Randomized clinical trials in dentistry: Risks of bias, risks of random errors, reporting quality, and methodologic quality over the years 1955-2013.

PubMed

Saltaji, Humam; Armijo-Olivo, Susan; Cummings, Greta G; Amin, Maryam; Flores-Mir, Carlos

2017-01-01

To examine the risks of bias, risks of random errors, reporting quality, and methodological quality of randomized clinical trials of oral health interventions and the development of these aspects over time. We included 540 randomized clinical trials from 64 selected systematic reviews. We extracted, in duplicate, details from each of the selected randomized clinical trials with respect to publication and trial characteristics, reporting and methodologic characteristics, and Cochrane risk of bias domains. We analyzed data using logistic regression and Chi-square statistics. Sequence generation was assessed to be inadequate (at unclear or high risk of bias) in 68% (n = 367) of the trials, while allocation concealment was inadequate in the majority of trials (n = 464; 85.9%). Blinding of participants and blinding of the outcome assessment were judged to be inadequate in 28.5% (n = 154) and 40.5% (n = 219) of the trials, respectively. A sample size calculation before the initiation of the study was not performed/reported in 79.1% (n = 427) of the trials, while the sample size was assessed as adequate in only 17.6% (n = 95) of the trials. Two thirds of the trials were not described as double blinded (n = 358; 66.3%), while the method of blinding was appropriate in 53% (n = 286) of the trials. We identified a significant decrease over time (1955-2013) in the proportion of trials assessed as having inadequately addressed methodological quality items (P < 0.05) in 30 out of the 40 quality criteria, or as being inadequate (at high or unclear risk of bias) in five domains of the Cochrane risk of bias tool: sequence generation, allocation concealment, incomplete outcome data, other sources of bias, and overall risk of bias. The risks of bias, risks of random errors, reporting quality, and methodological quality of randomized clinical trials of oral health interventions have improved over time; however, further efforts that contribute to the development of more stringent

Randomized clinical trials in dentistry: Risks of bias, risks of random errors, reporting quality, and methodologic quality over the years 1955–2013

PubMed Central

Armijo-Olivo, Susan; Cummings, Greta G.; Amin, Maryam; Flores-Mir, Carlos

2017-01-01

Objectives To examine the risks of bias, risks of random errors, reporting quality, and methodological quality of randomized clinical trials of oral health interventions and the development of these aspects over time. Methods We included 540 randomized clinical trials from 64 selected systematic reviews. We extracted, in duplicate, details from each of the selected randomized clinical trials with respect to publication and trial characteristics, reporting and methodologic characteristics, and Cochrane risk of bias domains. We analyzed data using logistic regression and Chi-square statistics. Results Sequence generation was assessed to be inadequate (at unclear or high risk of bias) in 68% (n = 367) of the trials, while allocation concealment was inadequate in the majority of trials (n = 464; 85.9%). Blinding of participants and blinding of the outcome assessment were judged to be inadequate in 28.5% (n = 154) and 40.5% (n = 219) of the trials, respectively. A sample size calculation before the initiation of the study was not performed/reported in 79.1% (n = 427) of the trials, while the sample size was assessed as adequate in only 17.6% (n = 95) of the trials. Two thirds of the trials were not described as double blinded (n = 358; 66.3%), while the method of blinding was appropriate in 53% (n = 286) of the trials. We identified a significant decrease over time (1955–2013) in the proportion of trials assessed as having inadequately addressed methodological quality items (P < 0.05) in 30 out of the 40 quality criteria, or as being inadequate (at high or unclear risk of bias) in five domains of the Cochrane risk of bias tool: sequence generation, allocation concealment, incomplete outcome data, other sources of bias, and overall risk of bias. Conclusions The risks of bias, risks of random errors, reporting quality, and methodological quality of randomized clinical trials of oral health interventions have improved over time; however, further efforts that contribute

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

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.

Methodological review of the quality of reach out and read: does it "work"?

PubMed

Yeager Pelatti, Christina; Pentimonti, Jill M; Justice, Laura M

2014-04-01

A considerable percentage of American children and adults fail to learn adequate literacy skills and read below a third grade level. Shared book reading is perhaps the single most important activity to prepare young children for success in reading. The primary objective of this manuscript was to critically review the methodological quality of Read Out and Read (ROR), a clinically based literacy program/intervention that teaches parents strategies to incorporate while sharing books with children as a method of preventing reading difficulties and academic struggles. A PubMed search was conducted. Articles that met three criteria were considered. First, the study must be clinically based and include parent contact with a pediatrician. Second, parental counseling ("anticipatory guidance") about the importance of parent-child book reading must be included. Third, only experimental or quasi-experimental studies were included; no additional criteria were used. Published articles from any year and peer-reviewed journal were considered. Study quality was determined using a modified version of the Downs and Black (1998) checklist assessing four categories: (1) Reporting, (2) External Validity, (3) Internal Validity-Bias, and (4) Internal Validity-Confounding. We were also interested in whether quality differed based on study design, children's age, sample size, and study outcome. Eleven studies met the inclusion criteria. The overall quality of evidence was variable across all studies; Reporting and External Validity categories were relatively strong while methodological concerns were found in the area of internal validity. Quality scores differed on the four study characteristics. Implications related to clinical practice and future studies are discussed.

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 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 guidelines in gastroenterology.

PubMed

Malheiro, Rui; de Monteiro-Soares, Matilde; Hassan, Cesare; Dinis-Ribeiro, Mário

2014-06-01

Clinical guidelines are a common feature in modern endoscopy practice and they are being produced faster than ever. However, their methodological quality is rarely assessed. This study evaluated the methodological quality of current clinical guidelines in the field of gastroenterology, with an emphasis on endoscopy. Practice guidelines published by the American College of Gastroenterology (ACG), American Gastroenterological Association (AGA), American Society for Gastrointestinal Endoscopy (ASGE), European Society of Gastrointestinal Endoscopy (ESGE), British Society of Gastroenterology (BSG), National Institute for Health and Care Excellence (NICE), and the Scottish Intercollegiate Guidelines Network (SIGN) were searched between September and October 2012 and evaluated using the AGREE II (Appraisal of Guidelines for Research and Evaluation) instrument (23 items, scores 1 - 7 for each item; higher scores mean better quality). A total of 100 guidelines were assessed. The mean number of items scoring 6 or 7 per guideline was 9.2 (out of 23 items). Overall, 99 % of guidelines failed to include the target population in the development process, and 96 % did not report facilitators and barriers to guideline application. In addition, 86 % did not include advice or tools, and 94 % did not present monitoring or auditing criteria. The global methodological quality of clinical guidelines in the field of gastroenterology is poor, particularly regarding involvement of the target population in the development of guidelines and in the provision of clear suggestions to practitioners. © Georg Thieme Verlag KG Stuttgart · New York.

Methodological Reporting Quality of Randomized Controlled Trials in 3 Leading Diabetes Journals From 2011 to 2013 Following CONSORT Statement: A System Review.

PubMed

Zhai, Xiao; Wang, Yiran; Mu, Qingchun; Chen, Xiao; Huang, Qin; Wang, Qijin; Li, Ming

2015-07-01

To appraise the current reporting methodological quality of randomized clinical trials (RCTs) in 3 leading diabetes journals.We systematically searched the literature for RCTs in Diabetes Care, Diabetes and Diabetologia from 2011 to 2013.Characteristics were extracted based on Consolidated Standards of Reporting Trials (CONSORT) statement. Generation of allocation, concealment of allocation, intention-to-treat (ITT) analysis and handling of dropouts were defined as primary outcome and "low risk of bias." Sample size calculation, type of intervention, country, number of patients, funding source were also revealed and descriptively reported. Trials were compared among journals, study years, and other characters.A total of 305 RCTs were enrolled in this study. One hundred eight (35.4%) trials reported adequate generation of allocation, 87 (28.5%) trials reported adequate concealment of allocation, 53 (23.8%) trials used ITT analysis, and 130 (58.3%) trials were adequate in handling of dropouts. Only 15 (4.9%) were "low risk of bias" trials. Studies at a large scale (n > 100) or from European presented with more "low risk of bias" trials than those at a small scale (n ≤ 100) or from other regions. No improvements were found in these 3 years.This study shows that methodological reporting quality of RCTs in the major diabetes journals remains suboptimal. It can be further improved to meet and keep up with the standards of the CONSORT statement.

Systematic review adherence to methodological or reporting quality.

PubMed

Pussegoda, Kusala; Turner, Lucy; Garritty, Chantelle; Mayhew, Alain; Skidmore, Becky; Stevens, Adrienne; Boutron, Isabelle; Sarkis-Onofre, Rafael; Bjerre, Lise M; Hróbjartsson, Asbjørn; Altman, Douglas G; Moher, David

2017-07-19

Guidelines for assessing methodological and reporting quality of systematic reviews (SRs) were developed to contribute to implementing evidence-based health care and the reduction of research waste. As SRs assessing a cohort of SRs is becoming more prevalent in the literature and with the increased uptake of SR evidence for decision-making, methodological quality and standard of reporting of SRs is of interest. The objective of this study is to evaluate SR adherence to the Quality of Reporting of Meta-analyses (QUOROM) and PRISMA reporting guidelines and the A Measurement Tool to Assess Systematic Reviews (AMSTAR) and Overview Quality Assessment Questionnaire (OQAQ) quality assessment tools as evaluated in methodological overviews. The Cochrane Library, MEDLINE®, and EMBASE® databases were searched from January 1990 to October 2014. Title and abstract screening and full-text screening were conducted independently by two reviewers. Reports assessing the quality or reporting of a cohort of SRs of interventions using PRISMA, QUOROM, OQAQ, or AMSTAR were included. All results are reported as frequencies and percentages of reports and SRs respectively. Of the 20,765 independent records retrieved from electronic searching, 1189 reports were reviewed for eligibility at full text, of which 56 reports (5371 SRs in total) evaluating the PRISMA, QUOROM, AMSTAR, and/or OQAQ tools were included. Notable items include the following: of the SRs using PRISMA, over 85% (1532/1741) provided a rationale for the review and less than 6% (102/1741) provided protocol information. For reports using QUOROM, only 9% (40/449) of SRs provided a trial flow diagram. However, 90% (402/449) described the explicit clinical problem and review rationale in the introduction section. Of reports using AMSTAR, 30% (534/1794) used duplicate study selection and data extraction. Conversely, 80% (1439/1794) of SRs provided study characteristics of included studies. In terms of OQAQ, 37% (499/1367) of the

Is the Stock of VET Skills Adequate? Assessment Methodologies.

ERIC Educational Resources Information Center

Blandy, Richard; Freeland, Brett

In Australia and elsewhere, four approaches have been used to determine whether stocks of vocational education and training (VET) skills are adequate to meet industry needs. The four methods are as follows: (1) the manpower requirements approach; (2) the international, national, and industry comparisons approach; (3) the labor market analysis…

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 Quality of Consensus Guidelines in Implant Dentistry.

PubMed

Faggion, Clovis Mariano; Apaza, Karol; Ariza-Fritas, Tania; Málaga, Lilian; Giannakopoulos, Nikolaos Nikitas; Alarcón, Marco Antonio

2017-01-01

Consensus guidelines are useful to improve clinical decision making. Therefore, the methodological evaluation of these guidelines is of paramount importance. Low quality information may guide to inadequate or harmful clinical decisions. To evaluate the methodological quality of consensus guidelines published in implant dentistry using a validated methodological instrument. The six implant dentistry journals with impact factors were scrutinised for consensus guidelines related to implant dentistry. Two assessors independently selected consensus guidelines, and four assessors independently evaluated their methodological quality using the Appraisal of Guidelines for Research & Evaluation (AGREE) II instrument. Disagreements in the selection and evaluation of guidelines were resolved by consensus. First, the consensus guidelines were analysed alone. Then, systematic reviews conducted to support the guidelines were included in the analysis. Non-parametric statistics for dependent variables (Wilcoxon signed rank test) was used to compare both groups. Of 258 initially retrieved articles, 27 consensus guidelines were selected. Median scores in four domains (applicability, rigour of development, stakeholder involvement, and editorial independence), expressed as percentages of maximum possible domain scores, were below 50% (median, 26%, 30.70%, 41.70%, and 41.70%, respectively). The consensus guidelines and consensus guidelines + systematic reviews data sets could be compared for 19 guidelines, and the results showed significant improvements in all domain scores (p < 0.05). Methodological improvement of consensus guidelines published in major implant dentistry journals is needed. The findings of the present study may help researchers to better develop consensus guidelines in implant dentistry, which will improve the quality and trust of information needed to make proper clinical decisions.

Quality of reporting of surveys in critical care journals: a methodologic review.

PubMed

Duffett, Mark; Burns, Karen E; Adhikari, Neill K; Arnold, Donald M; Lauzier, François; Kho, Michelle E; Meade, Maureen O; Hayani, Omar; Koo, Karen; Choong, Karen; Lamontagne, François; Zhou, Qi; Cook, Deborah J

2012-02-01

Adequate reporting is needed to judge methodologic quality and assess the risk of bias of surveys. The objective of this study is to describe the methodology and quality of reporting of surveys published in five critical care journals. All issues (1996-2009) of the American Journal of Respiratory and Critical Care Medicine, Critical Care, Critical Care Medicine, Intensive Care Medicine, and Pediatric Critical Care Medicine. Two reviewers hand-searched all issues in duplicate. We included publications of self-administered questionnaires of health professionals and excluded surveys that were part of a multi-method study or measured the effect of an intervention. Data were abstracted in duplicate. We included 151 surveys. The frequency of survey publication increased at an average rate of 0.38 surveys per 1000 citations per year from 1996-2009 (p for trend = 0.001). The median number of respondents and reported response rates were 217 (interquartile range 90 to 402) and 63.3% (interquartile range 45.0% to 81.0%), respectively. Surveys originated predominantly from North America (United States [40.4%] and Canada [18.5%]). Surveys most frequently examined stated practice (78.8%), attitudes or opinions (60.3%), and less frequently knowledge (9.9%). The frequency of reporting on the survey design and methods were: 1) instrument development: domains (59.1%), item generation (33.1%), item reduction (12.6%); 2) instrument testing: pretesting or pilot testing (36.2%) and assessments of clarity (25.2%) or clinical sensibility (15.7%); and 3) clinimetric properties: qualitative or quantitative description of at least one of face, content, construct validity, intra- or inter-rater reliability, or consistency (28.5%). The reporting of five key elements of survey design and conduct did not significantly change over time. Surveys, primarily conducted in North America and focused on self-reported practice, are increasingly published in highly cited critical care journals. More

Methodological Quality of Consensus Guidelines in Implant Dentistry

PubMed Central

Faggion, Clovis Mariano; Apaza, Karol; Ariza-Fritas, Tania; Málaga, Lilian; Giannakopoulos, Nikolaos Nikitas; Alarcón, Marco Antonio

2017-01-01

Background Consensus guidelines are useful to improve clinical decision making. Therefore, the methodological evaluation of these guidelines is of paramount importance. Low quality information may guide to inadequate or harmful clinical decisions. Objective To evaluate the methodological quality of consensus guidelines published in implant dentistry using a validated methodological instrument. Methods The six implant dentistry journals with impact factors were scrutinised for consensus guidelines related to implant dentistry. Two assessors independently selected consensus guidelines, and four assessors independently evaluated their methodological quality using the Appraisal of Guidelines for Research & Evaluation (AGREE) II instrument. Disagreements in the selection and evaluation of guidelines were resolved by consensus. First, the consensus guidelines were analysed alone. Then, systematic reviews conducted to support the guidelines were included in the analysis. Non-parametric statistics for dependent variables (Wilcoxon signed rank test) was used to compare both groups. Results Of 258 initially retrieved articles, 27 consensus guidelines were selected. Median scores in four domains (applicability, rigour of development, stakeholder involvement, and editorial independence), expressed as percentages of maximum possible domain scores, were below 50% (median, 26%, 30.70%, 41.70%, and 41.70%, respectively). The consensus guidelines and consensus guidelines + systematic reviews data sets could be compared for 19 guidelines, and the results showed significant improvements in all domain scores (p < 0.05). Conclusions Methodological improvement of consensus guidelines published in major implant dentistry journals is needed. The findings of the present study may help researchers to better develop consensus guidelines in implant dentistry, which will improve the quality and trust of information needed to make proper clinical decisions. PMID:28107405

Methodological Quality of National Guidelines for Pediatric Inpatient Conditions

PubMed Central

Hester, Gabrielle; Nelson, Katherine; Mahant, Sanjay; Eresuma, Emily; Keren, Ron; Srivastava, Rajendu

2014-01-01

Background Guidelines help inform standardization of care for quality improvement (QI). The Pediatric Research in Inpatient Settings (PRIS) network published a prioritization list of inpatient conditions with high prevalence, cost, and variation in resource utilization across children’s hospitals. The methodological quality of guidelines for priority conditions is unknown. Objective To rate the methodological quality of national guidelines for 20 priority pediatric inpatient conditions. Design We searched sources including PubMed for national guidelines published 2002–2012. Guidelines specific to one organism, test or treatment, or institution were excluded. Guidelines were rated by two raters using a validated tool (AGREE II) with an overall rating on a 7-point scale (7–highest). Inter-rater reliability was measured with a weighted kappa coefficient. Results 17 guidelines met inclusion criteria for 13 conditions, 7 conditions yielded no relevant national guidelines. The highest methodological quality guidelines were for asthma, tonsillectomy, and bronchiolitis (mean overall rating 7, 6.5 and 6.5 respectively); the lowest were for sickle cell disease (2 guidelines) and dental caries (mean overall rating 4, 3.5, and 3 respectively). The overall weighted kappa was 0.83 (95% confidence interval 0.78–0.87). Conclusions We identified a group of moderate to high methodological quality national guidelines for priority pediatric inpatient conditions. Hospitals should consider these guidelines to inform QI initiatives. PMID:24677729

Q methodology, risk training and quality management.

PubMed

McKeown, M; Hinks, M; Stowell-Smith, M; Mercer, D; Forster, J

1999-01-01

The results of a Q methodological study of professional understandings of the notion of risk in mental health services within the UK are discussed in relation to the relevance for staff training and quality assurance. The study attempted to access the diversity of understandings of risk issues amongst a multi-professional group of staff (n = 60) attending inter-agency risk training workshops in 1998. Q methodology is presented as both an appropriate means for such inquiry and as a novel experiential technique for training purposes. A tentative argument is advanced that the qualitative accounts generated by Q research could assist in systematic reviews of quality, complementing the singularly quantitative approaches typically represented in the audit process.

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

Using Q Methodology in Quality Improvement Projects.

PubMed

Tiernon, Paige; Hensel, Desiree; Roy-Ehri, Leah

Q methodology consists of a philosophical framework and procedures to identify subjective viewpoints that may not be well understood, but its use in nursing is still quite limited. We describe how Q methodology can be used in quality improvement projects to better understand local viewpoints that act as facilitators or barriers to the implementation of evidence-based practice. We describe the use of Q methodology to identify nurses' attitudes about the provision of skin-to-skin care after cesarean birth. Copyright © 2017 AWHONN, the Association of Women's Health, Obstetric and Neonatal Nurses. Published by Elsevier Inc. All rights reserved.

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.

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.

The impact of urban gardens on adequate and healthy food: a systematic review.

PubMed

Garcia, Mariana T; Ribeiro, Silvana M; Germani, Ana Claudia Camargo Gonçalves; Bógus, Cláudia M

2018-02-01

To examine the impacts on food and nutrition-related outcomes resulting from participation in urban gardens, especially on healthy food practices, healthy food access, and healthy food beliefs, knowledge and attitudes. The systematic review identified studies by searching the PubMed, ERIC, LILACS, Web of Science and Embase databases. An assessment of quality and bias risk of the studies was carried out and a narrative summary was produced. Studies published as original articles in peer-reviewed scientific journals in English, Spanish or Portuguese between 2005 and 2015 were included. The studies included were based on data from adult participants in urban gardens. Twenty-four studies were initially selected based on the eligibility criteria, twelve of which were included. There was important heterogeneity of settings, population and assessment methods. Assessment of quality and bias risk of the studies revealed the need for greater methodological rigour. Most studies investigated community gardens and employed a qualitative approach. The following were reported: greater fruit and vegetable consumption, better access to healthy foods, greater valuing of cooking, harvest sharing with family and friends, enhanced importance of organic production, and valuing of adequate and healthy food. Thematic patterns related to adequate and healthy food associated with participation in urban gardens were identified, revealing a positive impact on practices of adequate and healthy food and mainly on food perceptions.

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

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

[Methodological quality and reporting quality evaluation of randomized controlled trials published in China Journal of Chinese Materia Medica].

PubMed

Yu, Dan-Dan; Xie, Yan-Ming; Liao, Xing; Zhi, Ying-Jie; Jiang, Jun-Jie; Chen, Wei

2018-02-01

To evaluate the methodological quality and reporting quality of randomized controlled trials(RCTs) published in China Journal of Chinese Materia Medica, we searched CNKI and China Journal of Chinese Materia webpage to collect RCTs since the establishment of the magazine. The Cochrane risk of bias assessment tool was used to evaluate the methodological quality of RCTs. The CONSORT 2010 list was adopted as reporting quality evaluating tool. Finally, 184 RCTs were included and evaluated methodologically, of which 97 RCTs were evaluated with reporting quality. For the methodological evaluating, 62 trials(33.70%) reported the random sequence generation; 9(4.89%) trials reported the allocation concealment; 25(13.59%) trials adopted the method of blinding; 30(16.30%) trials reported the number of patients withdrawing, dropping out and those lost to follow-up;2 trials （1.09%） reported trial registration and none of the trial reported the trial protocol; only 8(4.35%) trials reported the sample size estimation in details. For reporting quality appraising, 3 reporting items of 25 items were evaluated with high-quality,including: abstract, participants qualified criteria, and statistical methods; 4 reporting items with medium-quality, including purpose, intervention, random sequence method, and data collection of sites and locations; 9 items with low-quality reporting items including title, backgrounds, random sequence types, allocation concealment, blindness, recruitment of subjects, baseline data, harms, and funding;the rest of items were of extremely low quality(the compliance rate of reporting item<10%). On the whole, the methodological and reporting quality of RCTs published in the magazine are generally low. Further improvement in both methodological and reporting quality for RCTs of traditional Chinese medicine are warranted. It is recommended that the international standards and procedures for RCT design should be strictly followed to conduct high-quality trials

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.

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

Organ Donation European Quality System: ODEQUS project methodology.

PubMed

Manyalich, M; Guasch, X; Gomez, M P; Páez, G; Teixeira, L

2013-01-01

Differences in the number of organ donors among hospitals cannot be explained only by the number of intensive care unit beds used or neurologic patients treated. The figures obtained are influenced by the organizational structure of the donation process and how efficient it is. The Organ Donation European Quality System (ODEQUS) is a 3-year project (from October 2010 to September 2013) co-financed by the European Agency for Health and Consumers (EAHC20091108) which aims to define a methodology to evaluate organ procurement performance at the hospital level. ODEQUS's specific objectives are to identify quality criteria and to develop quality indicators in three types of organ donation (after brain death, after cardiac death, and living donation). Those tools will be useful for hospitals' self-assessment as well as for developing an international auditing model. A consortium has been established involving 14 associated partners from Austria, Croatia, France, Germany, Italy, Poland, Portugal, Romania, Spain, Sweden, and the United Kingdom, as well as five collaborating partners from Greece, Hungary, Malta, Slovenia, and Turkey. The project has been established in three steps: 1) Design of a survey about the use of quality tools in a wide sample of European hospitals; 2) Development of quality criteria and quality indicators by the project experts. The main fields considered have been organizational structures, clinical procedures, and outcomes; and 3) Elaboration of an evaluation system to test the quality indicators in 11 European hospitals. Two types of training have been designed and performed: one concerns the development of quality criteria and quality indicators, whereas another is focused on how to use evaluation tools. Following this methodology, the project has so far identified 131 quality criteria and developed 31 quality indicators. Currently, the quality indicators are being tested in 11 selected hospitals. Copyright © 2013 Elsevier Inc. All rights

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.

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.

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.

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.

Reporting and Methodological Quality of Randomised Controlled Trials in Vascular and Endovascular Surgery.

PubMed

Hajibandeh, S; Hajibandeh, S; Antoniou, G A; Green, P A; Maden, M; Torella, F

2015-11-01

Randomised controlled trials (RCTs) are subject to bias if they lack methodological quality. Moreover, optimal and transparent reporting of RCT findings aids their critical appraisal and interpretation. The aim of this study was to ascertain whether the methodological and reporting quality of RCTs in vascular and endovascular surgery is improving. The most recent 75 and oldest 75 RCTs published in leading journals over a 10-year period (2003-2012) were identified. The reporting quality and methodological quality data of the old and new RCTs were extracted and compared. The former was analysed using the Consolidated Standards of Reporting Trials (CONSORT) statement, the latter with the Scottish Intercollegiate Guidelines Network (SIGN) checklist. Reporting quality measured by CONSORT was better in the new studies than in the old studies (0.68 [95% CI, 0.66-0.7] vs. 0.60 [95% CI, 0.58-0.62], p < .001); however, both new and old studies had similar methodological quality measured by SIGN (0.9 [IQR 0.1] vs. .09 [IQR: 0.2], p = .787). Unlike clinical items, the methodological items of the CONSORT statement were not well reported in old and new RCTs. More trials in the new group were endovascular related (33.33% vs. 17.33%, p = .038) and industry sponsored (28% vs. 6.67%, p = .001). Despite some progress, there remains room for improvement in the reporting quality of RCTs in vascular and endovascular surgery. The methodological quality of recent RCTs is similar to that of trials performed >10 years ago. Copyright © 2015 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.

The exchangeability of self-reports and administrative health care resource use measurements: assessement of the methodological reporting quality.

PubMed

Noben, Cindy Yvonne; de Rijk, Angelique; Nijhuis, Frans; Kottner, Jan; Evers, Silvia

2016-06-01

To assess the exchangeability of self-reported and administrative health care resource use measurements for cost estimation. In a systematic review (NHS EED and MEDLINE), reviewers evaluate, in duplicate, the methodological reporting quality of studies comparing the validation evidence of instruments measuring health care resource use. The appraisal tool Methodological Reporting Quality (MeRQ) is developed by merging aspects form the Guidelines for Reporting Reliability and Agreement Studies and the Standards for Reporting Diagnostic Accuracy. Out of 173 studies, 35 full-text articles are assessed for eligibility. Sixteen articles are included in this study. In seven articles, more than 75% of the reporting criteria assessed by MERQ are considered "good." Most studies score at least "fair" on most of the reporting quality criteria. In the end, six studies score "good" on the minimal criteria for reporting. Varying levels of agreement among the different data sources are found, with correlations ranging from 0.14 up to 0.93 and with occurrences of both random and systematic errors. The validation evidence of the small number of studies with adequate MeRQ cautiously supports the exchangeability of both the self-reported and administrative resource use measurement methods. Copyright © 2016 Elsevier Inc. All rights reserved.

Methodology for stereoscopic motion-picture quality assessment

NASA Astrophysics Data System (ADS)

Voronov, Alexander; Vatolin, Dmitriy; Sumin, Denis; Napadovsky, Vyacheslav; Borisov, Alexey

2013-03-01

Creating and processing stereoscopic video imposes additional quality requirements related to view synchronization. In this work we propose a set of algorithms for detecting typical stereoscopic-video problems, which appear owing to imprecise setup of capture equipment or incorrect postprocessing. We developed a methodology for analyzing the quality of S3D motion pictures and for revealing their most problematic scenes. We then processed 10 modern stereo films, including Avatar, Resident Evil: Afterlife and Hugo, and analyzed changes in S3D-film quality over the years. This work presents real examples of common artifacts (color and sharpness mismatch, vertical disparity and excessive horizontal disparity) in the motion pictures we processed, as well as possible solutions for each problem. Our results enable improved quality assessment during the filming and postproduction stages.

Diet quality of Italian yogurt consumers: an application of the probability of adequate nutrient intake score (PANDiet).

PubMed

Mistura, Lorenza; D'Addezio, Laura; Sette, Stefania; Piccinelli, Raffaela; Turrini, Aida

2016-01-01

The diet quality in yogurt consumers and non-consumers was evaluated by applying the probability of adequate nutrient intake (PANDiet) index to a sample of adults and elderly from the Italian food consumption survey INRAN SCAI 2005-06. Overall, yogurt consumers had a significantly higher mean intake of energy, calcium and percentage of energy from total sugars whereas the mean percentage of energy from total fat, saturated fatty acid and total carbohydrate were significantly (p < 0.01) lower than in non-consumers. The PANDiet index was significantly higher in yogurt consumers than in non-consumers, (60.58 ± 0.33 vs. 58.58 ± 0.19, p < 0.001). The adequacy sub-score for 17 nutrients for which usual intake should be above the reference value was significantly higher among yogurt consumers. The items of calcium, potassium and riboflavin showed the major percentage variation between consumers and non-consumers. Yogurt consumers were more likely to have adequate intakes of vitamins and minerals, and a higher quality score of the diet.

Methodological quality of behavioural weight loss studies: a systematic review

PubMed Central

Lemon, S. C.; Wang, M. L.; Haughton, C. F.; Estabrook, D. P.; Frisard, C. F.; Pagoto, S. L.

2018-01-01

Summary This systematic review assessed the methodological quality of behavioural weight loss intervention studies conducted among adults and associations between quality and statistically significant weight loss outcome, strength of intervention effectiveness and sample size. Searches for trials published between January, 2009 and December, 2014 were conducted using PUBMED, MEDLINE and PSYCINFO and identified ninety studies. Methodological quality indicators included study design, anthropometric measurement approach, sample size calculations, intent-to-treat (ITT) analysis, loss to follow-up rate, missing data strategy, sampling strategy, report of treatment receipt and report of intervention fidelity (mean = 6.3). Indicators most commonly utilized included randomized design (100%), objectively measured anthropometrics (96.7%), ITT analysis (86.7%) and reporting treatment adherence (76.7%). Most studies (62.2%) had a follow-up rate >75% and reported a loss to follow-up analytic strategy or minimal missing data (69.9%). Describing intervention fidelity (34.4%) and sampling from a known population (41.1%) were least common. Methodological quality was not associated with reporting a statistically significant result, effect size or sample size. This review found the published literature of behavioural weight loss trials to be of high quality for specific indicators, including study design and measurement. Identified for improvement include utilization of more rigorous statistical approaches to loss to follow up and better fidelity reporting. PMID:27071775

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.

How to Select a Questionnaire with a Good Methodological Quality?

PubMed

Paiva, Saul Martins; Perazzo, Matheus de França; Ortiz, Fernanda Ruffo; Pordeus, Isabela Almeida; Martins-Júnior, Paulo Antônio

2018-01-01

In the last decades, several instruments have been used to evaluate the impact of oral health problems on the oral health-related quality of life (OHRQoL) of individuals. However, some instruments lack thorough methodological validation or present conceptual differences that hinder comparisons with instruments. Thus, it can be difficult to clinicians and researchers to select a questionnaire that accurately reflect what are really meaningful to individuals. This short communication aimed to discuss the importance of use an appropriate checklist to select an instrument with a good methodological quality. The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist was developed to provide tools for evidence-based instrument selection. The COSMIN checklist comprises ten boxes that evaluate whether a study meets the standard for good methodological quality and two additional boxes to meet studies that use the Item Response Theory method and general requirements for results generalization, resulting in four steps to be followed. In this way, it is required at least some expertise in psychometrics or clinimetrics to a wide-ranging use of this checklist. The COSMIN applications include its use to ensure the standardization of cross-cultural adaptations and safer comparisons between measurement studies and evaluation of methodological quality of systematic reviews of measurement properties. Also, it can be used by students when training about measurement properties and by editors and reviewers when revising manuscripts on this topic. The popularization of COSMIN checklist is therefore necessary to improve the selection and evaluation of health measurement instruments.

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

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

Quality and methodological challenges in Internet-based mental health trials.

PubMed

Ye, Xibiao; Bapuji, Sunita Bayyavarapu; Winters, Shannon; Metge, Colleen; Raynard, Mellissa

2014-08-01

To review the quality of Internet-based mental health intervention studies and their methodological challenges. We searched multiple literature databases to identify relevant studies according to the Population, Interventions, Comparators, Outcomes, and Study Design framework. Two reviewers independently assessed selection bias, allocation bias, confounding bias, blinding, data collection methods, and withdrawals/dropouts, using the Quality Assessment Tool for Quantitative Studies. We rated each component as strong, moderate, or weak and assigned a global rating (strong, moderate, or weak) to each study. We discussed methodological issues related to the study quality. Of 122 studies included, 31 (25%), 44 (36%), and 47 (39%) were rated strong, moderate, and weak, respectively. Only five studies were rated strong for all of the six quality components (three of them were published by the same group). Lack of blinding, selection bias, and low adherence were the top three challenges in Internet-based mental health intervention studies. The overall quality of Internet-based mental health intervention needs to improve. In particular, studies need to improve sample selection, intervention allocation, and blinding.

[Definition of low threshold volumes for quality assurance: conceptual and methodological issues involved in the definition and evaluation of thresholds for volume outcome relations in clinical care].

PubMed

Wetzel, Hermann

2006-01-01

In a large number of mostly retrospective association studies, a statistical relationship between volume and quality of health care has been reported. However, the relevance of these results is frequently limited by methodological shortcomings. In this article, criteria for the evidence and definition of thresholds for volume-outcome relations are proposed, e.g. the specification of relevant outcomes for quality indicators, analysis of volume as a continuous variable with an adequate case-mix and risk adjustment, accounting for cluster effects and considering mathematical models for the derivation of cut-off values. Moreover, volume thresholds are regarded as surrogate parameters for the indirect classification of the quality of care, whose diagnostic validity and effectiveness in improving health care quality need to be evaluated in prospective studies.

Region 9: California Adequate Letter (1/22/2018)

EPA Pesticide Factsheets

This December 19, 2017 letter form EPA, finding adequate certain motor vehicle emissions budgets for the 2006 fine particulate matter (PM2.5) National Ambient Air Quality Standars in the Final 2016 Air Quality Managemnet Plan for the South Coast area (2016

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.

Rating methodological quality: toward improved assessment and investigation.

PubMed

Moyer, Anne; Finney, John W

2005-01-01

Assessing methodological quality is considered essential in deciding what investigations to include in research syntheses and in detecting potential sources of bias in meta-analytic results. Quality assessment is also useful in characterizing the strengths and limitations of the research in an area of study. Although numerous instruments to measure research quality have been developed, they have lacked empirically-supported components. In addition, different summary quality scales have yielded different findings when they were used to weight treatment effect estimates for the same body of research. Suggestions for developing improved quality instruments include: distinguishing distinct domains of quality, such as internal validity, external validity, the completeness of the study report, and adherence to ethical practices; focusing on individual aspects, rather than domains of quality; and focusing on empirically-verified criteria. Other ways to facilitate the constructive use of quality assessment are to improve and standardize the reporting of research investigations, so that the quality of studies can be more equitably and thoroughly compared, and to identify optimal methods for incorporating study quality ratings into meta-analyses.

Improving the Quality of Patient Care Utilizing Tracer Methodology

DTIC Science & Technology

2011-01-25

Sharing Knowledge: Achieving Breakthrough Performance 2011 Military Health System Conference Improving the Quality of Patient Care Utilizing Tracer...Methodology 25 Jan 2011 Leslie Atkins, RN 1 Military Health System Conference T e Quadruple Aim Working Together, Achieving Success USA MEDDAC...25 JAN 2011 2. REPORT TYPE 3. DATES COVERED 00-00-2011 to 00-00-2011 4. TITLE AND SUBTITLE Improving the Quality of Patient Care Utilizing

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.

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

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

Methodological adequacy of articles published in two open-access Brazilian cardiology periodicals.

PubMed

Macedo, Cristiane Rufino; Silva, Davi Leite da; Puga, Maria Eduarda

2010-01-01

The use of rigorous scientific methods has contributed towards developing scientific articles of excellent methodological quality. This has made it possible to promote their citation and increase the impact factor. Brazilian periodicals have had to adapt to certain quality standards demanded by these indexing organizations, such as the content and the number of original articles published in each issue. This study aimed to evaluate the methodological adequacy of two Brazilian periodicals within the field of cardiology that are indexed in several databases and freely accessible through the Scientific Electronic Library Online (SciELO), and which are now indexed by the Web of Science (Institute for Scientific Information, ISI). Descriptive study at Brazilian Cochrane Center. All the published articles were evaluated according to merit assessment (content) and form assessment (performance). Ninety-six percent of the articles analyzed presented study designs that were adequate for answering the objectives. These two Brazilian periodicals within the field of cardiology published methodologically adequate articles, since they followed the quality standards. Thus, these periodicals can be considered both for consultation and as vehicles for publishing future articles. For further analyses, it is essential to apply other indicators of scientific activity such as bibliometrics, which evaluates quantitative aspects of the production, dissemination and use of information, and scientometrics, which is also concerned with the development of science policies, within which it is often superimposed on bibliometrics.

"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.

Methodological Quality Assessment of Meta-analyses in Endodontics.

PubMed

Kattan, Sereen; Lee, Su-Min; Kohli, Meetu R; Setzer, Frank C; Karabucak, Bekir

2018-01-01

The objectives of this review were to assess the methodological quality of published meta-analyses related to endodontics using the assessment of multiple systematic reviews (AMSTAR) tool and to provide a follow-up to previously published reviews. Three electronic databases were searched for eligible studies according to the inclusion and exclusion criteria: Embase via Ovid, The Cochrane Library, and Scopus. The electronic search was amended by a hand search of 6 dental journals (International Endodontic Journal; Journal of Endodontics; Australian Endodontic Journal; Oral Surgery, Oral Medicine, Oral Pathology, Oral Radiology; Endodontics and Dental Traumatology; and Journal of Dental Research). The searches were conducted to include articles published after July 2009, and the deadline for inclusion of the meta-analyses was November 30, 2016. The AMSTAR assessment tool was used to evaluate the methodological quality of all included studies. A total of 36 reports of meta-analyses were included. The overall quality of the meta-analyses reports was found to be medium, with an estimated mean overall AMSTAR score of 7.25 (95% confidence interval, 6.59-7.90). The most poorly assessed areas were providing an a priori design, the assessment of the status of publication, and publication bias. In recent publications in the field of endodontics, the overall quality of the reported meta-analyses is medium according to AMSTAR. Copyright © 2017 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

Association between bibliometric parameters, reporting and methodological quality of randomised controlled trials in vascular and endovascular surgery.

PubMed

Hajibandeh, Shahab; Hajibandeh, Shahin; Antoniou, George A; Green, Patrick A; Maden, Michelle; Torella, Francesco

2017-04-01

Purpose We aimed to investigate association between bibliometric parameters, reporting and methodological quality of vascular and endovascular surgery randomised controlled trials. Methods The most recent 75 and oldest 75 randomised controlled trials published in leading journals over a 10-year period were identified. The reporting quality was analysed using the CONSORT statement, and methodological quality with the Intercollegiate Guidelines Network checklist. We used exploratory univariate and multivariable linear regression analysis to investigate associations. Findings Bibliometric parameters such as type of journal, study design reported in title, number of pages; external funding, industry sponsoring and number of citations are associated with reporting quality. Moreover, parameters such as type of journal, subject area and study design reported in title are associated with methodological quality. Conclusions The bibliometric parameters of randomised controlled trials may be independent predictors for their reporting and methodological quality. Moreover, the reporting quality of randomised controlled trials is associated with their methodological quality and vice versa.

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. �

A Methodology for Anatomic Ultrasound Image Diagnostic Quality Assessment.

