Evaluating the statistical methodology of randomized trials on dentin hypersensitivity management.

Science.gov (United States)

Matranga, Domenica; Matera, Federico; Pizzo, Giuseppe

2017-12-27

The present study aimed to evaluate the characteristics and quality of statistical methodology used in clinical studies on dentin hypersensitivity management. An electronic search was performed for data published from 2009 to 2014 by using PubMed, Ovid/MEDLINE, and Cochrane Library databases. The primary search terms were used in combination. Eligibility criteria included randomized clinical trials that evaluated the efficacy of desensitizing agents in terms of reducing dentin hypersensitivity. A total of 40 studies were considered eligible for assessment of quality statistical methodology. The four main concerns identified were i) use of nonparametric tests in the presence of large samples, coupled with lack of information about normality and equality of variances of the response; ii) lack of P-value adjustment for multiple comparisons; iii) failure to account for interactions between treatment and follow-up time; and iv) no information about the number of teeth examined per patient and the consequent lack of cluster-specific approach in data analysis. Owing to these concerns, statistical methodology was judged as inappropriate in 77.1% of the 35 studies that used parametric methods. Additional studies with appropriate statistical analysis are required to obtain appropriate assessment of the efficacy of desensitizing agents.

Clinical trials of homoeopathy.

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

1991-01-01

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

Quality of clinical trials for selected priority mental and neurological disorders in sub-Saharan Africa: a systematic review

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Mulugeta A

2016-12-01

of the trials (71% were pharmacotherapeutics-based intervention. In terms of methodological quality in relation to the Jadad scale, 82% fulfilled the criteria for good methodological quality with a score of 3−5. However, the methodological quality according to the CONSORT criteria was more mixed.Conclusion: The overall quality of clinical trials conducted in sub-Saharan Africa is encouraging despite the limited number of studies. However, important quality limitations remain and have not improved over time. Hence, establishing clinical trial centers in these countries may be one approach to improving quality and quantity of trials. Keywords: randomized controlled trial, schizophrenia, depression, epilepsy, drug therapy, psychotherapy, Africa

METHODOLOGICAL ISSUES OF CLINICAL TRIALS IN THE PEDIATRIC POPULATION

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S.V. Topolyanskaya

2010-01-01

Full Text Available Conducting clinical trials on children population is a challenge both for organizers and pediatricians involved in trials. Difficulties in recruiting patients, a significant heterogenecity of the population, specific side reactions, difficulties in identifying the objective final points warrant the specific nature of designing clinical trials in pediatrics. The article illustrates key issues and methodology aspects: planning, design, control groups, patient recruitment. It stresses the need to carefully consider specific characteristics of a child’s system and multi-disciplinary approach involving a pediatrician at the early stages of planning, preliminary consultations with parent organizations, children and regulators.Key words: clinical trials, methodology, planning, design, patient recruitment, children. (Pediatric Pharmacology. – 2010; 7(5:6-10

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

Science.gov (United States)

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.

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

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

2007-01-01

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

Validity of randomized clinical trials in gastroenterology from 1964-2000

DEFF Research Database (Denmark)

Kjaergard, Lise L; Frederiksen, Sarah L; Gluud, Christian

2002-01-01

The internal validity of clinical trials depends on the adequacy of the reported methodological quality. We assessed the methodological quality of all 383 randomized clinical trials published in GASTROENTEROLOGY as original articles from 1964 to 2000.......The internal validity of clinical trials depends on the adequacy of the reported methodological quality. We assessed the methodological quality of all 383 randomized clinical trials published in GASTROENTEROLOGY as original articles from 1964 to 2000....

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

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Juan Luis Sanz-Cabanillas

Full Text Available 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

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

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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 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.

FDAAA legislation is working, but methodological flaws undermine the reliability of clinical trials: a cross-sectional study

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Douglas H. Marin dos Santos

2015-06-01

Full Text Available The relationship between clinical research and the pharmaceutical industry has placed clinical trials in jeopardy. According to the medical literature, more than 70% of clinical trials are industry-funded. Many of these trials remain unpublished or have methodological flaws that distort their results. In 2007, it was signed into law the Food and Drug Administration Amendments Act (FDAAA, aiming to provide publicly access to a broad range of biomedical information to be made available on the platform ClinicalTrials (available at https://www.clinicaltrials.gov. We accessed ClinicalTrials.gov and evaluated the compliance of researchers and sponsors with the FDAAA. Our sample comprised 243 protocols of clinical trials of biological monoclonal antibodies (mAb adalimumab, bevacizumab, infliximab, rituximab, and trastuzumab. We demonstrate that the new legislation has positively affected transparency patterns in clinical research, through a significant increase in publication and online reporting rates after the enactment of the law. Poorly designed trials, however, remain a challenge to be overcome, due to a high prevalence of methodological flaws. These flaws affect the quality of clinical information available, breaching ethical duties of sponsors and researchers, as well as the human right to health.

FDAAA legislation is working, but methodological flaws undermine the reliability of clinical trials: a cross-sectional study.

Science.gov (United States)

Marin Dos Santos, Douglas H; Atallah, Álvaro N

2015-01-01

The relationship between clinical research and the pharmaceutical industry has placed clinical trials in jeopardy. According to the medical literature, more than 70% of clinical trials are industry-funded. Many of these trials remain unpublished or have methodological flaws that distort their results. In 2007, it was signed into law the Food and Drug Administration Amendments Act (FDAAA), aiming to provide publicly access to a broad range of biomedical information to be made available on the platform ClinicalTrials (available at https://www.clinicaltrials.gov). We accessed ClinicalTrials.gov and evaluated the compliance of researchers and sponsors with the FDAAA. Our sample comprised 243 protocols of clinical trials of biological monoclonal antibodies (mAb) adalimumab, bevacizumab, infliximab, rituximab, and trastuzumab. We demonstrate that the new legislation has positively affected transparency patterns in clinical research, through a significant increase in publication and online reporting rates after the enactment of the law. Poorly designed trials, however, remain a challenge to be overcome, due to a high prevalence of methodological flaws. These flaws affect the quality of clinical information available, breaching ethical duties of sponsors and researchers, as well as the human right to health.

A Methodology for Quality Problems Diagnosis in SMEs

OpenAIRE

Humberto N. Teixeira; Isabel S. Lopes; Sérgio D. Sousa

2012-01-01

This article proposes a new methodology to be used by SMEs (Small and Medium enterprises) to characterize their performance in quality, highlighting weaknesses and area for improvement. The methodology aims to identify the principal causes of quality problems and help to prioritize improvement initiatives. This is a self-assessment methodology that intends to be easy to implement by companies with low maturity level in quality. The methodology is organized in six different steps which include...

The methodological quality of systematic reviews comparing temporomandibular joint disorder surgical and non-surgical treatment

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Vasconcelos Belmiro CE

2008-09-01

Full Text Available Abstract Background Temporomandibular joint disorders (TMJD are multifactor, complex clinical problems affecting approximately 60–70% of the general population, with considerable controversy about the most effective treatment. For example, reports claim success rates of 70% and 83% for non-surgical and surgical treatment, whereas other reports claim success rates of 40% to 70% for self-improvement without treatment. Therefore, the purpose of this study was to (1 identify systematic reviews comparing temporomandibular joint disorder surgical and non-surgical treatment, (2 evaluate their methodological quality, and (3 evaluate the evidence grade within the systematic reviews. Methods A search strategy was developed and implemented for MEDLINE, Cochrane Library, LILACS, and Brazilian Dentistry Bibliography databases. Inclusion criteria were: systematic reviews (± meta-analysis comparing surgical and non-surgical TMJD treatment, published in English, Spanish, Portuguese, Italian, or German between the years 1966 and 2007(up to July. Exclusion criteria were: in vitro or animal studies; narrative reviews or editorials or editorial letters; and articles published in other languages. Two investigators independently selected and evaluated systematic reviews. Three different instruments (AMSTAR, OQAQ and CASP were used to evaluate methodological quality, and the results averaged. The GRADE instrument was used to evaluate the evidence grade within the reviews. Results The search strategy identified 211 reports; of which 2 were systematic reviews meeting inclusion criteria. The first review met 23.5 ± 6.0% and the second met 77.5 ± 12.8% of the methodological quality criteria (mean ± sd. In these systematic reviews between 9 and 15% of the trials were graded as high quality, and 2 and 8% of the total number of patients were involved in these studies. Conclusion The results indicate that in spite of the widespread impact of TMJD, and the multitude of

Methodological quality of systematic reviews addressing femoroacetabular impingement.

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

2015-09-01

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

Methodological quality of systematic reviews on influenza vaccination.

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Remschmidt, Cornelius; Wichmann, Ole; Harder, Thomas

2014-03-26

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

Reporting Quality of Randomized, Controlled Trials Evaluating Combined Chemoradiotherapy in Nasopharyngeal Carcinoma

International Nuclear Information System (INIS)

Chen, Yu-Pei; Chen, Lei; Li, Wen-Fei; Lee, Anne W.M.; Vermorken, Jan B.; Wee, Joseph; O'Sullivan, Brian; Eisbruch, Avraham; Lin, Jin-Ching; Mai, Hai-Qiang; Zhang, Li; Guo, Ying; Lin, Ai-Hua; Sun, Ying

2017-01-01

Purpose: To comprehensively assess the reporting quality of randomized, controlled trials (RCTs) in nasopharyngeal carcinoma (NPC), and to identify significant predictors of quality. Methods and Materials: Two investigators searched MEDLINE and EMBASE for RCTs published between January 1988 and December 2015 that assessed the effect of combined chemoradiotherapy for NPC. The overall quality of each report was assessed using a 28-point overall quality score (OQS) based on the 2010 Consolidated Standards of Reporting Trials (CONSORT) statement. To provide baseline data for further evaluation, we also investigated the reporting quality of certain important issues in detail, including key methodologic items (allocation concealment, blinding, intention-to-treat principle), endpoints, follow-up, subgroup analyses, and adverse events. Results: We retrieved 24 relevant RCTs including 6591 patients. Median 2010 OQS was 15.5 (range, 10-24). Half of the items in the 2010 OQS were poorly reported in at least 40% of trials. Multivariable regression models revealed that publication after 2010 and high impact factor were significant predictors of improved 2010 OQS. Additionally, many issues that we consider significant were not reported adequately. Conclusions: Despite publication of the CONSORT statement more than a decade ago, overall reporting quality for RCTs in NPC was unsatisfactory. Additionally, substantial selectivity and heterogeneity exists in reporting of certain crucial issues. This survey provides the first prompt for NPC trial investigators to improve reporting quality according to the CONSORT statement; increased scrutiny and diligence by editors and peer reviewers is also required.

Reporting Quality of Randomized, Controlled Trials Evaluating Combined Chemoradiotherapy in Nasopharyngeal Carcinoma

Energy Technology Data Exchange (ETDEWEB)

Chen, Yu-Pei; Chen, Lei; Li, Wen-Fei [Department of Radiation Oncology, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre of Cancer Medicine, Guangzhou (China); Lee, Anne W.M. [Department of Clinical Oncology, The University of Hong Kong-Shenzhen Hospital, Shenzhen (China); Vermorken, Jan B. [Department of Medical Oncology, Antwerp University Hospital, Edegem (Belgium); Wee, Joseph [Department of Radiation Oncology, National Cancer Centre Singapore (Singapore); O' Sullivan, Brian [Department of Radiation Oncology, University of Toronto, Ontario Cancer Institute, University Health Network, Toronto, Ontario (Canada); Eisbruch, Avraham [Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan (United States); Lin, Jin-Ching [Department of Radiation Oncology, Taichung Veterans General Hospital, Taichung, Taiwan (China); Mai, Hai-Qiang [Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre of Cancer Medicine, Guangzhou (China); Zhang, Li [Department of Medical Oncology, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre of Cancer Medicine, Guangzhou (China); Guo, Ying [Clinical Trials Centre, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre of Cancer Medicine, Guangzhou (China); Lin, Ai-Hua [Department of Medical Statistics and Epidemiology, School of Public Health, Sun Yat-sen University, Guangzhou (China); Sun, Ying [Department of Radiation Oncology, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre of Cancer Medicine, Guangzhou (China); and others

2017-05-01

Purpose: To comprehensively assess the reporting quality of randomized, controlled trials (RCTs) in nasopharyngeal carcinoma (NPC), and to identify significant predictors of quality. Methods and Materials: Two investigators searched MEDLINE and EMBASE for RCTs published between January 1988 and December 2015 that assessed the effect of combined chemoradiotherapy for NPC. The overall quality of each report was assessed using a 28-point overall quality score (OQS) based on the 2010 Consolidated Standards of Reporting Trials (CONSORT) statement. To provide baseline data for further evaluation, we also investigated the reporting quality of certain important issues in detail, including key methodologic items (allocation concealment, blinding, intention-to-treat principle), endpoints, follow-up, subgroup analyses, and adverse events. Results: We retrieved 24 relevant RCTs including 6591 patients. Median 2010 OQS was 15.5 (range, 10-24). Half of the items in the 2010 OQS were poorly reported in at least 40% of trials. Multivariable regression models revealed that publication after 2010 and high impact factor were significant predictors of improved 2010 OQS. Additionally, many issues that we consider significant were not reported adequately. Conclusions: Despite publication of the CONSORT statement more than a decade ago, overall reporting quality for RCTs in NPC was unsatisfactory. Additionally, substantial selectivity and heterogeneity exists in reporting of certain crucial issues. This survey provides the first prompt for NPC trial investigators to improve reporting quality according to the CONSORT statement; increased scrutiny and diligence by editors and peer reviewers is also required.

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

Science.gov (United States)

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

2017-01-01

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

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.

Science.gov (United States)

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

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

Science.gov (United States)

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

Reporting and methodologic quality of Cochrane Neonatal review group systematic reviews

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Al Faleh Khalid

2009-06-01

Full Text Available Abstract Background The Cochrane Neonatal Review Group (CNRG has achieved a lot with limited resources in producing high quality systematic reviews to assist clinicians in evidence-based decision-making. A formal assessment of published CNRG systematic reviews has not been undertaken; we sought to provide a comprehensive assessment of the quality of systematic reviews (both methodologic and reporting quality published in CNRG. Methods We selected a random sample of published CNRG systematic reviews. Items of the QUOROM statement were utilized to assess quality of reporting, while items and total scores of the Oxman-Guyatt Overview Quality Assessment Questionnaire (OQAQ were used to assess methodologic quality. Two reviewers independently extracted data and assessed quality. A Student t-test was used to compare quality scores pre- and post-publication of the QUOROM statement. Results Sixty-one systematic reviews were assessed. Overall, the included reviews had good quality with minor flaws based on OQAQ total scores (mean, 4.5 [0.9]; 95% CI, 4.27–4.77. However, room for improvement was noted in some areas, such as the title, abstract reporting, a priori plan for heterogeneity assessment and how to handle heterogeneity in case it exists, and assessment of publication bias. In addition, reporting of agreement among reviewers, documentation of trials flow, and discussion of possible biases were addressed in the review process. Reviews published post the QUOROM statement had a significantly higher quality scores. Conclusion The systematic reviews published in the CNRG are generally of good quality with minor flaws. However, efforts should be made to improve the quality of reports. Readers must continue to assess the quality of published reports on an individual basis prior to implementing the recommendations.

Mesh fixation in endoscopic inguinal hernia repair: evaluation of methodology based on a systematic review of randomised clinical trials.

Science.gov (United States)

Lederhuber, Hans; Stiede, Franziska; Axer, Stephan; Dahlstrand, Ursula

2017-11-01

The issue of mesh fixation in endoscopic inguinal hernia repair is frequently debated and still no conclusive data exist on differences between methods regarding long-term outcome and postoperative complications. The quantity of trials and the simultaneous lack of high-quality evidence raise the question how future trials should be planned. PubMed, EMBASE and the Cochrane Library were searched, using the filters "randomised clinical trials" and "humans". Trials that compared one method of mesh fixation with another fixation method or with non-fixation in endoscopic inguinal hernia repair were eligible. To be included, the trial was required to have assessed at least one of the following primary outcome parameters: recurrence; surgical site infection; chronic pain; or quality-of-life. Fourteen trials assessing 2161 patients and 2562 hernia repairs were included. Only two trials were rated as low risk for bias. Eight trials evaluated recurrence or surgical site infection; none of these could show significant differences between methods of fixation. Two of 11 trials assessing chronic pain described significant differences between methods of fixation. One of two trials evaluating quality-of-life showed significant differences between fixation methods in certain functions. High-quality evidence for differences between the assessed mesh fixation techniques is still lacking. From a socioeconomic and ethical point of view, it is necessary that future trials will be properly designed. As small- and medium-sized single-centre trials have proven unable to find answers, register studies or multi-centre studies with an evident focus on methodology and study design are needed in order to answer questions about mesh fixation in inguinal hernia repair.

How informed is declared altruism in clinical trials? A qualitative interview study of patient decision-making about the QUEST trials (Quality of Life after Mastectomy and Breast Reconstruction)

OpenAIRE

Bidad, Natalie; MacDonald, Lindsay; Winters, Zoë E; Edwards, Sarah J L; Emson, Marie; Griffin, Clare L.; Bliss, Judith; Horne, Rob

2016-01-01

Background: Randomised controlled trials (RCTs) often fail to recruit sufficient participants, despite altruism being cited as their motivation. Previous investigations of factors influencing participation decisions have been methodologically limited. This study evaluated how women weigh up different motivations after initially expressing altruism, and explored their understanding of a trial and its alternatives. The trial was the 'Quality of Life after Mastectomy and Breast Reconstruction' (...

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

Science.gov (United States)

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.

Evaluation of the quality of the reporting of phase II clinical trials in oncology: A systematic review.

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Rivoirard, Romain; Langrand-Escure, Julien; Oriol, Mathieu; Tinquaut, Fabien; Chauvin, Franck; Rancoule, Chloé; Magné, Nicolas; Bourmaud, Aurélie

2018-05-01

To describe the current state of knowledge concerning the quality of reporting in phase II clinical trials in oncology and to describe the various methods published allowing this quality evaluation. databases including MEDLINE and COCHRANE were searched. Reviews and meta-analyses analyzing the quality of the reporting of phase II trials in oncology were included. Descriptive analysis of the results was performed. Thirteen publications were retained. Only 2 publications adopted a systematic approach of evaluation of the quality of reporting by overall scores. The Key Methodological Score (KMS), proposed by Grellety et al., gathering 3 items, seemed adapted for such an evaluation. A score of 3/3 was found in 16.1% of the 156 phase II trials analysed by this score. The other reviews used a qualitative analysis to evaluate the reporting, via an analysis of a single criterion, generally the statistical plan of the study. This item was considered as having been correctly reported in less than 50% of the analysed articles. The quality of reporting in phase II trials in oncology is a field that has been investigated very little (13 publications). When it is studied, the estimated level of quality is not satisfactory, whatever the method employed. The use of an overall score of evaluation is a path which should be pursued, in order to get reliable results. It also seems necessary to propose strong recommendations, which would create a consensus for the methodology and the reporting of these studies. Copyright © 2018 Elsevier B.V. All rights reserved.

Quality of reporting and of methodology of studies on interventions for trophic ulcers in leprosy: A systematic review

Directory of Open Access Journals (Sweden)

Forsetlund L

2008-01-01

Full Text Available Background: In the process of conducting a systematic review on interventions for skin lesions due to neuritis in leprosy, we assessed several primary papers with respect to the quality of reporting and methods used in the studies. Awareness of what constitutes weak points in previously conducted studies may be used to improve the planning, conducting and reporting of future clinical trials. Aims: To assess the quality of reporting and of methodology in studies of interventions for skin lesions due to neuritis in leprosy. Methods: Items of importance for preventing selection bias, detection bias, attrition bias and performance bias were among items assessed. The items for assessing methodological quality were used as a basis for making the checklist to assess the quality of reporting. Results: Out of the 854 references that we inspected eight studies were included on the basis of the inclusion criteria. The interventions tested were dressings, topical agents and footwear and in all studies healing of ulcers was the main outcome measure. Reporting of both, methods and results suffered from underreporting and disorganization. The most under-reported items were concealment of allocation, blinding of patients and outcome assessors, intention to treat and validation of outcomes. Conclusion: There is an apparent need to improve the methodological quality as well as the quality of reporting of trials in leprosy ulcer treatment. The most important threat in existing studies is the threat of selection bias. For the reporting of future studies, journals could promote and encourage the use of the CONSORT statement checklist by expecting and requiring that authors adhere to it in their reporting.

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

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

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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.

Quality of clinical trials: A moving target

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Bhatt, Arun

2011-01-01

Quality of clinical trials depends on data integrity and subject protection. Globalization, outsourcing and increasing complexicity of clinical trials have made the target of achieving global quality challenging. The quality, as judged by regulatory inspections of the investigator sites, sponsors/contract research organizations and Institutional Review Board, has been of concern to the US Food and Drug Administration, as there has been hardly any change in frequency and nature of common deficiencies. To meet the regulatory expectations, the sponsors need to improve quality by developing systems with specific standards for each clinical trial process. The quality systems include: personnel roles and responsibilities, training, policies and procedures, quality assurance and auditing, document management, record retention, and reporting and corrective and preventive action. With an objective to improve quality, the FDA has planned new inspection approaches such as risk-based inspections, surveillance inspections, real-time oversight, and audit of sponsor quality systems. The FDA has partnered with Duke University for Clinical Trials Transformation Initiative, which will conduct research projects on design principles, data quality and quantity including monitoring, study start-up, and adverse event reporting. These recent initiatives will go a long way in improving quality of clinical trials. PMID:22145122

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

Science.gov (United States)

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

2018-05-08

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

Quality of clinical trials: A moving target

Directory of Open Access Journals (Sweden)

Arun Bhatt

2011-01-01

Full Text Available Quality of clinical trials depends on data integrity and subject protection. Globalization, outsourcing and increasing complexicity of clinical trials have made the target of achieving global quality challenging. The quality, as judged by regulatory inspections of the investigator sites, sponsors/contract research organizations and Institutional Review Board, has been of concern to the US Food and Drug Administration, as there has been hardly any change in frequency and nature of common deficiencies. To meet the regulatory expectations, the sponsors need to improve quality by developing systems with specific standards for each clinical trial process. The quality systems include: personnel roles and responsibilities, training, policies and procedures, quality assurance and auditing, document management, record retention, and reporting and corrective and preventive action. With an objective to improve quality, the FDA has planned new inspection approaches such as risk-based inspections, surveillance inspections, real-time oversight, and audit of sponsor quality systems. The FDA has partnered with Duke University for Clinical Trials Transformation Initiative, which will conduct research projects on design principles, data quality and quantity including monitoring, study start-up, and adverse event reporting. These recent initiatives will go a long way in improving quality of clinical trials.

Methodology and Supporting Toolset Advancing Embedded Systems Quality

DEFF Research Database (Denmark)

Berger, Michael Stübert; Soler, José; Brewka, Lukasz Jerzy

2013-01-01

Software quality is of primary importance in the development of embedded systems that are often used in safety-critical applications. Moreover, as the life cycle of embedded products becomes increasingly tighter, productivity and quality are simultaneously required and closely interrelated towards...... delivering competitive products. In this context, the MODUS (Methodology and supporting toolset advancing embedded systems quality) project aims to provide a pragmatic and viable solution that will allow SMEs to substantially improve their positioning in the embedded-systems development market. This paper...... will describe the MODUS project with focus on the technical methodologies that will be developed advancing embedded system quality....

Quality assurance of asthma clinical trials.

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Malmstrom, Kerstin; Peszek, Iza; Al Botto; Lu, Susan; Enright, Paul L; Reiss, Theodore F

2002-04-01

Accuracy and repeatability of spirometry measurements are essential to obtain reliable efficacy data in randomized asthma clinical trials. We report our experience with a centralized spirometry quality assurance program that we implemented in our phase III asthma trials. Six asthma trials of 4 to 21 weeks in duration were conducted at 232 clinical centers in 31 countries. Approximately 23,100 prebronchodilator and 13,700 postbronchodilator spirometry tests were collected from 2523 adult and 336 pediatric asthmatic patients. The program used a standard spirometer (the Renaissance spirometry system) with maneuver quality messages and automated quality grading of the spirometry tests. Each clinical center transmitted spirometry data weekly to a central database, where uniform monitoring of data quality was performed and feedback was provided in weekly quality reports. Seventy-nine percent of all patients performed spirometry sessions with quality that either met or exceeded American Thoracic Society standards and improved over time. Good-quality spirometry was associated with (1) less severe asthma; (2) active treatment; (3) infrequent nocturnal awakenings; (4) age above 15 years; and (5) low body weight. Maneuver-induced bronchospasm was rare. Good-quality spirometry was observed in multicenter asthma clinical trials that employed a standard spirometer and continuous monitoring. Both within- and between-patient variability decreased. Spirometry quality improved with time as study participants and technicians gained experience.

The matching quality of experimental and control interventions in blinded pharmacological randomised clinical trials

DEFF Research Database (Denmark)

Bello, Segun; Wei, Maoling; Hilden, Jørgen

2016-01-01

to systematically identify and analyse studies of matching quality in drug trials. Our primary objective was to assess the proportion of studies that concluded that the matching was inadequate; our secondary objective was to describe mechanisms for inadequate matching. Methods: Systematic review. We searched Pub...... published before 1977. The studies differed considerably with regard to design, methodology and analysis. Sixteen of the 36 studies (44 %) concluded inadequate matching. When we adapted high or low thresholds for inadequate matching, the number of trials with inadequate matching was reduced to 12 (33...

New scoring methodology improves the sensitivity of the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog) in clinical trials.

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Verma, Nishant; Beretvas, S Natasha; Pascual, Belen; Masdeu, Joseph C; Markey, Mia K

2015-11-12

As currently used, the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog) has low sensitivity for measuring Alzheimer's disease progression in clinical trials. A major reason behind the low sensitivity is its sub-optimal scoring methodology, which can be improved to obtain better sensitivity. Using item response theory, we developed a new scoring methodology (ADAS-CogIRT) for the ADAS-Cog, which addresses several major limitations of the current scoring methodology. The sensitivity of the ADAS-CogIRT methodology was evaluated using clinical trial simulations as well as a negative clinical trial, which had shown an evidence of a treatment effect. The ADAS-Cog was found to measure impairment in three cognitive domains of memory, language, and praxis. The ADAS-CogIRT methodology required significantly fewer patients and shorter trial durations as compared to the current scoring methodology when both were evaluated in simulated clinical trials. When validated on data from a real clinical trial, the ADAS-CogIRT methodology had higher sensitivity than the current scoring methodology in detecting the treatment effect. The proposed scoring methodology significantly improves the sensitivity of the ADAS-Cog in measuring progression of cognitive impairment in clinical trials focused in the mild-to-moderate Alzheimer's disease stage. This provides a boost to the efficiency of clinical trials requiring fewer patients and shorter durations for investigating disease-modifying treatments.

Methodological quality of guidelines in gastroenterology.

Science.gov (United States)

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.

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

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

2017-12-11

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

Quality of natural product clinical trials: a comparison of those published in alternative medicine versus conventional medicine journals.

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Cochrane, Zara Risoldi; Gregory, Philip; Wilson, Amy

2011-06-01

To compare the quality of natural product clinical trials published in alternative medicine journals versus those published in conventional medicine journals. Systematic search and review of the literature. Randomized controlled trials of natural products were included if they were published in English between 2003 and 2008. Articles were categorized by their journal of publication (alternative medicine versus conventional medicine). Two independent reviewers evaluated study quality using guidelines from the Cochrane Collaboration. The results with respect to the primary outcome (positive or negative) were also assessed. Thirty articles were evaluated, 15 published in alternative medicine journals and 15 in conventional medicine journals. Of articles published in alternative medicine journals, 33.33% (n = 5) were considered low quality, and none were considered high quality. Of articles published in conventional medicine journals, 26.67% (n = 4) were considered low quality and 6.67% (n = 1) were considered high quality. Two thirds of all trials reviewed were of unclear quality, due to inadequate reporting of information relating to the study's methodology. Similar proportions of positive and negative primary outcomes were found in alternative and conventional medicine journals, and low-quality articles were not more likely to report a positive primary outcome (Fisher's exact test, two-tailed p = .287). The quality of natural product randomized controlled trials was similar among alternative and conventional medicine journals. Efforts should be made to improve the reporting of natural product clinical trials for accurate determinations of study quality to be possible.

A Quality-Driven Methodology for Information Systems Integration

Directory of Open Access Journals (Sweden)

Iyad Zikra

2017-10-01

Full Text Available Information systems integration is an essential instrument for organizations to attain advantage in today’s growing and fast changing business and technology landscapes. Integration solutions generate added value by combining the functionality and services of heterogeneous and diverse systems. Existing integration environments tend to rely heavily on technical, platform-dependent skills. Consequently, the solutions that they enable are not optimally aligned with the envisioned business goals of the organization. Furthermore, the gap between the goals and the solutions complicates the task of evaluating the quality of integration solutions. To address these challenges, we propose a quality-driven, model-driven methodology for designing and developing integration solutions. The methodology spans organizational and systems design details, providing a holistic view of the integration solution and its underlying business goals. A multi-view meta-model provides the basis for the integration design. Quality factors that affect various aspects of the integration solution guide and inform the progress of the methodology. An example business case is presented to demonstrate the application of the methodology.

The trials methodological research agenda: results from a priority setting exercise

Science.gov (United States)

2014-01-01

Background Research into the methods used in the design, conduct, analysis, and reporting of clinical trials is essential to ensure that effective methods are available and that clinical decisions made using results from trials are based on the best available evidence, which is reliable and robust. Methods An on-line Delphi survey of 48 UK Clinical Research Collaboration registered Clinical Trials Units (CTUs) was undertaken. During round one, CTU Directors were asked to identify important topics that require methodological research. During round two, their opinion about the level of importance of each topic was recorded, and during round three, they were asked to review the group’s average opinion and revise their previous opinion if appropriate. Direct reminders were sent to maximise the number of responses at each round. Results are summarised using descriptive methods. Results Forty one (85%) CTU Directors responded to at least one round of the Delphi process: 25 (52%) responded in round one, 32 (67%) responded in round two, 24 (50%) responded in round three. There were only 12 (25%) who responded to all three rounds and 18 (38%) who responded to both rounds two and three. Consensus was achieved amongst CTU Directors that the top three priorities for trials methodological research were ‘Research into methods to boost recruitment in trials’ (considered the highest priority), ‘Methods to minimise attrition’ and ‘Choosing appropriate outcomes to measure’. Fifty other topics were included in the list of priorities and consensus was reached that two topics, ‘Radiotherapy study designs’ and ‘Low carbon trials’, were not priorities. Conclusions This priority setting exercise has identified the research topics felt to be most important to the key stakeholder group of Directors of UKCRC registered CTUs. The use of robust methodology to identify these priorities will help ensure that this work informs the trials methodological research agenda, with

A Methodology for Equitable Performance Assessment and Presentation of Wave Energy Converters Based on Sea Trials

DEFF Research Database (Denmark)

Kofoed, Jens Peter; Pecher, Arthur; Margheritini, Lucia

2013-01-01

This paper provides a methodology for the analysis and presentation of data obtained from sea trials of wave energy converters (WEC). The equitable aspect of this methodology lies in its wide application, as any WEC at any scale or stage of development can be considered as long as the tests are p...... parameters influence the performance of the WEC can also be investigated using this methodology.......This paper provides a methodology for the analysis and presentation of data obtained from sea trials of wave energy converters (WEC). The equitable aspect of this methodology lies in its wide application, as any WEC at any scale or stage of development can be considered as long as the tests...... leads to testing campaigns that are not as extensive as desired. Therefore, the performance analysis should be robust enough to allow for not fully complete sea trials and sub optimal performance data. In other words, this methodology is focused at retrieving the maximum amount of useful information out...

Analysis of the Quality of Clinical Trials Published in Spanish-Language Dermatology Journals Between 1997 and 2012.

Science.gov (United States)

Sanclemente, G; Pardo, H; Sánchez, S; Bonfill, X

2016-01-01

The value of randomized clinical trials (RCTs) undertaken to identify an association between an intervention and an outcome is determined by their quality and scientific rigor. To assess the methodological quality of RCTs published in Spanish-language dermatology journals. By way of a systematic manual search, we identified all the RCTs in journals published in Spain and Latin America between 1997 (the year in which the CONSORT statement was published) and 2012. Risk of bias was evaluated for each RCT by assessing the following domains: randomization sequence generation, allocation concealment, blinding of patients and those assessing outcomes, missing data, and patient follow-up. Source of funding and conflict of interest statements, if any, were recorded for each study. The search identified 70 RCTs published in 21 journals. Most of the RCTs had a high risk of bias, primarily because of gaps in the reporting of important methodological aspects. The source of funding was reported in only 15 studies. In spite of the considerable number of Spanish and Latin American journals, few RCTs have been published in the 15 years analyzed. Most of the RCTs published had serious defects in that the authors omitted methodological information essential to any evaluation of the quality of the trial and failed to report sources of funding or possible conflicts of interest for the authors involved. Authors of experimental clinical research in dermatology published in Spain and Latin America need to substantially improve both the design of their trials and the reporting of results. Copyright © 2015 Elsevier España, S.L.U. and AEDV. All rights reserved.

Formalizing the ISDF Software Development Methodology

OpenAIRE

Mihai Liviu DESPA

2015-01-01

The paper is aimed at depicting the ISDF software development methodology by emphasizing quality management and software development lifecycle. The ISDF methodology was built especially for innovative software development projects. The ISDF methodology was developed empirically by trial and error in the process of implementing multiple innovative projects. The research process began by analysing key concepts like innovation and software development and by settling the important dilemma of wha...

Clinical trial quality: From supervision to collaboration and beyond.

Science.gov (United States)

Meeker-O'Connell, Ann; Glessner, Coleen

2018-02-01

Over the past decade, clinical trial quality has evolved from an after-the-fact, reactive activity to one focused on the important work of evidence generation from well-designed trials. This article explores the role the Clinical Trials Transformation Initiative has played in advancing quality as a core element of clinical trial design, through project work that initially focused on monitoring but evolved into a holistic, prospective, and comprehensive quality by design approach to clinical trial design and conduct.

Methodological Quality of Consensus Guidelines in Implant Dentistry.

Science.gov (United States)

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 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.

Q methodology, risk training and quality management.

Science.gov (United States)

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.

[Clinical trial data management and quality metrics system].

Science.gov (United States)

Chen, Zhao-hua; Huang, Qin; Deng, Ya-zhong; Zhang, Yue; Xu, Yu; Yu, Hao; Liu, Zong-fan

2015-11-01

Data quality management system is essential to ensure accurate, complete, consistent, and reliable data collection in clinical research. This paper is devoted to various choices of data quality metrics. They are categorized by study status, e.g. study start up, conduct, and close-out. In each category, metrics for different purposes are listed according to ALCOA+ principles such us completeness, accuracy, timeliness, traceability, etc. Some general quality metrics frequently used are also introduced. This paper contains detail information as much as possible to each metric by providing definition, purpose, evaluation, referenced benchmark, and recommended targets in favor of real practice. It is important that sponsors and data management service providers establish a robust integrated clinical trial data quality management system to ensure sustainable high quality of clinical trial deliverables. It will also support enterprise level of data evaluation and bench marking the quality of data across projects, sponsors, data management service providers by using objective metrics from the real clinical trials. We hope this will be a significant input to accelerate the improvement of clinical trial data quality in the industry.

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

Science.gov (United States)

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

A systematic methodology review of phase I radiation dose escalation trials

International Nuclear Information System (INIS)

Pijls-Johannesma, Madelon; Mastrigt, Ghislaine van; Hahn, Steve M.; De Ruysscher, Dirk; Baumert, Brigitta G.; Lammering, Guido; Buijsen, Jeroen; Bentzen, Soren M.; Lievens, Yolande; Kramar, Andrew; Lambin, Philippe

2010-01-01

Background and purpose: The purpose of this review is to evaluate the methodology used in published phase I radiotherapy (RT) dose escalation trials. A specific emphasis was placed on the frequency of reporting late complications as endpoint. Materials and methods: We performed a systematic literature review using a predefined search strategy to identify all phase I trials reporting on external radiotherapy dose escalation in cancer patients. Results: Fifty-three trials (phase I: n = 36, phase I-II: n = 17) fulfilled the inclusion criteria. Of these, 20 used a modified Fibonacci design for the RT dose escalation, but 32 did not specify a design. Late toxicity was variously defined as >3 months (n = 43) or > 6 months (n = 3) after RT, or not defined (n = 7). In only nine studies the maximum tolerated dose (MTD) was related to late toxicity, while only half the studies reported the minimum follow-up period for dose escalation (n = 26). Conclusion: In phase I RT trials, late complications are often not taken into account and there is currently no consensus on the methodology used for radiation dose escalation studies. We therefore propose a decision-tree algorithm which depends on the endpoint selected and whether a validated early surrogate endpoint is available, in order to choose the most appropriate study design.

Quality of reporting of randomized controlled trials of pharmacologic treatment of bipolar disorders: a systematic review.

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Strech, Daniel; Soltmann, Bettina; Weikert, Beate; Bauer, Michael; Pfennig, Andrea

2011-09-01

randomization procedures, with, for example, 16% of studies defining generation of random allocation sequence and 15% defining method of allocation concealment. Inadequate randomization increases the potential for bias to influence the final results. Authors of clinical guidelines or health technology assessments are forced to exclude or downgrade trials with inadequate reporting on randomization. Also, information with essential clinical relevance was generally reported inadequately, such as the effect size (in 18% of studies) and the number needed to treat (in 8% of studies). Both effect measures are more important for clinicians than individual point estimates that have been reported adequately. No consistent trend could be shown for improvement in quality of reporting over time or for reporting of essential methodological items differently in journals that endorse the Uniform Requirements for Manuscripts (URM). The reporting of information on clinical relevance and generalizability of results, however, showed a consistent trend toward better reporting in journals endorsing the URM, with significant differences for the reporting of secondary outcomes (100% vs 89.9%; P = .03) and adverse events (93.2% vs 73.8%; P = .011) and interpretation of results with regard to totality of data (30.2% vs 11.5%; P = .029). Our findings suggest that, while some trial-related information is well reported, a good part of the reporting quality of randomized controlled trials in bipolar disorder falls well below the required and also practically feasible level for many aspects essential for adequate interpretation of methodological quality and clinical relevance. Authors should be further encouraged to follow the CONSORT criteria. © Copyright 2011 Physicians Postgraduate Press, Inc.

Methodological characteristics of academic clinical drug trials--a retrospective cohort study of applications to the Danish Medicines Agency 1993-2005

DEFF Research Database (Denmark)

Berendt, Louise; Håkansson, Cecilia; Bach, Karin F

2010-01-01

The aim of this study was to investigate the temporal trends in characteristics of academic clinical drug trials. We here report characteristics on trial methodology.......The aim of this study was to investigate the temporal trends in characteristics of academic clinical drug trials. We here report characteristics on trial methodology....

The Helicobacter Eradication Aspirin Trial (HEAT: A Large Simple Randomised Controlled Trial Using Novel Methodology in Primary Care

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Jennifer S. Dumbleton

2015-09-01

Discussion: HEAT is important medically, because aspirin is so widely used, and methodologically, as a successful trial would show that large-scale studies of important clinical outcomes can be conducted at a fraction of the cost of those conducted by industry, which in turn will help to ensure that trials of primarily medical rather than commercial interest can be conducted successfully in the UK.

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

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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.

The development of a checklist to enhance methodological quality in intervention programs

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Salvador Chacón-Moscoso

2016-11-01

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

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

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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

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

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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.

Methodological quality and descriptive characteristics of prosthodontic-related systematic reviews.

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Aziz, T; Compton, S; Nassar, U; Matthews, D; Ansari, K; Flores-Mir, C

2013-04-01

Ideally, healthcare systematic reviews (SRs) should be beneficial to practicing professionals in making evidence-based clinical decisions. However, the conclusions drawn from SRs are directly related to the quality of the SR and of the included studies. The aim was to investigate the methodological quality and key descriptive characteristics of SRs published in prosthodontics. Methodological quality was analysed using the Assessment of Multiple Reviews (AMSTAR) tool. Several electronic resources (MEDLINE, EMBASE, Web of Science and American Dental Association's Evidence-based Dentistry website) were searched. In total 106 SRs were located. Key descriptive characteristics and methodological quality features were gathered and assessed, and descriptive and inferential statistical testing performed. Most SRs in this sample originated from the European continent followed by North America. Two to five authors conducted most SRs; the majority was affiliated with academic institutions and had prior experience publishing SRs. The majority of SRs were published in specialty dentistry journals, with implant or implant-related topics, the primary topics of interest for most. According to AMSTAR, most quality aspects were adequately fulfilled by less than half of the reviews. Publication bias and grey literature searches were the most poorly adhered components. Overall, the methodological quality of the prosthodontic-related systematic was deemed limited. Future recommendations would include authors to have prior training in conducting SRs and for journals to include a universal checklist that should be adhered to address all key characteristics of an unbiased SR process. © 2013 Blackwell Publishing Ltd.

Quality of reporting randomized controlled trials (RCTs) in diabetes in Iran; a systematic review.

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Gohari, Faeze; Baradaran, Hamid Reza; Tabatabaee, Morteza; Anijidani, Shabnam; Mohammadpour Touserkani, Fatemeh; Atlasi, Rasha; Razmgir, Maryam

2015-01-01

To determine the quality of randomized controlled clinical trial (RCT) reports in diabetes research in Iran. Systematized review. We included RCTs conducted on diabetes mellitus in Iran. Animal studies, educational interventions, and non-randomized trials were excluded. We excluded duplicated publications reporting the same groups of participants and intervention. Two independent reviewers identify all eligible articles specifically designed data extraction form. We searched through international databases; Scopus, ProQuest, EBSCO, Science Direct, Web of Science, Cochrane Library, PubMed; and national databases (In Persian language) such as Magiran, Scientific Information Database (SID) and IranMedex from January 1995 to January of 2013 Two investigators assessed the quality of reporting by CONSORT 2010 (Consolidated Standards of Reporting Trials) checklist statemen.t,. Discrepancies were resolved by third reviewer consulting. One hundred and eight five (185) studies were included and appraised. Half of them (55.7 %) were published in Iranian journals. Most (89.7 %) were parallel RCTs, and being performed on type2 diabetic patients (77.8 %). Less than half of the CONSORT items (43.2 %) were reported in studies, totally. The reporting of randomization and blinding were poor. A few studies 15.1 % mentioned the method of random sequence generation and strategy of allocation concealment. And only 34.8 % of trials report how blinding was applied. The findings of this study show that the quality of RCTs conducted in Iran in diabetes research seems suboptimal and the reporting is also incomplete however an increasing trend of improvement can be seen over time. Therefore, it is suggested Iranian researchers pay much more attention to design and methodological quality in conducting and reporting of diabetes RCTs.

