Identifying items to assess methodological quality in physical therapy trials: a factor analysis.

PubMed

Armijo-Olivo, Susan; Cummings, Greta G; Fuentes, Jorge; Saltaji, Humam; Ha, Christine; Chisholm, Annabritt; Pasichnyk, Dion; Rogers, Todd

2014-09-01

Numerous tools and individual items have been proposed to assess the methodological quality of randomized controlled trials (RCTs). The frequency of use of these items varies according to health area, which suggests a lack of agreement regarding their relevance to trial quality or risk of bias. The objectives of this study were: (1) to identify the underlying component structure of items and (2) to determine relevant items to evaluate the quality and risk of bias of trials in physical therapy by using an exploratory factor analysis (EFA). A methodological research design was used, and an EFA was performed. Randomized controlled trials used for this study were randomly selected from searches of the Cochrane Database of Systematic Reviews. Two reviewers used 45 items gathered from 7 different quality tools to assess the methodological quality of the RCTs. An exploratory factor analysis was conducted using the principal axis factoring (PAF) method followed by varimax rotation. Principal axis factoring identified 34 items loaded on 9 common factors: (1) selection bias; (2) performance and detection bias; (3) eligibility, intervention details, and description of outcome measures; (4) psychometric properties of the main outcome; (5) contamination and adherence to treatment; (6) attrition bias; (7) data analysis; (8) sample size; and (9) control and placebo adequacy. Because of the exploratory nature of the results, a confirmatory factor analysis is needed to validate this model. To the authors' knowledge, this is the first factor analysis to explore the underlying component items used to evaluate the methodological quality or risk of bias of RCTs in physical therapy. The items and factors represent a starting point for evaluating the methodological quality and risk of bias in physical therapy trials. Empirical evidence of the association among these items with treatment effects and a confirmatory factor analysis of these results are needed to validate these items. © 2014 American Physical Therapy Association.

On the design of decoupling controllers for advanced rotorcraft in the hover case

NASA Technical Reports Server (NTRS)

Fan, M. K. H.; Tits, A.; Barlow, J.; Tsing, N. K.; Tischler, M.; Takahashi, M.

1991-01-01

A methodology for design of helicopter control systems is proposed that can account for various types of concurrent specifications: stability, decoupling between longitudinal and lateral motions, handling qualities, and physical limitations of the swashplate motions. This is achieved by synergistic use of analytical techniques (Q-parameterization of all stabilizing controllers, transfer function interpolation) and advanced numerical optimization techniques. The methodology is used to design a controller for the UH-60 helicopter in hover. Good results are achieved for decoupling and handling quality specifications.

A PRELIMINARY METHODOLOGY FOR EVALUATING THE COST-EFFECTIVENESS OF ALTERNATIVE INDOOR AIR QUALITY APPROACHES

EPA Science Inventory

The report defines a simplified methodology that can be used by indoor air quality (IAQ) diagnosticians, architects/engineers, building owners/operators, and the scientific community for preliminary comparison of the cost-effectiveness of alternative IAQ control measures for any ...

The potential for error in sampling

Treesearch

Jack Lewis

2000-01-01

Editor's note: The measurement of water quality parameters in environmental laboratories follows standard quality control protocols using methodologies approved by the U.S. Environmental Protection Agency. However, little attention has been given to quality assurance and quality control in activities outside the laboratory. This article describes some of those...

The relationship between return on investment and quality of study methodology in workplace health promotion programs.

PubMed

Baxter, Siyan; Sanderson, Kristy; Venn, Alison J; Blizzard, C Leigh; Palmer, Andrew J

2014-01-01

To determine the relationship between return on investment (ROI) and quality of study methodology in workplace health promotion programs. Data were obtained through a systematic literature search of National Health Service Economic Evaluation Database (NHS EED), Database of Abstracts of Reviews of Effects (DARE), Health Technology Database (HTA), Cost Effectiveness Analysis (CEA) Registry, EconLit, PubMed, Embase, Wiley, and Scopus. Included were articles written in English or German reporting cost(s) and benefit(s) and single or multicomponent health promotion programs on working adults. Return-to-work and workplace injury prevention studies were excluded. Methodological quality was graded using British Medical Journal Economic Evaluation Working Party checklist. Economic outcomes were presented as ROI. ROI was calculated as ROI = (benefits - costs of program)/costs of program. Results were weighted by study size and combined using meta-analysis techniques. Sensitivity analysis was performed using two additional methodological quality checklists. The influences of quality score and important study characteristics on ROI were explored. Fifty-one studies (61 intervention arms) published between 1984 and 2012 included 261,901 participants and 122,242 controls from nine industry types across 12 countries. Methodological quality scores were highly correlated between checklists (r = .84-.93). Methodological quality improved over time. Overall weighted ROI [mean ± standard deviation (confidence interval)] was 1.38 ± 1.97 (1.38-1.39), which indicated a 138% return on investment. When accounting for methodological quality, an inverse relationship to ROI was found. High-quality studies (n = 18) had a smaller mean ROI, 0.26 ± 1.74 (.23-.30), compared to moderate (n = 16) 0.90 ± 1.25 (.90-.91) and low-quality (n = 27) 2.32 ± 2.14 (2.30-2.33) studies. Randomized control trials (RCTs) (n = 12) exhibited negative ROI, -0.22 ± 2.41(-.27 to -.16). Financial returns become increasingly positive across quasi-experimental, nonexperimental, and modeled studies: 1.12 ± 2.16 (1.11-1.14), 1.61 ± 0.91 (1.56-1.65), and 2.05 ± 0.88 (2.04-2.06), respectively. Overall, mean weighted ROI in workplace health promotion demonstrated a positive ROI. Higher methodological quality studies provided evidence of smaller financial returns. Methodological quality and study design are important determinants.

Comparison of methodological quality of positive versus negative comparative studies published in Indian medical journals: a systematic review.

PubMed

Charan, Jaykaran; Chaudhari, Mayur; Jackson, Ryan; Mhaskar, Rahul; Reljic, Tea; Kumar, Ambuj

2015-06-24

Published negative studies should have the same rigour of methodological quality as studies with positive findings. However, the methodological quality of negative versus positive studies is not known. The objective was to assess the reported methodological quality of positive versus negative studies published in Indian medical journals. A systematic review (SR) was performed of all comparative studies published in Indian medical journals with a clinical science focus and impact factor >1 between 2011 and 2013. The methodological quality of randomised controlled trials (RCTs) was assessed using the Cochrane risk of bias tool, and the Newcastle-Ottawa scale for observational studies. The results were considered positive if the primary outcome was statistically significant and negative otherwise. When the primary outcome was not specified, we used data on the first outcome reported in the history followed by the results section. Differences in various methodological quality domains between positive versus negative studies were assessed by Fisher's exact test. Seven journals with 259 comparative studies were included in this SR. 24% (63/259) were RCTs, 24% (63/259) cohort studies, and 49% (128/259) case-control studies. 53% (137/259) of studies explicitly reported the primary outcome. Five studies did not report sufficient data to enable us to determine if results were positive or negative. Statistical significance was determined by p value in 78.3% (199/254), CI in 2.8% (7/254), both p value and CI in 11.8% (30/254), and only descriptive in 6.3% (16/254) of studies. The overall methodological quality was poor and no statistically significant differences between reporting of methodological quality were detected between studies with positive versus negative findings. There was no difference in the reported methodological quality of positive versus negative studies. However, the uneven reporting of positive versus negative studies (72% vs 28%) indicates a publication bias in Indian medical journals with an impact factor of >1. 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.

Systematic review of the application of quality improvement methodologies from the manufacturing industry to surgical healthcare.

PubMed

Nicolay, C R; Purkayastha, S; Greenhalgh, A; Benn, J; Chaturvedi, S; Phillips, N; Darzi, A

2012-03-01

The demand for the highest-quality patient care coupled with pressure on funding has led to the increasing use of quality improvement (QI) methodologies from the manufacturing industry. The aim of this systematic review was to identify and evaluate the application and effectiveness of these QI methodologies to the field of surgery. MEDLINE, the Cochrane Database, Allied and Complementary Medicine Database, British Nursing Index, Cumulative Index to Nursing and Allied Health Literature, Embase, Health Business(™) Elite, the Health Management Information Consortium and PsycINFO(®) were searched according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. Empirical studies were included that implemented a described QI methodology to surgical care and analysed a named outcome statistically. Some 34 of 1595 articles identified met the inclusion criteria after consensus from two independent investigators. Nine studies described continuous quality improvement (CQI), five Six Sigma, five total quality management (TQM), five plan-do-study-act (PDSA) or plan-do-check-act (PDCA) cycles, five statistical process control (SPC) or statistical quality control (SQC), four Lean and one Lean Six Sigma; 20 of the studies were undertaken in the USA. The most common aims were to reduce complications or improve outcomes (11), to reduce infection (7), and to reduce theatre delays (7). There was one randomized controlled trial. QI methodologies from industry can have significant effects on improving surgical care, from reducing infection rates to increasing operating room efficiency. The evidence is generally of suboptimal quality, and rigorous randomized multicentre studies are needed to bring evidence-based management into the same league as evidence-based medicine. Copyright © 2011 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.

Extended cooperative control synthesis

NASA Technical Reports Server (NTRS)

Davidson, John B.; Schmidt, David K.

1994-01-01

This paper reports on research for extending the Cooperative Control Synthesis methodology to include a more accurate modeling of the pilot's controller dynamics. Cooperative Control Synthesis (CCS) is a methodology that addresses the problem of how to design control laws for piloted, high-order, multivariate systems and/or non-conventional dynamic configurations in the absence of flying qualities specifications. This is accomplished by emphasizing the parallel structure inherent in any pilot-controlled, augmented vehicle. The original CCS methodology is extended to include the Modified Optimal Control Model (MOCM), which is based upon the optimal control model of the human operator developed by Kleinman, Baron, and Levison in 1970. This model provides a modeling of the pilot's compensation dynamics that is more accurate than the simplified pilot dynamic representation currently in the CCS methodology. Inclusion of the MOCM into the CCS also enables the modeling of pilot-observation perception thresholds and pilot-observation attention allocation affects. This Extended Cooperative Control Synthesis (ECCS) allows for the direct calculation of pilot and system open- and closed-loop transfer functions in pole/zero form and is readily implemented in current software capable of analysis and design for dynamic systems. Example results based upon synthesizing an augmentation control law for an acceleration command system in a compensatory tracking task using the ECCS are compared with a similar synthesis performed by using the original CCS methodology. The ECCS is shown to provide augmentation control laws that yield more favorable, predicted closed-loop flying qualities and tracking performance than those synthesized using the original CCS methodology.

How effective is the comprehensive approach to rehabilitation (CARe) methodology? A cluster randomized controlled trial.

PubMed

Bitter, Neis; Roeg, Diana; van Assen, Marcel; van Nieuwenhuizen, Chijs; van Weeghel, Jaap

2017-12-11

The CARe methodology aims to improve the quality of life of people with severe mental illness by supporting them in realizing their goals, handling their vulnerability and improving the quality of their social environment. This study aims to investigate the effectiveness of the CARe methodology for people with severe mental illness on their quality of life, personal recovery, participation, hope, empowerment, self-efficacy beliefs and unmet needs. A cluster Randomized Controlled Trial (RCT) was conducted in 14 teams of three organizations for sheltered and supported housing in the Netherlands. Teams in the intervention group received training in the CARe methodology. Teams in the control group continued working according to care as usual. Questionnaires were filled out at baseline, after 10 months and after 20 months. A total of 263 clients participated in the study. Quality of life increased in both groups, however, no differences between the intervention and control group were found. Recovery and social functioning did not change over time. Regarding the secondary outcomes, the number of unmet needs decreased in both groups. All intervention teams received the complete training program. The model fidelity at T1 was 53.4% for the intervention group and 33.4% for the control group. At T2 this was 50.6% for the intervention group and 37.2% for the control group. All clients improved in quality of life. However we did not find significant differences between the clients of the both conditions on any outcome measure. Possible explanations of these results are: the difficulty to implement rehabilitation-supporting practice, the content of the methodology and the difficulty to improve the lives of a group of people with longstanding and severe impairments in a relatively short period. More research is needed on how to improve effects of rehabilitation trainings in practice and on outcome level. ISRCTN77355880 , retrospectively registered (05/07/2013).

A Control Law Design Method Facilitating Control Power, Robustness, Agility, and Flying Qualities Tradeoffs: CRAFT

NASA Technical Reports Server (NTRS)

Murphy, Patrick C.; Davidson, John B.

1998-01-01

A multi-input, multi-output control law design methodology, named "CRAFT", is presented. CRAFT stands for the design objectives addressed, namely, Control power, Robustness, Agility, and Flying Qualities Tradeoffs. The methodology makes use of control law design metrics from each of the four design objective areas. It combines eigenspace assignment, which allows for direct specification of eigenvalues and eigenvectors, with a graphical approach for representing the metrics that captures numerous design goals in one composite illustration. Sensitivity of the metrics to eigenspace choice is clearly displayed, enabling the designer to assess the cost of design tradeoffs. This approach enhances the designer's ability to make informed design tradeoffs and to reach effective final designs. An example of the CRAFT methodology applied to an advanced experimental fighter and discussion of associated design issues are provided.

Integrated microreactor for enzymatic reaction automation: An easy step toward the quality control of monoclonal antibodies.

PubMed

Ladner, Yoann; Mas, Silvia; Coussot, Gaelle; Bartley, Killian; Montels, Jérôme; Morel, Jacques; Perrin, Catherine

2017-12-15

The main purpose of the present work is to provide a fully integrated miniaturized electrophoretic methodology in order to facilitate the quality control of monoclonal antibodies (mAbs). This methodology called D-PES, which stands for Diffusion-mediated Proteolysis combined with an Electrophoretic Separation, permits to perform subsequently mAb tryptic digestion and electrophoresis separation of proteolysis products in an automated manner. Tryptic digestion conditions were optimized regarding the influence of enzyme concentration and incubation time in order to achieve similar enzymatic digestion efficiency to that obtained with the classical methodology (off-line). Then, the optimization of electrophoretic separation conditions concerning the nature of background electrolyte (BGE), ionic strength and pH was realized. Successful and repeatable electrophoretic profiles of three mAbs digests (Trastuzumab, Infliximab and Tocilizumab), comparable to the off-line digestion profiles, were obtained demonstrating the feasibility and robustness of the proposed methodology. In summary, the use of the proposed and optimized in-line approach opens a new, fast and easy way for the quality control of mAbs. Copyright © 2017 Elsevier B.V. All rights reserved.

A Comparison of Randomised Controlled Trials in Health and Education

ERIC Educational Resources Information Center

Torgerson, Carole J.; Torgerson, David J.; Birks, Yvonne F.; Porthouse, Jill

2005-01-01

Health care and educational trials face similar methodological challenges. Methodological reviews of health care trials have shown that a significant proportion have methodological flaws. Whether or not educational trials have a similar proportion of poor-quality trials is unknown. The authors undertook a methodological comparison between health…

10 CFR 26.137 - Quality assurance and quality control.

Code of Federal Regulations, 2013 CFR

2013-01-01

... validation of analytical procedures. Quality assurance procedures must be designed, implemented, and reviewed... resolving any technical, methodological, or administrative errors in the licensee testing facility's testing...

10 CFR 26.137 - Quality assurance and quality control.

Code of Federal Regulations, 2010 CFR

2010-01-01

... validation of analytical procedures. Quality assurance procedures must be designed, implemented, and reviewed... resolving any technical, methodological, or administrative errors in the licensee testing facility's testing...

10 CFR 26.137 - Quality assurance and quality control.

Code of Federal Regulations, 2011 CFR

2011-01-01

... validation of analytical procedures. Quality assurance procedures must be designed, implemented, and reviewed... resolving any technical, methodological, or administrative errors in the licensee testing facility's testing...

10 CFR 26.137 - Quality assurance and quality control.

Code of Federal Regulations, 2012 CFR

2012-01-01

... validation of analytical procedures. Quality assurance procedures must be designed, implemented, and reviewed... resolving any technical, methodological, or administrative errors in the licensee testing facility's testing...

10 CFR 26.137 - Quality assurance and quality control.

Code of Federal Regulations, 2014 CFR

2014-01-01

... validation of analytical procedures. Quality assurance procedures must be designed, implemented, and reviewed... resolving any technical, methodological, or administrative errors in the licensee testing facility's testing...

[Methodological quality of articles on therapeutic procedures published in Cirugía Española. Evaluation of the period 2005-2008].

PubMed

Manterola, Carlos; Grande, Luís

2010-04-01

To determine methodological quality of therapy articles published in Cirugía Española and to study its association with the publication year, the centre of origin and subjects. A literature study which included all therapy articles published between 2005 and 2008. All kinds of clinical designs were considered, excluding editorials, review articles, letters to editor and experimental studies. Variables analysed included: year of publication, centre of origin, design, and methodological quality of articles. A valid and reliable scale was applied to determine methodological quality. A total of 243 articles [206 series of cases (84.8%), 27 cohort studies (11.1%), 9 clinical trials (3.7%) and 1 case control study (0.4%)] were found. Studies came preferentially from Catalonia and Valencia (22.3% and 12.3% respectively). Thematic areas most frequently found were hepato-bilio-pancreatic and colorectal surgery (20.0% and 16.6%, respectively). Average and median of the methodological quality score calculated for the entire series were 9.5+/-4.3 points and 8 points, respectively. Association between methodological quality and geographical area (p=0.0101), subject area (p=0.0267), and university origin (p=0.0369) was found. A significant increase of methodological quality by publication year was observed (p=0.0004). Methodological quality of therapy articles published in Cirugía Española between 2005 and 2008 is low; but an increase tendency with statistical significance was observed.

78 FR 28854 - Agency Information Collection Activities; Proposed Collection; Comment Request; Infant Formula...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-16

... formula regulations, including infant formula labeling, quality control procedures, notification....S.C. 350a) requires manufacturers of infant formula to establish and adhere to quality control..., including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility...

The Use of Logistics n the Quality Parameters Control System of Material Flow

ERIC Educational Resources Information Center

Karpova, Natalia P.; Toymentseva, Irina A.; Shvetsova, Elena V.; Chichkina, Vera D.; Chubarkova, Elena V.

2016-01-01

The relevance of the research problem is conditioned on the need to justify the use of the logistics methodologies in the quality parameters control process of material flows. The goal of the article is to develop theoretical principles and practical recommendations for logistical system control in material flows quality parameters. A leading…

Methodological Quality of Randomized Clinical Trials of Respiratory Physiotherapy in Coronary Artery Bypass Grafting Patients in the Intensive Care Unit: a Systematic Review

PubMed Central

Lorscheitter, Jaqueline; Stein, Cinara; Plentz, Rodrigo Della Méa

2017-01-01

Objective To assess methodological quality of the randomized controlled trials of physiotherapy in patients undergoing coronary artery bypass grafting in the intensive care unit. Methods The studies published until May 2015, in MEDLINE, Cochrane and PEDro were included. The primary outcome extracted was proper filling of the Cochrane Collaboration's tool's items and the secondary was suitability to the requirements of the CONSORT Statement and its extension. Results From 807 studies identified, 39 were included. Most at CONSORT items showed a better adequacy after the statement's publication. Studies with positive outcomes presented better methodological quality. Conclusion The methodological quality of the studies has been improving over the years. However, many aspects can still be better designed. PMID:28977205

Using Lean Six Sigma Methodology to Improve Quality of the Anesthesia Supply Chain in a Pediatric Hospital.

PubMed

Roberts, Renée J; Wilson, Ashley E; Quezado, Zenaide

2017-03-01

Six Sigma and Lean methodologies are effective quality improvement tools in many health care settings. We applied the DMAIC methodology (define, measure, analyze, improve, control) to address deficiencies in our pediatric anesthesia supply chain. We defined supply chain problems by mapping existing processes and soliciting comments from those involved. We used daily distance walked by anesthesia technicians and number of callouts for missing supplies as measurements that we analyzed before and after implementing improvements (anesthesia cart redesign). We showed improvement in the metrics after those interventions were implemented, and those improvements were sustained and thus controlled 1 year after implementation.

75 FR 23777 - Agency Information Collection Activities; Proposed Collection; Comment Request; Infant Formula...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-04

... collection regarding the manufacture of infant formula, including infant formula labeling, quality control.... 350a) requires manufacturers of infant formula to establish and adhere to quality control procedures..., including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility...

Improving guideline adherence through intensive quality improvement and the use of a National Quality Register in Sweden for acute myocardial infarction.

PubMed

Peterson, Anette; Carlhed, Rickard; Lindahl, Bertil; Lindström, Gunilla; Aberg, Christina; Andersson-Gäre, Boel; Bojestig, Mats

2007-01-01

Data from the Swedish National Register in Cardiac Care have shown over the last 10 years an enduring gap between optimal treatment of acute myocardial infarction (AMI) according to current guidelines and the treatment actually given. We performed a controlled, prospective study in order to evaluate the effects of applying a multidisciplinary team-based improvement methodology to the use of evidence-based treatments in AMI, together with the use of a modified National Quality Register. The project engaged 25% of the Swedish hospitals. Multidisciplinary teams from 20 hospitals participating in the National Register in Cardiac Care, ranging from small to large hospitals, were trained in continuous quality improvement methodology. Twenty matched hospitals served as controls. Our efforts were focused on finding and applying tools and methods to increase adherence to the national guidelines for 5 different treatments for AMI. For measurement, specially designed quality control charts were made available in the National Register for Cardiac Care. To close the gap, an important issue for the teams was to get all 5 treatments in place. Ten of the hospitals in the study group reduced the gap in 5 of 5 treatments by 50%, while none of the control hospitals did so. This first, controlled prospective study of a registry supported by multidisciplinary team-based improvement methodology showed that this approach led to rapidly improved adherence to AMI guidelines in a broad spectrum of hospitals and that National Quality Registers can be helpful tools.

Survey of the prevalence and methodology of quality assurance for B-mode ultrasound image quality among veterinary sonographers.

PubMed

Hoscheit, Larry P; Heng, Hock Gan; Lim, Chee Kin; Weng, Hsin-Yi

2018-05-01

Image quality in B-mode ultrasound is important as it reflects the diagnostic accuracy and diagnostic information provided during clinical scanning. Quality assurance programs for B-mode ultrasound systems/components are comprised of initial quality acceptance testing and subsequent regularly scheduled quality control testing. The importance of quality assurance programs for B-mode ultrasound image quality using ultrasound phantoms is well documented in the human medical and medical physics literature. The purpose of this prospective, cross-sectional, survey study was to determine the prevalence and methodology of quality acceptance testing and quality control testing of image quality for ultrasound system/components among veterinary sonographers. An online electronic survey was sent to 1497 members of veterinary imaging organizations: the American College of Veterinary Radiology, the Veterinary Ultrasound Society, and the European Association of Veterinary Diagnostic Imaging, and a total of 167 responses were received. The results showed that the percentages of veterinary sonographers performing quality acceptance testing and quality control testing are 42% (64/151; 95% confidence interval 34-52%) and 26% (40/156: 95% confidence interval 19-33%) respectively. Of the respondents who claimed to have quality acceptance testing or quality control testing of image quality in place for their ultrasound system/components, 0% have performed quality acceptance testing or quality control testing correctly (quality acceptance testing 95% confidence interval: 0-6%, quality control testing 95% confidence interval: 0-11%). Further education and guidelines are recommended for veterinary sonographers in the area of quality acceptance testing and quality control testing for B-mode ultrasound equipment/components. © 2018 American College of Veterinary Radiology.

Quality in the Basic Grant Delivery System: Volume 3, Methodology.

ERIC Educational Resources Information Center

Advanced Technology, Inc., McLean, VA.

The research methodology of a study to assess 1980-1981 award accuracy of the Basic Educational Opportunity Grants (BEOG), or Pell grants, is described. The study is the first stage of a three-stage quality control project. During the spring of 1981 a nationally representative sample of 305 public, private, and proprietary institutions was…

75 FR 9572 - Submission for OMB Review; Comment Request: Correction

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-03

... Quality Control Reviews'' OMB control number 0584-0074. The document contained incorrect burden hours. The... methodology and assumptions used; (c) ways to enhance the quality, utility and clarity of the information to... information unless the collection of information displays a currently valid OMB control number and the agency...

[The technological innovation strategy for quality control of Chinese medicine based on Big Data].

PubMed

Li, Zhen-hao; Qian, Zhong-zhi; Cheng, Yi-yu

2015-09-01

The evolution of the quality control concepts of medical products within the global context and the development of the quality control technology of Chinese medicine are briefly described. Aimed at the bottlenecks in the regulation and quality control of Chinese medicine, using Big Data technology to address the significant challenges in Chinese medicine industry is proposed. For quality standard refinements and internationalization of Chinese medicine, a technological innovation strategy encompassing its methodology, and the R&D direction of the subsequent core technology are also presented.

Clinical trials of homoeopathy.

PubMed Central

Kleijnen, J; Knipschild, P; ter Riet, G

1991-01-01

OBJECTIVE--To establish whether there is evidence of the efficacy of homoeopathy from controlled trials in humans. DESIGN--Criteria based meta-analysis. Assessment of the methodological quality of 107 controlled trials in 96 published reports found after an extensive search. Trials were scored using a list of predefined criteria of good methodology, and the outcome of the trials was interpreted in relation to their quality. SETTING--Controlled trials published world wide. MAIN OUTCOME MEASURES--Results of the trials with the best methodological quality. Trials of classical homoeopathy and several modern varieties were considered separately. RESULTS--In 14 trials some form of classical homoeopathy was tested and in 58 trials the same single homoeopathic treatment was given to patients with comparable conventional diagnosis. Combinations of several homoeopathic treatments were tested in 26 trials; isopathy was tested in nine trials. Most trials seemed to be of very low quality, but there were many exceptions. The results showed a positive trend regardless of the quality of the trial or the variety of homeopathy used. Overall, of the 105 trials with interpretable results, 81 trials indicated positive results whereas in 24 trials no positive effects of homoeopathy were found. The results of the review may be complicated by publication bias, especially in such a controversial subject as homoeopathy. CONCLUSIONS--At the moment the evidence of clinical trials is positive but not sufficient to draw definitive conclusions because most trials are of low methodological quality and because of the unknown role of publication bias. This indicates that there is a legitimate case for further evaluation of homoeopathy, but only by means of well performed trials. PMID:1825800

Social cognition interventions for people with schizophrenia: a systematic review focussing on methodological quality and intervention modality.

PubMed

Grant, Nina; Lawrence, Megan; Preti, Antonio; Wykes, Til; Cella, Matteo

2017-08-01

People with a diagnosis of schizophrenia have significant social and functional difficulties. Social cognition was found to influences these outcomes and in recent years interventions targeting this domain were developed. This paper reviews the existing literature on social cognition interventions for people with a diagnosis of schizophrenia focussing on: i) comparing focussed (i.e. targeting only one social cognitive domain) and global interventions and ii) studies methodological quality. Systematic search was conducted on PubMed and PsycInfo. Studies were included if they were randomised control trials, participants had a diagnosis of schizophrenia or schizoaffective disorder, and the intervention targeted at least one out of four social cognition domains (i.e. theory of mind, affect recognition, social perception and attribution bias). All papers were assessed for methodological quality. Information on the intervention, control condition, study methodology and the main findings from each study were extracted and critically summarised. Data from 32 studies fulfilled the inclusion criteria, considering a total of 1440 participants. Taking part in social cognition interventions produced significant improvements in theory of mind and affect recognition compared to both passive and active control conditions. Results were less clear for social perception and attributional bias. Focussed and global interventions had similar results on outcomes. Overall study methodological quality was modest. There was very limited evidence showing that social cognitive intervention result in functional outcome improvement. The evidence considered suggests that social cognition interventions may be a valuable approach for people with a diagnosis of schizophrenia. However, evidence quality is limited by measure heterogeneity, modest study methodology and short follow-up periods. The findings point to a number of recommendations for future research, including measurement standardisation, appropriately powered studies and investigation of the impact of social cognition improvements on functioning problems. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

Methodological quality of randomised controlled trials in burns care. A systematic review.

PubMed

Danilla, Stefan; Wasiak, Jason; Searle, Susana; Arriagada, Cristian; Pedreros, Cesar; Cleland, Heather; Spinks, Anneliese

2009-11-01

To evaluate the methodological quality of published randomised controlled trials (RCTs) in burn care treatment and management. Using a predetermined search strategy we searched Ovid MEDLINE (1950 to January 2008) database to identify all English RCTs related to burn care. Full text studies identified were reviewed for key demographic and methodological characteristics. Methodological trial quality was assessed using the Jadad scale. A total of 257 studies involving 14,535 patients met the inclusion criteria. The median Jadad score was 2 (out of a best possible score of 5). Information was given in the introduction and discussion sections of most RCTs, although insufficient detail was provided on randomisation, allocation concealment, and blinding. The number of RCTs increased between 1950 and 2008 (Spearman's rho=0.6129, P<0.001), although the reporting quality did not improve over the same time period (P=0.1896) and was better in RCTs with larger sample sizes (median Jadad score, 4 vs. 2 points, P<0.0001). Methodological quality did not correlate with journal impact factor (P=0.2371). The reporting standards of RCTs are highly variable and less than optimal in most cases. The advent of evidence-based medicine heralds a new approach to burns care and systematic steps are needed to improve the quality of RCTs in this field. Identifying and reviewing the existing number of RCTs not only highlights the need for burn clinicians to conduct more trials, but may also encourage burn health clinicians to consider the importance of conducting trials that follow appropriate, evidence-based standards.

Do Men Produce Higher Quality Ejaculates When Primed With Thoughts of Partner Infidelity?

PubMed

Pham, Michael N; Barbaro, Nicole; Holub, Andrew M; Holden, Christopher J; Mogilski, Justin K; Lopes, Guilherme S; Nicolas, Sylis C A; Sela, Yael; Shackelford, Todd K; Zeigler-Hill, Virgil; Welling, Lisa L M

2018-01-01

Sperm competition theory can be used to generate the hypothesis that men alter the quality of their ejaculates as a function of sperm competition risk. Using a repeated measures experimental design, we investigated whether men produce a higher quality ejaculate when primed with cues to sperm competition (i.e., imagined partner infidelity) relative to a control prime. Men ( n = 45) submitted two masturbatory ejaculates-one ejaculate sample for each condition (i.e., sperm competition and control conditions). Ejaculates were assessed on 17 clinical parameters. The results did not support the hypothesis: Men did not produce higher quality ejaculates in the sperm competition condition relative to the control condition. Despite the null results of the current research, there is evidence for psychological and physiological adaptations to sperm competition in humans. We discuss methodological limitations that may have produced the null results and present methodological suggestions for research on human sperm competition.

[What is the methodological quality of articles on therapeutic procedures published in Cirugía Española?].

PubMed

Manterola, Carlos; Busquets, Juli; Pascual, Marta; Grande, Luis

2006-02-01

The aim of this study was to determine the methodological quality of articles on therapeutic procedures published in Cirugía Española and to study its association with the publication year, center, and subject-matter. A bibliometric study that included all articles on therapeutic procedures published in Cirugía Española between 2001 and 2004 was performed. All kinds of clinical designs were considered, excluding editorials, review articles, letters to editor, and experimental studies. The variables analyzed were: year of publication, center, design, and methodological quality. Methodological quality was determined by a valid and reliable scale. Descriptive statistics (calculation of means, standard deviation and medians) and analytical statistics (Pearson's chi2, nonparametric, ANOVA and Bonferroni tests) were used. A total of 244 articles were studied (197 case series [81%], 28 cohort studies [12%], 17 clinical trials [7%], 1 cross sectional study and 1 case-control study [0.8%]). The studies were performed mainly in Catalonia and Murcia (22% and 16%, respectively). The most frequent subject areas were soft tissue and hepatobiliopancreatic surgery (23% and 19%, respectively). The mean and median of the methodological quality score calculated for the entire series was 10.2 +/- 3.9 points and 9.5 points, respectively. Methodological quality significantly increased by publication year (p < 0.001). An association between methodological quality and subject area was observed but no association was detected with the center performing the study. The methodological quality of articles on therapeutic procedures published in Cirugía Española between 2001 and 2004 is low. However, a statistically significant trend toward improvement was observed.

Un modelo para el control de calidad academica de los textos de instruccion a distancia (A Model for Controlling the Academic Quality of Distance Education Texts).

ERIC Educational Resources Information Center

Bolanos-Mora, Guiselle; And Others

1992-01-01

In response to the need for a system of control over the academic quality of distance education texts, this article proposes a methodological model based on criteria that evaluate written materials based on their instructional quality, design, and production. A discussion and figures evaluate educational aspects of content, communication,…

Measurement control workshop instructional materials

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

Gibbs, Philip; Harvel, Charles; Clark, John

2012-09-01

An essential element in an effective nuclear materials control and accountability (MC&A) program is the measurement of the nuclear material as it is received, moved, processed and shipped. Quality measurement systems and methodologies determine the accuracy of the accountability values. Implementation of a measurement control program is essential to ensure that the measurement systems and methodologies perform as expected. A measurement control program also allows for a determination of the level of confidence in the accounting values.

Interpreting drinking water quality in the distribution system using Dempster-Shafer theory of evidence.

PubMed

Sadiq, Rehan; Rodriguez, Manuel J

2005-04-01

Interpreting water quality data routinely generated for control and monitoring purposes in water distribution systems is a complicated task for utility managers. In fact, data for diverse water quality indicators (physico-chemical and microbiological) are generated at different times and at different locations in the distribution system. To simplify and improve the understanding and the interpretation of water quality, methodologies for aggregation and fusion of data must be developed. In this paper, the Dempster-Shafer theory also called theory of evidence is introduced as a potential methodology for interpreting water quality data. The conceptual basis of this methodology and the process for its implementation are presented by two applications. The first application deals with the interpretation of spatial water quality data fusion, while the second application deals with the development of water quality index based on key monitored indicators. Based on the obtained results, the authors discuss the potential contribution of theory of evidence as a decision-making tool for water quality management.

"Assessing the methodological quality of systematic reviews in radiation oncology: A systematic review".

PubMed

Hasan, Haroon; Muhammed, Taaha; Yu, Jennifer; Taguchi, Kelsi; Samargandi, Osama A; Howard, A Fuchsia; Lo, Andrea C; Olson, Robert; Goddard, Karen

2017-10-01

The objective of our study was to evaluate the methodological quality of systematic reviews and meta-analyses in Radiation Oncology. A systematic literature search was conducted for all eligible systematic reviews and meta-analyses in Radiation Oncology from 1966 to 2015. Methodological characteristics were abstracted from all works that satisfied the inclusion criteria and quality was assessed using the critical appraisal tool, AMSTAR. Regression analyses were performed to determine factors associated with a higher score of quality. Following exclusion based on a priori criteria, 410 studies (157 systematic reviews and 253 meta-analyses) satisfied the inclusion criteria. Meta-analyses were found to be of fair to good quality while systematic reviews were found to be of less than fair quality. Factors associated with higher scores of quality in the multivariable analysis were including primary studies consisting of randomized control trials, performing a meta-analysis, and applying a recommended guideline related to establishing a systematic review protocol and/or reporting. Systematic reviews and meta-analyses may introduce a high risk of bias if applied to inform decision-making based on AMSTAR. We recommend that decision-makers in Radiation Oncology scrutinize the methodological quality of systematic reviews and meta-analyses prior to assessing their utility to inform evidence-based medicine and researchers adhere to methodological standards outlined in validated guidelines when embarking on a systematic review. Copyright © 2017 Elsevier Ltd. All rights reserved.

Sensory re-education after nerve injury of the upper limb: a systematic review.

PubMed

Oud, Tanja; Beelen, Anita; Eijffinger, Elianne; Nollet, Frans

2007-06-01

To systematically review the available evidence for the effectiveness of sensory re-education to improve the sensibility of the hand in patients with a peripheral nerve injury of the upper limb. Studies were identified by an electronic search in the databases MEDLINE, Cumulative Index to Nursing & Allied Health Literature (CINAHL), EMBASE, the Cochrane Library, the Physiotherapy Evidence Database (PEDro), and the database of the Dutch National Institute of Allied Health Professions (Doconline) and by screening the reference lists of relevant articles. Two reviewers selected studies that met the following inclusion criteria: all designs except case reports, adults with impaired sensibility of the hand due to a peripheral nerve injury of the upper limb, and sensibility and functional sensibility as outcome measures. The methodological quality of the included studies was independently assessed by two reviewers. A best-evidence synthesis was performed, based on design, methodological quality and significant findings on outcome measures. Seven studies, with sample sizes ranging from 11 to 49, were included in the systematic review and appraised for content. Five of these studies were of poor methodological quality. One uncontrolled study (N = 1 3 ) was considered to be of sufficient methodological quality, and one randomized controlled trial (N = 49) was of high methodological quality. Best-evidence synthesis showed that there is limited evidence for the effectiveness of sensory re-education, provided by a statistically significant improvement in sensibility found in one high-quality randomized controlled trial. There is a need for further well-defined clinical trials to assess the effectiveness of sensory re-education of patients with impaired sensibility of the hand due to a peripheral nerve injury.

Quality Perception within Corporate E-Learning Providers in Catalonia

ERIC Educational Resources Information Center

Sangra, Albert; Fernandez-Michels, Pedro

2011-01-01

Purpose: The paper seeks to describe the Catalan corporate e-learning providers from the perspective of quality perception, quality assessment and quality control. Design/methodology/approach: A literature review reveals key aspects of the definition of quality in e-learning. The results of the review constitute the basis for exploratory research…

Journal impact factor and methodological quality of surgical randomized controlled trials: an empirical study.

PubMed

Ahmed Ali, Usama; Reiber, Beata M M; Ten Hove, Joren R; van der Sluis, Pieter C; Gooszen, Hein G; Boermeester, Marja A; Besselink, Marc G

2017-11-01

The journal impact factor (IF) is often used as a surrogate marker for methodological quality. The objective of this study is to evaluate the relation between the journal IF and methodological quality of surgical randomized controlled trials (RCTs). Surgical RCTs published in PubMed in 1999 and 2009 were identified. According to IF, RCTs were divided into groups of low (<2), median (2-3) and high IF (>3), as well as into top-10 vs all other journals. Methodological quality characteristics and factors concerning funding, ethical approval and statistical significance of outcomes were extracted and compared between the IF groups. Additionally, a multivariate regression was performed. The median IF was 2.2 (IQR 2.37). The percentage of 'low-risk of bias' RCTs was 13% for top-10 journals vs 4% for other journals in 1999 (P < 0.02), and 30 vs 12% in 2009 (P < 0.02). Similar results were observed for high vs low IF groups. The presence of sample-size calculation, adequate generation of allocation and intention-to-treat analysis were independently associated with publication in higher IF journals; as were multicentre trials and multiple authors. Publication of RCTs in high IF journals is associated with moderate improvement in methodological quality compared to RCTs published in lower IF journals. RCTs with adequate sample-size calculation, generation of allocation or intention-to-treat analysis were associated with publication in a high IF journal. On the other hand, reporting a statistically significant outcome and being industry funded were not independently associated with publication in a higher IF journal.

An Application of Six Sigma to Reduce Supplier Quality Cost

NASA Astrophysics Data System (ADS)

Gaikwad, Lokpriya Mohanrao; Teli, Shivagond Nagappa; Majali, Vijay Shashikant; Bhushi, Umesh Mahadevappa

2016-01-01

This article presents an application of Six Sigma to reduce supplier quality cost in manufacturing industry. Although there is a wider acceptance of Six Sigma in many organizations today, there is still a lack of in-depth case study of Six Sigma. For the present research the case study methodology was used. The company decided to reduce quality cost and improve selected processes using Six Sigma methodologies. Regarding the fact that there is a lack of case studies dealing with Six Sigma especially in individual manufacturing organization this article could be of great importance also for the practitioners. This paper discusses the quality and productivity improvement in a supplier enterprise through a case study. The paper deals with an application of Six Sigma define-measure-analyze-improve-control methodology in an industry which provides a framework to identify, quantify and eliminate sources of variation in an operational process in question, to optimize the operation variables, improve and sustain performance viz. process yield with well-executed control plans. Six Sigma improves the process performance (process yield) of the critical operational process, leading to better utilization of resources, decreases variations and maintains consistent quality of the process output.

A Methodology for Performing Effects-Based Assessments

DTIC Science & Technology

2006-03-01

can then be used to make assessments (Smith, 2002:384). 2.8 Cause-and-Effect Diagrams Developed by Dr. Kaoru Ishikawa in the field of Quality Control...John Wiley & Sons, Inc., 2004. Ishikawa , Kaoru . Guide to Quality Control. White Plains NY: Asian Productivity Organization, 1989...various causes affecting product quality by sorting out and relating the causes. Cause-and-effect diagrams are sometimes called Ishikawa diagrams, or

E-therapy for mental health problems: a systematic review.

PubMed

Postel, Marloes G; de Haan, Hein A; De Jong, Cor A J

2008-09-01

The widespread availability of the Internet offers opportunities for improving access to therapy for people with mental health problems. There is a seemingly infinite supply of Internet-based interventions available on the World Wide Web. The aim of the present study is to systematically assess the methodological quality of randomized controlled trials (RCTs) concerning e-therapy for mental health problems. Two reviewers independently assessed the methodological quality of the RCTs, based on a list of criteria for the methodological quality assessment as recommended by the Cochrane Back Review Group. The search yielded 14 papers that reported RCTs concerning e-therapy for mental-health problems. The methodological quality of studies included in this review was generally low. It is concluded that e-therapy may turn out to be an appropriate therapeutic entity, but the evidence needs to be more convincing. Recommendations are made concerning the method of reporting RCTs and the need to add some content items to an e-therapy study.

A Methodological Analysis of Randomized Clinical Trials of Computer-Assisted Therapies for Psychiatric Disorders: Toward Improved Standards for an Emerging Field

PubMed Central

Kiluk, Brian D.; Sugarman, Dawn E.; Nich, Charla; Gibbons, Carly J.; Martino, Steve; Rounsaville, Bruce J.; Carroll, Kathleen M.

2013-01-01

Objective Computer-assisted therapies offer a novel, cost-effective strategy for providing evidence-based therapies to a broad range of individuals with psychiatric disorders. However, the extent to which the growing body of randomized trials evaluating computer-assisted therapies meets current standards of methodological rigor for evidence-based interventions is not clear. Method A methodological analysis of randomized clinical trials of computer-assisted therapies for adult psychiatric disorders, published between January 1990 and January 2010, was conducted. Seventy-five studies that examined computer-assisted therapies for a range of axis I disorders were evaluated using a 14-item methodological quality index. Results Results indicated marked heterogeneity in study quality. No study met all 14 basic quality standards, and three met 13 criteria. Consistent weaknesses were noted in evaluation of treatment exposure and adherence, rates of follow-up assessment, and conformity to intention-to-treat principles. Studies utilizing weaker comparison conditions (e.g., wait-list controls) had poorer methodological quality scores and were more likely to report effects favoring the computer-assisted condition. Conclusions While several well-conducted studies have indicated promising results for computer-assisted therapies, this emerging field has not yet achieved a level of methodological quality equivalent to those required for other evidence-based behavioral therapies or pharmacotherapies. Adoption of more consistent standards for methodological quality in this field, with greater attention to potential adverse events, is needed before computer-assisted therapies are widely disseminated or marketed as evidence based. PMID:21536689

Master Pump Shutdown MPS Software Quality Assurance Plan (SQAP)

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

BEVINS, R.R.

2000-09-20

The MPSS Software Quality Assurance (SQAP) describes the tools and strategy used in the development of the MPSS software. The document also describes the methodology for controlling and managing changes to the software.

10 CFR 26.167 - Quality assurance and quality control.

Code of Federal Regulations, 2012 CFR

2012-01-01

... be designed, implemented, and reviewed to monitor the conduct of each step of the testing process. (b... sample and the error is determined to be technical or methodological, the licensee or other entity shall...

10 CFR 26.167 - Quality assurance and quality control.

Code of Federal Regulations, 2011 CFR

2011-01-01

... be designed, implemented, and reviewed to monitor the conduct of each step of the testing process. (b... sample and the error is determined to be technical or methodological, the licensee or other entity shall...

10 CFR 26.167 - Quality assurance and quality control.

Code of Federal Regulations, 2014 CFR

2014-01-01

... be designed, implemented, and reviewed to monitor the conduct of each step of the testing process. (b... sample and the error is determined to be technical or methodological, the licensee or other entity shall...

10 CFR 26.167 - Quality assurance and quality control.

Code of Federal Regulations, 2010 CFR

2010-01-01

... be designed, implemented, and reviewed to monitor the conduct of each step of the testing process. (b... sample and the error is determined to be technical or methodological, the licensee or other entity shall...

10 CFR 26.167 - Quality assurance and quality control.

Code of Federal Regulations, 2013 CFR

2013-01-01

... be designed, implemented, and reviewed to monitor the conduct of each step of the testing process. (b... sample and the error is determined to be technical or methodological, the licensee or other entity shall...

Guidelines for software inspections

NASA Technical Reports Server (NTRS)

1983-01-01

Quality control inspections are software problem finding procedures which provide defect removal as well as improvements in software functionality, maintenance, quality, and development and testing methodology is discussed. The many side benefits include education, documentation, training, and scheduling.

Langley Wind Tunnel Data Quality Assurance-Check Standard Results

NASA Technical Reports Server (NTRS)

Hemsch, Michael J.; Grubb, John P.; Krieger, William B.; Cler, Daniel L.

2000-01-01

A framework for statistical evaluation, control and improvement of wind funnel measurement processes is presented The methodology is adapted from elements of the Measurement Assurance Plans developed by the National Bureau of Standards (now the National Institute of Standards and Technology) for standards and calibration laboratories. The present methodology is based on the notions of statistical quality control (SQC) together with check standard testing and a small number of customer repeat-run sets. The results of check standard and customer repeat-run -sets are analyzed using the statistical control chart-methods of Walter A. Shewhart long familiar to the SQC community. Control chart results are presented for. various measurement processes in five facilities at Langley Research Center. The processes include test section calibration, force and moment measurements with a balance, and instrument calibration.

Proactive telephone counseling for smoking cessation: meta-analyses by recruitment channel and methodological quality.

PubMed

Tzelepis, Flora; Paul, Christine L; Walsh, Raoul A; McElduff, Patrick; Knight, Jenny

2011-06-22

Systematic reviews demonstrated that proactive telephone counseling increases smoking cessation rates. However, these reviews did not differentiate studies by recruitment channel, did not adequately assess methodological quality, and combined different measures of abstinence. Twenty-four randomized controlled trials published before December 31, 2008, included seven of active recruitment, 16 of passive recruitment, and one of mixed recruitment. We rated methodological quality on selection bias, study design, confounders, blinding, data collection methods, withdrawals, and dropouts, according to the Quality Assessment Tool for Quantitative Studies. We conducted random effects meta-analysis to pool the results according to abstinence type and follow-up time for studies overall and segregated by recruitment channel, and methodological quality. The level of statistical heterogeneity was quantified by I(2). All statistical tests were two-sided. Methodological quality ratings indicated two strong, 10 moderate, and 12 weak studies. Overall, compared with self-help materials or no intervention control groups, proactive telephone counseling had a statistically significantly greater effect on point prevalence abstinence (nonsmoking at follow-up or abstinent for at least 24 hours, 7 days before follow-up) at 6-9 months (relative risk [RR] = 1.26, 95% confidence interval [CI] = 1.11 to 1.43, P < .001, I(2) = 21.4%) but not at 12-15 months after recruitment. This pattern also emerged when studies were segregated by recruitment channel (active, passive) or methodological quality (strong/moderate, weak). Overall, the positive effect on prolonged/continuous abstinence (abstinent for 3 months or longer before follow-up) was also statistically significantly greater at 6-9 months (RR = 1.58, CI = 1.26 to 1.98, P < .001, I(2) = 49.1%) and 12-18 months after recruitment (RR = 1.40, CI = 1.23 to 1.60, P < .001, I(2) = 18.5%). With the exception of point prevalence abstinence in the long term, these data support previous results showing that proactive telephone counseling has a positive impact on smoking cessation. Proactive telephone counseling increased prolonged/continuous abstinence long term for both actively and passively recruited smokers.

Optimization-based controller design for rotorcraft

NASA Technical Reports Server (NTRS)

Tsing, N.-K.; Fan, M. K. H.; Barlow, J.; Tits, A. L.; Tischler, M. B.

1993-01-01

An optimization-based methodology for linear control system design is outlined by considering the design of a controller for a UH-60 rotorcraft in hover. A wide range of design specifications is taken into account: internal stability, decoupling between longitudinal and lateral motions, handling qualities, and rejection of windgusts. These specifications are investigated while taking into account physical limitations in the swashplate displacements and rates of displacement. The methodology crucially relies on user-machine interaction for tradeoff exploration.

Methodological reporting of randomized controlled trials in major hepato-gastroenterology journals in 2008 and 1998: a comparative study

PubMed Central

2011-01-01

Background It was still unclear whether the methodological reporting quality of randomized controlled trials (RCTs) in major hepato-gastroenterology journals improved after the Consolidated Standards of Reporting Trials (CONSORT) Statement was revised in 2001. Methods RCTs in five major hepato-gastroenterology journals published in 1998 or 2008 were retrieved from MEDLINE using a high sensitivity search method and their reporting quality of methodological details were evaluated based on the CONSORT Statement and Cochrane Handbook for Systematic Reviews of interventions. Changes of the methodological reporting quality between 2008 and 1998 were calculated by risk ratios with 95% confidence intervals. Results A total of 107 RCTs published in 2008 and 99 RCTs published in 1998 were found. Compared to those in 1998, the proportion of RCTs that reported sequence generation (RR, 5.70; 95%CI 3.11-10.42), allocation concealment (RR, 4.08; 95%CI 2.25-7.39), sample size calculation (RR, 3.83; 95%CI 2.10-6.98), incomplete outecome data addressed (RR, 1.81; 95%CI, 1.03-3.17), intention-to-treat analyses (RR, 3.04; 95%CI 1.72-5.39) increased in 2008. Blinding and intent-to-treat analysis were reported better in multi-center trials than in single-center trials. The reporting of allocation concealment and blinding were better in industry-sponsored trials than in public-funded trials. Compared with historical studies, the methodological reporting quality improved with time. Conclusion Although the reporting of several important methodological aspects improved in 2008 compared with those published in 1998, which may indicate the researchers had increased awareness of and compliance with the revised CONSORT statement, some items were still reported badly. There is much room for future improvement. PMID:21801429

Controlled Trials in Children: Quantity, Methodological Quality and Descriptive Characteristics of Pediatric Controlled Trials Published 1948-2006

PubMed Central

Thomson, Denise; Hartling, Lisa; Cohen, Eyal; Vandermeer, Ben; Tjosvold, Lisa; Klassen, Terry P.

2010-01-01

Background The objective of this study was to describe randomized controlled trials (RCTs) and controlled clinical trials (CCTs) in child health published between 1948 and 2006, in terms of quantity, methodological quality, and publication and trial characteristics. We used the Trials Register of the Cochrane Child Health Field for overall trends and a sample from this to explore trial characteristics in more detail. Methodology/Principal Findings We extracted descriptive data on a random sample of 578 trials. Ninety-six percent of the trials were published in English; the percentage of child-only trials was 90.5%. The most frequent diagnostic categories were infectious diseases (13.2%), behavioural and psychiatric disorders (11.6%), neonatal critical care (11.4%), respiratory disorders (8.9%), non-critical neonatology (7.9%), and anaesthesia (6.5%). There were significantly fewer child-only studies (i.e., more mixed child and adult studies) over time (P = 0.0460). The proportion of RCTs to CCTs increased significantly over time (P<0.0001), as did the proportion of multicentre trials (P = 0.002). Significant increases over time were found in methodological quality (Jadad score) (P<0.0001), the proportion of double-blind studies (P<0.0001), and studies with adequate allocation concealment (P<0.0001). Additionally, we found an improvement in reporting over time: adequate description of withdrawals and losses to follow-up (P<0.0001), sample size calculations (P<0.0001), and intention-to-treat analysis (P<0.0001). However, many trials still do not describe their level of blinding, and allocation concealment was inadequately reported in the majority of studies across the entire time period. The proportion of studies with industry funding decreased slightly over time (P = 0.003), and these studies were more likely to report positive conclusions (P = 0.028). Conclusions/Significance The quantity and quality of pediatric controlled trials has increased over time; however, much work remains to be done, particularly in improving methodological issues around conduct and reporting of trials. PMID:20927344

Photovoltaic Impact Assessment of Smart Inverter Volt-VAR Control on Distribution System Conservation Voltage Reduction and Power Quality

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

Ding, Fei; Nagarajan, Adarsh; Chakraborty, Sudipta

This report presents an impact assessment study of distributed photovoltaic (PV) with smart inverter Volt-VAR control on conservation voltage reduction (CVR) energy savings and distribution system power quality. CVR is a methodology of flattening and lowering a distribution system voltage profile in order to conserve energy. Traditional CVR relies on operating utility voltage regulators and switched capacitors. However, with the increased penetration of distributed PV systems, smart inverters provide the new opportunity to control local voltage and power factor by regulating the reactive power output, leading to a potential increase in CVR energy savings. This report proposes a methodology tomore » implement CVR scheme by operating voltage regulators, capacitors, and autonomous smart inverter Volt-VAR control in order to achieve increased CVR benefit. Power quality is an important consideration when operating a distribution system, especially when implementing CVR. It is easy to measure the individual components that make up power quality, but a comprehensive method to incorporate all of these values into a single score has yet to be undertaken. As a result, this report proposes a power quality scoring mechanism to measure the relative power quality of distribution systems using a single number, which is aptly named the 'power quality score' (PQS). Both the CVR and PQS methodologies were applied to two distribution system models, one obtained from the Hawaiian Electric Company (HECO) and another obtained from Pacific Gas and Electric (PG&E). These two models were converted to the OpenDSS platform using previous model conversion tools that were developed by NREL. Multiple scenarios including various PV penetration levels and smart inverter densities were simulated to analyze the impact of smart inverter Volt-VAR support on CVR energy savings and feeder power quality. In order to analyze the CVR benefit and PQS, an annual simulation was conducted for each scenario.« less

Association of journal quality indicators with methodological quality of clinical research articles.

PubMed

Lee, Kirby P; Schotland, Marieka; Bacchetti, Peter; Bero, Lisa A

2002-06-05

The ability to identify scientific journals that publish high-quality research would help clinicians, scientists, and health-policy analysts to select the most up-to-date medical literature to review. To assess whether journal characteristics of (1) peer-review status, (2) citation rate, (3) impact factor, (4) circulation, (5) manuscript acceptance rate, (6) MEDLINE indexing, and (7) Brandon/Hill Library List indexing are predictors of methodological quality of research articles, we conducted a cross-sectional study of 243 original research articles involving human subjects published in general internal medical journals. The mean (SD) quality score of the 243 articles was 1.37 (0.22). All journals reported a peer-review process and were indexed on MEDLINE. In models that controlled for article type (randomized controlled trial [RCT] or non-RCT), journal citation rate was the most statistically significant predictor (0.051 increase per doubling; 95% confidence interval [CI], 0.037-0.065; P<.001). In separate analyses by article type, acceptance rate was the strongest predictor for RCT quality (-0.113 per doubling; 95% CI, -0.148 to -0.078; P<.001), while journal citation rate was the most predictive factor for non-RCT quality (0.051 per doubling; 95% CI, 0.044-0.059; P<.001). High citation rates, impact factors, and circulation rates, and low manuscript acceptance rates and indexing on Brandon/Hill Library List appear to be predictive of higher methodological quality scores for journal articles.

Advancement in modern approaches to mineral production quality control

NASA Astrophysics Data System (ADS)

Freidina, EV; Botvinnik, AA; Dvornikova, AN

2017-02-01

The natural resource potential of mineral deposits is represented by three categories: upside, attainable and investment. A modern methodology is proposed in this paper for production quality control, and its tools aimed at ensuring agreement between the product quality and the market requirements are described. The definitions of the costs of the product quality compliance and incompliance with the consumer requirements are introduced; the latter is suggested to use in evaluating resource potential of mineral deposits at a certain degree of probability.

A Validity-Based Approach to Quality Control and Assurance of Automated Scoring

ERIC Educational Resources Information Center

Bejar, Isaac I.

2011-01-01

Automated scoring of constructed responses is already operational in several testing programmes. However, as the methodology matures and the demand for the utilisation of constructed responses increases, the volume of automated scoring is likely to increase at a fast pace. Quality assurance and control of the scoring process will likely be more…

Controlled trials in children: quantity, methodological quality and descriptive characteristics of pediatric controlled trials published 1948-2006.

PubMed

Thomson, Denise; Hartling, Lisa; Cohen, Eyal; Vandermeer, Ben; Tjosvold, Lisa; Klassen, Terry P

2010-09-30

The objective of this study was to describe randomized controlled trials (RCTs) and controlled clinical trials (CCTs) in child health published between 1948 and 2006, in terms of quantity, methodological quality, and publication and trial characteristics. We used the Trials Register of the Cochrane Child Health Field for overall trends and a sample from this to explore trial characteristics in more detail. We extracted descriptive data on a random sample of 578 trials. Ninety-six percent of the trials were published in English; the percentage of child-only trials was 90.5%. The most frequent diagnostic categories were infectious diseases (13.2%), behavioural and psychiatric disorders (11.6%), neonatal critical care (11.4%), respiratory disorders (8.9%), non-critical neonatology (7.9%), and anaesthesia (6.5%). There were significantly fewer child-only studies (i.e., more mixed child and adult studies) over time (P = 0.0460). The proportion of RCTs to CCTs increased significantly over time (P<0.0001), as did the proportion of multicentre trials (P = 0.002). Significant increases over time were found in methodological quality (Jadad score) (P<0.0001), the proportion of double-blind studies (P<0.0001), and studies with adequate allocation concealment (P<0.0001). Additionally, we found an improvement in reporting over time: adequate description of withdrawals and losses to follow-up (P<0.0001), sample size calculations (P<0.0001), and intention-to-treat analysis (P<0.0001). However, many trials still do not describe their level of blinding, and allocation concealment was inadequately reported in the majority of studies across the entire time period. The proportion of studies with industry funding decreased slightly over time (P = 0.003), and these studies were more likely to report positive conclusions (P = 0.028). The quantity and quality of pediatric controlled trials has increased over time; however, much work remains to be done, particularly in improving methodological issues around conduct and reporting of trials.

Methods for the guideline-based development of quality indicators--a systematic review

PubMed Central

2012-01-01

Background Quality indicators (QIs) are used in many healthcare settings to measure, compare, and improve quality of care. For the efficient development of high-quality QIs, rigorous, approved, and evidence-based development methods are needed. Clinical practice guidelines are a suitable source to derive QIs from, but no gold standard for guideline-based QI development exists. This review aims to identify, describe, and compare methodological approaches to guideline-based QI development. Methods We systematically searched medical literature databases (Medline, EMBASE, and CINAHL) and grey literature. Two researchers selected publications reporting methodological approaches to guideline-based QI development. In order to describe and compare methodological approaches used in these publications, we extracted detailed information on common steps of guideline-based QI development (topic selection, guideline selection, extraction of recommendations, QI selection, practice test, and implementation) to predesigned extraction tables. Results From 8,697 hits in the database search and several grey literature documents, we selected 48 relevant references. The studies were of heterogeneous type and quality. We found no randomized controlled trial or other studies comparing the ability of different methodological approaches to guideline-based development to generate high-quality QIs. The relevant publications featured a wide variety of methodological approaches to guideline-based QI development, especially regarding guideline selection and extraction of recommendations. Only a few studies reported patient involvement. Conclusions Further research is needed to determine which elements of the methodological approaches identified, described, and compared in this review are best suited to constitute a gold standard for guideline-based QI development. For this research, we provide a comprehensive groundwork. PMID:22436067

Develop a Methodology to Evaluate the Effectiveness of QC/QA Specifications (Phase II)

DOT National Transportation Integrated Search

1998-08-01

The Texas Department of Transportation (TxDOT) has been implementing statistically based quality control/quality assurance (QC/QA) specifications for hot mix asphalt concrete pavements since the early 1990s. These specifications have been continuousl...

What is covered by "cancer rehabilitation" in PubMed? A review of randomized controlled trials 1990-2011.

PubMed

Gudbergsson, Sævar Berg; Dahl, Alv A; Loge, Jon Håvard; Thorsen, Lene; Oldervoll, Line M; Grov, Ellen K

2015-02-01

This focused review examines randomized controlled studies included by the term "cancer rehabilitation" in PubMed. The research questions concern the type of interventions performed and their methodological quality. Using the Medical Subject Headings (MeSH) terms: neoplasm AND rehabilitation, all articles with randomized controlled studies that included adult cancer patients, written in English, were extracted from PubMed. Papers covering physical exercise, psychiatric/psychological treatment or social support only were excluded as they had been reviewed recently. Abstracts and papers were assessed by 3 pairs of reviewers, and descriptive information was extracted systematically. Methodological quality was rated on a 10-item index scale, and the cut-off for acceptable quality was set at ≥ 8. A total of 132 (19%) of the 683 identified papers met the eligibility criteria and were assessed in detail. The papers were grouped into 5 thematic categories: 44 physical; 15 art and expressive; 47 psycho-educative; 21 emotionally supportive; and 5 others. Good quality of design was observed in 32 studies, 18 of them uni-dimensional and 14 multi-dimensional. Published randomized controlled studies on cancer rehabilitation are heterogeneous in terms of content and samples, and are mostly characterized by suboptimal design quality. Future studies should be more specific and well-designed with sufficient statistical strength.

Interest and limits of the six sigma methodology in medical laboratory.

PubMed

Scherrer, Florian; Bouilloux, Jean-Pierre; Calendini, Ors'Anton; Chamard, Didier; Cornu, François

2017-02-01

The mandatory accreditation of clinical laboratories in France provides an incentive to develop real tools to measure performance management methods and to optimize the management of internal quality controls. Six sigma methodology is an approach commonly applied to software quality management and discussed in numerous publications. This paper discusses the primary factors that influence the sigma index (the choice of the total allowable error, the approach used to address bias) and compares the performance of different analyzers on the basis of the sigma index. Six sigma strategy can be applied to the policy management of internal quality control in a laboratory and demonstrates through a comparison of four analyzers that there is no single superior analyzer in clinical chemistry. Similar sigma results are obtained using approaches toward bias based on the EQAS or the IQC. The main difficulty in using the six sigma methodology lies in the absence of official guidelines for the definition of the total error acceptable. Despite this drawback, our comparison study suggests that difficulties with defined analytes do not vary with the analyzer used.

A Proposal for Six Sigma Integration for Large-Scale Production of Penicillin G and Subsequent Conversion to 6-APA.

PubMed

Nandi, Anirban; Pan, Sharadwata; Potumarthi, Ravichandra; Danquah, Michael K; Sarethy, Indira P

2014-01-01

Six Sigma methodology has been successfully applied to daily operations by several leading global private firms including GE and Motorola, to leverage their net profits. Comparatively, limited studies have been conducted to find out whether this highly successful methodology can be applied to research and development (R&D). In the current study, we have reviewed and proposed a process for a probable integration of Six Sigma methodology to large-scale production of Penicillin G and its subsequent conversion to 6-aminopenicillanic acid (6-APA). It is anticipated that the important aspects of quality control and quality assurance will highly benefit from the integration of Six Sigma methodology in mass production of Penicillin G and/or its conversion to 6-APA.

A Proposal for Six Sigma Integration for Large-Scale Production of Penicillin G and Subsequent Conversion to 6-APA

PubMed Central

Nandi, Anirban; Danquah, Michael K.

2014-01-01

Six Sigma methodology has been successfully applied to daily operations by several leading global private firms including GE and Motorola, to leverage their net profits. Comparatively, limited studies have been conducted to find out whether this highly successful methodology can be applied to research and development (R&D). In the current study, we have reviewed and proposed a process for a probable integration of Six Sigma methodology to large-scale production of Penicillin G and its subsequent conversion to 6-aminopenicillanic acid (6-APA). It is anticipated that the important aspects of quality control and quality assurance will highly benefit from the integration of Six Sigma methodology in mass production of Penicillin G and/or its conversion to 6-APA. PMID:25057428

Clinical trials in palliative care: a systematic review of their methodological characteristics and of the quality of their reporting.

PubMed

Bouça-Machado, Raquel; Rosário, Madalena; Alarcão, Joana; Correia-Guedes, Leonor; Abreu, Daisy; Ferreira, Joaquim J

2017-01-25

Over the past decades there has been a significant increase in the number of published clinical trials in palliative care. However, empirical evidence suggests that there are methodological problems in the design and conduct of studies, which raises questions about the validity and generalisability of the results and of the strength of the available evidence. We sought to evaluate the methodological characteristics and assess the quality of reporting of clinical trials in palliative care. We performed a systematic review of published clinical trials assessing therapeutic interventions in palliative care. Trials were identified using MEDLINE (from its inception to February 2015). We assessed methodological characteristics and describe the quality of reporting using the Cochrane Risk of Bias tool. We retrieved 107 studies. The most common medical field studied was oncology, and 43.9% of trials evaluated pharmacological interventions. Symptom control and physical dimensions (e.g. intervention on pain, breathlessness, nausea) were the palliative care-specific issues most studied. We found under-reporting of key information in particular on random sequence generation, allocation concealment, and blinding. While the number of clinical trials in palliative care has increased over time, methodological quality remains suboptimal. This compromises the quality of studies. Therefore, a greater effort is needed to enable the appropriate performance of future studies and increase the robustness of evidence-based medicine in this important field.

Developing a stochastic conflict resolution model for urban runoff quality management: Application of info-gap and bargaining theories

NASA Astrophysics Data System (ADS)

Ghodsi, Seyed Hamed; Kerachian, Reza; Estalaki, Siamak Malakpour; Nikoo, Mohammad Reza; Zahmatkesh, Zahra

2016-02-01

In this paper, two deterministic and stochastic multilateral, multi-issue, non-cooperative bargaining methodologies are proposed for urban runoff quality management. In the proposed methodologies, a calibrated Storm Water Management Model (SWMM) is used to simulate stormwater runoff quantity and quality for different urban stormwater runoff management scenarios, which have been defined considering several Low Impact Development (LID) techniques. In the deterministic methodology, the best management scenario, representing location and area of LID controls, is identified using the bargaining model. In the stochastic methodology, uncertainties of some key parameters of SWMM are analyzed using the info-gap theory. For each water quality management scenario, robustness and opportuneness criteria are determined based on utility functions of different stakeholders. Then, to find the best solution, the bargaining model is performed considering a combination of robustness and opportuneness criteria for each scenario based on utility function of each stakeholder. The results of applying the proposed methodology in the Velenjak urban watershed located in the northeastern part of Tehran, the capital city of Iran, illustrate its practical utility for conflict resolution in urban water quantity and quality management. It is shown that the solution obtained using the deterministic model cannot outperform the result of the stochastic model considering the robustness and opportuneness criteria. Therefore, it can be concluded that the stochastic model, which incorporates the main uncertainties, could provide more reliable results.

[Audit and feedback, and continuous quality improvement strategies to improve the quality of care for type 2 diabetes: a systematic review of literature].

PubMed

Vecchi, Simona; Agabiti, Nera; Mitrova, Susanna; Cacciani, Laura; Amato, Laura; Davoli, Marina; Bargagli, Anna Maria

2016-01-01

we analysed evidence on effective interventions to improve the quality of care and management in patients with diabetes type 2. This review focuses particularly on audit and feedback intervention, targeted to healthcare providers, and continuous quality improvement (CQI) involving health professionals and health care systems, respectively. we searched The Cochrane Library, PubMed, and EMBASE (search period: January 2005-December 2015) to identify systematic reviews (SR) and randomized controlled trials (RCTs) considering patients' outcomes and process measures as quality indicators in diabetes care. Selection of studies and data extraction were carried out independently by two reviewers. Methodological quality of individual studies was assessed using the checklist «Assessment of methodological quality of systematic review» (AMSTAR) and the Cochrane's tool, respectively. We produced summaries of results for each study design. the search process resulted in 810 citations. One SR and 7 RCTs that compared any intervention in which audit and feedback and CQI was a component vs. other interventions were selected. The SR found that audit and feedback activity was associated with improvements of glycaemic (mean difference: 0.26; 95%CI 0.08;0.44) and cholesterol control (mean difference: 0.03; 95%CI -0.04;0.10). CQI interventions were not associated with an improvement of quality of diabetes care. The RCTs considered in this review compared a broad range of interventions including feedback as unique activity or as part of more complex strategies. The methodological quality was generally poor in all the included trials. the available evidence suggests that audit and feedback and CQI improve quality of care in diabetic patients, although the effect is small and heterogeneous among process and outcomes indicators.

Systematic Review of Knowledge Translation Strategies to Promote Research Uptake in Child Health Settings.

PubMed

Albrecht, Lauren; Archibald, Mandy; Snelgrove-Clarke, Erna; Scott, Shannon D

2016-01-01

Strategies to assist evidence-based decision-making for healthcare professionals are crucial to ensure high quality patient care and outcomes. The goal of this systematic review was to identify and synthesize the evidence on knowledge translation interventions aimed at putting explicit research evidence into child health practice. A comprehensive search of thirteen electronic databases was conducted, restricted by date (1985-2011) and language (English). Articles were included if: 1) studies were randomized controlled trials (RCT), controlled clinical trials (CCT), or controlled before-and-after (CBA) studies; 2) target population was child health professionals; 3) interventions implemented research in child health practice; and 4) outcomes were measured at the professional/process, patient, or economic level. Two reviewers independently extracted data and assessed methodological quality. Study data were aggregated and analyzed using evidence tables. Twenty-one studies (13 RCT, 2 CCT, 6 CBA) were included. The studies employed single (n=9) and multiple interventions (n=12). The methodological quality of the included studies was largely moderate (n=8) or weak (n=11). Of the studies with moderate to strong methodological quality ratings, three demonstrated consistent, positive effect(s) on the primary outcome(s); effective knowledge translation interventions were two single, non-educational interventions and one multiple, educational intervention. This multidisciplinary systematic review in child health setting identified effective knowledge translation strategies assessed by the most rigorous research designs. Given the overall poor quality of the research literature, specific recommendations were made to improve knowledge translation efforts in child health. Copyright © 2016 Elsevier Inc. All rights reserved.

Designing, Evaluating, and Deploying Automated Scoring Systems with Validity in Mind: Methodological Design Decisions

ERIC Educational Resources Information Center

Rupp, André A.

2018-01-01

This article discusses critical methodological design decisions for collecting, interpreting, and synthesizing empirical evidence during the design, deployment, and operational quality-control phases for automated scoring systems. The discussion is inspired by work on operational large-scale systems for automated essay scoring but many of the…

Presentation of flight control design and handling quality commonality by separate surface stability augmentation for the family of commuter airplanes

NASA Technical Reports Server (NTRS)

Hensley, Douglas; Creighton, Thomas; Haddad, Raphael; Hendrich, Louis; Morgan, Louise; Russell, Mark; Swift, Gerald

1987-01-01

The methodology and results for a flight control design and implementation for common handling qualities by Separate Surface Stability Augmentation (SSSA) for the family of commuter airplanes are contained. The open and closed loop dynamics and the design results of augmenting for common handling qualities are presented. The physical and technology requirements are presented for implementing the SSSA system. The conclusion of this report and recommendations for changes or improvement are discussed.

Integrated Control Using the SOFFT Control Structure

NASA Technical Reports Server (NTRS)

Halyo, Nesim

1996-01-01

The need for integrated/constrained control systems has become clearer as advanced aircraft introduced new coupled subsystems such as new propulsion subsystems with thrust vectoring and new aerodynamic designs. In this study, we develop an integrated control design methodology which accomodates constraints among subsystem variables while using the Stochastic Optimal Feedforward/Feedback Control Technique (SOFFT) thus maintaining all the advantages of the SOFFT approach. The Integrated SOFFT Control methodology uses a centralized feedforward control and a constrained feedback control law. The control thus takes advantage of the known coupling among the subsystems while maintaining the identity of subsystems for validation purposes and the simplicity of the feedback law to understand the system response in complicated nonlinear scenarios. The Variable-Gain Output Feedback Control methodology (including constant gain output feedback) is extended to accommodate equality constraints. A gain computation algorithm is developed. The designer can set the cross-gains between two variables or subsystems to zero or another value and optimize the remaining gains subject to the constraint. An integrated control law is designed for a modified F-15 SMTD aircraft model with coupled airframe and propulsion subsystems using the Integrated SOFFT Control methodology to produce a set of desired flying qualities.

Characteristics and quality of published animal research in the field of radiology.

PubMed

Yoon, Soo Jeong; Yoon, Dae Young; Cho, Young Kwon; Baek, Sora; Lim, Kyoung Ja; Seo, Young Lan; Yun, Eun Joo

2017-06-01

Background Animal research has played an important role in the field of radiology. Purpose To evaluate the characteristics and quality of published radiological animal research. Material and Methods A PubMed search was performed for radiological animal research articles (defined as studies using animal models with a radiologist as the first author) published in 1994, 2004, and 2014. The following information was extracted from each article: journal name, radiological subspecialty, imaging technique, animal species, number of animals used, number of authors, declared funding, country of origin, methodological quality, and ethical quality. Methodological and ethical quality of studies were assessed with seven-item (sample size calculation, animal age, animal sex, animal weight, inclusion and exclusion criteria, randomization, and blinded outcome assessment) and four-item (ethical review committee approval, anesthesia, pain control, and euthanasia) scales, respectively. Results The numbers of radiological animal studies markedly increased, from 91 in 1994 to 163 in 2004 and to 305 in 2014. One hundred and sixty-two (29.0%) articles focused on the neuroradiology/head and neck subspecialty, 233 (41.7%) used magnetic resonance imaging (MRI), 190 (34.0%) used mice, 254 (45.4%) used 10-30 animals, 297 (53.1%) had 4-7 authors, 392 (70.1%) were funded, and 222 (39.7%) were from the USA. Six of 7 methodological and 3/4 ethical quality items significantly improved over time. Conclusion The quantity and quality of radiological animal research has increased over the last two decades; however, methodological and ethical quality remains suboptimal.

Methodological issues of genetic association studies.

PubMed

Simundic, Ana-Maria

2010-12-01

Genetic association studies explore the association between genetic polymorphisms and a certain trait, disease or predisposition to disease. It has long been acknowledged that many genetic association studies fail to replicate their initial positive findings. This raises concern about the methodological quality of these reports. Case-control genetic association studies often suffer from various methodological flaws in study design and data analysis, and are often reported poorly. Flawed methodology and poor reporting leads to distorted results and incorrect conclusions. Many journals have adopted guidelines for reporting genetic association studies. In this review, some major methodological determinants of genetic association studies will be discussed.

An introduction to statistical process control in research proteomics.

PubMed

Bramwell, David

2013-12-16

Statistical process control is a well-established and respected method which provides a general purpose, and consistent framework for monitoring and improving the quality of a process. It is routinely used in many industries where the quality of final products is critical and is often required in clinical diagnostic laboratories [1,2]. To date, the methodology has been little utilised in research proteomics. It has been shown to be capable of delivering quantitative QC procedures for qualitative clinical assays [3] making it an ideal methodology to apply to this area of biological research. To introduce statistical process control as an objective strategy for quality control and show how it could be used to benefit proteomics researchers and enhance the quality of the results they generate. We demonstrate that rules which provide basic quality control are easy to derive and implement and could have a major impact on data quality for many studies. Statistical process control is a powerful tool for investigating and improving proteomics research work-flows. The process of characterising measurement systems and defining control rules forces the exploration of key questions that can lead to significant improvements in performance. This work asserts that QC is essential to proteomics discovery experiments. Every experimenter must know the current capabilities of their measurement system and have an objective means for tracking and ensuring that performance. Proteomic analysis work-flows are complicated and multi-variate. QC is critical for clinical chemistry measurements and huge strides have been made in ensuring the quality and validity of results in clinical biochemistry labs. This work introduces some of these QC concepts and works to bridge their use from single analyte QC to applications in multi-analyte systems. This article is part of a Special Issue entitled: Standardization and Quality Control in Proteomics. Copyright © 2013 The Author. Published by Elsevier B.V. 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

Poor methodological quality and reporting standards of systematic reviews in burn care management.

PubMed

Wasiak, Jason; Tyack, Zephanie; Ware, Robert; Goodwin, Nicholas; Faggion, Clovis M

2017-10-01

The methodological and reporting quality of burn-specific systematic reviews has not been established. The aim of this study was to evaluate the methodological quality of systematic reviews in burn care management. Computerised searches were performed in Ovid MEDLINE, Ovid EMBASE and The Cochrane Library through to February 2016 for systematic reviews relevant to burn care using medical subject and free-text terms such as 'burn', 'systematic review' or 'meta-analysis'. Additional studies were identified by hand-searching five discipline-specific journals. Two authors independently screened papers, extracted and evaluated methodological quality using the 11-item A Measurement Tool to Assess Systematic Reviews (AMSTAR) tool and reporting quality using the 27-item Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklist. Characteristics of systematic reviews associated with methodological and reporting quality were identified. Descriptive statistics and linear regression identified features associated with improved methodological quality. A total of 60 systematic reviews met the inclusion criteria. Six of the 11 AMSTAR items reporting on 'a priori' design, duplicate study selection, grey literature, included/excluded studies, publication bias and conflict of interest were reported in less than 50% of the systematic reviews. Of the 27 items listed for PRISMA, 13 items reporting on introduction, methods, results and the discussion were addressed in less than 50% of systematic reviews. Multivariable analyses showed that systematic reviews associated with higher methodological or reporting quality incorporated a meta-analysis (AMSTAR regression coefficient 2.1; 95% CI: 1.1, 3.1; PRISMA regression coefficient 6·3; 95% CI: 3·8, 8·7) were published in the Cochrane library (AMSTAR regression coefficient 2·9; 95% CI: 1·6, 4·2; PRISMA regression coefficient 6·1; 95% CI: 3·1, 9·2) and included a randomised control trial (AMSTAR regression coefficient 1·4; 95%CI: 0·4, 2·4; PRISMA regression coefficient 3·4; 95% CI: 0·9, 5·8). The methodological and reporting quality of systematic reviews in burn care requires further improvement with stricter adherence by authors to the PRISMA checklist and AMSTAR tool. © 2016 Medicalhelplines.com Inc and John Wiley & Sons Ltd.

