bleeding within 14 days of procedure, infection or symptomatic metabolic complications. The 19 indicators of safety compromise in endoscopy, identified by a rigorous, evidence-based consensus process, provide clear outcomes to be recorded by all facilities as part of their continuing quality improvement programs.

Clinical and cost-effectiveness, safety and acceptability of community intravenous antibiotic service models: CIVAS systematic review.

PubMed

Mitchell, E D; Czoski Murray, C; Meads, D; Minton, J; Wright, J; Twiddy, M

2017-04-20

Evaluate evidence of the efficacy, safety, acceptability and cost-effectiveness of outpatient parenteral antimicrobial therapy (OPAT) models. A systematic review. MEDLINE, EMBASE, CINAHL, Cochrane Library, National Health Service (NHS) Economic Evaluation Database (EED), Research Papers in Economics (RePEc), Tufts Cost-Effectiveness Analysis (CEA) Registry, Health Business Elite, Health Information Management Consortium (HMIC), Web of Science Proceedings, International Pharmaceutical Abstracts, British Society for Antimicrobial Chemotherapy website. Searches were undertaken from 1993 to 2015. All studies, except case reports, considering adult patients or practitioners involved in the delivery of OPAT were included. Studies combining outcomes for adults and children or non-intravenous (IV) and IV antibiotic groups were excluded, as were those focused on process of delivery or clinical effectiveness of 1 antibiotic over another. Titles/abstracts were screened by 1 reviewer (20% verified). 2 authors independently screened studies for inclusion. 128 studies involving >60 000 OPAT episodes were included. 22 studies (17%) did not indicate the OPAT model used; only 29 involved a comparator (23%). There was little difference in duration of OPAT treatment compared with inpatient therapy, and overall OPAT appeared to produce superior cure/improvement rates. However, when models were considered individually, outpatient delivery appeared to be less effective, and self-administration and specialist nurse delivery more effective. Drug side effects, deaths and hospital readmissions were similar to those for inpatient treatment, but there were more line-related complications. Patient satisfaction was high, with advantages seen in being able to resume daily activities and having greater freedom and control. However, most professionals perceived challenges in providing OPAT. There were no systematic differences related to the impact of OPAT on treatment duration or adverse events. However, evidence of its clinical benefit compared with traditional inpatient treatment is lacking, primarily due to the dearth of good quality comparative studies. There was high patient satisfaction with OPAT use but the few studies considering practitioner acceptability highlighted organisational and logistic barriers to its delivery. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Clinical and cost-effectiveness, safety and acceptability of community intravenous antibiotic service models: CIVAS systematic review

PubMed Central

Czoski Murray, C; Meads, D; Minton, J; Twiddy, M

2017-01-01

Objective Evaluate evidence of the efficacy, safety, acceptability and cost-effectiveness of outpatient parenteral antimicrobial therapy (OPAT) models. Design A systematic review. Data sources MEDLINE, EMBASE, CINAHL, Cochrane Library, National Health Service (NHS) Economic Evaluation Database (EED), Research Papers in Economics (RePEc), Tufts Cost-Effectiveness Analysis (CEA) Registry, Health Business Elite, Health Information Management Consortium (HMIC), Web of Science Proceedings, International Pharmaceutical Abstracts, British Society for Antimicrobial Chemotherapy website. Searches were undertaken from 1993 to 2015. Study selection All studies, except case reports, considering adult patients or practitioners involved in the delivery of OPAT were included. Studies combining outcomes for adults and children or non-intravenous (IV) and IV antibiotic groups were excluded, as were those focused on process of delivery or clinical effectiveness of 1 antibiotic over another. Titles/abstracts were screened by 1 reviewer (20% verified). 2 authors independently screened studies for inclusion. Results 128 studies involving >60 000 OPAT episodes were included. 22 studies (17%) did not indicate the OPAT model used; only 29 involved a comparator (23%). There was little difference in duration of OPAT treatment compared with inpatient therapy, and overall OPAT appeared to produce superior cure/improvement rates. However, when models were considered individually, outpatient delivery appeared to be less effective, and self-administration and specialist nurse delivery more effective. Drug side effects, deaths and hospital readmissions were similar to those for inpatient treatment, but there were more line-related complications. Patient satisfaction was high, with advantages seen in being able to resume daily activities and having greater freedom and control. However, most professionals perceived challenges in providing OPAT. Conclusions There were no systematic differences related to the impact of OPAT on treatment duration or adverse events. However, evidence of its clinical benefit compared with traditional inpatient treatment is lacking, primarily due to the dearth of good quality comparative studies. There was high patient satisfaction with OPAT use but the few studies considering practitioner acceptability highlighted organisational and logistic barriers to its delivery. PMID:28428184

Antenatal interventions to reduce preterm birth: an overview of Cochrane systematic reviews