PubMed

Hemmsen, Martin Christian; Lange, Theis; Brandt, Andreas Hjelm; Nielsen, Michael Bachmann; Jensen, Jorgen Arendt

2017-01-01

This paper discusses the methods for the assessment of ultrasound image quality based on our experiences with evaluating new methods for anatomic imaging. It presents a methodology to ensure a fair assessment between competing imaging methods using clinically relevant evaluations. The methodology is valuable in the continuing process of method optimization and guided development of new imaging methods. It includes a three phased study plan covering from initial prototype development to clinical assessment. Recommendations to the clinical assessment protocol, software, and statistical analysis are presented. Earlier uses of the methodology has shown that it ensures validity of the assessment, as it separates the influences between developer, investigator, and assessor once a research protocol has been established. This separation reduces confounding influences on the result from the developer to properly reveal the clinical value. This paper exemplifies the methodology using recent studies of synthetic aperture sequential beamforming tissue harmonic imaging.

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.

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.

Development of Management Methodology for Engineering Production Quality

NASA Astrophysics Data System (ADS)

Gorlenko, O.; Miroshnikov, V.; Borbatc, N.

2016-04-01

The authors of the paper propose four directions of the methodology developing the quality management of engineering products that implement the requirements of new international standard ISO 9001:2015: the analysis of arrangement context taking into account stakeholders, the use of risk management, management of in-house knowledge, assessment of the enterprise activity according to the criteria of effectiveness

Importance of methodology on (99m)technetium dimercapto-succinic acid scintigraphic image quality: imaging pilot study for RIVUR (Randomized Intervention for Children With Vesicoureteral Reflux) multicenter investigation.

PubMed

Ziessman, Harvey A; Majd, Massoud

2009-07-01

We reviewed our experience with (99m)technetium dimercapto-succinic acid scintigraphy obtained during an imaging pilot study for a multicenter investigation (Randomized Intervention for Children With Vesicoureteral Reflux) of the effectiveness of daily antimicrobial prophylaxis for preventing recurrent urinary tract infection and renal scarring. We analyzed imaging methodology and its relation to diagnostic image quality. (99m)Technetium dimercapto-succinic acid imaging guidelines were provided to participating sites. High-resolution planar imaging with parallel hole or pinhole collimation was required. Two core reviewers evaluated all submitted images. Analysis included appropriate views, presence or lack of patient motion, adequate magnification, sufficient counts and diagnostic image quality. Inter-reader agreement was evaluated. We evaluated 70, (99m)technetium dimercapto-succinic acid studies from 14 institutions. Variability was noted in methodology and image quality. Correlation (r value) between dose administered and patient age was 0.780. For parallel hole collimator imaging good correlation was noted between activity administered and counts (r = 0.800). For pinhole imaging the correlation was poor (r = 0.110). A total of 10 studies (17%) were rejected for quality issues of motion, kidney overlap, inadequate magnification, inadequate counts and poor quality images. The submitting institution was informed and provided with recommendations for improving quality, and resubmission of another study was required. Only 4 studies (6%) were judged differently by the 2 reviewers, and the differences were minor. Methodology and image quality for (99m)technetium dimercapto-succinic acid scintigraphy varied more than expected between institutions. The most common reason for poor image quality was inadequate count acquisition with insufficient attention to the tradeoff between administered dose, length of image acquisition, start time of imaging and resulting image

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

Impact of sampling techniques on measured stormwater quality data for small streams

USDA-ARS?s Scientific Manuscript database

Science-based sampling methodologies are needed to enhance water quality characterization for developing Total Maximum Daily Loads (TMDLs), setting appropriate water quality standards, and managing nonpoint source pollution. Storm event sampling, which is vital for adequate assessment of water qual...

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.

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.

Identifying Items to Assess Methodological Quality in Physical Therapy Trials: A Factor Analysis

PubMed Central

Cummings, Greta G.; Fuentes, Jorge; Saltaji, Humam; Ha, Christine; Chisholm, Annabritt; Pasichnyk, Dion; Rogers, Todd

2014-01-01

Background 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. Objective 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). Design A methodological research design was used, and an EFA was performed. Methods 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. Results 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. Limitation Because of the exploratory nature of the results, a confirmatory factor analysis is needed to validate this model. Conclusions 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

Assessment of methodological quality of economic evaluations in belgian drug reimbursement applications.

PubMed

Simoens, Steven

2013-01-01

This paper aims to assess the methodological quality of economic evaluations included in Belgian reimbursement applications for Class 1 drugs. For 19 reimbursement applications submitted during 2011 and Spring 2012, a descriptive analysis assessed the methodological quality of the economic evaluation, evaluated the assessment of that economic evaluation by the Drug Reimbursement Committee and the response to that assessment by the company. Compliance with methodological guidelines issued by the Belgian Healthcare Knowledge Centre was assessed using a detailed checklist of 23 methodological items. The rate of compliance was calculated based on the number of economic evaluations for which the item was applicable. Economic evaluations tended to comply with guidelines regarding perspective, target population, subgroup analyses, comparator, use of comparative clinical data and final outcome measures, calculation of costs, incremental analysis, discounting and time horizon. However, more attention needs to be paid to the description of limitations of indirect comparisons, the choice of an appropriate analytic technique, the expression of unit costs in values for the current year, the estimation and valuation of outcomes, the presentation of results of sensitivity analyses, and testing the face validity of model inputs and outputs. Also, a large variation was observed in the scope and depth of the quality assessment by the Drug Reimbursement Committee. Although general guidelines exist, pharmaceutical companies and the Drug Reimbursement Committee would benefit from the existence of a more detailed checklist of methodological items that need to be reported in an economic evaluation.

Region 8: Utah Adequate Letter (6/10/2005)

EPA Pesticide Factsheets

This letter from EPA to Utah Department of Environmental Quality determined Salt Lake Citys' and Ogdens' Carbon Monoxide (CO) maintenance plan for Motor Vehicle Emissions Budgets adequate for transportation conformity purposes.

[Systematic Review of the Methodology Quality in Lung Cancer Screening Guidelines].

PubMed

Li, Jiang; Su, Kai; Li, Fang; Tang, Wei; Huang, Yao; Wang, Le; Huang, Huiyao; Shi, Jufang; Dai, Min

2016-10-20

Lung cancer is the most common malignancy and screening can decrease the mortality. High quality screening guideline is necessary and important for effective work. Our study is to review and evaluate the basic characteristics and methodology quality of the current global lung cancer screening guidelines so as to provide useful information for domestic study in the future. Electronic searches were done in English and Chinese databases including PubMed, the Cochrane Library, Web of Science, Embase, CNKI, CBM, Wanfang, and some cancer official websites. Articles were screened according to the predefined inclusion and exclusion criteria by two researchers. The quality of guidelines was assessed by AGREE II. At last, a total of 11 guidelines with methodology were included. The guidelines were issued mainly by USA (81%). Canada and China developed one, respectively. As for quality, the average score in the "Scale and objective" of all guidelines was 80, the average score in the "Participants" was 52, the average score in the "rigorism" was 50, the average score in the "clarity" was 76, the average score in the "application" was 43 and the average score in the "independence" was 59. The highest average score was found in 2013 and 2015. Canada guideline had higher quality in six domains. 7 guidelines were evaluated as A level. The number of clinical guidelines showed an increasing trend. Most guidelines were issued by developed countries with heavy burden. Multi-country contribution to one guideline was another trend. Evidence-based methodology was accepted globally in the guideline development.

Methodological and Reporting Quality of Comparative Studies Evaluating Health-Related Quality of Life of Colorectal Cancer Patients and Controls: A Systematic Review.

PubMed

Wong, Carlos K H; Guo, Vivian Y W; Chen, Jing; Lam, Cindy L K

2016-11-01

Health-related quality of life is an important outcome measure in patients with colorectal cancer. Comparison with normative data has been increasingly undertaken to assess the additional impact of colorectal cancer on health-related quality of life. This review aimed to critically appraise the methodological details and reporting characteristics of comparative studies evaluating differences in health-related quality of life between patients and controls. A systematic search of English-language literature published between January 1985 and May 2014 was conducted through a database search of PubMed, Web of Science, Embase, and Medline. Comparative studies reporting health-related quality-of-life outcomes among patients who have colorectal cancer and controls were selected. Methodological and reporting quality per comparison study was evaluated based on a 11-item methodological checklist proposed by Efficace in 2003 and a set of criteria predetermined by reviewers. Thirty-one comparative studies involving >10,000 patients and >10,000 controls were included. Twenty-three studies (74.2%) originated from European countries, with the largest number from the Netherlands (n = 6). Twenty-eight studies (90.3%) compared the health-related quality of life of patients with normative data published elsewhere, whereas the remaining studies recruited a group of patients who had colorectal cancer and a group of control patients within the same studies. The European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 was the most extensively used instrument (n = 16; 51.6%). Eight studies (25.8%) were classified as "probably robust" for clinical decision making according to the Efficace standard methodological checklist. Our further quality assessment revealed the lack of score differences reported (61.3%), contemporary comparisons (36.7%), statistical significance tested (38.7%), and matching of control group (58.1%), possibly leading to

Evaluative methodology for comprehensive water quality management planning

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

Dyer, H. L.

Computer-based evaluative methodologies have been developed to provide for the analysis of coupled phenomena associated with natural resource comprehensive planning requirements. Provisions for planner/computer interaction have been included. Each of the simulation models developed is described in terms of its coded procedures. An application of the models for water quality management planning is presented; and the data requirements for each of the models are noted.

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.

Region 6: Texas Adequate Letter (4/16/2010)

EPA Pesticide Factsheets

This letter from EPA to Texas Commission on Environmental Quality determined 2021 motor vehicle emission budgets for nitrogen oxides (NOx) and volatile organic compounds (VOCs) for Beaumont/Port Arthur area adequate for transportation conformity purposes

Assessment of Methodological Quality of Economic Evaluations in Belgian Drug Reimbursement Applications

PubMed Central

Simoens, Steven

2013-01-01

Objectives This paper aims to assess the methodological quality of economic evaluations included in Belgian reimbursement applications for Class 1 drugs. Materials and Methods For 19 reimbursement applications submitted during 2011 and Spring 2012, a descriptive analysis assessed the methodological quality of the economic evaluation, evaluated the assessment of that economic evaluation by the Drug Reimbursement Committee and the response to that assessment by the company. Compliance with methodological guidelines issued by the Belgian Healthcare Knowledge Centre was assessed using a detailed checklist of 23 methodological items. The rate of compliance was calculated based on the number of economic evaluations for which the item was applicable. Results Economic evaluations tended to comply with guidelines regarding perspective, target population, subgroup analyses, comparator, use of comparative clinical data and final outcome measures, calculation of costs, incremental analysis, discounting and time horizon. However, more attention needs to be paid to the description of limitations of indirect comparisons, the choice of an appropriate analytic technique, the expression of unit costs in values for the current year, the estimation and valuation of outcomes, the presentation of results of sensitivity analyses, and testing the face validity of model inputs and outputs. Also, a large variation was observed in the scope and depth of the quality assessment by the Drug Reimbursement Committee. Conclusions Although general guidelines exist, pharmaceutical companies and the Drug Reimbursement Committee would benefit from the existence of a more detailed checklist of methodological items that need to be reported in an economic evaluation. PMID:24386474

Methodologic European external quality assurance for DNA sequencing: the EQUALseq program.

PubMed

Ahmad-Nejad, Parviz; Dorn-Beineke, Alexandra; Pfeiffer, Ulrike; Brade, Joachim; Geilenkeuser, Wolf-Jochen; Ramsden, Simon; Pazzagli, Mario; Neumaier, Michael

2006-04-01

DNA sequencing is a key technique in molecular diagnostics, but to date no comprehensive methodologic external quality assessment (EQA) programs have been instituted. Between 2003 and 2005, the European Union funded, as specific support actions, the EQUAL initiative to develop methodologic EQA schemes for genotyping (EQUALqual), quantitative PCR (EQUALquant), and sequencing (EQUALseq). Here we report on the results of the EQUALseq program. The participating laboratories received a 4-sample set comprising 2 DNA plasmids, a PCR product, and a finished sequencing reaction to be analyzed. Data and information from detailed questionnaires were uploaded online and evaluated by use of a scoring system for technical skills and proficiency of data interpretation. Sixty laboratories from 21 European countries registered, and 43 participants (72%) returned data and samples. Capillary electrophoresis was the predominant platform (n = 39; 91%). The median contiguous correct sequence stretch was 527 nucleotides with considerable variation in quality of both primary data and data evaluation. The association between laboratory performance and the number of sequencing assays/year was statistically significant (P <0.05). Interestingly, more than 30% of participants neither added comments to their data nor made efforts to identify the gene sequences or mutational positions. Considerable variations exist even in a highly standardized methodology such as DNA sequencing. Methodologic EQAs are appropriate tools to uncover strengths and weaknesses in both technique and proficiency, and our results emphasize the need for mandatory EQAs. The results of EQUALseq should help improve the overall quality of molecular genetics findings obtained by DNA sequencing.

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

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…

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.

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.

Evaluation of the methodological quality of studies of the performance of diagnostic tests for bovine tuberculosis using QUADAS.

PubMed

Downs, Sara H; More, Simon J; Goodchild, Anthony V; Whelan, Adam O; Abernethy, Darrell A; Broughan, Jennifer M; Cameron, Angus; Cook, Alasdair J; Ricardo de la Rua-Domenech, R; Greiner, Matthias; Gunn, Jane; Nuñez-Garcia, Javier; Rhodes, Shelley; Rolfe, Simon; Sharp, Michael; Upton, Paul; Watson, Eamon; Welsh, Michael; Woolliams, John A; Clifton-Hadley, Richard S; Parry, Jessica E

2018-05-01

There has been little assessment of the methodological quality of studies measuring the performance (sensitivity and/or specificity) of diagnostic tests for animal diseases. In a systematic review, 190 studies of tests for bovine tuberculosis (bTB) in cattle (published 1934-2009) were assessed by at least one of 18 reviewers using the QUADAS (Quality Assessment of Diagnostic Accuracy Studies) checklist adapted for animal disease tests. VETQUADAS (VQ) included items measuring clarity in reporting (n = 3), internal validity (n = 9) and external validity (n = 2). A similar pattern for compliance was observed in studies of different diagnostic test types. Compliance significantly improved with year of publication for all items measuring clarity in reporting and external validity but only improved in four of the nine items measuring internal validity (p < 0.05). 107 references, of which 83 had performance data eligible for inclusion in a meta-analysis were reviewed by two reviewers. In these references, agreement between reviewers' responses was 71% for compliance, 32% for unsure and 29% for non-compliance. Mean compliance with reporting items was 2, 5.2 for internal validity and 1.5 for external validity. The index test result was described in sufficient detail in 80.1% of studies and was interpreted without knowledge of the reference standard test result in only 33.1%. Loss to follow-up was adequately explained in only 31.1% of studies. The prevalence of deficiencies observed may be due to inadequate reporting but may also reflect lack of attention to methodological issues that could bias the results of diagnostic test performance estimates. QUADAS was a useful tool for assessing and comparing the quality of studies measuring the performance of diagnostic tests but might be improved further by including explicit assessment of population sampling strategy. Crown Copyright © 2017. Published by Elsevier B.V. All rights reserved.

[Quality of life of people with severe dementia in nursing oases: empirical results and methodological implications].

PubMed

Brandenburg, H

2013-07-01

Nursing oases (NOs) are a variant of segregated care for people with severe dementia in nursing homes. They can be understood as a constant living arrangement in one room for 4-7 persons with a special care concept and environmental design. During the daytime nurses are permanently present. Quality of life (QoL) is the focus because the efficacy of medical and nursing interventions should include measurement of QoL. There is a controversy whether NOs are really different from the traditional caring settings in long-term care. Advocates see NOs as a substantial contribution to improve QoL, especially for people with severe dementia but critics fear a rollback to the era of multibed rooms in nursing homes and emphasize the risk of losing autonomy. This article is differentiated into four parts. Firstly, reasons are given why NOs are an option for a professional and adequate fulfillment of needs for people with severe dementia and a definition of NOs is given. Secondly, selected results of NOs studies in Germany are shown which have mainly documented positive effects. Thirdly, on the background of US American research into Special Care Units methodological questions are discussed. The focus is on designs and the utilization of standardized and non-standardized instruments. In the concluding remarks it is discussed whether QoL is an adequate indicator of a good life for people with severe dementia in long-term care.

Volume and methodological quality of randomized controlled trials in laparoscopic surgery: assessment over a 10-year period.

PubMed

Antoniou, Stavros A; Andreou, Alexandros; Antoniou, George A; Koch, Oliver O; Köhler, Gernot; Luketina, Ruzica-R; Bertsias, Antonios; Pointner, Rudolph; Granderath, Frank-Alexander

2015-11-01

Measures have been taken to improve methodological quality of randomized controlled trials (RCTs). This review systematically assessed the trends in volume and methodological quality of RCTs on minimally invasive surgery within a 10-year period. RCTs on minimally invasive surgery were searched in the 10 most cited general surgical journals and the 5 most cited journals of laparoscopic interest for the years 2002 and 2012. Bibliometric and methodological quality components were abstracted using the Scottish Intercollegiate Guidelines Network. The pooled number of RCTs from low-contribution regions demonstrated an increasing proportion of the total published RCTs, compensating for a concomitant decrease of the respective contributions from Europe and North America. International collaborations were more frequent in 2012. Acceptable or high quality RCTs accounted for 37.9% and 54.4% of RCTs published in 2002 and 2012, respectively. Components of external validity were poorly reported. Both the volume and the reporting quality of laparoscopic RCTs have increased from 2002 to 2012, but there seems to be ample room for improvement of methodological quality. Copyright © 2015 Elsevier Inc. All rights reserved.

Methodological quality of systematic reviews analyzing the use of laser therapy in restorative dentistry.

PubMed

Salmos, Janaina; Gerbi, Marleny E M M; Braz, Rodivan; Andrade, Emanuel S S; Vasconcelos, Belmiro C E; Bessa-Nogueira, Ricardo V

2010-01-01

The purpose of this study was to identify systematic reviews (SRs) that compared laser with other dental restorative procedures and to evaluate their methodological quality. A search strategy was developed and implemented for MEDLINE, the Cochrane Library, LILACS, and the Brazilian Dentistry Bibliography (1966- 2007). Inclusion criteria were: the article had to be an SR (+/- meta-analysis); primary focus was the use of laser in restorative dentistry; published in English, Spanish, Portuguese, Italian, German. Two investigators independently selected and evaluated the SRs. The overview quality assessment questionnaire (OQAQ) was used to evaluate methodological quality, and the results were averaged. There were 145 references identified, of which seven were SRs that met the inclusion criteria (kappa=0.81). Of the SRs, 71.4% appraised lasers in dental caries diagnosis. The mean overall OQAQ score was 4.4 [95% confidence interval (CI) 2.4- 6.5]. Of the SRs, 57.1% had major flaws, scoring < or = 4. SR methodological quality is low; therefore, clinicians should critically appraise them prior to considering their recommendations to guide patient care.

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

Region 10: Oregon Oakridge Adequate Letter (6/21/2017)

EPA Pesticide Factsheets

EPA approves motor vehicle emissions budget in the Oakridge-Westfir PM2.5 Attainment State Implementation Plan for the 2006 PM2.5 national ambient air quality standard, adequate for transportation conformity purposes.

Development of AMSTAR: a measurement tool to assess the methodological quality of systematic reviews.

PubMed

Shea, Beverley J; Grimshaw, Jeremy M; Wells, George A; Boers, Maarten; Andersson, Neil; Hamel, Candyce; Porter, Ashley C; Tugwell, Peter; Moher, David; Bouter, Lex M

2007-02-15

Our objective was to develop an instrument to assess the methodological quality of systematic reviews, building upon previous tools, empirical evidence and expert consensus. A 37-item assessment tool was formed by combining 1) the enhanced Overview Quality Assessment Questionnaire (OQAQ), 2) a checklist created by Sacks, and 3) three additional items recently judged to be of methodological importance. This tool was applied to 99 paper-based and 52 electronic systematic reviews. Exploratory factor analysis was used to identify underlying components. The results were considered by methodological experts using a nominal group technique aimed at item reduction and design of an assessment tool with face and content validity. The factor analysis identified 11 components. From each component, one item was selected by the nominal group. The resulting instrument was judged to have face and content validity. A measurement tool for the 'assessment of multiple systematic reviews' (AMSTAR) was developed. The tool consists of 11 items and has good face and content validity for measuring the methodological quality of systematic reviews. Additional studies are needed with a focus on the reproducibility and construct validity of AMSTAR, before strong recommendations can be made on its use.

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

The methodological quality of nurse-sensitive indicators in Dutch hospitals: A descriptive exploratory research study.

PubMed

Kieft, R A M M; Stalpers, D; Jansen, A P M; Francke, A L; Delnoij, D M J

2018-06-01

Nurse-sensitive indicators (NSIs) are increasingly being developed and used to establish quality of nursing care in Western countries. The objective was to gain insights into the methodological quality of mandatory NSIs in Dutch hospitals, including indicators for pain, wound care, malnutrition and delirium. A descriptive exploratory design was used, starting with desk research into publicly available documents and reports describing the development of the NSIs included in this study. We used the validated Appraisal of Indicators through Research and Evaluation (AIRE) instrument to evaluate the methodological quality. Although the purpose and relevance of each individual NSI have been described, no detailed information about the criteria for selecting these topics is available. It is not clear which specific stakeholders participated and how their input was used. We found no information about the process of collecting and compiling scientific evidence. It is unclear whether and to what extent the usability of NSIs has been tested. The methodological quality of NSIs used in Dutch hospitals is less than optimal in various ways and it is therefore questionable if the indicators are accurate enough to identify changes or improve nursing practice. Our study also provides an example of how the methodological quality of NSIs can be assessed systematically, which is relevant considering the increasing use of NSIs in various countries. Copyright © 2018 Elsevier B.V. All rights reserved.

A Methodological Proposal for Learning Games Selection and Quality Assessment

ERIC Educational Resources Information Center

Dondi, Claudio; Moretti, Michela

2007-01-01

This paper presents a methodological proposal elaborated in the framework of two European projects dealing with game-based learning, both of which have focused on "quality" aspects in order to create suitable tools that support European educators, practitioners and lifelong learners in selecting and assessing learning games for use in…

[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.

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

PubMed Central

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

2015-01-01

Objectives 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. Design 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. Results 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. Conclusions There was no difference in the reported methodological quality of positive versus negative studies. However, the uneven reporting of positive versus negative studies

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

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

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.

Evaluation of Quality of Lower Limb Arthroplasty Observational Studies Using the Assessment of Quality in Lower Limb Arthroplasty (AQUILA) Checklist.

PubMed

Cowan, James B; Mlynarek, Ryan A; Nelissen, Rob G H H; Pijls, Bart G C W; Gagnier, Joel J

2015-09-01

This study used the assessment of quality in lower limb arthroplasty (AQUILA) checklist to assess the quality of lower limb arthroplasty observational studies. Among 132 studies the mean reporting quality score was 5.4 (SD=1.2) out of 8 possible points. Most studies adequately reported reasons for revisions (98%) and prosthesis brand and fixation (95%) in sufficient detail. Only 3% of studies adequately reported the number of patients unwilling to participate, 15% stated a clear primary research question or hypothesis, 11% reported a worst-case analysis or competing risk analysis for endpoints, and 42% reported more than 5% of patients were lost to follow-up. There is significant room for improvement in the reporting and methodology of lower limb arthroplasty observational studies. Level III. Copyright © 2015 Elsevier Inc. All rights reserved.

Methodological quality of economic evaluations of new pharmaceuticals in The Netherlands.

PubMed

Hoomans, Ties; Severens, Johan L; van der Roer, Nicole; Delwel, Gepke O

2012-03-01

In the Netherlands, decisions about the reimbursement of new pharmaceuticals are based on cost effectiveness, as well as therapeutic value and budget impact. Since 1 January 2005, drug manufacturers are formally required to substantiate the cost effectiveness of drugs that have therapeutic added value in comparison with existing ones through pharmacoeconomic evaluations. Dutch guidelines for pharmacoeconomic research provide methods guidance, ensuring consistency in both the evidence and the decision-making process about drug reimbursement. This study reviewed the methodological quality of all 21 formally required pharmacoeconomic evaluations of new pharmaceuticals between 1 January 2005 and 1 October 2008, and verified whether these evaluations complied with pharmacoeconomic guidelines. Data on the quality of the pharmacoeconomic evaluations were extracted from the pharmacoeconomic reports published by the Dutch Health Care Insurance Board (CVZ). The Board's newsletters provided information on the advice to, and reimbursement decisions made by, the Dutch Minister of Health. All data extraction was carried out by two independent reviewers, and descriptive analyses were conducted. The methodological quality was sound in only 8 of the 21 pharmacoeconomic evaluations. In most cases, the perspective of analysis, the comparator drugs, and the reporting of both total and incremental costs and effects were correct. However, drug indication, form (i.e. cost utility/cost effectiveness) and time horizon of the evaluations were frequently flawed. Moreover, the costs and effects of the pharmaceuticals were not always analysed correctly, and modelling studies were often non-transparent. Twelve drugs were reimbursed, and nine were not. The compliance with pharmacoeconomic guidelines in economic evaluations of new pharmaceuticals can be improved. This would improve the methodological quality of the pharmacoeconomic evaluations and ensure consistency in the evidence and the

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…

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…

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.

Specific guidelines for assessing and improving the methodological quality of economic evaluations of newborn screening

PubMed Central

2012-01-01

Background Economic evaluation of newborn screening poses specific methodological challenges. Amongst others, these challenges refer to the use of quality adjusted life years (QALYs) in newborns, and which costs and outcomes need to be considered in a full evaluation of newborn screening programmes. Because of the increasing scale and scope of such programmes, a better understanding of the methods of high-quality economic evaluations may be crucial for both producers/authors and consumers/reviewers of newborn screening-related economic evaluations. The aim of this study was therefore to develop specific guidelines designed to assess and improve the methodological quality of economic evaluations in newborn screening. Methods To develop the guidelines, existing guidelines for assessing the quality of economic evaluations were identified through a literature search, and were reviewed and consolidated using a deductive iterative approach. In a subsequent test phase, these guidelines were applied to various economic evaluations which acted as case studies. Results The guidelines for assessing and improving the methodological quality of economic evaluations in newborn screening are organized into 11 categories: “bibliographic details”, “study question and design”, “modelling”, “health outcomes”, “costs”, “discounting”, “presentation of results”, “sensitivity analyses”, “discussion”, “conclusions”, and “commentary”. Conclusions The application of the guidelines highlights important issues regarding newborn screening-related economic evaluations, and underscores the need for such issues to be afforded greater consideration in future economic evaluations. The variety in methodological quality detected by this study reveals the need for specific guidelines on the appropriate methods for conducting sound economic evaluations in newborn screening. PMID:22947299

Methodological and reporting quality of systematic reviews on tuberculosis.

PubMed

Nicolau, I; Ling, D; Tian, L; Lienhardt, C; Pai, M

2013-09-01

Systematic reviews are used to inform tuberculosis (TB) guidelines. However, there are no data on whether TB systematic reviews are conducted well and reported transparently. We searched four databases for reviews published between 2005 and 2010. Methodological quality was evaluated using AMSTAR and quality of reporting was assessed using PRISMA. Of 152 articles, 137 (90%) met the inclusion criteria. Only 3 of 11 AMSTAR quality items were met in most reviews: appropriate methods to combine findings (67%), comprehensive literature search (72%) and presentation of characteristics of included studies (90%). The other eight items were met in 4-53% of the reviews. Only 4% of the reviews disclosed conflicts of interest. The majority of the PRISMA items were reported in more than 60-76% of the reviews. Only nine items were reported in less than 55% of the reviews, the lowest being the full-search strategy (30%), risk of bias across studies in the Methods (27%) and Results (21%) sections, and indication of a review protocol (15%). Systematic reviews in our survey were well reported but generally of moderate to low quality. Better training, use of reporting guidelines and registration of systematic reviews could improve the quality of TB reviews.

Methodological issues in the quantitative assessment of quality of life.

PubMed

Panagiotakos, Demosthenes B; Yfantopoulos, John N

2011-10-01

The term quality of life can be identified in Aristotle's classical writings of 330 BC. In his Nichomachian ethics he recognises the multiple relationships between happiness, well-being, "eudemonia" and quality of life. Historically the concept of quality of life has undergone various interpretations. It involves personal experience, perceptions and beliefs, attitudes concerning philosophical, cultural, spiritual, psychological, political, and financial aspects of everyday living. Quality of life has been extensively used both as an outcome and an explanatory factor in relation to human health, in various clinical trials, epidemiologic studies and health interview surveys. Because of the variations in the definition of quality of life, both in theory and in practice, there are also a wide range of procedures that are used to assess quality of life. In this paper several methodological issues regarding the tools used to evaluate quality of life is discussed. In summary, the use of components consisted of large number of classes, as well as the use of specific weights for each scale component, and the low-to-moderate inter-correlation level between the components, is evident from simulated and empirical studies.

Epidemiological characteristics and methodological quality of meta-analyses on diabetes mellitus treatment: a systematic review.

PubMed

Wu, Xin Yin; Lam, Victor C K; Yu, Yue Feng; Ho, Robin S T; Feng, Ye; Wong, Charlene H L; Yip, Benjamin H K; Tsoi, Kelvin K F; Wong, Samuel Y S; Chung, Vincent C H

2016-11-01

Well-conducted meta-analyses (MAs) are considered as one of the best sources of clinical evidence for treatment decision. MA with methodological flaws may introduce bias and mislead evidence users. The aim of this study is to investigate the characteristics and methodological quality of MAs on diabetes mellitus (DM) treatments. Systematic review. Cochrane Database of Systematic Review and Database of Abstract of Reviews of Effects were searched for relevant MAs. Assessing methodological quality of systematic reviews (AMSTAR) tool was used to evaluate the methodological quality of included MAs. Logistic regression analysis was used to identify association between characteristics of MA and AMSTAR results. A total of 252 MAs including 4999 primary studies and 13,577,025 patients were included. Over half of the MAs (65.1%) only included type 2 DM patients and 160 MAs (63.5%) focused on pharmacological treatments. About 89.7% MAs performed comprehensive literature search and 89.3% provided characteristics of included studies. Included MAs generally had poor performance on the remaining AMSTAR items, especially in assessing publication bias (39.3%), providing lists of studies (19.0%) and declaring source of support comprehensively (7.5%). Only 62.7% MAs mentioned about harm of interventions. MAs with corresponding author from Asia performed less well in providing MA protocol than those from Europe. Methodological quality of MA on DM treatments was unsatisfactory. There is considerable room for improvement, especially in assessing publication bias, providing lists of studies and declaring source of support comprehensively. Also, there is an urgent need for MA authors to report treatment harm comprehensively. © 2016 European Society of Endocrinology.

Methodological Validation of Quality of Life Questionnaire for Coal Mining Groups-Indian Scenario

ERIC Educational Resources Information Center

Sen, Sayanti; Sen, Goutam; Tewary, B. K.

2012-01-01

Maslow's hierarchy-of-needs theory has been used to predict development of Quality of Life (QOL) in countries over time. In this paper an attempt has been taken to derive a methodological validation of quality of life questionnaire which have been prepared for the study area. The objective of the study is to standardize a questionnaire tool to…

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

Methodology of quality improvement projects for the Texas Medicare population.

PubMed

Pendergrass, P W; Abel, R L; Bing, M; Vaughn, R; McCauley, C

1998-07-01

The Texas Medical Foundation, the quality improvement organization for the state of Texas, develops local quality improvement projects for the Medicare population. These projects are developed as part of the Health Care Quality Improvement Program undertaken by the Health Care Financing Administration. The goal of a local quality improvement project is to collaborate with providers to identify and reduce the incidence of unintentional variations in the delivery of care that negatively impact outcomes. Two factors are critical to the success of a quality improvement project. First, as opposed to peer review that is based on implicit criteria, quality improvement must be based on explicit criteria. These criteria represent key steps in the delivery of care that have been shown to improve outcomes for a specific disease. Second, quality improvement must be performed in partnership with the health care community. As such, the health care community must play an integral role in the design and evaluation of a quality improvement project and in the design and implementation of the resulting quality improvement plan. Specifically, this article provides a historical perspective for the transition from peer review to quality improvement. It discusses key steps used in developing and implementing local quality improvement projects including topic selection, quality indicator development, collaborator recruitment, and measurement of performance/improvement. Two Texas Medical Foundation projects are described to highlight the current methodology and to illustrate the impact of quality improvement projects.

Surrogate outcomes are associated with low methodological quality of studies of rheumatoid arthritis treated with antitumour necrosis factor agents: a systematic review.

PubMed

Nobre, Moacyr Roberto Cuce; da Costa, Frnanda Marques

2012-02-01

Surrogate endpoints may be used as substitutes for, but often do not predict clinically relevant events. Objective To assess the methodological quality of articles that present their conclusions based on clinically relevant or surrogate outcomes in a systematic review of randomised trials and cohort studies of patients with rheumatoid arthritis treated with antitumour necrosis factor (TNF) agents. PubMed, Embase and Cochrane databases were searched. The Jadad score, the percentage of Consolidated Standards Of Reporting Trials (CONSORT) statement items adequately reported and levels-of-evidence (Center for Evidence-based Medicine, Oxford) were used in a descriptive synthesis. Among 88 articles appraised, 27 had surrogate endpoints, mainly radiographic, and 44 were duplicate publications; 74% of articles with surrogate and 39% of articles with clinical endpoints (p=0.006). Fewer articles with surrogate endpoints represented a high level of evidence (Level 1b, 33% vs 62%, p=0.037) and the mean percentage of CONSORT statement items met was also lower for articles with surrogate endpoints (62.5 vs 70.7, p=0.026). Although fewer articles with surrogate endpoints were randomised trials (63% vs 74%, p=0.307) and articles with surrogate endpoints had lower Jadad scores (3.0 vs 3.2, p=0.538), these differences were not statistically significant. Studies of anti-TNF agents that report surrogate outcomes are of lesser methodological quality. As such, inclusion of such studies in evidence syntheses may bias results.

Methodology for Air Quality Forecast Downscaling from Regional- to Street-Scale

NASA Astrophysics Data System (ADS)

Baklanov, Alexander; Nuterman, Roman; Mahura, Alexander; Amstrup, Bjarne; Hansen Saas, Bent; Havskov Sørensen, Jens; Lorenzen, Thomas; Weismann, Jakob

2010-05-01

The most serious air pollution events occur in cities where there is a combination of high population density and air pollution, e.g. from vehicles. The pollutants can lead to serious human health problems, including asthma, irritation of the lungs, bronchitis, pneumonia, decreased resistance to respiratory infections, and premature death. In particular air pollution is associated with increase in cardiovascular disease and lung cancer. In 2000 WHO estimated that between 2.5 % and 11 % of total annual deaths are caused by exposure to air pollution. However, European-scale air quality models are not suited for local forecasts, as their grid-cell is typically of the order of 5 to 10km and they generally lack detailed representation of urban effects. Two suites are used in the framework of the EC FP7 project MACC (Monitoring of Atmosphere Composition and Climate) to demonstrate how downscaling from the European MACC ensemble to local-scale air quality forecast will be carried out: one will illustrate capabilities for the city of Copenhagen (Denmark); the second will focus on the city of Bucharest (Romania). This work is devoted to the first suite, where methodological aspects of downscaling from regional (European/ Denmark) to urban scale (Copenhagen), and from the urban down to street scale. The first results of downscaling according to the proposed methodology are presented. The potential for downscaling of European air quality forecasts by operating urban and street-level forecast models is evaluated. This will bring a strong support for continuous improvement of the regional forecast modelling systems for air quality in Europe, and underline clear perspectives for the future regional air quality core and downstream services for end-users. At the end of the MACC project, requirements on "how-to-do" downscaling of European air-quality forecasts to the city and street levels with different approaches will be formulated.

A methodology for space-time classification of groundwater quality.

PubMed

Passarella, G; Caputo, M C

2006-04-01

Safeguarding groundwater from civil, agricultural and industrial contamination is matter of great interest in water resource management. During recent years, much legislation has been produced stating the importance of groundwater as a source for drinking water supplies, underlining its vulnerability and defining the required quality standards. Thus, schematic tools, able to characterise the quality and quantity of groundwater systems, are of very great interest in any territorial planning and/or water resource management activity. This paper proposes a groundwater quality classification method which has been applied to a real aquifer, starting from several studies published by the Italian National Hydrogeologic Catastrophe Defence Group (GNDCI). The methodology is based on the concentration values of several parameters used as indexes of the natural hydro-chemical water condition and of potential man-induced modifications of groundwater quality. The resulting maps, although representative of the quality, do not include any information on its evolution in time. In this paper, this "stationary" classification method has been improved by crossing the quality classes with three indexes of temporal behaviour during recent years. It was then applied to data from monitoring campaigns, performed in spring and autumn, from 1990 to 1996, in the plain of Modena aquifer (central Italy). The results are reported in the form of space-time classification table and maps.

Methodological and Reporting Quality of Systematic Reviews and Meta-analyses in Endodontics.

PubMed

Nagendrababu, Venkateshbabu; Pulikkotil, Shaju Jacob; Sultan, Omer Sheriff; Jayaraman, Jayakumar; Peters, Ove A

2018-06-01

The aim of this systematic review (SR) was to evaluate the quality of SRs and meta-analyses (MAs) in endodontics. A comprehensive literature search was conducted to identify relevant articles in the electronic databases from January 2000 to June 2017. Two reviewers independently assessed the articles for eligibility and data extraction. SRs and MAs on interventional studies with a minimum of 2 therapeutic strategies in endodontics were included in this SR. Methodologic and reporting quality were assessed using A Measurement Tool to Assess Systematic Reviews (AMSTAR) and Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA), respectively. The interobserver reliability was calculated using the Cohen kappa statistic. Statistical analysis with the level of significance at P < .05 was performed using Kruskal-Wallis tests and simple linear regression analysis. A total of 30 articles were selected for the current SR. Using AMSTAR, the item related to the scientific quality of studies used in conclusion was adhered by less than 40% of studies. Using PRISMA, 3 items were reported by less than 40% of studies, which were on objectives, protocol registration, and funding. No association was evident comparing the number of authors and country with quality. Statistical significance was observed when quality was compared among journals, with studies published as Cochrane reviews superior to those published in other journals. AMSTAR and PRISMA scores were significantly related. SRs in endodontics showed variability in both methodologic and reporting quality. Copyright © 2018 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

[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.

Methodological Quality Assessment of Meta-Analyses and Systematic Reviews of Probiotics in Inflammatory Bowel Disease and Pouchitis.

PubMed

Dong, Jinpei; Teng, Guigen; Wei, Tiantong; Gao, Wen; Wang, Huahong

2016-01-01

Probiotics are widely used for the induction and maintenance of remission in inflammatory bowel disease (IBD) and pouchitis. There are a large number of meta-analyses (MAs)/ systematic reviews (SRs) on this subject, the methodological quality of which has not been evaluated. This study aimed to evaluate the methodological quality of and summarize the evidence obtained from MAs/SRs of probiotic treatments for IBD and pouchitis patients. The PubMed, EMBASE, Cochrane Library and China National Knowledge Infrastructure (CNKI) databases were searched to identify Chinese and English language MAs/SRs of the use of probiotics for IBD and pouchitis. The Assessment of Multiple Systematic Reviews (AMSTAR) scale was used to assess the methodological quality of the studies. A total of 36 MAs/SRs were evaluated. The AMSTAR scores of the included studies ranged from 1 to 10, and the average score was 5.81. According to the Canadian Agency for Drugs and Technologies in Health, 4 articles were classified as high quality, 24 articles were classified as moderate quality, and 8 articles were classified as low quality. Most of the MAs/SRs suggested that probiotics had potential benefits for patients with ulcerative colitis (UC), but failed to show effectiveness in the induction and maintenance of remission in Crohn's disease (CD). The probiotic preparation VSL#3 may play a beneficial role in pouchitis. The overall methodological quality of the current MAs/SRs in the field of probiotics for IBD and pouchitis was found to be low to moderate. More MAs/SRs of high quality are required to support using probiotics to treat IBD and pouchitis.

