Improving the Reporting Quality of Nonrandomized Evaluations of Behavioral and Public Health Interventions: The TREND Statement

PubMed Central

Des Jarlais, Don C.; Lyles, Cynthia; Crepaz, Nicole

2004-01-01

Developing an evidence base for making public health decisions will require using data from evaluation studies with randomized and nonrandomized designs. Assessing individual studies and using studies in quantitative research syntheses require transparent reporting of the study, with sufficient detail and clarity to readily see differences and similarities among studies in the same area. The Consolidated Standards of Reporting Trials (CONSORT) statement provides guidelines for transparent reporting of randomized clinical trials. We present the initial version of the Transparent Reporting of Evaluations with Nonrandomized Designs (TREND) statement. These guidelines emphasize the reporting of theories used and descriptions of intervention and comparison conditions, research design, and methods of adjusting for possible biases in evaluation studies that use nonrandomized designs. PMID:14998794

Reporting guidelines for primary research: Saying what you did.

PubMed

O'Connor, Annette

2010-12-01

Reporting guidelines aim to facilitate publication of a full and accurate description of research conducted. The motivations for a full and accurate description of research is to enable reproduction of the study, assessment of bias, extraction of data from the study, and to fulfill an ethical obligation to maximize the utility of research findings. Many reporting guidelines exist and most are based on a specific study design such as randomized controlled trials (CONSORT statement) and observational studies (STROBE statement). The REFLECT statement focuses on randomized control trials in livestock and food safety studies. The REFLECT statement has increased emphasis on conveying information about animal housing, group level allocation and challenge studies. Guidelines can be used by authors, reviewers and editors to provide readers with a full and accurate description of the work conducted. Copyright © 2010 Elsevier B.V. All rights reserved.

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

PubMed Central

2011-01-01

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

Characteristics of funding of clinical trials: cross-sectional survey and proposed guidance.

PubMed

Hakoum, Maram B; Jouni, Nahla; Abou-Jaoude, Eliane A; Hasbani, Divina Justina; Abou-Jaoude, Elias A; Lopes, Luciane Cruz; Khaldieh, Mariam; Hammoud, Mira Zein; Al-Gibbawi, Mounir; Anouti, Sirine; Guyatt, Gordon; Akl, Elie A

2017-10-05

To provide a detailed and current characterisation of funding of a representative sample clinical trials. We also aimed to develop guidance for standardised reporting of funding information. We addressed the extent to which clinical trials published in 2015 in any of the 119 Core Clinical Journals included a statement on the funding source (eg, whether a not-for-profit organisation was supported by a private-for-profit organisation), type of funding, amount and role of funder. We used a stepwise approach to develop a guidance and an instrument for standardised reporting of funding information. Of 200 trials, 178 (89%) included a funding statement, of which 171 (96%) reported being funded. Funding statements in the 171 funded trials indicated the source in 100%, amount in 1% and roles of funders in 50%. The most frequent sources were governmental (58%) and private-for-profit (40%). Of 54 funding statements in which the source was a not-for-profit organisation, we found evidence of undisclosed support of those from private-for-profit organisation(s) in 26 (48%). The most frequently reported roles of funders in the 171 funded trials related to study design (42%) and data analysis, interpretation or management (41%). Of 139 randomised controlled trials (RCTs) addressing pharmacological or surgical interventions, 29 (21%) reported information on the supplier of the medication or device. The proposed guidance addresses both the funding information that RCTs should report and the reporting process. Attached to the guidance is a fillable PDF document for use as an instrument for standardised reporting of funding information. Although the majority of RCTs report funding, there is considerable variability in the reporting of funding source, amount and roles of funders. A standardised approach to reporting of funding information would address these limitations. Future research should explore the implications of funding by not-for-profit organisations that are supported by for-profit organisations. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

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

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

Chen, Yu-Pei; Chen, Lei; Li, Wen-Fei

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 (allocationmore » 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.« less

Guidelines for reporting embedded recruitment trials.

PubMed

Madurasinghe, Vichithranie W

2016-01-14

Recruitment to clinical trials is difficult with many trials failing to recruit to target and within time. Embedding trials of recruitment interventions within host trials may provide a successful way to improve this. There are no guidelines for reporting such embedded methodology trials. As part of the Medical Research Council funded Systematic Techniques for Assisting Recruitment to Trials (MRC START) programme designed to test interventions to improve recruitment to trials, we developed guidelines for reporting embedded trials. We followed a three-phase guideline development process: (1) pre-meeting literature review to generate items for the reporting guidelines; (2) face-to-face consensus meetings to draft the reporting guidelines; and (3) post-meeting feedback review, and pilot testing, followed by finalisation of the reporting guidelines. We developed a reporting checklist based on the Consolidated Standards for Reporting Trials (CONSORT) statement 2010. Embedded trials evaluating recruitment interventions should follow the CONSORT statement 2010 and report all items listed as essential. We used a number of examples to illustrate key issues that arise in embedded trials and how best to report them, including (a) how to deal with description of the host trial; (b) the importance of describing items that may differ in the host and embedded trials (such as the setting and the eligible population); and (c) the importance of identifying clearly the point at which the recruitment interventions were embedded in the host trial. Implementation of these guidelines will improve the quality of reports of embedded recruitment trials while advancing the science, design and conduct of embedded trials as a whole.

Agreements between Industry and Academia on Publication Rights: A Retrospective Study of Protocols and Publications of Randomized Clinical Trials

PubMed Central

Kasenda, Benjamin; von Elm, Erik; You, John J.; Tomonaga, Yuki; Saccilotto, Ramon; Amstutz, Alain; Bengough, Theresa; Meerpohl, Joerg J.; Stegert, Mihaela; Olu, Kelechi K.; Tikkinen, Kari A. O.; Neumann, Ignacio; Carrasco-Labra, Alonso; Faulhaber, Markus; Mulla, Sohail M.; Mertz, Dominik; Akl, Elie A.; Bassler, Dirk; Busse, Jason W.; Nordmann, Alain; Gloy, Viktoria; Ebrahim, Shanil; Schandelmaier, Stefan; Sun, Xin; Vandvik, Per O.; Johnston, Bradley C.; Walter, Martin A.; Burnand, Bernard; Hemkens, Lars G.; Bucher, Heiner C.; Guyatt, Gordon H.; Briel, Matthias

2016-01-01

Background Little is known about publication agreements between industry and academic investigators in trial protocols and the consistency of these agreements with corresponding statements in publications. We aimed to investigate (i) the existence and types of publication agreements in trial protocols, (ii) the completeness and consistency of the reporting of these agreements in subsequent publications, and (iii) the frequency of co-authorship by industry employees. Methods and Findings We used a retrospective cohort of randomized clinical trials (RCTs) based on archived protocols approved by six research ethics committees between 13 January 2000 and 25 November 2003. Only RCTs with industry involvement were eligible. We investigated the documentation of publication agreements in RCT protocols and statements in corresponding journal publications. Of 647 eligible RCT protocols, 456 (70.5%) mentioned an agreement regarding publication of results. Of these 456, 393 (86.2%) documented an industry partner’s right to disapprove or at least review proposed manuscripts; 39 (8.6%) agreements were without constraints of publication. The remaining 24 (5.3%) protocols referred to separate agreement documents not accessible to us. Of those 432 protocols with an accessible publication agreement, 268 (62.0%) trials were published. Most agreements documented in the protocol were not reported in the subsequent publication (197/268 [73.5%]). Of 71 agreements reported in publications, 52 (73.2%) were concordant with those documented in the protocol. In 14 of 37 (37.8%) publications in which statements suggested unrestricted publication rights, at least one co-author was an industry employee. In 25 protocol-publication pairs, author statements in publications suggested no constraints, but 18 corresponding protocols documented restricting agreements. Conclusions Publication agreements constraining academic authors’ independence are common. Journal articles seldom report on publication agreements, and, if they do, statements can be discrepant with the trial protocol. PMID:27352244

A Coorientational Analysis of Trial Lawyer and News Reporter Relationships.

ERIC Educational Resources Information Center

Lipschultz, Jeremy Harris

A study considered the relationships of trial lawyers and news reporters, using the coorientation measurement model and Q-methodology, and adapting an analysis of variance experimental design. Sixty statements were constructed and administered to 24 subjects (12 trial lawyers and 12 news reporters) in two large midwestern cities. It was found…

CONSORT-EHEALTH: Improving and Standardizing Evaluation Reports of Web-based and Mobile Health Interventions

PubMed Central

2011-01-01

Background Web-based and mobile health interventions (also called “Internet interventions” or "eHealth/mHealth interventions") are tools or treatments, typically behaviorally based, that are operationalized and transformed for delivery via the Internet or mobile platforms. These include electronic tools for patients, informal caregivers, healthy consumers, and health care providers. The Consolidated Standards of Reporting Trials (CONSORT) statement was developed to improve the suboptimal reporting of randomized controlled trials (RCTs). While the CONSORT statement can be applied to provide broad guidance on how eHealth and mHealth trials should be reported, RCTs of web-based interventions pose very specific issues and challenges, in particular related to reporting sufficient details of the intervention to allow replication and theory-building. Objective To develop a checklist, dubbed CONSORT-EHEALTH (Consolidated Standards of Reporting Trials of Electronic and Mobile HEalth Applications and onLine TeleHealth), as an extension of the CONSORT statement that provides guidance for authors of eHealth and mHealth interventions. Methods A literature review was conducted, followed by a survey among eHealth experts and a workshop. Results A checklist instrument was constructed as an extension of the CONSORT statement. The instrument has been adopted by the Journal of Medical Internet Research (JMIR) and authors of eHealth RCTs are required to submit an electronic checklist explaining how they addressed each subitem. Conclusions CONSORT-EHEALTH has the potential to improve reporting and provides a basis for evaluating the validity and applicability of eHealth trials. Subitems describing how the intervention should be reported can also be used for non-RCT evaluation reports. As part of the development process, an evaluation component is essential; therefore, feedback from authors will be solicited, and a before-after study will evaluate whether reporting has been improved. PMID:22209829

Internet-based randomised controlled trials for the evaluation of complementary and alternative medicines: probiotics in spondyloarthropathy

PubMed Central

Brophy, Sinead; Burrows, Claire L; Brooks, Caroline; Gravenor, Michael B; Siebert, Stefan; Allen, Stephen J

2008-01-01

Background The clinical effectiveness of complementary and alternative medicines (CAMs) is widely debated because of a lack of clinical trials. The internet may provide an effective and economical approach for undertaking randomised controlled trials (RCTs) of low-risk interventions. We investigated whether the internet could be used to perform an internet-based RCT of a CAM fulfilling the revised CONSORT (Consolidated Standards of Reporting Trials) statement quality checklist for reporting of RCTs. A secondary aim was to examine the effect of probiotics compared to placebo in terms of well-being over 12 weeks. Methods People aged ≥18 years with confirmed spondyloarthropathy living in the United Kingdom with internet access were invited to participate in an internet-based RCT of probiotic compared to placebo for improving well-being and bowel symptoms. The intervention was a probiotic containing 4 strains of live bacteria or identical placebo taken by mouth daily for 3 months. The primary outcome measure was the performance of the trial according to the revised CONSORT statement. Results 147 people were randomised into the trial. The internet-based trial of the CAM fulfilled the revised CONSORT statement such as efficient blinding, allocation concealment, intention to treat analysis and flow of participants through the trial. Recruitment of the required number of participants was completed in 19 months. Sixty-five percent (96/147) completed the entire 3 months of the trial. The trial was low cost and demonstrated that in an intention to treat analysis, probiotics did not improve well-being or bowel symptoms. Conclusion The internet-based RCT proved to be a successful and economical method for examining this CAM intervention. Recruitment, adherence and completion rate were all similar to those reported with conventional RCTs but at a fraction of the cost. Internet-based RCTs can fulfil all the criteria of the revised CONSORT statement and are an appropriate method for studying low-risk interventions. Trial registration ISRCTN36133252 PMID:18190710

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

PubMed

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.