PubMed Central

2014-01-01

Background Several factors are associated with an increased risk of preterm birth (PTB); therefore, various interventions might have the potential to influence it. Due to the large number of interventions that address PTB, the objective of this overview is to summarise evidence from Cochrane reviews regarding the effects and safety of these different interventions. Methods We conducted a systematic literature search in the Cochrane Database of Systematic Reviews. Included reviews should be based on randomised controlled trials comparing antenatal non-pharmacological and pharmacological interventions that directly or indirectly address PTB with placebo/no treatment or routine care in pregnant women at less than 37 completed weeks of gestation without signs of threatened preterm labour. We considered PTB at less than 37 completed weeks of gestation as the primary outcome. Results We included 56 Cochrane systematic reviews. Three interventions increased PTB risk significantly. Twelve interventions led to a statistically significant lower incidence of PTBs. However, this reduction was mostly observed in defined at-risk subgroups of pregnant women. The remaining antenatal interventions failed to prove a significant effect on PTB < 37 weeks, but some of them at least showed a positive effect in secondary outcomes (e.g., reduction in early PTBs). As an unintended result of this review, we identified 28 additional Cochrane reviews which intended to report on PTB < 37 weeks, but were not able to find any RCTs reporting appropriate data. Conclusions The possible effects of a diverse range of interventions on PTB have been evaluated in Cochrane systematic reviews. Few interventions have been demonstrated to be effective and a small number have been found to be harmful. For around half of the interventions evaluated, the Cochrane review concluded that there was insufficient evidence to provide sound recommendations for clinical practice. No RCT evidence is available for a number of potentially relevant interventions. PMID:24758148

Antenatal interventions to reduce preterm birth: an overview of Cochrane Systematic Reviews.

PubMed

Piso, Brigitte; Zechmeister-Koss, Ingrid; Winkler, Roman

2014-04-23

Several factors are associated with an increased risk of preterm birth (PTB); therefore, various interventions might have the potential to influence it. Due to the large number of interventions that address PTB, the objective of this overview is to summarise evidence from Cochrane reviews regarding the effects and safety of these different interventions. We conducted a systematic literature search in the Cochrane Database of Systematic Reviews. Included reviews should be based on randomised controlled trials comparing antenatal non-pharmacological and pharmacological interventions that directly or indirectly address PTB with placebo/no treatment or routine care in pregnant women at less than 37 completed weeks of gestation without signs of threatened preterm labour. We considered PTB at less than 37 completed weeks of gestation as the primary outcome. We included 56 Cochrane systematic reviews. Three interventions increased PTB risk significantly. Twelve interventions led to a statistically significant lower incidence of PTBs. However, this reduction was mostly observed in defined at-risk subgroups of pregnant women. The remaining antenatal interventions failed to prove a significant effect on PTB < 37 weeks, but some of them at least showed a positive effect in secondary outcomes (e.g., reduction in early PTBs). As an unintended result of this review, we identified 28 additional Cochrane reviews which intended to report on PTB < 37 weeks, but were not able to find any RCTs reporting appropriate data. The possible effects of a diverse range of interventions on PTB have been evaluated in Cochrane systematic reviews. Few interventions have been demonstrated to be effective and a small number have been found to be harmful. For around half of the interventions evaluated, the Cochrane review concluded that there was insufficient evidence to provide sound recommendations for clinical practice. No RCT evidence is available for a number of potentially relevant interventions.

The Efficacy and Clinical Safety of Various Analgesic Combinations for Post-Operative Pain after Third Molar Surgery: A Systematic Review and Meta-Analysis

PubMed Central

Au, Alvin Ho Yeung; Choi, Siu Wai; Cheung, Chi Wai; Leung, Yiu Yan

2015-01-01

Objectives To run a systematic review and meta-analysis of randomized clinical trials aiming to answer the clinical question “which analgesic combination and dosage is potentially the most effective and safe for acute post-operative pain control after third molar surgery?”. Materials and Methods A systematic search of computer databases and journals was performed. The search and the evaluations of articles were performed by 2 independent reviewers in 3 rounds. Randomized clinical trials related to analgesic combinations for acute post-operative pain control after lower third molar surgery that matched the selection criteria were evaluated to enter in the final review. Results Fourteen studies with 3521 subjects, with 10 groups (17 dosages) of analgesic combinations were included in the final review. The analgesic efficacy were presented by the objective pain measurements including sum of pain intensity at 6 hours (SPID6) and total pain relief at 6 hours (TOTPAR6). The SPID6 scores and TOTPAR6 scores of the reported analgesic combinations were ranged from 1.46 to 6.44 and 3.24 – 10.3, respectively. Ibuprofen 400mg with oxycodone HCL 5mg had superior efficacy (SPID6: 6.44, TOTPAR6: 9.31). Nausea was the most common adverse effect, with prevalence ranging from 0-55%. Ibuprofen 200mg with caffeine 100mg or 200mg had a reasonable analgesic effect with fewer side effects. Conclusion This systematic review and meta-analysis may help clinicians in their choices of prescribing an analgesic combination for acute post-operative pain control after lower third molar surgery. It was found in this systematic review Ibuprofen 400mg combined with oxycodone HCL 5mg has superior analgesic efficacy when compared to the other analgesic combinations included in this study. PMID:26053953

Neck pain with radiculopathy.