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

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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.

Industry funded clinical trials: bias and quality.

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Del Parigi, Angelo

2012-01-01

The quality of the clinical data supporting the development and ultimately the approval for medical use of new drugs is often challenged. Many share the perception that the business goals of the pharmaceutical industry overrule the best scientific efforts to accrue critical knowledge on a new molecule, in order to inform investment of resources, regulatory approvals and appropriate use by patients. Despite this common belief, few scientists have attempted to assess objectively the quality of industry funded (IF) clinical trials by measuring it and comparing it with non-industry funded (NIF) clinical trials in a data-driven fashion. Overall, the average quality of IF clinical research has been reported to be higher than the quality of NIF clinical research.

A quality evaluation methodology of health web-pages for non-professionals.

Science.gov (United States)

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.

The main aspects of methodology of quality management system

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Smirnova E.K.

2017-03-01

Full Text Available this article describes the formation and development of quality management as an integrated system. The author considers the theory and methodology of quality management since the early XXth century to the present day and describes the main problems encountered in the process of quality management system, as well as the ways to overcome them.

Global health trials methodological research agenda:results from a priority setting exercise

OpenAIRE

Blazeby, Jane; Nasser, Mona; Soares-Weiser, Karla; Sydes, Matthew R.; Zhang, Junhua; Williamson, Paula R

2018-01-01

BackgroundMethodological research into the design, conduct, analysis and reporting of trials is essential to optimise the process. UK specialists in the field have established a set of top priorities in aid of this research. These priorities however may not be reflected in the needs of similar research in low to middle income countries (LMICs) with different healthcare provision, resources and research infrastructure. The aim of the study was to identify the top priorities for methodological ...

An objective methodology for the evaluation of the air quality stations positioning

International Nuclear Information System (INIS)

Benassi, A.; Marson, G.; Baraldo, E.; Dalan, F.; Lorenzet, K.; Bellasio, R.; Bianconi, R.

2006-01-01

This work describes a methodology for the evaluation of the correct positioning of the monitoring stations of an air quality network. The methodology is based on the Italian legislation, the European Directives and on some technical documents used as guidelines at European level. The paper describes all the assumption on which the methodology is based and the results of its application to the air quality network of Region Veneto (Italy) [it

Formalizing the ISDF Software Development Methodology

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Mihai Liviu DESPA

2015-01-01

Full Text Available The paper is aimed at depicting the ISDF software development methodology by emphasizing quality management and software development lifecycle. The ISDF methodology was built especially for innovative software development projects. The ISDF methodology was developed empirically by trial and error in the process of implementing multiple innovative projects. The research process began by analysing key concepts like innovation and software development and by settling the important dilemma of what makes a web application innovative. Innovation in software development is presented from the end-user, project owner and project manager’s point of view. The main components of a software development methodology are identified. Thus a software development methodology should account for people, roles, skills, teams, tools, techniques, processes, activities, standards, quality measuring tools, and team values. Current software development models are presented and briefly analysed. The need for a dedicated innovation oriented software development methodology is emphasized by highlighting shortcomings of current software development methodologies when tackling innovation. The ISDF methodology is presented in the context of developing an actual application. The ALHPA application is used as a case study for emphasizing the characteristics of the ISDF methodology. The development life cycle of the ISDF methodology includes research, planning, prototyping, design, development, testing, setup and maintenance. Artefacts generated by the ISDF methodology are presented. Quality is managed in the ISDF methodology by assessing compliance, usability, reliability, repeatability, availability and security. In order to properly asses each quality component a dedicated indicator is built. A template for interpreting each indicator is provided. Conclusions are formulated and new related research topics are submitted for debate.

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

Science.gov (United States)

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 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.

Research on quality assurance classification methodology for domestic AP1000 nuclear power projects

International Nuclear Information System (INIS)

Bai Jinhua; Jiang Huijie; Li Jingyan

2012-01-01

To meet the quality assurance classification requirements of domestic nuclear safety codes and standards, this paper analyzes the quality assurance classification methodology of domestic AP1000 nuclear power projects at present, and proposes the quality assurance classification methodology for subsequent AP1000 nuclear power projects. (authors)

OpenKnowledge Deliverable 3.3.: A methodology for ontology matching quality evaluation

OpenAIRE

Yatskevich, Mikalai; Giunchiglia, Fausto; McNeill, Fiona; Shvaiko, Pavel

2007-01-01

This document presents an evaluation methodology for the assessment of quality results produced by ontology matchers. In particular, it discusses: (i) several standard quality measures used in the ontology matching evaluation, (ii) a methodology of how to build semiautomatically an incomplete reference alignment allowing for the assessment of quality results produced by ontology matchers and (iii) a preliminary empirical evaluation of the OpenKnowledge ontology matching component.

No short-cut in assessing trial quality: a case study

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Hirji Karim F

2009-01-01

Full Text Available Abstract Background Assessing the quality of included trials is a central part of a systematic review. Many check-list type of instruments for doing this exist. Using a trial of antibiotic treatment for acute otitis media, Burke et al., BMJ, 1991, as the case study, this paper illustrates some limitations of the check-list approach to trial quality assessment. Results The general verdict from the check list type evaluations in nine relevant systematic reviews was that Burke et al. (1991 is a good quality trial. All relevant meta-analyses extensively used its data to formulate therapeutic evidence. My comprehensive evaluation, on the other hand, brought to the surface a series of serious problems in the design, conduct, analysis and report of this trial that were missed by the earlier evaluations. Conclusion A check-list or instrument based approach, if used as a short-cut, may at times rate deeply flawed trials as good quality trials. Check lists are crucial but they need to be augmented with an in-depth review, and where possible, a scrutiny of the protocol, trial records, and original data. The extent and severity of the problems I uncovered for this particular trial warrant an independent audit before it is included in a systematic review.

Clinical trials in allied medical fields: A cross-sectional analysis of World Health Organization International Clinical Trial Registry Platform

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S. Kannan

2016-03-01

Conclusion: The number of clinical trials done in allied fields of medicine other than the allopathic system has lowered down, and furthermore focus is required regarding the methodological quality of these trials and more support from various organizations.

Organ Donation European Quality System: ODEQUS project methodology.

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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

Quality of radiotherapy reporting in randomized controlled trials of prostate cancer.

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Soon, Yu Yang; Chen, Desiree; Tan, Teng Hwee; Tey, Jeremy

2018-06-07

Good radiotherapy reporting in clinical trials of prostate radiotherapy is important because it will allow accurate reproducibility of radiotherapy treatment and minimize treatment variations that can affect patient outcomes. The aim of our study is to assess the quality of prostate radiotherapy (RT) treatment reporting in randomized controlled trials in prostate cancer. We searched MEDLINE for randomized trials of prostate cancer, published from 1996 to 2016 and included prostate RT as one of the intervention arms. We assessed if the investigators reported the ten criteria adequately in the trial reports: RT dose prescription method; RT dose-planning procedures; organs at risk (OAR) dose constraints; target volume definition, simulation procedures; treatment verification procedures; total RT dose; fractionation schedule; conduct of quality assurance (QA) as well as presence or absence of deviations in RT treatment planning and delivery. We performed multivariate logistic regression to determine the factors that may influence the quality of reporting. We found 59 eligible trials. There was significant variability in the quality of reporting. Target volume definition, total RT dose and fractionation schedule were reported adequately in 97% of included trials. OAR constraints, simulation procedures and presence or absence of deviations in RT treatment planning and delivery were reported adequately in 30% of included trials. Twenty-four trials (40%) reported seven criteria or more adequately. Multivariable logistic analysis showed that trials that published their quality assurance results and cooperative group trials were more likely to have adequate quality in reporting in at least seven criteria. There is significant variability in the quality of reporting on prostate radiotherapy treatment in randomized trials of prostate cancer. We need to have consensus guidelines to standardize the reporting of radiotherapy treatment in randomized trials.

Implementation and results of an integrated data quality assurance protocol in a randomized controlled trial in Uttar Pradesh, India.

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Gass, Jonathon D; Misra, Anamika; Yadav, Mahendra Nath Singh; Sana, Fatima; Singh, Chetna; Mankar, Anup; Neal, Brandon J; Fisher-Bowman, Jennifer; Maisonneuve, Jenny; Delaney, Megan Marx; Kumar, Krishan; Singh, Vinay Pratap; Sharma, Narender; Gawande, Atul; Semrau, Katherine; Hirschhorn, Lisa R

2017-09-07

There are few published standards or methodological guidelines for integrating Data Quality Assurance (DQA) protocols into large-scale health systems research trials, especially in resource-limited settings. The BetterBirth Trial is a matched-pair, cluster-randomized controlled trial (RCT) of the BetterBirth Program, which seeks to improve quality of facility-based deliveries and reduce 7-day maternal and neonatal mortality and maternal morbidity in Uttar Pradesh, India. In the trial, over 6300 deliveries were observed and over 153,000 mother-baby pairs across 120 study sites were followed to assess health outcomes. We designed and implemented a robust and integrated DQA system to sustain high-quality data throughout the trial. We designed the Data Quality Monitoring and Improvement System (DQMIS) to reinforce six dimensions of data quality: accuracy, reliability, timeliness, completeness, precision, and integrity. The DQMIS was comprised of five functional components: 1) a monitoring and evaluation team to support the system; 2) a DQA protocol, including data collection audits and targets, rapid data feedback, and supportive supervision; 3) training; 4) standard operating procedures for data collection; and 5) an electronic data collection and reporting system. Routine audits by supervisors included double data entry, simultaneous delivery observations, and review of recorded calls to patients. Data feedback reports identified errors automatically, facilitating supportive supervision through a continuous quality improvement model. The five functional components of the DQMIS successfully reinforced data reliability, timeliness, completeness, precision, and integrity. The DQMIS also resulted in 98.33% accuracy across all data collection activities in the trial. All data collection activities demonstrated improvement in accuracy throughout implementation. Data collectors demonstrated a statistically significant (p = 0.0004) increase in accuracy throughout

The methodological quality of systematic reviews of animal studies in dentistry.

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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.

Review of Recent Methodological Developments in Group-Randomized Trials: Part 2-Analysis.

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Turner, Elizabeth L; Prague, Melanie; Gallis, John A; Li, Fan; Murray, David M

2017-07-01

In 2004, Murray et al. reviewed methodological developments in the design and analysis of group-randomized trials (GRTs). We have updated that review with developments in analysis of the past 13 years, with a companion article to focus on developments in design. We discuss developments in the topics of the earlier review (e.g., methods for parallel-arm GRTs, individually randomized group-treatment trials, and missing data) and in new topics, including methods to account for multiple-level clustering and alternative estimation methods (e.g., augmented generalized estimating equations, targeted maximum likelihood, and quadratic inference functions). In addition, we describe developments in analysis of alternative group designs (including stepped-wedge GRTs, network-randomized trials, and pseudocluster randomized trials), which require clustering to be accounted for in their design and analysis.

A Methodology for Anatomic Ultrasound Image Diagnostic Quality Assessment

DEFF Research Database (Denmark)

Hemmsen, Martin Christian; Lange, Theis; Brandt, Andreas Hjelm

2017-01-01

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......This paper discusses methods for 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...... to properly reveal the clinical value. The paper exemplifies the methodology using recent studies of Synthetic Aperture Sequential Beamforming tissue harmonic imaging....

Methodology for stereoscopic motion-picture quality assessment

Science.gov (United States)

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.

Use of IMMPACT domains in clinical trials of acupuncture for chronic pain: a protocol for a methodological survey.

Science.gov (United States)

Mazzei, Lauren Giustti; Bergamaschi, Cristiane de Cássia; Silva, Marcus Tolentino; Lopes, Luciane Cruz

2017-09-27

Pain is one of the most common and most debilitating complaints among patients. It affects the individual, their relationship with friends and family, their ability to function at work, and their sociability. Acupuncture is one of the therapeutic resources for managing chronic pain. Given the variability of outcome measures in controlled randomised clinical trials on non-oncologicchronic pain (CRCT-NOCP), the Initiative in Methods, Measurements and Pain Assessment in Clinical Trials (IMMPACT) recommends six domains to be covered in evaluating the effectiveness of treatments for chronic pain. To check whether the methodological quality of outcome reporting in published trials has used IMMPACT recommendations in measuring CRCT-NOCP outcomes when acupuncture was used as a treatment. This is a methodological study. We will systematically search for eligible studies in specific databases with a defined strategy. We will use the MeSHterms of 'acupuncture', 'chronic pain' and similar terms, without restrictions on idiom. Eligible studies will include those which are randomised and chose NOCP patients to be treated with acupuncture or control (sham acupuncture or no acupuncture), recruited after September 2004, with ≥100 patients. The measured outcomes are to be the presence of outcome domains recommended by IMMPACT, domains reported by the patient or clinician, tools used to measure such domains, as well as other features of the studies. We shall conduct a regression analysis to explore factors which can be associated with the presence of outcome domains according to IMMPACT recommendations. This survey will be submitted for presentation at congresses and for publication in a scientific journal. The findings obtained in this study will allow us to measure the quality of the evidence and provide greater transparency in decisions regarding the use of acupuncture as a viable alternative to managing chronic pain. © Article author(s) (or their employer(s) unless otherwise

Quality assurance in clinical trials : a multi-disciplinary approach

International Nuclear Information System (INIS)

Cornes, D.

2001-01-01

Full text: Multi-disciplinary groups, such as medical physicists and radiation therapists, which work effectively together, can ensure continued improvements in radiation therapy quality. The same is also true for clinical trials, which have the added complication of requiring multi-institutional participation to collate sufficient data to effectively assess treatment benefits. It can be difficult to manage quality across all aspects of a multi-disciplinary and multi-institutional trial. A planned system of quality assurance is necessary to provide support for participating centres and facilitate a collaborative approach. To ensure protocol compliance a good relationship between the clinical trial group and treatment centre is idea with definition of mutual goals and objectives before and during the trial, and ongoing consultation and feedback throughout the trial process. To ensure good quality data and maximise the validity of results the study protocol must be strictly adhered to. Because of the need for meticulous attention to detail, both in treatment delivery and standards of documentation, clinical trials are often seen to further complicate the process of delivery of radiation therapy treatment. The Declaration of Helsinki and Good Clinical Practise Guidelines (adopted in May 1996, ICH) provide 'international ethical and scientific standards for designing, conducting, recording and reporting clinical research' and multi-disciplinary groups in each participating centre should also adhere to these guidelines. Copyright (2001) Australasian College of Physical Scientists and Engineers in Medicine

QUALITY IMPROVEMENT IN MULTIRESPONSE EXPERIMENTS THROUGH ROBUST DESIGN METHODOLOGY

Directory of Open Access Journals (Sweden)

M. Shilpa

2012-06-01

Full Text Available Robust design methodology aims at reducing the variability in the product performance in the presence of noise factors. Experiments involving simultaneous optimization of more than one quality characteristic are known as multiresponse experiments which are used in the development and improvement of industrial processes and products. In this paper, robust design methodology is applied to optimize the process parameters during a particular operation of rotary driving shaft manufacturing process. The three important quality characteristics of the shaft considered here are of type Nominal-the-best, Smaller-the-better and Fraction defective. Simultaneous optimization of these responses is carried out by identifying the control parameters and conducting the experimentation using L9 orthogonal array.

Imaging Mental Representations of Sex-Typed Bodies: The Effect of Number of Trials on Image Quality

Directory of Open Access Journals (Sweden)

David James Lick

2013-07-01

Full Text Available Sex categorization is a critical process in social perception. While psychologists have long theorized that perceivers have distinct mental representations of men and women that help them to achieve efficient sex categorizations, researchers have only recently begun using reverse-correlation to visualize the content of these mental representations. The present research addresses two issues concerning this relatively new methodological tool. First, previous studies of reverse-correlation have focused almost exclusively on perceivers’ mental representations of faces. Our study demonstrates that this technique can also be used to visualize mental representations of sex-typed bodies. Second, most studies of reverse-correlation have employed a relatively large number of trials (1,000+ to capture perceivers’ mental representations of a given category. Our study demonstrated that, at least for sex-typed representations of bodies, high quality reverse-correlation images can be obtained with as few as 100 trials. Overall, our findings enhance knowledge of reverse-correlation methodology in general and sex categorization in particular, providing new information for researchers interested in using this technique to understand the complex processes underlying social perception.

How informed is declared altruism in clinical trials? A qualitative interview study of patient decision-making about the QUEST trials (Quality of Life after Mastectomy and Breast Reconstruction).

Science.gov (United States)

Bidad, Natalie; MacDonald, Lindsay; Winters, Zoë E; Edwards, Sarah J L; Emson, Marie; Griffin, Clare L; Bliss, Judith; Horne, Rob

2016-09-02

Randomised controlled trials (RCTs) often fail to recruit sufficient participants, despite altruism being cited as their motivation. Previous investigations of factors influencing participation decisions have been methodologically limited. This study evaluated how women weigh up different motivations after initially expressing altruism, and explored their understanding of a trial and its alternatives. The trial was the 'Quality of Life after Mastectomy and Breast Reconstruction' (QUEST) trial. Thirty-nine women participated in qualitative interviews 1 month post-surgery. Twenty-seven women (10 trial decliners and 17 acceptors) who spontaneously mentioned 'altruism' were selected for thematic analysis. Verbatim transcripts were coded independently by two researchers. Participants' motivations to accept or decline randomisation were cross-referenced with their understanding of the QUEST trials and the process of randomisation. The seven emerging themes were: (1) altruism expressed by acceptors and decliners; (2) overriding personal needs in decliners; (3) pure altruism in acceptors; (4) 'hypothetical altruism' amongst acceptors; (5) weak altruism amongst acceptors; (6) conditional altruism amongst acceptors; and (7) sense of duty to participate. Poor understanding of the trial rationale and its implications was also evident. Altruism was a motivating factor for participation in the QUEST randomised controlled trials where the main outcomes comprised quality of life and allocated treatments comprised established surgical procedures. Women's decisions were influenced by their understanding of the trial. Both acceptors and decliners of the trial expressed 'altruism', but most acceptors lacked an obvious treatment preference, hoped for personal benefits regarding a treatment allocation, or did not articulate complete understanding of the trial. QUEST A, ISRCTN38846532 ; Date assigned 6 January 2010. QUEST B, ISRCTN92581226 ; Date assigned 6 January 2010.

A Cluster-Randomised Trial of Staff Education to Improve the Quality of Life of People with Dementia Living in Residential Care: The DIRECT Study

OpenAIRE

Beer, Christopher; Horner, Barbara; Flicker, Leon; Scherer, Samuel; Lautenschlager, Nicola T.; Bretland, Nick; Flett, Penelope; Schaper, Frank; Almeida, Osvaldo P.

2011-01-01

BACKGROUND: The Dementia In Residential care: EduCation intervention Trial (DIRECT) was conducted to determine if delivery of education designed to meet the perceived need of GPs and care staff improves the quality of life of participants with dementia living in residential care. METHODOLOGY/PRINCIPAL FINDINGS: This cluster-randomised controlled trial was conducted in 39 residential aged care facilities in the metropolitan area of Perth, Western Australia. 351 care facility residents aged 65 ...

Urbanism & urban qualities New data and methodologies

DEFF Research Database (Denmark)

2009-01-01

The interest in urban spaces and their qualities has become stronger in recent years. A substantial volume of projects aims to create attractive urban spaces reasons of Sustainability, Quality of Life and urban vitality. But who actually uses the urban spaces, which urban spaces are used? How do...... they use them? What characterizes the good urban space? And how and by who is it evaluated? How is a better co-operation between urban space researchers, decision makers and users established? Is it the right urban spaces which receive investments? How can research optimize the basis for decisions......?   Proceedings from the conference "Urbanism & urban qualities - new data & methodologies" held 24th of June 2009 at The Royal Danish Academy of Fine Arts in Copenhagen....

Quality Assurance for Clinical Trials

Science.gov (United States)

Ibbott, Geoffrey S.; Haworth, Annette; Followill, David S.

2013-01-01

Cooperative groups, of which the Radiation Therapy Oncology Group is one example, conduct national clinical trials that often involve the use of radiation therapy. In preparation for such a trial, the cooperative group prepares a protocol to define the goals of the trial, the rationale for its design, and the details of the treatment procedure to be followed. The Radiological Physics Center (RPC) is one of several quality assurance (QA) offices that is charged with assuring that participating institutions deliver doses that are clinically consistent and comparable. The RPC does this by conducting a variety of independent audits and credentialing processes. The RPC has compiled data showing that credentialing can help institutions comply with the requirements of a cooperative group clinical protocol. Phantom irradiations have been demonstrated to exercise an institution’s procedures for planning and delivering advanced external beam techniques (1–3). Similarly, RPC data indicate that a rapid review of patient treatment records or planning procedures can improve compliance with clinical trials (4). The experiences of the RPC are presented as examples of the contributions that a national clinical trials QA center can make to cooperative group trials. These experiences illustrate the critical need for comprehensive QA to assure that clinical trials are successful and cost-effective. The RPC is supported by grants CA 10953 and CA 81647 from the National Cancer Institute, NIH, DHHS. PMID:24392352

Methodological and reporting quality in laboratory studies of human eating behavior

NARCIS (Netherlands)

Robinson, E.; Bevelander, K.E.; Field, M.; Jones, A.

2018-01-01

The methodological quality and reporting practices of laboratory studies of human eating behavior determine the validity and replicability of nutrition science. The aim of this research was to examine basic methodology and reporting practices in recent representative laboratory studies of human

ASSESSMENT OF QUALITY OF LIFE: PRESENT AND FUTURE METHODOLOGICAL CHALLENGES

Directory of Open Access Journals (Sweden)

Isabel Benítez

2016-01-01

Full Text Available The growing importance of quality of life in diverse domains, such as health, school performance and social participation, has led to the development of new conceptualisations and assessments of the construct. This diversity of perspectives brings about many benefits, but it also creates an obstacle for the formulation of a single unifying definition of the construct and, therefore, an agreed instrument or assessment framework. The aim of this study is to discuss the current methodological challenges in the measurement of quality of life. Firstly, we provide a brief description of the construct as defined in various areas, then we examine the new methodological developments and different applications. We also present an overview of the different possibilities for future developments in defining and measuring quality of life in national and international studies.

Chinese herbal medicine for cancer-related fatigue: a systematic review of randomized clinical trials.

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Su, Chun-Xiang; Wang, Li-Qiong; Grant, Suzanne J; Liu, Jian-Ping

2014-06-01

To assess the effectiveness and safety of Chinese herbal medicine for the treatment of cancer-related fatigue. We systematically searched seven electronic databases and two trial registries for randomized clinical trials of Chinese herbal medicine for cancer-related fatigue. Two authors independently extracted data and assessed the methodological quality of the included trials using the Cochrane risk of bias tool. Data were synthesized using RevMan 5.2 software. A total of 10 trials involving 751 participants with cancer-related fatigue were identified and the methodological quality of the included trials was generally poor. Chinese herbal medicine used alone or in combination with chemotherapy or supportive care showed significant relief in cancer-related fatigue compared to placebo, chemotherapy or supportive care based on single trials. Chinese herbal medicine plus chemotherapy or supportive care was superior to chemotherapy or supportive care in improving quality of life. Data from one trial demonstrated Chinese herbal medicine exerted a greater beneficial effect on relieving anxiety but no difference in alleviating depression. Seven trials reported adverse events and no severe adverse effects were found in Chinese herbal medicine groups. The findings from limited number of trials suggest that Chinese herbal medicine seems to be effective and safe in the treatment of cancer-related fatigue. However, the current evidence is insufficient to draw a confirmative conclusion due to the poor methodological quality of included trials. Thus, conducting rigorously designed trials on potential Chinese herbal medicine is warranted. Copyright © 2014 Elsevier Ltd. All rights reserved.

Implementing the PAIN RelieveIt Randomized Controlled Trial in Hospice Care: Mechanisms for Success and Meeting PCORI Methodology Standards.

Science.gov (United States)

Ezenwa, Miriam O; Suarez, Marie L; Carrasco, Jesus D; Hipp, Theresa; Gill, Anayza; Miller, Jacob; Shea, Robert; Shuey, David; Zhao, Zhongsheng; Angulo, Veronica; McCurry, Timothy; Martin, Joanna; Yao, Yingwei; Molokie, Robert E; Wang, Zaijie Jim; Wilkie, Diana J

2017-07-01

This purpose of this article is to describe how we adhere to the Patient-Centered Outcomes Research Institute's (PCORI) methodology standards relevant to the design and implementation of our PCORI-funded study, the PAIN RelieveIt Trial. We present details of the PAIN RelieveIt Trial organized by the PCORI methodology standards and components that are relevant to our study. The PAIN RelieveIt Trial adheres to four PCORI standards and 21 subsumed components. The four standards include standards for formulating research questions, standards associated with patient centeredness, standards for data integrity and rigorous analyses, and standards for preventing and handling missing data. In the past 24 months, we screened 2,837 cancer patients and their caregivers; 874 dyads were eligible; 223.5 dyads consented and provided baseline data. Only 55 patients were lost to follow-up-a 25% attrition rate. The design and implementation of the PAIN RelieveIt Trial adhered to PCORI's methodology standards for research rigor.

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

Science.gov (United States)

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

2016-06-01

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

A food quality management research methodology integrating technological and managerial theories

NARCIS (Netherlands)

Luning, P.A.; Marcelis, W.J.

2009-01-01

In this article it is argued how the complexity of food quality management combined with the high requirements on food quality requires a specific research methodology. It is concluded that food quality management research has to deal with two quite different paradigms, the one from technological

Measuring the Quality of Publications : New Methodology and Case Study

NARCIS (Netherlands)

Kleijnen, J.P.C.; van Groenendaal, W.J.H.

2000-01-01

n practice, it is important to evaluate the quality of research, in order to make decisions on tenure, funding, and so on. This article develops a methodology using citations to measure the quality of journals, proceedings, and book publishers. (Citations are also used by the Science and Social

Identifying approaches for assessing methodological and reporting quality of systematic reviews

DEFF Research Database (Denmark)

Pussegoda, Kusala; Turner, Lucy; Garritty, Chantelle

2017-01-01

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......BACKGROUND: 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...... 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...

Methodology of phase II clinical trials in metastatic elderly breast cancer: a literature review.

Science.gov (United States)

Cabarrou, B; Mourey, L; Dalenc, F; Balardy, L; Kanoun, D; Roché, H; Boher, J M; Rougé-Bugat, M E; Filleron, Thomas

2017-08-01

As the incidence of invasive breast cancer will increase with age, the number of elderly patients with a diagnosis metastatic breast cancer will also rise. But the use of cytotoxic drugs in elderly metastatic breast cancer patients is not systematic and is dreaded by medical oncologists. The need for prospective oncologic data from this population seems increasingly obvious. The main objective of this review is to investigate design and characteristics of phase II trials that assess activity and feasibility of chemotherapies in elderly advanced/metastatic breast cancer patients. An electronic search in PUBMED allowed us to retrieve articles published in English language on phase II trials in elderly metastatic breast cancer between January 2002 and May 2016. Sixteen publications were finally included in this review. The primary endpoint was a simple, a composite, and a co-primary endpoints in 11, three, and two studies, respectively. Efficacy was the primary objective in 15 studies: simple (n = 10), composite (n = 3), co-primary endpoints (n = 2). Composite or co-primary endpoints combined efficacy and toxicity. Thirteen studies used multistage designs. Only five studies evaluated the feasibility, i.e., to jointly assess efficacy and tolerance to treatment (toxicity, quality of life, etc) as primary endpoint. Development of elderly specific phase III clinical trials might be challenging, it therefore seems essential to conduct phase II clinical trials evaluating jointly efficacy and toxicity in a well-defined geriatric population. Use of multistage designs that take into account heterogeneity would allow to identify a subpopulation at interim analysis and to reduce the number of patients exposed to an inefficient or a toxic treatment regimen. It is crucial to evaluate new therapies (targeted therapies, immunotherapies) using adequate methodologies (Study design, endpoint).

Methodological Quality Assessment of Meta-analyses in Endodontics.

Science.gov (United States)

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.

Assessment of adherence to the CONSORT statement for quality of reports on randomized controlled trial abstracts from four high-impact general medical journals.

Science.gov (United States)

Ghimire, Saurav; Kyung, Eunjung; Kang, Wonku; Kim, Eunyoung

2012-06-07

The extended Consolidated Standards of Reporting Trials (CONSORT) Statement for Abstracts was developed to improve the quality of reports of randomized controlled trials (RCTs) because readers often base their assessment of a trial solely on the abstract. To date, few data exist regarding whether it has achieved this goal. We evaluated the extent of adherence to the CONSORT for Abstract statement for quality of reports on RCT abstracts by four high-impact general medical journals. A descriptive analysis of published RCT abstracts in The New England Journal of Medicine (NEJM), The Lancet, The Journal of American Medical Association (JAMA), and the British Medical Journal (BMJ) in the year 2010 was conducted by two reviewers, independently extracting data from a MEDLINE/PubMed search. We identified 271 potential RCT abstracts meeting our inclusion criteria. More than half of the abstracts identified the study as randomized in the title (58.7%; 159/271), reported the specific objective/hypothesis (72.7%; 197/271), described participant eligibility criteria with settings for data collection (60.9%; 165/271), detailed the interventions for both groups (90.8%; 246/271), and clearly defined the primary outcome (94.8%; 257/271). However, the methodological quality domains were inadequately reported: allocation concealment (11.8%; 32/271) and details of blinding (21.0%; 57/271). Reporting the primary outcome results for each group was done in 84.1% (228/271). Almost all of the abstracts reported trial registration (99.3%; 269/271), whereas reports of funding and of harm or side effects from the interventions were found in only 47.6% (129/271) and 42.8% (116/271) of the abstracts, respectively. These findings show inconsistencies and non-adherence to the CONSORT for abstract guidelines, especially in the methodological quality domains. Improvements in the quality of RCT reports can be expected by adhering to existing standards and guidelines as expressed by the CONSORT group.

Laser in Glaucoma and Ocular Hypertension (LiGHT) trial. A multicentre, randomised controlled trial: design and methodology.

Science.gov (United States)

Gazzard, Gus; Konstantakopoulou, Evgenia; Garway-Heath, David; Barton, Keith; Wormald, Richard; Morris, Stephen; Hunter, Rachael; Rubin, Gary; Buszewicz, Marta; Ambler, Gareth; Bunce, Catey

2018-05-01

The Laser in Glaucoma and Ocular Hypertension (LiGHT) Trial aims to establish whether initial treatment with selective laser trabeculoplasty (SLT) is superior to initial treatment with topical medication for primary open-angle glaucoma (POAG) or ocular hypertension (OHT). The LiGHT Trial is a prospective, unmasked, multicentre, pragmatic, randomised controlled trial. 718 previously untreated patients with POAG or OHT were recruited at six collaborating centres in the UK between 2012 and 2014. The trial comprises two treatment arms: initial SLT followed by conventional medical therapy as required, and medical therapy without laser therapy. Randomisation was provided online by a web-based randomisation service. Participants will be monitored for 3 years, according to routine clinical practice. The target intraocular pressure (IOP) was set at baseline according to an algorithm, based on disease severity and lifetime risk of loss of vision at recruitment, and subsequently adjusted on the basis of IOP control, optic disc and visual field. The primary outcome measure is health-related quality of life (HRQL) (EQ-5D five-level). Secondary outcomes are treatment pathway cost and cost-effectiveness, Glaucoma Utility Index, Glaucoma Symptom Scale, Glaucoma Quality of Life, objective measures of pathway effectiveness, visual function and safety profiles and concordance. A single main analysis will be performed at the end of the trial on an intention-to-treat basis. The LiGHT Trial is a multicentre, pragmatic, randomised clinical trial that will provide valuable data on the relative HRQL, clinical effectiveness and cost-effectiveness of SLT and topical IOP-lowering medication. ISRCTN32038223, Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Methodology for Multileaf Collimator Quality Assurance in clinical conditions

International Nuclear Information System (INIS)

Diaz M, R. M.; Rodriguez Z, M.; Juarez D, A.; Romero R, R.

2013-01-01

Multileaf Collimators (MLCs) have become an important technological advance as part of clinical linear accelerators (linacs) for radiotherapy. Treatment planning and delivery were substantially modified after these devices. However, it was needed to develop Quality Assurance (QA) methodologies related to the performance of these developments. The most common methods for QA of MLC are made in basic conditions that hardly cover all possible difficulties in clinical practice. Diaz et. el. developed a methodology based upon volumetric detectors bidimensional arrays that can be extended to more demanding situations. In this work, the Auril methodology of Diaz et. al. was implemented to the irradiation with the linac gantry in horizontal position. A mathematical procedure was developed to ease the dosimetric centering of the device with the Auril centering tool. System calibration was made as in the typical Auril methodology. Patterns with leaf misplacements in known positions were irradiated. the method allowed the detection of leafs' misplacements with a minimum number of false positives. We concluded that Auril methodology can be applied in clinical conditions. (Author)

Processes for Quality Improvements in Radiation Oncology Clinical Trials

International Nuclear Information System (INIS)

FitzGerald, T.J.; Urie, Marcia; Ulin, Kenneth; Laurie, Fran; Yorty, Jeffrey C.; Hanusik, Richard; Kessel, Sandy; Jodoin, Maryann Bishop; Osagie, Gani; Cicchetti, M. Giulia; Pieters, Richard; McCarten, Kathleen; Rosen, Nancy

2008-01-01

Quality assurance in radiotherapy (RT) has been an integral aspect of cooperative group clinical trials since 1970. In early clinical trials, data acquisition was nonuniform and inconsistent and computational models for radiation dose calculation varied significantly. Process improvements developed for data acquisition, credentialing, and data management have provided the necessary infrastructure for uniform data. With continued improvement in the technology and delivery of RT, evaluation processes for target definition, RT planning, and execution undergo constant review. As we move to multimodality image-based definitions of target volumes for protocols, future clinical trials will require near real-time image analysis and feedback to field investigators. The ability of quality assurance centers to meet these real-time challenges with robust electronic interaction platforms for imaging acquisition, review, archiving, and quantitative review of volumetric RT plans will be the primary challenge for future successful clinical trials

Development of Management Methodology for Engineering Production Quality

Science.gov (United States)

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

Measurement of Quality of Life I. A Methodological Framework

Directory of Open Access Journals (Sweden)

Soren Ventegodt

2003-01-01

Full Text Available Despite the widespread acceptance of quality of life (QOL as the ideal guideline in healthcare and clinical research, serious conceptual and methodological problems continue to plague this area. In an attempt to remedy this situation, we propose seven criteria that a quality-of-life concept must meet to provide a sound basis for investigation by questionnaire. The seven criteria or desiderata are: (1 an explicit definition of quality of life; (2 a coherent philosophy of human life from which the definition is derived; (3 a theory that operationalizes the philosophy by specifying unambiguous, nonoverlapping, and jointly exhaustive questionnaire items; (4 response alternatives that permit a fraction-scale interpretation; (5 technical checks of reproducibility; (6 meaningfulness to investigators, respondents, and users; and (7 an overall aesthetic appeal of the questionnaire. These criteria have guided the design of a validated 5-item generic, global quality-of-life questionnaire (QOL5, and a validated 317-item generic, global quality-of-life questionnaire (SEQOL, administered to a well-documented birth cohort of 7,400 Danes born in 1959�1961, as well as to a reference sample of 2,500 Danes. Presented in outline, the underlying integrative quality-of-life (IQOL theory is a meta-theory. To illustrate the seven criteria at work, we show the extent to which they are satisfied by one of the eight component theories. Next, two sample results of our investigation are presented: satisfaction with one's sex life has the expected covariation with one's quality of life, and so does mother's smoking during pregnancy, albeit to a much smaller extent. It is concluded that the methodological framework presented has proved helpful in designing a questionnaire that is capable of yielding acceptably valid and reliable measurements of global and generic quality of life.

COLLABORATIVE TRIAL AND QUALITY CONTROL IN CHEMICAL ANALYSIS

Directory of Open Access Journals (Sweden)

Narsito Narsito

2010-06-01

Full Text Available Abstract                                                             This paper deals with some practical problems related to the quality of analytical chemical data usually met in practice. Special attention is given to the topic of quality control in analytical chemistry, since analytical data is one of the primary information from which some important scientifically based decision are to be made. The present paper starts with brief description on some fundamental aspects associated with quality of analytical data, such as sources of variation of analytical data, criteria for quality of analytical method, quality assurance in chemical analysis. The assessment of quality parameter for analytical method like the use of standard materials as well as standard methods is given. Concerning with the quality control of analytical data, the use of several techniques, such as control samples and control charts, in monitoring analytical data in quality control program are described qualitatively.  In the final part of this paper, some important remarks for the preparation of collaborative trials, including the evaluation of accuracy and reproducibility of analytical method are also given Keywords: collaborative trials, quality control, analytical data Abstract                                                             This paper deals with some practical problems related to the quality of analytical chemical data usually met in practice. Special attention is given to the topic of quality control in analytical chemistry, since analytical data is one of the primary information from which some important scientifically based decision are to be made. The present paper starts with brief description on some fundamental aspects associated with quality of analytical data, such as sources of variation of analytical data, criteria for quality of

A semi-automated tool for treatment plan-quality evaluation and clinical trial quality assurance

Science.gov (United States)

Wang, Jiazhou; Chen, Wenzhou; Studenski, Matthew; Cui, Yunfeng; Lee, Andrew J.; Xiao, Ying

2013-07-01

The goal of this work is to develop a plan-quality evaluation program for clinical routine and multi-institutional clinical trials so that the overall evaluation efficiency is improved. In multi-institutional clinical trials evaluating the plan quality is a time-consuming and labor-intensive process. In this note, we present a semi-automated plan-quality evaluation program which combines MIMVista, Java/MATLAB, and extensible markup language (XML). More specifically, MIMVista is used for data visualization; Java and its powerful function library are implemented for calculating dosimetry parameters; and to improve the clarity of the index definitions, XML is applied. The accuracy and the efficiency of the program were evaluated by comparing the results of the program with the manually recorded results in two RTOG trials. A slight difference of about 0.2% in volume or 0.6 Gy in dose between the semi-automated program and manual recording was observed. According to the criteria of indices, there are minimal differences between the two methods. The evaluation time is reduced from 10-20 min to 2 min by applying the semi-automated plan-quality evaluation program.

A semi-automated tool for treatment plan-quality evaluation and clinical trial quality assurance

International Nuclear Information System (INIS)

Wang, Jiazhou; Chen, Wenzhou; Studenski, Matthew; Cui, Yunfeng; Xiao, Ying; Lee, Andrew J

2013-01-01

The goal of this work is to develop a plan-quality evaluation program for clinical routine and multi-institutional clinical trials so that the overall evaluation efficiency is improved. In multi-institutional clinical trials evaluating the plan quality is a time-consuming and labor-intensive process. In this note, we present a semi-automated plan-quality evaluation program which combines MIMVista, Java/MATLAB, and extensible markup language (XML). More specifically, MIMVista is used for data visualization; Java and its powerful function library are implemented for calculating dosimetry parameters; and to improve the clarity of the index definitions, XML is applied. The accuracy and the efficiency of the program were evaluated by comparing the results of the program with the manually recorded results in two RTOG trials. A slight difference of about 0.2% in volume or 0.6 Gy in dose between the semi-automated program and manual recording was observed. According to the criteria of indices, there are minimal differences between the two methods. The evaluation time is reduced from 10–20 min to 2 min by applying the semi-automated plan-quality evaluation program. (note)

Priorities for methodological research on patient and public involvement in clinical trials: A modified Delphi process.

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Kearney, Anna; Williamson, Paula; Young, Bridget; Bagley, Heather; Gamble, Carrol; Denegri, Simon; Muir, Delia; Simon, Natalie A; Thomas, Stephen; Elliot, Jim T; Bulbeck, Helen; Crocker, Joanna C; Planner, Claire; Vale, Claire; Clarke, Mike; Sprosen, Tim; Woolfall, Kerry

2017-12-01

Despite increasing international interest, there is a lack of evidence about the most efficient, effective and acceptable ways to implement patient and public involvement (PPI) in clinical trials. To identify the priorities of UK PPI stakeholders for methodological research to help resolve uncertainties about PPI in clinical trials. A modified Delphi process including a two round online survey and a stakeholder consensus meeting. In total, 237 people registered of whom 219 (92%) completed the first round. One hundred and eighty-seven of 219 (85%) completed the second; 25 stakeholders attended the consensus meeting. Round 1 of the survey comprised 36 topics; 42 topics were considered in round 2 and at the consensus meeting. Approximately 96% of meeting participants rated the top three topics as equally important. These were as follows: developing strong and productive working relationships between researchers and PPI contributors; exploring PPI practices in selecting trial outcomes of importance to patients; and a systematic review of PPI activity to improve the accessibility and usefulness of trial information (eg participant information sheets) for participants. The prioritized methodological research topics indicate important areas of uncertainty about PPI in trials. Addressing these uncertainties will be critical to enhancing PPI. Our findings should be used in the planning and funding of PPI in clinical trials to help focus research efforts and minimize waste. © 2017 The Authors Health Expectations Published by John Wiley & Sons Ltd.

FDAAA legislation is working, but methodological flaws undermine the reliability of clinical trials: a cross-sectional study

OpenAIRE

Douglas H. Marin dos Santos; Álvaro N. Atallah

2015-01-01

The relationship between clinical research and the pharmaceutical industry has placed clinical trials in jeopardy. According to the medical literature, more than 70% of clinical trials are industry-funded. Many of these trials remain unpublished or have methodological flaws that distort their results. In 2007, it was signed into law the Food and Drug Administration Amendments Act (FDAAA), aiming to provide publicly access to a broad range of biomedical information to be made available on the ...

Have CONSORT guidelines improved the quality of reporting of randomised controlled trials published in public health dentistry journals?

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Savithra, Prakash; Nagesh, Lakshminarayan Shetty

2013-01-01

To assess a) whether the quality of reporting of randomised controlled trials (RCTs) has improved since the formulation of the Consolidated Standards of Reporting Trials (CONSORT) statement and b) whether there is any difference in reporting of RCTs between the selected public health dentistry journals. A hand search of the journals of public health dentistry was performed and four journals were identified for the study. They were Community Dentistry and Oral Epidemiology (CDOE), Community Dental Health (CDH), Journal of Public Health Dentistry (JPHD) and Oral Health and Preventive Dentistry (OHPD). A total of 114 RCTs published between 1990 and 2009 were selected. CONSORT guidelines were applied to each selected article in order to assess and determine any improvement since the publication of CONSORT guidelines. The chi-square test was employed to determine any statistical significant difference in quality of reporting of RCTs before and after the publication of the CONSORT guidelines. A comparison was also done to determine any statistically significant difference in quality of reporting of RCTs between the selected journals. Title, abstract, discussion and conclusion sections of the selected articles showed adherence to the CONSORT guidelines, whereas the compliance was poor with respect to the methodology section. The quality of reporting of RCTs is generally poor in public health dentistry journals. Overall, the quality of reporting has not substantially improved since the publication of CONSORT guidelines.

