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Sample records for methodological quality trials

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

    Science.gov (United States)

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

    2018-02-01

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

  2. Clinical trial methodology

    National Research Council Canada - National Science Library

    Peace, Karl E; Chen, Ding-Geng

    2011-01-01

    ... in the pharmaceutical industry, Clinical trial methodology emphasizes the importance of statistical thinking in clinical research and presents the methodology as a key component of clinical research...

  3. Quality of methodological reporting of randomized clinical trials of sodium-glucose cotransporter-2 (sglt2 inhibitors

    Directory of Open Access Journals (Sweden)

    Hadeel Alfahmi

    2017-01-01

    Full Text Available Sodium-glucose cotransporter-2 (SGLT2 inhibitors are a new class of medicines approved recently for the treatment of type 2 diabetes. To improve the quality of randomized clinical trial (RCT reports, the Consolidated Standards of Reporting Trials (CONSORT statement for methodological features was created. For achieving our objective in this study, we assessed the quality of methodological reporting of RCTs of SGLT2 inhibitors according to the 2010 CONSORT statement. We reviewed and analyzed the methodology of SGLT2 inhibitors RCTs that were approved by the Food & Drug Administration (FDA. Of the 27 trials, participants, eligibility criteria, and additional analyses were reported in 100% of the trials. In addition, trial design, interventions, and statistical methods were reported in 96.3% of the trials. Outcomes were reported in 93.6% of the trials. Settings were reported in 85.2% of the trials. Blinding and sample size were reported in 66.7 and 59.3% of the trials, respectively. Sequence allocation and the type of randomization were reported in 63 and 74.1% of the trials, respectively. Besides those, a few methodological items were inadequate in the trials. Allocation concealment was inadequate in most of the trials. It was reported only in 11.1% of the trials. The majority of RCTs have high percentage adherence for more than half of the methodological items of the 2010 CONSORT statement.

  4. Clinical trial methodology

    National Research Council Canada - National Science Library

    Peace, Karl E; Chen, Ding-Geng

    2011-01-01

    "Now viewed as its own scientific discipline, clinical trial methodology encompasses the methods required for the protection of participants in a clinical trial and the methods necessary to provide...

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

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

    2016-11-01

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

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

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    Humam Saltaji

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

  7. Patient-reported Outcomes in Randomised Controlled Trials of Prostate Cancer: Methodological Quality and Impact on Clinical Decision Making

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

    2014-01-01

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

  8. 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

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

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

    2008-08-01

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

  10. 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.

  11. 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.

  12. Methodological quality of guidelines in gastroenterology.

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    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.

  13. Q methodology, risk training and quality management.

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    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.

  14. Methodological aspects of clinical trials in tinnitus: A proposal for an international standard

    Science.gov (United States)

    Landgrebe, Michael; Azevedo, Andréia; Baguley, David; Bauer, Carol; Cacace, Anthony; Coelho, Claudia; Dornhoffer, John; Figueiredo, Ricardo; Flor, Herta; Hajak, Goeran; van de Heyning, Paul; Hiller, Wolfgang; Khedr, Eman; Kleinjung, Tobias; Koller, Michael; Lainez, Jose Miguel; Londero, Alain; Martin, William H.; Mennemeier, Mark; Piccirillo, Jay; De Ridder, Dirk; Rupprecht, Rainer; Searchfield, Grant; Vanneste, Sven; Zeman, Florian; Langguth, Berthold

    2013-01-01

    Chronic tinnitus is a common condition with a high burden of disease. While many different treatments are used in clinical practice, the evidence for the efficacy of these treatments is low and the variance of treatment response between individuals is high. This is most likely due to the great heterogeneity of tinnitus with respect to clinical features as well as underlying pathophysiological mechanisms. There is a clear need to find effective treatment options in tinnitus, however, clinical trials differ substantially with respect to methodological quality and design. Consequently, the conclusions that can be derived from these studies are limited and jeopardize comparison between studies. Here, we discuss our view of the most important aspects of trial design in clinical studies in tinnitus and make suggestions for an international methodological standard in tinnitus trials. We hope that the proposed methodological standard will stimulate scientific discussion and will help to improve the quality of trials in tinnitus. PMID:22789414

  15. 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

  16. 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....

  17. 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...

  18. 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

  19. Air quality estimation by computational intelligence methodologies

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    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

  20. Quality Assurance in Trichiasis Surgery: a methodology

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    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

  1. Quality assurance in trichiasis surgery: a methodology.

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    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.

  2. A taxonomy of multinational ethical and methodological standards for clinical trials of therapeutic interventions

    Science.gov (United States)

    Ashton, Carol M; Wray, Nelda P; Jarman, Anna F; Kolman, Jacob M; Wenner, Danielle M; Brody, Baruch A

    2013-01-01

    Background If trials of therapeutic interventions are to serve society’s interests, they must be of high methodological quality and must satisfy moral commitments to human subjects. The authors set out to develop a clinical-trials compendium in which standards for the ethical treatment of human subjects are integrated with standards for research methods. Methods The authors rank-ordered the world’s nations and chose the 31 with >700 active trials as of 24 July 2008. Governmental and other authoritative entities of the 31 countries were searched, and 1004 English-language documents containing ethical and/or methodological standards for clinical trials were identified. The authors extracted standards from 144 of those: 50 designated as ‘core’, 39 addressing trials of invasive procedures and a 5% sample (N=55) of the remainder. As the integrating framework for the standards we developed a coherent taxonomy encompassing all elements of a trial’s stages. Findings Review of the 144 documents yielded nearly 15 000 discrete standards. After duplicates were removed, 5903 substantive standards remained, distributed in the taxonomy as follows: initiation, 1401 standards, 8 divisions; design, 1869 standards, 16 divisions; conduct, 1473 standards, 8 divisions; analysing and reporting results, 997 standards, four divisions; and post-trial standards, 168 standards, 5 divisions. Conclusions The overwhelming number of source documents and standards uncovered in this study was not anticipated beforehand and confirms the extraordinary complexity of the clinical trials enterprise. This taxonomy of multinational ethical and methodological standards may help trialists and overseers improve the quality of clinical trials, particularly given the globalisation of clinical research. PMID:21429960

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

    Science.gov (United States)

    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.

  4. Quality of clinical trials: A moving target

    Science.gov (United States)

    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

  5. 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.

  6. The main aspects of methodology of quality management system

    Directory of Open Access Journals (Sweden)

    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.

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

    Science.gov (United States)

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

    2018-04-01

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

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

    Science.gov (United States)

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

    2010-03-03

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

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

    Directory of Open Access Journals (Sweden)

    André R Brunoni

    2010-03-01

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

  10. 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....

  11. Dynamic benchmarking methodology for Quality Function Deployment

    NARCIS (Netherlands)

    Raharjo, H.; Brombacher, A.C.; Chai, K.H.; Bergman, B.

    2008-01-01

    A competitive advantage, generally, can be gained if a firm produces a product that not only addresses what the customer values most, but also performs better than its competitors in terms of quality, cost, and timeliness. However, these two factors, namely, the customer needs and competitorspsila

  12. Methodologies for defining quality of life

    Energy Technology Data Exchange (ETDEWEB)

    Glicken, J. [Ecological Planning and Toxicology, Inc., Albuquerque, NM (United States); Engi, D. [Sandia National Labs., Albuquerque, NM (United States)

    1996-10-10

    Quality of life as a concept has been used in many ways in the public policy arena. It can be used in summative evaluations to assess the impacts of policies or programs. Alternatively, it can be applied to formative evaluations to provide input to the formation of new policies. In short, it provides the context for the understanding needed to evaluate the results of choices that have been made in the public policy arena, or the potential of choices yet to be made. In either case, the public policy question revolves around the positive or negative impact the choice will have on quality of life, and the magnitude of that impact. This discussion will develop a conceptual framework that proposes that an assessment of quality of life is based on a comparison of expectations with experience. The framework defines four basic components from which these expectations arise: natural conditions, social conditions, the body, and the mind. Each one of these components is generally described, and associated with a general policy or rhetorical category which gives it its policy vocabulary--environmental quality, economic well-being, human health, and self-fulfillment.

  13. Methodological quality of systematic reviews on influenza vaccination.

    Science.gov (United States)

    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.

  14. 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....

  15. Quality assurance of asthma clinical trials.

    Science.gov (United States)

    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.

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

    Science.gov (United States)

    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.

  17. Methodological quality of systematic reviews addressing femoroacetabular impingement.

    Science.gov (United States)

    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.

  18. A quality assessment of randomized controlled trial reports in endodontics.

    Science.gov (United States)

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

    2017-03-01

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

  19. 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

  20. "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.

  1. Cluster Randomised Trials in Cochrane Reviews: Evaluation of Methodological and Reporting Practice.

    Directory of Open Access Journals (Sweden)

    Marty Richardson

    Full Text Available Systematic reviews can include cluster-randomised controlled trials (C-RCTs, which require different analysis compared with standard individual-randomised controlled trials. However, it is not known whether review authors follow the methodological and reporting guidance when including these trials. The aim of this study was to assess the methodological and reporting practice of Cochrane reviews that included C-RCTs against criteria developed from existing guidance.Criteria were developed, based on methodological literature and personal experience supervising review production and quality. Criteria were grouped into four themes: identifying, reporting, assessing risk of bias, and analysing C-RCTs. The Cochrane Database of Systematic Reviews was searched (2nd December 2013, and the 50 most recent reviews that included C-RCTs were retrieved. Each review was then assessed using the criteria.The 50 reviews we identified were published by 26 Cochrane Review Groups between June 2013 and November 2013. For identifying C-RCTs, only 56% identified that C-RCTs were eligible for inclusion in the review in the eligibility criteria. For reporting C-RCTs, only eight (24% of the 33 reviews reported the method of cluster adjustment for their included C-RCTs. For assessing risk of bias, only one review assessed all five C-RCT-specific risk-of-bias criteria. For analysing C-RCTs, of the 27 reviews that presented unadjusted data, only nine (33% provided a warning that confidence intervals may be artificially narrow. Of the 34 reviews that reported data from unadjusted C-RCTs, only 13 (38% excluded the unadjusted results from the meta-analyses.The methodological and reporting practices in Cochrane reviews incorporating C-RCTs could be greatly improved, particularly with regard to analyses. Criteria developed as part of the current study could be used by review authors or editors to identify errors and improve the quality of published systematic reviews incorporating

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

    Science.gov (United States)

    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.

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

    Science.gov (United States)

    2011-01-01

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

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

    Science.gov (United States)

    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).

  5. Industry funded clinical trials: bias and quality.

    Science.gov (United States)

    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.

  6. 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.

  7. 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

  8. 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.

  9. 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

  10. 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.

  11. 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.

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

    Science.gov (United States)

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

    2015-01-08

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

  13. Organ Donation European Quality System: ODEQUS project methodology.

    Science.gov (United States)

    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

  14. ASSESSMENT OF QUALITY OF LIFE: PRESENT AND FUTURE METHODOLOGICAL CHALLENGES

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    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.

  15. A Quality-Driven Methodology for Information Systems Integration

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    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.

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

    Directory of Open Access Journals (Sweden)

    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

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  1. 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)

  2. 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.

  3. 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.

  4. 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.

  5. Reporting and methodologic quality of Cochrane Neonatal review group systematic reviews

    Directory of Open Access Journals (Sweden)

    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.

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

    Directory of Open Access Journals (Sweden)

    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.

  7. 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.

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

    Science.gov (United States)

    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.

  9. 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.

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

    Energy Technology Data Exchange (ETDEWEB)

    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)

  11. 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

  12. Quality of reporting in oncology phase II trials: A 5-year assessment through systematic review.

    Science.gov (United States)

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

    2017-01-01

    Phase II clinical trials are a cornerstone of the development in experimental treatments They work as a "filter" for phase III trials confirmation. Surprisingly the attrition ratio in Phase III trials in oncology is significantly higher than in any other medical specialty. This suggests phase II trials in oncology fail to achieve their goal. Objective The present study aims at estimating the quality of reporting in published oncology phase II clinical trials. A literature review was conducted among all phase II and phase II/III clinical trials published during a 5-year period (2010-2015). All articles electronically published by three randomly-selected oncology journals with Impact-Factors>4 were included: Journal of Clinical Oncology, Annals of Oncology and British Journal of Cancer. Quality of reporting was assessed using the Key Methodological Score. 557 articles were included. 315 trials were single-arm studies (56.6%), 193 (34.6%) were randomized and 49 (8.8%) were non-randomized multiple-arm studies. The Methodological Score was equal to 0 (lowest level), 1, 2, 3 (highest level) respectively for 22 (3.9%), 119 (21.4%), 270 (48.5%) and 146 (26.2%) articles. The primary end point is almost systematically reported (90.5%), while sample size calculation is missing in 66% of the articles. 3 variables were independently associated with reporting of a high standard: presence of statistical design (p-value <0.001), multicenter trial (p-value = 0.012), per-protocol analysis (p-value <0.001). Screening was mainly performed by a sole author. The Key Methodological Score was based on only 3 items, making grey zones difficult to translate. This literature review highlights the existence of gaps concerning the quality of reporting. It therefore raised the question of the suitability of the methodology as well as the quality of these trials, reporting being incomplete in the corresponding articles.

  13. 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).

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

    Science.gov (United States)

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

    2014-01-14

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

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

    Directory of Open Access Journals (Sweden)

    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

  16. 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)

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

    Directory of Open Access Journals (Sweden)

    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.

  18. [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.

  19. 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 ...

  20. 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' (...

  1. 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...

  2. 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)

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

    Science.gov (United States)

    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.

  4. 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…

  5. Assessing quality of reports on randomized clinical trials in nursing journals.

    Science.gov (United States)

    Parent, Nicole; Hanley, James A

    2009-01-01

    Several surveys have presented the quality of reports on randomized clinical trials (RCTs) published in general and specialty medical journals. The aim of these surveys was to raise scientific consciousness on methodological aspects pertaining to internal and external validity. These reviews have suggested that the methodological quality could be improved. We conducted a survey of reports on RCTs published in nursing journals to assess their methodological quality. The features we considered included sample size, flow of participants, assessment of baseline comparability, randomization, blinding, and statistical analysis. We collected data from all reports of RCTs published between January 1994 and December 1997 in Applied Nursing Research, Heart & Lung and Nursing Research. We hand-searched the journals and included all 54 articles in which authors reported that individuals have been randomly allocated to distinct groups. We collected data using a condensed form of the Consolidated Standards of Reporting Trials (CONSORT) statement for structured reporting of RCTs (Begg et al., 1996). Sample size calculations were included in only 22% of the reports. Only 48% of the reports provided information about the type of randomization, and a mere 22% described blinding strategies. Comparisons of baseline characteristics using hypothesis tests were abusively produced in more than 76% of the reports. Excessive use and unstructured reports of significance testing were common (59%), and all reports failed to provide magnitude of treatment differences with confidence intervals. Better methodological quality in reports of RCTs will contribute to increase the standards of nursing research.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

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

    Science.gov (United States)

    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.

  11. 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

  12. 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

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

    Science.gov (United States)

    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.

  14. 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...

  15. 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.

  16. 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.

  17. 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

  18. 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

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

    Directory of Open Access Journals (Sweden)

    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

  20. 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.

  1. Systematic review adherence to methodological or reporting quality

    DEFF Research Database (Denmark)

    Pussegoda, Kusala; Turner, Lucy; Garritty, Chantelle

    2017-01-01

    /1741) provided a rationale for the review and less than 6% (102/1741) provided protocol information. For reports using QUOROM, only 9% (40/449) of SRs provided a trial flow diagram. However, 90% (402/449) described the explicit clinical problem and review rationale in the introduction section. Of reports using...

  2. 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.

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

    Directory of Open Access Journals (Sweden)

    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.

  4. 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

  5. Methodology for Evaluating Quality and Reusability of Learning Objects

    Science.gov (United States)

    Kurilovas, Eugenijus; Bireniene, Virginija; Serikoviene, Silvija

    2011-01-01

    The aim of the paper is to present the scientific model and several methods for the expert evaluation of quality of learning objects (LOs) paying especial attention to LOs reusability level. The activities of eQNet Quality Network for a European Learning Resource Exchange (LRE) aimed to improve reusability of LOs of European Schoolnet's LRE…

  6. Dictionary quality and dictionary design: a methodology for ...

    African Journals Online (AJOL)

    Although recent dictionaries for the ESL market have been praised for their innovative design features, the prime concern of users, lexicographers and metalexicographers is the functional quality of the dictionary products provided for the market. The functional quality of dictionaries and the scientific assessment thereof ...

  7. [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.

  8. 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

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

    Science.gov (United States)

    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.

  10. 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

  11. 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

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

    Science.gov (United States)

    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.

  13. 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…

  14. 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

  15. Automatic ECG quality scoring methodology: mimicking human annotators

    International Nuclear Information System (INIS)

    Johannesen, Lars; Galeotti, Loriano

    2012-01-01

    An algorithm to determine the quality of electrocardiograms (ECGs) can enable inexperienced nurses and paramedics to record ECGs of sufficient diagnostic quality. Previously, we proposed an algorithm for determining if ECG recordings are of acceptable quality, which was entered in the PhysioNet Challenge 2011. In the present work, we propose an improved two-step algorithm, which first rejects ECGs with macroscopic errors (signal absent, large voltage shifts or saturation) and subsequently quantifies the noise (baseline, powerline or muscular noise) on a continuous scale. The performance of the improved algorithm was evaluated using the PhysioNet Challenge database (1500 ECGs rated by humans for signal quality). We achieved a classification accuracy of 92.3% on the training set and 90.0% on the test set. The improved algorithm is capable of detecting ECGs with macroscopic errors and giving the user a score of the overall quality. This allows the user to assess the degree of noise and decide if it is acceptable depending on the purpose of the recording. (paper)

  16. 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

  17. 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....

  18. A methodology of healthcare quality measurement: a case study

    International Nuclear Information System (INIS)

    Pecoraro, F; Luzi, D; Federico II, Naples (Italy))" data-affiliation=" (Department of Electrical Engineering and Information Technology and Interuniversity Centre of Bioengineering of the Human Neuromusculoskeletal System, University of Naples, Federico II, Naples (Italy))" >Cesarelli, M; Clemente, F

    2015-01-01

    In this paper we present a comprehensive model for quality assessment taking into account structure, process and outcome dimensions introduced in the Donabedian framework. To test our hypothesis a case study based on the Italian healthcare services is reported focusing on the analysis of the hospital bed management and on the phenomenon of both active and passive patient mobility

  19. Measurement of quality of life I. A methodological framework

    DEFF Research Database (Denmark)

    Ventegodt, Søren; Hilden, Jørgen; Merrick, Joav

    2003-01-01

    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...

  20. Future vision for the quality assurance of oncology clinical trials

    Directory of Open Access Journals (Sweden)

    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.

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

    Science.gov (United States)

    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

  2. Terminology and methodology in modelling for water quality management

    DEFF Research Database (Denmark)

    Carstensen, J.; Vanrolleghem, P.; Rauch, W.

    1997-01-01

    There is a widespread need for a common terminology in modelling for water quality management. This paper points out sources of confusion in the communication between researchers due to misuse of existing terminology or use of unclear terminology. The paper attempts to clarify the context...... of the most widely used terms for characterising models and within the process of model building. It is essential to the ever growing society of researchers within water quality management, that communication is eased by establishing a common terminology. This should not be done by giving broader definitions...... of the terms, but by stressing the use of a stringent terminology. Therefore, the goal of the paper is to advocate the use of such a well defined and clear terminology. (C) 1997 IAWQ. Published by Elsevier Science Ltd....

  3. KAIZEN METHODOLOGY IN QUALITY MANAGEMENT TO REDUCE WASTES

    Directory of Open Access Journals (Sweden)

    Boca Gratiela Dana

    2011-01-01

    Full Text Available Kaizen cannot deal with all problems and one size does not fit all but a flexibleimplementation opens up the dimension of collaboration between the workforce, themanagement and the technical departments. In every company, it operates in a differentway to suit the circumstances but all consider it indispensable. It is more flexible andtolerant than may be expected; it is a tool for integration of technological strategy with thebusiness strategy of the organization. Technology is forcing organizations to become morecompetitive as at every instance innovations take place. Recent innovations in the form oftotal quality management, reengineering work process, flexible manufacturing system haveonly one thing in common - well serving the customer by improved operational efficiency.For instant Quality Management advocates emphasize the importance of achieving higherquality and flexibility at lower level of cost and waste.

  4. The economic valuation of environmental quality: A methodological study

    International Nuclear Information System (INIS)

    Sung Yucsheng.

    1991-01-01

    Conducted in the context of sportfishing, this study uses Michigan data to estimate fishing demand and resulting consumer surplus accruing from environmental-policy implementation. For the modeling of fish-species and site decisions, a nested multinomial logit model is employed. On a pre-determined choice occasion during which a trip of a specific duration will be taken, an angler is assumed first to make a fish-species decision, then choose a site. The seasonal-participation decision is modeled by a competing-risks stochastic renewal process, incorporating time-varying parameters to account for changes in site quality through time. Since the number of trips would most likely change after a potential site-quality improvement, the proposed seasonal compensating variation (CV) calculation takes into account (1) the CV associated with the trips that would have been taken before the quality improvement, and (2) the CV associated with the new trips. The approach proposed in this study is applied to two real world policy scenarios: The termination of the Ludington Pumped Storage plant operation, and the removal of PCB contamination in the Kalamazoo River. The compensating variation is derived for both applications

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

    Directory of Open Access Journals (Sweden)

    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.

  6. 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

  7. 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 ...

  8. 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…

  9. 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…

  10. 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.

  11. 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…

  12. Dosimetric quality control in radiotherapy using TLD methodology

    International Nuclear Information System (INIS)

    Saravi, M.C.; Kessler, C.; Alvarez, P.E.; Feld, D.B.

    2002-01-01

    In the frame of the IAEA Co-ordinated Research Project 'Development of a Quality Assurance Program for Radiation Therapy Dosimetry in Developing Countries' a Dosimetric Quality Control Group was set up in Argentina in 1996, to develop a program in order to improve radiotherapy in the country. Nowadays, this Group, briefly called External Audit Group (EAG), is composed by the national Secondary Standard Dosimetry Laboratory (SSDL), which has the responsibility for dose determinations, traceability to international dosimetry chain and TLD measurements, and two Medical Physicists from CNEA who are working at the Oncology Hospital 'Marie Curie' in Buenos Aires. The present paper reports the activities performed by the EAG with external high energy photon beams in reference conditions and the results of two pilot studies on cobalt 60 beams in non-reference conditions. The first step of the program was to update the existing data base about the radiotherapy centres operating in the country. A form was sent to each of them in order to obtain basic information about their staff, number and type of treatment machines, brachytherapy sources, measuring devices, beam calibration, treatment planning system, simulator and other relevant data. 90 radiotherapy centres were registered in the EAG data base. Forms were completed by 75/90 centres. There are nowadays 69 cobalt 60 units and 42 LINACs operating in the country (18/42 LINACs producing high energy X ray and electron beams). EAG deals with measurements performed with mailed TLD irradiated at radiotherapy centres. Internal quality control on our TLD system is made during each audit by means of reference capsules irradiated by IAEA; external controls consist in blind tests performed by IAEA once a year. The correction factor, K en , determined at our SSDL for high energy X-rays was checked with the collaboration of IAEA and Prague National Radiation Protection Institute (PNRPI) by means of a blind test. Results for 4 MV, 6 MV

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

    Science.gov (United States)

    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.

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

    Science.gov (United States)

    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.