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

PubMed

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

2016-11-01

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

CONSORT in China: past development and future direction.

PubMed

Song, Tian-Jiao; Leng, Hou-Fu; Zhong, Linda Ld; Wu, Tai-Xiang; Bian, Zhao-Xiang

2015-06-01

The Consolidated Standards of Reporting Trials (CONSORT) Statement was published in 1996, and first introduced to China in 2001. Although CONSORT has been widely accepted in high-quality international journals, we still need to have more investigation on how many Chinese journals have adopted the CONSORT Statement, and whether the quality of reporting has improved. A systematic search of the "Instructions to authors" in all Chinese medical journals in China Academic Journals (CAJ) Full-text Database was conducted up to February 2012 and only 7 journals officially listed the requirements of the CONSORT Statement. The research articles about randomized controlled trials (RCTs) published in 2002, 2004, 2006, 2008, and 2010 from journals which had specifically adopted the CONSORT Statement, and from 30 top journals based on the Chinese Science Citation Index (CSCI) 2011 as the control group, were identified. The quality of both cohorts of articles was assessed using the revised CONSORT Checklist and Jadad scale. A total of 1221 Chinese medical journals was identified. Only seven journals stated clearly in the "Instructions to authors" that authors should adopt the CONSORT requirement in the clinical trial paper. None of these journals is among the control group in the CSCI 2011. In the selected years, a total of 171 articles from 7 journals which had adopted CONSORT and 232 articles in the control were identified as including RCT trials. The average scores according to the revised CONSORT Checklist were 29.47 for the CONSORT-adopting journals and 25.57 for the control group; while the average scores based on the Jadad scale were 2.53 for CONSORT-adopting journals and 1.97 for the control group. Few journals among Chinese medical journals have adopted the CONSORT Statement. The overall quality of RCT reports in the 7 journals which have adopted CONSORT was better than those in the top 30 journals which have not adopted CONSORT. The quality of RCT reports in Chinese journals needs further improvement, and the CONSORT Statement could be a very helpful guideline.

Quality of surgical randomized controlled trials for acute cholecystitis: assessment based on CONSORT and additional check items.

PubMed

Shikata, Satoru; Nakayama, Takeo; Yamagishi, Hisakazu

2008-01-01

In this study, we conducted a limited survey of reports of surgical randomized controlled trials, using the consolidated standards of reporting trials (CONSORT) statement and additional check items to clarify problems in the evaluation of surgical reports. A total of 13 randomized trials were selected from two latest review articles on biliary surgery. Each randomized trial was evaluated according to 28 quality measures that comprised items from the CONSORT statement plus additional items. Analysis focused on relationships between the quality of each study and the estimated effect gap ("pooled estimate in meta-analysis" -- "estimated effect of each study"). No definite relationships were found between individual study quality and the estimated effect gap. The following items could have been described but were not provided in almost all the surgical RCT reports: "clearly defined outcomes"; "details of randomization"; "participant flow charts"; "intention-to-treat analysis"; "ancillary analyses"; and "financial conflicts of interest". The item, "participation of a trial methodologist in the study" was not found in any of the reports. Although the quality of reporting trials is not always related to a biased estimation of treatment effect, the items used for quality measures must be described to enable readers to evaluate the quality and applicability of the reporting. Further development of an assessment tool is needed for items specific to surgical randomized controlled trials.

Does the reporting of randomized clinical trials published in Chinese pediatrics journals improve after the CONSORT Statement is adopted?

PubMed

Ma, Bin; Ke, Fa-yong; Chen, Zhi-min; Qi, Guo-qing; Li, Hai-min; Liu, Wen-jie; Zhang, Yuan; Hu, Qing; Yang, Ke-hu

2012-09-01

There is no systematic assessment whether the quality of reporting has been improved since the CONSORT Statement was introduced into China in 1997. The aim of this study is to determine whether the use of the CONSORT Statement is associated with improved quality of reporting of RCTs published in Chinese pediatrics journals. Six core Chinese pediatrics journals that included Journal of Clinical Pediatrics, Chinese Journal of Contemporary Pediatrics, Chinese Journal of Practical Pediatrics, Chinese Journal of Evidence-based Pediatrics, Chinese Journal of Pediatrics, and Chinese Journal of Pediatric Surgery were searched from inception through Dec. 2010. The CONSORT checklists were used to assess the quality of reporting. Data was collected using a standardized form. Analyses were performed using SPSS 15.0 software. A total of 619 RCTs were included. The quality of reporting has improved significantly in aspects such as introduction, recruitment, baseline data, and ancillary analyses (p<0.05), but not in several important methodological components, including sample size calculation (0.63% vs.1.08%), randomization sequence generation (3.18% vs. 7.58%), allocation concealment (0% vs. 1.08%), and blinding (0% vs. 0.87%). The quality of reporting of RCTs has not significantly improved since the CONSORT Statement was introduced into China. The reporting remains poor, and often inadequate for assessment of the rigor of studies. Chinese pediatrics journals should reinforce the use of the CONSORT Statement in the reporting of trials. Copyright © 2012 Elsevier Inc. All rights reserved.

Quality of reporting of modern randomized controlled trials in medical oncology: a systematic review.

PubMed

Péron, Julien; Pond, Gregory R; Gan, Hui K; Chen, Eric X; Almufti, Roula; Maillet, Denis; You, Benoit

2012-07-03

The Consolidated Standards of Reporting Trials (CONSORT) guidelines were developed in the mid-1990s for the explicit purpose of improving clinical trial reporting. However, there is little information regarding the adherence to CONSORT guidelines of recent publications of randomized controlled trials (RCTs) in oncology. All phase III RCTs published between 2005 and 2009 were reviewed using an 18-point overall quality score for reporting based on the 2001 CONSORT statement. Multivariable linear regression was used to identify features associated with improved reporting quality. To provide baseline data for future evaluations of reporting quality, RCTs were also assessed according to the 2010 revised CONSORT statement. All statistical tests were two-sided. A total of 357 RCTs were reviewed. The mean 2001 overall quality score was 13.4 on a scale of 0-18, whereas the mean 2010 overall quality score was 19.3 on a scale of 0-27. The overall RCT reporting quality score improved by 0.21 points per year from 2005 to 2009. Poorly reported items included method used to generate the random allocation (adequately reported in 29% of trials), whether and how blinding was applied (41%), method of allocation concealment (51%), and participant flow (59%). High impact factor (IF, P = .003), recent publication date (P = .008), and geographic origin of RCTs (P = .003) were independent factors statistically significantly associated with higher reporting quality in a multivariable regression model. Sample size, tumor type, and positivity of trial results were not associated with higher reporting quality, whereas funding source and treatment type had a borderline statistically significant impact. The results show that numerous items remained unreported for many trials. Thus, given the potential impact of poorly reported trials, oncology journals should require even stricter adherence to the CONSORT guidelines.

[Evaluation of methodological quality in published RCTs on cataract surgery : Pilot study on the degree of adherence to CONSORT statement requirements and their qualitative validity].

PubMed

Baulig, C; Krummenauer, F; Knippschild, S

2018-01-01

The CONSORT statement can be considered as a guideline to ensure transparency in the reporting of randomized clinical trials (RCT), in addition to specific author instructions and requirements of journals. It provides a total of 25 criteria and 12 additional subcriteria on methodological and regulatorical determinants of clinical trials. The availability of the CONSORT recommendations, however, does not necessarily imply adherence to their obligations and correct realisation of the latter from a methodological perspective, so that even in ophthalmology a lack of transparency in trial reporting cannot be excluded. The question was whether a consistent consideration of the CONSORT checklist criteria by authors actually implied transparent reporting of underlying study results. This pilot study was based on a random sample of six published RCTs on cataract surgery extracted from an existing trial publication register. Compliance with each of the 25 CONSORT criteria and its 12 subcriteria and the content accuracy of the latter were independently assessed by two parallel raters for the six trial publications. The median compliance with the 37 CONSORT criteria and subcriteria was 62% [min-max 48-81%]; the median fraction of their correct implementation was 47% [min-max 34-69%]. Promotion of transparent reporting by means of the CONSORT statement appears to be problematic in implementation. There is a discrepancy between information as required by CONSORT and the content accuracy of its actual presentation. Thus, in particular, reviewers of clinical trial publications should not only check for the presence of data to be provided according to CONSORT, but also verify the meaningfulness in the respective context, at least on a random basis.

Improving the Quality of Web Surveys: The Checklist for Reporting Results of Internet E-Surveys (CHERRIES)

PubMed Central

2004-01-01

Analogous to checklists of recommendations such as the CONSORT statement (for randomized trials), or the QUORUM statement (for systematic reviews), which are designed to ensure the quality of reports in the medical literature, a checklist of recommendations for authors is being presented by the Journal of Medical Internet Research (JMIR) in an effort to ensure complete descriptions of Web-based surveys. Papers on Web-based surveys reported according to the CHERRIES statement will give readers a better understanding of the sample (self-)selection and its possible differences from a “representative” sample. It is hoped that author adherence to the checklist will increase the usefulness of such reports. PMID:15471760

The CONSORT Statement: Application within and adaptations for orthodontic trials.