Comparison of methodological quality rating of systematic reviews on neuropathic pain using AMSTAR and R-AMSTAR.

PubMed

Dosenovic, Svjetlana; Jelicic Kadic, Antonia; Vucic, Katarina; Markovina, Nikolina; Pieper, Dawid; Puljak, Livia

2018-05-08

Systematic reviews (SRs) in the field of neuropathic pain (NeuP) are increasingly important for decision-making. However, methodological flaws in SRs can reduce the validity of conclusions. Hence, it is important to assess the methodological quality of NeuP SRs critically. Additionally, it remains unclear which assessment tool should be used. We studied the methodological quality of SRs published in the field of NeuP and compared two assessment tools. We systematically searched 5 electronic databases to identify SRs of randomized controlled trials of interventions for NeuP available up to March 2015. Two independent reviewers assessed the methodological quality of the studies using the Assessment of Multiple Systematic Reviews (AMSTAR) and the revised AMSTAR (R-AMSTAR) tools. The scores were converted to percentiles and ranked into 4 grades to allow comparison between the two checklists. Gwet's AC1 coefficient was used for interrater reliability assessment. The 97 included SRs had a wide range of methodological quality scores (AMSTAR median (IQR): 6 (5-8) vs. R-AMSTAR median (IQR): 30 (26-35)). The overall agreement score between the 2 raters was 0.62 (95% CI 0.39-0.86) for AMSTAR and 0.62 (95% CI 0.53-0.70) for R-AMSTAR. The 31 Cochrane systematic reviews (CSRs) were consistently ranked higher than the 66 non-Cochrane systematic reviews (NCSRs). The analysis of individual domains showed the best compliance in a comprehensive literature search (item 3) on both checklists. The results for the domain that was the least compliant differed: conflict of interest (item 11) was the item most poorly reported on AMSTAR vs. publication bias assessment (item 10) on R-AMSTAR. A high positive correlation between the total AMSTAR and R-AMSTAR scores for all SRs, as well as for CSRs and NCSRs, was observed. The methodological quality of analyzed SRs in the field of NeuP was not optimal, and CSRs had a higher quality than NCSRs. Both AMSTAR and R-AMSTAR tools produced comparable quality ratings. Our results point out to weaknesses in the methodology of existing SRs on interventions for the management NeuP and call for future improvement by better adherence to analyzed quality checklists, either AMSTAR or R-AMSTAR.

A methodology model for quality management in a general hospital.

PubMed

Stern, Z; Naveh, E

1997-01-01

A reappraisal is made of the relevance of industrial modes of quality management to the issues of medical care. Analysis of the nature of medical care, which differentiates it from the supplier-client relationships of industry, presents the main intrinsic characteristics, which create problems in application of the industrial quality management approaches to medical care. Several examples are the complexity of the relationship between the medical action and the result obtained, the client's nonacceptance of economic profitability as a value in his medical care, and customer satisfaction biased by variable standards of knowledge. The real problems unique to hospitals are addressed, and a methodology model for their quality management is offered. Included is a sample of indicator vectors, measurements of quality care, cost of medical care, quality of service, and human resources. These are based on the trilogy of planning quality, quality control, and improving quality. The conclusions confirm the inadequacy of industrial quality management approaches for medical institutions and recommend investment in formulation of appropriate concepts.

Interventions to Improve Parental Communication About Sex: A Systematic Review

PubMed Central

Holland, Cynthia L.; Bost, James

2011-01-01

CONTEXT: The relative effectiveness of interventions to improve parental communication with adolescents about sex is not known. OBJECTIVE: To compare the effectiveness and methodologic quality of interventions for improving parental communication with adolescents about sex. METHODS: We searched 6 databases: OVID/Medline, PsychInfo, ERIC, Cochrane Review, Communication and Mass Media, and the Cumulative Index to Nursing and Allied Health Literature. We included studies published between 1980 and July 2010 in peer-reviewed English-language journals that targeted US parents of adolescents aged 11 to 18 years, used an experimental or quasi-experimental design, included a control group, and had a pretest/posttest design. We abstracted data on multiple communication outcomes defined by the integrative conceptual model (communication frequency, content, skills, intentions, self-efficacy, perceived environmental barriers/facilitators, perceived social norms, attitudes, outcome expectations, knowledge, and beliefs). Methodologic quality was assessed using the 11-item methodologic quality score. RESULTS: Twelve studies met inclusion criteria. Compared with controls, parents who participated in these interventions experienced improvements in multiple communication domains including the frequency, quality, intentions, comfort, and self-efficacy for communicating. We noted no effects on parental attitudes toward communicating or the outcomes they expected to occur as a result of communicating. Four studies were of high quality, 7 were of medium quality, and 1 was of lower quality. CONCLUSIONS: Our review was limited by the lack of standardized measures for assessing parental communication. Still, interventions for improving parent-adolescent sex communication are well designed and have some targeted effects. Wider dissemination could augment efforts by schools, clinicians, and health educators. PMID:21321027

Interventions to improve parental communication about sex: a systematic review.

PubMed

Akers, Aletha Y; Holland, Cynthia L; Bost, James

2011-03-01

The relative effectiveness of interventions to improve parental communication with adolescents about sex is not known. To compare the effectiveness and methodologic quality of interventions for improving parental communication with adolescents about sex. We searched 6 databases: OVID/Medline, PsychInfo, ERIC, Cochrane Review, Communication and Mass Media, and the Cumulative Index to Nursing and Allied Health Literature. We included studies published between 1980 and July 2010 in peer-reviewed English-language journals that targeted US parents of adolescents aged 11 to 18 years, used an experimental or quasi-experimental design, included a control group, and had a pretest/posttest design. We abstracted data on multiple communication outcomes defined by the integrative conceptual model (communication frequency, content, skills, intentions, self-efficacy, perceived environmental barriers/facilitators, perceived social norms, attitudes, outcome expectations, knowledge, and beliefs). Methodologic quality was assessed using the 11-item methodologic quality score. Twelve studies met inclusion criteria. Compared with controls, parents who participated in these interventions experienced improvements in multiple communication domains including the frequency, quality, intentions, comfort, and self-efficacy for communicating. We noted no effects on parental attitudes toward communicating or the outcomes they expected to occur as a result of communicating. Four studies were of high quality, 7 were of medium quality, and 1 was of lower quality. Our review was limited by the lack of standardized measures for assessing parental communication. Still, interventions for improving parent-adolescent sex communication are well designed and have some targeted effects. Wider dissemination could augment efforts by schools, clinicians, and health educators.

Physical activity interventions for people with mental illness: a systematic review and meta-analysis.

PubMed

Rosenbaum, Simon; Tiedemann, Anne; Sherrington, Catherine; Curtis, Jackie; Ward, Philip B

2014-09-01

To determine effects of physical activity on depressive symptoms (primary objective), symptoms of schizophrenia, anthropometric measures, aerobic capacity, and quality of life (secondary objectives) in people with mental illness and explore between-study heterogeneity. MEDLINE, Cochrane Controlled Trials Register, PsycINFO, CINAHL, Embase, and the Physiotherapy Evidence Database (PEDro) were searched from earliest record to 2013. Randomized controlled trials of adults with a DSM-IV-TR, ICD-10, or clinician-confirmed diagnosis of a mental illness other than dysthymia or eating disorders were selected. Interventions included exercise programs, exercise counseling, lifestyle interventions, tai chi, or physical yoga. Study methodological quality and intervention compliance with American College of Sports Medicine (ACSM) guidelines were also assessed. Two investigators extracted data. Data were pooled using random-effects meta-analysis. Meta-regression was used to examine sources of between-study heterogeneity. Thirty-nine eligible trials were identified. The primary meta-analysis found a large effect of physical activity on depressive symptoms (n = 20; standardized mean difference (SMD) = 0.80). The effect size in trial interventions that met ACSM guidelines for aerobic exercise did not differ significantly from those that did not meet these guidelines. The effect for trials with higher methodological quality was smaller than that observed for trials with lower methodological quality (SMD = 0.39 vs 1.35); however, the difference was not statistically significant. A large effect was found for schizophrenia symptoms (SMD = 1.0), a small effect was found for anthropometry (SMD = 0.24), and moderate effects were found for aerobic capacity (SMD = 0.63) and quality of life (SMD = 0.64). Physical activity reduced depressive symptoms in people with mental illness. Larger effects were seen in studies of poorer methodological quality. Physical activity reduced symptoms of schizophrenia and improved anthropometric measures, aerobic capacity, and quality of life among people with mental illness. PROSPERO registration #CRD42012002012. © Copyright 2014 Physicians Postgraduate Press, Inc.

11 CFR 9405.5 - Categories of exemptions.

Code of Federal Regulations, 2012 CFR

2012-01-01

... descriptions of manufacturing process, quality control methodology, and test results. The following procedures... lawful national security intelligence investigation, information furnished by a confidential source; (v...

11 CFR 9405.5 - Categories of exemptions.

Code of Federal Regulations, 2013 CFR

2013-01-01

... descriptions of manufacturing process, quality control methodology, and test results. The following procedures... lawful national security intelligence investigation, information furnished by a confidential source; (v...

11 CFR 9405.5 - Categories of exemptions.

Code of Federal Regulations, 2011 CFR

2011-01-01

... descriptions of manufacturing process, quality control methodology, and test results. The following procedures... lawful national security intelligence investigation, information furnished by a confidential source; (v...

11 CFR 9405.5 - Categories of exemptions.

Code of Federal Regulations, 2014 CFR

2014-01-01

... descriptions of manufacturing process, quality control methodology, and test results. The following procedures... lawful national security intelligence investigation, information furnished by a confidential source; (v...

Methodological quality of quantitative lesbian, gay, bisexual, and transgender nursing research from 2000 to 2010.

PubMed

Johnson, Michael; Smyer, Tish; Yucha, Carolyn

2012-01-01

The purpose of this study was to evaluate the methodological quality of quantitative lesbian, gay, bisexual, and transgender nursing research from 2000 to 2010. Using a key word search in Cumulative Index to Nursing and Allied Health Literature, 188 studies were identified and 40 met the criteria, which included descriptive, experimental, quasi-experimental, or observational (case control, cohort, and cross-sectional) design. The methodological quality of these studies was similar to that reported for medical and nursing educational research. The foci of these lesbian, gay, bisexual, and transgender studies were biased toward human immunodeficiency virus, acquired immunodeficiency syndrome, and sexually transmitted diseases, and 58.5% of the funded research was related to human immunodeficiency virus or acquired immunodeficiency syndrome. To provide evidence-based health care to these populations, an understanding of the current state of research is crucial.

An Overview of Meta-Analyses of Danhong Injection for Unstable Angina.

PubMed

Zhang, Xiaoxia; Wang, Hui; Chang, Yanxu; Wang, Yuefei; Lei, Xiang; Fu, Shufei; Zhang, Junhua

2015-01-01

Objective. To systematically collect evidence and evaluate the effects of Danhong injection (DHI) for unstable angina (UA). Methods. A comprehensive search was conducted in seven electronic databases up to January 2015. The methodological and reporting quality of included studies was assessed by using AMSTAR and PRISMA. Result. Five articles were included. The conclusions suggest that DHI plus conventional medicine treatment was effective for UA pectoris treatment, could alleviate symptoms of angina and ameliorate electrocardiograms. Flaws of the original studies and systematic reviews weaken the strength of evidence. Limitations of the methodology quality include performing an incomprehensive literature search, lacking detailed characteristics, ignoring clinical heterogeneity, and not assessing publication bias and other forms of bias. The flaws of reporting systematic reviews included the following: not providing a structured summary, no standardized search strategy. For the pooled findings, researchers took statistical heterogeneity into consideration, but clinical and methodology heterogeneity were ignored. Conclusion. DHI plus conventional medicine treatment generally appears to be effective for UA treatment. However, the evidence is not hard enough due to methodological flaws in original clinical trials and systematic reviews. Furthermore, rigorous designed randomized controlled trials are also needed. The methodology and reporting quality of systematic reviews should be improved.

An Overview of Meta-Analyses of Danhong Injection for Unstable Angina

PubMed Central

Zhang, Xiaoxia; Chang, Yanxu; Wang, Yuefei; Lei, Xiang; Fu, Shufei; Zhang, Junhua

2015-01-01

Objective. To systematically collect evidence and evaluate the effects of Danhong injection (DHI) for unstable angina (UA). Methods. A comprehensive search was conducted in seven electronic databases up to January 2015. The methodological and reporting quality of included studies was assessed by using AMSTAR and PRISMA. Result. Five articles were included. The conclusions suggest that DHI plus conventional medicine treatment was effective for UA pectoris treatment, could alleviate symptoms of angina and ameliorate electrocardiograms. Flaws of the original studies and systematic reviews weaken the strength of evidence. Limitations of the methodology quality include performing an incomprehensive literature search, lacking detailed characteristics, ignoring clinical heterogeneity, and not assessing publication bias and other forms of bias. The flaws of reporting systematic reviews included the following: not providing a structured summary, no standardized search strategy. For the pooled findings, researchers took statistical heterogeneity into consideration, but clinical and methodology heterogeneity were ignored. Conclusion. DHI plus conventional medicine treatment generally appears to be effective for UA treatment. However, the evidence is not hard enough due to methodological flaws in original clinical trials and systematic reviews. Furthermore, rigorous designed randomized controlled trials are also needed. The methodology and reporting quality of systematic reviews should be improved. PMID:26539221

A Model of Risk Analysis in Analytical Methodology for Biopharmaceutical Quality Control.

PubMed

Andrade, Cleyton Lage; Herrera, Miguel Angel De La O; Lemes, Elezer Monte Blanco

2018-01-01

One key quality control parameter for biopharmaceutical products is the analysis of residual cellular DNA. To determine small amounts of DNA (around 100 pg) that may be in a biologically derived drug substance, an analytical method should be sensitive, robust, reliable, and accurate. In principle, three techniques have the ability to measure residual cellular DNA: radioactive dot-blot, a type of hybridization; threshold analysis; and quantitative polymerase chain reaction. Quality risk management is a systematic process for evaluating, controlling, and reporting of risks that may affects method capabilities and supports a scientific and practical approach to decision making. This paper evaluates, by quality risk management, an alternative approach to assessing the performance risks associated with quality control methods used with biopharmaceuticals, using the tool hazard analysis and critical control points. This tool provides the possibility to find the steps in an analytical procedure with higher impact on method performance. By applying these principles to DNA analysis methods, we conclude that the radioactive dot-blot assay has the largest number of critical control points, followed by quantitative polymerase chain reaction, and threshold analysis. From the analysis of hazards (i.e., points of method failure) and the associated method procedure critical control points, we conclude that the analytical methodology with the lowest risk for performance failure for residual cellular DNA testing is quantitative polymerase chain reaction. LAY ABSTRACT: In order to mitigate the risk of adverse events by residual cellular DNA that is not completely cleared from downstream production processes, regulatory agencies have required the industry to guarantee a very low level of DNA in biologically derived pharmaceutical products. The technique historically used was radioactive blot hybridization. However, the technique is a challenging method to implement in a quality control laboratory: It is laborious, time consuming, semi-quantitative, and requires a radioisotope. Along with dot-blot hybridization, two alternatives techniques were evaluated: threshold analysis and quantitative polymerase chain reaction. Quality risk management tools were applied to compare the techniques, taking into account the uncertainties, the possibility of circumstances or future events, and their effects upon method performance. By illustrating the application of these tools with DNA methods, we provide an example of how they can be used to support a scientific and practical approach to decision making and can assess and manage method performance risk using such tools. This paper discusses, considering the principles of quality risk management, an additional approach to the development and selection of analytical quality control methods using the risk analysis tool hazard analysis and critical control points. This tool provides the possibility to find the method procedural steps with higher impact on method reliability (called critical control points). Our model concluded that the radioactive dot-blot assay has the larger number of critical control points, followed by quantitative polymerase chain reaction and threshold analysis. Quantitative polymerase chain reaction is shown to be the better alternative analytical methodology in residual cellular DNA analysis. © PDA, Inc. 2018.

Improved Atmospheric Soundings and Error Estimates from Analysis of AIRS/AMSU Data

NASA Technical Reports Server (NTRS)

Susskind, Joel

2007-01-01

The AIRS Science Team Version 5.0 retrieval algorithm became operational at the Goddard DAAC in July 2007 generating near real-time products from analysis of AIRS/AMSU sounding data. This algorithm contains many significant theoretical advances over the AIRS Science Team Version 4.0 retrieval algorithm used previously. Three very significant developments of Version 5 are: 1) the development and implementation of an improved Radiative Transfer Algorithm (RTA) which allows for accurate treatment of non-Local Thermodynamic Equilibrium (non-LTE) effects on shortwave sounding channels; 2) the development of methodology to obtain very accurate case by case product error estimates which are in turn used for quality control; and 3) development of an accurate AIRS only cloud clearing and retrieval system. These theoretical improvements taken together enabled a new methodology to be developed which further improves soundings in partially cloudy conditions, without the need for microwave observations in the cloud clearing step as has been done previously. In this methodology, longwave C02 channel observations in the spectral region 700 cm-' to 750 cm-' are used exclusively for cloud clearing purposes, while shortwave C02 channels in the spectral region 2195 cm-' to 2395 cm-' are used for temperature sounding purposes. The new methodology for improved error estimates and their use in quality control is described briefly and results are shown indicative of their accuracy. Results are also shown of forecast impact experiments assimilating AIRS Version 5.0 retrieval products in the Goddard GEOS 5 Data Assimilation System using different quality control thresholds.

Application of control theory to dynamic systems simulation

NASA Technical Reports Server (NTRS)

Auslander, D. M.; Spear, R. C.; Young, G. E.

1982-01-01

The application of control theory is applied to dynamic systems simulation. Theory and methodology applicable to controlled ecological life support systems are considered. Spatial effects on system stability, design of control systems with uncertain parameters, and an interactive computing language (PARASOL-II) designed for dynamic system simulation, report quality graphics, data acquisition, and simple real time control are discussed.

A coupled stochastic inverse-management framework for dealing with nonpoint agriculture pollution under groundwater parameter uncertainty

NASA Astrophysics Data System (ADS)

Llopis-Albert, Carlos; Palacios-Marqués, Daniel; Merigó, José M.

2014-04-01

In this paper a methodology for the stochastic management of groundwater quality problems is presented, which can be used to provide agricultural advisory services. A stochastic algorithm to solve the coupled flow and mass transport inverse problem is combined with a stochastic management approach to develop methods for integrating uncertainty; thus obtaining more reliable policies on groundwater nitrate pollution control from agriculture. The stochastic inverse model allows identifying non-Gaussian parameters and reducing uncertainty in heterogeneous aquifers by constraining stochastic simulations to data. The management model determines the spatial and temporal distribution of fertilizer application rates that maximizes net benefits in agriculture constrained by quality requirements in groundwater at various control sites. The quality constraints can be taken, for instance, by those given by water laws such as the EU Water Framework Directive (WFD). Furthermore, the methodology allows providing the trade-off between higher economic returns and reliability in meeting the environmental standards. Therefore, this new technology can help stakeholders in the decision-making process under an uncertainty environment. The methodology has been successfully applied to a 2D synthetic aquifer, where an uncertainty assessment has been carried out by means of Monte Carlo simulation techniques.

How completely are physiotherapy interventions described in reports of randomised trials?

PubMed

Yamato, Tiê P; Maher, Chris G; Saragiotto, Bruno T; Hoffmann, Tammy C; Moseley, Anne M

2016-06-01

Incomplete descriptions of interventions are a common problem in reports of randomised controlled trials. To date no study has evaluated the completeness of the descriptions of physiotherapy interventions. To evaluate the completeness of the descriptions of physiotherapy interventions in a random sample of reports of randomised controlled trials (RCTs). A random sample of 200 reports of RCTs from the PEDro database. We included full text papers, written in English, and reporting trials with two arms. We included trials evaluating any type of physiotherapy interventions and subdisciplines. The methodological quality was evaluated using the PEDro scale and completeness of intervention description using the Template for Intervention Description and Replication (TIDieR) checklist. The proportion and 95% confidence interval were calculated for intervention and control groups, and used to present the relationship between completeness and methodological quality, and subdisciplines. Completeness of intervention reporting in physiotherapy RCTs was poor. For intervention groups, 46 (23%) trials did not describe at least half of the items. Reporting was worse for control groups, 149 (75%) trials described less than half of the items. There was no clear difference in the completeness across subdisciplines or methodological quality. Our sample were restricted to trials published in English in 2013. Descriptions of interventions in physiotherapy RCTs are typically incomplete. Authors and journals should aim for more complete descriptions of interventions in physiotherapy trials. Copyright © 2016 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

An Improvement in Instructional Quality: Can Evaluation of Teaching Effectiveness Make a Difference?

ERIC Educational Resources Information Center

Ngware, Moses Waithanji; Ndirangu, Mwangi

2005-01-01

Purpose: To report study findings on teaching effectiveness and feedback mechanisms in Kenyan universities, which can guide management in developing a comprehensive quality control policy. Design/methodology/approach: The study adopted an exploratory descriptive design. Three public and two private universities were randomly selected to…

Health-Related Quality of Life in Non–Small-Cell Lung Cancer: An Update of a Systematic Review on Methodologic Issues in Randomized Controlled Trials

PubMed Central

Claassens, Lily; van Meerbeeck, Jan; Coens, Corneel; Quinten, Chantal; Ghislain, Irina; Sloan, Elizabeth K.; Wang, Xin Shelly; Velikova, Galina; Bottomley, Andrew

2011-01-01

Purpose This study is an update of a systematic review of health-related quality-of-life (HRQOL) methodology reporting in non–small-cell lung cancer (NSCLC) randomized controlled trials (RCTs). The objective was to evaluate HRQOL methodology reporting over the last decade and its benefit for clinical decision making. Methods A MEDLINE systematic literature review was performed. Eligible RCTs implemented patient-reported HRQOL assessments and regular oncology treatments for newly diagnosed adult patients with NSCLC. Included studies were published in English from August 2002 to July 2010. Two independent reviewers evaluated all included RCTs. Results Fifty-three RCTs were assessed. Of the 53 RCTs, 81% reported that there was no significant difference in overall survival (OS). However, 50% of RCTs that were unable to find OS differences reported a significant difference in HRQOL scores. The quality of HRQOL reporting has improved; both reporting of clinically significant differences and statistical testing of HRQOL have improved. A European Organisation for Research and Treatment of Cancer HRQOL questionnaire was used in 57% of the studies. However, reporting of HRQOL hypotheses and rationales for choosing HRQOL instruments were significantly less than before 2002 (P < .05). Conclusion The number of NSCLC RCTs incorporating HRQOL assessments has considerably increased. HRQOL continues to demonstrate its importance in RCTs, especially in those studies in which no OS difference is found. Despite the improved quality of HRQOL methodology reporting, certain aspects remain underrepresented. Our findings suggest need for an international standardization of HRQOL reporting similar to the CONSORT guidelines for clinical findings. PMID:21464420

Education in cardiopulmonary resuscitation in Russia: A systematic review of the available evidence

PubMed Central

Birkun, Alexei; Glotov, Maksim

2017-01-01

BACKGROUND: To summarise and appraise cumulative published scientific evidence relevant to cardiopulmonary resuscitation (CPR) education in Russia. DATA RESOURCES: We searched Medline, Scopus, Science Direct and Russian Science Citation Index databases from December 1991 to December 2016 to identify studies pertaining to the field of CPR education that were carried out by Russian researchers and/or investigated the topic of interest for Russia/Russian population. Reference lists of eligible publications, contents pages of relevant Russian journals and Google Scholar were also searched. There was no limitation based on publication language or study design. RESULTS: Of 7 964 unique citations identified, 22 studies were included. All studies were published from 2009 to 2016, mainly in Russian. Only three studies were reported to be randomized controlled. Non-medical individuals constituted 17% of studied populations. Most of the studies aimed to assess effects of CPR educational interventions, generally suggesting positive influence of the training conducted. The studies were highly heterogeneous as for methodological approaches, structure and duration of educational interventions, evaluation methods and criteria being used. Methodological quality was generally poor, with >40% publications not passing quality screening and only 2 studies meeting the criteria of moderate high quality. CONCLUSION: The results suggest paucity, low population coverage, high thematic and methodological heterogeneity and low quality of the studies addressing CPR education, which were carried out in the Russian Federation. There is a critical need in conducting methodologically consistent, large-scale, randomized, controlled studies evaluating and comparing efficiency of educational interventions for teaching CPR in different population categories of Russia. PMID:29123601

A systematic review of the therapeutic effects of Reiki.

PubMed

vanderVaart, Sondra; Gijsen, Violette M G J; de Wildt, Saskia N; Koren, Gideon

2009-11-01

Reiki is an ancient form of Japanese healing. While this healing method is widely used for a variety of psychologic and physical symptoms, evidence of its effectiveness is scarce and conflicting. The purpose of this systematic review was to try to evaluate whether Reiki produces a significant treatment effect. Studies were identified using an electronic search of Medline, EMBASE, Cochrane Library, and Google Scholar. Quality of reporting was evaluated using a modified CONSORT Criteria for Herbal Interventions, while methodological quality was assessed using the Jadad Quality score. Two (2) researchers selected articles based on the following features: placebo or other adequate control, clinical investigation on humans, intervention using a Reiki practitioner, and published in English. They independently extracted data on study design, inclusion criteria, type of control, sample size, result, and nature of outcome measures. The modified CONSORT Criteria indicated that all 12 trials meeting the inclusion criteria were lacking in at least one of the three key areas of randomization, blinding, and accountability of all patients, indicating a low quality of reporting. Nine (9) of the 12 trials detected a significant therapeutic effect of the Reiki intervention; however, using the Jadad Quality score, 11 of the 12 studies ranked "poor." The serious methodological and reporting limitations of limited existing Reiki studies preclude a definitive conclusion on its effectiveness. High-quality randomized controlled trials are needed to address the effectiveness of Reiki over placebo.

Helicopter mathematical models and control law development for handling qualities research

NASA Technical Reports Server (NTRS)

Chen, Robert T. N.; Lebacqz, J. Victor; Aiken, Edwin W.; Tischler, Mark B.

1988-01-01

Progress made in joint NASA/Army research concerning rotorcraft flight-dynamics modeling, design methodologies for rotorcraft flight-control laws, and rotorcraft parameter identification is reviewed. Research into these interactive disciplines is needed to develop the analytical tools necessary to conduct flying qualities investigations using both the ground-based and in-flight simulators, and to permit an efficient means of performing flight test evaluation of rotorcraft flying qualities for specification compliance. The need for the research is particularly acute for rotorcraft because of their mathematical complexity, high order dynamic characteristics, and demanding mission requirements. The research in rotorcraft flight-dynamics modeling is pursued along two general directions: generic nonlinear models and nonlinear models for specific rotorcraft. In addition, linear models are generated that extend their utilization from 1-g flight to high-g maneuvers and expand their frequency range of validity for the design analysis of high-gain flight control systems. A variety of methods ranging from classical frequency-domain approaches to modern time-domain control methodology that are used in the design of rotorcraft flight control laws is reviewed. Also reviewed is a study conducted to investigate the design details associated with high-gain, digital flight control systems for combat rotorcraft. Parameter identification techniques developed for rotorcraft applications are reviewed.

Acupuncture and moxibustion for lateral elbow pain: a systematic review of randomized controlled trials

PubMed Central

2014-01-01

Background Acupuncture and moxibustion have widely been used to treat lateral elbow pain (LEP). A comprehensive systematic review of randomized controlled trials (RCTs) including both English and Chinese databases was conducted to assess the efficacy of acupuncture and moxibustion in the treatment of LEP. Methods Revised STRICTA (2010) criteria were used to appraise the acupuncture procedures, the Cochrane risk of bias tool was used to assess the methodological quality of the studies. A total of 19 RCTs that compared acupuncture and/or moxibustion with sham acupuncture, another form of acupuncture, or conventional treatment were included. Results All studies had at least one domain rated as high risk or uncertain risk of bias in the Cochrane risk of bias tool. Results from three RCTs of moderate quality showed that acupuncture was more effective than sham acupuncture. Results from 10 RCTs of mostly low quality showed that acupuncture or moxibustion was superior or equal to conventional treatment, such as local anesthetic injection, local steroid injection, non-steroidal anti- inflammatory drugs, or ultrasound. There were six low quality RCTs that compared acupuncture and moxibustion combined with manual acupuncture alone, and all showed that acupuncture and moxibustion combined was superior to manual acupuncture alone. Conclusion Moderate quality studies suggest that acupuncture is more effective than sham acupuncture. Interpretations of findings regarding acupuncture vs. conventional treatment, and acupuncture and moxibustion combined vs. manual acupuncture alone are limited by the methodological qualities of these studies. Future studies with improved methodological design are warranted to confirm the efficacy of acupuncture and moxibustion for LEP. PMID:24726029

Is reflexology an effective intervention? A systematic review of randomised controlled trials.

PubMed

Ernst, Edzard

2009-09-07

To evaluate the evidence for and against the effectiveness of reflexology for treating any medical condition. Six electronic databases were searched from their inception to February 2009 to identify all relevant randomised controlled trials (RCTs). No language restrictions were applied. RCTs of reflexology delivered by trained reflexologists to patients with specific medical conditions. Condition studied, study design and controls, primary outcome measures, follow-up, and main results were extracted. 18 RCTs met all the inclusion criteria. The studies examined a range of conditions: anovulation, asthma, back pain, dementia, diabetes, cancer, foot oedema in pregnancy, headache, irritable bowel syndrome, menopause, multiple sclerosis, the postoperative state and premenstrual syndrome. There were > 1 studies for asthma, the postoperative state, cancer palliation and multiple sclerosis. Five RCTs yielded positive results. Methodological quality was evaluated using the Jadad scale. The methodological quality was often poor, and sample sizes were generally low. Most higher-quality trials did not generate positive findings. The best evidence available to date does not demonstrate convincingly that reflexology is an effective treatment for any medical condition.

Application of the Critical Success Factor Methodology to DoD Organization.

DTIC Science & Technology

1984-09-01

high technology manufacturing, banking, airline, insurance, railway, and automobile . Sullen (6t22-25) lists the current CSFs of the 14 S automobile ...industry as image, quality dealer system, cost control, and meting energy standards. However, in 1981 the automobile CSFs included only styling, quality...bearing on current car purchases as well as future car buys. And finally cost control influenced the auto industry as a CSF, since profit per automobile had

Analytical and simulator study of advanced transport

NASA Technical Reports Server (NTRS)

Levison, W. H.; Rickard, W. W.

1982-01-01

An analytic methodology, based on the optimal-control pilot model, was demonstrated for assessing longitidunal-axis handling qualities of transport aircraft in final approach. Calibration of the methodology is largely in terms of closed-loop performance requirements, rather than specific vehicle response characteristics, and is based on a combination of published criteria, pilot preferences, physical limitations, and engineering judgment. Six longitudinal-axis approach configurations were studied covering a range of handling qualities problems, including the presence of flexible aircraft modes. The analytical procedure was used to obtain predictions of Cooper-Harper ratings, a solar quadratic performance index, and rms excursions of important system variables.

The internal audit of clinical areas: a pilot of the internal audit methodology in a health service emergency department.

PubMed

Brown, Alison; Santilli, Mario; Scott, Belinda

2015-12-01

Governing bodies of health services need assurance that major risks to achieving the health service objectives are being controlled. Currently, the main assurance mechanisms generated within the organization are through the review of implementation of policies and procedures and review of clinical audits and quality data. The governing bodies of health services need more robust, objective data to inform their understanding of the control of clinical risks. Internal audit provides a methodological framework that provides independent and objective assurance to the governing body on the control of significant risks. The article describes the pilot of the internal audit methodology in an emergency unit in a health service. An internal auditor was partnered with a clinical expert to assess the application of clinical criteria based on best practice guidelines. The pilot of the internal audit of a clinical area was successful in identifying significant clinical risks that required further management. The application of an internal audit methodology to a clinical area is a promising mechanism to gain robust assurance at the governance level regarding the management of significant clinical risks. This approach needs further exploration and trial in a range of health care settings. © The Author 2015. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.

The methodological quality assessment tools for preclinical and clinical studies, systematic review and meta-analysis, and clinical practice guideline: a systematic review.

PubMed

Zeng, Xiantao; Zhang, Yonggang; Kwong, Joey S W; Zhang, Chao; Li, Sheng; Sun, Feng; Niu, Yuming; Du, Liang

2015-02-01

To systematically review the methodological assessment tools for pre-clinical and clinical studies, systematic review and meta-analysis, and clinical practice guideline. We searched PubMed, the Cochrane Handbook for Systematic Reviews of Interventions, Joanna Briggs Institute (JBI) Reviewers Manual, Centre for Reviews and Dissemination, Critical Appraisal Skills Programme (CASP), Scottish Intercollegiate Guidelines Network (SIGN), and the National Institute for Clinical Excellence (NICE) up to May 20th, 2014. Two authors selected studies and extracted data; quantitative analysis was performed to summarize the characteristics of included tools. We included a total of 21 assessment tools for analysis. A number of tools were developed by academic organizations, and some were developed by only a small group of researchers. The JBI developed the highest number of methodological assessment tools, with CASP coming second. Tools for assessing the methodological quality of randomized controlled studies were most abundant. The Cochrane Collaboration's tool for assessing risk of bias is the best available tool for assessing RCTs. For cohort and case-control studies, we recommend the use of the Newcastle-Ottawa Scale. The Methodological Index for Non-Randomized Studies (MINORS) is an excellent tool for assessing non-randomized interventional studies, and the Agency for Healthcare Research and Quality (ARHQ) methodology checklist is applicable for cross-sectional studies. For diagnostic accuracy test studies, the Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2) tool is recommended; the SYstematic Review Centre for Laboratory animal Experimentation (SYRCLE) risk of bias tool is available for assessing animal studies; Assessment of Multiple Systematic Reviews (AMSTAR) is a measurement tool for systematic reviews/meta-analyses; an 18-item tool has been developed for appraising case series studies, and the Appraisal of Guidelines, Research and Evaluation (AGREE)-II instrument is widely used to evaluate clinical practice guidelines. We have successfully identified a variety of methodological assessment tools for different types of study design. However, further efforts in the development of critical appraisal tools are warranted since there is currently a lack of such tools for other fields, e.g. genetic studies, and some existing tools (nested case-control studies and case reports, for example) are in need of updating to be in line with current research practice and rigor. In addition, it is very important that all critical appraisal tools remain subjective and performance bias is effectively avoided. © 2015 Chinese Cochrane Center, West China Hospital of Sichuan University and Wiley Publishing Asia Pty Ltd.

Techniques for designing rotorcraft control systems

NASA Technical Reports Server (NTRS)

Yudilevitch, Gil; Levine, William S.

1994-01-01

Over the last two and a half years we have been demonstrating a new methodology for the design of rotorcraft flight control systems (FCS) to meet handling qualities requirements. This method is based on multicriterion optimization as implemented in the optimization package CONSOL-OPTCAD (C-O). This package has been developed at the Institute for Systems Research (ISR) at the University of Maryland at College Park. This design methodology has been applied to the design of a FCS for the UH-60A helicopter in hover having the ADOCS control structure. The controller parameters have been optimized to meet the ADS-33C specifications. Furthermore, using this approach, an optimal (minimum control energy) controller has been obtained and trade-off studies have been performed.

[Methodological quality of an article on the treatment of gastric cancer adopted as protocol by some Chilean hospitals].

PubMed

Manterola, Carlos; Torres, Rodrigo; Burgos, Luis; Vial, Manuel; Pineda, Viviana

2006-07-01

Surgery is a curative treatment for gastric cancer (GC). As relapse is frequent, adjuvant therapies such as postoperative chemo radiotherapy have been tried. In Chile, some hospitals adopted Macdonald's study as a protocol for the treatment of GC. To determine methodological quality and internal and external validity of the Macdonald study. Three instruments were applied that assess methodological quality. A critical appraisal was done and the internal and external validity of the methodological quality was analyzed with two scales: MINCIR (Methodology and Research in Surgery), valid for therapy studies and CONSORT (Consolidated Standards of Reporting Trials), valid for randomized controlled trials (RCT). Guides and scales were applied by 5 researchers with training in clinical epidemiology. The reader's guide verified that the Macdonald study was not directed to answer a clearly defined question. There was random assignment, but the method used is not described and the patients were not considered until the end of the study (36% of the group with surgery plus chemo radiotherapy did not complete treatment). MINCIR scale confirmed a multicentric RCT, not blinded, with an unclear randomized sequence, erroneous sample size estimation, vague objectives and no exclusion criteria. CONSORT system proved the lack of working hypothesis and specific objectives as well as an absence of exclusion criteria and identification of the primary variable, an imprecise estimation of sample size, ambiguities in the randomization process, no blinding, an absence of statistical adjustment and the omission of a subgroup analysis. The instruments applied demonstrated methodological shortcomings that compromise the internal and external validity of the.

Long story short: an introduction to the short-term and long-term Six Sigma quality and its importance in the laboratory medicine for the management of extra-analytical processes.

PubMed

Ialongo, Cristiano; Bernardini, Sergio

2018-06-18

There is a compelling need for quality tools that enable effective control of the extra-analytical phase. In this regard, Six Sigma seems to offer a valid methodological and conceptual opportunity, and in recent times, the International Federation of Clinical Chemistry and Laboratory Medicine has adopted it for indicating the performance requirements for non-analytical laboratory processes. However, the Six Sigma implies a distinction between short-term and long-term quality that is based on the dynamics of the processes. These concepts are still not widespread and applied in the field of laboratory medicine although they are of fundamental importance to exploit the full potential of this methodology. This paper reviews the Six Sigma quality concepts and shows how they originated from Shewhart's control charts, in respect of which they are not an alternative but a completion. It also discusses the dynamic nature of process and how it arises, concerning particularly the long-term dynamic mean variation, and explains why this leads to the fundamental distinction of quality we previously mentioned.

Effect of periodontal treatment on preterm birth rate: a systematic review of meta-analyses.

PubMed

López, Néstor J; Uribe, Sergio; Martinez, Benjamín

2015-02-01

Preterm birth is a major cause of neonatal morbidity and mortality in both developed and developing countries. Preterm birth is a highly complex syndrome that includes distinct clinical subtypes in which many different causes may be involved. The results of epidemiological, molecular, microbiological and animal-model studies support a positive association between maternal periodontal disease and preterm birth. However, the results of intervention studies carried out to determine the effect of periodontal treatment on reducing the risk of preterm birth are controversial. This systematic review critically analyzes the methodological issues of meta-analyses of the studies to determine the effect of periodontal treatment to reduce preterm birth. The quality of the individual randomized clinical trials selected is of highest relevance for a systematic review. This article describes the methodological features that should be identified a priori and assessed individually to determine the quality of a randomized controlled trial performed to evaluate the effect of periodontal treatment on pregnancy outcomes. The AMSTAR and the PRISMA checklist tools were used to assess the quality of the six meta-analyses selected, and the bias domain of the Cochrane Collaboration's Tool was applied to evaluate each of the trials included in the meta-analyses. In addition, the methodological characteristics of each clinical trial were assessed. The majority of the trials included in the meta-analyses have significant methodological flaws that threaten their internal validity. The lack of effect of periodontal treatment on preterm birth rate concluded by four meta-analyses, and the positive effect of treatment for reducing preterm birth risk concluded by the remaining two meta-analyses are not based on consistent scientific evidence. Well-conducted randomized controlled trials using rigorous methodology, including appropriate definition of the exposure, adequate control of confounders for preterm birth and application of effective periodontal interventions to eliminate periodontal infection, are needed to confirm the positive association between periodontal disease and preterm birth. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Improved Temperature Sounding and Quality Control Methodology Using AIRS/AMSU Data: The AIRS Science Team Version 5 Retrieval Algorithm

NASA Technical Reports Server (NTRS)

Susskind, Joel; Blaisdell, John M.; Iredell, Lena; Keita, Fricky

2009-01-01

This paper describes the AIRS Science Team Version 5 retrieval algorithm in terms of its three most significant improvements over the methodology used in the AIRS Science Team Version 4 retrieval algorithm. Improved physics in Version 5 allows for use of AIRS clear column radiances in the entire 4.3 micron CO2 absorption band in the retrieval of temperature profiles T(p) during both day and night. Tropospheric sounding 15 micron CO2 observations are now used primarily in the generation of clear column radiances .R(sub i) for all channels. This new approach allows for the generation of more accurate values of .R(sub i) and T(p) under most cloud conditions. Secondly, Version 5 contains a new methodology to provide accurate case-by-case error estimates for retrieved geophysical parameters and for channel-by-channel clear column radiances. Thresholds of these error estimates are used in a new approach for Quality Control. Finally, Version 5 also contains for the first time an approach to provide AIRS soundings in partially cloudy conditions that does not require use of any microwave data. This new AIRS Only sounding methodology, referred to as AIRS Version 5 AO, was developed as a backup to AIRS Version 5 should the AMSU-A instrument fail. Results are shown comparing the relative performance of the AIRS Version 4, Version 5, and Version 5 AO for the single day, January 25, 2003. The Goddard DISC is now generating and distributing products derived using the AIRS Science Team Version 5 retrieval algorithm. This paper also described the Quality Control flags contained in the DISC AIRS/AMSU retrieval products and their intended use for scientific research purposes.

[Methodology for the comprehensive evaluation of the quality of performance of activities of medical and social experts].

PubMed

Moskalenko, V F; Gorban', Ie M; Marunich, V V; Ipatov, A V; Sergiieni, O V

2001-01-01

The paper scientifically substantiates methodology, approaches, criteria, and control indices for assessment of activities of establishments of medical-and-social performance. Most indices for efficiency and certain indices for week points in the work of establishments of the service depend on interaction thereof with curative- and prophylactic institutions; the best results with the problem of prevention of disability and rehabilitation of invalids are supposed to be achieved through collaborative efforts. Other criteria and intermediate indices having an effect on the quality of activities reflect the resource- and trained personnel supplies of establishments of the service, amount of work, organizational measures designed to raise the quality of medical-and-social expert performance.

[Education for patients with fibromyalgia. A systematic review of randomised clinical trials].

PubMed

Elizagaray-Garcia, Ignacio; Muriente-Gonzalez, Jorge; Gil-Martinez, Alfonso

2016-01-16

To analyse the effectiveness of education about pain, quality of life and functionality in patients with fibromyalgia. The search for articles was carried out in electronic databases. Eligibility criteria were: controlled randomised clinical trials (RCT), published in English and Spanish, that had been conducted on patients with fibromyalgia, in which the therapeutic procedure was based on patient education. Two independent reviewers analysed the methodological quality using the PEDro scale. Five RCT were selected, of which four offered good methodological quality. In three of the studies, patient education, in combination with another intervention based on therapeutic exercise, improved the outcomes in the variables assessing pain and quality of life as compared with the same procedures performed separately. Moreover, an RCT with a high quality methodology showed that patient education activated inhibitory neural pathways capable of lowering the level of pain. The quantitative analysis yields strong-moderate evidence that patient education, in combination with other therapeutic exercise procedures, offers positive results in the variables pain, quality of life and functionality. Patient education in itself has not proved to be effective for pain, quality of life or functionality in patients with fibromyalgia. There is strong evidence, however, of the effectiveness of combining patient education with exercise and active strategies for coping with pain, quality of life and functionality in the short, medium and long term in patients with fibromyalgia.

Application of quality improvement analytic methodology in emergency medicine research: A comparative evaluation.

PubMed

Harries, Bruce; Filiatrault, Lyne; Abu-Laban, Riyad B

2018-05-30

Quality improvement (QI) analytic methodology is rarely encountered in the emergency medicine literature. We sought to comparatively apply QI design and analysis techniques to an existing data set, and discuss these techniques as an alternative to standard research methodology for evaluating a change in a process of care. We used data from a previously published randomized controlled trial on triage-nurse initiated radiography using the Ottawa ankle rules (OAR). QI analytic tools were applied to the data set from this study and evaluated comparatively against the original standard research methodology. The original study concluded that triage nurse-initiated radiographs led to a statistically significant decrease in mean emergency department length of stay. Using QI analytic methodology, we applied control charts and interpreted the results using established methods that preserved the time sequence of the data. This analysis found a compelling signal of a positive treatment effect that would have been identified after the enrolment of 58% of the original study sample, and in the 6th month of this 11-month study. Our comparative analysis demonstrates some of the potential benefits of QI analytic methodology. We found that had this approach been used in the original study, insights regarding the benefits of nurse-initiated radiography using the OAR would have been achieved earlier, and thus potentially at a lower cost. In situations where the overarching aim is to accelerate implementation of practice improvement to benefit future patients, we believe that increased consideration should be given to the use of QI analytic methodology.

Wearable sensor use for assessing standing balance and walking stability in people with Parkinson's disease: a systematic review.

PubMed

Hubble, Ryan P; Naughton, Geraldine A; Silburn, Peter A; Cole, Michael H

2015-01-01

Postural instability and gait disability threaten the independence and well-being of people with Parkinson's disease and increase the risk of falls and fall-related injuries. Prospective research has shown that commonly-used clinical assessments of balance and walking lack the sensitivity to accurately and consistently identify those people with Parkinson's disease who are at a higher risk of falling. Wearable sensors provide a portable and affordable alternative for researchers and clinicians who are seeking to objectively assess movements and falls risk in the clinical setting. However, no consensus currently exists on the optimal placements for sensors and the best outcome measures to use for assessing standing balance and walking stability in Parkinson's disease patients. Hence, this systematic review aimed to examine the available literature to establish the best sensor types, locations and outcomes to assess standing balance and walking stability in this population. Papers listed in three electronic databases were searched by title and abstract to identify articles measuring standing balance or walking stability with any kind of wearable sensor among adults diagnosed with PD. To be eligible for inclusion, papers were required to be full-text articles published in English between January 1994 and December 2014 that assessed measures of standing balance or walking stability with wearable sensors in people with PD. Articles were excluded if they; i) did not use any form of wearable sensor to measure variables associated with standing balance or walking stability; ii) did not include a control group or control condition; iii) were an abstract and/or included in the proceedings of a conference; or iv) were a review article or case study. The targeted search of the three electronic databases identified 340 articles that were potentially eligible for inclusion, but following title, abstract and full-text review only 26 articles were deemed to meet the inclusion criteria. Included articles were assessed for methodological quality and relevant data from the papers were extracted and synthesized. Quality assessment of these included articles indicated that 31% were of low methodological quality, while 58% were of moderate methodological quality and 11% were of high methodological quality. All studies adopted a cross-sectional design and used a variety of sensor types and outcome measures to assess standing balance or walking stability in people with Parkinson's disease. Despite the typically low to moderate methodological quality, 81% of the studies reported differences in sensor-based measures of standing balance or walking stability between different groups of Parkinson's disease patients and/or healthy controls. These data support the use of wearable sensors for detecting differences in standing balance and walking stability between people with PD and controls. Further high-quality research is needed to better understand the utility of wearable sensors for the early identification of Parkinson's disease symptoms and for assessing falls risk in this population. CRD42014010838.

Wearable Sensor Use for Assessing Standing Balance and Walking Stability in People with Parkinson’s Disease: A Systematic Review

PubMed Central

Hubble, Ryan P.; Naughton, Geraldine A.; Silburn, Peter A.; Cole, Michael H.

2015-01-01

Background Postural instability and gait disability threaten the independence and well-being of people with Parkinson’s disease and increase the risk of falls and fall-related injuries. Prospective research has shown that commonly-used clinical assessments of balance and walking lack the sensitivity to accurately and consistently identify those people with Parkinson’s disease who are at a higher risk of falling. Wearable sensors provide a portable and affordable alternative for researchers and clinicians who are seeking to objectively assess movements and falls risk in the clinical setting. However, no consensus currently exists on the optimal placements for sensors and the best outcome measures to use for assessing standing balance and walking stability in Parkinson’s disease patients. Hence, this systematic review aimed to examine the available literature to establish the best sensor types, locations and outcomes to assess standing balance and walking stability in this population. Methods Papers listed in three electronic databases were searched by title and abstract to identify articles measuring standing balance or walking stability with any kind of wearable sensor among adults diagnosed with PD. To be eligible for inclusion, papers were required to be full-text articles published in English between January 1994 and December 2014 that assessed measures of standing balance or walking stability with wearable sensors in people with PD. Articles were excluded if they; i) did not use any form of wearable sensor to measure variables associated with standing balance or walking stability; ii) did not include a control group or control condition; iii) were an abstract and/or included in the proceedings of a conference; or iv) were a review article or case study. The targeted search of the three electronic databases identified 340 articles that were potentially eligible for inclusion, but following title, abstract and full-text review only 26 articles were deemed to meet the inclusion criteria. Included articles were assessed for methodological quality and relevant data from the papers were extracted and synthesized. Results Quality assessment of these included articles indicated that 31% were of low methodological quality, while 58% were of moderate methodological quality and 11% were of high methodological quality. All studies adopted a cross-sectional design and used a variety of sensor types and outcome measures to assess standing balance or walking stability in people with Parkinson’s disease. Despite the typically low to moderate methodological quality, 81% of the studies reported differences in sensor-based measures of standing balance or walking stability between different groups of Parkinson’s disease patients and/or healthy controls. Conclusion These data support the use of wearable sensors for detecting differences in standing balance and walking stability between people with PD and controls. Further high-quality research is needed to better understand the utility of wearable sensors for the early identification of Parkinson’s disease symptoms and for assessing falls risk in this population. PROSPERO Registration CRD42014010838 PMID:25894561

Development and Validation of a Combined Methodology for Assessing the Total Quality Control of Herbal Medicinal Products – Application to Oleuropein Preparations

PubMed Central

Lemonakis, Nikolaos; Gikas, Evagelos; Halabalaki, Maria; Skaltsounis, Alexios-Leandros

2013-01-01

Oleuropein (OE) is a secoiridoid glycoside, which occurs mostly in the Oleaceae family presenting several pharmacological properties, including antioxidant, cardio-protective, anti-atherogenic effects etc. Based on these findings OE is commercially available, as Herbal Medicinal Product (HMP), claimed for its antioxidant effects. As there are general provisions of the medicine regulating bodies e.g. European Medicines Agency, the quality of the HMP’s must always be demonstrated. Therefore, a novel LC-MS methodology was developed and validated for the simultaneous quantification of OE and its main degradation product, hydroxytyrosol (HT), for the relevant OE claimed HMP’s. The internal standard (IS) methodology was employed and separation of OE, HT and IS was achieved on a C18 Fused Core column with 3.1 min overall run time employing the SIM method for the analytical signal acquisition. The method was validated according to the International Conference on Harmonisation requirements and the results show adequate linearity (r2 > 0.99) over a wide concentration range [0.1–15 μg/mL (n=12)] and a LLOQ value of 0.1 μg/mL, for both OE and HT. Furthermore, as it would be beneficial to control the quality taking into account all the substances of the OE claimed HMP’s; a metabolomics-like approach has been developed and applied for the total quality control of the different preparations employing UHPLC-HRMS-multivariate analysis (MVA). Four OE-claimed commercial HMP’s have been randomly selected and MVA similarity-based measurements were performed. The results showed that the examined samples could also be differentiated as evidenced according to their scores plot. Batch to batch reproducibility between the samples of the same brand has also been determined and found to be acceptable. Overall, the developed combined methodology has been found to be an efficient tool for the monitoring of the HMP’s total quality. Only one OE HMP has been found to be consistent to its label claim. PMID:24205178

31P NMR spectroscopy in the quality control and authentication of extra-virgin olive oil: a review of recent progress.

PubMed

Dais, Photis; Spyros, Apostolos

2007-05-01

This review is a brief account on the application of a novel methodology to the quality control and authentication of extra-virgin olive oil. This methodology is based on the derivatization of the labile hydrogens of functional groups, such as hydroxyl and carboxyl groups, of olive oil constituents with the phosphorus reagent 2-chloro-4,4,5,5-tetramethyldioxaphospholane, and the use of the (31)P chemical shifts to identify the phosphitylated compounds. Various experimental aspects such as pertinent instrumentation, sample preparation, acquisition parameters and properties of the phosphorus reagent are reviewed. The strategy to assign the (31)P signals of the phosphitylated model compounds and olive oil constituents by employing 1D and 2D NMR experiments is presented. Finally, the capability of this technique to assess the quality and the genuineness of extra-virgin olive oil and to detect fraud is discussed. Copyright (c) 2007 John Wiley & Sons, Ltd.

Feasibility study of using statistical process control to customized quality assurance in proton therapy.

PubMed

Rah, Jeong-Eun; Shin, Dongho; Oh, Do Hoon; Kim, Tae Hyun; Kim, Gwe-Ya

2014-09-01

To evaluate and improve the reliability of proton quality assurance (QA) processes and, to provide an optimal customized tolerance level using the statistical process control (SPC) methodology. The authors investigated the consistency check of dose per monitor unit (D/MU) and range in proton beams to see whether it was within the tolerance level of the daily QA process. This study analyzed the difference between the measured and calculated ranges along the central axis to improve the patient-specific QA process in proton beams by using process capability indices. The authors established a customized tolerance level of ±2% for D/MU and ±0.5 mm for beam range in the daily proton QA process. In the authors' analysis of the process capability indices, the patient-specific range measurements were capable of a specification limit of ±2% in clinical plans. SPC methodology is a useful tool for customizing the optimal QA tolerance levels and improving the quality of proton machine maintenance, treatment delivery, and ultimately patient safety.

Enantiomer fractions of polychlorinated biphenyls in three selected Standard Reference Materials.

PubMed

Morrissey, Joshua A; Bleackley, Derek S; Warner, Nicholas A; Wong, Charles S

2007-01-01

The enantiomer composition of six chiral polychlorinated biphenyls (PCBs) were measured in three different certified Standard Reference Materials (SRMs) from the US National Institute of Standards and Technology (NIST): SRM 1946 (Lake Superior fish tissue), SRM 1939a (PCB Congeners in Hudson River Sediment), and SRM 2978 (organic contaminants in mussel tissue--Raritan Bay, New Jersey) to aid in quality assurance/quality control methodologies in the study of chiral pollutants in sediments and biota. Enantiomer fractions (EFs) of PCBs 91, 95, 136, 149, 174, and 183 were measured using a suite of chiral columns by gas chromatography/mass spectrometry. Concentrations of target analytes were in agreement with certified values. Target analyte EFs in reference materials were measured precisely (<2% relative standard deviation), indicating the utility of SRM in quality assurance/control methodologies for analyses of chiral compounds in environmental samples. Measured EFs were also in agreement with previously published analyses of similar samples, indicating that similar enantioselective processes were taking place in these environmental matrices.

Robust, Decoupled, Flight Control Design with Rate Saturating Actuators

NASA Technical Reports Server (NTRS)

Snell, S. A.; Hess, R. A.

1997-01-01

Techniques for the design of control systems for manually controlled, high-performance aircraft must provide the following: (1) multi-input, multi-output (MIMO) solutions, (2) acceptable handling qualities including no tendencies for pilot-induced oscillations, (3) a tractable approach for compensator design, (4) performance and stability robustness in the presence of significant plant uncertainty, and (5) performance and stability robustness in the presence actuator saturation (particularly rate saturation). A design technique built upon Quantitative Feedback Theory is offered as a candidate methodology which can provide flight control systems meeting these requirements, and do so over a considerable part of the flight envelope. An example utilizing a simplified model of a supermaneuverable fighter aircraft demonstrates the proposed design methodology.

Electron-beam lithography with character projection technique for high-throughput exposure with line-edge quality control

NASA Astrophysics Data System (ADS)

Ikeno, Rimon; Maruyama, Satoshi; Mita, Yoshio; Ikeda, Makoto; Asada, Kunihiro

2016-07-01

The high throughput of character projection (CP) electron-beam (EB) lithography makes it a promising technique for low-to-medium volume device fabrication with regularly arranged layouts, such as for standard-cell logics and memory arrays. However, non-VLSI applications such as MEMS and MOEMS may not be able to fully utilize the benefits of the CP method due to the wide variety of layout figures including curved and oblique edges. In addition, the stepwise shapes that appear because of the EB exposure process often result in intolerable edge roughness, which degrades device performances. In this study, we propose a general EB lithography methodology for such applications utilizing a combination of the CP and variable-shaped beam methods. In the process of layout data conversion with CP character instantiation, several control parameters were optimized to minimize the shot count, improve the edge quality, and enhance the overall device performance. We have demonstrated EB shot reduction and edge-quality improvement with our methodology by using a leading-edge EB exposure tool, ADVANTEST F7000S-VD02, and a high-resolution hydrogen silsesquioxane resist. Atomic force microscope observations were used to analyze the resist edge profiles' quality to determine the influence of the control parameters used in the data conversion process.

Development and implementation of an audit tool for quality control of parenteral nutrition.

PubMed

García-Rodicio, Sonsoles; Abajo, Celia; Godoy, Mercedes; Catalá, Miguel Angel

2009-01-01

The aim of this article is to describe the development of a quality control methodology applied to patients receiving parenteral nutrition (PN) and to present the results obtained over the past 10 years. Development of the audit tool: In 1995, a total of 13 PN quality criteria and their standards were defined based on literature and past experiences. They were applied during 5 different 6-month audits carried out in subsequent years. According to the results of each audit, the criteria with lower validity were eliminated, while others were optimized and new criteria were introduced to complete the monitoring of other areas not previously examined. Currently, the quality control process includes 22 quality criteria and their standards that examine the following 4 different areas: (1) indication and duration of PN; (2) nutrition assessment, adequacy of the nutrition support, and monitoring; (3) metabolic and infectious complications; and (4) global efficacy of the nutrition support regimen. The authors describe the current definition of each criterion and present the results obtained in the 5 audits performed. In the past year, 9 of the 22 criteria reached the predefined standards. The areas detected for further improvements were: indication for PN, nutrition assessment, and management of catheter infections. The definition of quality criteria and their standards is an efficient method of providing a qualitative and quantitative analysis of the clinical care of patients receiving PN. It detects areas for improvement and assists in developing a methodology to work efficiently.

Worldwide trends in volume and quality of published protocols of randomized controlled trials

PubMed Central

Alldinger, Ingo; Cieslak, Kasia P.; Wennink, Roos; Clarke, Mike; Ali, Usama Ahmed; Besselink, Marc G. H.

2017-01-01

Introduction Publishing protocols of randomized controlled trials (RCT) facilitates a more detailed description of study rational, design, and related ethical and safety issues, which should promote transparency. Little is known about how the practice of publishing protocols developed over time. Therefore, this study describes the worldwide trends in volume and methodological quality of published RCT protocols. Methods A systematic search was performed in PubMed and EMBASE, identifying RCT protocols published over a decade from 1 September 2001. Data were extracted on quality characteristics of RCT protocols. The primary outcome, methodological quality, was assessed by individual methodological characteristics (adequate generation of allocation, concealment of allocation and intention-to-treat analysis). A comparison was made by publication period (First, September 2001- December 2004; Second, January 2005-May 2008; Third, June 2008-September 2011), geographical region and medical specialty. Results The number of published RCT protocols increased from 69 in the first, to 390 in the third period (p<0.0001). Internal medicine and paediatrics were the most common specialty topics. Whereas most published RCT protocols in the first period originated from North America (n = 30, 44%), in the second and third period this was Europe (respectively, n = 65, 47% and n = 190, 48%, p = 0.02). Quality of RCT protocols was higher in Europe and Australasia, compared to North America (OR = 0.63, CI = 0.40–0.99, p = 0.04). Adequate generation of allocation improved with time (44%, 58%, 67%, p = 0.001), as did concealment of allocation (38%, 53%, 55%, p = 0.03). Surgical protocols had the highest quality among the three specialty topics used in this study (OR = 1.94, CI = 1.09–3.45, p = 0.02). Conclusion Publishing RCT protocols has become popular, with a five-fold increase in the past decade. The quality of published RCT protocols also improved, although variation between geographical regions and across medical specialties was seen. This emphasizes the importance of international standards of comprehensive training in RCT methodology. PMID:28296925

Efficacy of surgery for rotator cuff tendinopathy: a systematic review.

PubMed

Toliopoulos, Panagiota; Desmeules, François; Boudreault, Jennifer; Roy, Jean-Sébastien; Frémont, Pierre; MacDermid, Joy C; Dionne, Clermont E

2014-01-01

The objective of this study is to review randomized controlled trials evaluating the efficacy of surgery for the treatment of rotator cuff (RC) tendinopathy. Studies up to August 2013 were located in the PubMed, Embase, CINAHL, and PEDro databases using relevant keywords. Studies were included if: (1) participants had rotator cuff tendinopathy, (2) the trials were conducted on an adult population (≥18 years old), (3) at least one of the interventions studied was a surgical procedure, (4) study design was a randomized controlled trial (RCT), and (5) the article was written in English or French. Characteristics of the included studies were extracted using a standardized form. Two independent raters reviewed the methodological quality of the studies using the Risk of Bias Assessment tool developed by the Cochrane Collaboration Group. Differences were resolved by consensus. Fifteen trials met our inclusion criteria. After consensus, the mean methodological quality for all studies was 58.9 ± 10.8 %. In three out of four RCTs of moderate or low methodological quality, no significant difference in treatment effectiveness was observed between open or arthroscopic acromioplasty compared to exercises in the treatment of RC tendinopathy. Based on two studies of low or moderate methodological quality, no difference in treatment effectiveness was observed between arthroscopic and open acromioplasty. Two other RCTs of low to moderate quality, however, found that arthroscopic acromioplasty yielded better results in the short-term for shoulder range of motion in flexion but that both procedures were comparable in the long-term. One additional study favored open acromioplasty over arthroscopic acromioplasty for the treatment of RC tendinopathy. Based on low- to moderate-quality evidence, acromioplasty, be it open or arthroscopic, is no more effective than exercises for the treatment of RC tendinopathy. Low-grade evidence also suggests that arthroscopic acromioplasty may yield better results in the short-term for shoulder range of motion in flexion compared to open acromioplasty, but long-term results are comparable between the two types of surgery. More high-quality RCTs are required in order to provide comprehensive treatment guidelines to healthcare providers.

Quality transitivity and traceability system of herbal medicine products based on quality markers.

PubMed

Liu, Changxiao; Guo, De-An; Liu, Liang

2018-05-15

Due to a variety of factors to affect the herb quality, the existing quality management model is unable to evaluate the process control. The development of the concept of "quality marker" (Q-marker) lays basis for establishing an independent process quality control system for herbal products. To ensure the highest degree of safety, effectiveness and quality process control of herbal products, it is aimed to establish a quality transitivity and traceability system of quality and process control from raw materials to finished herbal products. Based on the key issues and challenges of quality assessment, the current status of quality and process controls from raw materials to herbal medicinal products listed in Pharmacopoeia were analyzed and the research models including discovery and identification of Q-markers, analysis and quality management of risk evaluation were designed. Authors introduced a few new technologies and methodologies, such as DNA barcoding, chromatographic technologies, fingerprint analysis, chemical markers, bio-responses, risk management and solution for quality process control. The quality and process control models for herbal medicinal products were proposed and the transitivity and traceability system from raw materials to the finished products was constructed to improve the herbal quality from the entire supply and production chain. The transitivity and traceability system has been established based on quality markers, especially on how to control the production process under Good Engineering Practices, as well as to implement the risk management for quality and process control in herbal medicine production. Copyright © 2018 Elsevier GmbH. All rights reserved.

Design of experiments enhanced statistical process control for wind tunnel check standard testing

NASA Astrophysics Data System (ADS)

Phillips, Ben D.

The current wind tunnel check standard testing program at NASA Langley Research Center is focused on increasing data quality, uncertainty quantification and overall control and improvement of wind tunnel measurement processes. The statistical process control (SPC) methodology employed in the check standard testing program allows for the tracking of variations in measurements over time as well as an overall assessment of facility health. While the SPC approach can and does provide researchers with valuable information, it has certain limitations in the areas of process improvement and uncertainty quantification. It is thought by utilizing design of experiments methodology in conjunction with the current SPC practices that one can efficiently and more robustly characterize uncertainties and develop enhanced process improvement procedures. In this research, methodologies were developed to generate regression models for wind tunnel calibration coefficients, balance force coefficients and wind tunnel flow angularities. The coefficients of these regression models were then tracked in statistical process control charts, giving a higher level of understanding of the processes. The methodology outlined is sufficiently generic such that this research can be applicable to any wind tunnel check standard testing program.

CT radiation profile width measurement using CR imaging plate raw data

PubMed Central

Yang, Chang‐Ying Joseph

2015-01-01

This technical note demonstrates computed tomography (CT) radiation profile measurement using computed radiography (CR) imaging plate raw data showing it is possible to perform the CT collimation width measurement using a single scan without saturating the imaging plate. Previously described methods require careful adjustments to the CR reader settings in order to avoid signal clipping in the CR processed image. CT radiation profile measurements were taken as part of routine quality control on 14 CT scanners from four vendors. CR cassettes were placed on the CT scanner bed, raised to isocenter, and leveled. Axial scans were taken at all available collimations, advancing the cassette for each scan. The CR plates were processed and raw CR data were analyzed using MATLAB scripts to measure collimation widths. The raw data approach was compared with previously established methodology. The quality control analysis scripts are released as open source using creative commons licensing. A log‐linear relationship was found between raw pixel value and air kerma, and raw data collimation width measurements were in agreement with CR‐processed, bit‐reduced data, using previously described methodology. The raw data approach, with intrinsically wider dynamic range, allows improved measurement flexibility and precision. As a result, we demonstrate a methodology for CT collimation width measurements using a single CT scan and without the need for CR scanning parameter adjustments which is more convenient for routine quality control work. PACS numbers: 87.57.Q‐, 87.59.bd, 87.57.uq PMID:26699559

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

Costa, Mafalda T., E-mail: mafaldatcosta@gmail.com; Carolino, Elisabete, E-mail: lizcarolino@gmail.com; Oliveira, Teresa A., E-mail: teresa.oliveira@uab.pt

In water supply systems with distribution networkthe most critical aspects of control and Monitoring of water quality, which generates crises system, are the effects of cross-contamination originated by the network typology. The classics of control of quality systems through the application of Shewhart charts are generally difficult to manage in real time due to the high number of charts that must be completed and evaluated. As an alternative to the traditional control systems with Shewhart charts, this study aimed to apply a simplified methodology of a monitoring plan quality parameters in a drinking water distribution, by applying Hotelling’s T{sup 2}more » charts and supplemented with Shewhart charts with Bonferroni limits system, whenever instabilities with processes were detected.« less

Methodological reporting quality of randomized controlled trials: A survey of seven core journals of orthopaedics from Mainland China over 5 years following the CONSORT statement.

PubMed

Zhang, J; Chen, X; Zhu, Q; Cui, J; Cao, L; Su, J

2016-11-01

In recent years, the number of randomized controlled trials (RCTs) in the field of orthopaedics is increasing in Mainland China. However, randomized controlled trials (RCTs) are inclined to bias if they lack methodological quality. Therefore, we performed a survey of RCT to assess: (1) What about the quality of RCTs in the field of orthopedics in Mainland China? (2) Whether there is difference between the core journals of the Chinese department of orthopedics and Orthopaedics Traumatology Surgery & Research (OTSR). This research aimed to evaluate the methodological reporting quality according to the CONSORT statement of randomized controlled trials (RCTs) in seven key orthopaedic journals published in Mainland China over 5 years from 2010 to 2014. All of the articles were hand researched on Chongqing VIP database between 2010 and 2014. Studies were considered eligible if the words "random", "randomly", "randomization", "randomized" were employed to describe the allocation way. Trials including animals, cadavers, trials published as abstracts and case report, trials dealing with subgroups analysis, or trials without the outcomes were excluded. In addition, eight articles selected from Orthopaedics Traumatology Surgery & Research (OTSR) between 2010 and 2014 were included in this study for comparison. The identified RCTs are analyzed using a modified version of the Consolidated Standards of Reporting Trials (CONSORT), including the sample size calculation, allocation sequence generation, allocation concealment, blinding and handling of dropouts. A total of 222 RCTs were identified in seven core orthopaedic journals. No trials reported adequate sample size calculation, 74 (33.4%) reported adequate allocation generation, 8 (3.7%) trials reported adequate allocation concealment, 18 (8.1%) trials reported adequate blinding and 16 (7.2%) trials reported handling of dropouts. In OTSR, 1 (12.5%) trial reported adequate sample size calculation, 4 (50.0%) reported adequate allocation generation, 1 (12.5%) trials reported adequate allocation concealment, 2 (25.0%) trials reported adequate blinding and 5 (62.5%) trials reported handling of dropouts. There were statistical differences as for sample size calculation and handling of dropouts between papers from Mainland China and OTSR (P<0.05). The findings of this study show that the methodological reporting quality of RCTs in seven core orthopaedic journals from the Mainland China is far from satisfaction and it needs to further improve to keep up with the standards of the CONSORT statement. Level III case control. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

Quality Assessment of Studies Published in Open Access and Subscription Journals: Results of a Systematic Evaluation.

PubMed

Pastorino, Roberta; Milovanovic, Sonja; Stojanovic, Jovana; Efremov, Ljupcho; Amore, Rosarita; Boccia, Stefania

2016-01-01

Along with the proliferation of Open Access (OA) publishing, the interest for comparing the scientific quality of studies published in OA journals versus subscription journals has also increased. With our study we aimed to compare the methodological quality and the quality of reporting of primary epidemiological studies and systematic reviews and meta-analyses published in OA and non-OA journals. In order to identify the studies to appraise, we listed all OA and non-OA journals which published in 2013 at least one primary epidemiologic study (case-control or cohort study design), and at least one systematic review or meta-analysis in the field of oncology. For the appraisal, we picked up the first studies published in 2013 with case-control or cohort study design from OA journals (Group A; n = 12), and in the same time period from non-OA journals (Group B; n = 26); the first systematic reviews and meta-analyses published in 2013 from OA journals (Group C; n = 15), and in the same time period from non-OA journals (Group D; n = 32). We evaluated the methodological quality of studies by assessing the compliance of case-control and cohort studies to Newcastle and Ottawa Scale (NOS) scale, and the compliance of systematic reviews and meta-analyses to Assessment of Multiple Systematic Reviews (AMSTAR) scale. The quality of reporting was assessed considering the adherence of case-control and cohort studies to STrengthening the Reporting of OBservational studies in Epidemiology (STROBE) checklist, and the adherence of systematic reviews and meta-analyses to Preferred Reporting Items for Systematic reviews and Meta-Analysis (PRISMA) checklist. Among case-control and cohort studies published in OA and non-OA journals, we did not observe significant differences in the median value of NOS score (Group A: 7 (IQR 7-8) versus Group B: 8 (7-9); p = 0.5) and in the adherence to STROBE checklist (Group A, 75% versus Group B, 80%; p = 0.1). The results did not change after adjustment for impact factor. The compliance with AMSTAR and adherence to PRISMA checklist were comparable between systematic reviews and meta-analyses published in OA and non-OA journals (Group C, 46.0% versus Group D, 55.0%; p = 0.06), (Group C, 72.0% versus Group D, 76.0%; p = 0.1), respectively). The epidemiological studies published in OA journals in the field of oncology approach the same methodological quality and quality of reporting as studies published in non-OA journals.

Quality Assessment of Studies Published in Open Access and Subscription Journals: Results of a Systematic Evaluation

PubMed Central

Pastorino, Roberta; Milovanovic, Sonja; Stojanovic, Jovana; Efremov, Ljupcho; Amore, Rosarita; Boccia, Stefania

2016-01-01

Introduction Along with the proliferation of Open Access (OA) publishing, the interest for comparing the scientific quality of studies published in OA journals versus subscription journals has also increased. With our study we aimed to compare the methodological quality and the quality of reporting of primary epidemiological studies and systematic reviews and meta-analyses published in OA and non-OA journals. Methods In order to identify the studies to appraise, we listed all OA and non-OA journals which published in 2013 at least one primary epidemiologic study (case-control or cohort study design), and at least one systematic review or meta-analysis in the field of oncology. For the appraisal, we picked up the first studies published in 2013 with case-control or cohort study design from OA journals (Group A; n = 12), and in the same time period from non-OA journals (Group B; n = 26); the first systematic reviews and meta-analyses published in 2013 from OA journals (Group C; n = 15), and in the same time period from non-OA journals (Group D; n = 32). We evaluated the methodological quality of studies by assessing the compliance of case-control and cohort studies to Newcastle and Ottawa Scale (NOS) scale, and the compliance of systematic reviews and meta-analyses to Assessment of Multiple Systematic Reviews (AMSTAR) scale. The quality of reporting was assessed considering the adherence of case-control and cohort studies to STrengthening the Reporting of OBservational studies in Epidemiology (STROBE) checklist, and the adherence of systematic reviews and meta-analyses to Preferred Reporting Items for Systematic reviews and Meta-Analysis (PRISMA) checklist. Results Among case-control and cohort studies published in OA and non-OA journals, we did not observe significant differences in the median value of NOS score (Group A: 7 (IQR 7–8) versus Group B: 8 (7–9); p = 0.5) and in the adherence to STROBE checklist (Group A, 75% versus Group B, 80%; p = 0.1). The results did not change after adjustment for impact factor. The compliance with AMSTAR and adherence to PRISMA checklist were comparable between systematic reviews and meta-analyses published in OA and non-OA journals (Group C, 46.0% versus Group D, 55.0%; p = 0.06), (Group C, 72.0% versus Group D, 76.0%; p = 0.1), respectively). Conclusion The epidemiological studies published in OA journals in the field of oncology approach the same methodological quality and quality of reporting as studies published in non-OA journals. PMID:27167982

Funding source and the quality of reports of chronic wounds trials: 2004 to 2011

PubMed Central

2014-01-01

Background Critical commentaries suggest that wound care randomised controlled trials (RCTs) are often poorly reported with many methodological flaws. Furthermore, interventions in chronic wounds, rather than being drugs, are often medical devices for which there are no requirements for RCTs to bring products to market. RCTs in wounds trials therefore potentially represent a form of marketing. This study presents a methodological overview of chronic wound trials published between 2004 and 2011 and investigates the influence of industry funding on methodological quality. Methods A systematic search for RCTs for the treatment of chronic wounds published in the English language between 2004 and 2011 (inclusive) in the Cochrane Wounds Group Specialised Register of Trials was carried out. Data were extracted on aspects of trial design, conduct and quality including sample size, duration of follow-up, specification of a primary outcome, use of surrogate outcomes, and risks of bias. In addition, the prevalence of industry funding was assessed and its influence on the above aspects of trial design, conduct and quality was assessed. Results A total of 167 RCTs met our inclusion criteria. We found chronic wound trials often have short durations of follow-up (median 12 weeks), small sample sizes (median 63), fail to define a primary outcome in 41% of cases, and those that do define a primary outcome, use surrogate measures of healing in 40% of cases. Only 40% of trials used appropriate methods of randomisation, 25% concealed allocation and 34% blinded outcome assessors. Of the included trials, 41% were wholly or partially funded by industry, 33% declared non-commercial funding and 26% did not report a funding source. Industry funding was not statistically significantly associated with any measure of methodological quality, though this analysis was probably underpowered. Conclusions This overview confirms concerns raised about the methodological quality of RCTs in wound care and illustrates that greater efforts must be made to follow international standards for conducting and reporting RCTs. There is currently minimal evidence of an influence of industry funding on methodological quality although analyses had limited power and funding source was not reported for a quarter of studies. PMID:24422753

Funding source and the quality of reports of chronic wounds trials: 2004 to 2011.

PubMed

Hodgson, Robert; Allen, Richard; Broderick, Ellen; Bland, J Martin; Dumville, Jo C; Ashby, Rebecca; Bell-Syer, Sally; Foxlee, Ruth; Hall, Jill; Lamb, Karen; Madden, Mary; O'Meara, Susan; Stubbs, Nikki; Cullum, Nicky

2014-01-14

Critical commentaries suggest that wound care randomised controlled trials (RCTs) are often poorly reported with many methodological flaws. Furthermore, interventions in chronic wounds, rather than being drugs, are often medical devices for which there are no requirements for RCTs to bring products to market. RCTs in wounds trials therefore potentially represent a form of marketing. This study presents a methodological overview of chronic wound trials published between 2004 and 2011 and investigates the influence of industry funding on methodological quality. A systematic search for RCTs for the treatment of chronic wounds published in the English language between 2004 and 2011 (inclusive) in the Cochrane Wounds Group Specialised Register of Trials was carried out.Data were extracted on aspects of trial design, conduct and quality including sample size, duration of follow-up, specification of a primary outcome, use of surrogate outcomes, and risks of bias. In addition, the prevalence of industry funding was assessed and its influence on the above aspects of trial design, conduct and quality was assessed. A total of 167 RCTs met our inclusion criteria. We found chronic wound trials often have short durations of follow-up (median 12 weeks), small sample sizes (median 63), fail to define a primary outcome in 41% of cases, and those that do define a primary outcome, use surrogate measures of healing in 40% of cases. Only 40% of trials used appropriate methods of randomisation, 25% concealed allocation and 34% blinded outcome assessors. Of the included trials, 41% were wholly or partially funded by industry, 33% declared non-commercial funding and 26% did not report a funding source. Industry funding was not statistically significantly associated with any measure of methodological quality, though this analysis was probably underpowered. This overview confirms concerns raised about the methodological quality of RCTs in wound care and illustrates that greater efforts must be made to follow international standards for conducting and reporting RCTs. There is currently minimal evidence of an influence of industry funding on methodological quality although analyses had limited power and funding source was not reported for a quarter of studies.

Most systematic reviews of high methodological quality on psoriasis interventions are classified as high risk of bias using ROBIS tool.