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

    Science.gov (United States)

    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

  16. Quality Improvement Methodologies Increase Autologous Blood Product Administration

    Science.gov (United States)

    Hodge, Ashley B.; Preston, Thomas J.; Fitch, Jill A.; Harrison, Sheilah K.; Hersey, Diane K.; Nicol, Kathleen K.; Naguib, Aymen N.; McConnell, Patrick I.; Galantowicz, Mark

    2014-01-01

    Abstract: Whole blood from the heart–lung (bypass) machine may be processed through a cell salvaging device (i.e., cell saver [CS]) and subsequently administered to the patient during cardiac surgery. It was determined at our institution that CS volume was being discarded. A multidisciplinary team consisting of anesthesiologists, perfusionists, intensive care physicians, quality improvement (QI) professionals, and bedside nurses met to determine the challenges surrounding autologous blood delivery in its entirety. A review of cardiac surgery patients’ charts (n = 21) was conducted for analysis of CS waste. After identification of practices that were leading to CS waste, interventions were designed and implemented. Fishbone diagram, key driver diagram, Plan–Do–Study–Act (PDSA) cycles, and data collection forms were used throughout this QI process to track and guide progress regarding CS waste. Of patients under 6 kg (n = 5), 80% had wasted CS blood before interventions, whereas those patients larger than 36 kg (n = 8) had 25% wasted CS before interventions. Seventy-five percent of patients under 6 kg who had wasted CS blood received packed red blood cell transfusions in the cardiothoracic intensive care unit within 24 hours of their operation. After data collection and didactic education sessions (PDSA Cycle I), CS blood volume waste was reduced to 5% in all patients. Identification and analysis of the root cause followed by implementation of education, training, and management of change (PDSA Cycle II) resulted in successful use of 100% of all CS blood volume. PMID:24783313

  17. 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

  18. 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.

  19. 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...

  20. 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.

  1. 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.

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

    Science.gov (United States)

    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.

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

    Science.gov (United States)

    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.

  4. 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...

  5. 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

  6. 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.

  7. 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.

  8. 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?

  9. 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

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

    Science.gov (United States)

    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.

  11. #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

  12. 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.

  13. 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....

  14. 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…

  15. 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

  16. 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

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

    Science.gov (United States)

    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.

  18. 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)

  19. A systematic review of the quality of homeopathic clinical trials

    Science.gov (United States)

    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

  20. 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)

  1. 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.

  2. 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

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

    Science.gov (United States)

    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.

  4. [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).

  5. Lumbar Sympathetic Plexus Block as a Treatment for Postamputation Pain: Methodology for a Randomized Controlled Trial.

    Science.gov (United States)

    McCormick, Zachary L; Hendrix, Andrew; Dayanim, David; Clay, Bryan; Kirsling, Amy; Harden, Norman

    2018-03-08

    We present a technical protocol for rigorous assessment of patient-reported outcomes and psychophysical testing relevant to lumbar sympathetic blocks for the treatment of postamputation pain (PAP). This description is intended to inform future prospective investigation. Series of four participants from a blinded randomized sham-controlled trial. Tertiary, urban, academic pain medicine center. Four participants with a single lower limb amputation and associated chronic PAP. Participants were randomized to receive a lumbar sympathetic block with 0.25% bupivacaine or sham needle placement. Patient-rated outcome measures included the numerical rating scale (NRS) for pain, the McGill Pain Questionnaire-Short Form, Center for Epidemiological Studies Depression Scale, Pain and Anxiety Symptoms Scale-short version, and Pain Disability Index (PDI). Psychophysical and biometric testing was also performed, which included vibration sensation testing, pinprick sensation testing, brush sensation testing, Von Frey repeated weighted pinprick sensation, and thermal quantitative sensory testing. In the four described cases, treatment of PAP with a single lumbar sympathetic block but not sham intervention resulted in reduction of both residual limb pain and phantom limb pain as well as perceived disability on the PDI at three-month follow-up. An appropriately powered randomized controlled study using this methodology may not only aid in determining the possible clinical efficacy of lumbar sympathetic block in PAP, but could also improve our understanding of underlying pathophysiologic mechanisms of PAP.

  6. 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.

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

    Directory of Open Access Journals (Sweden)

    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.

  8. Clinical trials of homoeopathy.

    Science.gov (United States)

    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

  9. 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

  10. 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.

  11. 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)

  12. 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 ...

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

    Science.gov (United States)

    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.

  14. 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)

  15. 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...

  16. 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...

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

    Science.gov (United States)

    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.

  18. 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.

  19. 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.

  20. A methodology to improve higher education quality using the quality function deployment and analytic hierarchy process

    NARCIS (Netherlands)

    Raharjo, H.; Xie, M.; Goh, T.N.; Brombacher, A.C.

    2007-01-01

    In order to formulate an effective strategic plan in a customer-driven education context, it is important to recognize who the customers are and what they want. Using Quality Function Deployment (QFD), this information can be translated into strategies to achieve customer satisfaction. Since the

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

    Directory of Open Access Journals (Sweden)

    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.

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

    Directory of Open Access Journals (Sweden)

    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

  3. 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...

  4. 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

  5. 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.

  6. The reporting quality of randomized controlled trials in orthodontics.

    Science.gov (United States)

    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

  7. 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.

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

    Directory of Open Access Journals (Sweden)

    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.

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

    Science.gov (United States)

    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

  10. 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...

  11. 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)

  12. 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)

  13. 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)

  14. 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.

  15. Methodological considerations for a randomised controlled trial of podiatry care in rheumatoid arthritis: lessons from an exploratory trial

    OpenAIRE

    Turner, Deborah E; Helliwell, Philip S; Woodburn, James

    2007-01-01

    Abstract Background Whilst evidence exists to support the use of single treatments such as orthoses and footwear, the effectiveness of podiatry-led care as a complex intervention for patients with rheumatoid arthritis (RA) related foot problems is unknown. The aim of this study was to undertake an exploratory randomised controlled parallel arm clinical trial (RheumAFooT) to inform the design and implementation of a definitive trial and to understand the potential benefits of this care. Method...

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

    Science.gov (United States)

    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.

  17. 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

  18. 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

  19. 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

  20. 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...

  1. 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.

  2. 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.

  3. 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.

  4. THE QUALITY IMPROVEMENT OF PRIMER PACKAGING PROCESS USING SIX SIGMA METHODOLOGY

    Directory of Open Access Journals (Sweden)

    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.

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

    Science.gov (United States)

    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

  6. 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...

  7. 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.

    Science.gov (United States)

    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

  8. 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

  9. Quality assurance and quality control methodologies used within the austrian UV monitoring network

    International Nuclear Information System (INIS)

    Mario, B.

    2004-01-01

    The Austrian UVB monitoring network is operational since 1997. Nine detectors for measuring erythemally weighted solar UV irradiance are distributed over Austria in order to cover the main populated areas as well as different levels of altitude. The detectors are calibrated to indicate the UV-Index, the internationally agreed unit for erythemally weighted solar UV irradiance. Calibration is carried out in the laboratory for determination of spectral sensitivity of each detector, and under the sun for absolute comparison with a well-calibrated, double-monochromator spectro-radiometer. For the conversion from detector-weighted units to erythemally weighted units a lookup table is used, which is calculated using a radiative transfer model and which reflects the dependence of the conversion on the solar zenith angle and total ozone content of the atmosphere. The uncertainty of the calibration is about ±7%, dominated by the uncertainty of the calibration lamp for the spectro-radiometer (±4%). The long-term stability of this type of detectors has been found to be not satisfactory. Therefore, routinely every year all detectors are completely re-calibrated. Variations of the calibration factors up to ±10% are found. Thus, during routine operation, several measures take place for quality control. The measured data are compared to results of model calculations with a radiative transfer model, where clear sky and an aerosol-free atmosphere are assumed. At each site, the UV data are also compared with data from a co-located pyrano-meter measuring total solar irradiance. These two radiation quantities are well correlated, especially on clear days and when the ozone content is taken into account. If suspicious measurements are found for one detector in the network, a well-calibrated travelling reference detector of the same type is set up side-by-side, allowing the identification of relative differences of ∼3%. If necessary, a recalibration is carried out. As the main aim

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

    Science.gov (United States)

    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

  11. 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

  12. 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

  13. 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.

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

    Science.gov (United States)

    Solazzo, Efisio; Vardoulakis, Sotiris; Cai, Xiaoming

    2011-09-01

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

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

    Directory of Open Access Journals (Sweden)

    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

  16. Use of Proteomic Methodology in Optimization of Processing and Quality Control of Food of Animal Origin

    Directory of Open Access Journals (Sweden)

    Dajana Gašo-Sokač

    2011-01-01

    Full Text Available Food of animal origin, namely meat, seafood, milk and milk products, is the main protein source in human nutrition. These types of food are very complex mixtures that contain proteins and other components, and proteomic techniques enable simultaneous study of several hundred up to several thousand proteins. The use of proteomic methodology for quality control and quality assessment in production as well as for the optimization and development of new manufacturing processes is presented. Newly developed, faster and more selective methods for sample preparation followed by more sensitive mass spectrometry for identification of less abundant proteins are discussed. These techniques will help to understand variations in production, and to find markers for food quality criteria. Furthermore, biologically active peptides in food of animal origin have recently been the focus of proteomic and peptidomic investigations. Isolation and production of biologically active proteins and peptides, including the low abundance ones, will also be a focus of future research. The use of proteomics, peptidomics and metabonomics for the determination of product quality and the detection of adulterations in meat production, seafood identification and in the production of milk and milk products is also discussed.

  17. 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

  18. 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.

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

    Science.gov (United States)

    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.

  20. Methodological considerations for a randomised controlled trial of podiatry care in rheumatoid arthritis: lessons from an exploratory trial

    Directory of Open Access Journals (Sweden)

    Helliwell Philip S

    2007-11-01

    Full Text Available Abstract Background Whilst evidence exists to support the use of single treatments such as orthoses and footwear, the effectiveness of podiatry-led care as a complex intervention for patients with rheumatoid arthritis (RA related foot problems is unknown. The aim of this study was to undertake an exploratory randomised controlled parallel arm clinical trial (RheumAFooT to inform the design and implementation of a definitive trial and to understand the potential benefits of this care. Methods Patients with a definite diagnosis of RA, stable drug management 3 months prior to entry, and a current history of foot problems (pain, deformity, stiffness, skin or nail lesions, or footwear problems were recruited from a hospital outpatient rheumatology clinic and randomised to receive 12 months of podiatry treatment or no care. The primary outcome was change in foot health status using the impairment/footwear (LFISIF and activity limitation/participation restriction (LFISAP subscales of the Leeds Foot Impact Scale. Disease Activity Score (DAS, Health Assessment Questionnaire (HAQ score and walking speed (m/s were also recorded. Results Of the 80 patients identified, 64 patients were eligible to participate in the pilot and 34 were recruited. 16 patients were randomised to receive podiatry led foot care and 18 received no care. Against a backdrop of stable disease (DAS and HAQ scores, there was a statistically significant between group difference in the change in foot health status for foot impairment (LFISIF but not activity/participation (LFISAP or function (walking speed over 12 months. In the podiatry arm, 1 patient declined treatment following randomisation (did not want additional hospital visits and 3 self-withdrew (lost to follow-up. Patients received an average of 3 consultations for assessment and treatment comprising routine care for skin and nail lesions (n = 3, foot orthoses (n = 9, footwear referral to the orthotist (n = 5, and ultrasound

  1. Methodological challenges in designing dementia prevention trials - The European Dementia Prevention Initiative (EDPI)

    NARCIS (Netherlands)

    Richard, Edo; Andrieu, Sandrine; Solomon, Alina; Mangialasche, Francesca; Ahtiluoto, Satu; Moll van Charante, Eric P.; Coley, Nicola; Fratiglioni, Laura; Neely, Anna Stigsdotter; Vellas, Bruno; van Gool, Willem A.; Kivipelto, Miia

    2012-01-01

    Recent epidemiological studies have indicated numerous associations between vascular and lifestyle related risk factors and incident dementia. However, evidence from randomised controlled trials (RCT) showing effectiveness of interventions aimed at these risk factors in preventing or postponing

  2. Development of a quality management system for borehole investigations. (1) Quality assurance and quality control methodology for hydraulic packer testing

    International Nuclear Information System (INIS)

    Takeuchi, Shinji; Kunimaru, Takanori; Ota, Kunio; Frieg, Bernd

    2011-01-01

    A quality assurance and quality control (QA/QC) system for the hydraulic packer tests has been established based on the surface-based investigations at JAEA's underground research laboratories in Mizunami and Horonobe. The established QA/QC system covers field investigations (data acquisition) and data analysis. For the field investigations, the adopted procedure is selection of a test section based on a detail fluid logging and checking with tally list, followed by inspection of test tools such as pressure transducers and shut-in valves, etc., test method selection using a 'sequential hydraulic test' for deciding appropriate method, and finally data quality confirmation by pressure changes and derivatives on a log-log plots during testing. Test event logs should also be described during testing for traceability. For the test data analysis, a quick analysis for rough estimation of hydraulic parameters, and a detailed analysis using type curve and/or numerical analyses are conducted stepwise. The established QA/QC system has been applied to the recent borehole investigations and its efficiency has been confirmed. (author)

  3. [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.

  4. 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.

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

    Science.gov (United States)

    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

  6. Methodological considerations for a randomised controlled trial of podiatry care in rheumatoid arthritis: lessons from an exploratory trial.

    Science.gov (United States)

    Turner, Deborah E; Helliwell, Philip S; Woodburn, James

    2007-11-06

    Whilst evidence exists to support the use of single treatments such as orthoses and footwear, the effectiveness of podiatry-led care as a complex intervention for patients with rheumatoid arthritis (RA) related foot problems is unknown. The aim of this study was to undertake an exploratory randomised controlled parallel arm clinical trial (RheumAFooT) to inform the design and implementation of a definitive trial and to understand the potential benefits of this care. Patients with a definite diagnosis of RA, stable drug management 3 months prior to entry, and a current history of foot problems (pain, deformity, stiffness, skin or nail lesions, or footwear problems) were recruited from a hospital outpatient rheumatology clinic and randomised to receive 12 months of podiatry treatment or no care. The primary outcome was change in foot health status using the impairment/footwear (LFISIF) and activity limitation/participation restriction (LFISAP) subscales of the Leeds Foot Impact Scale. Disease Activity Score (DAS), Health Assessment Questionnaire (HAQ) score and walking speed (m/s) were also recorded. Of the 80 patients identified, 64 patients were eligible to participate in the pilot and 34 were recruited. 16 patients were randomised to receive podiatry led foot care and 18 received no care. Against a backdrop of stable disease (DAS and HAQ scores), there was a statistically significant between group difference in the change in foot health status for foot impairment (LFISIF) but not activity/participation (LFISAP) or function (walking speed) over 12 months. In the podiatry arm, 1 patient declined treatment following randomisation (did not want additional hospital visits) and 3 self-withdrew (lost to follow-up). Patients received an average of 3 consultations for assessment and treatment comprising routine care for skin and nail lesions (n = 3), foot orthoses (n = 9), footwear referral to the orthotist (n = 5), and ultrasound guided intra-articular steroid injection

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

    Science.gov (United States)

    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.

  8. 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.

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

    Science.gov (United States)

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

    2018-01-01

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

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

    Science.gov (United States)

    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.

  11. Report on use of a methodology for commissioning and quality assurance of a VMAT system.

    Directory of Open Access Journals (Sweden)

    Charles Mayo

    Full Text Available 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 QA measurement approach is defined. RESULTS: Agreement in the static vs. VMAT picket fence control point test was better than 0.5 mm. Control point tests varying gantry rotation speed, leaf speed and dose rate, demonstrated agreement with predicted values better than 1%. Angular dependence of the MatriXX array, varied over a range of 0.94-1.06, with respect to the calibration condition. Phantom measurements demonstrated central axis dose accuracy for un-modulated four field box plans was ≥2.5% vs. 1% with and without angular correction respectively with better results for VMAT (0.4% vs. IMRT (1.6% plans. Daily QA results demonstrated average agreement all three chambers within 0.4% over 9 month period with no false positives at a 3% threshold. DISCUSSION: The methodology described is simple in design and characterizes both the inherit limitations of the measurement system as well at the dose based measurements that may be directly related to patient plan QA.

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

    Science.gov (United States)

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

    2015-07-14

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

  13. Investigation Of Infrared Drying Behaviour Of Spinach Leaves Using ANN Methodology And Dried Product Quality

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    Sarimeseli Ayse

    2015-12-01

    Full Text Available Effects of infrared power output and sample mass on drying behaviour, colour parameters, ascorbic acid degradation, rehydration characteristics and some sensory scores of spinach leaves were investigated. Within both of the range of the infrared power outputs, 300–500 W, and sample amounts, 15–60 g, moisture content of the leaves was reduced from 6.0 to 0.1±(0.01 kg water/kg dry base value. It was recorded that drying times of the spinach leaves varied between 3.5–10 min for constant sample amount, and 4–16.5 min for constant power output. Experimental drying data obtained were successfully investigated by using artificial neural network methodology. Some changes were recorded in the quality parameters of the dried leaves, and acceptable sensory scores for the dried leaves were observed in all of the experimental conditions.

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

    Science.gov (United States)

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

    2015-05-15

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

  15. Methodological quality of systematic reviews in subfertility: a comparison of two different approaches.

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    Ivor Popovich

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

  16. 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

  17. 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.

  18. Reducing DNACPR complaints to zero: designing and implementing a treatment escalation plan using quality improvement methodology.

    Science.gov (United States)

    Shermon, Elizabeth; Munglani, Laura; Oram, Sarah; William, Linda; Abel, Julian

    2017-01-01

    Do Not Attempt Resuscitation (DNAR)decisions have traditionally formed the basis of ceiling of care discussions. However, poor quality discussions can lead to high patient and relative dissatisfaction, generating hospital complaints. Treatment escalation plans (TEPs) aim to highlight the wider remit of treatment options with a focus on effective communication. We aimed to improve TEP discussions and documentation at Weston General Hospital by introducing a standardised form. We aimed to develop a TEP document to reduce resuscitation-related complaints by improving communication and documentation. Qualitative and quantitative data were collected over 2 years and used to develop plan-do-study-act (PDSA) cycles using quality improvement methodology. Main barriers to improvement included time constraints and clinician's resistance. Analysis of patient liaison services data showed a progressive reduction in complaints regarding resuscitation, with no complaints having been received for the final six months of the project. Through use of a standardised form including treatment prompts, the quality of discussions and plans improved. Qualitative feedback demonstrated increased patient and relative satisfaction. In addition, junior doctors report the plans are helpful when making out-of-hours decisions. Development of a user-friendly form to document patient-guided TEPs helped junior doctors to lead advanced care planning discussions. The use of PDSA cycles demonstrated improvement in the quality of forms, which in turn improved communication, documentation and satisfaction. Future developments could include involvement of specialist teams to ensure TEP forms remain relevant to all clinical areas. In addition, with widespread use of the TEP forms, the traditional tick-box DNAR could be replaced to focus on patient-led care planning.

  19. 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.

  20. [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

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

    Science.gov (United States)

    Esposito, Pasquale; Dal Canton, Antonio

    2014-01-01

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

  2. 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.

  3. 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.

  4. 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

  5. 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.

  6. Social control of the quality of public services: Theory, methodology and results of empirical research

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    Evgeny A. Kapoguzov

    2017-06-01

    Full Text Available The article reveals the theoretical and methodological aspect of the problem of social control in relation to the possibility of its implementation in the production of public services. The interdisciplinary nature of the discourse on the nature of social control is presented, the evolution of ideas about it in the framework of social science concepts is presented, and the relationship with related categories is revealed, in particular, "public control", "civil control". The evolution of essence is also traced the category "institutionalization", it is shown the lack of unambiguousness in its interpretation. The normative value of the institutionalization of social practices in the implementation of institutional design is presented, in particular, with regard to the improvement of the provision of public services. The barriers of institutionalization of social control (resource, information, institutional for quality of public services are characterized. The results of a mass survey of consumers of public services conducted in December 2016 in the Multifunctional Center (MFC of city Omsk are presented. Unlike other surveys and publications that only assess the level of customer satisfaction and do not give a detailed explanation of the attitude of consumers to the ongoing institutional changes, this paper presents an analysis of consumer attitudes and beliefs to meaningful attributes of the quality of public services on the one hand, and for various institutional alternatives of influence on the quality of public services on the other. According to the results of the mass survey, the low readiness for social action was established due to high transaction costs, the rational ignorance and a free-rider problem. The possibility of institutionalizing the practice of social action and setting up consumers for the creation of a specialized organization for the protection of consumer rights in the production of public services was discussed.

  7. Development of a calibration methodology for instruments used to interventional radiology quality control

    International Nuclear Information System (INIS)

    Miranda, Jurema Aparecida de

    2009-01-01

    Interventional radiology is the technique where X radiation images are used as a tool in the conduction of diagnostic or/and therapeutic procedures. The exposition times are long for both procedures, diagnostic and therapeutic, may cause serious injuries in the patient, and also contribute to the dose of the clinical staff. In Brazil there are not yet well established rules to determine the doses and to make the dosimetry in fluoroscopic beams. There is great interest in this study, in relation to the beam quality, the half-value-layer, and others parameters. In this work a Medicor Neo Diagnomax clinical X ray generator, fluoroscopy mode, was used to develop a calibration methodology for instruments used in interventional radiology quality control. One plane parallel ionization chamber PTW was used as monitor. The ionization chambers recommended for fluoroscopy measurements had been evaluated and calibrated in relation to the IPEN Calibration Laboratory reference ionization chamber. The RQR3, RQR5 and RQR7 radiation qualities and the specific ones for fluoroscopy, RQC3, RQC5 and RQC7, were established following the norm IEC 61267. All beams characteristics were determined. Ionization chambers positioning system and the acrylic phantoms to the entrance and exit doses determination were developed and constructed. The results obtained show air kerma rates of 4.5x10 -3 , 1.2x10 -2 and 1.9x10 -2 Gy/min for RQC3, RQC5 and RQC7 respectively. Tests with and without the collimation just after the monitor chamber, were carried out and the results showed a difference of +5.5%, +0.6% e + 0.8%, confirming the importance of the collimation use in these interventionist procedures. (author)

  8. 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....

  9. THE ARTHRITIS AND MUSCULOSKELETAL QUALITY IMPROVEMENT PROGRAM (AMQUIP: A BREAKTHROUGH SERIES METHODOLOGY PROJECT

    Directory of Open Access Journals (Sweden)

    MASTURA I

    2008-01-01

    Full Text Available The Australian government had funded the National Primary Care Collaborative (NPCC program with funding of $14.6 million over three years. One of the pilots project was the Arthritis and Musculoskeletal Quality Improvement Program (AMQuIP.The study aims to optimize general practitioners (GPs management of patients with osteoarthritis (OA of the hip and knee by identifying gaps between their current practice and best practice. The Breakthrough Series Collaborative methodology with several Plan-Do-Study-Act (PDSA cycles was employed. Participants comprises of 12 GPs/practices from two Victorian Divisions of general Practice (one rural, one metropolitan with 10 patients per GP/practice. GPs/practices attended an orientation and three learning workshops and a videoconference. GPs/practices completed PDSA cycles between workshop and reported results at workshops. GPs/practices reported use of guidelines, change in patient management and change in practice management/systems. All recruited patients completed the SF-12v2 Health Survey and WOMAC OA Index Questionnaire twice. Follow up activities including focus groups and face-to-face interviews were held six months after the final workshop. All GPs/practices used the guidelines/key messages, introduced “new” management strategies to patients, and made positive changes to their practice management/systems. Patient reported positive changes and outcomes. By using a structured methodology and evidence-based guidelines/key messages; GPs can introduce new patient management strategies, and by identifying gaps in practice management systems, positive changes can be achieved.