PubMed

Pandis, Nikolaos; Fleming, Padhraig S; Hopewell, Sally; Altman, Douglas G

2015-06-01

High-quality randomized controlled trials (RCTs) are an integral part of evidence-based medicine. RCTs are the bricks and mortar of high-quality systematic reviews, which are important determinants of health care policy and clinical practice. For published research to be used most effectively, investigators and authors should follow the guidelines for accurate and transparent reporting of RCTs. The consolidated standards of reporting trials (CONSORT) statement and its extensions are among the most widely used reporting guidelines in biomedical research. CONSORT was adopted by the American Journal of Orthodontics and Dentofacial Orthopedics in 2004. Since 2011, this Journal has been actively implementing compliance with the CONSORT reporting guidelines. The objective of this explanatory article is to highlight the relevance and implications of the various CONSORT items to help authors to achieve CONSORT compliance in their research submissions of RCTs to this and other orthodontic journals. Copyright © 2015 American Association of Orthodontists. Published by Elsevier Inc. All rights reserved.

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

PubMed

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

2016-11-01

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

The value of structured data elements from electronic health records for identifying subjects for primary care clinical trials.

PubMed

Ateya, Mohammad B; Delaney, Brendan C; Speedie, Stuart M

2016-01-11

An increasing number of clinical trials are conducted in primary care settings. Making better use of existing data in the electronic health records to identify eligible subjects can improve efficiency of such studies. Our study aims to quantify the proportion of eligibility criteria that can be addressed with data in electronic health records and to compare the content of eligibility criteria in primary care with previous work. Eligibility criteria were extracted from primary care studies downloaded from the UK Clinical Research Network Study Portfolio. Criteria were broken into elemental statements. Two expert independent raters classified each statement based on whether or not structured data items in the electronic health record can be used to determine if the statement was true for a specific patient. Disagreements in classification were discussed until 100 % agreement was reached. Statements were also classified based on content and the percentages of each category were compared to two similar studies reported in the literature. Eligibility criteria were retrieved from 228 studies and decomposed into 2619 criteria elemental statements. 74 % of the criteria elemental statements were considered likely associated with structured data in an electronic health record. 79 % of the studies had at least 60 % of their criteria statements addressable with structured data likely to be present in an electronic health record. Based on clinical content, most frequent categories were: "disease, symptom, and sign", "therapy or surgery", and "medication" (36 %, 13 %, and 10 % of total criteria statements respectively). We also identified new criteria categories related to provider and caregiver attributes (2.6 % and 1 % of total criteria statements respectively). Electronic health records readily contain much of the data needed to assess patients' eligibility for clinical trials enrollment. Eligibility criteria content categories identified by our study can be incorporated as data elements in electronic health records to facilitate their integration with clinical trial management systems.

Endorsement of CONSORT by Chinese medical journals: a survey of "instruction to authors".

PubMed

Xiao, Lu; Hu, Jing; Zhang, Li; Shang, Hong-cai

2014-07-01

To determine the extent to which Chinese medical (CM) journals incorporate Consolidated Standards for Reporting of Trials (CONSORT) into their "instruction to authors". We reviewed the latest "instruction to authors" of the CM journals in China which indexed by MEDLINE in 2010 or Excerpta Medica Database (EMBASE) in 2012 and extracted all information of CONSORT, International Committee of Medical Journal Editors (ICMJE), other reporting guidelines or clinical trial registration. By reading the instructions to authors and reviewing recent studies published in those journals, those that do not publish clinical trials were excluded. We also contacted each of journals by telephone on contributor's status to ask them whether mentioned CONSORT in their instructions and incorporated it into their editorial and peer-review process. Full-text papers of randomized controlled trials (RCTs, from January 2011 to March 2012) published in the journals which mentioned "CONSORT" in their instructions for authors were downloaded. Seven CM journals were included. Three of these journals mentioned CONSORT in its instructions. By telephone survey, all journals gave responses and all respondents knew CONSORT statement. Three of 7 journals required authors to comply with the CONSORT statement and provide the CONSORT checklist and a flow chart of the trial. The rest 4 journals recommended authors of RCTs to refer to the CONSORT statement. From January 2011 to March 2012, a total of 50 RCTs were obtained from the 3 journals endorsing the CONSORT statement; 17 (17/50, 34%) contained a flow diagram in their manuscript, and none of those RCTs had mentioned the trial registration information. The endorsement of CONSORT by CM journals' "instruction to authors" was not satisfactory. The spread of CONSORT endorsement should be wider in instructing the performance of CM clinical trials in the future. Chinese journals should introduce CONSORT to their authors and require authors to comply with CONSORT when they submit their research.

Reporting quality of N-of-1 trials published between 1985 and 2013: a systematic review.

PubMed

Li, Jiang; Gao, Wei; Punja, Salima; Ma, Bin; Vohra, Sunita; Duan, Naihua; Gabler, Nicole; Yang, Kehu; Kravitz, Richard L

2016-08-01

To evaluate the quality of reporting of single-patient (N-of-1) trials published in the medical literature based on the CONSORT Extension for N-of-1 Trials (CENT) statement and to examine factors that influence reporting quality in these trials. Through a search of 10 electronic databases, we identified N-of-1 trials in clinical medicine published between January 1, 1985, and December 31, 2013. Two reviewers screened articles for eligibility and independently extracted data. Quality assessment was performed using the CENT statement. Discrepancies were resolved by consensus. We identified 112 eligible N-of-1 trials published in 87 journals and involving a total of 2,278 patients. Overall, kappa agreement between the two evaluators for compliance with CENT criteria was 0.80 (95% confidence interval: 0.79, 0.82). Trials assessed pharmacology and therapeutics (87%), behavior (11%), or diagnosis (2%). Although 87% of articles described the trial design (including the planned number of subjects and length of treatment period), the median percentage of specific CENT elements reported in the Methods was 41% (range, 16-87%), and the median percentage in the Results was 38% (range, 32-93%). First authors were predominantly from North America (46%), Europe (29%), and Australia (17%). Quality of reporting was higher in articles published in journals with relatively high-impact factors (P = 0.004). The quality of reporting of published N-of-1 trials is variable and in need of improvement. Because the CENT guidelines were not published until near the end of the period of this review, these results represent a baseline from which improvement may be expected in the future. Copyright © 2016 Elsevier Inc. All rights reserved.

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

PubMed

Lu, Liming; Luo, Gaoquan; Xiao, Fang

2013-08-01

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

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

PubMed

Lee, Paul H; Tse, Andy C Y

2017-05-01

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

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

PubMed

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

2013-09-01

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

Improving the Reporting of Clinical Trials of Infertility Treatments (IMPRINT): modifying the CONSORT statement.

PubMed

2014-10-01

Clinical trials testing infertility treatments often do not report on the major outcomes of interest to patients and clinicians and the public (such as live birth) nor on the harms, including maternal risks during pregnancy and fetal anomalies. This is complicated by the multiple participants in infertility trials which may include a woman (mother), a man (father), and a third individual if successful, their offspring (child), who is also the desired outcome of treatment. The primary outcome of interest and many adverse events occur after cessation of infertility treatment and during pregnancy and the puerperium, which creates a unique burden of follow-up for clinical trial investigators and participants. In 2013, because of the inconsistencies in trial reporting and the unique aspects of infertility trials not adequately addressed by existing Consolidated Standards of Reporting Trials (CONSORT) statements, we convened a consensus conference in Harbin, China, with the aim of planning modifications to the CONSORT checklist to improve the quality of reporting of clinical trials testing infertility treatment. The consensus group recommended that the preferred primary outcome of all infertility trials is live birth (defined as any delivery of a live infant after ≥20 weeks' gestation) or cumulative live birth, defined as the live birth per women over a defined time period (or number of treatment cycles). In addition, harms to all participants should be systematically collected and reported, including during the intervention, any resulting pregnancy, and the neonatal period. Routine information should be collected and reported on both male and female participants in the trial. We propose to track the change in quality that these guidelines may produce in published trials testing infertility treatments. Our ultimate goal is to increase the transparency of benefits and risks of infertility treatments to provide better medical care to affected individuals and couples. Copyright © 2014 The Author. Published by Elsevier Inc. All rights reserved.

Hematology journals do not sufficiently adhere to reporting guidelines: a systematic review.

PubMed

Wayant, C; Smith, C; Sims, M; Vassar, M

2017-04-01

Essentials Reporting guidelines and trial/review registration aim to limit bias in research. We systematically reviewed hematology journals to examine the use of these policies. Forty-eight percent of journals made no use of these policies. Improving the use of reporting guidelines will improve research for all stakeholders. Background Reporting guidelines and trial/review registration policies have been instituted in order to minimize bias and improve research practices. Objective The objective of this study was to investigate the policies of hematology journals concerning reporting guideline adoption and trial/review registration. Methods We performed a web-based data abstraction from the Instructions for Authors of 67 hematology journals catalogued in the Expanded Science Citation Index of the 2014 Journal Citation Reports to identify whether each journal required, recommended or made no mention of the following reporting guidelines: EQUATOR, ICMJE, CONSORT, MOOSE, QUOROM, PRISMA, STARD, STROBE, ARRIVE and CARE. We also extracted whether journals required or recommended trial or systematic review registration. We e-mailed editors three times to determine which types of studies their journal accepts. Results Forty-eight per cent (32/67) of hematology journals do not adhere to any reporting guidelines. For responding journals, the QUOROM statement, MOOSE, CARE and PROSPERO were the least often mentioned, whereas the ICMJE guidelines, CONSORT statement and general trial registration were most often mentioned. Discussion Reporting guidelines are infrequently required or recommended by hematology journals. Furthermore, few require clinical trial or systematic review database registration. A higher rate of adherence to reporting guidelines can prevent bias from entering the literature. Participation from all stakeholders, including authors and journal editors, to improve reporting guideline and policy practices is required. © 2017 International Society on Thrombosis and Haemostasis.

The reporting characteristics of bovine respiratory disease clinical intervention trials published prior to and following publication of the REFLECT statement.