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

Methodological quality of systematic reviews referenced in clinical practice guidelines for the treatment of opioid use disorder.

PubMed

Ross, Andrew; Rankin, Justin; Beaman, Jason; Murray, Kelly; Sinnett, Philip; Riddle, Ross; Haskins, Jordan; Vassar, Matt

2017-01-01

With efforts to combat opioid use disorder, there is an increased interest in clinical practice guidelines (CPGs) for opioid use disorder treatments. No literature exists examining the quality of systematic reviews used in opioid use disorder CPGs. This study aims to describe the methodological quality and reporting clarity of systematic reviews (SRs) used to create CPGs for opioid use disorder. From June to July 2016 guideline clearinghouses and medical literature databases were searched for relevant CPGs used in the treatment of opioid use disorder. Included CPGs must have been recognized by a national organization. SRs from the reference section of each CPG was scored by using AMSTAR (a measurement tool to assess the methodological quality of systematic reviews) tool and PRISMA (preferred reporting items for systematic reviews and meta-analyses) checklist. Seventeen CPGs from 2006-2016 were included in the review. From these, 57 unique SRs were extracted. SRS comprised 0.28% to 17.92% of all references found in the CPGs. All SRs obtained moderate or high methodological quality score on the AMSTAR tool. All reviews met at least 70% of PRISMA criteria. In PRISMA, underperforming areas included accurate title labeling, protocol registration, and risk of bias. Underperforming areas in AMSTAR included conflicts of interest, funding, and publication bias. A positive correlation was found between AMSTAR and PRISMA scores (r = .79). Although the SRs in the CPGs were of good quality, there are still areas for improvement. Systematic reviewers should consult PRISMA and AMSTAR when conducting and reporting reviews. It is important for CPG developers to consider methodological quality as a factor when developing CPG recommendations, recognizing that the quality of systematic reviews underpinning guidelines does not necessarily correspond to the quality of the guideline itself.

The methodological quality of systematic reviews published in high-impact nursing journals: a review of the literature.

PubMed

Pölkki, Tarja; Kanste, Outi; Kääriäinen, Maria; Elo, Satu; Kyngäs, Helvi

2014-02-01

To analyse systematic review articles published in the top 10 nursing journals to determine the quality of the methods employed within them. Systematic review is defined as a scientific research method that synthesises high-quality scientific knowledge on a given topic. The number of such reviews in nursing science has increased dramatically during recent years, but their methodological quality has not previously been assessed. A review of the literature using a narrative approach. Ranked impact factor scores for nursing journals were obtained from the Journal Citation Report database of the Institute of Scientific Information (ISI Web of Knowledge). All issues from the years 2009 and 2010 of the top 10 ranked journals were included. CINAHL and MEDLINE databases were searched to locate studies using the search terms 'systematic review' and 'systematic literature review'. A total of 39 eligible studies were identified. Their methodological quality was evaluated through the specific criteria of quality assessment, description of synthesis and strengths and weaknesses reported in the included studies. Most of the eligible systematic reviews included several different designs or types of quantitative study. The majority included a quality assessment, and a total of 17 different criteria were identified. The method of synthesis was mentioned in about half of the reviews, the most common being narrative synthesis. The weaknesses of reviews were discussed, while strengths were rarely highlighted. The methodological quality of the systematic reviews examined varied considerably, although they were all published in nursing journals with a high-impact factor. Despite the fact that systematic reviews are considered the most robust source of research evidence, they vary in methodological quality. This point is important to consider in clinical practice when applying the results to patient care. © 2013 Blackwell Publishing Ltd.

Region 10: Idaho Northern Ada County Adequate Letter (6/21/2013)

EPA Pesticide Factsheets

EPA approves motor vehicle emissions budget in the Northern Ada County PM10 State Implementation Plan, Maintenance Plan: Ten-Year Update for PM10 national ambient air quality standard, adequate for transportation conformity purposes.

The reporting characteristics and methodological quality of Cochrane reviews about health policy research.

PubMed

Xiu-xia, Li; Ya, Zheng; Yao-long, Chen; Ke-hu, Yang; Zong-jiu, Zhang

2015-04-01

The systematic review has increasingly become a popular tool for researching health policy. However, due to the complexity and diversity in the health policy research, it has also encountered more challenges. We set out the Cochrane reviews on health policy research as a representative to provide the first examination of epidemiological and descriptive characteristics as well as the compliance of methodological quality with the AMSTAR. 99 reviews were included by inclusion criteria, 73% of which were Implementation Strategies, 15% were Financial Arrangements and 12% were Governance Arrangements; involved Public Health (34%), Theoretical Exploration (18%), Hospital Management (17%), Medical Insurance (12%), Pharmaceutical Policy (9%), Community Health (7%) and Rural Health (2%). Only 39% conducted meta-analysis, and 49% reported being updates, and none was rated low methodological quality. Our research reveals that the quantity and quality of the evidence should be improved, especially Financial Arrangements and Governance Arrangements involved Rural Health, Health Care Reform and Health Equity, etc. And the reliability of AMSTAR needs to be tested in larger range in this field. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

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.

Are the defined substrate-based methods adequate to determine the microbiological quality of natural recreational waters?

PubMed

Valente, Marta Sofia; Pedro, Paulo; Alonso, M Carmen; Borrego, Juan J; Dionísio, Lídia

2010-03-01

Monitoring the microbiological quality of water used for recreational activities is very important to human public health. Although the sanitary quality of recreational marine waters could be evaluated by standard methods, they are time-consuming and need confirmation. For these reasons, faster and more sensitive methods, such as the defined substrate-based technology, have been developed. In the present work, we have compared the standard method of membrane filtration using Tergitol-TTC agar for total coliforms and Escherichia coli, and Slanetz and Bartley agar for enterococci, and the IDEXX defined substrate technology for these faecal pollution indicators to determine the microbiological quality of natural recreational waters. ISO 17994:2004 standard was used to compare these methods. The IDEXX for total coliforms and E. coli, Colilert, showed higher values than those obtained by the standard method. Enterolert test, for the enumeration of enterococci, showed lower values when compared with the standard method. It may be concluded that more studies to evaluate the precision and accuracy of the rapid tests are required in order to apply them for routine monitoring of marine and freshwater recreational bathing areas. The main advantages of these methods are that they are more specific, feasible and simpler than the standard methodology.

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…

42 CFR 438.207 - Assurances of adequate capacity and services.

Code of Federal Regulations, 2010 CFR

2010-10-01

... HUMAN SERVICES (CONTINUED) MEDICAL ASSISTANCE PROGRAMS MANAGED CARE Quality Assessment and Performance Improvement Access Standards § 438.207 Assurances of adequate capacity and services. (a) Basic rule. The State... with the State's requirements for availability of services, as set forth in § 438.206. (e) CMS' right...

Evolution of the methodological quality of controlled clinical trials for myofascial trigger point treatments for the period 1978-2015: A systematic review.

PubMed

Stoop, Rahel; Clijsen, Ron; Leoni, Diego; Soldini, Emiliano; Castellini, Greta; Redaelli, Valentina; Barbero, Marco

2017-08-01

The methodological quality of controlled clinical trials (CCTs) of physiotherapeutic treatment modalities for myofascial trigger points (MTrP) has not been investigated yet. To detect the methodological quality of CCTs for physiotherapy treatments of MTrPs and demonstrating the possible increase over time. Systematic review. A systematic search was conducted in two databases, Physiotherapy Evidence Database (PEDro) and Medicine Medical Literature Analysis and Retrieval System online (MEDLINE), using the same keywords and selection procedure corresponding to pre-defined inclusion criteria. The methodological quality, assessed by the 11-item PEDro scale, served as outcome measure. The CCTs had to compare at least two interventions, where one intervention had to lay within the scope of physiotherapy. Participants had to be diagnosed with myofascial pain syndrome or trigger points (active or latent). A total of n = 230 studies was analysed. The cervico-thoracic region was the most frequently treated body part (n = 143). Electrophysical agent applications was the most frequent intervention. The average methodological quality reached 5.5 on the PEDro scale. A total of n = 6 studies scored the value of 9. The average PEDro score increased by 0.7 points per decade between 1978 and 2015. The average PEDro score of CCTs for MTrP treatments does not reach the cut-off of 6 proposed for moderate to high methodological quality. Nevertheless, a promising trend towards an increase of the average methodological quality of CCTs for MTrPs was recorded. More high-quality CCT studies with thorough research procedures are recommended to enhance methodological quality. Copyright © 2017 The Author(s). Published by Elsevier Ltd.. All rights reserved.

Translating Oral Health-Related Quality of Life Measures: Are There Alternative Methodologies?

ERIC Educational Resources Information Center

Brondani, Mario; He, Sarah

2013-01-01

Translating existing sociodental indicators to another language involves a rigorous methodology, which can be costly. Free-of-charge online translator tools are available, but have not been evaluated in the context of research involving quality of life measures. To explore the value of using online translator tools to develop oral health-related…

Identifying approaches for assessing methodological and reporting quality of systematic reviews: a descriptive study.

PubMed

Pussegoda, Kusala; Turner, Lucy; Garritty, Chantelle; Mayhew, Alain; Skidmore, Becky; Stevens, Adrienne; Boutron, Isabelle; Sarkis-Onofre, Rafael; Bjerre, Lise M; Hróbjartsson, Asbjørn; Altman, Douglas G; Moher, David

2017-06-19

The methodological quality and completeness of reporting of the systematic reviews (SRs) is fundamental to optimal implementation of evidence-based health care and the reduction of research waste. Methods exist to appraise SRs yet little is known about how they are used in SRs or where there are potential gaps in research best-practice guidance materials. The aims of this study are to identify reports assessing the methodological quality (MQ) and/or reporting quality (RQ) of a cohort of SRs and to assess their number, general characteristics, and approaches to 'quality' assessment over time. The Cochrane Library, MEDLINE®, and EMBASE® were searched from January 1990 to October 16, 2014, for reports assessing MQ and/or RQ of SRs. Title, abstract, and full-text screening of all reports were conducted independently by two reviewers. Reports assessing the MQ and/or RQ of a cohort of ten or more SRs of interventions were included. All results are reported as frequencies and percentages of reports. Of 20,765 unique records retrieved, 1189 of them were reviewed for full-text review, of which 76 reports were included. Eight previously published approaches to assessing MQ or reporting guidelines used as proxy to assess RQ were used in 80% (61/76) of identified reports. These included two reporting guidelines (PRISMA and QUOROM) and five quality assessment tools (AMSTAR, R-AMSTAR, OQAQ, Mulrow, Sacks) and GRADE criteria. The remaining 24% (18/76) of reports developed their own criteria. PRISMA, OQAQ, and AMSTAR were the most commonly used published tools to assess MQ or RQ. In conjunction with other approaches, published tools were used in 29% (22/76) of reports, with 36% (8/22) assessing adherence to both PRISMA and AMSTAR criteria and 26% (6/22) using QUOROM and OQAQ. The methods used to assess quality of SRs are diverse, and none has become universally accepted. The most commonly used quality assessment tools are AMSTAR, OQAQ, and PRISMA. As new tools and guidelines are

Systematic Review of the Application of Lean and Six Sigma Quality Improvement Methodologies in Radiology.

PubMed

Amaratunga, Thelina; Dobranowski, Julian

2016-09-01

Preventable yet clinically significant rates of medical error remain systemic, while health care spending is at a historic high. Industry-based quality improvement (QI) methodologies show potential for utility in health care and radiology because they use an empirical approach to reduce variability and improve workflow. The aim of this review was to systematically assess the literature with regard to the use and efficacy of Lean and Six Sigma (the most popular of the industrial QI methodologies) within radiology. MEDLINE, the Allied & Complementary Medicine Database, Embase Classic + Embase, Health and Psychosocial Instruments, and the Ovid HealthStar database, alongside the Cochrane Library databases, were searched on June 2015. Empirical studies in peer-reviewed journals were included if they assessed the use of Lean, Six Sigma, or Lean Six Sigma with regard to their ability to improve a variety of quality metrics in a radiology-centered clinical setting. Of the 278 articles returned, 23 studies were suitable for inclusion. Of these, 10 assessed Six Sigma, 7 assessed Lean, and 6 assessed Lean Six Sigma. The diverse range of measured outcomes can be organized into 7 common aims: cost savings, reducing appointment wait time, reducing in-department wait time, increasing patient volume, reducing cycle time, reducing defects, and increasing staff and patient safety and satisfaction. All of the included studies demonstrated improvements across a variety of outcomes. However, there were high rates of systematic bias and imprecision as per the Grading of Recommendations Assessment, Development and Evaluation guidelines. Lean and Six Sigma QI methodologies have the potential to reduce error and costs and improve quality within radiology. However, there is a pressing need to conduct high-quality studies in order to realize the true potential of these QI methodologies in health care and radiology. Recommendations on how to improve the quality of the literature are proposed

Implications of the Integration of Computing Methodologies into Conventional Marketing Research upon the Quality of Students' Understanding of the Concept

ERIC Educational Resources Information Center

Ayman, Umut; Serim, Mehmet Cenk

2004-01-01

It has been an ongoing concern among academicians teaching social sciences to develop a better methodology to ease understanding of students. Since verbal emphasis is at the core of the concepts within such disciplines it has been observed that the adequate or desired level of conceptual understanding of the students to transforms the theories…

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 quality of randomized controlled trials of spinal manipulation and mobilization in tension-type headache, migraine, and cervicogenic headache.

PubMed

Fernández-de-las-Peñas, César; Alonso-Blanco, Cristina; San-Roman, Jesús; Miangolarra-Page, Juan C

2006-03-01

Literature review of quality of clinical trials. To determine the methodological quality of published randomized controlled trials that used spinal manipulation and/or mobilization to treat patients with tension-type headache (TTH), cervicogenic headache (CeH), and migraine (M) in the last decade. TTH, CeH, and M are the most prevalent types of headaches seen in adults. Individuals who have headaches frequently use physical therapy, manual therapy, or chiropractic care. Randomized controlled trials are considered an optimal method with which to assess the efficacy of any intervention. Computerized literature searches were performed in MEDLINE, EMBASE, COCHRANE, AMED, MANTIS, CINHAL, and PEDro databases. Randomized controlled trials in which spinal manipulation and/or mobilization had been used for TTH, CeH, and M published in a peer-reviewed journal as full text, and with at least 1 clinically relevant outcome measure (ie, headache intensity, duration, or frequency) were reviewed. The methodological quality of the studies was assessed independently by 2 reviewers using a set of predefined criteria. Only 8 studies met all the inclusion criteria. One clinical trial evaluated spinal manipulation and mobilization together, and the remaining 7 assessed spinal manipulative therapy. No controlled trials analyzing exclusively the effects of spinal mobilization were found. Methodological scores ranged from 35 to 56 points out of a theoretical maximum of 100 points, indicating an overall poor methodology of the studies. Only 2 studies obtained a high-quality score (greater than 50 points). No significant differences in quality scores were found based on the type of headache investigated. Methodological quality was not associated with the year of publication (before 2000, or later) nor with the results (positive, neutral, negative) reported in the studies. The most common flaws were a small sample size, the absence of a placebo control group, lack of blinded patients, and no

Approaches and Methodological As Well As Interpretative Issues in Quality of Life Research in Malaysia

PubMed Central

Hasanah, C. I.

2003-01-01

Quality of life measures are designed to enable patients’ perspectives on the impact of health and healthcare interventions on their lives to be assessed and taken into account in clinical decision-making and research. This paper discusses some approaches, methodological as well as interpretative issues of health related quality of life research. PMID:23386798

Use of methodological tools for assessing the quality of studies in periodontology and implant dentistry: a systematic review.

PubMed

Faggion, Clovis M; Huda, Fahd; Wasiak, Jason

2014-06-01

To evaluate the methodological approaches used to assess the quality of studies included in systematic reviews (SRs) in periodontology and implant dentistry. Two electronic databases (PubMed and Cochrane Database of Systematic Reviews) were searched independently to identify SRs examining interventions published through 2 September 2013. The reference lists of included SRs and records of 10 specialty dental journals were searched manually. Methodological approaches were assessed using seven criteria based on the Cochrane Handbook for Systematic Reviews of Interventions. Temporal trends in methodological quality were also explored. Of the 159 SRs with meta-analyses included in the analysis, 44 (28%) reported the use of domain-based tools, 15 (9%) reported the use of checklists and 7 (4%) reported the use of scales. Forty-two (26%) SRs reported use of more than one tool. Criteria were met heterogeneously; authors of 15 (9%) publications incorporated the quality of evidence of primary studies into SRs, whereas 69% of SRs reported methodological approaches in the Materials/Methods section. Reporting of four criteria was significantly better in recent (2010-2013) than in previous publications. The analysis identified several methodological limitations of approaches used to assess evidence in studies included in SRs in periodontology and implant dentistry. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

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...

Systematic review of the methodological and reporting quality of case series in surgery.

PubMed

Agha, R A; Fowler, A J; Lee, S-Y; Gundogan, B; Whitehurst, K; Sagoo, H K; Jeong, K J L; Altman, D G; Orgill, D P

2016-09-01

Case series are an important and common study type. No guideline exists for reporting case series and there is evidence of key data being missed from such reports. The first step in the process of developing a methodologically sound reporting guideline is a systematic review of literature relevant to the reporting deficiencies of case series. A systematic review of methodological and reporting quality in surgical case series was performed. The electronic search strategy was developed by an information specialist and included MEDLINE, Embase, Cochrane Methods Register, Science Citation Index and Conference Proceedings Citation index, from the start of indexing to 5 November 2014. Independent screening, eligibility assessments and data extraction were performed. Included articles were then analysed for five areas of deficiency: failure to use standardized definitions, missing or selective data (including the omission of whole cases or important variables), transparency or incomplete reporting, whether alternative study designs were considered, and other issues. Database searching identified 2205 records. Through the process of screening and eligibility assessments, 92 articles met inclusion criteria. Frequencies of methodological and reporting issues identified were: failure to use standardized definitions (57 per cent), missing or selective data (66 per cent), transparency or incomplete reporting (70 per cent), whether alternative study designs were considered (11 per cent) and other issues (52 per cent). The methodological and reporting quality of surgical case series needs improvement. The data indicate that evidence-based guidelines for the conduct and reporting of case series may be useful. © 2016 BJS Society Ltd Published by John Wiley & Sons Ltd.

State Implementation Plans (SIP): Submissions that EPA has Found Adequate or Inadequate

EPA Pesticide Factsheets

EPA/OTAQ’s State and Local Transportation Resources are for air quality and transportation government and community leaders. Information on state implementation plans (SIPs) that EPA has found either adequate or inadequate is provided here.

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

Methodology and guidelines for regulating traffic flows under air quality constraints in metropolitan areas.

DOT National Transportation Integrated Search

2010-02-01

This project developed a methodology to couple a new pollutant dispersion model with a traffic : assignment process to contain air pollution while maximizing mobility. The overall objective of the air : quality modeling part of the project is to deve...

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 ...

Methodology and reporting quality of reporting guidelines: systematic review.

PubMed

Wang, Xiaoqin; Chen, Yaolong; Yang, Nan; Deng, Wei; Wang, Qi; Li, Nan; Yao, Liang; Wei, Dang; Chen, Gen; Yang, Kehu

2015-09-22

With increasing attention put on the methodology of reporting guidelines, Moher et al. conducted a review of reporting guidelines up to December 2009. Information gaps appeared on many aspects. Therefore, in 2010, the Guidance for Developers of Health Research Reporting Guidelines was developed. With more than four years passed and a considerable investment was put into reporting guideline development, a large number of new, updated, and expanded reporting guidelines have become available since January 2010. We aimed to systematically review the reporting guidelines published since January 2010, and investigate the application of the Guidance. We systematically searched databases including the Cochrane Methodology Register, MEDLINE, and EMBASE, and retrieved EQUATOR and the website (if available) to find reporting guidelines as well as their accompanying documents. We screened the titles and abstracts resulting from searches and extracted data. We focused on the methodology and reporting of the included guidelines, and described information with a series of tables and narrative summaries. Data were summarized descriptively using frequencies, proportions, and medians as appropriate. Twenty-eight and 32 reporting guidelines were retrieved from databases and EQUATOR network, respectively. Reporting guidelines were designed for a broad spectrum of types of research. A considerable number of reporting guidelines were published and updated in recent years. Methods of initial items were given in 45 (75%) guidelines. Thirty-eight (63%) guidelines reported they have reached consensus, and 35 (58%) described their consensus methods. Only 9 (15%) guidelines followed the Guidance. Only few guidelines were developed complying with the Guidance. More attention should be paid to the quality of reporting guidelines.

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

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.

Methodologic quality of meta-analyses and systematic reviews on the Mediterranean diet and cardiovascular disease outcomes: a review.

PubMed

Huedo-Medina, Tania B; Garcia, Marissa; Bihuniak, Jessica D; Kenny, Anne; Kerstetter, Jane

2016-03-01

Several systematic reviews/meta-analyses published within the past 10 y have examined the associations of Mediterranean-style diets (MedSDs) on cardiovascular disease (CVD) risk. However, these reviews have not been evaluated for satisfying contemporary methodologic quality standards. This study evaluated the quality of recent systematic reviews/meta-analyses on MedSD and CVD risk outcomes by using an established methodologic quality scale. The relation between review quality and impact per publication value of the journal in which the article had been published was also evaluated. To assess compliance with current standards, we applied a modified version of the Assessment of Multiple Systematic Reviews (AMSTARMedSD) quality scale to systematic reviews/meta-analyses retrieved from electronic databases that had met our selection criteria: 1) used systematic or meta-analytic procedures to review the literature, 2) examined MedSD trials, and 3) had MedSD interventions independently or combined with other interventions. Reviews completely satisfied from 8% to 75% of the AMSTARMedSD items (mean ± SD: 31.2% ± 19.4%), with those published in higher-impact journals having greater quality scores. At a minimum, 60% of the 24 reviews did not disclose full search details or apply appropriate statistical methods to combine study findings. Only 5 of the reviews included participant or study characteristics in their analyses, and none evaluated MedSD diet characteristics. These data suggest that current meta-analyses/systematic reviews evaluating the effect of MedSD on CVD risk do not fully comply with contemporary methodologic quality standards. As a result, there are more research questions to answer to enhance our understanding of how MedSD affects CVD risk or how these effects may be modified by the participant or MedSD characteristics. To clarify the associations between MedSD and CVD risk, future meta-analyses and systematic reviews should not only follow methodologic

Methodological quality and implications for practice of systematic Cochrane reviews in pediatric oral health: a critical assessment

PubMed Central

2014-01-01

Background To ensure evidence-based decision-making in pediatric oral health, Cochrane systematic reviews that address topics pertinent to this field are necessary. We aimed to identify all systematic reviews of paediatric dentistry and oral health by the Cochrane Oral Health Group (COHG), summarize their characteristics and assess their methodological quality. Our second objective was to assess implications for practice in the review conclusions and provide an overview of clinical implications about the usefulness of paediatric oral health interventions in practice. Methods We conducted a methodological survey including all paediatric dentistry reviews from the COHG. We extracted data on characteristics of included reviews, then assessed the methodological quality using a validated 11-item quality assessment tool (AMSTAR). Finally, we coded each review to indicate whether its authors concluded that an intervention should be implemented in practice, was not supported or was refuted by the evidence, or should be used only in research (inconclusive evidence). Results We selected 37 reviews; most concerned the prevention of caries. The methodological quality was high, except for the assessment of reporting bias. In 7 reviews (19%), the research showed that benefits outweighed harms; in 1, the experimental intervention was found ineffective; and in 29 (78%), evidence was insufficient to assess benefits and harms. In the 7 reviews, topical fluoride treatments (with toothpaste, gel or varnish) were found effective for permanent and deciduous teeth in children and adolescents, and sealants for occlusal tooth surfaces of permanent molars. Conclusions Cochrane reviews of paediatric dentistry were of high quality. They provided strong evidence that topical fluoride treatments and sealants are effective for children and adolescents and thus should be implemented in practice. However, a substantial number of reviews yielded inconclusive evidence. PMID:24716532

[A Methodological Quality Assessment of South Korean Nursing Research using Structural Equation Modeling in South Korea].

PubMed

Kim, Jung-Hee; Shin, Sujin; Park, Jin-Hwa

2015-04-01

The purpose of this study was to evaluate the methodological quality of nursing studies using structural equation modeling in Korea. Databases of KISS, DBPIA, and National Assembly Library up to March 2014 were searched using the MeSH terms 'nursing', 'structure', 'model'. A total of 152 studies were screened. After removal of duplicates and non-relevant titles, 61 papers were read in full. Of the sixty-one articles retrieved, 14 studies were published between 1992 and 2000, 27, between 2001 and 2010, and 20, between 2011 and March 2014. The methodological quality of the review examined varied considerably. The findings of this study suggest that more rigorous research is necessary to address theoretical identification, two indicator rule, distribution of sample, treatment of missing values, mediator effect, discriminant validity, convergent validity, post hoc model modification, equivalent models issues, and alternative models issues should be undergone. Further research with robust consistent methodological study designs from model identification to model respecification is needed to improve the validity of the research.

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

Review and evaluation of the methodological quality of the existing guidelines and recommendations for inherited neurometabolic disorders.

PubMed

Cassis, Linda; Cortès-Saladelafont, Elisenda; Molero-Luis, Marta; Yubero, Delia; González, Maria Julieta; Ormazábal, Aida; Fons, Carme; Jou, Cristina; Sierra, Cristina; Castejon Ponce, Esperanza; Ramos, Federico; Armstrong, Judith; O'Callaghan, M Mar; Casado, Mercedes; Montero, Raquel; Meavilla-Olivas, Silvia; Artuch, Rafael; Barić, Ivo; Bartoloni, Franco; Bellettato, Cinzia Maria; Bonifazi, Fedele; Ceci, Adriana; Cvitanović-Šojat, Ljerka; Dali, Christine I; D'Avanzo, Francesca; Fumic, Ksenija; Giannuzzi, Viviana; Lampe, Christina; Scarpa, Maurizio; Garcia-Cazorla, Ángels

2015-12-30

Inherited neurometabolic disorders (iNMDs) represent a group of almost seven hundred rare diseases whose common manifestations are clinical neurologic or cognitive symptoms that can appear at any time, in the first months/years of age or even later in adulthood. Early diagnosis and timely treatments are often pivotal for the favorable course of the disease. Thus, the elaboration of new evidence-based recommendations for iNMD diagnosis and management is increasingly requested by health care professionals and patients, even though the methodological quality of existing guidelines is largely unclear. InNerMeD-I-Network is the first European network on iNMDs that was created with the aim of sharing and increasing validated information about diagnosis and management of neurometabolic disorders. One of the goals of the project was to determine the number and the methodological quality of existing guidelines and recommendations for iNMDs. We performed a systematic search on PubMed, the National Guideline Clearinghouse (NGC), the Guidelines International Network (G-I-N), the Scottish Intercollegiate Guideline Network (SIGN) and the National Institute for Health and Care Excellence (NICE) to identify all the published guidelines and recommendations for iNMDs from January 2000 to June 2015. The methodological quality of the selected documents was determined using the AGREE II instrument, an appraisal tool composed of 6 domains covering 23 key items. A total of 55 records met the inclusion criteria, 11 % were about groups of disorders, whereas the majority encompassed only one disorder. Lysosomal disorders, and in particular Fabry, Gaucher disease and mucopolysaccharidoses where the most studied. The overall methodological quality of the recommendation was acceptable and increased over time, with 25 % of the identified guidelines strongly recommended by the appraisers, 64 % recommended, and 11 % not recommended. However, heterogeneity in the obtained scores for each domain

School-Based Methylphenidate Placebo Protocols: Methodological and Practical Issues.

ERIC Educational Resources Information Center

Hyman, Irwin A.; Wojtowicz, Alexandra; Lee, Kee Duk; Haffner, Mary Elizabeth; Fiorello, Catherine A.; And Others

1998-01-01

Focuses on methodological issues involved in choosing instruments to monitor behavior, once a comprehensive evaluation has suggested trials on Ritalin. Case examples illustrate problems of teacher compliance in filling out measures, supplying adequate placebos, and obtaining physical cooperation. Emerging school-based methodologies are discussed…

Evaluation of AMSTAR to assess the methodological quality of systematic reviews in overviews of reviews of healthcare interventions.

PubMed

Pollock, Michelle; Fernandes, Ricardo M; Hartling, Lisa

2017-03-23

Overviews of reviews (overviews) compile information from multiple systematic reviews (SRs) to provide a single synthesis of relevant evidence for decision-making. It is recommended that authors assess and report the methodological quality of SRs in overviews-for example, using A MeaSurement Tool to Assess systematic Reviews (AMSTAR). Currently, there is variation in whether and how overview authors assess and report SR quality, and limited guidance is available. Our objectives were to: examine methodological considerations involved in using AMSTAR to assess the quality of Cochrane and non-Cochrane SRs in overviews of healthcare interventions; identify challenges (and develop potential decision rules) when using AMSTAR in overviews; and examine the potential impact of considering methodological quality when making inclusion decisions in overviews. We selected seven overviews of healthcare interventions and included all SRs meeting each overview's inclusion criteria. For each SR, two reviewers independently conducted AMSTAR assessments with consensus and discussed challenges encountered. We also examined the correlation between AMSTAR assessments and SR results/conclusions. Ninety-five SRs were included (30 Cochrane, 65 non-Cochrane). Mean AMSTAR assessments (9.6/11 vs. 5.5/11; p < 0.001) and inter-rater reliability (AC1 statistic: 0.84 vs. 0.69; "almost perfect" vs. "substantial" using the Landis & Koch criteria) were higher for Cochrane compared to non-Cochrane SRs. Four challenges were identified when applying AMSTAR in overviews: the scope of the SRs and overviews often differed; SRs examining similar topics sometimes made different methodological decisions; reporting of non-Cochrane SRs was sometimes poor; and some non-Cochrane SRs included other SRs as well as primary studies. Decision rules were developed to address each challenge. We found no evidence that AMSTAR assessments were correlated with SR results/conclusions. Results indicate that the AMSTAR

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.

A Call for a New National Norming Methodology.

ERIC Educational Resources Information Center

Ligon, Glynn; Mangino, Evangelina

Issues related to achieving adequate national norms are reviewed, and a new methodology is proposed that would work to provide a true measure of national achievement levels on an annual basis and would enable reporting results in current-year norms. Statistical methodology and technology could combine to create a national norming process that…

Methodological Advances in the Study of Self-Concept.

ERIC Educational Resources Information Center

Schwartz, Terrence J.

Critical review of previous techniques for the measurement of an individual's self-concept (SC) is a necessary prelude to the development of more adequate methodologies. This paper focuses on recent methodological innovations in the study of the self, namely, those derived from cognitive social psychology. A view of the self as a cognitive…

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.

Rating the methodological quality in systematic reviews of studies on measurement properties: a scoring system for the COSMIN checklist.

PubMed

Terwee, Caroline B; Mokkink, Lidwine B; Knol, Dirk L; Ostelo, Raymond W J G; Bouter, Lex M; de Vet, Henrica C W

2012-05-01

The COSMIN checklist is a standardized tool for assessing the methodological quality of studies on measurement properties. It contains 9 boxes, each dealing with one measurement property, with 5-18 items per box about design aspects and statistical methods. Our aim was to develop a scoring system for the COSMIN checklist to calculate quality scores per measurement property when using the checklist in systematic reviews of measurement properties. The scoring system was developed based on discussions among experts and testing of the scoring system on 46 articles from a systematic review. Four response options were defined for each COSMIN item (excellent, good, fair, and poor). A quality score per measurement property is obtained by taking the lowest rating of any item in a box ("worst score counts"). Specific criteria for excellent, good, fair, and poor quality for each COSMIN item are described. In defining the criteria, the "worst score counts" algorithm was taken into consideration. This means that only fatal flaws were defined as poor quality. The scores of the 46 articles show how the scoring system can be used to provide an overview of the methodological quality of studies included in a systematic review of measurement properties. Based on experience in testing this scoring system on 46 articles, the COSMIN checklist with the proposed scoring system seems to be a useful tool for assessing the methodological quality of studies included in systematic reviews of measurement properties.

Quality and Safety Aspects of Cereals (Wheat) and Their Products.

PubMed

Varzakas, Theo

2016-11-17

Cereals and, most specifically, wheat are described in this chapter highlighting on their safety and quality aspects. Moreover, wheat quality aspects are adequately addressed since they are used to characterize dough properties and baking quality. Determination of dough properties is also mentioned and pasta quality is also described in this chapter. Chemometrics-multivariate analysis is one of the analyses carried out. Regarding production weighing/mixing of flours, kneading, extruded wheat flours, and sodium chloride are important processing steps/raw materials used in the manufacturing of pastry products. Staling of cereal-based products is also taken into account. Finally, safety aspects of cereal-based products are well documented with special emphasis on mycotoxins, acrylamide, and near infrared methodology.

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.

Reporting and methodological quality of survival analysis in articles published in Chinese oncology journals.

PubMed

Zhu, Xiaoyan; Zhou, Xiaobin; Zhang, Yuan; Sun, Xiao; Liu, Haihua; Zhang, Yingying

2017-12-01

Survival analysis methods have gained widespread use in the filed of oncology. For achievement of reliable results, the methodological process and report quality is crucial. This review provides the first examination of methodological characteristics and reporting quality of survival analysis in articles published in leading Chinese oncology journals.To examine methodological and reporting quality of survival analysis, to identify some common deficiencies, to desirable precautions in the analysis, and relate advice for authors, readers, and editors.A total of 242 survival analysis articles were included to be evaluated from 1492 articles published in 4 leading Chinese oncology journals in 2013. Articles were evaluated according to 16 established items for proper use and reporting of survival analysis.The application rates of Kaplan-Meier, life table, log-rank test, Breslow test, and Cox proportional hazards model (Cox model) were 91.74%, 3.72%, 78.51%, 0.41%, and 46.28%, respectively, no article used the parametric method for survival analysis. Multivariate Cox model was conducted in 112 articles (46.28%). Follow-up rates were mentioned in 155 articles (64.05%), of which 4 articles were under 80% and the lowest was 75.25%, 55 articles were100%. The report rates of all types of survival endpoint were lower than 10%. Eleven of 100 articles which reported a loss to follow-up had stated how to treat it in the analysis. One hundred thirty articles (53.72%) did not perform multivariate analysis. One hundred thirty-nine articles (57.44%) did not define the survival time. Violations and omissions of methodological guidelines included no mention of pertinent checks for proportional hazard assumption; no report of testing for interactions and collinearity between independent variables; no report of calculation method of sample size. Thirty-six articles (32.74%) reported the methods of independent variable selection. The above defects could make potentially inaccurate

Reporting and methodological quality of survival analysis in articles published in Chinese oncology journals

PubMed Central

Zhu, Xiaoyan; Zhou, Xiaobin; Zhang, Yuan; Sun, Xiao; Liu, Haihua; Zhang, Yingying

2017-01-01

Abstract Survival analysis methods have gained widespread use in the filed of oncology. For achievement of reliable results, the methodological process and report quality is crucial. This review provides the first examination of methodological characteristics and reporting quality of survival analysis in articles published in leading Chinese oncology journals. To examine methodological and reporting quality of survival analysis, to identify some common deficiencies, to desirable precautions in the analysis, and relate advice for authors, readers, and editors. A total of 242 survival analysis articles were included to be evaluated from 1492 articles published in 4 leading Chinese oncology journals in 2013. Articles were evaluated according to 16 established items for proper use and reporting of survival analysis. The application rates of Kaplan–Meier, life table, log-rank test, Breslow test, and Cox proportional hazards model (Cox model) were 91.74%, 3.72%, 78.51%, 0.41%, and 46.28%, respectively, no article used the parametric method for survival analysis. Multivariate Cox model was conducted in 112 articles (46.28%). Follow-up rates were mentioned in 155 articles (64.05%), of which 4 articles were under 80% and the lowest was 75.25%, 55 articles were100%. The report rates of all types of survival endpoint were lower than 10%. Eleven of 100 articles which reported a loss to follow-up had stated how to treat it in the analysis. One hundred thirty articles (53.72%) did not perform multivariate analysis. One hundred thirty-nine articles (57.44%) did not define the survival time. Violations and omissions of methodological guidelines included no mention of pertinent checks for proportional hazard assumption; no report of testing for interactions and collinearity between independent variables; no report of calculation method of sample size. Thirty-six articles (32.74%) reported the methods of independent variable selection. The above defects could make potentially

[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.

Sugar-Sweetened Beverages and Obesity Risk in Children and Adolescents: A Systematic Analysis on How Methodological Quality May Influence Conclusions.

PubMed

Bucher Della Torre, Sophie; Keller, Amélie; Laure Depeyre, Jocelyne; Kruseman, Maaike

2016-04-01

In the context of a worldwide high prevalence of childhood obesity, the role of sugar-sweetened beverage (SSB) consumption as a cause of excess weight gain remains controversial. Conflicting results may be due to methodological issues in original studies and in reviews. The aim of this review was to systematically analyze the methodology of studies investigating the influence of SSB consumption on risk of obesity and obesity among children and adolescents, and the studies' ability to answer this research question. A systematic review of cohort and experimental studies published until December 2013 in peer-reviewed journals was performed on Medline, CINAHL, Web of Knowledge, and ClinicalTrials.gov. Studies investigating the influence of SSB consumption on risk of obesity and obesity among children and adolescents were included, and methodological quality to answer this question was assessed independently by two investigators using the Academy of Nutrition and Dietetics Quality Criteria Checklist. Among the 32 identified studies, nine had positive quality ratings and 23 studies had at least one major methodological issue. Main methodological issues included SSB definition and inadequate measurement of exposure. Studies with positive quality ratings found an association between SSB consumption and risk of obesity or obesity (n=5) (ie, when SSB consumption increased so did obesity) or mixed results (n=4). Studies with a neutral quality rating found a positive association (n=7), mixed results (n=9), or no association (n=7). The present review shows that the majority of studies with strong methodology indicated a positive association between SSB consumption and risk of obesity or obesity, especially among overweight children. In addition, study findings highlight the need for the careful and precise measurement of the consumption of SSBs and of important confounders. Copyright © 2016 Academy of Nutrition and Dietetics. Published by Elsevier Inc. All rights reserved.

7 CFR 3017.900 - Adequate evidence.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 15 2010-01-01 2010-01-01 false Adequate evidence. 3017.900 Section 3017.900 Agriculture Regulations of the Department of Agriculture (Continued) OFFICE OF THE CHIEF FINANCIAL OFFICER... Adequate evidence. Adequate evidence means information sufficient to support the reasonable belief that a...

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.

29 CFR 98.900 - Adequate evidence.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 29 Labor 1 2012-07-01 2012-07-01 false Adequate evidence. 98.900 Section 98.900 Labor Office of the Secretary of Labor GOVERNMENTWIDE DEBARMENT AND SUSPENSION (NONPROCUREMENT) Definitions § 98.900 Adequate evidence. Adequate evidence means information sufficient to support the reasonable belief that a...

29 CFR 98.900 - Adequate evidence.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 29 Labor 1 2011-07-01 2011-07-01 false Adequate evidence. 98.900 Section 98.900 Labor Office of the Secretary of Labor GOVERNMENTWIDE DEBARMENT AND SUSPENSION (NONPROCUREMENT) Definitions § 98.900 Adequate evidence. Adequate evidence means information sufficient to support the reasonable belief that a...