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

    Science.gov (United States)

    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.

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

    Science.gov (United States)

    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.

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

    Directory of Open Access Journals (Sweden)

    Carmel Jacobs

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

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

    Science.gov (United States)

    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

  14. 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.

  15. Evaluation of methodologies for assessing the overall diet: dietary quality scores and dietary pattern analysis.

    Science.gov (United States)

    Ocké, Marga C

    2013-05-01

    This paper aims to describe different approaches for studying the overall diet with advantages and limitations. Studies of the overall diet have emerged because the relationship between dietary intake and health is very complex with all kinds of interactions. These cannot be captured well by studying single dietary components. Three main approaches to study the overall diet can be distinguished. The first method is researcher-defined scores or indices of diet quality. These are usually based on guidelines for a healthy diet or on diets known to be healthy. The second approach, using principal component or cluster analysis, is driven by the underlying dietary data. In principal component analysis, scales are derived based on the underlying relationships between food groups, whereas in cluster analysis, subgroups of the population are created with people that cluster together based on their dietary intake. A third approach includes methods that are driven by a combination of biological pathways and the underlying dietary data. Reduced rank regression defines linear combinations of food intakes that maximally explain nutrient intakes or intermediate markers of disease. Decision tree analysis identifies subgroups of a population whose members share dietary characteristics that influence (intermediate markers of) disease. It is concluded that all approaches have advantages and limitations and essentially answer different questions. The third approach is still more in an exploration phase, but seems to have great potential with complementary value. More insight into the utility of conducting studies on the overall diet can be gained if more attention is given to methodological issues.

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

    Directory of Open Access Journals (Sweden)

    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.

  17. 40 CFR Appendix D to Part 132 - Great Lakes Water Quality Initiative Methodology for the Development of Wildlife Criteria

    Science.gov (United States)

    2010-07-01

    ... Methodology for the Development of Wildlife Criteria D Appendix D to Part 132 Protection of Environment... Development of Wildlife Criteria Great Lakes States and Tribes shall adopt provisions consistent with (as protective as) this appendix. I. Introduction A. A Great Lakes Water Quality Wildlife Criterion (GLWC) is the...

  18. 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...

  19. 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

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

    Science.gov (United States)

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

    2018-04-01

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

  1. 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...

  2. Can teaching research methodology influence students' attitude toward science? Cohort study and nonrandomized trial in a single medical school.

    Science.gov (United States)

    Vujaklija, Ana; Hren, Darko; Sambunjak, Dario; Vodopivec, Ivana; Ivanis, Ana; Marusić, Ana; Marusić, Matko

    2010-02-01

    Medical teaching aims to develop attitudes and behaviors underlying professional competence of future physicians. We investigated whether a mandatory course on scientific methodology in the second study year could affect students' attitudes toward science in medicine. In a longitudinal study, students (n = 241) enrolling in 2001-2002 academic year at a single medical school were followed up until graduation in 2006-2007. Each year, they filled out a Likert-type questionnaire of 18 statements evaluating attitude toward science. Direct influence of the course on students' attitudes was tested in a nonrandomized controlled trial with the 2006-2007 second year student cohort. Positive students' attitudes toward science increased during study years (mean [SD] score of the maximum score of 90): from 57.6 (6.0) in the first to 69.8 (10.4) in the sixth year. There was a significant trend of increase in attitudes with the years of study (cubic trend by polynomial contrasts analysis, P = 0.011). Attendance of a course on research methodology significantly increased positive attitudes (score, 67.0 [7.0] before and 70.8 [7.5] after course, P = 0.032 vs control group), regardless of grade point average. The intervention had an effect even when the influence of the initial attitude was accounted for (F1,140 = 9.25, P = 0.003; analysis of covariance). The attitude changes after the course was greatest in students with low initial attitude scores (Spearman rinitial score, score difference, -0.44). Medical students have positive attitudes toward science and scientific method in medicine. Attendance of a course on research methodology had positive short-term effect on students' attitudes toward science. This positive effect should be maintained by vertical integration of the course in the medical curriculum.

  3. 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.

  4. A randomised controlled trial of the efficacy of the ABCD Parenting Young Adolescents Program: rationale and methodology

    Directory of Open Access Journals (Sweden)

    Burke Kylie

    2010-08-01

    Full Text Available Abstract Background The transition to adolescence is a time of increased vulnerability for risk taking and poor health, social and academic outcomes. Parents have an important role in protecting their children from these potential harms. While the effectiveness of parenting programs in reducing problem behavior has been demonstrated, it is not known if parenting programs that target families prior to the onset of significant behavioral difficulties in early adolescence (9-14 years improve the wellbeing of adolescents and their parents. This paper describes the rationale and methodology of a randomised controlled trial testing the efficacy of a parenting program for the promotion of factors known to be associated with positive adolescent outcomes, such as positive parenting practices, parent-adolescent relationships and adolescent behavior. Methods/Design One hundred and eighty parents were randomly allocated to an intervention or wait list control group. Parents in the intervention group participated in the ABCD Parenting Young Adolescents Program, a 6-session behavioral family intervention program which also incorporates acceptance-based strategies. Participants in the Wait List control group did not receive the intervention during a six month waiting period. The study was designed to comply with recommendations of the CONSORT statement. The primary outcome measures were reduction in parent-adolescent conflict and improvements in parent-adolescent relationships. Secondary outcomes included improvements in parent psychosocial wellbeing, parenting self-efficacy and perceived effectiveness, parent-adolescent communication and adolescent behavior. Conclusions Despite the effectiveness of parenting programs in reducing child behavioral difficulties, very few parenting programs for preventing problems in adolescents have been described in the peer reviewed literature. This study will provide data which can be used to examine the efficacy of a

  5. Rationale, design, methodology and sample characteristics for the Vietnam pre-conceptual micronutrient supplementation trial (PRECONCEPT: a randomized controlled study

    Directory of Open Access Journals (Sweden)

    Nguyen Phuong H

    2012-10-01

    Full Text Available Abstract Background Low birth weight and maternal anemia remain intractable problems in many developing countries. The adequacy of the current strategy of providing iron-folic acid (IFA supplements only during pregnancy has been questioned given many women enter pregnancy with poor iron stores, the substantial micronutrient demand by maternal and fetal tissues, and programmatic issues related to timing and coverage of prenatal care. Weekly IFA supplementation for women of reproductive age (WRA improves iron status and reduces the burden of anemia in the short term, but few studies have evaluated subsequent pregnancy and birth outcomes. The Preconcept trial aims to determine whether pre-pregnancy weekly IFA or multiple micronutrient (MM supplementation will improve birth outcomes and maternal and infant iron status compared to the current practice of prenatal IFA supplementation only. This paper provides an overview of study design, methodology and sample characteristics from baseline survey data and key lessons learned. Methods/design We have recruited 5011 WRA in a double-blind stratified randomized controlled trial in rural Vietnam and randomly assigned them to receive weekly supplements containing either: 1 2800 μg folic acid 2 60 mg iron and 2800 μg folic acid or 3 MM. Women who become pregnant receive daily IFA, and are being followed through pregnancy, delivery, and up to three months post-partum. Study outcomes include birth outcomes and maternal and infant iron status. Data are being collected on household characteristics, maternal diet and mental health, anthropometry, infant feeding practices, morbidity and compliance. Discussion The study is timely and responds to the WHO Global Expert Consultation which identified the need to evaluate the long term benefits of weekly IFA and MM supplementation in WRA. Findings will generate new information to help guide policy and programs designed to reduce the burden of anemia in women and

  6. 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.

  7. Development of a methodology for the analysis of the crystalline quality of single crystals

    International Nuclear Information System (INIS)

    Metairon, Sabrina

    1999-01-01

    This work aims to establish a methodology for the analysis of the crystalline quality of single crystals. It is shown in the work as from neutron diffraction tridimensional rocking curves it is possible to determine the intrinsic widths at half maximum of the crystalline domains of a crystal, as well as the relative intensities of such domains and the angular distances between them. The construction of contour maps, on the bases of the tridimensional curves, make easier the determination of the above characteristics. For the development of the method, tridimensional rocking curves (I x ω x χ) have been obtained with neutrons from a barium lithium fluoride (BaLiF 3 ) and an aluminum crystal. The intensity I was obtained as rocking curves around the ω axis, with the angle % varying in a convenient interval. The individual (I x ω) and (I x χ) curves, which constitute the tridimensional rocking curve, were fitted by Gaussians and, in continuation of the process, the instrumental broadenings in directions ω and χ were deconvoluted from them. The instrumental broadenings were obtained with perfect type lithium fluoride (LiF) single crystals in the form of rocking curves around the ω and χ axes. Due to an enhanced Lorentz factor in direction χ, the scale in this direction was 'shrunk' by a correction factor in order to make the widths at half maximum of domains equivalent to those found in direction co. The contour map constructed with the deconvoluted rocking curves for BaLiF 3 , showed the existence of a 'proximity effect' that occurs when the widths at half maximum of domains have values near the value of the instrumental broadening. The contour map constructed with the deconvoluted rocking curves for aluminum, showed five domains of the mosaic type. Such domains were characterized concerning the width at half maximum, relative intensity and distance between them. (author)

  8. 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.

  9. MODERN CONCEPTS OF THE SIX SIGMA METHODOLOGY FOR IMPROVING THE QUALITY

    Directory of Open Access Journals (Sweden)

    MARGARITA JANESKA

    2018-02-01

    Full Text Available Product quality is generally accepted as being crucial in today’s industrial business. The traditional aspects of product quality are connected to product design (translating customer demands into attractive features and technical specifications and to the design and specification of high performance production processes with low defect rates. Quality management is the general expression for all actions leading to quality. Quality management is focused on improving customer satisfaction through continuous improvement of processes including the removal of uncertain activities, and continuous improvement of the quality of processes, products and services. The quality management includes four key processes, such as quality planning, quality assurance, quality control and quality costs. The main accent in this paper will be on quality control and the application of one of the quality control tools in order to improve it. Six Sigma is different from other quality improvement concepts in that its framework is comprised of many principles, tools and techniques, which, together with experience, are all integrated and translated into best practices. Bearing in mind that the goal of every company is to work effectively and effectively in the long run, this paper focuses on Six Sigma as a way to continuously improve quality. Namely, this paper emphasizes the key features of the quality of products / services, the Need for the application of Six Sigma for quality assurance, and also a detailed list of tools and techniques that can be used during the implementation of Six Sigma.

  10. 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

  11. 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.

  12. The chronic autoimmune thyroiditis quality of life selenium trial (CATALYST)

    DEFF Research Database (Denmark)

    Winther, Kristian Hillert; Watt, Torquil; Bjørner, Jakob Bue

    2014-01-01

    Patients with chronic autoimmune thyroiditis have impaired health-related quality of life. The thyroid gland has a high selenium concentration, and specific selenoprotein enzyme families are crucial to immune function, and catalyze thyroid hormone metabolism and redox processes in thyroid cells......-enriched yeast or matching placebo tablets daily for 12 months. The experimental supplement will be SelenoPrecise(R). The primary outcome is thyroid-related quality of life assessed by the Thyroid Patient-Reported Outcome (ThyPRO) questionnaire. Secondary outcomes include serum thyroid peroxidase antibody...

  13. 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.

  14. 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

  15. Methodology for a Trial of Brain-Centered versus Anti-cholinergic Therapy for Women with Urgency Urinary Incontinence

    Science.gov (United States)

    Komesu, Yuko M.; Ketai, Loren H.; Sapien, Robert E.; Rogers, Rebecca G.; Schrader, Ronald M.; Simmerman-Sierra, Timothy; Mayer, Andrew R.

    2016-01-01

    Introduction This paper describes the rationale and methodology a study which investigates mind-body treatment versus pharmacotherapy for women with urgency urinary incontinence (UUI). To explore brain associations in UUI, a subset of patients will also undergo functional magnetic resonance imaging (fMRI). We hypothesize that hypnotherapy a mind-body intervention, will be at least as effective pharmacotherapy in treating UUI. We also hypothesize that fMRI findings will change following treatment, with changes potentially differing between groups. Methods The purpose of this manuscript is to recount the development and design challenges of a study evaluating the efficacy of hypnotherapy compared to conventional pharmacotherapy in UUI treatment. The study randomizes women to either of these treatments and outcome measures include bladder diaries and validated questionnaires. Sample size estimates, based on a non-inferiority test (alpha=.025, beta=0.20), after considering drop-out/loss to follow-up, indicated approximately 150 woman would be required to test the hypothesis that hypnotherapy is non-inferior to pharmacotherapy within a 5% non-inferiority margin. The study will also evaluate fMRI change in a subset of participants before and after therapy. Study challenges included designing a study with a mind-body therapy and a comparison treatment equally acceptable to participants, standardizing the interventions, confronting the reality that trials are time-consuming for participants and making appropriate accommodations. Results Study enrollment began March 2013 and is ongoing. Conclusions This manuscript details the design a of randomized controlled trial (RCT) comparing mind-body therapy to medications in treatment of UUI and describes the challenges encountered in its planning. PMID:27752750

  16. Methodology and lessons-learned from the efficacy clinical trial of the pentavalent rotavirus vaccine in Bangladesh.

    Science.gov (United States)

    Zaman, K; Yunus, M; El Arifeen, Shams; Azim, Tasnim; Faruque, A S G; Huq, Ehsanul; Hossain, Ilias; Luby, Stephen P; Victor, John C; Dallas, Michael J; Lewis, Kristen D C; Rivers, Stephen B; Steele, A Duncan; Neuzil, Kathleen M; Ciarlet, Max; Sack, David A

    2012-04-27

    An efficacy clinical trial with pentavalent rotavirus vaccine (PRV), RotaTeq(®), was conducted at Matlab field site of ICDDR,B, Bangladesh from March 2007 to March 2009. The methodology, including operation logistics, and lessons-learned are described in this report. Vaccination was organized at 41 fixed-site clinics twice/month. A total of 1136 infants were randomized 1:1 to receive 3 doses of PRV/placebo at approximately 6-, 10-, and 14-weeks of age with routine vaccines of the Expanded Programme on Immunization (EPI) schedule. Twelve field-workers routinely visited study participants for safety and efficacy follow-up. The study was conducted following good clinical practices and maintaining cold-chain requirements. There were no temperature deviations of clinical vaccine supplies. Data entry was done using the source documents to a central database developed by the sponsor which was linked to web. Among enrolled infants, 1128 (99.3%) received 3 doses of PRV/placebo and efficacy follow-up was conducted for a median of 554 days. For the evaluation of immunogenicity, blood samples were collected from 150 participants predose 1 and from 147 (98%) of the same participants post dose 3. Stool samples were collected from 778 (99.9%) acute gastroenteritis episodes among children who reported to diarrhoea treatment centres. Thirty-nine serious adverse events, including 6 deaths, occurred among study participants. The efficacy of PRV against severe rotavirus gastroenteritis was 42.7% through the entire follow-up period; serum anti-rotavirus IgA response was 78.1%. Inclement weather, difficult transportation, and movement of study participants were some of the challenges identified. This is the first vaccine trial in rural Bangladesh with online data entry. The study was well accepted in the community and was completed successfully. Copyright © 2011 Elsevier Ltd. All rights reserved.

  17. 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.

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

    Directory of Open Access Journals (Sweden)

    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.

  19. The saving and empowering young lives in Europe (SEYLE) randomized controlled trial (RCT): methodological issues and participant characteristics.

    Science.gov (United States)

    Carli, Vladimir; Wasserman, Camilla; Wasserman, Danuta; Sarchiapone, Marco; Apter, Alan; Balazs, Judit; Bobes, Julio; Brunner, Romuald; Corcoran, Paul; Cosman, Doina; Guillemin, Francis; Haring, Christian; Kaess, Michael; Kahn, Jean Pierre; Keeley, Helen; Keresztény, Agnes; Iosue, Miriam; Mars, Ursa; Musa, George; Nemes, Bogdan; Postuvan, Vita; Reiter-Theil, Stella; Saiz, Pilar; Varnik, Peeter; Varnik, Airi; Hoven, Christina W

    2013-05-16

    Mental health problems and risk behaviours among young people are of great public health concern. Consequently, within the VII Framework Programme, the European Commission funded the Saving and Empowering Young Lives in Europe (SEYLE) project. This Randomized Controlled Trial (RCT) was conducted in eleven European countries, with Sweden as the coordinating centre, and was designed to identify an effective way to promote mental health and reduce suicidality and risk taking behaviours among adolescents. To describe the methodological and field procedures in the SEYLE RCT among adolescents, as well as to present the main characteristics of the recruited sample. Analyses were conducted to determine: 1) representativeness of study sites compared to respective national data; 2) response rate of schools and pupils, drop-out rates from baseline to 3 and 12 month follow-up, 3) comparability of samples among the four Intervention Arms; 4) properties of the standard scales employed: Beck Depression Inventory, Second Edition (BDI-II), Zung Self-Rating Anxiety Scale (Z-SAS), Strengths and Difficulties Questionnaire (SDQ), World Health Organization Well-Being Scale (WHO-5). Participants at baseline comprised 12,395 adolescents (M/F: 5,529/6,799; mean age=14.9±0.9) from Austria, Estonia, France, Germany, Hungary, Ireland, Israel, Italy, Romania, Slovenia and Spain. At the 3 and 12 months follow up, participation rates were 87.3% and 79.4%, respectively. Demographic characteristics of participating sites were found to be reasonably representative of their respective national population. Overall response rate of schools was 67.8%. All scales utilised in the study had good to very good internal reliability, as measured by Cronbach's alpha (BDI-II: 0.864; Z-SAS: 0.805; SDQ: 0.740; WHO-5: 0.799). SEYLE achieved its objective of recruiting a large representative sample of adolescents within participating European countries. Analysis of SEYLE data will shed light on the effectiveness

  20. 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

  1. Feasibility study and methodology to create a quality-evaluated database of primary care data

    Directory of Open Access Journals (Sweden)

    Alison Bourke

    2004-11-01

    Conclusions In the group of practices studied, levels of recording were generally assessed to be of sufficient quality to enable a database of quality-evaluated, anonymised primary care records to be created.

  2. 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

  3. 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.

  4. On the quality of global emission inventories. Approaches, methodologies, input data and uncertainties

    International Nuclear Information System (INIS)

    Olivier, J.G.J.

    2002-01-01

    Four key scientific questions will be investigated: (1) How does a user define the 'quality' of a global (or national) emission inventory? (Chapter 2); (2) What determines the quality of a global emission inventory? (Chapters 2 and 7); (3) How can inventory quality be achieved in practice and expressed in quantitative terms ('uncertainty')? (Chapters 3 to 6); and (4) What is the preferred approach for compiling a global emission inventory, given the practical limitations and the desired inventory quality? (Chapters 7 and 8)

  5. A staffing decision support methodology using a quality loss function : a cross-disciplinary quantitative study

    NARCIS (Netherlands)

    Mincsovics, G.Z.

    2009-01-01

    Background Understanding the quality loss implications of short staffing is essential in maintaining service quality on a limited budget. Objectives For elaborate financial control on staffing decisions, it is necessary to quantify the cost of the incidental quality loss that a given workload and

  6. Some problems in methodology of economjc evaluation of radiation technique quality

    International Nuclear Information System (INIS)

    Kodyukov, V.M.; Purtova, M.I.; Sokolova, Z.I.; Smirnova, Z.M.

    1976-01-01

    The quality of radiation equipment (RE) should essentially be assessed when designing, standardizing, planning, and evaluating the cost and economy of RE. The basic factors are sited upon which subsequent economic assessment of quality levels were based. It also discusses the specifics involved in determining the principal quality factors for radioisotopic flaw-detection equipment and gamma-therapeutic instruments

  7. Quality Adjusted Life Years and Trade Off Exercises : exploring methodology and validity

    NARCIS (Netherlands)

    Verschuuren, Marieke

    2006-01-01

    Quality Adjusted Life Years (QALYs) are a popular outcome measure in cost-effectiveness analyses. QALYs are computed by multiplying follow-up or survival by a scaling factor reflecting health related quality of life, and as such capture quantity and quality gains simultaneously. Issues with regard

  8. [Assessment of the methodological quality of theses submitted to the Faculty of Medicine Fez].

    Science.gov (United States)

    Boly, A; Tachfouti, N; Zohoungbogbo, I S S; Achhab, Y El; Nejjari, C

    2014-06-09

    A thesis in medicine is a scientific work which allows a medical student to acquire a Doctor of Medicine degree. It is therefore recommended that theses presented by students fulfill essential methodological criteria in order to obtain scientifically credible results and recommendations. The aim of this study was to assess the methodology of thesis presented to the Faculty of Medicine in Fez in 2008. We developed an evaluation table containing questions on the different sections of the IMRAD structure on which these theses were based and we estimated the proportion of theses that conformed to each criterion. There were 160 theses on various specialties presented in 2008. The majority of the theses (79.3%) were case series. Research questions were clearly expressed in 62.0% but the primary objectives were pertinent in only 52.0%. Our study shows that there were important deficiencies in the methodological rigor of the theses and very little representation of the theses in publications.

  9. 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

  10. 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.

  11. 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

  12. 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.

  13. 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.

  14. Applying the Tropos Methodology for Analysing Web Services Requirements and Reasoning about Qualities of Services

    NARCIS (Netherlands)

    Aiello, Marco; Giorgini, Paolo

    2004-01-01

    The shift in software engineering from the design, implementation and management of isolated software elements towards a network of autonomous interoperable service is calling for a shift in the way software is designed. We propose the use of the agent-oriented methodology Tropos for the analysis of

  15. A Comparison of the Methodological Quality of Articles in Computer Science Education Journals and Conference Proceedings

    Science.gov (United States)

    Randolph, Justus J.; Julnes, George; Bednarik, Roman; Sutinen, Erkki

    2007-01-01

    In this study we empirically investigate the claim that articles published in computer science education journals are more methodologically sound than articles published in computer science education conference proceedings. A random sample of 352 articles was selected from those articles published in major computer science education forums between…

  16. 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....

  17. Adult Congenital Heart Disease-Coping And REsilience (ACHD-CARE): Rationale and methodology of a pilot randomized controlled trial.

    Science.gov (United States)

    Kovacs, Adrienne H; Bandyopadhyay, Mimi; Grace, Sherry L; Kentner, Amanda C; Nolan, Robert P; Silversides, Candice K; Irvine, M Jane

    2015-11-01

    One-third of North American adults with congenital heart disease (CHD) have diagnosable mood or anxiety disorders and most do not receive mental health treatment. There are no published interventions targeting the psychosocial needs of patients with CHD of any age. We describe the development of a group psychosocial intervention aimed at improving the psychosocial functioning, quality of life, and resilience of adults with CHD and the design of a study protocol to determine the feasibility of a potential full-scale randomized controlled trial (RCT). Drawing upon our quantitative and qualitative research, we developed the Adult CHD-Coping And REsilience (ACHD-CARE) intervention and designed a feasibility study that included a 2-parallel arm non-blinded pilot RCT. Eligible participants (CHD, age ≥ 18 years, no planned surgery, symptoms suggestive of a mood and/or anxiety disorder) were randomized to the ACHD-CARE intervention or Usual Care (1:1 allocation ratio). The group intervention was delivered during eight 90-minute weekly sessions. Feasibility will be assessed in the following domains: (i) process (e.g. recruitment and retention), (ii) resources, (iii) management, (iv) scientific outcomes, and (v) intervention acceptability. This study underscores the importance of carefully developing and testing the feasibility of psychosocial interventions in medical populations before moving to full-scale clinical trials. At study conclusion, we will be poised to make one of three determinations for a full-scale RCT: (1) feasible, (2) feasible with modifications, or (3) not feasible. This study will guide the future evaluation and provision of psychosocial treatment for adults with CHD. Copyright © 2015. Published by Elsevier Inc.