PubMed

Totton, Sarah C; Cullen, Jonah N; Sargeant, Jan M; O'Connor, Annette M

2018-02-01

The goal of the REFLECT Statement (Reporting guidElines For randomized controLled trials in livEstoCk and food safeTy) (published in 2010) was to provide the veterinary research community with reporting guidelines tailored for randomized controlled trials for livestock and food safety. Our objective was to determine the prevalence of REFLECT Statement reporting of items 1-19 in controlled trials published in journals between 1970 and 2017 examining the comparative efficacy of FDA-registered antimicrobials against naturally acquired BRD (bovine respiratory disease) in weaned beef calves in Canada or the USA, and to compare the prevalence of reporting before and after 2010, when REFLECT was published. We divided REFLECT Statement, items 3, 5, 10, and 11 into subitems, because each dealt with multiple elements requiring separate assessment. As a result, 28 different items or subitems were evaluated independently. We searched MEDLINE ® and CABI (CAB Abstracts ® and Global Health ® ) (Web of Science™) in April 2017 and screened 2327 references. Two reviewers independently assessed the reporting of each item and subitem. Ninety-five references were eligible for the study. The reporting of the REFLECT items showed a point estimate for the prevalence ratio >1 (i.e. a higher proportion of studies published post-2010 reported this item compared to studies published pre-2010), apart from items 10.3, i.e., item 10, subitem 3 (who assigned study units to the interventions), 13 (the flow of study units through the study), 16 (number of study units in analysis), 18 (multiplicity), and 19 (adverse effects). Fifty-three (79%) of 67 studies published before 2010 and all 28 (100%) papers published after 2010 reported using a random allocation method in either the title, abstract, or methods (Prevalence ratio = 1.25; 95% CI (1.09,1.43)). However, 8 studies published prior to 2010 and 7 studies published post-2010 reported the term "systematic randomization" or variations of this term (which is not true randomization) to describe the allocation procedure. Fifty-five percent (37/67) of studies published pre-2010 reported blinding status (blinded/not blinded) of outcome assessors, compared to 24/28 (86%) of studies published post-2010 (Prevalence ratio = 1.5, 95% CI (1.19, 2.02)). The reporting of recommended items in journal articles in this body of work is generally improving; however, there is also evidence of confusion about what constitutes a random allocation procedure, and this suggests an educational need. As this study is observational, this precludes concluding that the publication of the REFLECT Statement was the cause of this trend. Copyright © 2017 Elsevier B.V. All rights reserved.

A quality analysis of clinical anaesthesia study protocols from the Chinese clinical trials registry according to the SPIRIT statement.

PubMed

Yang, Lei; Chen, Shouming; Yang, Di; Li, Jiajin; Wu, Taixiang; Zuo, Yunxia

2018-05-15

To learn about the overall quality of clinical anaesthesia study protocols from the Chinese Clinical Trials Registry and to discuss the way to improve study protocol quality. We defined completeness of each sub-item in SPIRIT as N/A (not applicable) or with a score of 0, 1, or 2. For each protocol, we calculated the proportion of adequately reported items (score = 2 and N/A) and unreported items (score = 0). Protocol quality was determined according to the proportion of reported items, with values >50% indicating high quality. Protocol quality was determined according to the proportion of reported items. For each sub-item in SPIRIT, we calculated the adequately reported rate (percentage of all protocols with score 2 and NA on one sub-item) as well as the unreported rate (percentage of all protocols with score 0 on one sub-item). Total 126 study protocols were available for assessment. Among these, 88.1% were assessed as being of low quality. By comparison, the percentage of low-quality protocols was 88.9% after the publication of the SPIRIT statement. Among the 51 SPIRIT sub-items, 18 sub-items had an unreported rate above 90% while 16 had a higher adequately reported rate than an unreported rate. The overall quality of clinical anaesthesia study protocols registered in the ChiCTR was poor. A mandatory protocol upload and self-check based on the SPIRIT statement during the trial registration process may improve protocol quality in the future.

Endorsement for improving the quality of reports on randomized controlled trials of traditional medicine journals in Korea: a systematic review.

PubMed

Choi, Jiae; Jun, Ji Hee; Kang, Byoung Kab; Kim, Kun Hyung; Lee, Myeong Soo

2014-11-05

The aim of this study was to assess the endorsement of reporting guidelines in Korean traditional medicine (TM) journals by reviewing their instructions to authors. We examined the instructions to authors in all of the TM journals published in Korea to assess the appropriate use of reporting guidelines for research studies. The randomized controlled trials (RCTs) published after 2010 in journals that endorsed reporting guidelines were obtained. The reporting quality was assessed using the following guidelines: the 38-item Consolidated Standards of Reporting Trials (CONSORT) statement for non-pharmacological trials (NPT); the 17-item Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) statement, instead of the 5-item CONSORT for acupuncture trials; and the 22-item CONSORT extensions for herbal medicine trials. The overall item score was calculated and expressed as a proportion.One journal that endorsed reporting guidelines was identified. Twenty-nine RCTs published in this journal after 2010 met the selection criteria. General editorial policies such as those of the International Committee of Medical Journal Editors (ICMJE) were endorsed by 15 journals. In each of the CONSORT-NPT articles, 21.6 to 56.8% of the items were reported, with an average of 11.3 items (29.7%) being reported. In the 24 RCTs (24/29, 82.8%) appraised using the STRICTA items, an average of 10.6 items (62.5%) were addressed, with a range of 41.2 to 100%. For the herbal intervention reporting, 17 items (77.27%) were reported. In the RCT studies before and after the endorsement of CONSORT and STRICTA guidelines by each journal, all of the STRICTA items had significant improvement, whereas the CONSORT-NPT items improved without statistical significance.The endorsement of reporting guidelines is limited in the TM journals in Korea. Authors should adhere to the reporting guidelines, and editorial departments should refer authors to the various reporting guidelines to improve the quality of their articles.

Reporting Quality Assessment of Randomized Controlled Trials Published in Nephrology Urology Monthly Journal.

PubMed

Mehrazmay, Alireza; Karambakhsh, Alireza; Salesi, Mahmood

2015-07-01

Randomized controlled trials (RCTs) are important tools for evidence-based health care decisions. It is, therefore, important that they be conducted and reported with the highest possible standards. The aim of this study was to evaluate the reporting quality of the RCTs published in nephrology urology monthly journal and to examine whether there was a change over time in the reporting quality. The quality of each report was assessed using the Consolidated Standards of Reporting Trials (CONSORT) 2010 Statement checklist and a 5-point quality assessment instrument, i.e. the Jadad scale. Eighteen (14 Iranian and 4 non-Iranian) RCTs were published from 2012 to 2014 on topics including renal stone (16.6%), hemodialysis and transplantation (38.8%), and prostate conditions (11.1%). Interventions comprised surgery, drugs, and teaching method in 7 (38 %), 10 (55%), and 1 (5%) of them, respectively. According to the CONSORT checklist, the weakest reported items were registration number, identification as a randomized trial in the title, and settings and locations where the data were collected. The mean Jadad score of the reports was 2.72 ± 1.36 (54% of their maximum possible total score). According to the Jadad and CONSORT scales, there was an increase in the quality of reporting from 2012 to 2014. This assessment shows low reporting quality scores in reports. Training courses for researchers, using standard reporting tools (e.g. CONSORT 2010 Statement checklist), and consultation with methodologists can improve the quality of published RCTs.

Impact of the CONSORT Statement endorsement in the completeness of reporting of randomized clinical trials in restorative dentistry.

PubMed

Sarkis-Onofre, Rafael; Poletto-Neto, Victório; Cenci, Maximiliano Sérgio; Pereira-Cenci, Tatiana; Moher, David

2017-03-01

The aim of this study was to assess if journal endorsement of the CONSORT Statement is associated with improved completeness of reporting of randomized controlled trials (RCTs) in restorative dentistry. RCTs in restorative dentistry published in two journals that have (Journal of Dentistry and Clinical Oral Investigations) and have not (Operative Dentistry and Journal of Prosthetic Dentistry) endorsed the CONSORT Statement were selected. We compared the completeness of reporting between comparison groups (endorsers versus non-endorsers, before versus after endorsement) using a risk ratio (RR) with a 99% confidence interval for each outcome of CONSORT 2010. Also, the risk of bias of each study was evaluated. The electronic search retrieved a total of 3701 records. After the title and abstract evaluation, 169 full texts were screened and 79 RCTs identified. Considering CONSORT-endorsing journals before and after CONSORT endorsement, six items had effect estimates indicating a relatively higher proportion of completely reported RCTs published after CONSORT endorsement. Considering CONSORT-endorsing journals compared to non-endorsing journals, twelve items indicated a relatively higher proportion of completely reported RCTs published in CONSORT-endorsing journals. In both analyses the overall evidence did not present statistical significance. Although CONSORT endorsement has been linked with some improvement in the completeness of RCTs reports in the biomedical literature, this was not reflected in the present analysis confined to restorative dentistry. More innovative and involved approaches to enhancing reported may therefore be required. Inadequate reporting of randomized controlled trials can produce important consequences for all stakeholders including waste of resources and implication on healthcare decisions. A broad understandment of the use of reporting guidelines is necessary to lead to better results. Copyright © 2017 Elsevier Ltd. All rights reserved.

Do Chinese Researchers Conduct Ethical Research and Use Ethics Committee Review in Clinical Trials of Anti-Dementia Drugs? An Analysis of Biomedical Publications Originating from China.

PubMed

Zeng, Lingfeng; Liang, Weixiong; Pan, Jianke; Cao, Ye; Liu, Jun; Wang, Qi; Wang, Lu; Zou, Yuanping; Wang, Kezhu; Kong, Lingshuo; Xie, Hui; Xu, Weihua; Li, Weirong; Zhao, Wei; Mi, Suiqing; Chen, Yunbo; Cheng, Shuyi; Li, Xiaoyan; Cao, Qian; Zeng, Xing; Wang, Ningsheng

2016-03-25

Medical research using human participants must conform to the basic ethical principles found in the Declaration of Helsinki (DoH) of the World Medical Association. The purpose of this review was to assess whether journals in China have improved in regard to the fulfillment of ethical disclosure procedures for clinical trials of anti-dementia drugs. Four medical databases were searched for articles reporting clinical trials of oral anti-dementia drugs published in China in 2003, 2009, and 2014. The frequencies of reporting of informed consent from participants (ICP), approval of a regional ethical committee (REC), reference to DoH, and study registration were estimated respectively. Statistical analyses were conducted with SPSS v21 software. Among those randomized controlled trials published in 2003, 2009, and 2014, disclosure of REC approval was present for 2.67%, 1.15%, and 6.84%; statements of ICP were included in 9.33%, 7.76%, and 17.34%; reference to DoH was found for 4.00%, 1.44%, and 7.45%; and study registration reporting was included in 2.67%, 2.59%, and 9.28%, respectively. Improvements to reporting rates between 2009 and 2014 were seen, with more than twice as many trials reporting REC approval, ICP, reference to DoH, and study registration compared with 2009. Compared with 2003 and 2009, reporting rates for REC approval, ICP, reference to DoH, and study registration for clinical trials of anti-dementia drugs were enhanced in 2014 in the major medical journals of China. However, biomedical publications without definite statements of ethical considerations remain common, and this continues to be seen in Chinese journals. It is imperative that measures are taken to reinforce the ethical protection in clinical trials in China.