PubMed

Bhagawati, Dimpu; Gwilym, Stephen

2015-12-23

Non-specific neck pain has a postural or mechanical basis and affects about two-thirds of people at some stage, especially in middle age. Acute neck pain resolves within days or weeks, but may become chronic in about 10% of people. Whiplash injuries follow sudden acceleration-deceleration of the neck, such as in road traffic or sporting accidents. Up to 40% of people continue to report symptoms 15 years after the accident, although this varies between countries. We conducted a systematic overview, aiming to answer the following clinical questions: What are the effects of surgical treatments for neck pain with radiculopathy? What are the effects of injection treatments for neck pain with radiculopathy? What are the effects of drug treatments for neck pain with radiculopathy? We searched: Medline, Embase, The Cochrane Library, and other important databases up to September 2014 (Clinical Evidence overviews are updated periodically; please check our website for the most up-to-date version of this overview). At this update, searching of electronic databases retrieved 368 studies. After deduplication and removal of conference abstracts, 226 records were screened for inclusion in the overview. Appraisal of titles and abstracts led to the exclusion of 142 studies and the further review of 41 full publications. Of the 41 full articles evaluated, four systematic reviews and one RCT were added at this update. We performed a GRADE evaluation for three PICO combinations. In this systematic overview, we categorised the efficacy for three interventions based on information about the effectiveness and safety of drug treatments, injection treatments, and surgical treatments.

Herbal treatments for alleviating premenstrual symptoms: a systematic review.

PubMed

Dante, Giulia; Facchinetti, Fabio

2011-03-01

Premenstrual syndrome (PMS) is a condition of cyclical and recurrent physical and psychological discomfort occurring 1 to 2 weeks before menstrual period. More severe psychological symptoms have been described for the premenstrual dysphoric disorder (PMDD). No single treatment is universally recognised as effective and many patients often turn to therapeutic approaches outside of conventional medicine. This systematic review is aimed at analysing the effects of herb remedies in the above conditions. Systematic literature searches were performed in electronic databases, covering the period January 1980 to September 2010. Randomised controlled clinical trials (RCTs) were included. Papers quality was evaluated with the Jadad' scale. A further evaluation of PMS/PMDD diagnostic criteria was also done. Of 102 articles identified, 17 RCTs were eligible and 10 of them were included. The heterogeneity of population included, study design and outcome presentation refrained from a meta-analysis. Vitex agnus castus was the more investigated remedy (four trials, about 500 women), and it was reported to consistently ameliorate PMS better than placebo. Single trials also support the use of either Gingko biloba or Crocus sativus. On the contrary, neither evening primrose oil nor St. John's Wort show an effect different than placebo. None of the herbs was associated with major health risks, although the reduced number of tested patients does not allow definitive conclusions on safety. Some herb remedies seem useful for the treatment of PMS. However, more RCTs are required to account for the heterogeneity of the syndrome.

[A systemic risk analysis of hospital management processes by medical employees--an effective basis for improving patient safety].

PubMed

Sobottka, Stephan B; Eberlein-Gonska, Maria; Schackert, Gabriele; Töpfer, Armin

2009-01-01

Due to the knowledge gap that exists between patients and health care staff the quality of medical treatment usually cannot be assessed securely by patients. For an optimization of safety in treatment-related processes of medical care, the medical staff needs to be actively involved in preventive and proactive quality management. Using voluntary, confidential and non-punitive systematic employee surveys, vulnerable topics and areas in patient care revealing preventable risks can be identified at an early stage. Preventive measures to continuously optimize treatment quality can be defined by creating a risk portfolio and a priority list of vulnerable topics. Whereas critical incident reporting systems are suitable for continuous risk assessment by detecting safety-relevant single events, employee surveys permit to conduct a systematic risk analysis of all treatment-related processes of patient care at any given point in time.

Violence and legalized brothel prostitution in Nevada: examining safety, risk, and prostitution policy.

PubMed

Brents, Barbara G; Hausbeck, Kathryn

2005-03-01

This article examines violence in legalized brothels in Nevada. Debates over prostitution policies in the United States have long focused on questions of safety and risk. These discourses inevitably invoke the coupling of violence and prostitution, though systematic examinations of the relationship between the two are sparse. This article explores the issue of violence in the Nevada brothel industry. By drawing on interviews with prostitutes, managers, and policy makers, this article examines both prostitutes' perceptions of safety and risk and brothel managers' practices designed to mitigate violence. Discourses relate to three types of violence: interpersonal violence against prostitutes, violence against community order, and sexually transmitted diseases as violence. The authors conclude by arguing that the legalization of prostitution brings a level of public scrutiny, official regulation, and bureaucratization to brothels that decreases the risk of these 3 types of systematic violence.

Possible overexposure of pregnant women to emissions from a walk through metal detector.

PubMed

Wu, Dagang; Qiang, Rui; Chen, Ji; Seidman, Seth; Witters, Donald; Kainz, Wolfgang

2007-10-07

This paper presents a systematic procedure to evaluate the induced current densities and electric fields due to walk-through metal detector (WTMD) exposure. This procedure is then used to assess the exposure of nine pregnant women models exposed to one WTMD model. First, we measured the magnetic field generated by the WTMD, then we extracted the equivalent current source to represent the WTMD emissions and finally we calculated the induced current densities and electric fields using the impedance method. The WTMD emissions and the induced fields in the pregnant women and fetus models are then compared to the ICNIRP Guidelines and the IEEE C95.6 exposure safety standard. The results prove the consistency between maximum permissible exposure (MPE) levels and basic restrictions for the ICNIRP Guidelines and IEEE C95.6. We also found that this particular WTMD complies with the ICNIRP basic restrictions for month 1-5 models, but leads to both fetus and pregnant women overexposure for month 6-9 models. The IEEE C95.6 restrictions (MPEs and basic restrictions) are not exceeded. The fetus overexposure of this particular WTMD calls for carefully conducted safety evaluations of security systems before they are deployed.