  18. A randomised controlled trial on hypnotherapy for irritable bowel syndrome: design and methodological challenges (the IMAGINE study

    Directory of Open Access Journals (Sweden)

    Flik Carla E

    2011-12-01

    Full Text Available Abstract Background Irritable Bowel Syndrome (IBS is a common gastro-intestinal disorder in primary and secondary care, characterised by abdominal pain, discomfort, altered bowel habits and/or symptoms of bloating and distension. In general the efficacy of drug therapies is poor. Hypnotherapy as well as Cognitive Behaviour Therapy and short Psychodynamic Therapy appear to be useful options for patients with refractory IBS in secondary care and are cost-effective, but the evidence is still limited. The IMAGINE-study is therefore designed to assess the overall benefit of hypnotherapy in IBS as well as comparing the efficacy of individual versus group hypnotherapy in treating this condition. Methods/Design The design is a randomised placebo-controlled trial. The study group consists of 354 primary care and secondary care patients (aged 18-65 with IBS (Rome-III criteria. Patients will be randomly allocated to either 6 sessions of individual hypnotherapy, 6 sessions of group hypnotherapy or 6 sessions of educational supportive therapy in a group (placebo, with a follow up of 9 months post treatment for all patients. Ten hospitals and four primary care psychological practices in different parts of The Netherlands will collaborate in this study. The primary efficacy parameter is the responder rate for adequate relief of IBS symptoms. Secondary efficacy parameters are changes in the IBS symptom severity, quality of life, cognitions, psychological complaints, self-efficacy as well as direct and indirect costs of the condition. Hypnotherapy is expected to be more effective than the control therapy, and group hypnotherapy is expected not to be inferior to individual hypnotherapy. Discussion If hypnotherapy is effective and if there is no difference in efficacy between individual and group hypnotherapy, this group form of treatment could be offered to more IBS patients, at lower costs. Trial registration number ISRCTN: ISRCTN22888906

  19. Maps of sharpness: a methodology to present results of quality control for mammographic system

    International Nuclear Information System (INIS)

    Oliveira, Henrique Jesus Quintino de; Marques, Marcio Alexandre; Frere, Annie France; Schiable, Homero; Marques, Paulo M. Azevedo; Irita, Ricardo Toshiyuki

    1996-01-01

    A new method for evaluating radiologic imaging systems quality is presented. This method intends to relate the numeric results from quality control procedures to the magnitude of shadow and penumbra in the image from given objects. This evaluation is based on a computer simulation and it can be performed for any system and any object placed in any location of the radiation field

  20. Outcomes of Quality Assurance: A Discussion of Knowledge, Methodology and Validity

    Science.gov (United States)

    Stensaker, Bjorn

    2008-01-01

    A common characteristic in many quality assurance schemes around the world is their implicit and often narrowly formulated understanding of how organisational change is to take place as a result of the process. By identifying some of the underlying assumptions related to organisational change in current quality assurance schemes, the aim of this…

  1. Combined evaluations of competency to stand trial and mental state at the time of the offense: An overlooked methodological consideration?

    Science.gov (United States)

    Kois, Lauren; Wellbeloved-Stone, James M; Chauhan, Preeti; Warren, Janet I

    2017-06-01

    Combined evaluations of competency to stand trial (CST; competency) and mental state at the time of the offense (MSO; sanity) frequently co-occur. However, most research examines the 2 as discrete constructs without considering 4 potential combined evaluation outcomes: competent-sane, incompetent-sane, competent-insane, and incompetent-insane. External validity can be improved if research more closely mirrored practice. It may be incorrect to assume incompetent defendants are similar across CST-only and combined evaluations, and insane defendants are similar across MSO-only and combined evaluations. Using a sample of 2,751 combined evaluations, we examined demographic, clinical, offense, evaluation, and psycholegal characteristics associated with evaluators' combined evaluation opinions. Multinomial regression analyses revealed older defendants were more likely to be opined incompetent-insane. Defendants with psychotic disorders were more often opined insane, regardless of competency status. Affective diagnoses predicted competent-insane opinions. Developmental disorders were closely related to incompetence, regardless of sanity status. Defendants with organic disorders tended to have global psycholegal impairment, in that they were more often opined incompetent-insane, incompetent-sane, or competent-insane, relative to competent-sane. Prior hospitalization predicted competent-insane relative to competent-sane opinions. Defendants not under the influence of a substance during the offense or with no prior convictions were more likely to be opined insane, regardless of competency status. We interpret these findings in light of psycholegal theory and provide recommendations for research and practice. Collectively, results suggest incorporation of combined evaluations into CST and MSO research is an important methodological consideration not to be overlooked. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

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

    Science.gov (United States)

    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.

  3. Quality benchmarking methodology: Case study of finance and culture industries in Latvia

    Directory of Open Access Journals (Sweden)

    Ieva Zemīte

    2011-01-01

    Full Text Available Political, socio-economic and cultural changes that have taken place in the world during the last years have influenced all the spheres. Constant improvements are necessary to sustain in rival and shrinking markets. This sets high quality standards for the service industries. Therefore it is important to conduct comparison of quality criteria to ascertain which practices are achieving superior performance levels. At present companies in Latvia do not carry out mutual benchmarking, and as a result of that do not know how they rank against their peers in terms of quality, as well as they do not see benefits in sharing of information and in benchmarking.The purpose of this paper is to determine the criteria of qualitative benchmarking, and to investigate the use of the benchmarking quality in service industries, particularly: finance and culture sectors in Latvia in order to determine the key driving factors of quality, to explore internal and foreign benchmarks, and to reveal the full potential of inputs’ reduction and efficiency growth for the aforementioned industries.Case study and other tools are used to define the readiness of the company for benchmarking. Certain key factors are examined for their impact on quality criteria. The results are based on the research conducted in professional associations in defined fields (insurance and theatre.Originality/value – this is the first study that adopts the benchmarking models for measuring quality criteria and readiness for mutual comparison in insurance and theatre industries in Latvia.

  4. 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

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

    Directory of Open Access Journals (Sweden)

    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.

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

    Science.gov (United States)

    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

  7. Effect of Rosa damascene aromatherapy on sleep quality in cardiac patients: a randomized controlled trial.

    Science.gov (United States)

    Hajibagheri, Ali; Babaii, Atye; Adib-Hajbaghery, Mohsen

    2014-08-01

    Sleep disorders are common among patients hospitalized in coronary care unit (CCU). This study aimed to investigate the effect of Rosa damascene aromatherapy on sleep quality of patients hospitalized in CCU. In this randomized controlled trial, 60 patients who met the inclusion criteria were conveniently sampled and randomly allocated to the experimental and control groups. Patients in the control group received routine care. In the experimental group, patients received routine care and Rosa damascene aromatherapy for three subsequent nights. In the both groups the sleep quality was assessed using the Pittsburgh Sleep Quality Index. After the study, the mean scores of five domains of Pittsburg Sleep Quality Index as well as the mean of total score of the index in the experimental group were significantly lower than the control group. Rosa damascene aromatherapy can significantly improve the sleep quality of patients hospitalized in CCUs. Copyright © 2014 Elsevier Ltd. All rights reserved.

  8. Quality Control in Screening for Infectious Diseases at Blood Banks. Rationale and Methodology.

    Science.gov (United States)

    Sáez-Alquezar, Amadeo; Albajar-Viñas, Pedro; Guimarães, André Valpassos; Corrêa, José Abol

    2015-11-01

    Quality control procedures are indispensable to ensure the reliability of the results provided by laboratories responsible for serological screening in blood banks. International recommendations on systems of quality management classify as a top component the inclusion of two types of control: (a) internal quality control (IQC) and (b) external quality control (EQC). In EQC it is essential to have, at least, a monthly frequency of laboratory assessment. On the other hand, IQC involves the daily use of low-reactivity control sera, which should be systematically added in all run, carried out in the laboratory for each parameter. Through the IQC analysis some variations in the criteria of run acceptance and rejection may be revealed, but it is of paramount importance to ensure the previous definition of these criteria and even more importantly, the adherence to them; and that corresponds to the validation of analytical runs of each test. Since 2010 this has been, for instance, the experience of the PNCQ*, developing external quality control programmes on serology for blood banks. These programmes use samples of lyophilized sera well-characterized for the reactivity related to the parameters used for the serological screening of blood donors. The programmes have used blind panels of six samples for monthly assessments. In the last 50 assessments, which involved 68 blood banks in Brazil, a significant number of instances of non-compliance were observed in all monthly assessments. These results provide strong support to the recommendation of systematic monthly assessments. (*) National Quality Control Programme (PNCQ).

  9. 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...

  10. 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.

  11. A methodological framework for assessing agreement between cost-effectiveness outcomes estimated using alternative sources of data on treatment costs and effects for trial-based economic evaluations.

    Science.gov (United States)

    Achana, Felix; Petrou, Stavros; Khan, Kamran; Gaye, Amadou; Modi, Neena

    2018-01-01

    A new methodological framework for assessing agreement between cost-effectiveness endpoints generated using alternative sources of data on treatment costs and effects for trial-based economic evaluations is proposed. The framework can be used to validate cost-effectiveness endpoints generated from routine data sources when comparable data is available directly from trial case report forms or from another source. We illustrate application of the framework using data from a recent trial-based economic evaluation of the probiotic Bifidobacterium breve strain BBG administered to babies less than 31 weeks of gestation. Cost-effectiveness endpoints are compared using two sources of information; trial case report forms and data extracted from the National Neonatal Research Database (NNRD), a clinical database created through collaborative efforts of UK neonatal services. Focusing on mean incremental net benefits at £30,000 per episode of sepsis averted, the study revealed no evidence of discrepancy between the data sources (two-sided p values >0.4), low probability estimates of miscoverage (ranging from 0.039 to 0.060) and concordance correlation coefficients greater than 0.86. We conclude that the NNRD could potentially serve as a reliable source of data for future trial-based economic evaluations of neonatal interventions. We also discuss the potential implications of increasing opportunity to utilize routinely available data for the conduct of trial-based economic evaluations.

  12. Interdepartmental interaction model on the extracurricular activities of students in the city of Surgut in the quality management system of the municipal state institution "Information and Methodological Center"

    OpenAIRE

    Loseva E. A.

    2018-01-01

    in this article the author considers interdepartmental interaction model in the field of extracurricular activities of students in the quality management system. The topic is examined on the example of the municipal state institution "Information and Methodological Center".

  13. Application of kaizen methodology to foster departmental engagement in quality improvement.

    Science.gov (United States)

    Knechtges, Paul; Decker, Michael Christopher

    2014-12-01

    The Toyota Production System, also known as Lean, is a structured approach to continuous quality improvement that has been developed over the past 50 years to transform the automotive manufacturing process. In recent years, these techniques have been successfully applied to quality and safety improvement in the medical field. One of these techniques is kaizen, which is the Japanese word for "good change." The central tenant of kaizen is the quick analysis of the small, manageable components of a problem and the rapid implementation of a solution with ongoing, real-time reassessment. Kaizen adds an additional "human element" that all stakeholders, not just management, must be involved in such change. Because of the small size of the changes involved in a kaizen event and the inherent focus on human factors and change management, a kaizen event can serve as good introduction to continuous quality improvement for a radiology department. Copyright © 2014. Published by Elsevier Inc.

  14. [Quality of life - methodology and clinical practice aspects with a focus on ocular medicine].

    Science.gov (United States)

    Franke, G H; Gall, C

    2008-08-01

    Due to the demographic development in western industrialised countries, the proportion of visually impaired persons is likely to increase in the future. Currently there is a shift in scientific recognition from relative neglect of psychopathological distress in the visually impaired to better notice of disease-related subjective impairments that are detectable with specific questionnaire measures. Visual acuity primarily determines the subjective rating of visual functioning independent from the eye disease. Ophthalmic patients who show only mild symptoms from a medical point of view normally suffer considerably diminished vision-related quality of life with respect to physical, functional, mental, and social aspects. Treatment effects have been shown using vision-related quality-of-life measures for different ophthalmic diseases, particularly cataract surgery. Assessment of vision-related quality of life provides a meaningful complement to objective data.

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

    Energy Technology Data Exchange (ETDEWEB)

    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.

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

    Directory of Open Access Journals (Sweden)

    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

  17. 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.

  18. 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.

  19. New methodology to implement quality control programs in medical imaging departments

    International Nuclear Information System (INIS)

    Furquim, Tania A.C.; Yanikian, Denise; Costa, Paulo R.

    1996-01-01

    The implementation of quality control programmes is studied in order to assure a better performance in medical imaging departments. The necessity of a continuous training of all technicians involved is highlighted. The contribution of these professionals is emphasized as fundamental to the success of the project

  20. Quality approach in in vivo nuclear medicine - Certification V2010 - Methodological guide

    International Nuclear Information System (INIS)

    Abdelmoumene, Nafissa; Ferreol, Dominique; Blondet, Emmanuelle; Bonardel, Gerald; Bourrel, Francois; Broglia, Jean Marc; Guilabert, Nadine; Israel, Jean-Marc; Machacek, Catherine; Martineau, Antoine; Remy, Herve; Rousseliere, Francis; Abelmann, Caroline

    2013-01-01

    This document first presents the different components of the activity in in-vivo nuclear medicine: techniques (functional imagery, vectorized internal radiotherapy, cases outside the nuclear medicine department), team composition and missions, radiation protection regulations, benefits and risks. Then, it addresses the quality approach: quality management system defined according to a process-oriented approach, documentation. It proposes a sheet to assess the implementation of the quality approach. This sheet contains 129 criteria which are related to management (strategy, activity steering and coordination), to support functions (management of human resources and abilities, management of radioactive sources and wastes, radio-pharmacy within the nuclear medicine department, management of medical devices, information system), to patient taking on (management of appointments and patient identification, imagery examination justification, patient reception, patients presenting risks and peculiar situations, checking before radio-pharmaceutical drug administering, taking on for diagnosis purpose, taking for therapeutic purposes), and to assessment, analysis and improvement (management of undesirable events associated with cares, quality follow-up for continuous improvement)

  1. Quality evaluation of health information system's architectures developed using the HIS-DF methodology.

    Science.gov (United States)

    López, Diego M; Blobel, Bernd; Gonzalez, Carolina

    2010-01-01

    Requirement analysis, design, implementation, evaluation, use, and maintenance of semantically interoperable Health Information Systems (HIS) have to be based on eHealth standards. HIS-DF is a comprehensive approach for HIS architectural development based on standard information models and vocabulary. The empirical validity of HIS-DF has not been demonstrated so far. Through an empirical experiment, the paper demonstrates that using HIS-DF and HL7 information models, semantic quality of HIS architecture can be improved, compared to architectures developed using traditional RUP process. Semantic quality of the architecture has been measured in terms of model's completeness and validity metrics. The experimental results demonstrated an increased completeness of 14.38% and an increased validity of 16.63% when using the HIS-DF and HL7 information models in a sample HIS development project. Quality assurance of the system architecture in earlier stages of HIS development presumes an increased quality of final HIS systems, which supposes an indirect impact on patient care.

  2. Interrelationships between man, energy, and water quality: a new methodology for integrative analyses

    International Nuclear Information System (INIS)

    Kaplan, E.; Thode, H.C. Jr.

    1979-01-01

    The STORET/MSP option was used to obtain county aggregated information on ambient water quality for sixty parameters during the period 1950 to 1978. Masks, extended EXTRACT specifications and bounds on allowable values limited inclusion of erroneous data. Remark codes were required to aggregate STORET parameters to obtain increased numbers of observations. Numerous statistical analyses led to the conclusions that medians were more useful than means, that trimming on number of observations was required to eliminate counties with extreme values, and that many parameters required logarithmic transformation to be useful in regional analyses. County aggregated data for nineteen water quality parameters were examined in terms of their ability to describe qualitative chemical characteristics of water. Anion--cation balances as well as expected relationships between conductivity and other parameters were correctly accounted for. Factor analysis indicated the existence of three principal components describing patterns between metal ions, non-metal ions, and alkalinity-bicarbonate, respectively. These factors were used in place of the original complete set of water quality parameters in a structural equation approach describing relationships between variables of mans activites. It was found that counties with high industrial electric consumption, farming and mineral shipments tended to have increased levels of most water quality parameters. It was also found that simpler path diagrams may be indicated to reduce the effects of redundancy in adequately describing energy--water relationships

  3. Control Charts in Healthcare Quality Improvement A Systematic Review on Adherence to Methodological Criteria

    NARCIS (Netherlands)

    Koetsier, A.; van der Veer, S. N.; Jager, K. J.; Peek, N.; de Keizer, N. F.

    2012-01-01

    Objectives: Use of Shewhart control charts in quality improvement (QI) initiatives is increasing. These charts are typically used in one or more phases of the Plan Do Study Act (PDSA) cycle to monitor summaries of process and outcome data, abstracted from clinical information systems, over time. We

  4. An evaluation of contaminated estuarine sites using sediment quality guidelines and ecological assessment methodologies.

    Science.gov (United States)

    Fulton, M; Key, P; Wirth, E; Leight, A K; Daugomah, J; Bearden, D; Sivertsen, S; Scott, G

    2006-10-01

    Toxic contaminants may enter estuarine ecosystems through a variety of pathways. When sediment contaminant levels become sufficiently high, they may impact resident biota. One approach to predict sediment-associated toxicity in estuarine ecosystems involves the use of sediment quality guidelines (ERMs, ERLs) and site-specific contaminant chemistry while a second approach utilizes site-specific ecological sampling to assess impacts at the population or community level. The goal of this study was to utilize an integrated approach including chemical contaminant analysis, sediment quality guidelines and grass shrimp population monitoring to evaluate the impact of contaminants from industrial sources. Three impacted sites and one reference site were selected for study. Grass shrimp populations were sampled using a push-netting approach. Sediment samples were collected at each site and analyzed for metals, polycyclic aromatic hydrocarbons (PAHs), polychlorinated biphenyls (PCBs) and pesticides. Contaminant levels were then compared to sediment quality guidelines. In general, grass shrimp population densities at the sites decreased as the ERM quotients increased. Grass shrimp densities were significantly reduced at the impacted site that had an ERM exceedance for chromium and the highest Mean ERM quotient. Regression analysis indicated that sediment chromium concentrations were negatively correlated with grass shrimp density. Grass shrimp size was reduced at two sites with intermediate levels of contamination. These findings support the use of both sediment quality guidelines and site-specific population monitoring to evaluate the impacts of sediment-associated contaminants in estuarine systems.

  5. Combining Statistical Methodologies in Water Quality Monitoring in a Hydrological Basin - Space and Time Approaches

    OpenAIRE

    Costa, Marco; A. Manuela Gonçalves

    2012-01-01

    In this work are discussed some statistical approaches that combine multivariate statistical techniques and time series analysis in order to describe and model spatial patterns and temporal evolution by observing hydrological series of water quality variables recorded in time and space. These approaches are illustrated with a data set collected in the River Ave hydrological basin located in the Northwest region of Portugal.

  6. Data fusion methodologies for food and beverage authentication and quality assessment – A review

    International Nuclear Information System (INIS)

    Borràs, Eva; Ferré, Joan; Boqué, Ricard; Mestres, Montserrat; Aceña, Laura; Busto, Olga

    2015-01-01

    The ever increasing interest of consumers for safety, authenticity and quality of food commodities has driven the attention towards the analytical techniques used for analyzing these commodities. In recent years, rapid and reliable sensor, spectroscopic and chromatographic techniques have emerged that, together with multivariate and multiway chemometrics, have improved the whole control process by reducing the time of analysis and providing more informative results. In this progression of more and better information, the combination (fusion) of outputs of different instrumental techniques has emerged as a means for increasing the reliability of classification or prediction of foodstuff specifications as compared to using a single analytical technique. Although promising results have been obtained in food and beverage authentication and quality assessment, the combination of data from several techniques is not straightforward and represents an important challenge for chemometricians. This review provides a general overview of data fusion strategies that have been used in the field of food and beverage authentication and quality assessment. - Highlights: • Multivariate data fusion is used in food authentication and quality assessment. • Data fusion approaches and their applications are reviewed. • Data preprocessing, variable selection and feature extraction are considered. • Model selection and validation are also considered.

  7. Data fusion methodologies for food and beverage authentication and quality assessment – A review

    Energy Technology Data Exchange (ETDEWEB)

    Borràs, Eva [iSens Group, Department of Analytical Chemistry and Organic Chemistry, Universitat Rovira i Virgili, Campus Sescelades, 43007 Tarragona (Spain); Ferré, Joan, E-mail: joan.ferre@urv.cat [Chemometrics, Qualimetrics and Nanosensors Group, Department of Analytical Chemistry and Organic Chemistry, Universitat Rovira i Virgili, Campus Sescelades, 43007 Tarragona (Spain); Boqué, Ricard [Chemometrics, Qualimetrics and Nanosensors Group, Department of Analytical Chemistry and Organic Chemistry, Universitat Rovira i Virgili, Campus Sescelades, 43007 Tarragona (Spain); Mestres, Montserrat; Aceña, Laura; Busto, Olga [iSens Group, Department of Analytical Chemistry and Organic Chemistry, Universitat Rovira i Virgili, Campus Sescelades, 43007 Tarragona (Spain)

    2015-09-03

    The ever increasing interest of consumers for safety, authenticity and quality of food commodities has driven the attention towards the analytical techniques used for analyzing these commodities. In recent years, rapid and reliable sensor, spectroscopic and chromatographic techniques have emerged that, together with multivariate and multiway chemometrics, have improved the whole control process by reducing the time of analysis and providing more informative results. In this progression of more and better information, the combination (fusion) of outputs of different instrumental techniques has emerged as a means for increasing the reliability of classification or prediction of foodstuff specifications as compared to using a single analytical technique. Although promising results have been obtained in food and beverage authentication and quality assessment, the combination of data from several techniques is not straightforward and represents an important challenge for chemometricians. This review provides a general overview of data fusion strategies that have been used in the field of food and beverage authentication and quality assessment. - Highlights: • Multivariate data fusion is used in food authentication and quality assessment. • Data fusion approaches and their applications are reviewed. • Data preprocessing, variable selection and feature extraction are considered. • Model selection and validation are also considered.

  8. 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.

  9. Quality of life in a randomized trial of early closure of temporary ileostomy after rectal resection for cancer (EASY trial)

    DEFF Research Database (Denmark)

    Park, J; Danielsen, A K; Angenete, E

    2018-01-01

    BACKGROUND: A temporary ileostomy may reduce symptoms from anastomotic leakage after rectal cancer resection. Earlier results of the EASY trial showed that early closure of the temporary ileostomy was associated with significantly fewer postoperative complications. The aim of the present study...... was to compare health-related quality of life (HRQOL) following early versus late closure of a temporary ileostomy. METHODS: Early closure of a temporary ileostomy (at 8-13 days) was compared with late closure (at more than 12 weeks) in a multicentre RCT (EASY) that included patients who underwent rectal...... after resection using the European Organisation for Research and Treatment of Cancer (EORTC) questionnaires QLQ-C30 and QLQ-CR29 and Short Form 36 (SF-36®). RESULTS: There were 112 patients available for analysis. Response rates of the questionnaires were 82-95 per cent, except for EORTC QLQ-C30 at 12...

  10. Iohexol and iopamidol myelography in the dog: a clinical trial comparing adverse effects and myelographic quality

    International Nuclear Information System (INIS)

    Widmer, W.R.; Blevins, W.E.; Jakovljevic, S.; Teclaw, R.F.; Han, C.M.; Hurd, C.D.