29 CFR 98.900 - Adequate evidence.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 29 Labor 1 2013-07-01 2013-07-01 false Adequate evidence. 98.900 Section 98.900 Labor Office of the Secretary of Labor GOVERNMENTWIDE DEBARMENT AND SUSPENSION (NONPROCUREMENT) Definitions § 98.900 Adequate evidence. Adequate evidence means information sufficient to support the reasonable belief that a...

2 CFR 180.900 - Adequate evidence.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 2 Grants and Agreements 1 2013-01-01 2013-01-01 false Adequate evidence. 180.900 Section 180.900 Grants and Agreements Office of Management and Budget Guidance for Grants and Agreements OFFICE OF... Adequate evidence. Adequate evidence means information sufficient to support the reasonable belief that a...

2 CFR 180.900 - Adequate evidence.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 2 Grants and Agreements 1 2012-01-01 2012-01-01 false Adequate evidence. 180.900 Section 180.900 Grants and Agreements Office of Management and Budget Guidance for Grants and Agreements OFFICE OF... Adequate evidence. Adequate evidence means information sufficient to support the reasonable belief that a...

Social exclusion in academia through biases in methodological quality evaluation: On the situation of women in science and philosophy.

PubMed

Leuschner, Anna

2015-12-01

Empirical studies show that academia is socially exclusive. I argue that this social exclusion works, at least partly, through the systematic methodological disqualification of contributions from members of underrepresented social groups. As methodological quality criteria are underdetermined their interpretation and weighting can be biased with relation to gender, race, social background, etc. Such biased quality evaluation can take place on a local or global level. The current situation of women in academic philosophy illuminates this. I conclude that only mechanical solutions can effectively change the situation. Copyright © 2015 Elsevier Ltd. All rights reserved.

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

The methodological quality of health economic evaluations for the management of hip fractures: A systematic review of the literature.

PubMed

Sabharwal, Sanjeeve; Carter, Alexander; Darzi, Lord Ara; Reilly, Peter; Gupte, Chinmay M

2015-06-01

Approximately 76,000 people a year sustain a hip fracture in the UK and the estimated cost to the NHS is £1.4 billion a year. Health economic evaluations (HEEs) are one of the methods employed by decision makers to deliver healthcare policy supported by clinical and economic evidence. The objective of this study was to (1) identify and characterize HEEs for the management of patients with hip fractures, and (2) examine their methodological quality. A literature search was performed in MEDLINE, EMBASE and the NHS Economic Evaluation Database. Studies that met the specified definition for a HEE and evaluated hip fracture management were included. Methodological quality was assessed using the Consensus on Health Economic Criteria (CHEC). Twenty-seven publications met the inclusion criteria of this study and were included in our descriptive and methodological analysis. Domains of methodology that performed poorly included use of an appropriate time horizon (66.7% of studies), incremental analysis of costs and outcomes (63%), future discounting (44.4%), sensitivity analysis (40.7%), declaration of conflicts of interest (37%) and discussion of ethical considerations (29.6%). HEEs for patients with hip fractures are increasing in publication in recent years. Most of these studies fail to adopt a societal perspective and key aspects of their methodology are poor. The development of future HEEs in this field must adhere to established principles of methodology, so that better quality research can be used to inform health policy on the management of patients with a hip fracture. Copyright © 2014 Royal College of Surgeons of Edinburgh (Scottish charity number SC005317) and Royal College of Surgeons in Ireland. Published by Elsevier Ltd. All rights reserved.

An integrated view of data quality in Earth observation

PubMed Central

Yang, X.; Blower, J. D.; Bastin, L.; Lush, V.; Zabala, A.; Masó, J.; Cornford, D.; Díaz, P.; Lumsden, J.

2013-01-01

Data quality is a difficult notion to define precisely, and different communities have different views and understandings of the subject. This causes confusion, a lack of harmonization of data across communities and omission of vital quality information. For some existing data infrastructures, data quality standards cannot address the problem adequately and cannot fulfil all user needs or cover all concepts of data quality. In this study, we discuss some philosophical issues on data quality. We identify actual user needs on data quality, review existing standards and specifications on data quality, and propose an integrated model for data quality in the field of Earth observation (EO). We also propose a practical mechanism for applying the integrated quality information model to a large number of datasets through metadata inheritance. While our data quality management approach is in the domain of EO, we believe that the ideas and methodologies for data quality management can be applied to wider domains and disciplines to facilitate quality-enabled scientific research. PMID:23230156

An integrated view of data quality in Earth observation.

PubMed

Yang, X; Blower, J D; Bastin, L; Lush, V; Zabala, A; Masó, J; Cornford, D; Díaz, P; Lumsden, J

2013-01-28

Data quality is a difficult notion to define precisely, and different communities have different views and understandings of the subject. This causes confusion, a lack of harmonization of data across communities and omission of vital quality information. For some existing data infrastructures, data quality standards cannot address the problem adequately and cannot fulfil all user needs or cover all concepts of data quality. In this study, we discuss some philosophical issues on data quality. We identify actual user needs on data quality, review existing standards and specifications on data quality, and propose an integrated model for data quality in the field of Earth observation (EO). We also propose a practical mechanism for applying the integrated quality information model to a large number of datasets through metadata inheritance. While our data quality management approach is in the domain of EO, we believe that the ideas and methodologies for data quality management can be applied to wider domains and disciplines to facilitate quality-enabled scientific research.

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.

Methodological Quality of Systematic Reviews Published in the Urological Literature from 1998 to 2012.

PubMed

Corbyons, Katherine; Han, Julia; Neuberger, Molly M; Dahm, Philipp

2015-11-01

Systematic reviews synthesize the current best evidence to address a clinical question. Given the growing emphasis on evidence-based clinical practice, systematic reviews are being increasingly sought after and published. We previously reported limitations in the methodological quality of 57 individual systematic reviews published from 1998 to 2008. We provide an update to our previous study, adding systematic reviews published from 2009 to 2012. We systematically searched PubMed® and hand searched the table of contents of 4 major urological journals to identify systematic reviews related to questions of prevention and therapy. Two independent reviewers with prior formal evidence-based medicine training assessed the methodological quality using the validated 11-point AMSTAR (A Measurement Tool to Assess Systematic Reviews) instrument. We performed predefined statistical hypothesis testing for differences by publication period (1998 to 2008 vs 2009 to 2012) and journal of publication. We performed statistical testing using SPSS®, version 23.0 with a 2-sided α of 0.05 using the Student t-test, ANOVA and the chi-square test. A total of 113 systematic reviews published from 2009 to 2012 met study inclusion criteria. The most common topics were oncology (44 reviews or 38.9%), voiding dysfunction (26 or 23.0%) and stones/endourology (13 or 11.5%). The largest contributor was European Urology (46 reviews or 40.7%), followed by BJU International (31 or 27.4%) and The Journal of Urology® (22 or 19.5%). The mean ± SD AMSTAR score for the 2009 to 2012 period was 5.3 ± 2.3 compared to 4.8 ± 2.0 for 1998 to 2008 with a mean difference of 0.5 (95% CI 0.2 to 1.2, p = 0.133). While the number of systematic reviews published in the urological literature has increased substantially, the methodological quality of these studies remains suboptimal. Systematic review authors and editors should make every effort to adhere to well established methodological standards to enhance

Cross-cultural adaptation and translation of a quality of life tool for new mothers: a methodological and experiential account from six countries.

PubMed

Symon, Andrew; Nagpal, Jitender; Maniecka-Bryła, Irena; Nowakowska-Głąb, Agata; Rashidian, Arash; Khabiri, Roghayeh; Mendes, Isabel; Pinheiro, Ana Karina Bezerra; de Oliveira, Mirna Fontenele; Wu, Liping

2013-04-01

To examine the challenges and solutions encountered in the translation and cross-cultural adaptation of an English language quality of life tool in India, China, Iran, Portugal, Brazil, and Poland. Those embarking on research involving translation and cross-cultural adaptation must address certain practical and conceptual issues. These include instrument choice, linguistic factors, and cultural or philosophical differences, which may render an instrument inappropriate, even when expertly translated. Publication bias arises when studies encountering difficulties do not admit to these, or are not published at all. As an educative guide to the potential pitfalls involved in the cross-cultural adaptation process, this article reports the conceptual, linguistic, and methodological experiences of researchers in six countries, who translated and adapted the Mother-Generated Index, a quality of life tool originally developed in English. Principal investigator experience from six stand-alone studies (two published) ranging from postgraduate research to citywide surveys. DISCUSSION/IMPLICATIONS FOR NURSING: This analysis of a series of stand-alone cross-cultural studies provides lessons about how conceptual issues, such as the uniqueness of perceived quality of life and the experience of new motherhood, can be addressed. This original international approach highlights practical lessons relating to instrument choice, and the resources available to researchers with different levels of experience. Although researchers may be confident of effective translation, conceptual and practical difficulties may be more problematic. Instrument choice is crucial. Researchers must negotiate adequate resources for cross-cultural research, including time, translation facilities, and expert advice about conceptual issues. © 2012 Blackwell Publishing Ltd.

Methodological review: quality of randomized controlled trials in health literacy.

PubMed

Brainard, Julii; Wilsher, Stephanie Howard; Salter, Charlotte; Loke, Yoon Kong

2016-07-11

The growing move towards patient-centred care has led to substantial research into improving the health literacy skills of patients and members of the public. Hence, there is a pressing need to assess the methodology used in contemporary randomized controlled trials (RCTs) of interventions directed at health literacy, in particular the quality (risk of bias), and the types of outcomes reported. We conducted a systematic database search for RCTs involving interventions directed at health literacy in adults, published from 2009 to 2014. The Cochrane Risk of Bias tool was used to assess quality of RCT implementation. We also checked the sample size calculation for primary outcomes. Reported evidence of efficacy (statistical significance) was extracted for intervention outcomes in any of three domains of effect: knowledge, behaviour, health status. Demographics of intervention participants were also extracted, including socioeconomic status. We found areas of methodological strength (good randomization and allocation concealment), but areas of weakness regarding blinding of participants, people delivering the intervention and outcomes assessors. Substantial attrition (losses by monitoring time point) was seen in a third of RCTs, potentially leading to insufficient power to obtain precise estimates of intervention effect on primary outcomes. Most RCTs showed that the health literacy interventions had some beneficial effect on knowledge outcomes, but this was typically for less than 3 months after intervention end. There were far fewer reports of significant improvements in substantive patient-oriented outcomes, such as beneficial effects on behavioural change or health (clinical) status. Most RCTs featured participants from vulnerable populations. Our evaluation shows that health literacy trial design, conduct and reporting could be considerably improved, particularly by reducing attrition and obtaining longer follow-up. More meaningful RCTs would also result if health

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

Systematic review of the methodological quality of clinical guideline development for the management of chronic disease in Europe.

PubMed

Knai, Cécile; Brusamento, Serena; Legido-Quigley, Helena; Saliba, Vanessa; Panteli, Dimitra; Turk, Eva; Car, Josip; McKee, Martin; Busse, Reinhard

2012-10-01

The use of evidence-based clinical guidelines is an essential component of chronic disease management. However, there is well-documented concern about variability in the quality of clinical guidelines, with evidence of persisting methodological shortcomings. The most widely accepted approach to assessing the quality of guidelines is the Appraisal of Guidelines for Research and Evaluation (AGREE) instrument. We have conducted a systematic review of the methodological quality (as assessed by AGREE) of clinical guidelines developed in Europe for the management of chronic diseases published since 2000. The systematic review was undertaken in accordance with the Cochrane methodology. The inclusion criteria were that studies should have appraised European clinical guidelines for certain selected chronic disorders using the AGREE instrument. We searched five databases (Cab Abstracts, EMBASE, MEDLINE, Trip and EPPI). Nine studies reported in 10 papers, analysing a total of 28 European guidelines from eight countries as well as pan-European, were included. There was considerable variation in the quality of clinical guidelines across the AGREE domains. The least well addressed domains were 'editorial independence' (with a mean domain score of 41%), 'applicability' (44%), 'stakeholder involvement' (55%), and 'rigour of development' (64%), while 'clarity of presentation' (80%) and 'scope and purpose' (84%) were less problematic. This review indicates that there is considerable scope for improvement in the methods used to develop clinical guidelines for the prevention, management and treatment of chronic diseases in Europe. Given the importance of decision support strategies such as clinical guidelines in chronic disease management, improvement measures should include the explicit and transparent involvement of key stakeholders (especially scientific experts, guideline users and methodological specialists) and consideration of the implications for guideline implementation and

[Types of medical registries - definitions, methodological aspects and quality of the scientific work with registries].

PubMed

Mathis-Edenhofer, Stefan; Piso, Brigitte

2011-12-01

This work presents a comprehensive list of registry definitions including broader and narrower definitions. Compared to each other different methodological issues can be identified. Some of these issues are common for all registry types; some can be assigned more easily to a specific registry type. Instruments for evaluating the quality of registers reflect many of the mentioned aspects. Generally, and especially at registers with a descriptive or exploratory research dimension it is important to consider their intended purpose and in about it was achieved. This includes, for instance, whether the purpose and the methodology are coordinated. From the start of registration an initiator should be - based on the purpose - aware of the methodological dimension of the registry. This helps to apply the correct type of the registry, the appropriate guidance and, ultimately, the arguments for the effort (cost-benefit ratio).

Archetype modeling methodology.

PubMed

Moner, David; Maldonado, José Alberto; Robles, Montserrat

2018-03-01

Clinical Information Models (CIMs) expressed as archetypes play an essential role in the design and development of current Electronic Health Record (EHR) information structures. Although there exist many experiences about using archetypes in the literature, a comprehensive and formal methodology for archetype modeling does not exist. Having a modeling methodology is essential to develop quality archetypes, in order to guide the development of EHR systems and to allow the semantic interoperability of health data. In this work, an archetype modeling methodology is proposed. This paper describes its phases, the inputs and outputs of each phase, and the involved participants and tools. It also includes the description of the possible strategies to organize the modeling process. The proposed methodology is inspired by existing best practices of CIMs, software and ontology development. The methodology has been applied and evaluated in regional and national EHR projects. The application of the methodology provided useful feedback and improvements, and confirmed its advantages. The conclusion of this work is that having a formal methodology for archetype development facilitates the definition and adoption of interoperable archetypes, improves their quality, and facilitates their reuse among different information systems and EHR projects. Moreover, the proposed methodology can be also a reference for CIMs development using any other formalism. Copyright © 2018 Elsevier Inc. All rights reserved.

The landscape of systematic reviews in urology (1998 to 2015): an assessment of methodological quality.

PubMed

Han, Julia L; Gandhi, Shreyas; Bockoven, Crystal G; Narayan, Vikram M; Dahm, Philipp

2017-04-01

To assess the quality of published systematic reviews in the urology literature (an extension of our previously reported work), as high-quality systematic reviews play a paramount role in informing evidence-based clinical practice. Our focus was on systematic reviews in the urology literature that incorporated questions of prevention and therapy. To identify such reviews published during a 36-month period (2013-2015), we systematically searched PubMed and hand-searched the table of contents of four major urology journals. Two reviewers independently assessed the methodological quality of those reviews, using the 11-point 'Assessment of Multiple Systematic Reviews' (AMSTAR) instrument. We performed protocol-driven analyses of the data from our present study's 36-month period alone, as well as in aggregate with the data from our previously reported work's study periods (2009-2012 and 1998-2008). In our literature search of the 36-month period (2013-2015), we initially identified 490 possibly relevant reviews, of which 125 met our inclusion criteria. The most common topic of reviews for the 2013-2015 period was oncology (51.2%; n = 64), followed by voiding dysfunction (21.6%; n = 27). The mean [standard deviation (SD)] AMSTAR score in the 2013-2015 period (n = 125) was 4.8 (2.4); 2009-2012 (n = 113), 5.4 (2.3); and 1998-2008 (n = 57), 4.8 (2.0) (P = 0.127). In the 2013-2015 period, the mean (SD) AMSTAR score for the BJU International (n = 25) was 5.6 (2.9); for The Journal of Urology (n = 20), 5.1 (2.6); for European Urology (n = 60), 4.5 (2.2); and for Urology (n = 20), 4.4 (2.2) (P = 0.106). The number of systematic reviews published in the urology literature has exponentially increased, year by year, but their methodological quality has stagnated. To enhance the validity and impact of systematic reviews, all authors and editors must apply established methodological standards. © 2016 The Authors BJU International © 2016 BJU International Published by John Wiley

Temporal trends in receipt of adequate lymphadenectomy in bladder cancer 1988 to 2010.

PubMed

Cole, Alexander P; Dalela, Deepansh; Hanske, Julian; Mullane, Stephanie A; Choueiri, Toni K; Meyer, Christian P; Nguyen, Paul L; Menon, Mani; Kibel, Adam S; Preston, Mark A; Bellmunt, Joaquim; Trinh, Quoc-Dien

2015-12-01

The importance of pelvic lymphadenectomy (LND) for diagnostic and therapeutic purposes at the time of radical cystectomy (RC) for bladder cancer is well documented. Although some debate remains on the optimal number of lymph nodes removed, 10 nodes has been proposed as constituting an adequate LND. We used data from the Surveillance, Epidemiology, and End Results database to examine predictors and temporal trends in the receipt of an adequate LND at the time of RC for bladder cancer. Within the Surveillance, Epidemiology, and End Results database, we extracted data on all patients with nonmetastatic bladder cancer receiving RC in the years 1988 to 2010. First, we assess the proportion of individuals undergoing RC who received an adequate LND (≥10 nodes removed) over time. Second, we calculate odds ratios (ORs) of receiving an adequate LND using logistic regression modeling to compare study periods. Covariates included sex, race, age, region, tumor stage, urban vs. rural location, and insurance status. Among the 5,696 individuals receiving RC during the years 1988 to 2010, 2,576 (45.2%) received an adequate LND. Over the study period, the proportion of individuals receiving an adequate LND increased from 26.4% to 61.3%. The odds of receiving an adequate LND increased over the study period; a patient undergoing RC in 2008 to 2010 was over 4-fold more likely to receive an adequate LND relative to a patient treated in 1988 to 1991 (OR = 4.63, 95% CI: 3.32-6.45). In addition to time of surgery, tumor stage had a positive association with receipt of adequate LND (OR = 1.49 for stage IV [T4 N1 or N0] vs. stage I [T1 or Tis], 95% CI: 1.22-1.82). Age, sex, marital status, and race were not significant predictors of adequate LND. Adequacy of pelvic LND remains an important measure of surgical quality in bladder cancer. Our data show that over the years 1988 to 2010, the likelihood of receiving an adequate LND has increased substantially; however, a substantial minority of

Q methodology in health economics.

PubMed

Baker, Rachel; Thompson, Carl; Mannion, Russell

2006-01-01

The recognition that health economists need to understand the meaning of data if they are to adequately understand research findings which challenge conventional economic theory has led to the growth of qualitative modes of enquiry in health economics. The use of qualitative methods of exploration and description alongside quantitative techniques gives rise to a number of epistemological, ontological and methodological challenges: difficulties in accounting for subjectivity in choices, the need for rigour and transparency in method, and problems of disciplinary acceptability to health economists. Q methodology is introduced as a means of overcoming some of these challenges. We argue that Q offers a means of exploring subjectivity, beliefs and values while retaining the transparency, rigour and mathematical underpinnings of quantitative techniques. The various stages of Q methodological enquiry are outlined alongside potential areas of application in health economics, before discussing the strengths and limitations of the approach. We conclude that Q methodology is a useful addition to economists' methodological armoury and one that merits further consideration and evaluation in the study of health services.

“The 3/3 Strategy”: A Successful Multifaceted Hospital Wide Hand Hygiene Intervention Based on WHO and Continuous Quality Improvement Methodology

PubMed Central

Mestre, Gabriel; Berbel, Cristina; Tortajada, Purificación; Alarcia, Margarita; Coca, Roser; Gallemi, Gema; Garcia, Irene; Fernández, Mari Mar; Aguilar, Mari Carmen; Martínez, José Antonio; Rodríguez-Baño, Jesús

2012-01-01

Background Only multifaceted hospital wide interventions have been successful in achieving sustained improvements in hand hygiene (HH) compliance. Methodology/Principal Findings Pre-post intervention study of HH performance at baseline (October 2007– December 2009) and during intervention, which included two phases. Phase 1 (2010) included multimodal WHO approach. Phase 2 (2011) added Continuous Quality Improvement (CQI) tools and was based on: a) Increase of alcohol hand rub (AHR) solution placement (from 0.57 dispensers/bed to 1.56); b) Increase in frequency of audits (three days every three weeks: “3/3 strategy”); c) Implementation of a standardized register form of HH corrective actions; d) Statistical Process Control (SPC) as time series analysis methodology through appropriate control charts. During the intervention period we performed 819 scheduled direct observation audits which provided data from 11,714 HH opportunities. The most remarkable findings were: a) significant improvements in HH compliance with respect to baseline (25% mean increase); b) sustained high level (82%) of HH compliance during intervention; c) significant increase in AHRs consumption over time; c) significant decrease in the rate of healthcare-acquired MRSA; d) small but significant improvements in HH compliance when comparing phase 2 to phase 1 [79.5% (95% CI: 78.2–80.7) vs 84.6% (95% CI:83.8–85.4), p<0.05]; e) successful use of control charts to identify significant negative and positive deviations (special causes) related to the HH compliance process over time (“positive”: 90.1% as highest HH compliance coinciding with the “World hygiene day”; and “negative”:73.7% as lowest HH compliance coinciding with a statutory lay-off proceeding). Conclusions/Significance CQI tools may be a key addition to WHO strategy to maintain a good HH performance over time. In addition, SPC has shown to be a powerful methodology to detect special causes in HH performance (positive

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

Incorporating BIRD-based homodecoupling in the dual-optimized, inverted 1 JCC 1,n-ADEQUATE experiment.

PubMed

Saurí, Josep; Bermel, Wolfgang; Parella, Teodor; Thomas Williamson, R; Martin, Gary E

2018-03-13

1,n-ADEQUATE is a powerful NMR technique for elucidating the structure of proton-deficient small molecules that can help establish the carbon skeleton of a given molecule by providing long-range three-bond 13 C─ 13 C correlations. Care must be taken when using the experiment to identify the simultaneous presence of one-bond 13 C─ 13 C correlations that are not filtered out, unlike the HMBC experiment that has a low-pass J-filter to filter 1 J CH responses out. Dual-optimized, inverted 1 J CC 1,n-ADEQUATE is an improved variant of the experiment that affords broadband inversion of direct responses, obviating the need to take additional steps to identify these correlations. Even though ADEQUATE experiments can now be acquired in a reasonable amount of experimental time if a cryogenic probe is available, low sensitivity is still the main impediment limiting the application of this elegant experiment. Here, we wish to report a further refinement that incorporates real-time bilinear rotation decoupling-based homodecoupling methodology into the dual-optimized, inverted 1 J CC 1,n-ADEQUATE pulse sequence. Improved sensitivity and resolution are achieved by collapsing homonuclear proton-proton couplings from the observed multiplets for most spin systems. The application of the method is illustrated with several model compounds. Copyright © 2018 John Wiley & Sons, Ltd.

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

5 CFR 919.900 - Adequate evidence.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 5 Administrative Personnel 2 2010-01-01 2010-01-01 false Adequate evidence. 919.900 Section 919.900 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT (CONTINUED) CIVIL SERVICE REGULATIONS.... Adequate evidence means information sufficient to support the reasonable belief that a particular act or...

5 CFR 919.900 - Adequate evidence.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 5 Administrative Personnel 2 2011-01-01 2011-01-01 false Adequate evidence. 919.900 Section 919.900 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT (CONTINUED) CIVIL SERVICE REGULATIONS.... Adequate evidence means information sufficient to support the reasonable belief that a particular act or...

5 CFR 919.900 - Adequate evidence.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 5 Administrative Personnel 2 2014-01-01 2014-01-01 false Adequate evidence. 919.900 Section 919.900 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT (CONTINUED) CIVIL SERVICE REGULATIONS.... Adequate evidence means information sufficient to support the reasonable belief that a particular act or...

5 CFR 919.900 - Adequate evidence.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 5 Administrative Personnel 2 2013-01-01 2013-01-01 false Adequate evidence. 919.900 Section 919.900 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT (CONTINUED) CIVIL SERVICE REGULATIONS.... Adequate evidence means information sufficient to support the reasonable belief that a particular act or...

5 CFR 919.900 - Adequate evidence.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 5 Administrative Personnel 2 2012-01-01 2012-01-01 false Adequate evidence. 919.900 Section 919.900 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT (CONTINUED) CIVIL SERVICE REGULATIONS.... Adequate evidence means information sufficient to support the reasonable belief that a particular act or...

Forty years of quality-of-life research in congenital heart disease: Temporal trends in conceptual and methodological rigor.

PubMed

Bratt, Ewa-Lena; Moons, Philip

2015-09-15

The first study on quality of life (QoL) in patients with congenital heart disease was published 40 years ago. Since then, the number of QoL articles on these patients has grown exponentially. We conducted a systematic literature review of all empirical studies on QoL in patients with congenital heart disease published since 1974, with the aim of determining the range of conceptual and methodological rigor of studies and identifying temporal trends in these parameters. PubMed, Embase, and Cinahl were searched for empirical studies addressing QoL in children, adolescents, or adults with congenital heart disease, published between January 1, 1974, and December 31, 2014. We applied 10 review criteria that were previously developed by Gill and Feinstein in 1994 and further refined by Moons et al. in 2004. Overall, 234 articles were reviewed. We found slight but non-significant temporal improvements in conceptual and methodological rigor and in use of assessment methods. This indicates a trend toward a more professional and exacting approach in QoL assessments. However, the majority of articles still had substantial conceptual and methodological deficits. Furthermore, we observed that citation of the publications of Gill and Feinstein and Moons et al. in published QoL research is associated with higher quality scores, suggesting that these articles have a positive impact on conceptual and methodological caliber. Despite 40 years of QoL research in this field, this review shows that major weaknesses in methodological rigor remain highly prevalent, which may make QoL studies inconclusive. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Reduced bone mineral density is not associated with significantly reduced bone quality in men and women practicing long-term calorie restriction with adequate nutrition.

PubMed

Villareal, Dennis T; Kotyk, John J; Armamento-Villareal, Reina C; Kenguva, Venkata; Seaman, Pamela; Shahar, Allon; Wald, Michael J; Kleerekoper, Michael; Fontana, Luigi

2011-02-01

Calorie restriction (CR) reduces bone quantity but not bone quality in rodents. Nothing is known regarding the long-term effects of CR with adequate intake of vitamin and minerals on bone quantity and quality in middle-aged lean individuals. In this study, we evaluated body composition, bone mineral density (BMD), and serum markers of bone turnover and inflammation in 32 volunteers who had been eating a CR diet (approximately 35% less calories than controls) for an average of 6.8 ± 5.2 years (mean age 52.7 ± 10.3 years) and 32 age- and sex-matched sedentary controls eating Western diets (WD). In a subgroup of 10 CR and 10 WD volunteers, we also measured trabecular bone (TB) microarchitecture of the distal radius using high-resolution magnetic resonance imaging. We found that the CR volunteers had significantly lower body mass index than the WD volunteers (18.9 ± 1.2 vs. 26.5 ± 2.2 kg m(-2) ; P = 0.0001). BMD of the lumbar spine (0.870 ± 0.11 vs. 1.138 ± 0.12 g cm(-2) , P = 0.0001) and hip (0.806 ± 0.12 vs. 1.047 ± 0.12 g cm(-2) , P = 0.0001) was also lower in the CR than in the WD group. Serum C-terminal telopeptide and bone-specific alkaline phosphatase concentration were similar between groups, while serum C-reactive protein (0.19 ± 0.26 vs. 1.46 ± 1.56 mg L(-1) , P = 0.0001) was lower in the CR group. Trabecular bone microarchitecture parameters such as the erosion index (0.916 ± 0.087 vs. 0.877 ± 0.088; P = 0.739) and surface-to-curve ratio (10.3 ± 1.4 vs. 12.1 ± 2.1, P = 0.440) were not significantly different between groups. These findings suggest that markedly reduced BMD is not associated with significantly reduced bone quality in middle-aged men and women practicing long-term calorie restriction with adequate nutrition.

Systematic Reviews and Meta-Analyses of Home Telemonitoring Interventions for Patients With Chronic Diseases: A Critical Assessment of Their Methodological Quality

PubMed Central

2013-01-01

Background Systematic reviews and meta-analyses of home telemonitoring interventions for patients with chronic diseases have increased over the past decade and become increasingly important to a wide range of clinicians, policy makers, and other health care stakeholders. While a few criticisms about their methodological rigor and synthesis approaches have recently appeared, no formal appraisal of their quality has been conducted yet. Objective The primary aim of this critical review was to evaluate the methodology, quality, and reporting characteristics of prior reviews that have investigated the effects of home telemonitoring interventions in the context of chronic diseases. Methods Ovid MEDLINE, the Database of Abstract of Reviews of Effects (DARE), and Health Technology Assessment Database (HTA) of the Cochrane Library were electronically searched to find relevant systematic reviews, published between January 1966 and December 2012. Potential reviews were screened and assessed for inclusion independently by three reviewers. Data pertaining to the methods used were extracted from each included review and examined for accuracy by two reviewers. A validated quality assessment instrument, R-AMSTAR, was used as a framework to guide the assessment process. Results Twenty-four reviews, nine of which were meta-analyses, were identified from more than 200 citations. The bibliographic search revealed that the number of published reviews has increased substantially over the years in this area and although most reviews focus on studying the effects of home telemonitoring on patients with congestive heart failure, researcher interest has extended to other chronic diseases as well, such as diabetes, hypertension, chronic obstructive pulmonary disease, and asthma. Nevertheless, an important number of these reviews appear to lack optimal scientific rigor due to intrinsic methodological issues. Also, the overall quality of reviews does not appear to have improved over time

Balancing benefit and risk of medicines: a systematic review and classification of available methodologies.

PubMed

Mt-Isa, Shahrul; Hallgreen, Christine E; Wang, Nan; Callréus, Torbjörn; Genov, Georgy; Hirsch, Ian; Hobbiger, Stephen F; Hockley, Kimberley S; Luciani, Davide; Phillips, Lawrence D; Quartey, George; Sarac, Sinan B; Stoeckert, Isabelle; Tzoulaki, Ioanna; Micaleff, Alain; Ashby, Deborah

2014-07-01

The need for formal and structured approaches for benefit-risk assessment of medicines is increasing, as is the complexity of the scientific questions addressed before making decisions on the benefit-risk balance of medicines. We systematically collected, appraised and classified available benefit-risk methodologies to facilitate and inform their future use. A systematic review of publications identified benefit-risk assessment methodologies. Methodologies were appraised on their fundamental principles, features, graphical representations, assessability and accessibility. We created a taxonomy of methodologies to facilitate understanding and choice. We identified 49 methodologies, critically appraised and classified them into four categories: frameworks, metrics, estimation techniques and utility survey techniques. Eight frameworks describe qualitative steps in benefit-risk assessment and eight quantify benefit-risk balance. Nine metric indices include threshold indices to measure either benefit or risk; health indices measure quality-of-life over time; and trade-off indices integrate benefits and risks. Six estimation techniques support benefit-risk modelling and evidence synthesis. Four utility survey techniques elicit robust value preferences from relevant stakeholders to the benefit-risk decisions. Methodologies to help benefit-risk assessments of medicines are diverse and each is associated with different limitations and strengths. There is not a 'one-size-fits-all' method, and a combination of methods may be needed for each benefit-risk assessment. The taxonomy introduced herein may guide choice of adequate methodologies. Finally, we recommend 13 of 49 methodologies for further appraisal for use in the real-life benefit-risk assessment of medicines. Copyright © 2014 John Wiley & Sons, Ltd.

Quality Assurance in Trichiasis Surgery: a methodology

PubMed Central

Buchan, John C; Limburg, Hans; Burton, Matthew J

2013-01-01

SUMMARY Trachoma remains a significant cause of blindness in many parts of the world. The major route to blindness involves upper lid entropion leading to trachomatous trichiasis (TT) which promotes progressive corneal opacification. The provision of surgery to correct TT in the populations most severely affected is a major challenge for the global effort to eliminate Trachoma blindness by the year 2020. Most attention has been paid to increasing the quantity of TT surgery performed, and large numbers of non-doctor operators have been trained to this end. Surgical audit by those performing TT surgery is not a routine part of any national trachoma control programme, and no effective mechanism exists for identifying surgeons experiencing poor outcomes. We propose a methodology for surgical audit at the level of the individual surgeon based on Lot Quality Assurance. A set number of patients operated on previously for upper eyelid TT are examined to detect the recurrence of TT. The number of recurrent cases found will lead to categorisation of the TT surgeon to either “high recurrence” or “low recurrence” with reasonable confidence. The threshold of unacceptability can be set by individual programmes according to previous local studies of recurrence rates or those from similar settings. Identification of surgeons delivering unacceptably high levels of recurrent TT will guide managers on the need for remedial intervention such as re-training. PMID:20881027

Methodological quality evaluation of systematic reviews or meta-analyses on ERCC1 in non-small cell lung cancer: a systematic review.

PubMed

Tao, Huan; Zhang, Yueyuan; Li, Qian; Chen, Jin

2017-11-01

To assess the methodological quality of systematic reviews (SRs) or meta-analysis concerning the predictive value of ERCC1 in platinum chemotherapy of non-small cell lung cancer. We searched the PubMed, EMbase, Cochrane library, international prospective register of systematic reviews, Chinese BioMedical Literature Database, China National Knowledge Infrastructure, Wan Fang and VIP database for SRs or meta-analysis. The methodological quality of included literatures was evaluated by risk of bias in systematic review (ROBIS) scale. Nineteen eligible SRs/meta-analysis were included. The most frequently searched databases were EMbase (74%), PubMed, Medline and CNKI. Fifteen SRs did additional retrieval manually, but none of them retrieved the registration platform. 47% described the two-reviewers model in the screening for eligible original articles, and seven SRs described the two reviewers to extract data. In methodological quality assessment, inter-rater reliability Kappa was 0.87 between two reviewers. Research question were well related to all SRs in phase 1 and the eligibility criteria was suitable for each SR, and rated as 'low' risk bias. But the 'high' risk bias existed in all the SRs regarding methods used to identify and/or select studies, and data collection and study appraisal. More than two-third of SRs or meta-analysis were finished with high risk of bias in the synthesis, findings and the final phase. The study demonstrated poor methodological quality of SRs/meta-analysis assessing the predictive value of ERCC1 in chemotherapy among the NSCLC patients, especially the high performance bias. Registration or publishing the protocol is recommended in future research.

2 CFR 180.900 - Adequate evidence.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 2 Grants and Agreements 1 2014-01-01 2014-01-01 false Adequate evidence. 180.900 Section 180.900 Grants and Agreements Office of Management and Budget Guidance for Grants and Agreements OFFICE OF.... Adequate evidence means information sufficient to support the reasonable belief that a particular act or...

2 CFR 180.900 - Adequate evidence.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 2 Grants and Agreements 1 2011-01-01 2011-01-01 false Adequate evidence. 180.900 Section 180.900 Grants and Agreements Office of Management and Budget Guidance for Grants and Agreements OFFICE OF.... Adequate evidence means information sufficient to support the reasonable belief that a particular act or...

Development and Field Test of an Audit Tool and Tracer Methodology for Clinician Assessment of Quality in End-of-Life Care.

PubMed

Bookbinder, Marilyn; Hugodot, Amandine; Freeman, Katherine; Homel, Peter; Santiago, Elisabeth; Riggs, Alexa; Gavin, Maggie; Chu, Alice; Brady, Ellen; Lesage, Pauline; Portenoy, Russell K

2018-02-01

Quality improvement in end-of-life care generally acquires data from charts or caregivers. "Tracer" methodology, which assesses real-time information from multiple sources, may provide complementary information. The objective of this study was to develop a valid brief audit tool that can guide assessment and rate care when used in a clinician tracer to evaluate the quality of care for the dying patient. To identify items for a brief audit tool, 248 items were created to evaluate overall quality, quality in specific content areas (e.g., symptom management), and specific practices. Collected into three instruments, these items were used to interview professional caregivers and evaluate the charts of hospitalized patients who died. Evidence that this information could be validly captured using a small number of items was obtained through factor analyses, canonical correlations, and group comparisons. A nurse manager field tested tracer methodology using candidate items to evaluate the care provided to other patients who died. The survey of 145 deaths provided chart data and data from 445 interviews (26 physicians, 108 nurses, 18 social workers, and nine chaplains). The analyses yielded evidence of construct validity for a small number of items, demonstrating significant correlations between these items and content areas identified as latent variables in factor analyses. Criterion validity was suggested by significant differences in the ratings on these items between the palliative care unit and other units. The field test evaluated 127 deaths, demonstrated the feasibility of tracer methodology, and informed reworking of the candidate items into the 14-item Tracer EoLC v1. The Tracer EoLC v1 can be used with tracer methodology to guide the assessment and rate the quality of end-of-life care. Copyright © 2017 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

[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.

A systematic review of studies evaluating Australian indigenous community development projects: the extent of community participation, their methodological quality and their outcomes.

PubMed

Snijder, Mieke; Shakeshaft, Anthony; Wagemakers, Annemarie; Stephens, Anne; Calabria, Bianca

2015-11-21

Community development is a health promotion approach identified as having great potential to improve Indigenous health, because of its potential for extensive community participation. There has been no systematic examination of the extent of community participation in community development projects and little analysis of their effectiveness. This systematic review aims to identify the extent of community participation in community development projects implemented in Australian Indigenous communities, critically appraise the qualitative and quantitative methods used in their evaluation, and summarise their outcomes. Ten electronic peer-reviewed databases and two electronic grey literature databases were searched for relevant studies published between 1990 and 2015. The level of community participation and the methodological quality of the qualitative and quantitative components of the studies were assessed against standardised criteria. Thirty one evaluation studies of community development projects were identified. Community participation varied between different phases of project development, generally high during project implementation, but low during the evaluation phase. For the majority of studies, methodological quality was low and the methods were poorly described. Although positive qualitative or quantitative outcomes were reported in all studies, only two studies reported statistically significant outcomes. Partnerships between researchers, community members and service providers have great potential to improve methodological quality and community participation when research skills and community knowledge are integrated to design, implement and evaluate community development projects. The methodological quality of studies evaluating Australian Indigenous community development projects is currently too weak to confidently determine the cost-effectiveness of community development projects in improving the health and wellbeing of Indigenous Australians

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.

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

Standard Review Plan for Environmental Restoration Program Quality Management Plans. Revision 2

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

Not Available

1993-12-01

The Department of Energy, Richland Operations Office (RL) Manual Environmental Restoration Program Quality System Requirements (QSR) for the Hanford Site, defines all quality requirements governing Hanford Environmental Restoration (ER) Program activities. The QSR requires that ER Program participants develop Quality Management Plans (QMPs) that describe how the QSR requirements will be implemented for their assigned scopes of work. This standard review plan (SRP) describes the ER program participant responsibilities for submittal of QMPs to the RL Environmental Restoration Division for review and the RL methodology for performing the reviews of participant QMPS. The SRP serves the following functions: acts asmore » a guide in the development or revision of QMPs to assure that the content is complete and adequate; acts as a checklist to be used by the RL staff in their review of participant QMPs; acts as an index or matrix between the requirements of the QSR and implementing methodologies described in the QMPs; decreases the time and subjectivity of document reviews; and provides a formal, documented method for describing exceptions, modifications, or waivers to established ER Program quality requirements.« less

Quality and rigor of the concept mapping methodology: a pooled study analysis.