Statistical testing of baseline differences in sports medicine RCTs: a systematic evaluation.

PubMed

Peterson, Ross L; Tran, Matthew; Koffel, Jonathan; Stovitz, Steven D

2017-01-01

The CONSORT (Consolidated Standards of Reporting Trials) statement discourages reporting statistical tests of baseline differences between groups in randomised controlled trials (RCTs). However, this practice is still common in many medical fields. Our aim was to determine the prevalence of this practice in leading sports medicine journals. We conducted a comprehensive search in Medline through PubMed to identify RCTs published in the years 2005 and 2015 from 10 high-impact sports medicine journals. Two reviewers independently confirmed the trial design and reached consensus on which articles contained statistical tests of baseline differences. Our search strategy identified a total of 324 RCTs, with 85 from the year 2005 and 239 from the year 2015. Overall, 64.8% of studies (95% CI (59.6, 70.0)) reported statistical tests of baseline differences; broken down by year, this percentage was 67.1% in 2005 (95% CI (57.1, 77.1)) and 64.0% in 2015 (95% CI (57.9, 70.1)). Although discouraged by the CONSORT statement, statistical testing of baseline differences remains highly prevalent in sports medicine RCTs. Statistical testing of baseline differences can mislead authors; for example, by failing to identify meaningful baseline differences in small studies. Journals that ask authors to follow the CONSORT statement guidelines should recognise that many manuscripts are ignoring the recommendation against statistical testing of baseline differences.

Applying the CONSORT and STROBE statements to evaluate the reporting quality of neovascular age-related macular degeneration studies.

PubMed

Fung, Anne E; Palanki, Ram; Bakri, Sophie J; Depperschmidt, Eric; Gibson, Andrea

2009-02-01

To evaluate the quality of reporting in the neovascular age-related macular degeneration (nvAMD) literature by applying the Consolidated Standards for Reporting Trials (CONSORT) and Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement writing standards. CONSORT and STROBE impact analysis; literature review. Phase III randomized controlled trials (RCTs) of verteporfin photodynamic therapy, pegaptanib, and ranibizumab, and interventional case studies of bevacizumab for nvAMD. A literature search identified eligible articles published before October 31, 2007. We assessed the report quality of Phase III RCTs using the CONSORT statement and case series publications using the STROBE statement, both with indicators relevant to nvAMD. Presence or absence of CONSORT or STROBE statement indicators. Seven publications of Phase III RCTs and 29 publications on bevacizumab interventional case studies for nvAMD met our inclusion criteria. Of 37 possible CONSORT writing guideline items, the mean report quality for RCTs was 30.6 (83%), with a range from 23 to 35 (65%-95%). Of 35 possible STROBE writing guideline items, the mean report quality grade for intravitreal bevacizumab case series was 23 (70%), with a range from 16 to 31 (46%-94%). Among the bevacizumab studies, more than 90% reported scientific background, drug dose and administration, baseline characteristics, unadjusted results, and adverse events. Fewer than 20% reported study size calculations, handling of missing data, or a discussion of bias. Since the adoption of the CONSORT standards by Ophthalmology and other journals in 1996, the reporting quality for RCTs has further improved among this cohort of nvAMD articles. On the other hand, no reporting standards for case series have existed until the recent publication of the STROBE statement. In this first application of the STROBE standards to ophthalmology, we found that the small interventional studies in our series had an average reporting score lower than the RCTs, but also that some individual scores were higher than the RCTs. This outcome demonstrates that good, useful articles can be written about small studies. Although not a direct measure of the quality of a study, good reporting allows a reader to assess the validity and applicability of the study's findings. Proprietary or commercial disclosure may be found after the references.

Reporting of clinical trials: a review of research funders' guidelines

PubMed Central

Dwan, Kerry; Gamble, Carrol; Williamson, Paula R; Altman, Douglas G

2008-01-01

Background Randomised controlled trials (RCTs) represent the gold standard methodological design to evaluate the effectiveness of an intervention in humans but they are subject to bias, including study publication bias and outcome reporting bias. National and international organisations and charities give recommendations for good research practice in relation to RCTs but to date no review of these guidelines has been undertaken with respect to reporting bias. Methods National and international organisations and UK based charities listed on the Association for Medical Research Charities website were contacted in 2007; they were considered eligible for this review if they funded RCTs. Guidelines were obtained and assessed in relation to what was written about trial registration, protocol adherence and trial publication. It was also noted whether any monitoring against these guidelines was undertaken. This information was necessary to discover how much guidance researchers are given on the publication of results, in order to prevent study publication bias and outcome reporting bias. Results Seventeen organisations and 56 charities were eligible of 140 surveyed for this review, although there was no response from 12. Trial registration, protocol adherence, trial publication and monitoring against the guidelines were often explicitly discussed or implicitly referred too. However, only eleven of these organisations or charities mentioned the publication of negative as well as positive outcomes and just three of the organisations specifically stated that the statistical analysis plan should be strictly adhered to and all changes should be reported. Conclusion Our review indicates that there is a need to provide more detailed guidance for those conducting and reporting clinical trials to help prevent the selective reporting of results. Statements found in the guidelines generally refer to publication bias rather than outcome reporting bias. Current guidelines need to be updated and include the statement that all primary and secondary outcomes prespecified in the protocol should be fully reported and should not be selected for inclusion in the final report based on their results. PMID:19032743

A quality analysis of clinical anaesthesia study protocols from the Chinese clinical trials registry according to the SPIRIT statement

PubMed Central

Yang, Lei; Chen, Shouming; Yang, Di; Li, Jiajin; Wu, Taixiang; Zuo, Yunxia

2018-01-01

Objective To learn about the overall quality of clinical anaesthesia study protocols from the Chinese Clinical Trials Registry and to discuss the way to improve study protocol quality. Methods We defined completeness of each sub-item in SPIRIT as N/A (not applicable) or with a score of 0, 1, or 2. For each protocol, we calculated the proportion of adequately reported items (score = 2 and N/A) and unreported items (score = 0). Protocol quality was determined according to the proportion of reported items, with values >50% indicating high quality. Protocol quality was determined according to the proportion of reported items. For each sub-item in SPIRIT, we calculated the adequately reported rate (percentage of all protocols with score 2 and NA on one sub-item) as well as the unreported rate (percentage of all protocols with score 0 on one sub-item). Results Total 126 study protocols were available for assessment. Among these, 88.1% were assessed as being of low quality. By comparison, the percentage of low-quality protocols was 88.9% after the publication of the SPIRIT statement. Among the 51 SPIRIT sub-items, 18 sub-items had an unreported rate above 90% while 16 had a higher adequately reported rate than an unreported rate. Conclusions The overall quality of clinical anaesthesia study protocols registered in the ChiCTR was poor. A mandatory protocol upload and self-check based on the SPIRIT statement during the trial registration process may improve protocol quality in the future. PMID:29872509

What is the strength of evidence for heart failure disease-management programs?

PubMed

Clark, Alexander M; Savard, Lori A; Thompson, David R

2009-07-28

Heart failure (HF) disease-management programs are increasingly common. However, some large and recent trials of programs have not reported positive findings. There have also been parallel recent advances in reporting standards and theory around complex nonpharmacological interventions. These developments compel reconsideration in this Viewpoint of how research into HF-management programs should be evaluated, the quality, specificity, and usefulness of this evidence, and the recommendations for future research. Addressing the main determinants of intervention effectiveness by using the PICO (Patient, Intervention, Comparison, and Outcome) approach and the recent CONSORT (Consolidated Standards of Reporting Trials) statement on nonpharmacological trials, we will argue that in both current trials and meta-analyses, interventions and comparisons are not sufficiently well described; that complex programs have been excessively oversimplified; and that potentially salient differences in programs, populations, and settings are not incorporated into analyses. In preference to more general meta-analyses of programs, adequate descriptions are first needed of populations, interventions, comparisons, and outcomes in past and future trials. This could be achieved via a systematic survey of study authors based on the CONSORT statement. These more detailed data on studies should be incorporated into future meta-analyses of comparable trials and used with other techniques such as patient-based outcomes data and meta-regression. Although trials and meta-analyses continue to have potential to generate useful evidence, a more specific evidence base is needed to support the development of effective programs for different populations and settings.

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

PubMed

Djulbegovic, Benjamin; Cantor, Alan; Clarke, Mike

2003-01-01

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

The Single-Case Reporting Guideline In BEhavioural Interventions (SCRIBE) 2016 Statement.