Possible overexposure of pregnant women to emissions from a walk through metal detector

NASA Astrophysics Data System (ADS)

Wu, Dagang; Qiang, Rui; Chen, Ji; Seidman, Seth; Witters, Donald; Kainz, Wolfgang

2007-09-01

This paper presents a systematic procedure to evaluate the induced current densities and electric fields due to walk-through metal detector (WTMD) exposure. This procedure is then used to assess the exposure of nine pregnant women models exposed to one WTMD model. First, we measured the magnetic field generated by the WTMD, then we extracted the equivalent current source to represent the WTMD emissions and finally we calculated the induced current densities and electric fields using the impedance method. The WTMD emissions and the induced fields in the pregnant women and fetus models are then compared to the ICNIRP Guidelines and the IEEE C95.6 exposure safety standard. The results prove the consistency between maximum permissible exposure (MPE) levels and basic restrictions for the ICNIRP Guidelines and IEEE C95.6. We also found that this particular WTMD complies with the ICNIRP basic restrictions for month 1-5 models, but leads to both fetus and pregnant women overexposure for month 6-9 models. The IEEE C95.6 restrictions (MPEs and basic restrictions) are not exceeded. The fetus overexposure of this particular WTMD calls for carefully conducted safety evaluations of security systems before they are deployed.

The effect of volatility on percutaneous absorption.

PubMed

Rouse, Nicole C; Maibach, Howard I

2016-01-01

Topically applied chemicals may volatilize, or evaporate, from skin leaving behind a chemical residue with new percutaneous absorptive capabilities. Understanding volatilization of topical medications, such as sunscreens, fragrances, insect repellants, cosmetics and other commonly applied topicals may have implications for their safety and efficacy. A systematic review of English language articles from 1979 to 2014 was performed using key search terms. Articles were evaluated to assess the relationship between volatility and percutaneous absorption. A total of 12 articles were selected and reviewed. Key findings were that absorption is enhanced when coupled with a volatile substance, occlusion prevents evaporation and increases absorption, high ventilation increases volatilization and reduces absorption, and pH of skin has an affect on a chemical's volatility. The articles also brought to light that different methods may have an affect on volatility: different body regions; in vivo vs. in vitro; human vs. Data suggest that volatility is crucial for determining safety and efficacy of cutaneous exposures and therapies. Few articles have been documented reporting evaporation in the context of percutaneous absorption, and of those published, great variability exists in methods. Further investigation of volatility is needed to properly evaluate its role in percutaneous absorption.

Preclinical evaluations of norcantharidin-loaded intravenous lipid microspheres with low toxicity.

PubMed

Lin, Xia; Zhang, Bo; Zhang, Keru; Zhang, Yu; Wang, Juan; Qi, Na; Yang, Shenshen; He, Haibing; Tang, Xing

2012-12-01

The aim of this study was to perform a systematic preclinical evaluation of norcantharidin (NCTD)-loaded intravenous lipid microspheres (NLM). Pharmacokinetics, biodistribution, antitumor efficacy and drug safety assessment (including acute toxicity, subchronic toxicity, hemolysis testing, intravenous stimulation and injection anaphylaxis) of NLM were carried out in comparison with the commercial product disodium norcantharidate injection (NI). The pharmacokinetics of NLM in rats was similar to that of NI, and a non-linear correlation was observed between AUC and dose. A comparable antitumor efficacy of NLM and NI was observed in mice inoculated with A549, BEL7402 and BCAP-37 cell lines. It was worth noting that the NLM produced a lower drug concentration in heart compared with NI, and significantly reduced the cardiac and renal toxicity. The LD(50) of NLM was twice higher than that of NI. In NLM, over 80% of NCTD was loaded in the lipid phase or bound with phospholipids. Thus, NCTD was sequestered by direct contacting with body fluids and largely avoided distribution into tissues, consequently leading to significantly reduced cardiac and renal toxicity. These preclinical results suggested that NLM could be a useful potential carrier for parenteral administration of NCTD, while providing a superior safety profile.

Exercise Therapy in Juvenile Idiopathic Arthritis: A Systematic Review and Meta-Analysis.