PubMed

Rosas, Scott R; Kane, Mary

2012-05-01

The use of concept mapping in research and evaluation has expanded dramatically over the past 20 years. Researchers in academic, organizational, and community-based settings have applied concept mapping successfully without the benefit of systematic analyses across studies to identify the features of a methodologically sound study. Quantitative characteristics and estimates of quality and rigor that may guide for future studies are lacking. To address this gap, we conducted a pooled analysis of 69 concept mapping studies to describe characteristics across study phases, generate specific indicators of validity and reliability, and examine the relationship between select study characteristics and quality indicators. Individual study characteristics and estimates were pooled and quantitatively summarized, describing the distribution, variation and parameters for each. In addition, variation in the concept mapping data collection in relation to characteristics and estimates was examined. Overall, results suggest concept mapping yields strong internal representational validity and very strong sorting and rating reliability estimates. Validity and reliability were consistently high despite variation in participation and task completion percentages across data collection modes. The implications of these findings as a practical reference to assess the quality and rigor for future concept mapping studies are discussed. Copyright © 2011 Elsevier Ltd. All rights reserved.

A Comparison of Methodological Approaches for Evaluating the Quality of Basic Skills Programs. AIR Forum 1982 Paper.

ERIC Educational Resources Information Center

Dumont, Richard G.; And Others

A multiple-indicator and multiple-design approach for evaluating the quality of basic skills programs in reading, writing, and mathematics that has been implemented within a statewide system of higher education in the southeastern United States was assessed. Several of the evaluation methodologies are compared in order to determine whether results…

The methodological quality of animal research in critical care: the public face of science.

PubMed

Bara, Meredith; Joffe, Ari R

2014-01-01

Animal research (AR) findings often do not translate to humans; one potential reason is the poor methodological quality of AR. We aimed to determine this quality of AR reported in critical care journals. All AR published from January to June 2012 in three high-impact critical care journals were reviewed. A case report form and instruction manual with clear definitions were created, based on published recommendations, including the ARRIVE guidelines. Data were analyzed with descriptive statistics. Seventy-seven AR publications were reviewed. Our primary outcome (animal strain, sex, and weight or age described) was reported in 52 (68%; 95% confidence interval, 56% to 77%). Of the 77 publications, 47 (61%) reported randomization; of these, 3 (6%) reported allocation concealment, and 1 (2%) the randomization procedure. Of the 77 publications, 31 (40%) reported some type of blinding; of these, disease induction (2, 7%), intervention (7, 23%), and/or subjective outcomes (17, 55%) were blinded. A sample size calculation was reported in 4/77 (5%). Animal numbers were missing in the Methods section in 16 (21%) publications; when stated, the median was 32 (range 6 to 320; interquartile range, 21 to 70). Extra animals used were mentioned in the Results section in 31 (40%) publications; this number was unclear in 23 (74%), and >100 for 12 (16%). When reporting most outcomes, numbers with denominators were given in 35 (45%), with no unaccounted numbers in 24 (31%), and no animals excluded from analysis in 20 (26%). Most (49, 64%) studies reported >40, and another 19 (25%) reported 21 to 40 statistical comparisons. Internal validity limitations were discussed in 7 (9%), and external validity (to humans) discussed in 71 (92%), most with no (30, 42%) or only a vague (9, 13%) limitation to this external validity mentioned. The reported methodological quality of AR was poor. Unless the quality of AR significantly improves, the practice may be in serious jeopardy of losing public

The methodological quality of animal research in critical care: the public face of science

PubMed Central

2014-01-01

Background Animal research (AR) findings often do not translate to humans; one potential reason is the poor methodological quality of AR. We aimed to determine this quality of AR reported in critical care journals. Methods All AR published from January to June 2012 in three high-impact critical care journals were reviewed. A case report form and instruction manual with clear definitions were created, based on published recommendations, including the ARRIVE guidelines. Data were analyzed with descriptive statistics. Results Seventy-seven AR publications were reviewed. Our primary outcome (animal strain, sex, and weight or age described) was reported in 52 (68%; 95% confidence interval, 56% to 77%). Of the 77 publications, 47 (61%) reported randomization; of these, 3 (6%) reported allocation concealment, and 1 (2%) the randomization procedure. Of the 77 publications, 31 (40%) reported some type of blinding; of these, disease induction (2, 7%), intervention (7, 23%), and/or subjective outcomes (17, 55%) were blinded. A sample size calculation was reported in 4/77 (5%). Animal numbers were missing in the Methods section in 16 (21%) publications; when stated, the median was 32 (range 6 to 320; interquartile range, 21 to 70). Extra animals used were mentioned in the Results section in 31 (40%) publications; this number was unclear in 23 (74%), and >100 for 12 (16%). When reporting most outcomes, numbers with denominators were given in 35 (45%), with no unaccounted numbers in 24 (31%), and no animals excluded from analysis in 20 (26%). Most (49, 64%) studies reported >40, and another 19 (25%) reported 21 to 40 statistical comparisons. Internal validity limitations were discussed in 7 (9%), and external validity (to humans) discussed in 71 (92%), most with no (30, 42%) or only a vague (9, 13%) limitation to this external validity mentioned. Conclusions The reported methodological quality of AR was poor. Unless the quality of AR significantly improves, the practice may be

Evaluation Methodology for UML and GML Application Schemas Quality

NASA Astrophysics Data System (ADS)

Chojka, Agnieszka

2014-05-01

INSPIRE Directive implementation in Poland has caused the significant increase of interest in making spatial data and services available, particularly among public administration and private institutions. This entailed a series of initiatives that aim to harmonise different spatial data sets, so to ensure their internal logical and semantic coherence. Harmonisation lets to reach the interoperability of spatial databases, then among other things enables joining them together. The process of harmonisation requires either working out new data structures or adjusting existing data structures of spatial databases to INSPIRE guidelines and recommendations. Data structures are described with the use of UML and GML application schemas. Although working out accurate and correct application schemas isn't an easy task. There should be considered many issues, for instance recommendations of ISO 19100 series of Geographic Information Standards, appropriate regulations for given problem or topic, production opportunities and limitations (software, tools). In addition, GML application schema is deeply connected with UML application schema, it should be its translation. Not everything that can be expressed in UML, though can be directly expressed in GML, and this can have significant influence on the spatial data sets interoperability, and thereby the ability to valid data exchange. For these reasons, the capability to examine and estimate UML and GML application schemas quality, therein also the capability to explore their entropy, would be very important. The principal subject of this research is to propose an evaluation methodology for UML and GML application schemas quality prepared in the Head Office of Geodesy and Cartography in Poland within the INSPIRE Directive implementation works.

Systematic reviews and meta-analyses on psoriasis: role of funding sources, conflict of interest and bibliometric indices as predictors of methodological quality.

PubMed

Gómez-García, F; Ruano, J; Aguilar-Luque, M; Gay-Mimbrera, J; Maestre-Lopez, B; Sanz-Cabanillas, J L; Carmona-Fernández, P J; González-Padilla, M; Vélez García-Nieto, A; Isla-Tejera, B

2017-06-01

The quality of systematic reviews and meta-analyses on psoriasis, a chronic inflammatory skin disease that severely impairs quality of life and is associated with high costs, remains unknown. To assess the methodological quality of systematic reviews published on psoriasis. After a comprehensive search in MEDLINE, Embase and the Cochrane Database (PROSPERO: CDR42016041611), the quality of studies was assessed by two raters using the Assessment of Multiple Systematic Reviews (AMSTAR) tool. Article metadata and journal-related bibliometric indices were also obtained. Systematic reviews were classified as low (0-4), moderate (5-8) or high (9-11) quality. A prediction model for methodological quality was fitted using principal component and multivariate ordinal logistic regression analyses. We classified 220 studies as high (17·2%), moderate (55·0%) or low (27·8%) quality. Lower compliance rates were found for AMSTAR question (Q)5 (list of studies provided, 11·4%), Q10 (publication bias assessed, 27·7%), Q4 (status of publication included, 39·5%) and Q1 (a priori design provided, 40·9%). Factors such as meta-analysis inclusion [odds ratio (OR) 6·22; 95% confidence interval (CI) 2·78-14·86], funding by academic institutions (OR 2·90, 95% CI 1·11-7·89), Article Influence score (OR 2·14, 95% CI 1·05-6·67), 5-year impact factor (OR 1·34, 95% CI 1·02-1·40) and article page count (OR 1·08, 95% CI 1·02-1·15) significantly predicted higher quality. A high number of authors with a conflict of interest (OR 0·90, 95% CI 0·82-0·99) was significantly associated with lower quality. The methodological quality of systematic reviews published about psoriasis remains suboptimal. The type of funding sources and author conflicts may compromise study quality, increasing the risk of bias. © 2017 British Association of Dermatologists.

General physicians do not take adequate travel histories.

PubMed

Price, Victoria A; Smith, Rachel A S; Douthwaite, Sam; Thomas, Sherine; Almond, D Solomon; Miller, Alastair R O; Beeching, Nicholas J; Thompson, Gail; Ustianowski, Andrew; Beadsworth, Mike B J

2011-01-01

Our aim was to document how often travel histories were taken and the quality of their content. Patients admitted over 2 months to acute medical units of two hospitals in the Northwest of England with a history of fever, rash, diarrhea, vomiting, jaundice, or presenting as "unwell post-travel" were identified. The initial medical clerking was assessed. A total of 132 relevant admissions were identified. A travel history was documented in only 26 patients (19.7%). Of the 16 patients who had traveled, there was no documentation of pretravel advice or of sexual/other activities abroad in 15 (93.8%) and 12 (75.0%) patients, respectively. There needs to be better awareness and education about travel-related illness and the importance of taking an adequate travel history. © 2011 International Society of Travel Medicine.

Methodological quality is underrated in systematic reviews and meta-analyses in health psychology.

PubMed

Oliveras, Isabel; Losilla, Josep-Maria; Vives, Jaume

2017-06-01

In this paper, we compile and describe the main approaches proposed in the literature to include methodological quality (MQ) or risk of bias (RoB) into research synthesis. We also meta-review how the RoB of observational primary studies is being assessed and to what extent the results are incorporated in the conclusions of research synthesis. Electronic databases were searched for systematic reviews or meta-analyses related to health and clinical psychology. A random sample of 90 reviews published between January 2010 and May 2016 was examined. A total of 46 reviews (51%) performed a formal assessment of the RoB of primary studies. Only 17 reviews (19%) linked the outcomes of quality assessment with the results of the review. According to the previous literature, our results corroborate the lack of guidance to incorporate the RoB assessment in the results of systematic reviews and meta-analyses. Our recommendation is to appraise MQ according to domains of RoB to rate the degree of credibility of the results of a research synthesis, as well as subgroup analysis or meta-regression as analytical methods to incorporate the quality assessment. Copyright © 2017 Elsevier Inc. All rights reserved.

Mobile and Web 2.0 interventions for weight management: an overview of review evidence and its methodological quality

PubMed Central

Smith, Jane R.; Samaha, Laya; Abraham, Charles

2016-01-01

Abstract Background : The use of Internet and related technologies for promoting weight management (WM), physical activity (PA), or dietary-related behaviours has been examined in many articles and systematic reviews. This overview aims to summarize and assess the quality of the review evidence specifically focusing on mobile and Web 2.0 technologies, which are the most utilized, currently available technologies. Methods: Following a registered protocol (CRD42014010323), we searched 16 databases for articles published in English until 31 December 2014 discussing the use of either mobile or Web 2.0 technologies to promote WM or related behaviors, i.e. diet and physical activity (PA). Two reviewers independently selected reviews and assessed their methodological quality using the AMSTAR checklist. Citation matrices were used to determine the overlap among reviews. Results: Forty-four eligible reviews were identified, 39 of which evaluated the effects of interventions using mobile or Web 2.0 technologies. Methodological quality was generally low with only 7 reviews (16%) meeting the highest standards. Suggestive evidence exists for positive effects of mobile technologies on weight-related outcomes and, to a lesser extent, PA. Evidence is inconclusive regarding Web 2.0 technologies. Conclusions : Reviews on mobile and Web 2.0 interventions for WM and related behaviors suggest that these technologies can, under certain circumstances, be effective, but conclusions are limited by poor review quality based on a heterogeneous evidence base. PMID:27335330

VALIDATION OF AMBIENT WATER QUALITY CRITERIA (AWQC) BIOACCUMULATION METHODOLOGY USING FIELD DATA FROM GREEN BAY AND THE HUDSON RIVER

EPA Science Inventory

In 1998, EPA published its draft revision to the methodology for deriving ambient water quality criteria to protect human health. Four methods were proposed to determine lipid-normalized bioaccumulation factors based on freely-dissolved water concentrations (BAFs) for nonpolar or...

41 CFR 105-68.900 - Adequate evidence.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 41 Public Contracts and Property Management 3 2010-07-01 2010-07-01 false Adequate evidence. 105-68.900 Section 105-68.900 Public Contracts and Property Management Federal Property Management... evidence. Adequate evidence means information sufficient to support the reasonable belief that a particular...

41 CFR 105-68.900 - Adequate evidence.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 41 Public Contracts and Property Management 3 2011-01-01 2011-01-01 false Adequate evidence. 105-68.900 Section 105-68.900 Public Contracts and Property Management Federal Property Management... evidence. Adequate evidence means information sufficient to support the reasonable belief that a particular...

41 CFR 105-68.900 - Adequate evidence.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 41 Public Contracts and Property Management 3 2013-07-01 2013-07-01 false Adequate evidence. 105-68.900 Section 105-68.900 Public Contracts and Property Management Federal Property Management... evidence. Adequate evidence means information sufficient to support the reasonable belief that a particular...

41 CFR 105-68.900 - Adequate evidence.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 41 Public Contracts and Property Management 3 2014-01-01 2014-01-01 false Adequate evidence. 105-68.900 Section 105-68.900 Public Contracts and Property Management Federal Property Management... evidence. Adequate evidence means information sufficient to support the reasonable belief that a particular...

41 CFR 105-68.900 - Adequate evidence.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 41 Public Contracts and Property Management 3 2012-01-01 2012-01-01 false Adequate evidence. 105-68.900 Section 105-68.900 Public Contracts and Property Management Federal Property Management... evidence. Adequate evidence means information sufficient to support the reasonable belief that a particular...

Toward the Long-Term Scientific Study of Encounter Group Phenomena: I. Methodological Considerations.

ERIC Educational Resources Information Center

Diamond, Michael Jay; Shapiro, Jerrold Lee

This paper proposes a model for the long-term scientific study of encounter, T-, and sensitivity groups. The authors see the need for overcoming major methodological and design inadequacies of such research. They discuss major methodological flaws in group outcome research as including: (1) lack of adequate base rate or pretraining measures; (2)…

[Satisfaction and perceived quality of people insured by the Social Health Protection in Mexico. Methodological foundations].

PubMed

Saturno-Hernández, Pedro J; Gutiérrez-Reyes, Juan Pablo; Vieyra-Romero, Waldo Ivan; Romero-Martínez, Martín; O'Shea-Cuevas, Gabriel Jaime; Lozano-Herrera, Javier; Tavera-Martínez, Sonia; Hernández-Ávila, Mauricio

2016-01-01

To describe the conceptual framework and methods for implementation and analysis of the satisfaction survey of the Mexican System for Social Protection in Health. We analyze the methodological elements of the 2013, 2014 and 2015 surveys, including the instrument, sampling method and study design, conceptual framework, and characteristics and indicators of the analysis. The survey captures information on perceived quality and satisfaction. Sampling has national and State representation. Simple and composite indicators (index of satisfaction and rate of reported quality problems) are built and described. The analysis is completed using Pareto diagrams, correlation between indicators and association with satisfaction by means of multivariate models. The measurement of satisfaction and perceived quality is a complex but necessary process to comply with regulations and to identify strategies for improvement. The described survey presents a design and rigorous analysis focused on its utility for improving.

Which Food Security Determinants Predict Adequate Vegetable Consumption among Rural Western Australian Children?

PubMed Central

Godrich, Stephanie L.; Lo, Johnny; Davies, Christina R.; Darby, Jill; Devine, Amanda

2017-01-01

Improving the suboptimal vegetable consumption among the majority of Australian children is imperative in reducing chronic disease risk. The objective of this research was to determine whether there was a relationship between food security determinants (FSD) (i.e., food availability, access, and utilisation dimensions) and adequate vegetable consumption among children living in regional and remote Western Australia (WA). Caregiver-child dyads (n = 256) living in non-metropolitan/rural WA completed cross-sectional surveys that included questions on FSD, demographics and usual vegetable intake. A total of 187 dyads were included in analyses, which included descriptive and logistic regression analyses via IBM SPSS (version 23). A total of 13.4% of children in this sample had adequate vegetable intake. FSD that met inclusion criteria (p ≤ 0.20) for multivariable regression analyses included price; promotion; quality; location of food outlets; variety of vegetable types; financial resources; and transport to outlets. After adjustment for potential demographic confounders, the FSD that predicted adequate vegetable consumption were, variety of vegetable types consumed (p = 0.007), promotion (p = 0.017), location of food outlets (p = 0.027), and price (p = 0.043). Food retail outlets should ensure that adequate varieties of vegetable types (i.e., fresh, frozen, tinned) are available, vegetable messages should be promoted through food retail outlets and in community settings, towns should include a range of vegetable purchasing options, increase their reliance on a local food supply and increase transport options to enable affordable vegetable purchasing. PMID:28054955

Which Food Security Determinants Predict Adequate Vegetable Consumption among Rural Western Australian Children?

PubMed

Godrich, Stephanie L; Lo, Johnny; Davies, Christina R; Darby, Jill; Devine, Amanda

2017-01-03

Improving the suboptimal vegetable consumption among the majority of Australian children is imperative in reducing chronic disease risk. The objective of this research was to determine whether there was a relationship between food security determinants (FSD) (i.e., food availability, access, and utilisation dimensions) and adequate vegetable consumption among children living in regional and remote Western Australia (WA). Caregiver-child dyads ( n = 256) living in non-metropolitan/rural WA completed cross-sectional surveys that included questions on FSD, demographics and usual vegetable intake. A total of 187 dyads were included in analyses, which included descriptive and logistic regression analyses via IBM SPSS (version 23). A total of 13.4% of children in this sample had adequate vegetable intake. FSD that met inclusion criteria ( p ≤ 0.20) for multivariable regression analyses included price; promotion; quality; location of food outlets; variety of vegetable types; financial resources; and transport to outlets. After adjustment for potential demographic confounders, the FSD that predicted adequate vegetable consumption were, variety of vegetable types consumed ( p = 0.007), promotion ( p = 0.017), location of food outlets ( p = 0.027), and price ( p = 0.043). Food retail outlets should ensure that adequate varieties of vegetable types (i.e., fresh, frozen, tinned) are available, vegetable messages should be promoted through food retail outlets and in community settings, towns should include a range of vegetable purchasing options, increase their reliance on a local food supply and increase transport options to enable affordable vegetable purchasing.

On the methodology of Engineering Geodesy

NASA Astrophysics Data System (ADS)

Brunner, Fritz K.

2007-09-01

Textbooks on geodetic surveying usually describe a very small number of principles which should provide the foundation of geodetic surveying. Here, the author argues that an applied field, such as engineering geodesy, has a methodology as foundation rather than a few principles. Ten methodological elements (ME) are identified: (1) Point discretisation of natural surfaces and objects, (2) distinction between coordinate and observation domain, (3) definition of reference systems, (4) specification of unknown parameters and desired precisions, (5) geodetic network and observation design, (6) quality control of equipment, (7) quality control of measurements, (8) establishment of measurement models, (9) establishment of parameter estimation models, (10) quality control of results. Each ME consists of a suite of theoretical developments, geodetic techniques and calculation procedures, which will be discussed. This paper is to be considered a first attempt at identifying the specific elements of the methodology of engineering geodesy. A better understanding of this methodology could lead to an increased objectivity, to a transformation of subjective practical experiences into objective working methods, and consequently to a new structure for teaching this rather diverse subject.

40 CFR 716.25 - Adequate file search.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 32 2013-07-01 2013-07-01 false Adequate file search. 716.25 Section 716.25 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT HEALTH AND SAFETY DATA REPORTING General Provisions § 716.25 Adequate file search. The scope of a...

40 CFR 716.25 - Adequate file search.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Adequate file search. 716.25 Section 716.25 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT HEALTH AND SAFETY DATA REPORTING General Provisions § 716.25 Adequate file search. The scope of a...

40 CFR 716.25 - Adequate file search.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 31 2014-07-01 2014-07-01 false Adequate file search. 716.25 Section 716.25 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT HEALTH AND SAFETY DATA REPORTING General Provisions § 716.25 Adequate file search. The scope of a...

40 CFR 716.25 - Adequate file search.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 32 2012-07-01 2012-07-01 false Adequate file search. 716.25 Section 716.25 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT HEALTH AND SAFETY DATA REPORTING General Provisions § 716.25 Adequate file search. The scope of a...

40 CFR 716.25 - Adequate file search.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 31 2011-07-01 2011-07-01 false Adequate file search. 716.25 Section 716.25 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT HEALTH AND SAFETY DATA REPORTING General Provisions § 716.25 Adequate file search. The scope of a...

Adequate supervision for children and adolescents.

PubMed

Anderst, James; Moffatt, Mary

2014-11-01

Primary care providers (PCPs) have the opportunity to improve child health and well-being by addressing supervision issues before an injury or exposure has occurred and/or after an injury or exposure has occurred. Appropriate anticipatory guidance on supervision at well-child visits can improve supervision of children, and may prevent future harm. Adequate supervision varies based on the child's development and maturity, and the risks in the child's environment. Consideration should be given to issues as wide ranging as swimming pools, falls, dating violence, and social media. By considering the likelihood of harm and the severity of the potential harm, caregivers may provide adequate supervision by minimizing risks to the child while still allowing the child to take "small" risks as needed for healthy development. Caregivers should initially focus on direct (visual, auditory, and proximity) supervision of the young child. Gradually, supervision needs to be adjusted as the child develops, emphasizing a safe environment and safe social interactions, with graduated independence. PCPs may foster adequate supervision by providing concrete guidance to caregivers. In addition to preventing injury, supervision includes fostering a safe, stable, and nurturing relationship with every child. PCPs should be familiar with age/developmentally based supervision risks, adequate supervision based on those risks, characteristics of neglectful supervision based on age/development, and ways to encourage appropriate supervision throughout childhood. Copyright 2014, SLACK Incorporated.

[Efficiency versus quality in the NHS, in Portugal: methodologies for evaluation].

PubMed

Giraldes, Maria do Rosário

2008-01-01

To proceed to the evaluation of the efficiency and quality in the NHS, based in methodologies of evaluation of management, indicators of benchmarking and indicators of process and outcome. The 1980 and 1990 decades have seen the proliferation of all forms of process indicators as a way to control health services. It is not a coincidence that the increase in managed care has been accompanied by an explosion of process indicators, as it has happened in the health system of the USA. More recently the attention has turned away from measures of performance, which measure the process (what has been done) to those which measure outcomes (what was the result). Quality indicators have been developed in Europe, first to be used in hospitals, but also to be used in primary health care. Conceptually the justification for the introduction of process indicators comes from the principle that their use will reinforce a modification in the quality of the proceedings, which will give origin to better outcomes as well at population level, as resource saving. Outcome indicators compared with process indicators in health care shows that process indicators have the advantage of being more sensitive than outcome indicators to differences in the quality. Optimizing health care quality has the objective of establishing a quantitative relationship between the quality of the health services and cost-effectiveness. To identify quality indicators and benchmarking and to implement plans to measure the quality of health care. In a study made in a group of senior GP, in the UK, with the objective of determining which process indicators better reflect the quality of the services in primary health care services a Delphi method was used. Only seven indicators were chosen by 75% of the respondents: the percentage of eligible patients receiving cervical screening; the percentage of generic prescribing; the percentage of eligible patients receiving childhood immunization; the percentage of eligible

Quality of life and related concepts in Parkinson's disease: a systematic review.

PubMed

Den Oudsten, Brenda L; Van Heck, Guus L; De Vries, Jolanda

2007-08-15

Several studies have investigated the quality of life (QOL) of patients with Parkinson's disease (PD). The purpose of this study was to review the conceptual and methodological quality of quality of life (QOL) studies among patients with PD and to identify factors associated with poor (HR)QOL. Computerized bibliographic databases were screened for publications from 1960 to January 2007. According to a list of predefined criteria, the methodological quality of the 61 studies, was moderate. The term 'QOL' was often used inappropriately. In fact, almost all studies in this review actually assessed health status (HS) instead of QOL. The functioning of patients with PD on physical, social, and emotional domains is affected by PD. Their HS seems to be lower when compared to healthy persons or patients with other chronic diseases. HS studies augment the insight in self-perceived functioning. Therefore, HS is conceived as a valuable construct. However, QOL is also an important factor in health care. Attention towards QOL is needed in order to draw valid conclusions regarding a person's subjective experience of well-being in a broad sense. In order to accomplish this, future studies should apply the QOL concept with more rigor, should use an adequate operational definition, and should employ sound measures. Copyright (c) 2007 Movement Disorder Society.

Indirect Lightning Safety Assessment Methodology

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

Ong, M M; Perkins, M P; Brown, C G

2009-04-24

Lightning is a safety hazard for high-explosives (HE) and their detonators. In the However, the current flowing from the strike point through the rebar of the building The methodology for estimating the risk from indirect lighting effects will be presented. It has two parts: a method to determine the likelihood of a detonation given a lightning strike, and an approach for estimating the likelihood of a strike. The results of these two parts produce an overall probability of a detonation. The probability calculations are complex for five reasons: (1) lightning strikes are stochastic and relatively rare, (2) the quality ofmore » the Faraday cage varies from one facility to the next, (3) RF coupling is inherently a complex subject, (4) performance data for abnormally stressed detonators is scarce, and (5) the arc plasma physics is not well understood. Therefore, a rigorous mathematical analysis would be too complex. Instead, our methodology takes a more practical approach combining rigorous mathematical calculations where possible with empirical data when necessary. Where there is uncertainty, we compensate with conservative approximations. The goal is to determine a conservative estimate of the odds of a detonation. In Section 2, the methodology will be explained. This report will discuss topics at a high-level. The reasons for selecting an approach will be justified. For those interested in technical details, references will be provided. In Section 3, a simple hypothetical example will be given to reinforce the concepts. While the methodology will touch on all the items shown in Figure 1, the focus of this report is the indirect effect, i.e., determining the odds of a detonation from given EM fields. Professor Martin Uman from the University of Florida has been characterizing and defining extreme lightning strikes. Using Professor Uman's research, Dr. Kimball Merewether at Sandia National Laboratory in Albuquerque calculated the EM fields inside a Faraday

Applying Statistical Process Quality Control Methodology to Educational Settings.

ERIC Educational Resources Information Center

Blumberg, Carol Joyce

A subset of Statistical Process Control (SPC) methodology known as Control Charting is introduced. SPC methodology is a collection of graphical and inferential statistics techniques used to study the progress of phenomena over time. The types of control charts covered are the null X (mean), R (Range), X (individual observations), MR (moving…

Progressive failure methodologies for predicting residual strength and life of laminated composites

NASA Technical Reports Server (NTRS)

Harris, Charles E.; Allen, David H.; Obrien, T. Kevin

1991-01-01

Two progressive failure methodologies currently under development by the Mechanics of Materials Branch at NASA Langley Research Center are discussed. The damage tolerance/fail safety methodology developed by O'Brien is an engineering approach to ensuring adequate durability and damage tolerance by treating only delamination onset and the subsequent delamination accumulation through the laminate thickness. The continuum damage model developed by Allen and Harris employs continuum damage laws to predict laminate strength and life. The philosophy, mechanics framework, and current implementation status of each methodology are presented.

Quality of Informal Care Is Multidimensional

PubMed Central

Christie, Juliette; Smith, G. Rush; Williamson, Gail M.; Lance, Charles. E.; Shovali, Tamar E.; Silva, Luciana

2010-01-01

Purpose To demonstrate that assessing quality of informal care involves more than merely determining whether care recipient needs for assistance with activities of daily living (ADLs) are satisfied on a routine basis. Potentially harmful behavior (PHB), adequate care, and exemplary care (EC) are conceptually distinct dimensions of quality of care. We investigated the extent to which these three dimensions also are empirically distinguishable. Design 237 care recipients completed the quality of care measures, and their caregivers completed psychosocial measures of depressed affect, life events, cognitive status, and perceived pre-illness relationship quality. Results Confirmatory factor analyses indicated that PHB, adequate care, and EC are empirically distinct factors. Although PHB was moderately related to EC, adequate care was not associated with PHB and was only slightly related to EC. Psychosocial variables were not related to adequate care but were differentially associated with PHB and EC, providing further evidence for the distinction between the measures of quality of care used in this study. Conclusions Assessing quality of informal care is a complex endeavor. ADL assistance can be adequate in the presence of PHB and/or the absence of EC. Declines in EC may signal increases in PHB, independent of adequacy of care. These findings produce a brief, portable, and more comprehensive instrument for assessing quality of informal care. PMID:19469607

Quality of care along the cancer continuum: does receiving adequate lymph node evaluation for colon cancer lead to comprehensive postsurgical care?

PubMed

Parsons, Helen M; Tuttle, Todd M; Kuntz, Karen M; Begun, James W; McGovern, Patricia M; Virnig, Beth A

2012-09-01

Among surgically treated patients with colon cancer, lower long-term mortality has been demonstrated in those with 12 or more lymph nodes evaluated. We examined whether patients receiving adequate lymph node evaluation were also more likely to receive comprehensive postsurgical care, leading to lower mortality. We used the 1992 to 2007 Surveillance, Epidemiology, and End Results (SEER)-Medicare data to identify surgically treated American Joint Committee on Cancer (AJCC) stage III colon cancer patients. We used chi-square analyses and logistic regression to evaluate the association between adequate (≥12) lymph node evaluation and receipt of postsurgical care (adjuvant chemotherapy, surveillance colonoscopy, CT scans, and CEA testing) and Cox proportional hazards regression to evaluate 10-year all-cause mortality, adjusting for postsurgical care. Among 17,906 surgically treated stage III colon cancer patients, adequate (≥12) lymph node evaluation was not associated with receiving comprehensive postsurgical care after adjustment for patient and tumor characteristics (p > 0.05 for all). Initially, adequate lymph node evaluation was associated with lower all-cause mortality (hazard ratio [HR] 0.88; 95% CI [0.85 to 0.91]), but among 3-year survivors, the impact of adequate lymph node evaluation on lower mortality was diminished (HR 0.94; 95% CI [0.88 to 1.01]). However, receiving comprehensive postsurgical care was associated with continued lower mortality in 3-year survivors. Adequate lymph node evaluation for colon cancer was associated with lower mortality among all patients. However, among 3-year survivors, the association between lymph node evaluation and lower hazard of death was no longer significant, while postsurgical care remained strongly associated with lower long-term mortality, indicating that postsurgical care may partially explain the relationship between lymph node evaluation and mortality. Copyright © 2012 American College of Surgeons. Published

10 CFR 1304.114 - Responsibility for maintaining adequate safeguards.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 4 2011-01-01 2011-01-01 false Responsibility for maintaining adequate safeguards. 1304.114 Section 1304.114 Energy NUCLEAR WASTE TECHNICAL REVIEW BOARD PRIVACY ACT OF 1974 § 1304.114 Responsibility for maintaining adequate safeguards. The Board has the responsibility for maintaining adequate...

10 CFR 1304.114 - Responsibility for maintaining adequate safeguards.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 4 2014-01-01 2014-01-01 false Responsibility for maintaining adequate safeguards. 1304.114 Section 1304.114 Energy NUCLEAR WASTE TECHNICAL REVIEW BOARD PRIVACY ACT OF 1974 § 1304.114 Responsibility for maintaining adequate safeguards. The Board has the responsibility for maintaining adequate...

10 CFR 1304.114 - Responsibility for maintaining adequate safeguards.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 4 2012-01-01 2012-01-01 false Responsibility for maintaining adequate safeguards. 1304.114 Section 1304.114 Energy NUCLEAR WASTE TECHNICAL REVIEW BOARD PRIVACY ACT OF 1974 § 1304.114 Responsibility for maintaining adequate safeguards. The Board has the responsibility for maintaining adequate...

10 CFR 1304.114 - Responsibility for maintaining adequate safeguards.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 4 2013-01-01 2013-01-01 false Responsibility for maintaining adequate safeguards. 1304.114 Section 1304.114 Energy NUCLEAR WASTE TECHNICAL REVIEW BOARD PRIVACY ACT OF 1974 § 1304.114 Responsibility for maintaining adequate safeguards. The Board has the responsibility for maintaining adequate...

Methodological and Statistical Quality in Research Evaluating Nutritional Attitudes in Sports.

PubMed

Kouvelioti, Rozalia; Vagenas, George

2015-12-01

The assessment of dietary attitudes and behaviors provides information of interest to sports nutritionists. Although there has been little analysis of the quality of research undertaken in this field, there is evidence of a number of flaws and methodological concerns in some of the studies in the available literature. This review undertook a systematic assessment of the attributes of research assessing the nutritional knowledge and attitudes of athletes and coaches. Sixty questionnaire-based studies were identified by a search of official databases using specific key terms with subsequent analysis by certain inclusion-exclusion criteria. These studies were then analyzed using 33 research quality criteria related to the methods, questionnaires, and statistics used. We found that many studies did not provide information on critical issues such as research hypotheses (92%), the gaining of ethics approval (50%) or informed consent (35%), or acknowledgment of limitations in the implementation of studies or interpretation of data (72%). Many of the samples were nonprobabilistic (85%) and rather small (42%). Many questionnaires were of unknown origin (30%), validity (72%), and reliability (70%) and resulted in low (≤ 60%) response rates (38%). Pilot testing was not undertaken in 67% of the studies. Few studies dealt with sample size (2%), power (3%), assumptions (7%), confidence intervals (3%), or effect sizes (3%). Improving some of these problems and deficits may enhance future research in this field.

[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.

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.

A critical appraisal of the methodology and quality of evidence of systematic reviews and meta-analyses of traditional Chinese medical nursing interventions: a systematic review of reviews

PubMed Central

Jin, Ying-Hui; Wang, Guo-Hao; Sun, Yi-Rong; Li, Qi; Zhao, Chen; Li, Ge; Si, Jin-Hua; Li, Yan; Lu, Cui; Shang, Hong-Cai

2016-01-01

Objective To assess the methodology and quality of evidence of systematic reviews and meta-analyses of traditional Chinese medical nursing (TCMN) interventions in Chinese journals. These interventions include acupressure, massage, Tai Chi, Qi Gong, electroacupuncture and use of Chinese herbal medicines—for example, in enemas, foot massage and compressing the umbilicus. Design A systematic literature search for systematic reviews and meta-analyses of TCMN interventions was performed. Review characteristics were extracted. The methodological quality and the quality of the evidence were evaluated using the Assessment of Multiple Systematic Reviews (AMSTAR) and Grading of Recommendations Assessment, Development and Evaluation (GRADE) approaches. Result We included 20 systematic reviews and meta-analyses, and a total of 11 TCMN interventions were assessed in the 20 reviews. The compliance with AMSTAR checklist items ranged from 4.5 to 8 and systematic reviews/meta-analyses were, on average, of medium methodological quality. The quality of the evidence we assessed ranged from very low to moderate; no high-quality evidence was found. The top two causes for downrating confidence in effect estimates among the 31 bodies of evidence assessed were the risk of bias and inconsistency. Conclusions There is room for improvement in the methodological quality of systematic reviews/meta-analyses of TCMN interventions published in Chinese journals. Greater efforts should be devoted to ensuring a more comprehensive search strategy, clearer specification of the interventions of interest in the eligibility criteria and identification of meaningful outcomes for clinicians and patients (consumers). The overall quality of evidence among reviews remains suboptimal, which raise concerns about their roles in influencing clinical practice. Thus, the conclusions in reviews we assessed must be treated with caution and their roles in influencing clinical practice should be limited. A critical

A novel methodology for interpreting air quality measurements from urban streets using CFD modelling

NASA Astrophysics Data System (ADS)

Solazzo, Efisio; Vardoulakis, Sotiris; Cai, Xiaoming

2011-09-01

In this study, a novel computational fluid dynamics (CFD) based methodology has been developed to interpret long-term averaged measurements of pollutant concentrations collected at roadside locations. The methodology is applied to the analysis of pollutant dispersion in Stratford Road (SR), a busy street canyon in Birmingham (UK), where a one-year sampling campaign was carried out between August 2005 and July 2006. Firstly, a number of dispersion scenarios are defined by combining sets of synoptic wind velocity and direction. Assuming neutral atmospheric stability, CFD simulations are conducted for all the scenarios, by applying the standard k-ɛ turbulence model, with the aim of creating a database of normalised pollutant concentrations at specific locations within the street. Modelled concentration for all wind scenarios were compared with hourly observed NO x data. In order to compare with long-term averaged measurements, a weighted average of the CFD-calculated concentration fields was derived, with the weighting coefficients being proportional to the frequency of each scenario observed during the examined period (either monthly or annually). In summary the methodology consists of (i) identifying the main dispersion scenarios for the street based on wind speed and directions data, (ii) creating a database of CFD-calculated concentration fields for the identified dispersion scenarios, and (iii) combining the CFD results based on the frequency of occurrence of each dispersion scenario during the examined period. The methodology has been applied to calculate monthly and annually averaged benzene concentration at several locations within the street canyon so that a direct comparison with observations could be made. The results of this study indicate that, within the simplifying assumption of non-buoyant flow, CFD modelling can aid understanding of long-term air quality measurements, and help assessing the representativeness of monitoring locations for population

The quality of reporting methods and results of cost-effectiveness analyses in Spain: a methodological systematic review.

PubMed

Catalá-López, Ferrán; Ridao, Manuel; Alonso-Arroyo, Adolfo; García-Altés, Anna; Cameron, Chris; González-Bermejo, Diana; Aleixandre-Benavent, Rafael; Bernal-Delgado, Enrique; Peiró, Salvador; Tabarés-Seisdedos, Rafael; Hutton, Brian

2016-01-07

Cost-effectiveness analysis has been recognized as an important tool to determine the efficiency of healthcare interventions and services. There is a need for evaluating the reporting of methods and results of cost-effectiveness analyses and establishing their validity. We describe and examine reporting characteristics of methods and results of cost-effectiveness analyses conducted in Spain during more than two decades. A methodological systematic review was conducted with the information obtained through an updated literature review in PubMed and complementary databases (e.g. Scopus, ISI Web of Science, National Health Service Economic Evaluation Database (NHS EED) and Health Technology Assessment (HTA) databases from Centre for Reviews and Dissemination (CRD), Índice Médico Español (IME) Índice Bibliográfico Español en Ciencias de la Salud (IBECS)). We identified cost-effectiveness analyses conducted in Spain that used quality-adjusted life years (QALYs) as outcome measures (period 1989-December 2014). Two reviewers independently extracted the data from each paper. The data were analysed descriptively. In total, 223 studies were included. Very few studies (10; 4.5 %) reported working from a protocol. Most studies (200; 89.7 %) were simulation models and included a median of 1000 patients. Only 105 (47.1 %) studies presented an adequate description of the characteristics of the target population. Most study interventions were categorized as therapeutic (189; 84.8 %) and nearly half (111; 49.8 %) considered an active alternative as the comparator. Effectiveness of data was derived from a single study in 87 (39.0 %) reports, and only few (40; 17.9 %) used evidence synthesis-based estimates. Few studies (42; 18.8 %) reported a full description of methods for QALY calculation. The majority of the studies (147; 65.9 %) reported that the study intervention produced "more costs and more QALYs" than the comparator. Most studies (200; 89.7 %) reported favourable

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

Testing the methodology for dosimetry audit of heterogeneity corrections and small MLC-shaped fields: Results of IAEA multi-center studies.