    1992-01-01

    In a blind clinical trial, adverse effects after iohexol and iopamidol myelography were evaluated in 151 dogs. Eighty-one dogs were given iohexol (240 mgI/ml) and 70 dogs were given iopamidol (200 mgI/ml) by pre-determined assignment. Each dog was evaluated postmyelographically for seizures, hyperthermia, prolonged recovery from anesthesia and intensification of pre-existing neural signs. Myelographic quality was evaluated with a subjective scoring method. In comparing iohexol and iopamidol groups, there was not a statistically significant difference in the incidence of adverse effects or in myelographic quality. Iopamidol and iohexol appeared to be equally efficacious for routine canine myelography

  11. 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.

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

    Science.gov (United States)

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

    2009-01-01

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

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

    Science.gov (United States)

    Kite, Elaine; Davy, Carol

    2015-12-01

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

  14. 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.

  15. Modelling the effects of transglutaminase and L-ascorbic acid on substandard quality wheat flour by response surface methodology

    Directory of Open Access Journals (Sweden)

    Šimurina Olivera D.

    2014-01-01

    Full Text Available In recent decade, there have been observed extreme variations in climatic conditions which in combination with inadequate agro techniques lead to decreased quality of mercantile wheat, actally flour. The application of improvers can optimise the quality of substandard wheat flour. This paper focuses to systematic analysis of individual and interaction effects of ascorbic acid and transglutaminase as dough strengthening improvers. The effects were investigated using the Response Surface Methodology. Transglutaminase had much higher linear effect on the rheological and fermentative properties of dough from substandard flour than L-ascorbic acid. Both transglutaminase and L-ascorbic acid additions had a significant linear effect on the increase of bread specific volume. Effects of transglutaminase and ascorbic acid are dependent on the applied concentrations and it is necessary to determine the optimal concentration in order to achieve the maximum quality of the dough and bread. Optimal levels of tested improvers were determined using appropriate statistical techniques which applied the desirability function. It was found that the combination of 30 mg/kg of transglutaminase and 75.8 mg/kg of L-ascorbic acid achieved positive synergistic effect on rheological and fermentative wheat dough properties, as well on textural properties and specific volume of bread made from substandard quality flour.

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

    Science.gov (United States)

    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.

  17. 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.

  18. 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...

  19. A randomised controlled trial on hypnotherapy for irritable bowel syndrome: design and methodological challenges (the IMAGINE study).

    Science.gov (United States)

    Flik, Carla E; van Rood, Yanda R; Laan, Wijnand; Smout, André Jpm; Weusten, Bas Lam; Whorwell, Peter J; de Wit, Niek J

    2011-12-20

    Irritable Bowel Syndrome (IBS) is a common gastro-intestinal disorder in primary and secondary care, characterised by abdominal pain, discomfort, altered bowel habits and/or symptoms of bloating and distension. In general the efficacy of drug therapies is poor. Hypnotherapy as well as Cognitive Behaviour Therapy and short Psychodynamic Therapy appear to be useful options for patients with refractory IBS in secondary care and are cost-effective, but the evidence is still limited. The IMAGINE-study is therefore designed to assess the overall benefit of hypnotherapy in IBS as well as comparing the efficacy of individual versus group hypnotherapy in treating this condition. The design is a randomised placebo-controlled trial. The study group consists of 354 primary care and secondary care patients (aged 18-65) with IBS (Rome-III criteria). Patients will be randomly allocated to either 6 sessions of individual hypnotherapy, 6 sessions of group hypnotherapy or 6 sessions of educational supportive therapy in a group (placebo), with a follow up of 9 months post treatment for all patients. Ten hospitals and four primary care psychological practices in different parts of The Netherlands will collaborate in this study. The primary efficacy parameter is the responder rate for adequate relief of IBS symptoms. Secondary efficacy parameters are changes in the IBS symptom severity, quality of life, cognitions, psychological complaints, self-efficacy as well as direct and indirect costs of the condition. Hypnotherapy is expected to be more effective than the control therapy, and group hypnotherapy is expected not to be inferior to individual hypnotherapy. If hypnotherapy is effective and if there is no difference in efficacy between individual and group hypnotherapy, this group form of treatment could be offered to more IBS patients, at lower costs. ISRCTN: ISRCTN22888906.

  20. 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.

  1. Evaluation of chips quality by the analysis of two different harvesting methodologies

    Energy Technology Data Exchange (ETDEWEB)

    Pari, L.; Civitarese, V.; Del Giudice, A. [Council for Research in Agriculture, Agricultural Engineering Research Unit, Rome (Italy)

    2010-07-01

    The Council for Research in Agriculture, Agricultural Engineering Research Unit (CRA-ING) in Rome, Italy has developed an innovative short-rotation forestry (SRF) harvesting system. The system involves a 2 step operation, notably the tree felling and inter-row windrowing performed by a feller windrower equipment; and subsequent chipping performed by a harvester equipped with a pick-up device. The low moisture content of the windrowed trees at harvesting time affects their physical qualities and mechanical strength throughout the chipping operation. The purpose of this study was to analyze the moisture losses of windrowed trees, in relation to the windrow location, on field storage and weather condition. In addition, the study characterized chips quality changes during on field storage by the 2 different harvesting systems. The innovative 2-step system was compared with the traditional 1-step harvesting system.

  2. Methodology for the construction of a physical phantom for quality control of images in digital radiography

    International Nuclear Information System (INIS)

    Santos, Tayline T.; Vieira, Jose Wilson; Oliveira, Alex Cristovao H. de; Lima, Fernando R. de Andrade

    2013-01-01

    The advancement of technology in recent years has provided the production of increasingly sophisticated devices, aiming to acquire medical images with high technical level and also facilitate the operational readiness of the equipment. In order to ensure the most accurate diagnosis with minimum dose without exposing patients to obtain data and verify the performance of a radiographic system for quality control purposes we use the so-called phantoms. Phantoms are physical or computational models used to simulate the transport of ionizing radiation, their interactions in the tissues of the human body and evaluate the deposition of energy. Besides, they are made from materials with behavior similar to human tissues when exposed to ionizing radiation - the so-called tissue-equivalent materials. This paper describes the construction of a physical phantom that allows the execution of the main acceptance tests of the quality control protocols in digital radiography

  3. Data fusion methodologies for food and beverage authentication and quality assessment - a review.

    Science.gov (United States)

    Borràs, Eva; Ferré, Joan; Boqué, Ricard; Mestres, Montserrat; Aceña, Laura; Busto, Olga

    2015-09-03

    The ever increasing interest of consumers for safety, authenticity and quality of food commodities has driven the attention towards the analytical techniques used for analyzing these commodities. In recent years, rapid and reliable sensor, spectroscopic and chromatographic techniques have emerged that, together with multivariate and multiway chemometrics, have improved the whole control process by reducing the time of analysis and providing more informative results. In this progression of more and better information, the combination (fusion) of outputs of different instrumental techniques has emerged as a means for increasing the reliability of classification or prediction of foodstuff specifications as compared to using a single analytical technique. Although promising results have been obtained in food and beverage authentication and quality assessment, the combination of data from several techniques is not straightforward and represents an important challenge for chemometricians. This review provides a general overview of data fusion strategies that have been used in the field of food and beverage authentication and quality assessment. Copyright © 2015 Elsevier B.V. All rights reserved.

  4. The Quality Initiative in Rectal Cancer (QIRC trial: study protocol of a cluster randomized controlled trial in surgery

    Directory of Open Access Journals (Sweden)

    Thabane Lehana

    2008-02-01

    Full Text Available Abstract Background Two unfortunate outcomes for patients treated surgically for rectal cancer are placement of a permanent colostomy and local tumor recurrence. Total mesorectal excision is a new technique for rectal cancer surgery that can lead to improved patient outcomes. We describe a cluster randomized controlled trial that is testing if the above patient outcomes can be improved through a knowledge translation strategy called the Quality Initiative in Rectal Cancer (QIRC strategy. The strategy is designed to optimize the use of total mesorectal excision techniques. Methods and Design Hospitals were randomized to the QIRC strategy (experimental group versus normal practice environment (control group. Participating hospitals, and the respective surgeon group operating in them, are from Ontario, Canada and have an annual procedure volume for major rectal cancer resections of 15 or greater. Patients were eligible if they underwent major rectal surgery for a diagnosis of primary rectal cancer. The surgeon-directed QIRC interventions included a workshop, use of opinion leaders, operative demonstrations, a post-operative questionnaire, and, audit and feedback. For an operative demonstration participating surgeons invited a study team surgeon to assist them with a case of rectal cancer surgery. The intent was to demonstrate total mesorectal excision techniques. Control arm surgeons received no intervention. Sample size calculations were two-sided, considered the clustering of data at the hospital level, and were driven by requirements for the outcome local recurrence. To detect an improvement in local recurrence from 20% to 8% with confidence we required 16 hospitals and 672 patients – 8 hospitals and 336 patients in each arm. Outcomes data are collected via chart review for at least 30 months after surgery. Analyses will use an intention-to-treat principle and will consider the clustering of data. Data collection will be complete by the end of

  5. 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

  6. 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

  7. Future trials of endovascular mechanical recanalisation therapy in acute ischemic stroke patients - a position paper endorsed by ESMINT and ESNR : part II: methodology of future trials.

    Science.gov (United States)

    Fiehler, Jens; Söderman, Michael; Turjman, Francis; White, Philip M; Bakke, Søren Jacob; Mangiafico, Salvatore; von Kummer, Rüdiger; Muto, Mario; Cognard, Christophe; Gralla, Jan

    2012-12-01

    Based on current data and experience, the joint working group of the European Society of Minimally Invasive Neurological Therapy (ESMINT) and the European Society of Neuroradiology (ESNR) make suggestions on trial design and conduct aimed to investigate therapeutic effects of mechanical thrombectomy (MT). We anticipate that this roadmap will facilitate the setting up and conduct of successful trials in close collaboration with our neighbouring disciplines.

  8. Future trials of endovascular mechanical recanalisation therapy in acute ischemic stroke patients - A position paper endorsed by ESMINT and ESNR. Pt. 2. Methodology of future trials

    Energy Technology Data Exchange (ETDEWEB)

    Fiehler, Jens [University Medical Centre Hamburg-Eppendorf, Department of Neuroradiology, Hamburg (Germany); Soederman, Michael [Karolinska University Hospital, Department of Neuroradiology, Stockholm (Sweden); Turjman, Francis [Hopital neurologique, Centre de Neurosciences Cognitives, Department of Neuroradiology, Lyon (France); White, Philip M. [University of Edinburgh, Department of Clinical Neurosciences, Western General Hospital, Edinburgh (United Kingdom); Bakke, Soeren Jacob [Oslo University Hospital, Department of Neuroradiology, Oslo (Norway); Mangiafico, Salvatore [University Hospital Careggi, Interventional Neuroradiology Unit, Florence (Italy); Kummer, Ruediger von [University of Dresden, Department of Neuroradiology, Dresden (Germany); Muto, Mario [University of Naples, Department of Neuroradiology, Naples (Italy); Cognard, Christophe [Hopital Purpan, Service de Neuroradiologie, Toulouse (France); Gralla, Jan [Inselspital Bern, Department of Neuroradiology, Bern (Switzerland)

    2012-12-15

    Based on current data and experience, the joint working group of the European Society of Minimally Invasive Neurological Therapy (ESMINT) and the European Society of Neuroradiology (ESNR) make suggestions on trial design and conduct aimed to investigate therapeutic effects of mechanical thrombectomy (MT). We anticipate that this roadmap will facilitate the setting up and conduct of successful trials in close collaboration with our neighbouring disciplines. (orig.)

  9. Palliative healthcare: cost reduction and quality enhancement using end-of-life survey methodology.

    Science.gov (United States)

    Falls, Christopher Edward

    2008-01-01

    American medical institutions throughout the 20th century prescribed high customer satisfaction, but when it came to death, largely ignored it. An accelerated accumulation of esoteric medical information and the application of this knowledge to affect new cures and longer lives instilled an unquestioning reverence for the medical community among the patient population. Diminishing marginal gains in life expectancy, escalating costs related to life sustaining technologies, and a psychographic shift in the dominant consumer base have challenged this traditional reverence. Armed with unprecedented access to medical information, a more knowledgeable and assertive patient population has emerged in the 21st century to institute its own standards of what constitutes quality health care. In terms of end of life care, this has meant recognition that the emotional needs of the dying have been largely underserved by the current American medical model. Patients and their families are no longer willing to accept the traditional medical perspective of death as failure and have numerous international palliative care models that serve as benchmarks of success when it comes to quality of dying. When cure is a possibility, Americans will pursue it at all costs, but when it is not a possibility, they want honest communication and the opportunity to say good-bye to their loved ones. In the context of these emergent needs, life review is offered as a solution. The value proposition targets not only dying patients and their families, but also society as a whole.

  10. Non-Communicable Disease Clinical Practice Guidelines in Brazil: A Systematic Assessment of Methodological Quality and Transparency.

    Directory of Open Access Journals (Sweden)

    Caroline de Godoi Rezende Costa Molino

    Full Text Available Annually, non-communicable diseases (NCDs kill 38 million people worldwide, with low and middle-income countries accounting for three-quarters of these deaths. High-quality clinical practice guidelines (CPGs are fundamental to improving NCD management. The present study evaluated the methodological rigor and transparency of Brazilian CPGs that recommend pharmacological treatment for the most prevalent NCDs.We conducted a systematic search for CPGs of the following NCDs: asthma, atrial fibrillation, benign prostatic hyperplasia, chronic obstructive pulmonary disease, congestive heart failure, coronary artery disease and/or stable angina, dementia, depression, diabetes, gastroesophageal reflux disease, hypercholesterolemia, hypertension, osteoarthritis, and osteoporosis. CPGs comprising pharmacological treatment recommendations were included. No language or year restrictions were applied. CPGs were excluded if they were merely for local use and referred to NCDs not listed above. CPG quality was independently assessed by two reviewers using the Appraisal of Guidelines Research and Evaluation instrument, version II (AGREE II."Scope and purpose" and "clarity and presentation" domains received the highest scores. Sixteen of 26 CPGs were classified as low quality, and none were classified as high overall quality. No CPG was recommended without modification (77% were not recommended at all. After 2009, 2 domain scores ("rigor of development" and "clarity and presentation" increased (61% and 73%, respectively. However, "rigor of development" was still rated < 30%.Brazilian healthcare professionals should be concerned with CPG quality for the treatment of selected NCDs. Features that undermined AGREE II scores included the lack of a multidisciplinary team for the development group, no consideration of patients' preferences, insufficient information regarding literature searches, lack of selection criteria, formulating recommendations, authors' conflict of

  11. 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.

  12. Randomized Controlled Trial on the Effects of CCTV Training on Quality of Life, Depression, and Adaptation to Vision Loss

    NARCIS (Netherlands)

    Burggraaff, M.C.; van Nispen, R.M.A.; Knol, D.L.; Ringens, P.J.; van Rens, G.H.M.B.

    2012-01-01

    PURPOSE. In addition to performance-based measures, visionrelated quality of life (QOL) and other subjective measures of psychosocial functioning are considered important outcomes of training in the visually impaired. In a multicenter, masked, randomized controlled trial, subjective effects of

  13. 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

  14. 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

  15. Verification of dosimetric methodology for auditing radiotherapy quality under non-reference condition in Hubei province

    International Nuclear Information System (INIS)

    Ma Xinxing; Luo Suming; He Zhijian; Zhou Wenshan

    2014-01-01

    Objective: To verify the reliability of TLD-based quality audit for radiotherapy dosimetry of medical electron accelerator in non-reference condition by monitoring the dose variations from electron beams with different field sizes and 45° wedge and the dose variations from photon beams with different field sizes and source-skin distance. Methods: Both TLDs and finger ionization chambers were placed at a depth of 10 cm in water to measure the absorbed dose from photon beams, and also placed at the depth of maximum dose from electron beams under non-reference condition. TLDs were then mailed to National Institute for Radiological Protection, China CDC for further measurement. Results: Among the 70 measuring points for photon beams, 58 points showed the results with a relative error less than ±7.0% (IAEA's acceptable deviation: ±7.0%) between TLDs and finger ionization chambers measurements, and the percentage of qualified point numbers was 82.8%. After corrected by Ps value, 62 points were qualified and the percentage was up to 88.6%. All of the measuring points for electron beams, with the total number of 24, presented a relative error within ±5.0% (IAEA's acceptable deviation: ±5.0%) between TLDs and finger ioization cylindrical chambers measurements. Conclusions: TLD-based quality audit is convenient for determining radiotherapy dosimetric parameters of electron beams in non-reference condition and can improve the accuracy of the measuring parameters in connection with finger chambers. For electron beams of 5 MeV < E_0 < 10 MeV, the absorbed dose parameters measured by finger ionization chambers, combined with TLD audit, can help obtain the precise and reliable results. (authors)

  16. 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....

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

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    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

  18. 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

  19. Multicentre quality assurance of intensity-modulated radiation therapy plans: a precursor to clinical trials

    International Nuclear Information System (INIS)

    Williams, M. J.; Bailey, M. J.; Forstner, D.; Metcalfe, P. E

    2007-01-01

    Full text: A multicentre planning study comparing intensity-modulated radiation therapy (IMRT) plans for the treatment of a head and neck cancer has been carried out. Three Australian radiotherapy centres, each with a different planning system, were supplied a fully contoured CT dataset and requested to generate an IMRT plan in accordance with the requirements of an IMRT-based radiation therapy oncology group clinical trial. Plan analysis was carried out using software developed specifically for reviewing multicentre clinical trial data. Two out of the three plans failed to meet the prescription requirements with one misinterpreting the prescription and the third failed to meet one of the constraints. Only one plan achieved all of the dose objectives for the critical structures and normal tissues. Although each centre used very similar planning parameters and beam arrangements the resulting plans were quite different. The subjective interpretation and application of the prescription and planning objectives emphasize one of the many difficulties in carrying out multicentre IMRT planning studies. The treatment prescription protocol in a clinical trial must be both lucid and unequivocally stated to avoid misinterpretation. Australian radiotherapy centres must show that they can produce a quality IMRT plan and that they can adhere to protocols for IMRT planning before using it in a clinical trial

  20. 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.

  1. Prevalence of high blood pressure in Brazilian adolescents and quality of the employed methodological procedures: systematic review

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    Marina Gabriella Pereira de Andrada Magalhães

    2013-12-01

    Full Text Available OBJECTIVE: To review the literature on studies that estimated the prevalence of high blood pressure (HBP or systemic arterial hypertension (SAH in Brazilian adolescents, considering the employed methodological procedures. METHODS: Bibliographical research of prevalence studies of HBP/SAH in adolescents from 1995 to 2010. The search was conducted in the electronic databases PubMed/Medline, Lilacs, SciELO, and Isi Adolec. The descriptors "hypertension", "BP", "teen", "students", "cross-sectional", "prevalence" and "Brazil" were used in Portuguese and English. Furthermore, a score ranging from 0 to 18 based on Recommendations for Blood Pressure Measurement in Humans and Experimental Animals and the VI Brazilian Guidelines of Hypertension was elaborated, in order to analyze the procedures used to measure BP in studies. RESULTS: Twenty-one articles were identified, mostly published in the last 10 years, and 90.5% were performed in school-based and regions of the Southeast, Northeast and South. The prevalence of HBP/SAH ranged from 2.5 to 30.9%. The score of the studies ranged from 0 to 16. A significant negative correlation (rho = -0.504; p = 0.020 was observed between the prevalence of HBP/SAH and the score of BP measurement quality. CONCLUSION: The great variability of PAE/SAH estimates appears to be influenced by methodological procedures used in the studies.

  2. Artificial intelligence methodologies applied to quality control of the positioning services offered by the Red Andaluza de Posicionamiento (RAP network

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    Antonio José Gil

    2012-12-01

    Full Text Available On April 26, 2012, Elena Giménez de Ory defend-ed her Ph.D. thesis at University of Jaén, entitled: “Robust methodologies applied to quality control of the positioning services offered by the Red Andaluza de Posicionamiento (RAP network”. Elena Giménez de Ory defended her dissertation in a publicly open presentation held in the Higher Polytechnic School at the University of Jaén, and was able to comment on every question raised by her thesis committee and the audience. The thesis was supervised by her advisor, Prof. Antonio J. Gil Cruz, and the rest of his thesis committee, Prof. Manuel Sánchez de la Orden, Dr. Antonio Miguel Ruiz Armenteros and Dr. Gracia Rodríguez Caderot. The thesis has been read and approved by his thesis committee, receiving the highest rating. All of them were present at the presentation.

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

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    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.

  4. The Effect of Footbath on Sleep Quality of the Elderly: A Blinded Randomized Clinical Trial

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    Allehe Seyyedrasooli

    2013-11-01

    Full Text Available Introduction: The progressive increase in the elderly population of developing countries has drawn attention to their health. Sleep Pattern and quality can affect life quality in old people. We need more documents about footbath (a non-invasive method. The purpose of this research was to examine footbath on sleep quality of the elderly. Methods: This study is a blinded, randomized, clinical trial on 46 old men that had health documents in health center, 2013. Participants in the research were divided into two groups. One group had footbath (experimental group and another group did not have footbath (control group. The experimental group participants were asked to put their feet in warm water (41-42 ºC for 20 minutes before sleeping for 6 weeks. The co-researcher completed the Pittsburgh Sleep Quality Index (PSQI before and after the intervention by individual interview. Data were analyzed by SPSS software. Results: The comparison of changes in sleep quality score the old men showed the sleep duration and total sleep quality has significantly improved in the experimental group. Conclusion: According to the study results, the maximum effect of footbath was on sleep latency and sleep duration disturbances. In this study, the researchers had limited access to the elderly in Tabriz; therefore, it is recommended that future research be conducted in a higher number of health centers.

  5. Improvement of Quality of Life (QOL in Osteoporotic Patients by Elcatonin Treatment: A Trial Taking the Participants’ Preference into Account

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    K. Yoh

    2012-01-01

    Full Text Available Osteoporosis is associated with compromised quality of life (QOL, to which pain has the most important contribution. Elcatonin, a derivative of calcitonin, is widely used in the treatment of osteoporosis in two ways. One is as the inhibitor of osteoclastic bone resorption. The other is for osteoporosis-related pain based on the unique analgesic effects of elcatonin. Since pain is subjective in nature, and QOL is the only clinical outcome representing the patients’ subjective perception of health status, pain associated with osteoporosis would be best evaluated based on QOL assessment. Evidence based medicine gives the highest remarks to the double-blinded, randomized controlled trial, which, however, cannot be free from methodological problems on some occasions. For example, it is practically impossible to remain blinded in the trial of a potent analgesia, which in turn causes biases. Thus, the significance of taking the patients’ preference into account is increasingly acknowledged. In this study, 45 osteoporotic patients were given brochures describing the pros and cons on the three treatment choices; calcium and alfacalcidol, additional use of elcatonin, and additional use of bisphosphonate. Those who favored elcatonin were older, had more vertebral fractures, and lower QOL scores. QOL was evaluated before and three months after the treatment using SF-8; the most widely used generic questionnaire, and RDQ; a lumbago-specific measure. Elcatonin treatment improved physical function, general health, and vitality of SF-8, and RDQ score. Although this is a preliminary study, our results suggest that patients with vertebral fracture(s have impaired QOL and more likely to favor elcatonin treatment expecting analgesia.