PubMed

Kuntze, Gregor; Nesbitt, Colleen; Whittaker, Jackie L; Nettel-Aguirre, Alberto; Toomey, Clodagh; Esau, Shane; Doyle-Baker, Patricia K; Shank, Jena; Brooks, Julia; Benseler, Susanne; Emery, Carolyn A

2018-01-01

To conduct a systematic review to evaluate the efficacy of exercise interventions in improving outcomes across domains of functioning and disability in children and adolescents with juvenile idiopathic arthritis (JIA). Seven electronic databases were systematically searched up to November 16, 2016. Original data, analytic prospective design, physical therapy-led exercise intervention evaluation, children and adolescents with JIA, and assessment of functional, structural, activity, participation, or quality of life outcomes. Two authors screened search results, and discrepancies were resolved by consensus. Of 5037 potentially relevant studies, 9 randomized controlled trials and 1 cohort study were included and scored. Study quality (Downs and Black quality assessment tool) and level of evidence (Oxford Centre of Evidence-Based Medicine model) were assessed and meta-analysis conducted where appropriate. Alternatively, a descriptive summary approach was chosen. All randomized controlled trials were moderate-quality intervention studies (level 2b evidence; median Downs and Black score, 20 out of 32; range, 15-27). Interventions included aquatic, strengthening, proprioceptive, aerobic, and Pilates exercises. Pediatric activity capacity (Child Health Assessment Questionnaire) improved with exercise (mean difference, .45; 95% confidence interval, .05-.76). Furthermore, descriptive summaries indicated improved activity capacity, body function and structure (pain and muscle strength), and quality of life outcomes. Exercise therapy appears to be well tolerated and beneficial across clinically relevant outcomes in patients with JIA. The paucity of high-quality evidence and study heterogeneity limited the ability to provide conclusive, generalizing evidence for the efficacy of exercise therapy and to provide specific recommendations for clinical practice at this time. Future research evaluating exercise program implementation using validated outcomes and detailed adherence and safety assessment is needed to optimize clinical decision pathways in patients with JIA. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Efficacy and safety of oral tranexamic acid in total knee arthroplasty: A systematic review and meta-analysis.

PubMed

Guo, Peipei; He, Zike; Wang, Yanhua; Gao, Fuqiang; Sun, Wei; Guo, Wanshou; Li, Zirong; Cheng, Liming

2018-05-01

Tranexamic acid (TXA) is an antifibrinolytic drug widely used as a blood-sparing technique in total knee arthroplasty (TKA), and it is usually administrated by intravenous or intraarticular injection. Recently, the oral form of TXA has been applied in TKA patients. However, there is no final consensus regarding the effectiveness and safety of oral TXA. The purpose of this systematic review and meta-analysis of randomized controlled trials (RCTs) was to evaluate the efficacy and safety of oral TXA versus control for blood loss after TKA. We searched PubMed, Embase, Medline, Web of Science, and Cochrane Library databases for relevant studies through August 2017. The mean difference (MD) of total blood loss, hemoglobin (Hb) drop, hematocrit (Hct), drain output, and risk difference (RD) of transfusion rate and thromboembolic complications in the TXA and control groups were pooled throughout the study. The outcomes were pooled by Stata 12.0. A total of 5 RCTs (608 patients) were included in this study. All the included studies were randomized and the quality of included studies was relatively high. The pooled results indicated that the oral TXA group had significantly less Hb drop (standardized mean difference [SMD], -0.936; 95% confidence intervals [CI], -1.118,-0.754), Hct drop (SMD, -0.693; 95% CI, -1.113, -0.274), and drain output (SMD, -0.793; 95% CI, -0.959, -0.628) than the control group. No statistically significant differences were found in transfusion rate and the incidence of thromboembolic complications between the 2 groups. Total blood loss could not be evaluated for the insufficient date. Our meta-analysis suggested that the administration of oral TXA provided significantly better results with respect to Hb drop, Hct drop, and drain output without increasing the transfusion rate and the risk of thromboembolic complications after TKA. Nevertheless, our current study with some limitations such as the small sample size only provided limited quality of evidence, confirmation from further meta-analysis with large-scale, well-designed RCTs is required.

Rapid intravenous rehydration of children with acute gastroenteritis and dehydration: a systematic review and meta-analysis.

PubMed

Iro, M A; Sell, T; Brown, N; Maitland, K

2018-02-09

The World Health Organization (WHO) recommends rapid intravenous rehydration, using fluid volumes of 70-100mls/kg over 3-6 h, with some of the initial volume given rapidly as initial fluid boluses to treat hypovolaemic shock for children with acute gastroenteritis (AGE) and severe dehydration. The evidence supporting the safety and efficacy of rapid versus slower rehydration remains uncertain. We conducted a systematic review of randomised controlled trials (RCTs) on 11th of May 2017 comparing different rates of intravenous fluid therapy in children with AGE and moderate or severe dehydration, using standard search terms. Two authors independently assessed trial quality and extracted data. Non-RCTs and non-English articles were excluded. The primary endpoint was mortality and secondary endpoints included adverse events (safety) and treatment efficacy. Of the 1390 studies initially identified, 18 were assessed for eligibility. Of these, 3 studies (n = 464) fulfilled a priori criteria for inclusion; most studied children with moderate dehydration and none were conducted in resource-poor settings. Volumes and rates of fluid replacement varied from 20 to 60 ml/kg given over 1-2 h (fast) versus 2-4 h (slow). There was substantial heterogeneity in methodology between the studies with only one adjudicated to be of high quality. There were no deaths in any study. Safety endpoints only identified oedema (n = 6) and dysnatraemia (n = 2). Pooled analysis showed no significant difference between the rapid and slow intravenous rehydration groups for the proportion of treatment failures (N = 468): pooled RR 1.30 (95% CI: 0.87, 1.93) and the readmission rates (N = 439): pooled RR 1.39 (95% CI: 0.68, 2.85). Despite wide implementation of WHO Plan C guideline for severe AGE, we found no clinical evaluation in resource-limited settings, and only limited evaluation of the rate and volume of rehydration in other parts of the world. Recent concerns over aggressive fluid expansion warrants further research to inform guidelines on rates of intravenous rehydration therapy for severe AGE.