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

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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

[Methodological controversies in chronic obstructive pulmonary disease therapeutic trials].

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Suissa, Samy

2009-03-01

Pharmacological treatment of chronic obstructive pulmonary disease (COPD) relies principally on long-acting bronchodilators. Inhaled corticosteroids (ICS) were introduced for COPD two decades ago, despite the fact that no randomized trial had yet assessed their efficacy for this indication. Since then, the numerous randomized trials and meta-analyses performed to justify their use in COPD have been contradictory and controversial. Moreover, observational studies have reported efficacy rates so exceptional that they are almost too good to be true. These studies contain important methodological flaws that produce the appearance of efficacy. The randomized trials infringe the fundamental principle of intention-to-treat analysis, an analysis necessary to prevent important biases. Two other complications are the interruption of treatment at the moment of randomization and the use of a run-in period; in both cases, the withdrawal of treatment can introduce bias. The observational studies reporting phenomenal reductions in mortality with ICS were distorted by "immortal time" bias. Finally, recent data suggest that the effect of ICS/bronchodilator combinations is due mainly to the effect of the long-acting bronchodilator. Given the absence of proof of the efficacy of inhaled corticosteroids in COPD and their associated risks, especially of ocular damage and pneumonia, and particularly among the elderly, as well as the high doses currently prescribed in COPD, it is difficult to recommend their use in this indication. They should be prescribed in COPD for at most a limited population of patients.

Methodology Series Module 4: Clinical Trials.

Science.gov (United States)

Setia, Maninder Singh

2016-01-01

In a clinical trial, study participants are (usually) divided into two groups. One group is then given the intervention and the other group is not given the intervention (or may be given some existing standard of care). We compare the outcomes in these groups and assess the role of intervention. Some of the trial designs are (1) parallel study design, (2) cross-over design, (3) factorial design, and (4) withdrawal group design. The trials can also be classified according to the stage of the trial (Phase I, II, III, and IV) or the nature of the trial (efficacy vs. effectiveness trials, superiority vs. equivalence trials). Randomization is one of the procedures by which we allocate different interventions to the groups. It ensures that all the included participants have a specified probability of being allocated to either of the groups in the intervention study. If participants and the investigator know about the allocation of the intervention, then it is called an "open trial." However, many of the trials are not open - they are blinded. Blinding is useful to minimize bias in clinical trials. The researcher should familiarize themselves with the CONSORT statement and the appropriate Clinical Trials Registry of India.

Research methodological issues in evaluating herbal interventions

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Dipika Bansal

2010-02-01

Full Text Available Dipika Bansal, Debasish Hota, Amitava ChakrabartiPostgraduate Institute of Medical Education and Research, Chandigarh, IndiaAbstract: Randomized controlled trials provide the best evidence, and is seen as the gold standard for allopathic research. Herbal therapies are not an integral part of conventional care although they are still used by patients in their health care management. These medicines need to be subjected to rigorous research to establish their effectiveness and safety. Clearly defined treatments are required and should be recorded in a manner that enables other suitably trained researchers to reproduce them reliably. Quality control of herbal products is also a prerequisite of credible clinical trials. Methodological strategies for investigating the herbal interventions and the issues regarding appropriate patient selection, randomization and blinding, placebo effects and choice of comparator, occupational standardization and the selection of appropriate study endpoints to prove efficacy are being discussed. This paper will review research options and propose some suggestions for future research design.Keywords: CAM research, herbal therapies, methodology, clinical trial

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

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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.

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

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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

Improved quality monitoring of multi-center acupuncture clinical trials in China

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Zheng Hui

2009-12-01

Full Text Available Abstract Background In 2007, the Chinese Science Division of the State Administration of Traditional Chinese Medicine(TCM convened a special conference to discuss quality control for TCM clinical research. Control and assurance standards were established to guarantee the quality of clinical research. This paper provides practical guidelines for implementing strict and reproducible quality control for acupuncture randomized controlled trials (RCTs. Methods A standard quality control program (QCP was established to monitor the quality of acupuncture trials. Case report forms were designed; qualified investigators, study personnel and data management personnel were trained. Monitors, who were directly appointed by the project leader, completed the quality control programs. They guaranteed data accuracy and prevented or detected protocol violations. Clinical centers and clinicians were audited, the randomization system of the centers was inspected, and the treatment processes were audited as well. In addition, the case report forms were reviewed for completeness and internal consistency, the eligibility and validity of the patients in the study was verified, and data was monitored for compliance and accuracy. Results and discussion The monitors complete their reports and submit it to quality assurance and the sponsors. Recommendations and suggestions are made for improving performance. By holding regular meetings to discuss improvements in monitoring standards, the monitors can improve quality and efficiency. Conclusions Supplementing and improving the existed guidelines for quality monitoring will ensure that large multi-centre acupuncture clinical trials will be considered as valid and scientifically stringent as pharmaceutical clinical trials. It will also develop academic excellence and further promote the international recognition of acupuncture.

Methodology series module 4: Clinical trials

Directory of Open Access Journals (Sweden)

Maninder Singh Setia

2016-01-01

Full Text Available In a clinical trial, study participants are (usually divided into two groups. One group is then given the intervention and the other group is not given the intervention (or may be given some existing standard of care. We compare the outcomes in these groups and assess the role of intervention. Some of the trial designs are (1 parallel study design, (2 cross-over design, (3 factorial design, and (4 withdrawal group design. The trials can also be classified according to the stage of the trial (Phase I, II, III, and IV or the nature of the trial (efficacy vs. effectiveness trials, superiority vs. equivalence trials. Randomization is one of the procedures by which we allocate different interventions to the groups. It ensures that all the included participants have a specified probability of being allocated to either of the groups in the intervention study. If participants and the investigator know about the allocation of the intervention, then it is called an "open trial." However, many of the trials are not open - they are blinded. Blinding is useful to minimize bias in clinical trials. The researcher should familiarize themselves with the CONSORT statement and the appropriate Clinical Trials Registry of India.

The Methodological Approaches to Formation of the Internal System of Quality of Education of Higher Education Institution

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Doronin Stepan A.

2017-12-01

Full Text Available The necessity of creation of a national conception of formation of the internal system of quality assurance of higher education institutions with obligatory introduction of methodological approach in its structure is substantiated; the variant of its terminological provision with clarification of the content of concepts of «quality of education», «internal system of quality of education», «methodological approach» is proposed; positioning of the approach in the system of other standard scientific instruments (method, methodology, program, algorithm is done; arguments for the orientation of the methodology of formation of the internal system of quality assurance of higher education institutions towards the socio-cultural model of paradigm are provided; a hierarchical classification of methodological approaches with allocation of the philosophical, scientific, concrete-scientific, technological levels and the characteristics of their purpose and contents is presented.

Bayesian methodology for the design and interpretation of clinical trials in critical care medicine: a primer for clinicians.

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Kalil, Andre C; Sun, Junfeng

2014-10-01

To review Bayesian methodology and its utility to clinical decision making and research in the critical care field. Clinical, epidemiological, and biostatistical studies on Bayesian methods in PubMed and Embase from their inception to December 2013. Bayesian methods have been extensively used by a wide range of scientific fields, including astronomy, engineering, chemistry, genetics, physics, geology, paleontology, climatology, cryptography, linguistics, ecology, and computational sciences. The application of medical knowledge in clinical research is analogous to the application of medical knowledge in clinical practice. Bedside physicians have to make most diagnostic and treatment decisions on critically ill patients every day without clear-cut evidence-based medicine (more subjective than objective evidence). Similarly, clinical researchers have to make most decisions about trial design with limited available data. Bayesian methodology allows both subjective and objective aspects of knowledge to be formally measured and transparently incorporated into the design, execution, and interpretation of clinical trials. In addition, various degrees of knowledge and several hypotheses can be tested at the same time in a single clinical trial without the risk of multiplicity. Notably, the Bayesian technology is naturally suited for the interpretation of clinical trial findings for the individualized care of critically ill patients and for the optimization of public health policies. We propose that the application of the versatile Bayesian methodology in conjunction with the conventional statistical methods is not only ripe for actual use in critical care clinical research but it is also a necessary step to maximize the performance of clinical trials and its translation to the practice of critical care medicine.

The ABT methodology employment for VET of quality auditors

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Liviu Moldovan

2011-12-01

Full Text Available This paper presents some achievements of the project entitled “Disseminating Open and Innovative Tools and Services for Vocational Education and Training in Quality Assurance” (acronym Do-IT financed by European Commission. The recent developments and results obtained during pilot testing of new pedagogical models and services, in Do-IT project, targeting engineering education in Romania are presented. This include the activity Based Training methodology (ABT for quality management system audit course according to ISO 19011 and ISO 9001 and evaluation of theoretical achievements with Student Response System (SRS.

Systematic Review of the Methodology Quality in Lung Cancer Screening Guidelines

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Jiang LI

2016-10-01

Full Text Available Background and objective 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. Methods 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. Results 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. Conclusion 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.

[Evidence-based quality assessment of 10-year orthodontic clinical trials in 4 major dental journals].

Science.gov (United States)

Sun, Yan-nan; Lei, Fei-fei; Cao, Yan-li; Fu, Min-kui

2010-02-01

To assess the quality of orthodontic clinical trials published in 4 major dental journals in the past 10 years and establish the reference standard for orthodontic clinical trials and quality control of dental journals. All the clinical trials published in Chinese Journal of Stomatology, West China Journal of Stomatology, Journal of Practice Stomatology and Chinese Journal of Orthodontics from 1999 to 2008 were searched. The demographic information of the papers was extracted and the quality of the clinical trials according to the consolidated standards of reporting trials (CONSORT) was assessed. Four hundred and ninety-four clinical trials were retrieved, and 21.3% (105/494) of them were supported by grants. For the study design, only 26.1% (129/494) were prospective studies, and 3.8% (19/494) were randomized clinical trials. It was hard to evaluate precisely due to the lack of information about the details of the study designs. For the randomized clinical trials, the lack of details for randomization, allocation concealment, blinding and intention to treat compromised the quality. The general quality of clinical trials in orthodontics is poor. It needs to be improved both in the clinical study design and the paper writing.

Design and Methodology of the Trial to Assess Chelation Therapy (TACT)

Science.gov (United States)

Lamas, Gervasio A.; Goertz, Christine; Boineau, Robin; Mark, Daniel B.; Rozema, Theodore; Nahin, Richard L.; Drisko, Jeanne A.; Lee, Kerry L.

2011-01-01

The Trial to Assess Chelation Therapy (TACT) is an NIH-sponsored, randomized, double blind, placebo-controlled, 2×2 factorial clinical trial testing the benefits and risks of 40 infusions of a multi-component Na2EDTA-chelation solution compared with placebo, and of an oral, high-dose multivitamin and mineral supplement. TACT has randomized and will follow 1708 patients for an average of approximately 4 years. The primary endpoint is a composite of all cause mortality, myocardial infarction, stroke, coronary revascularization, and hospitalization for angina. A 900 patient substudy will examine quality of life outcomes. The trial is designed to have >85% power to detect a 25% relative reduction in the primary endpoint for each treatment factor. Enrollment began in September 2003 and completed in October 2010. PMID:22172430

Impact Evaluation of Quality Assurance in Higher Education: Methodology and Causal Designs

Science.gov (United States)

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…

A methodology model for quality management in a general hospital.

Science.gov (United States)

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.

Methodology for Speech Assessment in the Scandcleft Project-An International Randomized Clinical Trial on Palatal Surgery

DEFF Research Database (Denmark)

Willadsen, Elisabeth

2009-01-01

Objective: To present the methodology for speech assessment in the Scandcleft project and discuss issues from a pilot study. Design: Description of methodology and blinded test for speech assessment. Speech samples and instructions for data collection and analysis for comparisons of speech outcomes...... across five included languages were developed and tested. Participants and Materials: Randomly selected video recordings of 10 5-year-old children from each language (n = 50) were included in the project. Speech material consisted of test consonants in single words, connected speech, and syllable chains......-sum and the overall rating of VPC was 78%. Conclusions: Pooling data of speakers of different languages in the same trial and comparing speech outcome across trials seems possible if the assessment of speech concerns consonants and is confined to speech units that are phonetically similar across languages. Agreed...

Methodology of quality control for brachytherapy {sup 125}I seeds

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Moura, Eduardo S.; Zeituni, Carlos A.; Manzoli, Jose E.; Rostelato, Maria Elisa C.M. [Instituto de Pesquisas Energeticas e Nucleares (IPEN/CNEN-SP), Sao Paulo, SP (Brazil)]. E-mail: esmoura@ipen.br

2007-07-01

This paper presents the methodology of quality control of {sup 125}I seeds used for brachytherapy. The {sup 125}I seeds are millimeter titanium capsules widely used in permanent implants of prostate cancer, allowing a high dose within the tumour and a low dose on the surrounding tissues, with very low harm to the other tissues. Besides, with this procedure, the patients have a low impotence rate and a small incidence of urinary incontinence. To meet the medical standards, an efficient quality control is necessary, showing values with the minimum uncertainness possible, concerning the seeds dimensions and their respective activities. The medical needles are used to insert the seeds inside the prostate. The needles used in brachytherapy have an internal diameter of 1.0 mm, so it is necessary {sup 125}I seeds with an external maximum diameter of 0.85 mm. For the seeds and the spacer positioning on the planning sheet, the seeds must have a length between 4.5 and 5.0 mm. The activities must not vary more than 5% in each batch of {sup 125}I seeds. For this methodology, we used two ionization chamber detectors and one caliper. In this paper, the methodology using one control batch with 75 seeds manufactured by GE Health care Ltd is presented. (author)

Quality expectations and tolerance limits of trial master files (TMF) - Developing a risk-based approach for quality assessments of TMFs.

Science.gov (United States)

Hecht, Arthur; Busch-Heidger, Barbara; Gertzen, Heiner; Pfister, Heike; Ruhfus, Birgit; Sanden, Per-Holger; Schmidt, Gabriele B

2015-01-01

This article addresses the question of when a trial master file (TMF) can be considered sufficiently accurate and complete: What attributes does the TMF need to have so that a clinical trial can be adequately reconstructed from documented data and procedures? Clinical trial sponsors face significant challenges in assembling the TMF, especially when dealing with large, international, multicenter studies; despite all newly introduced archiving techniques it is becoming more and more difficult to ensure that the TMF is complete. This is directly reflected in the number of inspection findings reported and published by the EMA in 2014. Based on quality risk management principles in clinical trials the authors defined the quality expectations for the different document types in a TMF and furthermore defined tolerance limits for missing documents. This publication provides guidance on what type of documents and processes are most important, and in consequence, indicates on which documents and processes trial team staff should focus in order to achieve a high-quality TMF. The members of this working group belong to the CQAG Group (Clinical Quality Assurance Germany) and are QA (quality assurance) experts (auditors or compliance functions) with long-term experience in the practical handling of TMFs.

Guidance on assessing the methodological and reporting quality of toxicologically relevant studies: A scoping review.

Science.gov (United States)

Samuel, Gbeminiyi O; Hoffmann, Sebastian; Wright, Robert A; Lalu, Manoj Mathew; Patlewicz, Grace; Becker, Richard A; DeGeorge, George L; Fergusson, Dean; Hartung, Thomas; Lewis, R Jeffrey; Stephens, Martin L

2016-01-01

Assessments of methodological and reporting quality are critical to adequately judging the credibility of a study's conclusions and to gauging its potential reproducibility. To aid those seeking to assess the methodological or reporting quality of studies relevant to toxicology, we conducted a scoping review of the available guidance with respect to four types of studies: in vivo and in vitro, (quantitative) structure-activity relationships ([Q]SARs), physico-chemical, and human observational studies. Our aims were to identify the available guidance in this diverse literature, briefly summarize each document, and distill the common elements of these documents for each study type. In general, we found considerable guidance for in vivo and human studies, but only one paper addressed in vitro studies exclusively. The guidance for (Q)SAR studies and physico-chemical studies was scant but authoritative. There was substantial overlap across guidance documents in the proposed criteria for both methodological and reporting quality. Some guidance documents address toxicology research directly, whereas others address preclinical research generally or clinical research and therefore may not be fully applicable to the toxicology context without some translation. Another challenge is the degree to which assessments of methodological quality in toxicology should focus on risk of bias - as in clinical medicine and healthcare - or be broadened to include other quality measures, such as confirming the identity of test substances prior to exposure. Our review is intended primarily for those in toxicology and risk assessment seeking an entry point into the extensive and diverse literature on methodological and reporting quality applicable to their work. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

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

Science.gov (United States)

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 methodological quality is low; therefore, clinicians should critically appraise them prior to considering their recommendations to guide patient care.

METHODOLOGICAL APPROACHES TO EXPERT EVALUATION OF PRECLINICAL AND CLINICAL TRIALS OF HUMAN IMMUNOGLOBULIN PRODUCTS

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V. B. Ivanov

2017-01-01

Full Text Available The article considers the experience of Russian and leading foreign regulatory agencies in organisation and conduction of preclinical and clinical trials of human immunoglobulin products. The authors suggest a classification of human immunoglobulins and provide updated information on authorization of these products in Russia. The article summarizes methodological approaches, basic scientific principles and criteria relating to expert evaluation of preclinical and clinical trials of blood products. The authors further define the expert body’s requirements for data on preclinical and clinical trials of human normal immuniglobulins and human specific immunoglobulins for the prevention and/or treatment of infectious and non-infectious diseases which are submitted as part of applications for marketing authorization or marketing authorization variation. The article suggests programs of preclinical and clinical trials for human normal immunoglobulins and human specific immunoglobulins for the prevention and/or treatment of infectious and non-infectious diseases that are aligned with the Russian legislation and Eurasian Economic Union’s regulations on medicines circulation, and have been elaborated with respect to the guidelines of the European Medicines Agency.

Application of Taguchi methodology to improve the functional quality of a mechanical device

International Nuclear Information System (INIS)

Regeai, Awatef Omar

2005-01-01

Manufacturing and quality control are recognized branches of engineering management. special attention has been made to improve thr tools and methods for the purpose of improving the products quality and finding solutions for any Obstacles and/or problems during the production process. Taguchi methodology is one of the most powerful techniques for improving product and manufacturing process quality at low cost. It is a strategical and practical method that aims to assist managers and industrial engineers to tackle manufacturing quality problems in a systematic and structured manner. The potential benefit of Taguchi methodology lies in its ease of use, its emphasis on reducing variability to give more economical products and hence the accessibility to the engineering fraternity for solving real life quality problems. This study applies Taguchi methodology to improve the functional quality of a local made chain gear by a purposed heat treatment process. The hardness of steel is generally a function not of its composition only, but rather of its heat treatment. The study investigates the effects of various heat treatment parameters, including ramp rate of heating, normalizing holding time, normalizing temperature, annealing holding time, annealing temperature, hardening holding time, hardening temperature, quenching media, tempering temperature and tempering holding time upon the hardness, which is a measure of resistance to plastic deformation. Both the analysis of means (ANOM) and Signal to Noise ratio (S/N) have been carried out for determining the optimal condition of the process. A significant improvement of the functional quality characteristic (hardness) by more than 32% was obtained. The Scanning Electron Microscopy technique was used in this study to obtain visual evidence of the quality and continuous improvement of the heat treated samples. (author)

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

Science.gov (United States)

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

Hypothermia after cardiac arrest should be further evaluated-A systematic review of randomised trials with meta-analysis and trial sequential analysis

DEFF Research Database (Denmark)

Nielsen, Niklas; Friberg, Hans; Gluud, Christian

2011-01-01

BACKGROUND: Guidelines recommend mild induced hypothermia (MIH) to reduce mortality and neurological impairment after out-of-hospital cardiac arrest. Our objective was to systematically evaluate the evidence for MIH taking into consideration the risks of systematic and random error and to GRADE...... the evidence. METHODS: Systematic review with meta-analysis and trial sequential analysis of randomised trials evaluating MIH after cardiac arrest in adults. We searched CENTRAL, MEDLINE, and EMBASE databases until May 2009. Retrieved trials were evaluated with Cochrane methodology. Meta-analytic estimates....... The substantial risk of bias and concerns with directness rated down the quality of the evidence to low. CONCLUSIONS: Evidence regarding MIH after out-of-hospital cardiac arrest is still inconclusive and associated with non-negligible risks of systematic and random errors. Using GRADE-methodology, we conclude...

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

Science.gov (United States)

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

Factor Analysis in Assessing the Research Methodology Quality of Systematic Reviews

Directory of Open Access Journals (Sweden)

Andrada Elena URDA-CÎMPEAN

2011-12-01

Full Text Available Introduction: Many high quality systematic reviews available from medical journals, data bases and other electronic sources differ in quality and provide different answers to the same question. The literature recommended the use of a checklist type approach, which exceeds many of the problems associated with measurements. Aim: This study proposes to identify in a checklist type approach the most commonly used factors (from a methodological point of view in assessing the quality of systematic reviews, and then mirror the actual stage of medical writing. We want to analyze the factors’ occurrence and / or their development in the text and in the abstract of systematic reviews published in 2011. Methods: The present study randomly selected only free full text systematic reviews published in 2011, systematic reviews found in Pubmed and in Cochrane Database. The most commonly used factors were identified in PRISMA statement and quality measurement tools. Results: The evaluated systematic reviews mentioned or developed several of the factors studied. Only 78% of the papers surveyed have used the correct IMRAD format and 59% of them have mentioned the sample size used. The correspondence between the content of the paper and its abstract is summarized in the proportion of 54.63% and 51.85% for the two sets of factors, and it can lead to scarce appreciation of the article provided that only abstracts are read. Conclusions: Researchers do not properly take into consideration scientific articles and assessment tools used for quality evaluation. They should place more value over methodological factors which help assess systematic review quality, while journals form the only party who can enforce quality standards in medical writing.

Using Guasha to treat musculoskeletal pain: A systematic review of controlled clinical trials

Directory of Open Access Journals (Sweden)

Choi Sun-Mi

2010-01-01

Full Text Available Abstract Background Guasha is a therapeutic method for pain management using tools to scrape or rub the surface of the body to relieve blood stagnation. This study aims to systematically review the controlled clinical trials on the effectiveness of using Guasha to treat musculoskeletal pain. Methods We searched 11 databases (without language restrictions: MEDLINE, Allied and Complementary Medicine (AMED, EMBASE, Cumulative Index to Nursing and Allied Health Literature (CINAHL, Korean Studies Information (KSI, DBPIA, Korea Institute of Science and Technology Information (KISTI, KoreaMed, Research Information Service System (RISS, China National Knowledge Infrastructure (CNKI and the Cochrane Library. The search strategy was Guasha (OR scraping AND pain. Risk of bias was assessed with the Cochrane criteria (i.e. sequence generation, blinding, incomplete outcome measures and allocation concealment. Results Five randomized controlled trials (RCTs and two controlled clinical trials (CCTs were included in the present study. Two RCTs compared Guasha with acupuncture in terms of effectiveness, while the other trials compared Guasha with no treatment (1 trial, acupuncture (4 trials, herbal injection (1 trial and massage or electric current therapy (1 trial. While two RCTs suggested favorable effects of Guasha on pain reduction and response rate, the quality of these RCTs was poor. One CCT reported beneficial effects of Guasha on musculoskeletal pain but had low methodological quality. Conclusion Current evidence is insufficient to show that Guasha is effective in pain management. Further RCTs are warranted and methodological quality should be improved.

Clinical Trials Infrastructure as a Quality Improvement Intervention in Low- and Middle-Income Countries.

Science.gov (United States)

Denburg, Avram; Rodriguez-Galindo, Carlos; Joffe, Steven

2016-06-01

Mounting evidence suggests that participation in clinical trials confers neither advantage nor disadvantage on those enrolled. Narrow focus on the question of a "trial effect," however, distracts from a broader mechanism by which patients may benefit from ongoing clinical research. We hypothesize that the existence of clinical trials infrastructure-the organizational culture, systems, and expertise that develop as a product of sustained participation in cooperative clinical trials research-may function as a quality improvement lever, improving the quality of care and outcomes of all patients within an institution or region independent of their individual participation in trials. We further contend that this "infrastructure effect" can yield particular benefits for patients in low- and middle-income countries (LMICs). The hypothesis of an infrastructure effect as a quality improvement intervention, if correct, justifies enhanced research capacity in LMIC as a pillar of health system development.

Improving the Quality of Experience Journals: Training Educational Psychology Students in Basic Qualitative Methodology

Science.gov (United States)

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…

Quality expectations and tolerance limits of trial master files (TMF) – Developing a risk-based approach for quality assessments of TMFs

Science.gov (United States)

Hecht, Arthur; Busch-Heidger, Barbara; Gertzen, Heiner; Pfister, Heike; Ruhfus, Birgit; Sanden, Per-Holger; Schmidt, Gabriele B.

2015-01-01

This article addresses the question of when a trial master file (TMF) can be considered sufficiently accurate and complete: What attributes does the TMF need to have so that a clinical trial can be adequately reconstructed from documented data and procedures? Clinical trial sponsors face significant challenges in assembling the TMF, especially when dealing with large, international, multicenter studies; despite all newly introduced archiving techniques it is becoming more and more difficult to ensure that the TMF is complete. This is directly reflected in the number of inspection findings reported and published by the EMA in 2014. Based on quality risk management principles in clinical trials the authors defined the quality expectations for the different document types in a TMF and furthermore defined tolerance limits for missing documents. This publication provides guidance on what type of documents and processes are most important, and in consequence, indicates on which documents and processes trial team staff should focus in order to achieve a high-quality TMF. The members of this working group belong to the CQAG Group (Clinical Quality Assurance Germany) and are QA (quality assurance) experts (auditors or compliance functions) with long-term experience in the practical handling of TMFs. PMID:26693218

Quality expectations and tolerance limits of trial master files (TMF – Developing a risk-based approach for quality assessments of TMFs

Directory of Open Access Journals (Sweden)

Hecht, Arthur

2015-12-01

Full Text Available This article addresses the question of when a trial master file (TMF can be considered sufficiently accurate and complete: What attributes does the TMF need to have so that a clinical trial can be adequately reconstructed from documented data and procedures? Clinical trial sponsors face significant challenges in assembling the TMF, especially when dealing with large, international, multicenter studies; despite all newly introduced archiving techniques it is becoming more and more difficult to ensure that the TMF is complete. This is directly reflected in the number of inspection findings reported and published by the EMA in 2014. Based on quality risk management principles in clinical trials the authors defined the quality expectations for the different document types in a TMF and furthermore defined tolerance limits for missing documents. This publication provides guidance on what type of documents and processes are most important, and in consequence, indicates on which documents and processes trial team staff should focus in order to achieve a high-quality TMF.The members of this working group belong to the CQAG Group (Clinical Quality Assurance Germany and are QA (quality assurance experts (auditors or compliance functions with long-term experience in the practical handling of TMFs.

Quality control of CT units - methodology of performance I

International Nuclear Information System (INIS)

Prlic, I.; Radalj, Z.

1996-01-01

Increasing use of x-ray computed tomography systems (CT scanners) in the diagnostic requires an efficient means of evaluating the performance of them. Therefore, this paper presents the way to measure (Quality Control procedure-Q/C) and define the CT scanner performance through a special phantom which is based on the recommendation of the American association of Physicists in Medicine (AAPM). The performance parameters measurable with the phantom represent the capability, so periodical evaluation of the parameters enable the users to recognize the stability of the CT scanner no matter on the manufacturer, model or software option of the scanner. There are five important performance parameters which are to be measured: Noise, Contrast scale, Nominal tomographic section thickness, High and Low contrast resolution (MTF). The sixth parameter is, of course the dose per scan and slice which gives the patient dose for the certain diagnostic procedure. The last but not the least parameter is the final image quality which is given through the image processing device connected to the scanner. This is the final medical information needed for the good medical practice according to the Quality Assurance (Q/A) procedures in diagnostic radiology. We have to assure the results of the performance evaluation without environmental influences (the measurements are to be made under the certain conditions according Q/A). This paper will give no detailed methodology recipe but will show on the one example; the system noise measurements and linearity; the need and relevant results of the measurements.1 The rest of the methodology is to be published. (author)

How product trial changes quality perception of four new processed beef products

DEFF Research Database (Denmark)

Saeed, Faiza; Grunert, Klaus G; Therkildsen, Margrethe

2013-01-01

evaluation, quality evaluation and purchase motive fulfillment. For two of the tested products, trial resulted in a decline of the evaluation of cues, quality and purchase motive fulfillment compared to pre-trial expectations. For these products, positive expectations were created by giving information about...... and gender, which may be due to underlying differences in previous experience. The study gives useful insights for testing of new processed meat products before market introduction....

Comparison of methodologic quality and study/report characteristics between quantitative clinical nursing and nursing education research articles.

Science.gov (United States)

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.

A systematic review of cluster randomised trials in residential facilities for older people suggests how to improve quality.

Science.gov (United States)

Diaz-Ordaz, Karla; Froud, Robert; Sheehan, Bart; Eldridge, Sandra

2013-10-22

Previous reviews of cluster randomised trials have been critical of the quality of the trials reviewed, but none has explored determinants of the quality of these trials in a specific field over an extended period of time. Recent work suggests that correct conduct and reporting of these trials may require more than published guidelines. In this review, our aim was to assess the quality of cluster randomised trials conducted in residential facilities for older people, and to determine whether (1) statistician involvement in the trial and (2) strength of journal endorsement of the Consolidated Standards of Reporting Trials (CONSORT) statement influence quality. We systematically identified trials randomising residential facilities for older people, or parts thereof, without language restrictions, up to the end of 2010, using National Library of Medicine (Medline) via PubMed and hand-searching. We based quality assessment criteria largely on the extended CONSORT statement for cluster randomised trials. We assessed statistician involvement based on statistician co-authorship, and strength of journal endorsement of the CONSORT statement from journal websites. 73 trials met our inclusion criteria. Of these, 20 (27%) reported accounting for clustering in sample size calculations and 54 (74%) in the analyses. In 29 trials (40%), methods used to identify/recruit participants were judged by us to have potentially caused bias or reporting was unclear to reach a conclusion. Some elements of quality improved over time but this appeared not to be related to the publication of the extended CONSORT statement for these trials. Trials with statistician/epidemiologist co-authors were more likely to account for clustering in sample size calculations (unadjusted odds ratio 5.4, 95% confidence interval 1.1 to 26.0) and analyses (unadjusted OR 3.2, 1.2 to 8.5). Journal endorsement of the CONSORT statement was not associated with trial quality. Despite international attempts to improve

Proposal of a methodology for quality control in thermoluminescent dosimetry laboratory

International Nuclear Information System (INIS)

Feital, Joao Carlos da S.; Almeida, Claudio Domingues de; Bezerra, Marcos A.

2005-01-01

Taken into account that in thermoluminescence dosimetry adequate selection procedures as well as accurate TLD readings are necessary, this paper presents results of methodology that can be applied as part of quality control programs in thermoluminescence dosimetry laboratories. For the experiment, a set of 200 TLDs ( LiF 100 ) were used and 9 from which were selected, a standard source of Cs -137 , a PTW kiln, a TL 'Harshaw' reader - model 5500 operating under the 'Win Rem' software and a Sr 90 / Y 90 'Bicron' irradiator. In the proceeding the selected dosimeters were irradiated and read 28 times during 18 months, then by one of the standard deviation properties, values up to 14 % were found, for a confidence level of 95 %. The results found and the bibliographic data related to the responses (arbitrary reading) in the crystals used in TLDs, have shown that this methodology can be applied in quality control programs. (author)

Trial-based economic evaluations in occupational health: principles, methods, and recommendations.

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van Dongen, Johanna M; van Wier, Marieke F; Tompa, Emile; Bongers, Paulien M; van der Beek, Allard J; van Tulder, Maurits W; Bosmans, Judith E

2014-06-01

To allocate available resources as efficiently as possible, decision makers need information on the relative economic merits of occupational health and safety (OHS) interventions. Economic evaluations can provide this information by comparing the costs and consequences of alternatives. Nevertheless, only a few of the studies that consider the effectiveness of OHS interventions take the extra step of considering their resource implications. Moreover, the methodological quality of those that do is generally poor. Therefore, this study aims to help occupational health researchers conduct high-quality trial-based economic evaluations by discussing the theory and methodology that underlie them, and by providing recommendations for good practice regarding their design, analysis, and reporting. This study also helps consumers of this literature with understanding and critically appraising trial-based economic evaluations of OHS interventions.

Guidelines for controlled trials of drugs in tension-type headache: second edition

DEFF Research Database (Denmark)

Bendtsen, L; Bigal, M E; Cerbo, R

2010-01-01

and chronic tension-type headache have been published, providing new information on trial methodology for this disorder. Furthermore, the classification of the headaches, including tension-type headache, has been revised. These developments support the need for also revising the guidelines for drug treatments......The Clinical Trials Subcommittee of the International Headache Society published its first edition of the guidelines on controlled trials of drugs in tension-type headache in 1995. These aimed 'to improve the quality of controlled clinical trials in tension-type headache', because 'good quality...... controlled trials are the only way to convincingly demonstrate the efficacy of a drug, and form the basis for international agreement on drug therapy'. The Committee published similar guidelines for clinical trials in migraine and cluster headache. Since 1995 several studies on the treatment of episodic...

Multi-attribute Evaluation of Website Quality in E-business Using an Integrated Fuzzy AHPTOPSIS Methodology

Directory of Open Access Journals (Sweden)

Tolga Kaya

2010-09-01

Full Text Available Success of an e-business company is strongly associated with the relative quality of its website compared to that of its competitors. The purpose of this study is to propose a multi-attribute e-business website quality evaluation methodology based on a modified fuzzy TOPSIS approach. In the proposed methodology, weights of the evaluation criteria are generated by a fuzzy AHP procedure. In performance evaluation problems, the judgments of the experts may usually be vague in form. As fuzzy logic can successfully deal with this kind of uncertainty in human preferences, both classical TOPSIS and classical AHP procedures are implemented under fuzzy environment. The proposed TOPSIS-AHP methodology has successfully been applied to a multi-attribute website quality evaluation problem in Turkish e-business market. Nine sub-criteria under four main categories are used in the evaluation of the most popular e-business websites of Turkey. A sensitivity analysis is also provided.

Standards for reporting randomized controlled trials in neurosurgery.

Science.gov (United States)

Kiehna, Erin N; Starke, Robert M; Pouratian, Nader; Dumont, Aaron S

2011-02-01

The Consolidated Standards for Reporting of Trials (CONSORT) criteria were published in 1996 to standardize the reporting and improve the quality of clinical trials. Despite having been endorsed by major medical journals and shown to improve the quality of reported trials, neurosurgical journals have yet to formally adopt these reporting criteria. The purpose of this study is to evaluate the quality and reporting of randomized controlled trials (RCTs) in neurosurgery and the factors that may affect the quality of reported trials. The authors evaluated all neurosurgical RCTs published in 2006 and 2007 in the principal neurosurgical journals (Journal of Neurosurgery; Neurosurgery; Surgical Neurology; Journal of Neurology, Neurosurgery, and Psychiatry; and Acta Neurochirurgica) and in 3 leading general medical journals (Journal of the American Medical Association, Lancet, and the New England Journal of Medicine). Randomized controlled trials that addressed operative decision making or the treatment of neurosurgical patients were included in this analysis. The RCT quality was evaluated using the Jadad score and the CONSORT checklist. In 2006 and 2007, 27 RCTs relevant to intracranial neurosurgery were reported. Of these trials, only 59% had a Jadad score ≥ 3. The 3 major medical journals all endorsed the CONSORT guidelines, while none of the neurosurgical journals have adopted these guidelines. Randomized controlled trials published in the 3 major medical journals had a significantly higher mean CONSORT score (mean 41, range 39-44) compared with those published in neurosurgical journals (mean 26.4, range 17-38; p journals (mean 3.42, range 2-5) than neurosurgical journals (mean 2.45, range 1-5; p = 0.05). Despite the growing volume of RCTs in neurosurgery, the quality of reporting of these trials remains suboptimal, especially in the neurosurgical journals. Improved awareness of the CONSORT guidelines by journal editors, reviewers, and authors of these papers could

Quality control of radiation therapy in clinical trials

International Nuclear Information System (INIS)

Kramer, S.; Lustig, R.; Grundy, G.

1983-01-01

The RTOG is a group of participating institutions which has a major interest in furthering clinical radiation oncology. They have formulated protocols for clinical investigation in which radiation therapy is the major modality of treatment. In addition, other modalities, such as chemotherapy, radiation sensitizers, and hyperthermia, are used in combined approach to cancer. Quality control in all aspects of patient management is necessary to insure quality data. These areas include evaluation of pathology, physics, and dosimetry, and clinical patient data. Quality control is both time consuming and expensive. However, by dividing these tasks into various levels and time frames, by using computerized data-control mechanisms, and by employing appropriate levels of ancillary personnel expertise, quality control can improve compliance and decrease the cost of investigational trials

Methodology of clinical measures of healthcare quality delivered to patients with cardiovascular diseases

Directory of Open Access Journals (Sweden)

Posnenkova O.M.

2014-03-01

Full Text Available The results of implementation the methodology proposed by American Colleague of Cardiology and American Heart Association (ACC/AHA for development of Russian clinical quality measures for patients with arterial hypertension, coronary heart disease and chronic heart failure. Created quality measures cover the key elements of medical care influencing directly on clinical outcomes of treatment.

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

Science.gov (United States)

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…

Obstacles to researching the researchers: a case study of the ethical challenges of undertaking methodological research investigating the reporting of randomised controlled trials.

Science.gov (United States)

McKenzie, Joanne E; Herbison, G Peter; Roth, Paul; Paul, Charlotte

2010-03-21

Recent cohort studies of randomised controlled trials have provided evidence of within-study selective reporting bias; where statistically significant outcomes are more likely to be more completely reported compared to non-significant outcomes. Bias resulting from selective reporting can impact on meta-analyses, influencing the conclusions of systematic reviews, and in turn, evidence based clinical practice guidelines.In 2006 we received funding to investigate if there was evidence of within-study selective reporting in a cohort of RCTs submitted to New Zealand Regional Ethics Committees in 1998/99. This research involved accessing ethics applications, their amendments and annual reports, and comparing these with corresponding publications. We did not plan to obtain informed consent from trialists to view their ethics applications for practical and scientific reasons. In November 2006 we sought ethical approval to undertake the research from our institutional ethics committee. The Committee declined our application on the grounds that we were not obtaining informed consent from the trialists to view their ethics application. This initiated a seventeen month process to obtain ethical approval. This publication outlines what we planned to do, the issues we encountered, discusses the legal and ethical issues, and presents some potential solutions. Methodological research such as this has the potential for public benefit and there is little or no harm for the participants (trialists) in undertaking it. Further, in New Zealand, there is freedom of information legislation, which in this circumstance, unambiguously provided rights of access and use of the information in the ethics applications. The decision of our institutional ethics committee defeated this right and did not recognise the nature of this observational research. Methodological research, such as this, can be used to develop processes to improve quality in research reporting. Recognition of the potential

Methodology of quality improvement projects for the Texas Medicare population.

Science.gov (United States)

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.

Economic evaluation studies in reproductive medicine: a systematic review of methodologic quality

NARCIS (Netherlands)

Moolenaar, Lobke M.; Vijgen, Sylvia M. C.; Hompes, Peter; van der Veen, Fulco; Mol, Ben Willem J.; Opmeer, Brent C.

2013-01-01

To evaluate the methodologic quality of economic analyses published in the field of reproductive medicine. Systematic review. Centers for reproductive care. Infertility patients. We performed a Medline search to identify economic evaluation studies in reproductive medicine. We included studies that

Methodological issues in systematic reviews of headache trials: adapting historical diagnostic classifications and outcome measures to present-day standards.

Science.gov (United States)

McCrory, Douglas C; Gray, Rebecca N; Tfelt-Hansen, Peer; Steiner, Timothy J; Taylor, Frederick R

2005-05-01

Recent efforts to make headache diagnostic classification and clinical trial methodology more consistent provide valuable advice to trialists generating new evidence on effectiveness of treatments for headache; however, interpreting older trials that do not conform to new standards remains problematic. Systematic reviewers seeking to utilize historical data can adapt currently recommended diagnostic classification and clinical trial methodological approaches to interpret all available data relative to current standards. In evaluating study populations, systematic reviewers can: (i) use available data to attempt to map study populations to diagnoses in the new International Classification of Headache Disorders; and (ii) stratify analyses based on the extent to which study populations are precisely specified. In evaluating outcome measures, systematic reviewers can: (i) summarize prevention studies using headache frequency, incorporating headache index in a stratified analysis if headache frequency is not available; (ii) summarize acute treatment studies using pain-free response as reported in directly measured headache improvement or headache severity outcomes; and (iii) avoid analysis of recurrence or relapse data not conforming to the sustained pain-free response definition.

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

Science.gov (United States)

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.

Investigation of Super Learner Methodology on HIV-1 Small Sample: Application on Jaguar Trial Data.

Science.gov (United States)

Houssaïni, Allal; Assoumou, Lambert; Marcelin, Anne Geneviève; Molina, Jean Michel; Calvez, Vincent; Flandre, Philippe

2012-01-01

Background. Many statistical models have been tested to predict phenotypic or virological response from genotypic data. A statistical framework called Super Learner has been introduced either to compare different methods/learners (discrete Super Learner) or to combine them in a Super Learner prediction method. Methods. The Jaguar trial is used to apply the Super Learner framework. The Jaguar study is an "add-on" trial comparing the efficacy of adding didanosine to an on-going failing regimen. Our aim was also to investigate the impact on the use of different cross-validation strategies and different loss functions. Four different repartitions between training set and validations set were tested through two loss functions. Six statistical methods were compared. We assess performance by evaluating R(2) values and accuracy by calculating the rates of patients being correctly classified. Results. Our results indicated that the more recent Super Learner methodology of building a new predictor based on a weighted combination of different methods/learners provided good performance. A simple linear model provided similar results to those of this new predictor. Slight discrepancy arises between the two loss functions investigated, and slight difference arises also between results based on cross-validated risks and results from full dataset. The Super Learner methodology and linear model provided around 80% of patients correctly classified. The difference between the lower and higher rates is around 10 percent. The number of mutations retained in different learners also varys from one to 41. Conclusions. The more recent Super Learner methodology combining the prediction of many learners provided good performance on our small dataset.