PubMed

Gómez-García, Francisco; Ruano, Juan; Gay-Mimbrera, Jesus; Aguilar-Luque, Macarena; Sanz-Cabanillas, Juan Luis; Alcalde-Mellado, Patricia; Maestre-López, Beatriz; Carmona-Fernández, Pedro Jesús; González-Padilla, Marcelino; García-Nieto, Antonio Vélez; Isla-Tejera, Beatriz

2017-12-01

No gold standard exists to assess methodological quality of systematic reviews (SRs). Although Assessing the Methodological Quality of Systematic Reviews (AMSTAR) is widely accepted for analyzing quality, the ROBIS instrument has recently been developed. This study aimed to compare the capacity of both instruments to capture the quality of SRs concerning psoriasis interventions. Systematic literature searches were undertaken on relevant databases. For each review, methodological quality and bias risk were evaluated using the AMSTAR and ROBIS tools. Descriptive and principal component analyses were conducted to describe similarities and discrepancies between both assessment tools. We classified 139 intervention SRs as displaying high/moderate/low methodological quality and as high/low risk of bias. A high risk of bias was detected for most SRs classified as displaying high or moderate methodological quality by AMSTAR. When comparing ROBIS result profiles, responses to domain 4 signaling questions showed the greatest differences between bias risk assessments, whereas domain 2 items showed the least. When considering SRs published about psoriasis, methodological quality remains suboptimal, and the risk of bias is elevated, even for SRs exhibiting high methodological quality. Furthermore, the AMSTAR and ROBIS tools may be considered as complementary when conducting quality assessment of SRs. Copyright © 2017 Elsevier Inc. All rights reserved.

Effectiveness of physical therapy interventions for children with cerebral palsy: A systematic review

PubMed Central

Anttila, Heidi; Autti-Rämö, Ilona; Suoranta, Jutta; Mäkelä, Marjukka; Malmivaara, Antti

2008-01-01

Background To assess the effectiveness of physical therapy (PT) interventions on functioning in children with cerebral palsy (CP). Methods A search was made in Medline, Cinahl, PEDro and the Cochrane library for the period 1990 to February 2007. Only randomized controlled trials (RCTs) on PT interventions in children with diagnosed CP were included. Two reviewers independently assessed the methodological quality and extracted the data. The outcomes measured in the trials were classified using the International Classification of Functioning, Disability and Health (ICF). Results Twenty-two trials were identified. Eight intervention categories were distinguished. Four trials were of high methodological quality. Moderate evidence of effectiveness was established for two intervention categories: effectiveness of upper extremity treatments on attained goals and active supination, and of prehensile hand treatment and neurodevelopmental therapy (NDT) or NDT twice a week on developmental status, and of constraint-induced therapy on amount and quality of hand use. Moderate evidence of ineffectiveness was found of strength training on walking speed and stride length. Conflicting evidence was found for strength training on gross motor function. For the other intervention categories the evidence was limited due to low methodological quality and the statistically insignificant results of the studies. Conclusion Due to limitations in methodological quality and variations in population, interventions and outcomes, mostly limited evidence on the effectiveness of most PT interventions is available through RCTs. Moderate evidence was found for some effectiveness of upper extremity training. Well-designed trials are needed especially for focused PT interventions. PMID:18435840

Aircraft flight test trajectory control

NASA Technical Reports Server (NTRS)

Menon, P. K. A.; Walker, R. A.

1988-01-01

Two control law design techniques are compared and the performance of the resulting controllers evaluated. The design requirement is for a flight test trajectory controller (FTTC) capable of closed-loop, outer-loop control of an F-15 aircraft performing high-quality research flight test maneuvers. The maneuver modeling, linearization, and design methodologies utilized in this research, are detailed. The results of applying these FTTCs to a nonlinear F-15 simulation are presented.

Efficacy of exercise therapy in workers with rotator cuff tendinopathy: a systematic review

PubMed Central

Desmeules, François; Boudreault, Jennifer; Dionne, Clermont E.; Frémont, Pierre; Lowry, Véronique; MacDermid, Joy C.; Roy, Jean-Sébastien

2016-01-01

Objective: To perform a systematic review of randomized controlled trials (RCTs) on the efficacy of therapeutic exercises for workers suffering from rotator cuff (RC) tendinopathy. Methods: A literature search in four bibliographical databases (Pubmed, CINAHL, EMBASE, and PEDro) was conducted from inception up to February 2015. RCTs were included if participants were workers suffering from RC tendinopathy, the outcome measures included work-related outcomes, and at least one of the interventions under study included exercises. The methodological quality of the studies was evaluated with the Cochrane Risk of Bias Assessment tool. Results: The mean methodological score of the ten included studies was 54.4%±17.2%. Types of workers included were often not defined, and work-related outcome measures were heterogeneous and often not validated. Three RCTs of moderate methodological quality concluded that exercises were superior to a placebo or no intervention in terms of function and return-to-work outcomes. No significant difference was found between surgery and exercises based on the results of two studies of low to moderate methodological quality. One study of low methodological quality, comparing a workplace-based exercise program focusing on the participants' work demands to an exercise program delivered in a clinical setting, concluded that the work-based intervention was superior in terms of function and return-to-work outcomes. Conclusion: There is low to moderate-grade evidence that therapeutic exercises provided in a clinical setting are an effective modality to treat workers suffering from RC tendinopathy and to promote return-to-work. Further high quality studies comparing different rehabilitation programs including exercises in different settings with defined workers populations are needed to draw firm conclusions on the optimal program to treat workers. PMID:27488037

Efficacy of exercise therapy in workers with rotator cuff tendinopathy: a systematic review.

PubMed

Desmeules, François; Boudreault, Jennifer; Dionne, Clermont E; Frémont, Pierre; Lowry, Véronique; MacDermid, Joy C; Roy, Jean-Sébastien

2016-09-30

To perform a systematic review of randomized controlled trials (RCTs) on the efficacy of therapeutic exercises for workers suffering from rotator cuff (RC) tendinopathy. A literature search in four bibliographical databases (Pubmed, CINAHL, EMBASE, and PEDro) was conducted from inception up to February 2015. RCTs were included if participants were workers suffering from RC tendinopathy, the outcome measures included work-related outcomes, and at least one of the interventions under study included exercises. The methodological quality of the studies was evaluated with the Cochrane Risk of Bias Assessment tool. The mean methodological score of the ten included studies was 54.4%±17.2%. Types of workers included were often not defined, and work-related outcome measures were heterogeneous and often not validated. Three RCTs of moderate methodological quality concluded that exercises were superior to a placebo or no intervention in terms of function and return-to-work outcomes. No significant difference was found between surgery and exercises based on the results of two studies of low to moderate methodological quality. One study of low methodological quality, comparing a workplace-based exercise program focusing on the participants' work demands to an exercise program delivered in a clinical setting, concluded that the work-based intervention was superior in terms of function and return-to-work outcomes. There is low to moderate-grade evidence that therapeutic exercises provided in a clinical setting are an effective modality to treat workers suffering from RC tendinopathy and to promote return-to-work. Further high quality studies comparing different rehabilitation programs including exercises in different settings with defined workers populations are needed to draw firm conclusions on the optimal program to treat workers.

Systematic Review of Integrative Health Care Research: Randomized Control Trials, Clinical Controlled Trials, and Meta-Analysis

PubMed Central

Khorsan, Raheleh; Coulter, Ian D.; Crawford, Cindy; Hsiao, An-Fu

2011-01-01

A systematic review was conducted to assess the level of evidence for integrative health care research. We searched PubMed, Allied and Complementary Medicine (AMED), BIOSIS Previews, EMBASE, the entire Cochrane Library, MANTIS, Social SciSearch, SciSearch Cited Ref Sci, PsychInfo, CINAHL, and NCCAM grantee publications listings, from database inception to May 2009, as well as searches of the “gray literature.” Available studies published in English language were included. Three independent reviewers rated each article and assessed the methodological quality of studies using the Scottish Intercollegiate Guidelines Network (SIGN 50). Our search yielded 11,891 total citations but 6 clinical studies, including 4 randomized, met our inclusion criteria. There are no available systematic reviews/meta-analyses published that met our inclusion criteria. The methodological quality of the included studies was assessed independently using quality checklists of the SIGN 50. Only a small number of RCTs and CCTs with a limited number of patients and lack of adequate control groups assessing integrative health care research are available. These studies provide limited evidence of effective integrative health care on some modalities. However, integrative health care regimen appears to be generally safe. PMID:20953383

Author-paper affiliation network architecture influences the methodological quality of systematic reviews and meta-analyses of psoriasis.

PubMed

Sanz-Cabanillas, Juan Luis; Ruano, Juan; Gomez-Garcia, Francisco; Alcalde-Mellado, Patricia; Gay-Mimbrera, Jesus; Aguilar-Luque, Macarena; Maestre-Lopez, Beatriz; Gonzalez-Padilla, Marcelino; Carmona-Fernandez, Pedro J; Velez Garcia-Nieto, Antonio; Isla-Tejera, Beatriz

2017-01-01

Moderate-to-severe psoriasis is associated with significant comorbidity, an impaired quality of life, and increased medical costs, including those associated with treatments. Systematic reviews (SRs) and meta-analyses (MAs) of randomized clinical trials are considered two of the best approaches to the summarization of high-quality evidence. However, methodological bias can reduce the validity of conclusions from these types of studies and subsequently impair the quality of decision making. As co-authorship is among the most well-documented forms of research collaboration, the present study aimed to explore whether authors' collaboration methods might influence the methodological quality of SRs and MAs of psoriasis. Methodological quality was assessed by two raters who extracted information from full articles. After calculating total and per-item Assessment of Multiple Systematic Reviews (AMSTAR) scores, reviews were classified as low (0-4), medium (5-8), or high (9-11) quality. Article metadata and journal-related bibliometric indices were also obtained. A total of 741 authors from 520 different institutions and 32 countries published 220 reviews that were classified as high (17.2%), moderate (55%), or low (27.7%) methodological quality. The high methodological quality subnetwork was larger but had a lower connection density than the low and moderate methodological quality subnetworks; specifically, the former contained relatively fewer nodes (authors and reviews), reviews by authors, and collaborators per author. Furthermore, the high methodological quality subnetwork was highly compartmentalized, with several modules representing few poorly interconnected communities. In conclusion, structural differences in author-paper affiliation network may influence the methodological quality of SRs and MAs on psoriasis. As the author-paper affiliation network structure affects study quality in this research field, authors who maintain an appropriate balance between scientific quality and productivity are more likely to develop higher quality reviews.

75 FR 13076 - Privacy Act of 1974; Altered System of Records

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-18

....C., Sections 141 and 193 and the U.S. Census Bureau; and to undertake methodological evaluations and enhancements leading to improved data collection and quality control studies. Also, information collected by...

[Investigation on production process quality control of traditional Chinese medicine--Banlangen granule as an example].

PubMed

Tan, Manrong; Yan, Dan; Qiu, Lingling; Chen, Longhu; Yan, Yan; Jin, Cheng; Li, Hanbing; Xiao, Xiaohe

2012-04-01

For the quality management system of herbal medicines, intermediate and finished products it exists the " short board" effect of methodologies. Based on the concept of process control, new strategies and new methods of the production process quality control had been established with the consideration of the actual production of traditional Chinese medicine an the characteristics of Chinese medicine. Taking Banlangen granule as a practice example, which was effective and widespread application, character identification, determination of index components, chemical fingerprint and biometrics technology were sequentially used respectively to assess the quality of Banlangen herbal medicines, intermediate (water extraction and alcohol precipitation) and finished product. With the transfer rate of chemical information and biological potency as indicators, the effectiveness and transmission of the above different assessments and control methods had been researched. And ultimately, the process quality control methods of Banlangen granule, which were based on chemical composition analysis-biometric analysis, had been set up. It can not only validly solute the current status that there were many manufacturers varying quality of Banlangen granule, but also ensure and enhance its clinical efficacy. Furthermore it provided a foundation for the construction of the quality control of traditional Chinese medicine production process.

Anti-tobacco mass media and socially disadvantaged groups: a systematic and methodological review.

PubMed

Guillaumier, Ashleigh; Bonevski, Billie; Paul, Chris

2012-07-01

Only a limited amount of research has been conducted to explore whether there are socioeconomic status differences in responses to mass media. However, the methodological quality of this evidence has not been assessed, limiting confidence in conclusions that can be drawn regarding study outcomes. A systematic review of the effectiveness of anti-tobacco mass media campaigns with socially disadvantaged groups was conducted, and the methodological quality of included studies was assessed. Medline, The Cochrane Library, PsycInfo, Embase and Web of Science were searched using MeSH and keywords for quantitative studies conducted in Western countries prior to March 2012. A methodological quality assessment and narrative analysis of included studies was undertaken. Seventeen relevant studies (reported in 18 papers) were identified; however, weak study designs and selection bias were common characteristics, limiting strong conclusions about effectiveness. Using predominantly non-cessation related outcome measures reviewed papers indicated mixed results for mass media tobacco control campaign effectiveness among various social groups. Most studies assessed mass media impact on low socioeconomic status groups rather than highly socially disadvantaged groups. Methodological rigour of evaluations in this field must be improved to aid understanding regarding the effectiveness of mass media campaigns in driving cessation among disadvantaged groups. The results of this review indicate a gap in methodologically rigorous research into the effectiveness of mass media campaigns among socially disadvantaged groups, particularly the highly disadvantaged. © 2012 Australasian Professional Society on Alcohol and other Drugs.

[A strategy of constructing the technological system for quality control of Chinese medicine based on process control and management].

PubMed

Cheng, Yi-Yu; Qian, Zhong-Zhi; Zhang, Bo-Li

2017-01-01

The current situation, bottleneck problems and severe challenges in quality control technology of Chinese Medicine (CM) are briefly described. It is presented to change the phenomenon related to the post-test as the main means and contempt for process control in drug regulation, reverse the situation of neglecting the development of process control and management technology for pharmaceutical manufacture and reconstruct the technological system for quality control of CM products. The regulation and technology system based on process control and management for controlling CM quality should be established to solve weighty realistic problems of CM industry from the root causes, including backwardness of quality control technology, weakness of quality risk control measures, poor reputation of product quality and so on. By this way, the obstacles from poor controllability of CM product quality could be broken. Concentrating on those difficult problems and weak links in the technical field of CM quality control, it is proposed to build CMC (Chemistry, Manufacturing and Controls) regulation for CM products with Chinese characteristics and promote the regulation international recognition as soon as possible. The CMC technical framework, which is clinical efficacy-oriented, manufacturing manner-centered and process control-focused, was designed. To address the clinical characteristics of traditional Chinese medicine (TCM) and the production feature of CM manufacture, it is suggested to establish quality control engineering for CM manufacturing by integrating pharmaceutical analysis, TCM chemistry, TCM pharmacology, pharmaceutical engineering, control engineering, management engineering and other disciplines. Further, a theoretical model of quality control engineering for CM manufacturing and the methodology of digital pharmaceutical engineering are proposed. A technology pathway for promoting CM standard and realizing the strategic goal of CM internationalization is elaborated. Copyright© by the Chinese Pharmaceutical Association.

Applications of flight control system methods to an advanced combat rotorcraft

NASA Technical Reports Server (NTRS)

Tischler, Mark B.; Fletcher, Jay W.; Morris, Patrick M.; Tucker, George T.

1989-01-01

Advanced flight control system design, analysis, and testing methodologies developed at the Ames Research Center are applied in an analytical and flight test evaluation of the Advanced Digital Optical Control System (ADOCS) demonstrator. The primary objectives are to describe the knowledge gained about the implications of digital flight control system design for rotorcraft, and to illustrate the analysis of the resulting handling-qualities in the context of the proposed new handling-qualities specification for rotorcraft. Topics covered in-depth are digital flight control design and analysis methods, flight testing techniques, ADOCS handling-qualities evaluation results, and correlation of flight test results with analytical models and the proposed handling-qualities specification. The evaluation of the ADOCS demonstrator indicates desirable response characteristics based on equivalent damping and frequency, but undersirably large effective time-delays (exceeding 240 m sec in all axes). Piloted handling-qualities are found to be desirable or adequate for all low, medium, and high pilot gain tasks; but handling-qualities are inadequate for ultra-high gain tasks such as slope and running landings.

A design procedure for the handling qualities optimization of the X-29A aircraft

NASA Technical Reports Server (NTRS)

Bosworth, John T.; Cox, Timothy H.

1989-01-01

A design technique for handling qualities improvement was developed for the X-29A aircraft. As with any new aircraft, the X-29A control law designers were presented with a relatively high degree of uncertainty in their mathematical models. The presence of uncertainties, and the high level of static instability of the X-29A caused the control law designers to stress stability and robustness over handling qualities. During flight test, the mathematical models of the vehicle were validated or corrected to match the vehicle dynamic behavior. The updated models were then used to fine tune the control system to provide fighter-like handling characteristics. A design methodology was developed which works within the existing control system architecture to provide improved handling qualities and acceptable stability with a minimum of cost in both implementation as well as software verification and validation.

Composite and Loose Concepts, Historical Analogies, and the Logic of Control in Comparative Historical Analysis

ERIC Educational Resources Information Center

Møller, Jørgen

2016-01-01

The use of controlled comparisons pervades comparative historical analysis. Heated debates have surrounded the methodological purchase of such comparisons. However, the quality and validity of the conceptual building blocks on which the comparisons are based have largely been ignored. This article discusses a particular problem pertaining to these…

Closed-loop, pilot/vehicle analysis of the approach and landing task

NASA Technical Reports Server (NTRS)

Schmidt, D. K.; Anderson, M. R.

1985-01-01

Optimal-control-theoretic modeling and frequency-domain analysis is the methodology proposed to evaluate analytically the handling qualities of higher-order manually controlled dynamic systems. Fundamental to the methodology is evaluating the interplay between pilot workload and closed-loop pilot/vehicle performance and stability robustness. The model-based metric for pilot workload is the required pilot phase compensation. Pilot/vehicle performance and loop stability is then evaluated using frequency-domain techniques. When these techniques were applied to the flight-test data for thirty-two highly-augmented fighter configurations, strong correlation was obtained between the analytical and experimental results.

Using COPE To Improve Quality of Care: The Experience of the Family Planning Association of Kenya.

ERIC Educational Resources Information Center

Bradley, Janet

1998-01-01

COPE (Client-Oriented, Provider-Efficient) methodology, a self-assessment tool that has been used in 35 countries around the world, was used to improve the quality of care in family planning clinics in Kenya. COPE involves a process that legitimately invests power with providers and clinic-level staff. It gives providers more control over their…

A Monte Carlo analysis of breast screening randomized trials.

PubMed

Zamora, Luis I; Forastero, Cristina; Guirado, Damián; Lallena, Antonio M

2016-12-01

To analyze breast screening randomized trials with a Monte Carlo simulation tool. A simulation tool previously developed to simulate breast screening programmes was adapted for that purpose. The history of women participating in the trials was simulated, including a model for survival after local treatment of invasive cancers. Distributions of time gained due to screening detection against symptomatic detection and the overall screening sensitivity were used as inputs. Several randomized controlled trials were simulated. Except for the age range of women involved, all simulations used the same population characteristics and this permitted to analyze their external validity. The relative risks obtained were compared to those quoted for the trials, whose internal validity was addressed by further investigating the reasons of the disagreements observed. The Monte Carlo simulations produce results that are in good agreement with most of the randomized trials analyzed, thus indicating their methodological quality and external validity. A reduction of the breast cancer mortality around 20% appears to be a reasonable value according to the results of the trials that are methodologically correct. Discrepancies observed with Canada I and II trials may be attributed to a low mammography quality and some methodological problems. Kopparberg trial appears to show a low methodological quality. Monte Carlo simulations are a powerful tool to investigate breast screening controlled randomized trials, helping to establish those whose results are reliable enough to be extrapolated to other populations and to design the trial strategies and, eventually, adapting them during their development. Copyright © 2016 Associazione Italiana di Fisica Medica. Published by Elsevier Ltd. All rights reserved.

Randomized controlled trials of simulation-based interventions in Emergency Medicine: a methodological review.

PubMed

Chauvin, Anthony; Truchot, Jennifer; Bafeta, Aida; Pateron, Dominique; Plaisance, Patrick; Yordanov, Youri

2018-04-01

The number of trials assessing Simulation-Based Medical Education (SBME) interventions has rapidly expanded. Many studies show that potential flaws in design, conduct and reporting of randomized controlled trials (RCTs) can bias their results. We conducted a methodological review of RCTs assessing a SBME in Emergency Medicine (EM) and examined their methodological characteristics. We searched MEDLINE via PubMed for RCT that assessed a simulation intervention in EM, published in 6 general and internal medicine and in the top 10 EM journals. The Cochrane Collaboration risk of Bias tool was used to assess risk of bias, intervention reporting was evaluated based on the "template for intervention description and replication" checklist, and methodological quality was evaluated by the Medical Education Research Study Quality Instrument. Reports selection and data extraction was done by 2 independents researchers. From 1394 RCTs screened, 68 trials assessed a SBME intervention. They represent one quarter of our sample. Cardiopulmonary resuscitation (CPR) is the most frequent topic (81%). Random sequence generation and allocation concealment were performed correctly in 66 and 49% of trials. Blinding of participants and assessors was performed correctly in 19 and 68%. Risk of attrition bias was low in three-quarters of the studies (n = 51). Risk of selective reporting bias was unclear in nearly all studies. The mean MERQSI score was of 13.4/18.4% of the reports provided a description allowing the intervention replication. Trials assessing simulation represent one quarter of RCTs in EM. Their quality remains unclear, and reproducing the interventions appears challenging due to reporting issues.

Assessment of the methodological and ethical quality of clinical trials published in family medicine journals

PubMed

Castaño-García, Alberto; Guillén-Grima, Francisco; León-Sanz, Pilar

2018-01-01

To evaluate some methodological and ethical quality variables of clinical trials (CTs) published in 10 family medicine journals. Quality descriptive study of 10 family medicine journals including CTs in humans published since 2010 to 2013. We obtained 141 CT and 2447 were excluded. CTs parallels controlled in 92.9% (95% confidence interval [95% CI]: 92.0-93.9). Masked randomization in 72.3% (95% CI: 71.7-73.1), decentralized in 51.8% (95% CI: 51.4-52.4) and using as control an active treatment in 82.2% (95% CI: 81.5-83.1). Wrote informed consent in 48.9% (95% CI: 48.5-49.5) and it was not withdrawn in 56.0% of cases (95% CI: 55.5-56.7). Approval by clinical research ethics committee (CREC) in 134, and there was no conflict of interest in 117 CTs. Average κ was 0.96 (95% CI: 0.93-0.99). We observe an increase in some quality variables like masked randomization (19.6%) and approval by CREC (75%) post CONSORT, in CTs published in 10 family medicine journals (2010-2013). Copyright: © 2018 SecretarÍa de Salud

Public Health Interventions for Aedes Control in the Time of Zikavirus– A Meta-Review on Effectiveness of Vector Control Strategies

PubMed Central

Bouzid, Maha; Brainard, Julii; Hooper, Lee; Hunter, Paul R.

2016-01-01

Background There is renewed interest in effective measures to control Zika and dengue vectors. A synthesis of published literature with a focus on the quality of evidence is warranted to determine the effectiveness of vector control strategies. Methodology We conducted a meta-review assessing the effectiveness of any Aedes control measure. We searched Scopus and Medline for relevant reviews through to May 2016. Titles, abstracts and full texts were assessed independently for inclusion by two authors. Data extraction was performed in duplicate and validity of the evidence was assessed using GRADE criteria. Findings 13 systematic reviews that investigated the effect of control measures on entomological parameters or disease incidence were included. Biological controls seem to achieve better reduction of entomological indices than chemical controls, while educational campaigns can reduce breeding habitats. Integrated vector control strategies may not always increase effectiveness. The efficacy of any control programme is dependent on local settings, intervention type, resources and study duration, which may partly explain the varying degree of success between studies. Nevertheless, the quality of evidence was mostly low to very low due to poor reporting of study design, observational methodologies, heterogeneity, and indirect outcomes, thus hindering an evidence-based recommendation. Conclusions The evidence for the effectiveness of Aedes control measures is mixed. Chemical control, which is commonly used, does not appear to be associated with sustainable reductions of mosquito populations over time. Indeed, by contributing to a false sense of security, chemical control may reduce the effectiveness of educational interventions aimed at encouraging local people to remove mosquito breeding sites. Better quality studies of the impact of vector control interventions on the incidence of human infections with Dengue or Zika are still needed. PMID:27926934

Appraisal of systematic reviews on the management of peri-implant diseases with two methodological tools.

PubMed

Faggion, Clovis Mariano; Monje, Alberto; Wasiak, Jason

2018-06-01

This study aimed to evaluate and compare the performance of two methodological instruments to appraise systematic reviews and to identify potential disagreements of systematic review authors regarding risk of bias (RoB) evaluation of randomized controlled trials (RCTs) included in systematic reviews on peri-implant diseases. We searched Medline, Web of Science, Cochrane Library, PubMed Central, and Google Scholar for systematic reviews on peri-implant diseases published before July 11, 2017. Two authors independently evaluated the RoB and methodological quality of the systematic reviews by applying the Risk of Bias in Systematic Reviews (ROBIS) tool and Assessing the Methodological Quality of Systematic Reviews (AMSTAR) checklist, respectively. We assessed the RoB scores of the same RCTs published in different systematic reviews. Of the 32 systematic reviews identified, 23 reviews addressed the clinical topic of peri-implantitis. A high RoB was detected for most systematic reviews (n=25) using ROBIS, whilst five systematic reviews displayed low methodological quality by AMSTAR. Almost 30% of the RoB comparisons (for the same RCTs) had different RoB ratings across systematic reviews. The ROBIS tool appears to provide more conservative results than AMSTAR checklist. Considerable disagreement was found among systematic review authors rating the same RCT included in different systematic reviews. © 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

A systematic review of physical therapy interventions for patients with anorexia and bulemia nervosa.

PubMed

Vancampfort, Davy; Vanderlinden, Johan; De Hert, Marc; Soundy, Andrew; Adámkova, Milena; Skjaerven, Liv Helvik; Catalán-Matamoros, Daniel; Lundvik Gyllensten, Amanda; Gómez-Conesa, Antonia; Probst, Michel

2014-01-01

The purpose of this systematic review was to summarise the evidence from randomised controlled trials examining the effectiveness of physical therapy compared with care as usual or a wait-list condition on eating pathology and on physiological and psychological parameters in patients with anorexia and bulimia nervosa. EMBASE, PsycINFO, PubMed, Cumulative Index to Nursing and Allied Health Literature, Physiotherapy Evidence Database and The Cochrane Library were searched from their inception until February, 2013. Articles were eligible if they utilised a randomised controlled trial design, compared physical therapy with a placebo condition, control intervention, or standard care and included patients with anorexia and bulimia nervosa. The methodological quality was assessed with the Jadad scale. Eight randomised controlled trials involving 213 patients (age range: 16-36 years) met all selection criteria. Three of the 8 included studies were of strong methodological quality (Jadad score≥3). Major methodological weaknesses were attrition and selection bias. The main results demonstrate that aerobic and resistance training result in significantly increased muscle strength, body mass index and body fat percentage in anorexia patients. In addition, aerobic exercise, yoga, massage and basic body awareness therapy significantly lowered scores of eating pathology and depressive symptoms in both anorexia and bulimia nervosa patients. No adverse effects were reported. The paucity and heterogeneity of available studies limits overall conclusions and highlights the need for further research. Implications for Rehabilitation Supervised physical therapy might increase weight in anorexia nervosa patients. Aerobic exercise, massage, basic body awareness therapy and yoga might reduce eating pathology in patients with anorexia and bulimia nervosa. Aerobic exercise, yoga and basic body awareness therapy might improve mental and physical quality of life in patients with an eating disorder.

Current Evidence on Heart Rate Variability Biofeedback as a Complementary Anticraving Intervention.

PubMed

Alayan, Nour; Eller, Lucille; Bates, Marsha E; Carmody, Dennis P

2018-05-21

The limited success of conventional anticraving interventions encourages research into new treatment strategies. Heart rate variability biofeedback (HRVB), which is based on slowed breathing, was shown to improve symptom severity in various disorders. HRVB, and certain rates of controlled breathing (CB), may offer therapeutic potential as a complementary drug-free treatment option to help control substance craving. This review evaluated current evidence on the effectiveness of HRVB and CB training as a complementary anticraving intervention, based on guidelines from the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols. Studies that assessed a cardiorespiratory feedback or CB intervention with substance craving as an outcome were selected. Effect sizes were calculated for each study. The Scale for Assessing Scientific Quality of Investigations in Complementary and Alternative Medicine was used to evaluate the quality of each study reviewed. A total of eight articles remained for final review, including controlled studies with or without randomization, as well as noncontrolled trials. Most studies showed positive results with a variety of methodological quality levels and effect size. Current HRVB studies rated moderately on methodological rigor and showed inconsistent magnitudes of calculated effect size (0.074-0.727) across populations. The largest effect size was found in a nonclinical college population of high food cravers utilizing the most intensive HRVB training time of 240 min. Despite the limitations of this review, there is beginning evidence that HRVB and CB training can be of significant therapeutic potential. Larger clinical trials are needed with methodological improvements such as longer treatment duration, adequate control conditions, measures of adherence and compliance, longitudinal examination of craving changes, and more comprehensive methods of craving measurement.

Root Cause Analysis of Quality Defects Using HPLC-MS Fingerprint Knowledgebase for Batch-to-batch Quality Control of Herbal Drugs.

PubMed

Yan, Binjun; Fang, Zhonghua; Shen, Lijuan; Qu, Haibin

2015-01-01

The batch-to-batch quality consistency of herbal drugs has always been an important issue. To propose a methodology for batch-to-batch quality control based on HPLC-MS fingerprints and process knowledgebase. The extraction process of Compound E-jiao Oral Liquid was taken as a case study. After establishing the HPLC-MS fingerprint analysis method, the fingerprints of the extract solutions produced under normal and abnormal operation conditions were obtained. Multivariate statistical models were built for fault detection and a discriminant analysis model was built using the probabilistic discriminant partial-least-squares method for fault diagnosis. Based on multivariate statistical analysis, process knowledge was acquired and the cause-effect relationship between process deviations and quality defects was revealed. The quality defects were detected successfully by multivariate statistical control charts and the type of process deviations were diagnosed correctly by discriminant analysis. This work has demonstrated the benefits of combining HPLC-MS fingerprints, process knowledge and multivariate analysis for the quality control of herbal drugs. Copyright © 2015 John Wiley & Sons, Ltd.

Systematic review of communication partner training in aphasia: methodological quality.

PubMed

Cherney, Leora R; Simmons-Mackie, Nina; Raymer, Anastasia; Armstrong, Elizabeth; Holland, Audrey

2013-10-01

Twenty-three studies identified from a previous systematic review examining the effects of communication partner training on persons with aphasia and their communication partners were evaluated for methodological quality. Two reviewers rated the studies on defined methodological quality criteria relevant to each study design. There were 11 group studies, seven single-subject participant design studies, and five qualitative studies. Quality scores were derived for each study. The mean inter-rater reliability of scores for each study design ranged from 85-93%, with Cohen's Kappa indicating substantial agreement between raters. Methodological quality of research on communication partner training in aphasia was highly varied. Overall, group studies employed the least rigorous methodology as compared to single subject and qualitative research. Only two of 11 group studies complied with more than half of the quality criteria. No group studies reported therapist blinding and only one group study reported participant blinding. Across all types of studies, the criterion of treatment fidelity was most commonly omitted. Failure to explicitly report certain methodological quality criteria may account for low ratings. Using methodological rating scales specific to the type of study design may help improve the methodological quality of aphasia treatment studies, including those on communication partner training.

Irritable Bowel Syndrome and Complementary Health Practices: What the Science Says

MedlinePlus

... controlled trials on various herbal preparations; however, the methodological quality of most of these studies is poor. ... if improperly manufactured. A 2012 systematic review of case reports and case series concluded that using certain ...

MERCURY MEASUREMENTS USING DIRECT-ANALYZER METHODOLOGY

EPA Science Inventory

Under EPA's Water Quality Research Program, exposure studies are needed to determine how well control strategies and guidance are working. Consequently, reliable and convenient techniques that minimize waste production are of special interest. While traditional methods for determ...

Quality of systematic reviews in pediatric oncology--a systematic review.

PubMed

Lundh, Andreas; Knijnenburg, Sebastiaan L; Jørgensen, Anders W; van Dalen, Elvira C; Kremer, Leontien C M

2009-12-01

To ensure evidence-based decision making in pediatric oncology systematic reviews are necessary. The objective of our study was to evaluate the methodological quality of all currently existing systematic reviews in pediatric oncology. We identified eligible systematic reviews through a systematic search of the literature. Data on clinical and methodological characteristics of the included systematic reviews were extracted. The methodological quality of the included systematic reviews was assessed using the overview quality assessment questionnaire, a validated 10-item quality assessment tool. We compared the methodological quality of systematic reviews published in regular journals with that of Cochrane systematic reviews. We included 117 systematic reviews, 99 systematic reviews published in regular journals and 18 Cochrane systematic reviews. The average methodological quality of systematic reviews was low for all ten items, but the quality of Cochrane systematic reviews was significantly higher than systematic reviews published in regular journals. On a 1-7 scale, the median overall quality score for all systematic reviews was 2 (range 1-7), with a score of 1 (range 1-7) for systematic reviews in regular journals compared to 6 (range 3-7) in Cochrane systematic reviews (p<0.001). Most systematic reviews in the field of pediatric oncology seem to have serious methodological flaws leading to a high risk of bias. While Cochrane systematic reviews were of higher methodological quality than systematic reviews in regular journals, some of them also had methodological problems. Therefore, the methodology of each individual systematic review should be scrutinized before accepting its results.

Application of an integrated flight/propulsion control design methodology to a STOVL aircraft

NASA Technical Reports Server (NTRS)

Garg, Sanjay; Mattern, Duane L.

1991-01-01

Results are presented from the application of an emerging Integrated Flight/Propulsion Control (IFPC) design methodology to a Short Take Off and Vertical Landing (STOVL) aircraft in transition flight. The steps in the methodology consist of designing command shaping prefilters to provide the overall desired response to pilot command inputs. A previously designed centralized controller is first validated for the integrated airframe/engine plant used. This integrated plant is derived from a different model of the engine subsystem than the one used for the centralized controller design. The centralized controller is then partitioned in a decentralized, hierarchical structure comprising of airframe lateral and longitudinal subcontrollers and an engine subcontroller. Command shaping prefilters from the pilot control effector inputs are then designed and time histories of the closed loop IFPC system response to simulated pilot commands are compared to desired responses based on handling qualities requirements. Finally, the propulsion system safety and nonlinear limited protection logic is wrapped around the engine subcontroller and the response of the closed loop integrated system is evaluated for transients that encounter the propulsion surge margin limit.

Efficacy of hypnosis/guided imagery in fibromyalgia syndrome - a systematic review and meta-analysis of controlled trials

PubMed Central

2011-01-01

Background Recent systematic reviews on psychological therapies of fibromyalgia syndrome (FMS) did not consider hypnosis/guided imagery (H/GI). Therefore we performed a systematic review with meta-analysis of the efficacy of H/GI in FMS. Methods We screened http://ClinicalTrials.gov, Cochrane Library, MEDLINE, PsycINFO and SCOPUS (through December 2010). (Quasi-) randomized controlled trials (CTs) comparing H/GI with controls were analyzed. Outcomes were pain, sleep, fatigue, depressed mood and health-related quality of life (HRQOL). Effects were summarized using standardized mean differences (SMD). Results Six CTs with 239 subjects with a median of 9 (range 7-12) H/GI-sessions were analysed. The median number of patients in the H/GI groups was 20 (range 8-26). Three studies performed follow-ups. H/GI reduced pain compared to controls at final treatment (SMD -1.17 [95% CI -2.21, -0.13]; p = 0.03). H/GI did not reduce limitations of HRQOL at final treatment (SMD -0.90 [95% CI -2.55, 0.76]; p = 0.29) compared to controls. Effect sizes on fatigue, sleep and depressed mood at final treatment and follow-up and on pain and HRQOL at follow-up were not calculated because of limited data available. The significant effect on pain at final treatment was associated with low methodological and low treatment quality. Conclusion Further studies with better treatment quality and adequate methodological quality assessing all key domains of FMS are necessary to clarify the efficacy of H/GI in FMS. PMID:21676255

Effects of whole body vibration on pulmonary function, functional exercise capacity and quality of life in people with chronic obstructive pulmonary disease: a systematic review.

PubMed

Yang, Xiaotian; Zhou, Yujing; Wang, Pu; He, Chengqi; He, Hongchen

2016-05-01

To examine the effect of whole-body vibration in enhancing pulmonary function, functional exercise capacity and quality of life in people with chronic obstructive pulmonary disease and examine its safety. Randomized controlled trials examining the effects of whole body vibration among people with chronic obstructive pulmonary disease were identified by two independent researchers. Articles were excluded if they were studies on people with other primary diagnosis, abstracts published in the conferences or books. PEDro scale was used to assess the methodological quality of the selected studies. We evaluated the level of evidence by using the GRADE approach. The results were extracted by two researchers and confirmed by the third researcher if disagreement existed. Sources included Cochrane Central Register of Controlled Trials, PubMed, CINAHL, EMBASE, PEDro, AMED, PsycINFO, ClinicalTrials.gov, Current Controlled Trials and reference lists of all relevant articles. Four studies involving 206 participants were included in this systematic review. Methodological quality was rated as good for two studies. No great benefits on pulmonary function were found in whole body vibration treatment group. Two studies showed that quality of life was improved in people with chronic obstructive pulmonary disease. Whole body vibration led to significant improvements in functional exercise capacity measured with six minutes walking test. Nearly no adverse events were observed. Whole body vibration may improve functional exercise capacity and quality of life in people with chronic obstructive pulmonary disease. There was insufficient evidence to prove the effects of whole body vibration on pulmonary function. © The Author(s) 2015.

A Chip and Pixel Qualification Methodology on Imaging Sensors

NASA Technical Reports Server (NTRS)

Chen, Yuan; Guertin, Steven M.; Petkov, Mihail; Nguyen, Duc N.; Novak, Frank

2004-01-01

This paper presents a qualification methodology on imaging sensors. In addition to overall chip reliability characterization based on sensor s overall figure of merit, such as Dark Rate, Linearity, Dark Current Non-Uniformity, Fixed Pattern Noise and Photon Response Non-Uniformity, a simulation technique is proposed and used to project pixel reliability. The projected pixel reliability is directly related to imaging quality and provides additional sensor reliability information and performance control.

Panning for the gold in health research: incorporating studies' methodological quality in meta-analysis.

PubMed

Johnson, Blair T; Low, Robert E; MacDonald, Hayley V

2015-01-01

Systematic reviews now routinely assess methodological quality to gauge the validity of the included studies and of the synthesis as a whole. Although trends from higher quality studies should be clearer, it is uncertain how often meta-analyses incorporate methodological quality in models of study results either as predictors, or, more interestingly, in interactions with theoretical moderators. We survey 200 meta-analyses in three health promotion domains to examine when and how meta-analyses incorporate methodological quality. Although methodological quality assessments commonly appear in contemporary meta-analyses (usually as scales), they are rarely incorporated in analyses, and still more rarely analysed in interaction with theoretical determinants of the success of health promotions. The few meta-analyses (2.5%) that did include such an interaction analysis showed that moderator results remained significant in higher quality studies or were present only among higher quality studies. We describe how to model quality interactively with theoretically derived moderators and discuss strengths and weaknesses of this approach and in relation to current meta-analytic practice. In large literatures exhibiting heterogeneous effects, meta-analyses can incorporate methodological quality and generate conclusions that enable greater confidence not only about the substantive phenomenon but also about the role that methodological quality itself plays.

Reporting of health-related quality of life (HRQOL) data in oncology trials: a comparison of the European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) and the Functional Assessment of Cancer Therapy-General (FACT-G).

PubMed

Smith, Adam B; Cocks, Kim; Parry, David; Taylor, Matthew

2014-04-01

The inclusion of patient-reported outcome (PRO) instruments to record patient health-related quality of life (HRQOL) data has virtually become the norm in oncology randomised controlled trials (RCTs). Despite this fact, recent concerns have focused on the quality of reporting of HRQOL. The primary aim of this study was to evaluate the quality of reporting of HRQOL data from two common instruments in oncology RCTs. A meta-review was undertaken of systematic reviews reporting HRQOL data collected using PRO instruments in oncology randomised controlled trials (RCTs). English language articles published between 2000 and 2012 were included and evaluated against a methodology checklist. Four hundred and thirty-five potential articles were identified. Six systematic reviews were included in the analysis. A total of 70,403 patients had completed PROs. The European Organization for Research and Treatment of Cancer QLQ-C30 and Functional Assessment of Cancer Therapy-General questionnaire accounted for 55 % of RCTs. Eighty per cent of RCTs had used psychometrically validated instruments; 70 % reported culturally valid instruments and almost all reported the assessment timing (96 %). Thirty per cent of RCTS reported clinical significance and missing data. In terms of methodological design, only 25 % of RCTs could be categorised as probably robust. The majority of oncology RCTs has shortcomings in terms of reporting HRQOL data when assessed against regulatory and methodology guidelines. These limitations will need to be addressed if HRQOL data are to be used to successfully support clinical decision-making, treatment options and labelling claims in oncology.

Rating the methodological quality of single-subject designs and n-of-1 trials: introducing the Single-Case Experimental Design (SCED) Scale.

PubMed

Tate, Robyn L; McDonald, Skye; Perdices, Michael; Togher, Leanne; Schultz, Regina; Savage, Sharon

2008-08-01

Rating scales that assess methodological quality of clinical trials provide a means to critically appraise the literature. Scales are currently available to rate randomised and non-randomised controlled trials, but there are none that assess single-subject designs. The Single-Case Experimental Design (SCED) Scale was developed for this purpose and evaluated for reliability. Six clinical researchers who were trained and experienced in rating methodological quality of clinical trials developed the scale and participated in reliability studies. The SCED Scale is an 11-item rating scale for single-subject designs, of which 10 items are used to assess methodological quality and use of statistical analysis. The scale was developed and refined over a 3-year period. Content validity was addressed by identifying items to reduce the main sources of bias in single-case methodology as stipulated by authorities in the field, which were empirically tested against 85 published reports. Inter-rater reliability was assessed using a random sample of 20/312 single-subject reports archived in the Psychological Database of Brain Impairment Treatment Efficacy (PsycBITE). Inter-rater reliability for the total score was excellent, both for individual raters (overall ICC = 0.84; 95% confidence interval 0.73-0.92) and for consensus ratings between pairs of raters (overall ICC = 0.88; 95% confidence interval 0.78-0.95). Item reliability was fair to excellent for consensus ratings between pairs of raters (range k = 0.48 to 1.00). The results were replicated with two independent novice raters who were trained in the use of the scale (ICC = 0.88, 95% confidence interval 0.73-0.95). The SCED Scale thus provides a brief and valid evaluation of methodological quality of single-subject designs, with the total score demonstrating excellent inter-rater reliability using both individual and consensus ratings. Items from the scale can also be used as a checklist in the design, reporting and critical appraisal of single-subject designs, thereby assisting to improve standards of single-case methodology.

Feasibility study of using statistical process control to customized quality assurance in proton therapy

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

Rah, Jeong-Eun; Oh, Do Hoon; Shin, Dongho

Purpose: To evaluate and improve the reliability of proton quality assurance (QA) processes and, to provide an optimal customized tolerance level using the statistical process control (SPC) methodology. Methods: The authors investigated the consistency check of dose per monitor unit (D/MU) and range in proton beams to see whether it was within the tolerance level of the daily QA process. This study analyzed the difference between the measured and calculated ranges along the central axis to improve the patient-specific QA process in proton beams by using process capability indices. Results: The authors established a customized tolerance level of ±2% formore » D/MU and ±0.5 mm for beam range in the daily proton QA process. In the authors’ analysis of the process capability indices, the patient-specific range measurements were capable of a specification limit of ±2% in clinical plans. Conclusions: SPC methodology is a useful tool for customizing the optimal QA tolerance levels and improving the quality of proton machine maintenance, treatment delivery, and ultimately patient safety.« less

Technology transfer through a network of standard methods and recommended practices - The case of petrochemicals

NASA Astrophysics Data System (ADS)

Batzias, Dimitris F.; Karvounis, Sotirios

2012-12-01

Technology transfer may take place in parallel with cooperative action between companies participating in the same organizational scheme or using one another as subcontractor (outsourcing). In this case, cooperation should be realized by means of Standard Methods and Recommended Practices (SRPs) to achieve (i) quality of intermediate/final products according to specifications and (ii) industrial process control as required to guarantee such quality with minimum deviation (corresponding to maximum reliability) from preset mean values of representative quality parameters. This work deals with the design of the network of SRPs needed in each case for successful cooperation, implying also the corresponding technology transfer, effectuated through a methodological framework developed in the form of an algorithmic procedure with 20 activity stages and 8 decision nodes. The functionality of this methodology is proved by presenting the path leading from (and relating) a standard test method for toluene, as petrochemical feedstock in the toluene diisocyanate production, to the (6 generations distance upstream) performance evaluation of industrial process control systems (ie., from ASTM D5606 to BS EN 61003-1:2004 in the SRPs network).

Methods for a study of Anticipatory and Preventive multidisciplinary Team Care in a family practice.

PubMed

Dahrouge, Simone; Hogg, William; Lemelin, Jacques; Liddy, Clare; Legault, Frances

2010-02-01

BACKGROUND T o examine the methodology used to evaluate whether focusing the work of nurse practitioners and a pharmacist on frail and at-risk patients would improve the quality of care for such patients. Evaluation of methodology of a randomized controlled trial including analysis of quantitative and qualitative data over time and analysis of cost-effectiveness. A single practice in a rural area near Ottawa, Ont. A total of 241 frail patients, aged 50 years and older, at risk of experiencing adverse health outcomes. At-risk patients were randomly assigned to receive Anticipatory and Preventive Team Care (from their family physicians, 1 of 3 nurse practitioners, and a pharmacist) or usual care. The principal outcome for the study was the quality of care for chronic disease management. Secondary outcomes included other quality of care measures and evaluation of the program process and its cost-effectiveness. This article examines the effectiveness of the methodology used. Quantitative data from surveys, administrative databases, and medical records were supplemented with qualitative information from interviews, focus groups, work logs, and study notes. Three factors limit our ability to fully demonstrate the potential effects of this team structure. For reasons outside our control, the intervention duration was shorter than intended; the practice's physical layout did not facilitate interactions between the care providers; and contamination of the intervention effect into the control arm cannot be excluded. The study used a randomized design, relied on a multifaceted approach to evaluating its effects, and used several sources of data. TRIAL REGISTRATION NUMBER NCT00238836 (CONSORT).

Systematic review of the cost effectiveness of prophylactic treatments in the prevention of gastropathy in patients with rheumatoid arthritis or osteoarthritis taking non-steroidal anti-inflammatory drugs

PubMed Central

van Dieten, H. E M; Bos, I.; van Tulder, M. W; Lems, W.; Dijkmans, B.; Boers, M.

2000-01-01

A systematic review on the cost effectiveness of prophylactic treatments of non-steroidal anti-inflammatory drug (NSAID) induced gastropathy in patients with osteoarthritis or rheumatoid arthritis was conducted. Two reviewers conducted the literature search and the review. Both full and partial economic evaluations published in English, Dutch, or German were included. The criteria list published in the textbook of Drummond was used to determine the quality of the economic evaluations. The methodological quality of three randomised controlled trials (RCTs) in which the economic evaluations obtained probability estimates of NSAID induced gastropathy and adverse events was assessed by a list of internal validity criteria. The conclusions were based on a rating system consisting of four levels of evidence.
  Ten economic evaluations were included; three were based on RCTs. All evaluations studied misoprostol as prophylactic treatment: in one evaluation misoprostol was studied as a fixed component in a combination with diclofenac (Arthrotec). All economic evaluations comprised analytical studies containing a decision tree. The three trials were of high methodological quality. Nine economic evaluations were considered high quality and one economic evaluation was considered of low methodological quality. There is strong evidence (level "A") that the use of misoprostol for the prevention of NSAID induced gastropathy is cost effective, and limited evidence (level "C") that the use of Arthrotec is cost effective. Although the levels of evidence used in this review are arbitrary, it is believed that a qualitative analysis is useful: quantitative analyses in this field are hampered by the heterogeneity of economic evaluations. Existing criteria to evaluate the methodological quality of economic evaluations may need refinement for use in systematic reviews.

 PMID:11005773

Systematic review of the cost effectiveness of prophylactic treatments in the prevention of gastropathy in patients with rheumatoid arthritis or osteoarthritis taking non-steroidal anti-inflammatory drugs.

PubMed

van Dieten, H E; Korthals-de Bos, I B; van Tulder, M W; Lems, W F; Dijkmans, B A; Boers, M

2000-10-01

A systematic review on the cost effectiveness of prophylactic treatments of non-steroidal anti-inflammatory drug (NSAID) induced gastropathy in patients with osteoarthritis or rheumatoid arthritis was conducted. Two reviewers conducted the literature search and the review. Both full and partial economic evaluations published in English, Dutch, or German were included. The criteria list published in the textbook of Drummond was used to determine the quality of the economic evaluations. The methodological quality of three randomised controlled trials (RCTs) in which the economic evaluations obtained probability estimates of NSAID induced gastropathy and adverse events was assessed by a list of internal validity criteria. The conclusions were based on a rating system consisting of four levels of evidence. Ten economic evaluations were included; three were based on RCTs. All evaluations studied misoprostol as prophylactic treatment: in one evaluation misoprostol was studied as a fixed component in a combination with diclofenac (Arthrotec). All economic evaluations comprised analytical studies containing a decision tree. The three trials were of high methodological quality. Nine economic evaluations were considered high quality and one economic evaluation was considered of low methodological quality. There is strong evidence (level "A") that the use of misoprostol for the prevention of NSAID induced gastropathy is cost effective, and limited evidence (level "C") that the use of Arthrotec is cost effective. Although the levels of evidence used in this review are arbitrary, it is believed that a qualitative analysis is useful: quantitative analyses in this field are hampered by the heterogeneity of economic evaluations. Existing criteria to evaluate the methodological quality of economic evaluations may need refinement for use in systematic reviews.

Author-paper affiliation network architecture influences the methodological quality of systematic reviews and meta-analyses of psoriasis

PubMed Central

Gomez-Garcia, Francisco; Alcalde-Mellado, Patricia; Gay-Mimbrera, Jesus; Aguilar-Luque, Macarena; Maestre-Lopez, Beatriz; Gonzalez-Padilla, Marcelino; Carmona-Fernandez, Pedro J.; Velez Garcia-Nieto, Antonio; Isla-Tejera, Beatriz

2017-01-01

Moderate-to-severe psoriasis is associated with significant comorbidity, an impaired quality of life, and increased medical costs, including those associated with treatments. Systematic reviews (SRs) and meta-analyses (MAs) of randomized clinical trials are considered two of the best approaches to the summarization of high-quality evidence. However, methodological bias can reduce the validity of conclusions from these types of studies and subsequently impair the quality of decision making. As co-authorship is among the most well-documented forms of research collaboration, the present study aimed to explore whether authors’ collaboration methods might influence the methodological quality of SRs and MAs of psoriasis. Methodological quality was assessed by two raters who extracted information from full articles. After calculating total and per-item Assessment of Multiple Systematic Reviews (AMSTAR) scores, reviews were classified as low (0-4), medium (5-8), or high (9-11) quality. Article metadata and journal-related bibliometric indices were also obtained. A total of 741 authors from 520 different institutions and 32 countries published 220 reviews that were classified as high (17.2%), moderate (55%), or low (27.7%) methodological quality. The high methodological quality subnetwork was larger but had a lower connection density than the low and moderate methodological quality subnetworks; specifically, the former contained relatively fewer nodes (authors and reviews), reviews by authors, and collaborators per author. Furthermore, the high methodological quality subnetwork was highly compartmentalized, with several modules representing few poorly interconnected communities. In conclusion, structural differences in author-paper affiliation network may influence the methodological quality of SRs and MAs on psoriasis. As the author-paper affiliation network structure affects study quality in this research field, authors who maintain an appropriate balance between scientific quality and productivity are more likely to develop higher quality reviews. PMID:28403245

Methodological Quality Assessment of Meta-Analyses of Hyperthyroidism Treatment.

PubMed

Qin, Yahong; Yao, Liang; Shao, Feifei; Yang, Kehu; Tian, Limin

2018-01-01

Hyperthyroidism is a common condition that is associated with increased morbidity and mortality. A number of meta-analyses (MAs) have assessed the therapeutic measures for hyperthyroidism, including antithyroid drugs, surgery, and radioiodine, however, the methodological quality has not been evaluated. This study evaluated the methodological quality and summarized the evidence obtained from MAs of hyperthyroidism treatments for radioiodine, antithyroid drugs, and surgery. We searched the PubMed, EMBASE, Cochrane Library, Web of Science, and Chinese Biomedical Literature Database databases. Two investigators independently assessed the meta-analyses titles and abstracts for inclusion. Methodological quality was assessed using the validated AMSTAR (Assessing the Methodological Quality of Systematic Reviews) tool. A total of 26 MAs fulfilled the inclusion criteria. Based on the AMSTAR scores, the average methodological quality was 8.31, with large variability ranging from 4 to 11. The methodological quality of English meta-analyses was better than that of Chinese meta-analyses. Cochrane reviews had better methodological quality than non-Cochrane reviews due to better study selection and data extraction, the inclusion of unpublished studies, and better reporting of study characteristics. The authors did not report conflicts of interest in 53.8% meta-analyses, and 19.2% did not report the harmful effects of treatment. Publication bias was not assessed in 38.5% of meta-analyses, and 19.2% did not report the follow-up time. Large-scale assessment of methodological quality of meta-analyses of hyperthyroidism treatment highlighted methodological strengths and weaknesses. Consideration of scientific quality when formulating conclusions should be made explicit. Future meta-analyses should improve on reporting conflict of interest. © Georg Thieme Verlag KG Stuttgart · New York.

[Reevaluation of the methodological quality in meta-analyses of accelerated rehabilitation on recovery after surgery for colorectal cancer].

PubMed

Ding, S N; Pan, H Y; Zhang, J G

2017-03-14

Objective: To evaluate the methodological quality and impacts on outcomes for systematic reviews (SRs) of accelerated rehabilitation versus traditional control for colorectal surgery. Methods: We comprehensively searched six databases and additional websites to collect SRs, or meta-analysis from inception to July 2016. The Overview Quality Assessment Questionnaire (OQAQ) was applied for quality assessment of the included studies, the tools recommended by the Cochrane Collaboration was applied for quality assessment for RCT and CCT and the Newcastle-Ottawa Scale (NOS) was applied to assess observational study. The relative ratios (RRs) and 95% confidence intervals (CIs) were integrated using Review Manager 5.3 software. Results: Fourteen meta-analyses were included in total. The mean OQAQ score was 3.8 with 95% CI 3.2 to 4.3. Only three meta-analyses were assessed as good quality. Two studies misused statistical models. A total of 42 primary studies referenced by meta-analyses were included, of which, 25 RCTs were levelled grade B and 1 CCT was levelled grade C. An estimated mean NOS score of 16 observation studies was 6.75 (totally scored 9 with 95% CI 6.4 to 7.1), of which, 10 studies scored ≥7 were high quality, 6 studies scored 6 were moderate quality. Conclusions: Currently, the overall quality of meta-analyses about comparing the effects and safety between accelerated rehabilitation and traditional control for colorectal surgery is fairly poor and the evidence level is lower. Health providers should apply the evidence with caution in clinical practice.

Is there relationship between temporomandibular disorders and head and cervical posture? A systematic review.

PubMed

Rocha, C P; Croci, C S; Caria, P H F

2013-11-01

The objective of this systematic review was to find sufficient evidence to deny or accept the association between the head and cervical posture and temporomandibular disorders (TMDs), and thus assist health professionals in the evaluation and treatment of patients with TMDs. A search was conducted through all publications written in English about this topic using the databases from Medline, ISI Web of Science, EMBASE, PubMed and Lilacs. The abstracts that fulfilled the initial guideline were retrieved and evaluated to ensure they met the inclusion criteria. To assess the methodological quality of the studies, we developed a questionnaire considering the following criteria: participant's eligibility, control group, diagnosis of TMDs, posture diagnosis and randomisation. Twenty-two studies were selected as potential studies based on their abstracts. Only seventeen studies actually fulfilled the inclusion criteria. The search provided information about the methodological quality of the studies, in which several methodological defects were found. The evidence presented in this systematic review shows that the relation between TMDs and the head and neck posture is still controversial and unclear. The insufficient number of articles considered of excellent methodological quality is a factor that hinders the acceptance or denial of this association. © 2013 John Wiley & Sons Ltd.

Changes in clinical trials methodology over time: a systematic review of six decades of research in psychopharmacology.

PubMed

Brunoni, André R; Tadini, Laura; Fregni, Felipe

2010-03-03

There have been many changes in clinical trials methodology since the introduction of lithium and the beginning of the modern era of psychopharmacology in 1949. The nature and importance of these changes have not been fully addressed to date. As methodological flaws in trials can lead to false-negative or false-positive results, the objective of our study was to evaluate the impact of methodological changes in psychopharmacology clinical research over the past 60 years. We performed a systematic review from 1949 to 2009 on MEDLINE and Web of Science electronic databases, and a hand search of high impact journals on studies of seven major drugs (chlorpromazine, clozapine, risperidone, lithium, fluoxetine and lamotrigine). All controlled studies published 100 months after the first trial were included. Ninety-one studies met our inclusion criteria. We analyzed the major changes in abstract reporting, study design, participants' assessment and enrollment, methodology and statistical analysis. Our results showed that the methodology of psychiatric clinical trials changed substantially, with quality gains in abstract reporting, results reporting, and statistical methodology. Recent trials use more informed consent, periods of washout, intention-to-treat approach and parametric tests. Placebo use remains high and unchanged over time. Clinical trial quality of psychopharmacological studies has changed significantly in most of the aspects we analyzed. There was significant improvement in quality reporting and internal validity. These changes have increased study efficiency; however, there is room for improvement in some aspects such as rating scales, diagnostic criteria and better trial reporting. Therefore, despite the advancements observed, there are still several areas that can be improved in psychopharmacology clinical trials.

Approaching the Challenge of Student Retention through the Lens of Quality Control: A Conceptual Model of University Business Student Retention Utilizing Six Sigma

ERIC Educational Resources Information Center

Jenicke, Lawrence O.; Holmes, Monica C.; Pisani, Michael J.

2013-01-01

Student retention in higher education is a major issue as academic institutions compete for fewer students and face declining enrollments. A conceptual model of applying the quality improvement methodology of Six Sigma to the problem of undergraduate student retention in a college of business is presented. Improvement techniques such as cause and…

[Current situation of health surveys in Spain].

PubMed

Requena, María Luisa; Suárez, Mónica; Pérez, Óscar

2013-01-01

To describe the evolution of health interview surveys in Spain (as of 01/01/2012), whether national or regional, its main characteristics and methodology, and in the case of general health surveys (GHIS), its contents. An adapted version of Eurostat quality control template European Health Interview Survey Technical and Methodological Report was filled in by those responsible for GHIS in each region (autonomous communities) and at the national level. The first part (11 questions) gathers general information about health surveys, both GHIS and surveys targeted to specific populations or health problems (SHIS). The second part (109 questions) asks about methodological characteristics of most recent GHIS. 1) regional or supra-regional scope; 2) for the second part, GHIS currently active series. Quality control was performed using double data entry and validated by informants.100 HIS were identified. 16 were GHIS and 84 SHIS. 32 (38%) of the latter were national and 52 (62%) regional. Nutrition 21 (25%), drug use 10 (12%), opinion polls 7 (9%) and dental health 7 (9%) were the most frequent topics in SHIS. Highest GHIS density was reached after year 2000, with several surveys on field at a time (mode=3). 11 GHIS (2 national, 9 regional) met inclusion criteria for the second part. All complied with general quality benchmarks. Few differences were observed in content.GHIS show more similarities than differences in objectives, methods and content. Rationalization and harmonization are needed. Physical activity, alcohol consumption, quality of life and mental health instruments are not yet consensual. Valid and comparable data are required on health status and its determinants to inform health policy.

Quality assurance and quality control in mammography: a review of available guidance worldwide.

PubMed

Reis, Cláudia; Pascoal, Ana; Sakellaris, Taxiarchis; Koutalonis, Manthos

2013-10-01

Review available guidance for quality assurance (QA) in mammography and discuss its contribution to harmonise practices worldwide. Literature search was performed on different sources to identify guidance documents for QA in mammography available worldwide in international bodies, healthcare providers, professional/scientific associations. The guidance documents identified were reviewed and a selection was compared for type of guidance (clinical/technical), technology and proposed QA methodologies focusing on dose and image quality (IQ) performance assessment. Fourteen protocols (targeted at conventional and digital mammography) were reviewed. All included recommendations for testing acquisition, processing and display systems associated with mammographic equipment. All guidance reviewed highlighted the importance of dose assessment and testing the Automatic Exposure Control (AEC) system. Recommended tests for assessment of IQ showed variations in the proposed methodologies. Recommended testing focused on assessment of low-contrast detection, spatial resolution and noise. QC of image display is recommended following the American Association of Physicists in Medicine guidelines. The existing QA guidance for mammography is derived from key documents (American College of Radiology and European Union guidelines) and proposes similar tests despite the variations in detail and methodologies. Studies reported on QA data should provide detail on experimental technique to allow robust data comparison. Countries aiming to implement a mammography/QA program may select/prioritise the tests depending on available technology and resources. •An effective QA program should be practical to implement in a clinical setting. •QA should address the various stages of the imaging chain: acquisition, processing and display. •AEC system QC testing is simple to implement and provides information on equipment performance.

Methodological quality of diagnostic accuracy studies on non-invasive coronary CT angiography: influence of QUADAS (Quality Assessment of Diagnostic Accuracy Studies included in systematic reviews) items on sensitivity and specificity.

PubMed

Schueler, Sabine; Walther, Stefan; Schuetz, Georg M; Schlattmann, Peter; Dewey, Marc

2013-06-01

To evaluate the methodological quality of diagnostic accuracy studies on coronary computed tomography (CT) angiography using the QUADAS (Quality Assessment of Diagnostic Accuracy Studies included in systematic reviews) tool. Each QUADAS item was individually defined to adapt it to the special requirements of studies on coronary CT angiography. Two independent investigators analysed 118 studies using 12 QUADAS items. Meta-regression and pooled analyses were performed to identify possible effects of methodological quality items on estimates of diagnostic accuracy. The overall methodological quality of coronary CT studies was merely moderate. They fulfilled a median of 7.5 out of 12 items. Only 9 of the 118 studies fulfilled more than 75 % of possible QUADAS items. One QUADAS item ("Uninterpretable Results") showed a significant influence (P = 0.02) on estimates of diagnostic accuracy with "no fulfilment" increasing specificity from 86 to 90 %. Furthermore, pooled analysis revealed that each QUADAS item that is not fulfilled has the potential to change estimates of diagnostic accuracy. The methodological quality of studies investigating the diagnostic accuracy of non-invasive coronary CT is only moderate and was found to affect the sensitivity and specificity. An improvement is highly desirable because good methodology is crucial for adequately assessing imaging technologies. • Good methodological quality is a basic requirement in diagnostic accuracy studies. • Most coronary CT angiography studies have only been of moderate design quality. • Weak methodological quality will affect the sensitivity and specificity. • No improvement in methodological quality was observed over time. • Authors should consider the QUADAS checklist when undertaking accuracy studies.

Sexual health education interventions for young people: a methodological review.

PubMed Central

Oakley, A.; Fullerton, D.; Holland, J.; Arnold, S.; France-Dawson, M.; Kelley, P.; McGrellis, S.

1995-01-01

OBJECTIVES--To locate reports of sexual health education interventions for young people, assess the methodological quality of evaluations, identify the subgroup with a methodologically sound design, and assess the evidence with respect to the effectiveness of different approaches to promoting young people's sexual health. DESIGN--Survey of reports in English by means of electronic databases and hand searches for relevant studies conducted in the developed world since 1982. Papers were reviewed for eight methodological qualities. The evidence on effectiveness generated by studies meeting four core criteria was assessed. Judgments on effectiveness by reviewers and authors were compared. PAPERS--270 papers reporting sexual health interventions. MAIN OUTCOME MEASURE--The methodological quality of evaluations. RESULTS--73 reports of evaluations of sexual health interventions examining the effectiveness of these interventions in changing knowledge, attitudes, or behavioural outcomes were identified, of which 65 were separate outcome evaluations. Of these studies, 45 (69%) lacked random control groups, 44 (68%) failed to present preintervention and 38 (59%) postintervention data, and 26 (40%) omitted to discuss the relevance of loss of data caused by drop outs. Only 12 (18%) of the 65 outcome evaluations were judged to be methodologically sound. Academic reviewers were more likely than authors to judge studies as unclear because of design faults. Only two of the sound evaluations recorded interventions which were effective in showing an impact on young people's sexual behaviour. CONCLUSIONS--The design of evaluations in sexual health intervention needs to be improved so that reliable evidence of the effectiveness of different approaches to promoting young people's sexual health may be generated. PMID:7833754

An Overview of Controls and Flying Qualities Technology on the F/A-18 High Alpha Research Vehicle

NASA Technical Reports Server (NTRS)

Pahle, Joseph W.; Wichman, Keith D.; Foster, John V.; Bundick, W. Thomas

1996-01-01

The NASA F/A-18 High Alpha Research Vehicle (HARV) has been the flight test bed of a focused technology effort to significantly increase maneuvering capability at high angles of attack. Development and flight test of control law design methodologies, handling qualities metrics, performance guidelines, and flight evaluation maneuvers are described. The HARV has been modified to include two research control effectors, thrust vectoring, and actuated forebody strakes in order to provide increased control power at high angles of attack. A research flight control system has been used to provide a flexible, easily modified capability for high-angle-of-attack research controls. Different control law design techniques have been implemented and flight-tested, including eigenstructure assignment, variable gain output feedback, pseudo controls, and model-following. Extensive piloted simulation has been used to develop nonlinear performance guide-lines and handling qualities criteria for high angles of attack. This paper reviews the development and evaluation of technologies useful for high-angle-of-attack control. Design, development, and flight test of the research flight control system, control laws, flying qualities specifications, and flight test maneuvers are described. Flight test results are used to illustrate some of the lessons learned during flight test and handling qualities evaluations.

Back schools for non-specific low-back pain.

PubMed

Heymans, M W; van Tulder, M W; Esmail, R; Bombardier, C; Koes, B W

2004-10-18

Since the introduction of the Swedish back school in 1969, back schools have frequently been used for treating patients with low-back pain (LBP). However, the content of back schools has changed and appears to vary widely today. To assess the effectiveness of back schools for patients with non-specific LBP. We searched the MEDLINE and EMBASE databases and the Cochrane Central Register of Controlled Trials to May 2003 for relevant trials reported in English, Dutch, French or German. We also screened references from relevant reviews and included trials. Randomized controlled trials (RCTs) that reported on any type of back school for non-specific LBP were included. Four reviewers, blinded to authors, institution and journal, independently extracted the data and assessed the quality of the trials. We set the high quality level, a priori, at a trial meeting six or more of 11 internal validity criteria. As data were clinically and statistically too heterogeneous to perform a meta-analysis, we used a qualitative review (best evidence synthesis) to summarize the results. The evidence was classified into four levels (strong, moderate, limited or no evidence), taking into account the methodological quality of the studies. We also evaluated the clinical relevance of the studies. Nineteen RCTs (3584 patients) were included in this updated review. Overall, the methodological quality was low, with only six trials considered to be high quality. It was not possible to perform relevant subgroup analyses for LBP with radiation versus LBP without radiation. The results indicate that there is moderate evidence suggesting that back schools have better short and intermediate-term effects on pain and functional status than other treatments for patients with recurrent and chronic LBP. There is moderate evidence suggesting that back schools for chronic LBP in an occupational setting, are more effective than other treatments and placebo or waiting list controls on pain, functional status and return to work during short and intermediate-term follow-up. In general, the clinical relevance of the studies was rated as insufficient. There is moderate evidence suggesting that back schools, in an occupational setting, reduce pain, and improve function and return-to-work status, in the short and intermediate-term, compared to exercises, manipulation, myofascial therapy, advice, placebo or waiting list controls, for patients with chronic and recurrent LBP. However, future trials should improve methodological quality and clinical relevance and evaluate the cost-effectiveness of back schools.

Social and behavioral interventions for improving quality of life of HIV infected people receiving antiretroviral therapy: a systematic review and meta-analysis.

PubMed

Bhatta, Dharma Nand; Liabsuetrakul, Tippawan; McNeil, Edward B

2017-04-24

Improvement in quality of life is crucial for HIV infected people. Social and behavioral interventions have been implemented in different contexts to improve the quality of life among HIV infected people. This review appraises the evidence for available interventions that focused on quality of life of HIV infected people receiving antiretroviral therapy (ART). We searched electronic databases for randomized controlled trials of interventions to improve the quality of life of HIV infected people receiving ART. We searched PUBMED and the Cochrane Centre Register of Controlled Trials (CENTRAL) with the terms "social", "behavioral", "educational", "quality of life", "HIV", and "RCT". Searches were conducted for articles published from 1980 to December 16, 2015. Standardized data abstraction methods and searching steps were applied. Twenty-eight studies reported the impact of social or behavioral interventions in quality of life among HIV infected people, of which 15 were conducted in United States of America. A total of 4136 participants were enrolled. Of the 28 studies, four studies included females, two studies included males and remaining studies excluded both males and females. The overall reported methodological quality of the studies was subject to a high risk of bias and the study criteria were unclear in most studies. Twenty-one studies reported a significant intervention effect on at least one quality of life domain. Meta-analyses showed significant improvement in general health, mental health, physical function and environment domains of quality of life among intervention groups. However, the expected impact of the intervention was low to moderate because the rigorousness of the studies was low, information was limited, the sample sizes were small and other the quality of the study designs were poor. Although the available evidence suggests that existing social and behavioral interventions can improve some quality of life domains, the quality of evidence was insufficient to support the notion that these interventions can improve the overall quality of life of HIV infected people receiving ART. Well-designed and rigorous randomized controlled trials with high methodological quality are required.

Strategy for design NIR calibration sets based on process spectrum and model space: An innovative approach for process analytical technology.

PubMed

Cárdenas, V; Cordobés, M; Blanco, M; Alcalà, M

2015-10-10

The pharmaceutical industry is under stringent regulations on quality control of their products because is critical for both, productive process and consumer safety. According to the framework of "process analytical technology" (PAT), a complete understanding of the process and a stepwise monitoring of manufacturing are required. Near infrared spectroscopy (NIRS) combined with chemometrics have lately performed efficient, useful and robust for pharmaceutical analysis. One crucial step in developing effective NIRS-based methodologies is selecting an appropriate calibration set to construct models affording accurate predictions. In this work, we developed calibration models for a pharmaceutical formulation during its three manufacturing stages: blending, compaction and coating. A novel methodology is proposed for selecting the calibration set -"process spectrum"-, into which physical changes in the samples at each stage are algebraically incorporated. Also, we established a "model space" defined by Hotelling's T(2) and Q-residuals statistics for outlier identification - inside/outside the defined space - in order to select objectively the factors to be used in calibration set construction. The results obtained confirm the efficacy of the proposed methodology for stepwise pharmaceutical quality control, and the relevance of the study as a guideline for the implementation of this easy and fast methodology in the pharma industry. Copyright © 2015 Elsevier B.V. All rights reserved.

Quality reporting of carotid intima-media thickness methodology; Current state of the science in the field of spinal cord injury.

PubMed

Hoskin, Jordan D; Miyatani, Masae; Craven, B Catharine

2017-03-30

Carotid intima-media thickness (cIMT) may be used increasingly as a cardiovascular disease (CVD) screening tool in individuals with spinal cord injury (SCI) as other routine invasive diagnostic tests are often unfeasible. However, variation in cIMT acquisition and analysis methods is an issue in the current published literature. The growth of the field is dependent on cIMT quality acquisition and analysis to ensure accurate reporting of CVD risk. The purpose of this study is to evaluate the quality of the reported methodology used to collect cIMT values in SCI. Data from 12 studies, which measured cIMT in individuals with SCI, were identified from the Medline, Embase and CINAHL databases. The quality of the reported methodologies was scored based on adherence to cIMT methodological guidelines abstracted from two consensus papers. Five studies were scored as 'moderate quality' in methodological reporting, having specified 9 to 11 of 15 quality reporting criterion. The remaining seven studies were scored as 'low quality', having reported less than 9 of 15 quality reporting criterion. No study had methodological reporting that was scored as 'high quality'. The overall reporting of quality methodology was poor in the published SCI literature. A greater adherence to current methodological guidelines is needed to advance the field of cIMT in SCI. Further research is necessary to refine cIMT acquisition and analysis guidelines to aid authors designing research and journals in screening manuscripts for publication.

The NCC project: A quality management perspective

NASA Technical Reports Server (NTRS)

Lee, Raymond H.

1993-01-01

The Network Control Center (NCC) Project introduced the concept of total quality management (TQM) in mid-1990. The CSC project team established a program which focused on continuous process improvement in software development methodology and consistent deliveries of high quality software products for the NCC. The vision of the TQM program was to produce error free software. Specific goals were established to allow continuing assessment of the progress toward meeting the overall quality objectives. The total quality environment, now a part of the NCC Project culture, has become the foundation for continuous process improvement and has resulted in the consistent delivery of quality software products over the last three years.

The research gap in chronic paediatric pain: A systematic review of randomised controlled trials.

PubMed

Boulkedid, R; Abdou, A Y; Desselas, E; Monégat, M; de Leeuw, T G; Avez-Couturier, J; Dugue, S; Mareau, C; Charron, B; Alberti, C; Kaguelidou, F

2018-02-01

Chronic pain is associated with significant functional and social impairment. The objective of this review was to assess the characteristics and quality of randomized controlled trials (RCTs) evaluating pain management interventions in children and adolescents with chronic pain. We performed a systematic search of PubMed, Embase and the Cochrane Library up to July 2017. We included RCTs that involved children and adolescents (3 months-18 years) and evaluated the use of pharmacological or non-pharmacological intervention(s) in the context of pain persisting or re-occurring for more than 3 months. Methodological quality was evaluated using the Cochrane Risk of Bias (ROB) Tool. A total of 58 RCTs were identified and numbers steadily increased over time. The majority were conducted in single hospital institutions, with no information on study funding. Median sample size was 47.5 participants (Q1,Q3: 32, 70). Forty-five percent of RCTs included both adults and children and the median of the mean ages at inclusion was 12.9 years (Q1,Q3: 11, 15). Testing of non-pharmacological interventions was predominant and only 5 RCTs evaluated analgesics or co-analgesics. Abdominal pain, headache/migraine and musculoskeletal pain were the most common types of chronic pain among participants. Methodological quality was poor with 90% of RCTs presenting a high or unclear ROB. Evaluation of analgesics targeting chronic pain relief in children and adolescents through RCTs is marginal. Infants and children with long-lasting painful conditions are insufficiently represented in RCTs. We discuss possible research constraints and challenges as well as methodologies to circumvent them. There is a substantial research gap regarding analgesic interventions for children and adolescents with chronic pain. Most clinical trials in the field focus on the evaluation of non-pharmacological interventions and are of low methodological quality. There is also a specific lack of trials involving infants and children and adolescents with long-lasting diseases. © 2017 European Pain Federation - EFIC®.

Virtual reality exposure therapy for the treatment of posttraumatic stress disorder: a methodological review using CONSORT guidelines.

PubMed

Motraghi, Terri E; Seim, Richard W; Meyer, Eric C; Morissette, Sandra B

2014-03-01

Virtual reality exposure therapy (VRET) is an extension of traditional exposure therapy and has been used to treat a variety of anxiety disorders. VRET utilizes a computer-generated virtual environment to present fear-relevant stimuli. Recent studies have evaluated the use of VRET for treatment of PTSD; however, a systematic evaluation of the methodological quality of these studies has yet to be conducted. This review aims to (a) identify treatment outcome studies examining the use of VRET for the treatment of PTSD and (b) appraise the methodological quality of each study using the 2010 Consolidating Standards of Reporting Trials (CONSORT) Statement and its 2008 extension for nonpharmacologic interventions. Two independent assessors conducted a database search (PsycINFO, Medline, CINAHL, Google Scholar) of studies published between January 1990 and June 2013 that reported outcome data comparing VRET with another type of treatment or a control condition. Next, a CONSORT quality appraisal of each study was completed. The search yielded nine unique studies. The CONSORT appraisal revealed that the methodological quality of studies examining VRET as a treatment for PTSD was variable. Although preliminary findings suggest some positive results for VRET as a form of exposure treatment for PTSD, additional research using well-specified randomization procedures, assessor blinding, and monitoring of treatment adherence is warranted. Movement toward greater standardization of treatment manuals, virtual environments, and equipment would further facilitate interpretation and consolidation of this literature. © 2013 Wiley Periodicals, Inc.

A Lean Six Sigma approach to the improvement of the selenium analysis method.

PubMed

Cloete, Bronwyn C; Bester, André

2012-11-02

Reliable results represent the pinnacle assessment of quality of an analytical laboratory, and therefore variability is considered to be a critical quality problem associated with the selenium analysis method executed at Western Cape Provincial Veterinary Laboratory (WCPVL). The elimination and control of variability is undoubtedly of significant importance because of the narrow margin of safety between toxic and deficient doses of the trace element for good animal health. A quality methodology known as Lean Six Sigma was believed to present the most feasible solution for overcoming the adverse effect of variation, through steps towards analytical process improvement. Lean Six Sigma represents a form of scientific method type, which is empirical, inductive and deductive, and systematic, which relies on data, and is fact-based. The Lean Six Sigma methodology comprises five macro-phases, namely Define, Measure, Analyse, Improve and Control (DMAIC). Both qualitative and quantitative laboratory data were collected in terms of these phases. Qualitative data were collected by using quality-tools, namely an Ishikawa diagram, a Pareto chart, Kaizen analysis and a Failure Mode Effect analysis tool. Quantitative laboratory data, based on the analytical chemistry test method, were collected through a controlled experiment. The controlled experiment entailed 13 replicated runs of the selenium test method, whereby 11 samples were repetitively analysed, whilst Certified Reference Material (CRM) was also included in 6 of the runs. Laboratory results obtained from the controlled experiment was analysed by using statistical methods, commonly associated with quality validation of chemistry procedures. Analysis of both sets of data yielded an improved selenium analysis method, believed to provide greater reliability of results, in addition to a greatly reduced cycle time and superior control features. Lean Six Sigma may therefore be regarded as a valuable tool in any laboratory, and represents both a management discipline, and a standardised approach to problem solving and process optimisation.