Information processing requirements for on-board monitoring of automatic landing

NASA Technical Reports Server (NTRS)

Sorensen, J. A.; Karmarkar, J. S.

1977-01-01

A systematic procedure is presented for determining the information processing requirements for on-board monitoring of automatic landing systems. The monitoring system detects landing anomalies through use of appropriate statistical tests. The time-to-correct aircraft perturbations is determined from covariance analyses using a sequence of suitable aircraft/autoland/pilot models. The covariance results are used to establish landing safety and a fault recovery operating envelope via an event outcome tree. This procedure is demonstrated with examples using the NASA Terminal Configured Vehicle (B-737 aircraft). The procedure can also be used to define decision height, assess monitoring implementation requirements, and evaluate alternate autoland configurations.

Management of Fatigue in Persons with Multiple Sclerosis

PubMed Central

Khan, Fary; Amatya, Bhasker; Galea, Mary

2014-01-01

Fatigue is one of the most common symptoms of multiple sclerosis. Despite advances in pharmacological and non-pharmacological treatment, fatigue continues to be the disabling symptom in persons with MS (pwMS), affecting almost 80% of pwMS. In current practice, both pharmacological and non-pharmacological interventions are used in combination, encompassing a multi-disciplinary approach. The body of research investigating the effect of these interventions is growing. This review systematically evaluated the existing evidence on the effectiveness and safety of different interventions currently applied for the management of fatigue in person with multiple sclerosis in improving patient outcomes, to guide treating clinicians. PMID:25309504

Cannabis for the Management of Pain: Assessment of Safety Study (COMPASS).

PubMed

Ware, Mark A; Wang, Tongtong; Shapiro, Stan; Collet, Jean-Paul

2015-12-01

Cannabis is widely used as a self-management strategy by patients with a wide range of symptoms and diseases including chronic non-cancer pain. The safety of cannabis use for medical purposes has not been systematically evaluated. We conducted a prospective cohort study to describe safety issues among individuals with chronic non-cancer pain. A standardized herbal cannabis product (12.5% tetrahydrocannabinol) was dispensed to eligible individuals for a 1-year period; controls were individuals with chronic pain from the same clinics who were not cannabis users. The primary outcome consisted of serious adverse events and non-serious adverse events. Secondary safety outcomes included pulmonary and neurocognitive function and standard hematology, biochemistry, renal, liver, and endocrine function. Secondary efficacy parameters included pain and other symptoms, mood, and quality of life. Two hundred and fifteen individuals with chronic pain were recruited to the cannabis group (141 current users and 58 ex-users) and 216 controls (chronic pain but no current cannabis use) from 7 clinics across Canada. The median daily cannabis dose was 2.5 g/d. There was no difference in risk of serious adverse events (adjusted incidence rate ratio = 1.08, 95% confidence interval = .57-2.04) between groups. Medical cannabis users were at increased risk of non-serious adverse events (adjusted incidence rate ratio = 1.73, 95% confidence interval = 1.41-2.13); most were mild to moderate. There were no differences in secondary safety assessments. Quality-controlled herbal cannabis, when used by patients with experience of cannabis use as part of a monitored treatment program over 1 year, appears to have a reasonable safety profile. Longer-term monitoring for functional outcomes is needed. The study was registered with www.controlled-trials.com (ISRCTN19449752). This study evaluated the safety of cannabis use by patients with chronic pain over 1 year. The study found that there was a higher rate of adverse events among cannabis users compared with controls but not for serious adverse events at an average dose of 2.5 g herbal cannabis per day. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

How Effective Are Incident-Reporting Systems for Improving Patient Safety? A Systematic Literature Review

PubMed Central

Stavropoulou, Charitini; Doherty, Carole; Tosey, Paul

2015-01-01

Context Incident-reporting systems (IRSs) are used to gather information about patient safety incidents. Despite the financial burden they imply, however, little is known about their effectiveness. This article systematically reviews the effectiveness of IRSs as a method of improving patient safety through organizational learning. Methods Our systematic literature review identified 2 groups of studies: (1) those comparing the effectiveness of IRSs with other methods of error reporting and (2) those examining the effectiveness of IRSs on settings, structures, and outcomes in regard to improving patient safety. We used thematic analysis to compare the effectiveness of IRSs with other methods and to synthesize what was effective, where, and why. Then, to assess the evidence concerning the ability of IRSs to facilitate organizational learning, we analyzed studies using the concepts of single-loop and double-loop learning. Findings In total, we identified 43 studies, 8 that compared IRSs with other methods and 35 that explored the effectiveness of IRSs on settings, structures, and outcomes. We did not find strong evidence that IRSs performed better than other methods. We did find some evidence of single-loop learning, that is, changes to clinical settings or processes as a consequence of learning from IRSs, but little evidence of either improvements in outcomes or changes in the latent managerial factors involved in error production. In addition, there was insubstantial evidence of IRSs enabling double-loop learning, that is, a cultural change or a change in mind-set. Conclusions The results indicate that IRSs could be more effective if the criteria for what counts as an incident were explicit, they were owned and led by clinical teams rather than centralized hospital departments, and they were embedded within organizations as part of wider safety programs. PMID:26626987

Safety profile of biologic drugs in the therapy of Crohn disease: A systematic review and network meta-analysis.