The measurement of health-related quality of life (QOL in paediatric clinical trials: a systematic review

Directory of Open Access Journals (Sweden)

Eiser Christine

2004-11-01

Full Text Available Abstract Background The goal of much care in chronic childhood illness is to improve quality of life (QOL. However, surveys suggest QOL measures are not routinely included. In addition, there is little consensus about the quality of many QOL measures. Objectives To determine the extent to which quality of life (QOL measures are used in paediatric clinical trials and evaluate the quality of measures used. Design Systematic literature review. Review Methods Included paediatric trials published in English between 1994 and 2003 involving children and adolescents up to the age of 20 years, and use of a standardised QOL measure. Data Sources included MEDLINE, CINAHL, EMB Reviews, AMED, BNI, PSYCHINFO, the Cochrane library, Internet, and reference lists from review articles. Results We identified 18 trials including assessment of QOL (4 Asthma, 4 Rhinitis, 2 Dermatitis, and single studies of Eczema, Cystic fibrosis, Otis media, Amblyopia, Diabetes, Obesity associated with a brain tumour, Idiopathic short stature, and Congenital agranulocytosis. In three trials, parents rated their own QOL but not their child's. Fourteen different QOL measures were used but only two fulfilled our minimal defined criteria for quality. Conclusions This review confirms previous reports of limited use of QOL measures in paediatric clinical trials. Our review provides information about availability and quality of measures which will be of especial value to trial developers.

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

Science.gov (United States)

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

2016-05-01

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

Future vision for the quality assurance of oncology clinical trials

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Thomas eFitzGerald, MD

2013-03-01

Full Text Available The National Cancer Institute clinical cooperative groups have been instrumental over the past 50 years in developing clinical trials and evidence based process improvements for clinical oncology patient care. The cooperative groups are undergoing a transformation process as we further integrate molecular biology into personalized patient care and move to incorporate international partners in clinical trials. To support this vision, data acquisition and data management informatics tools must become both nimble and robust to support transformational research at an enterprise level. Information, including imaging, pathology, molecular biology, radiation oncology, surgery, systemic therapy and patient outcome data needs to be integrated into the clinical trial charter using adaptive clinical trial mechanisms for design of the trial. This information needs to be made available to investigators using digital processes for real time data analysis. Future clinical trials will need to be designed and completed in a timely manner facilitated by nimble informatics processes for data management. This paper discusses both past experience and future vision for clinical trials as we move to develop data management and quality assurance processes to meet the needs of the modern trial.

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

Science.gov (United States)

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

2015-10-26

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

Quality at the source (QATS) system design under six sigma methodology

Energy Technology Data Exchange (ETDEWEB)

Aguirre, F; Ballasteros, I; Maricalva, J [Emperesa Nacional del Uranio, S.A. (ENUSA), Nuclear Fuel Manufacturing Plant, Juzbado, Salamanca (Spain)

2000-07-01

One of the main objectives in the manufacturing of fuel assemblies, is to fulfill the customer expectations with a product that assures its reliability during its stay in the NPP. By mean of the QATS System design under 6-Sigma methodology, all the customer requirements are included in the product specifications and drawings. Product characteristics and process variables are classified and process capability is evaluated. All this information permits to identify CTQ's (Critical to Quality) product characteristics and process variables, and to define a quality system (QATS) based in the process and on-line characteristics control handled by the manufacturing workers. At the end, this system ensures a continuous product quality improvement, and a strong commitment with the customer requirements. (author)

Quality at the source (QATS) system design under six sigma methodology

International Nuclear Information System (INIS)

Aguirre, F.; Ballasteros, I.; Maricalva, J.

2000-01-01

One of the main objectives in the manufacturing of fuel assemblies, is to fulfill the customer expectations with a product that assures its reliability during its stay in the NPP. By mean of the QATS System design under 6-Sigma methodology, all the customer requirements are included in the product specifications and drawings. Product characteristics and process variables are classified and process capability is evaluated. All this information permits to identify CTQ's (Critical to Quality) product characteristics and process variables, and to define a quality system (QATS) based in the process and on-line characteristics control handled by the manufacturing workers. At the end, this system ensures a continuous product quality improvement, and a strong commitment with the customer requirements. (author)

Endorsement of the CONSORT guidelines, trial registration, and the quality of reporting randomised controlled trials in leading nursing journals: A cross-sectional analysis.

Science.gov (United States)

Jull, Andrew; Aye, Phyu Sin

2015-06-01

To establish the reporting quality of trials published in leading nursing journals and investigate associations between CONSORT Statement or trial registration endorsment and reporting of design elements. The top 15 nursing journals were searched using Medline for randomised controlled trials published in 2012. Journals were categorised as CONSORT and trial registration promoting based on requirements of submitting authors or the journal's webpage as at January 2014. Data on sequence generation, allocation concealment, follow up, blinding, baseline equivalence and sample size calculation were extracted by one author and independently verified by the second author against source data. Seven journals were CONSORT promoting and three of these journals were also trial registration promoting. 114 citations were identified and 83 were randomised controlled trials. Eighteen trials (21.7%) were registered and those published in trial registration promoting journals were more likely to be registered (RR 2.64 95%CI 1.14-6.09). We assessed 68.7% of trials to be low risk of bias for sequence generation, 20.5% for allocation concealment, 38.6% for blinding, 55.4% for completeness of follow up and 79.5% for baseline equivalence. Trials published in CONSORT promoting journals were more likely to be at low risk of bias for blinding (RR 2.33, 95%CI 1.01-5.34) and completeness of follow up (RR 1.77, 95%CI 1.02-3.10), but journal endorsement of the CONSORT Statement or trial registration otherwise had no significant effect. Trials published in CONSORT and trial registration promoting journals were more likely to have high quality sample size calculations (RR 2.91, 95%CI 1.18-7.19 and RR 1.69, 95%CI 1.08-2.64, respectively). Simple endorsement of the CONSORT Statement and trials registration is insufficient action to encourage improvement of the quality of trial reporting across the most important of trial design elements. Copyright © 2014 Elsevier Ltd. All rights reserved.

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

Science.gov (United States)

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.

#eVALUate: Monetizing Service Acquisition Trade-offs Using the QUALITY-INFUSED Price Methodology

Science.gov (United States)

2016-04-01

they determine their source selection methodology along the best-value spectrum, ranging from lowest price technically acceptable (LPTA) to full...sidering factors determined to be germane to service value to the agency (Finkenstadt, 2015). Once an offeror’s prices are determined to be fair and... determine whether the quality rating system would affect the quality trade-off. In this case, the highest priced yet highest rated offeror was selected

Quality Assurance and Its Impact from Higher Education Institutions' Perspectives: Methodological Approaches, Experiences and Expectations

Science.gov (United States)

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…

Systematic literature review of clinical trials evaluating pharmacotherapy for overactive bladder in elderly patients: An assessment of trial quality.

Science.gov (United States)

Kistler, Kristin D; Xu, Yingxin; Zou, Kelly H; Ntanios, Fady; Chapman, Douglass S; Luo, Xuemei

2018-01-01

Overactive bladder (OAB) disproportionately affects older-aged adults, yet most randomized controlled trials (RCTs) underrepresent patients ≥65. This systematic literature review (SLR) identified RCTs evaluating β-3 adrenergic agonists or muscarinic antagonists in elderly patients with OAB, and compared study quality across trials. MEDLINE ® , Embase ® , and Cochrane Collaboration Central Register of Clinical Trials databases were searched from inception through April 28, 2015 to identify published, peer-reviewed RCT reports evaluating β-3 adrenergic agonists or muscarinic antagonists in elderly OAB patients (either ≥65 years or study-described as "elderly"). To assess study quality of RCT reports, we focused on internal/external validity, assessed via two scales: the validated Effective Public Health Practice Project [EPHPP]): Quality Assessment Tool for Quantitative Studies, and a tool commissioned by the Agency for Healthcare Research and Quality (AHRQ). Database searches yielded 1380 records that were then screened according to predefined inclusion/exclusion criteria. We included eight papers meeting study criteria. Despite scientific community efforts to improve RCT reporting standards, published reports still include incomplete and inconsistent reporting-of subject attrition, baseline patient characteristics, inclusion/exclusion criteria, and other important details. Only three of the eight OAB RCTs in this review received quality ratings of Strong (EPHPP) or Fair (AHRQ) and were multicenter with large samples. Despite the prevalence of OAB among older age individuals, relatively few RCTs evaluate OAB treatments explicitly among elderly subjects. The findings from this quality assessment suggest some areas for improvement in both conduct and reporting of future RCTs assessing OAB treatment in elderly. © 2017 Wiley Periodicals, Inc.

Development of Management Quality Assessment Methodology in the Public Sector: Problems and Contradictions

Directory of Open Access Journals (Sweden)

Olga Vladimirovna Kozhevina

2015-09-01

Full Text Available The development management quality assessment methodology in the public sector is relevant scientific and practical problem of economic research. The utilization of the results of the assessment on the basis of the authors’ methodology allows us to rate the public sector organizations, to justify decisions on the reorganization and privatization, and to monitor changes in the level of the management quality of the public sector organizations. The study determined the place of the quality of the control processes of the public sector organization in the system of “Quality of public administration — the effective operation of the public sector organization,” the contradictions associated with the assessment of management quality are revealed, the conditions for effective functioning of the public sector organizations are proved, a mechanism of comprehensive assessment and algorithm for constructing and evaluating the control models of management quality are developed, the criteria for assessing the management quality in the public sector organizations, including economic, budgetary, social and public, informational, innovation and institutional criteria are empirically grounded. By utilizing the proposed algorithm, the assessment model of quality management in the public sector organizations, including the financial, economic, social, innovation, informational and institutional indicators is developed. For each indicator of quality management, the coefficients of importance in the management quality assessment model, as well as comprehensive and partial evaluation indicators are determined on the basis of the expert evaluations. The main conclusion of the article is that management quality assessment for the public sector organizations should be based not only on the indicators achieved in the dynamics and utilized for analyzing the effectiveness of management, but also should take into account the reference levels for the values of these

Grey literature in meta-analyses of randomized trials of health care interventions.

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Hopewell, S; McDonald, S; Clarke, M; Egger, M

2007-04-18

The inclusion of grey literature (i.e. literature that has not been formally published) in systematic reviews may help to overcome some of the problems of publication bias, which can arise due to the selective availability of data. To review systematically research studies, which have investigated the impact of grey literature in meta-analyses of randomized trials of health care interventions. We searched the Cochrane Methodology Register (The Cochrane Library Issue 3, 2005), MEDLINE (1966 to 20 May 2005), the Science Citation Index (June 2005) and contacted researchers who may have carried out relevant studies. A study was considered eligible for this review if it compared the effect of the inclusion and exclusion of grey literature on the results of a cohort of meta-analyses of randomized trials. Data were extracted from each report independently by two reviewers. The main outcome measure was an estimate of the impact of trials from the grey literature on the pooled effect estimates of the meta-analyses. Information was also collected on the area of health care, the number of meta-analyses, the number of trials, the number of trial participants, the year of publication of the trials, the language and country of publication of the trials, the number and type of grey and published literature, and methodological quality. Five studies met the inclusion criteria. All five studies showed that published trials showed an overall greater treatment effect than grey trials. This difference was statistically significant in one of the five studies. Data could be combined for three of the five studies. This showed that, on average, published trials showed a 9% greater treatment effect than grey trials (ratio of odds ratios for grey versus published trials 1.09; 95% CI 1.03-1.16). Overall there were more published trials included in the meta-analyses than grey trials (median 224 (IQR 108-365) versus 45(IQR 40-102)). Published trials had more participants on average. The most

Economic evaluations of occupational health interventions from a corporate perspective - A systematic review of methodological quality

NARCIS (Netherlands)

Uegaki, K.; Bruijne, M.C. de; Lambeek, L.; Anema, J.R.; Beek, A.J. van der; Mechelen, W. van; Tulder, M.W. van

2010-01-01

Objective: Using a standardized quality criteria list, we appraised the methodological quality of economic evaluations of occupational safety and health (OSH) interventions conducted from a corporate perspective. Methods: The primary literature search was conducted in Medline and Embase.

Quality assurance of the SCOPE 1 trial in oesophageal radiotherapy.

Science.gov (United States)

Wills, Lucy; Maggs, Rhydian; Lewis, Geraint; Jones, Gareth; Nixon, Lisette; Staffurth, John; Crosby, Tom

2017-11-15

SCOPE 1 was the first UK based multi-centre trial involving radiotherapy of the oesophagus. A comprehensive radiotherapy trials quality assurance programme was launched with two main aims: 1. To assist centres, where needed, to adapt their radiotherapy techniques in order to achieve protocol compliance and thereby enable their participation in the trial. 2. To support the trial's clinical outcomes by ensuring the consistent planning and delivery of radiotherapy across all participating centres. A detailed information package was provided and centres were required to complete a benchmark case in which the delineated target volumes and organs at risk, dose distribution and completion of a plan assessment form were assessed prior to recruiting patients into the trial. Upon recruiting, the quality assurance (QA) programme continued to monitor the outlining and planning of radiotherapy treatments. Completion of a questionnaire was requested in order to gather information about each centre's equipment and techniques relating to their trial participation and to assess the impact of the trial nationally on standard practice for radiotherapy of the oesophagus. During the trial, advice was available for individual planning issues, and was circulated amongst the SCOPE 1 community in response to common areas of concern using bulletins. 36 centres were supported through QA processes to enable their participation in SCOPE1. We discuss the issues which have arisen throughout this process and present details of the benchmark case solutions, centre questionnaires and on-trial protocol compliance. The range of submitted benchmark case GTV volumes was 29.8-67.8cm 3 ; and PTV volumes 221.9-513.3 cm 3 . For the dose distributions associated with these volumes, the percentage volume of the lungs receiving 20Gy (V20Gy) ranged from 20.4 to 33.5%. Similarly, heart V40Gy ranged from 16.1 to 33.0%. Incidence of incorrect outlining of OAR volumes increased from 50% of centres at benchmark

Vision-Related Quality-of-Life Outcomes in the Mycotic Ulcer Treatment Trial I: A Randomized Clinical Trial.

Science.gov (United States)

Rose-Nussbaumer, Jennifer; Prajna, N Venkatesh; Krishnan, K Tiruvengada; Mascarenhas, Jeena; Rajaraman, Revathi; Srinivasan, Muthiah; Raghavan, Anita; Oldenburg, Catherine E; O'Brien, Kieran S; Ray, Kathryn J; McLeod, Stephen D; Porco, Travis C; Lietman, Thomas M; Acharya, Nisha R; Keenan, Jeremy D

2015-06-01

Given the limitations in health care resources, quality-of-life measures for interventions have gained importance. To determine whether vision-related quality-of-life outcomes were different between the natamycin and voriconazole treatment arms in the Mycotic Ulcer Treatment Trial I, as measured by an Indian Vision Function Questionnaire. Secondary analysis (performed October 11-25, 2014) of a double-masked, multicenter, randomized, active comparator-controlled, clinical trial at multiple locations of the Aravind Eye Care System in South India that enrolled patients with culture- or smear-positive filamentous fungal corneal ulcers who had a baseline visual acuity of 20/40 to 20/400 (logMAR of 0.3-1.3). Study participants were randomly assigned to topical voriconazole, 1%, or topical natamycin, 5%. Subscale score on the Indian Vision Function Questionnaire from each of the 4 subscales (mobility, activity limitation, psychosocial impact, and visual function) at 3 months. A total of 323 patients were enrolled in the trial, and 292 (90.4%) completed the Indian Vision Function Questionnaire at 3 months. The majority of study participants had subscale scores consistent with excellent function. After adjusting for baseline visual acuity and organism, we found that study participants in the natamycin-treated group scored, on average, 4.3 points (95% CI, 0.1-8.5) higher than study participants in the voriconazole-treated group (P = .046). In subgroup analyses looking at ulcers caused by Fusarium species and adjusting for baseline best spectacle-corrected visual acuity, the natamycin-treated group scored 8.4 points (95% CI, 1.9-14.9) higher than the voriconazole-treated group (P = .01). Differences in quality of life were not detected for patients with Aspergillus or other non-Fusarium species as the causative organism (1.5 points [95% CI, -3.9 to 6.9]; P = .52). We found evidence of improvement in vision-related quality of life among patients with fungal ulcers

Does Quality of Radiation Therapy Predict Outcomes of Multicenter Cooperative Group Trials? A Literature Review

Energy Technology Data Exchange (ETDEWEB)

Fairchild, Alysa, E-mail: alysa.fairchild@albertahealthservices.ca [Department of Radiation Oncology, Cross Cancer Institute, Edmonton, Alberta (Canada); Straube, William [Advanced Technology Consortium, Imaged-Guided Therapy QA Center, St. Louis, Missouri (United States); Laurie, Fran [Quality Assurance Review Center, Lincoln, Rhode Island (United States); Followill, David [Radiological Physics Center, University of Texas MD Anderson Cancer Centre, Houston, Texas (United States)

2013-10-01

Central review of radiation therapy (RT) delivery within multicenter clinical trials was initiated in the early 1970s in the United States. Early quality assurance publications often focused on metrics related to process, logistics, and timing. Our objective was to review the available evidence supporting correlation of RT quality with clinical outcomes within cooperative group trials. A MEDLINE search was performed to identify multicenter studies that described central subjective assessment of RT protocol compliance (quality). Data abstracted included method of central review, definition of deviations, and clinical outcomes. Seventeen multicenter studies (1980-2012) were identified, plus one Patterns of Care Study. Disease sites were hematologic, head and neck, lung, breast, and pancreas. Between 0 and 97% of treatment plans received an overall grade of acceptable. In 7 trials, failure rates were significantly higher after inadequate versus adequate RT. Five of 9 and 2 of 5 trials reported significantly worse overall and progression-free survival after poor-quality RT, respectively. One reported a significant correlation, and 2 reported nonsignificant trends toward increased toxicity with noncompliant RT. Although more data are required, protocol-compliant RT may decrease failure rates and increase overall survival and likely contributes to the ability of collected data to answer the central trial question.

Does Quality of Radiation Therapy Predict Outcomes of Multicenter Cooperative Group Trials? A Literature Review

International Nuclear Information System (INIS)

Fairchild, Alysa; Straube, William; Laurie, Fran; Followill, David

2013-01-01

Central review of radiation therapy (RT) delivery within multicenter clinical trials was initiated in the early 1970s in the United States. Early quality assurance publications often focused on metrics related to process, logistics, and timing. Our objective was to review the available evidence supporting correlation of RT quality with clinical outcomes within cooperative group trials. A MEDLINE search was performed to identify multicenter studies that described central subjective assessment of RT protocol compliance (quality). Data abstracted included method of central review, definition of deviations, and clinical outcomes. Seventeen multicenter studies (1980-2012) were identified, plus one Patterns of Care Study. Disease sites were hematologic, head and neck, lung, breast, and pancreas. Between 0 and 97% of treatment plans received an overall grade of acceptable. In 7 trials, failure rates were significantly higher after inadequate versus adequate RT. Five of 9 and 2 of 5 trials reported significantly worse overall and progression-free survival after poor-quality RT, respectively. One reported a significant correlation, and 2 reported nonsignificant trends toward increased toxicity with noncompliant RT. Although more data are required, protocol-compliant RT may decrease failure rates and increase overall survival and likely contributes to the ability of collected data to answer the central trial question

A comparative analysis of quality management standards for contract research organisations in clinical trials.

Science.gov (United States)

Murray, Elizabeth; McAdam, Rodney

2007-01-01

This article compares and contrasts the main quality standards in the highly regulated pharmaceutical industry with specific focus on Good Clinical Practice (GCP), the standard for designing, conducting, recording and reporting clinical trials involving human participants. Comparison is made to ISO quality standards, which can be applied to all industries and types of organisation. The study is then narrowed to that of contract research organisations (CROs) involved in the conduct of clinical trials. The paper concludes that the ISO 9000 series of quality standards can act as a company-wide framework for quality management within such organisations by helping to direct quality efforts on a long-term basis without any loss of compliance. This study is valuable because comparative analysis in this domain is uncommon.

Methodological recommendations for cognition trials in bipolar disorder by the International Society for Bipolar Disorders Targeting Cognition Task Force

DEFF Research Database (Denmark)

Miskowiak, K W; Burdick, K E; Martinez-Aran, A

2017-01-01

OBJECTIVES: To aid the development of treatment for cognitive impairment in bipolar disorder, the International Society for Bipolar Disorders (ISBD) convened a task force to create a consensus-based guidance paper for the methodology and design of cognition trials in bipolar disorder. METHODS...... of treatments to illness stage and using a multimodal approach. CONCLUSIONS: This ISBD task force guidance paper provides the first consensus-based recommendations for cognition trials in bipolar disorder. Adherence to these recommendations will likely improve the sensitivity in detecting treatment efficacy...

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

Science.gov (United States)

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…

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

Science.gov (United States)

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

A literature review of applied adaptive design methodology within the field of oncology in randomised controlled trials and a proposed extension to the CONSORT guidelines.

Science.gov (United States)

Mistry, Pankaj; Dunn, Janet A; Marshall, Andrea

2017-07-18

The application of adaptive design methodology within a clinical trial setting is becoming increasingly popular. However the application of these methods within trials is not being reported as adaptive designs hence making it more difficult to capture the emerging use of these designs. Within this review, we aim to understand how adaptive design methodology is being reported, whether these methods are explicitly stated as an 'adaptive design' or if it has to be inferred and to identify whether these methods are applied prospectively or concurrently. Three databases; Embase, Ovid and PubMed were chosen to conduct the literature search. The inclusion criteria for the review were phase II, phase III and phase II/III randomised controlled trials within the field of Oncology that published trial results in 2015. A variety of search terms related to adaptive designs were used. A total of 734 results were identified, after screening 54 were eligible. Adaptive designs were more commonly applied in phase III confirmatory trials. The majority of the papers performed an interim analysis, which included some sort of stopping criteria. Additionally only two papers explicitly stated the term 'adaptive design' and therefore for most of the papers, it had to be inferred that adaptive methods was applied. Sixty-five applications of adaptive design methods were applied, from which the most common method was an adaptation using group sequential methods. This review indicated that the reporting of adaptive design methodology within clinical trials needs improving. The proposed extension to the current CONSORT 2010 guidelines could help capture adaptive design methods. Furthermore provide an essential aid to those involved with clinical trials.

Does Deregulation of Quality Standards in Telecomunications Improve Social Welfare? A Methodological Note Does Deregulation of Quality Standards in Telecomunications Improve Social Welfare? A Methodological Note

OpenAIRE

Felipe Morandé

1990-01-01

Does Deregulation of Quality Standards in Telecomunications Improve Social Welfare? A Methodological Note One of the main reasons behind the bit difference observed in the per capita number of telephones between develope and developing countries is the high capital cost -a scarce resource in LDC's- of expanding telecommunications infrastructure. A reasonable question to raise in this context is the extent to which that high capital cost of investment could be diminished if international quali...

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

Science.gov (United States)

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

2016-01-01

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

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

Science.gov (United States)

Ernst, Edzard

2009-09-07

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

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

International Nuclear Information System (INIS)

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

2013-01-01

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

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

Energy Technology Data Exchange (ETDEWEB)

Schueler, Sabine; Walther, Stefan; Schuetz, Georg M. [Humboldt-Universitaet zu Berlin, Freie Universitaet Berlin, Charite Medical School, Department of Radiology, Berlin (Germany); Schlattmann, Peter [University Hospital of Friedrich Schiller University Jena, Department of Medical Statistics, Informatics, and Documentation, Jena (Germany); Dewey, Marc [Humboldt-Universitaet zu Berlin, Freie Universitaet Berlin, Charite Medical School, Department of Radiology, Berlin (Germany); Charite, Institut fuer Radiologie, Berlin (Germany)

2013-06-15

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

Quality of Reporting of Randomized Clinical Trials in Tai Chi Interventions—A Systematic Review

Directory of Open Access Journals (Sweden)

Jing-Yi Li

2011-01-01

Full Text Available Objectives. To evaluate the reporting quality of published randomized clinical trials (RCTs in the Tai Chi literature following the publication of the CONSORT guidelines in 2001. Data Sources. The OVID MEDLINE and PUBMED databases. Review Methods. To survey the general characteristics of Tai Chi RCTs in the literature, we included any report if (i it was an original report of the trial; (ii its design was RCT; (iii one of the treatments being tested was Tai Chi; and (iv it was in English. In addition, we assessed the reporting quality of RCTs that were published between 2002 and 2007, using a modified CONSORT checklist of 40 items. The adequate description of Tai Chi interventions in these trials was examined against a 10-item checklist adapted from previous reviews. Results. The search yielded 31 Tai Chi RCTs published from 2002 to 2007 and only 11 for 1992–2001. Among trials published during 2002–2007, the most adequately reported criteria were related to background, participant eligibility and interpretation of the study results. Nonetheless, the most poorly reported items were associated with randomization allocation concealment, implementation of randomization and the definitions of period of recruitment and follow-up. In addition, only 23% of RCTs provided adequate details of Tai Chi intervention used in the trials. Conclusion. The findings in this review indicated that the reporting quality of Tai Chi intervention trials is sub-optimal. Substantial improvement is required to meet the CONSORT guidelines and allow assessment of the quality of evidence. We believe that not only investigators, but also journal editors, reviewers and funding agencies need to follow the CONSORT guidelines to improve the standards of research and strengthen the evidence base for Tai Chi and for complementary and alternative medicine.

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

Science.gov (United States)

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.

Quantity and quality assessment of randomized controlled trials on orthodontic practice in PubMed.

Science.gov (United States)

Shimada, Tatsuo; Takayama, Hisako; Nakamura, Yoshiki

2010-07-01

To find current high-quality evidence for orthodontic practice within a reasonable time, we tested the performance of a PubMed search. PubMed was searched using publication type randomized controlled trial and medical subject heading term "orthodontics" for articles published between 2003 and 2007. The PubMed search results were compared with those from a hand search of four orthodontic journals to determine the sensitivity of PubMed search. We evaluated the precision of the PubMed search result and assessed the quality of individual randomized controlled trials using the Jadad scale. Sensitivity and precision were 97.46% and 58.12%, respectively. In PubMed, of the 277 articles retrieved, 161 (58.12%) were randomized controlled trials on orthodontic practice, and 115 of the 161 articles (71.42%) were published in four orthodontic journals: American Journal of Orthodontics and Dentofacial Orthopedics, The Angle Orthodontist, the European Journal of Orthodontics, and the Journal of Orthodontics. Assessment by the Jadad scale revealed 60 high-quality randomized controlled trials on orthodontic practice, of which 45 (75%) were published in these four journals. PubMed is a highly desirable search engine for evidence-based orthodontic practice. To stay current and get high-quality evidence, it is reasonable to look through four orthodontic journals: American Journal of Orthodontics and Dentofacial Orthopedics, The Angle Orthodontist, the European Journal of Orthodontics, and the Journal of Orthodontics.

Methodological issues for designing and conducting a multicenter, international clinical trial in Acute Stroke: Experience from ARTSS-2 trial.

Science.gov (United States)

Rahbar, Mohammad H; Dickerson, Aisha S; Cai, Chunyan; Pedroza, Claudia; Hessabi, Manouchehr; Shen, Loren; Pandurengan, Renganayaki; Jacobs, Amber Nicole M; Indupuru, Hari; Sline, Melvin R; Delgado, Rigoberto I; Macdonald, Claire; Ford, Gary A; Grotta, James C; Barreto, Andrew D

2015-09-01

We describe innovations in the study design and the efficient data coordination of a randomized multicenter trial of Argatroban in Combination with Recombinant Tissue Plasminogen Activator for Acute Stroke (ARTSS-2). ARTSS-2 is a 3-arm, multisite/multiregional randomized controlled trials (RCTs) of two doses of Argatroban injection (low, high) in combination with recombinant tissue plasminogen activator (rt-PA) in acute ischemic stroke patients and rt-PA alone. We developed a covariate adaptive randomization program that balanced the study arms with respect to study site as well as hemorrhage after thrombolysis (HAT) score and presence of distal internal carotid artery occlusion (DICAO). We used simulation studies to validate performance of the randomization program before making any adaptations during the trial. For the first 90 patients enrolled in ARTSS-2, we evaluated performance of our randomization program using chi-square tests of homogeneity or extended Fisher's exact test. We also designed a four-step partly Bayesian safety stopping rule for low and high dose Argatroban arms. Homogeneity of the study arms was confirmed with respect to distribution of study site (UK sites vs. US sites, P=0.98), HAT score (0-2 vs. 3-5, P=1.0), and DICAO (N/A vs. No vs. Yes, P=0.97). Our stopping thresholds for safety of low and high dose Argatroban were not crossed. Despite challenges, data quality was assured. We recommend adaptive designs for randomization and Bayesian safety stopping rules for multisite Phase I/II RCTs for maintaining additional flexibility. Efficient data coordination could lead to improved data quality. Copyright © 2015. Published by Elsevier Inc.

Systematic review: quality of trials on the symptomatic effects of the low FODMAP diet for irritable bowel syndrome

DEFF Research Database (Denmark)

Krogsgaard, L. R.; Lyngesen, M.; Bytzer, P.

2017-01-01

Background The low Fermentable Oligo-, Di- Monosaccharides, and Polyoles (FODMAP) diet is a new treatment option for irritable bowel syndrome (IBS). Experts refer to the diet as supported by high level of evidence, but an evaluation of the quality of trials is lacking. Aim To provide a systematic...... review of the quality of trials on the symptomatic effects of the low FODMAP diet for IBS. Methods Pubmed and EMBASE were searched for randomised controlled trials (RCTs) reporting effect of the low FODMAP diet on IBS symptoms. The quality of trials was evaluated by estimating risk of bias and assessing...... was instruction by a dietician and a variety of control interventions were used, all with limited established efficacy. Domains with a high risk of bias were identified for all the trials. High risk of bias dominated domains regarding blinding, with only one trial double-blinded. Conclusions The RCTs on the low...

Evaluation of the quality of the environmental participation: A methodological proposal

International Nuclear Information System (INIS)

Zuluaga M, Clara; Carmona M, Sergio Ivan

2004-01-01

The advances in the way to sustainability are inseparable to the achievement in the citizenship construction, because the citizen condition is only realized in the proactive compromise with the territorial themes, the environmental management effectiveness requests high quality in their participative processes; therefore, pertinent tools are required to know and to appraise these processes. The goodness of these tools proceeds of their functionality in the knowledge of the participation quality purpose, that to environmental participative processes, is conceived in terms of legitimacy, representatively, democratization of the environmental knowledge, social cohesion, capacity of interlocution, and incidence in the decision making, with the coherent conceptual structure of these facets shapes the theoretical-methodological scaffolding that permits their joining in attributes, variables and indicators relatives to the characteristics of the participative planning processes, proper to account of the environmental participation quality. With the appraisal of the environmental participation quality in planning processes, supported in the integration of the constitutive attributes, is possible to obtain the index that facilitates their diagnostic and improvement

Association between framing of the research question using the PICOT format and reporting quality of randomized controlled trials

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Thabane Lehana

2010-02-01

Full Text Available Abstract Background Experts recommend formulating a structured research question to guide the research design. However, the basis for this recommendation has not been formally evaluated. The aim of this study was to examine if a structured research question using the PICOT (Population, Intervention, Comparator, Outcome, Time-frame format is associated with a better reporting quality of randomized controlled trials (RCTs. Methods We evaluated 89 RCTs reports published in three endocrinology journals in 2005 and 2006, the quality of reporting of which was assessed in a previous study. We examined whether the reports stated each of the five elements of a structured research question: population, intervention, comparator, outcome and time-frame. A PICOT score was created with a possible score between 0 and 5. Outcomes were: 1 a 14-point overall reporting quality score (OQS based on the Consolidated Standards for Reporting Trials; and 2 a 3-point key score (KS, based on allocation concealment, blinding and use of intention-to-treat analysis. We conducted multivariable regression analyses using generalized estimating equations to determine if a higher PICOT score or the use of a structured research question were independently associated with a better reporting quality. Journal of publication, funding source and sample size were identified as factors associated with OQS in our previous report on this dataset, and therefore included in the model. Results A higher PICOT score was independently associated with OQS (incidence rate ratio (IRR = 1.021, 95% CI: 1.012 to 1.029 and KS (IRR = 1.142, 95% CI: 1.079 to 1.210. A structured research question was present in 33.7% of the reports and it was associated with a better OQS (IRR = 1.095, 95% CI 1.059-1.132 and KS (IRR = 1.530, 95% CI 1.311-1.786. Conclusions Better framing of the research question using the PICOT format is independently associated with better overall reporting quality - although the effect

Clinical Trials in Dentistry: A Cross-sectional Analysis of World Health Organization-International Clinical Trial Registry Platform.

Science.gov (United States)

Sivaramakrishnan, Gowri; Sridharan, Kannan

2016-06-01

Clinical trials are the back bone for evidence-based practice (EBP) and recently EBP has been considered the best source of treatment strategies available. Clinical trial registries serve as databases of clinical trials. As regards to dentistry in specific data on the number of clinical trials and their quality is lacking. Hence, the present study was envisaged. Clinical trials registered in WHO-ICTRP (http://apps.who.int/trialsearch/AdvSearch.aspx) in dental specialties were considered. The details assessed from the collected trials include: Type of sponsors; Health condition; Recruitment status; Study design; randomization, method of randomization and allocation concealment; Single or multi-centric; Retrospective or prospective registration; and Publication status in case of completed studies. A total of 197 trials were identified. Maximum trials were from United States (n = 30) and United Kingdom (n = 38). Seventy six trials were registered in Clinical Trials.gov, 54 from International Standards of Reporting Clinical Trials, 13 each from Australia and New Zealand Trial Register and Iranian Registry of Clinical Trials, 10 from German Clinical Trial Registry, eight each from Brazilian Clinical Trial Registry and Nederland's Trial Register, seven from Japan Clinical Trial Registry, six from Clinical Trial Registry of India and two from Hong Kong Clinical Trial Registry. A total of 78.7% studies were investigator-initiated and 64% were completed while 3% were terminated. Nearly four-fifths of the registered trials (81.7%) were interventional studies of which randomized were the large majority (94.4%) with 63.2% being open label, 20.4% using single blinding technique and 16.4% were doubled blinded. The number, methodology and the characteristics of clinical trials in dentistry have been noted to be poor especially in terms of being conducted multi-centrically, employing blinding and the method for randomization and allocation concealment. More emphasis has to be

Non-inferiority trials: methodological and regulatory challenges

NARCIS (Netherlands)

Wangge, G.

2012-01-01

A randomized clinical trial (RCT) is the gold standard to evaluate the intended effects of drugs. In such trials a drug can be compared with a placebo or with another active compound for the same indication. RCTs can be used to demonstrate that a drug is superior to placebo or an active comparator

Development of a methodology for automated assessment of the quality of digitized images in mammography

International Nuclear Information System (INIS)

Santana, Priscila do Carmo

2010-01-01

The process of evaluating the quality of radiographic images in general, and mammography in particular, can be much more accurate, practical and fast with the help of computer analysis tools. The purpose of this study is to develop a computational methodology to automate the process of assessing the quality of mammography images through techniques of digital imaging processing (PDI), using an existing image processing environment (ImageJ). With the application of PDI techniques was possible to extract geometric and radiometric characteristics of the images evaluated. The evaluated parameters include spatial resolution, high-contrast detail, low contrast threshold, linear detail of low contrast, tumor masses, contrast ratio and background optical density. The results obtained by this method were compared with the results presented in the visual evaluations performed by the Health Surveillance of Minas Gerais. Through this comparison was possible to demonstrate that the automated methodology is presented as a promising alternative for the reduction or elimination of existing subjectivity in the visual assessment methodology currently in use. (author)

Vitex agnus-castus extracts for female reproductive disorders: a systematic review of clinical trials.

Science.gov (United States)

van Die, M Diana; Burger, Henry G; Teede, Helena J; Bone, Kerry M

2013-05-01

Vitex agnus-castus L. (chaste tree; chasteberry) is a popular herbal treatment, predominantly used for a range of female reproductive conditions in Anglo-American and European practice. The objective of this systematic review was to evaluate the evidence for the efficacy and safety of Vitex extracts from randomised, controlled trials investigating women's health.Eight databases were searched using Latin and common names for Vitex and phytotherapeutic preparations of the herb as a sole agent, together with filters for randomised, controlled trials or clinical trials. Methodological quality was assessed according to the Cochrane risk of bias and Jadad scales, as well as the proposed elaboration of CONSORT for reporting trials on herbal interventions.Thirteen randomised, controlled trials were identified and twelve are included in this review, of which eight investigated premenstrual syndrome, two premenstrual dysphoric disorder, and two latent hyperprolactinaemia. For premenstrual syndrome, seven of eight trials found Vitex extracts to be superior to placebo (5 of 6 studies), pyridoxine (1), and magnesium oxide (1). In premenstrual dysphoric disorder, one study reported Vitex to be equivalent to fluoxetine, while in the other, fluoxetine outperformed Vitex. In latent hyperprolactinaemia, one trial reported it to be superior to placebo for reducing TRH-stimulated prolactin secretion, normalising a shortened luteal phase, increasing mid-luteal progesterone and 17β-oestradiol levels, while the other found Vitex comparable to bromocriptine for reducing serum prolactin levels and ameliorating cyclic mastalgia. Adverse events with Vitex were mild and generally infrequent. The methodological quality of the included studies varied, but was generally moderate-to-high. Limitations include small sample sizes in some studies, heterogeneity of conditions being treated, and a range of reference treatments.Despite some methodological limitations, the results from randomised

Effectiveness of a structured education reminiscence-based programme for staff on the quality of life of residents with dementia in long-stay units: A study protocol for a cluster randomised trial

LENUS (Irish Health Repository)

O'Shea, Eamon

2011-02-14

Abstract Background Current projections indicate that there will be a significant increase in the number of people with dementia in Ireland, from approximately 40,000 at present to 100,000 by 2036. Psychosocial interventions, such as reminiscence, have the potential to improve the quality of life of people with dementia. However, while reminiscence is used widely in dementia care, its impact on the quality of life of people with dementia remains largely undocumented and there is a need for a robust and fair assessment of its overall effectiveness. The DementiA education programme incorporating REminiscence for Staff study will evaluate the effectiveness of a structured reminiscence-based education programme for care staff on the quality of life of residents with dementia in long-stay units. Methods\\/Design The study is a two-group, single-blind cluster randomised trial conducted in public and private long-stay residential settings in Ireland. Randomisation to control and intervention is at the level of the long-stay residential unit. Sample size calculations suggest that 18 residential units each containing 17 people with dementia are required for randomisation to control and intervention groups to achieve power of at least 80% with alpha levels of 0.05. Each resident in the intervention group is linked with a nurse and care assistant who have taken the structured reminiscence-based education programme. Participants in the control group will receive usual care. The primary outcome is quality of life of residents as measured by the Quality of Life-AD instrument. Secondary outcomes include agitation, depression and carer burden. Blinded outcome assessment is undertaken at baseline and at 18-22 weeks post-randomisation. Discussion Trials on reminiscence-based interventions for people with dementia have been scarce and the quality of the information arising from those that have been done has been undermined by methodological problems, particularly in relation to scale

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

Science.gov (United States)

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.

Pre-trial quality assurance processes for an intensity-modulated radiation therapy (IMRT) trial: PARSPORT, a UK multicentre Phase III trial comparing conventional radiotherapy and parotid-sparing IMRT for locally advanced head and neck cancer.

Science.gov (United States)

Clark, C H; Miles, E A; Urbano, M T Guerrero; Bhide, S A; Bidmead, A M; Harrington, K J; Nutting, C M

2009-07-01

The purpose of this study was to compare conventional radiotherapy with parotid gland-sparing intensity-modulated radiation therapy (IMRT) using the PARSPORT trial. The validity of such a trial depends on the radiotherapy planning and delivery meeting a defined standard across all centres. At the outset, many of the centres had little or no experience of delivering IMRT; therefore, quality assurance processes were devised to ensure consistency and standardisation of all processes for comparison within the trial. The pre-trial quality assurance (QA) programme and results are described. Each centre undertook exercises in target volume definition and treatment planning, completed a resource questionnaire and produced a process document. Additionally, the QA team visited each participating centre. Each exercise had to be accepted before patients could be recruited into the trial. 10 centres successfully completed the quality assurance exercises. A range of treatment planning systems, linear accelerators and delivery methods were used for the planning exercises, and all the plans created reached the standard required for participation in this multicentre trial. All 10 participating centres achieved implementation of a comprehensive and robust IMRT programme for treatment of head and neck cancer.

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

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Weijun Peng

2014-01-01

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

Methodological recommendations for cognition trials in bipolar disorder by the International Society for Bipolar Disorders Targeting Cognition Task Force

DEFF Research Database (Denmark)

Miskowiak, K W; Burdick, K E; Martinez-Aran, A

2017-01-01

OBJECTIVES: To aid the development of treatment for cognitive impairment in bipolar disorder, the International Society for Bipolar Disorders (ISBD) convened a task force to create a consensus-based guidance paper for the methodology and design of cognition trials in bipolar disorder. METHODS...... symptoms and concomitant medication. Task force recommendations are to: (i) enrich trials with objectively measured cognitively impaired patients; (ii) generally select a broad cognitive composite score as the primary outcome and a functional measure as a key secondary outcome; and (iii) include remitted...... of treatments to illness stage and using a multimodal approach. CONCLUSIONS: This ISBD task force guidance paper provides the first consensus-based recommendations for cognition trials in bipolar disorder. Adherence to these recommendations will likely improve the sensitivity in detecting treatment efficacy...

Huperzine A for Alzheimer's disease: a systematic review and meta-analysis of randomized clinical trials.

Directory of Open Access Journals (Sweden)

Guoyan Yang

Full Text Available Huperzine A is a Chinese herb extract used for Alzheimer's disease. We conducted this review to evaluate the beneficial and harmful effect of Huperzine A for treatment of Alzheimer's disease.We searched for randomized clinical trials (RCTs of Huperzine A for Alzheimer's disease in PubMed, Cochrane Library, and four major Chinese electronic databases from their inception to June 2013. We performed meta-analyses using RevMan 5.1 software. (Protocol ID: CRD42012003249.20 RCTs including 1823 participants were included. The methodological quality of most included trials had a high risk of bias. Compared with placebo, Huperzine A showed a significant beneficial effect on the improvement of cognitive function as measured by Mini-Mental State Examination (MMSE at 8 weeks, 12 weeks and 16 weeks, and by Hastgawa Dementia Scale (HDS and Wechsler Memory Scale (WMS at 8 weeks and 12 weeks. Activities of daily living favored Huperzine A as measured by Activities of Daily Living Scale (ADL at 6 weeks, 12 weeks and 16 weeks. One trial found Huperzine A improved global clinical assessment as measured by Clinical Dementia Rating Scale (CDR. One trial demonstrated no significant change in cognitive function as measured by Alzheimer's disease Assessment Scale-Cognitive Subscale (ADAS-Cog and activity of daily living as measured by Alzheimer's disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL in Huperzine A group. Trials comparing Huperzine A with no treatment, psychotherapy and conventional medicine demonstrated similar findings. No trial evaluated quality of life. No trial reported severe adverse events of Huperzine A.Huperzine A appears to have beneficial effects on improvement of cognitive function, daily living activity, and global clinical assessment in participants with Alzheimer's disease. However, the findings should be interpreted with caution due to the poor methodological quality of the included trials.