Quality Assurance of UMLS Semantic Type Assignments Using SNOMED CT Hierarchies.

PubMed

Gu, H; Chen, Y; He, Z; Halper, M; Chen, L

2016-01-01

The Unified Medical Language System (UMLS) is one of the largest biomedical terminological systems, with over 2.5 million concepts in its Metathesaurus repository. The UMLS's Semantic Network (SN) with its collection of 133 high-level semantic types serves as an abstraction layer on top of the Metathesaurus. In particular, the SN elaborates an aspect of the Metathesaurus's concepts via the assignment of one or more types to each concept. Due to the scope and complexity of the Metathesaurus, errors are all but inevitable in this semantic-type assignment process. To develop a semi-automated methodology to help assure the quality of semantic-type assignments within the UMLS. The methodology uses a cross-validation strategy involving SNOMED CT's hierarchies in combination with UMLS semantic types. Semantically uniform, disjoint concept groups are generated programmatically by partitioning the collection of all concepts in the same SNOMED CT hierarchy according to their respective semantic-type assignments in the UMLS. Domain experts are then called upon to review the concepts in any group having a small number of concepts. It is our hypothesis that a semantic-type assignment combination applicable only to a very small number of concepts in a SNOMED CT hierarchy is an indicator of potential problems. The methodology was applied to the UMLS 2013AA release along with the SNOMED CT from January 2013. An overall error rate of 33% was found for concepts proposed by the quality-assurance methodology. Supporting our hypothesis, that number was four times higher than the error rate found in control samples. The results show that the quality-assurance methodology can aid in effective and efficient identification of UMLS semantic-type assignment errors.

Back schools for nonspecific low back pain: a systematic review within the framework of the Cochrane Collaboration Back Review Group.

PubMed

Heymans, M W; van Tulder, M W; Esmail, R; Bombardier, C; Koes, B W

2005-10-01

A systematic review within the Cochrane Collaboration Back Review Group. To assess the effectiveness of back schools for patients with nonspecific low back pain (LBP). Since the introduction of the Swedish back school in 1969, back schools have frequently been used for treating patients with LBP. However, the content of back schools has changed and appears to vary widely today. We searched the MEDLINE and EMBASE databases and the Cochrane Central Register of Controlled Trials to November 2004 for relevant trials reported in English, Dutch, French, or German. We also screened references from relevant reviews and included trials. Randomized controlled trials that reported on any type of back school for nonspecific LBP were included. Four reviewers, blinded to authors, institution, and journal, independently extracted the data and assessed the quality of the trials. We set the high-quality level, a priori, at a trial meeting six or more of 11 internal validity criteria. Because data were clinically and statistically too heterogeneous to perform a meta-analysis, we used a qualitative review (best evidence synthesis) to summarize the results. The evidence was classified into four levels (strong, moderate, limited, or no evidence), taking into account the methodologic quality of the studies. We also evaluated the clinical relevance of the studies. Nineteen randomized controlled trials (3,584 patients) were included in this updated review. Overall, the methodologic quality was low, with only six trials considered to be high-quality. It was not possible to perform relevant subgroup analyses for LBP with radiation versus LBP without radiation. The results indicate that there is moderate evidence suggesting that back schools have better short- and intermediate-term effects on pain and functional status than other treatments for patients with recurrent and chronic LBP. There is moderate evidence suggesting that back schools for chronic LBP in an occupational setting are more effective than other treatments and placebo or waiting list controls on pain, functional status, and return to work during short- and intermediate-term follow-up. In general, the clinical relevance of the studies was rated as insufficient. There is moderate evidence suggesting that back schools, in an occupational setting, reduce pain and improve function and return-to-work status, in the short- and intermediate-term, compared with exercises, manipulation, myofascial therapy, advice, placebo, or waiting list controls, for patients with chronic and recurrent LBP. However, future trials should improve methodologic quality and clinical relevance and evaluate the cost-effectiveness of back schools.

Relationships between abstract features and methodological quality explained variations of social media activity derived from systematic reviews about psoriasis interventions.

PubMed

Ruano, J; Aguilar-Luque, M; Isla-Tejera, B; Alcalde-Mellado, P; Gay-Mimbrera, J; Hernandez-Romero, José Luis; Sanz-Cabanillas, J L; Maestre-López, B; González-Padilla, M; Carmona-Fernández, P J; Gómez-García, F; García-Nieto, A Vélez

2018-05-24

The aim of this study was to describe the relationship among abstract structure, readability, and completeness, and how these features may influence social media activity and bibliometric results, considering systematic reviews (SRs) about interventions in psoriasis classified by methodological quality. Systematic literature searches about psoriasis interventions were undertaken on relevant databases. For each review, methodological quality was evaluated using the Assessing the Methodological Quality of Systematic Reviews (AMSTAR) tool. Abstract extension, structure, readability, and quality and completeness of reporting were analyzed. Social media activity, which consider Twitter and Facebook mention counts, as well as Mendeley readers and Google scholar citations were obtained for each article. Analyses were conducted to describe any potential influence of abstract characteristics on review's social media diffusion. We classified 139 intervention SRs as displaying high/moderate/low methodological quality. We observed that abstract readability of SRs has been maintained high for last 20 years, although there are some differences based on their methodological quality. Free-format abstracts were most sensitive to the increase of text readability as compared with more structured abstracts (IMRAD or 8-headings), yielding opposite effects on their quality and completeness depending on the methodological quality: a worsening in low quality reviews and an improvement in those of high-quality. Both readability indices and PRISMA for Abstract total scores showed an inverse relationship with social media activity and bibliometric results in high methodological quality reviews but not in those of lower quality. Our results suggest that increasing abstract readability must be specially considered when writing free-format summaries of high-quality reviews, because this fact correlates with an improvement of their completeness and quality, and this may help to achieve broader social media visibility and article usage. Copyright © 2018 Elsevier Inc. All rights reserved.

Multi-criteria analysis for PM10 planning

NASA Astrophysics Data System (ADS)

Pisoni, Enrico; Carnevale, Claudio; Volta, Marialuisa

To implement sound air quality policies, Regulatory Agencies require tools to evaluate outcomes and costs associated to different emission reduction strategies. These tools are even more useful when considering atmospheric PM10 concentrations due to the complex nonlinear processes that affect production and accumulation of the secondary fraction of this pollutant. The approaches presented in the literature (Integrated Assessment Modeling) are mainly cost-benefit and cost-effective analysis. In this work, the formulation of a multi-objective problem to control particulate matter is proposed. The methodology defines: (a) the control objectives (the air quality indicator and the emission reduction cost functions); (b) the decision variables (precursor emission reductions); (c) the problem constraints (maximum feasible technology reductions). The cause-effect relations between air quality indicators and decision variables are identified tuning nonlinear source-receptor models. The multi-objective problem solution provides to the decision maker a set of not-dominated scenarios representing the efficient trade-off between the air quality benefit and the internal costs (emission reduction technology costs). The methodology has been implemented for Northern Italy, often affected by high long-term exposure to PM10. The source-receptor models used in the multi-objective analysis are identified processing long-term simulations of GAMES multiphase modeling system, performed in the framework of CAFE-Citydelta project.

The effectiveness of structured exercise in the south Asian population with type 2 diabetes: a systematic review.

PubMed

Albalawi, Hani; Coulter, Elaine; Ghouri, Nazim; Paul, Lorna

2017-11-01

The impact of exercise interventions on south Asians with type 2 diabetes (T2DM), who have a higher T2DM incidence rate compared to other ethnic groups, is inconclusive. This study aimed to systematically review the effect of exercise interventions in south Asians with T2DM. Five electronic databases were searched up to April 2017 for controlled trials investigating the impact of exercise interventions on south Asian adults with T2DM. The PEDro scale was used to assess the quality of the included studies. Eighteen trials examining the effect of aerobic, resistance, balance or combined exercise programs met the eligibility criteria. All types of exercise were associated with improvements in glycemic control, blood pressure, waist circumference, blood lipids, muscle strength, functional mobility, quality of life or neuropathy progression. The majority of included studies were of poor methodological quality. Few studies compared different types or dose of exercise. In conclusion, this review supports the benefits of exercise for south Asians with T2DM, although it was not possible to identify the most effective exercise prescription. Further studies of good methodological quality are required to determine the most effective dosage and type of exercise to manage T2DM in this population.

Acupuncture for Functional Dyspepsia: What Strength Does It Have? A Systematic Review and Meta-Analysis of Randomized Controlled Trials

PubMed Central

Li, Jing; Li, Bo; Hu, Ya-Cai; Cai, Qiu-Han

2016-01-01

Background. Although the effectiveness of acupuncture therapy on functional dyspepsia (FD) has been systematically reviewed, the available reports are still contradictive and no robust evidence has been provided to date. Objective. To assess the current evidence of high quality on the effects of acupuncture for patients with FD. Methods. A comprehensive literature database search was conducted to identify randomized controlled trials (RCTs) comparing acupuncture therapies (including manual acupuncture and electroacupuncture) to sham acupuncture and medication use. A meta-analysis was performed following a strict methodology. Results. 16 RCTs involving 1436 participants were included. The majority of the trials were determined to be of low quality. Positive results were found for acupuncture in improving the Nepean Dyspepsia Index (NDI) and scores of the MOS 36-Item Short-Form Health Survey (SF-36), as well as in alleviating relevant symptoms (especially postprandial fullness and early satiation) of FD patients. Conclusion. Based on current available evidence, acupuncture therapy achieves statistically significant effect for FD in comparison with sham acupuncture and is superior to medication (prokinetic agents) in improving the symptoms and quality of life of FD patients. Nonetheless, despite stringent methodological analyses, the conclusion of our review still needs to be strengthened by additional RCTs of higher quality. PMID:28119758

Methodological quality of randomized trials published in the Journal of the American Podiatric Medical Association, 1999-2013.

PubMed

Landorf, Karl B; Menz, Hylton B; Armstrong, David G; Herbert, Robert D

2015-07-01

Randomized trials must be of high methodological quality to yield credible, actionable findings. The main aim of this project was to evaluate whether there has been an improvement in the methodological quality of randomized trials published in the Journal of the American Podiatric Medical Association (JAPMA). Randomized trials published in JAPMA during a 15-year period (January 1999 to December 2013) were evaluated. The methodological quality of randomized trials was evaluated using the PEDro scale (scores range from 0 to 10, with 0 being lowest quality). Linear regression was used to assess changes in methodological quality over time. A total of 1,143 articles were published in JAPMA between January 1999 and December 2013. Of these, 44 articles were reports of randomized trials. Although the number of randomized trials published each year increased, there was only minimal improvement in their methodological quality (mean rate of improvement = 0.01 points per year). The methodological quality of the trials studied was typically moderate, with a mean ± SD PEDro score of 5.1 ± 1.5. Although there were a few high-quality randomized trials published in the journal, most (84.1%) scored between 3 and 6. Although there has been an increase in the number of randomized trials published in JAPMA, there is substantial opportunity for improvement in the methodological quality of trials published in the journal. Researchers seeking to publish reports of randomized trials should seek to meet current best-practice standards in the conduct and reporting of their trials.

Effective Software Engineering Leadership for Development Programs

ERIC Educational Resources Information Center

Cagle West, Marsha

2010-01-01

Software is a critical component of systems ranging from simple consumer appliances to complex health, nuclear, and flight control systems. The development of quality, reliable, and effective software solutions requires the incorporation of effective software engineering processes and leadership. Processes, approaches, and methodologies for…

A retrospective survey of the quality of reports and their correlates among randomized controlled trials of immunotherapy for Guillain-Barré syndrome.

PubMed

Lu, Liming; Luo, Gaoquan; Xiao, Fang

2013-08-01

This study aims to assess the quality of reports and their correlates in randomized controlled trials (RCTs) of immunotherapy for Guillain-Barré syndrome (GBS). A search was performed in multiple databases of reports published between April 1992 and November 2012. Reporting quality was assessed by items of the Consolidated Standards of Reporting Trials (CONSORT) 2010 Statement. An overall quality score (OQS) and a key methodological index score (MIS) were calculated for each trial. Factors associated with OQS and MIS were then identified. A total of 19 RCTs were included in the full text. The median OQS was 7.0, with a range of 1-10. However, the quality of reporting in items of 'flow chart' and 'ancillary analyses' was poor with a positive rate of less than 40%. The median MIS was 0 with a range of 0-2. Twelve (63.2%) did not report any of the three key methodological items. Specifically, the mean OQS increased by approximately 2.73 for manuscripts published in the New England Journal of Medicine, The Lancet, Pediatrics and Neurology (95% CI: 0.35-5.12; p < 0.05). Multivariate linear regression and the Poisson regression model could not be presented as the number of included trials was too small. The reporting quality in RCTs on immunotherapy for GBS was poor, which indicated that reporting in RCTs of immunotherapy for GBS needed substantial improvement in order to meet the guideline of the CONSORT Statement.

Development of Process Control Methodology for Tracking the Quality and Safety of Pain, Agitation, and Sedation Management in Critical Care Units.

PubMed

Walsh, Timothy S; Kydonaki, Kalliopi; Lee, Robert J; Everingham, Kirsty; Antonelli, Jean; Harkness, Ronald T; Cole, Stephen; Quasim, Tara; Ruddy, James; McDougall, Marcia; Davidson, Alan; Rutherford, John; Richards, Jonathan; Weir, Christopher J

2016-03-01

To develop sedation, pain, and agitation quality measures using process control methodology and evaluate their properties in clinical practice. A Sedation Quality Assessment Tool was developed and validated to capture data for 12-hour periods of nursing care. Domains included pain/discomfort and sedation-agitation behaviors; sedative, analgesic, and neuromuscular blocking drug administration; ventilation status; and conditions potentially justifying deep sedation. Predefined sedation-related adverse events were recorded daily. Using an iterative process, algorithms were developed to describe the proportion of care periods with poor limb relaxation, poor ventilator synchronization, unnecessary deep sedation, agitation, and an overall optimum sedation metric. Proportion charts described processes over time (2 monthly intervals) for each ICU. The numbers of patients treated between sedation-related adverse events were described with G charts. Automated algorithms generated charts for 12 months of sequential data. Mean values for each process were calculated, and variation within and between ICUs explored qualitatively. Eight Scottish ICUs over a 12-month period. Mechanically ventilated patients. None. The Sedation Quality Assessment Tool agitation-sedation domains correlated with the Richmond Sedation Agitation Scale score (Spearman ρ = 0.75) and were reliable in clinician-clinician (weighted kappa; κ = 0.66) and clinician-researcher (κ = 0.82) comparisons. The limb movement domain had fair correlation with Behavioral Pain Scale (ρ = 0.24) and was reliable in clinician-clinician (κ = 0.58) and clinician-researcher (κ = 0.45) comparisons. Ventilator synchronization correlated with Behavioral Pain Scale (ρ = 0.54), and reliability in clinician-clinician (κ = 0.29) and clinician-researcher (κ = 0.42) comparisons was fair-moderate. Eight hundred twenty-five patients were enrolled (range, 59-235 across ICUs), providing 12,385 care periods for evaluation (range 655-3,481 across ICUs). The mean proportion of care periods with each quality metric varied between ICUs: excessive sedation 12-38%; agitation 4-17%; poor relaxation 13-21%; poor ventilator synchronization 8-17%; and overall optimum sedation 45-70%. Mean adverse event intervals ranged from 1.5 to 10.3 patients treated. The quality measures appeared relatively stable during the observation period. Process control methodology can be used to simultaneously monitor multiple aspects of pain-sedation-agitation management within ICUs. Variation within and between ICUs could be used as triggers to explore practice variation, improve quality, and monitor this over time.

Characteristics and Methodological Quality of Meta-Analyses on Hypertension Treatments-A Cross-Sectional Study.

PubMed

Wu, Xin Yin; Du, Xin Jian; Ho, Robin S T; Lee, Clarence C Y; Yip, Benjamin H K; Wong, Martin C S; Wong, Samuel Y S; Chung, Vincent C H

2017-02-01

Methodological quality of meta-analyses on hypertension treatments can affect treatment decision-making. The authors conducted a cross-sectional study to investigate the methodological quality of meta-analyses on hypertension treatments. One hundred and fifty-eight meta-analyses were identified. Overall, methodological quality was unsatisfactory in the following aspects: comprehensive reporting of financial support (1.9%), provision of included and excluded lists of studies (22.8%), inclusion of grey literature (27.2%), and inclusion of protocols (32.9%). The 126 non-Cochrane meta-analyses had poor performance on almost all the methodological items. Non-Cochrane meta-analyses focused on nonpharmacologic treatments were more likely to consider scientific quality of included studies when making conclusions. The 32 Cochrane meta-analyses generally had good methodological quality except for comprehensive reporting of the sources of support. These results highlight the need for cautious interpretation of these meta-analyses, especially among physicians and policy makers when guidelines are formulated. Future meta-analyses should pay attention to improving these methodological aspects. ©2016 Wiley Periodicals, Inc.

Methodology of Global Adult Tobacco Survey (GATS), Malaysia, 2011

PubMed Central

Omar, Azahadi; Yusoff, Muhammad Fadhli Mohd; Hiong, Tee Guat; Aris, Tahir; Morton, Jeremy; Pujari, Sameer

2015-01-01

Introduction Malaysia participated in the second phase of the Global Adult Tobacco Survey (GATS) in 2011. GATS, a new component of the Global Tobacco Surveillance System, is a nationally representative household survey of adults 15 years old or above. The objectives of GATS Malaysia were to (i) systematically monitor tobacco use among adults and track key indicators of tobacco control and (ii) track the implementation of some of the Framework Convention of Tobacco Control (FCTC)-recommended demand related policies. Methods GATS Malaysia 2011 was a nationwide cross-sectional survey using multistage stratified sampling to select 5112 nationally representative households. One individual aged 15 years or older was randomly chosen from each selected household and interviewed using handheld device. GATS Core Questionnaire with optional questions was pre-tested and uploaded into handheld devices after repeated quality control processes. Data collectors were trained through a centralized training. Manuals and picture book were prepared to aid in the training of data collectors and during data collection. Field-level data were aggregated on a daily basis and analysed twice a week. Quality controls were instituted to ensure collection of high quality data. Sample weighting and analysis were conducted with the assistance of researchers from the Centers for Disease Control and Prevention, Atlanta, USA Results GATS Malaysia received a total response rate of 85.3% from 5112 adults surveyed. Majority of the respondents were 25–44 years old and Malays. Conclusions The robust methodology used in the GATS Malaysia provides national estimates for tobacco used classified by socio-demographic characteristics and reliable data on various dimensions of tobacco control. PMID:26451348

Current evidence demonstrates similar effects of kilohertz-frequency and low-frequency current on quadriceps evoked torque and discomfort in healthy individuals: a systematic review with meta-analysis.

PubMed

da Silva, Vinicius Zacarias Maldaner; Durigan, João Luiz Quaglioti; Arena, Ross; de Noronha, Marcos; Gurney, Burke; Cipriano, Gerson

2015-01-01

Neuromuscular electrical stimulation (NMES) is widely utilized to enhance muscle performance. However, the optimal NMES waveform with respect to treatment effect has not been established. To investigate the effects of kilohertz-frequency alternating current (KFAC) and low-frequency pulsed current (PC) on quadriceps evoked torque and self-reported discomfort. PubMed, The Cochrane Library, EMBASE, MEDLINE, Physiotherapy Evidence Database (PEDro), SinoMed, ISI Web of Knowledge, and CINAHL were searched for randomized controlled trials (RCTs) and quasi-randomized controlled trials (QRCTs). Two reviewers independently selected potential studies according to the inclusion criteria, extracted data, and assessed methodological quality. Studies were eligible if they compared KFAC versus PC interventions. Studies that included outcome measures for percentage of maximal isometric voluntary contraction (%MIVC) torque and self-reported discomfort level were eligible for evaluation. Seven studies involving 127 individuals were included. The methodological quality of eligible trials was moderate, with a mean of 5 on the 10-point PEDro scale. Overall, PC was no better than KFAC in terms of evoked torque and there was no difference in self-reported discomfort level. KFAC and PC have similar effects on quadriceps evoked torque and self-reported discomfort level in healthy individuals. The small number and overall methodological quality of currently available studies included in this meta-analysis indicate that new RCTs are needed to better determine optimal NMES treatment parameters.

Patient-reported outcomes in randomised controlled trials of colorectal cancer: an analysis determining the availability of robust data to inform clinical decision-making

PubMed Central

Whale, Katie; Fish, Daniel; Fayers, Peter; Cafaro, Valentina; Pusic, Andrea; Blazeby, Jane M.; Efficace, Fabio

2016-01-01

Purpose Randomised controlled trials (RCTs) are the most robust study design measuring outcomes of colorectal cancer (CRC) treatments, but to influence clinical practice trial design and reporting of patient-reported outcomes (PROs) must be of high quality. Objectives of this study were as follows: to examine the quality of PRO reporting in RCTs of CRC treatment; to assess the availability of robust data to inform clinical decision-making; and to investigate whether quality of reporting improved over time. Methods A systematic review from January 2004–February 2012 identified RCTs of CRC treatment describing PROs. Relevant abstracts were screened and manuscripts obtained. Methodological quality was assessed using International Society for Quality of Life Research—patient-reported outcome reporting standards. Changes in reporting quality over time were established by comparison with previous data, and risk of bias was assessed with the Cochrane risk of bias tool. Results Sixty-six RCTs were identified, seven studies (10 %) reported survival benefit favouring the experimental treatment, 35 trials (53 %) identified differences in PROs between treatment groups, and the clinical significance of these differences was discussed in 19 studies (29 %). The most commonly reported treatment type was chemotherapy (n = 45; 68 %). Improvements over time in key methodological issues including the documentation of missing data and the discussion of the clinical significance of PROs were found. Thirteen trials (20 %) had high-quality reporting. Conclusions Whilst improvements in PRO quality reporting over time were found, several recent studies still fail to robustly inform clinical practice. Quality of PRO reporting must continue to improve to maximise the clinical impact of PRO findings. PMID:25910987

Psychologically mediated effects of the physical healthcare environment on work-related outcomes of healthcare personnel.

PubMed

Tanja-Dijkstra, Karin; Pieterse, Marcel E

2010-12-08

The physical healthcare environment is capable of affecting patients. This concept of 'healing environments' refers to the psychological impact of environmental stimuli through sensory perceptions. It excludes more physiological effects such as those produced by ergonomic (i.e. fall prevention) or facilitative (i.e. hygiene-related) variables. The importance of an atmosphere in the healthcare environment that promotes the health and well-being of patients is evident, but this environment should not negatively affect healthcare personnel. The physical healthcare environment is part of the personnel's 'workscape'. This can make the environment an important determinant of subjective work-related outcomes like job satisfaction and well-being, as well as of objective outcomes like absenteeism or quality of care. In order to effectively build or renovate healthcare facilities, it is necessary to pay attention to the needs of both patients and healthcare personnel. To assess the psychological effects of the physical healthcare environment on healthcare personnel. We searched the Cochrane EPOC Group Specialised Register; Cochrane Central Register of Controlled Trials; Database of Abstracts and Reviews of Effects; MEDLINE; EMBASE; CINAHL; Civil Engineering Database and Compendex. We also searched the reference lists of included studies. We included randomised controlled trials (RCT), controlled clinical trials (CCT), controlled before and after studies (CBA), and interrupted time series (ITS) of psychological effects of the physical healthcare environment interventions for healthcare staff. The outcomes included measures of job satisfaction, satisfaction with the physical healthcare environment, quality of life, and quality of care. Two reviewers independently assessed studies for eligibility, extracted data, and assessed methodological quality. We identified one study, which adopted a CBA study design to investigate the simultaneous effects of multiple environmental stimuli. Staff mood improved in this study, while no effects were found on ward atmosphere or unscheduled absences. One study was included in this review. This review therefore indicates that, at present, there is insufficient evidence to support or refute the impact of the physical healthcare environment on work-related outcomes of healthcare staff. Methodological shortcomings, particularly confounding with other variables and the lack of adequate control conditions, partially account for this lack of evidence. Given these methodological issues, the field is in need of well-conducted controlled trials.

The psychological effects of the physical healthcare environment on healthcare personnel.

PubMed

Tanja-Dijkstra, Karin; Pieterse, Marcel E

2011-01-19

The physical healthcare environment is capable of affecting patients. This concept of 'healing environments' refers to the psychological impact of environmental stimuli through sensory perceptions. It excludes more physiological effects such as those produced by ergonomic (i.e. fall prevention) or facilitative (i.e. hygiene-related) variables. The importance of an atmosphere in the healthcare environment that promotes the health and well-being of patients is evident, but this environment should not negatively affect healthcare personnel. The physical healthcare environment is part of the personnel's 'workscape'. This can make the environment an important determinant of subjective work-related outcomes like job satisfaction and well-being, as well as of objective outcomes like absenteeism or quality of care. In order to effectively build or renovate healthcare facilities, it is necessary to pay attention to the needs of both patients and healthcare personnel. To assess the psychological effects of the physical healthcare environment on healthcare personnel. We searched the Cochrane EPOC Group Specialised Register; Cochrane Central Register of Controlled Trials; Database of Abstracts and Reviews of Effects; MEDLINE; EMBASE; CINAHL; Civil Engineering Database and Compendex. We also searched the reference lists of included studies. We included randomised controlled trials (RCT), controlled clinical trials (CCT), controlled before and after studies (CBA), and interrupted time series (ITS) of psychological effects of the physical healthcare environment interventions for healthcare staff. The outcomes included measures of job satisfaction, satisfaction with the physical healthcare environment, quality of life, and quality of care. Two reviewers independently assessed studies for eligibility, extracted data, and assessed methodological quality. We identified one study, which adopted a CBA study design to investigate the simultaneous effects of multiple environmental stimuli. Staff mood improved in this study, while no effects were found on ward atmosphere or unscheduled absences. One study was included in this review. This review therefore indicates that, at present, there is insufficient evidence to support or refute the impact of the physical healthcare environment on work-related outcomes of healthcare staff. Methodological shortcomings, particularly confounding with other variables and the lack of adequate control conditions, partially account for this lack of evidence. Given these methodological issues, the field is in need of well-conducted controlled trials.

Methodological quality assessment of paper-based systematic reviews published in oral health.

PubMed

Wasiak, J; Shen, A Y; Tan, H B; Mahar, R; Kan, G; Khoo, W R; Faggion, C M

2016-04-01

This study aimed to conduct a methodological assessment of paper-based systematic reviews (SR) published in oral health using a validated checklist. A secondary objective was to explore temporal trends on methodological quality. Two electronic databases (OVID Medline and OVID EMBASE) were searched for paper-based SR of interventions published in oral health from inception to October 2014. Manual searches of the reference lists of paper-based SR were also conducted. Methodological quality of included paper-based SR was assessed using an 11-item questionnaire, Assessment of Multiple Systematic Reviews (AMSTAR) checklist. Methodological quality was summarized using the median and inter-quartile range (IQR) of the AMSTAR score over different categories and time periods. A total of 643 paper-based SR were included. The overall median AMSTAR score was 4 (IQR 2-6). The highest median score (5) was found in the pain dentistry and periodontology fields, while the lowest median score (3) was found in implant dentistry, restorative dentistry, oral medicine, and prosthodontics. The number of paper-based SR per year and the median AMSTAR score increased over time (median score in 1990s was 2 (IQR 2-3), 2000s was 4 (IQR 2-5), and 2010 onwards was 5 (IQR 3-6)). Although the methodological quality of paper-based SR published in oral health has improved in the last few years, there is still scope for improving quality in most evaluated dental specialties. Large-scale assessment of methodological quality of dental SR highlights areas of methodological strengths and weaknesses that can be targeted in future publications to encourage better quality review methodology.

Crowding measures associated with the quality of emergency department care: a systematic review.

PubMed

Stang, Antonia S; Crotts, Jennifer; Johnson, David W; Hartling, Lisa; Guttmann, Astrid

2015-06-01

Despite the substantial body of literature on emergency department (ED) crowding, to the best of our knowledge, there is no agreement on the measure or measures that should be used to quantify crowding. The objective of this systematic review was to identify existing measures of ED crowding that have been linked to quality of care as defined by the Institute of Medicine (IOM) quality domains (safe, effective, patient-centered, efficient, timely, and equitable). Six major bibliographic databases were searched from January 1980 to January 2012, and hand searches were conducted of relevant journals and conference proceedings. Observational studies (cross-sectional, cohort, and case-control), quality improvement studies, quasi-experimental (e.g., before/after) studies, and randomized controlled trials were considered for inclusion. Studies that did not provide measures of ED crowding were excluded. Studies that did not provide quantitative data on the link between crowding measures and quality of care were also excluded. Two independent reviewers assessed study eligibility, completed data extraction, and assessed study quality using the Newcastle-Ottawa Quality Assessment Scale (NOS) for observational studies and a modified version of the NOS for cross-sectional studies. The search identified 7,413 articles. Thirty-two articles were included in the review: six cross-sectional, one case-control, 23 cohort, and two retrospective reviews of performance improvement data. Methodologic quality was moderate, with weaknesses in the reporting of study design and methodology. Overall, 15 of the crowding measures studied had quantifiable links to quality of care. The three measures most frequently linked to quality of care were the number of patients in the waiting room, ED occupancy (percentage of overall ED beds filled), and the number of admitted patients in the ED awaiting inpatient beds. None of the articles provided data on the link between crowding measures and the IOM domains reflecting equitable and efficient care. The results of this review provide data on the association between ED crowding measures and quality of care. Three simple crowding measures have been linked to quality of care in multiple publications. © 2015 by the Society for Academic Emergency Medicine.

METHODOLOGICAL QUALITY OF ECONOMIC EVALUATIONS ALONGSIDE TRIALS OF KNEE PHYSIOTHERAPY.

PubMed

García-Pérez, Lidia; Linertová, Renata; Arvelo-Martín, Alejandro; Guerra-Marrero, Carolina; Martínez-Alberto, Carlos Enrique; Cuéllar-Pompa, Leticia; Escobar, Antonio; Serrano-Aguilar, Pedro

2017-01-01

The methodological quality of an economic evaluation performed alongside a clinical trial can be underestimated if the paper does not report key methodological features. This study discusses methodological assessment issues on the example of a systematic review on cost-effectiveness of physiotherapy for knee osteoarthritis. Six economic evaluation studies included in the systematic review and related clinical trials were assessed using the 10-question check-list by Drummond and the Physiotherapy Evidence Database (PEDro) scale. All economic evaluations were performed alongside a clinical trial but the studied interventions were too heterogeneous to be synthesized. Methodological quality of the economic evaluations reported in the papers was not free of drawbacks, and in some cases, it improved when information from the related clinical trial was taken into account. Economic evaluation papers dedicate little space to methodological features of related clinical trials; therefore, the methodological quality can be underestimated if evaluated separately from the trials. Future economic evaluations should follow more strictly the recommendations about methodology and the authors should pay special attention to the quality of reporting.

Methodological quality of meta-analyses on treatments for chronic obstructive pulmonary disease: a cross-sectional study using the AMSTAR (Assessing the Methodological Quality of Systematic Reviews) tool.

PubMed

Ho, Robin S T; Wu, Xinyin; Yuan, Jinqiu; Liu, Siya; Lai, Xin; Wong, Samuel Y S; Chung, Vincent C H

2015-01-08

Meta-analysis (MA) of randomised trials is considered to be one of the best approaches for summarising high-quality evidence on the efficacy and safety of treatments. However, methodological flaws in MAs can reduce the validity of conclusions, subsequently impairing the quality of decision making. To assess the methodological quality of MAs on COPD treatments. A cross-sectional study on MAs of COPD trials. MAs published during 2000-2013 were sampled from the Cochrane Database of Systematic Reviews and Database of Abstracts of Reviews of Effect. Methodological quality was assessed using the validated AMSTAR (Assessing the Methodological Quality of Systematic Reviews) tool. Seventy-nine MAs were sampled. Only 18% considered the scientific quality of primary studies when formulating conclusions and 49% used appropriate meta-analytic methods to combine findings. The problems were particularly acute among MAs on pharmacological treatments. In 48% of MAs the authors did not report conflict of interest. Fifty-eight percent reported harmful effects of treatment. Publication bias was not assessed in 65% of MAs, and only 10% had searched non-English databases. The methodological quality of the included MAs was disappointing. Consideration of scientific quality when formulating conclusions should be made explicit. Future MAs should improve on reporting conflict of interest and harm, assessment of publication bias, prevention of language bias and use of appropriate meta-analytic methods.

Methodological quality of meta-analyses on treatments for chronic obstructive pulmonary disease: a cross-sectional study using the AMSTAR (Assessing the Methodological Quality of Systematic Reviews) tool

PubMed Central

Ho, Robin ST; Wu, Xinyin; Yuan, Jinqiu; Liu, Siya; Lai, Xin; Wong, Samuel YS; Chung, Vincent CH

2015-01-01

Background: Meta-analysis (MA) of randomised trials is considered to be one of the best approaches for summarising high-quality evidence on the efficacy and safety of treatments. However, methodological flaws in MAs can reduce the validity of conclusions, subsequently impairing the quality of decision making. Aims: To assess the methodological quality of MAs on COPD treatments. Methods: A cross-sectional study on MAs of COPD trials. MAs published during 2000–2013 were sampled from the Cochrane Database of Systematic Reviews and Database of Abstracts of Reviews of Effect. Methodological quality was assessed using the validated AMSTAR (Assessing the Methodological Quality of Systematic Reviews) tool. Results: Seventy-nine MAs were sampled. Only 18% considered the scientific quality of primary studies when formulating conclusions and 49% used appropriate meta-analytic methods to combine findings. The problems were particularly acute among MAs on pharmacological treatments. In 48% of MAs the authors did not report conflict of interest. Fifty-eight percent reported harmful effects of treatment. Publication bias was not assessed in 65% of MAs, and only 10% had searched non-English databases. Conclusions: The methodological quality of the included MAs was disappointing. Consideration of scientific quality when formulating conclusions should be made explicit. Future MAs should improve on reporting conflict of interest and harm, assessment of publication bias, prevention of language bias and use of appropriate meta-analytic methods. PMID:25569783

Patient-reported outcomes in randomised controlled trials of prostate cancer: methodological quality and impact on clinical decision making.

PubMed

Efficace, Fabio; Feuerstein, Michael; Fayers, Peter; Cafaro, Valentina; Eastham, James; Pusic, Andrea; Blazeby, Jane

2014-09-01

Patient-reported outcomes (PRO) data from randomised controlled trials (RCTs) are increasingly used to inform patient-centred care as well as clinical and health policy decisions. The main objective of this study was to investigate the methodological quality of PRO assessment in RCTs of prostate cancer (PCa) and to estimate the likely impact of these studies on clinical decision making. A systematic literature search of studies was undertaken on main electronic databases to retrieve articles published between January 2004 and March 2012. RCTs were evaluated on a predetermined extraction form, including (1) basic trial demographics and clinical and PRO characteristics; (2) level of PRO reporting based on the recently published recommendations by the International Society for Quality of Life Research; and (3) bias, assessed using the Cochrane Risk of Bias tool. Studies were systematically analysed to evaluate their relevance for supporting clinical decision making. Sixty-five RCTs enrolling a total of 22 071 patients were evaluated, with 31 (48%) in patients with nonmetastatic disease. When a PRO difference between treatments was found, it related in most cases to symptoms only (n=29, 58%). Although the extent of missing data was generally documented (72% of RCTs), few reported details on statistical handling of this data (18%) and reasons for dropout (35%). Improvements in key methodological aspects over time were found. Thirteen (20%) RCTs were judged as likely to be robust in informing clinical decision making. Higher-quality PRO studies were generally associated with those RCTs that had higher internal validity. Including PRO in RCTs of PCa patients is critical for better evaluating the treatment effectiveness of new therapeutic approaches. Marked improvements in PRO quality reporting over time were found, and it is estimated that at least one-fifth of PRO RCTs have provided sufficient details to allow health policy makers and physicians to make critical appraisals of results. In this report, we have investigated the methodological quality of PCa trials that have included a PRO assessment. We conclude that including PRO is critical to better evaluating the treatment effectiveness of new therapeutic approaches from the patient's perspective. Also, at least one-fifth of PRO RCTs in PCa have provided sufficient details to allow health policy makers and physicians to make a critical appraisal of results. Copyright © 2013. Published by Elsevier B.V.

The Development of a Checklist to Enhance Methodological Quality in Intervention Programs.

PubMed

Chacón-Moscoso, Salvador; Sanduvete-Chaves, Susana; Sánchez-Martín, Milagrosa

2016-01-01

The methodological quality of primary studies is an important issue when performing meta-analyses or systematic reviews. Nevertheless, there are no clear criteria for how methodological quality should be analyzed. Controversies emerge when considering the various theoretical and empirical definitions, especially in relation to three interrelated problems: the lack of representativeness, utility, and feasibility. In this article, we (a) systematize and summarize the available literature about methodological quality in primary studies; (b) propose a specific, parsimonious, 12-items checklist to empirically define the methodological quality of primary studies based on a content validity study; and (c) present an inter-coder reliability study for the resulting 12-items. This paper provides a precise and rigorous description of the development of this checklist, highlighting the clearly specified criteria for the inclusion of items and a substantial inter-coder agreement in the different items. Rather than simply proposing another checklist, however, it then argues that the list constitutes an assessment tool with respect to the representativeness, utility, and feasibility of the most frequent methodological quality items in the literature, one that provides practitioners and researchers with clear criteria for choosing items that may be adequate to their needs. We propose individual methodological features as indicators of quality, arguing that these need to be taken into account when designing, implementing, or evaluating an intervention program. This enhances methodological quality of intervention programs and fosters the cumulative knowledge based on meta-analyses of these interventions. Future development of the checklist is discussed.

The Development of a Checklist to Enhance Methodological Quality in Intervention Programs

PubMed Central

Chacón-Moscoso, Salvador; Sanduvete-Chaves, Susana; Sánchez-Martín, Milagrosa

2016-01-01

The methodological quality of primary studies is an important issue when performing meta-analyses or systematic reviews. Nevertheless, there are no clear criteria for how methodological quality should be analyzed. Controversies emerge when considering the various theoretical and empirical definitions, especially in relation to three interrelated problems: the lack of representativeness, utility, and feasibility. In this article, we (a) systematize and summarize the available literature about methodological quality in primary studies; (b) propose a specific, parsimonious, 12-items checklist to empirically define the methodological quality of primary studies based on a content validity study; and (c) present an inter-coder reliability study for the resulting 12-items. This paper provides a precise and rigorous description of the development of this checklist, highlighting the clearly specified criteria for the inclusion of items and a substantial inter-coder agreement in the different items. Rather than simply proposing another checklist, however, it then argues that the list constitutes an assessment tool with respect to the representativeness, utility, and feasibility of the most frequent methodological quality items in the literature, one that provides practitioners and researchers with clear criteria for choosing items that may be adequate to their needs. We propose individual methodological features as indicators of quality, arguing that these need to be taken into account when designing, implementing, or evaluating an intervention program. This enhances methodological quality of intervention programs and fosters the cumulative knowledge based on meta-analyses of these interventions. Future development of the checklist is discussed. PMID:27917143

Interventions to Promote Physical Activity in Older People with Type 2 Diabetes Mellitus: A Systematic Review

PubMed Central

Sazlina, Shariff-Ghazali; Browning, Colette; Yasin, Shajahan

2013-01-01

Introduction: Type 2 diabetes mellitus (T2DM) among people aged 60 years and above is a growing public health problem. Regular physical activity is one of the key elements in the management of T2DM. Recommendations suggest that older people with T2DM will benefit from regular physical activity for better disease control and delaying complications. Despite the known benefits, many remain sedentary. Hence, this review assessed interventions for promoting physical activity in persons aged 65 years and older with T2DM. Methods: A literature search was conducted using Ovid MEDLINE, PubMed, EMBASE, SPORTDiscus, and CINAHL databases to retrieve articles published between January 2000 and December 2012. Randomized controlled trials and quasi-experimental designs comparing different strategies to increase physical activity level in persons aged 65 years and older with T2DM were included. The methodological quality of studies was assessed. Results: Twenty-one eligible studies were reviewed, only six studies were rated as good quality and only one study specifically targeted persons aged 65 years and older. Personalized coaching, goal setting, peer support groups, use of technology, and physical activity monitors were proven to increase the level of physical activity. Incorporation of health behavior theories and follow-up supports also were successful strategies. However, the methodological quality and type of interventions promoting physical activity of the included studies in this review varied widely across the eligible studies. Conclusion: Strategies that increased level of physical activity in persons with T2DM are evident but most studies focused on middle-aged persons and there was a lack of well-designed trials. Hence, more studies of satisfactory methodological quality with interventions promoting physical activity in older people are required. PMID:24392445

Integrative treatment for low back pain: An exploratory systematic review and meta-analysis of randomized controlled trials.

PubMed

Hu, Xiao-Yang; Chen, Ni-Ni; Chai, Qian-Yun; Yang, Guo-Yan; Trevelyan, Esmé; Lorenc, Ava; Liu, Jian-Ping; Robinson, Nicola

2015-10-26

Low back pain (LBP) is a common musculoskeletal condition often treated using integrative medicine (IM). Most reviews have focused on a single complementary and alternative medicine (CAM) therapy for LBP rather than evaluating wider integrative approaches. This exploratory systematic review aimed to identify randomized controlled trials (RCTs) and provide evidence on the effectiveness, cost effectiveness and adverse effects of integrative treatment for LBP. A literature search was conducted in 12 English and Chinese databases. RCTs evaluating an integrative treatment for musculoskeletal related LBP were included. Reporting, methodological quality and relevant clinical characteristics were assessed and appraised. Metaanalyses were performed for outcomes where trials were sufficiently homogenous. Fifty-six RCTs were identified evaluating integrative treatment for LBP. Although reporting and methodological qualities were poor, meta-analysis showed a favourable effect for integrative treatment over conventional and CAM treatment for back pain and function at 3 months or less follow-up. Two trials investigated costs, reporting £ 5332 per quality adjusted life years with 6 Alexander technique lessons plus exercise at 12 months follow-up; and an increased total costs of $244 when giving an additional up to 15 sessions of CAM package of care at 12 weeks. Sixteen trials mentioned safety; no severe adverse effects were reported. Integrative treatment that combines CAM with conventional therapies appeared to have beneficial effects on pain and function. However, evidence is limited due to heterogeneity, the relatively small numbers available for subgroup analyses and the low methodological quality of the included trials. Identification of studies of true IM was not possible due to lack of reporting of the intervention details (registration No. CRD42013003916).

The Modern Measurement Technology And Checking Of Shafs Parameters

NASA Astrophysics Data System (ADS)

Tichá, Šárka; Botek, Jan

2015-12-01

This paper is focused on rationalization checking parameters of shaft in companies engaged in the production of components of electric motors, wind turbines and vacuum systems. Customers increasing constantly their requirements to ensure the overall quality of the product, i.e. the quality of machining, dimensional and shape accuracy and overall purity of the subscribed products. The aim of this paper is to introduce using modern measurement technology in controlling these components and compare the results with existing control methodology. The main objective of this rationalization is to eliminate mistakes and shortcomings of current inspection methods.

Methodological quality of systematic reviews addressing femoroacetabular impingement.

PubMed

Kowalczuk, Marcin; Adamich, John; Simunovic, Nicole; Farrokhyar, Forough; Ayeni, Olufemi R

2015-09-01

As the body of literature on femoroacetabular impingement (FAI) continues to grow, clinicians turn to systematic reviews to remain current with the best available evidence. The quality of systematic reviews in the FAI literature is currently unknown. The goal of this study was to assess the quality of the reporting of systematic reviews addressing FAI over the last 11 years (2003-2014) and to identify the specific methodological shortcomings and strengths. A search of the electronic databases, MEDLINE, EMBASE and PubMed, was performed to identify relevant systematic reviews. Methodological quality was assessed by two reviewers using the revised assessment of multiple systematic reviews (R-AMSTAR) scoring tool. An intraclass correlation coefficient (ICC) with 95 % confidence intervals (CI) was used to determine agreement between reviewers on R-AMSTAR quality scores. A total of 22 systematic reviews were assessed for methodological quality. The mean consensus R-AMSTAR score across all studies was 26.7 out of 40.0, indicating fair methodological quality. An ICC of 0.931, 95 % CI 0.843-0.971 indicated excellent agreement between reviewers during the scoring process. The systematic reviews addressing FAI are generally of fair methodological quality. Use of tools such as the R-AMSTAR score or PRISMA guidelines while designing future systematic reviews can assist in eliminating methodological shortcomings identified in this review. These shortcomings need to be kept in mind by clinicians when applying the current literature to their patient populations and making treatment decisions. Systematic reviews of highest methodological quality should be used by clinicians when possible to answer clinical questions.

NIR spectroscopy for the quality control of Moringa oleifera (Lam.) leaf powders: Prediction of minerals, protein and moisture contents.

PubMed

Rébufa, Catherine; Pany, Inès; Bombarda, Isabelle

2018-09-30

A rapid methodology was developed to simultaneously predict water content and activity values (a w ) of Moringa oleifera leaf powders (MOLP) using near infrared (NIR) signatures and experimental sorption isotherms. NIR spectra of MOLP samples (n = 181) were recorded. A Partial Least Square Regression model (PLS2) was obtained with low standard errors of prediction (SEP of 1.8% and 0.07 for water content and a w respectively). Experimental sorption isotherms obtained at 20, 30 and 40 °C showed similar profiles. This result is particularly important to use MOLP in food industry. In fact, a temperature variation of the drying process will not affect their available water content (self-life). Nutrient contents based on protein and selected minerals (Ca, Fe, K) were also predicted from PLS1 models. Protein contents were well predicted (SEP of 2.3%). This methodology allowed for an improvement in MOLP safety, quality control and traceability. Published by Elsevier Ltd.

Is there an "abortion trauma syndrome"? Critiquing the evidence.

PubMed

Robinson, Gail Erlick; Stotland, Nada L; Russo, Nancy Felipe; Lang, Joan A; Occhiogrosso, Mallay

2009-01-01

The objective of this review is to identify and illustrate methodological issues in studies used to support claims that induced abortion results in an "abortion trauma syndrome" or a psychiatric disorder. After identifying key methodological issues to consider when evaluating such research, we illustrate these issues by critically examining recent empirical studies that are widely cited in legislative and judicial testimony in support of the existence of adverse psychiatric sequelae of induced abortion. Recent studies that have been used to assert a causal connection between abortion and subsequent mental disorders are marked by methodological problems that include, but not limited to: poor sample and comparison group selection; inadequate conceptualization and control of relevant variables; poor quality and lack of clinical significance of outcome measures; inappropriateness of statistical analyses; and errors of interpretation, including misattribution of causal effects. By way of contrast, we review some recent major studies that avoid these methodological errors. The most consistent predictor of mental disorders after abortion remains preexisting disorders, which, in turn, are strongly associated with exposure to sexual abuse and intimate violence. Educating researchers, clinicians, and policymakers how to appropriately assess the methodological quality of research about abortion outcomes is crucial. Further, methodologically sound research is needed to evaluate not only psychological outcomes of abortion, but also the impact of existing legislation and the effects of social attitudes and behaviors on women who have abortions.

Methodological quality of meta-analyses of single-case experimental studies.

PubMed

Jamshidi, Laleh; Heyvaert, Mieke; Declercq, Lies; Fernández-Castilla, Belén; Ferron, John M; Moeyaert, Mariola; Beretvas, S Natasha; Onghena, Patrick; Van den Noortgate, Wim

2017-12-28

Methodological rigor is a fundamental factor in the validity and credibility of the results of a meta-analysis. Following an increasing interest in single-case experimental design (SCED) meta-analyses, the current study investigates the methodological quality of SCED meta-analyses. We assessed the methodological quality of 178 SCED meta-analyses published between 1985 and 2015 through the modified Revised-Assessment of Multiple Systematic Reviews (R-AMSTAR) checklist. The main finding of the current review is that the methodological quality of the SCED meta-analyses has increased over time, but is still low according to the R-AMSTAR checklist. A remarkable percentage of the studies (93.80% of the included SCED meta-analyses) did not even reach the midpoint score (22, on a scale of 0-44). The mean and median methodological quality scores were 15.57 and 16, respectively. Relatively high scores were observed for "providing the characteristics of the included studies" and "doing comprehensive literature search". The key areas of deficiency were "reporting an assessment of the likelihood of publication bias" and "using the methods appropriately to combine the findings of studies". Although the results of the current review reveal that the methodological quality of the SCED meta-analyses has increased over time, still more efforts are needed to improve their methodological quality. Copyright © 2017 Elsevier Ltd. All rights reserved.

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.

[Methodological quality evaluation of randomized controlled trials for traditional Chinese medicines for treatment of sub-health].

PubMed

Zhao, Jun; Liao, Xing; Zhao, Hui; Li, Zhi-Geng; Wang, Nan-Yue; Wang, Li-Min

2016-11-01

To evaluate the methodological quality of the randomized controlled trials(RCTs) for traditional Chinese medicines for treatment of sub-health, in order to provide a scientific basis for the improvement of clinical trials and systematic review. Such databases as CNKI, CBM, VIP, Wanfang, EMbase, Medline, Clinical Trials, Web of Science and Cochrane Library were searched for RCTS for traditional Chinese medicines for treatment of sub-health between the time of establishment and February 29, 2016. Cochrane Handbook 5.1 was used to screen literatures and extract data, and CONSORT statement and CONSORT for traditional Chinese medicine statement were adopted as the basis for quality evaluation. Among the 72 RCTs included in this study, 67 (93.05%) trials described the inter-group baseline data comparability, 39(54.17%) trials described the unified diagnostic criteria, 28(38.89%) trials described the unified standards of efficacy, 4 (5.55%) trials mentioned the multi-center study, 19(26.38%) trials disclosed the random distribution method, 6(8.33%) trials used the random distribution concealment, 15(20.83%) trials adopted the method of blindness, 3(4.17%) study reported the sample size estimation in details, 5 (6.94%) trials showed a sample size of more than two hundred, 19(26.38%) trials reported the number of withdrawal, defluxion cases and those lost to follow-up, but only 2 trials adopted the ITT analysis,10(13.89%) trials reported the follow-up results, none of the trial reported the test registration and the test protocol, 48(66.7%) trials reported all of the indicators of expected outcomes, 26(36.11%) trials reported the adverse reactions and adverse events, and 4(5.56%) trials reported patient compliance. The overall quality of these randomized controlled trials for traditional Chinese medicines for treatment of sub-health is low, with methodological defects in different degrees. Therefore, it is still necessary to emphasize the correct application of principles such as blindness, randomization and control in RCTs, while requiring reporting in accordance with international standards. Copyright© by the Chinese Pharmaceutical Association.

What Is the Methodologic Quality of Human Therapy Studies in ISI Surgical Publications?

PubMed Central

Manterola, Carlos; Pineda, Viviana; Vial, Manuel; Losada, Héctor

2006-01-01

Objective: To determine the methodologic quality of therapy articles about humans published in ISI surgical journals, and to explore the association between methodologic quality, origin, and subject matter. Summary Background Data: It is supposed that ISI journals contain the best methodologic articles. Methods: This is a bibliometric study. All journals listed in the 2002 ISI under the subject heading of “Surgery” were included. A simple randomized sampling was conducted for selected journals (Annals of Surgery, The American Surgeon, Archives of Surgery, British Journal of Surgery, European Journal of Surgery, Journal of the American College of Surgeons, Surgery, and World Journal of Surgery). Published articles related to therapy on humans of the selected journals were reviewed and analyzed. All kinds of clinical designs were considered, excluding editorials, review articles, letters to the editor, and experimental studies. The variables considered were: place of origin, design, and the methodologic quality of articles, which was determined by applying a valid and reliable scale. The review was performed interchangeably and independently by 2 research teams. Descriptive and analytical statistics were used. Statistical significance was defined as P values less than 1%. Results: A total of 653 articles were studied. Studies came predominantly from the United States and Europe (43.6% and 36.8%, respectively). The subject areas most frequently found were digestive and hepatobiliopancreatic surgery (29.1% and 24.5%, respectively). Average and median methodologic quality scores of the entire series were 11.6 ± 4.9 points and 11 points, respectively. The association between methodologic quality and journals was determined. Also, the association between methodologic quality and origin was observed, but no association with subject area was verified. Conclusions: The methodologic quality of therapy articles published in the journals analyzed is low; however, statistical significance was determined between them. Association was observed between methodologic quality and origin, but not with subject matter. PMID:17060778

Writing standard operating procedures (SOPs) for cryostorage protocols: using shoot meristem cryopreservation as an example.

PubMed

Harding, Keith; Benson, Erica E

2015-01-01

Standard operating procedures are a systematic way of making sure that biopreservation processes, tasks, protocols, and operations are correctly and consistently performed. They are the basic documents of biorepository quality management systems and are used in quality assurance, control, and improvement. Methodologies for constructing workflows and writing standard operating procedures and work instructions are described using a plant cryopreservation protocol as an example. This chapter is pertinent to other biopreservation sectors because how methods are written, interpreted, and implemented can affect the quality of storage outcomes.

Parametric Optimization Of Gas Metal Arc Welding Process By Using Grey Based Taguchi Method On Aisi 409 Ferritic Stainless Steel

NASA Astrophysics Data System (ADS)

Ghosh, Nabendu; Kumar, Pradip; Nandi, Goutam

2016-10-01

Welding input process parameters play a very significant role in determining the quality of the welded joint. Only by properly controlling every element of the process can product quality be controlled. For better quality of MIG welding of Ferritic stainless steel AISI 409, precise control of process parameters, parametric optimization of the process parameters, prediction and control of the desired responses (quality indices) etc., continued and elaborate experiments, analysis and modeling are needed. A data of knowledge - base may thus be generated which may be utilized by the practicing engineers and technicians to produce good quality weld more precisely, reliably and predictively. In the present work, X-ray radiographic test has been conducted in order to detect surface and sub-surface defects of weld specimens made of Ferritic stainless steel. The quality of the weld has been evaluated in terms of yield strength, ultimate tensile strength and percentage of elongation of the welded specimens. The observed data have been interpreted, discussed and analyzed by considering ultimate tensile strength ,yield strength and percentage elongation combined with use of Grey-Taguchi methodology.

Financial conflicts of interest and their association with outcome and quality of fibromyalgia drug therapy randomized controlled trials.

PubMed

Pang, Winnie K; Yeter, Karen C; Torralba, Karina D; Spencer, Horace J; Khan, Nasim A

2015-07-01

To evaluate the association of financial conflicts of interest (FCOI) with the characteristics, outcome and reported methodological quality of fibromyalgia drug therapy randomized controlled trials (FM-RCTs). A cross-sectional study of original, parallel-group, drug therapy FM-RCTs published between 1997 and 2011 from Medline and Cochrane Central Register of Controlled Trials was conducted. Two reviewers independently assessed each RCT for funding source, authors' FCOI(s), study characteristics, reporting of methodological measures important for internal validity and outcome (positive [statistically significant result favoring experimental drug for the primary outcome] or non-positive). Forty-seven RCTs were eligible with funding source as: 26 (55.3%) industry; eight (17%) non-profit source(s); five (10.6%) mixed; and eight (17%) unspecified. Industry-funded RCTs were more likely to be multicenter and enroll greater number of patients. Reporting of key methodological measures was suboptimal; however, industry and non-profit funded RCTs did not differ in their reporting. Thirty (63.8%) RCTs had ≥ one author who disclosed an FCOI (receipt of research grant [21, 44.7%], industry sponsor employee [20, 42.6%], receipt of consultancy fee/honorarium [16, 34%] and stock ownership [11, 23.4%]). Although industry funding and certain authors' FCOIs (employment and receipt of consultancy fee/honorarium) were univariately associated with positive outcome, such association was not observed after adjusting for study sample size. The majority of FM-RCTs were industry-sponsored, and had at least one author with an FCOI. Reporting of key methodological measures was suboptimal. After adjusting for study sample size, no association of industry funding or author's FCOI with study outcome was seen. © 2015 Asia Pacific League of Associations for Rheumatology and Wiley Publishing Asia Pty Ltd.

Expert Opinion Is Necessary: Delphi Panel Methodology Facilitates a Scientific Approach to Consensus.

PubMed

Hohmann, Erik; Brand, Jefferson C; Rossi, Michael J; Lubowitz, James H

2018-02-01

Our current trend and focus on evidence-based medicine is biased in favor of randomized controlled trials, which are ranked highest in the hierarchy of evidence while devaluing expert opinion, which is ranked lowest in the hierarchy. However, randomized controlled trials have weaknesses as well as strengths, and no research method is flawless. Moreover, stringent application of scientific research techniques, such as the Delphi Panel methodology, allows survey of experts in a high quality and scientific manner. Level V evidence (expert opinion) remains a necessary component in the armamentarium used to determine the answer to a clinical question. Copyright © 2017 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

The Statistical point of view of Quality: the Lean Six Sigma methodology

PubMed Central

Viti, Andrea; Terzi, Alberto

2015-01-01

Six Sigma and Lean are two quality improvement methodologies. The Lean Six Sigma methodology is applicable to repetitive procedures. Therefore, the use of this methodology in the health-care arena has focused mainly on areas of business operations, throughput, and case management and has focused on efficiency outcomes. After the revision of methodology, the paper presents a brief clinical example of the use of Lean Six Sigma as a quality improvement method in the reduction of the complications during and after lobectomies. Using Lean Six Sigma methodology, the multidisciplinary teams could identify multiple modifiable points across the surgical process. These process improvements could be applied to different surgical specialties and could result in a measurement, from statistical point of view, of the surgical quality. PMID:25973253

The Statistical point of view of Quality: the Lean Six Sigma methodology.

PubMed

Bertolaccini, Luca; Viti, Andrea; Terzi, Alberto

2015-04-01

Six Sigma and Lean are two quality improvement methodologies. The Lean Six Sigma methodology is applicable to repetitive procedures. Therefore, the use of this methodology in the health-care arena has focused mainly on areas of business operations, throughput, and case management and has focused on efficiency outcomes. After the revision of methodology, the paper presents a brief clinical example of the use of Lean Six Sigma as a quality improvement method in the reduction of the complications during and after lobectomies. Using Lean Six Sigma methodology, the multidisciplinary teams could identify multiple modifiable points across the surgical process. These process improvements could be applied to different surgical specialties and could result in a measurement, from statistical point of view, of the surgical quality.

Cognitive remediation in schizophrenia: A methodological appraisal of systematic reviews and meta-analyses.

PubMed

Bryce, Shayden; Sloan, Elise; Lee, Stuart; Ponsford, Jennie; Rossell, Susan

2016-04-01

Systematic reviews and meta-analyses are a primary source of evidence when evaluating the benefit(s) of cognitive remediation (CR) in schizophrenia. These studies are designed to rigorously synthesize scientific literature; however, cannot be assumed to be of high methodological quality. The aims of this report were to: 1) review the use of systematic reviews and meta-analyses regarding CR in schizophrenia; 2) conduct a systematic methodological appraisal of published reports examining the benefits of this intervention on core outcome domains; and 3) compare the correspondence between methodological and reporting quality. Electronic databases were searched for relevant articles. Twenty-one reviews met inclusion criteria and were scored according to the AMSTAR checklist-a validated scale of methodological quality. Five meta-analyses were also scored according to PRISMA statement to compare 'quality of conduct' with 'quality of reporting'. Most systematic reviews and meta-analyses shared strengths and fell within a 'medium' level of methodological quality. Nevertheless, there were consistent areas of potential weakness that were not addressed by most reviews. These included the lack of protocol registration, uncertainty regarding independent data extraction and consensus procedures, and the minimal assessment of publication bias. Moreover, quality of conduct may not necessarily parallel quality of reporting, suggesting that consideration of these methods independently may be important. Reviews concerning CR for schizophrenia are a valuable source of evidence. However, the methodological quality of these reports may require additional consideration. Enhancing quality of conduct is essential for enabling research literature to be interpreted with confidence. Copyright © 2016 Elsevier Ltd. All rights reserved.

40 CFR 204.57-3 - Test compressor preparation.

Code of Federal Regulations, 2010 CFR

2010-07-01

... PROGRAMS NOISE EMISSION STANDARDS FOR CONSTRUCTION EQUIPMENT Portable Air Compressors § 204.57-3 Test... measurement methodology. (c) In the event of compressor manfunction (i.e., failure to start, misfiring... in a normal manner. (d) No quality control, testing, assembly, or selection procedures shall be used...

Abstract analysis method facilitates filtering low-methodological quality and high-bias risk systematic reviews on psoriasis interventions.

PubMed

Gómez-García, Francisco; Ruano, Juan; Aguilar-Luque, Macarena; Alcalde-Mellado, Patricia; Gay-Mimbrera, Jesús; Hernández-Romero, José Luis; Sanz-Cabanillas, Juan Luis; Maestre-López, Beatriz; González-Padilla, Marcelino; Carmona-Fernández, Pedro J; García-Nieto, Antonio Vélez; Isla-Tejera, Beatriz

2017-12-29

Article summaries' information and structure may influence researchers/clinicians' decisions to conduct deeper full-text analyses. Specifically, abstracts of systematic reviews (SRs) and meta-analyses (MA) should provide structured summaries for quick assessment. This study explored a method for determining the methodological quality and bias risk of full-text reviews using abstract information alone. Systematic literature searches for SRs and/or MA about psoriasis were undertaken on MEDLINE, EMBASE, and Cochrane database. For each review, quality, abstract-reporting completeness, full-text methodological quality, and bias risk were evaluated using Preferred Reporting Items for Systematic Reviews and Meta-analyses for abstracts (PRISMA-A), Assessing the Methodological Quality of Systematic Reviews (AMSTAR), and ROBIS tools, respectively. Article-, author-, and journal-derived metadata were systematically extracted from eligible studies using a piloted template, and explanatory variables concerning abstract-reporting quality were assessed using univariate and multivariate-regression models. Two classification models concerning SRs' methodological quality and bias risk were developed based on per-item and total PRISMA-A scores and decision-tree algorithms. This work was supported, in part, by project ICI1400136 (JR). No funding was received from any pharmaceutical company. This study analysed 139 SRs on psoriasis interventions. On average, they featured 56.7% of PRISMA-A items. The mean total PRISMA-A score was significantly higher for high-methodological-quality SRs than for moderate- and low-methodological-quality reviews. SRs with low-bias risk showed higher total PRISMA-A values than reviews with high-bias risk. In the final model, only 'authors per review > 6' (OR: 1.098; 95%CI: 1.012-1.194), 'academic source of funding' (OR: 3.630; 95%CI: 1.788-7.542), and 'PRISMA-endorsed journal' (OR: 4.370; 95%CI: 1.785-10.98) predicted PRISMA-A variability. Reviews with a total PRISMA-A score < 6, lacking identification as SR or MA in the title, and lacking explanation concerning bias risk assessment methods were classified as low-methodological quality. Abstracts with a total PRISMA-A score ≥ 9, including main outcomes results and explanation bias risk assessment method were classified as having low-bias risk. The methodological quality and bias risk of SRs may be determined by abstract's quality and completeness analyses. Our proposal aimed to facilitate synthesis of evidence evaluation by clinical professionals lacking methodological skills. External validation is necessary.

A stochastic optimal feedforward and feedback control methodology for superagility

NASA Technical Reports Server (NTRS)

Halyo, Nesim; Direskeneli, Haldun; Taylor, Deborah B.

1992-01-01

A new control design methodology is developed: Stochastic Optimal Feedforward and Feedback Technology (SOFFT). Traditional design techniques optimize a single cost function (which expresses the design objectives) to obtain both the feedforward and feedback control laws. This approach places conflicting demands on the control law such as fast tracking versus noise atttenuation/disturbance rejection. In the SOFFT approach, two cost functions are defined. The feedforward control law is designed to optimize one cost function, the feedback optimizes the other. By separating the design objectives and decoupling the feedforward and feedback design processes, both objectives can be achieved fully. A new measure of command tracking performance, Z-plots, is also developed. By analyzing these plots at off-nominal conditions, the sensitivity or robustness of the system in tracking commands can be predicted. Z-plots provide an important tool for designing robust control systems. The Variable-Gain SOFFT methodology was used to design a flight control system for the F/A-18 aircraft. It is shown that SOFFT can be used to expand the operating regime and provide greater performance (flying/handling qualities) throughout the extended flight regime. This work was performed under the NASA SBIR program. ICS plans to market the software developed as a new module in its commercial CACSD software package: ACET.

Static body postural misalignment in individuals with temporomandibular disorders: a systematic review

PubMed Central

Chaves, Thaís C.; Turci, Aline M.; Pinheiro, Carina F.; Sousa, Letícia M.; Grossi, Débora B.

2014-01-01

BACKGROUND: The association between body postural changes and temporomandibular disorders (TMD) has been widely discussed in the literature, however, there is little evidence to support this association. OBJECTIVES: The aim of the present study was to conduct a systematic review to assess the evidence concerning the association between static body postural misalignment and TMD. METHOD: A search was conducted in the PubMed/Medline, Embase, Lilacs, Scielo, Cochrane, and Scopus databases including studies published in English between 1950 and March 2012. Cross-sectional, cohort, case control, and survey studies that assessed body posture in TMD patients were selected. Two reviewers performed each step independently. A methodological checklist was used to evaluate the quality of the selected articles. RESULTS: Twenty studies were analyzed for their methodological quality. Only one study was classified as a moderate quality study and two were classified as strong quality studies. Among all studies considered, only 12 included craniocervical postural assessment, 2 included assessment of craniocervical and shoulder postures,, and 6 included global assessment of body posture. CONCLUSION: There is strong evidence of craniocervical postural changes in myogenous TMD, moderate evidence of cervical postural misalignment in arthrogenous TMD, and no evidence of absence of craniocervical postural misalignment in mixed TMD patients or of global body postural misalignment in patients with TMD. It is important to note the poor methodological quality of the studies, particularly those regarding global body postural misalignment in TMD patients. PMID:25590441

Use of qualitative methods alongside randomised controlled trials of complex healthcare interventions: methodological study

PubMed Central

Glenton, Claire; Oxman, Andrew D

2009-01-01

Objective To examine the use of qualitative approaches alongside randomised trials of complex healthcare interventions. Design Review of randomised controlled trials of interventions to change professional practice or the organisation of care. Data sources Systematic sample of 100 trials published in English from the register of the Cochrane Effective Practice and Organisation of Care Review Group. Methods Published and unpublished qualitative studies linked to the randomised controlled trials were identified through database searches and contact with authors. Data were extracted from each study by two reviewers using a standard form. We extracted data describing the randomised controlled trials and qualitative studies, the quality of these studies, and how, if at all, the qualitative and quantitative findings were combined. A narrative synthesis of the findings was done. Results 30 of the 100 trials had associated qualitative work and 19 of these were published studies. 14 qualitative studies were done before the trial, nine during the trial, and four after the trial. 13 studies reported an explicit theoretical basis and 11 specified their methodological approach. Approaches to sampling and data analysis were poorly described. For most cases (n=20) we found no indication of integration of qualitative and quantitative findings at the level of either analysis or interpretation. The quality of the qualitative studies was highly variable. Conclusions Qualitative studies alongside randomised controlled trials remain uncommon, even where relatively complex interventions are being evaluated. Most of the qualitative studies were carried out before or during the trials with few studies used to explain trial results. The findings of the qualitative studies seemed to be poorly integrated with those of the trials and often had major methodological shortcomings. PMID:19744976

Methodologic quality and relevance of references in pharmaceutical advertisements in a Canadian medical journal.

PubMed

Lexchin, J; Holbrook, A

1994-07-01

To evaluate the methodologic quality and relevance of references in pharmaceutical advertisements in the Canadian Medical Association Journal (CMAJ). Analytic study. All 114 references cited in the first 22 distinct pharmaceutical advertisements in volume 146 of CMAJ. Mean methodologic quality score (modified from the 6-point scale used to assess articles in the American College of Physicians' Journal Club) and mean relevance score (based on a new 5-point scale) for all references in each advertisement. Twenty of the 22 companies responded, sending 78 (90%) of the 87 references requested. The mean methodologic quality score was 58% (95% confidence limits [CL] 51% and 65%) and the mean relevance score 76% (95% CL 72% and 80%). The two mean scores were statistically lower than the acceptable score of 80% (p < 0.05), and the methodologic quality score was outside the preset clinically significant difference of 15%. The poor rating for methodologic quality was primarily because of the citation of references to low-quality review articles and "other" sources (i.e., other than reports of clinical trials). Half of the advertisements had a methodologic quality score of less than 65%, but only five had a relevance score of less than 65%. Although the relevance of most of the references was within minimal acceptable limits, the methodologic quality was often unacceptable. Because advertisements are an important part of pharmaceutical marketing and education, we suggest that companies develop written standards for their advertisements and monitor their advertisements for adherence to these standards. We also suggest that the Pharmaceutical Advertising Advisory Board develop more stringent guidelines for advertising and that it enforce these guidelines in a consistent, rigorous fashion.

Methodologic quality and relevance of references in pharmaceutical advertisements in a Canadian medical journal.

PubMed Central

Lexchin, J; Holbrook, A

1994-01-01

OBJECTIVE: To evaluate the methodologic quality and relevance of references in pharmaceutical advertisements in the Canadian Medical Association Journal (CMAJ). DESIGN: Analytic study. DATA SOURCE: All 114 references cited in the first 22 distinct pharmaceutical advertisements in volume 146 of CMAJ. MAIN OUTCOME MEASURES: Mean methodologic quality score (modified from the 6-point scale used to assess articles in the American College of Physicians' Journal Club) and mean relevance score (based on a new 5-point scale) for all references in each advertisement. MAIN RESULTS: Twenty of the 22 companies responded, sending 78 (90%) of the 87 references requested. The mean methodologic quality score was 58% (95% confidence limits [CL] 51% and 65%) and the mean relevance score 76% (95% CL 72% and 80%). The two mean scores were statistically lower than the acceptable score of 80% (p < 0.05), and the methodologic quality score was outside the preset clinically significant difference of 15%. The poor rating for methodologic quality was primarily because of the citation of references to low-quality review articles and "other" sources (i.e., other than reports of clinical trials). Half of the advertisements had a methodologic quality score of less than 65%, but only five had a relevance score of less than 65%. CONCLUSIONS: Although the relevance of most of the references was within minimal acceptable limits, the methodologic quality was often unacceptable. Because advertisements are an important part of pharmaceutical marketing and education, we suggest that companies develop written standards for their advertisements and monitor their advertisements for adherence to these standards. We also suggest that the Pharmaceutical Advertising Advisory Board develop more stringent guidelines for advertising and that it enforce these guidelines in a consistent, rigorous fashion. PMID:8004560

Optimal early active mobilisation protocol after extensor tendon repairs in zones V and VI: A systematic review of literature.

PubMed

Collocott, Shirley Jf; Kelly, Edel; Ellis, Richard F

2018-03-01

Early mobilisation protocols after repair of extensor tendons in zone V and VI provide better outcomes than immobilisation protocols. This systematic review investigated different early active mobilisation protocols used after extensor tendon repair in zone V and VI. The purpose was to determine whether any one early active mobilisation protocol provides superior results. An extensive literature search was conducted to identify articles investigating the outcomes of early active mobilisation protocols after extensor tendon repair in zone V and VI. Databases searched were AMED, Embase, Medline, Cochrane and CINAHL. Studies were included if they involved participants with extensor tendon repairs in zone V and VI in digits 2-5 and described a post-operative rehabilitation protocol which allowed early active metacarpophalangeal joint extension. Study designs included were randomised controlled trials, observational studies, cohort studies and case series. The Structured Effectiveness Quality Evaluation Scale was used to evaluate the methodological quality of the included studies. Twelve articles met the inclusion criteria. Two types of early active mobilisation protocols were identified: controlled active motion protocols and relative motion extension splinting protocols. Articles describing relative motion extension splinting protocols were more recent but of lower methodological quality than those describing controlled active motion protocols. Participants treated with controlled active motion and relative motion extension splinting protocols had similar range of motion outcomes, but those in relative motion extension splinting groups returned to work earlier. The evidence reviewed suggested that relative motion extension splinting protocols may allow an earlier return to function than controlled active motion protocols without a greater risk of complication.

Platelet-rich plasma in arthroscopic rotator cuff repair: a meta-analysis of randomized controlled trials.

PubMed

Zhao, Jia-Guo; Zhao, Li; Jiang, Yan-Xia; Wang, Zeng-Liang; Wang, Jia; Zhang, Peng

2015-01-01

The purpose of this study was to appraise the retear rate and clinical outcomes of platelet-rich plasma use in patients undergoing arthroscopic full-thickness rotator cuff repair. We searched the Cochrane Library, PubMed, and EMBASE databases for randomized controlled trials comparing the outcomes of arthroscopic rotator cuff surgery with or without the use of platelet-rich plasma. Methodological quality was assessed by the Detsky quality scale. When there was no high heterogeneity, we used a fixed-effects model. Dichotomous variables were presented as risk ratios (RRs) with 95% confidence intervals (CIs), and continuous data were measured as mean differences with 95% CIs. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system was used to assess the quality of evidence for each individual outcome. Eight randomized controlled trials were included, with the sample size ranging from 28 to 88. Overall methodological quality was high. Fixed-effects analysis showed that differences were not significant between the 2 groups in retear rate (RR, 0.94; 95% CI, 0.70 to 1.25; P = .66), Constant score (mean difference, 1.12; 95% CI, -1.38 to 3.61; P = .38), and University of California at Los Angeles (UCLA) score (mean difference, -0.68; 95% CI, -2.00 to 0.65; P = .32). The strength of GRADE evidence was categorized respectively as low for retear, moderate for Constant score, and low for UCLA shoulder score. Our meta-analysis does not support the use of platelet-rich plasma in the arthroscopic repair of full-thickness rotator cuff tears over repairs without platelet-rich plasma because of similar retear rates and clinical outcomes. Level II, meta-analysis of Level I and II randomized controlled trials. Copyright © 2015 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

Efficacy of Chinese herbal medicine on health-related quality of life (SF-36) in hypertensive patients: A systematic review and meta-analysis of randomized controlled trials.

PubMed

Jiao, Hua-Chen; Ju, Jian-Qing; Li, Yun-Lun; Ma, Xue-Sheng; Jiang, Hai-Qiang; Zhao, Jing; Shen, Zhen-Zhen; Yang, Wen-Qing

2015-06-01

This study aims to evaluate published randomized controlled trials (RCTs) of Chinese Herbal Medicine (CHM) improving health-related quality of life (HRQL) in hypertensive patients that employ the Short-Form 36-Item Health questionnaire (SF-36) as an outcome measure. Five electronic databases were searched up to October 2013 to identify RCTs of CHM for hypertension. The primary outcome was SF-36. Trial selection, data extraction, methodological quality assessment, and data analyses were conducted according to the Cochrane handbook. Eleven RCTs with total of 1043 participants were identified. The majority of the included trials were assessed to be of poor methodological quality and high clinical heterogeneity. Meta-analysis shows a significant improvement both in physical component summary (PCS) measure and mental component summary (MCS) measure of SF-36, with physical functioning (WMD=8.54[5.34, 11.74], p<0.001), role physical (WMD=13.32[7.03, 19.61], p<0.001), bodily pain (WMD=10.53[6.46, 14.60], p<0.001), general health (WMD=-5.56[2.09, 9.02], p<0.001), vitality (WMD=6.84[4.33, 9.53], p<0.001), social functioning (WMD=7.50[2.63, 12.36], p<0.001), role emotional (WMD=12.06[4.45, 19.68], p<0.001) and mental health (WMD=-5.68[2.90, 8.47], p<0.001). CHM can also decrease systolic blood pressure (WMD=-4.45 [-6.71, -2.19], p<0.001) and relieve symptoms related to hypertension. CHM appears to have beneficial effects on improvement of HRQL in hypertensive patients. However, the findings should be interpreted with caution due to the poor methodological quality and high clinical heterogeneity of the included trials. Further clinical trials should be carried out to provide more reliable evidence. Copyright © 2015 Elsevier Ltd. All rights reserved.

Statins and tendinopathy: a systematic review.

PubMed

Teichtahl, Andrew J; Brady, Sharmayne R E; Urquhart, Donna M; Wluka, Anita E; Wang, Yuanyuan; Shaw, Jonathan E; Cicuttini, Flavia M

2016-02-15

To systematically review the evidence on whether statin therapy, commonly used in clinical practice to treat hypercholesterolaemia for primary and secondary prevention of cardiovascular disease, contributes to tendinopathy; and to examine causality according to the Bradford Hill criteria. A systematic review of studies examining the relationship between statin therapy and tendinopathy. Included studies were rated based on their methodological quality. A best evidence synthesis was used to summarise the results, and Bradford Hill criteria were used to assess causation. Ovid MEDLINE, CINAHL Plus, PubMed and Embase databases. We included adult human studies published in the English language between January 1966 and October 2015. Study designs eligible for inclusion were randomised controlled trials and cross-sectional, cohort or case-control studies. Four studies (three cohort studies and one case-control study) were included, with a mean methodological quality score of 67%. Three studies were deemed high quality. Tendon rupture was the primary outcome in three studies, and rotator cuff disease in the other. All studies found no positive association between statin therapy and tendon rupture for the total study population. There was evidence that simvastatin reduces the risk of tendinopathy. To date, there is a paucity of evidence to implicate statin therapy as a well established risk factor or causal mechanism for tendon rupture in the general population. There is strong evidence that simvastatin reduces the risk of tendinopathy.