PubMed

Moćko, Paweł; Kawalec, Paweł; Pilc, Andrzej

2016-12-01

Crohn disease (CD) is an inflammatory bowel disease which occurs especially in developed countries of Western Europe and North America. The aim of the study was to compare the safety profile of biologic drugs in patients with CD. A systematic literature search was performed using PubMed, Embase, and CENTRAL databases, until April 27, 2016. We included randomized controlled trials (RCTs) that compared the safety of biologic drugs (infliximab, adalimumab, vedolizumab, certolizumab pegol, and ustekinumab) with one another or with placebo in patients with CD. The network meta-analysis (NMA) was conducted for an induction phase (6-10 weeks) and maintenance phase (52-56 weeks) with a Bayesian hierarchical random effects model in the ADDIS ® software. The PROSPERO registration number was CRD42016032606. Ten RCTs were included in the systematic review with NMA. In the case of the induction phase, the NMA could be conducted for the assessment of the relative safety profile of adalimumab, vedolizumab, certolizumab pegol, and ustekinumab, and in the case of the maintenance phase-of infliximab, adalimumab, and vedolizumab. There were no significant differences in the rate of adverse events in patients treated with biologics. Statistical analysis revealed that vedolizumab had the greatest probability of being the safest treatment in most endpoints in the induction phase and adalimumab-in the maintenance phase. No significant differences between the biologics in the relative safety profile analysis were observed. Further studies are needed to confirm our findings, including head-to-head comparisons between the analyzed biologics. Copyright © 2016 Institute of Pharmacology, Polish Academy of Sciences. Published by Elsevier Urban & Partner Sp. z o.o. All rights reserved.

The effects, safety and acceptability of compact, pre-filled, autodisable injection devices when delivered by lay health workers.

PubMed

Glenton, Claire; Khanna, Rajesh; Morgan, Chris; Nilsen, Elin Strømme

2013-08-01

To systematically assess (i) the effects and safety and (ii) the acceptability of using lay health workers (LHWs) to deliver vaccines and medicines to mothers and children through compact pre-filled autodisable devices (CPADs). We searched electronic databases and grey literature. For the systematic review of effects and safety, we sought randomised and non-randomised controlled trials, controlled before-after studies and interrupted time series studies. For the systematic review of acceptability, we sought qualitative studies. Two researchers independently carried out data extraction, study quality assessment and thematic analysis of the qualitative data. No studies met our criteria for the review exploring the effects and safety of using LHWs to deliver CPADs. For the acceptability review, six qualitative studies assessed the acceptability of using LHWs to deliver hepatitis B vaccine, tetanus toxoid vaccine, gentamicin or oxytocin using Uniject™ devices. All studies took place in low- or middle-income countries and explored the perceptions of community members, LHWs, supervisors, health professionals or programme managers. Most of the studies were of low quality. Recipients generally accepted the intervention. Most health professionals were confident that LHWs could deliver the intervention with sufficient training and supervision, but some had problems delivering supervision. The LHWs perceived Uniject™ as effective and important and were motivated by positive responses from the community. However, some LHWs feared the consequences if harm should come to recipients. Evidence of the effects and safety of using CPADs delivered by LHWs is lacking. Evidence regarding acceptability suggests that this intervention may be acceptable although LHWs may feel vulnerable to blame. © 2013 John Wiley & Sons Ltd.

23 CFR 630.1006 - Work zone safety and mobility policy.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 23 Highways 1 2010-04-01 2010-04-01 false Work zone safety and mobility policy. 630.1006 Section... policy. Each State shall implement a policy for the systematic consideration and management of work zone impacts on all Federal-aid highway projects. This policy shall address work zone impacts throughout the...

Violence and Legalized Brothel Prostitution in Nevada: Examining Safety, Risk, and Prostitution Policy

ERIC Educational Resources Information Center

Brents, Barbara G.; Hausbeck, Kathryn

2005-01-01

This article examines violence in legalized brothels in Nevada. Debates over prostitution policies in the United States have long focused on questions of safety and risk. These discourses inevitably invoke the coupling of violence and prostitution, though systematic examinations of the relationship between the two are sparse. This article explores…

Making Safety Systematic at City University of New York.