Quality Assurance Issues in Conducting Multi-Institutional Advanced Technology Clinical Trials

International Nuclear Information System (INIS)

Purdy, James A.

2008-01-01

The National Cancer Institute-sponsored Advanced Technology Quality Assurance (QA) Consortium, which consisted of the Image-Guided Therapy QA Center, Radiation Therapy Oncology Group, Radiological Physics Center, Quality Assurance Review Center, and Resource Center for Emerging Technologies, has pioneered the development of an infrastructure and QA method for advanced technology clinical trials that requires volumetric digital data submission of a protocol patient's treatment plan and verification data. In particular, the Image-Guided Therapy QA Center has nearly 15 years experience in facilitating QA review for Radiation Therapy Oncology Group advanced technology clinical trials. This QA process includes (1) a data integrity review for completeness of protocol required elements, the format of data, and possible data corruption, and recalculation of dose-volume histograms; (2) a review of compliance with target volume and organ-at-risk contours by study chairs; and (3) a review of dose prescription and dose heterogeneity compliance by the Radiation Therapy Oncology Group Headquarters Dosimetry Group or the Radiological Physics Center dosimetrists (for brachytherapy protocols). This report reviews the lessons learned and the QA challenges presented by the use of advanced treatment modalities in clinical trials requiring volumetric digital data submission

Air quality estimation by computational intelligence methodologies

Directory of Open Access Journals (Sweden)

Ćirić Ivan T.

2012-01-01

Full Text Available The subject of this study is to compare different computational intelligence methodologies based on artificial neural networks used for forecasting an air quality parameter - the emission of CO2, in the city of Niš. Firstly, inputs of the CO2 emission estimator are analyzed and their measurement is explained. It is known that the traffic is the single largest emitter of CO2 in Europe. Therefore, a proper treatment of this component of pollution is very important for precise estimation of emission levels. With this in mind, measurements of traffic frequency and CO2 concentration were carried out at critical intersections in the city, as well as the monitoring of a vehicle direction at the crossroad. Finally, based on experimental data, different soft computing estimators were developed, such as feed forward neural network, recurrent neural network, and hybrid neuro-fuzzy estimator of CO2 emission levels. Test data for some characteristic cases presented at the end of the paper shows good agreement of developed estimator outputs with experimental data. Presented results are a true indicator of the implemented method usability. [Projekat Ministarstva nauke Republike Srbije, br. III42008-2/2011: Evaluation of Energy Performances and br. TR35016/2011: Indoor Environment Quality of Educational Buildings in Serbia with Impact to Health and Research of MHD Flows around the Bodies, in the Tip Clearances and Channels and Application in the MHD Pumps Development

The methodological quality of economic evaluation studies in obstetrics and gynecology: a systematic review

NARCIS (Netherlands)

Vijgen, Sylvia M. C.; Opmeer, Brent C.; Mol, Ben Willem J.

2013-01-01

We evaluated the methodological quality of economic evaluation studies in the field of obstetrics and gynecology published in the last decade. A MEDLINE search was performed to find economic evaluation studies in obstetrics and gynecology from the years 1997 through 2009. We included full economic

Implementation of External Quality Assurance Trials for Immunohistochemically Determined Breast Cancer Biomarkers in Germany.

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von Wasielewski, Reinhard; Krusche, Claudia A; Rüschoff, Joseph; Fisseler-Eckhoff, Anette; Kreipe, Hans

2008-01-01

Besides typing and grading of breast cancer, Pathologists are involved in the determination of biomarkers, such as steroid hormone receptors and HER2, which are of utmost importance in adjuvant therapy. There have been concerns with regard to security and reproducibility of the biomarker assays done on tissue sections applying either immunohistochemistry or in-situ hybridisation. In order to assure the quality of these biomarker assays, a number of measures are required, among them external proficiency testing. Therefore, external quality assurance trials have been implemented in Germany. In the period of 2002-2007, 5 consecutive trials were conducted with up to 180 participating laboratories. Tissue microarrays with 20-24 different breast cancer samples including cell lines enabled that a huge number of pathologists were challenged with identical samples which provides the prerequisite for comparability. Because there is no legal duress to undergo external proficiency testing in histopathology, all laboratories that took part volunteered to do so. These innovative quality assurance trials (Qualitätsinitiative Pathologie, QuIP) will be continued in the future on an annual or bi-annual basis. Participation is recommended for pathology departments involved in the service for breast units. The organisational frame work of the trials is described here.

The effect of technology-based interventions on pain, depression, and quality of life in patients with cancer: a systematic review of randomized controlled trials.

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Agboola, Stephen O; Ju, Woong; Elfiky, Aymen; Kvedar, Joseph C; Jethwani, Kamal

2015-03-13

The burden of cancer is increasing; projections over the next 2 decades suggest that the annual cases of cancer will rise from 14 million in 2012 to 22 million. However, cancer patients in the 21st century are living longer due to the availability of novel therapeutic regimens, which has prompted a growing focus on maintaining patients' health-related quality of life. Telehealth is increasingly being used to connect with patients outside of traditional clinical settings, and early work has shown its importance in improving quality of life and other clinical outcomes in cancer care. The aim of this study was to systematically assess the literature for the effect of supportive telehealth interventions on pain, depression, and quality of life in cancer patients via a systematic review of clinical trials. We searched PubMed, EMBASE, Google Scholar, CINAHL, and PsycINFO in July 2013 and updated the literature search again in January 2015 for prospective randomized trials evaluating the effect of telehealth interventions in cancer care with pain, depression, and quality of life as main outcomes. Two of the authors independently reviewed and extracted data from eligible randomized controlled trials, based on pre-determined selection criteria. Methodological quality of studies was assessed by the Cochrane Collaboration risk of bias tool. Of the 4929 articles retrieved from databases and relevant bibliographies, a total of 20 RCTs were included in the final review. The studies were largely heterogeneous in the type and duration of the intervention as well as in outcome assessments. A majority of the studies were telephone-based interventions that remotely connected patients with their health care provider or health coach. The intervention times ranged from 1 week to 12 months. In general, most of the studies had low risk of bias across the domains of the Cochrane Collaboration risk of bias tool, but most of the studies had insufficient information about the allocation

Network meta-analysis-highly attractive but more methodological research is needed

Directory of Open Access Journals (Sweden)

Singh Sonal

2011-06-01

Full Text Available Abstract Network meta-analysis, in the context of a systematic review, is a meta-analysis in which multiple treatments (that is, three or more are being compared using both direct comparisons of interventions within randomized controlled trials and indirect comparisons across trials based on a common comparator. To ensure validity of findings from network meta-analyses, the systematic review must be designed rigorously and conducted carefully. Aspects of designing and conducting a systematic review for network meta-analysis include defining the review question, specifying eligibility criteria, searching for and selecting studies, assessing risk of bias and quality of evidence, conducting a network meta-analysis, interpreting and reporting findings. This commentary summarizes the methodologic challenges and research opportunities for network meta-analysis relevant to each aspect of the systematic review process based on discussions at a network meta-analysis methodology meeting we hosted in May 2010 at the Johns Hopkins Bloomberg School of Public Health. Since this commentary reflects the discussion at that meeting, it is not intended to provide an overview of the field.

The reporting quality of randomized controlled trials in orthodontics.

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Lempesi, Evangelia; Koletsi, Despina; Fleming, Padhraig S; Pandis, Nikolaos

2014-06-01

Accurate trial reporting facilitates evaluation and better use of study results. The objective of this article is to investigate the quality of reporting of randomized controlled trials (RCTs) in leading orthodontic journals, and to explore potential predictors of improved reporting. The 50 most recent issues of 4 leading orthodontic journals until November 2013 were electronically searched. Reporting quality assessment was conducted using the modified CONSORT statement checklist. The relationship between potential predictors and the modified CONSORT score was assessed using linear regression modeling. 128 RCTs were identified with a mean modified CONSORT score of 68.97% (SD = 11.09). The Journal of Orthodontics (JO) ranked first in terms of completeness of reporting (modified CONSORT score 76.21%, SD = 10.1), followed by American Journal of Orthodontics and Dentofacial Orthopedics (AJODO) (73.05%, SD = 10.1). Journal of publication (AJODO: β = 10.08, 95% CI: 5.78, 14.38; JO: β = 16.82, 95% CI: 11.70, 21.94; EJO: β = 7.21, 95% CI: 2.69, 11.72 compared to Angle), year of publication (β = 0.98, 95% CI: 0.28, 1.67 for each additional year), region of authorship (Europe: β = 5.19, 95% CI: 1.30, 9.09 compared to Asia/other), statistical significance (significant: β = 3.10, 95% CI: 0.11, 6.10 compared to non-significant) and methodologist involvement (involvement: β = 5.60, 95% CI: 1.66, 9.54 compared to non-involvement) were all significant predictors of improved modified CONSORT scores in the multivariable model. Additionally, median overall Jadad score was 2 (IQR = 2) across journals, with JO (median = 3, IQR = 1) and AJODO (median = 3, IQR = 2) presenting the highest score values. The reporting quality of RCTs published in leading orthodontic journals is considered suboptimal in various CONSORT areas. This may have a bearing in trial result interpretation and use in clinical decision making and evidence- based orthodontic treatment interventions. Copyright �

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

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

2018-02-01

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

Global Harmonization of Quality Assurance Naming Conventions in Radiation Therapy Clinical Trials

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Melidis, Christos, E-mail: christos.melidis@eortc.be [European Organization for the Research and Treatment of Cancer–Radiation Oncology Group (EORTC-ROG), Radiation Therapy Quality Assurance (RTQA), Brussels (Belgium); Bosch, Walther R. [Washington University, representing Advanced Technology Consortium, Radiation Oncology, St. Louis, Missouri (United States); Izewska, Joanna [Dosimetry Laboratory, International Atomic Energy Agency, Vienna (Austria); Fidarova, Elena; Zubizarreta, Eduardo [Applied Radiation Biology and Radiotherapy Section, International Atomic Energy Agency, Vienna (Austria); Ulin, Kenneth [Department of Radiation Oncology, University of Massachusetts Medical School, Representing Quality Assurance Review Center, Worcester, Massachusetts (United States); Ishikura, Satoshi [Department of Radiation Oncology, Juntendo University, Representing Japan Clinical Oncology Group, RTQA, Tokyo (Japan); Followill, David [Department of Radiation Physics, The University of Texas MD Anderson Cancer Center, Representing Radiological Physics Center, RTQA, Houston, Texas (United States); Galvin, James [Department of Radiation Oncology, Thomas Jefferson University, Representing Radiation Therapy Oncology Group, RTQA, Philadelphia, Pennsylvania (United States); Haworth, Annette [Department of Physical Sciences, Peter MacCallum Cancer Centre, Melbourne, representing TransTasman Radiation Oncology Group (TROG) Cancer Research, Newcastle (Australia); Besuijen, Deidre [North West Cancer Centre, Representing TROG Cancer Research, Newcastle (Australia); Clark, Clark H. [Department of Medical Physics, St. Luke' s Cancer Centre, Royal Surrey County Hospital, Guildford, Surrey and National Physical Laboratory, Teddington, Middlesex, representing Radiation Therapy Trials Quality Assurance (RTTQA) (United Kingdom); Miles, Elizabeth; Aird, Edwin [Mount Vernon Cancer Centre, Northwood, Middlesex representing RTTQA (United Kingdom); and others

2014-12-01

Purpose: To review the various radiation therapy quality assurance (RTQA) procedures used by the Global Clinical Trials RTQA Harmonization Group (GHG) steering committee members and present the harmonized RTQA naming conventions by amalgamating procedures with similar objectives. Methods and Materials: A survey of the GHG steering committee members' RTQA procedures, their goals, and naming conventions was conducted. The RTQA procedures were classified as baseline, preaccrual, and prospective/retrospective data capture and analysis. After all the procedures were accumulated and described, extensive discussions took place to come to harmonized RTQA procedures and names. Results: The RTQA procedures implemented within a trial by the GHG steering committee members vary in quantity, timing, name, and compliance criteria. The procedures of each member are based on perceived chances of noncompliance, so that the quality of radiation therapy planning and treatment does not negatively influence the trial measured outcomes. A comparison of these procedures demonstrated similarities among the goals of the various methods, but the naming given to each differed. After thorough discussions, the GHG steering committee members amalgamated the 27 RTQA procedures to 10 harmonized ones with corresponding names: facility questionnaire, beam output audit, benchmark case, dummy run, complex treatment dosimetry check, virtual phantom, individual case review, review of patients' treatment records, and protocol compliance and dosimetry site visit. Conclusions: Harmonized RTQA harmonized naming conventions, which can be used in all future clinical trials involving radiation therapy, have been established. Harmonized procedures will facilitate future intergroup trial collaboration and help to ensure comparable RTQA between international trials, which enables meta-analyses and reduces RTQA workload for intergroup studies.

Characteristics and quality of systematic reviews of acupuncture, herbal medicines, and homeopathy

NARCIS (Netherlands)

Linde, K.; ter Riet, G.; Hondras, M.; Melchart, D.; Willich, S. N.

2003-01-01

Background: We aimed to describe the approaches and characteristics of systematic reviews on three major complementary therapies and to assess their methodological quality. Methods: Systematic reviews of clinical trials of acupuncture, herbal medicines, and homeopathy were identified from a database

Intention to treat (ITT) analysis as reported in orthodontic randomized controlled trials-evaluations of methodology and recommendations for the accurate use of ITT analysis and handling dropouts.

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Bondemark, Lars; Abdulraheem, Salem

2017-10-21

To systematically evaluate in five orthodontic journals how many randomized controlled trials (RCTs) use intention to treat (ITT) analysis and to assess the methodological quality of the ITT analysis, and finally, to demonstrate in an academic way how outcomes can be affected when not implementing the ITT analysis. A search of the database, Medline, was performed via PubMed for publication type 'randomized controlled trial' published for each journal between 1 January 2013 and 30 April 2017. The five orthodontic journals assessed were the American Journal of Orthodontics and Dentofacial Orthopedics, Angle Orthodontics, European Journal of Orthodontics, Journal of Orthodontics, and Orthodontics and Craniofacial Research. Two independent reviewers assessed each RCT to determine whether the trial reported an ITT or not or if a per-protocol analysis was accomplished. The initial search generated 137 possible trials. After applying the inclusion and exclusion criteria, 90 RCTs were included and assessed. Seventeen out of 90 RCTs (18.9%) either reported an ITT analysis in the text and/or supported the ITT by flow diagrams or tables. However, six RCTs applied and reported the ITT analysis correctly, while the majority performed a per-protocol analysis instead. Nearly all the trials that applied the ITT analysis incorrectly analysed the results using a per-protocol analysis, and thus, overestimating the results and/or having a reduced sample size which then could produce a diminished statistical power. © The Author 2017. Published by Oxford University Press on behalf of the European Orthodontic Society. All rights reserved. For permissions, please email: journals.permissions@oup.com

Clinical trials in dentistry in India: Analysis from trial registry.

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Gowri, S; Kannan, Sridharan

2017-01-01

Evidence-based practice requires clinical trials to be performed. In India, if any clinical trial has to be performed, it has to be registered with clinical trial registry of India. Studies have shown that the report of clinical trials is poor in dentistry. Hence, the present study has been conducted to assess the type and trends of clinical trials being undertaken in dentistry in India over a span of 6 years. All the clinical trials which were registered with the Central Trial Registry of India (CTRI) (www.ctri.nic.in) from January 1, 2007 to March 3, 2014 were evaluated using the keyword "dental." Following information were collected for each of the clinical trials obtained from the search; number of centres (single center/multicentric), type of the institution undertaking the research (government/private/combined), study (observational/interventional), study design (randomized/single blinded/double-blinded), type of health condition, type of participants (healthy/patients), sponsors (academia/commercial), phase of clinical trial (Phase 1/2/3/4), publication details (published/not published), whether it was a postgraduate thesis or not and prospective or retrospective registration of clinical trials, methodological quality (method of randomization, allocation concealment). Descriptive statistics was used for analysis of various categories. Trend analysis was done to assess the changes over a period of time. The search yielded a total of 84 trials of which majority of them were single centered. Considering the study design more than half of the registered clinical trials were double-blinded (47/84 [56%]). With regard to the place of conducting a trial, most of the trials were planned to be performed in private hospitals (56/84 [66.7%]). Most (79/84, 94.1%) of the clinical trials were interventional while only 5/84 (5.9%) were observational. Majority (65/84, 77.4%) of the registered clinical trials were recruiting patients while the rest were being done in healthy

Train the Trainer Effectiveness Trials of Behavioral Intervention for Individuals with Autism: A Systematic Review

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Shire, Stephanie Yoshiko; Kasari, Connie

2014-01-01

This systematic review examines train the trainer (TTT) effectiveness trials of behavioral interventions for individuals with autism spectrum disorder (ASD). Published methodological quality scales were used to assess studies including participant description, research design, intervention, outcomes, and analysis. Twelve studies including 9 weak…

A systematic review of the quality of homeopathic clinical trials

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Jonas, Wayne B; Anderson, Rachel L; Crawford, Cindy C; Lyons, John S

2001-01-01

Background While a number of reviews of homeopathic clinical trials have been done, all have used methods dependent on allopathic diagnostic classifications foreign to homeopathic practice. In addition, no review has used established and validated quality criteria allowing direct comparison of the allopathic and homeopathic literature. Methods In a systematic review, we compared the quality of clinical-trial research in homeopathy to a sample of research on conventional therapies using a validated and system-neutral approach. All clinical trials on homeopathic treatments with parallel treatment groups published between 1945–1995 in English were selected. All were evaluated with an established set of 33 validity criteria previously validated on a broad range of health interventions across differing medical systems. Criteria covered statistical conclusion, internal, construct and external validity. Reliability of criteria application is greater than 0.95. Results 59 studies met the inclusion criteria. Of these, 79% were from peer-reviewed journals, 29% used a placebo control, 51% used random assignment, and 86% failed to consider potentially confounding variables. The main validity problems were in measurement where 96% did not report the proportion of subjects screened, and 64% did not report attrition rate. 17% of subjects dropped out in studies where this was reported. There was practically no replication of or overlap in the conditions studied and most studies were relatively small and done at a single-site. Compared to research on conventional therapies the overall quality of studies in homeopathy was worse and only slightly improved in more recent years. Conclusions Clinical homeopathic research is clearly in its infancy with most studies using poor sampling and measurement techniques, few subjects, single sites and no replication. Many of these problems are correctable even within a "holistic" paradigm given sufficient research expertise, support and methods

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

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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.

Recent randomized controlled trials in otolaryngology.

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Banglawala, Sarfaraz M; Lawrence, Lauren A; Franko-Tobin, Emily; Soler, Zachary M; Schlosser, Rodney J; Ioannidis, John

2015-03-01

To assess recent trends in the prevalence and quality of reporting of randomized controlled trials (RCTs) in 4 otolaryngology journals. Methodology and reporting analysis. Randomized controlled trials in 4 otolaryngology journals. All RCTs published from 2011 to 2013 in 4 major otolaryngology journals were examined for characteristics of study design, quality of design and reporting, and funding. Of 5279 articles published in 4 leading otolaryngology journals from 2011 to 2013, 189 (3.3%) were RCTs. The majority of RCTs were clinical studies (86%), with the largest proportion consisting of sinonasal topics (31%). Most interventions were medical (46%), followed by surgical (38%) and mixed (16%). In terms of quality, randomization method was reported in 54% of RCTs, blinding in 33%, and adverse events in 65%. Intention-to-treat analysis was used in 32%; P values were reported in 87% and confidence intervals in 10%. Research funding was most often absent or not reported (55%), followed by not-for-profit (25%). Based on review of 4 otolaryngology journals, RCTs are still a small proportion of all published studies in the field of otolaryngology. There seem to be trends toward improvement in quality of design and reporting of RCTs, although many quality features remain suboptimal. Practitioners both designing and interpreting RCTs should critically evaluate RCTs for quality. © American Academy of Otolaryngology—Head and Neck Surgery Foundation 2014.

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

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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.

СONTENTS OF THE METHODOLOGICAL AND TECHNOLOGICAL SUPPORT OF THE EDUCATION QUALITY MANAGEMENT INFORMATION SYSTEM FOR FUTURE ECONOMISTS

Directory of Open Access Journals (Sweden)

Kostiantyn S. Khoruzhyi

2014-12-01

Full Text Available In the article, the content and nature of organizational activities in scope of methodological and technological support of the education quality management information system (EQMIS for future economists are described. The content of the organizational activities for the implementation of methodological and technological support of EQMIS for future economists includes four stages (preparatory, instructional/adaptational, methodological/basic, as well as experimental/evaluational and contains a set of methodological and technological measures for each of the stages of the EQMIS implementation. A study of the pedagogical impact of the proposed methodology of using EQMIS in the formation of professional competence of economics students was also conducted. The main stages, methods and sequence of implementation arrangements for the methodological and technological support of EQMIS are defined.

A methodology for texture feature-based quality assessment in nucleus segmentation of histopathology image

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Si Wen

2017-01-01

Full Text Available Context: Image segmentation pipelines often are sensitive to algorithm input parameters. Algorithm parameters optimized for a set of images do not necessarily produce good-quality-segmentation results for other images. Even within an image, some regions may not be well segmented due to a number of factors, including multiple pieces of tissue with distinct characteristics, differences in staining of the tissue, normal versus tumor regions, and tumor heterogeneity. Evaluation of quality of segmentation results is an important step in image analysis. It is very labor intensive to do quality assessment manually with large image datasets because a whole-slide tissue image may have hundreds of thousands of nuclei. Semi-automatic mechanisms are needed to assist researchers and application developers to detect image regions with bad segmentations efficiently. Aims: Our goal is to develop and evaluate a machine-learning-based semi-automated workflow to assess quality of nucleus segmentation results in a large set of whole-slide tissue images. Methods: We propose a quality control methodology, in which machine-learning algorithms are trained with image intensity and texture features to produce a classification model. This model is applied to image patches in a whole-slide tissue image to predict the quality of nucleus segmentation in each patch. The training step of our methodology involves the selection and labeling of regions by a pathologist in a set of images to create the training dataset. The image regions are partitioned into patches. A set of intensity and texture features is computed for each patch. A classifier is trained with the features and the labels assigned by the pathologist. At the end of this process, a classification model is generated. The classification step applies the classification model to unlabeled test images. Each test image is partitioned into patches. The classification model is applied to each patch to predict the patch

Climbing for preventing and treating health problems: a systematic review of randomized controlled trials

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Fechtelpeter, Dennis

2011-01-01

Full Text Available Objective: To summarize the best available evidence on effectiveness of therapeutic or sport climbing in preventing or treating health problems. Methods: We searched Medline, Embase, CENTRAL, PsycINFO, PEDro, OTseeker and SportDiscus for randomized controlled trials published up to December 26, 2010. We included all trials assessing patient-relevant outcomes. Two reviewers independently selected relevant studies, assessed their methodological quality and extracted data. Quality of evidence was rated using the GRADE system. Data were entered into RevMan 5 to calculate effect sizes and 95% confidence intervals where appropriate.Results: Eligible for inclusion were four RCTs studying the effectiveness of climbing in (a geriatric patients, (b adults with multiple sclerosis, (c adults with chronic low-back pain and (d children with disabilities and poor motor function. The sample sizes ranged between 20 and 95. All trials had major methodological limitations. We found very low quality evidence that therapeutic climbing may improve activities of daily living in geriatric patients compared to physiotherapy as measured by the Barthel index (difference in mean change score: 2.32 [95%-CI: 0.45 to 4.19]. We found very low quality evidence that therapeutic climbing compared to standard exercise therapy may improve physical functioning (difference in mean change score: 16.15 [95%-CI: 4.45 to 27.85] and general physical health (13.14 [95%-CI: 3.61 to 22.67] as measured by the SF-36 in adults with chronic low back-pain. Conclusions: Evidence for the effectiveness of therapeutic climbing is limited to small trials at high risk of bias. The effects of therapeutic climbing are therefore unclear.

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

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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

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

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

2013-01-01

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

Complementary religious and spiritual interventions in physical health and quality of life: A systematic review of randomized controlled clinical trials.

Directory of Open Access Journals (Sweden)

Juliane Piasseschi de Bernardin Gonçalves

Full Text Available To examine whether religious and spiritual interventions (RSIs can promote physical health and quality of life in individuals.The following databases were used to conduct a systematic review: PubMed, Scopus, Web of Science, EMBASE, PsycINFO, Cochrane, and Scielo. Randomized controlled trials that evaluated RSIs regarding physical health outcomes and/or quality of life in English, Spanish or Portuguese were included. RSI protocols performed at a distance (i.e. intercessory prayer or for psychiatric disorders were excluded. This study consisted of two phases: (a reading titles and abstracts, and (b assessing the full articles and their methodological quality using the Cochrane Back Review Group scale.In total, 7,070 articles were identified in the search, but 6884 were excluded in phase 1 because they were off topic or repeated in databases. Among the 186 articles included in phase 2, 140 were excluded because they did not fit the inclusion criteria and 16 did not have adequate randomization process. Thus, a final selection of 30 articles remained. The participants of the selected studies were classified in three groups: chronic patients (e.g., cancer, obesity, pain, healthy individuals and healthcare professionals. The outcomes assessed included quality of life, physical activity, pain, cardiac outcomes, promotion of health behaviors, clinical practice of healthcare professionals and satisfaction with protocols. The divergence concerning scales and protocols proposed did not allow a meta-analysis. RSIs as a psychotherapy approach were performed in 40% of the studies, and the control group was more likely to use an educational intervention (56.7%. The results revealed small effect sizes favoring RSIs in quality of life and pain outcomes and very small effects sizes in physical activity, promotion of health behaviors and clinical practice of health professionals compared with other complementary strategies. Other outcomes, such as cardiac measures

Quality assurance trials for Ki67 assessment in pathology.

Science.gov (United States)

Raap, M; Ließem, S; Rüschoff, J; Fisseler-Eckhoff, A; Reiner, A; Dirnhofer, S; von Wasielewski, R; Kreipe, H

2017-10-01

Ki67 is a broadly used proliferation marker in surgical pathology with an obvious need for standardization to improve reproducibility of assessment. Here, we present results of the so far only existing round robin tests on Ki67, organized annually in Germany, Austria, and Switzerland from 2010 to 2015 with up to 160 participating laboratories (QuIP). In each quality assessment trial, eight probes from each breast cancer, neuroendocrine tumor, and malignant lymphoma were compiled on a tissue microarray (TMA). TMAs were stained in the participants' laboratories with antibodies and procedures also applied in their daily routine. Participating pathologists were expected to assign Ki67 values to one of four different categories for each tumor type. All local stainings and evaluations were reassessed by the organizing panel and compared to a preset standard. On average, 95% of participants reached the benchmark of over 80% concordance rates with the Ki67 category pre-established by the panel. Automatization and type of antibody did not affect the success rate. Concordance rates differed between tumor entities being highest in each tumor type with either very high or very low labeling indices. Lower rates were seen for intermediate Ki67 levels. Staining quality improved during the observation period as did inter-observer concordance with 85% of participants achieving excellent agreement (kappa > 0.8) in the first year and over 95% in 2015. In conclusion, regular external quality assurance trials have been established as a tool to improve the reproducibility and reliability of the prognostic and predictive proliferation marker Ki67.

Vision-Related Quality-of-Life Outcomes in the Mycotic Ulcer Treatment Trial I

Science.gov (United States)

Rose-Nussbaumer, Jennifer; Prajna, N. Venkatesh; Krishnan, K. Tiruvengada; Mascarenhas, Jeena; Rajaraman, Revathi; Srinivasan, Muthiah; Raghavan, Anita; Oldenburg, Catherine E.; O’Brien, Kieran S.; Ray, Kathryn J.; McLeod, Stephen D.; Porco, Travis C.; Lietman, Thomas M.; Acharya, Nisha R.; Keenan, Jeremy D.

2016-01-01

IMPORTANCE Given the limitations in health care resources, quality-of-life measures for interventions have gained importance. OBJECTIVE To determine whether vision-related quality-of-life outcomes were different between the natamycin and voriconazole treatment arms in the Mycotic Ulcer Treatment Trial I, as measured by an Indian Vision Function Questionnaire. DESIGN, SETTING, AND PARTICIPANTS Secondary analysis (performed October 11–25, 2014) of a double-masked, multicenter, randomized, active comparator–controlled, clinical trial at multiple locations of the Aravind Eye Care System in South India that enrolled patients with culture- or smear-positive filamentous fungal corneal ulcers who had a baseline visual acuity of 20/40 to 20/400 (logMAR of 0.3–1.3). INTERVENTIONS Study participants were randomly assigned to topical voriconazole, 1%, or topical natamycin, 5%. MAIN OUTCOMES AND MEASURES Subscale score on the Indian Vision Function Questionnaire from each of the 4 subscales (mobility, activity limitation, psychosocial impact, and visual function) at 3 months. RESULTS A total of 323 patients were enrolled in the trial, and 292 (90.4%) completed the Indian Vision Function Questionnaire at 3 months. The majority of study participants had subscale scores consistent with excellent function. After adjusting for baseline visual acuity and organism, we found that study participants in the natamycin-treated group scored, on average, 4.3 points (95% CI, 0.1–8.5) higher than study participants in the voriconazole-treated group (P = .046). In subgroup analyses looking at ulcers caused by Fusarium species and adjusting for baseline best spectacle–corrected visual acuity, the natamycin-treated group scored 8.4 points (95% CI, 1.9–14.9) higher than the voriconazole-treated group (P = .01). Differences in quality of life were not detected for patients with Aspergillus or other non-Fusarium species as the causative organism (1.5 points [95% CI, −3.9 to 6.9]; P

Promoting Continuous Quality Improvement in the Alabama Child Health Improvement Alliance Through Q-Sort Methodology and Learning Collaboratives.

Science.gov (United States)

Fifolt, Matthew; Preskitt, Julie; Rucks, Andrew; Corvey, Kathryn; Benton, Elizabeth Cason

Q-sort methodology is an underutilized tool for differentiating among multiple priority measures. The authors describe steps to identify, delimit, and sort potential health measures and use selected priority measures to establish an overall agenda for continuous quality improvement (CQI) activities within learning collaboratives. Through an iterative process, the authors vetted a list of potential child and adolescent health measures. Multiple stakeholders, including payers, direct care providers, and organizational representatives sorted and prioritized measures, using Q-methodology. Q-methodology provided the Alabama Child Health Improvement Alliance (ACHIA) an objective and rigorous approach to system improvement. Selected priority measures were used to design learning collaboratives. An open dialogue among stakeholders about state health priorities spurred greater organizational buy-in for ACHIA and increased its credibility as a statewide provider of learning collaboratives. The integrated processes of Q-sort methodology, learning collaboratives, and CQI offer a practical yet innovative way to identify and prioritize state measures for child and adolescent health and establish a learning agenda for targeted quality improvement activities.

Effectiveness of a structured education reminiscence-based programme for staff on the quality of life of residents with dementia in long-stay units: A study protocol for a cluster randomised trial

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Jordan Fionnuala

2011-02-01

Full Text Available Abstract Background Current projections indicate that there will be a significant increase in the number of people with dementia in Ireland, from approximately 40,000 at present to 100,000 by 2036. Psychosocial interventions, such as reminiscence, have the potential to improve the quality of life of people with dementia. However, while reminiscence is used widely in dementia care, its impact on the quality of life of people with dementia remains largely undocumented and there is a need for a robust and fair assessment of its overall effectiveness. The DementiA education programme incorporating REminiscence for Staff study will evaluate the effectiveness of a structured reminiscence-based education programme for care staff on the quality of life of residents with dementia in long-stay units. Methods/Design The study is a two-group, single-blind cluster randomised trial conducted in public and private long-stay residential settings in Ireland. Randomisation to control and intervention is at the level of the long-stay residential unit. Sample size calculations suggest that 18 residential units each containing 17 people with dementia are required for randomisation to control and intervention groups to achieve power of at least 80% with alpha levels of 0.05. Each resident in the intervention group is linked with a nurse and care assistant who have taken the structured reminiscence-based education programme. Participants in the control group will receive usual care. The primary outcome is quality of life of residents as measured by the Quality of Life-AD instrument. Secondary outcomes include agitation, depression and carer burden. Blinded outcome assessment is undertaken at baseline and at 18-22 weeks post-randomisation. Discussion Trials on reminiscence-based interventions for people with dementia have been scarce and the quality of the information arising from those that have been done has been undermined by methodological problems, particularly in

The effects of a randomised multi-centre trial and international accreditation on availability and quality of clinical guidelines

DEFF Research Database (Denmark)

Juul, Anne Benedicte; Gluud, Christian; Wetterslev, Jørn

2005-01-01

To examine the availability and quality of clinical guidelines on perioperative diabetes care in hospital units before and after a randomised clinical trial (RCT) and international accreditation.......To examine the availability and quality of clinical guidelines on perioperative diabetes care in hospital units before and after a randomised clinical trial (RCT) and international accreditation....

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

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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.

Water Quality Research Program: Development of Unstructured Grid Linkage Methodology and Software for CE-QUAL-ICM

National Research Council Canada - National Science Library

Chapman, Raymond

1997-01-01

This study was conducted for the purpose of developing a methodology and associated software for linking hydrodynamic output from the RMAlO finite element model to the CE-QUAL-ICM finite volume water quality model...

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

Science.gov (United States)

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

2016-01-16

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

Type 1 Diabetes TrialNet--an international collaborative clinical trials network.

Science.gov (United States)

Skyler, Jay S; Greenbaum, Carla J; Lachin, John M; Leschek, Ellen; Rafkin-Mervis, Lisa; Savage, Peter; Spain, Lisa

2008-12-01

Type 1 Diabetes TrialNet is an international consortium of clinical research centers aimed at the prevention or delay of type 1 diabetes (T1D). The fundamental goal of TrialNet is to counter the T1D disease process by immune modulation and/or enhancement of beta cell proliferation and regeneration. To achieve this goal, TrialNet researchers are working to better understand the natural history of the disease, to identify persons at risk, and to clinically evaluate novel therapies that balance potential risks and benefits. The particular focus is on studies of preventive measures. In addition, TrialNet evaluates therapies in individuals with newly diagnosed T1D with preserved beta cell function to help determine the risk/benefit profile and gain an initial assessment of potential efficacy in preservation of beta cell function, so that promising agents can be studied in prevention trials. In addition, TrialNet evaluates methodologies that enhance the conduct of its clinical trials, which includes tests of outcome assessment methodology, the evaluation of surrogate markers, and mechanistic studies laying the foundation for future clinical trials.

Conservative treatment of urge urinary incontinence in women: a systematic review of randomized clinical trials.

Science.gov (United States)

Berghmans, L C; Hendriks, H J; De Bie, R A; van Waalwijk van Doorn, E S; Bø, K; van Kerrebroeck, P E

2000-02-01

To assess the efficacy of physical therapies for first-line use in the treatment of urge urinary incontinence (UUI) in women, using a systematic review of randomized clinical trials (RCTs). A computer-aided and manual search was carried out for RCTs published between 1980 and 1999 investigating the treatment of UUI defined by the keywords 'physical therapies', e.g. bladder (re)training (including 'behavioural' treatment), pelvic floor muscle (PFM) exercises, with or without biofeedback and/or electrical stimulation. The methodological quality of the included trials was assessed using methodological criteria, based on generally accepted principles of interventional research. Fifteen RCTs were identified; the methodological quality of the studies was moderate, with a median (range) score of 6 (3-8.5) (maximum possible 10). Eight RCTs were considered of sufficient quality, i.e. an internal validity score of >/= 5.5 points on a scale of 0-10, and were included in a further analysis. Based on levels-of-evidence criteria, there is weak evidence to suggest that bladder (re)training is more effective than no treatment (controls), and that bladder (re)training is better than drug therapy. Stimulation types and parameters in the studies of electrical stimulation were heterogeneous. There is insufficient evidence that electrical stimulation is more effective than sham electrical simulation. To date there are too few studies to evaluate effects of PFM exercise with or without biofeedback, and of toilet training for women with UUI. Although almost all studies included reported positive results in favour of physical therapies for the treatment of UUI, more research of high methodological quality is required to evaluate the effects of each method in the range of physical therapies.

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

Science.gov (United States)

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

2018-02-01

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

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

Science.gov (United States)

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

Comparison of tools for assessing the methodological quality of primary and secondary studies in health technology assessment reports in Germany

Directory of Open Access Journals (Sweden)

Walter, Ulla

2010-01-01

Full Text Available Health care policy background: Findings from scientific studies form the basis for evidence-based health policy decisions. Scientific background: Quality assessments to evaluate the credibility of study results are an essential part of health technology assessment reports and systematic reviews. Quality assessment tools (QAT for assessing the study quality examine to what extent study results are systematically distorted by confounding or bias (internal validity. The tools can be divided into checklists, scales and component ratings. Research questions: What QAT are available to assess the quality of interventional studies or studies in the field of health economics, how do they differ from each other and what conclusions can be drawn from these results for quality assessments? Methods: A systematic search of relevant databases from 1988 onwards is done, supplemented by screening of the references, of the HTA reports of the German Agency for Health Technology Assessment (DAHTA and an internet search. The selection of relevant literature, the data extraction and the quality assessment are carried out by two independent reviewers. The substantive elements of the QAT are extracted using a modified criteria list consisting of items and domains specific to randomized trials, observational studies, diagnostic studies, systematic reviews and health economic studies. Based on the number of covered items and domains, more and less comprehensive QAT are distinguished. In order to exchange experiences regarding problems in the practical application of tools, a workshop is hosted. Results: A total of eight systematic methodological reviews is identified as well as 147 QAT: 15 for systematic reviews, 80 for randomized trials, 30 for observational studies, 17 for diagnostic studies and 22 for health economic studies. The tools vary considerably with regard to the content, the performance and quality of operationalisation. Some tools do not only include the

Comparison of tools for assessing the methodological quality of primary and secondary studies in health technology assessment reports in Germany.

Science.gov (United States)

Dreier, Maren; Borutta, Birgit; Stahmeyer, Jona; Krauth, Christian; Walter, Ulla

2010-06-14

HEALTH CARE POLICY BACKGROUND: Findings from scientific studies form the basis for evidence-based health policy decisions. Quality assessments to evaluate the credibility of study results are an essential part of health technology assessment reports and systematic reviews. Quality assessment tools (QAT) for assessing the study quality examine to what extent study results are systematically distorted by confounding or bias (internal validity). The tools can be divided into checklists, scales and component ratings. What QAT are available to assess the quality of interventional studies or studies in the field of health economics, how do they differ from each other and what conclusions can be drawn from these results for quality assessments? A systematic search of relevant databases from 1988 onwards is done, supplemented by screening of the references, of the HTA reports of the German Agency for Health Technology Assessment (DAHTA) and an internet search. The selection of relevant literature, the data extraction and the quality assessment are carried out by two independent reviewers. The substantive elements of the QAT are extracted using a modified criteria list consisting of items and domains specific to randomized trials, observational studies, diagnostic studies, systematic reviews and health economic studies. Based on the number of covered items and domains, more and less comprehensive QAT are distinguished. In order to exchange experiences regarding problems in the practical application of tools, a workshop is hosted. A total of eight systematic methodological reviews is identified as well as 147 QAT: 15 for systematic reviews, 80 for randomized trials, 30 for observational studies, 17 for diagnostic studies and 22 for health economic studies. The tools vary considerably with regard to the content, the performance and quality of operationalisation. Some tools do not only include the items of internal validity but also the items of quality of reporting and

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

Science.gov (United States)

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

Analysing data from patient-reported outcome and quality of life endpoints for cancer clinical trials

DEFF Research Database (Denmark)

Bottomley, Andrew; Pe, Madeline; Sloan, Jeff

2016-01-01

Measures of health-related quality of life (HRQOL) and other patient-reported outcomes generate important data in cancer randomised trials to assist in assessing the risks and benefits of cancer therapies and fostering patient-centred cancer care. However, the various ways these measures are anal......Measures of health-related quality of life (HRQOL) and other patient-reported outcomes generate important data in cancer randomised trials to assist in assessing the risks and benefits of cancer therapies and fostering patient-centred cancer care. However, the various ways these measures...... are analysed and interpreted make it difficult to compare results across trials, and hinders the application of research findings to inform publications, product labelling, clinical guidelines, and health policy. To address these problems, the Setting International Standards in Analyzing Patient......-Reported Outcomes and Quality of Life Endpoints Data (SISAQOL) initiative has been established. This consortium, directed by the European Organisation for Research and Treatment of Cancer (EORTC), was convened to provide recommendations on how to standardise the analysis of HRQOL and other patient-reported outcomes...

Effect of simulated dawn on quality of sleep – a community-based trial

Directory of Open Access Journals (Sweden)

Haukka Jari

2003-10-01

Full Text Available Abstract Background Morning light exposure administered as simulated dawn looks a promising method to treat Seasonal Affective Disorder, but it may moreover help with resetting the inaccurate organisation of body clock functions relative to sleep occurring in winter among people in general. Disturbances in sleep patterns are common and may compromise wellbeing even in the short term. Our hypothesis was that simulated dawn could improve the subjective quality of sleep during winter. Methods A community-based trial with 100 volunteer subjects provided with dawn simulators. Study period lasted for eight weeks, and subjects used the dawn simulators for two weeks at a time, each subject acting as his own control (ABAB-design. Main outcome measure was subjective quality of sleep recorded each morning with Groningen Sleep Quality Scale. Results 77 subjects completed the trial. Quality of sleep improved while subjects were using dawn simulator-devices (p = 0.001. The treatment became beneficial after six days' use of dawn simulator, but the effect did not last after the use was ceased. Conclusion Dawn simulation may help to improve the subjective quality of sleep, but the benefits are modest. Further research is needed to verify these findings and to elucidate the mechanism by which dawn simulation acts on the sleep-wake pattern.