  6. Quality of randomized controlled trials published in the International Urogynecology Journal 2007-2016.

    Science.gov (United States)

    Kim, Kyu Shik; Chung, Jae Hoon; Jo, Jung Ki; Kim, Jae Heon; Kim, Seungjun; Cho, Jeoung Man; Cho, Hee Ju; Choi, Hong Yong; Lee, Seung Wook

    2018-07-01

    Randomized controlled trials (RCTs) provide the best quality clinical evidence. The aim of this study was to assess the quality of RCTs published by the International Urogynecology Journal (IUJ) in 2007-2016. RCTs in original articles were extracted from PubMed and IUJ homepage. Change in RCT quality over time was assessed with Jadad and van Tulder scales and Cochrane Collaboration's risk of bias tool (CCRBT). Jadad scores of 3-5 or van Tulder scores of >5 indicated high-quality RCTs. The effect on RCT quality of including funding source and institutional review board (IRB) approval statements and describing the intervention was assessed. In addition, changes in RCT topics over time were assessed. Annual RCT frequencies did not change significantly (6.7-15.7%): 36.1% and 25.7% described blinding and allocation concealment, respectively. Both tended to increase between 2013 and 2016, particularly 2013 and 2014. Funding statement inclusion (39.1% overall) and intervention description (78.2% overall) tended to increase steadily. IRB statement inclusion (60.4% overall) increased significantly (p < 0.01). Jadad scores and van Tulder rose significantly until 2014 (p < 0.01). Frequencies of high-quality RCTs tended to rise. CCRBT indicated that RCTs with a low risk of bias tended to increase until 2014. However, from 2015, Jadad scores, van Tulder, and CCRBT the low risk tended to decreased. RCTs with funding and IRB approval statements had higher Jadad and van Tulder scores than unfunded RCTs (p < 0.01 and p < 0.01, respectively). Intervention description did not associate with better quality. RCT quality improved over time, but a dip in quality was observed in 2015-2016 because of decreased blinding and allocation concealment.

  7. Evaluation of the environmental epidemiologic data and methodology for the air quality standard in Beijing

    Science.gov (United States)

    Li, Xu; Jiang, Yanfeng; Yin, Ling; Liu, Bo; Du, Pengfei; Hassan, Mujtaba; Wang, Shigong; Li, Tanshi

    2017-09-01

    To evaluate the relationship between exposure to air pollutants and respiratory emergency room visits, a generalized additive model (GAM) was used to analyze the exposure-effect relationship between air pollutants and respiratory emergency room visits. The results showed that NO2, SO2, and PM10 have positive relationships with respiratory disease. Concentration increases of 10 μg/m3 in NO2, SO2, and PM10 corresponded to 3.90% (95%CI 3.56-4.25), 0.81% (95%CI -0.09-1.72), and 0.64% (95%CI 0.55-0.74) increases in respiratory emergency room visits. In addition, there is a strong synergic effect of PM10 and NO2 on respiratory diseases. The threshold values of the national standard grade II limits used in Beijing should be adjusted. An appropriate standard could effectively promote a significant decline in respiratory room visits and would eventually be beneficial to air quality management in residential areas.

  8. A Proposed Methodology to Assess the Quality of Public Use Management in Protected Areas

    Science.gov (United States)

    Muñoz-Santos, Maria; Benayas, Javier

    2012-07-01

    In recent years, the goal of nature preservation has faced, almost worldwide, an increase in the number of visitors who are interested in experiencing protected areas resources, landscapes and stories. Spain is a good example of this process. The rapidly increasing numbers of visitors have prompted administrations and managers to offer and develop a broad network of facilities and programs in order to provide these visitors with information, knowledge and recreation. But, are we doing it the best way? This research focuses on developing and applying a new instrument for evaluating the quality of visitor management in parks. Different areas are analyzed with this instrument (78 semi-quantitative indicators): planning and management capacity (planning, funding, human resources), monitoring, reception, information, interpretation, environmental education, training, participation and volunteer's programs. Thus, we attempt to gain a general impression of the development of the existing management model, detecting strengths and weaknesses. Although Spain's National Parks constituted the specific context within which to develop the evaluation instrument, the design thereof is intended to provide a valid, robust and flexible method for application to any system, network or set of protected areas in other countries. This paper presents the instrument developed, some results obtained following its application to Spanish National parks, along with a discussion on the limits and validity thereof.

  9. Methodology for Evaluating the Quality of Ecosystem Maps: A Case Study in the Andes

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    Dolors Armenteras

    2016-08-01

    Full Text Available Uncertainty in thematic maps has been tested mainly in maps with discrete or fuzzy classifications based on spectral data. However, many ecosystem maps in tropical countries consist of discrete polygons containing information on various ecosystem properties such as vegetation cover, soil, climate, geomorphology and biodiversity. The combination of these properties into one class leads to error. We propose a probability-based sampling design with two domains, multiple stages, and stratification with selection of primary sampling units (PSUs proportional to the richness of strata present. Validation is undertaken through field visits and fine resolution remote sensing data. A pilot site in the center of the Colombian Andes was chosen to validate a government official ecosystem map. Twenty primary sampling units (PSUs of 10 × 15 km were selected, and the final numbers of final sampling units (FSUs were 76 for the terrestrial domain and 46 for the aquatic domain. Our results showed a confidence level of 95%, with the accuracy in the terrestrial domain varying between 51.8% and 64.3% and in the aquatic domain varying between 75% and 92%. Governments need to account for uncertainty since they rely on the quality of these maps to make decisions and guide policies.

  10. Protocol adherence for continuously titrated interventions in randomized trials: an overview of the current methodology and case study

    Directory of Open Access Journals (Sweden)

    F. Lauzier

    2017-07-01

    Full Text Available Abstract Background The standard definition for protocol adherence is the proportion of all scheduled doses that are delivered. In clinical research, this definition has several limitations when evaluating protocol adherence in trials that study interventions requiring continuous titration. Discussion Building upon a specific case study, we analyzed a recent trial of a continuously titrated intervention to assess the impact of different definitions of protocol deviations on the interpretation of protocol adherence. The OVATION pilot trial was an open-label randomized controlled trial of higher (75–80 mmHg versus lower (60–65 mmHg mean arterial pressure (MAP targets for vasopressor therapy in shock. In this trial, potential protocol deviations were defined as MAP values outside the targeted range for >4 consecutive hours during vasopressor therapy without synchronous and consistent adjustments of vasopressor doses. An adjudication committee reviewed each potential deviation to determine if it was clinically-justified or not. There are four reasons for this contextual measurement and reporting of protocol adherence. First, between-arm separation is a robust measure of adherence to complex protocols. Second, adherence assessed by protocol deviations varies in function of the definition of deviations and the frequency of measurements. Third, distinguishing clinically-justified vs. not clinically-justified protocol deviations acknowledges clinically sensible bedside decision-making and offers a clear terminology before the trial begins. Finally, multiple metrics exist to report protocol deviations, which provides different information but complementary information on protocol adherence. Conclusions In trials of interventions requiring continuous titration, metrics used for defining protocol deviations have a considerable impact on the interpretation of protocol adherence. Definitions for protocol deviations should be prespecified and correlated

  11. Protocol adherence for continuously titrated interventions in randomized trials: an overview of the current methodology and case study.

    Science.gov (United States)

    Lauzier, F; Adhikari, N K; Seely, A; Koo, K K Y; Belley-Côté, E P; Burns, K E A; Cook, D J; D'Aragon, F; Rochwerg, B; Kho, M E; Oczkowksi, S J W; Duan, E H; Meade, M O; Day, A G; Lamontagne, F

    2017-07-17

    The standard definition for protocol adherence is the proportion of all scheduled doses that are delivered. In clinical research, this definition has several limitations when evaluating protocol adherence in trials that study interventions requiring continuous titration. Building upon a specific case study, we analyzed a recent trial of a continuously titrated intervention to assess the impact of different definitions of protocol deviations on the interpretation of protocol adherence. The OVATION pilot trial was an open-label randomized controlled trial of higher (75-80 mmHg) versus lower (60-65 mmHg) mean arterial pressure (MAP) targets for vasopressor therapy in shock. In this trial, potential protocol deviations were defined as MAP values outside the targeted range for >4 consecutive hours during vasopressor therapy without synchronous and consistent adjustments of vasopressor doses. An adjudication committee reviewed each potential deviation to determine if it was clinically-justified or not. There are four reasons for this contextual measurement and reporting of protocol adherence. First, between-arm separation is a robust measure of adherence to complex protocols. Second, adherence assessed by protocol deviations varies in function of the definition of deviations and the frequency of measurements. Third, distinguishing clinically-justified vs. not clinically-justified protocol deviations acknowledges clinically sensible bedside decision-making and offers a clear terminology before the trial begins. Finally, multiple metrics exist to report protocol deviations, which provides different information but complementary information on protocol adherence. In trials of interventions requiring continuous titration, metrics used for defining protocol deviations have a considerable impact on the interpretation of protocol adherence. Definitions for protocol deviations should be prespecified and correlated with between-arm separation, if it can be measured.

  12. 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.

  13. 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

  14. 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

  15. Formalizing the ISDF Software Development Methodology

    Directory of Open Access Journals (Sweden)

    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.

  16. 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.

  17. Clinical trial methodology and clinical cohorts: the importance of complete follow-up in trials evaluating the virological efficacy of anti-HIV medicines

    DEFF Research Database (Denmark)

    Kirk, Ole; Lundgren, Jens Dilling

    2004-01-01

    -up is still likely to be discontinued at a premature switch from study medication in a large number of the randomized trials published in 2002-2003. However, some studies, all initiated by investigators, did follow patients throughout the study period. In three of the studies, the proportions of patients...

  18. [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.

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

    Science.gov (United States)

    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

  20. 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.

  1. 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

  2. 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.

  3. A critical appraisal of the reporting quality of published randomized controlled trials in the fall injuries.

    Science.gov (United States)

    Asghari Jafarabadi, Mohammad; Sadeghi-Bazrgani, Homayoun; Dianat, Iman

    2018-06-01

    To evaluate the quality of reporting in published randomized controlled trials (RTCs) in the field of fall injuries. The 188 RTCs published between 2001 and 2011, indexed in EMBASE and Medline databases were extracted through searching by appropriate keywords and EMTree classification terms. The evaluation trustworthiness was assured through parallel evaluations of two experts in epidemiology and biostatistics. About 40%-75% of papers had problems in reporting random allocation method, allocation concealment, random allocation implementation, blinding and similarity among groups, intention to treat and balancing benefits and harms. Moreover, at least 10% of papers inappropriately/not reported the design, protocol violations, sample size justification, subgroup/adjusted analyses, presenting flow diagram, drop outs, recruitment time, baseline data, suitable effect size on outcome, ancillary analyses, limitations and generalizability. Considering the shortcomings found and due to the importance of the RCTs for fall injury prevention programmes, their reporting quality should be improved.

  4. Effectiveness of the Spirometry 360 Quality Improvement Program for Improving Asthma Care: A Cluster Randomized Trial.

    Science.gov (United States)

    Mangione-Smith, Rita; Zhou, Chuan; Corwin, Michael J; Taylor, James A; Rice, Fiona; Stout, James W

    To determine the effectiveness of the Spirometry 360 distance learning quality improvement (QI) program for enhancing the processes and outcomes of care for children with asthma. Cluster randomized controlled trial involving 25 matched pairs of pediatric primary care practices. Practices were recruited from 2 practice-based research networks: the Slone Center Office-based Research Network at Boston University, Boston, Mass, and the Puget Sound Pediatric Research Network, Seattle, Wash. Study participants included providers from one of the 50 enrolled pediatric practices and 626 of their patients with asthma. Process measures assessed included spirometry test quality and appropriate prescription of asthma controller medications. Outcome measures included asthma-specific health-related quality of life, and outpatient, emergency department, and inpatient utilization for asthma. At baseline, 25.4% of spirometry tests performed in control practices and 50.4% of tests performed in intervention practices were of high quality. During the 6-month postintervention period, 28.7% of spirometry tests performed in control practices and 49.9% of tests performed in intervention practices were of high quality. The adjusted difference-of-differences analysis revealed no intervention effect on spirometry test quality. Adjusted differences-of-differences analysis also revealed no intervention effect on appropriate use of controller medications or any of the parent- or patient-reported outcomes examined. In this study, the Spirometry 360 distance learning QI program was ineffective in improving spirometry test quality or parent- or patient-reported outcomes. QI programs like the one assessed here may need to focus on practices with lower baseline performance levels or may need to be tailored for those with higher baseline performance. Copyright © 2017 Academic Pediatric Association. Published by Elsevier Inc. All rights reserved.

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

    Science.gov (United States)

    Cornu, Catherine; Remontet, Laurent; Noel-Baron, Florence; Nicolas, Alain; Feugier-Favier, Nathalie; Roy, Pascal; Claustrat, Bruno; Saadatian-Elahi, Mitra; Kassaï, Behrouz

    2010-06-22

    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. 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. 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). The dietary supplement had neither effect on the perceived quality of sleep, nor on the melatonin metabolism and sleep-wake cycle. clinical trials.gov:NCT00484497.

  6. Assessment of data quality in an international multi-centre randomised trial of coronary artery surgery

    Directory of Open Access Journals (Sweden)

    Bochenek Andrzej

    2011-09-01

    Full Text Available Abstract Background ART is a multi-centre randomised trial of cardiac surgery which provided a unique opportunity to evaluate the data from a large number of centres from a variety of countries. We attempted to assess data quality, including recruitment rates, timeliness and completeness of the data obtained from the centres in different socio-economic strata. Methods The analysis was based on the 2-page CRF completed at the 6 week follow-up. CRF pages were categorised into "clean" (no edit query and "dirty" (any incomplete, inconsistent or illegible data. The timelines were assessed on the basis of the time interval from the visit and receipt of complete CRF. Data quality was defined as the number of data queries (in percent and time delay (in days between visit and receipt of correct data. Analyses were stratified according to the World Bank definitions into: "Developing" countries (Poland, Brazil and India and "Developed" (Italy, UK, Austria and Australia. Results There were 18 centres in the "Developed" and 10 centres in the "Developing" countries. The rate of enrolment did not differ significantly by economic level ("Developing":4.1 persons/month, "Developed":3.7 persons/month. The time interval for the receipt of data was longer for "Developing" countries (median:37 days compared to "Developed" ones (median:11 days (p Conclusions In this study we showed that data quality was comparable between centres from "Developed" and "Developing" countries. Data was received in a less timely fashion from Developing countries and appropriate systems should be instigated to minimize any delays. Close attention should be paid to the training of centres and to the central management of data quality. Trial registration ISRCTN46552265

  7. 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

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

    Directory of Open Access Journals (Sweden)

    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

  9. 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.

  10. Predictors of acceptance of offered care management intervention services in a quality improvement trial for dementia.

    Science.gov (United States)

    Kaisey, Marwa; Mittman, Brian; Pearson, Marjorie; Connor, Karen I; Chodosh, Joshua; Vassar, Stefanie D; Nguyen, France T; Vickrey, Barbara G

    2012-10-01

    Care management approaches have been proven to improve outcomes for patients with dementia and their family caregivers (dyads). However, acceptance of services in these programs is incomplete, impacting effectiveness. Acceptance may be related to dyad as well as healthcare system characteristics, but knowledge about factors associated with program acceptance is lacking. This study investigates patient, caregiver, and healthcare system characteristics associated with acceptance of offered care management services. This study analyzed data from the intervention arm of a cluster randomized controlled trial of a comprehensive dementia care management intervention. There were 408 patient-caregiver dyads enrolled in the study, of which 238 dyads were randomized to the intervention. Caregiver, patient, and health system factors associated with participation in offered care management services were assessed through bivariate and multivariate regression analyses. Out of the 238 dyads, 9 were ineligible for this analysis, leaving data of 229 dyads in this sample. Of these, 185 dyads accepted offered care management services, and 44 dyads did not. Multivariate analyses showed that higher likelihood of acceptance of care management services was uniquely associated with cohabitation of caregiver and patient (p management participation could result in increased adoption of successful programs to improve quality of care. Using these factors to revise both program design as well as program promotion may also benefit external validity of future quality improvement research trials. Copyright © 2011 John Wiley & Sons, Ltd.

  11. 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...

  12. The role of pragmatism in explaining heterogeneity in meta-analyses of randomised trials: a protocol for a cross-sectional methodological review

    Science.gov (United States)

    Aves, Theresa; Lawson, Daeria; Nieuwlaat, Robby; Beyene, Joseph; Mbuagbaw, Lawrence

    2017-01-01

    Introduction There has been increasing interest in pragmatic trials methodology. As a result, tools such as the Pragmatic-Explanatory Continuum Indicator Summary-2 (PRECIS-2) are being used prospectively to help researchers design randomised controlled trials (RCTs) within the pragmatic-explanatory continuum. There may be value in applying the PRECIS-2 tool retrospectively in a systematic review setting as it could provide important information about how to pool data based on the degree of pragmatism. Objectives To investigate the role of pragmatism as a source of heterogeneity in systematic reviews by (1) identifying systematic reviews with meta-analyses of RCTs that have moderate to high heterogeneity, (2) applying PRECIS-2 to RCTs of systematic reviews, (3) evaluating the inter-rater reliability of PRECIS-2, (4) determining how much of this heterogeneity may be explained by pragmatism. Methods A cross-sectional methodological review will be conducted on systematic reviews of RCTs published in the Cochrane Library from 1 January 2014 to 1 January 2017. Included systematic reviews will have a minimum of 10 RCTs in the meta-analysis of the primary outcome and moderate to substantial heterogeneity (I2≥50%). Of the eligible systematic reviews, a random selection of 10 will be included for quantitative evaluation. In each systematic review, RCTs will be scored using the PRECIS-2 tool, in duplicate. Agreement between raters will be measured using the intraclass correlation coefficient. Subgroup analyses and meta-regression will be used to evaluate how much variability in the primary outcome may be due to pragmatism. Dissemination This review will be among the first to evaluate the PRECIS-2 tool in a systematic review setting. Results from this research will provide inter-rater reliability information about PRECIS-2 and may be used to provide methodological guidance when dealing with pragmatism in systematic reviews and subgroup considerations. On completion, this

  13. The p-EVES study design and methodology: a randomised controlled trial to compare portable electronic vision enhancement systems (p-EVES) to optical magnifiers for near vision activities in visual impairment.

    Science.gov (United States)

    Taylor, John; Bambrick, Rachel; Dutton, Michelle; Harper, Robert; Ryan, Barbara; Tudor-Edwards, Rhiannon; Waterman, Heather; Whitaker, Chris; Dickinson, Chris

    2014-09-01

    evaluation will provide results on: the incremental cost-effectiveness of p-EVES compared to optical magnifiers; cost-effectiveness; and cost-utility. The evidence base in low vision rehabilitation is modest and further high quality clinical trials are required to inform decisions on healthcare provision. The p-EVES study findings are anticipated to contribute to this broader evidence requirement, with the methodological issues evident here being relevant to other trials within the field. © 2014 The Authors Ophthalmic & Physiological Optics © 2014 The College of Optometrists.

  14. Quality of diets with fluidized bed combustion residue treatment: I. Rat trials

    Energy Technology Data Exchange (ETDEWEB)

    Cahill, N.J.; Reid, R.L.; Head, M.K.; Hern, J.L.; Bennett, O.L.

    Feeding trials were conducted with rats (Rattus rattus) to examine effects of soil application, or dietary inclusion, of fluidized bed combustion residue (FBCR) on the composition and quality of foods. Four diets (vegetable protein, egg protein, chicken, chicken + dietary FBCR) prepared with either FBCR or lime (control) treatments, were fed to weanling, female rats in three growth and reproduction trials. Intake, growth rate, and composition of body and organs of rats were measured. Rats in one trial were bred, their litters maintained on dietary treatments, and the offspring rebred. Treatment (FBCR vs. lime) x diet interactions on food composition and animal responses generally were not significant. Treatment had little effect on element composition of diets; mineral concentrations were in normal ranges. Diet treatment with FBCR depressed (P<0.01) food intake and growth of rats in one trial, but not in others, and had no effect (P<0.05) on body water, protein, ether extract, or gross energy composition. Some differences in element concentrations in the carcass and organs of rats and pups resulted from FBCR treatment, but effects were small and inconsistent. Litters from the first reproductive cycle appeared normal, except for animals fed the chicken + dietary FBCR treatment, on which pups showed poor growth and anemia. Offspring from certain diets were rebred and litters showed a high mortality, although this was not associated specifically with FBCR treatment. Results indicated no major detrimental effects on food composition, or growth, tissue element accumulation, and reproduction in the rat relating to use of FBCR as a soil amendment. 20 refs., 9 tabs.

  15. The methodological quality of guidelines for hospital-acquired pneumonia and ventilator-associated pneumonia: A systematic review.

    Science.gov (United States)

    Ambaras Khan, R; Aziz, Z

    2018-05-02

    Clinical practice guidelines serve as a framework for physicians to make decisions and to support best practice for optimizing patient care. However, if the guidelines do not address all the important components of optimal care sufficiently, the quality and validity of the guidelines can be reduced. The objectives of this study were to systematically review current guidelines for hospital-acquired pneumonia (HAP) and ventilator-associated pneumonia (VAP), evaluate their methodological quality and highlight the similarities and differences in their recommendations for empirical antibiotic and antibiotic de-escalation strategies. This review is reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) statement. Electronic databases including MEDLINE, CINAHL, PubMed and EMBASE were searched up to September 2017 for relevant guidelines. Other databases such as NICE, Scottish Intercollegiate Guidelines Network (SIGN) and the websites of professional societies were also searched for relevant guidelines. The quality and reporting of included guidelines were assessed using the Appraisal of Guidelines for Research and Evaluation II (AGREE-II) instrument. Six guidelines were eligible for inclusion in our review. Among 6 domains of AGREE-II, "clarity of presentation" scored the highest (80.6%), whereas "applicability" scored the lowest (11.8%). All the guidelines supported the antibiotic de-escalation strategy, whereas the majority of the guidelines (5 of 6) recommended that empirical antibiotic therapy should be implemented in accordance with local microbiological data. All the guidelines suggested that for early-onset HAP/VAP, therapy should start with a narrow spectrum empirical antibiotic such as penicillin or cephalosporins, whereas for late-onset HAP/VAP, the guidelines recommended the use of a broader spectrum empirical antibiotic such as the penicillin extended spectrum carbapenems and glycopeptides. Expert guidelines

  16. Effect of an educational toolkit on quality of care: a pragmatic cluster randomized trial.

    Science.gov (United States)

    Shah, Baiju R; Bhattacharyya, Onil; Yu, Catherine H Y; Mamdani, Muhammad M; Parsons, Janet A; Straus, Sharon E; Zwarenstein, Merrick

    2014-02-01

    Printed educational materials for clinician education are one of the most commonly used approaches for quality improvement. The objective of this pragmatic cluster randomized trial was to evaluate the effectiveness of an educational toolkit focusing on cardiovascular disease screening and risk reduction in people with diabetes. All 933,789 people aged ≥40 years with diagnosed diabetes in Ontario, Canada were studied using population-level administrative databases, with additional clinical outcome data collected from a random sample of 1,592 high risk patients. Family practices were randomly assigned to receive the educational toolkit in June 2009 (intervention group) or May 2010 (control group). The primary outcome in the administrative data study, death or non-fatal myocardial infarction, occurred in 11,736 (2.5%) patients in the intervention group and 11,536 (2.5%) in the control group (p = 0.77). The primary outcome in the clinical data study, use of a statin, occurred in 700 (88.1%) patients in the intervention group and 725 (90.1%) in the control group (p = 0.26). Pre-specified secondary outcomes, including other clinical events, processes of care, and measures of risk factor control, were also not improved by the intervention. A limitation is the high baseline rate of statin prescribing in this population. The educational toolkit did not improve quality of care or cardiovascular outcomes in a population with diabetes. Despite being relatively easy and inexpensive to implement, printed educational materials were not effective. The study highlights the need for a rigorous and scientifically based approach to the development, dissemination, and evaluation of quality improvement interventions. http://www.ClinicalTrials.gov NCT01411865 and NCT01026688.