PubMed

Izewska, Joanna; Wesolowska, Paulina; Azangwe, Godfrey; Followill, David S; Thwaites, David I; Arib, Mehenna; Stefanic, Amalia; Viegas, Claudio; Suming, Luo; Ekendahl, Daniela; Bulski, Wojciech; Georg, Dietmar

2016-07-01

The International Atomic Energy Agency (IAEA) has a long tradition of supporting development of methodologies for national networks providing quality audits in radiotherapy. A series of co-ordinated research projects (CRPs) has been conducted by the IAEA since 1995 assisting national external audit groups developing national audit programs. The CRP 'Development of Quality Audits for Radiotherapy Dosimetry for Complex Treatment Techniques' was conducted in 2009-2012 as an extension of previously developed audit programs. The CRP work described in this paper focused on developing and testing two steps of dosimetry audit: verification of heterogeneity corrections, and treatment planning system (TPS) modeling of small MLC fields, which are important for the initial stages of complex radiation treatments, such as IMRT. The project involved development of a new solid slab phantom with heterogeneities containing special measurement inserts for thermoluminescent dosimeters (TLD) and radiochromic films. The phantom and the audit methodology has been developed at the IAEA and tested in multi-center studies involving the CRP participants. The results of multi-center testing of methodology for two steps of dosimetry audit show that the design of audit procedures is adequate and the methodology is feasible for meeting the audit objectives. A total of 97% TLD results in heterogeneity situations obtained in the study were within 3% and all results within 5% agreement with the TPS predicted doses. In contrast, only 64% small beam profiles were within 3 mm agreement between the TPS calculated and film measured doses. Film dosimetry results have highlighted some limitations in TPS modeling of small beam profiles in the direction of MLC leave movements. Through multi-center testing, any challenges or difficulties in the proposed audit methodology were identified, and the methodology improved. Using the experience of these studies, the participants could incorporate the auditing

Are normative sonographic values of kidney size in children valid and reliable? A systematic review of the methodological quality of ultrasound studies using the Anatomical Quality Assessment (AQUA) tool.

PubMed

Chhapola, Viswas; Tiwari, Soumya; Deepthi, Bobbity; Henry, Brandon Michael; Brar, Rekha; Kanwal, Sandeep Kumar

2018-06-01

A plethora of research is available on ultrasonographic kidney size standards. We performed a systematic review of methodological quality of ultrasound studies aimed at developing normative renal parameters in healthy children, by evaluating the risk of bias (ROB) using the 'Anatomical Quality Assessment (AQUA)' tool. We searched Medline, Scopus, CINAHL, and Google Scholar on June 04 2018, and observational studies measuring kidney size by ultrasonography in healthy children (0-18 years) were included. The ROB of each study was evaluated in five domains using a 20 item coding scheme based on AQUA tool framework. Fifty-four studies were included. Domain 1 (subject characteristics) had a high ROB in 63% of studies due to the unclear description of age, sex, and ethnicity. The performance in Domain 2 (study design) was the best with 85% of studies having a prospective design. Methodological characterization (Domain 3) was poor across the studies (< 10% compliance), with suboptimal performance in the description of patient positioning, operator experience, and assessment of intra/inter-observer reliability. About three-fourth of the studies had a low ROB in Domain 4 (descriptive anatomy). Domain 5 (reporting of results) had a high ROB in approximately half of the studies, the majority reporting results in the form of central tendency measures. Significant deficiencies and heterogeneity were observed in the methodological quality of USG studies performed to-date for measurement of kidney size in children. We hereby provide a framework for the conducting such studies in future. PROSPERO (CRD42017071601).

Quality of radiotherapy services in post-Soviet countries: An IAEA survey.

PubMed

Rosenblatt, Eduardo; Fidarova, Elena; Ghosh, Sunita; Zubizarreta, Eduardo; Unterkirhere, Olga; Semikoz, Natalia; Sinaika, Valery; Kim, Viktor; Karamyan, Nerses; Isayev, Isa; Akbarov, Kamal; Lomidze, Darejan; Bondareva, Oksana; Tuzlucov, Piotr; Zardodkhonova, Manzura; Tkachev, Sergey; Kislyakova, Marina; Alimov, Jamshid; Pidlubna, Tetiana; Barton, Michael; Mackillop, William

2018-04-25

The quality of radiotherapy services in post-Soviet countries has not yet been studied following a formal methodology. The IAEA conducted a survey using two sets of validated radiation oncology quality indicators (ROIs). Eleven post-Soviet countries were assessed. A coordinator was designated for each country and acted as the liaison between the country and the IAEA. The methodology was a one-time cross-sectional survey using a 58-question tool in Russian. The questionnaire was based on two validated sets of ROIs: for radiotherapy centres, the indicators proposed by Cionini et al., and for data at the country level, the Australasian ROIs. The overall response ratio was 66.3%, but for the Russian Federation, it was 24%. Data were updated on radiotherapy infrastructure and equipment. 256 radiotherapy centres are operating 275 linear accelerators and 337 Cobalt-60 units. 61% of teletherapy machines are older than ten years. Analysis of ROIs revealed significant differences between these countries and radiotherapy practices in the West. Naming, task profile and education programmes of radiotherapy professionals are different than in the West. Most countries need modernization of their radiotherapy infrastructure coupled with adequate staffing numbers and updated education programmes focusing on evidence-based medicine, quality, and safety. Copyright © 2018 Elsevier B.V. All rights reserved.

Prioritization Methodology for Chemical Replacement

NASA Technical Reports Server (NTRS)

Cruit, W.; Schutzenhofer, S.; Goldberg, B.; Everhart, K.

1993-01-01

This project serves to define an appropriate methodology for effective prioritization of efforts required to develop replacement technologies mandated by imposed and forecast legislation. The methodology used is a semiquantitative approach derived from quality function deployment techniques (QFD Matrix). This methodology aims to weigh the full environmental, cost, safety, reliability, and programmatic implications of replacement technology development to allow appropriate identification of viable candidates and programmatic alternatives. The results are being implemented as a guideline for consideration for current NASA propulsion systems.

Methodological convergence of program evaluation designs.

PubMed

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

2014-01-01

Nowadays, the confronting dichotomous view between experimental/quasi-experimental and non-experimental/ethnographic studies still exists but, despite the extensive use of non-experimental/ethnographic studies, the most systematic work on methodological quality has been developed based on experimental and quasi-experimental studies. This hinders evaluators and planners' practice of empirical program evaluation, a sphere in which the distinction between types of study is changing continually and is less clear. Based on the classical validity framework of experimental/quasi-experimental studies, we carry out a review of the literature in order to analyze the convergence of design elements in methodological quality in primary studies in systematic reviews and ethnographic research. We specify the relevant design elements that should be taken into account in order to improve validity and generalization in program evaluation practice in different methodologies from a practical methodological and complementary view. We recommend ways to improve design elements so as to enhance validity and generalization in program evaluation practice.

Cost-effectiveness analyses of hepatitis A vaccine: a systematic review to explore the effect of methodological quality on the economic attractiveness of vaccination strategies.

PubMed

Anonychuk, Andrea M; Tricco, Andrea C; Bauch, Chris T; Pham, Ba'; Gilca, Vladimir; Duval, Bernard; John-Baptiste, Ava; Woo, Gloria; Krahn, Murray

2008-01-01

Hepatitis A vaccines have been available for more than a decade. Because the burden of hepatitis A virus has fallen in developed countries, the appropriate role of vaccination programmes, especially universal vaccination strategies, remains unclear. Cost-effectiveness analysis is a useful method of relating the costs of vaccination to its benefits, and may inform policy. This article systematically reviews the evidence on the cost effectiveness of hepatitis A vaccination in varying populations, and explores the effects of methodological quality and key modelling issues on the cost-effectiveness ratios.Cost-effectiveness/cost-utility studies of hepatitis A vaccine were identified via a series of literature searches (MEDLINE, EMBASE, HSTAR and SSCI). Citations and full-text articles were reviewed independently by two reviewers. Reference searching, author searches and expert consultation ensured literature saturation. Incremental cost-effectiveness ratios (ICERs) were abstracted for base-case analyses, converted to $US, year 2005 values, and categorised to reflect various levels of cost effectiveness. Quality of reporting, methodological issues and key modelling issues were assessed using frameworks published in the literature.Thirty-one cost-effectiveness studies (including 12 cost-utility analyses) were included from full-text article review (n = 58) and citation screening (n = 570). These studies evaluated universal mass vaccination (n = 14), targeted vaccination (n = 17) and vaccination of susceptibles (i.e. individuals initially screened for antibody and, if susceptible, vaccinated) [n = 13]. For universal vaccination, 50% of the ICERs were <$US20 000 per QALY or life-year gained. Analyses evaluating vaccination in children, particularly in high incidence areas, produced the most attractive ICERs. For targeted vaccination, cost effectiveness was highly dependent on the risk of infection.Incidence, vaccine cost and discount rate were the most influential

Prioritization methodology for chemical replacement

NASA Technical Reports Server (NTRS)

Goldberg, Ben; Cruit, Wendy; Schutzenhofer, Scott

1995-01-01

This methodology serves to define a system for effective prioritization of efforts required to develop replacement technologies mandated by imposed and forecast legislation. The methodology used is a semi quantitative approach derived from quality function deployment techniques (QFD Matrix). QFD is a conceptual map that provides a method of transforming customer wants and needs into quantitative engineering terms. This methodology aims to weight the full environmental, cost, safety, reliability, and programmatic implications of replacement technology development to allow appropriate identification of viable candidates and programmatic alternatives.

The Concepts of Quality, Quality Assurance and Quality Enhancement

ERIC Educational Resources Information Center

Elassy, Noha

2015-01-01

Purpose: This paper aims to critically review and discuss different definitions of the concepts of quality, quality assurance (QA) and quality enhancement (QE) in higher education (HE) with presenting critical perspectives of the literature. Design/methodology/approach: The paper looks at literature concerns with the meaning of quality, QA and QE,…

Cost of Quality Evaluation Methodologies Handbook

DTIC Science & Technology

1988-07-28

policy. 2. Use multiple vendors for major procurements. 3. Establish a formal vendor qualification process. 4. Conduct joint quality planning; agree...and from which extrapolations and inter- polations may be extracted for estimating purposes. COST OF QUALITY - The costs of all efforts expended to...PRODUCIBILITY - The relative ease of producing an item or system which is governed by the characteristics and features of a design that enable

40 CFR 51.354 - Adequate tools and resources.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 2 2014-07-01 2014-07-01 false Adequate tools and resources. 51.354... Requirements § 51.354 Adequate tools and resources. (a) Administrative resources. The program shall maintain... assurance, data analysis and reporting, and the holding of hearings and adjudication of cases. A portion of...

40 CFR 51.354 - Adequate tools and resources.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 2 2011-07-01 2011-07-01 false Adequate tools and resources. 51.354... Requirements § 51.354 Adequate tools and resources. (a) Administrative resources. The program shall maintain... assurance, data analysis and reporting, and the holding of hearings and adjudication of cases. A portion of...

40 CFR 51.354 - Adequate tools and resources.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 2 2012-07-01 2012-07-01 false Adequate tools and resources. 51.354... Requirements § 51.354 Adequate tools and resources. (a) Administrative resources. The program shall maintain... assurance, data analysis and reporting, and the holding of hearings and adjudication of cases. A portion of...

40 CFR 51.354 - Adequate tools and resources.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 2 2013-07-01 2013-07-01 false Adequate tools and resources. 51.354... Requirements § 51.354 Adequate tools and resources. (a) Administrative resources. The program shall maintain... assurance, data analysis and reporting, and the holding of hearings and adjudication of cases. A portion of...

A critical appraisal of the methodology and quality of evidence of systematic reviews and meta-analyses of traditional Chinese medical nursing interventions: a systematic review of reviews.

PubMed

Jin, Ying-Hui; Wang, Guo-Hao; Sun, Yi-Rong; Li, Qi; Zhao, Chen; Li, Ge; Si, Jin-Hua; Li, Yan; Lu, Cui; Shang, Hong-Cai

2016-11-14

To assess the methodology and quality of evidence of systematic reviews and meta-analyses of traditional Chinese medical nursing (TCMN) interventions in Chinese journals. These interventions include acupressure, massage, Tai Chi, Qi Gong, electroacupuncture and use of Chinese herbal medicines-for example, in enemas, foot massage and compressing the umbilicus. A systematic literature search for systematic reviews and meta-analyses of TCMN interventions was performed. Review characteristics were extracted. The methodological quality and the quality of the evidence were evaluated using the Assessment of Multiple Systematic Reviews (AMSTAR) and Grading of Recommendations Assessment, Development and Evaluation (GRADE) approaches. We included 20 systematic reviews and meta-analyses, and a total of 11 TCMN interventions were assessed in the 20 reviews. The compliance with AMSTAR checklist items ranged from 4.5 to 8 and systematic reviews/meta-analyses were, on average, of medium methodological quality. The quality of the evidence we assessed ranged from very low to moderate; no high-quality evidence was found. The top two causes for downrating confidence in effect estimates among the 31 bodies of evidence assessed were the risk of bias and inconsistency. There is room for improvement in the methodological quality of systematic reviews/meta-analyses of TCMN interventions published in Chinese journals. Greater efforts should be devoted to ensuring a more comprehensive search strategy, clearer specification of the interventions of interest in the eligibility criteria and identification of meaningful outcomes for clinicians and patients (consumers). The overall quality of evidence among reviews remains suboptimal, which raise concerns about their roles in influencing clinical practice. Thus, the conclusions in reviews we assessed must be treated with caution and their roles in influencing clinical practice should be limited. A critical appraisal of systematic reviews

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

Can formal collaborative methodologies improve quality in primary health care in New Zealand? Insights from the EQUIPPED Auckland Collaborative.

PubMed

Palmer, Celia; Bycroft, Janine; Healey, Kate; Field, Adrian; Ghafel, Mazin

2012-12-01

Auckland District Health Board was one of four District Health Boards to trial the Breakthrough Series (BTS) methodology to improve the management of long-term conditions in New Zealand, with support from the Ministry of Health. To improve clinical outcomes, facilitate planned care and promote quality improvement within participating practices in Auckland. Implementation of the Collaborative followed the improvement model / Institute for Healthcare Improvement methodology. Three topic areas were selected: system redesign, cardio-vascular disease/diabetes, and self-management support. An expert advisory group and the Improvement Foundation Australia helped guide project development and implementation. Primary Health Organisation facilitators were trained in the methodology and 15 practice teams participated in the three learning workshops and action periods over 12 months. An independent evaluation study using both quantitative and qualitative methods was conducted. Improvements were recorded in cardiovascular disease risk assessment, practice-level systems of care, self-management systems and follow-up and coordination for patients. Qualitative research found improvements in coordination and teamwork, knowledge of practice populations and understanding of managing long-term conditions. The Collaborative process delivered some real improvements in the systems of care for people with long-term conditions and a change in culture among participating practices. The findings suggest that by strengthening facilitation processes, improving access to comprehensive population audit tools and lengthening the time frame, the process has the potential to make significant improvements in practice. Other organisations should consider this approach when investigating quality improvement programmes.

Appraisal of the methodological quality and summary of the findings of systematic reviews on the relationship between SSRIs and suicidality.

PubMed

Li, Wei; Li, Wei; Wan, Yumei; Ren, Juanjuan; Li, Ting; Li, Chunbo

2014-10-01

Several systematic reviews have been published about the relationship of the use of selective serotonin reuptake inhibitors (SSRIs) and risk of suicidal ideation or behavior but there has been no formal assessment of the quality of these reports. Assess the methodological quality of systematic reviews about the relationship of SSRI use and suicidal ideation and behavior; and provide overall conclusions based on this assessment. Systematic reviews of RCTs that compared SSRIs to placebo and used suicidal ideation or behavior as a key outcome variable were identified by searching Pubmed, Embase, The Cochrane Library, EBSCO, PsycINFO, Chinese National Knowledge Infrastructure, Chongqing VIP database for Chinese Technical Periodicals, WANFANG DATA, and the Chinese Biological Medical Literature Database. The methodological quality of included reviews was independently assessed by two expert raters using the 11-item Assessment of Multiple Systematic Reviews (AMSTAR) scale. Twelve systematic reviews and meta-analyses were identified. The inter-rater reliability of the overall AMSTAR quality score was excellent (ICC=0.86) but the inter-rater reliability of 5 of the 11 AMSTAR items was poor (Kappa <0.60). Based on the AMSTAR total score, there was one high-quality review, eight moderate-quality reviews, and three low-quality reviews. The high-quality review and three of the moderate-quality reviews reported a significantly increased risk of suicidal ideation or behavior in the SSRI group compared to the placebo group. Three of the four reviews limited to children and adolescents found a significantly increased risk of suicidal ideation or behavior with SSRI use which was most evident in teenagers taking paroxetine and in teenagers with depressive disorders. The available evidence suggests that adolescents may experience an increase in suicidal ideation and behavior with SSRI use, particularly those who have a depressive disorder and those treated with paroxetine. However

Non-pharmacological sleep interventions for youth with chronic health conditions: a critical review of the methodological quality of the evidence.

PubMed

Brown, Cary A; Kuo, Melissa; Phillips, Leah; Berry, Robyn; Tan, Maria

2013-07-01

Restorative sleep is clearly linked with well-being in youth with chronic health conditions. This review addresses the methodological quality of non-pharmacological sleep intervention (NPSI) research for youth with chronic health conditions. The Guidelines for Critical Review (GCR) and the Effective Public Health Practice Project Quality Assessment Tool (EPHPP) were used in the review. The search yielded 31 behavioural and 10 non-behavioural NPSI for review. Most studies had less than 10 participants. Autism spectrum disorders, attention deficit/hyperactivity disorders, down syndrome, intellectual disabilities, and visual impairments were the conditions that most studies focused upon. The global EPHPP scores indicated most reviewed studies were of weak quality. Only 7 studies were rated as moderate, none were strong. Studies rated as weak quality frequently had recruitment issues; non-blinded participants/parents and/or researchers; and used outcome measures without sound psychometric properties. Little conclusive evidence exists for NPSIs in this population. However, NPSIs are widely used and these preliminary studies demonstrate promising outcomes. There have not been any published reports of negative outcomes that would preclude application of the different NPSIs on a case-by-case basis guided by clinical judgement. These findings support the need for more rigorous, applied research. • Methodological Quality of Sleep Research • Disordered sleep (DS) in youth with chronic health conditions is pervasive and is important to rehabilitation therapists because DS contributes to significant functional problems across psychological, physical and emotional domains. • Rehabilitation therapists and other healthcare providers receive little education about disordered sleep and are largely unaware of the range of assessment and non-pharmacological intervention strategies that exist. An evidence-based website of pediatric sleep resources can be found at http

Fast methodology of analysing major steviol glycosides from Stevia rebaudiana leaves.

PubMed

Lorenzo, Cándida; Serrano-Díaz, Jéssica; Plaza, Miguel; Quintanilla, Carmen; Alonso, Gonzalo L

2014-08-15

The aim of this work is to propose an HPLC method for analysing major steviol glycosides as well as to optimise the extraction and clarification conditions for obtaining these compounds. Toward this aim, standards of stevioside and rebaudioside A with purities ⩾99.0%, commercial samples from different companies and Stevia rebaudiana Bertoni leaves from Paraguay supplied by Insobol, S.L., were used. The analytical method proposed is adequate in terms of selectivity, sensitivity and accuracy. Optimum extraction conditions and adequate clarification conditions have been set. Moreover, this methodology is safe and eco-friendly, as we use only water for extraction and do not use solid-phase extraction, which requires solvents that are banned in the food industry to condition the cartridge and elute the steviol glycosides. In addition, this methodology consumes little time as leaves are not ground and the filtration is faster, and the peak resolution is better as we used an HPLC method with gradient elution. Copyright © 2014 Elsevier Ltd. All rights reserved.

Methodological Quality of Systematic Reviews in Subfertility: A Comparison of Two Different Approaches

PubMed Central

Popovich, Ivor; Windsor, Bethany; Jordan, Vanessa; Showell, Marian; Shea, Bev; Farquhar, Cynthia M.

2012-01-01

Background Systematic reviews are used widely to guide health care decisions. Several tools have been created to assess systematic review quality. The measurement tool for assessing the methodological quality of systematic reviews known as the AMSTAR tool applies a yes/no score to eleven relevant domains of review methodology. This tool has been reworked so that each domain is scored based on a four point scale, producing R-AMSTAR. Methods and Findings We aimed to compare the AMSTAR and R-AMSTAR tools in assessing systematic reviews in the field of assisted reproduction for subfertility. All published systematic reviews on assisted reproductive technology, with the latest search for studies taking place from 2007–2011, were considered. Reviews that contained no included studies or considered diagnostic outcomes were excluded. Thirty each of Cochrane and non-Cochrane reviews were randomly selected from a search of relevant databases. Both tools were then applied to all sixty reviews. The results were converted to percentage scores and all reviews graded and ranked based on this. AMSTAR produced a much wider variation in percentage scores and achieved higher inter-rater reliability than R-AMSTAR according to kappa statistics. The average rating for Cochrane reviews was consistent between the two tools (88.3% for R-AMSTAR versus 83.6% for AMSTAR) but inconsistent for non-Cochrane reviews (63.9% R-AMSTAR vs. 38.5% AMSTAR). In comparing the rankings generated between the two tools Cochrane reviews changed an average of 4.2 places, compared to 2.9 for non-Cochrane. Conclusion R-AMSTAR provided greater guidance in the assessment of domains and produced quantitative results. However, there were many problems with the construction of its criteria and AMSTAR was much easier to apply consistently. We recommend that AMSTAR incorporates the findings of this study and produces additional guidance for its application in order to improve its reliability and usefulness. PMID

Impact of sampling techniques on measured stormwater quality data for small streams

USGS Publications Warehouse

Harmel, R.D.; Slade, R.M.; Haney, R.L.

2010-01-01

Science-based sampling methodologies are needed to enhance water quality characterization for setting appropriate water quality standards, developing Total Maximum Daily Loads, and managing nonpoint source pollution. Storm event sampling, which is vital for adequate assessment of water quality in small (wadeable) streams, is typically conducted by manual grab or integrated sampling or with an automated sampler. Although it is typically assumed that samples from a single point adequately represent mean cross-sectional concentrations, especially for dissolved constituents, this assumption of well-mixed conditions has received limited evaluation. Similarly, the impact of temporal (within-storm) concentration variability is rarely considered. Therefore, this study evaluated differences in stormwater quality measured in small streams with several common sampling techniques, which in essence evaluated within-channel and within-storm concentration variability. Constituent concentrations from manual grab samples and from integrated samples were compared for 31 events, then concentrations were also compared for seven events with automated sample collection. Comparison of sampling techniques indicated varying degrees of concentration variability within channel cross sections for both dissolved and particulate constituents, which is contrary to common assumptions of substantial variability in particulate concentrations and of minimal variability in dissolved concentrations. Results also indicated the potential for substantial within-storm (temporal) concentration variability for both dissolved and particulate constituents. Thus, failing to account for potential cross-sectional and temporal concentration variability in stormwater monitoring projects can introduce additional uncertainty in measured water quality data. Copyright ?? 2010 by the American Society of Agronomy, Crop Science Society of America, and Soil Science Society of America. All rights reserved.

[Dispatchers' impressions and actual quality of cardiopulmonary resuscitation during telephone-assisted bystander cardiopulmonary resuscitation: a pooled analysis of 94 simulated, manikin-based scenarios].

PubMed

van Tulder, Raphael; Roth, Dominik; Laggner, Roberta; Krammel, Mario; Schriefl, Christoph; Kienbacher, Calvin; Novosad, Heinz; Chwojka, Constantin Christof; Sterz, Fritz; Havel, Christof; Schreiber, Wolfgang; Herkner, Harald

2017-02-01

The quality of telephone-assisted cardiopulmonary resuscitation (CPR) needs improvement. This study investigates whether a dispatchers' perception is an adequate measure of the actual quality of CPR provided by laypersons. Individual participant data from 3 randomized simulation trials, with identical methodology but different interventions, were combined for this analysis. Professional dispatchers gave telephone assistance to laypersons, who each provided 10 minutes of CPR on a manikin. Dispatchers were requested to classify the quality of providers' CPR as adequate or inadequate. Based on actual readings from manikins we classified providers' performance as adequate at 5-6 cm for depth and 100-120 compressions per minute (cpm) for rate. We calculated metrics of dispatcher accuracy. Six dispatchers rated the performance of 94 laypersons (38 women [42%]) with a mean (SD) age of 37 (14) years. In 905 analyzed minutes of telephone-assisted CPR, the mean compression depth and rate was 41 (13) mm and 98 (24) cpm, respectively. Analysis of dispatchers' diagnostic test accuracy for adequate compression depth yielded a sensitivity of 65% (95 CI 36%-95%) and specificity of 42% (95% CI, 32%-53%). Analysis of their assessment of adequate compression rate yielded a sensitivity of 75% (95% CI, 64%-86%) and specificity of 42% (95% CI, 32%-52%). Although dispatchers always underestimated the actual values of CPR parameters, the female dispatchers evaluations were less inaccurate than the evaluations of make dispatchers; the dispatchers overall (males and females together) underestimated the adequacy of female laypersons' CPR performance to a greater degree than female dispatchers did. The ability of dispatchers to estimate the quality of telephone-assisted CPR is limited. Dispatchers estimates of CPR adequacy needs to be studied further in order to find ways that telephone-assisted CPR might be improved.

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.

Predictors of adequate depression treatment among Medicaid-enrolled adults.

PubMed

Teh, Carrie Farmer; Sorbero, Mark J; Mihalyo, Mark J; Kogan, Jane N; Schuster, James; Reynolds, Charles F; Stein, Bradley D

2010-02-01

To determine whether Medicaid-enrolled depressed adults receive adequate treatment for depression and to identify the characteristics of those receiving inadequate treatment. Claims data from a Medicaid-enrolled population in a large mid-Atlantic state between July 2006 and January 2008. We examined rates and predictors of minimally adequate psychotherapy and pharmacotherapy among adults with a new depression treatment episode during the study period (N=1,098). Many depressed adults received either minimally adequate psychotherapy or pharmacotherapy. Black individuals and individuals who began their depression treatment episode with an inpatient psychiatric stay for depression were markedly less likely to receive minimally adequate psychotherapy and more likely to receive inadequate treatment. Racial minorities and individuals discharged from inpatient treatment for depression are at risk for receiving inadequate depression treatment.

Inkjet printed large-area flexible circuits: a simple methodology for optimizing the printing quality

NASA Astrophysics Data System (ADS)

Cheng, Tao; Wu, Youwei; Shen, Xiaoqin; Lai, Wenyong; Huang, Wei

2018-01-01

In this work, a simple methodology was developed to enhance the patterning resolution of inkjet printing, involving process optimization as well as substrate modification and treatment. The line width of the inkjet-printed silver lines was successfully reduced to 1/3 of the original value using this methodology. Large-area flexible circuits with delicate patterns and good morphology were thus fabricated. The resultant flexible circuits showed excellent electrical conductivity as low as 4.5 Ω/□ and strong tolerance to mechanical bending. The simple methodology is also applicable to substrates with various wettability, which suggests a general strategy to enhance the printing quality of inkjet printing for manufacturing high-performance large-area flexible electronics. Project supported by the National Key Basic Research Program of China (Nos. 2014CB648300, 2017YFB0404501), the National Natural Science Foundation of China (Nos. 21422402, 21674050), the Natural Science Foundation of Jiangsu Province (Nos. BK20140060, BK20130037, BK20140865, BM2012010), the Program for Jiangsu Specially-Appointed Professors (No. RK030STP15001), the Program for New Century Excellent Talents in University (No. NCET-13-0872), the NUPT "1311 Project" and Scientific Foundation (Nos. NY213119, NY213169), the Synergetic Innovation Center for Organic Electronics and Information Displays, the Priority Academic Program Development of Jiangsu Higher Education Institutions (PAPD), the Leading Talent of Technological Innovation of National Ten-Thousands Talents Program of China, the Excellent Scientific and Technological Innovative Teams of Jiangsu Higher Education Institutions (No. TJ217038), the Program for Graduate Students Research and Innovation of Jiangsu Province (No. KYZZ16-0253), and the 333 Project of Jiangsu Province (Nos. BRA2017402, BRA2015374).

An ontological case base engineering methodology for diabetes management.

PubMed

El-Sappagh, Shaker H; El-Masri, Samir; Elmogy, Mohammed; Riad, A M; Saddik, Basema

2014-08-01

Ontology engineering covers issues related to ontology development and use. In Case Based Reasoning (CBR) system, ontology plays two main roles; the first as case base and the second as domain ontology. However, the ontology engineering literature does not provide adequate guidance on how to build, evaluate, and maintain ontologies. This paper proposes an ontology engineering methodology to generate case bases in the medical domain. It mainly focuses on the research of case representation in the form of ontology to support the case semantic retrieval and enhance all knowledge intensive CBR processes. A case study on diabetes diagnosis case base will be provided to evaluate the proposed methodology.

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.

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

Current psychometric and methodological issues in the measurement of overgeneral autobiographical memory.

PubMed

Griffith, James W; Sumner, Jennifer A; Raes, Filip; Barnhofer, Thorsten; Debeer, Elise; Hermans, Dirk

2012-12-01

Autobiographical memory is a multifaceted construct that is related to psychopathology and other difficulties in functioning. Across many studies, a variety of methods have been used to study autobiographical memory. The relationship between overgeneral autobiographical memory (OGM) and psychopathology has been of particular interest, and many studies of this cognitive phenomenon rely on the Autobiographical Memory Test (AMT) to assess it. In this paper, we examine several methodological approaches to studying autobiographical memory, and focus primarily on methodological and psychometric considerations in OGM research. We pay particular attention to what is known about the reliability, validity, and methodological variations of the AMT. The AMT has adequate psychometric properties, but there is great variability in methodology across studies that use it. Methodological recommendations and suggestions for future studies are presented. Copyright © 2011 Elsevier Ltd. All rights reserved.

An integrated quality function deployment and capital budgeting methodology for occupational safety and health as a systems thinking approach: the case of the construction industry.

PubMed

Bas, Esra

2014-07-01

In this paper, an integrated methodology for Quality Function Deployment (QFD) and a 0-1 knapsack model is proposed for occupational safety and health as a systems thinking approach. The House of Quality (HoQ) in QFD methodology is a systematic tool to consider the inter-relationships between two factors. In this paper, three HoQs are used to consider the interrelationships between tasks and hazards, hazards and events, and events and preventive/protective measures. The final priority weights of events are defined by considering their project-specific preliminary weights, probability of occurrence, and effects on the victim and the company. The priority weights of the preventive/protective measures obtained in the last HoQ are fed into a 0-1 knapsack model for the investment decision. Then, the selected preventive/protective measures can be adapted to the task design. The proposed step-by-step methodology can be applied to any stage of a project to design the workplace for occupational safety and health, and continuous improvement for safety is endorsed by the closed loop characteristic of the integrated methodology. Copyright © 2013 Elsevier Ltd. All rights reserved.

International drug price comparisons: quality assessment.

PubMed

Machado, Márcio; O'Brodovich, Ryan; Krahn, Murray; Einarson, Thomas R

2011-01-01

To quantitatively summarize results (i.e., prices and affordability) reported from international drug price comparison studies and assess their methodological quality. A systematic search of the most relevant databases-Medline, Embase, International Pharmaceutical Abstracts (IPA), and Scopus, from their inception to May 2009-was conducted to identify original research comparing international drug prices. International drug price information was extracted and recorded from accepted papers. Affordability was reported as drug prices adjusted for income. Study quality was assessed using six criteria: use of similar countries, use of a representative sample of drugs, selection of specific types of prices, identification of drug packaging, different weights on price indices, and the type of currency conversion used. Of the 1 828 studies identified, 21 were included. Only one study adequately addressed all quality issues. A large variation in study quality was observed due to the many methods used to conduct the drug price comparisons, such as different indices, economic parameters, price types, basket of drugs, and more. Thus, the quality of published studies was considered poor. Results varied across studies, but generally, higher income countries had higher drug prices. However, after adjusting drug prices for affordability, higher income countries had more affordable prices than lower income countries. Differences between drug prices and affordability in different countries were found. Low income countries reported less affordability of drugs, leaving room for potential problems with drug access, and consequently, a negative impact on health. The quality of the literature on this topic needs improvement.

Clinical practice guidelines for fertility preservation in young women undergoing gonadotoxic treatment: an overview and critical appraisal of methodological quality and content.

PubMed

Baysal, Özlem; Hamilton, Jozefien A M; Hamilton, Carl J C M; Braat, Didi D M; Beerendonk, Catharina C M; Nelen, Willianne L D M

2018-04-13

What is the methodological quality and content of internationally available clinical practice guidelines (CPGs) on fertility preservation (FP) care in adult women? Internationally available CPGs on FP care in adult women were identified after conducting an extensive literature search and consulting (inter)national key experts. The methodological quality of the CPGs was appraised by an (inter)national panel of experts using the Appraisal of Guidelines for Research and Evaluation (AGREE) II instrument. The content of the best CPGs, scoring ≥60% for the domain 'Rigour of development' of the AGREE II instrument, was extracted and categorized according to their topic. Thirty of the 1808 documents found were included. After consulting (inter)national key experts, 30 CPGs were included, six of which scored ≥60% for their 'Rigour of development'. The number of FP-related topics discussed by these six CPGs ranged from 4 to 12. The number of recommendations provided by the CPGs on these topics varied. The number of topics to which ≥5 recommendations were dedicated ranged from 0 to 4 between CPGs. CPGs on the subject of FP care are available, but there is room for improvement in quality and content. Although written for use in daily practice, the CPGs can also be used to develop quality indicators to monitor the quality of current FP care or to evaluate future improvement initiatives. Copyright © 2018 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.

Residency Training: Quality improvement projects in neurology residency and fellowship: applying DMAIC methodology.

PubMed

Kassardjian, Charles D; Williamson, Michelle L; van Buskirk, Dorothy J; Ernste, Floranne C; Hunderfund, Andrea N Leep

2015-07-14

Teaching quality improvement (QI) is a priority for residency and fellowship training programs. However, many medical trainees have had little exposure to QI methods. The purpose of this study is to review a rigorous and simple QI methodology (define, measure, analyze, improve, and control [DMAIC]) and demonstrate its use in a fellow-driven QI project aimed at reducing the number of delayed and canceled muscle biopsies at our institution. DMAIC was utilized. The project aim was to reduce the number of delayed muscle biopsies to 10% or less within 24 months. Baseline data were collected for 12 months. These data were analyzed to identify root causes for muscle biopsy delays and cancellations. Interventions were developed to address the most common root causes. Performance was then remeasured for 9 months. Baseline data were collected on 97 of 120 muscle biopsies during 2013. Twenty biopsies (20.6%) were delayed. The most common causes were scheduling too many tests on the same day and lack of fasting. Interventions aimed at patient education and biopsy scheduling were implemented. The effect was to reduce the number of delayed biopsies to 6.6% (6/91) over the next 9 months. Familiarity with QI methodologies such as DMAIC is helpful to ensure valid results and conclusions. Utilizing DMAIC, we were able to implement simple changes and significantly reduce the number of delayed muscle biopsies at our institution. © 2015 American Academy of Neurology.

Association between prospective registration and overall reporting and methodological quality of systematic reviews: a meta-epidemiological study.

PubMed

Ge, Long; Tian, Jin-Hui; Li, Ya-Nan; Pan, Jia-Xue; Li, Ge; Wei, Dang; Xing, Xin; Pan, Bei; Chen, Yao-Long; Song, Fu-Jian; Yang, Ke-Hu

2018-01-01

The aim of this study was to investigate the differences in main characteristics, reporting and methodological quality between prospectively registered and nonregistered systematic reviews. PubMed was searched to identify systematic reviews of randomized controlled trials published in 2015 in English. After title and abstract screening, potentially relevant reviews were divided into three groups: registered non-Cochrane reviews, Cochrane reviews, and nonregistered reviews. For each group, random number tables were generated in Microsoft Excel, and the first 50 eligible studies from each group were randomly selected. Data of interest from systematic reviews were extracted. Regression analyses were conducted to explore the association between total Revised Assessment of Multiple Systematic Review (R-AMSTAR) or Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) scores and the selected characteristics of systematic reviews. The conducting and reporting of literature search in registered reviews were superior to nonregistered reviews. Differences in 9 of the 11 R-AMSTAR items were statistically significant between registered and nonregistered reviews. The total R-AMSTAR score of registered reviews was higher than nonregistered reviews [mean difference (MD) = 4.82, 95% confidence interval (CI): 3.70, 5.94]. Sensitivity analysis by excluding the registration-related item presented similar result (MD = 4.34, 95% CI: 3.28, 5.40). Total PRISMA scores of registered reviews were significantly higher than nonregistered reviews (all reviews: MD = 1.47, 95% CI: 0.64-2.30; non-Cochrane reviews: MD = 1.49, 95% CI: 0.56-2.42). However, the difference in the total PRISMA score was no longer statistically significant after excluding the item related to registration (item 5). Regression analyses showed similar results. Prospective registration may at least indirectly improve the overall methodological quality of systematic reviews, although its impact

22 CFR 1006.900 - Adequate evidence.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 22 Foreign Relations 2 2014-04-01 2014-04-01 false Adequate evidence. 1006.900 Section 1006.900 Foreign Relations INTER-AMERICAN FOUNDATION GOVERNMENTWIDE DEBARMENT AND SUSPENSION (NONPROCUREMENT... reasonable belief that a particular act or omission has occurred. ...

22 CFR 1508.900 - Adequate evidence.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 22 Foreign Relations 2 2014-04-01 2014-04-01 false Adequate evidence. 1508.900 Section 1508.900 Foreign Relations AFRICAN DEVELOPMENT FOUNDATION GOVERNMENTWIDE DEBARMENT AND SUSPENSION (NONPROCUREMENT... reasonable belief that a particular act or omission has occurred. ...

Methodology or method? A critical review of qualitative case study reports.

PubMed

Hyett, Nerida; Kenny, Amanda; Dickson-Swift, Virginia

2014-01-01

Despite on-going debate about credibility, and reported limitations in comparison to other approaches, case study is an increasingly popular approach among qualitative researchers. We critically analysed the methodological descriptions of published case studies. Three high-impact qualitative methods journals were searched to locate case studies published in the past 5 years; 34 were selected for analysis. Articles were categorized as health and health services (n=12), social sciences and anthropology (n=7), or methods (n=15) case studies. The articles were reviewed using an adapted version of established criteria to determine whether adequate methodological justification was present, and if study aims, methods, and reported findings were consistent with a qualitative case study approach. Findings were grouped into five themes outlining key methodological issues: case study methodology or method, case of something particular and case selection, contextually bound case study, researcher and case interactions and triangulation, and study design inconsistent with methodology reported. Improved reporting of case studies by qualitative researchers will advance the methodology for the benefit of researchers and practitioners.

Methodology or method? A critical review of qualitative case study reports

PubMed Central

Hyett, Nerida; Kenny, Amanda; Dickson-Swift, Virginia

2014-01-01

Despite on-going debate about credibility, and reported limitations in comparison to other approaches, case study is an increasingly popular approach among qualitative researchers. We critically analysed the methodological descriptions of published case studies. Three high-impact qualitative methods journals were searched to locate case studies published in the past 5 years; 34 were selected for analysis. Articles were categorized as health and health services (n=12), social sciences and anthropology (n=7), or methods (n=15) case studies. The articles were reviewed using an adapted version of established criteria to determine whether adequate methodological justification was present, and if study aims, methods, and reported findings were consistent with a qualitative case study approach. Findings were grouped into five themes outlining key methodological issues: case study methodology or method, case of something particular and case selection, contextually bound case study, researcher and case interactions and triangulation, and study design inconsistent with methodology reported. Improved reporting of case studies by qualitative researchers will advance the methodology for the benefit of researchers and practitioners. PMID:24809980

Complicating Methodological Transparency

ERIC Educational Resources Information Center

Bridges-Rhoads, Sarah; Van Cleave, Jessica; Hughes, Hilary E.