Analysis and Thoughts about the Negative Results of International Clinical Trials on Acupuncture

Science.gov (United States)

Han, Yan-jing; Wang, Xiao-hong; Li, Chen; Liu, Wan-ning

2015-01-01

An increasing number of randomized controlled trials (RCTs) of acupuncture have proved the clinical benefits of acupuncture; however, there are some results that have shown negative results or placebo effects. The paper carried out an in-depth analysis on 33 RCTs in the 2011 SCI database, the quality of the reports was judged according to Jadad scores, and the “Necessary Information Included in Reporting Interventions in Clinical Trials of Acupuncture (STRICTA 2010)” was taken as the standard to analyze the rationality of the therapeutic principle. The difference between the methodology (Jadad) scores of the two types of research reports did not constitute statistical significance (P > 0.05). The studies with negative results or placebo effects showed the following deficiencies with respect to intervention details: (1) incompletely rational acupoint selection; (2) inconsistent ability of acupuncturists; (3) negligible needling response to needling; (4) acupuncture treatment frequency too low in most studies; and (5) irrational setting of placebo control. Thus, the primary basis for the negative results or placebo effects of international clinical trials on acupuncture is not in the quality of the methodology, but in noncompliance with the essential requirements proposed by acupuncture theory in terms of clinical manipulation details. PMID:26161126

Herbal Medicine for Xerostomia in Cancer Patients: A Systematic Review of Randomized Controlled Trials.

Science.gov (United States)

Park, Bongki; Noh, Hyeonseok; Choi, Dong-Jun

2018-06-01

Xerostomia (dry mouth) causes many clinical problems, including oral infections, speech difficulties, and impaired chewing and swallowing of food. Many cancer patients have complained of xerostomia induced by cancer therapy. The aim of this systematic review is to assess the efficacy of herbal medicine for the treatment of xerostomia in cancer patients. Randomized controlled trials investigating the use of herbal medicines to treat xerostomia in cancer patients were included. We searched the following 12 databases without restrictions on time or language. The risk of bias was assessed using the Cochrane Risk of Bias Tool. Twenty-five randomized controlled trials involving 1586 patients met the inclusion criteria. A total of 24 formulas were examined in the included trials. Most of the included trials were insufficiently reported in the methodology section. Five formulas were shown to significantly improve the salivary flow rate compared to comparators. Regarding the grade of xerostomia, all formulas with the exception of a Dark Plum gargle solution with normal saline were significantly effective in reducing the severity of dry mouth. Adverse events were reported in 4 trials, and adverse effects of herbal medicine were reported in 3 trials. We found herbal medicines had potential benefits for improving salivary function and reducing the severity of dry mouth in cancer patients. However, methodological limitations and a relatively small sample size reduced the strength of the evidence. More high-quality trials reporting sufficient methodological data are warranted to enforce the strength of evidence regarding the effectiveness of herbal medicines.

Field trials of the phenomena of concern for psychiatric/mental health nursing: proposed methodology.

Science.gov (United States)

Wilson, H S

1989-10-01

An important step in the development of the American Nurses' Association (ANA) Task Force's Classification of Phenomena of Concern for Psychiatric/Mental Health Nursing is a plan for conducting field trials to determine interrater diagnostic reliability using the classification system. The ANA Task Force identified field testing as stage two in a three-stage process for completion of our work. In this article, we identify methodologic directions that will allow us to answer two important questions. First, what is the interrater reliability of the system of psychiatric nursing diagnoses when applied to clients by psychiatric/mental health nurse clinicians in their practice, and second, how do the clinicians who use this system view its usefulness for planning and evaluating nursing care?

A cluster-randomised trial of staff education to improve the quality of life of people with dementia living in residential care: the DIRECT study.

Directory of Open Access Journals (Sweden)

Christopher Beer

Full Text Available BACKGROUND: The Dementia In Residential care: EduCation intervention Trial (DIRECT was conducted to determine if delivery of education designed to meet the perceived need of GPs and care staff improves the quality of life of participants with dementia living in residential care. METHODOLOGY/PRINCIPAL FINDINGS: This cluster-randomised controlled trial was conducted in 39 residential aged care facilities in the metropolitan area of Perth, Western Australia. 351 care facility residents aged 65 years and older with Mini-Mental State Examination ≤ 24, their GPs and facility staff participated. Flexible education designed to meet the perceived needs of learners was delivered to GPs and care facility staff in intervention groups. The primary outcome of the study was self-rated quality of life of participants with dementia, measured using the QOL-Alzheimer's Disease Scale (QOL-AD at 4 weeks and 6 months after the conclusion of the intervention. Analysis accounted for the effect of clustering by using multi-level regression analysis. Education of GPs or care facility staff did not affect the primary outcome at either 4 weeks or 6 months. In a post hoc analysis excluding facilities in which fewer than 50% of staff attended an education session, self-rated QOL-AD scores were 6.14 points (adjusted 95%CI 1.14, 11.15 higher at four-week follow-up among residents in facilities randomly assigned to the education intervention. CONCLUSION: The education intervention directed at care facilities or GPs did not improve the quality of life ratings of participants with dementia as a group. This may be explained by the poor adherence to the intervention programme, as participants with dementia living in facilities where staff participated at least minimally seemed to benefit. TRIAL REGISTRATION: ANZCTR.org.au ACTRN12607000417482.

A data grid for imaging-based clinical trials

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Zhou, Zheng; Chao, Sander S.; Lee, Jasper; Liu, Brent; Documet, Jorge; Huang, H. K.

2007-03-01

Clinical trials play a crucial role in testing new drugs or devices in modern medicine. Medical imaging has also become an important tool in clinical trials because images provide a unique and fast diagnosis with visual observation and quantitative assessment. A typical imaging-based clinical trial consists of: 1) A well-defined rigorous clinical trial protocol, 2) a radiology core that has a quality control mechanism, a biostatistics component, and a server for storing and distributing data and analysis results; and 3) many field sites that generate and send image studies to the radiology core. As the number of clinical trials increases, it becomes a challenge for a radiology core servicing multiple trials to have a server robust enough to administrate and quickly distribute information to participating radiologists/clinicians worldwide. The Data Grid can satisfy the aforementioned requirements of imaging based clinical trials. In this paper, we present a Data Grid architecture for imaging-based clinical trials. A Data Grid prototype has been implemented in the Image Processing and Informatics (IPI) Laboratory at the University of Southern California to test and evaluate performance in storing trial images and analysis results for a clinical trial. The implementation methodology and evaluation protocol of the Data Grid are presented.

mHealth in psychiatry: time for methodological change.

Science.gov (United States)

Nicholas, Jennifer; Boydell, Katherine; Christensen, Helen

2016-05-01

A multitude of mental health apps are available to consumers through the Apple and Google app stores. However, evidence supporting the effectiveness of mHealth is scant. We argue this gap between app availability and research evidence is primarily due to unsuitable knowledge translation practices and therefore suggest abandoning the randomised controlled trial as the primary app evaluation paradigm. Alternative evaluation methodologies such as iterative participatory research and single case designs are better aligned with mHealth translational needs. A further challenge to the use of mobile technology in mental health is the dissemination of information about app quality to consumers. Strategies to facilitate successful dissemination of quality resources must consider several factors, such as target audience and context. In practice, structured solutions to inform consumers of evidence-informed apps could range from the development of consumer used tools to app accreditation portals. Consumer enthusiasm for apps represents an opportunity to increase access and support for psychiatric populations. However, adoption of alternative research methodologies and the development of dissemination strategies are vital before this opportunity can be substantially seized. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Methodology for Assessing the Quality of Agribusiness Activity Based on the Environmentally Responsible Approach

Directory of Open Access Journals (Sweden)

Anna Antonovna Anfinogentova

2017-06-01

Full Text Available The article is devoted to the research and development of quality evaluation methods of agro-industrial enterprises activity in the regional economy with the use of the ecological approach. The hypothesis of the study is that the activity of the economic entities (as well as of agribusiness must be assessed not only in the context of economic efficiency and effectiveness, but also in the context of environmental ethics and environmental aggression. As the initial data, we have used the indicators of economic statistics of Russian agrarian-oriented regions, as well as the data received from management reporting on the sample of enterprises of three regions (the Belgorod and Moscow regions, Krasnodar Territory. The article offers the economic and mathematical approach for measuring the level of the environmental responsibility of agro-industrial enterprises on the basic formula of the Mandelbrot set and statistical indicator of Hurst. Our scientific contribution is the development of a modified methodology for assessing the quality of the activity of agro-industrial enterprises using the parameter characterizing the level of environmental ethics and environmental aggression of these entities. The main result of the study is the approbation of the method, which has shown its practical applicability and relative coherence with certain indicators of regional ecological statistics. The proposed method is characterized by the integration of the different mathematical approaches and as an adaptive assessment tool that can be used to assess the quality of the activity of both agro-industrial enterprises and enterprises of other industries and fields of the economy. In the further works, the authors plan to develop methodological approaches to the assessment of the quality of agro-industrial products. At the same time, the main attention will be paid to the ecological and social component of the quality.

Reported challenges in nurse-led randomised controlled trials

DEFF Research Database (Denmark)

Wang Vedelø, Tina; Lomborg, Kirsten

2011-01-01

Aims: The purpose of this integrative literature review was to explore and discuss the methodological challenges nurse researchers report after conducting nurse-led randomised controlled trials in clinical hospital settings. Our research questions were (i) what are the most commonly experienced...... and the clinical nursing staff. Two lessons learned from this integrative review can be highlighted. First, we recommend researchers openly to share their experiences of barriers and challenges. They should describe factors that may have inhibited the desired outcome. Second, efforts to improve the collaboration...... between nurse researchers and clinicians, including education, training and support may increase the success rate and quality of nurse-led studies using the randomised controlled trial....

CONSORT 2010 Explanation and Elaboration: Updated guidelines for reporting parallel group randomised trials

DEFF Research Database (Denmark)

Moher, David; Hopewell, Sally; Schulz, Kenneth F

2010-01-01

Overwhelming evidence shows the quality of reporting of randomised controlled trials (RCTs) is not optimal. Without transparent reporting, readers cannot judge the reliability and validity of trial findings nor extract information for systematic reviews. Recent methodological analyses indicate...... that inadequate reporting and design are associated with biased estimates of treatment effects. Such systematic error is seriously damaging to RCTs, which are considered the gold standard for evaluating interventions because of their ability to minimise or avoid bias. A group of scientists and editors developed......, this revised explanatory and elaboration document, and the associated website (www.consort-statement.org) should be helpful resources to improve reporting of randomised trials....

Randomized trials and quality assurance in gastric cancer surgery.

Science.gov (United States)

Dikken, Johan L; Cats, Annemieke; Verheij, Marcel; van de Velde, Cornelis J H

2013-03-01

A D2 lymphadenectomy can be considered standard of surgical care for advanced resectable gastric cancer. Currently, several multimodality strategies are used, including postoperative monochemotherapy in Asia, postoperative chemoradiotherapy in the United States, and perioperative chemotherapy in Europe. As the majority of gastric cancer patients are treated outside the framework of clinical trials, quality assurance programs, including referral to high-volume centers and clinical auditing are needed to improve gastric cancer care on a nationwide level. Copyright © 2012 Wiley Periodicals, Inc.

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

Science.gov (United States)

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.

Science.gov (United States)

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.

Disseminating quality improvement: study protocol for a large cluster-randomized trial

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French Michael T

2011-04-01

Full Text Available Abstract Background Dissemination is a critical facet of implementing quality improvement in organizations. As a field, addiction treatment has produced effective interventions but disseminated them slowly and reached only a fraction of people needing treatment. This study investigates four methods of disseminating quality improvement (QI to addiction treatment programs in the U.S. It is, to our knowledge, the largest study of organizational change ever conducted in healthcare. The trial seeks to determine the most cost-effective method of disseminating quality improvement in addiction treatment. Methods The study is evaluating the costs and effectiveness of different QI approaches by randomizing 201 addiction-treatment programs to four interventions. Each intervention used a web-based learning kit plus monthly phone calls, coaching, face-to-face meetings, or the combination of all three. Effectiveness is defined as reducing waiting time (days between first contact and treatment, increasing program admissions, and increasing continuation in treatment. Opportunity costs will be estimated for the resources associated with providing the services. Outcomes The study has three primary outcomes: waiting time, annual program admissions, and continuation in treatment. Secondary outcomes include: voluntary employee turnover, treatment completion, and operating margin. We are also seeking to understand the role of mediators, moderators, and other factors related to an organization's success in making changes. Analysis We are fitting a mixed-effect regression model to each program's average monthly waiting time and continuation rates (based on aggregated client records, including terms to isolate state and intervention effects. Admissions to treatment are aggregated to a yearly level to compensate for seasonality. We will order the interventions by cost to compare them pair-wise to the lowest cost intervention (monthly phone calls. All randomized sites

Criteria for designing an MRI quality assurance program. A multicenter trial

International Nuclear Information System (INIS)

Mascaro, L.; Baldassarri, A.M.

1999-01-01

The authors report the preliminary results of a multicenter trial aimed at defining methods, reference values and frequency of measurements for a magnetic resonance quality assurance program. In particular, they stress the definition of two attention levels (investigation and intervention) for image uniformity and signal-to-noise ratio (SNR) by means short-and long-term measurements [it

Health-related quality of life after laparoscopic and open surgery for rectal cancer in a randomized trial

DEFF Research Database (Denmark)

Andersson, J; Angenete, E; Gellerstedt, M

2013-01-01

Previous studies comparing laparoscopic and open surgical techniques have reported improved health-related quality of life (HRQL). This analysis compared HRQL 12¿months after laparoscopic versus open surgery for rectal cancer in a subset of a randomized trial.......Previous studies comparing laparoscopic and open surgical techniques have reported improved health-related quality of life (HRQL). This analysis compared HRQL 12¿months after laparoscopic versus open surgery for rectal cancer in a subset of a randomized trial....

METHODOLOGY OF DETERMINATION OF QUALITY INDEX OF MAINTENANCE SERVICE SYSTEM OF POWER EQUIPMENT OF TRACTION SUBSTATIONS

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O.O. Matusevych

2016-03-01

Full Text Available Purpose. The purpose of this paper is development of methodology for definition of a quality system of maintenance and repair (M and P power equipment of traction substations (TS of electrified railways operating under conditions of uncertainty based on expert information. Methodology. The basic tenets of the theory of fuzzy sets and marks, linguistic and interval estimates of experts were applied to solve this problem. Results. Analysis of the existing diversity of approaches to development of modern methods of improvement of M and P allows us to conclude that the improvement in the quality of the system is achieved by solving individual problems increase the operational reliability of power equipment of traction substations in the following main interrelated areas. There are technical, economic and organizational. The basis of the quality evaluation system is initial data and expertise developed version of the document formalized quality evaluation of electrical equipment of traction substations by experts. The choice of determining the level of Quality service system based on the marks, linguistic and interval estimates of experts, which are reflected in quantitative and / or qualitative form was done. The possible options for expert data presentation and their corresponding quantitative methods of calculating the integral index of quality improvement system maintenance and P of traction substations were described. The methodology and the method of assessing the quality of system maintenance and P of TS allows quickly respond to changing operating conditions of power equipment of traction substations, and to determine the most effective strategies for maintenance of electrical and P TS under conditions of uncertainty functioning distance electricity. Originality. The method of a systematic approach to improve the quality of the system maintenance and P of power equipment of traction substation under conditions of uncertainty based on expert

Recent methodological advances in male hormonal contraception.

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Liu, Peter Y; Swerdloff, Ronald S; Wang, Christina

2010-11-01

Landmark WHO-sponsored trials showed decades ago that male hormonal contraception (MHC) is an effective male-directed contraceptive approach. Considerable progress has been made particularly in the last 5 years, establishing for the first time the reversibility of MHC and its short-term safety. Methodological advances in recent years include the pooling of information and individual-level integrated analysis; the first-time use of centralized semen analysis and fluorescence to detect low sperm concentrations; the establishment of sperm quality reference ranges in fertile men; the measurement of blood steroid concentrations by gas chromatography/mass spectrometry; and the inclusion of placebo groups to delineate clearly possible adverse effects of androgens and progestins in men. We report integrated analyses of factors that are important in predicting suppression and recovery of spermatogenesis after MHC clinical trials for the past 15 years. These are the best data available and will provide guidance and reassurance for the larger-scale Phase III specific regimen efficacy studies that will be required to bring MHC to the population (market). Copyright © 2010 Elsevier Inc. All rights reserved.

Update on TROG trials

International Nuclear Information System (INIS)

Joseph, D.

2001-01-01

Full text: Validation of treatment methodologies can only be achieved in the context of unambiguous, efficiently managed, randomised and controlled clinical trials. Since 1991, the Trans-Tasman Radiation Oncology Group (TROG) has coordinated over 29 protocols in radiation oncology, including several key randomised controlled trials. The impetus behind TROG is the establishment of an evidence base for particular approaches to radiotherapy and its adjunct use with alternative and complementary treatment methods. As the level of technology incorporated into radiotherapy continues to increase, as the need for improved accuracy in dose assessment increases and as the requirements of realistic quality assurance (QA) for clinical trials becomes more demanding it is imperative that all professionals involved in radiotherapy, including physicists, become actively involved in the QA of trials. This is particularly important for large scale multi-centre trials which intend to prove the benefits of particular treatment approaches on a national or international stage rather then in the context of a single clinic. This talk will: 1. Examine the outcomes of TROG trials to date in terms of the information obtained. 2. Briefly consider current and impending TROG trials and their requirements in terms of clinical and physics input. 3. Examine the results of international clinical trials in terms of the influence they have had on radiotherapy practice and health outcomes, and the advantages they have obtained by consistent co-operation between clinical and technological staff. 4. Consider the benefits of multi-centre clinical trials and the QA controls that are necessary to ensure accuracy of resulting recommendations. Copyright (2001) Australasian College of Physical Scientists and Engineers in Medicine

Quality control for digital mammography: Part II recommendations from the ACRIN DMIST trial

International Nuclear Information System (INIS)

Yaffe, Martin J.; Bloomquist, Aili K.; Mawdsley, Gordon E.

2006-01-01

The Digital Mammography Imaging Screening Trial (DMIST), conducted under the auspices of the American College of Radiology Imaging Network (ACRIN), is a clinical trial designed to compare the accuracy of digital versus screen-film mammography in a screening population [E. Pisano et al., ACRIN 6652--Digital vs. Screen-Film Mammography, ACRIN (2001)]. Part I of this work described the Quality Control program developed to ensure consistency and optimal operation of the digital equipment. For many of the tests, there were no failures during the 24 months imaging was performed in DMIST. When systems failed, they generally did so suddenly rather than through gradual deterioration of performance. In this part, the utility and effectiveness of those tests are considered. This suggests that after verification of proper operation, routine extensive testing would be of minimal value. A recommended set of tests is presented including additional and improved tests, which we believe meet the intent and spirit of the Mammography Quality Standards Act regulations to ensure that full-field digital mammography systems are functioning correctly, and consistently producing mammograms of excellent image quality

Economic evidence for the clinical management of major depressive disorder: a systematic review and quality appraisal of economic evaluations alongside randomised controlled trials.

Science.gov (United States)

Karyotaki, E; Tordrup, D; Buntrock, C; Bertollini, R; Cuijpers, P

2017-10-01

The aim of this systematic review of economic evaluations alongside randomised controlled trials (RCTs) was to provide a comprehensive overview of the evidence concerning cost-effectiveness analyses of common treatment options for major depression. An existing database was used to identify studies reporting cost-effectiveness results from RCTs. This database has been developed by a systematic literature search in the bibliographic databases of PubMed, PsychINFO, Embase and Cochrane library from database inception to December 2014. We evaluated the quality of economic evaluations using a 10-item short version of the Drummond checklist. Results were synthesised narratively. The risk of bias of the included RCTs was assessed, based on the Cochrane risk of bias assessment tool. Fourteen RCTs were included from the 5580 articles screened on titles and abstracts. The methodological quality of the health economic evaluations was relatively high and the majority of the included RCTs had low risk of bias in most of Cochrane items except blinding of participants and personnel. Cognitive behavioural therapy was examined in seven trials as part of a variety of treatment protocols and seems cost-effective compared with pharmacotherapy in the long-term. However cost-effectiveness results for the combination of psychotherapy with pharmacotherapy are conflicting and should be interpreted with caution due to limited comparability between the examined trials. For several treatments, only a single economic evaluation was reported as part of a clinical trial. This was the case for comparisons between different classes of antidepressants, for several types of psychotherapy (behavioural activation, occupational therapy, interpersonal psychotherapy, short-term psychotherapy, psychodynamic psychotherapy, rational emotive behavioural therapy, solution focused therapy), and for transcranial magnetic stimulation v. electroconvulsive therapy. The limited evidence base for these interventions

Routine administration of standardized questionnaires that assess aspects of patients quality of life in medical oncology clinics: A systematic review

International Nuclear Information System (INIS)

Alsaleh, Kh.

2013-01-01

Purpose: Increasing interest in the Quality of Life outcomes in cancer patients led to increase implementation of their use in routine clinical practice. The aim of this systemic review is to review the scientific evidence behind recommending the use of quality of life (QoL) scales routinely in outpatient evaluation. Methods: Systematic review for all published randomized controlled trials in English language between January 1, 1990 till December 31, 2012. Out of 487 articles (476 identified by electronic search + 11 articles identified by manual search), six trials satisfied the eligibility criteria: (1) the study was a randomized controlled trial (RCT) with randomization of patients or health care providers; (2) the findings of the administered questionnaire or scale (the intervention) were given to health care provider, and compared to standard care with no questionnaire administered (the control); (3) study was conducted in outpatient oncology clinics; and (4) an outcome was measured that related to (i) QoL improvement, (ii) reduction in morbidity, (iii) reduction in stress for the patients, (iv) improvement in communication between patients and health care provider, or (v) improved patient satisfaction. Assessment for the quality of the study was done using the GRADE methodology. Results: Serious methodological issues were affecting most of the trials. Overall the evaluation of the quality of the evidence from these identified trials suggests that there is a weak recommendation to use QoL scales in routine oncology practice to improve communication between physicians and patients. Conclusion: The routine use of such tools in the outpatient settings at improving the patient outcome or satisfaction cannot be recommended based on the available evidence. The potential harm with the excess use of resources needed to implement, collect, store, analyse, and present such data to health care providers should be also considered. Further research and better designed

Efficacy of hydrotherapy in fibromyalgia syndrome--a meta-analysis of randomized controlled clinical trials.

Science.gov (United States)

Langhorst, Jost; Musial, Frauke; Klose, Petra; Häuser, Winfried

2009-09-01

To systematically review the efficacy of hydrotherapy in FM syndrome (FMS). We screened MEDLINE, PsychInfo, EMBASE, CAMBASE and CENTRAL (through December 2008) and the reference sections of original studies and systematic reviews on hydrotherapy in FMS. Randomized controlled trials (RCTs) on the treatment of FMS with hydrotherapy (spa-, balneo- and thalassotherapy, hydrotherapy and packing and compresses) were analysed. Methodological quality was assessed by the van Tulder score. Effects were summarized using standardized mean differences (SMDs). Ten out of 13 RCTs with 446 subjects, with a median sample size of 41 (range 24-80) and a median treatment time of 240 (range 200-300) min, were included into the meta-analysis. Only three studies had a moderate quality score. There was moderate evidence for reduction of pain (SMD -0.78; 95% CI -1.42, -0.13; P hydrotherapy has short-term beneficial effects on pain and HRQOL in FMS patients. There is a risk to over-estimate the effects of hydrotherapy due to methodological weaknesses of the studies and to small trials included in meta-analysis.

Is mindfulness research methodology improving over time? A systematic review.

Directory of Open Access Journals (Sweden)

Simon B Goldberg

Full Text Available Despite an exponential growth in research on mindfulness-based interventions, the body of scientific evidence supporting these treatments has been criticized for being of poor methodological quality.The current systematic review examined the extent to which mindfulness research demonstrated increased rigor over the past 16 years regarding six methodological features that have been highlighted as areas for improvement. These feature included using active control conditions, larger sample sizes, longer follow-up assessment, treatment fidelity assessment, and reporting of instructor training and intent-to-treat (ITT analyses.We searched PubMed, PsychInfo, Scopus, and Web of Science in addition to a publically available repository of mindfulness studies.Randomized clinical trials of mindfulness-based interventions for samples with a clinical disorder or elevated symptoms of a clinical disorder listed on the American Psychological Association's list of disorders with recognized evidence-based treatment.Independent raters screened 9,067 titles and abstracts, with 303 full text reviews. Of these, 171 were included, representing 142 non-overlapping samples.Across the 142 studies published between 2000 and 2016, there was no evidence for increases in any study quality indicator, although changes were generally in the direction of improved quality. When restricting the sample to those conducted in Europe and North America (continents with the longest history of scientific research in this area, an increase in reporting of ITT analyses was found. When excluding an early, high-quality study, improvements were seen in sample size, treatment fidelity assessment, and reporting of ITT analyses.Taken together, the findings suggest modest adoption of the recommendations for methodological improvement voiced repeatedly in the literature. Possible explanations for this and implications for interpreting this body of research and conducting future studies are

External quality assurance of malaria nucleic acid testing for clinical trials and eradication surveillance.

Science.gov (United States)

Murphy, Sean C; Hermsen, Cornelus C; Douglas, Alexander D; Edwards, Nick J; Petersen, Ines; Fahle, Gary A; Adams, Matthew; Berry, Andrea A; Billman, Zachary P; Gilbert, Sarah C; Laurens, Matthew B; Leroy, Odile; Lyke, Kristen E; Plowe, Christopher V; Seilie, Annette M; Strauss, Kathleen A; Teelen, Karina; Hill, Adrian V S; Sauerwein, Robert W

2014-01-01

Nucleic acid testing (NAT) for malaria parasites is an increasingly recommended diagnostic endpoint in clinical trials of vaccine and drug candidates and is also important in surveillance of malaria control and elimination efforts. A variety of reported NAT assays have been described, yet no formal external quality assurance (EQA) program provides validation for the assays in use. Here, we report results of an EQA exercise for malaria NAT assays. Among five centers conducting controlled human malaria infection trials, all centers achieved 100% specificity and demonstrated limits of detection consistent with each laboratory's pre-stated expectations. Quantitative bias of reported results compared to expected results was generally Quality Assessment program that fulfills the need for EQA of malaria NAT assays worldwide.

Application of Six Sigma Using DMAIC Methodology in the Process of Product Quality Control in Metallurgical Operation

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Girmanová Lenka

2017-12-01

Full Text Available The Six Sigma DMAIC can be considered a guide for problem solving and product or process improvement. The majority of companies start to implement Six Sigma using the DMAIC methodology. The paper deals with application of Six Sigma using the DMAIC methodology in the process of product quality control. The case study is oriented on the field of metallurgical operations. The goal of the Six Sigma project was to ensure the required metallurgic product quality and to avoid an increase in internal costs associated with poor product quality. In this case study, a variety of tools and techniques like flow chart, histogram, Pareto diagram, analysis of FMEA (Failure Mode and Effect Analysis data, cause and effect diagram, logical analysis was used. The Sigma level has improved by approximately 13%. The achieved improvements have helped to reduce the quantity of defective products and the processing costs (technology for re-adjusting. Benefits resulting from the DMAIC implementation can be divided into three levels: the qualitative, economic and safety level.

THE QUALITY IMPROVEMENT OF PRIMER PACKAGING PROCESS USING SIX SIGMA METHODOLOGY

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Prima Ditahardiyani

2008-01-01

Full Text Available The implementation of Six Sigma has become a common theme in many organizations. This paper presents the Six Sigma methodology and its implementation in a primer packaging process of Cranberry drink. DMAIC (Define, Measure, Analyze, Improve and Control approach is used to analyze and to improve the primer packaging process, which have high variability and defects output. After the improvement, the results showed that there was an increasing sigma level. However, it is not significantly and has not achieved the world standard quality, yet. Therefore, the implementation of Six Sigma in primer packaging process of Cranberry drink still has a room for doing a further research.

[On-site quality control of acupuncture randomized controlled trial: design of content and checklist of quality control based on PICOST].

Science.gov (United States)

Li, Hong-Jiao; He, Li-Yun; Liu, Zhi-Shun; Sun, Ya-Nan; Yan, Shi-Yan; Liu, Jia; Zhao, Ye; Liu, Bao-Yan

2014-02-01

To effectively guarantee quality of randomized controlld trial (RCT) of acupuncture and develop reasonable content and checklist of on-site quality control, influencing factors on quality of acupuncture RCT are analyzed and scientificity of quality control content and feasibility of on-site manipulation are put into overall consideration. Based on content and checklist of on-site quality control in National 11th Five-Year Plan Project Optimization of Comprehensive Treatment Plan for TCM in Prevention and Treatment of Serious Disease and Clinical Assessment on Generic Technology and Quality Control Research, it is proposed that on-site quality control of acupuncture RCT should be conducted with PICOST (patient, intervention, comparison, out come, site and time) as core, especially on quality control of interveners' skills and outcome assessment of blinding, and checklist of on-site quality control is developed to provide references for undertaking groups of the project.

Methodology for oversizing marginal quality riprap for erosion control at uranium mill tailings sites

International Nuclear Information System (INIS)

Staub, W.P.; Abt, S.R.

1987-01-01

Properly selected and oversized local sources of riprap may provide superior erosion protection compared with revegetation at a number of uranium mill tailings sites in arid regions of the United States. Whereas highly durable rock is appropriate for protecting diversion channels to the height of the 5-year flood, marginal quality rock may be adequate for protecting infrequently flooded side slopes of diversion channels, tailings embankments and caps. Marginal quality rock may require oversizing to guarantee that design size specifications are met at the end of the performance period (200 to 1000 years). This paper discusses a methodology for oversizing marginal quality rock. Results of cyclic freezing and thawing tests are used to determine oversizing requirements as functions of the performance period and environment. Test results show that marginal quality rock may be used in frequently saturated areas but in some cases oversizing will be substantial and in other cases marginal quality rock may be disqualified. Oversizing of marginal quality rock appears to be a practical reality in occasionally saturated areas (between the 5-year and 100-year floods). Furthermore, oversizing will not generally be required on slopes from the 100-year flood. 6 refs., 4 tabs

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

Science.gov (United States)

2012-01-01

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

Evidence for efficacy of acute treatment of episodic tension-type headache: methodological critique of randomised trials for oral treatments.

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Moore, R Andrew; Derry, Sheena; Wiffen, Philip J; Straube, Sebastian; Bendtsen, Lars

2014-11-01

The International Headache Society (IHS) provides guidance on the conduct of trials for acute treatment of episodic tension-type headache (TTH), a common disorder with considerable disability. Electronic and other searches identified randomised, double-blind trials of oral drugs treating episodic TTH with moderate or severe pain at baseline, or that tested drugs at first pain onset. The aims were to review methods, quality, and outcomes reported (in particular the IHS-recommended primary efficacy parameter pain-free after 2 hours), and to assess efficacy by meta-analysis. We identified 58 reports: 55 from previous reviews and searches, 2 unpublished reports, and 1 clinical trial report with results. We included 40 reports of 55 randomised trials involving 12,143 patients. Reporting quality was generally good, with potential risk of bias from incomplete outcome reporting and small size; the 23 largest trials involved 82% of patients. Few trials reported IHS outcomes. The number needed to treat values for being pain-free at 2 hours compared with placebo were 8.7 (95% confidence interval [CI] 6.2 to 15) for paracetamol 1000 mg, 8.9 (95% CI 5.9 to 18) for ibuprofen 400mg, and 9.8 (95% CI 5.1 to 146) for ketoprofen 25mg. Lower (better) number needed to treat values were calculated for outcomes of mild or no pain at 2 hours, and patient global assessment. These were similar to values for these drugs in migraine. No other drugs had evaluable results for these patient-centred outcomes. There was no evidence that any one outcome was better than others. The evidence available for treatment efficacy is small in comparison to the size of the clinical problem. Copyright © 2014 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.

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

Science.gov (United States)

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

Target for improvement: a cluster randomised trial of public involvement in quality-indicator prioritisation (intervention development and study protocol

Directory of Open Access Journals (Sweden)

Burgers Jako

2011-05-01

Full Text Available Abstract Background Public priorities for improvement often differ from those of clinicians and managers. Public involvement has been proposed as a way to bridge the gap between professional and public clinical care priorities but has not been studied in the context of quality-indicator choice. Our objective is to assess the feasibility and impact of public involvement on quality-indicator choice and agreement with public priorities. Methods We will conduct a cluster randomised controlled trial comparing quality-indicator prioritisation with and without public involvement. In preparation for the trial, we developed a 'menu' of quality indicators, based on a systematic review of existing validated indicator sets. Participants (public representatives, clinicians, and managers will be recruited from six participating sites. In intervention sites, public representatives will be involved through direct participation (public representatives, clinicians, and managers will deliberate together to agree on quality-indicator choice and use and consultation (individual public recommendations for improvement will be collected and presented to decision makers. In control sites, only clinicians and managers will take part in the prioritisation process. Data on quality-indicator choice and intended use will be collected. Our primary outcome will compare quality-indicator choice and agreement with public priorities between intervention and control groups. A process evaluation based on direct observation, videorecording, and participants' assessment will be conducted to help explain the study's results. The marginal cost of public involvement will also be assessed. Discussion We identified 801 quality indicators that met our inclusion criteria. An expert panel agreed on a final set of 37 items containing validated quality indicators relevant for chronic disease prevention and management in primary care. We pilot tested our public-involvement intervention with 27

Revisiting the Quality of Reporting Randomized Controlled Trials in Nursing Literature.

Science.gov (United States)

Adams, Yenupini Joyce; Kamp, Kendra; Liu, Cheng Ching; Stommel, Manfred; Thana, Kanjana; Broome, Marion E; Smith, Barbara

2018-03-01

To examine and update the literature on the quality of randomized controlled trials (RCTs) as reported in top nursing journals, based on manuscripts' adherence to the CONsolidated Standards of Reporting Trials (CONSORT) guidelines. Descriptive review of adherence of RCT manuscript to CONSORT guidelines. Top 40 International Scientific Indexing (ISI) ranked nursing journals that published 20 or more RCTs between 2010 and 2014, were included in the study. Selected articles were randomly assigned to four reviewers who assessed the quality of the articles using the CONSORT checklist. Data were analyzed using descriptive and inferential statistics. A total of 119 articles were included in the review. The mean CONSORT score significantly differed by journal but did not differ based on year of publication. The least consistently reported items included random allocation, who randomly assigned participants and whether those administering the interventions were blinded to group assignment. Although progress has been made, there is still room for improvement in the quality of RCT reporting in nursing journals. Special attention must be paid to how adequately studies adhere to the CONSORT prior to publication in nursing journals. Evidence from (RCTs) are thought to provide the best evidence for evaluating the impact of treatments and interventions by the U.S. Preventive Services Task Force. Since the evidence may be used for the development of clinical practice guidelines, it is critical that RCTs be designed, conducted, and reported appropriately and precisely. © 2017 Sigma Theta Tau International.

Methodological characteristics and treatment effect sizes in oral health randomised controlled trials: Is there a relationship? Protocol for a meta-epidemiological study.

Science.gov (United States)

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

2014-02-25

It is fundamental that randomised controlled trials (RCTs) are properly conducted in order to reach well-supported conclusions. However, there is emerging evidence that RCTs are subject to biases which can overestimate or underestimate the true treatment effect, due to flaws in the study design characteristics of such trials. The extent to which this holds true in oral health RCTs, which have some unique design characteristics compared to RCTs in other health fields, is unclear. As such, we aim to examine the empirical evidence quantifying the extent of bias associated with methodological and non-methodological characteristics in oral health RCTs. We plan to perform a meta-epidemiological study, where a sample size of 60 meta-analyses (MAs) including approximately 600 RCTs will be selected. The MAs will be randomly obtained from the Oral Health Database of Systematic Reviews using a random number table; and will be considered for inclusion if they include a minimum of five RCTs, and examine a therapeutic intervention related to one of the recognised dental specialties. RCTs identified in selected MAs will be subsequently included if their study design includes a comparison between an intervention group and a placebo group or another intervention group. Data will be extracted from selected trials included in MAs based on a number of methodological and non-methodological characteristics. Moreover, the risk of bias will be assessed using the Cochrane Risk of Bias tool. Effect size estimates and measures of variability for the main outcome will be extracted from each RCT included in selected MAs, and a two-level analysis will be conducted using a meta-meta-analytic approach with a random effects model to allow for intra-MA and inter-MA heterogeneity. The intended audiences of the findings will include dental clinicians, oral health researchers, policymakers and graduate students. The aforementioned will be introduced to the findings through workshops, seminars, round

CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials (Chinese version)

DEFF Research Database (Denmark)

Moher, David; Hopewell, Sally; Schulz, Kenneth F

2010-01-01

Overwhelming evidence shows the quality of reporting of randomised controlled trials (RCTs) is not optimal. Without transparent reporting, readers cannot judge the reliability and validity of trial findings nor extract information for systematic reviews. Recent methodological analyses indicate...... that inadequate reporting and design are associated with biased estimates of treatment effects. Such systematic error is seriously damaging to RCTs, which are considered the gold standard for evaluating interventions because of their ability to minimise or avoid bias. A group of scientists and editors developed......, this revised explanatory and elaboration document, and the associated website (www.consort-statement.org) should be helpful resources to improve reporting of randomised trials....

The HAZOP methodology applied to the study of the quality and the productivity

International Nuclear Information System (INIS)

Angel G, J.C.

1996-01-01

This article makes reference to an adaptation of the method HAZOP, used in Administration of Risks, to the study and solution of problems related with the quality and the productivity of matters cousins, processes, products and services. The described methodology, it is based in the definition of, intentions, or objectives for each part of the process, sub-process, product or service, with the purpose of finding, deviations, or problems of quality or productivity with the use of words g uide . It thinks about that each deviation should be analyzed for the determination of its causes and consequences, with the purpose of defining the corrective pertinent actions. The work of interdisciplinary groups intends as an unavoidable requirement, the same as the will of its members to make the things better every day

Total glucosides of paeony for rheumatoid arthritis: A systematic review of randomized controlled trials.

Science.gov (United States)

Luo, Jing; Jin, Di-Er; Yang, Guo-Yan; Zhang, Ying-Ze; Wang, Jian-Ming; Kong, Wei-Ping; Tao, Qing-Wen

2017-10-01

Total glucosides of paeony (TGP) is commonly used to treat rheumatoid arthritis (RA) in China. However, clinical practice hasn't been well informed by evidence from appropriately conducted systematic reviews. This PRISMA-compliant systematic review aims at examining the effectiveness and safety of TGP for RA. Randomized controlled trials (RCTs) comparing TGP with placebo, no treatment, or disease-modifying antirheumatic drugs (DMARDs) for patients with RA were retrieved by searching seven databases. Primary outcomes included disease improvement and disease remission. Secondary outcomes included adverse effects, pain, health-related quality of life, C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR). Data extraction and analyses were conducted according to the Cochrane standards. We assessed risk of bias for each included studies and quality of evidence on pre-specified outcomes. Eight studies enrolling 1209 patients with active RA were included in this systematic review. On the basis of traditional DMARD(s), TGP might be beneficial for patients with RA in improvement of American College of Rheumatology (ACR) 20 response rate, ACR 50 response rate, ACR70 response rate, and in reduction of adverse effects, compared with no treatment. The overall methodological quality of included studies and the quality of evidence for each outcome were limited. Current trials suggested potential benefits of TGP for RA on the basis of traditional DMARD(s). Therefore, TGP may be a good choice for RA as an adjuvant therapy. However, considering the limited methodological quality and strength of evidence, high-quality RCTs are warranted to support the use of TGP for RA. Copyright © 2017. Published by Elsevier Ltd.

Evaluation and validation of social and psychological markers in randomised trials of complex interventions in mental health: a methodological research programme.

Science.gov (United States)

Dunn, Graham; Emsley, Richard; Liu, Hanhua; Landau, Sabine; Green, Jonathan; White, Ian; Pickles, Andrew

2015-11-01

The development of the capability and capacity to evaluate the outcomes of trials of complex interventions is a key priority of the National Institute for Health Research (NIHR) and the Medical Research Council (MRC). The evaluation of complex treatment programmes for mental illness (e.g. cognitive-behavioural therapy for depression or psychosis) not only is a vital component of this research in its own right but also provides a well-established model for the evaluation of complex interventions in other clinical areas. In the context of efficacy and mechanism evaluation (EME) there is a particular need for robust methods for making valid causal inference in explanatory analyses of the mechanisms of treatment-induced change in clinical outcomes in randomised clinical trials. The key objective was to produce statistical methods to enable trial investigators to make valid causal inferences about the mechanisms of treatment-induced change in these clinical outcomes. The primary objective of this report is to disseminate this methodology, aiming specifically at trial practitioners. The three components of the research were (1) the extension of instrumental variable (IV) methods to latent growth curve models and growth mixture models for repeated-measures data; (2) the development of designs and regression methods for parallel trials; and (3) the evaluation of the sensitivity/robustness of findings to the assumptions necessary for model identifiability. We illustrate our methods with applications from psychological and psychosocial intervention trials, keeping the technical details to a minimum, leaving the reporting of the more theoretical and mathematically demanding results for publication in appropriate specialist journals. We show how to estimate treatment effects and introduce methods for EME. We explain the use of IV methods and principal stratification to evaluate the role of putative treatment effect mediators and therapeutic process measures. These results are

The Effect of a Standardized Ginger Extract on Chemotherapy-Induced Nausea-Related Quality of Life in Patients Undergoing Moderately or Highly Emetogenic Chemotherapy: A Double Blind, Randomized, Placebo Controlled Trial.

Science.gov (United States)

Marx, Wolfgang; McCarthy, Alexandra L; Ried, Karin; McKavanagh, Dan; Vitetta, Luis; Sali, Avni; Lohning, Anna; Isenring, Elisabeth

2017-08-12

Ginger supplementation could be an effective adjuvant treatment for chemotherapy-induced nausea (CIN). The aim of this clinical trial was to address significant methodological limitations in previous trials. Patients (N = 51) were randomly allocated to receive either 1.2 g of standardised ginger extract or placebo per day, in addition to standard anti-emetic therapy, during the first three cycles of chemotherapy. The primary outcome was CIN-related quality of life (QoL) measured with the Functional Living Index- Emesis (FLIE) questionnaire. Secondary outcomes included acute and delayed nausea, vomiting, and retching as well as cancer-related fatigue, nutritional status, and CIN and vomiting-specific prognostic factors. Over three consecutive chemotherapy cycles, nausea was more prevalent than vomiting (47% vs. 12%). In chemotherapy Cycle 1, intervention participants reported significantly better QoL related to CIN ( p = 0.029), chemotherapy-induced nausea and vomiting (CINV)-related QoL ( p = 0.043), global QoL ( p = 0.015) and less fatigue ( p = 0.006) than placebo participants. There were no significant results in Cycle 2. In Cycle 3, global QoL ( p = 0.040) and fatigue ( p = 0.013) were significantly better in the intervention group compared to placebo. This trial suggests adjuvant ginger supplementation is associated with better chemotherapy-induced nausea-related quality of life and less cancer-related fatigue, with no difference in adverse effects compared to placebo.