PubMed

Tate, Robyn L; Perdices, Michael; Rosenkoetter, Ulrike; Shadish, William; Vohra, Sunita; Barlow, David H; Horner, Robert; Kazdin, Alan; Kratochwill, Thomas; McDonald, Skye; Sampson, Margaret; Shamseer, Larissa; Togher, Leanne; Albin, Richard; Backman, Catherine; Douglas, Jacinta; Evans, Jonathan J; Gast, David; Manolov, Rumen; Mitchell, Geoffrey; Nickels, Lyndsey; Nikles, Jane; Ownsworth, Tamara; Rose, Miranda; Schmid, Christopher H; Wilson, Barbara

2016-07-01

We developed a reporting guideline to provide authors with guidance about what should be reported when writing a paper for publication in a scientific journal using a particular type of research design: the single-case experimental design. This report describes the methods used to develop the Single-Case Reporting guideline In BEhavioural interventions (SCRIBE) 2016. As a result of 2 online surveys and a 2-day meeting of experts, the SCRIBE 2016 checklist was developed, which is a set of 26 items that authors need to address when writing about single-case research. This article complements the more detailed SCRIBE 2016 Explanation and Elaboration article (Tate et al., 2016) that provides a rationale for each of the items and examples of adequate reporting from the literature. Both these resources will assist authors to prepare reports of single-case research with clarity, completeness, accuracy, and transparency. They will also provide journal reviewers and editors with a practical checklist against which such reports may be critically evaluated. We recommend that the SCRIBE 2016 is used by authors preparing manuscripts describing single-case research for publication, as well as journal reviewers and editors who are evaluating such manuscripts. Reporting guidelines, such as the Consolidated Standards of Reporting Trials (CONSORT) Statement, improve the reporting of research in the medical literature (Turner et al., 2012). Many such guidelines exist and the CONSORT Extension to Nonpharmacological Trials (Boutron et al., 2008) provides suitable guidance for reporting between-groups intervention studies in the behavioral sciences. The CONSORT Extension for N-of-1 Trials (CENT 2015) was developed for multiple crossover trials with single individuals in the medical sciences (Shamseer et al., 2015; Vohra et al., 2015), but there is no reporting guideline in the CONSORT tradition for single-case research used in the behavioral sciences. We developed the Single-Case Reporting guideline In BEhavioural interventions (SCRIBE) 2016 to meet this need. This Statement article describes the methodology of the development of the SCRIBE 2016, along with the outcome of 2 Delphi surveys and a consensus meeting of experts. We present the resulting 26-item SCRIBE 2016 checklist. The article complements the more detailed SCRIBE 2016 Explanation and Elaboration article (Tate et al., 2016) that provides a rationale for each of the items and examples of adequate reporting from the literature. Both these resources will assist authors to prepare reports of single-case research with clarity, completeness, accuracy, and transparency. They will also provide journal reviewers and editors with a practical checklist against which such reports may be critically evaluated. © 2016 The Author(s). Reprinted from: Tate RL, Perdices M, Rosenkoetter U, et al. The Single-Case Reporting Guideline In BEhavioural Interventions (SCRIBE) 2016 Statement. Arch Sci Psychol. 2016;4:1–9.

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

PubMed

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

2015-11-01

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

Valx: A system for extracting and structuring numeric lab test comparison statements from text

PubMed Central

Hao, Tianyong; Liu, Hongfang; Weng, Chunhua

2017-01-01

Objectives To develop an automated method for extracting and structuring numeric lab test comparison statements from text and evaluate the method using clinical trial eligibility criteria text. Methods Leveraging semantic knowledge from the Unified Medical Language System (UMLS) and domain knowledge acquired from the Internet, Valx takes 7 steps to extract and normalize numeric lab test expressions: 1) text preprocessing, 2) numeric, unit, and comparison operator extraction, 3) variable identification using hybrid knowledge, 4) variable - numeric association, 5) context-based association filtering, 6) measurement unit normalization, and 7) heuristic rule-based comparison statements verification. Our reference standard was the consensus-based annotation among three raters for all comparison statements for two variables, i.e., HbA1c and glucose, identified from all of Type 1 and Type 2 diabetes trials in ClinicalTrials.gov. Results The precision, recall, and F-measure for structuring HbA1c comparison statements were 99.6%, 98.1%, 98.8% for Type 1 diabetes trials, and 98.8%, 96.9%, 97.8% for Type 2 Diabetes trials, respectively. The precision, recall, and F-measure for structuring glucose comparison statements were 97.3%, 94.8%, 96.1% for Type 1 diabetes trials, and 92.3%, 92.3%, 92.3% for Type 2 diabetes trials, respectively. Conclusions Valx is effective at extracting and structuring free-text lab test comparison statements in clinical trial summaries. Future studies are warranted to test its generalizability beyond eligibility criteria text. The open-source Valx enables its further evaluation and continued improvement among the collaborative scientific community. PMID:26940748

Valx: A System for Extracting and Structuring Numeric Lab Test Comparison Statements from Text.

PubMed

Hao, Tianyong; Liu, Hongfang; Weng, Chunhua

2016-05-17

To develop an automated method for extracting and structuring numeric lab test comparison statements from text and evaluate the method using clinical trial eligibility criteria text. Leveraging semantic knowledge from the Unified Medical Language System (UMLS) and domain knowledge acquired from the Internet, Valx takes seven steps to extract and normalize numeric lab test expressions: 1) text preprocessing, 2) numeric, unit, and comparison operator extraction, 3) variable identification using hybrid knowledge, 4) variable - numeric association, 5) context-based association filtering, 6) measurement unit normalization, and 7) heuristic rule-based comparison statements verification. Our reference standard was the consensus-based annotation among three raters for all comparison statements for two variables, i.e., HbA1c and glucose, identified from all of Type 1 and Type 2 diabetes trials in ClinicalTrials.gov. The precision, recall, and F-measure for structuring HbA1c comparison statements were 99.6%, 98.1%, 98.8% for Type 1 diabetes trials, and 98.8%, 96.9%, 97.8% for Type 2 diabetes trials, respectively. The precision, recall, and F-measure for structuring glucose comparison statements were 97.3%, 94.8%, 96.1% for Type 1 diabetes trials, and 92.3%, 92.3%, 92.3% for Type 2 diabetes trials, respectively. Valx is effective at extracting and structuring free-text lab test comparison statements in clinical trial summaries. Future studies are warranted to test its generalizability beyond eligibility criteria text. The open-source Valx enables its further evaluation and continued improvement among the collaborative scientific community.

Recommendations for reporting outcome results in abdominal wall repair: results of a Consensus meeting in Palermo, Italy, 28-30 June 2012.

PubMed

Muysoms, F E; Deerenberg, E B; Peeters, E; Agresta, F; Berrevoet, F; Campanelli, G; Ceelen, W; Champault, G G; Corcione, F; Cuccurullo, D; DeBeaux, A C; Dietz, U A; Fitzgibbons, R J; Gillion, J F; Hilgers, R-D; Jeekel, J; Kyle-Leinhase, I; Köckerling, F; Mandala, V; Montgomery, A; Morales-Conde, S; Simmermacher, R K J; Schumpelick, V; Smietański, M; Walgenbach, M; Miserez, M

2013-08-01

The literature dealing with abdominal wall surgery is often flawed due to lack of adherence to accepted reporting standards and statistical methodology. The EuraHS Working Group (European Registry of Abdominal Wall Hernias) organised a consensus meeting of surgical experts and researchers with an interest in abdominal wall surgery, including a statistician, the editors of the journal Hernia and scientists experienced in meta-analysis. Detailed discussions took place to identify the basic ground rules necessary to improve the quality of research reports related to abdominal wall reconstruction. A list of recommendations was formulated including more general issues on the scientific methodology and statistical approach. Standards and statements are available, each depending on the type of study that is being reported: the CONSORT statement for the Randomised Controlled Trials, the TREND statement for non randomised interventional studies, the STROBE statement for observational studies, the STARLITE statement for literature searches, the MOOSE statement for metaanalyses of observational studies and the PRISMA statement for systematic reviews and meta-analyses. A number of recommendations were made, including the use of previously published standard definitions and classifications relating to hernia variables and treatment; the use of the validated Clavien-Dindo classification to report complications in hernia surgery; the use of "time-to-event analysis" to report data on "freedom-of-recurrence" rather than the use of recurrence rates, because it is more sensitive and accounts for the patients that are lost to follow-up compared with other reporting methods. A set of recommendations for reporting outcome results of abdominal wall surgery was formulated as guidance for researchers. It is anticipated that the use of these recommendations will increase the quality and meaning of abdominal wall surgery research.

Bibliography of Mock Trial Materials.

ERIC Educational Resources Information Center

National Inst. for Citizen Education in the Law, Washington, DC.

This catalog lists general articles on mock trials, information for arranging mock trial competitions, mock trial problem sets, and video tapes. The problem sets contain introductory material, applicable law, statements of facts, witness statements, and documents. The cases include issues in family, consumer, criminal, and immigration law. Several…

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

PubMed

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

2017-04-01

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

Do emergency medicine journals promote trial registration and adherence to reporting guidelines? A survey of "Instructions for Authors".

PubMed

Sims, Matthew T; Henning, Nolan M; Wayant, C Cole; Vassar, Matt

2016-11-24

The aim of this study was to evaluate the current state of two publication practices, reporting guidelines requirements and clinical trial registration requirements, by analyzing the "Instructions for Authors" of emergency medicine journals. We performed a web-based data abstraction from the "Instructions for Authors" of the 27 Emergency Medicine journals catalogued in the Expanded Science Citation Index of the 2014 Journal Citation Reports and Google Scholar Metrics h5-index to identify whether each journal required, recommended, or made no mention of the following reporting guidelines: EQUATOR Network, ICMJE, ARRIVE, CARE, CONSORT, STARD, TRIPOD, CHEERS, MOOSE, STROBE, COREQ, SRQR, SQUIRE, PRISMA-P, SPIRIT, PRISMA, and QUOROM. We also extracted whether journals required or recommended trial registration. Authors were blinded to one another's ratings until completion of the data validation. Cross-tabulations and descriptive statistics were calculated using IBM SPSS 22. Of the 27 emergency medicine journals, 11 (11/27, 40.7%) did not mention a single guideline within their "Instructions for Authors," while the remaining 16 (16/27, 59.3%) mentioned one or more guidelines. The QUOROM statement and SRQR were not mentioned by any journals whereas the ICMJE guidelines (18/27, 66.7%) and CONSORT statement (15/27, 55.6%) were mentioned most often. Of the 27 emergency medicine journals, 15 (15/27, 55.6%) did not mention trial or review registration, while the remaining 12 (12/27, 44.4%) at least mentioned one of the two. Trial registration through ClinicalTrials.gov was mentioned by seven (7/27, 25.9%) journals while the WHO registry was mentioned by four (4/27, 14.8%). Twelve (12/27, 44.4%) journals mentioned trial registration through any registry platform. The aim of this study was to evaluate the current state of two publication practices, reporting guidelines requirements and clinical trial registration requirements, by analyzing the "Instructions for Authors" of emergency medicine journals. In this study, there was not a single reporting guideline mentioned in more than half of the journals. This undermines efforts of other journals to improve the completeness and transparency of research reporting. Reporting guidelines are infrequently required or recommended by emergency medicine journals. Furthermore, few require clinical trial registration. These two mechanisms may limit bias and should be considered for adoption by journal editors in emergency medicine. UMIN000022486.

The Single-Case Reporting Guideline In BEhavioural Interventions (SCRIBE) 2016 Statement.