[Importance of quality control for the detection of β-lactam antibiotic resistance in Enterobacteriaceae].

PubMed

Rivera, Alba; Larrosa, Nieves; Mirelis, Beatriz; Navarro, Ferran

2014-02-01

β-lactam antimicrobial agents are frequently used to treat infections caused by Enterobacteriaceae. The main mechanism of resistance to these antibiotics is the production of certain enzymes, collectively named β-lactamases. Due to their substrate profile and their epidemiological implications, the most clinically important β-lactamases are extended-spectrum β-lactamases, class C β-lactamases and carbapenemases. Phenotypic detection of these enzymes may be complicated and is based on the use of specific inhibitors of each β-lactamase and on the loss of activity on some β-lactam indicators. Various international committees postulate that it is no longer necessary to interpret the susceptibility results or determine the mechanism of resistance. Several critics disagree, however, and consider that susceptibility results should be interpreted until more data are available on the clinical efficacy of treatment with β-lactams. Given these methodological difficulties and constant changes in the interpretation criteria, we consider that training and external quality controls are essential to keep updated in this field. For learning purposes, these external quality controls should always be accompanied by a review of the results and methodology used, and the analysis of errors. In this paper we review and contextualize all the aspects related to the detection and interpretation of these β-lactamases. Copyright © 2014 Elsevier España, S.L. All rights reserved.

A proven approach for more effective software development and maintenance

NASA Technical Reports Server (NTRS)

Pajerski, Rose; Hall, Dana; Sinclair, Craig

1994-01-01

Modern space flight mission operations and associated ground data systems are increasingly dependent upon reliable, quality software. Critical functions such as command load preparation, health and status monitoring, communications link scheduling and conflict resolution, and transparent gateway protocol conversion are routinely performed by software. Given budget constraints and the ever increasing capabilities of processor technology, the next generation of control centers and data systems will be even more dependent upon software across all aspects of performance. A key challenge now is to implement improved engineering, management, and assurance processes for the development and maintenance of that software; processes that cost less, yield higher quality products, and that self-correct for continual improvement evolution. The NASA Goddard Space Flight Center has a unique experience base that can be readily tapped to help solve the software challenge. Over the past eighteen years, the Software Engineering Laboratory within the code 500 Flight Dynamics Division has evolved a software development and maintenance methodology that accommodates the unique characteristics of an organization while optimizing and continually improving the organization's software capabilities. This methodology relies upon measurement, analysis, and feedback much analogous to that of control loop systems. It is an approach with a time-tested track record proven through repeated applications across a broad range of operational software development and maintenance projects. This paper describes the software improvement methodology employed by the Software Engineering Laboratory, and how it has been exploited within the Flight Dynamics Division with GSFC Code 500. Examples of specific improvement in the software itself and its processes are presented to illustrate the effectiveness of the methodology. Finally, the initial findings are given when this methodology was applied across the mission operations and ground data systems software domains throughout Code 500.

PRECEPT: an evidence assessment framework for infectious disease epidemiology, prevention and control.

PubMed

Harder, Thomas; Takla, Anja; Eckmanns, Tim; Ellis, Simon; Forland, Frode; James, Roberta; Meerpohl, Joerg J; Morgan, Antony; Rehfuess, Eva; Schünemann, Holger; Zuiderent-Jerak, Teun; de Carvalho Gomes, Helena; Wichmann, Ole

2017-10-01

Decisions in public health should be based on the best available evidence, reviewed and appraised using a rigorous and transparent methodology. The Project on a Framework for Rating Evidence in Public Health (PRECEPT) defined a methodology for evaluating and grading evidence in infectious disease epidemiology, prevention and control that takes different domains and question types into consideration. The methodology rates evidence in four domains: disease burden, risk factors, diagnostics and intervention. The framework guiding it has four steps going from overarching questions to an evidence statement. In step 1, approaches for identifying relevant key areas and developing specific questions to guide systematic evidence searches are described. In step 2, methodological guidance for conducting systematic reviews is provided; 15 study quality appraisal tools are proposed and an algorithm is given for matching a given study design with a tool. In step 3, a standardised evidence-grading scheme using the Grading of Recommendations Assessment, Development and Evaluation Working Group (GRADE) methodology is provided, whereby findings are documented in evidence profiles. Step 4 consists of preparing a narrative evidence summary. Users of this framework should be able to evaluate and grade scientific evidence from the four domains in a transparent and reproducible way.

PRECEPT: an evidence assessment framework for infectious disease epidemiology, prevention and control

PubMed Central

Harder, Thomas; Takla, Anja; Eckmanns, Tim; Ellis, Simon; Forland, Frode; James, Roberta; Meerpohl, Joerg J; Morgan, Antony; Rehfuess, Eva; Schünemann, Holger; Zuiderent-Jerak, Teun; de Carvalho Gomes, Helena; Wichmann, Ole

2017-01-01

Decisions in public health should be based on the best available evidence, reviewed and appraised using a rigorous and transparent methodology. The Project on a Framework for Rating Evidence in Public Health (PRECEPT) defined a methodology for evaluating and grading evidence in infectious disease epidemiology, prevention and control that takes different domains and question types into consideration. The methodology rates evidence in four domains: disease burden, risk factors, diagnostics and intervention. The framework guiding it has four steps going from overarching questions to an evidence statement. In step 1, approaches for identifying relevant key areas and developing specific questions to guide systematic evidence searches are described. In step 2, methodological guidance for conducting systematic reviews is provided; 15 study quality appraisal tools are proposed and an algorithm is given for matching a given study design with a tool. In step 3, a standardised evidence-grading scheme using the Grading of Recommendations Assessment, Development and Evaluation Working Group (GRADE) methodology is provided, whereby findings are documented in evidence profiles. Step 4 consists of preparing a narrative evidence summary. Users of this framework should be able to evaluate and grade scientific evidence from the four domains in a transparent and reproducible way. PMID:29019317

Indirect Comparisons: A Review of Reporting and Methodological Quality

PubMed Central

Donegan, Sarah; Williamson, Paula; Gamble, Carrol; Tudur-Smith, Catrin

2010-01-01

Background The indirect comparison of two interventions can be valuable in many situations. However, the quality of an indirect comparison will depend on several factors including the chosen methodology and validity of underlying assumptions. Published indirect comparisons are increasingly more common in the medical literature, but as yet, there are no published recommendations of how they should be reported. Our aim is to systematically review the quality of published indirect comparisons to add to existing empirical data suggesting that improvements can be made when reporting and applying indirect comparisons. Methodology/Findings Reviews applying statistical methods to indirectly compare the clinical effectiveness of two interventions using randomised controlled trials were eligible. We searched (1966–2008) Database of Abstracts and Reviews of Effects, The Cochrane library, and Medline. Full review publications were assessed for eligibility. Specific criteria to assess quality were developed and applied. Forty-three reviews were included. Adequate methodology was used to calculate the indirect comparison in 41 reviews. Nineteen reviews assessed the similarity assumption using sensitivity analysis, subgroup analysis, or meta-regression. Eleven reviews compared trial-level characteristics. Twenty-four reviews assessed statistical homogeneity. Twelve reviews investigated causes of heterogeneity. Seventeen reviews included direct and indirect evidence for the same comparison; six reviews assessed consistency. One review combined both evidence types. Twenty-five reviews urged caution in interpretation of results, and 24 reviews indicated when results were from indirect evidence by stating this term with the result. Conclusions This review shows that the underlying assumptions are not routinely explored or reported when undertaking indirect comparisons. We recommend, therefore, that the quality of indirect comparisons should be improved, in particular, by assessing assumptions and reporting the assessment methods applied. We propose that the quality criteria applied in this article may provide a basis to help review authors carry out indirect comparisons and to aid appropriate interpretation. PMID:21085712

Intra-Articular Cellular Therapy for Osteoarthritis and Focal Cartilage Defects of the Knee: A Systematic Review of the Literature and Study Quality Analysis.

PubMed

Chahla, Jorge; Piuzzi, Nicolas S; Mitchell, Justin J; Dean, Chase S; Pascual-Garrido, Cecilia; LaPrade, Robert F; Muschler, George F

2016-09-21

Intra-articular cellular therapy injections constitute an appealing strategy that may modify the intra-articular milieu or regenerate cartilage in the settings of osteoarthritis and focal cartilage defects. However, little consensus exists regarding the indications for cellular therapies, optimal cell sources, methods of preparation and delivery, or means by which outcomes should be reported. We present a systematic review of the current literature regarding the safety and efficacy of cellular therapy delivered by intra-articular injection in the knee that provided a Level of Evidence of III or higher. A total of 420 papers were screened. Methodological quality was assessed using a modified Coleman methodology score. Only 6 studies (4 Level II and 2 Level III) met the criteria to be included in this review; 3 studies were on treatment of osteoarthritis and 3 were on treatment of focal cartilage defects. These included 4 randomized controlled studies without blinding, 1 prospective cohort study, and 1 retrospective therapeutic case-control study. The studies varied widely with respect to cell sources, cell characterization, adjuvant therapies, and assessment of outcomes. Outcome was reported in a total of 300 knees (124 in the osteoarthritis studies and 176 in the cartilage defect studies). Mean follow-up was 21.0 months (range, 12 to 36 months). All studies reported improved outcomes with intra-articular cellular therapy and no major adverse events. The mean modified Coleman methodology score was 59.1 ± 16 (range, 32 to 82). The studies of intra-articular cellular therapy injections for osteoarthritis and focal cartilage defects in the human knee suggested positive results with respect to clinical improvement and safety. However, the improvement was modest and a placebo effect cannot be disregarded. The overall quality of the literature was poor, and the methodological quality was fair, even among Level-II and III studies. Effective clinical assessment and optimization of injection therapies will demand greater attention to study methodology, including blinding; standardized quantitative methods for cell harvesting, processing, characterization, and delivery; and standardized reporting of clinical and structural outcomes. Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence. Copyright © 2016 by The Journal of Bone and Joint Surgery, Incorporated.

Using Quality Tools and Methodologies to Improve a Hospital's Quality Position.

PubMed

Branco, Daniel; Wicks, Angela M; Visich, John K

2017-01-01

The authors identify the quality tools and methodologies most frequently used by quality-positioned hospitals versus nonquality hospitals. Northeastern U.S. hospitals in both groups received a brief, 12-question survey. The authors found that 93.75% of the quality hospitals and 81.25% of the nonquality hospitals used some form of process improvement methodologies. However, there were significant differences between the groups regarding the impact of quality improvement initiatives on patients. The findings indicate that in quality hospitals the use of quality improvement initiatives had a significantly greater positive impact on patient satisfaction and patient outcomes when compared to nonquality hospitals.

The effectiveness of hydrotherapy in the management of rheumatoid arthritis: a systematic review.

PubMed

Al-Qubaeissy, Khamis Y; Fatoye, Francis A; Goodwin, Peter C; Yohannes, Abebaw M

2013-03-01

Hydrotherapy is frequently indicated for the rehabilitation of patients with rheumatoid arthritis (RA); nevertheless, there has been inadequate appraisal of its effectiveness. The potential benefits of hydrotherapy for patients with RA are to improve and/or maintain functional ability and quality of life. The aim of this systematic review was to evaluate the effectiveness of hydrotherapy in the management of patients with RA. AMED, CINAHL, EMBASE, MEDLINE, PubMed, Science Direct and Web of Science were searched between 1988 and May 2011. Keywords used were rheumatoid arthritis, hydrotherapy, aquatic physiotherapy, aqua therapy and water therapy. Searches were supplemented with hand searches of references of selected articles. Randomized controlled trials were assessed for their methodological quality using the Physiotherapy Evidence Database (PEDro) scale. This scale ranks the methodological quality of a study scoring 7 out of 10 as 'high quality', 5-6 as 'moderate quality' and less than 4 as 'poor quality'. Initially, 197 studies were identified. Six studies met the inclusion criteria for further analysis. The average methodological quality for all studies was 6.8 using the PEDro scale. Most of the studies reported favourable outcomes for a hydrotherapy intervention compared with no treatment or other interventions for patients with RA. Improvement was particularly noted in reducing pain, joint tenderness, mood and tension symptoms, and increasing grip strength and patient satisfaction with hydrotherapy treatment in the short term. There is some evidence to suggest that hydrotherapy has a positive role in reducing pain and improving the health status of patients with RA compared with no or other interventions in the short term. However, the long-term benefit is unknown. Further studies are needed. Copyright © 2012 John Wiley & Sons, Ltd.

78 FR 38976 - Proposed Agency Information Collection Activities; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-28

... Reserve's functions; including whether the information has practical utility; b. The accuracy of the... the methodology and assumptions used; c. Ways to enhance the quality, utility, and clarity of the... Report Report title: Report of Selected Money Market Rates. Agency form number: FR 2420. OMB control...

76 FR 2645 - Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-14

.... These grants will be used for two purposes: (1) To fund feasibility studies, marketing and business... including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility and... a currently valid OMB control number. Rural Business-Cooperative Service Title: Value-Added Producer...

Problem-Solving Therapy for Depression in Adults: A Systematic Review

ERIC Educational Resources Information Center

Gellis, Zvi D.; Kenaley, Bonnie

2008-01-01

Objectives: This article presents a systematic review of the evidence on problem-solving therapy (PST) for depressive disorders in noninstitutionalized adults. Method: Intervention studies using randomized controlled designs are included and methodological quality is assessed using a standard set of criteria from the Cochrane Collaborative Review…

78 FR 22261 - Proposed Agency Information Collection Activities; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-15

... information collection, including the validity of the methodology and assumptions used; c. Ways to enhance the quality, utility, and clarity of the information to be collected; d. Ways to minimize the burden of... number: FR 2060. OMB control number: 7100-0232. Frequency: On occasion. Reporters: Small businesses and...

Framework for establishing records control in hospitals as an ISO 9001 requirement.

PubMed

Al-Qatawneh, Lina

2017-02-13

Purpose The purpose of this paper is to present the process followed to control records in a Jordanian private community hospital as an ISO 9001:2008 standard requirement. Design/methodology/approach Under the hospital quality council's supervision, the quality management and development office staff were responsible for designing, planning and implementing the quality management system (QMS) using the ISO 9001:2008 standard. A policy for records control was established. An action plan for establishing the records control was developed and implemented. On completion, a coding system for records was specified to be used by hospital staff. Finally, an internal audit was performed to verify conformity to the ISO 9001:2008 standard requirements. Findings Successful certification by a neutral body ascertained that the hospital's QMS conformed to the ISO 9001:2008 requirements. A framework was developed that describes the records controlling process, which can be used by staff in any healthcare organization wanting to achieve ISO 9001:2008 accreditation. Originality/value Given the increased interest among healthcare organizations to achieve the ISO 9001 certification, the proposed framework for establishing records control is developed and is expected to be a valuable management tool to improve and sustain healthcare quality.

Control of maglev vehicles with aerodynamic and guideway disturbances

NASA Technical Reports Server (NTRS)

Flueckiger, Karl; Mark, Steve; Caswell, Ruth; Mccallum, Duncan

1994-01-01

A modeling, analysis, and control design methodology is presented for maglev vehicle ride quality performance improvement as measured by the Pepler Index. Ride quality enhancement is considered through active control of secondary suspension elements and active aerodynamic surfaces mounted on the train. To analyze and quantify the benefits of active control, the authors have developed a five degree-of-freedom lumped parameter model suitable for describing a large class of maglev vehicles, including both channel and box-beam guideway configurations. Elements of this modeling capability have been recently employed in studies sponsored by the U.S. Department of Transportation (DOT). A perturbation analysis about an operating point, defined by vehicle and average crosswind velocities, yields a suitable linearized state space model for multivariable control system analysis and synthesis. Neglecting passenger compartment noise, the ride quality as quantified by the Pepler Index is readily computed from the system states. A statistical analysis is performed by modeling the crosswind disturbances and guideway variations as filtered white noise, whereby the Pepler Index is established in closed form through the solution to a matrix Lyapunov equation. Data is presented which indicates the anticipated ride quality achieved through various closed-loop control arrangements.

Recent Methodology in Ginseng Analysis

PubMed Central

Baek, Seung-Hoon; Bae, Ok-Nam; Park, Jeong Hill

2012-01-01

As much as the popularity of ginseng in herbal prescriptions or remedies, ginseng has become the focus of research in many scientific fields. Analytical methodologies for ginseng, referred to as ginseng analysis hereafter, have been developed for bioactive component discovery, phytochemical profiling, quality control, and pharmacokinetic studies. This review summarizes the most recent advances in ginseng analysis in the past half-decade including emerging techniques and analytical trends. Ginseng analysis includes all of the leading analytical tools and serves as a representative model for the analytical research of herbal medicines. PMID:23717112

Measurement properties of the upright motor control test for adults with stroke: a systematic review.

PubMed

Gorgon, Edward James R; Lazaro, Rolando T

2016-01-01

The Upright Motor Control Test (UMCT) has been used in clinical practice and research to assess functional strength of the hemiparetic lower limb in adults with stroke. It is unclear if evidence is sufficient to warrant its use. The purpose of this systematic review was to synthesize available evidence on the measurement properties of the UMCT for stroke rehabilitation. Electronic databases that indexed biomedical literature were systematically searched from inception until October 2015 (week 4): Embase, PubMed, Web of Science, CINAHL, PEDro, Cochrane Library, Scopus, ScienceDirect, SPORTDiscus, LILACS, DOAJ, and Google Scholar. All studies that had used the UMCT in the time period covered underwent hand searching for any additional study. Observational studies involving adults with stroke that explored any measurement property of the UMCT were included. The COnsensus-based Standards for the selection of health Measurement INstruments was used to assess the methodological quality of included studies. The CanChild Outcome Measures Rating Form was used for extracting data on measurement properties and clinical utility. The search yielded three methodologic studies that addressed criterion-related validity and contruct validity. Two studies of fair methodological quality demonstrated moderate-level evidence that Knee Extension and Knee Flexion subtest scores were predictive of community-level and household-level ambulation. One study of fair methodological quality provided limited-level evidence for the correlation of Knee Extension subtest scores with a laboratory measure of ground reaction forces. No published studies formally assessed reliability, responsiveness, or clinical utility. Limited information on responsiveness and clinical utility dimensions could be inferred from the included studies. The UMCT is a practical assessment tool for voluntary control or functional strength of the hemiparetic lower limb in standing in adults with stroke. Although different levels of evidence suggest that the Knee Extension and Knee Flexion subtests may possess criterion and construct validity, the lack of published literature examining content validity, reliability, and responsiveness raises questions regarding the use of the UMCT in routine clinical practice. These key findings highlight the need to further investigate the UMCT's measurement properties toward enhancing its standardization.

Update on the Methodological Quality of Research Published in The American Journal of Sports Medicine: Comparing 2011-2013 to 10 and 20 Years Prior.

PubMed

Brophy, Robert H; Kluck, Dylan; Marx, Robert G

2016-05-01

In recent years, the number of articles in The American Journal of Sports Medicine (AJSM) has risen dramatically, with an increasing emphasis on evidence-based medicine in orthopaedics and sports medicine. Despite the increase in the number of articles published in AJSM over the past decade, the methodological quality of articles in 2011-2013 has improved relative to those in 2001-2003 and 1991-1993. Meta-analysis. All articles published in AJSM during 2011-2013 were reviewed and classified by study design. For each article, the use of pertinent methodologies, such as prospective data collection, randomization, control groups, and blinding, was recorded. The frequency of each article type and the use of evidence-based techniques were compared relative to 1991-1993 and 2001-2003 by use of Pearson χ(2) testing. The number of research articles published in AJSM more than doubled from 402 in 1991-1993 and 423 in 2001-2003 to 953 in 2011-2013. Case reports decreased from 15.2% to 10.6% to 2.1% of articles published over the study period (P < .001). Cadaveric/human studies and meta-analysis/literature review studies increased from 5.7% to 7.1% to 12.4% (P < .001) and from 0.2% to 0.9% to 2.3% (P = .01), respectively. Randomized, prospective clinical trials increased from 2.7% to 5.9% to 7.4% (P = .007). Fewer studies used retrospective compared with prospective data collection (P < .001). More studies tested an explicit hypothesis (P < .001) and used controls (P < .001), randomization (P < .001), and blinding of those assessing outcomes (P < .001). Multi-investigator trials increased (P < .001), as did the proportion of articles citing a funding source (P < .001). Despite a dramatic increase in the number of published articles, the research published in AJSM shifted toward more prospective, randomized, controlled, and blinded designs during 2011-2013 compared with 2001-2003 and 1991-1993, demonstrating a continued improvement in methodological quality. © 2015 The Author(s).

Using PICO Methodology to Answer Questions About Smoking in COPD Patients.

PubMed

Jiménez Ruiz, Carlos A; Buljubasich, Daniel; Riesco Miranda, Juan Antonio; Acuña Izcaray, Agustín; de Granda Orive, José Ignacio; Chatkin, José Miguel; Zabert, Gustavo; Guerreros Benavides, Alfredo; Paez Espinel, Nelson; Noé, Valeri; Sánchez-Angarita, Efraín; Núñez-Sánchez, Ingrid; Sansores, Raúl H; Casas, Alejandro; Palomar Lever, Andrés; Alfageme Michavila, Inmaculada

2017-11-01

The ALAT and SEPAR Treatment and Control of Smoking Groups have collaborated in the preparation of this document which attempts to answer, by way of PICO methodology, different questions on health interventions for helping COPD patients to stop smoking. The main recommendations are: (i)moderate-quality evidence and strong recommendation for performing spirometry in COPD patients and in smokers with a high risk of developing the disease, as a motivational tool (particularly for showing evidence of lung age), a diagnostic tool, and for active case-finding; (ii)high-quality evidence and strong recommendation for using intensive dedicated behavioral counselling and drug treatment for helping COPD patients to stop smoking; (iii)high-quality evidence and strong recommendation for initiating interventions for helping COPD patients to stop smoking during hospitalization with improvement when the intervention is prolonged after discharge, and (iv)high-quality evidence and strong recommendation for funding treatment of smoking in COPD patients, in view of the impact on health and health economics. Copyright © 2017 SEPAR. Publicado por Elsevier España, S.L.U. All rights reserved.

Improving the wellbeing of staff who work in palliative care settings: A systematic review of psychosocial interventions.

PubMed

Hill, Rebecca C; Dempster, Martin; Donnelly, Michael; McCorry, Noleen K

2016-10-01

Staff in palliative care settings perform emotionally demanding roles which may lead to psychological distress including stress and burnout. Therefore, interventions have been designed to address these occupational risks. To investigate quantitative studies exploring the effectiveness of psychosocial interventions that attempt to improve psychological wellbeing of palliative care staff. A systematic review was conducted according to methodological guidance from UK Centre for Reviews and Dissemination. A search strategy was developed based on the initial scans of palliative care studies. Potentially eligible research articles were identified by searching the following databases: CINAHL, MEDLINE (Ovid), PsycINFO and Web of Science. Two reviewers independently screened studies against pre-set eligibility criteria. To assess quality, both researchers separately assessed the remaining studies using the Quality Assessment Tool for Quantitative Studies. A total of 1786 potentially eligible articles were identified - nine remained following screening and quality assessment. Study types included two randomised controlled trials, two non-randomised controlled trial designs, four one-group pre-post evaluations and one process evaluation. Studies took place in the United States and Canada (5), Europe (3) and Hong Kong (1). Interventions comprised a mixture of relaxation, education, support and cognitive training and targeted stress, fatigue, burnout, depression and satisfaction. The randomised controlled trial evaluations did not improve psychological wellbeing of palliative care staff. Only two of the quasi-experimental studies appeared to show improved staff wellbeing although these studies were methodologically weak. There is an urgent need to address the lack of intervention development work and high-quality research in this area. © The Author(s) 2016.

A new approach to subjectively assess quality of plenoptic content

NASA Astrophysics Data System (ADS)

Viola, Irene; Řeřábek, Martin; Ebrahimi, Touradj

2016-09-01

Plenoptic content is becoming increasingly popular thanks to the availability of acquisition and display devices. Thanks to image-based rendering techniques, a plenoptic content can be rendered in real time in an interactive manner allowing virtual navigation through the captured scenes. This way of content consumption enables new experiences, and therefore introduces several challenges in terms of plenoptic data processing, transmission and consequently visual quality evaluation. In this paper, we propose a new methodology to subjectively assess the visual quality of plenoptic content. We also introduce a prototype software to perform subjective quality assessment according to the proposed methodology. The proposed methodology is further applied to assess the visual quality of a light field compression algorithm. Results show that this methodology can be successfully used to assess the visual quality of plenoptic content.

Zhen gan xi feng decoction, a traditional chinese herbal formula, for the treatment of essential hypertension: a systematic review of randomized controlled trials.

PubMed

Xiong, Xingjiang; Yang, Xiaochen; Feng, Bo; Liu, Wei; Duan, Lian; Gao, Ao; Li, Haixia; Ma, Jizheng; Du, Xinliang; Li, Nan; Wang, Pengqian; Su, Kelei; Chu, Fuyong; Zhang, Guohao; Li, Xiaoke; Wang, Jie

2013-01-01

Objectives. To assess the clinical effectiveness and adverse effects of Zhen Gan Xi Feng Decoction (ZGXFD) for essential hypertension (EH). Methods. Five major electronic databases were searched up to August 2012 to retrieve any potential randomized controlled trials designed to evaluate the clinical effectiveness of ZGXFD for EH reported in any language, with main outcome measure as blood pressure (BP). Results. Six randomized trials were included. Methodological quality of the trials was evaluated as generally low. Four trials compared prescriptions based on ZGXFD with antihypertensive drugs. Meta-analysis showed that ZGXFD was more effective in BP control and TCM syndrome and symptom differentiation (TCM-SSD) scores than antihypertensive drugs. Two trials compared the combination of modified ZGXFD plus antihypertensive drugs with antihypertensive drugs. Meta-analysis showed that there is significant beneficial effect on TCM-SSD scores. However, no significant effect on BP was found. The safety of ZGXFD is still uncertain. Conclusions. ZGXFD appears to be effective in improving blood pressure and hypertension-related symptoms for EH. However, the evidence remains weak due to poor methodological quality of the included studies. More rigorous trials are warranted to support their clinical use.

Effect of Medicinal Herbs on Primary Dysmenorrhoea- a Systematic Review

PubMed Central

Mirabi, Parvaneh; Alamolhoda, Seideh Hanieh; Esmaeilzadeh, Seddigheh; Mojab, Faraz

2014-01-01

Conventional treatment for primary dysmenorrhoea has a failure rate of 20% to 25% and may be contraindicated or not tolerated by some women. Herbal medicine may be a suitable alternative. To determine the efficacy and safety of Iranian herbal medicine for primary dysmenorrhea when compared with placebo, no treatment, and other treatment. Electronic searches of the Cochrane Menstrual Disorders and Dysmenorrhoea Group Register of controlled trials, Scopus, Google Scholar, Medline, Pubmed were performed to identify relevant randomized controlled trials (RCTs). The study abstraction and quality assessment of all studies were undertaken following the detailed descriptions of these categories as described in the JADAD Criteria for Systematic Reviews of Interventions. 25 RCTs involving a total of women were included in the review. The review found promising evidence in the form of RCTs for the use of herbal medicine in the treatment of primary dysmenorrhoea compared with pharmacological treatment. However, the results were limited by methodological flaws. Further rigorous no penetrating placebo-controlled RCTs are warranted. The review found promising evidence supporting the use of herbal medicine for primary dysmenorrhoea; however, results are limited by the poor methodological quality of the included trials. PMID:25276177

Adverse effects of psychosocial work factors on blood pressure: systematic review of studies on demand-control-support and effort-reward imbalance models.

PubMed

Gilbert-Ouimet, Mahée; Trudel, Xavier; Brisson, Chantal; Milot, Alain; Vézina, Michel

2014-03-01

A growing body of research has investigated the adverse effects of psychosocial work factors on blood pressure (BP) elevation. There is now a clear need for an up-to-date, critical synthesis of reliable findings on this topic. This systematic review aimed to evaluate the adverse effects of psychosocial work factors of both the demand-control-support (DCS) and effort-reward imbalance (ERI) models on BP among men and women, according to the methodological quality of the studies. To be eligible, studies had to: (i) evaluate at least one psychosocial work factor, (ii) evaluate BP or hypertension, (iii) comprise ≥100 workers, (iv) be written in English or French, and (v) be published in a peer-reviewed journal. A total of 74 studies were included. Of these, 64 examined the DCS model, and 12 looked at the ERI model, with 2 studies considering both models. Approximately half the studies observed a significant adverse effect of psychosocial work factors on BP. A more consistent effect was observed, however, among men than women. For job strain, a more consistent effect was also observed in studies of higher methodological quality, ie, studies using a prospective design and ambulatory BP measures. A more consistent adverse effect of psychosocial work factors was observed among men than women and in studies of higher methodological quality. These findings contribute to the current effort of primary prevention of cardiovascular disease by documenting the psychosocial etiology of elevated BP, a major cardiovascular risk factor.

A systematic review of controlled clinical trials on the prevention of back pain in industry.

PubMed

van Poppel, M N; Koes, B W; Smid, T; Bouter, L M

1997-12-01

To assess the effectiveness of lumbar supports, education, and exercise in the prevention of back pain in industry. A computerised search for controlled clinical trials was conducted. A criteria list was used to assess the methodological quality of the studies. The available evidence for the effectiveness of the interventions was graded with a rating system for the level of evidence. Effect sizes of individual studies were combined if the studies were sufficiently similar. 11 studies were identified for the review. The methodological quality of all studies was low, with a maximum score of three out of seven for internal validity. There was no evidence for the effectiveness of lumbar supports due to contradictory outcomes of the studies. Five of the six studies on education reported no effect. Thus there is limited evidence that education does not help to prevent back pain. All three studies on exercise reported a positive result, indicating limited evidence for the effectiveness of exercise. The combined effect size for exercise was 0.53, which is a medium sized effect. Although widely used, there is little evaluative research on the preventive measures studied here. The review showed that there is limited evidence that exercise has some effect in the prevention of back pain and that education is not effective. No conclusive evidence was found for or against the effectiveness of lumbar supports. Research of higher methodological quality is needed before firm conclusions on the effectiveness of lumbar supports, education, and exercise in the prevention of back pain in industry can be drawn.

Systematic review of the effects of chronic disease management on quality-of-life in people with chronic obstructive pulmonary disease.

PubMed

Niesink, A; Trappenburg, J C A; de Weert-van Oene, G H; Lammers, J W J; Verheij, T J M; Schrijvers, A J P

2007-11-01

Chronic disease management for patients with chronic obstructive pulmonary disease (COPD) may improve quality, outcomes and access to care. To investigate effectiveness of chronic disease management programmes on the quality-of-life of people with COPD. Medline and Embase (1995-2005) were searched for relevant articles, and reference lists and abstracts were searched for controlled trials of chronic disease management programmes for patients with COPD. Quality-of-life was assessed as an outcome parameter. Two reviewers independently reviewed each paper for methodological quality and extracted the data. We found 10 randomized-controlled trials comparing chronic disease management with routine care. Patient populations, health-care professionals, intensity, and content of the intervention were heterogeneous. Different instruments were used to assess quality of life. Five out of 10 studies showed statistically significant positive outcomes on one or more domains of the quality of life instruments. Three studies, partly located in primary care, showed positive results. All chronic disease management projects for people with COPD involving primary care improved quality of life. In most of the studies, aspects of chronic disease management were applied to a limited extent. Quality of randomized-controlled trials was not optimal. More research is needed on chronic disease management programmes in patients with COPD across primary and secondary care.

"Total Deposition (TDEP) Maps" | Science Inventory | US EPA

EPA Pesticide Factsheets

The presentation provides an update on the use of a hybrid methodology that relies on measured values from national monitoring networks and modeled values from CMAQ to produce of maps of total deposition for use in critical loads and other ecological assessments. Additionally, comparisons of the deposition values from the hybrid approach are compared with deposition estimates from other methodologies. The National Exposure Research Laboratory (NERL) Atmospheric Modeling and Analysis Division (AMAD) conducts research in support of EPA mission to protect human health and the environment. AMAD research program is engaged in developing and evaluating predictive atmospheric models on all spatial and temporal scales for forecasting the air quality and for assessing changes in air quality and air pollutant exposures, as affected by changes in ecosystem management and regulatory decisions. AMAD is responsible for providing a sound scientific and technical basis for regulatory policies based on air quality models to improve ambient air quality. The models developed by AMAD are being used by EPA, NOAA, and the air pollution community in understanding and forecasting not only the magnitude of the air pollution problem, but also in developing emission control policies and regulations for air quality improvements.

A novel strategy with standardized reference extract qualification and single compound quantitative evaluation for quality control of Panax notoginseng used as a functional food.

PubMed

Li, S P; Qiao, C F; Chen, Y W; Zhao, J; Cui, X M; Zhang, Q W; Liu, X M; Hu, D J

2013-10-25

Root of Panax notoginseng (Burk.) F.H. Chen (Sanqi in Chinese) is one of traditional Chinese medicines (TCMs) based functional food. Saponins are the major bioactive components. The shortage of reference compounds or chemical standards is one of the main bottlenecks for quality control of TCMs. A novel strategy, i.e. standardized reference extract based qualification and single calibrated components directly quantitative estimation of multiple analytes, was proposed to easily and effectively control the quality of natural functional foods such as Sanqi. The feasibility and credibility of this methodology were also assessed with a developed fast HPLC method. Five saponins, including ginsenoside Rg1, Re, Rb1, Rd and notoginsenoside R1 were rapidly separated using a conventional HPLC in 20 min. The quantification method was also compared with individual calibration curve method. The strategy is feasible and credible, which is easily and effectively adapted for improving the quality control of natural functional foods such as Sanqi. Copyright © 2013 Elsevier B.V. All rights reserved.

Monitoring scale scores over time via quality control charts, model-based approaches, and time series techniques.

PubMed

Lee, Yi-Hsuan; von Davier, Alina A

2013-07-01

Maintaining a stable score scale over time is critical for all standardized educational assessments. Traditional quality control tools and approaches for assessing scale drift either require special equating designs, or may be too time-consuming to be considered on a regular basis with an operational test that has a short time window between an administration and its score reporting. Thus, the traditional methods are not sufficient to catch unusual testing outcomes in a timely manner. This paper presents a new approach for score monitoring and assessment of scale drift. It involves quality control charts, model-based approaches, and time series techniques to accommodate the following needs of monitoring scale scores: continuous monitoring, adjustment of customary variations, identification of abrupt shifts, and assessment of autocorrelation. Performance of the methodologies is evaluated using manipulated data based on real responses from 71 administrations of a large-scale high-stakes language assessment.

The importance of preservation of the ethical principle of equipoise in the design of clinical trials: relative impact of the methodological quality domains on the treatment effect in randomized controlled trials.

PubMed

Djulbegovic, Benjamin; Cantor, Alan; Clarke, Mike

2003-01-01

Previous research has identified methodological problems in the design and conduct of randomized trials that could, if left unaddressed, lead to biased results. In this report we discuss one such problem, inadequate control intervention, and argue that it can be by far the most important design characteristic of randomized trials in overestimating the effect of new treatments. Current guidelines for the design and reporting of randomized trials, such as the Consolidated Standards of Reporting Trials (CONSORT) statement, do not address the choice of the comparator intervention. We argue that an adequate control intervention can be selected if people designing a trial explicitly take into consideration the ethical principle of equipoise, also known as "the uncertainty principle."

Design and implementation of software for automated quality control and data analysis for a complex LC/MS/MS assay for urine opiates and metabolites.

PubMed

Dickerson, Jane A; Schmeling, Michael; Hoofnagle, Andrew N; Hoffman, Noah G

2013-01-16

Mass spectrometry provides a powerful platform for performing quantitative, multiplexed assays in the clinical laboratory, but at the cost of increased complexity of analysis and quality assurance calculations compared to other methodologies. Here we describe the design and implementation of a software application that performs quality control calculations for a complex, multiplexed, mass spectrometric analysis of opioids and opioid metabolites. The development and implementation of this application improved our data analysis and quality assurance processes in several ways. First, use of the software significantly improved the procedural consistency for performing quality control calculations. Second, it reduced the amount of time technologists spent preparing and reviewing the data, saving on average over four hours per run, and in some cases improving turnaround time by a day. Third, it provides a mechanism for coupling procedural and software changes with the results of each analysis. We describe several key details of the implementation including the use of version control software and automated unit tests. These generally useful software engineering principles should be considered for any software development project in the clinical lab. Copyright © 2012 Elsevier B.V. All rights reserved.

Parenting children with diabetes: exploring parenting styles on children living with type 1 diabetes mellitus.

PubMed

Sherifali, Diana; Ciliska, Donna; O'Mara, Linda

2009-01-01

The purpose of this study was to examine the extent to which parenting styles is associated with diabetes control in children (aged 5-12 years) with type 1 diabetes, and on child and parent quality of life. Data were collected from a total of 216 parent and child dyads, from 4 pediatric diabetes clinics in southern Ontario, using a cross-sectional survey methodology. Each parent and child independently completed the questionnaires. The study instruments included the Parenting Dimensions Inventory, Pediatric Quality of Life (diabetes specific), and chart reviews for glycosylated hemoglobin (A1C) levels. The results of the study demonstrated that parenting styles were not correlated with diabetes control and were weakly correlated with quality of life. Most parents reported behaviors of authoritative or democratic parenting. The mean glycosylated hemoglobin (A1C) for children in the study was slightly above optimal target range, at 8.4%. Parental education had a weak negative correlation with diabetes control. Parenting styles are not associated with diabetes control and quality of life in children with type 1 diabetes. However, further research should assess the impact of the determinants of parenting on children with type 1 diabetes and quality of life.

A proteomics performance standard to support measurement quality in proteomics.

PubMed

Beasley-Green, Ashley; Bunk, David; Rudnick, Paul; Kilpatrick, Lisa; Phinney, Karen

2012-04-01

The emergence of MS-based proteomic platforms as a prominent technology utilized in biochemical and biomedical research has increased the need for high-quality MS measurements. To address this need, National Institute of Standards and Technology (NIST) reference material (RM) 8323 yeast protein extract is introduced as a proteomics quality control material for benchmarking the preanalytical and analytical performance of proteomics-based experimental workflows. RM 8323 yeast protein extract is based upon the well-characterized eukaryote Saccharomyces cerevisiae and can be utilized in the design and optimization of proteomics-based methodologies from sample preparation to data analysis. To demonstrate its utility as a proteomics quality control material, we coupled LC-MS/MS measurements of RM 8323 with the NIST MS Quality Control (MSQC) performance metrics to quantitatively assess the LC-MS/MS instrumentation parameters that influence measurement accuracy, repeatability, and reproducibility. Due to the complexity of the yeast proteome, we also demonstrate how NIST RM 8323, along with the NIST MSQC performance metrics, can be used in the evaluation and optimization of proteomics-based sample preparation methods. © 2012 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

The application of quantitative methods for identifying and exploring the presence of bias in systematic reviews: PDE-5 inhibitors for erectile dysfunction.

PubMed

Bekkering, G E; Abou-Setta, A M; Kleijnen, J

2008-01-01

A systematic review of PDE-5 inhibitors for erectile dysfunction was performed to evaluate the utility of quantitative methods for identifying and exploring the influence of bias and study quality on pooled outcomes from meta-analyses. We included 123 randomized controlled trials (RCTs). Methodological quality was poorly reported. All three drugs appeared highly effective. Indirect adjusted analyses showed no differences between the three drugs. Funnel plots and statistical tests showed no evidence of small-study effects for sildenafil whereas there was evidence of such bias for tadalafil and vardenafil. Adjustment for missing studies using trim and fill techniques did not alter the pooled estimates substantially. The exclusion of previous sildenafil nonresponders was associated with larger treatment effects for tadalafil. This investigation was hampered by poor reporting of methodological quality, a low number of studies, heterogeneity and large effect sizes. Despite such limitations, a comprehensive assessment of biases should be a routine in systematic reviews.

Relationship between perceived politeness and spectral characteristics of voice

NASA Astrophysics Data System (ADS)

Ito, Mika

2005-04-01

This study investigates the role of voice quality in perceiving politeness under conditions of varying relative social status among Japanese male speakers. The work focuses on four important methodological issues: experimental control of sociolinguistic aspects, eliciting natural spontaneous speech, obtaining recording quality suitable for voice quality analysis, and assessment of glottal characteristics through the use of non-invasive direct measurements of the speech spectrum. To obtain natural, unscripted utterances, the speech data were collected with a Map Task. This methodology allowed us to study the effect of manipulating relative social status among participants in the same community. We then computed the relative amplitudes of harmonics and formant peaks in spectra obtained from the Map Task recordings. Finally, an experiment was conducted to observe the alignment between acoustic measures and the perceived politeness of the voice samples. The results suggest that listeners' perceptions of politeness are determined by spectral characteristics of speakers, in particular, spectral tilts obtained by computing the difference in amplitude between the first harmonic and the third formant.

Unified Theory for Aircraft Handling Qualities and Adverse Aircraft-Pilot Coupling

NASA Technical Reports Server (NTRS)

Hess, R. A.

1997-01-01

A unified theory for aircraft handling qualities and adverse aircraft-pilot coupling or pilot-induced oscillations is introduced. The theory is based on a structural model of the human pilot. A methodology is presented for the prediction of (1) handling qualities levels; (2) pilot-induced oscillation rating levels; and (3) a frequency range in which pilot-induced oscillations are likely to occur. Although the dynamics of the force-feel system of the cockpit inceptor is included, the methodology will not account for effects attributable to control sensitivity and is limited to single-axis tasks and, at present, to linear vehicle models. The theory is derived from the feedback topology of the structural model and an examination of flight test results for 32 aircraft configurations simulated by the U.S. Air Force/CALSPAN NT-33A and Total In-Flight Simulator variable stability aircraft. An extension to nonlinear vehicle dynamics such as that encountered with actuator saturation is discussed.

The efficacy of attentional distraction and sensory monitoring in chronic pain patients: A meta-analysis.

PubMed

Van Ryckeghem, Dimitri Ml; Van Damme, Stefaan; Eccleston, Christopher; Crombez, Geert

2018-02-01

Attentional strategies, such as distraction and sensory monitoring, are often offered to reduce pain and pain-related distress. However, evidence for their efficacy in chronic pain patients is equivocal. We report a meta-analysis on the efficacy of distraction and sensory monitoring in chronic pain patients, and explore possible methodological and theoretical moderators. The scientific literature was searched for relevant articles, which were coded for methodological quality and several theoretical and methodological moderator variables. Only 10 articles fulfilled the search criteria. Eight studies allowed us to compare distraction with a control condition, two studies to compare sensory monitoring with a control condition, and four studies to compare the effect of distraction with the effect of sensory monitoring. Overall, results indicate that distraction did not differ from control in altering pain experience (k=8; Hedges' g=0.10, ns) and distress (k=2; Hedges' g=0.549). Sensory monitoring did also not alter pain experience (k=2; Hedges' g=-0.21, ns) and distress (k=1; Hedges' g=-0.191, ns). We found no evidence to support the superiority of distraction or sensory monitoring in altering pain compared to control conditions. We offer guidance for future theory-driven research to investigate distraction and sensory monitoring in this largely unexplored field, albeit one replete with methodological difficulties. Copyright © 2017 Elsevier Ltd. All rights reserved.

Design requirements for SRB production control system. Volume 3: Package evaluation, modification and hardware

NASA Technical Reports Server (NTRS)

1981-01-01

The software package evaluation was designed to analyze commercially available, field-proven, production control or manufacturing resource planning management technology and software package. The analysis was conducted by comparing SRB production control software requirements and conceptual system design to software package capabilities. The methodology of evaluation and the findings at each stage of evaluation are described. Topics covered include: vendor listing; request for information (RFI) document; RFI response rate and quality; RFI evaluation process; and capabilities versus requirements.

Production system with process quality control: modelling and application

NASA Astrophysics Data System (ADS)

Tsou, Jia-Chi

2010-07-01

Over the past decade, there has been a great deal of research dedicated to the study of quality and the economics of production. In this article, we develop a dynamic model which is based on the hypothesis of a traditional economic production quantity model. Taguchi's cost of poor quality is used to evaluate the cost of poor quality in the dynamic production system. A practical case from the automotive industry, which uses the Six-sigma DMAIC methodology, is discussed to verify the proposed model. This study shows that there is an optimal value of quality investment to make the production system reach a reasonable quality level and minimise the production cost. Based on our model, the management can adjust its investment in quality improvement to generate considerable financial return.

40 CFR Appendix C to Part 132 - Great Lakes Water Quality Initiative Methodologies for Development of Human Health Criteria and...

Code of Federal Regulations, 2011 CFR

2011-07-01

... LAKES SYSTEM Pt. 132, App. C Appendix C to Part 132—Great Lakes Water Quality Initiative Methodologies...; or consuming fish from the water, and water-related recreation activities using the Methodologies for... 40 Protection of Environment 22 2011-07-01 2011-07-01 false Great Lakes Water Quality Initiative...

40 CFR Appendix C to Part 132 - Great Lakes Water Quality Initiative Methodologies for Development of Human Health Criteria and...

Code of Federal Regulations, 2010 CFR

2010-07-01

... LAKES SYSTEM Pt. 132, App. C Appendix C to Part 132—Great Lakes Water Quality Initiative Methodologies...; or consuming fish from the water, and water-related recreation activities using the Methodologies for... 40 Protection of Environment 21 2010-07-01 2010-07-01 false Great Lakes Water Quality Initiative...

Methodological reporting of randomized clinical trials in respiratory research in 2010.

PubMed

Lu, Yi; Yao, Qiuju; Gu, Jie; Shen, Ce

2013-09-01

Although randomized controlled trials (RCTs) are considered the highest level of evidence, they are also subject to bias, due to a lack of adequately reported randomization, and therefore the reporting should be as explicit as possible for readers to determine the significance of the contents. We evaluated the methodological quality of RCTs in respiratory research in high ranking clinical journals, published in 2010. We assessed the methodological quality, including generation of the allocation sequence, allocation concealment, double-blinding, sample-size calculation, intention-to-treat analysis, flow diagrams, number of medical centers involved, diseases, funding sources, types of interventions, trial registration, number of times the papers have been cited, journal impact factor, journal type, and journal endorsement of the CONSORT (Consolidated Standards of Reporting Trials) rules, in RCTs published in 12 top ranking clinical respiratory journals and 5 top ranking general medical journals. We included 176 trials, of which 93 (53%) reported adequate generation of the allocation sequence, 66 (38%) reported adequate allocation concealment, 79 (45%) were double-blind, 123 (70%) reported adequate sample-size calculation, 88 (50%) reported intention-to-treat analysis, and 122 (69%) included a flow diagram. Multivariate logistic regression analysis revealed that journal impact factor ≥ 5 was the only variable that significantly influenced adequate allocation sequence generation. Trial registration and journal impact factor ≥ 5 significantly influenced adequate allocation concealment. Medical interventions, trial registration, and journal endorsement of the CONSORT statement influenced adequate double-blinding. Publication in one of the general medical journal influenced adequate sample-size calculation. The methodological quality of RCTs in respiratory research needs improvement. Stricter enforcement of the CONSORT statement should enhance the quality of RCTs.

Design and numerical evaluation of full-authority flight control systems for conventional and thruster-augmented helicopters employed in NOE operations

NASA Technical Reports Server (NTRS)

Perri, Todd A.; Mckillip, R. M., Jr.; Curtiss, H. C., Jr.

1987-01-01

The development and methodology is presented for development of full-authority implicit model-following and explicit model-following optimal controllers for use on helicopters operating in the Nap-of-the Earth (NOE) environment. Pole placement, input-output frequency response, and step input response were used to evaluate handling qualities performance. The pilot was equipped with velocity-command inputs. A mathematical/computational trajectory optimization method was employed to evaluate the ability of each controller to fly NOE maneuvers. The method determines the optimal swashplate and thruster input histories from the helicopter's dynamics and the prescribed geometry and desired flying qualities of the maneuver. Three maneuvers were investigated for both the implicit and explicit controllers with and without auxiliary propulsion installed: pop-up/dash/descent, bob-up at 40 knots, and glideslope. The explicit controller proved to be superior to the implicit controller in performance and ease of design.

Maximum entropy approach to fuzzy control

NASA Technical Reports Server (NTRS)

Ramer, Arthur; Kreinovich, Vladik YA.

1992-01-01

For the same expert knowledge, if one uses different &- and V-operations in a fuzzy control methodology, one ends up with different control strategies. Each choice of these operations restricts the set of possible control strategies. Since a wrong choice can lead to a low quality control, it is reasonable to try to loose as few possibilities as possible. This idea is formalized and it is shown that it leads to the choice of min(a + b,1) for V and min(a,b) for &. This choice was tried on NASA Shuttle simulator; it leads to a maximally stable control.

New methodology of designing inexpensive hybrid control-acquisition systems for mechatronic constructions.

PubMed

Augustyn, Jacek

2013-12-13

This article presents a new methodology for designing a hybrid control and acquisition system consisting of a 32-bit SoC microsystem connected via a direct Universal Serial Bus (USB) with a standard commercial off-the-shelf (COTS) component running the Android operating system. It is proposed to utilize it avoiding the use of an additional converter. An Android-based component was chosen to explore the potential for a mobile, compact and energy efficient solution with easy to build user interfaces and easy wireless integration with other computer systems. This paper presents results of practical implementation and analysis of experimental real-time performance. It covers closed control loop time between the sensor/actuator module and the Android operating system as well as the real-time sensor data stream within such a system. Some optimisations are proposed and their influence on real-time performance was investigated. The proposed methodology is intended for acquisition and control of mechatronic systems, especially mobile robots. It can be used in a wide range of control applications as well as embedded acquisition-recording devices, including energy quality measurements, smart-grids and medicine. It is demonstrated that the proposed methodology can be employed without developing specific device drivers. The latency achieved was less than 0.5 ms and the sensor data stream throughput was on the order of 750 KB/s (compared to 3 ms latency and 300 KB/s in traditional solutions).

New Methodology of Designing Inexpensive Hybrid Control-Acquisition Systems for Mechatronic Constructions

PubMed Central

Augustyn, Jacek

2013-01-01

This article presents a new methodology for designing a hybrid control and acquisition system consisting of a 32-bit SoC microsystem connected via a direct Universal Serial Bus (USB) with a standard commercial off-the-shelf (COTS) component running the Android operating system. It is proposed to utilize it avoiding the use of an additional converter. An Android-based component was chosen to explore the potential for a mobile, compact and energy efficient solution with easy to build user interfaces and easy wireless integration with other computer systems. This paper presents results of practical implementation and analysis of experimental real-time performance. It covers closed control loop time between the sensor/actuator module and the Android operating system as well as the real-time sensor data stream within such a system. Some optimisations are proposed and their influence on real-time performance was investigated. The proposed methodology is intended for acquisition and control of mechatronic systems, especially mobile robots. It can be used in a wide range of control applications as well as embedded acquisition-recording devices, including energy quality measurements, smart-grids and medicine. It is demonstrated that the proposed methodology can be employed without developing specific device drivers. The latency achieved was less than 0.5 ms and the sensor data stream throughput was on the order of 750 KB/s (compared to 3 ms latency and 300 KB/s in traditional solutions). PMID:24351633

The methodological and reporting quality of systematic reviews from China and the USA are similar.

PubMed

Tian, Jinhui; Zhang, Jun; Ge, Long; Yang, Kehu; Song, Fujian

2017-05-01

To compare the methodological and reporting quality of systematic reviews by authors from China and those from the United States (USA). From systematic reviews of randomized trials published in 2014 in English, we randomly selected 100 from China and 100 from the USA. The methodological quality was assessed using the Assessing the Methodological Quality of Systematic Reviews (AMSTAR) tool, and reporting quality assessed using the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) tool. Compared with systematic reviews from the USA, those from China were more likely to be a meta-analysis, published in low-impact journals, and a non-Cochrane review. The mean summary Assessing the Methodological Quality of Systematic Reviews score was 6.7 (95% confidence interval: 6.5, 7.0) for reviews from China and 6.6 (6.1, 7.1) for reviews from the USA, and the mean summary Preferred Reporting Items for Systematic Reviews and Meta-analyses score was 21.2 (20.7, 21.6) for reviews from China and 20.6 (19.9, 21.3) for reviews from the USA. The differences in summary quality scores between China and the USA were statistically nonsignificant after adjusting for multiple review factors. The overall methodological and reporting quality of systematic reviews by authors from China are similar to those from the USA, although the quality of systematic reviews from both countries could be further improved. Copyright © 2017 The Author(s). Published by Elsevier Inc. All rights reserved.

Ambient air quality programmes for health impact assessment in the WHO European region.

PubMed

Mücke, H G

2000-06-01

An important aim of air quality assessment is to provide information about population exposure and health impact assessment. Numerous epidemiological studies have already shown that exposure to excessive levels of ambient air pollutants are associated with either acute or chronic health effects. Until recently, the adequacy of monitoring population exposure in relation to quantitative assessment of health effects of air pollution was rarely considered in ambient air monitoring strategies. This made the formulation of health-related recommendations to risk management difficult and weakens preventive and other measures to reduce adverse health effects of air pollution. To improve local and national capacities for health impact assessment, the European Centre for Environment and Health of the World Health Organization has prepared methodology guidelines concerning selected aspects of air monitoring. The WHO Collaborating Centre for Air Quality Management and Air Pollution Control support efforts in line with international programmes on quality assurance and control for Europe.

A systematic review of the quality of homeopathic pathogenetic trials published from 1945 to 1995.

PubMed

Dantas, F; Fisher, P; Walach, H; Wieland, F; Rastogi, D P; Teixeira, H; Koster, D; Jansen, J P; Eizayaga, J; Alvarez, M E P; Marim, M; Belon, P; Weckx, L L M

2007-01-01

The quality of information gathered from homeopathic pathogenetic trials (HPTs), also known as 'provings', is fundamental to homeopathy. We systematically reviewed HPTs published in six languages (English, German, Spanish, French, Portuguese and Dutch) from 1945 to 1995, to assess their quality in terms of the validity of the information they provide. The literature was comprehensively searched, only published reports of HPTs were included. Information was extracted by two reviewers per trial using a form with 87 items. Information on: medicines, volunteers, ethical aspects, blinding, randomization, use of placebo, adverse effects, assessments, presentation of data and number of claimed findings were recorded. Methodological quality was assessed by an index including indicators of internal and external validity, personal judgement and comments of reviewers for each study. 156 HPTs on 143 medicines, involving 2815 volunteers, produced 20,538 pathogenetic effects (median 6.5 per volunteer). There was wide variation in methods and results. Sample size (median 15, range 1-103) and trial duration (mean 34 days) were very variable. Most studies had design flaws, particularly absence of proper randomization, blinding, placebo control and criteria for analysis of outcomes. Mean methodological score was 5.6 (range 4-16). More symptoms were reported from HPTs of poor quality than from better ones. In 56% of trials volunteers took placebo. Pathogenetic effects were claimed in 98% of publications. On average about 84% of volunteers receiving active treatment developed symptoms. The quality of reports was in general poor, and much important information was not available. The HPTs were generally of low methodological quality. There is a high incidence of pathogenetic effects in publications and volunteers but this could be attributable to design flaws. Homeopathic medicines, tested in HPTs, appear safe. The central question of whether homeopathic medicines in high dilutions can provoke effects in healthy volunteers has not yet been definitively answered, because of methodological weaknesses of the reports. Improvement of the method and reporting of results of HPTs are required. References to all included RCTs are available on-line at.

The health impacts of women's low control in their living environment: A theory-based systematic review of observational studies in societies with profound gender discrimination.

PubMed

Pennington, Andy; Orton, Lois; Nayak, Shilpa; Ring, Adele; Petticrew, Mark; Sowden, Amanda; White, Martin; Whitehead, Margaret

2018-05-01

We conducted a systematic review of observational evidence on the health impacts of women's low control/autonomy in the living environment in societies with profound gender discrimination and gender bias. Thirty observational studies of varying methodological quality were included. Overall, the evidence suggests that women's lower control or autonomy (for example lack of freedom of movement outside the home, lack of authority to access healthcare for sick children) was associated with poorer mental and physical health for women and higher morbidity and mortality for their children, after adjusting for their socioeconomic circumstances. Further studies are needed to disentangle and understand the pathways between low control and health outcomes in contexts of profound gender discrimination. This systematic review has highlighted the general low quality of the evidence base on this research question. It identifies the pressing need for high quality, longitudinal studies in the future. Crown Copyright © 2018. Published by Elsevier Ltd. All rights reserved.

A methodology for model-based development and automated verification of software for aerospace systems

NASA Astrophysics Data System (ADS)

Martin, L.; Schatalov, M.; Hagner, M.; Goltz, U.; Maibaum, O.

Today's software for aerospace systems typically is very complex. This is due to the increasing number of features as well as the high demand for safety, reliability, and quality. This complexity also leads to significant higher software development costs. To handle the software complexity, a structured development process is necessary. Additionally, compliance with relevant standards for quality assurance is a mandatory concern. To assure high software quality, techniques for verification are necessary. Besides traditional techniques like testing, automated verification techniques like model checking become more popular. The latter examine the whole state space and, consequently, result in a full test coverage. Nevertheless, despite the obvious advantages, this technique is rarely yet used for the development of aerospace systems. In this paper, we propose a tool-supported methodology for the development and formal verification of safety-critical software in the aerospace domain. The methodology relies on the V-Model and defines a comprehensive work flow for model-based software development as well as automated verification in compliance to the European standard series ECSS-E-ST-40C. Furthermore, our methodology supports the generation and deployment of code. For tool support we use the tool SCADE Suite (Esterel Technology), an integrated design environment that covers all the requirements for our methodology. The SCADE Suite is well established in avionics and defense, rail transportation, energy and heavy equipment industries. For evaluation purposes, we apply our approach to an up-to-date case study of the TET-1 satellite bus. In particular, the attitude and orbit control software is considered. The behavioral models for the subsystem are developed, formally verified, and optimized.

Is Article Methodological Quality Associated With Conflicts of Interest?: An Analysis of the Plastic Surgery Literature.

PubMed

Cho, Brian H; Lopez, Joseph; Means, Jessica; Lopez, Sandra; Milton, Jacqueline; Tufaro, Anthony P; May, James W; Dorafshar, Amir H

2017-12-01

Conflicts of interest (COI) are an emerging area of discussion within the field of plastic surgery. Recently, several reports have found that research studies that disclose COI are associated with publication of positive outcomes. We hypothesize that this association is driven by higher-quality studies receiving industry funding. This study aimed to investigate the association between industry support and study methodological quality. We reviewed all entries in Plastic and Reconstructive Surgery, Annals of Plastic Surgery, and Journal of Plastic, Reconstructive, and Aesthetic Surgery within a 1-year period encompassing 2013. All clinical research articles were analyzed. Studies were evaluated blindly for methodology quality based on a validated scoring system. An ordinal logistic regression model was used to examine the association between methodology score and COI. A total of 1474 articles were reviewed, of which 483 met our inclusion criteria. These articles underwent methodological quality scoring. Conflicts of interest were reported in 28 (5.8%) of these articles. After adjusting for article characteristics in the ordinal logistic regression analysis, there was no significant association between articles with COI and higher methodological scores (P = 0.7636). Plastic surgery studies that disclose COI are not associated with higher methodological quality when compared with studies that do not disclose COI. These findings suggest that although the presence of COI is associated with positive findings, the association is not shown to be driven by higher-quality studies.

Improving patient satisfaction with pain management using Six Sigma tools.

PubMed

DuPree, Erin; Martin, Lisa; Anderson, Rebecca; Kathuria, Navneet; Reich, David; Porter, Carol; Chassin, Mark R

2009-07-01

Patient satisfaction as a direct and public measure of quality of care is changing the way hospitals address quality improvement. The feasibility of using the Six Sigma DMAIC (Define, Measure, Analyze, Improve, Control) methodology to improve patient satisfaction as it relates to pain management was evaluated. This project used the DMAIC methodology to improve patients' overall satisfaction with pain management on two inpatient units in an urban academic medical center. Pre- and postintervention patient surveys were conducted. The DMAIC methodology provided a data-driven structure to determine the optimal improvement strategies, as well as a long-term plan for maintaining any improvements. In addition, the Change Acceleration Process (CAP) was used throughout the project's various DMAIC stages to further the work of the team by creating a shared need to meet the objectives of the project. Overall satisfaction with pain management "excellent" ratings increased from 37% to 54%. Both units surpassed the goal of at least 50% of responses in the "excellent" category. Several key drivers of satisfaction with pain management were uncovered in the Analyze phase of the project, and each saw rating increases from the pre-intervention to postintervention surveys. Ongoing monitoring by the hospital inpatient satisfaction survey showed that the pain satisfaction score improved in subsequent quarters as compared with the pre-intervention period. The Six Sigma DMAIC methodology can be used successfully to improve patient satisfaction. The project led to measurable improvements in patient satisfaction with pain management, which have endured past the duration of the Six Sigma project. The Control phase of DMAIC allows the improvements to be incorporated into daily operations.

River water quality management considering agricultural return flows: application of a nonlinear two-stage stochastic fuzzy programming.

PubMed

Tavakoli, Ali; Nikoo, Mohammad Reza; Kerachian, Reza; Soltani, Maryam

2015-04-01

In this paper, a new fuzzy methodology is developed to optimize water and waste load allocation (WWLA) in rivers under uncertainty. An interactive two-stage stochastic fuzzy programming (ITSFP) method is utilized to handle parameter uncertainties, which are expressed as fuzzy boundary intervals. An iterative linear programming (ILP) is also used for solving the nonlinear optimization model. To accurately consider the impacts of the water and waste load allocation strategies on the river water quality, a calibrated QUAL2Kw model is linked with the WWLA optimization model. The soil, water, atmosphere, and plant (SWAP) simulation model is utilized to determine the quantity and quality of each agricultural return flow. To control pollution loads of agricultural networks, it is assumed that a part of each agricultural return flow can be diverted to an evaporation pond and also another part of it can be stored in a detention pond. In detention ponds, contaminated water is exposed to solar radiation for disinfecting pathogens. Results of applying the proposed methodology to the Dez River system in the southwestern region of Iran illustrate its effectiveness and applicability for water and waste load allocation in rivers. In the planning phase, this methodology can be used for estimating the capacities of return flow diversion system and evaporation and detention ponds.

Security Quality Requirements Engineering (SQUARE) Methodology

DTIC Science & Technology

2005-11-01

such as Joint Application Development and the Accelerated Requirements Method [Wood 89, Hubbard 99] • Soft Systems Methodology [Checkland 89...investigated were misuse cases [Jacobson 92], Soft Systems Methodology (SSM) [Checkland 89], Quality Function Deployment (QFD) [QFD 05], Con- trolled...html (2005). [Checkland 89] Checkland, Peter. Soft Systems Methodology . Rational Analysis for a Problematic World. New York, NY: John Wiley & Sons

Systematic Review and Meta-Analysis of Randomized Controlled Trials of Xingnaojing Treatment for Stroke

PubMed Central

Wang, Weihao; Xing, Zhihua

2014-01-01

Objective. Xingnaojing injection (XNJ) is a well-known traditional Chinese patent medicine (TCPM) for stroke. The aim of this study is to assess the efficacy of XNJ for stroke including ischemic stroke, intracerebral hemorrhage (ICH), and subarachnoid hemorrhage (SAH). Methods. An extensive search was performed within using eight databases up to November 2013. Randomized controlled trials (RCTs) on XNJ for treatment of stroke were collected. Study selection, data extraction, quality assessment, and meta-analysis were conducted according to the Cochrane standards, and RevMan5.0 was used for meta-analysis. Results. This review included 13 RCTs and a total of 1,514 subjects. The overall methodological quality was poor. The meta-analysis showed that XNJ combined with conventional treatment was more effective for total efficacy, neurological deficit improvement, and reduction of TNF-α levels compared with those of conventional treatment alone. Three trials reported adverse events, of these one trial reported mild impairment of kidney and liver function, whereas the other two studies failed to report specific adverse events. Conclusion. Despite the limitations of this review, we suggest that XNJ in combination with conventional medicines might be beneficial for the treatment of stroke. Currently there are various methodological problems in the studies. Therefore, high-quality, large-scale RCTs are urgently needed. PMID:24707306

Lean Six Sigma: a new approach to the management of patients undergoing prosthetic hip replacement surgery.

PubMed

Improta, Giovanni; Balato, Giovanni; Romano, Maria; Carpentieri, Francesco; Bifulco, Paolo; Alessandro Russo, Mario; Rosa, Donato; Triassi, Maria; Cesarelli, Mario

2015-08-01

In 2012, health care spending in Italy reached €114.5 billion, accounting for 7.2% of the Gross Domestic Product (GDP) and 14.2% of total public spending. Therefore, reducing waste in health facilities could generate substantial cost savings. The objective of this study is to show that Lean Six Sigma represents an appropriate methodology for the development of a clinical pathway which allows to improve quality and to reduce costs in prosthetic hip replacement surgery. The methodology used for the development of a new clinical pathway was Lean Six Sigma. Problem solving in Lean Six Sigma is the DMAIC (Define, Measure, Analyse, Improve, Control) roadmap, characterized by five operational phases which make possible to reach fixed goals through a rigorous process of defining, measuring, analysing, improving and controlling business problems. The following project indicated several variables influencing the inappropriate prolongation of the length of stay for inpatient treatment and corrective actions were performed to improve the effectiveness and efficiency of the process of care. The average length of stay was reduced from 18.9 to 10.6 days (-44%). This article shows there is no trade-off between quality and costs: Lean Six Sigma improves quality and, at the same time, reduces costs. © 2015 John Wiley & Sons, Ltd.

Evaluation of capillary zone electrophoresis for the quality control of complex biologic samples: Application to snake venoms.

PubMed

Kpaibe, André P S; Ben-Ameur, Randa; Coussot, Gaëlle; Ladner, Yoann; Montels, Jérôme; Ake, Michèle; Perrin, Catherine

2017-08-01

Snake venoms constitute a very promising resource for the development of new medicines. They are mainly composed of very complex peptide and protein mixtures, which composition may vary significantly from batch to batch. This latter consideration is a challenge for routine quality control (QC) in the pharmaceutical industry. In this paper, we report the use of capillary zone electrophoresis for the development of an analytical fingerprint methodology to assess the quality of snake venoms. The analytical fingerprint concept is being widely used for the QC of herbal drugs but rarely for venoms QC so far. CZE was chosen for its intrinsic efficiency in the separation of protein and peptide mixtures. The analytical fingerprint methodology was first developed and evaluated for a particular snake venom, Lachesis muta. Optimal analysis conditions required the use of PDADMAC capillary coating to avoid protein and peptide adsorption. Same analytical conditions were then applied to other snake venom species. Different electrophoretic profiles were obtained for each venom. Excellent repeatability and intermediate precision was observed for each batch. Analysis of different batches of the same species revealed inherent qualitative and quantitative composition variations of the venoms between individuals. © 2017 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Anti-bullying interventions in schools: a systematic literature review.

PubMed

Silva, Jorge Luiz da; Oliveira, Wanderlei Abadio de; Mello, Flávia Carvalho Malta de; Andrade, Luciane Sá de; Bazon, Marina Rezende; Silva, Marta Angélica Iossi

2017-07-01

This paper presents a systematic literature review addressing rigorously planned and assessed interventions intended to reduce school bullying. The search for papers was performed in four databases (Lilacs, Psycinfo, Scielo and Web of Science) and guided by the question: What are the interventions used to reduce bullying in schools? Only case-control studies specifically focusing on school bullying without a time frame were included. The methodological quality of investigations was assessed using the SIGN checklist. A total of 18 papers composed the corpus of analysis and all were considered to have high methodological quality. The interventions conducted in the revised studies were divided into four categories: multi-component or whole-school, social skills training, curricular, and computerized. The review synthesizes knowledge that can be used to contemplate practices and intervention programs in the education and health fields with a multidisciplinary nature.

Effects of Mat Pilates on Physical Functional Performance of Older Adults: A Meta-analysis of Randomized Controlled Trials.

PubMed

Bueno de Souza, Roberta Oliveira; Marcon, Liliane de Faria; Arruda, Alex Sandro Faria de; Pontes Junior, Francisco Luciano; Melo, Ruth Caldeira de

2018-06-01

The present meta-analysis aimed to examine evidence from randomized controlled trials to determine the effects of mat Pilates on measures of physical functional performance in the older population. A search was conducted in the MEDLINE/PubMed, Scopus, Scielo, and PEDro databases between February and March 2017. Only randomized controlled trials that were written in English, included subjects aged 60 yrs who used mat Pilates exercises, included a comparison (control) group, and reported performance-based measures of physical function (balance, flexibility, muscle strength, and cardiorespiratory fitness) were included. The methodological quality of the studies was analyzed according to the PEDro scale and the best-evidence synthesis. The meta-analysis was conducted with the Review Manager 5.3 software. The search retrieved 518 articles, nine of which fulfilled the inclusion criteria. High methodological quality was found in five of these studies. Meta-analysis indicated a large effect of mat Pilates on dynamic balance (standardized mean difference = 1.10, 95% confidence interval = 0.29-1.90), muscle strength (standardized mean difference = 1.13, 95% confidence interval = 0.30-1.96), flexibility (standardized mean difference = 1.22, 95% confidence interval = 0.39-2.04), and cardiorespiratory fitness (standardized mean difference = 1.48, 95% confidence interval = 0.42-2.54) of elderly subjects. There is evidence that mat Pilates improves dynamic balance, lower limb strength, hip and lower back flexibility, and cardiovascular endurance in elderly individuals. Furthermore, high-quality studies are necessary to clarify the effects of mat Pilates on other physical functional measurements among older adults.

78 FR 5810 - AHRQ Standing Workgroup for Quality Indicator Measure Specification

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-28

... AHRQ Quality Indicators (QIs), their technical specifications, and associated methodological issues.... The time- limited workgroup is more restricted to specific clinical or methodological issues, while..., data enhancements, and methodological advances. The standing workgroup may potentially provide guidance...

78 FR 22883 - AHRQ Standing Workgroup for Quality Indicator Measure Specification

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-17

... Quality Indicators (QIs), their technical specifications, and associated methodological issues. The...-limited workgroup is more restricted to specific clinical or methodological issues, while the standing... enhancements, and methodological advances. The standing workgroup may potentially provide guidance for the...

Further Development, Support and Enhancement of CONDUIT

NASA Technical Reports Server (NTRS)

Veronica, Moldoveanu; Levine, William S.

1999-01-01

From the first airplanes steered by handles, wheels, and pedals to today's advanced aircraft, there has been a century of revolutionary inventions, all of them contributing to flight quality. The stability and controllability of aircraft as they appear to a pilot are called flying or handling qualities. Many years after the first airplanes flew, flying qualities were identified and ranked from desirable to unsatisfactory. Later on engineers developed design methods to satisfy these practical criteria. CONDUIT, which stands for Control Designer's Unified Interface, is a modern software package that provides a methodology for optimization of flight control systems in order to improve the flying qualities. CONDUIT is dependent on an the optimization engine called CONSOL-OPTCAD (C-O). C-O performs multicriterion parametric optimization. C-O was successfully tested on a variety of control problems. The optimization-based computational system, C-O, requires a particular control system description as a MATLAB file and possesses the ability to modify the vector of design parameters in an attempt to satisfy performance objectives and constraints specified by the designer, in a C-type file. After the first optimization attempts on the UH-60A control system, an early interface system, named GIFCORCODE (Graphical Interface for CONSOL-OPTCAD for Rotorcraft Controller Design) was created.

Near infrared spectroscopy based monitoring of extraction processes of raw material with the help of dynamic predictive modeling

NASA Astrophysics Data System (ADS)

Wang, Haixia; Suo, Tongchuan; Wu, Xiaolin; Zhang, Yue; Wang, Chunhua; Yu, Heshui; Li, Zheng

2018-03-01

The control of batch-to-batch quality variations remains a challenging task for pharmaceutical industries, e.g., traditional Chinese medicine (TCM) manufacturing. One difficult problem is to produce pharmaceutical products with consistent quality from raw material of large quality variations. In this paper, an integrated methodology combining the near infrared spectroscopy (NIRS) and dynamic predictive modeling is developed for the monitoring and control of the batch extraction process of licorice. With the spectra data in hand, the initial state of the process is firstly estimated with a state-space model to construct a process monitoring strategy for the early detection of variations induced by the initial process inputs such as raw materials. Secondly, the quality property of the end product is predicted at the mid-course during the extraction process with a partial least squares (PLS) model. The batch-end-time (BET) is then adjusted accordingly to minimize the quality variations. In conclusion, our study shows that with the help of the dynamic predictive modeling, NIRS can offer the past and future information of the process, which enables more accurate monitoring and control of process performance and product quality.

Quality assurance of the international computerised 24 h dietary recall method (EPIC-Soft).

PubMed

Crispim, Sandra P; Nicolas, Genevieve; Casagrande, Corinne; Knaze, Viktoria; Illner, Anne-Kathrin; Huybrechts, Inge; Slimani, Nadia

2014-02-01

The interview-administered 24 h dietary recall (24-HDR) EPIC-Soft® has a series of controls to guarantee the quality of dietary data across countries. These comprise all steps that are part of fieldwork preparation, data collection and data management; however, a complete characterisation of these quality controls is still lacking. The present paper describes in detail the quality controls applied in EPIC-Soft, which are, to a large extent, built on the basis of the EPIC-Soft error model and are present in three phases: (1) before, (2) during and (3) after the 24-HDR interviews. Quality controls for consistency and harmonisation are implemented before the interviews while preparing the seventy databases constituting an EPIC-Soft version (e.g. pre-defined and coded foods and recipes). During the interviews, EPIC-Soft uses a cognitive approach by helping the respondent to recall the dietary intake information in a stepwise manner and includes controls for consistency (e.g. probing questions) as well as for completeness of the collected data (e.g. system calculation for some unknown amounts). After the interviews, a series of controls can be applied by dietitians and data managers to further guarantee data quality. For example, the interview-specific 'note files' that were created to track any problems or missing information during the interviews can be checked to clarify the information initially provided. Overall, the quality controls employed in the EPIC-Soft methodology are not always perceivable, but prove to be of assistance for its overall standardisation and possibly for the accuracy of the collected data.

Resource factors for mental health resilience in early childhood: An analysis with multiple methodologies

PubMed Central

2013-01-01

Background Given that relatively little is known about the development of resilience in early childhood, this longitudinal study aimed to identify preschool resource factors associated with young children’s mental health resilience to family adversity. Methods A community sample of 474 young Australian children was assessed in preschool (mean age 4.59 years, 49% male), and again two years later after their transition into formal schooling. At each assessment, standard questionnaires were used to obtain ratings from both parents and teachers about the quality of children’s relationships with parents and teachers, children’s self-concept and self-control, mental health (Strengths and Difficulties Questionnaire), and family adversities (including stressful life events and socioeconomic disadvantage). Results Greater exposure to cumulative family adversities was associated with both greater teacher- and parent-reported child mental health difficulties two years later. Multiple methodologies for operationalizing resilience were used to identify resources associated with resilient mental health outcomes. Higher quality child–parent and child-teacher relationships, and greater child self-concept and self-control were associated with resilient mental health outcomes. With the exception of child-teacher relationships, these resources were also prospective antecedents of subsequent resilient mental health outcomes in children with no pre-existing mental health difficulties. Child–parent relationships and child self-concept generally had promotive effects, being equally beneficial for children facing both low- and high-adversity. Child self-control demonstrated a small protective effect on teacher-reported outcomes, with greater self-control conferring greater protection to children under conditions of high-adversity. Conclusions Findings suggest that early intervention and prevention strategies that focus on fostering child-adult relationship quality, self-concept, and self-control in young children may help build children’s mental health and their resilience to family adversities. PMID:23432929

Resource factors for mental health resilience in early childhood: An analysis with multiple methodologies.

PubMed

Miller-Lewis, Lauren R; Searle, Amelia K; Sawyer, Michael G; Baghurst, Peter A; Hedley, Darren

2013-02-22

Given that relatively little is known about the development of resilience in early childhood, this longitudinal study aimed to identify preschool resource factors associated with young children's mental health resilience to family adversity. A community sample of 474 young Australian children was assessed in preschool (mean age 4.59 years, 49% male), and again two years later after their transition into formal schooling. At each assessment, standard questionnaires were used to obtain ratings from both parents and teachers about the quality of children's relationships with parents and teachers, children's self-concept and self-control, mental health (Strengths and Difficulties Questionnaire), and family adversities (including stressful life events and socioeconomic disadvantage). Greater exposure to cumulative family adversities was associated with both greater teacher- and parent-reported child mental health difficulties two years later. Multiple methodologies for operationalizing resilience were used to identify resources associated with resilient mental health outcomes. Higher quality child-parent and child-teacher relationships, and greater child self-concept and self-control were associated with resilient mental health outcomes. With the exception of child-teacher relationships, these resources were also prospective antecedents of subsequent resilient mental health outcomes in children with no pre-existing mental health difficulties. Child-parent relationships and child self-concept generally had promotive effects, being equally beneficial for children facing both low- and high-adversity. Child self-control demonstrated a small protective effect on teacher-reported outcomes, with greater self-control conferring greater protection to children under conditions of high-adversity. Findings suggest that early intervention and prevention strategies that focus on fostering child-adult relationship quality, self-concept, and self-control in young children may help build children's mental health and their resilience to family adversities.

A COMPREHENSIVE NONPOINT SOURCE FIELD STUDY FOR SEDIMENT, NUTRIENTS, AND PATHOGENS IN THE SOUTH FORK BROAD RIVER WATERSHED IN NORTHEAST GEORGIA

EPA Science Inventory

This technical report provides a description of the field project design, quality control, the sampling protocols and analysis methodology used, and standard operating procedures for the South Fork Broad River Watershed (SFBR) Total Maximum Daily Load (TMDL) project. This watersh...

Social Judgment Analysis: Methodology for Improving Interpersonal Communication and Understanding.