2016-01-01

A historical indicator of the quality, validity, and rigor of qualitative research has been the documentation and disclosure of the behind-the-scenes work of the researcher. In this paper, we use what we call "methodological data" as a tool to complicate the possibility and desirability of such transparency. Specifically, we draw on our…

Testing the methodology for dosimetry audit of heterogeneity corrections and small MLC-shaped fields: Results of IAEA multi-center studies

PubMed Central

Izewska, Joanna; Wesolowska, Paulina; Azangwe, Godfrey; Followill, David S.; Thwaites, David I.; Arib, Mehenna; Stefanic, Amalia; Viegas, Claudio; Suming, Luo; Ekendahl, Daniela; Bulski, Wojciech; Georg, Dietmar

2016-01-01

Abstract The International Atomic Energy Agency (IAEA) has a long tradition of supporting development of methodologies for national networks providing quality audits in radiotherapy. A series of co-ordinated research projects (CRPs) has been conducted by the IAEA since 1995 assisting national external audit groups developing national audit programs. The CRP ‘Development of Quality Audits for Radiotherapy Dosimetry for Complex Treatment Techniques’ was conducted in 2009–2012 as an extension of previously developed audit programs. Material and methods. The CRP work described in this paper focused on developing and testing two steps of dosimetry audit: verification of heterogeneity corrections, and treatment planning system (TPS) modeling of small MLC fields, which are important for the initial stages of complex radiation treatments, such as IMRT. The project involved development of a new solid slab phantom with heterogeneities containing special measurement inserts for thermoluminescent dosimeters (TLD) and radiochromic films. The phantom and the audit methodology has been developed at the IAEA and tested in multi-center studies involving the CRP participants. Results. The results of multi-center testing of methodology for two steps of dosimetry audit show that the design of audit procedures is adequate and the methodology is feasible for meeting the audit objectives. A total of 97% TLD results in heterogeneity situations obtained in the study were within 3% and all results within 5% agreement with the TPS predicted doses. In contrast, only 64% small beam profiles were within 3 mm agreement between the TPS calculated and film measured doses. Film dosimetry results have highlighted some limitations in TPS modeling of small beam profiles in the direction of MLC leave movements. Discussion. Through multi-center testing, any challenges or difficulties in the proposed audit methodology were identified, and the methodology improved. Using the experience of these

[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

22 CFR 208.900 - Adequate evidence.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 22 Foreign Relations 1 2011-04-01 2011-04-01 false Adequate evidence. 208.900 Section 208.900 Foreign Relations AGENCY FOR INTERNATIONAL DEVELOPMENT GOVERNMENTWIDE DEBARMENT AND SUSPENSION... support the reasonable belief that a particular act or omission has occurred. ...

22 CFR 208.900 - Adequate evidence.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 22 Foreign Relations 1 2010-04-01 2010-04-01 false Adequate evidence. 208.900 Section 208.900 Foreign Relations AGENCY FOR INTERNATIONAL DEVELOPMENT GOVERNMENTWIDE DEBARMENT AND SUSPENSION... support the reasonable belief that a particular act or omission has occurred. ...

10 CFR 503.35 - Inability to obtain adequate capital.

Code of Federal Regulations, 2010 CFR

2010-01-01

... capital investment, through tariffs, without unreasonably adverse economic effect on its service area... 10 Energy 4 2010-01-01 2010-01-01 false Inability to obtain adequate capital. 503.35 Section 503... New Facilities § 503.35 Inability to obtain adequate capital. (a) Eligibility. Section 212(a)(1)(D) of...

"Something Adequate"? In Memoriam Seamus Heaney, Sister Quinlan, Nirbhaya

ERIC Educational Resources Information Center

Parker, Jan

2014-01-01

Seamus Heaney talked of poetry's responsibility to represent the "bloody miracle", the "terrible beauty" of atrocity; to create "something adequate". This article asks, what is adequate to the burning and eating of a nun and the murderous gang rape and evisceration of a medical student? It considers Njabulo Ndebele's…

Response surface methodology for predicting quality characteristics of beef patties added with flaxseed and tomato paste.

PubMed

Valenzuela Melendres, M; Camou, J P; Torrentera Olivera, N G; Alvarez Almora, E; González Mendoza, D; Avendaño Reyes, L; González Ríos, H

2014-05-01

Response surface methodology was used to study the effect of flaxseed flour (FS) and tomato paste (TP) addition, from 0 to 10% and 0 to 20% respectively, on beef patty quality characteristics. The assessed quality characteristics were color (L, a, and b), pH and texture profile analysis (TPA). Also, sensory analysis was performed for the assessment of color, juiciness, firmness, and general acceptance. FS addition reduced L and a values and decreased weight loss of cooked products (P<0.05). An opposite effect was observed when TP was added (P<0.05). All TPA parameters decreased when percentages of FS and TP were increased in the formulation of beef patties. Furthermore, FS and TP addition adversely affected the sensory characteristics of the cooked product (P<0.05); nevertheless, all sensory characteristics evaluated had an acceptable score (>5.6). Thus FS and TP are ingredients that can be used in beef patty preparation. Copyright © 2014 Elsevier Ltd. All rights reserved.

Clinical audit, a valuable tool to improve quality of care: General methodology and applications in nephrology.

PubMed

Esposito, Pasquale; Dal Canton, Antonio

2014-11-06

Evaluation and improvement of quality of care provided to the patients are of crucial importance in the daily clinical practice and in the health policy planning and financing. Different tools have been developed, including incident analysis, health technology assessment and clinical audit. The clinical audit consist of measuring a clinical outcome or a process, against well-defined standards set on the principles of evidence-based medicine in order to identify the changes needed to improve the quality of care. In particular, patients suffering from chronic renal diseases, present many problems that have been set as topics for clinical audit projects, such as hypertension, anaemia and mineral metabolism management. Although the results of these studies have been encouraging, demonstrating the effectiveness of audit, overall the present evidence is not clearly in favour of clinical audit. These findings call attention to the need to further studies to validate this methodology in different operating scenarios. This review examines the principle of clinical audit, focusing on experiences performed in nephrology settings.

2 CFR 180.900 - Adequate evidence.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 2 Grants and Agreements 1 2010-01-01 2010-01-01 false Adequate evidence. 180.900 Section 180.900 Grants and Agreements OFFICE OF MANAGEMENT AND BUDGET GOVERNMENTWIDE GUIDANCE FOR GRANTS AND AGREEMENTS... belief that a particular act or omission has occurred. ...

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.

Object-oriented analysis and design: a methodology for modeling the computer-based patient record.

PubMed

Egyhazy, C J; Eyestone, S M; Martino, J; Hodgson, C L

1998-08-01

The article highlights the importance of an object-oriented analysis and design (OOAD) methodology for the computer-based patient record (CPR) in the military environment. Many OOAD methodologies do not adequately scale up, allow for efficient reuse of their products, or accommodate legacy systems. A methodology that addresses these issues is formulated and used to demonstrate its applicability in a large-scale health care service system. During a period of 6 months, a team of object modelers and domain experts formulated an OOAD methodology tailored to the Department of Defense Military Health System and used it to produce components of an object model for simple order processing. This methodology and the lessons learned during its implementation are described. This approach is necessary to achieve broad interoperability among heterogeneous automated information systems.

Theory and research in audiology education: understanding and representing complexity through informed methodological decisions.

PubMed

Ng, Stella L

2013-05-01

The discipline of audiology has the opportunity to embark on research in education from an informed perspective, learning from professions that began this journey decades ago. The goal of this article is to position our discipline as a new member in the academic field of health professional education (HPE), with much to learn and contribute. In this article, I discuss the need for theory in informing HPE research. I also stress the importance of balancing our research goals by selecting appropriate methodologies for relevant research questions, to ensure that we respect the complexity of social processes inherent in HPE. Examples of relevant research questions are used to illustrate the need to consider alternative methodologies and to rethink the traditional hierarchy of evidence. I also provide an example of the thought processes and decisions that informed the design of an educational research study using a constructivist grounded theory methodology. As audiology enters the scholarly field of HPE, we need to arm ourselves with some of the knowledge and perspective that informs the field. Thus, we need to broaden our conceptions of what we consider to be appropriate styles of academic writing, relevant research questions, and valid evidence. Also, if we are to embark on qualitative inquiry into audiology education (or other audiology topics), we need to ensure that we conduct this research with an adequate understanding of the theories and methodologies informing such approaches. We must strive to conduct high quality, rigorous qualitative research more often than uninformed, generic qualitative research. These goals are imperative to the advancement of the theoretical landscape of audiology education and evolving the place of audiology in the field of HPE. American Academy of Audiology.

21 CFR 1404.900 - Adequate evidence.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 9 2011-04-01 2011-04-01 false Adequate evidence. 1404.900 Section 1404.900 Food and Drugs OFFICE OF NATIONAL DRUG CONTROL POLICY GOVERNMENTWIDE DEBARMENT AND SUSPENSION... support the reasonable belief that a particular act or omission has occurred. ...

29 CFR 1471.900 - Adequate evidence.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 29 Labor 4 2011-07-01 2011-07-01 false Adequate evidence. 1471.900 Section 1471.900 Labor Regulations Relating to Labor (Continued) FEDERAL MEDIATION AND CONCILIATION SERVICE GOVERNMENTWIDE DEBARMENT... information sufficient to support the reasonable belief that a particular act or omission has occurred. ...

21 CFR 1404.900 - Adequate evidence.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 9 2014-04-01 2014-04-01 false Adequate evidence. 1404.900 Section 1404.900 Food and Drugs OFFICE OF NATIONAL DRUG CONTROL POLICY GOVERNMENTWIDE DEBARMENT AND SUSPENSION... support the reasonable belief that a particular act or omission has occurred. ...

29 CFR 1471.900 - Adequate evidence.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 29 Labor 4 2014-07-01 2014-07-01 false Adequate evidence. 1471.900 Section 1471.900 Labor Regulations Relating to Labor (Continued) FEDERAL MEDIATION AND CONCILIATION SERVICE GOVERNMENTWIDE DEBARMENT... information sufficient to support the reasonable belief that a particular act or omission has occurred. ...

29 CFR 1471.900 - Adequate evidence.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 29 Labor 4 2012-07-01 2012-07-01 false Adequate evidence. 1471.900 Section 1471.900 Labor Regulations Relating to Labor (Continued) FEDERAL MEDIATION AND CONCILIATION SERVICE GOVERNMENTWIDE DEBARMENT... information sufficient to support the reasonable belief that a particular act or omission has occurred. ...

21 CFR 1404.900 - Adequate evidence.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 9 2013-04-01 2013-04-01 false Adequate evidence. 1404.900 Section 1404.900 Food and Drugs OFFICE OF NATIONAL DRUG CONTROL POLICY GOVERNMENTWIDE DEBARMENT AND SUSPENSION... support the reasonable belief that a particular act or omission has occurred. ...

21 CFR 1404.900 - Adequate evidence.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 9 2012-04-01 2012-04-01 false Adequate evidence. 1404.900 Section 1404.900 Food and Drugs OFFICE OF NATIONAL DRUG CONTROL POLICY GOVERNMENTWIDE DEBARMENT AND SUSPENSION... support the reasonable belief that a particular act or omission has occurred. ...

29 CFR 1471.900 - Adequate evidence.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 29 Labor 4 2010-07-01 2010-07-01 false Adequate evidence. 1471.900 Section 1471.900 Labor Regulations Relating to Labor (Continued) FEDERAL MEDIATION AND CONCILIATION SERVICE GOVERNMENTWIDE DEBARMENT... information sufficient to support the reasonable belief that a particular act or omission has occurred. ...

21 CFR 1404.900 - Adequate evidence.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Adequate evidence. 1404.900 Section 1404.900 Food and Drugs OFFICE OF NATIONAL DRUG CONTROL POLICY GOVERNMENTWIDE DEBARMENT AND SUSPENSION... support the reasonable belief that a particular act or omission has occurred. ...

29 CFR 1471.900 - Adequate evidence.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 29 Labor 4 2013-07-01 2013-07-01 false Adequate evidence. 1471.900 Section 1471.900 Labor Regulations Relating to Labor (Continued) FEDERAL MEDIATION AND CONCILIATION SERVICE GOVERNMENTWIDE DEBARMENT... information sufficient to support the reasonable belief that a particular act or omission has occurred. ...

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.

Using Indigenist and Indigenous methodologies to connect to deeper understandings of Aboriginal and Torres Strait Islander peoples' quality of life.

PubMed

Kite, Elaine; Davy, Carol

2015-12-01

The lack of a common description makes measuring the concept of quality of life (QoL) a challenge. Whether QoL incorporates broader social features or is attributed to health conditions, the diverse range of descriptions applied by various disciplines has resulted in a concept that is multidimensional and vague. The variety of theoretical conceptualisations of QoL confounds and confuses even the most astute. Measuring QoL in Aboriginal and Torres Strait Islander populations is even more challenging. Instruments commonly developed and used to measure QoL are often derived from research methodologies shaped by Western cultural perspectives. Often they are simply translated for use among culturally and linguistically diverse Aboriginal and Torres Strait Islander peoples. This has implications for Aboriginal and Torres Strait Islander populations whose perceptions of health are derived from within their specific cultures, value systems and ways of knowing and being. Interconnections and relationships between themselves, their communities, their environment and the natural and spiritual worlds are complex. The way in which their QoL is currently measured indicates that very little attention is given to the diversity of Aboriginal and Torres Strait Islander peoples' beliefs or the ways in which those beliefs shape or give structure and meaning to their health and their lives. The use of Indigenist or Indigenous methodologies in defining what Aboriginal and Torres Strait Islander peoples believe gives quality to their lives is imperative. These methodologies have the potential to increase the congruency between their perceptions of QoL and instruments to measure it.

Habit Reversal Treatment of Tic Disorders: A Methodological Critique of the Literature

ERIC Educational Resources Information Center

Carr, James E.; Chong, Ivy M.

2005-01-01

One of the most commonly reported and successful behavioral interventions for tic disorders is habit reversal (HR). Several narrative literature reviews have adequately summarized the outcomes of these studies. The purpose of this article was to review studies that used HR to treat tics in terms of their methodological characteristics and rigor.…

[Quality of clinical studies published in the RBGO over one decade (1999-2009): methodological and ethical aspects and statistical procedures].

PubMed

de Sá, Joceline Cássia Ferezini; Marini, Gabriela; Gelaleti, Rafael Bottaro; da Silva, João Batista; de Azevedo, George Gantas; Rudge, Marilza Vieira Cunha

2013-11-01

To evaluate the methodological and statistical design evolution of the publications in the Brazilian Journal of Gynecology and Obstetrics (RBGO) from resolution 196/96. A review of 133 articles published in 1999 (65) and 2009 (68) was performed by two independent reviewers with training in clinical epidemiology and methodology of scientific research. We included all original clinical articles, case and series reports and excluded editorials, letters to the editor, systematic reviews, experimental studies, opinion articles, besides abstracts of theses and dissertations. Characteristics related to the methodological quality of the studies were analyzed in each article using a checklist that evaluated two criteria: methodological aspects and statistical procedures. We used descriptive statistics and the χ2 test for comparison of the two years. There was a difference between 1999 and 2009 regarding the study and statistical design, with more accuracy in the procedures and the use of more robust tests between 1999 and 2009. In RBGO, we observed an evolution in the methods of published articles and a more in-depth use of the statistical analyses, with more sophisticated tests such as regression and multilevel analyses, which are essential techniques for the knowledge and planning of health interventions, leading to fewer interpretation errors.

[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.

Microbiological concerns and methodological approaches related to bacterial water quality in spaceflight

NASA Technical Reports Server (NTRS)

Pyle, Barry H.; Mcfeters, Gordon A.

1992-01-01

A number of microbiological issues are of critical importance to crew health and system performance in spacecraft water systems. This presentation reviews an army of these concerns which include factors that influence water treatment and disinfection in spaceflight such as biofilm formation and the physiological responses of bacteria in clean water systems. Factors associated with spaceflight like aerosol formation under conditions of microgravity are also discussed within the context of airborne infections such as Legionellosis. Finally, a spectrum of analytical approaches is reviewed to provide an evaluation of methodological alternatives that have been suggested or used to detect microorganisms of interest in water systems. These range from classical approaches employing colony formation on specific microbiological growth media to direct (i.e. microscopic) and indirect (e.g. electrochemical) methods as well as the use of molecular approaches and gene probes. These techniques are critically evaluated for their potential utility in determining microbiological water quality through the detection of microorganisms under the influence of ambient environmental stress inherent in spaceflight water systems.

Deformable Surface Accommodating Intraocular Lens: Second Generation Prototype Design Methodology and Testing.

PubMed

McCafferty, Sean J; Schwiegerling, Jim T

2015-04-01

Present an analysis methodology for developing and evaluating accommodating intraocular lenses incorporating a deformable interface. The next generation design of extruded gel interface intraocular lens is presented. A prototype based upon similar previously in vivo proven design was tested with measurements of actuation force, lens power, interface contour, optical transfer function, and visual Strehl ratio. Prototype verified mathematical models were used to optimize optical and mechanical design parameters to maximize the image quality and minimize the required force to accommodate. The prototype lens produced adequate image quality with the available physiologic accommodating force. The iterative mathematical modeling based upon the prototype yielded maximized optical and mechanical performance through maximum allowable gel thickness to extrusion diameter ratio, maximum feasible refractive index change at the interface, and minimum gel material properties in Poisson's ratio and Young's modulus. The design prototype performed well. It operated within the physiologic constraints of the human eye including the force available for full accommodative amplitude using the eye's natural focusing feedback, while maintaining image quality in the space available. The parameters that optimized optical and mechanical performance were delineated as those, which minimize both asphericity and actuation pressure. The design parameters outlined herein can be used as a template to maximize the performance of a deformable interface intraocular lens. The article combines a multidisciplinary basic science approach from biomechanics, optical science, and ophthalmology to optimize an intraocular lens design suitable for preliminary animal trials.

Methodological standards in single-case experimental design: Raising the bar.

PubMed

Ganz, Jennifer B; Ayres, Kevin M

2018-04-12

Single-case experimental designs (SCEDs), or small-n experimental research, are frequently implemented to assess approaches to improving outcomes for people with disabilities, particularly those with low-incidence disabilities, such as some developmental disabilities. SCED has become increasingly accepted as a research design. As this literature base is needed to determine what interventions are evidence-based practices, the acceptance of SCED has resulted in increased critiques with regard to methodological quality. Recent trends include recommendations from a number of expert scholars and institutions. The purpose of this article is to summarize the recent history of methodological quality considerations, synthesize the recommendations found in the SCED literature, and provide recommendations to researchers designing SCEDs with regard to essential and aspirational standards for methodological quality. Conclusions include imploring SCED to increase the quality of their experiments, with particular consideration regarding the applied nature of SCED research to be published in Research in Developmental Disabilities and beyond. Copyright © 2018 Elsevier Ltd. All rights reserved.

31 CFR 19.900 - Adequate evidence.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 31 Money and Finance: Treasury 1 2012-07-01 2012-07-01 false Adequate evidence. 19.900 Section 19.900 Money and Finance: Treasury Office of the Secretary of the Treasury GOVERNMENTWIDE DEBARMENT AND... sufficient to support the reasonable belief that a particular act or omission has occurred. ...

31 CFR 19.900 - Adequate evidence.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 31 Money and Finance: Treasury 1 2011-07-01 2011-07-01 false Adequate evidence. 19.900 Section 19.900 Money and Finance: Treasury Office of the Secretary of the Treasury GOVERNMENTWIDE DEBARMENT AND... sufficient to support the reasonable belief that a particular act or omission has occurred. ...

34 CFR 85.900 - Adequate evidence.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 34 Education 1 2011-07-01 2011-07-01 false Adequate evidence. 85.900 Section 85.900 Education Office of the Secretary, Department of Education GOVERNMENTWIDE DEBARMENT AND SUSPENSION (NONPROCUREMENT... reasonable belief that a particular act or omission has occurred. (Authority: E.O. 12549 (3 CFR, 1986 Comp...

31 CFR 19.900 - Adequate evidence.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 31 Money and Finance: Treasury 1 2014-07-01 2014-07-01 false Adequate evidence. 19.900 Section 19.900 Money and Finance: Treasury Office of the Secretary of the Treasury GOVERNMENTWIDE DEBARMENT AND... sufficient to support the reasonable belief that a particular act or omission has occurred. ...

31 CFR 19.900 - Adequate evidence.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 31 Money and Finance: Treasury 1 2010-07-01 2010-07-01 false Adequate evidence. 19.900 Section 19.900 Money and Finance: Treasury Office of the Secretary of the Treasury GOVERNMENTWIDE DEBARMENT AND... sufficient to support the reasonable belief that a particular act or omission has occurred. ...

34 CFR 85.900 - Adequate evidence.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 34 Education 1 2010-07-01 2010-07-01 false Adequate evidence. 85.900 Section 85.900 Education Office of the Secretary, Department of Education GOVERNMENTWIDE DEBARMENT AND SUSPENSION (NONPROCUREMENT... reasonable belief that a particular act or omission has occurred. Authority: E.O. 12549 (3 CFR, 1986 Comp., p...

31 CFR 19.900 - Adequate evidence.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 31 Money and Finance: Treasury 1 2013-07-01 2013-07-01 false Adequate evidence. 19.900 Section 19.900 Money and Finance: Treasury Office of the Secretary of the Treasury GOVERNMENTWIDE DEBARMENT AND... sufficient to support the reasonable belief that a particular act or omission has occurred. ...

The methodological quality of diagnostic test accuracy studies for musculoskeletal conditions can be improved.

PubMed

Henschke, Nicholas; Keuerleber, Julia; Ferreira, Manuela; Maher, Christopher G; Verhagen, Arianne P

2014-04-01

To provide an overview of reporting and methodological quality in diagnostic test accuracy (DTA) studies in the musculoskeletal field and evaluate the use of the QUality Assessment of Diagnostic Accuracy Studies (QUADAS) checklist. A literature review identified all systematic reviews that evaluated the accuracy of clinical tests to diagnose musculoskeletal conditions and used the QUADAS checklist. Two authors screened all identified reviews and extracted data on the target condition, index tests, reference standard, included studies, and QUADAS items. A descriptive analysis of the QUADAS checklist was performed, along with Rasch analysis to examine the construct validity and internal reliability. A total of 19 systematic reviews were included, which provided data on individual items of the QUADAS checklist for 392 DTA studies. In the musculoskeletal field, uninterpretable or intermediate test results are commonly not reported, with 175 (45%) studies scoring "no" to this item. The proportion of studies fulfilling certain items varied from 22% (item 11) to 91% (item 3). The interrater reliability of the QUADAS checklist was good and Rasch analysis showed excellent construct validity and internal consistency. This overview identified areas where the reporting and performance of diagnostic studies within the musculoskeletal field can be improved. Copyright © 2014 Elsevier Inc. All rights reserved.

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

Experienced quality factors: qualitative evaluation approach to audiovisual quality

NASA Astrophysics Data System (ADS)

Jumisko-Pyykkö, Satu; Häkkinen, Jukka; Nyman, Göte

2007-02-01

Subjective evaluation is used to identify impairment factors of multimedia quality. The final quality is often formulated via quantitative experiments, but this approach has its constraints, as subject's quality interpretations, experiences and quality evaluation criteria are disregarded. To identify these quality evaluation factors, this study examined qualitatively the criteria participants used to evaluate audiovisual video quality. A semi-structured interview was conducted with 60 participants after a subjective audiovisual quality evaluation experiment. The assessment compared several, relatively low audio-video bitrate ratios with five different television contents on mobile device. In the analysis, methodological triangulation (grounded theory, Bayesian networks and correspondence analysis) was applied to approach the qualitative quality. The results showed that the most important evaluation criteria were the factors of visual quality, contents, factors of audio quality, usefulness - followability and audiovisual interaction. Several relations between the quality factors and the similarities between the contents were identified. As a research methodological recommendation, the focus on content and usage related factors need to be further examined to improve the quality evaluation experiments.

A methodology to analyze the quality of health information on the internet: the example of diabetic neuropathy.

PubMed

Chumber, Sundeep; Huber, Jörg; Ghezzi, Pietro

2015-02-01

The purpose of this work was to evaluate the criteria used to assess the quality of information on diabetic neuropathy on the Internet. Different search engines (Google, Yahoo, Bing, and Ask) and 1 governmental health website (MedlinePlus) were studied. The websites returned (200 for each search engine) were then classified according to their affiliation (eg, commercial, professional, patient groups). A scoring system was devised from the literature to assess quality of information. Websites were also analyzed using the 2 most widely used instruments for assessing the quality of health information, the Journal of the American Medical Association (JAMA) scoring system and the Health On the Net Foundation (HON) certification. Professional websites or health portals scored better according to most criteria. Google and MedlinePlus returned results scoring significantly higher than other engines in some of the criteria. The use of different instruments gave different results and indicates that the JAMA score and the HON certification may not be sufficient ones. This methodology could be used to evaluate the reliability and trustworthiness of information on the Internet on different topics to identify topic areas or websites where the available information is not appropriate. © 2014 The Author(s).

A quality assessment of randomized controlled trial reports in endodontics.

PubMed

Lucena, C; Souza, E M; Voinea, G C; Pulgar, R; Valderrama, M J; De-Deus, G

2017-03-01

To assess the quality of the randomized clinical trial (RCT) reports published in Endodontics between 1997 and 2012. Retrieval of RCTs in Endodontics was based on a search of the Thomson Reuters Web of Science (WoS) database (March 2013). Quality evaluation was performed using a checklist based on the Jadad criteria, CONSORT (Consolidated Standards of Reporting Trials) statement and SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials). Descriptive statistics were used for frequency distribution of data. Student's t-test and Welch test were used to identify the influence of certain trial characteristics upon report quality (α = 0.05). A total of 89 RCTs were evaluated, and several methodological flaws were found: only 45% had random sequence generation at low risk of bias, 75% did not provide information on allocation concealment, and 19% were nonblinded designs. Regarding statistics, only 55% of the RCTs performed adequate sample size estimations, only 16% presented confidence intervals, and 25% did not provide the exact P-value. Also, 2% of the articles used no statistical tests, and in 87% of the RCTs, the information provided was insufficient to determine whether the statistical methodology applied was appropriate or not. Significantly higher scores were observed for multicentre trials (P = 0.023), RCTs signed by more than 5 authors (P = 0.03), articles belonging to journals ranked above the JCR median (P = 0.03), and articles complying with the CONSORT guidelines (P = 0.000). The quality of RCT reports in key areas for internal validity of the study was poor. Several measures, such as compliance with the CONSORT guidelines, are important in order to raise the quality of RCTs in Endodontics. © 2016 International Endodontic Journal. Published by John Wiley & Sons Ltd.

Clinical audit, a valuable tool to improve quality of care: General methodology and applications in nephrology

PubMed Central

Esposito, Pasquale; Dal Canton, Antonio

2014-01-01

Evaluation and improvement of quality of care provided to the patients are of crucial importance in the daily clinical practice and in the health policy planning and financing. Different tools have been developed, including incident analysis, health technology assessment and clinical audit. The clinical audit consist of measuring a clinical outcome or a process, against well-defined standards set on the principles of evidence-based medicine in order to identify the changes needed to improve the quality of care. In particular, patients suffering from chronic renal diseases, present many problems that have been set as topics for clinical audit projects, such as hypertension, anaemia and mineral metabolism management. Although the results of these studies have been encouraging, demonstrating the effectiveness of audit, overall the present evidence is not clearly in favour of clinical audit. These findings call attention to the need to further studies to validate this methodology in different operating scenarios. This review examines the principle of clinical audit, focusing on experiences performed in nephrology settings. PMID:25374819

Quality of Reporting of Bioequivalence Trials Comparing Generic to Brand Name Drugs: A Methodological Systematic Review

PubMed Central

van der Meersch, Amélie; Dechartres, Agnès; Ravaud, Philippe

2011-01-01

Background Generic drugs are used by millions of patients for economic reasons, so their evaluation must be highly transparent. Objective To assess the quality of reporting of bioequivalence trials comparing generic to brand-name drugs. Methodology/Principal Findings PubMed was searched for reports of bioequivalence trials comparing generic to brand-name drugs between January 2005 and December 2008. Articles were included if the aim of the study was to assess the bioequivalency of generic and brand-name drugs. We excluded case studies, pharmaco-economic evaluations, and validation dosage assays of drugs. We evaluated whether important information about funding, methodology, location of trials, and participants were reported. We also assessed whether the criteria required by the Food and Drug Administration (FDA) and the European Medicine Agency (EMA) to conclude bioequivalence were reported and that the conclusions were in agreement with the results. We identified 134 potentially relevant articles but eliminated 55 because the brand-name or generic drug status of the reference drug was unknown. Thus, we evaluated 79 articles. The funding source and location of the trial were reported in 41% and 56% of articles, respectively. The type of statistical analysis was reported in 94% of articles, but the methods to generate the randomization sequence and to conceal allocation were reported in only 15% and 5%, respectively. In total, 65 articles of single-dose trials (89%) concluded bioequivalence. Of these, 20 (31%) did not report the 3 criteria within the limits required by the FDA and 11 (17%) did not report the 2 criteria within the limits required by the EMA. Conclusions/Significance Important information to judge the validity and relevance of results are frequently missing in published reports of trials assessing generic drugs. The quality of reporting of such trials is in need of improvement. PMID:21858184

Quality of life assessment in children: a review of conceptual and methodological issues in multidimensional health status measures.

PubMed Central

Pal, D K

1996-01-01

STUDY OBJECTIVE: To clarify concepts and methodological problems in existing multidimensional health status measures for children. DESIGN: Thematic review of instruments found by computerised and manual searches, 1979-95. SUBJECTS: Nine health status instruments. MAIN RESULTS: Many instruments did not satisfy criteria of being child centered or family focussed; few had sufficient psychometric properties for research or clinical use; underlying conceptual assumptions were rarely explicit. CONCLUSIONS: Quality of life measures should be viewed cautiously. Interdisciplinary discussion is required, as well as discussion with children and parents, to establish constructs that are truly useful. PMID:8882220

Funding the Formula Adequately in Oklahoma

ERIC Educational Resources Information Center

Hancock, Kenneth

2015-01-01

This report is a longevity, simulational study that looks at how the ratio of state support to local support effects the number of school districts that breaks the common school's funding formula which in turns effects the equity of distribution to the common schools. After nearly two decades of adequately supporting the funding formula, Oklahoma…

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

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.

9 CFR 2.33 - Attending veterinarian and adequate veterinary care.

Code of Federal Regulations, 2010 CFR

2010-01-01

... veterinary care. 2.33 Section 2.33 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE... adequate veterinary care. (a) Each research facility shall have an attending veterinarian who shall provide adequate veterinary care to its animals in compliance with this section: (1) Each research facility shall...

9 CFR 2.33 - Attending veterinarian and adequate veterinary care.

Code of Federal Regulations, 2011 CFR

2011-01-01

... veterinary care. 2.33 Section 2.33 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE... adequate veterinary care. (a) Each research facility shall have an attending veterinarian who shall provide adequate veterinary care to its animals in compliance with this section: (1) Each research facility shall...

Evaluation of cross-cultural adaptation and measurement properties of breast cancer-specific quality-of-life questionnaires: a systematic review.

PubMed

Oliveira, Indiara Soares; da Cunha Menezes Costa, Lucíola; Fagundes, Felipe Ribeiro Cabral; Cabral, Cristina Maria Nunes

2015-05-01

To assess the procedures of translation, cross-cultural adaptation, and measurement properties of breast cancer-specific quality-of-life questionnaires. Searches were conducted in the databases MEDLINE, EMBASE, CINAHL, and SciELO using the keywords: "Questionnaires," "Quality of life," and "Breast cancer." The studies were analyzed in terms of methodological quality according to the guidelines for the procedure of cross-cultural adaptation and the quality criteria for measurement properties of questionnaires. We found 24 eligible studies. Most of the articles assessed the translation and measurement properties of the instrument EORTC QLQ-BR23. Description about translation and cross-cultural adaptation was incomplete in 11 studies. Translation and back translation were the most tested phases, and synthesis of the translation was the most omitted phase in the articles. Information on assessing measurement properties was provided incompletely in 23 articles. Internal consistency was the most tested property in all of the eligible articles, but none of them provided information on agreement. Construct validity was adequately tested in only three studies that used the FACT-B and QLQ-BR23. Eight articles provided information on reliability; however, only four found positive classification. Responsiveness was tested in four articles, and ceiling and floor effects were tested in only three articles. None of the instruments showed fully adequate quality. There is limited evidence on cross-cultural adaptations and measurement properties; therefore, it is recommended that caution be exercised when using breast cancer-specific quality-of-life questionnaires that have been translated, adapted, and tested.

Adequate Initial Antidepressant Treatment Among Patients With Chronic Obstructive Pulmonary Disease in a Cohort of Depressed Veterans

PubMed Central

Pirraglia, Paul A.; Charbonneau, Andrea; Kader, Boris; Berlowitz, Dan R.

2006-01-01

Objective: Depression is common among patients with chronic obstructive pulmonary disease (COPD). Patients with COPD may be more likely to have inadequate treatment with antidepressant medications. We tested the hypothesis that depressed patients with COPD have lower odds of adequate duration of antidepressant therapy in the first 3 months of treatment compared to those without COPD. Method: Using administrative and centralized pharmacy data from 14 northeastern Veterans Affairs Medical Centers, we identified 778 veterans with depression (ICD-9-CM codes 296.2x, 296.3x, and 311.xx) who were in the acute phase of antidepressant treatment from June 1, 1999, through August 31, 1999. Within this group, we identified those patients with COPD (23%). An adequate duration of antidepressant treatment was defined as ≥ 80% of days on an antidepressant. We used multivariable logistic regression models to determine the adjusted odds of adequate acute phase antidepressant treatment duration. Results: Those patients with COPD had markedly lower odds of adequate acute phase treatment duration (odds ratio = 0.67, 95% CI = 0.47 to 0.96); this was not observed with other medical diagnoses such as coronary heart disease, diabetes mellitus, or osteoarthritis. Conclusions: The first few months of treatment appears to be a critical period for depressed patients with COPD who are started on antidepressants. The causes for early antidepressant treatment inadequacy among patients with COPD require further investigation. More intensive efforts may be necessary early in the course of treatment to assure high-quality pharmacologic therapy of depressed patients with COPD. PMID:16862230

Distal biceps brachii tendon repair: a systematic review of patient outcome determination using modified Coleman methodology score criteria.

PubMed

Nyland, John; Causey, Brandon; Wera, Jeff; Krupp, Ryan; Tate, David; Gupta, Amit

2017-07-01

This systematic literature review evaluated the methodological research design quality of studies that evaluated patient outcomes following distal biceps brachii tendon repair and developed evidence-based recommendations for future patient clinical outcomes research. Following the preferred reporting items for systematic reviews and meta-analyses criteria, and using "biceps brachii", "tendon", "repair" and "outcome assessment" search terms, the CINAHL, Academic Search Premier and MEDLINE databases were searched from January 1960-October 2015. The modified Coleman methodology score (MCMS) served as the primary outcome measure. Descriptive statistical analysis was performed for composite and component MCMS and for patient outcome assessment methodology use frequency. A total of 93 studies were evaluated. Overall MCMS was low (57.1 ± 14). Only 12 (12.9 %) had prospective cohort or randomized controlled trial designs. There was a moderate relationship between publication year and MCMS (r = 0.53, P < 0.0001). Although 61 studies (65.6 %) had adequate surgical descriptions, only 3 (3.2 %) had well-described rehabilitation. Of 2253 subjects, only 39 (1.7 %) were women. Studies published after 2008 had higher MCMS scores than studies published earlier (61.3 ± 10 versus 52.9 ± 16, P = 0.003). Although overall research study methodological scores improved on average since 2008, generally low MCMS scores, retrospective designs, lack of eccentric elbow flexor or supinator strength testing, and poorly described surgical and rehabilitation descriptions remain commonplace. These findings decrease clinical study validity and generalizability. III.

Quality assurance methodology for Varian RapidArc treatment plans

PubMed Central

Cirino, Eileen T.; Xiong, Li; Mower, Herbert W.

2010-01-01

With the commercial introduction of the Varian RapidArc, a new modality for treatment planning and delivery, the need has arisen for consistent and efficient techniques for performing patient‐specific quality assurance (QA) tests. In this paper we present our methodology for a RapidArc treatment plan QA procedure. For our measurements we used a 2D diode array (MapCHECK) embedded at 5 cm water equivalent depth in MapPHAN 5 phantom and an Exradin A16 ion chamber placed in six different positions in a cylindrical homogeneous phantom (QUASAR). We also checked the MUs for the RapidArc plans by using independent software (RadCalc). The agreement between Eclipse calculations and MapCHECK/MapPHAN 5 measurements was evaluated using both absolute distance‐to‐agreement (DTA) and gamma index with 10% dose threshold (TH), 3% dose difference (DD), and 3 mm DTA. The average agreement was 94.4% for the DTA approach and 96.3% for the gamma index approach. In high‐dose areas, the discrepancy between calculations and ion chamber measurements using the QUASAR phantom was within 4.5% for prostate cases. For the RadCalc calculations, we used the average SSD along the arc; however, for some patients the agreement for the MUs obtained with RadCalc versus Eclipse was inadequate (discrepancy>5%). In these cases, the plan was divided into partial arc plans so that RadCalc could perform a better estimation of the MUs. The discrepancy was further reduced to within ~4% using this approach. Regardless of the variation in prescribed dose and location of the treated areas, we obtained very good results for all patients studied in this paper. PACS number: 87.55.Qr

Establishing equivalence: methodological progress in group-matching design and analysis.

PubMed

Kover, Sara T; Atwoo, Amy K

2013-01-01

This methodological review draws attention to the challenges faced by intellectual and developmental disabilities researchers in the appropriate design and analysis of group comparison studies. We provide a brief overview of matching methodologies in the field, emphasizing group-matching designs used in behavioral research on cognition and language in neurodevelopmental disorders, including autism spectrum disorder, Fragile X syndrome, Down syndrome, and Williams syndrome. The limitations of relying on p values to establish group equivalence are discussed in the context of other existing methods: equivalence tests, propensity scores, and regression-based analyses. Our primary recommendation for advancing research on intellectual and developmental disabilities is the use of descriptive indices of adequate group matching: effect sizes (i.e., standardized mean differences) and variance ratios.

Establishing Equivalence: Methodological Progress in Group-Matching Design and Analysis

PubMed Central

Kover, Sara T.; Atwood, Amy K.

2017-01-01

This methodological review draws attention to the challenges faced by intellectual and developmental disabilities researchers in the appropriate design and analysis of group comparison studies. We provide a brief overview of matching methodologies in the field, emphasizing group-matching designs utilized in behavioral research on cognition and language in neurodevelopmental disorders, including autism spectrum disorder, fragile X syndrome, Down syndrome, and Williams syndrome. The limitations of relying on p-values to establish group equivalence are discussed in the context of other existing methods: equivalence tests, propensity scores, and regression-based analyses. Our primary recommendation for advancing research on intellectual and developmental disabilities is the use of descriptive indices of adequate group matching: effect sizes (i.e., standardized mean differences) and variance ratios. PMID:23301899

The iodized salt programme in Bangalore, India provides adequate iodine intakes in pregnant women and more-than-adequate iodine intakes in their children.