A systematic review of randomised control trials of sexual health interventions delivered by mobile technologies.

Science.gov (United States)

Burns, Kara; Keating, Patrick; Free, Caroline

2016-08-12

Sexually transmitted infections (STIs) pose a serious public health problem globally. The rapid spread of mobile technology creates an opportunity to use innovative methods to reduce the burden of STIs. This systematic review identified recent randomised controlled trials that employed mobile technology to improve sexual health outcomes. The following databases were searched for randomised controlled trials of mobile technology based sexual health interventions with any outcome measures and all patient populations: MEDLINE, EMBASE, PsycINFO, Global Health, The Cochrane Library (Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, Cochrane Methodology Register, NHS Health Technology Assessment Database, and Web of Science (science and social science citation index) (Jan 1999-July 2014). Interventions designed to increase adherence to HIV medication were not included. Two authors independently extracted data on the following elements: interventions, allocation concealment, allocation sequence, blinding, completeness of follow-up, and measures of effect. Trials were assessed for methodological quality using the Cochrane risk of bias tool. We calculated effect estimates using intention to treat analysis. A total of ten randomised trials were identified with nine separate study groups. No trials had a low risk of bias. The trials targeted: 1) promotion of uptake of sexual health services, 2) reduction of risky sexual behaviours and 3) reduction of recall bias in reporting sexual activity. Interventions employed up to five behaviour change techniques. Meta-analysis was not possible due to heterogeneity in trial assessment and reporting. Two trials reported statistically significant improvements in the uptake of sexual health services using SMS reminders compared to controls. One trial increased knowledge. One trial reported promising results in increasing condom use but no trial reported statistically significant increases in condom

Methodology for Knowledge Synthesis of the Management of Vaccination Pain and Needle Fear.

Science.gov (United States)

Taddio, Anna; McMurtry, C Meghan; Shah, Vibhuti; Yoon, Eugene W; Uleryk, Elizabeth; Pillai Riddell, Rebecca; Lang, Eddy; Chambers, Christine T; Noel, Melanie; MacDonald, Noni E

2015-10-01

A knowledge synthesis was undertaken to inform the development of a revised and expanded clinical practice guideline about managing vaccination pain in children to include the management of pain across the lifespan and the management of fear in individuals with high levels of needle fear. This manuscript describes the methodological details of the knowledge synthesis and presents the list of included clinical questions, critical and important outcomes, search strategy, and search strategy results. The Grading of Assessments, Recommendations, Development and Evaluation (GRADE) and Cochrane methodologies provided the general framework. The project team voted on clinical questions for inclusion and critically important and important outcomes. A broad search strategy was used to identify relevant randomized-controlled trials and quasi-randomized-controlled trials. Quality of research evidence was assessed using the Cochrane risk of bias tool and quality across studies was assessed using GRADE. Multiple measures of the same construct within studies (eg, observer-rated and parent-rated infant distress) were combined before pooling. The standardized mean difference and 95% confidence intervals (CI) or relative risk and 95% CI was used to express the effects of an intervention. Altogether, 55 clinical questions were selected for inclusion in the knowledge synthesis; 49 pertained to pain management during vaccine injections and 6 pertained to fear management in individuals with high levels of needle fear. Pain, fear, and distress were typically prioritized as critically important outcomes across clinical questions. The search strategy identified 136 relevant studies. This manuscript describes the methodological details of a knowledge synthesis about pain management during vaccination and fear management in individuals with high levels of needle fear. Subsequent manuscripts in this series will present the results for the included questions.

The efficacy of laser therapy for musculoskeletal and skin disorders : A criteria-based meta-analysis of randomized clinical trials

NARCIS (Netherlands)

Beckerman, H.; De Bie, R. A.; Bouter, L. M.; De Cuyper, H. J.; Oostendorp, R. A.B.

1992-01-01

The efficacy of laser therapy for musculoskeletal and skin disorders has been assessed on the basis of the results of 36 randomized clinical trials (RCTs) involving 1,704 patients. For this purpose, a criteria-based meta- analysis that took into account the methodological quality of the individual

Economic evaluation of nurse practitioner and clinical nurse specialist roles: A methodological review.

Science.gov (United States)

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

Exercise improves quality of life in androgen deprivation therapy-treated prostate cancer: systematic review of randomised controlled trials.

Science.gov (United States)

Teleni, Laisa; Chan, Raymond J; Chan, Alexandre; Isenring, Elisabeth A; Vela, Ian; Inder, Warrick J; McCarthy, Alexandra L

2016-02-01

Men receiving androgen deprivation therapy (ADT) for prostate cancer (PCa) are likely to develop metabolic conditions such as diabetes, cardiovascular disease, abdominal obesity and osteoporosis. Other treatment-related side effects adversely influence quality of life (QoL) including vasomotor distress, depression, anxiety, mood swings, poor sleep quality and compromised sexual function. The objective of this study was to systematically review the nature and effects of dietary and exercise interventions on QoL, androgen deprivation symptoms and metabolic risk factors in men with PCa undergoing ADT. An electronic search of CINAHL, CENTRAL, Medline, PsychINFO and reference lists was performed to identify peer-reviewed articles published between January 2004 and December 2014 in English. Eligible study designs included randomised controlled trials (RCTs) with pre- and post-intervention data. Data extraction and assessment of methodological quality with the Cochrane approach was conducted by two independent reviewers. Seven exercise studies were identified. Exercise significantly improved QoL, but showed no effect on metabolic risk factors (weight, waist circumference, lean or fat mass, blood pressure and lipid profile). Two dietary studies were identified, both of which tested soy supplements. Soy supplementation did not improve any outcomes. No dietary counselling studies were identified. No studies evaluated androgen-deficiency symptoms (libido, erectile function, sleep quality, mood swings, depression, anxiety and bone mineral density). Evidence from RCTs indicates that exercise enhances health- and disease-specific QoL in men with PCa undergoing ADT. Further studies are required to evaluate the effect of exercise and dietary interventions on QoL, androgen deprivation symptoms and metabolic risk factors in this cohort. © 2016 Society for Endocrinology.

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

DEFF Research Database (Denmark)

Cassis, Linda; Cortès-Saladelafont, Elisenda; Molero-Luis, Marta

2015-01-01

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...

Quality Assurance in Trichiasis Surgery: a methodology

Science.gov (United States)

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

Quality assurance in trichiasis surgery: a methodology.

Science.gov (United States)

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

2011-03-01

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 focused on 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. The authors 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 retraining.

Quality assurance in head and neck surgical oncology: EORTC 24954 trial on larynx preservation.

Science.gov (United States)

Leemans, C R; Tijink, B M; Langendijk, J A; Andry, G; Hamoir, M; Lefebvre, J L

2013-09-01

The Head and Neck Cancer Group (HNCG) of the EORTC conducted a quality assurance program in the EORTC 24954 trial on larynx preservation. In this multicentre study, patients with resectable advanced squamous cell carcinoma of the larynx or hypopharynx were randomly assigned for treatment with sequential or alternating chemoradiation. The need for a quality assurance program is the evaluation and prevention of differences in treatments between centres in this multidisciplinary study. The surgical subcommittee of the HNCG prepared a questionnaire, and clinical records of all patients were verified during audits of independent teams. Data relating institutional practices were collected during a face to face interview with members of the local team. 271 clinical records from the nine main contributing centres were reviewed. The main difference between centres was the time interval between first consultation and treatment initiation, with a mean of 45 days. On the pathology report the nodal involvement was described by level in 36% of the cases according to the American Academy of Otolaryngology-Head and Neck Surgery classification. Extranodal spread was not always described in neck dissection specimens. The EORTC 24954 trial on larynx preservation was the first prospective trial with a quality assurance program in head and neck surgical oncology. The analysis shows similarities in practices, but also points out some important differences between centres. Operation reports were fairly complete, but uniformity in pathology reports should be improved. Copyright © 2013 Elsevier Ltd. All rights reserved.

The implementation of the Quality Costs Methodology in the Public Transport Enterprise in Macedonia

Directory of Open Access Journals (Sweden)

Elizabeta Mitreva

2017-02-01

Full Text Available The implementation of TQM (Total Quality Management strategy in the public transport enterprises in Macedonia means improving the quality of services through examination of business processes not just in terms of defining, improvement and design of the process, but also improvement of productivity and optimization of the costs of quality. The purpose of this study is to point out the importance of determining the quality of the transport services, its methods, and techniques for measurement of the optimization of business processes in particular. The analysis of the quality costs when providing transport services can help managers to understand the impact of poor quality on the financial results and the bad image it gives to the enterprise. In this study, we proposed and applied the model for better performance and higher efficiency of the transport enterprise, through the optimization of business processes, change in the corporate culture and use of the complete business potentials. The need for this methodology was imposed as a result of the analysis made in the company in terms of whether is it doing an analysis on the costs of quality or not. The benefits from the utilization of this model will not only lead to increasing the business performance of the transport enterprise, but this model will also serve as a driving force for continuous improvements to the satisfaction of all stakeholders.

The relation between quality of clinical trials and acupuncture efficacy

Directory of Open Access Journals (Sweden)

David Gonçalves Nordon

2013-06-01

Full Text Available Introduction: Clinical trials of acupuncture not always have concordant results, mostly due to their great heterogeneity. Two indexes have been developed to analyze the quality of acupuncture trials. This study hypothesizes that, the more adequate the intervention and the control techniques, the more efficacious the acupuncture. Methods: Both indexes were applied to 27 randomized clinical trials comparing acupuncture to placebo. Results were compared by using the Mann-Whitney test. Results: Studies favorable to acupuncture had a intervention score’s median of 11.5; for the unfavorable ones, it was 7, p: 0.0017. Articles with and without statistically significant differences, though, had the same median for their scores in the control index: 6. Discussion: There is a positive relation between a better score for acupuncture technique and a statistically significant difference between acupuncture and interventional control. However, due to the little heterogeneity in the degree of physiological effect from each article, the control index had no statistical significance. Conclusion: This study established that, among acupuncture RCT controlled by placebo or sham of moderate physiological effect, the adequacy of the technique is more important than the adequacy of control in establishing a statistically significant difference between acupuncture and interventional control.

[Evaluation of the methodological quality of the Rémic (microbiology guidelines - bacteriology and mycology) of the Société française de microbiologie].

Science.gov (United States)

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.

Microcredit and willingness to pay for environmental quality: Evidence from a randomized-controlled trial of finance for sanitation in rural Cambodia.

Science.gov (United States)

Ben Yishay, Ariel; Fraker, Andrew; Guiteras, Raymond; Palloni, Giordano; Shah, Neil Buddy; Shirrell, Stuart; Wang, Paul

2017-11-01

Low willingness to pay (WTP) for environmental quality in developing countries is a key research question in environmental economics. One explanation is that missing credit markets may suppress WTP for environmental improvements that require large up-front investments. We test the impact of microloans on WTP for hygienic latrines via a randomized controlled trial in 30 villages in rural Cambodia. We find that microcredit dramatically raises WTP for improved latrines, with 60% of households in the Financing arm willing to purchase at an unsubsidized price, relative to 25% in the Non-financing arm. Effects on latrine installation are positive but muted by several factors, including a negative peer effect: randomly induced purchases by neighbors reduce a household's probability of installing its own latrine. On methodological grounds, this paper shows that a "decision-focused evaluation" can be integrated into academic analysis to provide insight into questions of general interest.

Citation bias of hepato-biliary randomized clinical trials

DEFF Research Database (Denmark)

Kjaergard, Lise L; Gluud, Christian

2002-01-01

-1996. From each trial, we extracted the statistical significance of the primary study outcome (positive or negative), the disease area, and methodological quality (randomization and double blinding). The number of citations during two calendar years after publication was obtained from Science Citation Index....... There was a significant positive association between a statistically significant study outcome and the citation frequency (beta, 0.55, 95% confidence interval, 0.39-0.72). The disease area and adequate generation of the allocation sequence were also significant predictors of the citation frequency. We concluded...

The relationship between image quality and trial slits CT-1010

International Nuclear Information System (INIS)

Yoshinaga, Toshihiko; Nakamura, Sumio; Kakoi, Iwao; Ohkubo, Mitsuo; Tomiyoshi, Tsukasa

1980-01-01

We had used trial slits for EMI scanner CT-1010 and CT images of good quality almost free artifacts could be obtained when the slice thickness decreased to 5 mm. In this study, we experimented changes of MTF (modulation transfer function) as the slice thickness changed. As a result, MTF got worse as the slice thickness decreased, but got better as the exposure dose increased. The high accuracy high definitions of a 10 mm slice thickness and a 5 mm one were nearly equal in MTF. (author)

Meta-analysis of randomized controlled trials on cognitive effects of Bacopa monnieri extract.

Science.gov (United States)

Kongkeaw, Chuenjid; Dilokthornsakul, Piyameth; Thanarangsarit, Phurit; Limpeanchob, Nanteetip; Norman Scholfield, C

2014-01-01

Bacopa monnieri has a long history in Ayurvedic medicine for neurological and behavioral defects. To assess its efficacy in improving cognitive function. MEDLINE, EMBASE, CINAHL, AMED, Cochrane Central of clinical trial, WHO registry, Thai Medical Index, Index Medicus Siriraj library and www.clinicaltrial.gov were searched from the inception date of each database to June 2013 using scientific and common synonyms of Bacopa monnieri, cognitive performance or memory. The reference lists of retrieved articles were also reviewed. Randomized, placebo controlled human intervention trials on chronic ≥ 12 weeks dosing of standardized extracts of Bacopa monnieri without any co-medication were included in this study. The methodological quality of studies was assessed using Cochrane's risk of bias assessment and Jadad's quality scales. The weighted mean difference and 95% confidence interval (95% CI) were performed using the random-effects model of the Dersimonian-Laird method. Nine studies met the inclusion criteria using 518 subjects. Overall quality of all included trials was low risk of bias and quality of reported information was high. Meta-analysis of 437 eligible subjects showed improved cognition by shortened Trail B test (-17.9 ms; 95% CI -24.6 to -11.2; pBacopa monnieri has the potential to improve cognition, particularly speed of attention but only a large well designed 'head-to-head' trial against an existing medication will provide definitive data on its efficacy on healthy or dementia patients using a standardized preparation. © 2013 Elsevier Ireland Ltd. All rights reserved.

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

Science.gov (United States)

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.

TENS and heat therapy for pain relief and quality of life improvement in individuals with primary dysmenorrhea: A systematic review.

Science.gov (United States)

Igwea, Sylvester Emeka; Tabansi-Ochuogu, Chidinma Samantha; Abaraogu, Ukachukwu Okoroafor

2016-08-01

The present systematic review aimed to synthesize evidence for the effectiveness of TENS and heat therapy interventions from randomized trials. Six relevant databases were searched for studies on TENS and heat therapy for primary dysmenorrhea. Menstrual pain intensity and quality of life were the primary and secondary outcomes respectively. The search yielded 46 citations from which six studies on TENS and three studies on heat therapy were systematically reviewed. On the PEDRO quality scale, the trials methodological quality was 4.8 out of 10 for TENS and 6.3 out of 10 for heat therapy. TENS and heat therapy both showed evidence of pain reduction, but no study included quality of life as an outcome. Meta-analysis was not possible due to substantial heterogeneity in included studies. TENS and heat therapy show potential as adjunct remedies in the management of primary dysmenorrhea, but rigorous high quality trials are still needed to made conclusive recommendation. Copyright © 2016 Elsevier Ltd. All rights reserved.

A dietary supplement to improve the quality of sleep: a randomized placebo controlled trial

Directory of Open Access Journals (Sweden)

Claustrat Bruno

2010-06-01

Full Text Available Abstract Background To evaluate the effect of a dietary supplement containing polyunsaturated fatty acids, in association with Humulus lupulus extract, on the quality of sleep using the Leeds sleep evaluation questionnaire (LSEQ in subjects with moderate to severe sleep disorders. Methods Randomized placebo-controlled trial, in a Population-based setting. Participants were adult patients 25 to 65 years old with a chronic primary insomnia who volunteered for the study. The tested intervention consisted of two soft gelatine capsules per day, containing either the dietary supplement (active group or olive oil (placebo group for a month. Subjects could also volunteer for two ancillary studies on melatonin and actigraphy. Evaluation criteria included i perception of the quality of sleep at the end of treatment using the LSEQ questionnaire, ii sleep efficiency measured by one-week actigraphic movement measurement performed before and during the treatment in a subsample of subjects, iii night melatonin and 6 sulfatoxymelatonin (aMT6S urine rates in a subsample of subjects. Results The average of Leeds score was similar in both groups (p = 0.95. A marked improvement in the quality of sleep was observed in both placebo (62% and active (65% group (p = 0.52. The evolution of urinary melatonin, aMT6S, and of the Mel/aMT6S ratio showed no differences between the two groups. Sleep efficiency, as measured by actigraphy, improved similarly in both groups during the treatment period, from 72% to 76% and 75% in the active and placebo group respectively (p = 0.91. Conclusions The dietary supplement had neither effect on the perceived quality of sleep, nor on the melatonin metabolism and sleep-wake cycle. Trial registration: clinical trials.gov:NCT00484497

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

Science.gov (United States)

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

2016-01-01

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

The implementation methodology of Total Quality Management in health services, as a best practice operation.

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Theodora Malamou

2016-09-01

Full Text Available Total Quality Management – TQM (Total Quality Management-TQM, health services, is a modern management philosophy to improve the quality and efficiency of the organization as a whole, with the involvement of all employees, at all levels. According to the research data, the concept of quality is distinguished in technical, interpersonal quality and hotel infrastructure and focuses on patient satisfaction. The Critical success factors of TQM, organizations for business excellence in continuous competitive changing environment, is the management commitment, customer focus, constant communication with employees, encouragement and reward, education and scientific training, continuous improvement quality of service, interdependent relationships with suppliers, active employee participation, creation of representative indicators, targets and benchmarking, continuous outcome assessment and continuous review, review of program procedures. The purpose of this article is through the review of Greek and international literature, to introduce the methodology of a project TQM, to health services, as everyday best practice, with emphasis on quality of service. According to the literature review, TQM contributes to improving the quality of health services, the cultivation of team spirit, cooperation between health professionals and leadership, with a view to satisfy all. TQM is purely anthropocentric theory of organization and administration. We need comprehensive effort approach to improving the quality of leadership and the introduction of the culture of workers.

[Systematic review on methodology of randomized controlled trials of post-marketing Chinese patent drugs for treatment of type 2 diabetes].

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Ma, Li-xin; Wang, Yu-yi; Li, Xin-xue; Liu, Jian-ping

2012-03-01

Randomized controlled trial (RCT) is considered as the gold standard for the efficacy assessment of medicines. With the increasing number of Chinese patent drugs for treatment of type 2 diabetes, the methodology of post-marketing RCTs evaluating the efficacy and specific effect has become more important. To investigate post-marketing Chinese patent drugs for treatment of type 2 diabetes, as well as the methodological quality of post-marketing RCTs. Literature was searched from the books of Newly Compiled Traditional Chinese Patent Medicine and Chinese Pharmacopeia, the websites of the State Food and Drug Administration and the Ministry of Human Resources and Social Security of the People's Republic of China, China National Knowledge Infrastructure Database, Chongqing VIP Chinese Science and Technology Periodical Database, Chinese Biomedical Database (SinoMed) and Wanfang Data. The time period for searching ran from the commencement of each database to August 2011. RCTs of post-marketing Chinese patent drugs for treatment of type 2 diabetes with intervention course no less than 3 months. Two authors independently evaluated the research quality of the RCTs by the checklist of risk bias assessment and the data collection forms based on the CONSORT Statement. Independent double data-extraction was performed. The authors identified a total of 149 Chinese patent drugs for treatment of type 2 diabetes. According to different indicative syndromes, the Chinese patent drugs can be divided into the following types, namely, yin deficiency and interior heat (n=48, 32%), dual deficiency of qi and yin (n=58, 39%) and dual deficiency of qi and yin combined with blood stasis (n=22, 15%). A total of 41 RCTs meeting the inclusion criteria were included. Neither multicenter RCTs nor endpoint outcome reports were found. Risk bias analysis showed that 81% of the included studies reported randomization for grouping without sequence generation, 98% of these studies did not report

The quality of the reported sample size calculations in randomized controlled trials indexed in PubMed.

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Lee, Paul H; Tse, Andy C Y

2017-05-01

There are limited data on the quality of reporting of information essential for replication of the calculation as well as the accuracy of the sample size calculation. We examine the current quality of reporting of the sample size calculation in randomized controlled trials (RCTs) published in PubMed and to examine the variation in reporting across study design, study characteristics, and journal impact factor. We also reviewed the targeted sample size reported in trial registries. We reviewed and analyzed all RCTs published in December 2014 with journals indexed in PubMed. The 2014 Impact Factors for the journals were used as proxies for their quality. Of the 451 analyzed papers, 58.1% reported an a priori sample size calculation. Nearly all papers provided the level of significance (97.7%) and desired power (96.6%), and most of the papers reported the minimum clinically important effect size (73.3%). The median (inter-quartile range) of the percentage difference of the reported and calculated sample size calculation was 0.0% (IQR -4.6%;3.0%). The accuracy of the reported sample size was better for studies published in journals that endorsed the CONSORT statement and journals with an impact factor. A total of 98 papers had provided targeted sample size on trial registries and about two-third of these papers (n=62) reported sample size calculation, but only 25 (40.3%) had no discrepancy with the reported number in the trial registries. The reporting of the sample size calculation in RCTs published in PubMed-indexed journals and trial registries were poor. The CONSORT statement should be more widely endorsed. Copyright © 2016 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.

Chinese Herbal Medicine for Acute Mountain Sickness: A Systematic Review of Randomized Controlled Trials

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Jie Wang

2013-01-01

Full Text Available Objectives. We aimed to assess the current clinical evidence of Chinese herbal medicine for AMS. Methods. Seven electronic databases were searched until January 2013. We included randomized clinical trials testing Chinese herbal medicine against placebo, no drugs, Western drugs, or a combination of routine treatment drugs against routine treatment drugs. Study selection, data extraction, quality assessment, and data analyses were conducted according to Cochrane standards. Results. Nine randomized trials were included. The methodological quality of the included trials was evaluated as low. Two trials compared prescriptions of Chinese formula used alone with Western drugs. A meta-analysis showed a beneficial effect in decreasing the score of AMS (MD: −2.23 [−3.98, −0.49], P=0.01. Only one trial compared prescriptions of Chinese formula used alone with no drugs. A meta-analysis showed a significant beneficial effect in decreasing the score of AMS (MD: −6.00 [−6.45, −5.55], P<0.00001. Four trials compared Chinese formula used alone with placebo. A meta-analysis also showed a significant beneficial effect in decreasing the score of AMS (MD: −1.10 [−1.64, −0.55], P<0.0001. Two trials compared the combination of Chinese formula plus routine treatment drugs with routine treatment drugs. A meta-analysis showed a beneficial effect in decreasing the score of AMS (MD: −5.99 [−11.11, −0.86], P=0.02. Conclusions. No firm conclusion on the effectiveness and safety of Chinese herbal medicine for AMS can be made. More rigorous high-quality trials are required to generate a high level of evidence and to confirm the results.

Additive effects of word frequency and stimulus quality: the influence of trial history and data transformations.

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Balota, David A; Aschenbrenner, Andrew J; Yap, Melvin J

2013-09-01

A counterintuitive and theoretically important pattern of results in the visual word recognition literature is that both word frequency and stimulus quality produce large but additive effects in lexical decision performance. The additive nature of these effects has recently been called into question by Masson and Kliegl (in press), who used linear mixed effects modeling to provide evidence that the additive effects were actually being driven by previous trial history. Because Masson and Kliegl also included semantic priming as a factor in their study and recent evidence has shown that semantic priming can moderate the additivity of word frequency and stimulus quality (Scaltritti, Balota, & Peressotti, 2012), we reanalyzed data from 3 published studies to determine if previous trial history moderated the additive pattern when semantic priming was not also manipulated. The results indicated that previous trial history did not influence the joint influence of word frequency and stimulus quality. More important, and independent of Masson and Kliegl's conclusions, we also show how a common transformation used in linear mixed effects analyses to normalize the residuals can systematically alter the way in which two variables combine to influence performance. Specifically, using transformed, rather than raw reaction times, consistently produces more underadditive patterns. PsycINFO Database Record (c) 2013 APA, all rights reserved.

Quality of diets with fludized bed combustion residue treatment: II. Swine trials

Energy Technology Data Exchange (ETDEWEB)

Whitsel, T.J.; Reid, R.L.; Stout, W.L.; Hern, J.L.; Bennett, O.L.

Growing pigs (Sus scrofa domesticus) were fed for an 8-wk period in two trials on diets produced on soils treated with fluidized bed combustion residue (FBCR) or limestone. Diets contained corn (Zea mays L.) and wheat (Triticum aestivum L.) mixtures with soybean (Glycine max (L.) Merr.) meal, supplemented with vegetables, fruits, and meat. Pigs were fed ad libitum and effects of diet treatment on rate of gain, N balance, blood composition, and element composition of the carcass and organs were determined. The FBCR diet caused a decrease (P<0.05 in Trial 1, P <0.07 in Trial 2) in body weight gains of pigs, but increased (P<0.05) N retention in one trial. Blood composition was not influenced markedly by diet treatment, with small but significant differences in serum Ca, triglycerides, certain amino acids, and whole blood Pb concentrations; effects were not consistent between trials. Urinary As concentration was slightly higher for pigs on FBCR diets. Analysis of the carcass and organs of pigs slaughtered posttrial showed significant differences in element levels from those of pretrial animals, but differences in tissue mineral concentrations related to diet treatment were few and inconsistent. Element concentrations in the organs of pigs were within normal ranges. No explanation for the depression in weight gain of pigs fed FBCR-treated diets was found. Except for the weight response, results support data from other trials with laboratory animals showing no apparent adverse effects of FBCR application to soils on nutritive quality of foods. 24 refs., 1 fig., 10 tabs.

Report on Use of a Methodology for Commissioning and Quality Assurance of a VMAT System

OpenAIRE

Mayo, Charles; Fong de los Santos, Luis; Kruse, Jon; Blackwell, Charles R.; McLemore, Luke B.; Pafundi, Deanna; Stoker, Joshua; Herman, Michael

2013-01-01

INTRODUCTION: Results of use of methodology for VMAT commissioning and quality assurance, utilizing both control point tests and dosimetric measurements are presented. METHODS AND MATERIALS: A generalizable, phantom measurement approach is used to characterize the accuracy of the measurement system. Correction for angular response of the measurement system and inclusion of couch structures are used to characterize the full range gantry angles desirable for clinical plans. A dose based daily Q...

Evaluation of the coat quality of sustained release pellets by individual pellet dissolution methodology.

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Xu, Min; Liew, Celine Valeria; Heng, Paul Wan Sia

2015-01-15

This study explored the application of 400-DS dissolution apparatus 7 for individual pellet dissolution methodology by a design of experiment approach and compared its capability with that of the USP dissolution apparatus 1 and 2 for differentiating the coat quality of sustained release pellets. Drug loaded pellets were prepared by extrusion-spheronization from powder blends comprising 50%, w/w metformin, 25%, w/w microcrystalline cellulose and 25%, w/w lactose, and then coated with ethyl cellulose to produce sustained release pellets with 8% and 10%, w/w coat weight gains. Various pellet properties were investigated, including cumulative drug release behaviours of ensemble and individual pellets. When USP dissolution apparatus 1 and 2 were used for drug release study of the sustained release pellets prepared, floating and clumping of pellets were observed and confounded the release profiles of the ensemble pellets. Hence, the release profiles obtained did not characterize the actual drug release from individual pellet and the applicability of USP dissolution apparatus 1 and 2 to evaluate the coat quality of sustained release pellets was limited. The cumulative release profile of individual pellet using the 400-DS dissolution apparatus 7 was found to be more precise at distinguishing differences in the applied coat quality. The dip speed and dip interval of the reciprocating holder were critical operational parameters of 400-DS dissolution apparatus 7 that affected the drug release rate of a sustained release pellet during the individual dissolution study. The individual dissolution methodology using the 400-DS dissolution apparatus 7 is a promising technique to evaluate the individual pellet coat quality without the influence of confounding factors such as pellet floating and clumping observed during drug release test with dissolution apparatus 1 and 2, as well as to facilitate the elucidation of the actual drug release mechanism conferred by the applied sustained

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

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

2014-03-01

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

Quality assurance in head and neck surgical oncology : EORTC 24954 trial on larynx preservation

NARCIS (Netherlands)

Leemans, C. R.; Tijink, B. M.; Langendijk, J. A.; Andry, G.; Hamoir, M.; Lefebvre, J. L.

Background: The Head and Neck Cancer Group (HNCG) of the EORTC conducted a quality assurance program in the EORTC 24954 trial on larynx preservation. In this multicentre study, patients with resectable advanced squamous cell carcinoma of the larynx or hypopharynx were randomly assigned for treatment

Does mentoring new peer reviewers improve review quality? A randomized trial

Directory of Open Access Journals (Sweden)

Houry Debra

2012-08-01

Full Text Available Abstract Background Prior efforts to train medical journal peer reviewers have not improved subsequent review quality, although such interventions were general and brief. We hypothesized that a manuscript-specific and more extended intervention pairing new reviewers with high-quality senior reviewers as mentors would improve subsequent review quality. Methods Over a four-year period we randomly assigned all new reviewers for Annals of Emergency Medicine to receive our standard written informational materials alone, or these materials plus a new mentoring intervention. For this program we paired new reviewers with a high-quality senior reviewer for each of their first three manuscript reviews, and asked mentees to discuss their review with their mentor by email or phone. We then compared the quality of subsequent reviews between the control and intervention groups, using linear mixed effects models of the slopes of review quality scores over time. Results We studied 490 manuscript reviews, with similar baseline characteristics between the 24 mentees who completed the trial and the 22 control reviewers. Mean quality scores for the first 3 reviews on our 1 to 5 point scale were similar between control and mentee groups (3.4 versus 3.5, as were slopes of change of review scores (-0.229 versus -0.549 and all other secondary measures of reviewer performance. Conclusions A structured training intervention of pairing newly recruited medical journal peer reviewers with senior reviewer mentors did not improve the quality of their subsequent reviews.

Evidence-based medicine and quality of care.

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Dickenson, Donna; Vineis, Paolo

2002-01-01

In this paper we set out to examine the arguments for and against the claim that Evidence-Based Medicine (EBM) will improve the quality of care. In particular, we examine the following issues: 1. Are there hidden ethical assumptions in the methodology of EBM? 2. Is there a tension between the duty of care and EBM? 3. How can patient preferences be incorporated into quality guidelines and effectiveness studies? 4. Is there a tension between the quality of a particular intervention and overall quality of care? 5. Are certain branches of medicine and patient groups innately or prima facie disadvantaged by a shift to EBM? In addition we consider a case study in the ethics of EBM, on a clinical trial concerning the collection of umbilical cord blood in utero and ex utero, during or after labour in childbirth.

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

Science.gov (United States)

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.

Stopping randomized trials early for benefit: a protocol of the Study Of Trial Policy Of Interim Truncation-2 (STOPIT-2)

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Briel, Matthias; Lane, Melanie; Montori, Victor M; Bassler, Dirk; Glasziou, Paul; Malaga, German; Akl, Elie A; Ferreira-Gonzalez, Ignacio; Alonso-Coello, Pablo; Urrutia, Gerard; Kunz, Regina; Culebro, Carolina Ruiz; da Silva, Suzana Alves; Flynn, David N; Elamin, Mohamed B; Strahm, Brigitte; Murad, M Hassan; Djulbegovic, Benjamin; Adhikari, Neill KJ; Mills, Edward J; Gwadry-Sridhar, Femida; Kirpalani, Haresh; Soares, Heloisa P; Elnour, Nisrin O Abu; You, John J; Karanicolas, Paul J; Bucher, Heiner C; Lampropulos, Julianna F; Nordmann, Alain J; Burns, Karen EA; Mulla, Sohail M; Raatz, Heike; Sood, Amit; Kaur, Jagdeep; Bankhead, Clare R; Mullan, Rebecca J; Nerenberg, Kara A; Vandvik, Per Olav; Coto-Yglesias, Fernando; Schünemann, Holger; Tuche, Fabio; Chrispim, Pedro Paulo M; Cook, Deborah J; Lutz, Kristina; Ribic, Christine M; Vale, Noah; Erwin, Patricia J; Perera, Rafael; Zhou, Qi; Heels-Ansdell, Diane; Ramsay, Tim; Walter, Stephen D; Guyatt, Gordon H

2009-01-01

Background Randomized clinical trials (RCTs) stopped early for benefit often receive great attention and affect clinical practice, but pose interpretational challenges for clinicians, researchers, and policy makers. Because the decision to stop the trial may arise from catching the treatment effect at a random high, truncated RCTs (tRCTs) may overestimate the true treatment effect. The Study Of Trial Policy Of Interim Truncation (STOPIT-1), which systematically reviewed the epidemiology and reporting quality of tRCTs, found that such trials are becoming more common, but that reporting of stopping rules and decisions were often deficient. Most importantly, treatment effects were often implausibly large and inversely related to the number of the events accrued. The aim of STOPIT-2 is to determine the magnitude and determinants of possible bias introduced by stopping RCTs early for benefit. Methods/Design We will use sensitive strategies to search for systematic reviews addressing the same clinical question as each of the tRCTs identified in STOPIT-1 and in a subsequent literature search. We will check all RCTs included in each systematic review to determine their similarity to the index tRCT in terms of participants, interventions, and outcome definition, and conduct new meta-analyses addressing the outcome that led to early termination of the tRCT. For each pair of tRCT and systematic review of corresponding non-tRCTs we will estimate the ratio of relative risks, and hence estimate the degree of bias. We will use hierarchical multivariable regression to determine the factors associated with the magnitude of this ratio. Factors explored will include the presence and quality of a stopping rule, the methodological quality of the trials, and the number of total events that had occurred at the time of truncation. Finally, we will evaluate whether Bayesian methods using conservative informative priors to "regress to the mean" overoptimistic tRCTs can correct observed

Stopping randomized trials early for benefit: a protocol of the Study Of Trial Policy Of Interim Truncation-2 (STOPIT-2

Directory of Open Access Journals (Sweden)

Mullan Rebecca J

2009-07-01

Full Text Available Abstract Background Randomized clinical trials (RCTs stopped early for benefit often receive great attention and affect clinical practice, but pose interpretational challenges for clinicians, researchers, and policy makers. Because the decision to stop the trial may arise from catching the treatment effect at a random high, truncated RCTs (tRCTs may overestimate the true treatment effect. The Study Of Trial Policy Of Interim Truncation (STOPIT-1, which systematically reviewed the epidemiology and reporting quality of tRCTs, found that such trials are becoming more common, but that reporting of stopping rules and decisions were often deficient. Most importantly, treatment effects were often implausibly large and inversely related to the number of the events accrued. The aim of STOPIT-2 is to determine the magnitude and determinants of possible bias introduced by stopping RCTs early for benefit. Methods/Design We will use sensitive strategies to search for systematic reviews addressing the same clinical question as each of the tRCTs identified in STOPIT-1 and in a subsequent literature search. We will check all RCTs included in each systematic review to determine their similarity to the index tRCT in terms of participants, interventions, and outcome definition, and conduct new meta-analyses addressing the outcome that led to early termination of the tRCT. For each pair of tRCT and systematic review of corresponding non-tRCTs we will estimate the ratio of relative risks, and hence estimate the degree of bias. We will use hierarchical multivariable regression to determine the factors associated with the magnitude of this ratio. Factors explored will include the presence and quality of a stopping rule, the methodological quality of the trials, and the number of total events that had occurred at the time of truncation. Finally, we will evaluate whether Bayesian methods using conservative informative priors to "regress to the mean" overoptimistic t

Redesigning Radiotherapy Quality Assurance: Opportunities to Develop an Efficient, Evidence-Based System to Support Clinical Trials

Science.gov (United States)

Bekelman, Justin E.; Deye, James A.; Vikram, Bhadrasain; Bentzen, Soren M.; Bruner, Deborah; Curran, Walter J.; Dignam, James; Efstathiou, Jason A.; FitzGerald, T. J.; Hurkmans, Coen; Ibbott, Geoffrey S.; Lee, J. Jack; Merchant, Timothy E.; Michalski, Jeff; Palta, Jatinder R.; Simon, Richard; Ten Haken, Randal K.; Timmerman, Robert; Tunis, Sean; Coleman, C. Norman; Purdy, James

2012-01-01

Background In the context of national calls for reorganizing cancer clinical trials, the National Cancer Institute (NCI) sponsored a two day workshop to examine the challenges and opportunities for optimizing radiotherapy quality assurance (QA) in clinical trial design. Methods Participants reviewed the current processes of clinical trial QA and noted the QA challenges presented by advanced technologies. Lessons learned from the radiotherapy QA programs of recent trials were discussed in detail. Four potential opportunities for optimizing radiotherapy QA were explored, including the use of normal tissue toxicity and tumor control metrics, biomarkers of radiation toxicity, new radiotherapy modalities like proton beam therapy, and the international harmonization of clinical trial QA. Results Four recommendations were made: 1) Develop a tiered (and more efficient) system for radiotherapy QA and tailor intensity of QA to clinical trial objectives. Tiers include (i) general credentialing, (ii) trial specific credentialing, and (iii) individual case review; 2) Establish a case QA repository; 3) Develop an evidence base for clinical trial QA and introduce innovative prospective trial designs to evaluate radiotherapy QA in clinical trials; and 4) Explore the feasibility of consolidating clinical trial QA in the United States. Conclusion Radiotherapy QA may impact clinical trial accrual, cost, outcomes and generalizability. To achieve maximum benefit, QA programs must become more efficient and evidence-based. PMID:22425219

Building an integrated methodology of learning that can optimally support improvements in healthcare.

Science.gov (United States)

Lynn, Joanne

2011-04-01

The methods for healthcare reform are strikingly underdeveloped, with much reliance on political power. A methodology that combined methods from sources such as clinical trials, experience-based wisdom, and improvement science could be among the aims of the upcoming work in the USA on comparative effectiveness and on the agenda of the Center for Medicare and Medicaid Innovation in the Centers for Medicare and Medicaid Services. Those working in quality improvement have an unusual opportunity to generate substantial input into these processes through professional organisations such as the Academy for Healthcare Improvement and dominant leadership organisations such as the Institute for Healthcare Improvement.

Pilates Method for Women's Health: Systematic Review of Randomized Controlled Trials.

Science.gov (United States)

Mazzarino, Melissa; Kerr, Debra; Wajswelner, Henry; Morris, Meg E

2015-12-01

To critically analyze the benefits of Pilates on health outcomes in women. CINAHL, MEDLINE, PubMed, Science Direct, SPORTDiscus, Physiotherapy Evidence Database (PEDro), Cochrane Central Register of Controlled Trials, and Web of Science. Databases were searched using the terms Pilates and Pilates Method. Published randomized controlled trials (RCTs) were included if they comprised female participants with a health condition and a health outcome was measured, Pilates needed to be administered, and the article was published in English in a peer-reviewed journal from 1980 to July 2014. Two authors independently applied the inclusion criteria to potential studies. Methodological quality was assessed using the PEDro scale. A best-evidence grading system was used to determine the strength of the evidence. Thirteen studies met the inclusion criteria. PEDro scale values ranged from 3 to 7 (mean, 4.5; median, 4.0), indicating a relatively low quality overall. In this sample, Pilates for breast cancer was most often trialed (n=2). The most frequent health outcomes investigated were pain (n=4), quality of life (n=4), and lower extremity endurance (n=2), with mixed results. Emerging evidence was found for reducing pain and improving quality of life and lower extremity endurance. There is a paucity of evidence on Pilates for improving women's health during pregnancy or for conditions including breast cancer, obesity, or low back pain. Further high-quality RCTs are warranted to determine the effectiveness of Pilates for improving women's health outcomes. Copyright © 2015 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Inconsistencies in quality of life data collection in clinical trials: a potential source of bias? Interviews with research nurses and trialists.

Science.gov (United States)

Kyte, Derek; Ives, Jonathan; Draper, Heather; Keeley, Thomas; Calvert, Melanie

2013-01-01

Patient-reported outcomes (PROs), such as health-related quality of life (HRQL) are increasingly used to evaluate treatment effectiveness in clinical trials, are valued by patients, and may inform important decisions in the clinical setting. It is of concern, therefore, that preliminary evidence, gained from group discussions at UK-wide Medical Research Council (MRC) quality of life training days, suggests there are inconsistent standards of HRQL data collection in trials and appropriate training and education is often lacking. Our objective was to investigate these reports, to determine if they represented isolated experiences, or were indicative of a potentially wider problem. We undertook a qualitative study, conducting 26 semi-structured interviews with research nurses, data managers, trial coordinators and research facilitators involved in the collection and entry of HRQL data in clinical trials, across one primary care NHS trust, two secondary care NHS trusts and two clinical trials units in the UK. We used conventional content analysis to analyze and interpret our data. Our study participants reported (1) inconsistent standards in HRQL measurement, both between, and within, trials, which appeared to risk the introduction of bias; (2), difficulties in dealing with HRQL data that raised concern for the well-being of the trial participant, which in some instances led to the delivery of non-protocol driven co-interventions, (3), a frequent lack of HRQL protocol content and appropriate training and education of trial staff, and (4) that HRQL data collection could be associated with emotional and/or ethical burden. Our findings suggest there are inconsistencies in the standards of HRQL data collection in some trials resulting from a general lack of HRQL-specific protocol content, training and education. These inconsistencies could lead to biased HRQL trial results. Future research should aim to develop HRQL guidelines and training programmes aimed at supporting

Quantifying and visualizing site performance in clinical trials.