ERIC Educational Resources Information Center

Rohrbaugh, John; Harmon, Joel

Research has found the Social Judgment Analysis (SJA) approach, with its focus on judgment policy and cognitive feedback, to be a significant factor in developing group member agreement and improving member performance. A controlled experiment was designed to assess the relative quality of the judgment making process provided by SJA.…

Development of Internalization from Age 2 to 6: Longitudinal Stability and Links with Temperament.

ERIC Educational Resources Information Center

Coy, Katherine C.; Parrot, Tracie A.

This study examined relations between internalization of conduct rules and the temperamental quality of inhibitory control in 103 children followed from toddlerhood to early school age; and used recent methodological suggestions to obtain better estimates of stability to examine longitudinal continuity of internalization. Maternal reports of…

40 CFR Appendix A to Part 132 - Great Lakes Water Quality Initiative Methodologies for Development of Aquatic Life Criteria and...

Code of Federal Regulations, 2010 CFR

2010-07-01

... LAKES SYSTEM Pt. 132, App. A Appendix A to Part 132—Great Lakes Water Quality Initiative Methodologies... 40 Protection of Environment 21 2010-07-01 2010-07-01 false Great Lakes Water Quality Initiative Methodologies for Development of Aquatic Life Criteria and Values A Appendix A to Part 132 Protection of...

40 CFR Appendix A to Part 132 - Great Lakes Water Quality Initiative Methodologies for Development of Aquatic Life Criteria and...

Code of Federal Regulations, 2011 CFR

2011-07-01

... LAKES SYSTEM Pt. 132, App. A Appendix A to Part 132—Great Lakes Water Quality Initiative Methodologies... 40 Protection of Environment 22 2011-07-01 2011-07-01 false Great Lakes Water Quality Initiative Methodologies for Development of Aquatic Life Criteria and Values A Appendix A to Part 132 Protection of...

Quality control methodology for high-throughput protein-protein interaction screening.

PubMed

Vazquez, Alexei; Rual, Jean-François; Venkatesan, Kavitha

2011-01-01

Protein-protein interactions are key to many aspects of the cell, including its cytoskeletal structure, the signaling processes in which it is involved, or its metabolism. Failure to form protein complexes or signaling cascades may sometimes translate into pathologic conditions such as cancer or neurodegenerative diseases. The set of all protein interactions between the proteins encoded by an organism constitutes its protein interaction network, representing a scaffold for biological function. Knowing the protein interaction network of an organism, combined with other sources of biological information, can unravel fundamental biological circuits and may help better understand the molecular basics of human diseases. The protein interaction network of an organism can be mapped by combining data obtained from both low-throughput screens, i.e., "one gene at a time" experiments and high-throughput screens, i.e., screens designed to interrogate large sets of proteins at once. In either case, quality controls are required to deal with the inherent imperfect nature of experimental assays. In this chapter, we discuss experimental and statistical methodologies to quantify error rates in high-throughput protein-protein interactions screens.

Meta-Analysis of the Effects of Xingnaojing Injection on Consciousness Disturbance

PubMed Central

Wu, Lijun; Zhang, Hua; Xing, Yanwei; Gao, Yonghong; Li, Yanda; Ren, Xiaomeng; Li, Jie; Nie, Bo; Zhu, Lingqun; Shang, Hongcai; Gao, Ying

2016-01-01

Abstract Xingnaojing (XNJ) is commonly extracted from Angongniuhuang, a classic Chinese emergency prescription, and widely used in the treatment of nervous system disorders including consciousness disturbance in China. To evaluate the beneficial and adverse effects of XNJ injection, on consciousness disturbance. Seven major electronic databases were searched to retrieve randomized controlled trials designed to evaluate the clinical efficacy of XNJ alone or combined with Western medicine in treating consciousness disturbance caused by conditions such as high fever, poisoning, and stroke. The methodological quality of the included studies was assessed using criteria from the Cochrane Handbook for Systematic Review of Interventions, and analyzed using the RevMan 5.3.0 software. Seventeen randomized controlled trials on XNJ were included in this study and the trials generally showed low methodological quality. The results revealed that XNJ alone or in combination with other medicines and adjuvant methods had a positive effect on patients with fever-, poisoning-, and stroke-induced coma. XNJ effectively treated consciousness disturbances that were caused by high fever, poisoning, or stroke. PMID:26886655

Quality indicators for hip fracture care, a systematic review.

PubMed

Voeten, S C; Krijnen, P; Voeten, D M; Hegeman, J H; Wouters, M W J M; Schipper, I B

2018-05-17

Quality indicators are used to measure quality of care and enable benchmarking. An overview of all existing hip fracture quality indicators is lacking. The primary aim was to identify quality indicators for hip fracture care reported in literature, hip fracture audits, and guidelines. The secondary aim was to compose a set of methodologically sound quality indicators for the evaluation of hip fracture care in clinical practice. A literature search according to the PRISMA guidelines and an internet search were performed to identify hip fracture quality indicators. The indicators were subdivided into process, structure, and outcome indicators. The methodological quality of the indicators was judged using the Appraisal of Indicators through Research and Evaluation (AIRE) instrument. For structure and process indicators, the construct validity was assessed. Sixteen publications, nine audits and five guidelines were included. In total, 97 unique quality indicators were found: 9 structure, 63 process, and 25 outcome indicators. Since detailed methodological information about the indicators was lacking, the AIRE instrument could not be applied. Seven indicators correlated with an outcome measure. A set of nine quality indicators was extracted from the literature, audits, and guidelines. Many quality indicators are described and used. Not all of them correlate with outcomes of care and have been assessed methodologically. As methodological evidence is lacking, we recommend the extracted set of nine indicators to be used as the starting point for further clinical research. Future research should focus on assessing the clinimetric properties of the existing quality indicators.

Using Lean Six Sigma Methodology to Improve a Mass Immunizations Process at the United States Naval Academy.

PubMed

Ha, Chrysanthy; McCoy, Donald A; Taylor, Christopher B; Kirk, Kayla D; Fry, Robert S; Modi, Jitendrakumar R

2016-06-01

Lean Six Sigma (LSS) is a process improvement methodology developed in the manufacturing industry to increase process efficiency while maintaining product quality. The efficacy of LSS application to the health care setting has not been adequately studied. This article presents a quality improvement project at the U.S. Naval Academy that uses LSS to improve the mass immunizations process for Midshipmen during in-processing. The process was standardized to give all vaccinations at one station instead of giving a different vaccination at each station. After project implementation, the average immunizations lead time decreased by 79% and staffing decreased by 10%. The process was shown to be in control with a capability index of 1.18 and performance index of 1.10, resulting in a defect rate of 0.04%. This project demonstrates that the LSS methodology can be applied successfully to the health care setting to make sustainable process improvements if used correctly and completely. Reprint & Copyright © 2016 Association of Military Surgeons of the U.S.

A systematic review of etiological and risk factors associated with bruxism.

PubMed

Feu, Daniela; Catharino, Fernanda; Quintão, Catia Cardoso Abdo; Almeida, Marco Antonio de Oliveira

2013-06-01

The aim of the present work was to systematically review the literature and identify all peer-reviewed papers dealing with etiological and risk factors associated with bruxism. Data extraction was carried out according to the standard Cochrane systematic review methodology. The following databases were searched for randomized clinical trials (RCT), controlled clinical trials (CCT) or cohort studies: Cochrane Library, Medline, and Embase from 1980 to 2011. Unpublished literature was searched electronically using ClinicalTrials.gov. The primary outcome was bruxism etiology. Studies should have a standardized method to assess bruxism. Screening of eligible studies, assessment of the methodological quality and data extraction were conducted independently and in duplicate. Two reviewers inspected the references using the same search strategy and then applied the same inclusion criteria to the selected studies. They used criteria for methodological quality that was previously described in the Cochrane Handbook. Among the 1247 related articles that were critically assessed, one randomized clinical trial, one controlled clinical trial and seven longitudinal studies were included in the critical appraisal. Of these studies, five were selected, but reported different outcomes. There is convincing evidence that (sleep-related) bruxism can be induced by esophageal acidification and also that it has an important relationship with smoking in a dose-dependent manner. Disturbances in the central dopaminergic system are also implicated in the etiology of bruxism.

A Systematic Review of Information and Communication Technology–Based Interventions for Promoting Physical Activity Behavior Change in Children and Adolescents

PubMed Central

Lau, Erica Y; Wong, Del P; Ransdell, Lynda

2011-01-01

Background A growing body of research has employed information and communication technologies (ICTs) such as the Internet and mobile phones for disseminating physical activity (PA) interventions with young populations. Although several systematic reviews have documented the effects of ICT-based interventions on PA behavior, very few have focused on children and adolescents specifically. Objectives The present review aimed to systematically evaluate the efficacy and methodological quality of ICT-based PA interventions for children and adolescents based on evidence from randomized controlled trials. Methods Electronic databases Medline, PsycInfo, CINAHL, and Web of Science were searched to retrieve English language articles published in international academic peer-reviewed journals from January 1, 1997, through December 31, 2009. Included were articles that provided descriptions of interventions designed to improve PA-related cognitive, psychosocial, and behavioral outcomes and that used randomized controlled trial design, included only children (6-12 years old) and adolescents (13-18 years old) in both intervention and control groups, and employed Internet, email, and/or short message services (SMS, also known as text messaging) as one or more major or assistive modes to deliver the intervention. Results In total, 9 studies were analyzed in the present review. All studies were published after 2000 and conducted in Western countries. Of the 9 studies, 7 demonstrated positive and significant within-group differences in at least one psychosocial or behavioral PA outcome. In all, 3 studies reported positive and significant between-group differences favoring the ICT group. When between-group differences were compared across studies, effect sizes were small in 6 studies and large in 3 studies. With respect to methodological quality, 7 of the 9 studies had good methodological quality. Failure to report allocation concealment, blinding to outcome assessment, and lack of long-term follow-up were the criteria met by the fewest studies. In addition, 5 studies measured the intervention exposure rate and only 1 study employed objective measures to record data. Conclusion The present review provides evidence supporting the positive effects of ICTs in PA interventions for children and adolescents, especially when used with other delivery approaches (ie, face-to-face). Because ICT delivery approaches are often mixed with other approaches and these studies sometimes lack a comparable control group, additional research is needed to establish the true independent effects of ICT as an intervention delivery mode. Although two-thirds of the studies demonstrated satisfactory methodological quality, several quality criteria should be considered in future studies: clear descriptions of allocation concealment and blinding of outcome assessment, extension of intervention duration, and employment of objective measures in intervention exposure rate. Due to the small number of studies that met inclusion criteria and the lack of consistent evidence, researchers should be cautious when interpreting the findings of the present review. PMID:21749967

A systematic review of information and communication technology-based interventions for promoting physical activity behavior change in children and adolescents.

PubMed

Lau, Patrick W C; Lau, Erica Y; Wong, Del P; Ransdell, Lynda

2011-07-13

A growing body of research has employed information and communication technologies (ICTs) such as the Internet and mobile phones for disseminating physical activity (PA) interventions with young populations. Although several systematic reviews have documented the effects of ICT-based interventions on PA behavior, very few have focused on children and adolescents specifically. The present review aimed to systematically evaluate the efficacy and methodological quality of ICT-based PA interventions for children and adolescents based on evidence from randomized controlled trials. Electronic databases Medline, PsycInfo, CINAHL, and Web of Science were searched to retrieve English language articles published in international academic peer-reviewed journals from January 1, 1997, through December 31, 2009. Included were articles that provided descriptions of interventions designed to improve PA-related cognitive, psychosocial, and behavioral outcomes and that used randomized controlled trial design, included only children (6-12 years old) and adolescents (13-18 years old) in both intervention and control groups, and employed Internet, email, and/or short message services (SMS, also known as text messaging) as one or more major or assistive modes to deliver the intervention. In total, 9 studies were analyzed in the present review. All studies were published after 2000 and conducted in Western countries. Of the 9 studies, 7 demonstrated positive and significant within-group differences in at least one psychosocial or behavioral PA outcome. In all, 3 studies reported positive and significant between-group differences favoring the ICT group. When between-group differences were compared across studies, effect sizes were small in 6 studies and large in 3 studies. With respect to methodological quality, 7 of the 9 studies had good methodological quality. Failure to report allocation concealment, blinding to outcome assessment, and lack of long-term follow-up were the criteria met by the fewest studies. In addition, 5 studies measured the intervention exposure rate and only 1 study employed objective measures to record data. The present review provides evidence supporting the positive effects of ICTs in PA interventions for children and adolescents, especially when used with other delivery approaches (ie, face-to-face). Because ICT delivery approaches are often mixed with other approaches and these studies sometimes lack a comparable control group, additional research is needed to establish the true independent effects of ICT as an intervention delivery mode. Although two-thirds of the studies demonstrated satisfactory methodological quality, several quality criteria should be considered in future studies: clear descriptions of allocation concealment and blinding of outcome assessment, extension of intervention duration, and employment of objective measures in intervention exposure rate. Due to the small number of studies that met inclusion criteria and the lack of consistent evidence, researchers should be cautious when interpreting the findings of the present review.

Assessing the Methodological Quality of Glaucoma Clinical Practice Guidelines and Their Recommendations on Microinvasive Glaucoma Surgery: A Systematic Review.

PubMed

Michaelov, Evan; Armstrong, James J; Nguyen, Mary; Instrum, Bridget; Lam, Tracey; Denstedt, James; Hutnik, Cindy M L

2018-02-01

Clinical practice guidelines (CPG) are regarded by many as critical communications providing guidance within specific medical fields. Over a decade ago, the first microinvasive glaucoma surgical (MIGS) procedures were introduced. Since then, a number of these novel intraocular pressure controlling surgical options have been approved worldwide. Governing bodies and health care administration often utilize CPGs when considering funding for newer technologies. This highlights the importance of well-written, accurate, and up-to-date CPGs in the rapidly evolving field of MIGS. If CPGs are unable to fill this role, their use in treatment decision-making is doing a disservice to patients, who will be denied currently available and potentially superior care. To determine the overall value of a CPG, the methodological quality with which it was developed, in addition to the current relevance and appropriateness of its recommendations, should be evaluated. The objective of the present study was to assess the methodological quality of currently available international glaucoma CPGs, as well as their coverage of MIGS as a surrogate marker of relevance and appropriateness to policy-makers and ophthalmologists alike. To identify potentially relevant CPGs, a predefined search strategy was used to search the following databases: Medline, EMBASE, BIOSIS, and Web of Science. All CPGs related to adult glaucoma and published in English were included. CPG methodological quality was assessed by 3 individuals using the Appraisal of Guidelines for Research and Evaluation II (AGREE II) tool. Studies were then assessed for coverage of MIGS devices and procedures. Search strategy and subsequent screening identified 11 CPGs for analysis. Eight were of high quality according to the AGREE II criteria. Three included basic information on MIGS, but none provided specific recommendations regarding their indications or which patient populations would benefit most. Many international glaucoma CPGs are of high methodological quality. However, coverage of MIGS is sparse, nonspecific and in many instances, absent. This causes CPGs to be a suboptimal source in guiding physicians and health policy-makers in areas characterized by novel and/or rapidly evolving technologies. Mechanisms to incorporate updated evidence in CPGs would have to be considered before they can be used as a source of contemporary clinical decision-making.

Methodological quality and scientific impact of quantitative nursing education research over 18 months.

PubMed

Yucha, Carolyn B; Schneider, Barbara St Pierre; Smyer, Tish; Kowalski, Susan; Stowers, Eva

2011-01-01

The methodological quality of nursing education research has not been rigorously studied. The purpose of this study was to evaluate the methodological quality and scientific impact of nursing education research reports. The methodological quality of 133 quantitative nursing education research articles published between July 2006 and December 2007 was evaluated using the Medical Education Research Study Quality Instrument (MERSQI).The mean (+/- SD) MERSQI score was 9.8 +/- 2.2. It correlated (p < .05) with several scientific impact indicators: citation counts from Scopus (r = .223), Google Scholar (r = .224), and journal impact factor (r = .216); it was not associated with Web of Science citation count, funding, or h Index. The similarities between this study's MERSQI ratings for nursing literature and those reported for the medical literature, coupled with the association with citation counts, suggest that the MERSQI is an appropriate instrument to evaluate the quality of nursing education research.

PQScal (Power Quality Score Calculation for Distribution Systems with DER Integration)

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

Power Quality is of great importance to evaluate the “health” of a distribution system, especially when the distributed energy resource (DER) penetration becomes more significant. The individual components that make up power quality, such as voltage magnitude and unbalance, can be measured in simulations or in the field, however, a comprehensive method to incorporate all of these values into a single score doesn't exist. As a result, we propose a methodology to quantify the power quality health using the single number value, named as Power Quality Score (PQS). The PQS is dependent on six metrics that are developed based onmore » both components that directly impact power quality and those are often reference in the context of power quality. These six metrics are named as System Average Voltage Magnitude Violation Index (SAVMVI), System Average Voltage Fluctuation Index (SAVFI), System Average Voltage Unbalance Index (SAVUI), System Control Device Operation Index (SCDOI), System Reactive Power Demand Index (SRPDI) and System Energy Loss Index (SELI). This software tool, PQScal, is developed based on this novel PQS methodology. Besides of traditional distribution systems, PQScal can also measure the power quality for distribution systems with various DER penetrations. PQScal has been tested on two utility distribution feeders with distinct model characteristics and its effectiveness has been proved. In sum, PQScal can help utilities or other parties to measure the power quality of distribution systems with DER integration easily and effectively.« less

A new transmission methodology for quality assurance in radiotherapy based on radiochromic film measurements

PubMed Central

do Amaral, Leonardo L.; Pavoni, Juliana F.; Sampaio, Francisco; Netto, Thomaz Ghilardi

2015-01-01

Despite individual quality assurance (QA) being recommended for complex techniques in radiotherapy (RT) treatment, the possibility of errors in dose delivery during therapeutic application has been verified. Therefore, it is fundamentally important to conduct in vivo QA during treatment. This work presents an in vivo transmission quality control methodology, using radiochromic film (RCF) coupled to the linear accelerator (linac) accessory holder. This QA methodology compares the dose distribution measured by the film in the linac accessory holder with the dose distribution expected by the treatment planning software. The calculated dose distribution is obtained in the coronal and central plane of a phantom with the same dimensions of the acrylic support used for positioning the film but in a source‐to‐detector distance (SDD) of 100 cm, as a result of transferring the IMRT plan in question with all the fields positioned with the gantry vertically, that is, perpendicular to the phantom. To validate this procedure, first of all a Monte Carlo simulation using PENELOPE code was done to evaluate the differences between the dose distributions measured by the film in a SDD of 56.8 cm and 100 cm. After that, several simple dose distribution tests were evaluated using the proposed methodology, and finally a study using IMRT treatments was done. In the Monte Carlo simulation, the mean percentage of points approved in the gamma function comparing the dose distribution acquired in the two SDDs were 99.92%±0.14%. In the simple dose distribution tests, the mean percentage of points approved in the gamma function were 99.85%±0.26% and the mean percentage differences in the normalization point doses were −1.41%. The transmission methodology was approved in 24 of 25 IMRT test irradiations. Based on these results, it can be concluded that the proposed methodology using RCFs can be applied for in vivo QA in RT treatments. PACS number: 87.55.Qr, 87.55.km, 87.55.N‐ PMID:26699306

Methological quality of systematic reviews and meta-analyses on acupuncture for stroke: A review of review.

PubMed

Chen, Xin-Lin; Mo, Chuan-Wei; Lu, Li-Ya; Gao, Ri-Yang; Xu, Qian; Wu, Min-Feng; Zhou, Qian-Yi; Hu, Yue; Zhou, Xuan; Li, Xian-Tao

2017-11-01

To assess the methodological quality of systematic reviews and meta-analyses regarding acupuncture intervention for stroke and the primary studies within them. Two researchers searched PubMed, Cumulative index to Nursing and Allied Health Literature, Embase, ISI Web of Knowledge, Cochrane, Allied and Complementary Medicine, Ovid Medline, Chinese Biomedical Literature Database, China National Knowledge Infrastructure, Wanfang and Traditional Chinese Medical Database to identify systematic reviews and meta-analyses about acupuncture for stroke published from the inception to December 2016. Review characteristics and the criteria for assessing the primary studies within reviews were extracted. The methodological quality of the reviews was assessed using adapted Oxman and Guyatt Scale. The methodological quality of primary studies was also assessed. Thirty-two eligible reviews were identified, 15 in English and 17 in Chinese. The English reviews were scored higher than the Chinese reviews (P=0.025), especially in criteria for avoiding bias and the scope of search. All reviews used the quality criteria to evaluate the methodological quality of primary studies, but some criteria were not comprehensive. The primary studies, in particular the Chinese reviews, had problems with randomization, allocation concealment, blinding, dropouts and withdrawals, intent-to-treat analysis and adverse events. Important methodological flaws were found in Chinese systematic reviews and primary studies. It was necessary to improve the methodological quality and reporting quality of both the systematic reviews published in China and primary studies on acupuncture for stroke.

Effects of image processing on the detective quantum efficiency

NASA Astrophysics Data System (ADS)

Park, Hye-Suk; Kim, Hee-Joung; Cho, Hyo-Min; Lee, Chang-Lae; Lee, Seung-Wan; Choi, Yu-Na

2010-04-01

Digital radiography has gained popularity in many areas of clinical practice. This transition brings interest in advancing the methodologies for image quality characterization. However, as the methodologies for such characterizations have not been standardized, the results of these studies cannot be directly compared. The primary objective of this study was to standardize methodologies for image quality characterization. The secondary objective was to evaluate affected factors to Modulation transfer function (MTF), noise power spectrum (NPS), and detective quantum efficiency (DQE) according to image processing algorithm. Image performance parameters such as MTF, NPS, and DQE were evaluated using the international electro-technical commission (IEC 62220-1)-defined RQA5 radiographic techniques. Computed radiography (CR) images of hand posterior-anterior (PA) for measuring signal to noise ratio (SNR), slit image for measuring MTF, white image for measuring NPS were obtained and various Multi-Scale Image Contrast Amplification (MUSICA) parameters were applied to each of acquired images. In results, all of modified images were considerably influence on evaluating SNR, MTF, NPS, and DQE. Modified images by the post-processing had higher DQE than the MUSICA=0 image. This suggests that MUSICA values, as a post-processing, have an affect on the image when it is evaluating for image quality. In conclusion, the control parameters of image processing could be accounted for evaluating characterization of image quality in same way. The results of this study could be guided as a baseline to evaluate imaging systems and their imaging characteristics by measuring MTF, NPS, and DQE.

Methodological quality and reporting of systematic reviews in hand and wrist pathology.

PubMed

Wasiak, J; Shen, A Y; Ware, R; O'Donohoe, T J; Faggion, C M

2017-10-01

The objective of this study was to assess methodological and reporting quality of systematic reviews in hand and wrist pathology. MEDLINE, EMBASE and Cochrane Library were searched from inception to November 2016 for relevant studies. Reporting quality was evaluated using Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and methodological quality using a measurement tool to assess systematic reviews, the Assessment of Multiple Systematic Reviews (AMSTAR). Descriptive statistics and linear regression were used to identify features associated with improved methodological quality. A total of 91 studies were included in the analysis. Most reviews inadequately reported PRISMA items regarding study protocol, search strategy and bias and AMSTAR items regarding protocol, publication bias and funding. Systematic reviews published in a plastics journal, or which included more authors, were associated with higher AMSTAR scores. A large proportion of systematic reviews within hand and wrist pathology literature score poorly with validated methodological assessment tools, which may affect the reliability of their conclusions. I.

A Six Sigma Trial For Reduction of Error Rates in Pathology Laboratory.

PubMed

Tosuner, Zeynep; Gücin, Zühal; Kiran, Tuğçe; Büyükpinarbaşili, Nur; Turna, Seval; Taşkiran, Olcay; Arici, Dilek Sema

2016-01-01

A major target of quality assurance is the minimization of error rates in order to enhance patient safety. Six Sigma is a method targeting zero error (3.4 errors per million events) used in industry. The five main principles of Six Sigma are defining, measuring, analysis, improvement and control. Using this methodology, the causes of errors can be examined and process improvement strategies can be identified. The aim of our study was to evaluate the utility of Six Sigma methodology in error reduction in our pathology laboratory. The errors encountered between April 2014 and April 2015 were recorded by the pathology personnel. Error follow-up forms were examined by the quality control supervisor, administrative supervisor and the head of the department. Using Six Sigma methodology, the rate of errors was measured monthly and the distribution of errors at the preanalytic, analytic and postanalytical phases was analysed. Improvement strategies were reclaimed in the monthly intradepartmental meetings and the control of the units with high error rates was provided. Fifty-six (52.4%) of 107 recorded errors in total were at the pre-analytic phase. Forty-five errors (42%) were recorded as analytical and 6 errors (5.6%) as post-analytical. Two of the 45 errors were major irrevocable errors. The error rate was 6.8 per million in the first half of the year and 1.3 per million in the second half, decreasing by 79.77%. The Six Sigma trial in our pathology laboratory provided the reduction of the error rates mainly in the pre-analytic and analytic phases.

Effectiveness and safety of acupuncture in the treatment of Parkinson's disease: A systematic review and meta-analysis of randomized controlled trials.

PubMed

Noh, Hyeonseok; Kwon, Seungwon; Cho, Seung-Yeon; Jung, Woo-Sang; Moon, Sang-Kwan; Park, Jung-Mi; Ko, Chang-Nam; Park, Seong-Uk

2017-10-01

This study aimed to examine the effectiveness and safety of acupuncture in the treatment of Parkinson's disease (PD). English, Chinese, and Korean electronic databases were searched up to June 2016. Randomized controlled trials (RCTs) were eligible. The methodological quality was assessed using Cochrane's risk of bias tool. Meta-analysis was performed using RevMan 5.3. In total, 42 studies involving 2625 participants were systematically reviewed. Participants treated using combined acupuncture and conventional medication (CM) showed significant improvements in total Unified PD Rating Scale (UPDRS), UPDRS I, UPDRS II, UPDRS III, and the Webster scale compared to those treated using CM alone. The combination of electroacupuncture and CM was significantly superior to CM alone in total UPDRS, UPDRS I, UPDRS II, and UPDRS IV. Similarly, the combination of scalp electroacupuncture, acupuncture, and CM was significantly more effective than CM alone in total UPDRS. However, our meta-analysis showed that the combination of electroacupuncture and CM was not significantly more effective than CM alone in UPDRS III, the Webster, and the Tension Assessment Scale. The results also failed to show that acupuncture was significantly more effective than placebo acupuncture in total UPDRS. Overall, the methodological quality of the RCTs was low. No serious adverse events were reported. We found that acupuncture might be a safe and useful adjunctive treatment for patients with PD. However, because of methodological flaws in the included studies, conclusive evidence is still lacking. More rigorous and well-designed placebo-controlled trials should be conducted. Copyright © 2017 Elsevier Ltd. All rights reserved.

Development of a Valid and Reliable Knee Articular Cartilage Condition-Specific Study Methodological Quality Score.

PubMed

Harris, Joshua D; Erickson, Brandon J; Cvetanovich, Gregory L; Abrams, Geoffrey D; McCormick, Frank M; Gupta, Anil K; Verma, Nikhil N; Bach, Bernard R; Cole, Brian J

2014-02-01

Condition-specific questionnaires are important components in evaluation of outcomes of surgical interventions. No condition-specific study methodological quality questionnaire exists for evaluation of outcomes of articular cartilage surgery in the knee. To develop a reliable and valid knee articular cartilage-specific study methodological quality questionnaire. Cross-sectional study. A stepwise, a priori-designed framework was created for development of a novel questionnaire. Relevant items to the topic were identified and extracted from a recent systematic review of 194 investigations of knee articular cartilage surgery. In addition, relevant items from existing generic study methodological quality questionnaires were identified. Items for a preliminary questionnaire were generated. Redundant and irrelevant items were eliminated, and acceptable items modified. The instrument was pretested and items weighed. The instrument, the MARK score (Methodological quality of ARticular cartilage studies of the Knee), was tested for validity (criterion validity) and reliability (inter- and intraobserver). A 19-item, 3-domain MARK score was developed. The 100-point scale score demonstrated face validity (focus group of 8 orthopaedic surgeons) and criterion validity (strong correlation to Cochrane Quality Assessment score and Modified Coleman Methodology Score). Interobserver reliability for the overall score was good (intraclass correlation coefficient [ICC], 0.842), and for all individual items of the MARK score, acceptable to perfect (ICC, 0.70-1.000). Intraobserver reliability ICC assessed over a 3-week interval was strong for 2 reviewers (≥0.90). The MARK score is a valid and reliable knee articular cartilage condition-specific study methodological quality instrument. This condition-specific questionnaire may be used to evaluate the quality of studies reporting outcomes of articular cartilage surgery in the knee.

Statistical process control methods allow the analysis and improvement of anesthesia care.

PubMed

Fasting, Sigurd; Gisvold, Sven E

2003-10-01

Quality aspects of the anesthetic process are reflected in the rate of intraoperative adverse events. The purpose of this report is to illustrate how the quality of the anesthesia process can be analyzed using statistical process control methods, and exemplify how this analysis can be used for quality improvement. We prospectively recorded anesthesia-related data from all anesthetics for five years. The data included intraoperative adverse events, which were graded into four levels, according to severity. We selected four adverse events, representing important quality and safety aspects, for statistical process control analysis. These were: inadequate regional anesthesia, difficult emergence from general anesthesia, intubation difficulties and drug errors. We analyzed the underlying process using 'p-charts' for statistical process control. In 65,170 anesthetics we recorded adverse events in 18.3%; mostly of lesser severity. Control charts were used to define statistically the predictable normal variation in problem rate, and then used as a basis for analysis of the selected problems with the following results: Inadequate plexus anesthesia: stable process, but unacceptably high failure rate; Difficult emergence: unstable process, because of quality improvement efforts; Intubation difficulties: stable process, rate acceptable; Medication errors: methodology not suited because of low rate of errors. By applying statistical process control methods to the analysis of adverse events, we have exemplified how this allows us to determine if a process is stable, whether an intervention is required, and if quality improvement efforts have the desired effect.

[Clinical practice guidelines in Peru: evaluation of its quality using the AGREE II instrument].

PubMed

Canelo-Aybar, Carlos; Balbin, Graciela; Perez-Gomez, Ángela; Florez, Iván D

2016-01-01

To evaluate the methodological quality of clinical practice guidelines (CPGs) put into practice by the Peruvian Ministry of Health (MINSA), 17 CPGs from the ministry, published between 2009 and 2014, were independently evaluated by three methodologic experts using the AGREE II instrument. The score of AGREE II domains was low and very low in all CPGs: scope and purpose (medium, 44%), clarity of presentation (medium, 47%), participation of decision-makers (medium, 8%), methodological rigor (medium, 5%), applicability (medium, 5%), and editorial independence (medium, 8%). In conclusion, the methodological quality of CPGs implemented by the MINSA is low. Consequently, its use could not be recommended. The implementation of the methodology for the development of CPGs described in the recentlypublished CPG methodological preparation manual in Peru is a pressing need.

In Defense of the Randomized Controlled Trial for Health Promotion Research

PubMed Central

Rosen, Laura; Manor, Orly; Engelhard, Dan; Zucker, David

2006-01-01

The overwhelming evidence about the role lifestyle plays in mortality, morbidity, and quality of life has pushed the young field of modern health promotion to center stage. The field is beset with intense debate about appropriate evaluation methodologies. Increasingly, randomized designs are considered inappropriate for health promotion research. We have reviewed criticisms against randomized trials that raise philosophical and practical issues, and we will show how most of these criticisms can be overcome with minor design modifications. By providing rebuttal to arguments against randomized trials, our work contributes to building a sound methodological base for health promotion research. PMID:16735622

Lifestyle interventions to improve the quality of life of men with prostate cancer: A systematic review of randomized controlled trials.

PubMed

Menichetti, Julia; Villa, Silvia; Magnani, Tiziana; Avuzzi, Barbara; Bosetti, Davide; Marenghi, Cristina; Morlino, Sara; Rancati, Tiziana; Van Poppel, Hein; Salvioni, Roberto; Valdagni, Riccardo; Bellardita, Lara

2016-12-01

Improving quality of life is a key issue for patients with prostate cancer (PCa). Lifestyle interventions could positively impact the quality of life of patients. However, there is no clear-cut understanding of the role of diet, exercise and risky behaviour reduction in improving the quality of life of men with PCa. The aim of this review was to systematically summarize randomized controlled trials on lifestyle in PCa patients with quality of life as main outcome. 17 trials were included. Most of them referred to exercise interventions (71%) and involved men undergoing androgen deprivation therapy (47%). Exercise studies yielded the greater amount of positive results on quality of life outcomes (67%), followed by dietary interventions (50%) and combined lifestyle interventions (33%). In particular, supervised exercise programs with resistance training sessions were the ones producing greater convincing evidence for benefits on quality of life. Further studies with high methodological quality providing adequate information to develop evidence-based, personalized lifestyle interventions that can effectively ameliorate PCa-related quality of life are needed. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Mindfulness for palliative care patients. Systematic review.

PubMed

Latorraca, Carolina de Oliveira Cruz; Martimbianco, Ana Luiza Cabrera; Pachito, Daniela Vianna; Pacheco, Rafael Leite; Riera, Rachel

2017-12-01

Nineteen million adults worldwide are in need of palliative care. Of those who have access to it, 80% fail to receive an efficient management of symptoms. To assess the effectiveness and safety of mindfulness meditation for palliative care patients. We searched CENTRAL, MEDLINE, Embase, LILACS, PEDro, CINAHL, PsycINFO, Opengrey, ClinicalTrials.gov and WHO-ICTRP. No restriction of language, status or date of publication was applied. We considered randomised clinical trials (RCTs) comparing any mindfulness meditation scheme vs any comparator for palliative care. Cochrane Risk of Bias (Rob) Table was used for assessing methodological quality of RCTs. Screening, data extraction and methodological assessments were performed by two reviewers. Mean differences (MD) (confidence intervals of 95% (CI 95%)) were considered for estimating effect size. Quality of evidence was appraised by GRADE. Four RCTs, 234 participants, were included. All studies presented high risk of bias in at least one RoB table criteria. We assessed 4 comparisons, but only 2 studies showed statistically significant difference for at least one outcome. 1. Mindfulness meditation (eight weeks, one session/week, daily individual practice) vs control: statistically significant difference in favour of control for quality of life - physical aspects. 2. Mindfulness meditation (single 5-minute session) vs control: benefit in favour of mindfulness for stress outcome in both time-points. None of the included studies analysed safety and harms outcomes. Although two studies have showed statistically significant difference, only one showed effectiveness of mindfulness meditation in improving perceived stress. This study focused on one single session of mindfulness of 5 minutes for adult cancer patients in palliative care, but it was considered as possessing high risk of bias. Other schemes of mindfulness meditation did not show benefit in any outcome evaluated (low and very low quality evidence). © 2017 John Wiley & Sons Ltd.

The Efficacy, Safety and Applications of Medical Hypnosis.

PubMed

Häuser, Winfried; Hagl, Maria; Schmierer, Albrecht; Hansen, Ernil

2016-04-29

The efficacy and safety of hypnotic techniques in somatic medicine, known as medical hypnosis, have not been supported to date by adequate scientific evidence. We systematically reviewed meta-analyses of randomized controlled trials (RCTs) of medical hypnosis. Relevant publications (January 2005 to June 2015) were sought in the Cochrane databases CDSR and DARE, and in PubMed. Meta-analyses involving at least 400 patients were included in the present analysis. Their methodological quality was assessed with AMSTAR (A Measurement Tool to Assess Systematic Reviews). An additional search was carried out in the CENTRAL and PubMed databases for RCTs of waking suggestion (therapeutic suggestion without formal trance induction) in somatic medicine. Out of the 391 publications retrieved, five were reports of metaanalyses that met our inclusion criteria. One of these meta-analyses was of high methodological quality; three were of moderate quality, and one was of poor quality. Hypnosis was superior to controls with respect to the reduction of pain and emotional stress during medical interventions (34 RCTs, 2597 patients) as well as the reduction of irritable bowel symptoms (8 RCTs, 464 patients). Two meta-analyses revealed no differences between hypnosis and control treatment with respect to the side effects and safety of treatment. The effect size of hypnosis on emotional stress during medical interventions was low in one meta-analysis, moderate in one, and high in one. The effect size on pain during medical interventions was low. Five RCTs indicated that waking suggestion is effective in medical procedures. Medical hypnosis is a safe and effective complementary technique for use in medical procedures and in the treatment of irritable bowel syndrome. Waking suggestions can be a component of effective doctor-patient communication in routine clinical situations.

Effects of yoga on psychologic function and quality of life in women with breast cancer: a meta-analysis of randomized controlled trials.

PubMed

Zhang, Jun; Yang, Ke-hu; Tian, Jin-hui; Wang, Chun-mei

2012-11-01

The aim of this meta-analysis was to evaluate the effects of yoga on psychologic function and quality of life (QoL) in women with breast cancer. A systematic search of PubMed, EMBASE, the Cochrane Library, the Chinese Biomedical Literature Database, and the Chinese Digital Journals Full-text Database was carried out. Randomized control trials (RCTs) examining the effects of yoga, versus a control group receiving no intervention, on psychologic functioning and QoL in women with breast cancer were included. Methodological quality of included RCTs was assessed according to the Cochrane Handbook for Systematic Reviews of Interventions 5.0.1, and data were analyzed using the Cochrane Collaboration's Review Manager 5.1. Six (6) studies involving 382 patients were included. The meta-analysis showed that yoga can improve QoL for women with breast cancer. A statistically significant effect favoring yoga for the outcome of QoL was found (standard mean difference=0.27, 95% confidence interval [0.02, 0.52], p=0.03). Although the effects of yoga on psychologic function outcomes--such as anxiety, depression, distress and sleep--were in the expected direction, these effects were not statistically significant (p>0.05). Fatigue showed no significant difference (p>0.05). The present data provided little indication of how effective yoga might be when they were applied by women with breast cancer except for mildly effective in QOL improvement. The findings were based on a small body of evidence in which methodological quality was not high. Further well-designed RCTs with large sample size are needed to clarify the utility of yoga practice for this population.

Residents-as-teachers programs in psychiatry: a systematic review.

PubMed

Dewey, Charlene M; Coverdale, John H; Ismail, Nadia J; Culberson, John W; Thompson, Britta M; Patton, Cynthia S; Friedland, Joan A

2008-02-01

Because psychiatry residents have important roles as teachers and significant opportunities to contribute to medical student education, we set out to: identify all randomized control trials (RCT) for residents' teaching skills programs in psychiatry and to identify the efficacy of those interventions for improving teaching skills; identify the strengths and weaknesses of the available studies across medical disciplines; and identify currently available methods for enhancing residents' teaching skills for residents training in psychiatry. The published English-language literature was searched using PubMed, Social Sciences Index, and PsycINFO databases, with key search words including: residents, teaching skills, residents as teachers, psychiatry, and assessments. Both RCT and controlled, nonrandomized trials of residents' teaching programs directed to enhance residents' teaching skills were selected and critically appraised. Of 13 trials identified and reviewed, most included residents in internal medicine. Only one included psychiatry residents and assessed their ability to teach interviewing skills to medical students. Along with other studies, this study demonstrated improvement in residents' teaching skills. Overall, interventions and outcome measures were heterogeneous while the quality of methodologies varied. Five studies were of higher quality, representing examples of quality educational research. Several described group differences, blinding, good follow-up, and use of valid, reliable tools. Only one trial exists that incorporated psychiatry residents. Significant opportunity to advance educational research in this field exists. Psychiatry residency program directors should incorporate high-quality methodologies and can benefit from the findings of trials in other disciplines.

Design optimization for cost and quality: The robust design approach

NASA Technical Reports Server (NTRS)

Unal, Resit

1990-01-01

Designing reliable, low cost, and operable space systems has become the key to future space operations. Designing high quality space systems at low cost is an economic and technological challenge to the designer. A systematic and efficient way to meet this challenge is a new method of design optimization for performance, quality, and cost, called Robust Design. Robust Design is an approach for design optimization. It consists of: making system performance insensitive to material and subsystem variation, thus allowing the use of less costly materials and components; making designs less sensitive to the variations in the operating environment, thus improving reliability and reducing operating costs; and using a new structured development process so that engineering time is used most productively. The objective in Robust Design is to select the best combination of controllable design parameters so that the system is most robust to uncontrollable noise factors. The robust design methodology uses a mathematical tool called an orthogonal array, from design of experiments theory, to study a large number of decision variables with a significantly small number of experiments. Robust design also uses a statistical measure of performance, called a signal-to-noise ratio, from electrical control theory, to evaluate the level of performance and the effect of noise factors. The purpose is to investigate the Robust Design methodology for improving quality and cost, demonstrate its application by the use of an example, and suggest its use as an integral part of space system design process.

The impact of specialized palliative care on cancer patients' health-related quality of life: a systematic review and meta-analysis.

PubMed

Kassianos, Angelos P; Ioannou, Myria; Koutsantoni, Marianna; Charalambous, Haris

2018-01-01

Specialized palliative care (SPC) is currently underutilized or provided late in cancer care. The aim of this systematic review and meta-analysis is to critically evaluate the impact of SPC on patients' health-related quality of life (HRQoL). Five databases were searched through June 2016. Randomized controlled trials (RCTs) and prospective studies using a pre- and post- assessment of HRQoL were included. The PRISMA reporting statement was followed. Criteria from available checklists were used to evaluate the studies' quality. A meta-analysis followed using random-effect models separately for RCTs and non-RCTs. Eleven studies including five RCTs and 2939 cancer patients published between 2001 and 2014 were identified. There was improved HRQoL in patients with cancer following SPC especially in symptoms like pain, nausea, and fatigue as well as improvement of physical and psychological functioning. Less or no improvements were observed in social and spiritual domains. In general, studies of inpatients showed a larger benefit from SPC than studies of outpatients whereas patients' age and treatment duration did not moderate the impact of SPC. Methodological shortcomings of included studies include high attrition rates, low precision, and power and poor reporting of control procedures. The methodological problems and publication bias call for higher-quality studies to be designed, funded, and published. However, there is a clear message that SPC is multi-disciplinary and aims at palliation of symptoms and burden in line with current recommendations.

Systematic review of the methodological quality of controlled trials evaluating Chinese herbal medicine in patients with rheumatoid arthritis

PubMed Central

Pan, Xin; Lopez-Olivo, Maria A; Song, Juhee; Pratt, Gregory; Suarez-Almazor, Maria E

2017-01-01

Objectives We appraised the methodological and reporting quality of randomised controlled clinical trials (RCTs) evaluating the efficacy and safety of Chinese herbal medicine (CHM) in patients with rheumatoid arthritis (RA). Design For this systematic review, electronic databases were searched from inception until June 2015. The search was limited to humans and non-case report studies, but was not limited by language, year of publication or type of publication. Two independent reviewers selected RCTs, evaluating CHM in RA (herbals and decoctions). Descriptive statistics were used to report on risk of bias and their adherence to reporting standards. Multivariable logistic regression analysis was performed to determine study characteristics associated with high or unclear risk of bias. Results Out of 2342 unique citations, we selected 119 RCTs including 18 919 patients: 10 108 patients received CHM alone and 6550 received one of 11 treatment combinations. A high risk of bias was observed across all domains: 21% had a high risk for selection bias (11% from sequence generation and 30% from allocation concealment), 85% for performance bias, 89% for detection bias, 4% for attrition bias and 40% for reporting bias. In multivariable analysis, fewer authors were associated with selection bias (allocation concealment), performance bias and attrition bias, and earlier year of publication and funding source not reported or disclosed were associated with selection bias (sequence generation). Studies published in non-English language were associated with reporting bias. Poor adherence to recommended reporting standards (<60% of the studies not providing sufficient information) was observed in 11 of the 23 sections evaluated. Limitations Study quality and data extraction were performed by one reviewer and cross-checked by a second reviewer. Translation to English was performed by one reviewer in 85% of the included studies. Conclusions Studies evaluating CHM often fail to meet expected methodological criteria, and high-quality evidence is lacking. PMID:28249848

[Investigation on pattern and methods of quality control for Chinese materia medica based on dao-di herbs and bioassay - bioassay for Coptis chinensis].

PubMed

Yan, Dan; Xiao, Xiao-he

2011-05-01

Establishment of bioassay methods is the technical issues to be faced with in the bioassay of Chinese materia medica. Taking the bioassay of Coptis chinensis Franch. as an example, the establishment process and application of the bioassay methods (including bio-potency and bio-activity fingerprint) were explained from the aspects of methodology, principle of selection, experimental design, method confirmation and data analysis. The common technologies were extracted and formed with the above aspects, so as to provide technical support for constructing pattern and method of the quality control for Chinese materia medica based on the dao-di herbs and bioassay.

Comparison of methodologic quality and study/report characteristics between quantitative clinical nursing and nursing education research articles.

PubMed

Schneider, Barbara St Pierre; Nicholas, Jennifer; Kurrus, Jeffrey E

2013-01-01

To compare the methodologic quality and study/report characteristics between quantitative clinical nursing and nursing education research articles. The methodologic quality of quantitative nursing education research needs to advance to a higher level. Clinical research can provide guidance for nursing education to reach this level. One hundred quantitative clinical research articles from-high impact journals published in 2007 and 37 education research articles from high impact journals published in 2006 to 2007 were chosen for analysis. Clinical articles had significantly higher quality scores than education articles in three domains: number of institutions studied, type of data, and outcomes. The findings indicate three ways in which nursing education researchers can strengthen the methodologic quality of their quantitative research. With this approach, greater funding may be secured for advancing the science of nursing education.

Methodological Challenges in Studies Examining the Effects of Breakfast on Cognitive Performance and Appetite in Children and Adolescents.

PubMed

Adolphus, Katie; Bellissimo, Nick; Lawton, Clare L; Ford, Nikki A; Rains, Tia M; Totosy de Zepetnek, Julia; Dye, Louise

2017-01-01

Breakfast is purported to confer a number of benefits on diet quality, health, appetite regulation, and cognitive performance. However, new evidence has challenged the long-held belief that breakfast is the most important meal of the day. This review aims to provide a comprehensive discussion of the key methodological challenges and considerations in studies assessing the effect of breakfast on cognitive performance and appetite control, along with recommendations for future research. This review focuses on the myriad challenges involved in studying children and adolescents specifically. Key methodological challenges and considerations include study design and location, sampling and sample section, choice of objective cognitive tests, choice of objective and subjective appetite measures, merits of providing a fixed breakfast compared with ad libitum, assessment and definition of habitual breakfast consumption, transparency of treatment condition, difficulty of isolating the direct effects of breakfast consumption, untangling acute and chronic effects, and influence of confounding variables. These methodological challenges have hampered a clear substantiation of the potential positive effects of breakfast on cognition and appetite control and contributed to the debate questioning the notion that breakfast is the most important meal of the day. © 2017 American Society for Nutrition.

Methodological Challenges in Studies Examining the Effects of Breakfast on Cognitive Performance and Appetite in Children and Adolescents123

PubMed Central

Bellissimo, Nick; Ford, Nikki A; Rains, Tia M

2017-01-01

Breakfast is purported to confer a number of benefits on diet quality, health, appetite regulation, and cognitive performance. However, new evidence has challenged the long-held belief that breakfast is the most important meal of the day. This review aims to provide a comprehensive discussion of the key methodological challenges and considerations in studies assessing the effect of breakfast on cognitive performance and appetite control, along with recommendations for future research. This review focuses on the myriad challenges involved in studying children and adolescents specifically. Key methodological challenges and considerations include study design and location, sampling and sample section, choice of objective cognitive tests, choice of objective and subjective appetite measures, merits of providing a fixed breakfast compared with ad libitum, assessment and definition of habitual breakfast consumption, transparency of treatment condition, difficulty of isolating the direct effects of breakfast consumption, untangling acute and chronic effects, and influence of confounding variables. These methodological challenges have hampered a clear substantiation of the potential positive effects of breakfast on cognition and appetite control and contributed to the debate questioning the notion that breakfast is the most important meal of the day. PMID:28096143

The association between head and cervical posture and temporomandibular disorders: a systematic review.

PubMed

Olivo, Susan Armijo; Bravo, Jaime; Magee, David J; Thie, Norman M R; Major, Paul W; Flores-Mir, Carlos

2006-01-01

To carry out a systematic review to assess the evidence concerning the association between head and cervical posture and temporomandibular disorders (TMD). A search of Medline, Pubmed, Embase, Web of Science, Lilacs, and Cochrane Library databases was conducted in all languages with the help of a health sciences librarian. Key words used in the search were posture, head posture, cervical spine or neck, vertebrae, cervical lordosis, craniomandibular disorders or temporomandibular disorders, temporomandibular disorders, and orofacial pain or facial pain. Abstracts which appeared to fulfill the initial selection criteria were selected by consensus. The original articles were retrieved and evaluated to ensure they met the inclusion criteria. A methodological checklist was used to evaluate the quality of the selected articles and their references were hand-searched for possible missing articles. Twelve studies met all inclusion criteria and were analyzed in detail for their methodology and information quality. Nine articles that analyzed the association between head posture and TMD included patients with mixed TMD diagnosis; 1 article differentiated among muscular, articular, and mixed symptomatology; and 3 articles analyzed information from patients with only articular problems. Finally, 2 studies evaluated the association between head posture and TMD in patients with muscular TMD. Several methodological defects were noted in the 12 studies. Since most of the studies included in this systematic review were of poor methodological quality, the findings of the studies should be interpreted with caution. The association between intra-articular and muscular TMD and head and cervical posture is still unclear, and better controlled studies with comprehensive TMD diagnoses, greater sample sizes, and objective posture evaluation are necessary.

Zhen Gan Xi Feng Decoction, a Traditional Chinese Herbal Formula, for the Treatment of Essential Hypertension: A Systematic Review of Randomized Controlled Trials

PubMed Central

Xiong, Xingjiang; Yang, Xiaochen; Feng, Bo; Liu, Wei; Duan, Lian; Gao, Ao; Li, Haixia; Ma, Jizheng; Du, Xinliang; Li, Nan; Wang, Pengqian; Su, Kelei; Chu, Fuyong; Zhang, Guohao; Li, Xiaoke; Wang, Jie

2013-01-01

Objectives. To assess the clinical effectiveness and adverse effects of Zhen Gan Xi Feng Decoction (ZGXFD) for essential hypertension (EH). Methods. Five major electronic databases were searched up to August 2012 to retrieve any potential randomized controlled trials designed to evaluate the clinical effectiveness of ZGXFD for EH reported in any language, with main outcome measure as blood pressure (BP). Results. Six randomized trials were included. Methodological quality of the trials was evaluated as generally low. Four trials compared prescriptions based on ZGXFD with antihypertensive drugs. Meta-analysis showed that ZGXFD was more effective in BP control and TCM syndrome and symptom differentiation (TCM-SSD) scores than antihypertensive drugs. Two trials compared the combination of modified ZGXFD plus antihypertensive drugs with antihypertensive drugs. Meta-analysis showed that there is significant beneficial effect on TCM-SSD scores. However, no significant effect on BP was found. The safety of ZGXFD is still uncertain. Conclusions. ZGXFD appears to be effective in improving blood pressure and hypertension-related symptoms for EH. However, the evidence remains weak due to poor methodological quality of the included studies. More rigorous trials are warranted to support their clinical use. PMID:23573163

Activity and participation, quality of life and user satisfaction outcomes of environmental control systems and smart home technology: a systematic review.

PubMed

Brandt, Ase; Samuelsson, Kersti; Töytäri, Outi; Salminen, Anna-Liisa

2011-01-01

To examine activity and participation, quality of life, and user satisfaction outcomes of environmental control systems (ECSs) and smart home technology (SHT) interventions for persons with impairments. A systematic review. Seventeen databases, three conference proceedings, and two journals were searched without language or study design restrictions covering the period January 1993 - June 2009. Reviewers selected studies, extracted data, and assessed the methodological quality independently. Of 1739 studies identified, five effect studies and six descriptive studies were included. One study was on SHT and the remainder on ECS; functionalities were overlapping. The studies varied in most aspects, and no synthesis could be drawn. However, ECS/SHT tended to increase study participants' independence, instrumental activities of daily living, socialising, and quality of life. Two studies showed high user satisfaction. The level of evidence was regarded as low, mainly due to small study sizes, lacking confounder control, and a majority of descriptive studies. Due to few and small studies and study diversity, it was not possible to determine whether ECS/SHT have positive outcomes for persons with impairment, even though the technologies seem to be promising. High quality outcomes studies such as randomised controlled trials, when feasible, and large longitudinal multi-centre studies are required.

75 FR 65039 - Submission for Review: Performance Measurement Surveys, OMB Control No. 3206-NEW

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-21

... June 21, 2010 at 75 FR 35092 allowing for a 60-day public comment period. No comments were received for... comments. The Office of Management and Budget is particularly interested in comments that: 1. Evaluate... of the methodology and assumptions used; 3. Enhance the quality, utility, and clarity of the...

Curbing variations in packaging process through Six Sigma way in a large-scale food-processing industry

NASA Astrophysics Data System (ADS)

Desai, Darshak A.; Kotadiya, Parth; Makwana, Nikheel; Patel, Sonalinkumar

2015-03-01

Indian industries need overall operational excellence for sustainable profitability and growth in the present age of global competitiveness. Among different quality and productivity improvement techniques, Six Sigma has emerged as one of the most effective breakthrough improvement strategies. Though Indian industries are exploring this improvement methodology to their advantage and reaping the benefits, not much has been presented and published regarding experience of Six Sigma in the food-processing industries. This paper is an effort to exemplify the application of Six Sigma quality improvement drive to one of the large-scale food-processing sectors in India. The paper discusses the phase wiz implementation of define, measure, analyze, improve, and control (DMAIC) on one of the chronic problems, variations in the weight of milk powder pouch. The paper wraps up with the improvements achieved and projected bottom-line gain to the unit by application of Six Sigma methodology.

Effect of IN718 Recycled Powder Reuse on Properties of Parts Manufactured by Means of Selective Laser Melting

NASA Astrophysics Data System (ADS)

Ardila, L. C.; Garciandia, F.; González-Díaz, J. B.; Álvarez, P.; Echeverria, A.; Petite, M. M.; Deffley, R.; Ochoa, J.

Powder quality control is essential to obtain parts with suitable mechanical properties in Selective Laser Melting manufacturing technique. One of the most important advantages of suchtechnique is that it allows an efficient use of the material, due to the possibility to recycle and reuse un-melted powder. Nevertheless, powder material properties may change due to repeated recycling, affecting this way the mechanicalbehavior of parts. In this paper the effect of powder reuse on its quality and on the mechanical properties of the resulting melted parts is studied via self-developed recycling methodology. The material considered for investigation was IN718, a nickel superalloy widely used in industry. After recycling powder up to 14 times, no significant changes were observed in powder and test parts properties. The results obtained in this work will help to validate powder recycling methodology for its use in current industrial Selective Laser Melting manufacturing.

The effectiveness of hydrotherapy in the management of fibromyalgia syndrome: a systematic review.

PubMed

McVeigh, Joseph G; McGaughey, Helen; Hall, Melissa; Kane, Patricia

2008-12-01

Hydrotherapy is often used in the treatment of fibromyalgia syndrome (FMS), however there has been limited evaluation of its effectiveness. The aim of this systematic review was therefore to examine the effectiveness of hydrotherapy in the management of FMS. AMED, BNI, CINAHL, The Cochrane Library, EMBASE, MEDLINE, ProQuest, PubMed, Science Direct and Web of Science were searched (1990-July 2006). Key words used 'fibromyalgia' and 'hydrotherapy', 'balneotherapy', 'aqua therapy', 'pool therapy', 'water therapy', 'swimming', 'hydrogalvanic', 'spa therapy', 'physiotherapy', 'physical therapy' and 'rehabilitation'. Searches were supplemented with hand searches of selected journals. Randomised controlled trials (RCTs) were assessed for methodological quality using the van Tulder scale. Ten RCTs met the inclusion criteria. Mean methodological quality was 4.5/9 on the van Tulder scale. Positive outcomes were reported for pain, health-status and tender point count. There is strong evidence for the use of hydrotherapy in the management of FMS.

Automated Quality Control of in Situ Soil Moisture from the North American Soil Moisture Database Using NLDAS-2 Products

NASA Astrophysics Data System (ADS)

Ek, M. B.; Xia, Y.; Ford, T.; Wu, Y.; Quiring, S. M.

2015-12-01

The North American Soil Moisture Database (NASMD) was initiated in 2011 to provide support for developing climate forecasting tools, calibrating land surface models and validating satellite-derived soil moisture algorithms. The NASMD has collected data from over 30 soil moisture observation networks providing millions of in situ soil moisture observations in all 50 states as well as Canada and Mexico. It is recognized that the quality of measured soil moisture in NASMD is highly variable due to the diversity of climatological conditions, land cover, soil texture, and topographies of the stations and differences in measurement devices (e.g., sensors) and installation. It is also recognized that error, inaccuracy and imprecision in the data set can have significant impacts on practical operations and scientific studies. Therefore, developing an appropriate quality control procedure is essential to ensure the data is of the best quality. In this study, an automated quality control approach is developed using the North American Land Data Assimilation System phase 2 (NLDAS-2) Noah soil porosity, soil temperature, and fraction of liquid and total soil moisture to flag erroneous and/or spurious measurements. Overall results show that this approach is able to flag unreasonable values when the soil is partially frozen. A validation example using NLDAS-2 multiple model soil moisture products at the 20 cm soil layer showed that the quality control procedure had a significant positive impact in Alabama, North Carolina, and West Texas. It had a greater impact in colder regions, particularly during spring and autumn. Over 433 NASMD stations have been quality controlled using the methodology proposed in this study, and the algorithm will be implemented to control data quality from the other ~1,200 NASMD stations in the near future.

Instruments evaluating the quality of the clinical learning environment in nursing education: A systematic review of psychometric properties.

PubMed

Mansutti, Irene; Saiani, Luisa; Grassetti, Luca; Palese, Alvisa

2017-03-01

The clinical learning environment is fundamental to nursing education paths, capable of affecting learning processes and outcomes. Several instruments have been developed in nursing education, aimed at evaluating the quality of the clinical learning environments; however, no systematic review of the psychometric properties and methodological quality of these studies has been performed to date. The aims of the study were: 1) to identify validated instruments evaluating the clinical learning environments in nursing education; 2) to evaluate critically the methodological quality of the psychometric property estimation used; and 3) to compare psychometric properties across the instruments available. A systematic review of the literature (using the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines) and an evaluation of the methodological quality of psychometric properties (using the COnsensus-based Standards for the selection of health Measurement INstruments guidelines). The Medline and CINAHL databases were searched. Eligible studies were those that satisfied the following criteria: a) validation studies of instruments evaluating the quality of clinical learning environments; b) in nursing education; c) published in English or Italian; d) before April 2016. The included studies were evaluated for the methodological quality of the psychometric properties measured and then compared in terms of both the psychometric properties and the methodological quality of the processes used. The search strategy yielded a total of 26 studies and eight clinical learning environment evaluation instruments. A variety of psychometric properties have been estimated for each instrument, with differing qualities in the methodology used. Concept and construct validity were poorly assessed in terms of their significance and rarely judged by the target population (nursing students). Some properties were rarely considered (e.g., reliability, measurement error, criterion validity), whereas others were frequently estimated, but using different coefficients and statistical analyses (e.g., internal consistency, structural validity), thus rendering comparison across instruments difficult. Moreover, the methodological quality adopted in the property assessments was poor or fair in most studies, compromising the goodness of the psychometric values estimated. Clinical learning placements represent the key strategies in educating the future nursing workforce: instruments evaluating the quality of the settings, as well as their capacity to promote significant learning, are strongly recommended. Studies estimating psychometric properties, using an increased quality of research methodologies are needed in order to support nursing educators in the process of clinical placements accreditation and quality improvement. Copyright © 2017 Elsevier Ltd. All rights reserved.

DPP-4 inhibitors for the treatment of type 2 diabetes: a methodology overview of systematic reviews.

PubMed

Ling, Juan; Ge, Long; Zhang, Ding-Hua; Wang, Yong-Feng; Xie, Zhuo-Lin; Tian, Jin-Hui; Xiao, Xiao-Hui; Yang, Ke-Hu

2018-06-01

To evaluate the methodological quality of systematic reviews (SRs), and summarize evidence of important outcomes from dipeptidyl peptidase-4 inhibitors (DPP4-I) in treating type 2 diabetes mellitus (T2DM). We included SRs of DPP4-I for the treatment of T2DM until January, 2018 by searching the Cochrane Library, PubMed, EMBASE and three Chinese databases. We evaluated the methodological qualities with the AMSTAR (Assessing the Methodological Quality of Systematic Reviews) tool and the GRADE (The Grading of Recommendations Assessment, Development and Evaluation) approach. Sixty-three SRs (a total of 2,603,140 participants) receiving DPP4-I for the treatment of T2DM were included. The results of AMSTAR showed that the lowest quality was "a list of studies (included and excluded) item" with only one (1.6%) study provided, followed by the "providing a priori design" item with only four (6.3%) studies conforming to this item, the next were "the status of publication (gray literature) used as an inclusion criterion item", with only 18 (28.9%) studies conforming to these items. Only seven (11.1%) studies scored more than nine points in AMSTAR, indicating high methodological quality. For GRADE, of the 128 outcomes, high quality evidence was provided in only 28 (21.9%), moderate in 70 (54.7%), low in 27 (21.1%), and very low in three (2.3%). The methodological quality of SRs of DPP4-I for type 2 diabetes mellitus is not high and there are common areas for improvement. Furthermore, the quality of evidence level is moderate and more high quality evidence is needed.

Combining controlled-source seismology and receiver function information to derive 3-D Moho topography for Italy

NASA Astrophysics Data System (ADS)

Spada, M.; Bianchi, I.; Kissling, E.; Agostinetti, N. Piana; Wiemer, S.

2013-08-01

The accurate definition of 3-D crustal structures and, in primis, the Moho depth, are the most important requirement for seismological, geophysical and geodynamic modelling in complex tectonic regions. In such areas, like the Mediterranean region, various active and passive seismic experiments are performed, locally reveal information on Moho depth, average and gradient crustal Vp velocity and average Vp/Vs velocity ratios. Until now, the most reliable information on crustal structures stems from controlled-source seismology experiments. In most parts of the Alpine region, a relatively large number of controlled-source seismology information are available though the overall coverage in the central Mediterranean area is still sparse due to high costs of such experiments. Thus, results from other seismic methodologies, such as local earthquake tomography, receiver functions and ambient noise tomography can be used to complement the controlled-source seismology information to increase coverage and thus the quality of 3-D crustal models. In this paper, we introduce a methodology to directly combine controlled-source seismology and receiver functions information relying on the strengths of each method and in relation to quantitative uncertainty estimates for all data to derive a well resolved Moho map for Italy. To obtain a homogeneous elaboration of controlled-source seismology and receiver functions results, we introduce a new classification/weighting scheme based on uncertainty assessment for receiver functions data. In order to tune the receiver functions information quality, we compare local receiver functions Moho depths and uncertainties with a recently derived well-resolved local earthquake tomography-derived Moho map and with controlled-source seismology information. We find an excellent correlation in the Moho information obtained by these three methodologies in Italy. In the final step, we interpolate the controlled-source seismology and receiver functions information to derive the map of Moho topography in Italy and surrounding regions. Our results show high-frequency undulation in the Moho topography of three different Moho interfaces, the European, the Adriatic-Ionian, and the Liguria-Corsica-Sardinia-Tyrrhenia, reflecting the complexity of geodynamical evolution.

Epidemiology characteristics, reporting characteristics, and methodological quality of systematic reviews and meta-analyses on traditional Chinese medicine nursing interventions published in Chinese journals.

PubMed

Yang, Min; Jiang, Li; Wang, Aihong; Xu, Guihua

2017-02-01

To evaluate the epidemiological characteristics, reporting characteristics, and methodological quality of systematic reviews in the traditional Chinese medicine nursing field published in Chinese journals. The number of systematic reviews in the traditional Chinese medicine nursing field has increased, but their epidemiology, quality, and reporting characteristics have not been assessed completely. We generated an overview of reviews using a narrative approach. Four Chinese databases were searched for systematic reviews from inception to December 2015. The Preferred Reporting Items of Systematic Reviews and Meta-analyses and the Assessment of Multiple Systematic Reviews checklists were adopted to evaluate reporting and methodological quality, respectively. A total of 73 eligible systematic reviews, published from 2005 to 2015, were included. The deficiencies in reporting characteristics mainly lay in the lack of structured abstract or protocol, incomplete reporting of search strategies, study selection, and risk of bias. The deficiencies in methodological quality were reflected in the lack of a priori design and conflict of interest, incomplete literature searches, and assessment of publication bias. The quality of the evaluated reviews was unsatisfactory; attention should be paid to the improvement of reporting and methodological quality in the conduct of systematic reviews. © 2016 John Wiley & Sons Australia, Ltd.

A methodology for least-squares local quasi-geoid modelling using a noisy satellite-only gravity field model

NASA Astrophysics Data System (ADS)

Klees, R.; Slobbe, D. C.; Farahani, H. H.

2018-04-01

The paper is about a methodology to combine a noisy satellite-only global gravity field model (GGM) with other noisy datasets to estimate a local quasi-geoid model using weighted least-squares techniques. In this way, we attempt to improve the quality of the estimated quasi-geoid model and to complement it with a full noise covariance matrix for quality control and further data processing. The methodology goes beyond the classical remove-compute-restore approach, which does not account for the noise in the satellite-only GGM. We suggest and analyse three different approaches of data combination. Two of them are based on a local single-scale spherical radial basis function (SRBF) model of the disturbing potential, and one is based on a two-scale SRBF model. Using numerical experiments, we show that a single-scale SRBF model does not fully exploit the information in the satellite-only GGM. We explain this by a lack of flexibility of a single-scale SRBF model to deal with datasets of significantly different bandwidths. The two-scale SRBF model performs well in this respect, provided that the model coefficients representing the two scales are estimated separately. The corresponding methodology is developed in this paper. Using the statistics of the least-squares residuals and the statistics of the errors in the estimated two-scale quasi-geoid model, we demonstrate that the developed methodology provides a two-scale quasi-geoid model, which exploits the information in all datasets.

"A manager in the minds of doctors:" a comparison of new modes of control in European hospitals.

PubMed

Kuhlmann, Ellen; Burau, Viola; Correia, Tiago; Lewandowski, Roman; Lionis, Christos; Noordegraaf, Mirko; Repullo, Jose

2013-07-02

Hospital governance increasingly combines management and professional self-governance. This article maps the new emergent modes of control in a comparative perspective and aims to better understand the relationship between medicine and management as hybrid and context-dependent. Theoretically, we critically review approaches into the managerialism-professionalism relationship; methodologically, we expand cross-country comparison towards the meso-level of organisations; and empirically, the focus is on processes and actors in a range of European hospitals. The research is explorative and was carried out as part of the FP7 COST action IS0903 Medicine and Management, Working Group 2. Comprising seven European countries, the focus is on doctors and public hospitals. We use a comparative case study design that primarily draws on expert information and document analysis as well as other secondary sources. The findings reveal that managerial control is not simply an external force but increasingly integrated in medical professionalism. These processes of change are relevant in all countries but shaped by organisational settings, and therefore create different patterns of control: (1) 'integrated' control with high levels of coordination and coherent patterns for cost and quality controls; (2) 'partly integrated' control with diversity of coordination on hospital and department level and between cost and quality controls; and (3) 'fragmented' control with limited coordination and gaps between quality control more strongly dominated by medicine, and cost control by management. Our comparison highlights how organisations matter and brings the crucial relevance of 'coordination' of medicine and management across the levels (hospital/department) and the substance (cost/quality-safety) of control into perspective. Consequently, coordination may serve as a taxonomy of emergent modes of control, thus bringing new directions for cost-efficient and quality-effective hospital governance into perspective.

Methodology for Knowledge Synthesis of the Management of Vaccination Pain and Needle Fear.

PubMed

Taddio, Anna; McMurtry, C Meghan; Shah, Vibhuti; Yoon, Eugene W; Uleryk, Elizabeth; Pillai Riddell, Rebecca; Lang, Eddy; Chambers, Christine T; Noel, Melanie; MacDonald, Noni E

2015-10-01

A knowledge synthesis was undertaken to inform the development of a revised and expanded clinical practice guideline about managing vaccination pain in children to include the management of pain across the lifespan and the management of fear in individuals with high levels of needle fear. This manuscript describes the methodological details of the knowledge synthesis and presents the list of included clinical questions, critical and important outcomes, search strategy, and search strategy results. The Grading of Assessments, Recommendations, Development and Evaluation (GRADE) and Cochrane methodologies provided the general framework. The project team voted on clinical questions for inclusion and critically important and important outcomes. A broad search strategy was used to identify relevant randomized-controlled trials and quasi-randomized-controlled trials. Quality of research evidence was assessed using the Cochrane risk of bias tool and quality across studies was assessed using GRADE. Multiple measures of the same construct within studies (eg, observer-rated and parent-rated infant distress) were combined before pooling. The standardized mean difference and 95% confidence intervals (CI) or relative risk and 95% CI was used to express the effects of an intervention. Altogether, 55 clinical questions were selected for inclusion in the knowledge synthesis; 49 pertained to pain management during vaccine injections and 6 pertained to fear management in individuals with high levels of needle fear. Pain, fear, and distress were typically prioritized as critically important outcomes across clinical questions. The search strategy identified 136 relevant studies. This manuscript describes the methodological details of a knowledge synthesis about pain management during vaccination and fear management in individuals with high levels of needle fear. Subsequent manuscripts in this series will present the results for the included questions.

Electronic symptom reporting between patient and provider for improved health care service quality: a systematic review of randomized controlled trials. part 2: methodological quality and effects.

PubMed

Johansen, Monika Alise; Berntsen, Gro K Rosvold; Schuster, Tibor; Henriksen, Eva; Horsch, Alexander

2012-10-03

We conducted in two parts a systematic review of randomized controlled trials (RCTs) on electronic symptom reporting between patients and providers to improve health care service quality. Part 1 reviewed the typology of patient groups, health service innovations, and research targets. Four innovation categories were identified: consultation support, monitoring with clinician support, self-management with clinician support, and therapy. To assess the methodological quality of the RCTs, and summarize effects and benefits from the methodologically best studies. We searched Medline, EMBASE, PsycINFO, Cochrane Central Register of Controlled Trials, and IEEE Xplore for original studies presented in English-language articles between 1990 and November 2011. Risk of bias and feasibility were judged according to the Cochrane recommendation, and theoretical evidence and preclinical testing were evaluated according to the Framework for Design and Evaluation of Complex Interventions to Improve Health. Three authors assessed the risk of bias and two authors extracted the effect data independently. Disagreement regarding bias assessment, extraction, and interpretation of results were resolved by consensus discussions. Of 642 records identified, we included 32 articles representing 29 studies. No articles fulfilled all quality requirements. All interventions were feasible to implement in a real-life setting, and theoretical evidence was provided for almost all studies. However, preclinical testing was reported in only a third of the articles. We judged three-quarters of the articles to have low risk for random sequence allocation and approximately half of the articles to have low risk for the following biases: allocation concealment, incomplete outcome data, and selective reporting. Slightly more than one fifth of the articles were judged as low risk for blinding of outcome assessment. Only 1 article had low risk of bias for blinding of participants and personnel. We excluded 12 articles showing high risk or unclear risk for both selective reporting and blinding of outcome assessment from the effect assessment. The authors' hypothesis was confirmed for 13 (65%) of the 20 remaining articles. Articles on self-management support were of higher quality, allowing us to assess effects in a larger proportion of studies. All except one self-management interventions were equally effective to or better than the control option. The self-management articles document substantial benefits for patients, and partly also for health professionals and the health care system. Electronic symptom reporting between patients and providers is an exciting area of development for health services. However, the research generally is of low quality. The field would benefit from increased focus on methods for conducting and reporting RCTs. It appears particularly important to improve blinding of outcome assessment and to precisely define primary outcomes to avoid selective reporting. Supporting self-management seems to be especially promising, but consultation support also shows encouraging results.

Electronic Symptom Reporting Between Patient and Provider for Improved Health Care Service Quality: A Systematic Review of Randomized Controlled Trials. Part 2: Methodological Quality and Effects

PubMed Central

Berntsen, Gro K Rosvold; Schuster, Tibor; Henriksen, Eva; Horsch, Alexander

2012-01-01

Background We conducted in two parts a systematic review of randomized controlled trials (RCTs) on electronic symptom reporting between patients and providers to improve health care service quality. Part 1 reviewed the typology of patient groups, health service innovations, and research targets. Four innovation categories were identified: consultation support, monitoring with clinician support, self-management with clinician support, and therapy. Objective To assess the methodological quality of the RCTs, and summarize effects and benefits from the methodologically best studies. Methods We searched Medline, EMBASE, PsycINFO, Cochrane Central Register of Controlled Trials, and IEEE Xplore for original studies presented in English-language articles between 1990 and November 2011. Risk of bias and feasibility were judged according to the Cochrane recommendation, and theoretical evidence and preclinical testing were evaluated according to the Framework for Design and Evaluation of Complex Interventions to Improve Health. Three authors assessed the risk of bias and two authors extracted the effect data independently. Disagreement regarding bias assessment, extraction, and interpretation of results were resolved by consensus discussions. Results Of 642 records identified, we included 32 articles representing 29 studies. No articles fulfilled all quality requirements. All interventions were feasible to implement in a real-life setting, and theoretical evidence was provided for almost all studies. However, preclinical testing was reported in only a third of the articles. We judged three-quarters of the articles to have low risk for random sequence allocation and approximately half of the articles to have low risk for the following biases: allocation concealment, incomplete outcome data, and selective reporting. Slightly more than one fifth of the articles were judged as low risk for blinding of outcome assessment. Only 1 article had low risk of bias for blinding of participants and personnel. We excluded 12 articles showing high risk or unclear risk for both selective reporting and blinding of outcome assessment from the effect assessment. The authors’ hypothesis was confirmed for 13 (65%) of the 20 remaining articles. Articles on self-management support were of higher quality, allowing us to assess effects in a larger proportion of studies. All except one self-management interventions were equally effective to or better than the control option. The self-management articles document substantial benefits for patients, and partly also for health professionals and the health care system. Conclusion Electronic symptom reporting between patients and providers is an exciting area of development for health services. However, the research generally is of low quality. The field would benefit from increased focus on methods for conducting and reporting RCTs. It appears particularly important to improve blinding of outcome assessment and to precisely define primary outcomes to avoid selective reporting. Supporting self-management seems to be especially promising, but consultation support also shows encouraging results. PMID:23032363

A flood tide of systematic reviews on endodontic posts: methodological assessment using of R-AMSTAR.

PubMed

Schmitter, M; Sterzenbach, G; Faggion, C M; Krastl, G

2013-06-01

To help the dental practitioner solve a specific clinical problem, systematic reviews (SRs) are seen as the best guide. In addition to the unmanageable quantity of SRs, however, one should be aware of their variable quality. The present review describes the methodological quality of SRs on postendodontic restorations to work out the value of these reviews for the dental practitioner. SRs were searched in April 2012, independently and in triplicate. Post survival was used as measure of outcome. The methodological quality of included SRs was assessed with the Revised Assessment of Multiple Systematic Reviews (R-AMSTAR) checklist. Kappa statistics were used to assess reviewer agreement. Three hundred sixty-three papers were retrieved from the initial search. Ten SRs were included. One SR achieved a high R-AMSTAR score, whereas the other nine SRs achieved scores that indicate a substantial lack of methodological quality. Especially the items "grey literature," "combination of findings," "likelihood of publication bias," and conflict of interest" showed low R-AMSTAR scores. The three reviews with the highest R-AMSTAR scores tended to conclude that fewer failures occurred when using nonmetal posts. The reviewer agreement was excellent (kappa ranged from 0.79 to 0.85) in the R-AMSTAR classification. The approach presented revealed a lack of SRs with high methodological quality. Thus, no decisive conclusion can be drawn with respect to this topic. It appears that there is a trend for the superiority of fiber-reinforced posts. SRs must be of high methodological quality. This can be achieved by taking into consideration the results of this review. Improved methodological quality would make SRs more supportive for the general practitioner.

Approaching the Practice Quality Improvement Project in Interventional Radiology.

PubMed

Reis, Stephen P; White, Benjamin; Sutphin, Patrick D; Pillai, Anil K; Kalva, Sanjeeva P; Toomay, Seth M

2015-12-01

An important component of maintenance of certification and quality improvement in radiology is the practice quality improvement (PQI) project. In this article, the authors describe several methodologies for initiating and completing PQI projects. Furthermore, the authors illustrate several tools that are vital in compiling, analyzing, and presenting data in an easily understandable and reproducible manner. Last, they describe two PQI projects performed in an interventional radiology division that have successfully improved the quality of care for patients. Using the DMAIC (define, measure, analyze, improve, control) quality improvement framework, interventional radiology throughput has been increased, to lessen mediport wait times from 43 to 8 days, and mediport infection rates have decreased from more than 2% to less than 0.4%. Copyright © 2015 American College of Radiology. Published by Elsevier Inc. All rights reserved.