  17. Quality assessment of reports on clinical trials in the Journal of Hepatology

    DEFF Research Database (Denmark)

    Gluud, C; Nikolova, D

    1998-01-01

    Electronic searches on databases for randomised clinical trials and controlled clinical trials do not identify as many trials as handsearches, and trial reporting may be flawed. The aims were to identify all fully reported randomised clinical trials in the Journal of Hepatology and to make...... a qualitative assessment of the reporting....

  18. 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.

  19. Optimization of edible coating formulations for improving postharvest quality and shelf life of pear fruit using response surface methodology.

    Science.gov (United States)

    Nandane, A S; Dave, Rudri K; Rao, T V Ramana

    2017-01-01

    The effect of composite edible films containing soy protein isolate (SPI) in combination with additives like hydroxypropyl methylcellulose (HPMC) and olive oil on 'Babughosha' pear ( Pyrus communis L.) stored at ambient temperature (28 ± 5 °C and 60 ± 10% RH) was evaluated using Response surface methodology (RSM). A total of 30 edible coating formulations comprising of SPI (2-6%, w/v), olive oil (0.7-1.1%, v/v), HPMC (0.1-0.5%, w/v) and potassium sorbate (0-0.4% w/v) were evaluated for optimizing the most suitable combination. Quality parameters like weight loss%, TSS, pH and titrable acidity of the stored pears were selected as response variables for optimization. The optimization procedure was carried out using RSM. It was observed that the response variables were mainly effected by concentration of SPI and olive oil in the formulation. Edible coating comprising of SPI 5%, HPMC 0.40%, olive oil 1% and potassium sorbate 0.22% was found to be most suitable combination for pear fruit with predicted values of response variables indicated as weight loss% 3.50, pH 3.41, TSS 11.13 and TA% 0.513.

  20. Roselle (Hibiscus sabdariffa L.) and soybean oil effects on quality characteristics of pork patties studied by response surface methodology.

    Science.gov (United States)

    Jung, Eunkyung; Joo, Nami

    2013-07-01

    Response surface methodology was used to investigate the effect and interactions of processing variables such as roselle extract (0.1-1.3%), soybean oil (5-20%) on physicochemical, textural and sensory properties of cooked pork patties. It was found that reduction in thickness, pH, L* and b* values decreased; however, water-holding capacity, reduction in diameter and a* values increased, respectively, as the amount of roselle increased. Soybean oil addition increased water-holding capacity, reduction in thickness, b* values of the patties. The hardness depended on the roselle and soybean oil added, as its linear effect was negative at proselle and soybean oil. The maximum overall quality score (5.42) was observed when 12.5 g of soybean oil and 0.7 g of roselle extract was added. The results of this optimization study would be useful for meat industry that tends to increase the product yield for patties using the optimum levels of ingredients by RSM. Copyright © 2013 Elsevier Ltd. All rights reserved.

  1. An investigation of laser cutting quality of 22MnB5 ultra high strength steel using response surface methodology

    Science.gov (United States)

    Tahir, Abdul Fattah Mohd; Aqida, Syarifah Nur

    2017-07-01

    In hot press forming, changes of mechanical properties in boron steel blanks have been a setback in trimming the final shape components. This paper presents investigation of kerf width and heat affected zone (HAZ) of ultra high strength 22MnB5 steel cutting. Sample cutting was conducted using a 4 kW Carbon Dioxide (CO2) laser machine with 10.6 μm wavelength with the laser spot size of 0.2 mm. A response surface methodology (RSM) using three level Box-Behnken design of experiment was developed with three factors of peak power, cutting speed and duty cycle. The parameters were optimised for minimum kerf width and HAZ formation. Optical evaluation using MITUTOYO TM 505 were conducted to measure the kerf width and HAZ region. From the findings, laser duty cycle was crucial to determine cutting quality of ultra-high strength steel; followed by cutting speed and laser power. Meanwhile, low power intensity with continuous wave contributes the narrowest kerf width formation and least HAZ region.

  2. 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.)

  3. 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.)

  4. Methodology and recruitment for a randomised controlled trial to evaluate the safety of wahakura for infant bedsharing.

    Science.gov (United States)

    Tipene-Leach, David; Baddock, Sally; Williams, Sheila; Jones, Raymond; Tangiora, Angeline; Abel, Sally; Taylor, Barry

    2014-09-28

    Sudden Unexpected Death in Infancy (SUDI) has persistent high rates in deprived indigenous communities and much of this mortality is attributable to unsafe sleep environments. Whilst health promotion worldwide has concentrated on avoidance of bedsharing, the indigenous Māori community in New Zealand has reproduced a traditional flax bassinet (wahakura) designed to be used in ways that include bedsharing. To date there has been no assessment of the safety of this traditional sleeping device. This two arm randomised controlled trial is being conducted with 200 mother-baby dyads recruited from Māori communities in areas of high deprivation in the Hawkes Bay, New Zealand. They are randomised to wahakura or bassinet use and investigation includes questionnaires at baseline (pregnancy), when baby is 1, 3, and 6 months, and an overnight video sleep study at 1 month with monitoring of baby temperature and oxygen saturation, and measurement of baby urinary cotinine and maternal salivary oxytocin. Outcome measures are amount of time head covered, amount of time in thermal comfort zone, number of hypoxic events, amount of time in the assigned sleep device, amount of time breastfeeding, number of parental (non-feed related) touching infant events, amount of time in the prone sleep position, the number of behavioural arousals and the amount of time infant is awake overnight. Survey data will compare breastfeeding patterns at 1, 3, and 6 months as well as data on maternal mind-mindedness, maternal wellbeing, attachment to baby, and maternal sleep patterns. Indigenous communities require creative SUDI interventions that fit within their prevailing world view. This trial, and its assessment of the safety of a wahakura relative to a standard bassinet, is an important contribution to the range of SUDI prevention research being undertaken worldwide. Australian New Zealand Clinical Trials Registry: ACTRN12610000993099 Registered 16th November 2010.

  5. Investigating the association between medication adherence and health-related quality of life in COPD : Methodological challenges when using a proxy measure of adherence

    NARCIS (Netherlands)

    Boland, Melinde R. S.; van Boven, Job F. M.; Kruis, Annemarije L.; Chavannes, Niels H.; van der Molen, Thys; Goossens, Lucas M. A.; Rutten-van Molken, Maureen P. M. H.

    Background: The association between non-adherence to medication and health-related quality-of-life (HRQoL) in Chronic Obstructive Pulmonary Disease (COPD) remains poorly understood. Different ways to deal with methodological challenges to estimate this association have probably contributed to

  6. A systematic review of the quality of randomized controlled trials in head and neck oncology surgery.

    Science.gov (United States)

    Carlton, Daniel A; Kocherginsky, Masha; Langerman, Alexander J

    2015-01-01

    To determine the quality of randomized controlled trials (RCTs) in head and neck surgery in which surgery was a primary intervention. Potential articles were identified in PubMed without publication date restrictions. Articles were scored using the CONSORT checklist and the relationship between the checklist score and whether the first and/or last authors were surgeons was investigated. Differences in the checklist score based on how many surgeons were among the first and last authors of the study were analyzed using the Kruskal-Wallis test. Fisher's exact test was used to examine if there was a significant difference of the reporting of individual items from the checklist between surgeons and nonsurgeons. A nonparametric trend test was used to determine whether there was a difference in the reporting of individual items based on whether there were none, one, or two surgeons among first and last authors. A total of 38 publications satisfied the inclusion criteria. There was a trend toward lower quality for studies in which surgeons were either first, last, or both first and last authors compared to studies that were first-authored and last-authored by nonsurgeons (P = 0.068). Nonsurgeons were more likely to report on critical elements regarding hypothesis, sample size determination, randomization, and eligibility of centers (P = 0.023-0.058). The quality of RCTs in head and neck surgery is poor. Improved training in conducting and reporting clinical research is needed in otolaryngology residencies. © 2014 The American Laryngological, Rhinological and Otological Society, Inc.

  7. A survey of radiotherapy quality control practice in the United Kingdom for the START trial

    International Nuclear Information System (INIS)

    Venables, Karen; Winfield, Elizabeth; Deighton, Amanda; Aird, Edwin; Hoskin, Peter

    2001-01-01

    Background and purpose: This paper compares the quality control checks performed in departments in the United Kingdom with those recommended by the Institute of Physics and Engineering in Medicine (IPEM) in Report 81. Method: The data were gathered by the quality assurance team for the START trial, during visits to individual departments. Data are compared with the frequencies suggested in IPEM report 81. Where applicable, data are also analyzed with respect to machine manufacturer. Results: All departments with linear accelerators check the output at least weekly for both photons and electrons, however 11% of departments do not perform a constancy check of the output on a daily basis. The majority of departments check flatness at gantry zero on a monthly basis. However 27% of departments never check at non-zero gantry angles. In 51% of departments no fluoroscopy checks are performed on simulators on a daily basis. Conclusion: The majority of departments are following the frequencies suggested in IPEM report 81 although there are a number of discrepancies particularly for simulators. Accelerator type needs to be considered when designing quality assurance checks. In many departments more time than is currently allocated is needed on equipment, particularly simulators, to complete all of the checks suggested in Report 81

  8. 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.

  9. 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.

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

    Science.gov (United States)

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

    2016-01-07

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

  11. Development of a dynamic quality assurance testing protocol for multisite clinical trial DCE-CT accreditation

    Energy Technology Data Exchange (ETDEWEB)

    Driscoll, B. [Department of Radiation Physics, Princess Margaret Cancer Center, 610 University Avenue, Toronto, Ontario M5G 2M9 (Canada); Keller, H. [Department of Radiation Physics, Princess Margaret Cancer Center, 610 University Avenue, Toronto, Ontario M5G 2M9, Canada and Department of Radiation Oncology, University of Toronto, 150 College Street, Toronto, Ontario M5S 3E2 (Canada); Jaffray, D.; Coolens, C. [Department of Radiation Physics, Princess Margaret Cancer Center, 610 University Avenue, Toronto, Ontario M5G 2M9 (Canada); Department of Radiation Oncology, University of Toronto, 150 College Street, Toronto, Ontario M5S 3E2 (Canada); Techna Institute, University Health Network, 124-100 College Street, Toronto, Ontario M5G 1L5 (Canada)

    2013-08-15

    Purpose: Credentialing can have an impact on whether or not a clinical trial produces useful quality data that is comparable between various institutions and scanners. With the recent increase of dynamic contrast enhanced-computed tomography (DCE-CT) usage as a companion biomarker in clinical trials, effective quality assurance, and control methods are required to ensure there is minimal deviation in the results between different scanners and protocols at various institutions. This paper attempts to address this problem by utilizing a dynamic flow imaging phantom to develop and evaluate a DCE-CT quality assurance (QA) protocol.Methods: A previously designed flow phantom, capable of producing predictable and reproducible time concentration curves from contrast injection was fully validated and then utilized to design a DCE-CT QA protocol. The QA protocol involved a set of quantitative metrics including injected and total mass error, as well as goodness of fit comparison to the known truth concentration curves. An additional region of interest (ROI) sensitivity analysis was also developed to provide additional details on intrascanner variability and determine appropriate ROI sizes for quantitative analysis. Both the QA protocol and ROI sensitivity analysis were utilized to test variations in DCE-CT results using different imaging parameters (tube voltage and current) as well as alternate reconstruction methods and imaging techniques. The developed QA protocol and ROI sensitivity analysis was then applied at three institutions that were part of clinical trial involving DCE-CT and results were compared.Results: The inherent specificity of robustness of the phantom was determined through calculation of the total intraday variability and determined to be less than 2.2 ± 1.1% (total calculated output contrast mass error) with a goodness of fit (R{sup 2}) of greater than 0.99 ± 0.0035 (n= 10). The DCE-CT QA protocol was capable of detecting significant deviations from

  12. The BNCT facility at the HFR Petten: Quality assurance for reactor facilities in clinical trials

    International Nuclear Information System (INIS)

    Moss, R.; Watkins, P.; Vroegindeweij, C.; Stecher-Rasmussen, F.; Huiskamp, R.; Ravensberg, K.; Appelman, K.; Sauerwein, W.; Hideghety, K.; Gabel, D.

    2001-01-01

    The first clinical trial in Europe of Boron Neutron Capture Therapy (BNCT) for the treatment of glioblastoma was opened in July 1997. The trial is a Phase I study with the principal aim to establish the maximum tolerated radiation dose and the dose limiting toxicity under defined conditions. It is the first time that a clinical application could be realised on a completely multi-national scale. The treatment takes place at the High Flux Reactor (HFR) in Petten, the Netherlands, is operated by an international team of experts under the leadership of a German radiotherapist, and treats patients coming from different European countries. It has therefore been necessary to create a very specialised organisation and contractual structure with the support of administrations from different countries, who had to find and adapt solutions within existing laws that had never foreseen such a situation. Furthermore, the treatment does not take place in an hospital environment and even more so, the facility is at a nuclear research reactor. Hence, special efforts were made on quality assurance, in order that the set-up at the facility and the personnel involved complied, as closely as possible, with similar practices in conventional radiotherapy departments. (author)

  13. [Interlaboratory trials for quality assurance of breast cancer biomarkers in Germany].

    Science.gov (United States)

    Krusche, C A; von Wasielewski, R; Rüschoff, J; Fisseler-Eckhoff, A; Kreipe, H H

    2008-07-01

    In the age of personalized medicine, and in addition to typing and grading, breast cancer pathologists are now also involved in determining biomarkers such as steroid hormone receptors and Her-2, which are of the utmost importance in adjuvant therapy. In order to assure quality of these biomarker assays, external proficiency testing has been implemented in Germany. Since 2002 trials have been conducted annually, with up to 180 participating laboratories. More than 85% of all participants achieved good results in clearly negative and positive cases seen in daily practice. If at all, discordant results were observed in the rarer low steroid-hormone receptor expressing tumors and Her-2 borderline cases (2+). Regular participation in interlaboratory testing leads to significantly improved immunohistochemical results, particularly in these problematic cases. Tissue microarrays (TMA) with 20-24 different breast cancer samples including cell lines meant that a huge number of pathologists were challenged with identical samples, providing the prerequisite for comparability. Participation is recommended for pathology departments involved in the service for breast units. The organizational frame work of the trials is described here. The confidence of cooperating disciplines in breast cancer biomarkers assessed by pathologists will be fostered by external proficiency testing as presented here.

  14. Pharmacist leadership in ICU quality improvement: coordinating spontaneous awakening and breathing trials.

    Science.gov (United States)

    Stollings, Joanna L; Foss, Julie J; Ely, E Wesley; Ambrose, Anna M; Rice, Todd W; Girard, Timothy D; Wheeler, Arthur P

    2015-08-01

    Coordinating efforts across disciplines in the intensive care unit is a key component of quality improvement (QI) efforts. Spontaneous awakening trials (SATs) and spontaneous breathing trials (SBTs) are considered key components of guidelines, yet unfortunately are often not done or coordinated properly. To determine if a pharmacist-driven awakening and breathing coordination (ABC) QI program would improve compliance (ie, process measures) as compared with the previous protocol, which did not involve pharmacists. The QI program included pharmacist-led education, daily discussion on rounds, and weekly performance reports to staff. Using a pre-QI versus during-QI versus post-QI intervention design, we compared data from 500 control ventilator-days (pre-QI period) versus 580 prospective ventilator-days (during-QI period). We then evaluated the sustainability of the QI program in 216 ventilator-days in the post-QI period. SAT safety screens were performed on only 20% pre-QI patient-days versus 97% of during-QI patient-days (P improved process measures compliance, comparing the pre-QI versus during-QI rates of screening, performing, and coordinating SAT and SBTs, and these results were sustained in the 8-month follow-up period post-QI program. © The Author(s) 2015.

  15. Quantitative Quality Assurance in a Multicenter HARDI Clinical Trial at 3T

    Science.gov (United States)

    Zhou, Xiaopeng; Sakaie, Ken E.; Debbins, Josef P.; Kirsch, John E.; Tatsuoka, Curtis; Fox, Robert J.; Lowe, Mark J.

    2016-01-01

    A phantom-based quality assurance (QA) protocol was developed for a multicenter clinical trial including high angular resolution diffusion imaging (HARDI). A total of 27 3T MR scanners from 2 major manufacturers, GE (Discovery and Signa scanners) and Siemens (Trio and Skyra scanners), were included in this trial. With this protocol, agar phantoms doped to mimic relaxation properties of brain tissue are scanned on a monthly basis, and quantitative procedures are used to detect spiking and to evaluate eddy current and Nyquist ghosting artifacts. In this study, simulations were used to determine alarm thresholds for minimal acceptable signal-to-noise ratio (SNR). Our results showed that spiking artifact was the most frequently observed type of artifact. Overall, Trio scanners exhibited less eddy current distortion than GE scanners, which in turn showed less distortion than Skyra scanners. This difference was mainly caused by the different sequences used on these scanners. The SNR for phantom scans was closely correlated with the SNR from volunteers. Nearly all of the phantom measurements with artifact-free images were above the alarm threshold, suggesting that the scanners are stable longitudinally. Software upgrades and hardware replacement sometimes affected SNR substantially but sometimes did not. In light of these results, it is important to monitor longitudinal SNR with phantom QA to help interpret potential effects on in vivo measurements. Our phantom QA procedure for HARDI scans was successful in tracking scanner performance and detecting unwanted artifacts. PMID:27587227

  16. 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

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

    Science.gov (United States)

    Trento, Marina; Durando, Olga; Lavecchia, Sonia; Charrier, Lorena; Cavallo, Franco; Costa, Miguel Angelo; Hernández, Cristina; Simó, Rafael; Porta, Massimo

    2017-07-01

    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 retinopathy were enrolled in a 2-year multicenter randomized controlled trial. The 25-item National Eye Institute Visual Functioning Questionnaire was used to explore 12 subscales of vision related quality of life. The patients were 62.8 ± 6.7 years old and had 11.1 ± 5.6 years known disease duration. 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 mental health and vision specific role difficulties. Patients with reduced retinal thickness at the ganglion cell layer (n = 36) did not differ for diabetic retinopathy but were older, had lower best corrected visual acuity and worse scores for ocular pain, color vision and peripheral vision. On multivariable analysis, worse scores for general vision remained associated with reduced retinal thickness, diabetes duration and best corrected visual acuity, and scores for visual specific mental health with diabetic retinopathy and lower best corrected visual acuity. Visual specific role difficulties were only associated with reduced best corrected visual acuity. Scores for driving decreased among females, with worsening of Hemoglobin A1c and best corrected visual acuity. Color vision depended only on reduced retinal thickness, and peripheral vision on both reduced thickness and best corrected visual acuity. The National Eye Institute Visual Functioning Questionnaire could detect subtle changes in patients' perception of visual function, despite absent/minimal diabetic

  18. Intraarticular Facet Injections for Low Back Pain: Design Considerations, Consensus Methodology to Develop the Protocol for a Randomized Controlled Trial.

    Science.gov (United States)

    Mars, Tom; Ellard, David R; Antrobus, James H L; Cairns, Melinda; Underwood, Martin; Haywood, Kirstie; Keohane, Susie; Sandhu, Harbinder; Griffiths, Frances

    2015-01-01

    Since the publication of guidelines by the UK National Institute for Health and Care Excellence (NICE) and the American Pain Society guidelines for low back pain in 2009 there have been deep divisions in the pain treatment community about the use of therapeutic intraarticular facet joint injections. While evidence for the effectiveness or not of intraarticular facet joint injections remains sparse, uncertainty will remain. The Warwick feasibility study, along with a concurrent study with a different design led by another group, aims to provide a stable platform from which the effectiveness and cost effectiveness of intraarticular facet joint injections added to normal care could be evaluated in randomized controlled trials (RCTs). To reach consensus on key design considerations for the Warwick facet feasibility study from which the study protocol and working manuals will be developed. A consensus conference involving expert professionals and lay members. Preliminary work identified 5 key design considerations for deliberation at our consensus conference. Three concerned patient assessment and treatment: diagnosis of possible facet joint pain, interaarticular facet joint injection technique, and best usual care. Two concerned trial analysis: a priori sub-groups and minimally important difference and are reported elsewhere. We did systematic evidence reviews of the design considerations and summarized the evidence. Our design questions and evidence summaries were distributed to all delegates. This formed the basis for discussions on the day. Clinical experts in all aspects of facet joint injection from across the UK along with lay people were invited via relevant organizations. Nominal group technique was used in 15 facilitated initial small group discussions. Further discussion and ranking was undertaken in plenary. All small group and plenary results were recorded and checked and verified post conference. Where necessary participants were contacted via email to

  19. Breast ductal lavage for biomarker assessment in high risk women: rationale, design and methodology of a randomized phase II clinical trial with nimesulide, simvastatin and placebo

    International Nuclear Information System (INIS)

    Lazzeroni, Matteo; Radice, Davide; Bonanni, Bernardo; Guerrieri-Gonzaga, Aliana; Serrano, Davide; Cazzaniga, Massimiliano; Mora, Serena; Casadio, Chiara; Jemos, Costantino; Pizzamiglio, Maria; Cortesi, Laura

    2012-01-01

    and the safety blood tests do not show any significant liver toxicity. There is an urgent need to confirm in the clinical setting the potential efficacy of other compounds in contrasting hormone non-responsive breast cancer. This paper is focused on the methodology and operational aspects of the clinical trial. (ClinicalTrials.gov Identifier: NCT01500577)

  20. Design and methodology of a randomized clinical trial of home-based telemental health treatment for U.S. military personnel and veterans with depression.

    Science.gov (United States)

    Luxton, David D; Pruitt, Larry D; O'Brien, Karen; Stanfill, Katherine; Jenkins-Guarnieri, Michael A; Johnson, Kristine; Wagner, Amy; Thomas, Elissa; Gahm, Gregory A

    2014-05-01

    Home-based telemental health (TMH) treatments have the potential to address current and future health needs of military service members, veterans, and their families, especially for those who live in rural or underserved areas. The use of home-based TMH treatments to address the behavioral health care needs of U.S. military healthcare beneficiaries is not presently considered standard of care in the Military Health System. The feasibility, safety, and clinical efficacy of home-based TMH treatments must be established before broad dissemination of home-based treatment programs can be implemented. This paper describes the design, methodology, and protocol of a clinical trial that compares in-office to home-based Behavioral Activation for Depression (BATD) treatment delivered via web-based video technology for service members and veterans with depression. This grant funded three-year randomized clinical trial is being conducted at the National Center for Telehealth and Technology at Joint-base Lewis-McChord and at the Portland VA Medical Center. Best practice recommendations regarding the implementation of in-home telehealth in the military setting as well as the cultural and contextual factors of providing in-home care to active duty and veteran military populations are also discussed. Published by Elsevier Inc.

  1. [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.