Science.gov (United States)

Yang, Eric; O'Donovan, Christopher; Phillips, JodiLyn; Atkinson, Leone; Ghosh, Krishnendu; Agrafiotis, Dimitris K

2018-03-01

One of the keys to running a successful clinical trial is the selection of high quality clinical sites, i.e., sites that are able to enroll patients quickly, engage them on an ongoing basis to prevent drop-out, and execute the trial in strict accordance to the clinical protocol. Intuitively, the historical track record of a site is one of the strongest predictors of its future performance; however, issues such as data availability and wide differences in protocol complexity can complicate interpretation. Here, we demonstrate how operational data derived from central laboratory services can provide key insights into the performance of clinical sites and help guide operational planning and site selection for new clinical trials. Our methodology uses the metadata associated with laboratory kit shipments to clinical sites (such as trial and anonymized patient identifiers, investigator names and addresses, sample collection and shipment dates, etc.) to reconstruct the complete schedule of patient visits and derive insights about the operational performance of those sites, including screening, enrollment, and drop-out rates and other quality indicators. This information can be displayed in its raw form or normalized to enable direct comparison of site performance across studies of varied design and complexity. Leveraging Covance's market leadership in central laboratory services, we have assembled a database of operational metrics that spans more than 14,000 protocols, 1400 indications, 230,000 unique investigators, and 23 million patient visits and represents a significant fraction of all clinical trials run globally in the last few years. By analyzing this historical data, we are able to assess and compare the performance of clinical investigators across a wide range of therapeutic areas and study designs. This information can be aggregated across trials and geographies to gain further insights into country and regional trends, sometimes with surprising results. The

Current Evidence to Justify, and the Methodological Considerations for a Randomised Controlled Trial Testing the Hypothesis that Statins Prevent the Malignant Progression of Barrett's Oesophagus

Directory of Open Access Journals (Sweden)

David Thurtle

2014-12-01

Full Text Available Barrett’s oesophagus is the predominant risk factor for oesophageal adenocarcinoma, a cancer whose incidence is increasing and which has a poor prognosis. This article reviews the latest experimental and epidemiological evidence justifying the development of a randomised controlled trial investigating the hypothesis that statins prevent the malignant progression of Barrett’s oesophagus, and explores the methodological considerations for such a trial. The experimental evidence suggests anti-carcinogenic properties of statins on oesophageal cancer cell lines, based on the inhibition of the mevalonate pathway and the production of pro-apoptotic proteins. The epidemiological evidence reports inverse associations between statin use and the incidence of oesophageal carcinoma in both general population and Barrett’s oesophagus cohorts. Such a randomised controlled trial would be a large multi-centre trial, probably investigating simvastatin, given the wide clinical experience with this drug, relatively low side-effect profile and low financial cost. As with any clinical trial, high adherence is important, which could be increased with therapy, patient, doctor and system-focussed interventions. We would suggest there is now sufficient evidence to justify a full clinical trial that attempts to prevent this aggressive cancer in a high-risk population.

THE ASSESSMENT METHODOLOGIES PTELR, ADRI AND CAE – THREE METHODOLOGIES FOR COORDINATING THE EFFORTS TO IMPROVE THE ORGANIZATIONAL PROCESSES TO ACHIEVE EXCELLENCE

Directory of Open Access Journals (Sweden)

Cristina Raluca POPESCU

2015-07-01

Full Text Available In the paper “The Assessment Methodologies PTELR, ADRI and CAE – Three Methodologies for Coordinating the Efforts to Improve the Organizational Processes to Achieve Excellence” the authors present the basic features of the assessment methodologies PTELR, ADRI and CAE that are designed to coordinate the efforts to improve the organizational processes in order to achieve excellence. In the first part of the paper (the introduction of the paper, the authors present the general background concerning the performance of management business processes and the importance of achieving excellence and furthermore correctly assessing/evaluating it. Aspects such as quality, quality control, quality assurance, performance and excellence are brought into discussion in the context generated by globalization, new technologies and new business models. Moreover, aspects regarding the methods employed to ensure the quality, maintaining it and continuous improvements, as well as total quality management, are also main pillars of this current research. In the content of the paper (the assessment methodologies PTELR, ADRI and CAE – as methodologies for coordinating the efforts to improve the organizational processes to achieve excellence, the authors describe the characteristics of the assessment methodologies PTELR, ADRI and CAE from a theoretical point of view.

Chinese patent medicines for the treatment of the common cold: a systematic review of randomized clinical trials.

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Chen, Wei; Liu, Bo; Wang, Li-qiong; Ren, Jun; Liu, Jian-ping

2014-07-30

Many Chinese patent medicines (CPMs) have been authorized by the Chinese State of Food and Drug Administration for the treatment of the common cold. A number of clinical trials have been conducted and published. However, there is no systematic review or meta-analysis on their efficacy and safety for the common cold to justify their clinical use. We searched CENTRAL, MEDLINE, EMBASE, SinoMed, CNKI, VIP, China Important Conference Papers Database, China Dissertation Database, and online clinical trial registry websites for published and unpublished randomized clinical trials (RCTs) of CPMs for the common cold till 31 March 2013. Revman 5.2 software was used for data analysis with effect estimate presented as relative risk (RR) and mean difference (MD) with a 95% confidence interval (CI). A total of five RCTs were identified. All of the RCTs were of high risk of bias with flawed study design and poor methodological quality. All RCTs included children aged between 6 months to 14 years. Results of individual trials showed that Shuanghuanglian oral liquid (RR 4.00; 95% CI: 2.26 to 7.08), and Xiaoer Resuqing oral liquid (RR 1.43; 95% CI: 1.15 to 1.77) had higher cure rates compared with antivirus drugs. Most of the trials did not report adverse events, and the safety of CPMs was still uncertain. Some CPMs showed a potential positive effect for the common cold on cure rate. However, due to the poor methodology quality and the defects in the clinical design of the included RCTs, such as the lack of placebo controlled trials, the inappropriate comparison intervention and outcome measurement, the confirmative conclusions on the beneficial effect of CPMs for the common cold could not be drawn.

Reporting quality of randomized controlled trial abstracts: survey of leading general dental journals.

Science.gov (United States)

Hua, Fang; Deng, Lijia; Kau, Chung How; Jiang, Han; He, Hong; Walsh, Tanya

2015-09-01

The authors conducted a study to assess the reporting quality of randomized controlled trial (RCT) abstracts published in leading general dental journals, investigate any improvement after the release of the Consolidated Standards of Reporting Trials (CONSORT) for Abstracts guidelines, and identify factors associated with better reporting quality. The authors searched PubMed for RCTs published in 10 leading general dental journals during the periods from 2005 to 2007 (pre-CONSORT period) and 2010 to 2012 (post-CONSORT period). The authors evaluated and scored the reporting quality of included abstracts by using the original 16-item CONSORT for Abstracts checklist. The authors used risk ratios and the t test to compare the adequate reporting rate of each item and the overall quality in the 2 periods. The authors used univariate and multivariate regressions to identify predictors of better reporting quality. The authors included and evaluated 276 RCT abstracts. Investigators reported significantly more checklist items during the post-CONSORT period (mean [standard deviation {SD}], 4.53 [1.69]) than during the pre-CONSORT period (mean [SD], 3.87 [1.10]; mean difference, -0.66 [95% confidence interval, -0.99 to -0.33]; P 80%). In contrast, the authors saw sufficient reporting of randomization, recruitment, outcome in the results section, and funding in none of the pre-CONSORT abstracts and less than 2% of the post-CONSORT abstracts. On the basis of the multivariate analysis, a higher impact factor (P general dental journals has improved significantly, but there is still room for improvement. Joint efforts by authors, reviewers, journal editors, and other stakeholders to improve the reporting of dental RCT abstracts are needed. Copyright © 2015 American Dental Association. Published by Elsevier Inc. All rights reserved.

MR imaging of the articular cartilage of the knee with arthroscopy as gold standard: assessment of methodological quality of clinical studies

International Nuclear Information System (INIS)

Duchateau, Florence; Berg, Bruno C. vande

2002-01-01

The purpose of this study was to assess the methodological quality of articles addressing the value of MR imaging of the knee cartilage with arthroscopy as a standard. Relevant papers were selected after Medline review (MEDLINE database search including the terms ''cartilage'' ''knee'', ''MR'' and ''arthroscopy''). Two observers reviewed independently 29 selected articles to determine how each study had met 15 individual standards that had been previously developed to assess the methodological quality of clinical investigations. The following criteria were met in variable percentage of articles including adequate definition of purpose (100%), statistical analysis (90%), avoidance of verification bias (86%), patient population description (83%), reference standard (79%), review bias (79%), study design (66%), inclusion criteria (41%) and method of analysis (41.5%), avoidance of diagnostic-review bias (24%), exclusion criteria (21%), indeterminate examination results (17%), analysis criteria (14%), interobserver reliability (14%) and intraobserver reliability (7%). The assessment of the methodological quality of clinical investigations addressing the value of MR imaging in the evaluation of the articular cartilage of the knee with arthroscopy as the standard of reference demonstrated that several standards were rarely met in the literature. Efforts should be made to rely on clearly defined lesion criteria and to determine reliability of the observations. (orig.)

Quality Assurance and Improvement in Head and Neck Cancer Surgery: From Clinical Trials to National Healthcare Initiatives.

Science.gov (United States)

Simon, Christian; Caballero, Carmela

2018-05-24

It is without question in the best interest of our patients, if we can identify ways to improve the quality of care we deliver to them. Great progress has been made within the last 25 years in terms of development and implementation of quality-assurance (QA) platforms and quality improvement programs for surgery in general, and within this context for head and neck surgery. As of now, we have successfully identified process indicators that impact outcome of our patients and the quality of care we deliver as surgeons. We have developed risk calculators to determine the risk for complications of individual surgical patients. We have created perioperative guidelines for complex head and neck procedures. We have in Europe and North America created audit registries that can gather and analyze data from institutions across the world to better understand which processes need change to obtain good outcomes and improve quality of care. QA platforms can be tested within the clearly defined environment of prospective clinical trials. If positive, such programs could be rolled out within national healthcare systems, if feasible. Testing quality programs in clinical trials could be a versatile tool to help head neck cancer patients benefit directly from such initiatives on a global level.

Yoga for Adults with Type 2 Diabetes: A Systematic Review of Controlled Trials

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Innes, Kim E.; Selfe, Terry Kit

2016-01-01

A growing body of evidence suggests yogic practices may benefit adults with type 2 diabetes (DM2). In this systematic review, we evaluate available evidence from prospective controlled trials regarding the effects of yoga-based programs on specific health outcomes pertinent to DM2 management. To identify qualifying studies, we searched nine databases and scanned bibliographies of relevant review papers and all identified articles. Controlled trials that did not target adults with diabetes, included only adults with type 1 diabetes, were under two-week duration, or did not include quantitative outcome data were excluded. Study quality was evaluated using the PEDro scale. Thirty-three papers reporting findings from 25 controlled trials (13 nonrandomized, 12 randomized) met our inclusion criteria (N = 2170 participants). Collectively, findings suggest that yogic practices may promote significant improvements in several indices of importance in DM2 management, including glycemic control, lipid levels, and body composition. More limited data suggest that yoga may also lower oxidative stress and blood pressure; enhance pulmonary and autonomic function, mood, sleep, and quality of life; and reduce medication use in adults with DM2. However, given the methodological limitations of existing studies, additional high-quality investigations are required to confirm and further elucidate the potential benefits of yoga programs in populations with DM2. PMID:26788520

Professional medical writing support and the quality of randomised controlled trial reporting: a cross-sectional study.

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Gattrell, William T; Hopewell, Sally; Young, Kate; Farrow, Paul; White, Richard; Wager, Elizabeth; Winchester, Christopher C

2016-02-21

Authors may choose to work with professional medical writers when writing up their research for publication. We examined the relationship between medical writing support and the quality and timeliness of reporting of the results of randomised controlled trials (RCTs). Cross-sectional study. Primary reports of RCTs published in BioMed Central journals from 2000 to 16 July 2014, subdivided into those with medical writing support (n=110) and those without medical writing support (n=123). Proportion of items that were completely reported from a predefined subset of the Consolidated Standards of Reporting Trials (CONSORT) checklist (12 items known to be commonly poorly reported), overall acceptance time (from manuscript submission to editorial acceptance) and quality of written English as assessed by peer reviewers. The effect of funding source and publication year was examined. The number of articles that completely reported at least 50% of the CONSORT items assessed was higher for those with declared medical writing support (39.1% (43/110 articles); 95% CI 29.9% to 48.9%) than for those without (21.1% (26/123 articles); 95% CI 14.3% to 29.4%). Articles with declared medical writing support were more likely than articles without such support to have acceptable written English (81.1% (43/53 articles); 95% CI 67.6% to 90.1% vs 47.9% (23/48 articles); 95% CI 33.5% to 62.7%). The median time of overall acceptance was longer for articles with declared medical writing support than for those without (167 days (IQR 114.5-231 days) vs 136 days (IQR 77-193 days)). In this sample of open-access journals, declared professional medical writing support was associated with more complete reporting of clinical trial results and higher quality of written English. Medical writing support may play an important role in raising the quality of clinical trial reporting. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go

A novel approach to measuring response and remission in schizophrenia in clinical trials.

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Aboraya, Ahmed; Leucht, Stefan; Nasrallah, Henry A; Samara, Myrto; Haro, Josep Maria; Elshazly, Ahmed; Zangeneh, Masood

2017-12-01

Pharmaceutical companies conduct clinical trials to show the efficacy and safety of new medications for the treatment of schizophrenia. After the new medications are marketed, clinicians treating patients with schizophrenia discover that a considerable number of patients do not respond to these new medications. The goals of the review are to examine the methodology and design of recent antipsychotic clinical trials, identify common flaws, and propose guidelines to fix the flaws and improve the quality of future clinical trials of antipsychotic medications. A review of recent antipsychotic clinical trials was conducted using a PubMed search. Ten recent trials published in the past four years were reviewed and their methods analyzed and critiqued. The authors identified six major methodological flaws that may explain the suboptimal response in many patients after a drug is approved. Most of the flaws are related to eligibility criteria, the misuse of the Positive and Negative Syndromes Scale (PANSS) and the lack of consensus on how to define remission, response and exacerbation in schizophrenia. Proposed guidelines for a more rigorous use of the PANSS are presented and recommendations are proposed for using uniform criteria for remission, response and exacerbation in schizophrenia. The authors recommend using standardized diagnostic interviews to screen patients for eligibility criteria and using the PANSS according to the author's recommendations and the proposed guidelines. Uniform criteria to define remission, response and exacerbation are recommended for clinical trials examining the efficacy and safety of antipsychotic drugs in schizophrenia. Copyright © 2017 Elsevier B.V. All rights reserved.

Effects of a psycho-educational programme on health-related quality of life in patients treated for colorectal and anal cancer: A feasibility trial.

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Ohlsson-Nevo, Emma; Karlsson, Jan; Nilsson, Ulrica

2016-04-01

Colorectal cancer (CRC) may have a negative impact on a person's quality of life. Psycho-educational interventions for patients with CRC are rarely studied. The purpose of this feasibility trial was to evaluate the effect of a psycho-educational programme (PEP) on the health-related quality of life (HRQL) of patients treated for CRC and anal cancer. Patients with CRC and anal cancer were randomly assigned to a PEP (n = 47) or standard treatment (n = 39). The PEP included informative lectures, discussion, and reflection. HRQL was evaluated using the SF-36 at baseline and 1, 6, and 12 months after the end of the PEP. Patients in the PEP group had significantly better Mental Health scores after 1 month and significantly better Bodily Pain scores after 6 months compared with patients who received standard care. The results of this study indicate that a PEP can have a short-term effect on the mental health and bodily pain of patients treated for CRC and anal cancer when comparing with a control group. The article discusses the methodological difficulties of evaluating an intervention such as this PEP in a clinical setting. Copyright © 2015. Published by Elsevier Ltd.

The Theoretical, Methodological, and Practical Background for Looking at International Students' Learning Styles, Backgrounds, and Quality Perceptions with Regard to ASB's Three English-Language M.Sc. Programs

DEFF Research Database (Denmark)

Skaates, Maria Anne

This paper looking at the methodological background for a questionnaire study of student perceptions with regard to own learning styles and backgrounds as well as the quality of education in Aarhus School of Business' 3 English-language M.Sc. programs (FIB, EU, and BPM). Theories and models about...... the internationalization of business schools, service quality, and student learning styles are discussed in the paper, as is the statistic methodology for treating the questionnaire responses of the respondents.......This paper looking at the methodological background for a questionnaire study of student perceptions with regard to own learning styles and backgrounds as well as the quality of education in Aarhus School of Business' 3 English-language M.Sc. programs (FIB, EU, and BPM). Theories and models about...

A Cluster-Randomized Trial of Restorative Practices: An Illustration to Spur High-Quality Research and Evaluation.

Science.gov (United States)

Acosta, Joie D; Chinman, Matthew; Ebener, Patricia; Phillips, Andrea; Xenakis, Lea; Malone, Patrick S

2016-01-01

Restorative Practices in schools lack rigorous evaluation studies. As an example of rigorous school-based research, this paper describes the first randomized control trial of restorative practices to date, the Study of Restorative Practices. It is a 5-year, cluster-randomized controlled trial (RCT) of the Restorative Practices Intervention (RPI) in 14 middle schools in Maine to assess whether RPI impacts both positive developmental outcomes and problem behaviors and whether the effects persist during the transition from middle to high school. The two-year RPI intervention began in the 2014-2015 school year. The study's rationale and theoretical concerns are discussed along with methodological concerns including teacher professional development. The theoretical rationale and description of the methods from this study may be useful to others conducting rigorous research and evaluation in this area.

Benefits of a comprehensive quality program for cryopreserved PBMC covering 28 clinical trials sites utilizing an integrated, analytical web-based portal.

Science.gov (United States)

Ducar, Constance; Smith, Donna; Pinzon, Cris; Stirewalt, Michael; Cooper, Cristine; McElrath, M Juliana; Hural, John

2014-07-01

The HIV Vaccine Trials Network (HVTN) is a global network of 28 clinical trial sites dedicated to identifying an effective HIV vaccine. Cryopreservation of high-quality peripheral blood mononuclear cells (PBMC) is critical for the assessment of vaccine-induced cellular immune functions. The HVTN PBMC Quality Management Program is designed to ensure that viable PBMC are processed, stored and shipped for clinical trial assays from all HVTN clinical trial sites. The program has evolved by developing and incorporating best practices for laboratory and specimen quality and implementing automated, web-based tools. These tools allow the site-affiliated processing laboratories and the central Laboratory Operations Unit to rapidly collect, analyze and report PBMC quality data. The HVTN PBMC Quality Management Program includes five key components: 1) Laboratory Assessment, 2) PBMC Training and Certification, 3) Internal Quality Control, 4) External Quality Control (EQC), and 5) Assay Specimen Quality Control. Fresh PBMC processing data is uploaded from each clinical site processing laboratory to a central HVTN Statistical and Data Management Center database for access and analysis on a web portal. Samples are thawed at a central laboratory for assay or specimen quality control and sample quality data is uploaded directly to the database by the central laboratory. Four year cumulative data covering 23,477 blood draws reveals an average fresh PBMC yield of 1.45×10(6)±0.48 cells per milliliter of useable whole blood. 95% of samples were within the acceptable range for fresh cell yield of 0.8-3.2×10(6) cells/ml of usable blood. Prior to full implementation of the HVTN PBMC Quality Management Program, the 2007 EQC evaluations from 10 international sites showed a mean day 2 thawed viability of 83.1% and a recovery of 67.5%. Since then, four year cumulative data covering 3338 specimens used in immunologic assays shows that 99.88% had acceptable viabilities (>66%) for use in

Methodological Choices in Muscle Synergy Analysis Impact Differentiation of Physiological Characteristics Following Stroke

Directory of Open Access Journals (Sweden)

Caitlin L. Banks

2017-08-01

Full Text Available Muscle synergy analysis (MSA is a mathematical technique that reduces the dimensionality of electromyographic (EMG data. Used increasingly in biomechanics research, MSA requires methodological choices at each stage of the analysis. Differences in methodological steps affect the overall outcome, making it difficult to compare results across studies. We applied MSA to EMG data collected from individuals post-stroke identified as either responders (RES or non-responders (nRES on the basis of a critical post-treatment increase in walking speed. Importantly, no clinical or functional indicators identified differences between the cohort of RES and nRES at baseline. For this exploratory study, we selected the five highest RES and five lowest nRES available from a larger sample. Our goal was to assess how the methodological choices made before, during, and after MSA affect the ability to differentiate two groups with intrinsic physiologic differences based on MSA results. We investigated 30 variations in MSA methodology to determine which choices allowed differentiation of RES from nRES at baseline. Trial-to-trial variability in time-independent synergy vectors (SVs and time-varying neural commands (NCs were measured as a function of: (1 number of synergies computed; (2 EMG normalization method before MSA; (3 whether SVs were held constant across trials or allowed to vary during MSA; and (4 synergy analysis output normalization method after MSA. MSA methodology had a strong effect on our ability to differentiate RES from nRES at baseline. Across all 10 individuals and MSA variations, two synergies were needed to reach an average of 90% variance accounted for (VAF. Based on effect sizes, differences in SV and NC variability between groups were greatest using two synergies with SVs that varied from trial-to-trial. Differences in SV variability were clearest using unit magnitude per trial EMG normalization, while NC variability was less sensitive to EMG

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

Science.gov (United States)

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

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

Science.gov (United States)

Bardus, Marco; Smith, Jane R; Samaha, Laya; Abraham, Charles

2016-08-01

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. 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. 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. 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. © The Author 2016. Published by Oxford University Press on behalf of the European Public Health Association. All rights reserved.

Do authors report surgical expertise in open spine surgery related randomized controlled trials? A systematic review on quality of reporting

NARCIS (Netherlands)

van Oldenrijk, Jakob; van Berkel, Youri; Kerkhoffs, Gino M. M. J.; Bhandari, Mohit; Poolman, Rudolf W.

2013-01-01

A systematic review of published trials in orthopedic spine literature. To determine the quality of reporting in open spine surgery randomized controlled trials (RCTs) between 2005 and 2010 with special focus on the reporting of surgical skill or expertise. In technically demanding procedures such

Methodology of a systematic review.

Science.gov (United States)

Linares-Espinós, E; Hernández, V; Domínguez-Escrig, J L; Fernández-Pello, S; Hevia, V; Mayor, J; Padilla-Fernández, B; Ribal, M J

2018-05-03

The objective of evidence-based medicine is to employ the best scientific information available to apply to clinical practice. Understanding and interpreting the scientific evidence involves understanding the available levels of evidence, where systematic reviews and meta-analyses of clinical trials are at the top of the levels-of-evidence pyramid. The review process should be well developed and planned to reduce biases and eliminate irrelevant and low-quality studies. The steps for implementing a systematic review include (i) correctly formulating the clinical question to answer (PICO), (ii) developing a protocol (inclusion and exclusion criteria), (iii) performing a detailed and broad literature search and (iv) screening the abstracts of the studies identified in the search and subsequently of the selected complete texts (PRISMA). Once the studies have been selected, we need to (v) extract the necessary data into a form designed in the protocol to summarise the included studies, (vi) assess the biases of each study, identifying the quality of the available evidence, and (vii) develop tables and text that synthesise the evidence. A systematic review involves a critical and reproducible summary of the results of the available publications on a particular topic or clinical question. To improve scientific writing, the methodology is shown in a structured manner to implement a systematic review. Copyright © 2018 AEU. Publicado por Elsevier España, S.L.U. All rights reserved.

Applying Statistical Process Quality Control Methodology to Educational Settings.

Science.gov (United States)

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…

The quality of reporting of RCTs used within a postoperative pain management meta-analysis, using the CONSORT statement

Directory of Open Access Journals (Sweden)

Borg Debono Victoria

2012-07-01

Full Text Available Abstract Background Randomized controlled trials (RCTs are routinely used in systematic reviews and meta-analyses that help inform healthcare and policy decision making. The proper reporting of RCTs is important because it acts as a proxy for health care providers and researchers to appraise the quality of the methodology, conduct and analysis of an RCT. The aims of this study are to analyse the overall quality of reporting in 23 RCTs that were used in a meta-analysis by assessing 3 key methodological items, and to determine factors associated with high quality of reporting. It is hypothesized that studies with larger sample sizes, that have funding reported, that are published in journals with a higher impact factor and that are in journals that have adopted or endorsed the CONSORT statement will be associated with better overall quality of reporting and reporting of key methodological items. Methods We systematically reviewed RCTs used within an anesthesiology related post-operative pain management meta-analysis. We included all of the 23 RCTs used, all of which were parallel design that addressed the use of femoral nerve block in improving outcomes after total knee arthroplasty. Data abstraction was done independently by two reviewers. The two main outcomes were: 1 15 point overall quality of reporting score (OQRS based on the Consolidated Standards for Reporting Trials (CONSORT and 2 3 point key methodological item score (KMIS based on allocation concealment, blinding and intention-to-treat analysis. Results Twenty-three RCTs were included. The median OQRS was 9.0 (Interquartile Range = 3. A multivariable regression analysis did not show any significant association between OQRS or KMIS and our four predictor variables hypothesized to improve reporting. The direction and magnitude of our results when compared to similar studies suggest that the sample size and impact factor are associated with improved key methodological item reporting

Trends in the number and the quality of trial protocols involving children submitted to a French Institutional Review Board

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Isabelle Gautier

2017-08-01

Full Text Available Abstract Background There is a great need for high quality clinical research for children. The European Pediatric Regulation aimed to improve the quality of clinical trials in order to increase the availability of treatments for children. The main purpose of this study was to assess the evolution of both the number and the quality of pediatric trial protocols that were submitted to a French Institutional Review Board (IRB00009118 before and after the initiation of the EU Pediatric Regulation. Methods All protocols submitted to the IRB00009118 between 2003 and 2014 and conducting research on subjects under eighteen years of age were eligible. The quality of randomized clinical trials was assessed according to the guidelines developed by the Enhancing the QUAlity and Transparency Of health Research (EQUATOR Network and ranked using the Jadad score. Results Out of 622 protocols submitted to the Institutional Review Board (IRB, 21% (133/622 included children. Among these 133 pediatric protocols, the number of submitted pediatric protocols doubled between the two studied periods. From 2003 to 2008, 47 protocols including 21 institutionally sponsored were submitted to the IRB and from 2009 until 2014, 86 protocols including 48 institutionally sponsored were submitted. No significant trend was observed on the quality of RCTs. The overall median score of RCTs on the Jadad scale was high (3.5, 70.0% of protocols had a Jadad score ≥ 3, and 30.0% had a score < 3. Conclusion Following the EU Pediatric Regulation, the number of pediatric protocols submitted to the IRB00009118 tends to increase, but no change was noticed regarding their quality.

Optimizing Radiation Therapy Quality Assurance in Clinical Trials: A TROG 08.03 RAVES Substudy

Energy Technology Data Exchange (ETDEWEB)

Trada, Yuvnik, E-mail: yuvnik@gmail.com [Calvary Mater Newcastle, Waratah, New South Wales (Australia); Kneebone, Andrew [Royal North Shore Hospital, St Lenoards, New South Wales (Australia); Paneghel, Andrea [Peter MacCallum Cancer Centre, Melbourne, Victoria (Australia); Pearse, Maria [Auckland Hospital, Auckland (New Zealand); Sidhom, Mark [Liverpool Hospital, Liverpool, New South Wales (Australia); Tang, Colin [Sir Charles Gairdner Hospital, Nedlands, Western Australia (Australia); Wiltshire, Kirsty; Haworth, Annette [Peter MacCallum Cancer Centre, Melbourne, Victoria (Australia); Fraser-Browne, Carol [Auckland Hospital, Auckland (New Zealand); Martin, Jarad [Calvary Mater Newcastle, Waratah, New South Wales (Australia)

2015-12-01

Purpose: To explore site- and clinician-level factors associated with protocol violations requiring real-time-review (RTR) resubmission in a multicenter clinical trial to help tailor future quality assurance (QA) protocols. Methods and Materials: RAVES (Radiation Therapy–Adjuvant vs Early Salvage) (Trans-Tasman Radiation Oncology Group 08.03) is a randomized trial comparing adjuvant with early salvage radiation therapy in men with positive surgical margins or pT3 disease after prostatectomy. Quality assurance in RAVES required each clinician and site to submit a credentialing dummy run (DR) and for each patient's radiation therapy plan to undergo external RTR before treatment. Prospectively defined major violations from trial protocol required remedy and resubmission. Site and clinician factors associated with RTR resubmission were examined using hierarchical modeling. Results: Data were collected from 171 consecutive patients, treated by 46 clinicians at 32 hospitals. There were 47 RTR resubmissions (27%) due to 65 major violations. The relative rate of resubmission decreased by 29% per year as the study progressed (odds ratio OR. 0.71, P=.02). The majority of resubmissions were due to contouring violations (39 of 65) and dosimetric violations (22 of 65). For each additional patient accrued, significant decreases in RTR resubmission were seen at both clinician level (OR 0.75, P=.02) and site level (OR 0.72, P=.01). The rate of resubmission due to dosimetric violations was only 1.6% after the first 5 patients. Use of IMRT was associated with lower rates of resubmission compared with 3-dimensional conformal radiation therapy (OR 0.38, P=.05). Conclusion: Several low- and high-risk factors that may assist with tailoring future clinical trial QA were identified. Because the real-time resubmission rate was largely independent of the credentialing exercise, some form of RTR QA is recommended. The greatest benefit from QA was derived early in trial activation

External quality assurance of malaria nucleic acid testing for clinical trials and eradication surveillance.

Directory of Open Access Journals (Sweden)

Sean C Murphy

Full Text Available Nucleic acid testing (NAT for malaria parasites is an increasingly recommended diagnostic endpoint in clinical trials of vaccine and drug candidates and is also important in surveillance of malaria control and elimination efforts. A variety of reported NAT assays have been described, yet no formal external quality assurance (EQA program provides validation for the assays in use. Here, we report results of an EQA exercise for malaria NAT assays. Among five centers conducting controlled human malaria infection trials, all centers achieved 100% specificity and demonstrated limits of detection consistent with each laboratory's pre-stated expectations. Quantitative bias of reported results compared to expected results was generally <0.5 log10 parasites/mL except for one laboratory where the EQA effort identified likely reasons for a general quantitative shift. The within-laboratory variation for all assays was low at <10% coefficient of variation across a range of parasite densities. Based on this study, we propose to create a Molecular Malaria Quality Assessment program that fulfills the need for EQA of malaria NAT assays worldwide.

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

Science.gov (United States)

2014-01-01

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

Vision related quality of life in patients with type 2 diabetes in the EUROCONDOR trial

DEFF Research Database (Denmark)

Trento, Marina; Durando, Olga; Lavecchia, Sonia

2017-01-01

To evaluate vision related quality of life in the patients enrolled in The European Consortium for the Early Treatment of Diabetic Retinopathy, a clinical trial on prevention of diabetic retinopathy. Four-hundred-forty-nine patients, 153 women, with type 2 Diabetes and no or mild diabetic retinop...... acuity. The National Eye Institute Visual Functioning Questionnaire could detect subtle changes in patients' perception of visual function, despite absent/minimal diabetic retinopathy.......To evaluate vision related quality of life in the patients enrolled in The European Consortium for the Early Treatment of Diabetic Retinopathy, a clinical trial on prevention of diabetic retinopathy. Four-hundred-forty-nine patients, 153 women, with type 2 Diabetes and no or mild diabetic....... Diabetic retinopathy was absent in 193 (43.0 %) and mild in 256 (57.0 %). Patients without diabetic retinopathy were older, had shorter diabetes duration and used less insulin and glucose-lowering agents but did not differ by gender, best corrected visual acuity or any subscale, except vision specific...

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

NARCIS (Netherlands)

Terwee, C.B.; Mokkink, L.B.; Knol, D.L.; Ostelo, R.W.J.G.; Bouter, L.M.; de Vet, H.C.W.

2012-01-01

Background: 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

Arts Therapies for Anxiety, Depression, and Quality of Life in Breast Cancer Patients: A Systematic Review and Meta-Analysis

Directory of Open Access Journals (Sweden)

Katja Boehm

2014-01-01

Full Text Available Background. Breast cancer is one of the most common types of cancer. However, only a few trials assess the effects of arts therapies. Material and Methods. We searched the Cochrane Central Register of Controlled Trials, PubMed, and Google Scholar from their start date to January 2012. We handsearched reference lists and contacted experts. All randomized controlled trials, quasi-randomized trials, and controlled clinical trials of art interventions in breast cancer patients were included. Data were extracted and risk of bias was assessed. Meta-analyses were performed using standardized mean differences. Results. Thirteen trials with a total of 606 patients were included. Arts therapies comprised music therapy interventions, various types of art therapy, and dance/movement therapies. The methodological quality ranged from poor to high quality with the majority scoring 3 of 4 points on the Jadad scale. Results suggest that arts therapies seem to positively affect patients’ anxiety (standardized mean difference: −1.10; 95%, confidence interval: −1.40 to −0.80 but not depression or quality of life. No conclusion could be drawn regarding the effects of arts therapy on pain, functional assessment, coping, and mood states. Discussion. Our review indicates that arts interventions may have beneficial effects on anxiety in patients with breast cancer.

Average effect estimates remain similar as evidence evolves from single trials to high-quality bodies of evidence: a meta-epidemiologic study.

Science.gov (United States)

Gartlehner, Gerald; Dobrescu, Andreea; Evans, Tammeka Swinson; Thaler, Kylie; Nussbaumer, Barbara; Sommer, Isolde; Lohr, Kathleen N

2016-01-01

The objective of our study was to use a diverse sample of medical interventions to assess empirically whether first trials rendered substantially different treatment effect estimates than reliable, high-quality bodies of evidence. We used a meta-epidemiologic study design using 100 randomly selected bodies of evidence from Cochrane reports that had been graded as high quality of evidence. To determine the concordance of effect estimates between first and subsequent trials, we applied both quantitative and qualitative approaches. For quantitative assessment, we used Lin's concordance correlation and calculated z-scores; to determine the magnitude of differences of treatment effects, we calculated standardized mean differences (SMDs) and ratios of relative risks. We determined qualitative concordance based on a two-tiered approach incorporating changes in statistical significance and magnitude of effect. First trials both overestimated and underestimated the true treatment effects in no discernible pattern. Nevertheless, depending on the definition of concordance, effect estimates of first trials were concordant with pooled subsequent studies in at least 33% but up to 50% of comparisons. The pooled magnitude of change as bodies of evidence advanced from single trials to high-quality bodies of evidence was 0.16 SMD [95% confidence interval (CI): 0.12, 0.21]. In 80% of comparisons, the difference in effect estimates was smaller than 0.5 SMDs. In first trials with large treatment effects (>0.5 SMD), however, estimates of effect substantially changed as new evidence accrued (mean change 0.68 SMD; 95% CI: 0.50, 0.86). Results of first trials often change, but the magnitude of change, on average, is small. Exceptions are first trials that present large treatment effects, which often dissipate as new evidence accrues. Copyright © 2016 Elsevier Inc. All rights reserved.

APPLICATION OF LOT QUALITY ASSURANCE SAMPLING FOR ASSESSING DISEASE CONTROL PROGRAMMES - EXAMINATION OF SOME METHODOLOGICAL ISSUES

OpenAIRE

T. R. RAMESH RAO

2011-01-01

Lot Quality Assurance Sampling (LQAS), a statistical tool in industrial setup, has been in use since 1980 for monitoring and evaluation of programs on disease control / immunization status among children / health workers performance in health system. While conducting LQAS in the field, there are occasions, even after due care of design, there are practical and methodological issues to be addressed before it is recommended for implementation and intervention. LQAS is applied under the assumpti...

Commentary: considerations for using the 'Trials within Cohorts' design in a clinical trial of an investigational medicinal product.

Science.gov (United States)

Bibby, Anna C; Torgerson, David J; Leach, Samantha; Lewis-White, Helen; Maskell, Nick A

2018-01-08

The 'trials within cohorts' (TwiC) design is a pragmatic approach to randomised trials in which trial participants are randomly selected from an existing cohort. The design has multiple potential benefits, including the option of conducting multiple trials within the same cohort. To date, the TwiC design methodology been used in numerous clinical settings but has never been applied to a clinical trial of an investigational medicinal product (CTIMP). We have recently secured the necessary approvals to undertake the first CTIMP using the TwiC design. In this paper, we describe some of the considerations and modifications required to ensure such a trial is compliant with Good Clinical Practice and international clinical trials regulations. We advocate using a two-stage consent process and using the consent stages to explicitly differentiate between trial participants and cohort participants who are providing control data. This distinction ensured compliance but had consequences with respect to costings, recruitment and the trial assessment schedule. We have demonstrated that it is possible to secure ethical and regulatory approval for a CTIMP TwiC. By including certain considerations at the trial design stage, we believe this pragmatic and efficient methodology could be utilised in other CTIMPs in future.

Workflow in clinical trial sites & its association with near miss events for data quality: ethnographic, workflow & systems simulation.

Science.gov (United States)

de Carvalho, Elias Cesar Araujo; Batilana, Adelia Portero; Claudino, Wederson; Reis, Luiz Fernando Lima; Schmerling, Rafael A; Shah, Jatin; Pietrobon, Ricardo

2012-01-01

With the exponential expansion of clinical trials conducted in (Brazil, Russia, India, and China) and VISTA (Vietnam, Indonesia, South Africa, Turkey, and Argentina) countries, corresponding gains in cost and enrolment efficiency quickly outpace the consonant metrics in traditional countries in North America and European Union. However, questions still remain regarding the quality of data being collected in these countries. We used ethnographic, mapping and computer simulation studies to identify/address areas of threat to near miss events for data quality in two cancer trial sites in Brazil. Two sites in Sao Paolo and Rio Janeiro were evaluated using ethnographic observations of workflow during subject enrolment and data collection. Emerging themes related to threats to near miss events for data quality were derived from observations. They were then transformed into workflows using UML-AD and modeled using System Dynamics. 139 tasks were observed and mapped through the ethnographic study. The UML-AD detected four major activities in the workflow evaluation of potential research subjects prior to signature of informed consent, visit to obtain subject́s informed consent, regular data collection sessions following study protocol and closure of study protocol for a given project. Field observations pointed to three major emerging themes: (a) lack of standardized process for data registration at source document, (b) multiplicity of data repositories and (c) scarcity of decision support systems at the point of research intervention. Simulation with policy model demonstrates a reduction of the rework problem. Patterns of threats to data quality at the two sites were similar to the threats reported in the literature for American sites. The clinical trial site managers need to reorganize staff workflow by using information technology more efficiently, establish new standard procedures and manage professionals to reduce near miss events and save time/cost. Clinical trial

Huangqi Jianzhong Tang for Treatment of Chronic Gastritis: A Systematic Review of Randomized Clinical Trials

Science.gov (United States)

Wei, Yue; Ma, Li-Xin; Yin, Sheng-Jun; An, Jing; Wei, Qi; Yang, Jin-Xiang

2015-01-01

To assess the clinical effects and safety of Huangqi Jianzhong Tang (HQJZ) for the treatment of chronic gastritis (CG), three English databases and four Chinese databases were searched through the inception to January 2015. In randomized controlled trials (RCTs) comparing HQJZ with placebo, no intervention and western medicine were included. A total of 9 RCTs involving 979 participants were identified. The methodological quality of the included trials was generally poor. Meta-analyses demonstrated that HQJZ plus conventional medicine was more effective in improving overall gastroscopy outcome than western medicine alone for treatment of chronic superficial gastritis with the pooling result of overall improvement [OR 3.78 (1.29,11.06), P = 0.02]. In addition, the combination of HQJZ with antibiotics has higher overall effect rate than antibiotics alone for the treatment of CG [OR 2.60 (1.49,4.54), P = 0.0007]. There were no serious adverse events reported in both the intervention and controlled groups. HQJZ has the potential of improvement of the patients' gastroscopy outcomes, Helicobacter pylori clearance rate, traditional Chinese Medicine syndromes, and overall effect rate alone or in combination use with conventional western medicine for chronic atrophic gastritis. However, due to poor methodological quality, the beneficial effect and safeties of HQJZ for CG could not be confirmed. PMID:26819622

Quality assessment of digital annotated ECG data from clinical trials by the FDA ECG Warehouse.

Science.gov (United States)

Sarapa, Nenad

2007-09-01

The FDA mandates that digital electrocardiograms (ECGs) from 'thorough' QTc trials be submitted into the ECG Warehouse in Health Level 7 extended markup language format with annotated onset and offset points of waveforms. The FDA did not disclose the exact Warehouse metrics and minimal acceptable quality standards. The author describes the Warehouse scoring algorithms and metrics used by FDA, points out ways to improve FDA review and suggests Warehouse benefits for pharmaceutical sponsors. The Warehouse ranks individual ECGs according to their score for each quality metric and produces histogram distributions with Warehouse-specific thresholds that identify ECGs of questionable quality. Automatic Warehouse algorithms assess the quality of QT annotation and duration of manual QT measurement by the central ECG laboratory.

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

Science.gov (United States)

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.

The health-related quality of life was not improved by targeting higher hemoglobin in the Normal Hematocrit Trial.

Science.gov (United States)

Coyne, Daniel W

2012-07-01

The Normal Hematocrit Trial (NHT) was the largest trial of epoetin randomizing 1265 hemodialysis patients with cardiac disease to lower (9-11 g/dl) or higher (13-15 g/dl) hemoglobin (Hgb), hypothesizing that higher Hgb would reduce mortality, and improve survival and quality of life. The trial was terminated early, and a 1998 publication reported that targeting higher hematocrit levels led to an insignificant increase in the primary end points (death or myocardial infarct), or risk ratio 1.3, 95% confidence interval (CI), 0.9-1.90, but the P-value was not given, and all-cause death risk was not reported. A higher target reportedly did not increase hospitalization rates, but did significantly improve the 'physical function' domain of quality of life. Comparing the 1996 Food and Drug Administration (FDA)-filed clinical trial report to the 1998 publication, however, found several discrepancies. Among these, the 1998 article reported interim trial results with only the adjusted CI but did not state that the unadjusted CIs were 99.912th percentile, and despite being a secondary end point, reported only the association of achieved Hgb with higher quality of life score. Randomization to the higher target had actually increased the risk for the primary end point (risk ratio 1.28, 95% CI=1.06-1.56; P=0.0112; 99.92% CI=0.92-1.78), the risk of death (risk ratio 1.27, 95% CI=1.04-1.54), non-access thrombotic events (P=0.041), and hospitalization rate (P=0.04), while 'physical function' did not improve (P=0.88). Hence, disclosure of these results in the 1998 publication or access to the FDA-filed report on the NHT in the late 1990s would likely have led to earlier concerns about epoetin safety and greater doubts about its benefits.

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

Science.gov (United States)

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.

Subjective and objective outcomes in randomized clinical trials

DEFF Research Database (Denmark)

Moustgaard, Helene; Bello, Segun; Miller, Franklin G

2014-01-01

explicitly defined the terms. CONCLUSION: The terms "subjective" and "objective" are ambiguous when used to describe outcomes in randomized clinical trials. We suggest that the terms should be defined explicitly when used in connection with the assessment of risk of bias in a clinical trial......OBJECTIVES: The degree of bias in randomized clinical trials varies depending on whether the outcome is subjective or objective. Assessment of the risk of bias in a clinical trial will therefore often involve categorization of the type of outcome. Our primary aim was to examine how the concepts...... "subjective outcome" and "objective outcome" are defined in methodological publications and clinical trial reports. To put this examination into perspective, we also provide an overview of how outcomes are classified more broadly. STUDY DESIGN AND SETTING: A systematic review of methodological publications...