Evidence-based decision-making in infectious diseases epidemiology, prevention and control: matching research questions to study designs and quality appraisal tools

PubMed Central

2014-01-01

Background The Project on a Framework for Rating Evidence in Public Health (PRECEPT) was initiated and is being funded by the European Centre for Disease Prevention and Control (ECDC) to define a methodology for evaluating and grading evidence and strength of recommendations in the field of public health, with emphasis on infectious disease epidemiology, prevention and control. One of the first steps was to review existing quality appraisal tools (QATs) for individual research studies of various designs relevant to this area, using a question-based approach. Methods Through team discussions and expert consultations, we identified 20 relevant types of public health questions, which were grouped into six domains, i.e. characteristics of the pathogen, burden of disease, diagnosis, risk factors, intervention, and implementation of intervention. Previously published systematic reviews were used and supplemented by expert consultation to identify suitable QATs. Finally, a matrix was constructed for matching questions to study designs suitable to address them and respective QATs. Key features of each of the included QATs were then analyzed, in particular in respect to its intended use, types of questions and answers, presence/absence of a quality score, and if a validation was performed. Results In total we identified 21 QATs and 26 study designs, and matched them. Four QATs were suitable for experimental quantitative study designs, eleven for observational quantitative studies, two for qualitative studies, three for economic studies, one for diagnostic test accuracy studies, and one for animal studies. Included QATs consisted of six to 28 items. Six of the QATs had a summary quality score. Fourteen QATs had undergone at least one validation procedure. Conclusions The results of this methodological study can be used as an inventory of potentially relevant questions, appropriate study designs and QATs for researchers and authorities engaged with evidence-based decision-making in infectious disease epidemiology, prevention and control. PMID:24886571

Evidence-based decision-making in infectious diseases epidemiology, prevention and control: matching research questions to study designs and quality appraisal tools.

PubMed

Harder, Thomas; Takla, Anja; Rehfuess, Eva; Sánchez-Vivar, Alex; Matysiak-Klose, Dorothea; Eckmanns, Tim; Krause, Gérard; de Carvalho Gomes, Helena; Jansen, Andreas; Ellis, Simon; Forland, Frode; James, Roberta; Meerpohl, Joerg J; Morgan, Antony; Schünemann, Holger; Zuiderent-Jerak, Teun; Wichmann, Ole

2014-05-21

The Project on a Framework for Rating Evidence in Public Health (PRECEPT) was initiated and is being funded by the European Centre for Disease Prevention and Control (ECDC) to define a methodology for evaluating and grading evidence and strength of recommendations in the field of public health, with emphasis on infectious disease epidemiology, prevention and control. One of the first steps was to review existing quality appraisal tools (QATs) for individual research studies of various designs relevant to this area, using a question-based approach. Through team discussions and expert consultations, we identified 20 relevant types of public health questions, which were grouped into six domains, i.e. characteristics of the pathogen, burden of disease, diagnosis, risk factors, intervention, and implementation of intervention. Previously published systematic reviews were used and supplemented by expert consultation to identify suitable QATs. Finally, a matrix was constructed for matching questions to study designs suitable to address them and respective QATs. Key features of each of the included QATs were then analyzed, in particular in respect to its intended use, types of questions and answers, presence/absence of a quality score, and if a validation was performed. In total we identified 21 QATs and 26 study designs, and matched them. Four QATs were suitable for experimental quantitative study designs, eleven for observational quantitative studies, two for qualitative studies, three for economic studies, one for diagnostic test accuracy studies, and one for animal studies. Included QATs consisted of six to 28 items. Six of the QATs had a summary quality score. Fourteen QATs had undergone at least one validation procedure. The results of this methodological study can be used as an inventory of potentially relevant questions, appropriate study designs and QATs for researchers and authorities engaged with evidence-based decision-making in infectious disease epidemiology, prevention and control.

Cluster Randomised Trials in Cochrane Reviews: Evaluation of Methodological and Reporting Practice.

PubMed

Richardson, Marty; Garner, Paul; Donegan, Sarah

2016-01-01

Systematic reviews can include cluster-randomised controlled trials (C-RCTs), which require different analysis compared with standard individual-randomised controlled trials. However, it is not known whether review authors follow the methodological and reporting guidance when including these trials. The aim of this study was to assess the methodological and reporting practice of Cochrane reviews that included C-RCTs against criteria developed from existing guidance. Criteria were developed, based on methodological literature and personal experience supervising review production and quality. Criteria were grouped into four themes: identifying, reporting, assessing risk of bias, and analysing C-RCTs. The Cochrane Database of Systematic Reviews was searched (2nd December 2013), and the 50 most recent reviews that included C-RCTs were retrieved. Each review was then assessed using the criteria. The 50 reviews we identified were published by 26 Cochrane Review Groups between June 2013 and November 2013. For identifying C-RCTs, only 56% identified that C-RCTs were eligible for inclusion in the review in the eligibility criteria. For reporting C-RCTs, only eight (24%) of the 33 reviews reported the method of cluster adjustment for their included C-RCTs. For assessing risk of bias, only one review assessed all five C-RCT-specific risk-of-bias criteria. For analysing C-RCTs, of the 27 reviews that presented unadjusted data, only nine (33%) provided a warning that confidence intervals may be artificially narrow. Of the 34 reviews that reported data from unadjusted C-RCTs, only 13 (38%) excluded the unadjusted results from the meta-analyses. The methodological and reporting practices in Cochrane reviews incorporating C-RCTs could be greatly improved, particularly with regard to analyses. Criteria developed as part of the current study could be used by review authors or editors to identify errors and improve the quality of published systematic reviews incorporating C-RCTs.

Critical appraisal of clinical trials in multiple system atrophy: Toward better quality.

PubMed

Castro Caldas, Ana; Levin, Johannes; Djaldetti, Ruth; Rascol, Olivier; Wenning, Gregor; Ferreira, Joaquim J

2017-10-01

Multiple system atrophy (MSA) is a rare neurodegenerative disease of undetermined cause. Although many clinical trials have been conducted, there is still no treatment that cures the disease or slows its progression. We sought to assess the clinical trials, methodology, and quality of reporting of clinical trails conducted in MSA patients. We conducted a systematic review of all trials with at least 1 MSA patient subject to any pharmacological/nonpharmacological interventions. Two independent reviewers evaluated the methodological characteristics and quality of reporting of trials. A total of 60 clinical trials were identified, including 1375 MSA patients. Of the trials, 51% (n = 31) were single-arm studies. A total of 28% (n = 17) had a parallel design, half of which (n = 13) were placebo controlled. Of the studies, 8 (13.3%) were conducted in a multicenter setting, 3 of which were responsible for 49.3% (n = 678) of the total included MSA patients. The description of primary outcomes was unclear in 60% (n = 40) of trials. Only 10 (16.7%) clinical trials clearly described the randomization process. Blinding of the participants, personnel, and outcome assessments were at high risk of bias in the majority of studies. The number of dropouts/withdrawals was high (n = 326, 23.4% among the included patients). Overall, the design and quality of reporting of the reviewed studies is unsatisfactory. The most frequent clinical trials were small and single centered. Inadequate reporting was related to the information on the randomization process, sequence generation, allocation concealment, blinding of participants, and sample size calculations. Although improved during the recent years, methodological quality and trial design need to be optimized to generate more informative results. © 2017 International Parkinson and Movement Disorder Society. © 2017 International Parkinson and Movement Disorder Society.

Music for medical indications in the neonatal period: a systematic review of randomised controlled trials.

PubMed

Hartling, L; Shaik, M S; Tjosvold, L; Leicht, R; Liang, Y; Kumar, M

2009-09-01

To conduct a systematic review of the efficacy of music for medical indications in term or preterm neonates. We searched 17 electronic databases, subject bibliographies, reference lists and trials registries. Two reviewers independently screened studies for inclusion, assessed methodological quality, and extracted data. Meta-analysis was not feasible due to heterogeneity in outcomes so a qualitative analysis is presented. Nine randomised trials were included. The methodological quality was generally poor (median Jadad score = 1). The outcomes most commonly reported were physiological measures (heart rate (HR), respiratory rate, oxygen saturation (SaO2)), behavioural state and pain. Six studies evaluated music for the painful procedures circumcision (three trials) and heel prick (three trials). For circumcisions, one high quality pilot study (n = 23) showed benefits of music for the outcomes of HR, SaO2 and pain, while two low quality studies showed no difference. For heel prick, three low quality studies provided some evidence that music may be beneficial primarily for measures of behaviour and pain. The remaining studies evaluated the use of music in preterm infants to improve physiological and behavioural parameters (n = 31; benefits observed for behavioural parameters), to reinforce non-nutritive sucking via use of a pacifier activated lullaby (n = 32; significant increase in feeding rates), and to influence physiological stability and behaviours in infants with chronic lung disease (n = 22; no significant differences for outcomes assessed). The heterogeneity in study populations, interventions and outcomes precludes definitive conclusions around efficacy. There is preliminary evidence for some therapeutic benefits of music for specific indications; however, these findings need to be confirmed in methodologically rigorous trials.

Effectiveness of treatments for infantile colic: systematic review.

PubMed

Lucassen, P L; Assendelft, W J; Gubbels, J W; van Eijk, J T; van Geldrop, W J; Neven, A K

1998-05-23

To evaluate the effectiveness of diets, drug treatment, and behavioural interventions on infantile colic in trials with crying or the presence of colic as the primary outcome measure. Controlled clinical trials identified by a highly sensitive search strategy in Medline (1966-96), Embase (1986-95), and the Cochrane Controlled Trials Register, in combination with reference checking for further relevant publications. Keywords were crying and colic. Two independent assessors selected controlled trials with interventions lasting at least 3 days that included infants younger than 6 months who cried excessively. Methodological quality was assessed by two assessors independently with a quality assessment scale (range 0-5). Effect sizes were calculated as percentage success. Effect sizes of trials using identical interventions were pooled using a random effects model. 27 controlled trials were identified. Elimination of cows' milk protein was effective when substituted by hypoallergenic formula milks (effect size 0.22 (95% confidence interval 0.09 to 0.34)). The effectiveness of substitution by soy formula milks was unclear when only trials of good methodological quality were considered. The benefit of eliminating cows' milk protein was not restricted to highly selected populations. Dicyclomine was effective (effect size 0.46 (0.33 to 0.60)), but serious side effects have been reported. The advice to reduce stimulation was beneficial (effect size 0.48 (0.23 to 0.74)), whereas the advice to increase carrying and holding seemed not to reduce crying. No benefit was shown for simethicone. Uncertainty remained about the effectiveness of low lactose formula milks. Infantile colic should preferably be treated by advising carers to reduce stimulation and with a one week trial of a hypoallergenic formula milk.

Obstetric Safety and Quality.

PubMed

Pettker, Christian M; Grobman, William A

2015-07-01

Obstetric safety and quality is an emerging and important topic not only as a result of the pressures of patient and regulatory expectations, but also because of the genuine interest of caregivers to reduce harm, improve outcomes, and optimize care. Although each seeks to improve care by using scientific approaches beyond human physiology and pathophysiology, patient safety methodologies seek to avoid preventable adverse events, whereas health care quality projects aim to achieve the best possible outcomes. It is well-documented that an increasingly complex medical system controlled by human workers is a circumstance subject to recurrent failure. A safety culture encourages a proactive approach to mitigate failure before, during, and after it occurs. This article highlights the key concepts in health care safety and quality and reviews the background of the quality improvement sciences with particular emphasis on obstetric outcomes and quality measures.

Bone mass improved effect of icariin for postmenopausal osteoporosis in ovariectomy-induced rats: a meta-analysis and systematic review.

PubMed

Xu, Jin-Hai; Yao, Min; Ye, Jie; Wang, Guo-Dong; Wang, Jing; Cui, Xue-Jun; Mo, Wen

2016-10-01

Ovariectomy (OVX)-induced rats are the most frequently used animal model to research postmenopausal osteoporosis. Our objective was to summarize and critically assess the bone mass improved effect of icariin (ICA) for treatment of postmenopausal osteoporosis in an OVX-induced rat model. The PUBMED, EMBASE, and Chinese databases were searched from their inception date to February 2015. Two reviewers independently selected animal studies that evaluated the bone mass improved effect of ICA compared with control in OVX-induced rats. Extracted data were analyzed by RevMan statistical software, and the methodological quality of each study was assessed. Seven studies with adequate randomization were included in the systematic review. Overall, ICA seemed to significantly improve bone mass as assessed using the bone mineral density (seven studies, n = 169; weighted mean difference, 0.02; 95% CI, 0.01-0.02, I = 77%, P < 0.00001) using a random-effects model. There is no significant difference between ICA and estrogen (E) (six studies, n = 128; weighted mean difference, 0.00; 95% CI, -0.00 to 0.01, I = 54%, P = 0.01). Bone mass improved effect of ICA for postmenopausal osteoporosis was observed in OVX-induced rats. Assessment of the methodological quality of studies involving OVX-induced animal models is required, and good methodological quality should be valued in systematic reviews of animal studies.

Quality Measurement Recommendations Relevant to Clinical Guidelines in Germany and the United Kingdom: (What) Can We Learn From Each Other?

PubMed Central

Petzold, Thomas; Deckert, Stefanie; Williamson, Paula R.; Schmitt, Jochen

2018-01-01

We conducted a systematic review of clinical guidelines (CGs) to examine the methodological approaches of quality indicator derivation in CGs, the frequency of quality indicators to check CG recommendations in routine care, and clinimetric properties of quality indicators. We analyzed the publicly available CG databases of the Association of the Scientific Medical Societies in Germany (AWMF) and National Institute for Health and Care Excellence (NICE). Data on the methodology of subsequent quality indicator derivation, the content and definition of recommended quality indicators, and clinimetric properties of measurement instruments were extracted. In Germany, no explicit methodological guidance exists, but 3 different approaches are used. For NICE, a general approach is used for the derivation of quality indicators out of quality standards. Quality indicators were defined in 34 out of 87 CGs (39%) in Germany and for 58 out of 133 (43%) NICE CGs. Statements regarding measurement properties of instruments for quality indicator assessment were missing in German and NICE documents. Thirteen pairs of CGs (32%) have associated quality indicators. Thirty-four quality indicators refer to the same aspect of the quality of care, which corresponds to 27% of the German and 7% of NICE quality indicators. The development of a standardized and internationally accepted methodology for the derivation of quality indicators relevant to CGs is needed to measure and compare quality of care in health care systems. PMID:29591538

Improving the Quality of Experience Journals: Training Educational Psychology Students in Basic Qualitative Methodology

ERIC Educational Resources Information Center

Reynolds-Keefer, Laura

2010-01-01

This study evaluates the impact of teaching basic qualitative methodology to preservice teachers enrolled in an educational psychology course in the quality of observation journals. Preservice teachers enrolled in an educational psychology course requiring 45 hr of field experience were given qualitative methodological training as a part of the…

Defining a reference set to support methodological research in drug safety.

PubMed

Ryan, Patrick B; Schuemie, Martijn J; Welebob, Emily; Duke, Jon; Valentine, Sarah; Hartzema, Abraham G

2013-10-01

Methodological research to evaluate the performance of methods requires a benchmark to serve as a referent comparison. In drug safety, the performance of analyses of spontaneous adverse event reporting databases and observational healthcare data, such as administrative claims and electronic health records, has been limited by the lack of such standards. To establish a reference set of test cases that contain both positive and negative controls, which can serve the basis for methodological research in evaluating methods performance in identifying drug safety issues. Systematic literature review and natural language processing of structured product labeling was performed to identify evidence to support the classification of drugs as either positive controls or negative controls for four outcomes: acute liver injury, acute kidney injury, acute myocardial infarction, and upper gastrointestinal bleeding. Three-hundred and ninety-nine test cases comprised of 165 positive controls and 234 negative controls were identified across the four outcomes. The majority of positive controls for acute kidney injury and upper gastrointestinal bleeding were supported by randomized clinical trial evidence, while the majority of positive controls for acute liver injury and acute myocardial infarction were only supported based on published case reports. Literature estimates for the positive controls shows substantial variability that limits the ability to establish a reference set with known effect sizes. A reference set of test cases can be established to facilitate methodological research in drug safety. Creating a sufficient sample of drug-outcome pairs with binary classification of having no effect (negative controls) or having an increased effect (positive controls) is possible and can enable estimation of predictive accuracy through discrimination. Since the magnitude of the positive effects cannot be reliably obtained and the quality of evidence may vary across outcomes, assumptions are required to use the test cases in real data for purposes of measuring bias, mean squared error, or coverage probability.

Application of response surface methodology to maximize the productivity of scalable automated human embryonic stem cell manufacture.

PubMed

Ratcliffe, Elizabeth; Hourd, Paul; Guijarro-Leach, Juan; Rayment, Erin; Williams, David J; Thomas, Robert J

2013-01-01

Commercial regenerative medicine will require large quantities of clinical-specification human cells. The cost and quality of manufacture is notoriously difficult to control due to highly complex processes with poorly defined tolerances. As a step to overcome this, we aimed to demonstrate the use of 'quality-by-design' tools to define the operating space for economic passage of a scalable human embryonic stem cell production method with minimal cell loss. Design of experiments response surface methodology was applied to generate empirical models to predict optimal operating conditions for a unit of manufacture of a previously developed automatable and scalable human embryonic stem cell production method. Two models were defined to predict cell yield and cell recovery rate postpassage, in terms of the predictor variables of media volume, cell seeding density, media exchange and length of passage. Predicted operating conditions for maximized productivity were successfully validated. Such 'quality-by-design' type approaches to process design and optimization will be essential to reduce the risk of product failure and patient harm, and to build regulatory confidence in cell therapy manufacturing processes.

Effects of aquatic exercise on physical function and fitness among people with spinal cord injury: A systematic review.

PubMed

Li, Chunxiao; Khoo, Selina; Adnan, Athirah

2017-03-01

The aim of this review is to synthesize the evidence on the effects of aquatic exercise interventions on physical function and fitness among people with spinal cord injury. Six major databases were searched from inception till June 2015: MEDLINE, CINAHL, EMBASE, PsychInfo, SPORTDiscus, and Cochrane Center Register of Controlled Trials. Two reviewers independently rated methodological quality using the modified Downs and Black Scale and extracted and synthesized key findings (i.e., participant characteristics, study design, physical function and fitness outcomes, and adverse events). Eight of 276 studies met the inclusion criteria, of which none showed high research quality. Four studies assessed physical function outcomes and 4 studies evaluated aerobic fitness as outcome measures. Significant improvements on these 2 outcomes were generally found. Other physical or fitness outcomes including body composition, muscular strength, and balance were rarely reported. There is weak evidence supporting aquatic exercise training to improve physical function and aerobic fitness among adults with spinal cord injury. Suggestions for future research include reporting details of exercise interventions, evaluating other physical or fitness outcomes, and improving methodological quality.

Lean Six Sigma in health care and the challenge of implementation of Six Sigma methodologies at a Veterans Affairs Medical Center.

PubMed

Pocha, Christine

2010-01-01

Six Sigma and Lean Thinking are quality initiatives initially deployed in industry to improve operational efficiency leading to better quality and subsequent cost savings. The financial rationale for embarking on this quality journey is clear; applying it to today's health care remains challenging. The cost of medical care is increasing at an alarming rate; most of these cost increases are attributed to an aging population and technological advances; therefore, largely beyond control. Furthermore, health care cost increases are caused by unnecessary operational inefficiency associated with the direct medical service delivery process. This article describes the challenging journey of implementing Six Sigma methodology at a tertiary care medical center. Many lessons were learned; however, of utmost importance were team approach, "buy in" of the stakeholders, and the willingness of team members to change daily practice and to adapt new and innovative ways how health care can be delivered. Six Sigma incorporated as part of the "company's or hospital's culture" would be most desirable but the learning curve will be steep.

The effectiveness of manual therapy in treating cervicogenic dizziness: a systematic review.

PubMed

Yaseen, Khalid; Hendrick, Paul; Ismail, Ayah; Felemban, Mohannad; Alshehri, Mansour Abdullah

2018-01-01

[Purpose] This review provides an evaluation of the evidence for the effectiveness of using manual therapy to treat cervicogenic dizziness. [Subjects and Methods] The literature was systematically searched on the May 2, 2016 using the following online databases: Medline, EMBASE, CINAHL and PEDro. This review included randomised controlled trials and compared the efficacy of manual therapy for the treatment of cervicogenic dizziness, compared to other types of intervention. This study measured changes based on dizziness intensity and frequency. [Results] The primary search found 30 articles, but only four articles met the inclusion criteria. Assessment of methodological quality was performed by two researchers using the PEDro scale. The level of evidence was determined using a recognised grading scale. Three out of the four articles were deemed to have high methodological quality, while the fourth was rated as moderate quality. The attributed level of evidence was moderate (level 2). [Conclusion] Manual therapy is potentially effective for managing cervicogenic dizziness. However, due to the heterogeneity of the results and techniques and the low number of studies, further research is recommended to provide conclusive evidence.

Choosing Wisely: assessment of current US top five list recommendations’ trustworthiness using a pragmatic approach

PubMed Central

Horvath, Karl; Semlitsch, Thomas; Jeitler, Klaus; Abuzahra, Muna E; Posch, Nicole; Domke, Andreas; Siebenhofer, Andrea

2016-01-01

Objectives Identification of sufficiently trustworthy top 5 list recommendations from the US Choosing Wisely campaign. Setting Not applicable. Participants All top 5 list recommendations available from the American Board of Internal Medicine Foundation website. Main outcome measures/interventions Compilation of US top 5 lists and search for current German highly trustworthy (S3) guidelines. Extraction of guideline recommendations, including grade of recommendation (GoR), for suggestions comparable to top 5 list recommendations. For recommendations without guideline equivalents, the methodological quality of the top 5 list development process was assessed using criteria similar to that used to judge guidelines, and relevant meta-literature was identified in cited references. Judgement of sufficient trustworthiness of top 5 list recommendations was based either on an ‘A’ GoR of guideline equivalents or on high methodological quality and citation of relevant meta-literature. Results 412 top 5 list recommendations were identified. For 75 (18%), equivalents were found in current German S3 guidelines. 44 of these recommendations were associated with an ‘A’ GoR, or a strong recommendation based on strong evidence, and 26 had a ‘B’ or a ‘C’ GoR. No GoR was provided for 5 recommendations. 337 recommendations had no equivalent in the German S3 guidelines. The methodological quality of the development process was high and relevant meta-literature was cited for 87 top 5 list recommendations. For a further 36, either the methodological quality was high without any meta-literature citations or meta-literature citations existed but the methodological quality was lacking. For the remaining 214 recommendations, either the methodological quality was lacking and no literature was cited or the methodological quality was generally unsatisfactory. Conclusions 131 of current US top 5 list recommendations were found to be sufficiently trustworthy. For a substantial number of current US top 5 list recommendations, their trustworthiness remains unclear. Methodological requirements for developing top 5 lists are recommended. PMID:27855098

Likelihood of achieving air quality targets under model uncertainties.

PubMed

Digar, Antara; Cohan, Daniel S; Cox, Dennis D; Kim, Byeong-Uk; Boylan, James W

2011-01-01

Regulatory attainment demonstrations in the United States typically apply a bright-line test to predict whether a control strategy is sufficient to attain an air quality standard. Photochemical models are the best tools available to project future pollutant levels and are a critical part of regulatory attainment demonstrations. However, because photochemical models are uncertain and future meteorology is unknowable, future pollutant levels cannot be predicted perfectly and attainment cannot be guaranteed. This paper introduces a computationally efficient methodology for estimating the likelihood that an emission control strategy will achieve an air quality objective in light of uncertainties in photochemical model input parameters (e.g., uncertain emission and reaction rates, deposition velocities, and boundary conditions). The method incorporates Monte Carlo simulations of a reduced form model representing pollutant-precursor response under parametric uncertainty to probabilistically predict the improvement in air quality due to emission control. The method is applied to recent 8-h ozone attainment modeling for Atlanta, Georgia, to assess the likelihood that additional controls would achieve fixed (well-defined) or flexible (due to meteorological variability and uncertain emission trends) targets of air pollution reduction. The results show that in certain instances ranking of the predicted effectiveness of control strategies may differ between probabilistic and deterministic analyses.

Effectiveness of vocational rehabilitation intervention on the return to work and employment of persons with multiple sclerosis.

PubMed

Khan, Fary; Ng, Louisa; Turner-Stokes, Lynne

2009-01-21

Multiple sclerosis is a neurological disease that frequently affects adults of working age, resulting in a range of physical, cognitive and psychosocial deficits that impact on workforce participation. Although, the literature supports vocational rehabilitation (VR) approaches in persons with multiple sclerosis (pwMS), the evidence for its effectiveness is yet to be established. To evaluate the effectiveness of VR programs compared to alternative programs or care as usual on return to work, workability and employment in pwMS; to evaluate the cost effectiveness of these programs. Electronic searches included: Cochrane Central Register of Controlled Trials "CENTRAL" 2008 issue 3, MEDLINE (PubMed) (1966- 2008), EMBASE (1988- 2008), CINAHL (1982- 2008), PEDro (1990- 2008), the Cochrane Rehabilitation and Related Therapies Field trials Register and the National Health Service National Research Register. Randomized and controlled clinical trials, including before - after controlled trials, that compare VR rehabilitation with alternative intervention such as standard or a lesser form of intervention or waitlist controls. Two reviewers selected trials and rated their methodological quality independently. A 'best evidence' synthesis was performed, based on methodological quality. Trials were grouped in terms of type and setting of VR programs. Two trials (one RCT and one CCT) (total 80 participants) met the review criteria. Both trials scored poorly on the methodological quality assessment. There was 'insufficient evidence' for VR programs for (a)'competitive employment', in altering rates of job retention, changes in employment, improvement in rates of re-entry into the labour force; (b) for altering 'work ability' by improving participants' confidence in the accommodation request process, or employability maturity or job seeking activity. No evidence could be assimilated for changes in proportions of persons in supported employment or on disability pensions, nor for cost-effectiveness. There was inconclusive evidence to support VR for pwMS. However, the review highlights some of the challenges in providing VR for pwMS. Clinicians need to be aware of vocational issues, and to understand and manage barriers for maintaining employment. Proactive and timely VR programs should incorporate practical solutions to deal with work disability, workplace accommodation and educate employers, and the wider community. Liaison with policy makers is imperative for government initiatives that encourage work focused VR programs. Future research in VR should focus on improving methodological and scientific rigour of clinical trials; on the development of appropriate and valid outcome measures; and on cost effectiveness of VR programs.

Taichi exercise for self-rated sleep quality in older people: a systematic review and meta-analysis.

PubMed

Du, Shizheng; Dong, Jianshu; Zhang, Heng; Jin, Shengji; Xu, Guihua; Liu, Zengxia; Chen, Lixia; Yin, Haiyan; Sun, Zhiling

2015-01-01

Self-reported sleep disorders are common in older adults, resulting in serious consequences. Non-pharmacological measures are important complementary interventions, among which Taichi exercise is a popular alternative. Some experiments have been performed; however, the effect of Taichi exercise in improving sleep quality in older people has yet to be validated by systematic review. Using systematic review and meta-analysis, this study aimed to examine the efficacy of Taichi exercise in promoting self-reported sleep quality in older adults. Systematic review and meta-analysis of randomized controlled studies. 4 English databases: Pubmed, Cochrane Library, Web of Science and CINAHL, and 4 Chinese databases: CBMdisc, CNKI, VIP, and Wanfang database were searched through December 2013. Two reviewers independently selected eligible trials, conducted critical appraisal of the methodological quality by using the quality appraisal criteria for randomized controlled studies recommended by Cochrane Handbook. A standardized data form was used to extract information. Meta-analysis was performed. Five randomized controlled studies met inclusion criteria. All suffered from some methodological flaws. The results of this study showed that Taichi has large beneficial effect on sleep quality in older people, as indicated by decreases in the global Pittsburgh Sleep Quality Index score [standardized mean difference=-0.87, 95% confidence intervals (95% confidence interval) (-1.25, -0.49)], as well as its sub-domains of subjective sleep quality [standardized mean difference=-0.83, 95% confidence interval (-1.08, -0.57)], sleep latency [standardized mean difference=-0.75, 95% confidence interval (-1.42, -0.07)], sleep duration [standardized mean difference=-0.55, 95% confidence interval (-0.90, -0.21)], habitual sleep efficiency [standardized mean difference=-0.49, 95% confidence interval (-0.74, -0.23)], sleep disturbance [standardized mean difference=-0.44, 95% confidence interval (-0.69, -0.19)], and daytime dysfunction [standardized mean difference=-0.34, 95% confidence interval (-0.59, -0.09)]. Daytime sleepiness improvement was also observed. Weak evidence shows that Taichi exercise has a beneficial effect in improving self-rated sleep quality for older adults, suggesting that Taichi could be an effective alternative and complementary approach to existing therapies for older people with sleep problems. More rigorous experimental studies are required. Copyright © 2014 Elsevier Ltd. All rights reserved.

Development of Innovative Business Model of Modern Manager's Qualities

ERIC Educational Resources Information Center

Yashkova, Elena V.; Sineva, Nadezda L.; Shkunova, Angelika A.; Bystrova, Natalia V.; Smirnova, Zhanna V.; Kolosova, Tatyana V.

2016-01-01

The paper defines a complex of manager's qualities based on theoretical and methodological analysis and synthesis methods, available national and world literature, research papers and publications. The complex approach methodology was used, which provides an innovative view of the development of modern manager's qualities. The methodological…

The Effectiveness of Manual Therapy for Relieving Pain, Stiffness, and Dysfunction in Knee Osteoarthritis: A Systematic Review and Meta-Analysis.

PubMed

Xu, Qinguang; Chen, Bei; Wang, Yueyi; Wang, Xuezong; Han, Dapeng; Ding, Daofang; Zheng, Yuxin; Cao, Yuelong; Zhan, Hongsheng; Zhou, Yao

2017-05-01

Knee osteoarthritis (KOA) is the most common form of arthritis, leading to pain disability in seniors and increased health care utilization. Manual therapy is one widely used physical treatment for KOA. To evaluate the effectiveness and adverse events (AEs) of manual therapy compared to other treatments for relieving pain, stiffness, and physical dysfunction in patients with KOA. A systematic review and meta-analysis of manual therapy for KOA. We searched PubMed, EMBASE, the Cochrane Library, and Chinese databases for relevant randomized controlled trials (RCTs) of manual therapy for patients with KOA from the inception to October 2015 without language restrictions. RCTs compared manual therapy to the placebo or other interventional control with an appropriate description of randomization. Two reviewers independently conducted the search results identification, data extraction, and methodological quality assessment. The methodological quality was assessed by PEDro scale. Pooled data was expressed as standard mean difference (SMD), with 95% confident intervals (CIs) in a random effects model. The meta-analysis of manual therapy for KOA on pain, stiffness, and physical function were conducted. Fourteen studies involving 841 KOA participants compared to other treatments were included. The methodological quality of most included RCTs was poor. The mean PEDro scale score was 6.6. The meta-analyses results showed that manual therapy had statistically significant effects on relieving pain (standardized mean difference, SMD = -0.61, 95% CI -0.95 to -0.28, P = 76%), stiffness (SMD = -0.58, 95% CI -0.95 to -0.21, P = 81%), improving physical function (SMD = -0.49, 95% CI -0.76 to -0.22, P = 65%), and total score (SMD = -0.56, 95% CI -0.78 to -0.35, P = 50%). But in the subgroups, manual therapy did not show significant improvements on stiffness and physical function when treatment duration was less than 4 weeks. And the long-term information for manual therapy was insufficient. The limitations of this systematic review include the paucity of literature and inevitable heterogeneity between included studies. The preliminary evidence from our study suggests that manual therapy might be effective and safe for improving pain, stiffness, and physical function in KOA patients and could be treated as complementary and alternative options. However, the evidence may be limited by potential bias and poor methodological quality of included studies. High-quality RCTs with long-term follow-up are warranted to confirm our findings.Key words: Knee osteoarthritis, manual therapy, systematic review.

Physician-delivered injection therapies for mechanical neck disorders: a systematic review update (non-oral, non-intravenous pharmacological interventions for neck pain).

PubMed

Gross, Anita R; Peloso, Paul M; Galway, Erin; Navasero, Neenah; Essen, Karis Van; Graham, Nadine; Goldsmith, Charlie H; Gzeer, Wisam; Shi, Qiyun; Haines, Ted And Cog

2013-01-01

Controversy persists regarding medicinal injections for mechanical neck disorders (MNDs). To determine the effectiveness of physician-delivered injections on pain, function/disability, quality of life, global perceived effect and patient satisfaction for adults with MNDs. We updated our previous searches of CENTRAL, MEDLINE and EMBASE from December 2006 through to March 2012. We included randomized controlled trials of adults with neck disorders treated by physician-delivered injection therapies. Two authors independently selected articles, abstracted data and assessed methodological quality. When clinical heterogeneity was absent, we combined studies using random-effects models. We included 12 trials (667 participants). No high or moderate quality studies were found with evidence of benefit over control. Moderate quality evidence suggests little or no difference in pain or function/disability between nerve block injection of steroid and bupivacaine vs bupivacaine alone at short, intermediate and long-term for chronic neck pain. We found limited very low quality evidence of an effect on pain with intramuscular lidocaine vs control for chronic myofascial neck pain. Two low quality studies showed an effect on pain with anaesthetic nerve block vs saline immediately post treatment and in the short-term. All other studies were of low or very low quality with no evidence of benefit over controls. Current evidence does not confirm the effectiveness of IM-lidocaine injection for chronic mechanical neck pain nor anaesthetic nerve block for cervicogenic headache. There is moderate evidence of no benefit for steroid blocks vs controls for mechanical neck pain.

Mindcontrol: A web application for brain segmentation quality control.

PubMed

Keshavan, Anisha; Datta, Esha; M McDonough, Ian; Madan, Christopher R; Jordan, Kesshi; Henry, Roland G

2018-04-15

Tissue classification plays a crucial role in the investigation of normal neural development, brain-behavior relationships, and the disease mechanisms of many psychiatric and neurological illnesses. Ensuring the accuracy of tissue classification is important for quality research and, in particular, the translation of imaging biomarkers to clinical practice. Assessment with the human eye is vital to correct various errors inherent to all currently available segmentation algorithms. Manual quality assurance becomes methodologically difficult at a large scale - a problem of increasing importance as the number of data sets is on the rise. To make this process more efficient, we have developed Mindcontrol, an open-source web application for the collaborative quality control of neuroimaging processing outputs. The Mindcontrol platform consists of a dashboard to organize data, descriptive visualizations to explore the data, an imaging viewer, and an in-browser annotation and editing toolbox for data curation and quality control. Mindcontrol is flexible and can be configured for the outputs of any software package in any data organization structure. Example configurations for three large, open-source datasets are presented: the 1000 Functional Connectomes Project (FCP), the Consortium for Reliability and Reproducibility (CoRR), and the Autism Brain Imaging Data Exchange (ABIDE) Collection. These demo applications link descriptive quality control metrics, regional brain volumes, and thickness scalars to a 3D imaging viewer and editing module, resulting in an easy-to-implement quality control protocol that can be scaled for any size and complexity of study. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Wordless intervention for epilepsy in learning disabilities (WIELD): study protocol for a randomized controlled feasibility trial.

PubMed

Durand, Marie-Anne; Gates, Bob; Parkes, Georgina; Zia, Asif; Friedli, Karin; Barton, Garry; Ring, Howard; Oostendorp, Linda; Wellsted, David

2014-11-20

Epilepsy is the most common neurological problem that affects people with learning disabilities. The high seizure frequency, resistance to treatments, associated skills deficit and co-morbidities make the management of epilepsy particularly challenging for people with learning disabilities. The Books Beyond Words booklet for epilepsy uses images to help people with learning disabilities manage their condition and improve quality of life. Our aim is to conduct a randomized controlled feasibility trial exploring key methodological, design and acceptability issues, in order to subsequently undertake a large-scale randomized controlled trial of the Books Beyond Words booklet for epilepsy. We will use a two-arm, single-centre randomized controlled feasibility design, over a 20-month period, across five epilepsy clinics in Hertfordshire, United Kingdom. We will recruit 40 eligible adults with learning disabilities and a confirmed diagnosis of epilepsy and will randomize them to use either the Books Beyond Words booklet plus usual care (intervention group) or to receive routine information and services (control group). We will collect quantitative data about the number of eligible participants, number of recruited participants, demographic data, discontinuation rates, variability of the primary outcome measure (quality of life: Epilepsy and Learning Disabilities Quality of Life scale), seizure severity, seizure control, intervention's patterns of use, use of other epilepsy-related information, resource use and the EQ-5D-5L health questionnaire. We will also gather qualitative data about the feasibility and acceptability of the study procedures and the Books Beyond Words booklet. Ethical approval for this study was granted on 28 April 2014, by the Wales Research Ethics Committee 5. Recruitment began on 1 July 2014. The outcomes of this feasibility study will be used to inform the design and methodology of a definitive study, adequately powered to determine the impact of the Books Beyond Words intervention to improve the management of epilepsy in people with learning disabilities. http://ISRCTN80067039 (Date of ISRCTN assignation: 23 April 2014).

Methodological quality of systematic reviews on treatments for depression: a cross-sectional study.

PubMed

Chung, V C H; Wu, X Y; Feng, Y; Ho, R S T; Wong, S Y S; Threapleton, D

2017-05-02

Depression is one of the most common mental disorders and identifying effective treatment strategies is crucial for the control of depression. Well-conducted systematic reviews (SRs) and meta-analyses can provide the best evidence for supporting treatment decision-making. Nevertheless, the trustworthiness of conclusions can be limited by lack of methodological rigour. This study aims to assess the methodological quality of a representative sample of SRs on depression treatments. A cross-sectional study on the bibliographical and methodological characteristics of SRs published on depression treatments trials was conducted. Two electronic databases (the Cochrane Database of Systematic Reviews and the Database of Abstracts of Reviews of Effects) were searched for potential SRs. SRs with at least one meta-analysis on the effects of depression treatments were considered eligible. The methodological quality of included SRs was assessed using the validated AMSTAR (Assessing the Methodological Quality of Systematic Reviews) tool. The associations between bibliographical characteristics and scoring on AMSTAR items were analysed using logistic regression analysis. A total of 358 SRs were included and appraised. Over half of included SRs (n = 195) focused on non-pharmacological treatments and harms were reported in 45.5% (n = 163) of all studies. Studies varied in methods and reporting practices: only 112 (31.3%) took the risk of bias among primary studies into account when formulating conclusions; 245 (68.4%) did not fully declare conflict of interests; 93 (26.0%) reported an 'a priori' design and 104 (29.1%) provided lists of both included and excluded studies. Results from regression analyses showed: more recent publications were more likely to report 'a priori' designs [adjusted odds ratio (AOR) 1.31, 95% confidence interval (CI) 1.09-1.57], to describe study characteristics fully (AOR 1.16, 95% CI 1.06-1.28), and to assess presence of publication bias (AOR 1.13, 95% CI 1.06-1.19), but were less likely to list both included and excluded studies (AOR 0.86, 95% CI 0.81-0.92). SRs published in journals with higher impact factor (AOR 1.14, 95% CI 1.04-1.25), completed by more review authors (AOR 1.12, 95% CI 1.01-1.24) and SRs on non-pharmacological treatments (AOR 1.62, 95% CI 1.01-2.59) were associated with better performance in publication bias assessment. The methodological quality of included SRs is disappointing. Future SRs should strive to improve rigour by considering of risk of bias when formulating conclusions, reporting conflict of interests and authors should explicitly describe harms. SR authors should also use appropriate methods to combine the results, prevent language and publication biases, and ensure timely updates.

A Narrative Review of High-Quality Literature on the Effects of Resident Duty Hours Reforms.

PubMed

Lin, Henry; Lin, Emery; Auditore, Stephanie; Fanning, Jon

2016-01-01

To summarize current high-quality studies evaluating the effect and efficacy of resident duty hours reforms (DHRs) on patient safety and resident education and well-being. The authors searched PubMed and Medline in August 2012 and again in May 2013 for literature (1987-2013) about the effects of DHRs. They assessed the quality of articles using the Medical Education Research Study Quality Instrument (MERSQI) scoring system. They considered randomized controlled trials (RCTs), partial RCTs, and all studies with a MERSQI score ≥ 14 to be "high-quality" methodology studies. A total of 72 high-quality studies met inclusion criteria. Most studies showed no change or slight improvement in mortality and complication rates after DHRs. Resident well-being was generally improved, but there was a perceived negative impact on education (knowledge acquisition, skills, and cognitive performance) following DHRs. Eleven high-quality studies assessed the impact of DHR interventions; all reported a neutral to positive impact. Seven high-quality studies assessed costs associated with DHRs and demonstrated an increase in hospital costs. The results of most studies that allow enough time for DHR interventions to take effect suggest a benefit to patient safety and resident well-being, but the effect on the quality of training remains unknown. Additional methodologically sound studies on the impact of DHRs are necessary. Priorities for future research include approaches to optimizing education and clinical proficiency and studies on the effect of intervention strategies on both education and patient safety. Such studies will provide additional information to help improve duty hours policies.

Quality of the written radiology report: a review of the literature.

PubMed

Pool, Felicity; Goergen, Stacy

2010-08-01

A literature review was carried out, guided by the question, What are the important elements of a high-quality radiology written report? Two papers known to the authors were used as a basis for 5 PubMed search strategies. Exclusion criteria were applied to retrieved citations. Reference lists of retrieved citations were scanned for additional relevant papers and exclusion criteria applied to these. Web sites of professional radiology organizations were scanned for guidelines relating to the written radiology report. Retrieved guidelines were appraised using the Appraisal of Guidelines for Research & Evaluation instrument. Methodologies of retrieved papers were not suitable for conventional appraisal, and an evidence table was constructed. The search strategy identified 25 published papers and 4 guidelines. Published study methodologies included 1 randomized controlled trial; 1 before-and-after study of interventions; 10 observational studies, audits, or analyses; 12 surveys; and 1 narrative review of the literature. Existing guidelines have a number of weaknesses with regard to scope and purpose, methods of development, stakeholder consultation, and editorial independence and applicability. There is a major gap in published studies relating to testing of interventions to improve report quality using conventional randomized controlled trial methods. Published studies and guidelines generally support report content, including clinical history, examination quality, description of findings, comparison, and diagnosis. Important report attributes include accuracy, clarity, and certainty. There is wide variation in the language used to describe imaging findings and diagnostic certainty. Survey participants strongly preferred reports with structured or itemized formats, but few studies exist regarding the effect of report structure on quality. Copyright 2010 American College of Radiology. Published by Elsevier Inc. All rights reserved.

Warpage optimisation on the moulded part with straight-drilled and conformal cooling channels using response surface methodology (RSM) and glowworm swarm optimisation (GSO)

NASA Astrophysics Data System (ADS)

Hazwan, M. H. M.; Shayfull, Z.; Sharif, S.; Nasir, S. M.; Zainal, N.

2017-09-01

In injection moulding process, quality and productivity are notably important and must be controlled for each product type produced. Quality is measured as the extent of warpage of moulded parts while productivity is measured as a duration of moulding cycle time. To control the quality, many researchers have introduced various of optimisation approaches which have been proven enhanced the quality of the moulded part produced. In order to improve the productivity of injection moulding process, some of researches have proposed the application of conformal cooling channels which have been proven reduced the duration of moulding cycle time. Therefore, this paper presents an application of alternative optimisation approach which is Response Surface Methodology (RSM) with Glowworm Swarm Optimisation (GSO) on the moulded part with straight-drilled and conformal cooling channels mould. This study examined the warpage condition of the moulded parts before and after optimisation work applied for both cooling channels. A front panel housing have been selected as a specimen and the performance of proposed optimisation approach have been analysed on the conventional straight-drilled cooling channels compared to the Milled Groove Square Shape (MGSS) conformal cooling channels by simulation analysis using Autodesk Moldflow Insight (AMI) 2013. Based on the results, melt temperature is the most significant factor contribute to the warpage condition and warpage have optimised by 39.1% after optimisation for straight-drilled cooling channels and cooling time is the most significant factor contribute to the warpage condition and warpage have optimised by 38.7% after optimisation for MGSS conformal cooling channels. In addition, the finding shows that the application of optimisation work on the conformal cooling channels offers the better quality and productivity of the moulded part produced.

Mobile phone use and risk of brain tumours: a systematic review of association between study quality, source of funding, and research outcomes.

PubMed

Prasad, Manya; Kathuria, Prachi; Nair, Pallavi; Kumar, Amit; Prasad, Kameshwar

2017-05-01

Mobile phones emit electromagnetic radiations that are classified as possibly carcinogenic to humans. Evidence for increased risk for brain tumours accumulated in parallel by epidemiologic investigations remains controversial. This paper aims to investigate whether methodological quality of studies and source of funding can explain the variation in results. PubMed and Cochrane CENTRAL searches were conducted from 1966 to December 2016, which was supplemented with relevant articles identified in the references. Twenty-two case control studies were included for systematic review. Meta-analysis of 14 case-control studies showed practically no increase in risk of brain tumour [OR 1.03 (95% CI 0.92-1.14)]. However, for mobile phone use of 10 years or longer (or >1640 h), the overall result of the meta-analysis showed a significant 1.33 times increase in risk. The summary estimate of government funded as well as phone industry funded studies showed 1.07 times increase in odds which was not significant, while mixed funded studies did not show any increase in risk of brain tumour. Metaregression analysis indicated that the association was significantly associated with methodological study quality (p < 0.019, 95% CI 0.009-0.09). Relationship between source of funding and log OR for each study was not statistically significant (p < 0.32, 95% CI 0.036-0.010). We found evidence linking mobile phone use and risk of brain tumours especially in long-term users (≥10 years). Studies with higher quality showed a trend towards high risk of brain tumour, while lower quality showed a trend towards lower risk/protection.

A quality evaluation methodology of health web-pages for non-professionals.

PubMed

Currò, Vincenzo; Buonuomo, Paola Sabrina; Onesimo, Roberta; de Rose, Paola; Vituzzi, Andrea; di Tanna, Gian Luca; D'Atri, Alessandro

2004-06-01

The proposal of an evaluation methodology for determining the quality of healthcare web sites for the dissemination of medical information to non-professionals. Three (macro) factors are considered for the quality evaluation: medical contents, accountability of the authors, and usability of the web site. Starting from two results in the literature the problem of whether or not to introduce a weighting function has been investigated. This methodology has been validated on a specialized information content, i.e., sore throats, due to the large interest such a topic enjoys with target users. The World Wide Web was accessed using a meta-search system merging several search engines. A statistical analysis was made to compare the proposed methodology with the obtained ranks of the sample web pages. The statistical analysis confirms that the variables examined (per item and sub factor) show substantially similar ranks and are capable of contributing to the evaluation of the main quality macro factors. A comparison between the aggregation functions in the proposed methodology (non-weighted averages) and the weighting functions, derived from the literature, allowed us to verify the suitability of the method. The proposed methodology suggests a simple approach which can quickly award an overall quality score for medical web sites oriented to non-professionals.

Test-treatment RCTs are susceptible to bias: a review of the methodological quality of randomized trials that evaluate diagnostic tests.

PubMed

Ferrante di Ruffano, Lavinia; Dinnes, Jacqueline; Sitch, Alice J; Hyde, Chris; Deeks, Jonathan J

2017-02-24

There is a growing recognition for the need to expand our evidence base for the clinical effectiveness of diagnostic tests. Many international bodies are calling for diagnostic randomized controlled trials to provide the most rigorous evidence of impact to patient health. Although these so-called test-treatment RCTs are very challenging to undertake due to their methodological complexity, they have not been subjected to a systematic appraisal of their methodological quality. The extent to which these trials may be producing biased results therefore remains unknown. We set out to address this issue by conducting a methodological review of published test-treatment trials to determine how often they implement adequate methods to limit bias and safeguard the validity of results. We ascertained all test-treatment RCTs published 2004-2007, indexed in CENTRAL, including RCTs which randomized patients to diagnostic tests and measured patient outcomes after treatment. Tests used for screening, monitoring or prognosis were excluded. We assessed adequacy of sequence generation, allocation concealment and intention-to-treat, appropriateness of primary analyses, blinding and reporting of power calculations, and extracted study characteristics including the primary outcome. One hundred three trials compared 105 control with 119 experimental interventions, and reported 150 primary outcomes. Randomization and allocation concealment were adequate in 57 and 37% of trials. Blinding was uncommon (patients 5%, clinicians 4%, outcome assessors 21%), as was an adequate intention-to-treat analysis (29%). Overall 101 of 103 trials (98%) were at risk of bias, as judged using standard Cochrane criteria. Test-treatment trials are particularly susceptible to attrition and inadequate primary analyses, lack of blinding and under-powering. These weaknesses pose much greater methodological and practical challenges to conducting reliable RCT evaluations of test-treatment strategies than standard treatment interventions. We suggest a cautious approach that first examines whether a test-treatment intervention can accommodate the methodological safeguards necessary to minimize bias, and highlight that test-treatment RCTs require different methods to ensure reliability than standard treatment trials. Please see the companion paper to this article: http://bmcmedresmethodol.biomedcentral.com/articles/10.1186/s12874-016-0286-0 .

Sleep disturbance in psoriasis - a case-controlled study.

PubMed

Jensen, P; Zachariae, C; Skov, L; Zachariae, R

2018-04-28

Sleep is essential for daytime functioning and health. Given the physical symptoms of psoriasis, a higher prevalence of sleep disorders could be expected. So far, the studies examining sleep disturbance in psoriasis have been of less-than-optimal methodological quality and with mixed results. We aimed to: 1) examine the prevalence of sleep disturbance in patients with plaque psoriasis compared to controls, 2) evaluate associations with health-related quality of life (HRQoL), and 3) examine possible disease-related predictors of disturbed sleep. We used a cross-sectional, case-controlled design. Participants included 179 consecutively recruited patients with plaque psoriasis and 105 controls. Measures included psoriasis severity (Psoriasis Area and Severity index [PASI]); HRQoL (Dermatology Life Quality Index [DLQI]); insomnia severity (Insomnia Severity Index [ISI]); sleep quality (Pittsburgh Sleep Quality Index [PSQI]); stress (Perceived Stress Scale [PSS]); Itch (Itch Severity Scale [ISS]); and depressive symptoms (Beck Depression Inventory [BDI]). Analyses included group comparisons and regression analyses to identify predictors of sleep disturbance. Twenty-five per cent of patients with psoriasis reported clinical insomnia (ISI > 15), compared with 10.5% of controls. In all, 53.9% of patients with psoriasis were poor sleepers (PSQI > 5), compared with 21.9% of controls. Itch was statistically significantly associated with all sleep-related outcomes. A higher proportion of patients with psoriasis suffer from poor sleep than controls from the general population. Itch was the main predictor of impaired sleep. Improved control of psoriasis with decreased itch may improve sleep disturbance in psoriasis. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Association between funding source, methodological quality and research outcomes in randomized controlled trials of synbiotics, probiotics and prebiotics added to infant formula: A Systematic Review

PubMed Central

2013-01-01

Background There is little or no information available on the impact of funding by the food industry on trial outcomes and methodological quality of synbiotics, probiotics and prebiotics research in infants. The objective of this study was to compare the methodological quality, outcomes of food industry sponsored trials versus non industry sponsored trials, with regards to supplementation of synbiotics, probiotics and prebiotics in infant formula. Methods A comprehensive search was conducted to identify published and unpublished randomized clinical trials (RCTs). Cochrane methodology was used to assess the risk of bias of included RCTs in the following domains: 1) sequence generation; 2) allocation concealment; 3) blinding; 4) incomplete outcome data; 5) selective outcome reporting; and 6) other bias. Clinical outcomes and authors’ conclusions were reported in frequencies and percentages. The association between source of funding, risk of bias, clinical outcomes and conclusions were assessed using Pearson’s Chi-square test and the Fisher’s exact test. A p-value < 0.05 was statistically significant. Results Sixty seven completed and 3 on-going RCTs were included. Forty (59.7%) were funded by food industry, 11 (16.4%) by non-industry entities and 16 (23.9%) did not specify source of funding. Several risk of bias domains, especially sequence generation, allocation concealment and blinding, were not adequately reported. There was no significant association between the source of funding and sequence generation, allocation concealment, blinding and selective reporting, majority of reported clinical outcomes or authors’ conclusions. On the other hand, source of funding was significantly associated with the domains of incomplete outcome data, free of other bias domains as well as reported antibiotic use and conclusions on weight gain. Conclusion In RCTs on infants fed infant formula containing probiotics, prebiotics or synbiotics, the source of funding did not influence the majority of outcomes in favour of the sponsors’ products. More non-industry funded research is needed to further assess the impact of funding on methodological quality, reported clinical outcomes and authors’ conclusions. PMID:24219082

Job Rotation Designed to Prevent Musculoskeletal Disorders and Control Risk in Manufacturing Industries: A Systematic Review

PubMed Central

Padula, Rosimeire Simprini; Comper, Maria Luiza Caires; Sparer, Emily H.; Dennerlein, Jack T

2017-01-01

To better understand job rotation in the manufacturing industry, we completed a systematic review asking the following questions: 1) How do job-rotation programs impact work-related musculoskeletal disorders (MSDs) and related risk control for these MSDs, as well as psychosocial factors? and 2) How best should the job rotation programs be designed? We searched MEDLINE, EMBASE, Business Source Premier, ISI Web of Knowledge, CINAHL, PsyINFO, Scopus, and SciELO databases for articles published in peer-reviewed journals. Eligible studies were examined by two independent reviewers for relevance (population of manufacturing workers, outcomes of musculoskeletal disease, physical factors, psychosocial factors, and strategies used in job-rotation implantation) and methodological quality rating. From 10,809 potential articles, 71 were read for full text analysis. Of the 14 studies included for data extraction, two were non-randomized control trial studies, one was a case-control study, and 11 were cross-sectional comparisons. Only one, with a case-control design, was scored with good methodological quality. Currently, weak evidence exists supporting job rotation as a strategy for the prevention and control of musculoskeletal disorders. Job rotation did not appear to reduce the exposure of physical risk factors; yet, there are positive correlations between job rotation and higher job satisfaction. Worker training has been described as a crucial component of a successful job-rotation program. The studies reported a range of parameters used to implement and measure job-rotation programs. More rigorous studies are needed to better understand the full impact of job rotation on production and health. PMID:27633235

Multiple fingerprinting analyses in quality control of Cassiae Semen polysaccharides.

PubMed

Cheng, Jing; He, Siyu; Wan, Qiang; Jing, Pu

2018-03-01

Quality control issue overshadows potential health benefits of Cassiae Semen due to the analytic limitations. In this study, multiple-fingerprint analysis integrated with several chemometrics was performed to assess the polysaccharide quality of Cassiae Semen harvested from different locations. FT-IR, HPLC, and GC fingerprints of polysaccharide extracts from the authentic source were established as standard profiles, applying to assess the quality of foreign sources. Analyses of FT-IR fingerprints of polysaccharide extracts using either Pearson correlation analysis or principal component analysis (PCA), or HPLC fingerprints of partially hydrolyzed polysaccharides with PCA, distinguished the foreign sources from the authentic source. However, HPLC or GC fingerprints of completely hydrolyzed polysaccharides couldn't identify all foreign sources and the methodology using GC is quite limited in determining the monosaccharide composition. This indicates that FT-IR/HPLC fingerprints of non/partially-hydrolyzed polysaccharides, respectively, accompanied by multiple chemometrics methods, might be potentially applied in detecting and differentiating sources of Cassiae Semen. Copyright © 2018 Elsevier B.V. All rights reserved.

An update of a systematic review of controlled clinical trials on the primary prevention of back pain at the workplace.

PubMed

van Poppel, Mireille N M; Hooftman, Wendela E; Koes, Bart W

2004-08-01

To update the evidence on the effectiveness of lumbar supports, education and exercise in the primary prevention of low back pain at the workplace. A computerized search for controlled clinical trials published between 1997 and 2002 was conducted, and the methodological quality of the studies was assessed using a criteria list. The available evidence was graded with a rating system for the level of evidence. Effect sizes of individual studies were combined if the studies were sufficiently similar. Five new papers were identified for the update. These trials were added to the previously available trials (n = 11). The methodological quality of most studies was low. Since three of four RCTs on lumbar supports reported no effect, there is no evidence for the effectiveness of lumbar supports. No evidence for education could be found either, since all six RCTs showed negative results. The four RCTs on exercise consistently reported a positive effect, indicating limited evidence for the effectiveness of exercise. There is no evidence for the effectiveness of lumbar supports or education in the primary prevention of low back pain at the workplace. There is limited evidence for the efficacy of exercise, and the effect that can be obtained is moderate. There is still a need for methodologically sound studies and studies on the cost-effectiveness of exercise. Also the possible effect of lumbar supports in the treatment of back pain needs further investigation.

TRAINING ERRORS AND RUNNING RELATED INJURIES: A SYSTEMATIC REVIEW

PubMed Central

Buist, Ida; Sørensen, Henrik; Lind, Martin; Rasmussen, Sten

2012-01-01

Purpose: The purpose of this systematic review was to examine the link between training characteristics (volume, duration, frequency, and intensity) and running related injuries. Methods: A systematic search was performed in PubMed, Web of Science, Embase, and SportDiscus. Studies were included if they examined novice, recreational, or elite runners between the ages of 18 and 65. Exposure variables were training characteristics defined as volume, distance or mileage, time or duration, frequency, intensity, speed or pace, or similar terms. The outcome of interest was Running Related Injuries (RRI) in general or specific RRI in the lower extremity or lower back. Methodological quality was evaluated using quality assessment tools of 11 to 16 items. Results: After examining 4561 titles and abstracts, 63 articles were identified as potentially relevant. Finally, nine retrospective cohort studies, 13 prospective cohort studies, six case-control studies, and three randomized controlled trials were included. The mean quality score was 44.1%. Conflicting results were reported on the relationships between volume, duration, intensity, and frequency and RRI. Conclusion: It was not possible to identify which training errors were related to running related injuries. Still, well supported data on which training errors relate to or cause running related injuries is highly important for determining proper prevention strategies. If methodological limitations in measuring training variables can be resolved, more work can be conducted to define training and the interactions between different training variables, create several hypotheses, test the hypotheses in a large scale prospective study, and explore cause and effect relationships in randomized controlled trials. Level of evidence: 2a PMID:22389869

Does updating improve the methodological and reporting quality of systematic reviews?

PubMed

Shea, Beverley; Boers, Maarten; Grimshaw, Jeremy M; Hamel, Candyce; Bouter, Lex M

2006-06-13

Systematic reviews (SRs) must be of high quality. The purpose of our research was to compare the methodological and reporting quality of original versus updated Cochrane SRs to determine whether updating had improved these two quality dimensions. We identified updated Cochrane SRs published in issue 4, 2002 of the Cochrane Library. We assessed the updated and original versions of the SRs using two instruments: the 10 item enhanced Overview Quality Assessment Questionnaire (OQAQ), and an 18-item reporting quality checklist and flow chart based upon the Quality of Reporting of Meta-analyses (QUOROM) statement. At least two reviewers extracted data and assessed quality. We calculated the percentage (with a 95% confidence interval) of 'yes' answers to each question. We calculated mean differences in percentage, 95% confidence intervals and p-values for each of the individual items and the overall methodological quality score of the updated and pre-updated versions using OQAQ. We assessed 53 SRs. There was no significant improvement in the global quality score of the OQAQ (mean difference 0.11 (-0.28; 0.70 p = 0.52)). Updated reviews showed a significant improvement of 18.9 (7.2; 30.6 p < .01) on the OQAQ item assessing whether the conclusions drawn by the author(s) were supported by the data and/or analysis presented in the SR. The QUOROM statement showed that the quality of reporting of Cochrane reviews improved in some areas with updating. Improvements were seen on the items relating to data sources reported in the abstract, with a significant difference of 17.0 (9.8; 28.7 p = 0.01), review methods, reported in the abstract 35 (24.1; 49.1 p = 0.00), searching methods 18.9 (9.7; 31.6 p = 0.01), and data abstraction 18.9 (11.7; 30.9 p = 0.00). The overall quality of Cochrane SRs is fair-to-good. Although reporting quality improved on certain individual items there was no overall improvement seen with updating and methodological quality remained unchanged. Further improvement of quality of reporting is possible. There is room for improvement of methodological quality as well. Authors updating reviews should address identified methodological or reporting weaknesses. We recommend to give full attention to both quality domains when updating SRs.

Inventory of Personal Factors Influencing Conditioned Pain Modulation in Healthy People: A Systematic Literature Review.

PubMed

Hermans, Linda; Van Oosterwijck, Jessica; Goubert, Dorien; Goudman, Lisa; Crombez, Geert; Calders, Patrick; Meeus, Mira

2016-07-01

Conditioned pain modulation (CPM) is believed to play an important role in the development and exacerbation of chronic pain, because dysfunction of CPM is associated with a shift in balance between pain facilitation and pain inhibition. In many patients with central sensitization, CPM is less efficacious. Besides that, efficacy of CPM is highly variable in healthy people. Consequently, it seems that several individual variables may influence CPM. A systematic review examining personal factors influencing CPM was conducted. This systematic review follows the PRISMA guidelines. "Pubmed" and "Web of Science" were searched using different synonyms of CPM. Full-text clinical reports addressing the influence of personal factors on CPM in healthy adults were included. Checklists for RCTs and case-control studies provided by the Dutch Institute for Healthcare Improvement (CBO) and the Dutch Cochrane Centre were utilized to assess methodological quality. Levels of evidence and strength of conclusion were assigned using the CBO guidelines. Forty-six articles were identified that reported the influence of personal factors on CPM. Quality assessment revealed 10 studies with a methodological quality less than 50% wherefore they were excluded (21.8%), resulting in a general total methodological quality score of 72.5%. Overall younger adult age, male gender, ovulatory phase, positive expectations, attention to the conditioning stimulus, and carrier of the 5-HTTLPR long allele result in better CPM. It is advised for future studies to take these factors into account. Further research regarding the influence of oral contraceptives, catastrophizing, information about conditioning stimulation, distraction, physical activity, and genetics on CPM magnitude is required. © 2015 World Institute of Pain.

Impact Evaluation of Quality Assurance in Higher Education: Methodology and Causal Designs

ERIC Educational Resources Information Center

Leiber, Theodor; Stensaker, Bjørn; Harvey, Lee

2015-01-01

In this paper, the theoretical perspectives and general methodological elements of impact evaluation of quality assurance in higher education institutions are discussed, which should be a cornerstone of quality development in higher education and contribute to improving the knowledge about the effectiveness (or ineffectiveness) of quality…

Improving inferior vena cava filter retrieval rates with the define, measure, analyze, improve, control methodology.

PubMed

Sutphin, Patrick D; Reis, Stephen P; McKune, Angie; Ravanzo, Maria; Kalva, Sanjeeva P; Pillai, Anil K

2015-04-01

To design a sustainable process to improve optional inferior vena cava (IVC) filter retrieval rates based on the Define, Measure, Analyze, Improve, Control (DMAIC) methodology of the Six Sigma process improvement paradigm. DMAIC, an acronym for Define, Measure, Analyze, Improve, and Control, was employed to design and implement a quality improvement project to increase IVC filter retrieval rates at a tertiary academic hospital. Retrievable IVC filters were placed in 139 patients over a 2-year period. The baseline IVC filter retrieval rate (n = 51) was reviewed through a retrospective analysis, and two strategies were devised to improve the filter retrieval rate: (a) mailing of letters to clinicians and patients for patients who had filters placed within 8 months of implementation of the project (n = 43) and (b) a prospective automated scheduling of a clinic visit at 4 weeks after filter placement for all new patients (n = 45). The effectiveness of these strategies was assessed by measuring the filter retrieval rates and estimated increase in revenue to interventional radiology. IVC filter retrieval rates increased from a baseline of 8% to 40% with the mailing of letters and to 52% with the automated scheduling of a clinic visit 4 weeks after IVC filter placement. The estimated revenue per 100 IVC filters placed increased from $2,249 to $10,518 with the mailing of letters and to $17,022 with the automated scheduling of a clinic visit. Using the DMAIC methodology, a simple and sustainable quality improvement intervention was devised that markedly improved IVC filter retrieval rates in eligible patients. Copyright © 2015 SIR. Published by Elsevier Inc. All rights reserved.

Lean management in health care: definition, concepts, methodology and effects reported (systematic review protocol).

PubMed

Lawal, Adegboyega K; Rotter, Thomas; Kinsman, Leigh; Sari, Nazmi; Harrison, Liz; Jeffery, Cathy; Kutz, Mareike; Khan, Mohammad F; Flynn, Rachel

2014-09-19

Lean is a set of operating philosophies and methods that help create a maximum value for patients by reducing waste and waits. It emphasizes the consideration of the customer's needs, employee involvement and continuous improvement. Research on the application and implementation of lean principles in health care has been limited. This is a protocol for a systematic review, following the Cochrane Effective Practice and Organisation of Care (EPOC) methodology. The review aims to document, catalogue and synthesize the existing literature on the effects of lean implementation in health care settings especially the potential effects on professional practice and health care outcomes. We have developed a Medline keyword search strategy, and this focused strategy will be translated into other databases. All search strategies will be provided in the review. The method proposed by the Cochrane EPOC group regarding randomized study designs, non-randomised controlled trials controlled before and after studies and interrupted time series will be followed. In addition, we will also include cohort, case-control studies, and relevant non-comparative publications such as case reports. We will categorize and analyse the review findings according to the study design employed, the study quality (low- versus high-quality studies) and the reported types of implementation in the primary studies. We will present the results of studies in a tabular form. Overall, the systematic review aims to identify, assess and synthesize the evidence to underpin the implementation of lean activities in health care settings as defined in this protocol. As a result, the review will provide an evidence base for the effectiveness of lean and implementation methodologies reported in health care. PROSPERO CRD42014008853.

Lean management in health care: definition, concepts, methodology and effects reported (systematic review protocol)

PubMed Central

2014-01-01

Background Lean is a set of operating philosophies and methods that help create a maximum value for patients by reducing waste and waits. It emphasizes the consideration of the customer’s needs, employee involvement and continuous improvement. Research on the application and implementation of lean principles in health care has been limited. Methods This is a protocol for a systematic review, following the Cochrane Effective Practice and Organisation of Care (EPOC) methodology. The review aims to document, catalogue and synthesize the existing literature on the effects of lean implementation in health care settings especially the potential effects on professional practice and health care outcomes. We have developed a Medline keyword search strategy, and this focused strategy will be translated into other databases. All search strategies will be provided in the review. The method proposed by the Cochrane EPOC group regarding randomized study designs, non-randomised controlled trials controlled before and after studies and interrupted time series will be followed. In addition, we will also include cohort, case–control studies, and relevant non-comparative publications such as case reports. We will categorize and analyse the review findings according to the study design employed, the study quality (low- versus high-quality studies) and the reported types of implementation in the primary studies. We will present the results of studies in a tabular form. Discussion Overall, the systematic review aims to identify, assess and synthesize the evidence to underpin the implementation of lean activities in health care settings as defined in this protocol. As a result, the review will provide an evidence base for the effectiveness of lean and implementation methodologies reported in health care. Systematic review registration PROSPERO CRD42014008853 PMID:25238974

A methodology for calculating transport emissions in cities with limited traffic data: Case study of diesel particulates and black carbon emissions in Murmansk.

PubMed

Kholod, N; Evans, M; Gusev, E; Yu, S; Malyshev, V; Tretyakova, S; Barinov, A

2016-03-15

This paper presents a methodology for calculating exhaust emissions from on-road transport in cities with low-quality traffic data and outdated vehicle registries. The methodology consists of data collection approaches and emission calculation methods. For data collection, the paper suggests using video survey and parking lot survey methods developed for the International Vehicular Emissions model. Additional sources of information include data from the largest transportation companies, vehicle inspection stations, and official vehicle registries. The paper suggests using the European Computer Programme to Calculate Emissions from Road Transport (COPERT) 4 model to calculate emissions, especially in countries that implemented European emissions standards. If available, the local emission factors should be used instead of the default COPERT emission factors. The paper also suggests additional steps in the methodology to calculate emissions only from diesel vehicles. We applied this methodology to calculate black carbon emissions from diesel on-road vehicles in Murmansk, Russia. The results from Murmansk show that diesel vehicles emitted 11.7 tons of black carbon in 2014. The main factors determining the level of emissions are the structure of the vehicle fleet and the level of vehicle emission controls. Vehicles without controls emit about 55% of black carbon emissions. Copyright © 2015 Elsevier B.V. All rights reserved.

Methodological reporting of randomized trials in five leading Chinese nursing journals.

PubMed

Shi, Chunhu; Tian, Jinhui; Ren, Dan; Wei, Hongli; Zhang, Lihuan; Wang, Quan; Yang, Kehu

2014-01-01

Randomized controlled trials (RCTs) are not always well reported, especially in terms of their methodological descriptions. This study aimed to investigate the adherence of methodological reporting complying with CONSORT and explore associated trial level variables in the Chinese nursing care field. In June 2012, we identified RCTs published in five leading Chinese nursing journals and included trials with details of randomized methods. The quality of methodological reporting was measured through the methods section of the CONSORT checklist and the overall CONSORT methodological items score was calculated and expressed as a percentage. Meanwhile, we hypothesized that some general and methodological characteristics were associated with reporting quality and conducted a regression with these data to explore the correlation. The descriptive and regression statistics were calculated via SPSS 13.0. In total, 680 RCTs were included. The overall CONSORT methodological items score was 6.34 ± 0.97 (Mean ± SD). No RCT reported descriptions and changes in "trial design," changes in "outcomes" and "implementation," or descriptions of the similarity of interventions for "blinding." Poor reporting was found in detailing the "settings of participants" (13.1%), "type of randomization sequence generation" (1.8%), calculation methods of "sample size" (0.4%), explanation of any interim analyses and stopping guidelines for "sample size" (0.3%), "allocation concealment mechanism" (0.3%), additional analyses in "statistical methods" (2.1%), and targeted subjects and methods of "blinding" (5.9%). More than 50% of trials described randomization sequence generation, the eligibility criteria of "participants," "interventions," and definitions of the "outcomes" and "statistical methods." The regression analysis found that publication year and ITT analysis were weakly associated with CONSORT score. The completeness of methodological reporting of RCTs in the Chinese nursing care field is poor, especially with regard to the reporting of trial design, changes in outcomes, sample size calculation, allocation concealment, blinding, and statistical methods.

[Evaluation of the methodological quality of the Rémic (microbiology guidelines - bacteriology and mycology) of the Société française de microbiologie].

PubMed

Fonfrède, Michèle; Couaillac, Jean Paul; Augereau, Christine; De Moüy, Danny; Lepargneur, Jean Pierre; Szymanowicz, Anton; Watine, Joseph

2011-01-01

We have evaluated the methodological quality of the Rémic (microbiology guidelines - bacteriology and mycology) of the Société française de microbiologie (edition2007), using to AGREE criteria, which are consensual at an international level, in particular at the the World Health Organisation (WHO) and at the European Union. The methodological quality of the Rémic appears to be sub-optimal. These shortcomings in quality are mainly observed in AGREE domain n° 5 (applicability), in AGREE item n° 5 (patients' opinions were not considered), and in AGREE item n° 23 (conflicts of interest were not declared). The users of the Rémic must be aware of these few methodological shortcomings in order for them to be careful before they put its recommendation in practice. In conclusion, we advise the editors of the Rémic to insert at least a methodological chapter in their next edition.

Determination of fragrance content in perfume by Raman spectroscopy and multivariate calibration

NASA Astrophysics Data System (ADS)

Godinho, Robson B.; Santos, Mauricio C.; Poppi, Ronei J.

2016-03-01

An alternative methodology is herein proposed for determination of fragrance content in perfumes and their classification according to the guidelines established by fine perfume manufacturers. The methodology is based on Raman spectroscopy associated with multivariate calibration, allowing the determination of fragrance content in a fast, nondestructive, and sustainable manner. The results were considered consistent with the conventional method, whose standard error of prediction values was lower than the 1.0%. This result indicates that the proposed technology is a feasible analytical tool for determination of the fragrance content in a hydro-alcoholic solution for use in manufacturing, quality control and regulatory agencies.

Appraising the methodological quality of the clinical practice guideline for diabetes mellitus using the AGREE II instrument: a methodological evaluation.

PubMed

Radwan, Mahmoud; Akbari Sari, Ali; Rashidian, Arash; Takian, Amirhossein; Abou-Dagga, Sanaa; Elsous, Aymen

2017-02-01

To evaluate the methodological quality of the Palestinian Clinical Practice Guideline for Diabetes Mellitus using the Translated Arabic Version of the AGREE II. Methodological evaluation. A cross-cultural adaptation framework was followed to translate and develop a standardised Translated Arabic Version of the AGREE II. Palestinian Primary Healthcare Centres. Sixteen appraisers independently evaluated the Clinical Practice Guideline for Diabetes Mellitus using the Translated Arabic Version of the AGREE II. Methodological quality of diabetic guideline. The Translated Arabic Version of the AGREE II showed an acceptable reliability and validity. Internal consistency ranged between 0.67 and 0.88 (Cronbach's α). Intra-class coefficient among appraisers ranged between 0.56 and 0.88. The quality of this guideline is low. Both domains 'Scope and Purpose' and 'Clarity of Presentation' had the highest quality scores (66.7% and 61.5%, respectively), whereas the scores for 'Applicability', 'Stakeholder Involvement', 'Rigour of Development' and 'Editorial Independence' were the lowest (27%, 35%, 36.5%, and 40%, respectively). The findings suggest that the quality of this Clinical Practice Guideline is disappointingly low. To improve the quality of current and future guidelines, the AGREE II instrument is extremely recommended to be incorporated as a gold standard for developing, evaluating or updating the Palestinian Clinical Practice Guidelines. Future guidelines can be improved by setting specific strategies to overcome implementation barriers with respect to economic considerations, engaging of all relevant end-users and patients, ensuring a rigorous methodology for searching, selecting and synthesising the evidences and recommendations, and addressing potential conflict of interests within the development group.

[Advances in research on automatic exposure control of mammography system].

PubMed

Wang, Guoyi; Ye, Chengfu; Wu, Haiming; Wang, Tainfu; Zhang, Hong

2014-12-01

Mammography imaging is one of the most demanding imaging modalities from the point of view of the bal- ance between image quality (the visibility of small size and/or low contrast structures) and dose (screening of many asymptomatic people). Therefore, since the introduction of the first dedicated mammographic units, many efforts have been directed to seek the best possible image quality while minimizing patient dose. The performance of auto- matic exposure control (AEC) is the manifestation of this demand. The theory of AEC includes exposure detection and optimization and also involves some accomplished methodology. This review presents the development and present situa- tion of spectrum optimization, detector evolution, and the way how to accomplish and evaluate AEC methods.

Qualification Procedures for VHSIC/VLSI

DTIC Science & Technology

1990-12-01

alternative approach for qualification of complex microcircuits. To address the technical issues related to a process oriented qualification approach, the...methodology of microcircuit process control to promote the United States to a position of supplying the nighest quality and most reliable...available resources . o Coordinate document reviews with weekly and monthly status reviews on progress. o Summarize results and collate into four basic

Collaborative Evaluation of a High School Prevention Curriculum: How Methods of Collaborative Evaluation Enhanced a Randomized Control Trial to Inform Program Improvement

ERIC Educational Resources Information Center

Orsini, Muhsin Michael; Wyrick, David L.; Milroy, Jeffrey J.

2012-01-01

Blending high-quality and rigorous research with pure evaluation practice can often be best accomplished through thoughtful collaboration. The evaluation of a high school drug prevention program (All Stars Senior) is an example of how perceived competing purposes and methodologies can coexist to investigate formative and summative outcome…

Young runoff fractions control streamwater age and solute concentration dynamics

Treesearch

Paolo Benettin; Scott W. Bailey; Andrea Rinaldo; Gene E. Likens; Kevin J. McGuire; Gianluca Botter

2017-01-01

We introduce a new representation of coupled solute and water age dynamics at the catchment scale, which shows how the contributions of young runoff waters can be directly referenced to observed water quality patterns. The methodology stems from recent trends in hydrologic transport that acknowledge the dynamic nature of streamflow age and explores the use of water age...

Interventional Radiology Clinical Practice Guideline Recommendations for Neurovascular Disorders Are Not Based on High-Quality Systematic Reviews.

PubMed

Chong, A B; Taylor, M; Schubert, G; Vassar, M

2017-04-01

In recent years, clinical practice guidelines have been criticized for biased interpretations of research evidence, and interventional radiology is no exception. Our aim was to evaluate the methodologic quality and transparency of reporting in systematic reviews used as evidence in interventional radiology clinical practice guidelines for neurovascular disorders from the Society of Interventional Radiology. Our sources were 9 neurovascular disorder clinical practice guidelines from the Society of Interventional Radiology. We selected 65 systematic reviews and meta-analyses. A Measurement Tool to Assess Systematic Reviews (AMSTAR) and Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) tools were used to assess the methodologic quality and reporting transparency of systematic reviews. Radial plots were created on the basis of average scores for PRISMA and AMSTAR items. On the basis of AMSTAR scores, 3 (4.62%) reviews were high-quality, 28 reviews (43.08%) were moderate-quality, and 34 reviews (52.31%) were low-quality, with an average quality score of 3.66 (34.32%; minimum, 0%; maximum, 81.82%). The average PRISMA score was 18.18 (69.41%). We were unable to obtain previous versions for 8 reviews, 7 of which were from the Cochrane Database of Systematic Reviews. The methodologic quality of systematic reviews needs to be improved. Although reporting clarity was much better than the methodologic quality, it still has room for improvement. The methodologic quality and transparency of reporting did not vary much among clinical practice guidelines. This study can also be applied to other medical specialties to examine the quality of studies used as evidence in their own clinical practice guidelines. © 2017 by American Journal of Neuroradiology.

State of the evidence: Cannabinoids and cancer pain-A systematic review.

PubMed

Tateo, Sydney

2017-02-01

Cannabinoids are widely used to alleviate intractable symptoms such as pain, nausea, and muscle spasticity. The purpose of this review was to ascertain the current state of the science regarding use of cannabinoids for cancer pain. Four electronic databases were searched for randomized control trials of cannabinoids and cancer pain. Studies included examined the analgesic effects of cannabinoids for cancer pain. Methodological quality was assessed using the Jadad scale. Eight randomized control trials met the inclusion criteria for review. Most trials found analgesic effects from cannabinoids when compared to placebo, although not all associations reached statistical significance. The analgesic effects of cannabinoids were also limited by dose-dependent side effects. Side effects most commonly reported were changes in cognition, sedation, and dizziness. There is evidence that cannabinoids are effective adjuvants for cancer pain not completely relieved by opioid therapy, but there is a dearth of high-quality studies to support a stronger conclusion. Cannabinoids appear to be safe in low and medium doses. Methodological limitations of the trials limited the ability to make sound conclusions. Further research is warranted before efficacy, safety, and utility of cannabinoids for cancer pain can be determined. ©2016 American Association of Nurse Practitioners.