PubMed

Jaiswal, Nidhi; Melse-Boonstra, Alida; Sharma, Surjeet Kaur; Srinivasan, Krishnamachari; Zimmermann, Michael B

2015-02-01

To compare the iodine status of pregnant women and their children who were sharing all meals in Bangalore, India. A cross-sectional study evaluating demographic characteristics, household salt iodine concentration and salt usage patterns, urinary iodine concentrations (UIC) in women and children, and maternal thyroid volume (ultrasound). Antenatal clinic of an urban tertiary-care hospital, which serves a low-income population. Healthy pregnant women in all trimesters, aged 18-35 years, who had healthy children aged 3-15 years. Median (range) iodine concentrations of household powdered and crystal salt were 55·9 (17·2-65·9) ppm and 18·9 (2·2-68·2) ppm, respectively. The contribution of iodine-containing supplements and multi-micronutrient powders to iodine intake in the families was negligible. Adequately iodized salt, together with small amounts of iodine in local foods, were providing adequate iodine during pregnancy: (i) the overall median (range) UIC in women was 172 (5-1024) µg/l; (ii) the median UIC was >150 µg/l in all trimesters; and (iii) thyroid size was not significantly different across trimesters. At the same time, the median (range) UIC in children was 220 (10-782) µg/l, indicating more-than-adequate iodine intake at this age. Median UIC was significantly higher in children than in their mothers (P=0·008). In this selected urban population of southern India, the iodized salt programme provides adequate iodine to women throughout pregnancy, at the expense of higher iodine intake in their children. Thus we suggest that the current cut-off for median UIC in children indicating more-than-adequate intake, recommended by the WHO/UNICEF/International Council for the Control of Iodine Deficiency Disorders may, need to be reconsidered.

The Detection of Individual and Group Values in Young People: Relevant Methodological Solutions

ERIC Educational Resources Information Center

Geger, A. E.

2011-01-01

Life values, value orientations, social attitudes, and other corresponding social collisions have been the object of many studies. Research on the values of youth in Russia is marred by methodological problems that have not been adequately addressed, and more careful approaches show that there may not be a finite list of values that are held and…

Systematic design methodology for robust genetic transistors based on I/O specifications via promoter-RBS libraries.

PubMed

Lee, Yi-Ying; Hsu, Chih-Yuan; Lin, Ling-Jiun; Chang, Chih-Chun; Cheng, Hsiao-Chun; Yeh, Tsung-Hsien; Hu, Rei-Hsing; Lin, Che; Xie, Zhen; Chen, Bor-Sen

2013-10-27

Synthetic genetic transistors are vital for signal amplification and switching in genetic circuits. However, it is still problematic to efficiently select the adequate promoters, Ribosome Binding Sides (RBSs) and inducer concentrations to construct a genetic transistor with the desired linear amplification or switching in the Input/Output (I/O) characteristics for practical applications. Three kinds of promoter-RBS libraries, i.e., a constitutive promoter-RBS library, a repressor-regulated promoter-RBS library and an activator-regulated promoter-RBS library, are constructed for systematic genetic circuit design using the identified kinetic strengths of their promoter-RBS components.According to the dynamic model of genetic transistors, a design methodology for genetic transistors via a Genetic Algorithm (GA)-based searching algorithm is developed to search for a set of promoter-RBS components and adequate concentrations of inducers to achieve the prescribed I/O characteristics of a genetic transistor. Furthermore, according to design specifications for different types of genetic transistors, a look-up table is built for genetic transistor design, from which we could easily select an adequate set of promoter-RBS components and adequate concentrations of external inducers for a specific genetic transistor. This systematic design method will reduce the time spent using trial-and-error methods in the experimental procedure for a genetic transistor with a desired I/O characteristic. We demonstrate the applicability of our design methodology to genetic transistors that have desirable linear amplification or switching by employing promoter-RBS library searching.

Systematic design methodology for robust genetic transistors based on I/O specifications via promoter-RBS libraries

PubMed Central

2013-01-01

Background Synthetic genetic transistors are vital for signal amplification and switching in genetic circuits. However, it is still problematic to efficiently select the adequate promoters, Ribosome Binding Sides (RBSs) and inducer concentrations to construct a genetic transistor with the desired linear amplification or switching in the Input/Output (I/O) characteristics for practical applications. Results Three kinds of promoter-RBS libraries, i.e., a constitutive promoter-RBS library, a repressor-regulated promoter-RBS library and an activator-regulated promoter-RBS library, are constructed for systematic genetic circuit design using the identified kinetic strengths of their promoter-RBS components. According to the dynamic model of genetic transistors, a design methodology for genetic transistors via a Genetic Algorithm (GA)-based searching algorithm is developed to search for a set of promoter-RBS components and adequate concentrations of inducers to achieve the prescribed I/O characteristics of a genetic transistor. Furthermore, according to design specifications for different types of genetic transistors, a look-up table is built for genetic transistor design, from which we could easily select an adequate set of promoter-RBS components and adequate concentrations of external inducers for a specific genetic transistor. Conclusion This systematic design method will reduce the time spent using trial-and-error methods in the experimental procedure for a genetic transistor with a desired I/O characteristic. We demonstrate the applicability of our design methodology to genetic transistors that have desirable linear amplification or switching by employing promoter-RBS library searching. PMID:24160305

Systematic review of the methodological quality of controlled trials evaluating Chinese herbal medicine in patients with rheumatoid arthritis.

PubMed

Pan, Xin; Lopez-Olivo, Maria A; Song, Juhee; Pratt, Gregory; Suarez-Almazor, Maria E

2017-03-01

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). 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. 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. 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. Studies evaluating CHM often fail to meet expected methodological criteria, and high-quality

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.

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

The quality of dietary intake methodology and reporting in child and adolescent obesity intervention trials: a systematic review.

PubMed

Burrows, T; Golley, R K; Khambalia, A; McNaughton, S A; Magarey, A; Rosenkranz, R R; Alllman-Farinelli, M; Rangan, A M; Truby, H; Collins, C

2012-12-01

Assessing dietary intake is important in evaluating childhood obesity intervention effectiveness. The purpose of this review was to evaluate the dietary intake methods and reporting in intervention studies that included a dietary component to treat overweight or obese children. A systematic review of studies published in the English language, between 1985 and August 2010 in health databases. The search identified 2,295 papers, of which 335 were retrieved and 31 met the inclusion criteria. Twenty-three studies reported energy intake as an outcome measure, 20 reported macronutrient intakes and 10 studies reported food intake outcomes. The most common dietary method employed was the food diary (n = 13), followed by 24-h recall (n = 5), food frequency questionnaire (FFQ) (n = 4) and dietary questionnaire (n = 4). The quality of the dietary intake methods reporting was rated as 'poor' in 15 studies (52%) and only 3 were rated as 'excellent'. The reporting quality of FFQs tended to be higher than food diaries/recalls. Deficiencies in the quality of dietary intake methods reporting in child obesity studies were identified. Use of a dietary intake methods reporting checklist is recommended. This will enable the quality of dietary intake results to be evaluated, and an increased ability to replicate study methodology by other researchers. © 2012 The Authors. obesity reviews © 2012 International Association for the Study of Obesity.

Getting quality in qualitative research: a short introduction to feminist methodology and methods.

PubMed

Landman, Maeve

2006-11-01

The present paper reflects a practical activity undertaken by the Nutrition Society's qualitative research network in October 2005. It reflects the structure of that exercise. First, there is an introduction to feminist methodology and methods. The informing premise is that feminist methodology is of particular interest to practitioners (professional and/or academic) engaged in occupations numerically dominated by women, such as nutritionists. A critical argument is made for a place for feminist methodology in related areas of social research. The discussion points to the differences that exist between various feminist commentators, although the central aims of feminist research are broadly shared. The paper comprises an overview of organizing concepts, discussion and questions posed to stimulate discussion on the design and process of research informed by feminist methodology. Issues arising from that discussion are summarized.

Analytical procedure validation and the quality by design paradigm.

PubMed

Rozet, Eric; Lebrun, Pierre; Michiels, Jean-François; Sondag, Perceval; Scherder, Tara; Boulanger, Bruno

2015-01-01

Since the adoption of the ICH Q8 document concerning the development of pharmaceutical processes following a quality by design (QbD) approach, there have been many discussions on the opportunity for analytical procedure developments to follow a similar approach. While development and optimization of analytical procedure following QbD principles have been largely discussed and described, the place of analytical procedure validation in this framework has not been clarified. This article aims at showing that analytical procedure validation is fully integrated into the QbD paradigm and is an essential step in developing analytical procedures that are effectively fit for purpose. Adequate statistical methodologies have also their role to play: such as design of experiments, statistical modeling, and probabilistic statements. The outcome of analytical procedure validation is also an analytical procedure design space, and from it, control strategy can be set.

IMSF: Infinite Methodology Set Framework

NASA Astrophysics Data System (ADS)

Ota, Martin; Jelínek, Ivan

Software development is usually an integration task in enterprise environment - few software applications work autonomously now. It is usually a collaboration of heterogeneous and unstable teams. One serious problem is lack of resources, a popular result being outsourcing, ‘body shopping’, and indirectly team and team member fluctuation. Outsourced sub-deliveries easily become black boxes with no clear development method used, which has a negative impact on supportability. Such environments then often face the problems of quality assurance and enterprise know-how management. The used methodology is one of the key factors. Each methodology was created as a generalization of a number of solved projects, and each methodology is thus more or less connected with a set of task types. When the task type is not suitable, it causes problems that usually result in an undocumented ad-hoc solution. This was the motivation behind formalizing a simple process for collaborative software engineering. Infinite Methodology Set Framework (IMSF) defines the ICT business process of adaptive use of methods for classified types of tasks. The article introduces IMSF and briefly comments its meta-model.

The research questions and methodological adequacy of clinical studies of the voice and larynx published in Brazilian and international journals.

PubMed

Vieira, Vanessa Pedrosa; De Biase, Noemi; Peccin, Maria Stella; Atallah, Alvaro Nagib

2009-06-01

To evaluate the methodological adequacy of voice and laryngeal study designs published in speech-language pathology and otorhinolaryngology journals indexed for the ISI Web of Knowledge (ISI Web) and the MEDLINE database. A cross-sectional study conducted at the Universidade Federal de São Paulo (Federal University of São Paulo). Two Brazilian speech-language pathology and otorhinolaryngology journals (Pró-Fono and Revista Brasileira de Otorrinolaringologia) and two international speech-language pathology and otorhinolaryngology journals (Journal of Voice, Laryngoscope), all dated between 2000 and 2004, were hand-searched by specialists. Subsequently, voice and larynx publications were separated, and a speech-language pathologist and otorhinolaryngologist classified 374 articles from the four journals according to objective and study design. The predominant objective contained in the articles was that of primary diagnostic evaluation (27%), and the most frequent study design was case series (33.7%). A mere 7.8% of the studies were designed adequately with respect to the stated objectives. There was no statistical difference in the methodological quality of studies indexed for the ISI Web and the MEDLINE database. The studies published in both national journals, indexed for the MEDLINE database, and international journals, indexed for the ISI Web, demonstrate weak methodology, with research poorly designed to meet the proposed objectives. There is much scientific work to be done in order to decrease uncertainty in the field analysed.

What Are the Strength of Recommendations and Methodologic Reporting in Health Economic Studies in Orthopaedic Surgery?

PubMed

Makhni, Eric C; Steinhaus, Michael E; Swart, Eric; Bozic, Kevin J

2015-10-01

intervention, adequate description of a comparator, study perspective clearly stated, and reported discount rate for future costs and quality-adjusted life years. Reporting costs variables included economic data collected alongside a clinical trial or another primary source and clear statement of the year of monetary units. Finally, results reporting included whether a sensitivity analysis was performed. Given that a considerable portion of orthopaedic cost-effectiveness studies provide weak recommendations and that methodologic reporting practices varied greatly among strong and weak studies, we believe that clinicians should exercise great caution when considering the conclusions of cost-effectiveness studies. Future research could assess the effect of such cost-effectiveness studies in clinical practice, and whether the strength of recommendations of a study's conclusions has any effect on practice patterns. Given the increasing use of cost-effectiveness studies in orthopaedic surgery, understanding the quality of these studies and the reasons that limit the ability of studies to provide more definitive recommendations is critical. Highlighting the heterogeneity of methodologic reporting practices will aid clinicians in interpreting the conclusions of cost-effectiveness studies and improve future research efforts.

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.

Region 8: Colorado Adequate Letter (10/29/2001)

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This letter from EPA to Colorado Department of Public Health and Environment determined Denvers' particulate matter (PM10) maintenance plan for Motor Vehicle Emissions Budgets adequate for transportation conformity purposes.

Region 1: Connecticut Adequate Letter (6/14/2017)

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Letter from Office of Ecosystem Protection to Connecticut Department of Energy & Environmental Protection determined submitted 2017 Motor Vehicle Emissions Budgets adequate for transportation conformity purposes, Greater Connecticut area. (March 20, 2017)

30 CFR 74.6 - Quality control.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Quality control. 74.6 Section 74.6 Mineral... of the CMDPSU will be maintained in production through adequate quality control procedures, MSHA and... DUST SAMPLING DEVICES Approval Requirements for Coal Mine Dust Personal Sampler Unit § 74.6 Quality...

Clinical practice guidelines and consensus statements in oncology--an assessment of their methodological quality.

PubMed

Jacobs, Carmel; Graham, Ian D; Makarski, Julie; Chassé, Michaël; Fergusson, Dean; Hutton, Brian; Clemons, Mark

2014-01-01

Consensus statements and clinical practice guidelines are widely available for enhancing the care of cancer patients. Despite subtle differences in their definition and purpose, these terms are often used interchangeably. We systematically assessed the methodological quality of consensus statements and clinical practice guidelines published in three commonly read, geographically diverse, cancer-specific journals. Methods Consensus statements and clinical practice guidelines published between January 2005 and September 2013 in Current Oncology, European Journal of Cancer and Journal of Clinical Oncology were evaluated. Each publication was assessed using the Appraisal of Guidelines for Research and Evaluation II (AGREE II) rigour of development and editorial independence domains. For assessment of transparency of document development, 7 additional items were taken from the Institute of Medicine's standards for practice guidelines and the Journal of Clinical Oncology guidelines for authors of guidance documents. Consensus statements and clinical practice guidelines published between January 2005 and September 2013 in Current Oncology, European Journal of Cancer and Journal of Clinical Oncology were evaluated. Each publication was assessed using the Appraisal of Guidelines for Research and Evaluation II (AGREE II) rigour of development and editorial independence domains. For assessment of transparency of document development, 7 additional items were taken from the Institute of Medicine's standards for practice guidelines and the Journal of Clinical Oncology guidelines for authors of guidance documents. Thirty-four consensus statements and 67 clinical practice guidelines were evaluated. The rigour of development score for consensus statements over the three journals was 32% lower than that of clinical practice guidelines. The editorial independence score was 15% lower for consensus statements than clinical practice guidelines. One journal scored consistently lower than

Systematic evaluation of the methodology of randomized controlled trials of anticoagulation in patients with cancer.

PubMed

Rada, Gabriel; Schünemann, Holger J; Labedi, Nawman; El-Hachem, Pierre; Kairouz, Victor F; Akl, Elie A

2013-02-14

Randomized controlled trials (RCTs) that are inappropriately designed or executed may provide biased findings and mislead clinical practice. In view of recent interest in the treatment and prevention of thrombotic complications in cancer patients we evaluated the characteristics, risk of bias and their time trends in RCTs of anticoagulation in patients with cancer. We conducted a comprehensive search, including a search of four electronic databases (MEDLINE, EMBASE, ISI the Web of Science, and CENTRAL) up to February 2010. We included RCTs in which the intervention and/or comparison consisted of: vitamin K antagonists, unfractionated heparin (UFH), low molecular weight heparin (LMWH), direct thrombin inhibitors or fondaparinux. We performed descriptive analyses and assessed the association between the variables of interest and the year of publication. We included 67 RCTs with 24,071 participants. In twenty one trials (31%) DVT diagnosis was triggered by clinical suspicion; the remaining trials either screened for DVT or were unclear about their approach. 41 (61%), 22 (33%), and 11 (16%) trials respectively reported on major bleeding, minor bleeding, and thrombocytopenia. The percentages of trials satisfying risk of bias criteria were: adequate sequence generation (85%), adequate allocation concealment (61%), participants' blinding (39%), data collectors' blinding (44%), providers' blinding (41%), outcome assessors' blinding (75%), data analysts' blinding (15%), intention to treat analysis (57%), no selective outcome reporting (12%), no stopping early for benefit (97%). The mean follow-up rate was 96%. Adequate allocation concealment and the reporting of intention to treat analysis were the only two quality criteria that improved over time. Many RCTs of anticoagulation in patients with cancer appear to use insufficiently rigorous outcome assessment methods and to have deficiencies in key methodological features. It is not clear whether this reflects a problem in the

Measuring quality in community based housing support - the QPC-H instrument.

PubMed

Lundqvist, Lars-Olov; Rask, Mikael; Brunt, David; Ivarsson, Ann-Britt; Schröder, Agneta

2016-04-18

Purpose - The purpose of this paper is to test the psychometric properties and dimensionality of the instrument Quality in Psychiatric Care-Housing (QPC-H) and briefly describe the residents' perception of quality of housing support. Design/methodology/approach - A sample of 174 residents from 22 housing support services in nine Swedish municipalities participated in the study. Confirmatory factor analysis (CFA) revealed that the QPC-H consisted of six dimensions and had a factor structure largely corresponding to that found among other instruments in the Quality in Psychiatric Care (QPC) family of instruments. Findings - CFA revealed that the QPC-H consisted of six dimensions and had a factor structure largely corresponding to that found among other instruments in the QPC family of instruments. The internal consistency of the factors was acceptable except in the case of secure and secluded environment, probably due to few numbers of items. With this exception, the QPC-H shows adequate psychometric properties. Social implications - The residents' ratings of quality of housing service were generally high; the highest rating was for secluded environment and the lowest for participation. This dimension would thus seem to indicate an important area for improvement. Originality/value - The QPC-H includes important aspects of residents' assessment of quality of housing service and offers a simple and inexpensive way to evaluate housing support services from the residents' perspective.

Development of an Optimization Methodology for the Aluminum Alloy Wheel Casting Process

NASA Astrophysics Data System (ADS)

Duan, Jianglan; Reilly, Carl; Maijer, Daan M.; Cockcroft, Steve L.; Phillion, Andre B.

2015-08-01

An optimization methodology has been developed for the aluminum alloy wheel casting process. The methodology is focused on improving the timing of cooling processes in a die to achieve improved casting quality. This methodology utilizes (1) a casting process model, which was developed within the commercial finite element package, ABAQUS™—ABAQUS is a trademark of Dassault Systèms; (2) a Python-based results extraction procedure; and (3) a numerical optimization module from the open-source Python library, Scipy. To achieve optimal casting quality, a set of constraints have been defined to ensure directional solidification, and an objective function, based on the solidification cooling rates, has been defined to either maximize, or target a specific, cooling rate. The methodology has been applied to a series of casting and die geometries with different cooling system configurations, including a 2-D axisymmetric wheel and die assembly generated from a full-scale prototype wheel. The results show that, with properly defined constraint and objective functions, solidification conditions can be improved and optimal cooling conditions can be achieved leading to process productivity and product quality improvements.

Assessment of Registration Information on Methodological Design of Acupuncture RCTs: A Review of 453 Registration Records Retrieved from WHO International Clinical Trials Registry Platform

PubMed Central

Gu, Jing; Wang, Qi; Wang, Xiaogang; Li, Hailong; Gu, Mei; Ming, Haixia; Dong, Xiaoli; Yang, Kehu; Wu, Hongyan

2014-01-01

Background. This review provides the first methodological information assessment of protocol of acupuncture RCTs registered in WHO International Clinical Trials Registry Platform (ICTRP). Methods. All records of acupuncture RCTs registered in the ICTRP have been collected. The methodological design assessment involved whether the randomization methods, allocation concealment, and blinding were adequate or not based on the information of registration records (protocols of acupuncture RCTs). Results. A total of 453 records, found in 11 registries, were examined. Methodological details were insufficient in registration records; there were 76.4%, 89.0%, and 21.4% records that did not provide information on randomization methods, allocation concealment, and blinding respectively. The proportions of adequate randomization methods, allocation concealment, and blinding were only 107 (23.6%), 48 (10.6%), and 210 (46.4%), respectively. The methodological design improved year by year, especially after 2007. Additionally, methodology of RCTs with ethics approval was clearly superior to those without ethics approval and different among registries. Conclusions. The overall methodological design based on registration records of acupuncture RCTs is not very well but improved year by year. The insufficient information on randomization methods, allocation concealment, and blinding maybe due to the relevant description is not taken seriously in acupuncture RCTs' registration. PMID:24688591

Assessment of Registration Information on Methodological Design of Acupuncture RCTs: A Review of 453 Registration Records Retrieved from WHO International Clinical Trials Registry Platform.

PubMed

Gu, Jing; Wang, Qi; Wang, Xiaogang; Li, Hailong; Gu, Mei; Ming, Haixia; Dong, Xiaoli; Yang, Kehu; Wu, Hongyan

2014-01-01

Background. This review provides the first methodological information assessment of protocol of acupuncture RCTs registered in WHO International Clinical Trials Registry Platform (ICTRP). Methods. All records of acupuncture RCTs registered in the ICTRP have been collected. The methodological design assessment involved whether the randomization methods, allocation concealment, and blinding were adequate or not based on the information of registration records (protocols of acupuncture RCTs). Results. A total of 453 records, found in 11 registries, were examined. Methodological details were insufficient in registration records; there were 76.4%, 89.0%, and 21.4% records that did not provide information on randomization methods, allocation concealment, and blinding respectively. The proportions of adequate randomization methods, allocation concealment, and blinding were only 107 (23.6%), 48 (10.6%), and 210 (46.4%), respectively. The methodological design improved year by year, especially after 2007. Additionally, methodology of RCTs with ethics approval was clearly superior to those without ethics approval and different among registries. Conclusions. The overall methodological design based on registration records of acupuncture RCTs is not very well but improved year by year. The insufficient information on randomization methods, allocation concealment, and blinding maybe due to the relevant description is not taken seriously in acupuncture RCTs' registration.

Evacuated blood-collection tubes for haematological tests - a quality evaluation prior to their intended use for specimen collection.

PubMed

Gros, Nataša

2013-05-01

An inappropriate anticoagulant concentration in a blood sample can cause cell shrinkage and affect the haematocrit and mean corpuscular volume (MCV). In evacuated blood-collection tubes there are two parameters affecting the quality of the product: the anticoagulant amount introduced into the tube during its production and the internal under-pressure at the instant of the blood-specimen collection affecting the draw-volume. No testing procedures that would give an insight into the anticoagulant concentration that can be expected for blood samples after specimen collection have been available up until now. The methodology suggested here combines the draw-volume test performed with deionised water using a laboratory made measuring device, and a conductivity measurement. The corrections taking into account the air pressure and ambient temperature provide an insight into the anticoagulant concentration that can be expected for blood samples. Results presented in the form of a nomogram facilitate the routine use of the suggested methodology. Our 338-day study confirmed significant differences and variations in the quality and the anticoagulant concentrations of the K₃EDTA and K2EDTA tubes of different producers and identified different examples of non-compliance with the norms during the shelf life of the tubes. The quality evaluation of the evacuated blood-collection tubes prior to their intended use as suggested here can, in everyday laboratory practice, ensure that the tubes are used only if, and only until, their quality is adequate.

Region 9: Nevada Adequate Letter (3/30/2006)

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This is a letter from Deborah Jordan, Director, to Leo M. Drozdoff regarding Nevada's motor vehicle emissions budgets in the 2005 Truckee Meadows CO Redesignation Request and Maintenance Plan are adequate for transportation conformity decisions.

Region 6: Texas Adequate Letter (6/21/17)

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Letter from EPA approves Motor Vehicle Emissions Budgets contained in latest revisions to Houston/Galveston/Brazoria (HGB) 2008 8-hour Ozone State Implementation Plan, adequate for transportation conformity purposes and announced in the Federal Register.

ACCF/AHA methodology for the development of quality measures for cardiovascular technology: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Performance Measures.

PubMed

Bonow, Robert O; Douglas, Pamela S; Buxton, Alfred E; Cohen, David J; Curtis, Jeptha P; Delong, Elizabeth; Drozda, Joseph P; Ferguson, T Bruce; Heidenreich, Paul A; Hendel, Robert C; Masoudi, Frederick A; Peterson, Eric D; Taylor, Allen J

2011-09-27

Consistent with the growing national focus on healthcare quality, the American College of Cardiology Foundation (ACCF) and the American Heart Association (AHA) have taken a leadership role over the past decade in developing measures of the quality of cardiovascular care by convening a joint ACCF/AHA Task Force on Performance Measures. The Task Force is charged with identifying the clinical topics appropriate for the development of performance measures and with assembling writing committees composed of clinical and methodological experts in collaboration with appropriate subspecialty societies. The Task Force has also created methodology documents that offer guidance in the development of process, outcome, composite, and efficiency measures. Cardiovascular performance measures using existing ACCF/AHA methodology are based on Class I or Class III guidelines recommendations, usually with Level A evidence. These performance measures, based on evidence-based ACCF/AHA guidelines, remain the most rigorous quality measures for both internal quality improvement and public reporting. However, many of the tools for diagnosis and treatment of cardiovascular disease involve advanced technologies, such as cardiac imaging, for which there are often no underlying guideline documents. Because these technologies affect the quality of cardiovascular care and also have the potential to contribute to cardiovascular health expenditures, there is a need for more critical assessment of the use of technology, including the development of quality and performance measures in areas in which guideline recommendations are absent. The evaluation of quality in the use of cardiovascular technologies requires consideration of multiple parameters that differ from other healthcare processes. The present document describes methodology for development of 2 new classes of quality measures in these situations, appropriate use measures and structure/safety measures. Appropriate use measures are based on

Region 8: Colorado Adequate Letter (1/20/2004)

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This letter from EPA to Colorado Department of Public Health and Environment determined Greeleys' Carbon Monoxide (CO) maintenance plan for Motor Vehicle Emissions Budgets adequate for transportation conformity purposes and will be announced in the FR.

Region 4: Tennessee Adequate Letter (9/30/2010)

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This letter acknowledges that the EPA has reviewed Tennessee's Knoxville Area redesignation request and maintenace plan, as well as the motor vehicle emissions budgets (MVEBs) and have determined that these MVEBs are adequate for transportation conformity

Region 9: California Adequate Letter (7/14/2017)

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EPA approves California Air Resources Board Motor Vehicle Emissions Budgets in San Joaquin Valley Unified Air Pollution Control Districts 2016 Plan for 2008 8-Hour Ozone Standard adequate for transportation conformity purposes announced in Federal Register

Region 9: Arizona Adequate Letter (10/14/2003)

EPA Pesticide Factsheets

This is a letter from Jack P. Broadben,. Director, to Nancy Wrona and Dennis Smith informing them that Maricopa County's motor vehicle emissions budgets in the 2003 MAGCO Maintenance Plan are adequate for transportation conformity purposes.

[Cross-cultural adaptation of the Quality of Life Index Spinal Cord Injury - Version III].

PubMed

Reis, Priscila Alencar Mendes; Carvalho, Zuila Maria de Figueiredo; Tirado Darder, Juan José; Oriá, Mônica Oliveira Batista; Studart, Rita Mônica Borges; Maniva, Samia Jardelle Costa de Freitas

2015-06-01

To translate and culturally adapt to Portuguese the Ferrans and Powers Quality of Life Index Spinal Cord Injury - Version III and characterize the sample in relation to sociodemographic and clinical aspects. A methodological study with view to cross-cultural adaptation, following the particular steps of this method: initial translation, translation synthesis, back-translation (translation back to the original language), review by a committee of judges and pretest of the final version. The pretest was carried out with 30 patients with spinal cord injury. An index of 74 items divided into two parts (satisfaction/importance) was obtained. The criteria of semantic equivalence were evaluated as very adequate translation, higher than 87%, and vocabulary and were grammar higher than 86%. Idiomatic equivalence was higher than 74%, experimental greater than 78% and conceptual was greater than 70%. After cross-cultural adaptation, the instrument proved semantic, idiomatic, experimental and conceptual adequacy, in addition to helping the evaluation of the quality of life of people with spinal cord injury.

Debate on vaccines and autoimmunity: Do not attack the author, yet discuss it methodologically.

PubMed

Bragazzi, Nicola Luigi; Watad, Abdulla; Amital, Howard; Shoenfeld, Yehuda

2017-10-09

Since Jenner, vaccines and vaccinations have stirred a hot, highly polarized debate, leading to contrasting positions and feelings, ranging from acritical enthusiasm to blind denial. On the one hand, we find anti-vaccination movements which divulge and disseminate misleading information, myths, prejudices, and even frauds, with the main aim of denying that vaccination practices represent a major public health measure, being effective in controlling infectious diseases and safeguarding the wellbeing of entire communities. Recently, the authors of many vaccine safety investigations are being personally criticized rather than the actual science being methodologically assessed and critiqued. Unfortunately, this could result in making vaccine safety science a "hazardous occupation". Critiques should focus on the science and not on the authors and on the scientists that publish reasonably high-quality science suggesting a problem with a given vaccine. These scientists require adequate professional protection so there are not disincentives to publish and to carry out researches in the field. The issues for vaccine safety are not dissimilar to other areas such as medical errors and drug safety. Copyright © 2017 Elsevier Ltd. All rights reserved.

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.

Vending machine assessment methodology. A systematic review.

PubMed

Matthews, Melissa A; Horacek, Tanya M

2015-07-01

The nutritional quality of food and beverage products sold in vending machines has been implicated as a contributing factor to the development of an obesogenic food environment. How comprehensive, reliable, and valid are the current assessment tools for vending machines to support or refute these claims? A systematic review was conducted to summarize, compare, and evaluate the current methodologies and available tools for vending machine assessment. A total of 24 relevant research studies published between 1981 and 2013 met inclusion criteria for this review. The methodological variables reviewed in this study include assessment tool type, study location, machine accessibility, product availability, healthfulness criteria, portion size, price, product promotion, and quality of scientific practice. There were wide variations in the depth of the assessment methodologies and product healthfulness criteria utilized among the reviewed studies. Of the reviewed studies, 39% evaluated machine accessibility, 91% evaluated product availability, 96% established healthfulness criteria, 70% evaluated portion size, 48% evaluated price, 52% evaluated product promotion, and 22% evaluated the quality of scientific practice. Of all reviewed articles, 87% reached conclusions that provided insight into the healthfulness of vended products and/or vending environment. Product healthfulness criteria and complexity for snack and beverage products was also found to be variable between the reviewed studies. These findings make it difficult to compare results between studies. A universal, valid, and reliable vending machine assessment tool that is comprehensive yet user-friendly is recommended. Copyright © 2015 Elsevier Ltd. All rights reserved.

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.

Systematic reviews do not adequately report or address missing outcome data in their analyses: a methodological survey.

PubMed

Kahale, Lara A; Diab, Batoul; Brignardello-Petersen, Romina; Agarwal, Arnav; Mustafa, Reem A; Kwong, Joey; Neumann, Ignacio; Li, Ling; Lopes, Luciane Cruz; Briel, Matthias; Busse, Jason W; Iorio, Alfonso; Vandvik, Per Olav; Alexander, Paul Elias; Guyatt, Gordon; Akl, Elie A

2018-07-01

To describe how systematic review authors report and address categories of participants with potential missing outcome data of trial participants. Methodological survey of systematic reviews reporting a group-level meta-analysis. We included a random sample of 50 Cochrane and 50 non-Cochrane systematic reviews. Of these, 25 reported in their methods section a plan to consider at least one of the 10 categories of missing outcome data; 42 reported in their results, data for at least one category of missing data. The most reported category in the methods and results sections was "unexplained loss to follow-up" (n = 34 in methods section and n = 6 in the results section). Only 19 reported a method to handle missing data in their primary analyses, which was most often complete case analysis. Few reviews (n = 9) reported in the methods section conducting sensitivity analysis to judge risk of bias associated with missing outcome data at the level of the meta-analysis; and only five of them presented the results of these analyses in the results section. Most systematic reviews do not explicitly report sufficient information on categories of trial participants with potential missing outcome data or address missing data in their primary analyses. Copyright © 2018 Elsevier Inc. All rights reserved.

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

HOW GOOD ARE MY DATA? INFORMATION QUALITY ASSESSMENT METHODOLOGY

EPA Science Inventory

Quality assurance techniques used in software development and hardware maintenance/reliability help to ensure that data in a computerized information management system are maintained well. However, information workers may not know the quality of the data resident in their inf...

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

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

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

[Needs assessment to improve the applicability and methodological quality of a German S3 guideline].

PubMed

Burckhardt, Marion; Hoffmann, Cristina; Nink-Grebe, Brigitte; Sänger, Sylvia

2018-04-01

Clinical practice guidelines can change the practice in healthcare only if their recommendations are implemented in a comprehensive way. The German S3 guideline "Local Therapy of Chronic Wounds in Patients with Peripheral Vascular Disease, Chronic Venous Insufficiency, and Diabetes" will be updated in 2017. The emphasis here is on the guideline's validity, user-friendliness and implementation into practice. Therefore, the aim was to identify the improvements required in regard to the guideline's methods and content presentation. The methodological approach used was the critical appraisal of the guideline according to established quality criteria and an additional stakeholder survey. Both were conducted between August and November 2016. The guideline and its related documents were reviewed independently by two researchers according to the criteria of the "Appraisal of Guidelines for Research and Evaluation" (AGREE-II). Published reviews and peer reviews by external experts and organisations were also taken into account. For the stakeholder survey, a questionnaire with open questions was distributed by e-mail and via the Internet to health professionals and organisations involved in the care of patients with leg ulcers in Germany. The questions were aimed at amendments and new topics based on the stakeholders' experience in inpatient and outpatient care. In addition, the survey focused on gathering suggestions to improve the applicability of the guideline. Suggested new topics and amendments were summarised thematically. The stakeholders' suggestions to improve the applicability, the results of the critical appraisal and the relevant aspects of the external reviews were then summarised according to the AGREE-II domains and presented in a cause and effect diagram. 17 questionnaires (out of 864 sent out by e-mail) were returned. Due to high practice relevance, the stakeholders suggested an expansion of the inclusion criteria to patients with infected wounds and

Genetic variation for agronomic and fiber quality traits in a population derived from high-quality cotton germplasm

USDA-ARS?s Scientific Manuscript database

Genetic improvement of fiber quality is necessary to meet the requirements of processors and users of cotton fiber. To foster genetic improvement of cotton fiber quality, adequate genetic variation for the quantitatively inherited physical properties of cotton is required. Additionally, knowledge of...

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.

Region 5: Wisconsin Adequate Letter (4/16/2015)

EPA Pesticide Factsheets

This March 13, 2015 letter from EPA approves Wisconsins Kenosha and Sheboygan counties Early Progress Plan for year 2015 Motor Vehicle Emissions Budgets (MVEBs) for VOC and NOx finding them adequate for transportation conformity purposes and will be announ

Environmental risk assessment of water quality in harbor areas: a new methodology applied to European ports.

PubMed

Gómez, Aina G; Ondiviela, Bárbara; Puente, Araceli; Juanes, José A

2015-05-15

This work presents a standard and unified procedure for assessment of environmental risks at the contaminant source level in port aquatic systems. Using this method, port managers and local authorities will be able to hierarchically classify environmental hazards and proceed with the most suitable management actions. This procedure combines rigorously selected parameters and indicators to estimate the environmental risk of each contaminant source based on its probability, consequences and vulnerability. The spatio-temporal variability of multiple stressors (agents) and receptors (endpoints) is taken into account to provide accurate estimations for application of precisely defined measures. The developed methodology is tested on a wide range of different scenarios via application in six European ports. The validation process confirms its usefulness, versatility and adaptability as a management tool for port water quality in Europe and worldwide. Copyright © 2015 Elsevier Ltd. All rights reserved.

Selection of adequate site location during early stages of construction project management: A multi-criteria decision analysis approach

NASA Astrophysics Data System (ADS)

Marović, Ivan; Hanak, Tomaš

2017-10-01

In the management of construction projects special attention should be given to the planning as the most important phase of decision-making process. Quality decision-making based on adequate and comprehensive collaboration of all involved stakeholders is crucial in project’s early stages. Fundamental reasons for existence of this problem arise from: specific conditions of construction industry (final products are inseparable from the location i.e. location has a strong influence of building design and its structural characteristics as well as technology which will be used during construction), investors’ desires and attitudes, and influence of socioeconomic and environment aspects. Considering all mentioned reasons one can conclude that selection of adequate construction site location for future investment is complex, low structured and multi-criteria problem. To take into account all the dimensions, the proposed model for selection of adequate site location is devised. The model is based on AHP (for designing the decision-making hierarchy) and PROMETHEE (for pairwise comparison of investment locations) methods. As a result of mixing basis feature of both methods, operational synergies can be achieved in multi-criteria decision analysis. Such gives the decision-maker a sense of assurance, knowing that if the procedure proposed by the presented model has been followed, it will lead to a rational decision, carefully and systematically thought out.

Improving Mathematics Performance among Secondary Students with EBD: A Methodological Review

ERIC Educational Resources Information Center

Mulcahy, Candace A.; Krezmien, Michael P.; Travers, Jason

2016-01-01

In this methodological review, the authors apply special education research quality indicators and standards for single case design to analyze mathematics intervention studies for secondary students with emotional and behavioral disorders (EBD). A systematic methodological review of literature from 1975 to December 2012 yielded 19 articles that…

Qualitative case study methodology in nursing research: an integrative review.

PubMed

Anthony, Susan; Jack, Susan

2009-06-01

This paper is a report of an integrative review conducted to critically analyse the contemporary use of qualitative case study methodology in nursing research. Increasing complexity in health care and increasing use of case study in nursing research support the need for current examination of this methodology. In 2007, a search for case study research (published 2005-2007) indexed in the CINAHL, MEDLINE, EMBASE, PsychINFO, Sociological Abstracts and SCOPUS databases was conducted. A sample of 42 case study research papers met the inclusion criteria. Whittemore and Knafl's integrative review method guided the analysis. Confusion exists about the name, nature and use of case study. This methodology, including terminology and concepts, is often invisible in qualitative study titles and abstracts. Case study is an exclusive methodology and an adjunct to exploring particular aspects of phenomena under investigation in larger or mixed-methods studies. A high quality of case study exists in nursing research. Judicious selection and diligent application of literature review methods promote the development of nursing science. Case study is becoming entrenched in the nursing research lexicon as a well-accepted methodology for studying phenomena in health and social care, and its growing use warrants continued appraisal to promote nursing knowledge development. Attention to all case study elements, process and publication is important in promoting authenticity, methodological quality and visibility.

Region 8: Colorado Adequate Letter (8/17/2011)

EPA Pesticide Factsheets

This March 4, 2011 letter from EPA to Chistopher E. Urbina M.D., MPH, Colorado Department of Public Health and Environment states that EPA has found that the Greeley, CO second 10 year Limited Maintenance Plan (LMP) adequate for transportation conformity

Region 8: Colorado Adequate Letter (6/11/2012)

EPA Pesticide Factsheets

This August 9, 2011 letter from EPA to Chistopher E. Urbina M.D., MPH, Colorado Department of Public Health and Environment states that EPA has found that the Fort Collins, CO second 10 year Limited Maintenance Plan (LMP) adequate for transportation

Using Multitheory Model of Health Behavior Change to Predict Adequate Sleep Behavior.