PubMed

Tate, Robyn L; Perdices, Michael; Rosenkoetter, Ulrike; Shadish, William; Vohra, Sunita; Barlow, David H; Horner, Robert; Kazdin, Alan; Kratochwill, Thomas; McDonald, Skye; Sampson, Margaret; Shamseer, Larissa; Togher, Leanne; Albin, Richard; Backman, Catherine; Douglas, Jacinta; Evans, Jonathan J; Gast, David; Manolov, Rumen; Mitchell, Geoffrey; Nickels, Lyndsey; Nikles, Jane; Ownsworth, Tamara; Rose, Miranda; Schmid, Christopher H; Wilson, Barbara

2017-01-01

We developed a reporting guideline to provide authors with guidance about what should be reported when writing a paper for publication in a scientific journal using a particular type of research design: the single-case experimental design. This report describes the methods used to develop the Single-Case Reporting guideline In BEhavioural interventions (SCRIBE) 2016. As a result of 2 online surveys and a 2-day meeting of experts, the SCRIBE 2016 checklist was developed, which is a set of 26 items that authors need to address when writing about single-case research. This article complements the more detailed SCRIBE 2016 Explanation and Elaboration article (Tate et al., 2016 ) that provides a rationale for each of the items and examples of adequate reporting from the literature. Both these resources will assist authors to prepare reports of single-case research with clarity, completeness, accuracy, and transparency. They will also provide journal reviewers and editors with a practical checklist against which such reports may be critically evaluated. We recommend that the SCRIBE 2016 is used by authors preparing manuscripts describing single-case research for publication, as well as journal reviewers and editors who are evaluating such manuscripts. SCIENTIFIC ABSTRACT Reporting guidelines, such as the Consolidated Standards of Reporting Trials (CONSORT) Statement, improve the reporting of research in the medical literature (Turner et al., 2012 ). Many such guidelines exist and the CONSORT Extension to Nonpharmacological Trials (Boutron et al., 2008 ) provides suitable guidance for reporting between-groups intervention studies in the behavioural sciences. The CONSORT Extension for N-of-1 Trials (CENT 2015) was developed for multiple crossover trials with single individuals in the medical sciences (Shamseer et al., 2015 ; Vohra et al., 2015 ), but there is no reporting guideline in the CONSORT tradition for single-case research used in the behavioural sciences. We developed the Single-Case Reporting guideline In BEhavioural interventions (SCRIBE) 2016 to meet this need. This Statement article describes the methodology of the development of the SCRIBE 2016, along with the outcome of 2 Delphi surveys and a consensus meeting of experts. We present the resulting 26-item SCRIBE 2016 checklist. The article complements the more detailed SCRIBE 2016 Explanation and Elaboration article (Tate et al., 2016 ) that provides a rationale for each of the items and examples of adequate reporting from the literature. Both these resources will assist authors to prepare reports of single-case research with clarity, completeness, accuracy, and transparency. They will also provide journal reviewers and editors with a practical checklist against which such reports may be critically evaluated.

The Single-Case Reporting Guideline In BEhavioural Interventions (SCRIBE) 2016 Statement †

PubMed Central

Tate, Robyn L.; Perdices, Michael; Rosenkoetter, Ulrike; Shadish, William; Vohra, Sunita; Barlow, David H.; Horner, Robert; Kazdin, Alan; Kratochwill, Thomas; McDonald, Skye; Sampson, Margaret; Shamseer, Larissa; Togher, Leanne; Albin, Richard; Backman, Catherine; Douglas, Jacinta; Evans, Jonathan J.; Gast, David; Manolov, Rumen; Mitchell, Geoffrey; Nickels, Lyndsey; Nikles, Jane; Ownsworth, Tamara; Rose, Miranda; Schmid, Christopher H.; Wilson, Barbara

2017-01-01

ABSTRACT We developed a reporting guideline to provide authors with guidance about what should be reported when writing a paper for publication in a scientific journal using a particular type of research design: the single-case experimental design. This report describes the methods used to develop the Single-Case Reporting guideline In BEhavioural interventions (SCRIBE) 2016. As a result of 2 online surveys and a 2-day meeting of experts, the SCRIBE 2016 checklist was developed, which is a set of 26 items that authors need to address when writing about single-case research. This article complements the more detailed SCRIBE 2016 Explanation and Elaboration article (Tate et al., 2016) that provides a rationale for each of the items and examples of adequate reporting from the literature. Both these resources will assist authors to prepare reports of single-case research with clarity, completeness, accuracy, and transparency. They will also provide journal reviewers and editors with a practical checklist against which such reports may be critically evaluated. We recommend that the SCRIBE 2016 is used by authors preparing manuscripts describing single-case research for publication, as well as journal reviewers and editors who are evaluating such manuscripts. SCIENTIFIC ABSTRACT Reporting guidelines, such as the Consolidated Standards of Reporting Trials (CONSORT) Statement, improve the reporting of research in the medical literature (Turner et al., 2012). Many such guidelines exist and the CONSORT Extension to Nonpharmacological Trials (Boutron et al., 2008) provides suitable guidance for reporting between-groups intervention studies in the behavioural sciences. The CONSORT Extension for N-of-1 Trials (CENT 2015) was developed for multiple crossover trials with single individuals in the medical sciences (Shamseer et al., 2015; Vohra et al., 2015), but there is no reporting guideline in the CONSORT tradition for single-case research used in the behavioural sciences. We developed the Single-Case Reporting guideline In BEhavioural interventions (SCRIBE) 2016 to meet this need. This Statement article describes the methodology of the development of the SCRIBE 2016, along with the outcome of 2 Delphi surveys and a consensus meeting of experts. We present the resulting 26-item SCRIBE 2016 checklist. The article complements the more detailed SCRIBE 2016 Explanation and Elaboration article (Tate et al., 2016) that provides a rationale for each of the items and examples of adequate reporting from the literature. Both these resources will assist authors to prepare reports of single-case research with clarity, completeness, accuracy, and transparency. They will also provide journal reviewers and editors with a practical checklist against which such reports may be critically evaluated. PMID:27499422

Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): extending the CONSORT statement

PubMed Central

MacPherson, Hugh; Altman, Douglas G; Hammerschlag, Richard; Li, Youping; Wu, Taixiang; White, Adrian; Moher, David

2010-01-01

The STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) were published in five journals in 2001 and 2002. These guidelines, in the form of a checklist and explanations for use by authors and journal editors, were designed to improve reporting of acupuncture trials, particularly the interventions, thereby facilitating their interpretation and replication. Subsequent reviews of the application and impact of STRICTA have highlighted the value of STRICTA as well as scope for improvements and revision. To manage the revision process a collaboration between the STRICTA Group, the CONSORT Group and the Chinese Cochrane Centre was developed in 2008. An expert panel with 47 participants was convened that provided electronic feedback on a revised draft of the checklist. At a subsequent face-to-face meeting in Freiburg, a group of 21 participants further revised the STRICTA checklist and planned dissemination. The new STRICTA checklist, which is an official extension of CONSORT, includes 6 items and 17 subitems. These set out reporting guidelines for the acupuncture rationale, the details of needling, the treatment regimen, other components of treatment, the practitioner background and the control or comparator interventions. In addition, and as part of this revision process, the explanations for each item have been elaborated, and examples of good reporting for each item are provided. In addition, the word ‘controlled’ in STRICTA is replaced by ‘clinical’, to indicate that STRICTA is applicable to a broad range of clinical evaluation designs, including uncontrolled outcome studies and case reports. It is intended that the revised STRICTA checklist, in conjunction with both the main CONSORT statement and extension for non-pharmacological treatment, will raise the quality of reporting of clinical trials of acupuncture. PMID:20615861

Challenging the epidemiologic evidence on passive smoking: tactics of tobacco industry expert witnesses.

PubMed

Francis, John A; Shea, Amy K; Samet, Jonathan M

2006-12-01

To analyse the statements given by tobacco industry defence witnesses during trial testimonies and depositions in second-hand smoke cases and in parallel, to review criticisms of epidemiology in industry-funded publications in order to identify strategies for discrediting epidemiologic evidence on passive smoking health effects. A collection of depositions and trial testimony transcripts from tobacco industry-related lawsuits filed in the United States during the 1990s, was compiled and indexed by the Tobacco Deposition and Trial Testimony Archive (DATTA). Statements in DATTA made by expert witnesses representing the tobacco industry relating to the health effects of passive smoking were identified and reviewed. Industry-supported publications within the peer-reviewed literature were also examined for statements on exposure misclassification, meta-analysis, and confounding. The witnesses challenged causation of adverse health effects of passive smoking by citing limitations of epidemiologic research, raising methodological and statistical issues, and disputing biological plausibility. Though not often cited directly by the witnesses, the defence tactics mirrored the strategies used in industry-funded reports in the peer-reviewed literature. The tobacco industry attempted to redirect the focus and dialogue related to the epidemiologic evidence on passive smoking. This approach, used by industry experts in trial testimony and depositions, placed bias as a certain alternative to causation of diseases related to passive smoking and proposed an unachievable standard for establishing the mechanism of disease.

Working towards a 'fit note': an experimental vignette survey of GPs.

PubMed

Sallis, Anna; Birkin, Richard; Munir, Fehmidah

2010-04-01

The Department for Work and Pensions (DWP) has designed a trial medical statement. To compare fitness for work assessment outcomes and written advice across current and trial medical statements. To examine the use of and suggestions to improve the trial medical statement. Comparative study with a two-way mixed design using questionnaire-based vignettes presenting GPs with three hypothetical sick leave cases (back pain, depression, combined back pain and depression) and medical statements (current or trial). The questionnaire also gathered GP views of using the trial Med 3. Nine primary care organisations (PCOs) in England, Scotland, and Wales. Five hundred and eighty-three GPs employed in PCOs in summer 2008 were randomised to receive a current or trial Med 3 postal questionnaire. GPs assessed vignette patients' fitness for work using the questionnaire medical statements. GPs using the trial Med 3 were less likely to advise refraining from work and more likely to provide written fitness for work advice compared to GPs using the current Med 3 form. Date sections of the trial Med 3 were used inconsistently, and a return to work date was unclear. GPs wanted further clarification of the implications of assessing a case as 'fit for some work' and its relationship to employers' willingness to follow GP advice about work. The study indicates a revised form may reduce the number of patients advised to refrain from work and increase the provision of written fitness for work information.

A multi-disciplinary consensus statement concerning surgical approaches to low-grade, high-grade astrocytomas and diffuse intrinsic pontine gliomas in childhood (CPN Paris 2011) using the Delphi method.