ERIC Educational Resources Information Center

Dodson, Ann Elizabeth; Hundley, Esther

2002-01-01

Describes a program involving the Dormitory Authority of the State of New York (DASNY) and the City University of New York (CUNY) in which a private contractor provides annual loss-prevention surveys and detailed safety reports for buildings at every CUNY campus. Discusses why the program has worked and its benefits. (EV)

Effectiveness of Occupational Health and Safety Training: A Systematic Review with Meta-Analysis

ERIC Educational Resources Information Center

Ricci, Federico; Chiesi, Andrea; Bisio, Carlo; Panari, Chiara; Pelosi, Annalisa

2016-01-01

Purpose: This meta-analysis aims to verify the efficacy of occupational health and safety (OHS) training in terms of knowledge, attitude and beliefs, behavior and health. Design/methodology/approach: The authors included studies published in English (2007-2014) selected from ten databases. Eligibility criteria were studies concerned with the…

A National Estimate of Performance: Statewide Highway Safety Program Assessment.

ERIC Educational Resources Information Center

National Highway Traffic Safety Administration (DOT), Washington, DC.

A nationwide systematic approach to assess the developments and achievements of highway safety activities was conducted to measure program outputs from 1969 through 1974 using key indicators of performance such as ratios and percentages. A sample of 10 states was selected with overall sample of 105 local jurisdictions which would provide estimated…

Immunogenicity, effectiveness and safety of combined hepatitis A and B vaccine: a systematic literature review.

PubMed

Bakker, Marina; Bunge, Eveline M; Marano, Cinzia; de Ridder, Marc; De Moerlooze, Laurence

2016-07-01

Hepatitis A and B are two of the most common vaccine-preventable diseases and vaccination for Hepatitis A virus (HAV) and hepatitis B virus (HBV) is recommended for those at risk of contracting HAV and/or HBV through their occupation, travel or lifestyle. To describe the vaccine efficacy, immunogenicity, effectiveness and safety of the combined vaccine against hepatitis A and hepatitis B. A systematic review of the literature published between 1990 and 2015. Anti-HAV seropositivity rates ranged from 96.2% to 100% and anti-HBs seroprotection rates from 82% to 100%. Antibodies persisted up to 15 years and geometric mean concentration (GMC) remained above the seropositivity cut-off value for both. Anti-HAV and anti-HBs immune responses were lower in less immunocompetent individuals one month after completion of the immunization schedule. The safety profiles of Twinrix(TM) and monovalent hepatitis A and B vaccines were similar. The vaccine offers satisfactory long-term immunogenicity rates, expected duration of protection and safety profile similar to the monovalent hepatitis A or B vaccines.

The relationship between patient safety climate and standard precaution adherence: a systematic review of the literature

PubMed Central

Hessels, Amanda; Larson, Elaine

2015-01-01

SUMMARY Standard precaution (SP) adherence is universally suboptimal, despite being a core component of healthcare-associated infection (HCAI) prevention and healthcare worker (HCW) safety. Emerging evidence suggests that patient safety climate (PSC) factors may improve HCW behaviours. Our aim was to examine the relationship between PSC and SP adherence by HCWs in acute care hospitals. A systematic review was conducted as guided by the Preferred Reporting Items for Systematic Reviews and Meta-Analysis. Three electronic databases were comprehensively searched for literature published or available in English between 2000 and 2014. Seven of 888 articles identified were eligible for final inclusion in the review. Two reviewers independently assessed study quality using a validated quality tool. The seven articles were assigned quality scores ranging from 7 to 10 of 10 possible points. Five measured all aspects of SP and two solely measured needlestick and sharps handling. Three included a secondary outcome of HCW exposure; none included HCAIs. All reported a statistically significant relationship between better PSC and greater SP adherence and used data from self-report surveys including validated PSC measures or measures of management support and leadership. Although limited in number, studies were of high quality and confirmed that PSC and SP adherence were correlated, suggesting that efforts to improve PSC may enhance adherence to a core component of HCAI prevention and HCW safety. More clearly evident is the need for additional high-quality research. PMID:26549480

Patient safety risks associated with telecare: a systematic review and narrative synthesis of the literature.

PubMed

Guise, Veslemøy; Anderson, Janet; Wiig, Siri

2014-11-25

Patient safety risk in the homecare context and patient safety risk related to telecare are both emerging research areas. Patient safety issues associated with the use of telecare in homecare services are therefore not clearly understood. It is unclear what the patient safety risks are, how patient safety issues have been investigated, and what research is still needed to provide a comprehensive picture of risks, challenges and potential harm to patients due to the implementation and use of telecare services in the home. Furthermore, it is unclear how training for telecare users has addressed patient safety issues. A systematic review of the literature was conducted to identify patient safety risks associated with telecare use in homecare services and to investigate whether and how these patient safety risks have been addressed in telecare training. Six electronic databases were searched in addition to hand searches of key items, reference tracking and citation tracking. Strict inclusion and exclusion criteria were set. All included items were assessed according to set quality criteria and subjected to a narrative synthesis to organise and synthesize the findings. A human factors systems framework of patient safety was used to frame and analyse the results. 22 items were included in the review. 11 types of patient safety risks associated with telecare use in homecare services emerged. These are in the main related to the nature of homecare tasks and practices, and person-centred characteristics and capabilities, and to a lesser extent, problems with the technology and devices, organisational issues, and environmental factors. Training initiatives related to safe telecare use are not described in the literature. There is a need to better identify and describe patient safety risks related to telecare services to improve understandings of how to avoid and minimize potential harm to patients. This process can be aided by reframing known telecare implementation challenges and user experiences of telecare with the help of a human factors systems approach to patient safety.