  2. Elderly Patients with Dementia-Related Symptoms of Severe Agitation and Aggression: Consensus Statement on Treatment Options, Clinical Trials Methodology, and Policy

    Science.gov (United States)

    Salzman, C; Jeste, D; Meyer, RE; Cohen-Mansfield, J; Cummings, J; Grossberg, G; Jarvik, L; Kraemer, H; Lebowitz, B; Maslow, K; Pollock, B; Raskind, M; Schultz, S; Wang, P; Zito, JM; Zubenko, GS

    2009-01-01

    Atypical antipsychotic drugs have been used off-label in clinical practice for treatment of serious dementia-associated agitation and aggression. Following reports of cerebrovascular adverse events associated with the use of atypical antipsychotic in elderly patients with dementia, the FDA issued black box warnings for several atypical antipsychotics, titled “Cerebrovascular Adverse Events, including Stroke, in Elderly Patients with Dementia.” Subsequently, the FDA initiated a meta-analysis of safety data from 17 registration trials across six antipsychotic drugs (five atypical antipsychotics and haloperidol). In 2005, the Agency issued a black box warning regarding increased risk of mortality associated with the use of atypical antipsychotic drugs in this patient population. Geriatric mental health experts participating in a 2006 consensus conference reviewed evidence on the safety and efficacy of antipsychotics, as well as nonpharmacologic approaches, in treating dementia-related symptoms of agitation and aggression. They concluded that, while problems in clinical trials design may have been one of the contributors to the failure to find a signal of drug efficacy, the findings related to drug safety should be taken seriously by clinicians in assessing the potential risks and benefits of treatment in a frail population, and in advising families about treatment. Information provided to patients and family members should be documented in the patient’s chart. Drugs should be used only when non-pharmacologic approaches have failed to adequately control behavioral disruption. Participants also agreed that that there is a need for an FDA-approved medication for the treatment of severe, persistent or recurrent dementia-related symptoms of agitation and aggression (even in the absence of psychosis), that are unresponsive to nonpharmacologic intervention. The authors have outlined methodological enhancements to better evaluate treatment approaches in future

  3. Building research capacity in Botswana: a randomized trial comparing training methodologies in the Botswana ethics training initiative

    Science.gov (United States)

    2013-01-01

    Background Little empirical data are available on the extent to which capacity-building programs in research ethics prepare trainees to apply ethical reasoning skills to the design, conduct, or review of research. A randomized controlled trial was conducted in Botswana in 2010 to assess the effectiveness of a case-based intervention using email to augment in-person seminars. Methods University faculty and current and prospective IRB/REC members took part in a semester-long training program in research ethics. Participants attended two 2-day seminars and were assigned at random to one of two on-line arms of the trial. Participants in both arms completed on-line international modules from the Collaborative Institutional Training Initiative. Between seminars, intervention-arm participants were also emailed a weekly case to analyze in response to set questions; responses and individualized faculty feedback were exchanged via email. Tests assessing ethics knowledge were administered at the start of each seminar. The post-test included an additional section in which participants were asked to identify the ethical issues highlighted in five case studies from a list of multiple-choice responses. Results were analyzed using regression and ANOVA. Results Of the 71 participants (36 control, 35 intervention) enrolled at the first seminar, 41 (57.7%) attended the second seminar (19 control, 22 intervention). In the intervention arm, 19 (54.3%) participants fully completed and 8 (22.9%) partially completed all six weekly cases. The mean score was higher on the post-test (30.3/40) than on the pre-test (28.0/40), and individual post- and pre-test scores were highly correlated (r = 0.65, p  0.84), but intervention-arm subjects who completed all assigned cases answered an average of 3.2 more questions correctly on the post-test than others, controlling for pre-test scores (p = 0.003). Conclusions Completion of the case-based intervention improved respondents’ test

  4. Building research capacity in Botswana: a randomized trial comparing training methodologies in the Botswana ethics training initiative.

    Science.gov (United States)

    Barchi, Francis H; Kasimatis-Singleton, Megan; Kasule, Mary; Khulumani, Pilate; Merz, Jon F

    2013-02-01

    Little empirical data are available on the extent to which capacity-building programs in research ethics prepare trainees to apply ethical reasoning skills to the design, conduct, or review of research. A randomized controlled trial was conducted in Botswana in 2010 to assess the effectiveness of a case-based intervention using email to augment in-person seminars. University faculty and current and prospective IRB/REC members took part in a semester-long training program in research ethics. Participants attended two 2-day seminars and were assigned at random to one of two on-line arms of the trial. Participants in both arms completed on-line international modules from the Collaborative Institutional Training Initiative. Between seminars, intervention-arm participants were also emailed a weekly case to analyze in response to set questions; responses and individualized faculty feedback were exchanged via email. Tests assessing ethics knowledge were administered at the start of each seminar. The post-test included an additional section in which participants were asked to identify the ethical issues highlighted in five case studies from a list of multiple-choice responses. Results were analyzed using regression and ANOVA. Of the 71 participants (36 control, 35 intervention) enrolled at the first seminar, 41 (57.7%) attended the second seminar (19 control, 22 intervention). In the intervention arm, 19 (54.3%) participants fully completed and 8 (22.9%) partially completed all six weekly cases. The mean score was higher on the post-test (30.3/40) than on the pre-test (28.0/40), and individual post- and pre-test scores were highly correlated (r = 0.65, p  0.84), but intervention-arm subjects who completed all assigned cases answered an average of 3.2 more questions correctly on the post-test than others, controlling for pre-test scores (p = 0.003). Completion of the case-based intervention improved respondents' test scores, with those who completed all six

  5. Model development for mechanical properties and weld quality class of friction stir welding using multi-objective Taguchi method and response surface methodology

    International Nuclear Information System (INIS)

    Mohamed, Mohamed Ackiel; Manurung, Yupiter HP; Berhan, Mohamed Nor

    2015-01-01

    This study presents the effect of the governing parameters in friction stir welding (FSW) on the mechanical properties and weld quality of a 6mm thick 6061 T651 Aluminum alloy butt joint. The main FSW parameters, the rotational and traverse speed were optimized based on multiple mechanical properties and quality features, which focus on the tensile strength, hardness and the weld quality class using the multi-objective Taguchi method (MTM). Multi signal to noise ratio (MSNR) was employed to determine the optimum welding parameters for MTM while further analysis concerning the significant level determination was accomplished via the well-established analysis of variance (ANOVA). Furthermore, the first order model for predicting the mechanical properties and weld quality class is derived by applying response surface methodology (RSM). Based on the experimental confirmation test, the proposed method can effectively estimate the mechanical properties and weld quality class which can be used to enhance the welding performance in FSW or other applications.

  6. Model development for mechanical properties and weld quality class of friction stir welding using multi-objective Taguchi method and response surface methodology

    Energy Technology Data Exchange (ETDEWEB)

    Mohamed, Mohamed Ackiel [University Kuala Lumpur Malaysia France Institute, Bandar Baru Bangi (Malaysia); Manurung, Yupiter HP; Berhan, Mohamed Nor [Universiti Teknologi MARA, Shah Alam (Malaysia)

    2015-06-15

    This study presents the effect of the governing parameters in friction stir welding (FSW) on the mechanical properties and weld quality of a 6mm thick 6061 T651 Aluminum alloy butt joint. The main FSW parameters, the rotational and traverse speed were optimized based on multiple mechanical properties and quality features, which focus on the tensile strength, hardness and the weld quality class using the multi-objective Taguchi method (MTM). Multi signal to noise ratio (MSNR) was employed to determine the optimum welding parameters for MTM while further analysis concerning the significant level determination was accomplished via the well-established analysis of variance (ANOVA). Furthermore, the first order model for predicting the mechanical properties and weld quality class is derived by applying response surface methodology (RSM). Based on the experimental confirmation test, the proposed method can effectively estimate the mechanical properties and weld quality class which can be used to enhance the welding performance in FSW or other applications.

  7. Sleep quality in nurses: a randomized clinical trial of day and night shift workers.

    Science.gov (United States)

    Niu, Shu-Fen; Chu, Hsin; Chung, Min-Huey; Lin, Chun-Chieh; Chang, Yu-Shiun; Chou, Kuei-Ru

    2013-07-01

    The study investigated the number of days off nurses working night shifts need to recover their sleep quality to the level of daytime workers during their days off. This study included 30 day-shift nurses and 32 night-shift nurses. It was conducted as a randomized clinical trial in the medical and surgical wards of a medical center in northern Taiwan in May and June 2010 using sleep diaries and sleep parameters collected by actigraphy on different workdays and days off. On workdays, the night-shift group had significantly less total sleep time (TST) on Day 5 and significantly lower sleep efficiency (SE) on Day 3 than the day-shift group. TSTs of the two groups on days off were higher than those on workdays. On the 4th consecutive day off, higher TST, a decrease in WASO, and an increase in SE suggests that the night-shift group had recovered their sleep quality to the level of the day-shift group on their days off. The SE of the night-shift group exceeded that of the day-shift group after the 4th consecutive day off, though the difference was not statistically significant in the present study. Based on these data, it is recommended that night-shift workers arrange a period of at least 4 days off after 5 consecutive night shifts and at least 5 days off if the staff who have previously worked night shifts are being assigned a set of different shifts.

  8. CEC quality criteria for diagnostic radiographic images and patient exposure trial

    International Nuclear Information System (INIS)

    Nahrstedt, U.; Wall, B.; Maccia, C.; Moores, B.M.; Padovani, R.

    1990-01-01

    The intention of this report has been to present the results of a multinational trial set up by a study group of the radiation protection programme of the CEC. In view of proceeding towards the harmonization and the optimization of the radiological techniques commonly used in different European countries, the relevance of quality criteria for radiographic images together with dose requirements were checked on about 900 examined patients. Due to the type of X-ray projections considered, more than 1 200 questionnaires concerning the real X-ray films were therefore collected and evaluated through a scoring system. Such an approach was relevant and contributed to providing practical considerations on how to reduce and optimize patient received dose while keeping the essential medical information imaged on the film. Indeed the results obtained allowed identification of technical modalities corresponding to that objective. Furthermore, analysis of results revealed two main areas which should be further taken into consideration: - personnel training in radiation protection (radiologists and radiographers), establishment of quality assurance programmes in diagnostic radiology (good usage of radiological equipment and reduction of wasted films)

  9. A pragmatic trial in the Rio de Janeiro subway to capture smokers for a quitline: methodological challenges and opportunities.

    Science.gov (United States)

    Szklo, André Salem; da Silva Freire Coutinho, Evandro; Reichenheim, Michael Eduardo

    2012-01-01

    According to the World Health Organization, smoking is an important cause of death worldwide. To encourage smoking cessation, persuasive messages can be used to raise smokers' risk perception. This article discusses challenges and solutions in designing a study to evaluate the effect of two different communication strategies ("gains from quitting" vs. "losses from continuing smoking") in encouraging calls to a quitline. The authors conducted an intervention study in two subway stations for 4 weeks, considering only 1 strategy per station. Large posters containing non-age-specific images and texts, on the basis of the theme"shortness of breath," were displayed on central dividing columns on the boarding platforms. Call rates from the selected stations, and respective rate ratios, overall and per study week, were calculated. Passengers who were smokers, exposed to the positive-content message, called on average 1.7 times more often than did those exposed to the negative-content message (p = .01). Moreover, call rate ratios did not decline over the 4 weeks of the study (p = .40). The effectiveness findings suggest that antismoking campaigns could use positive-content messages in order to recruit a larger smoker population. The proposed methodology can also be used to evaluate effectiveness of messages for "capturing" individuals with other health problems (e.g., alcohol abuse), thereby increasing its potential impact.

  10. Methodology of clinical trials evaluating the incorporation of new drugs in the first-line treatment of patients with diffuse large B-cell lymphoma (DLBCL): a critical review.

    Science.gov (United States)

    Iacoboni, G; Zucca, E; Ghielmini, M; Stathis, A

    2018-05-01

    The first-line treatment of diffuse large B-cell lymphoma (DLBCL) is the combination of rituximab with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) chemotherapy, curing approximately 60% of patients. Many clinical trials have been carried out over the last 10 years trying to improve the results of this treatment, but the appropriateness of their planning strategies could be rediscussed. Reports of phase III trials evaluating the addition of molecularly targeted agents or new monoclonal antibodies to the classic R-CHOP backbone in first-line induction or maintenance treatment were reviewed. The trial design, primary end point, number of patients enrolled, patient selection criteria, treatment schedule and results were registered for each one. In addition, the phases I and II trials which preceded these phase III trials were also reviewed. Among six phase III trials with results, only one trial evaluating lenalidomide maintenance after response to R-CHOP induction was positive and reached its primary end point. The other five trials did not show an improved outcome with the addition of the new agent. The preceding phases I and II trials were very heterogeneous in their end points and design. Even though most of these trials were considered positive, thus encouraging further investigation, so far they failed to predict the results of the subsequent phase III trials. The standard of care for DLBCL is still R-CHOP. Phase I/II trials failed to predict the results of subsequent phase III trials evaluating non-chemotherapeutic agents added to R-CHOP. The methodology of phase II trials evaluating new agents in DLBCL needs to be better defined in the future.

  11. Improvement of quality of reporting in randomised controlled trials to prevent hypotension after spinal anaesthesia for caesarean section

    NARCIS (Netherlands)

    A. Herdan; R. Roth; D. Grass; M. Klimek (Markus); S. Will; B. Schauf; R. Rossaint; M. Heesen

    2011-01-01

    textabstractHypotension is a frequent complication of spinal anaesthesia for caesarean section and can threaten the well-being of the unborn child. Numerous randomised controlled trials (RCTs) dealt with measures to prevent hypotension. The aim of this study was to determine the reporting quality of

  12. Clinical trial of telepathology as an alternative modality in breast histopathology quality assurance.

    Science.gov (United States)

    Leong, F J; Graham, A K; Schwarzmann, P; McGee, J O

    2000-01-01

    Telepathology is a potential alternative to conventional histopathology. A clinical trial using a robotic telepathology system was conducted to assess the clinical and technical utility and effectiveness of telepathology in the U.K. breast screening pathology quality assurance program. Eighty-seven cases of breast disease were chosen at random from a series of 192 cases from the U.K. Breast Screening Pathology National Quality Assurance Scheme (NEQAS) collection. There were 20 benign, 23 carcinoma in situ (CIS), and 44 invasive malignant cases. The diagnostic accuracy of telepathology (TP) compared with conventional light microscopic (LM) diagnosis was 98.8%; this included a single case deferred for LM examination. The figure was similar when compared with expert consensus diagnosis (CD). In invasive tumor typing, TP accuracy was 95.4% (42/44 cases), the difference being attributable to slide color fading and would have had no impact on patient management. The accuracy of TP versus LM and expert consensus in tumor grading was 91.3% for carcinoma in situ (21/23 cases), a discordance with no relevance to patient management. TP grading of invasive tumor compared with LM diagnosis, had an accuracy of 86.4% (38/44) with a clinically significant accuracy of 97.7% (43/44). The time taken for TP diagnosis averaged 3.9 minutes per case by the end of the study. This data demonstrates that telepathology diagnostic accuracy is comparable to conventional microscopy and may therefore be envisaged as an alternative to conventional light microscopy for more rapid proficiency testing in breast screening (and perhaps other) quality assurance schemes.

  13. Physical and technical quality assurance in the CHARTWEL-bronchus trial

    International Nuclear Information System (INIS)

    Lehmann, D.; Voigtmann, L.; Herrmann, T.; Baumann, M.; Leetz, H.K.; Hodapp, N.

    2003-01-01

    Background: On-site physical quality assurance (QA) was performed in the participating centers of the CHARTWEL-Bronchus trial to ensure that physical and technical treatment parameters correspond with the requirements of this trial. Material and Methods: Questionnaires were sent to the clinics to obtain information on the equipment and in-house QA policies. In addition, two phantoms with drillings for an ionization chamber were shipped with detailed instructions for CT-based treatment planning of a fixed field (RW3 phantom) and a standardized isocentric 3-field technique (Rando trademark humanoid phantom). Using their routine treatment planning system, the participating centers performed point dose calculations for the isocenters in both phantoms and for defined points in the lungs and the spinal cord of the Rando trademark phantom. During the on-site visit, the doses in these points and the deviation of the actual monitor calibration from the internal reference value of the department were determined. In addition, relevant geometric parameters of the accelerator were checked. Results: In the RW3 phantom, the maximum dose deviations from the prescribed value were 3.5% without correction for the actual monitor calibration and 2.1% after correction. The maximum dose deviation in the isocenter of the Rando trademark phantom was 4.0%. To separate the influence of the treatment planning system on this deviation from other sources, all measurements in the Rando trademark phantom were corrected for the deviations determined in the RW3 phantom. After this correction, the maximum deviation was 3.0% in the isocenter. For the other measurement points, the largest dose deviation of 7% was found in the left lung. Deviations of geometric parameters were negligible in all audited departments. Conclusion: The CHARTWEL-Bronchus physical QA program revealed a high conformity of geometric and dosimetric parameters and valid dose calculations by the CT-based treatment planning systems

  14. 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

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

    Science.gov (United States)

    Bas, Esra

    2014-07-01

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

  16. 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.

  17. Sleep Disordered Breathing in Chronic SCI: A Randomized Controlled Trial of Treatment Impact on Cognition, Quality of Life, and Cardiovascular Disease

    Science.gov (United States)

    2016-10-01

    Cognition, Quality of Life, and Cardiovascular Disease PRINCIPAL INVESTIGATOR: Shirin Shafazand, MD, MS CONTRACTING ORGANIZATION: University of Miami...with positive airway pressure (PAP) will improve cognitive impairment, sleep quality, quality of life, and cardiovascular disease (CVD) surrogate...Randomized Controlled Trial of Treatment Impact on Cognition, Quality of Life, and Cardiovascular Disease Shirin Shafazand, MD, MS Nothing listed 12

  18. 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.)

  19. Evaluating quality of life and cost implications of prophylactic radiotherapy in mesothelioma: Health economic analysis of the SMART trial.

    Science.gov (United States)

    Stewart, Samuel Alan; Clive, Amelia O; Maskell, Nick A; Penz, Erika

    2018-01-01

    The SMART trial is a UK-based, multicentre RCT comparing prophylactic radiotherapy and symptom-based (deferred) radiotherapy in 203 patients with Malignant Pleural Mesothelioma who had undergone large bore pleural interventions. Using costs and quality of life data collected alongside the clinical trial, we will estimate the cost-effectiveness of prophylactic radiotherapy compared to deferred radiotherapy over a 1-year period. Healthcare utilization and costs were captured during the trial. Utility weights produced by the EQ-5D questionnaire were used to determine quality-adjusted life-years (QALY) gained. The incremental cost-effectiveness ratio was calculated over the one-year trial period. Costs were similar in the immediate and deferred radiotherapy groups: £5480.40 (SD = £7040; n = 102) and £5461.40 (SD = £7770; n = 101) respectively. There was also no difference in QALY: 0.498 (95% CI: [0.45, 0.547]) in the prophylactic radiotherapy group versus 0.525 (95% CI: [0.471, 0.580]) in the deferred group. At a willingness to pay threshold of £30,000/QALY there was only a 24% chance that prophylactic radiotherapy was cost-effective compared to deferred radiotherapy. There was no significant effect of prophylactic radiotherapy on quality of life in the intervention group, nor was there any discernable decrease in healthcare costs. There is little evidence to suggest that prophylactic radiotherapy is a cost-effective intervention in this population. ISRCTN72767336 with ISRCTN.

  20. Improving the quality of colonoscopy bowel preparation using a smart phone application: a randomized trial.

    Science.gov (United States)

    Lorenzo-Zúñiga, Vicente; Moreno de Vega, Vicente; Marín, Ingrid; Barberá, Marta; Boix, Jaume

    2015-07-01

    Getting ready for a colonoscopy is difficult and involves many steps. Information given to patients is very important for adherence to treatment. We created a novel smart phone application (SPA) aimed to increase bowel preparation quality and patient satisfaction. We carried out a prospective, endoscopist-blinded, randomized, controlled trial. We enrolled 260 outpatient (58% female, age range 21-75 years) owners of a smartphone. Patients were allocated to two different protocols: instructions provided by SPA (SPA group; n = 108) or written instructions with visual aids (control group; n = 152). All procedures were carried out in the afternoon and patients received the same purgative regimen (2 L polyethylene glycol (PEG) solution plus ascorbic acid), in a full-dose same-day regimen. The study was designed to detect an improvement in quality of bowel preparation using the Harefield Cleansing Scale (HCS) scale. Effect of protocol on patient satisfaction was assessed with a specific questionnaire at the time of colonoscopy. Proportion of patients who obtained successful bowel preparation for colonoscopy (HCS A or B) was significantly higher in the SPA group than in the control group (100% vs 96.1%, respectively; P = 0.037). Mean global HCS scores were similar in both groups. Patient-reported tolerability and overall experience with the prescribed bowel preparation were significantly higher for the SPA group than for the control group. Successful cleansing and patient acceptability with the use of SPA were superior to written instructions in outpatients submitted for colonoscopy using 2 L PEG solution plus ascorbic acid. © 2015 The Authors. Digestive Endoscopy © 2015 Japan Gastroenterological Endoscopy Society.

  1. 78 FR 63972 - Notice of Proposed Methodology for the 2014 Delaware River and Bay Water Quality Assessment Report

    Science.gov (United States)

    2013-10-25

    ... Water Quality Assessment Report AGENCY: Delaware River Basin Commission. ACTION: Notice. SUMMARY: Notice....us , with ``Water Quality Assessment 2014'' as the subject line; via fax to 609-883-9522; via U.S. Mail to DRBC, Attn: Water Quality Assessment 2014, P.O. Box 7360, West Trenton, NJ 08628-0360; via...

  2. 76 FR 50188 - Notice of Proposed Methodology for the Delaware River and Bay Integrated List Water Quality...

    Science.gov (United States)

    2011-08-12

    ... Integrated List Water Quality Assessment AGENCY: Delaware River Basin Commission. ACTION: Notice. SUMMARY... Integrated List Water Quality Assessment is available for review and comment. DATES: Comments must be... should have the phrase ``Water Quality Assessment 2012'' in the subject line and should include the name...

  3. Oral health related quality of life among pregnant women: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Marta Liliana Musskopf

    2018-01-01

    Full Text Available Abstract: The aim of the present study was to compare negative impacts of oral conditions in Oral Heath Related Quality of Life (OHRQoL assessed by the Oral Health Impact Profile-14 (OHIP-14 scores in pregnant women receiving or not comprehensive periodontal treatment. This randomized controlled clinical trial included pregnant women aged between 18 and 35 years old. Participants were randomized in a test group with 96 and a control group with 114 women. Patients in the test group received comprehensive periodontal treatment, supra and subgingival scaling and root-planning and periodontal maintenance appointments. The OHIP-14 was applied before and after treatment. The primary outcome was changes in OHIP-14 scores after follow-up period. The impact of having received or not comprehensive periodontal treatment on the change of the OHIP-14 scores was also investigated. Both groups showed significant reduction in OHIP-14 scores and effect size for the test group was 0.60 and 0.36 for the control group. Multinomial logistic regression analysis showed that participants of the control group had 5.9-fold odds (CI 95% 1.88-18.52 of worsening in OHIP-14 scores and their perception of oral conditions in relation to test group. Comprehensive periodontal treatment during pregnancy can reduce the negative impacts in OHRQoL.

  4. Effects of Rosmarinus officinalis L. on memory performance, anxiety, depression, and sleep quality in university students: A randomized clinical trial.

    Science.gov (United States)

    Nematolahi, Pouya; Mehrabani, Mitra; Karami-Mohajeri, Somayyeh; Dabaghzadeh, Fatemeh

    2018-02-01

    To evaluate the effects of oral rosemary on memory performance, anxiety, depression, and sleep quality in university students. In this double-blinded randomized controlled trial, the 68 participating students randomly received 500 mg rosemary and placebo twice daily for one month. Prospective and retrospective memory performance, depression, anxiety and sleep quality of the students were measured using Prospective and Retrospective Memory Questionnaire, Hospital Anxiety and Depression Scale, and Pittsburgh Sleep Quality Inventory at baseline and after one month. The scores of all the scales and subscales except the sleep latency and sleep duration components of Pittsburgh Sleep Quality Inventory were significantly decreased in the rosemary group in comparison with the control group after one month. Rosemary as a traditional herb could be used to boost prospective and retrospective memory, reduce anxiety and depression, and improve sleep quality in university students. Copyright © 2017 Elsevier Ltd. All rights reserved.

  5. 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