Improved Methodology for Surface and Atmospheric Soundings, Error Estimates, and Quality Control Procedures: the AIRS Science Team Version-6 Retrieval Algorithm

NASA Technical Reports Server (NTRS)

Susskind, Joel; Blaisdell, John; Iredell, Lena

2014-01-01

The AIRS Science Team Version-6 AIRS/AMSU retrieval algorithm is now operational at the Goddard DISC. AIRS Version-6 level-2 products are generated near real-time at the Goddard DISC and all level-2 and level-3 products are available starting from September 2002. This paper describes some of the significant improvements in retrieval methodology contained in the Version-6 retrieval algorithm compared to that previously used in Version-5. In particular, the AIRS Science Team made major improvements with regard to the algorithms used to 1) derive surface skin temperature and surface spectral emissivity; 2) generate the initial state used to start the cloud clearing and retrieval procedures; and 3) derive error estimates and use them for Quality Control. Significant improvements have also been made in the generation of cloud parameters. In addition to the basic AIRS/AMSU mode, Version-6 also operates in an AIRS Only (AO) mode which produces results almost as good as those of the full AIRS/AMSU mode. This paper also demonstrates the improvements of some AIRS Version-6 and Version-6 AO products compared to those obtained using Version-5.

Multi-application controls: Robust nonlinear multivariable aerospace controls applications

NASA Technical Reports Server (NTRS)

Enns, Dale F.; Bugajski, Daniel J.; Carter, John; Antoniewicz, Bob

1994-01-01

This viewgraph presentation describes the general methodology used to apply Honywell's Multi-Application Control (MACH) and the specific application to the F-18 High Angle-of-Attack Research Vehicle (HARV) including piloted simulation handling qualities evaluation. The general steps include insertion of modeling data for geometry and mass properties, aerodynamics, propulsion data and assumptions, requirements and specifications, e.g. definition of control variables, handling qualities, stability margins and statements for bandwidth, control power, priorities, position and rate limits. The specific steps include choice of independent variables for least squares fits to aerodynamic and propulsion data, modifications to the management of the controls with regard to integrator windup and actuation limiting and priorities, e.g. pitch priority over roll, and command limiting to prevent departures and/or undesirable inertial coupling or inability to recover to a stable trim condition. The HARV control problem is characterized by significant nonlinearities and multivariable interactions in the low speed, high angle-of-attack, high angular rate flight regime. Systematic approaches to the control of vehicle motions modeled with coupled nonlinear equations of motion have been developed. This paper will discuss the dynamic inversion approach which explicity accounts for nonlinearities in the control design. Multiple control effectors (including aerodynamic control surfaces and thrust vectoring control) and sensors are used to control the motions of the vehicles in several degrees-of-freedom. Several maneuvers will be used to illustrate performance of MACH in the high angle-of-attack flight regime. Analytical methods for assessing the robust performance of the multivariable control system in the presence of math modeling uncertainty, disturbances, and commands have reached a high level of maturity. The structured singular value (mu) frequency response methodology is presented as a method for analyzing robust performance and the mu-synthesis method will be presented as a method for synthesizing a robust control system. The paper concludes with the author's expectations regarding future applications of robust nonlinear multivariable controls.

A Systematic Review of Herbal Medicine for Chemotherapy Induced Peripheral Neuropathy

PubMed Central

Noh, Hyeonseok

2018-01-01

Background Chemotherapy-induced peripheral neuropathy (CIPN) is a common adverse effect in cancer patients. The aim of this review was to assess the effectiveness of herbal medicine in preventing and treating CIPN. Methods Randomised controlled trials were included in this review. Extracting and assessing the data independently, two authors searched 13 databases. Results Twenty-eight trials involving 2174 patients met the inclusion criteria. Although there were some exceptions, the methodological quality was typically low. Seventeen trials reported the incidence rate of CIPN assessed by various tools and 14 showed a significant difference regarding the decrease of the incidence rate between the two groups. For clinical improvement, 12 trials reported it using various tools and 10 showed a significant difference between two groups. Two cases of adverse events occurred in one trial; the other nine trials reported no adverse events. Conclusions We found that herbal medicines in combination with and/or without other therapies potentially have preventive or therapeutic effects on CIPN. However, conclusions cannot be drawn because of the generally low quality of the methodology, the clinical heterogeneity, and the small sample size for each single herbal medicine. Trials that are more rigorous and report sufficient methodological data are needed. PMID:29636782

Methodology and reporting of diagnostic accuracy studies of automated perimetry in glaucoma: evaluation using a standardised approach.

PubMed

Fidalgo, Bruno M R; Crabb, David P; Lawrenson, John G

2015-05-01

To evaluate methodological and reporting quality of diagnostic accuracy studies of perimetry in glaucoma and to determine whether there had been any improvement since the publication of the Standards for Reporting of Diagnostic Accuracy (STARD) guidelines. A systematic review of English language articles published between 1993 and 2013 reporting the diagnostic accuracy of perimetry in glaucoma. Articles were appraised for methodological quality using the 14-item Quality assessment tool for diagnostic accuracy studies (QUADAS) and evaluated for quality of reporting by applying the STARD checklist. Fifty-eight articles were appraised. Overall methodological quality of these studies was moderate with a median number of QUADAS items rated as 'yes' equal to nine (out of a maximum of 14) (IQR 7-10). The studies were often poorly reported; median score of STARD items fully reported was 11 out of 25 (IQR 10-14). A comparison of the studies published in 10-year periods before and after the publication of the STARD checklist in 2003 found quality of reporting had not substantially improved. Methodological and reporting quality of diagnostic accuracy studies of perimetry is sub-optimal and appears not to have improved substantially following the development of the STARD reporting guidance. This observation is consistent with previous studies in ophthalmology and in other medical specialities. © 2015 The Authors Ophthalmic & Physiological Optics © 2015 The College of Optometrists.

Incorporating Handling Qualities Analysis into Rotorcraft Conceptual Design

NASA Technical Reports Server (NTRS)

Lawrence, Ben

2014-01-01

This paper describes the initial development of a framework to incorporate handling qualities analyses into a rotorcraft conceptual design process. In particular, the paper describes how rotorcraft conceptual design level data can be used to generate flight dynamics models for handling qualities analyses. Also, methods are described that couple a basic stability augmentation system to the rotorcraft flight dynamics model to extend analysis to beyond that of the bare airframe. A methodology for calculating the handling qualities characteristics of the flight dynamics models and for comparing the results to ADS-33E criteria is described. Preliminary results from the application of the handling qualities analysis for variations in key rotorcraft design parameters of main rotor radius, blade chord, hub stiffness and flap moment of inertia are shown. Varying relationships, with counteracting trends for different handling qualities criteria and different flight speeds are exhibited, with the action of the control system playing a complex part in the outcomes. Overall, the paper demonstrates how a broad array of technical issues across flight dynamics stability and control, simulation and modeling, control law design and handling qualities testing and evaluation had to be confronted to implement even a moderately comprehensive handling qualities analysis of relatively low fidelity models. A key outstanding issue is to how to 'close the loop' with an overall design process, and options for the exploration of how to feedback handling qualities results to a conceptual design process are proposed for future work.

Line-edge quality optimization of electron beam resist for high-throughput character projection exposure utilizing atomic force microscope analysis

NASA Astrophysics Data System (ADS)

Ikeno, Rimon; Mita, Yoshio; Asada, Kunihiro

2017-04-01

High-throughput electron-beam lithography (EBL) by character projection (CP) and variable-shaped beam (VSB) methods is a promising technique for low-to-medium volume device fabrication with regularly arranged layouts, such as standard-cell logics and memory arrays. However, non-VLSI applications like MEMS and MOEMS may not fully utilize the benefits of CP method due to their wide variety of layout figures including curved and oblique edges. In addition, the stepwise shapes that appear on such irregular edges by VSB exposure often result in intolerable edge roughness, which may degrade performances of the fabricated devices. In our former study, we proposed a general EBL methodology for such applications utilizing a combination of CP and VSB methods, and demonstrated its capabilities in electron beam (EB) shot reduction and edge-quality improvement by using a leading-edge EB exposure tool, ADVANTEST F7000S-VD02, and high-resolution Hydrogen Silsesquioxane resist. Both scanning electron microscope and atomic force microscope observations were used to analyze quality of the resist edge profiles to determine the influence of the control parameters used in the exposure-data preparation process. In this study, we carried out detailed analysis of the captured edge profiles utilizing Fourier analysis, and successfully distinguish the systematic undulation by the exposed CP character profiles from random roughness components. Such capability of precise edge-roughness analysis is useful to our EBL methodology to maintain both the line-edge quality and the exposure throughput by optimizing the control parameters in the layout data conversion.

Macroergonomic analysis and design for improved safety and quality performance.

PubMed

Kleiner, B M

1999-01-01

Macroergonomics, which emerged historically after sociotechnical systems theory, quality management, and ergonomics, is presented as the basis for a needed integrative methodology. A macroergonomics methodology was presented in some detail to demonstrate how aspects of microergonomics, total quality management (TQM), and sociotechnical systems (STS) can be triangulated in a common approach. In the context of this methodology, quality and safety were presented as 2 of several important performance criteria. To demonstrate aspects of the methodology, 2 case studies were summarized with safety and quality performance results where available. The first case manipulated both personnel and technical factors to achieve a "safety culture" at a nuclear site. The concept of safety culture is defined in INSAG-4 (International Atomic Energy Agency, 1991). as "that assembly of characteristics and attitudes in organizations and individuals which establishes that, as an overriding priority, nuclear plant safety issues receive the attention warranted by their significance." The second case described a tire manufacturing intervention to improve quality (as defined by Sink and Tuttle, 1989) through joint consideration of technical and social factors. It was suggested that macroergonomics can yield greater performance than can be achieved through ergonomic intervention alone. Whereas case studies help to make the case, more rigorous formative and summative research is needed to refine and validate the proposed methodology respectively.

[Development of an optimized formulation of damask marmalade with low energy level using Taguchi methodology].

PubMed

Villarroel, Mario; Castro, Ruth; Junod, Julio

2003-06-01

The goal of this present study was the development of an optimized formula of damask marmalade low in calories applying Taguchi methodology to improve the quality of this product. The selection of this methodology lies on the fact that in real life conditions the result of an experiment frequently depends on the influence of several variables, therefore, one expedite way to solve this problem is utilizing factorial desings. The influence of acid, thickener, sweetener and aroma additives, as well as time of cooking, and possible interactions among some of them, were studied trying to get the best combination of these factors to optimize the sensorial quality of an experimental formulation of dietetic damask marmalade. An orthogonal array L8 (2(7)) was applied in this experience, as well as level average analysis was carried out according Taguchi methodology to determine the suitable working levels of the design factors previously choiced, to achieve a desirable product quality. A sensory trained panel was utilized to analyze the marmalade samples using a composite scoring test with a descriptive acuantitative scale ranging from 1 = Bad, 5 = Good. It was demonstrated that the design factors sugar/aspartame, pectin and damask aroma had a significant effect (p < 0.05) on the sensory quality of the marmalade with 82% of contribution on the response. The optimal combination result to be: citric acid 0.2%; pectin 1%; 30 g sugar/16 mg aspartame/100 g, damask aroma 0.5 ml/100 g, time of cooking 5 minutes. Regarding chemical composition, the most important results turned out to be the decrease in carbohydrate content compaired with traditional marmalade with a reduction of 56% in coloric value and also the amount of dietary fiber greater than similar commercial products. Assays of storage stability were carried out on marmalade samples submitted to different temperatures held in plastic bags of different density. Non percetible sensorial, microbiological and chemical changes were detected after 90 days of storage under controlled conditions.

Guidelines to implement quality management systems in microbiology laboratories for tissue banking.

PubMed

Vicentino, W; Rodríguez, G; Saldías, M; Alvarez, I

2009-10-01

Human tissues for implants are a biomedical product that is being used more frequently by many medical disciplines. There are infections in the patients related to the implanted tissues. The early detection of infections transmitted by blood and the microbiological study of tissues before their clinical use are strategies in tissue banks to prevent these situations. This work sought to contribute to establish the bases for the operation of a laboratory applied to the microbiological quality control of tissues. Based on classical microbiological principles, we defined the operation of microbiological control and tissues sterilization since 2003. We determine lists of acceptable microorganisms for every tissue, criteria for the interpretation of results, and a diagnostic algorithm of microbiological quality. We observed that the circumstances of donor death can be a determinant of the quality. The environment and the operator should be investigated as probable sources of contamination in outbreaks. The criteria of work based on a solid methodology must help to avoid the transmission of infections between donor and recipient. This is a critical point in the quality management of a tissue bank.

The effects of group supervision of nurses: a systematic literature review.

PubMed

Francke, Anneke L; de Graaff, Fuusje M

2012-09-01

To gain insight into the existing scientific evidence on the effects of group supervision for nurses. A systematic literature study of original research publications. Searches were performed in February 2010 in PubMed, CINAHL, Cochrane Library, Embase, ERIC, the NIVEL catalogue, and PsycINFO. No limitations were applied regarding date of publication, language or country. Original research publications were eligible for review when they described group supervision programmes directed at nurses; used a control group or a pre-test post-test design; and gave information about the effects of group supervision on nurse or patient outcomes. The two review authors independently assessed studies for inclusion. The methodological quality of included studies was also independently assessed by the review authors, using a check list developed by Van Tulder et al. in collaboration with the Dutch Cochrane Centre. Data related to the original publications were extracted by one review author and checked by a second review author. No statistical pooling of outcomes was performed, because there was large heterogeneity of outcomes. A total of 1087 potentially relevant references were found. After screening of the references, eight studies with a control group and nine with a pre-test post-test design were included. Most of the 17 studies included have serious methodological limitations, but four Swedish publications in the field of dementia care had high methodological quality and all point to positive effects on nurses' attitudes and skills and/or nurse-patient interactions. However, in interpreting these positive results, it must be taken into account that these four high-quality publications concern sub-studies of one 'sliced' research project using the same study sample. Moreover, these four publications combined a group supervision intervention with the introduction of individual care planning, which also hampers conclusions about the effectiveness of group supervision alone. Although there are rather a lot of indications that group supervision of nurses is effective, evidence on the effects is still scarce. Further methodologically sound research is needed. Copyright © 2011 Elsevier Ltd. All rights reserved.

Interventions for treating pain and disability in adults with complex regional pain syndrome.

PubMed

O'Connell, Neil E; Wand, Benedict M; McAuley, James; Marston, Louise; Moseley, G Lorimer

2013-04-30

There is currently no strong consensus regarding the optimal management of complex regional pain syndrome although a multitude of interventions have been described and are commonly used. To summarise the evidence from Cochrane and non-Cochrane systematic reviews of the effectiveness of any therapeutic intervention used to reduce pain, disability or both in adults with complex regional pain syndrome (CRPS). We identified Cochrane reviews and non-Cochrane reviews through a systematic search of the following databases: Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects (DARE), Ovid MEDLINE, Ovid EMBASE, CINAHL, LILACS and PEDro. We included non-Cochrane systematic reviews where they contained evidence not covered by identified Cochrane reviews. The methodological quality of reviews was assessed using the AMSTAR tool.We extracted data for the primary outcomes pain, disability and adverse events, and the secondary outcomes of quality of life, emotional well being and participants' ratings of satisfaction or improvement. Only evidence arising from randomised controlled trials was considered. We used the GRADE system to assess the quality of evidence. We included six Cochrane reviews and 13 non-Cochrane systematic reviews. Cochrane reviews demonstrated better methodological quality than non-Cochrane reviews. Trials were typically small and the quality variable.There is moderate quality evidence that intravenous regional blockade with guanethidine is not effective in CRPS and that the procedure appears to be associated with the risk of significant adverse events.There is low quality evidence that bisphosphonates, calcitonin or a daily course of intravenous ketamine may be effective for pain when compared with placebo; graded motor imagery may be effective for pain and function when compared with usual care; and that mirror therapy may be effective for pain in post-stroke CRPS compared with a 'covered mirror' control. This evidence should be interpreted with caution. There is low quality evidence that local anaesthetic sympathetic blockade is not effective. Low quality evidence suggests that physiotherapy or occupational therapy are associated with small positive effects that are unlikely to be clinically important at one year follow up when compared with a social work passive attention control.For a wide range of other interventions, there is either no evidence or very low quality evidence available from which no conclusions should be drawn. There is a critical lack of high quality evidence for the effectiveness of most therapies for CRPS. Until further larger trials are undertaken, formulating an evidence-based approach to managing CRPS will remain difficult.

Cation-exchange high-performance liquid chromatography for variant hemoglobins and HbF/A2: What must hematopathologists know about methodology?

PubMed

Sharma, Prashant; Das, Reena

2016-03-26

Cation-exchange high-performance liquid chromatography (CE-HPLC) is a widely used laboratory test to detect variant hemoglobins as well as quantify hemoglobins F and A2 for the diagnosis of thalassemia syndromes. It's versatility, speed, reproducibility and convenience have made CE-HPLC the method of choice to initially screen for hemoglobin disorders. Despite its popularity, several methodological aspects of the technology remain obscure to pathologists and this may have consequences in specific situations. This paper discusses the basic principles of the technique, the initial quality control steps and the interpretation of various controls and variables that are available on the instrument output. Subsequent sections are devoted to methodological considerations that arise during reporting of cases. For instance, common problems of misidentified peaks, totals crossing 100%, causes of total area being above or below acceptable limits and the importance of pre-integration region peaks are dealt with. Ultimately, CE-HPLC remains an investigation, the reporting of which combines in-depth knowledge of the biological basics with more than a working knowledge of the technological aspects of the technique.

Analysis of CrIs/ATMS Using AIRS Version-7 Retrieval and QC Methodology

NASA Technical Reports Server (NTRS)

Susskind, Joel; Kouvaris, Louis; Blaisdell, John M.; Iredell, Lena

2017-01-01

The objective of this research is to develop and implement an algorithm to analyze a long term data record of CrIS/ATMS observations so as to produce monthly mean gridded Level-3 products which are consistent with, and will serve as a seamless follow on to, those of AIRS Version-7. We feel the best way to achieve this result is to analyze CrIS/ATMS data using retrieval and Quality Control (QC) methodologies which are scientifically equivalent to those used in AIRS Version-7. We developed and implemented a single retrieval program that uses as input either AIRS/AMSU or CrIS/ATMS radiance observations, and has appropriate switches that take into account the spectral and radiometric differences between CrIS and AIRS. Our methodology is call CHART (Climate Heritage AIRS Retrieval Technique).

Infection prevention and control self-audit: just a tick box exercise?

PubMed Central

2013-01-01

The National Health Service (NHS) in England continues to experience ongoing change in order to complete the transition to the new delivery system outlined in Liberating the NHS (Department of Health, 2010a). Treating and caring for patients in a safe environment and protecting them from acquiring avoidable infections remains a high priority and a central quality improvement component within the outcome Indicator set for 2013/14 (NHS Commissioning Board, 2012a). Infection prevention and control practitioners will be required to use a range of innovative quality improvement strategies to facilitate engagement with clinicians and meet the challenges that lie ahead for the NHS. The purpose of this paper is to report on the implementation of an infection prevention and control self-audit (IPCSA) project within general practice. The aim of the project was to empower practice staff to become actively involved with an infection prevention and control (IPC) audit in order to support the development of an IPC quality improvement culture within general practice teams. The paper outlines the methodology used to implement self-audit. The findings suggest that IPCSA can be used as an effective alternative to an IPC nurse-led infection prevention and control audit. PMID:28989357

Infection prevention and control self-audit: just a tick box exercise?

PubMed

Gorrell, Michelle

2014-03-01

The National Health Service (NHS) in England continues to experience ongoing change in order to complete the transition to the new delivery system outlined in Liberating the NHS (Department of Health, 2010a). Treating and caring for patients in a safe environment and protecting them from acquiring avoidable infections remains a high priority and a central quality improvement component within the outcome Indicator set for 2013/14 (NHS Commissioning Board, 2012a). Infection prevention and control practitioners will be required to use a range of innovative quality improvement strategies to facilitate engagement with clinicians and meet the challenges that lie ahead for the NHS. The purpose of this paper is to report on the implementation of an infection prevention and control self-audit (IPCSA) project within general practice. The aim of the project was to empower practice staff to become actively involved with an infection prevention and control (IPC) audit in order to support the development of an IPC quality improvement culture within general practice teams. The paper outlines the methodology used to implement self-audit. The findings suggest that IPCSA can be used as an effective alternative to an IPC nurse-led infection prevention and control audit.

Correlation Between Quality of Evidence and Number of Citations in Top 50 Cited Articles on Elbow Medial Ulnar Collateral Ligament Surgery.

PubMed

Jack, Robert A; Sochacki, Kyle R; Morehouse, Hannah A; McCulloch, Patrick C; Lintner, David M; Harris, Joshua D

2018-04-01

Several studies have analyzed the most cited articles in shoulder, elbow, pediatrics, and foot and ankle surgery. However, no study has analyzed the quality of the most cited articles in elbow medial ulnar collateral ligament (UCL) surgery. To (1) identify the top 50 most cited articles related to UCL surgery, (2) determine whether there was a correlation between the top cited articles and level of evidence, and (3) determine whether there was a correlation between study methodological quality and the top cited articles. Systematic review. Web of Science and Scopus online databases were searched to identify the top 50 cited articles in UCL surgery. Level of evidence, number of times cited, year of publication, name of journal, country of origin, and study type were recorded for each study. Study methodological quality was analyzed for each article with the Modified Coleman Methodology Score (MCMS) and the Methodological Index for Non-randomized Studies (MINORS). Correlation coefficients were calculated. The 50 most cited articles were published between 1981 and 2015. The number of citations per article ranged from 20 to 301 (mean ± SD, 71 ± 62 citations). Most articles (92%) were from the United States and were level 3 (16%), level 4 (58%), or unclassified (16%) evidence. There were no articles of level 1 evidence quality. The mean MCMS and MINORS scores were 28.1 ± 13.4 (range, 3-52) and 9.2 ± 3.6 (range, 2-19), respectively. There was no significant correlation between the mean number of citations and level of evidence or quality ( r s = -0.01, P = .917), MCMS ( r s = 0.09, P = .571), or MINORS ( r s = -0.26, P = .089). The top 50 cited articles in UCL surgery constitute a low level of evidence and low methodological quality, including no level 1 articles. There was no significant correlation between the mean number of citations and level of evidence or study methodological quality. However, weak correlations were observed for later publication date and improved level of evidence and methodological quality.

Correlation Between Quality of Evidence and Number of Citations in Top 50 Cited Articles on Elbow Medial Ulnar Collateral Ligament Surgery

PubMed Central

Jack, Robert A.; Sochacki, Kyle R.; Morehouse, Hannah A.; McCulloch, Patrick C.; Lintner, David M.; Harris, Joshua D.

2018-01-01

Background: Several studies have analyzed the most cited articles in shoulder, elbow, pediatrics, and foot and ankle surgery. However, no study has analyzed the quality of the most cited articles in elbow medial ulnar collateral ligament (UCL) surgery. Purpose: To (1) identify the top 50 most cited articles related to UCL surgery, (2) determine whether there was a correlation between the top cited articles and level of evidence, and (3) determine whether there was a correlation between study methodological quality and the top cited articles. Study Design: Systematic review. Methods: Web of Science and Scopus online databases were searched to identify the top 50 cited articles in UCL surgery. Level of evidence, number of times cited, year of publication, name of journal, country of origin, and study type were recorded for each study. Study methodological quality was analyzed for each article with the Modified Coleman Methodology Score (MCMS) and the Methodological Index for Non-randomized Studies (MINORS). Correlation coefficients were calculated. Results: The 50 most cited articles were published between 1981 and 2015. The number of citations per article ranged from 20 to 301 (mean ± SD, 71 ± 62 citations). Most articles (92%) were from the United States and were level 3 (16%), level 4 (58%), or unclassified (16%) evidence. There were no articles of level 1 evidence quality. The mean MCMS and MINORS scores were 28.1 ± 13.4 (range, 3-52) and 9.2 ± 3.6 (range, 2-19), respectively. There was no significant correlation between the mean number of citations and level of evidence or quality (rs = –0.01, P = .917), MCMS (rs = 0.09, P = .571), or MINORS (rs = –0.26, P = .089). Conclusion: The top 50 cited articles in UCL surgery constitute a low level of evidence and low methodological quality, including no level 1 articles. There was no significant correlation between the mean number of citations and level of evidence or study methodological quality. However, weak correlations were observed for later publication date and improved level of evidence and methodological quality. PMID:29780841

Methodological quality of systematic reviews in subfertility: a comparison of Cochrane and non-Cochrane systematic reviews in assisted reproductive technologies.

PubMed

Windsor, B; Popovich, I; Jordan, V; Showell, M; Shea, B; Farquhar, C

2012-12-01

Are there differences in the methodological quality of Cochrane systematic reviews (CRs) and non-Cochrane systematic reviews (NCRs) of assisted reproductive technologies? CRs on assisted reproduction are of higher methodological quality than similar reviews published in other journals. The quality of systematic reviews varies. This was a cross-sectional study of 30 CR and 30 NCR systematic reviews that were randomly selected from the eligible reviews identified from a literature search for the years 2007-2011. We extracted data on the reporting and methodological characteristics of the included systematic reviews. We assessed the methodological quality of the reviews using the 11-domain Measurement Tool to Assess the Methodological Quality of Systematic Reviews (AMSTAR) tool and subsequently compared CR and NCR systematic reviews. The AMSTAR quality assessment found that CRs were superior to NCRs. For 10 of 11 AMSTAR domains, the requirements were met in >50% of CRs, but only 4 of 11 domains showed requirements being met in >50% of NCRs. The strengths of CRs are the a priori study design, comprehensive literature search, explicit lists of included and excluded studies and assessments of internal validity. Significant failings in the CRs were found in duplicate study selection and data extraction (67% meeting requirements), assessment for publication bias (53% meeting requirements) and reporting of conflicts of interest (47% meeting requirements). NCRs were more likely to contain methodological weaknesses as the majority of the domains showed <40% of reviews meeting requirements, e.g. a priori study design (17%), duplicate study selection and data extraction (17%), assessment of study quality (27%), study quality in the formulation of conclusions (23%) and reporting of conflict of interests (10%). The AMSTAR assessment can only judge what is reported by authors. Although two of the five authors are involved in the production of CRs, the risk of bias was reduced by not involving these authors in the assessment of the systematic review quality. Not all systematic reviews are equal. The reader needs to consider the quality of the systematic review when they consider the results and the conclusions of a systematic review. There are no conflicts with any commercial organization. Funding was provided for the students by the summer studentship programme of the Faculty of Medical and Health Sciences of the University of Auckland.

The effectiveness of the Bobath concept in stroke rehabilitation: what is the evidence?

PubMed

Kollen, Boudewijn J; Lennon, Sheila; Lyons, Bernadette; Wheatley-Smith, Laura; Scheper, Mark; Buurke, Jaap H; Halfens, Jos; Geurts, Alexander C H; Kwakkel, Gert

2009-04-01

In the Western world, the Bobath Concept or neurodevelopmental treatment is the most popular treatment approach used in stroke rehabilitation, yet the superiority of the Bobath Concept as the optimal type of treatment has not been established. This systematic review of randomized, controlled trials aimed to evaluate the available evidence for the effectiveness of the Bobath Concept in stroke rehabilitation. Method- A systematic literature search was conducted in the bibliographic databases MEDLINE and CENTRAL (March 2008) and by screening the references of selected publications (including reviews). Studies in which the effects of the Bobath Concept were investigated were classified into the following domains: sensorimotor control of upper and lower limb; sitting and standing, balance control, and dexterity; mobility; activities of daily living; health-related quality of life; and cost-effectiveness. Due to methodological heterogeneity within the selected studies, statistical pooling was not considered. Two independent researchers rated all retrieved literature according to the Physiotherapy Evidence Database (PEDro) scale from which a best evidence synthesis was derived to determine the strength of the evidence for both effectiveness of the Bobath Concept and for its superiority over other approaches. The search strategy initially identified 2263 studies. After selection based on predetermined criteria, finally, 16 studies involving 813 patients with stroke were included for further analysis. There was no evidence of superiority of Bobath on sensorimotor control of upper and lower limb, dexterity, mobility, activities of daily living, health-related quality of life, and cost-effectiveness. Only limited evidence was found for balance control in favor of Bobath. Because of the limited evidence available, no best evidence synthesis was applied for the health-related quality-of-life domain and cost-effectiveness. This systematic review confirms that overall the Bobath Concept is not superior to other approaches. Based on best evidence synthesis, no evidence is available for the superiority of any approach. This review has highlighted many methodological shortcomings in the studies reviewed; further high-quality trials need to be published. Evidence-based guidelines rather than therapist preference should serve as a framework from which therapists should derive the most effective treatment.

Quality Assurance and Its Impact from Higher Education Institutions' Perspectives: Methodological Approaches, Experiences and Expectations

ERIC Educational Resources Information Center

Bejan, Stelian Andrei; Janatuinen, Tero; Jurvelin, Jouni; Klöpping, Susanne; Malinen, Heikki; Minke, Bernhard; Vacareanu, Radu

2015-01-01

This paper reports on methodological approaches, experiences and expectations referring to impact analysis of quality assurance from the perspective of three higher education institutions (students, teaching staff, quality managers) from Germany, Finland and Romania. The presentations of the three sample institutions focus on discussing the core…

A Synthesis of a Quality Management Model for Education in Universities

ERIC Educational Resources Information Center

Srikanthan, G.; Dalrymple, John

2004-01-01

The paper attempts to synthesise the features of the model for quality management in education based on the approaches spelt out in four well-articulated methodologies for the practice of quality in higher education. Each methodology contributes to different views of education from the learners' and the institution's perspectives, providing…

Improved methodology to assess modification and completion of landfill gas management in the aftercare period

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

Morris, Jeremy W.F., E-mail: jmorris@geosyntec.com; Crest, Marion, E-mail: marion.crest@suez-env.com; Barlaz, Morton A., E-mail: barlaz@ncsu.edu

Highlights: Black-Right-Pointing-Pointer Performance-based evaluation of landfill gas control system. Black-Right-Pointing-Pointer Analytical framework to evaluate transition from active to passive gas control. Black-Right-Pointing-Pointer Focus on cover oxidation as an alternative means of passive gas control. Black-Right-Pointing-Pointer Integrates research on long-term landfill behavior with practical guidance. - Abstract: Municipal solid waste landfills represent the dominant option for waste disposal in many parts of the world. While some countries have greatly reduced their reliance on landfills, there remain thousands of landfills that require aftercare. The development of cost-effective strategies for landfill aftercare is in society's interest to protect human health and the environmentmore » and to prevent the emergence of landfills with exhausted aftercare funding. The Evaluation of Post-Closure Care (EPCC) methodology is a performance-based approach in which landfill performance is assessed in four modules including leachate, gas, groundwater, and final cover. In the methodology, the objective is to evaluate landfill performance to determine when aftercare monitoring and maintenance can be reduced or possibly eliminated. This study presents an improved gas module for the methodology. While the original version of the module focused narrowly on regulatory requirements for control of methane migration, the improved gas module also considers best available control technology for landfill gas in terms of greenhouse gas emissions, air quality, and emissions of odoriferous compounds. The improved module emphasizes the reduction or elimination of fugitive methane by considering the methane oxidation capacity of the cover system. The module also allows for the installation of biologically active covers or other features designed to enhance methane oxidation. A methane emissions model, CALMIM, was used to assist with an assessment of the methane oxidation capacity of landfill covers.« less

Quality dependent fusion of intramodal and multimodal biometric experts

NASA Astrophysics Data System (ADS)

Kittler, J.; Poh, N.; Fatukasi, O.; Messer, K.; Kryszczuk, K.; Richiardi, J.; Drygajlo, A.

2007-04-01

We address the problem of score level fusion of intramodal and multimodal experts in the context of biometric identity verification. We investigate the merits of confidence based weighting of component experts. In contrast to the conventional approach where confidence values are derived from scores, we use instead raw measures of biometric data quality to control the influence of each expert on the final fused score. We show that quality based fusion gives better performance than quality free fusion. The use of quality weighted scores as features in the definition of the fusion functions leads to further improvements. We demonstrate that the achievable performance gain is also affected by the choice of fusion architecture. The evaluation of the proposed methodology involves 6 face and one speech verification experts. It is carried out on the XM2VTS data base.

Improvement of the customer satisfaction through Quality Assurance Matrix and QC-Story methods: A case study from automotive industry

NASA Astrophysics Data System (ADS)

Sicoe, G. M.; Belu, N.; Rachieru, N.; Nicolae, E. V.

2017-10-01

Presently, in the automotive industry, the tendency is to adapt permanently to the changes and introduce the market tendency in the new products that leads of the customer satisfaction. Many quality techniques were adopted in this field to continuous improvement of product and process quality and advantages were also gained. The present paper has focused on possibilities that offers the use of Quality Assurance Matrix (QAM) and Quality Control Story (QC Story) to provide largest protection against nonconformities in the production process, throughout a case study in the automotive industry. There is a direct relationship from the QAM to a QC Story analysis. The failures identified using QAM are treated with QC Story methodology. Using this methods, will help to decrease the PPM values and will increase the quality performance and the customer satisfaction.

The beauty of simple adaptive control and new developments in nonlinear systems stability analysis

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

Barkana, Itzhak, E-mail: ibarkana@gmail.com

Although various adaptive control techniques have been around for a long time and in spite of successful proofs of stability and even successful demonstrations of performance, the eventual use of adaptive control methodologies in practical real world systems has met a rather strong resistance from practitioners and has remained limited. Apparently, it is difficult to guarantee or even understand the conditions that can guarantee stable operations of adaptive control systems under realistic operational environments. Besides, it is difficult to measure the robustness of adaptive control system stability and allow it to be compared with the common and widely used measuremore » of phase margin and gain margin that is utilized by present, mainly LTI, controllers. Furthermore, customary stability analysis methods seem to imply that the mere stability of adaptive systems may be adversely affected by any tiny deviation from the pretty idealistic and assumably required stability conditions. This paper first revisits the fundamental qualities of customary direct adaptive control methodologies, in particular the classical Model Reference Adaptive Control, and shows that some of their basic drawbacks have been addressed and eliminated within the so-called Simple Adaptive Control methodology. Moreover, recent developments in the stability analysis methods of nonlinear systems show that prior conditions that were customarily assumed to be needed for stability are only apparent and can be eliminated. As a result, sufficient conditions that guarantee stability are clearly stated and lead to similarly clear proofs of stability. As many real-world applications show, once robust stability of the adaptive systems can be guaranteed, the added value of using Add-On Adaptive Control along with classical Control design techniques is pushing the desired performance beyond any previous limits.« less

Methodological issues in genetic association studies of inherited thrombophilia: original report of recent practice.

PubMed

Simundic, Ana-Maria; Nikolac, Nora; Topic, Elizabeta

2009-01-01

The aims of this article are to evaluate the methodological quality of genetic association studies on the inherited thrombophilia published during 2003 to 2005, to identify the most common mistakes made by authors of those studies, and to examine if overall quality of the article correlates with the quality of the journal. Articles were evaluated by 2 independent reviewers using the checklist of 16 items. A total of 58 eligible studies were identified. Average total score was 7.59 +/- 1.96. Total article score did not correlate with the journal impact factor (r = 0.3971; 95% confidence interval [CI], 0.1547-0.5944, P = .002). Total score did not differ across years (P = .624). Finally, it is concluded that methodological quality of genetic association studies is not optimal, and it does not depend on the quality of the journal. Journals should adopt methodological criteria for reporting the genetic association studies, and editors should encourage authors to strictly adhere to those criteria.

Measuring e-Commerce service quality from online customer review using sentiment analysis

NASA Astrophysics Data System (ADS)

Kencana Sari, Puspita; Alamsyah, Andry; Wibowo, Sulistyo

2018-03-01

The biggest e-Commerce challenge to understand their market is to chart their level of service quality according to customer perception. The opportunities to collect user perception through online user review is considered faster methodology than conducting direct sampling methodology. To understand the service quality level, sentiment analysis methodology is used to classify the reviews into positive and negative sentiment for five dimensions of electronic service quality (e-Servqual). As case study in this research, we use Tokopedia, one of the biggest e-Commerce service in Indonesia. We obtain the online review comments about Tokopedia service quality during several month observations. The Naïve Bayes classification methodology is applied for the reason of its high-level accuracy and support large data processing. The result revealed that personalization and reliability dimension required more attention because have high negative sentiment. Meanwhile, trust and web design dimension have high positive sentiments that means it has very good services. The responsiveness dimension have balance sentiment positive and negative.

Aircraft ride quality controller design using new robust root clustering theory for linear uncertain systems

NASA Technical Reports Server (NTRS)

Yedavalli, R. K.

1992-01-01

The aspect of controller design for improving the ride quality of aircraft in terms of damping ratio and natural frequency specifications on the short period dynamics is addressed. The controller is designed to be robust with respect to uncertainties in the real parameters of the control design model such as uncertainties in the dimensional stability derivatives, imperfections in actuator/sensor locations and possibly variations in flight conditions, etc. The design is based on a new robust root clustering theory developed by the author by extending the nominal root clustering theory of Gutman and Jury to perturbed matrices. The proposed methodology allows to get an explicit relationship between the parameters of the root clustering region and the uncertainty radius of the parameter space. The current literature available for robust stability becomes a special case of this unified theory. The bounds derived on the parameter perturbation for robust root clustering are then used in selecting the robust controller.

Economic evaluation of nurse practitioner and clinical nurse specialist roles: A methodological review.

PubMed

Lopatina, Elena; Donald, Faith; DiCenso, Alba; Martin-Misener, Ruth; Kilpatrick, Kelley; Bryant-Lukosius, Denise; Carter, Nancy; Reid, Kim; Marshall, Deborah A

2017-07-01

Advanced practice nurses (e.g., nurse practitioners and clinical nurse specialists) have been introduced internationally to increase access to high quality care and to tackle increasing health care expenditures. While randomised controlled trials and systematic reviews have demonstrated the effectiveness of nurse practitioner and clinical nurse specialist roles, their cost-effectiveness has been challenged. The poor quality of economic evaluations of these roles to date raises the question of whether current economic evaluation guidelines are adequate when examining their cost-effectiveness. To examine whether current guidelines for economic evaluation are appropriate for economic evaluations of nurse practitioner and clinical nurse specialist roles. Our methodological review was informed by a qualitative synthesis of four sources of information: 1) narrative review of literature reviews and discussion papers on economic evaluation of advanced practice nursing roles; 2) quality assessment of economic evaluations of nurse practitioner and clinical nurse specialist roles alongside randomised controlled trials; 3) review of guidelines for economic evaluation; and, 4) input from an expert panel. The narrative literature review revealed several challenges in economic evaluations of advanced practice nursing roles (e.g., complexity of the roles, variability in models and practice settings where the roles are implemented, and impact on outcomes that are difficult to measure). The quality assessment of economic evaluations of nurse practitioner and clinical nurse specialist roles alongside randomised controlled trials identified methodological limitations of these studies. When we applied the Guidelines for the Economic Evaluation of Health Technologies: Canada to the identified challenges and limitations, discussed those with experts and qualitatively synthesized all findings, we concluded that standard guidelines for economic evaluation are appropriate for economic evaluations of nurse practitioner and clinical nurse specialist roles and should be routinely followed. However, seven out of 15 current guideline sections (describing a decision problem, choosing type of economic evaluation, selecting comparators, determining the study perspective, estimating effectiveness, measuring and valuing health, and assessing resource use and costs) may require additional role-specific considerations to capture costs and effects of these roles. Current guidelines for economic evaluation should form the foundation for economic evaluations of nurse practitioner and clinical nurse specialist roles. The proposed role-specific considerations, which clarify application of standard guidelines sections to economic evaluation of nurse practitioner and clinical nurse specialist roles, may strengthen the quality and comprehensiveness of future economic evaluations of these roles. Copyright © 2017 Elsevier Ltd. All rights reserved.

Control over dark current densities and cutoff wavelengths of GaAs/AlGaAs QWIP grown by multi-wafer MBE reactor

NASA Astrophysics Data System (ADS)

Roodenko, K.; Choi, K. K.; Clark, K. P.; Fraser, E. D.; Vargason, K. W.; Kuo, J.-M.; Kao, Y.-C.; Pinsukanjana, P. R.

2016-09-01

Performance of quantum well infrared photodetector (QWIP) device parameters such as detector cutoff wavelength and the dark current density depend strongly on the quality and the control of the epitaxy material growth. In this work, we report on a methodology to precisely control these critical material parameters for long wavelength infrared (LWIR) GaAs/AlGaAs QWIP epi wafers grown by multi-wafer production Molecular beam epitaxy (MBE). Critical growth parameters such as quantum well (QW) thickness, AlGaAs composition and QW doping level are discussed.

Platelet-Rich Plasma (PRP) for Acute Muscle Injury: A Systematic Review

PubMed Central

A. Hamid, Mohamad Shariff; Yusof, Ashril; Mohamed Ali, Mohamed Razif

2014-01-01

Introduction Acute muscle injury is one of the commonest injuries that often result in loss of training and competition time. The best management for muscle injury has not been identified. Sports medicine practitioners used several approaches in attempt to accelerate time to recovery from muscle injury. More recently growing interest focussed on autologous blood product injection. Methods A literature search was conducted systematically using OvidMEDLINE, PubMed, EMBASE, SPORTDiscus and CINAHL databases to retrieve articles published until December 2012. Controlled trials and controlled laboratory studies comparing different strategies to promote early recovery of muscle injury were included. The methodological quality of studies was assessed. Results There are limited studies on the effects of PRP therapy for muscle injury. Three in vivo laboratory studies and one pilot human study were reviewed. The laboratory studies reported histological evidence on significant acceleration of muscle healing in animals treated with autologous conditioned serum (ACS), platelet-rich plasma (PRP) and platelet rich fibrin matrix (PRFM). A pilot human study found athletes treated with repeated ACS injection recovers significantly faster than retrospective controls. Conclusion Several in vivo laboratory studies suggest beneficial effects of ACS, PRP and PRFM in accelerating muscle recovery. Evidence to suggest similar effects on humans is however limited, as valuable information from robust human controlled trials is still not available at this moment. Hence, more studies of satisfactory methodological quality with platelet-rich plasma interventions on muscle injury are justified. PMID:24587389

A scoring system for appraising mixed methods research, and concomitantly appraising qualitative, quantitative and mixed methods primary studies in Mixed Studies Reviews.

PubMed

Pluye, Pierre; Gagnon, Marie-Pierre; Griffiths, Frances; Johnson-Lafleur, Janique

2009-04-01

A new form of literature review has emerged, Mixed Studies Review (MSR). These reviews include qualitative, quantitative and mixed methods studies. In the present paper, we examine MSRs in health sciences, and provide guidance on processes that should be included and reported. However, there are no valid and usable criteria for concomitantly appraising the methodological quality of the qualitative, quantitative and mixed methods studies. To propose criteria for concomitantly appraising the methodological quality of qualitative, quantitative and mixed methods studies or study components. A three-step critical review was conducted. 2322 references were identified in MEDLINE, and their titles and abstracts were screened; 149 potentially relevant references were selected and the full-text papers were examined; 59 MSRs were retained and scrutinized using a deductive-inductive qualitative thematic data analysis. This revealed three types of MSR: convenience, reproducible, and systematic. Guided by a proposal, we conducted a qualitative thematic data analysis of the quality appraisal procedures used in the 17 systematic MSRs (SMSRs). Of 17 SMSRs, 12 showed clear quality appraisal procedures with explicit criteria but no SMSR used valid checklists to concomitantly appraise qualitative, quantitative and mixed methods studies. In two SMSRs, criteria were developed following a specific procedure. Checklists usually contained more criteria than needed. In four SMSRs, a reliability assessment was described or mentioned. While criteria for quality appraisal were usually based on descriptors that require specific methodological expertise (e.g., appropriateness), no SMSR described the fit between reviewers' expertise and appraised studies. Quality appraisal usually resulted in studies being ranked by methodological quality. A scoring system is proposed for concomitantly appraising the methodological quality of qualitative, quantitative and mixed methods studies for SMSRs. This scoring system may also be used to appraise the methodological quality of qualitative, quantitative and mixed methods components of mixed methods research.

Methodological idiosyncracies, frameworks and challenges of non-pharmaceutical and non-technical treatment interventions.

PubMed

Schünemann, Holger J

2013-01-01

In this brief article which summarises a presentation given at the "6. Diskussionsforum zur Nutzenbewertung im Gesundheitswesen" of the German Ministry of Education and Research "Gesundheitsforschungsrat (GFR)" and the Institute for Quality and Efficiency in Healthcare (IQWiG) I will analyse some methodological idiosyncrasies of studies evaluating non-pharmacological non-technical interventions (NPNTI). I will focus on how the methodological framework of the Grading of Recommendations Assessment, Development and Evaluation (GRADE) working group may support design and appraisal of NPNTI. Specific design features that may be of particular value in NPNTI research, such as expertise-based randomised controlled trials, will be briefly described. Finally, based on an example, I will argue that - despite the methodological idiosyncrasies - there is neither a sufficient reason to accept different standards for the assessment of the confidence in the evidence from NPNTI nor for using study designs that are less rigorous compared to "simpler" interventions but that special measures have to be taken to reduce the risk of bias. The example that will be used in this article will primarily come from the field of respiratory rehabilitation, a typical multi-component or complex intervention and by definition a complex NPNTI, which has been evaluated in many randomised controlled trials. (As supplied by publisher). Copyright © 2013. Published by Elsevier GmbH.

Conservative treatment of tibialis posterior tendon dysfunction--a review.

PubMed

Bowring, Beverly; Chockalingam, Nachiappan

2010-03-01

Appropriate conservative treatment is considered essential to address symptoms associated with tibialis posterior tendon dysfunction (TPTD) and prevent its potential long-term disabling consequences. The main aim of this review, undertaken in 2007, was to evaluate the evidence from studies for the effects of conservative treatment modalities in the management of TPTD. This evidence could then be used as a basis for the development of a clinical guideline for the management of the condition. Studies were selected according to specific criteria and evaluated for methodological quality. As preliminary literature searches had identified no randomised controlled trials at the time of the review, studies of lower hierarchy were included. Five uncontrolled observational studies evaluating the outcomes of various orthotic treatments alone or in combination with other therapies were included in the review. Different study designs, methodological quality, population characteristics, interventions and outcome measures were found. Limited and poor quality evidence was found in this review regarding the conservative treatment of TPTD. Thus a cause-effect relationship between intervention and outcome could not be established nor an optimal conservative treatment regime for the condition. Further better quality research is warranted in this area to inform practice, particularly as there is no consensus in the literature regarding treatment of this condition. Copyright (c) 2009 Elsevier Ltd. All rights reserved.

Vitex agnus-castus extracts for female reproductive disorders: a systematic review of clinical trials.

PubMed

van Die, M Diana; Burger, Henry G; Teede, Helena J; Bone, Kerry M

2013-05-01

Vitex agnus-castus L. (chaste tree; chasteberry) is a popular herbal treatment, predominantly used for a range of female reproductive conditions in Anglo-American and European practice. The objective of this systematic review was to evaluate the evidence for the efficacy and safety of Vitex extracts from randomised, controlled trials investigating women's health.Eight databases were searched using Latin and common names for Vitex and phytotherapeutic preparations of the herb as a sole agent, together with filters for randomised, controlled trials or clinical trials. Methodological quality was assessed according to the Cochrane risk of bias and Jadad scales, as well as the proposed elaboration of CONSORT for reporting trials on herbal interventions.Thirteen randomised, controlled trials were identified and twelve are included in this review, of which eight investigated premenstrual syndrome, two premenstrual dysphoric disorder, and two latent hyperprolactinaemia. For premenstrual syndrome, seven of eight trials found Vitex extracts to be superior to placebo (5 of 6 studies), pyridoxine (1), and magnesium oxide (1). In premenstrual dysphoric disorder, one study reported Vitex to be equivalent to fluoxetine, while in the other, fluoxetine outperformed Vitex. In latent hyperprolactinaemia, one trial reported it to be superior to placebo for reducing TRH-stimulated prolactin secretion, normalising a shortened luteal phase, increasing mid-luteal progesterone and 17β-oestradiol levels, while the other found Vitex comparable to bromocriptine for reducing serum prolactin levels and ameliorating cyclic mastalgia. Adverse events with Vitex were mild and generally infrequent. The methodological quality of the included studies varied, but was generally moderate-to-high. Limitations include small sample sizes in some studies, heterogeneity of conditions being treated, and a range of reference treatments.Despite some methodological limitations, the results from randomised, controlled trials to date suggest benefits for Vitex extracts in the treatment of premenstrual syndrome, premenstrual dysphoric disorder and latent hyperprolactinaemia. Further research is recommended, and greater transparency in reporting for future trials. Georg Thieme Verlag KG Stuttgart · New York.

The effects of mental practice in neurological rehabilitation; a systematic review and meta-analysis

PubMed Central

Braun, Susy; Kleynen, Melanie; van Heel, Tessa; Kruithof, Nena; Wade, Derick; Beurskens, Anna

2013-01-01

Objective: To investigate the beneficial and adverse effects of a mental practice intervention on activities, cognition, and emotion in patients after stroke, patients with Parkinson's disease or multiple sclerosis. Methods: Electronic databases PubMed/Medline, PEDro, Science Direct, Cochrane Library, PsycINFO, Rehadat, Embase, and Picarta were searched until June 2012. Fourteen randomized controlled trials in stroke and two randomized controlled trials in Parkinson's disease were included, representing 491 patients (421 with stroke). No randomized controlled trials in multiple sclerosis were identified. The methodologic quality of the included trials was assessed with the Amsterdam-Maastricht-Consensus-List (AMCL). Information on study characteristics and outcomes was summarized and evidence for effects described. Data from individual studies in stroke with same outcome measures were pooled. Results: The included 16 randomized controlled trials were heterogeneous and methodologic quality varied. Ten trials reported significant effects in favor of mental practice in patients with stroke (n = 9) and Parkinson's disease (n = 1). In six studies mental practice had similar effects as therapy as usual (n = 5 in stroke and n = 1 in Parkinson's disease). Of six performed meta-analyses with identical measures in stroke studies only two showed significant effects of mental practice: short-term improvement of arm-hand-ability (ARAT: SMD 0.62; 95% CI: 0.05 to 1.19) and improvement of performance of activities (NRS: SMD 0.9; 95% CI: 0.04 to 1.77). Five studies found effects on cognition (e.g., effects on attention, plan actions in unfamiliar surroundings) and four reported observed side-effects, both positive (e.g., might increase motivation and arousal and reduce depression) and negative (e.g., diminished concentration, irritation). Conclusions: Mental practice might have positive effects on performance of activities in patients with neurological diseases, but this review reports less positive results than earlier published ones. Strengths and limitations of past studies are pointed out. Methodologic recommendations for future studies are given. PMID:23935572

Performance Optimization Control of ECH using Fuzzy Inference Application

NASA Astrophysics Data System (ADS)

Dubey, Abhay Kumar

Electro-chemical honing (ECH) is a hybrid electrolytic precision micro-finishing technology that, by combining physico-chemical actions of electro-chemical machining and conventional honing processes, provides the controlled functional surfaces-generation and fast material removal capabilities in a single operation. Process multi-performance optimization has become vital for utilizing full potential of manufacturing processes to meet the challenging requirements being placed on the surface quality, size, tolerances and production rate of engineering components in this globally competitive scenario. This paper presents an strategy that integrates the Taguchi matrix experimental design, analysis of variances and fuzzy inference system (FIS) to formulate a robust practical multi-performance optimization methodology for complex manufacturing processes like ECH, which involve several control variables. Two methodologies one using a genetic algorithm tuning of FIS (GA-tuned FIS) and another using an adaptive network based fuzzy inference system (ANFIS) have been evaluated for a multi-performance optimization case study of ECH. The actual experimental results confirm their potential for a wide range of machining conditions employed in ECH.

An effective and optimal quality control approach for green energy manufacturing using design of experiments framework and evolutionary algorithm

NASA Astrophysics Data System (ADS)

Saavedra, Juan Alejandro

Quality Control (QC) and Quality Assurance (QA) strategies vary significantly across industries in the manufacturing sector depending on the product being built. Such strategies range from simple statistical analysis and process controls, decision-making process of reworking, repairing, or scraping defective product. This study proposes an optimal QC methodology in order to include rework stations during the manufacturing process by identifying the amount and location of these workstations. The factors that are considered to optimize these stations are cost, cycle time, reworkability and rework benefit. The goal is to minimize the cost and cycle time of the process, but increase the reworkability and rework benefit. The specific objectives of this study are: (1) to propose a cost estimation model that includes energy consumption, and (2) to propose an optimal QC methodology to identify quantity and location of rework workstations. The cost estimation model includes energy consumption as part of the product direct cost. The cost estimation model developed allows the user to calculate product direct cost as the quality sigma level of the process changes. This provides a benefit because a complete cost estimation calculation does not need to be performed every time the processes yield changes. This cost estimation model is then used for the QC strategy optimization process. In order to propose a methodology that provides an optimal QC strategy, the possible factors that affect QC were evaluated. A screening Design of Experiments (DOE) was performed on seven initial factors and identified 3 significant factors. It reflected that one response variable was not required for the optimization process. A full factorial DOE was estimated in order to verify the significant factors obtained previously. The QC strategy optimization is performed through a Genetic Algorithm (GA) which allows the evaluation of several solutions in order to obtain feasible optimal solutions. The GA evaluates possible solutions based on cost, cycle time, reworkability and rework benefit. Finally it provides several possible solutions because this is a multi-objective optimization problem. The solutions are presented as chromosomes that clearly state the amount and location of the rework stations. The user analyzes these solutions in order to select one by deciding which of the four factors considered is most important depending on the product being manufactured or the company's objective. The major contribution of this study is to provide the user with a methodology used to identify an effective and optimal QC strategy that incorporates the number and location of rework substations in order to minimize direct product cost, and cycle time, and maximize reworkability, and rework benefit.

Guidance on assessing the methodological and reporting quality of toxicologically relevant studies: A scoping review.

PubMed

Samuel, Gbeminiyi O; Hoffmann, Sebastian; Wright, Robert A; Lalu, Manoj Mathew; Patlewicz, Grace; Becker, Richard A; DeGeorge, George L; Fergusson, Dean; Hartung, Thomas; Lewis, R Jeffrey; Stephens, Martin L

2016-01-01

Assessments of methodological and reporting quality are critical to adequately judging the credibility of a study's conclusions and to gauging its potential reproducibility. To aid those seeking to assess the methodological or reporting quality of studies relevant to toxicology, we conducted a scoping review of the available guidance with respect to four types of studies: in vivo and in vitro, (quantitative) structure-activity relationships ([Q]SARs), physico-chemical, and human observational studies. Our aims were to identify the available guidance in this diverse literature, briefly summarize each document, and distill the common elements of these documents for each study type. In general, we found considerable guidance for in vivo and human studies, but only one paper addressed in vitro studies exclusively. The guidance for (Q)SAR studies and physico-chemical studies was scant but authoritative. There was substantial overlap across guidance documents in the proposed criteria for both methodological and reporting quality. Some guidance documents address toxicology research directly, whereas others address preclinical research generally or clinical research and therefore may not be fully applicable to the toxicology context without some translation. Another challenge is the degree to which assessments of methodological quality in toxicology should focus on risk of bias - as in clinical medicine and healthcare - or be broadened to include other quality measures, such as confirming the identity of test substances prior to exposure. Our review is intended primarily for those in toxicology and risk assessment seeking an entry point into the extensive and diverse literature on methodological and reporting quality applicable to their work. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

Does pelvic floor muscle training improve female sexual function? A systematic review.

PubMed

Ferreira, Cristine Homsi Jorge; Dwyer, Peter L; Davidson, Melissa; De Souza, Alison; Ugarte, Julio Alvarez; Frawley, Helena C

2015-12-01

We performed a review of the literature reporting on the effects of pelvic floor muscle training (PFMT) on female sexual function (SF). Pubmed (from 1946 to December 2014), Ovid Medline (from 1946 to December 2014), CINAHL (from 1937 to December 2014), PsycINFO (from 1805 to December 2014), Scopus and Cochrane Central Register of Controlled Trials were searched by two independent reviewers. Randomised controlled trials (RCTs) investigating the impact of PFMT on women's SF published in English were included. Methodological quality was scored using the PEDro scale. Data were analysed qualitatively and interpreted. A total of 1341 women were included in the eight RCTs covered by this review. The studies were published between 1997 and 2014. Methodological scores were between 4 and 7. The sample included derived from heterogeneous populations of women. In only one study was SF the primary outcome measure. Pelvic floor dysfunction was an inclusion criterion in the majority of studies. Most studies reported a significant improvement in SF score after PFMT between control and intervention groups. Although most studies indicated an improvement of at least one sexual variable in women with pelvic floor dysfunction, and one study demonstrated an improvement in SF in postpartum women selected independently of their continence status, the results need to be interpreted with caution. High-quality RCTs specifically designed to investigate the impact of PFMT on women's SF are required.

The prevention of shin splints in sports: a systematic review of literature.

PubMed

Thacker, Stephen B; Gilchrist, Julie; Stroup, Donna F; Kimsey, C Dexter

2002-01-01

To review the published and unpublished evidence regarding risk factors associated with shin splints, assess the effectiveness of prevention strategies, and offer evidence-based recommendations to coaches, athletes, and researchers. We searched electronic data bases without language restriction, identified citations from reference sections of research papers retrieved, contacted experts in the field, and searched the Cochrane Collaboration. Of the 199 citations identified, we emphasized results of the four reports that compared methods to prevent shin splints. We assessed the methodologic quality of these reports by using a standardized instrument. The use of shock-absorbent insoles, foam heel pads, heel cord stretching, alternative footwear, as well as graduated running programs among military recruits have undergone assessment in controlled trials. There is no strong support for any of these interventions, and each of the four controlled trials is limited methodologically. Median quality scores in these four studies ranged from 29 to 47, and serious flaws in study design, control of bias, and statistical methods were identified. Our review yielded little objective evidence to support widespread use of any existing interventions to prevent shin splints. The most encouraging evidence for effective prevention of shin splints involves the use of shock-absorbing insoles. However, serious flaws in study design and implementation constrain the work in this field thus far. A rigorously implemented research program is critically needed to address this common sports medicine problem.

Bootstrap Signal-to-Noise Confidence Intervals: An Objective Method for Subject Exclusion and Quality Control in ERP Studies

PubMed Central

Parks, Nathan A.; Gannon, Matthew A.; Long, Stephanie M.; Young, Madeleine E.

2016-01-01

Analysis of event-related potential (ERP) data includes several steps to ensure that ERPs meet an appropriate level of signal quality. One such step, subject exclusion, rejects subject data if ERP waveforms fail to meet an appropriate level of signal quality. Subject exclusion is an important quality control step in the ERP analysis pipeline as it ensures that statistical inference is based only upon those subjects exhibiting clear evoked brain responses. This critical quality control step is most often performed simply through visual inspection of subject-level ERPs by investigators. Such an approach is qualitative, subjective, and susceptible to investigator bias, as there are no standards as to what constitutes an ERP of sufficient signal quality. Here, we describe a standardized and objective method for quantifying waveform quality in individual subjects and establishing criteria for subject exclusion. The approach uses bootstrap resampling of ERP waveforms (from a pool of all available trials) to compute a signal-to-noise ratio confidence interval (SNR-CI) for individual subject waveforms. The lower bound of this SNR-CI (SNRLB) yields an effective and objective measure of signal quality as it ensures that ERP waveforms statistically exceed a desired signal-to-noise criterion. SNRLB provides a quantifiable metric of individual subject ERP quality and eliminates the need for subjective evaluation of waveform quality by the investigator. We detail the SNR-CI methodology, establish the efficacy of employing this approach with Monte Carlo simulations, and demonstrate its utility in practice when applied to ERP datasets. PMID:26903849

The MRI-Linear Accelerator Consortium: Evidence-Based Clinical Introduction of an Innovation in Radiation Oncology Connecting Researchers, Methodology, Data Collection, Quality Assurance, and Technical Development.

PubMed

Kerkmeijer, Linda G W; Fuller, Clifton D; Verkooijen, Helena M; Verheij, Marcel; Choudhury, Ananya; Harrington, Kevin J; Schultz, Chris; Sahgal, Arjun; Frank, Steven J; Goldwein, Joel; Brown, Kevin J; Minsky, Bruce D; van Vulpen, Marco

2016-01-01

An international research consortium has been formed to facilitate evidence-based introduction of MR-guided radiotherapy (MR-linac) and to address how the MR-linac could be used to achieve an optimized radiation treatment approach to improve patients' survival, local, and regional tumor control and quality of life. The present paper describes the organizational structure of the clinical part of the MR-linac consortium. Furthermore, it elucidates why collaboration on this large project is necessary, and how a central data registry program will be implemented.

Development of Methodology and Technology for Identifying and Quantifying Emission Products from Open Burning and Open Detonation Thermal Treatment Methods. BangBox Test Series. Volume 3. Quality Assurance and Quality Control

DTIC Science & Technology

1992-01-01

software. This document may not be cited for purposes of advertisement. I I I I I I I’ I , , I SECURITY CLASSIF!CATION 0a . T - S PAGE Form Aoprovea...8217, 3 DISTRIBUTION 1AVAILABSLITY OF REPORT N/A 2b DECLASSIFICATION/DOWNGRADING SCHEDULE Unlimited N/A 4 PERFORMING ORGANIZATION REPORT NUMBER( S ) S ...MONITORING ORGANIZATION REPORT NUMBER( S , 6a NAME OF PERFORMING ORGANIZATION 6b. OFFICE SYMBOL 7a NAME OF MONITORING ORGANIZATION Andrulis Research

Development of Methodology and Technology for Identifying and Quantifying Emission Products from Open Burning and Open Detonation Thermal Treatment Methods. Field Test Series A, B, and C. Volume 2, Part B. Quality Assurance and Quality Control. Appendices

DTIC Science & Technology

1992-01-01

the uncertainty. The above method can give an estimate of the precision of the * analysis. However, determining the accuracy can not be done as...speciation has been determined from analyzing model samples as well as comparison with other methods and combinations of other methods with this method . 3...laboratory. The output of the sensor is characterized over its working range and an appropriate response factor determined by linear regression of the

Development of Methodology and Technology for Identifying and Quantifying Emission Products from Open Burning and Open Detonation Thermal Treatment Methods. Field Test Series A, B, and C. Volume 2, Part A. Quality Assurance and Quality Control

DTIC Science & Technology

1992-01-01

instrument logbook was maintained, but all calibration printouts for the SFC/MS were put in a dedicated loose- leaf notebook. The temperature of the...to-date temperature - monitoring sheets were located at the freezer. Each worker maintained a project-specific personal logbook to enter data...driven 10-cm-diameter gate valve into a 1.5-m3 carbon-impregnated polyethylene ( Velostat 7") sampling bag. The bag, constructed of electrically

Tracer methodology: an appropriate tool for assessing compliance with accreditation standards?

PubMed

Bouchard, Chantal; Jean, Olivier

2017-10-01

Tracer methodology has been used by Accreditation Canada since 2008 to collect evidence on the quality and safety of care and services, and to assess compliance with accreditation standards. Given the importance of this methodology in the accreditation program, the objective of this study is to assess the quality of the methodology and identify its strengths and weaknesses. A mixed quantitative and qualitative approach was adopted to evaluate consistency, appropriateness, effectiveness and stakeholder synergy in applying the methodology. An online questionnaire was sent to 468 Accreditation Canada surveyors. According to surveyors' perceptions, tracer methodology is an effective tool for collecting useful, credible and reliable information to assess compliance with Qmentum program standards and priority processes. The results show good coherence between methodology components (appropriateness of the priority processes evaluated, activities to evaluate a tracer, etc.). The main weaknesses are the time constraints faced by surveyors and management's lack of cooperation during the evaluation of tracers. The inadequate amount of time allowed for the methodology to be applied properly raises questions about the quality of the information obtained. This study paves the way for a future, more in-depth exploration of the identified weaknesses to help the accreditation organization make more targeted improvements to the methodology. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Physician-Delivered Injection Therapies for Mechanical Neck Disorders: A Systematic Review Update (Non-Oral, Non-Intravenous Pharmacological Interventions for Neck Pain)

PubMed Central

Gross, Anita R.; Peloso, Paul M.; Galway, Erin; Navasero, Neenah; Essen, Karis Van; Graham, Nadine; Goldsmith, Charlie H; Gzeer, Wisam; Shi, Qiyun; Haines, Ted and COG

2013-01-01

Background: Controversy persists regarding medicinal injections for mechanical neck disorders (MNDs). Objectives: To determine the effectiveness of physician-delivered injections on pain, function/disability, quality of life, global perceived effect and patient satisfaction for adults with MNDs. Search Methods: We updated our previous searches of CENTRAL, MEDLINE and EMBASE from December 2006 through to March 2012. Selection Criteria: We included randomized controlled trials of adults with neck disorders treated by physician-delivered injection therapies. Data Collection and Analysis: Two authors independently selected articles, abstracted data and assessed methodological quality. When clinical heterogeneity was absent, we combined studies using random-effects models. Results: We included 12 trials (667 participants). No high or moderate quality studies were found with evidence of benefit over control. Moderate quality evidence suggests little or no difference in pain or function/disability between nerve block injection of steroid and bupivacaine vs bupivacaine alone at short, intermediate and long-term for chronic neck pain. We found limited very low quality evidence of an effect on pain with intramuscular lidocaine vs control for chronic myofascial neck pain. Two low quality studies showed an effect on pain with anaesthetic nerve block vs saline immediately post treatment and in the short-term. All other studies were of low or very low quality with no evidence of benefit over controls. Authors' Conclusions: Current evidence does not confirm the effectiveness of IM-lidocaine injection for chronic mechanical neck pain nor anaesthetic nerve block for cervicogenic headache. There is moderate evidence of no benefit for steroid blocks vs controls for mechanical neck pain. PMID:24155806

75 FR 5589 - Science Advisory Board Staff Office; Request for Public Nominations of Experts To Conduct a Peer...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-03

... Conductivity Using Field Data: An Adaptation of the U.S. EPA's Standard Methodology for Deriving Water Quality... Adaptation of the U.S. EPA's Standard Methodology for Deriving Water Quality Criteria'' DATES: Nominations... Deriving Water Quality Criteria'' should be directed to Dr. Michael Slimak, ORD's Associate Director of...

The methodological quality of systematic reviews of animal studies in dentistry.

PubMed

Faggion, C M; Listl, S; Giannakopoulos, N N

2012-05-01

Systematic reviews and meta-analyses of animal studies are important for improving estimates of the effects of treatment and for guiding future clinical studies on humans. The purpose of this systematic review was to assess the methodological quality of systematic reviews and meta-analyses of animal studies in dentistry through using a validated checklist. A literature search was conducted independently and in duplicate in the PubMed and LILACS databases. References in selected systematic reviews were assessed to identify other studies not captured by the electronic searches. The methodological quality of studies was assessed independently and in duplicate by using the AMSTAR checklist; the quality was scored as low, moderate, or high. The reviewers were calibrated before the assessment and agreement between them was assessed using Cohen's Kappa statistic. Of 444 studies retrieved, 54 systematic reviews were selected after full-text assessment. Agreement between the reviewers was regarded as excellent. Only two studies were scored as high quality; 17 and 35 studies were scored as medium and low quality, respectively. There is room for improvement of the methodological quality of systematic reviews of animal studies in dentistry. Checklists, such as AMSTAR, can guide researchers in planning and executing systematic reviews and meta-analyses. For determining the need for additional investigations in animals and in order to provide good data for potential application in human, such reviews should be based on animal experiments performed according to sound methodological principles. Copyright © 2011 Elsevier Ltd. All rights reserved.

Methodological quality and descriptive characteristics of prosthodontic-related systematic reviews.

PubMed

Aziz, T; Compton, S; Nassar, U; Matthews, D; Ansari, K; Flores-Mir, C

2013-04-01

Ideally, healthcare systematic reviews (SRs) should be beneficial to practicing professionals in making evidence-based clinical decisions. However, the conclusions drawn from SRs are directly related to the quality of the SR and of the included studies. The aim was to investigate the methodological quality and key descriptive characteristics of SRs published in prosthodontics. Methodological quality was analysed using the Assessment of Multiple Reviews (AMSTAR) tool. Several electronic resources (MEDLINE, EMBASE, Web of Science and American Dental Association's Evidence-based Dentistry website) were searched. In total 106 SRs were located. Key descriptive characteristics and methodological quality features were gathered and assessed, and descriptive and inferential statistical testing performed. Most SRs in this sample originated from the European continent followed by North America. Two to five authors conducted most SRs; the majority was affiliated with academic institutions and had prior experience publishing SRs. The majority of SRs were published in specialty dentistry journals, with implant or implant-related topics, the primary topics of interest for most. According to AMSTAR, most quality aspects were adequately fulfilled by less than half of the reviews. Publication bias and grey literature searches were the most poorly adhered components. Overall, the methodological quality of the prosthodontic-related systematic was deemed limited. Future recommendations would include authors to have prior training in conducting SRs and for journals to include a universal checklist that should be adhered to address all key characteristics of an unbiased SR process. © 2013 Blackwell Publishing Ltd.

About subjective evaluation of adaptive video streaming

NASA Astrophysics Data System (ADS)

Tavakoli, Samira; Brunnström, Kjell; Garcia, Narciso

2015-03-01

The usage of HTTP Adaptive Streaming (HAS) technology by content providers is increasing rapidly. Having available the video content in multiple qualities, using HAS allows to adapt the quality of downloaded video to the current network conditions providing smooth video-playback. However, the time-varying video quality by itself introduces a new type of impairment. The quality adaptation can be done in different ways. In order to find the best adaptation strategy maximizing users perceptual quality it is necessary to investigate about the subjective perception of adaptation-related impairments. However, the novelties of these impairments and their comparably long time duration make most of the standardized assessment methodologies fall less suited for studying HAS degradation. Furthermore, in traditional testing methodologies, the quality of the video in audiovisual services is often evaluated separated and not in the presence of audio. Nevertheless, the requirement of jointly evaluating the audio and the video within a subjective test is a relatively under-explored research field. In this work, we address the research question of determining the appropriate assessment methodology to evaluate the sequences with time-varying quality due to the adaptation. This was done by studying the influence of different adaptation related parameters through two different subjective experiments using a methodology developed to evaluate long test sequences. In order to study the impact of audio presence on quality assessment by the test subjects, one of the experiments was done in the presence of audio stimuli. The experimental results were subsequently compared with another experiment using the standardized single stimulus Absolute Category Rating (ACR) methodology.

National Water Quality Laboratory - A Profile

USGS Publications Warehouse

Raese, Jon W.

2001-01-01

The U.S. Geological Survey (USGS) National Water Quality Laboratory (NWQL) is a full-service laboratory that specializes in environmental analytical chemistry. The NWQL's primary mission is to support USGS programs requiring environmental analyses that provide consistent methodology for national assessment and trends analysis. The NWQL provides the following: high-quality chemical data; consistent, published, state-of-the-art methodology; extremely low-detection levels; high-volume capability; biological unit for identifying benthic invertebrates; quality assurance for determining long-term water-quality trends; and a professional staff.

Information without Implementation: A Practical Example for Developing a Best Practice Education Control Group.

PubMed

Balderson, Benjamin H; McCurry, Susan M; Vitiello, Michael V; Shortreed, Susan M; Rybarczyk, Bruce D; Keefe, Francis J; Korff, Michael Von

2016-01-01

This article considers methodology for developing an education-only control group and proposes a simple approach to designing rigorous and well-accepted control groups. This approach is demonstrated in a large randomized trial. The Lifestyles trial (n = 367) compared three group interventions: (a) cognitive-behavioral treatment (CBT) for osteoarthritis pain, (b) CBT for osteoarthritis pain and insomnia, and (c) education-only control (EOC). EOC emulated the interventions excluding hypothesized treatment components and controlling for nonspecific treatment effects. Results showed this approach resulted in a control group that was highly credible and acceptable to patients. This approach can be an effective and practical guide for developing high-quality control groups in trials of behavioral interventions.

Exercise rehabilitation following intensive care unit discharge for recovery from critical illness: executive summary of a Cochrane Collaboration systematic review.

PubMed

Connolly, Bronwen; Salisbury, Lisa; O'Neill, Brenda; Geneen, Louise; Douiri, Abdel; Grocott, Michael P W; Hart, Nicholas; Walsh, Timothy S; Blackwood, Bronagh

2016-12-01

Skeletal muscle wasting and weakness are major complications of critical illness and underlie the profound physical and functional impairments experienced by survivors after discharge from the intensive care unit (ICU). Exercise-based rehabilitation has been shown to be beneficial when delivered during ICU admission. This review aimed to determine the effectiveness of exercise rehabilitation initiated after ICU discharge on primary outcomes of functional exercise capacity and health-related quality of life. We sought randomized controlled trials, quasi-randomized controlled trials, and controlled clinical trials comparing an exercise intervention commenced after ICU discharge vs. any other intervention or a control or 'usual care' programme in adult survivors of critical illness. Cochrane Central Register of Controlled Trials, Medical Literature Analysis and Retrieval System Online (MEDLINE), Excerpta Medica Database, and Cumulative Index to Nursing and Allied Health Literature databases were searched up to February 2015. Dual, independent screening of results, data extraction, and quality appraisal were performed. We included six trials involving 483 patients. Overall quality of evidence for both outcomes was very low. All studies evaluated functional exercise capacity, with three reporting positive effects in favour of the intervention. Only two studies evaluated health-related quality of life and neither reported differences between intervention and control groups. Meta-analyses of data were precluded due to variation in study design, types of interventions, and selection and reporting of outcome measurements. We were unable to determine an overall effect on functional exercise capacity or health-related quality of life of interventions initiated after ICU discharge for survivors of critical illness. Findings from ongoing studies are awaited. Future studies need to address methodological aspects of study design and conduct to enhance rigour, quality, and synthesis.

Measurement properties of rheumatoid arthritis-specific quality-of-life questionnaires: systematic review of the literature.

PubMed

Lee, Jiyeon; Kim, Soo Hyun; Moon, Seung Hei; Lee, Eun-Hyun

2014-12-01

This study conducted a systematic review of the methodological quality of the psychometric evaluation process and the quality of measurement properties of rheumatoid arthritis (RA)-specific health-related quality-of-life (HRQOL) questionnaires with the purpose of obtaining the best evidence to help in the selection of the most appropriate instrument for measuring HRQOL in RA patients. A systematic literature search was performed to identify RA-specific HRQOL questionnaires in databases. The methodological quality of the studies was assessed using the Consensus-based Standards for the Selection of Health Measurement Instruments checklist. The quality of the measurement properties was assessed using quality criteria. The evidence regarding the measurement properties was pooled using best-evidence synthesis, with considerations of the number and methodological quality of the studies, and the consistency of their findings in terms of the quality of the measurement properties. The search identified 37 studies describing 9 instruments. Best-evidence synthesis suggested that the Rheumatoid Arthritis Quality of Life (RAQoL) questionnaire had the strongest positive evidence, especially with respect to reliability, measurement error, and content validity, and moderate positive evidence with respect to hypothesis testing and responsiveness. The current evidence suggests that the best-validated instrument among the RA-specific HRQOL measures is the RAQoL questionnaire in terms of both methodological quality in the process of psychometric evaluation and the quality of the measurement properties. However, there is limited evidence regarding internal consistency and structural validity of the RAQoL. Further efforts are warranted to establish the psychometric quality of this questionnaire.

Integrity management of offshore structures and its implication on computation of structural action effects and resistance

NASA Astrophysics Data System (ADS)

Moan, T.

2017-12-01

An overview of integrity management of offshore structures, with emphasis on the oil and gas energy sector, is given. Based on relevant accident experiences and means to control the associated risks, accidents are categorized from a technical-physical as well as human and organizational point of view. Structural risk relates to extreme actions as well as structural degradation. Risk mitigation measures, including adequate design criteria, inspection, repair and maintenance as well as quality assurance and control of engineering processes, are briefly outlined. The current status of risk and reliability methodology to aid decisions in the integrity management is briefly reviewed. Finally, the need to balance the uncertainties in data, methods and computational efforts and the cautious use and quality assurance and control in applying high fidelity methods to avoid human errors, is emphasized, and with a plea to develop both high fidelity as well as efficient, simplified methods for design.

Effect of oral healthcare education on knowledge, attitude and skills of care home nurses: a systematic literature review.

PubMed

de Lugt-Lustig, Kersti H M E; Vanobbergen, Jacques N O; van der Putten, Gert-Jan; De Visschere, Luc M J; Schols, Jos M G A; de Baat, Cees

2014-02-01

To systematically review the literature on the effect of providing oral healthcare education to care home nurses on their oral healthcare knowledge and attitude and their oral hygiene care skills. A literature search was obtained for relevant articles on oral healthcare education of nurses in care homes, using five electronic retrieval systems and databases. The search was limited to human studies, articles published in English and articles published during the period January 1990 to December 2011. The methodological quality of an article was assessed on the basis of criteria published by the Cochrane Collaboration. For articles not meeting all methodological quality criteria, relevance criteria were used to determine how much scientific evidence could be assigned to the study findings. In accordance with the methodological quality criteria, two randomized controlled trials were included. Additionally, four studies were included after determining the scientific evidence of the study findings. The studies included revealed some scientific evidence and indications that an oral healthcare education programme for care home nurses may improve the nurses' oral healthcare knowledge and attitude. Any effect of oral healthcare education to care home nurses' oral hygiene care skills could not be determined. Oral healthcare education may have a positive effect on care home nurses' oral healthcare knowledge and attitude and on care home residents' oral hygiene, whereas any effect on care home nurses' oral hygiene care skills could not be found. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.