PubMed

Walker, David A; Liu, JoFen; Kieran, Mark; Jabado, Nada; Picton, Susan; Packer, Roger; St Rose, Christian

2013-04-01

Astrocytic tumors account for 42% of childhood brain tumors, arising in all anatomical regions and associated with neurofibromatosis type 1 (NF1) in 15%. Anatomical site determines the degree and risk of resectability; the more complete resection, the better the survival rates. New biological markers and modern radiotherapy techniques are altering the risk assessments of clinical decisions for tumor resection and biopsy. The increasingly distinct pediatric neuro-oncology multidisciplinary team (PNMDT) is developing a distinct evidence base. A multidisciplinary consensus conference on pediatric neurosurgery was held in February 2011, where 92 invited participants reviewed evidence for clinical management of hypothalamic chiasmatic glioma (HCLGG), diffuse intrinsic pontine glioma (DIPG), and high-grade glioma (HGG). Twenty-seven statements were drafted and subjected to online Delphi consensus voting by participants, seeking >70% agreement from >60% of respondents; where <70% consensus occurred, the statement was modified and resubmitted for voting. Twenty-seven statements meeting consensus criteria are reported. For HCLGG, statements describing overall therapeutic purpose and indications for biopsy, observation, or treatment aimed at limiting the risk of visual damage and the need for on-going clinical trials were made. Primary surgical resection was not recommended. For DIPG, biopsy was recommended to ascertain biological characteristics to enhance understanding and targeting of treatments, especially in clinical trials. For HGG, biopsy is essential, the World Health Organization classification was recommended; selection of surgical strategy to achieve gross total resection in a single or multistep process should be discussed with the PNMDT and integrated with trials based drug strategies for adjuvant therapies.

Guidelines for the Reporting of Treatment Trials for Alcohol Use Disorders

PubMed Central

Witkiewitz, Katie; Finney, John W.; Harris, Alex H.S; Kivlahan, Daniel R.; Kranzler, Henry R.

2015-01-01

Background The primary goals in conducting clinical trials of treatments for alcohol use disorders (AUDs) is to identify efficacious treatments and determine which treatments are most efficacious for which patients. Accurate reporting of study design features and results is imperative to enable readers of research reports to evaluate to what extent a study has achieved these goals. Guidance on quality of clinical trial reporting has evolved substantially over the past two decades, primarily through the publication and widespread adoption of the Consolidated Standards of Reporting Trials (CONSORT) statement. However, there is room to improve the adoption of those standards in reporting the design and findings of treatment trials for AUD. Methods Narrative review of guidance on reporting quality in AUD treatment trials. Results Despite improvements in the reporting of results of treatment trials for AUD over the past two decades, many published reports provide insufficient information on design or methods. Conclusions The reporting of alcohol treatment trial design, analysis, and results requires improvement in four primary areas: (1) trial registration, (2) procedures for recruitment and retention, (3) procedures for randomization and intervention design considerations, and (4) statistical methods used to assess treatment efficacy. Improvements in these areas and the adoption of reporting standards by authors, reviewers, and editors are critical to an accurate assessment of the reliability and validity of treatment effects. Continued developments in this area are needed to move AUD treatment research forward via systematic reviews and meta-analyses that maximize the utility of completed studies. PMID:26259958

Preferred Reporting Items for Systematic Review and Meta-Analyses of individual participant data: the PRISMA-IPD Statement.

PubMed

Stewart, Lesley A; Clarke, Mike; Rovers, Maroeska; Riley, Richard D; Simmonds, Mark; Stewart, Gavin; Tierney, Jayne F

2015-04-28

Systematic reviews and meta-analyses of individual participant data (IPD) aim to collect, check, and reanalyze individual-level data from all studies addressing a particular research question and are therefore considered a gold standard approach to evidence synthesis. They are likely to be used with increasing frequency as current initiatives to share clinical trial data gain momentum and may be particularly important in reviewing controversial therapeutic areas. To develop PRISMA-IPD as a stand-alone extension to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) Statement, tailored to the specific requirements of reporting systematic reviews and meta-analyses of IPD. Although developed primarily for reviews of randomized trials, many items will apply in other contexts, including reviews of diagnosis and prognosis. Development of PRISMA-IPD followed the EQUATOR Network framework guidance and used the existing standard PRISMA Statement as a starting point to draft additional relevant material. A web-based survey informed discussion at an international workshop that included researchers, clinicians, methodologists experienced in conducting systematic reviews and meta-analyses of IPD, and journal editors. The statement was drafted and iterative refinements were made by the project, advisory, and development groups. The PRISMA-IPD Development Group reached agreement on the PRISMA-IPD checklist and flow diagram by consensus. Compared with standard PRISMA, the PRISMA-IPD checklist includes 3 new items that address (1) methods of checking the integrity of the IPD (such as pattern of randomization, data consistency, baseline imbalance, and missing data), (2) reporting any important issues that emerge, and (3) exploring variation (such as whether certain types of individual benefit more from the intervention than others). A further additional item was created by reorganization of standard PRISMA items relating to interpreting results. Wording was modified in 23 items to reflect the IPD approach. PRISMA-IPD provides guidelines for reporting systematic reviews and meta-analyses of IPD.

Moving toward the reduction of publication/reporting biases in clinical trials using a new international standard.

PubMed

Doi, Yuriko

2016-01-01

Evidence-based medicine (EBM) is fundamental to ensuring high-quality medical care. It requires systematic reviews and meta-analyses to synthesize diverse information available from individual clinical studies. However, the literature reviewed may represent an incomplete and selective set of research findings, which could lead to publication/reporting biases and distort the true picture of research as a whole. Prospective registry of all clinical trials in the world is mandatory to reduce the biases, which have been disclosed on the International Clinical Trials Registry Platform (ICTRP) of the World Health Organization (WHO) since 2007. The Japan Primary Registries Network (JPRN) is included in the ICTRP. ClinicalTrials.gov, the U.S. clinical trial registry, reports the standardized data of registered trials and offers access to submitted outcomes online. However, the JPRN does not systematically include the outcomes. On April 14, 2015, the WHO published a new statement online on the public disclosure of clinical trial results, which requires researchers to define the timeframes of reporting main findings and key outcomes, to call for results-reporting older, but still unpublished trials, and to outline steps to improve linkages between clinical trial registry entries and their published results. The WHO's new position will facilitate global efforts to reduce publication/reporting biases in clinical trials. Japan will have to actively participate in these efforts as well.

Endorsement of the CONSORT statement by Chinese journals of Traditional Chinese Medicine: a survey of journal editors and review of journals' instructions for authors.

PubMed

Ma, Bin; Ke, Fa-Yong; Zheng, Er-Liang; Yang, Zun-Xian; Tang, Qing-Nan; Qi, Guo-Qing

2016-06-01

We aimed to assess the endorsement of the Consolidation Standards of Reporting Trials (CONSORT) statement by Chinese journals of Traditional Chinese Medicine (TCM) and its incorporation into their editorial processes. PubMed, Embase and major Chinese databases were searched to identify journals of TCM from China for inclusion. The latest 'instruction for authors' (IFA) of each included journal was obtained and any text mentioning CONSORT or CONSORT extension papers was extracted. Subsequently, the editor of each of the included journals was surveyed about their journal's endorsement of the CONSORT recommendations and their incorporation into editorial and peer review processes. Sixty-three journals of TCM from China were examined. Of these, only three (5%) and one (2%) of the 63 journals mentioned the CONSORT statement and extension papers, respectively, in their IFA. Fifty-four of 63 (86%) of surveyed journals responded, with the majority of respondents being editors. Only 20% (11/54) of the respondents reported that they had any knowledge of the CONSORT statement. Only 6% (3/54) of the editors reported that they required authors to comply with the CONSORT statement or that they incorporated it into their peer review and editorial processes. TCM journals in China endorsing the CONSORT statement constituted a small percentage of the total. The majority of editors surveyed were not familiar with the content of the CONSORT statement and extension papers. We strongly recommend that the China Periodicals Association issue a policy to promote the endorsement of the CONSORT statement and conduct relevant training for journal editors in China. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Consolidated FY 1995 Financial Report on Defense Organizations Receiving Department 97 Appropriations

DTIC Science & Technology

1996-10-31

consolidated financial statements for FY 1996 and each succeeding year. In his memorandum dated June 6, 1995, the DoD Deputy Chief Financial Officer notified the DoD Components of the FY 1996 requirement to prepare and submit financial statements in accordance with the Federal Financial Management Act of 1994. We reviewed the adjusted trial balance submissions of 29 Defense organizations that received a total of $37 billion in Department 97 funds for FY 1995. Department 97 funds are general fund appropriations allocated to Defense organizations and the Military

The Single-Case Reporting guideline In BEhavioural interventions (SCRIBE) 2016 statement.

PubMed

Tate, Robyn L; Perdices, Michael; Rosenkoetter, Ulrike; Shadish, William; Vohra, Sunita; Barlow, David H; Horner, Robert; Kazdin, Alan; Kratochwill, Thomas; McDonald, Skye; Sampson, Margaret; Shamseer, Larissa; Togher, Leanne; Albin, Richard; Backman, Catherine; Douglas, Jacinta; Evans, Jonathan J; Gast, David; Manolov, Rumen; Mitchell, Geoffrey; Nickels, Lyndsey; Nikles, Jane; Ownsworth, Tamara; Rose, Miranda; Schmid, Christopher H; Wilson, Barbara

2016-06-01

We developed a reporting guideline to provide authors with guidance about what should be reported when writing a paper for publication in a scientific journal using a particular type of research design: the single-case experimental design. This report describes the methods used to develop the Single-Case Reporting guideline In BEhavioural interventions (SCRIBE) 2016. As a result of 2 online surveys and a 2-day meeting of experts, the SCRIBE 2016 checklist was developed, which is a set of 26 items that authors need to address when writing about single-case research. This article complements the more detailed SCRIBE 2016 Explanation and Elaboration article (Tate et al., 2016) that provides a rationale for each of the items and examples of adequate reporting from the literature. Both these resources will assist authors to prepare reports of single-case research with clarity, completeness, accuracy, and transparency. They will also provide journal reviewers and editors with a practical checklist against which such reports may be critically evaluated. We recommend that the SCRIBE 2016 is used by authors preparing manuscripts describing single-case research for publication, as well as journal reviewers and editors who are evaluating such manuscripts. Reporting guidelines, such as the Consolidated Standards of Reporting Trials (CONSORT) Statement, improve the reporting of research in the medical literature (Turner et al., 2012). Many such guidelines exist and the CONSORT Extension to Nonpharmacological Trials (Boutron et al., 2008) provides suitable guidance for reporting between-groups intervention studies in the behavioral sciences. The CONSORT Extension for N-of-1 Trials (CENT 2015) was developed for multiple crossover trials with single individuals in the medical sciences (Shamseer et al., 2015; Vohra et al., 2015), but there is no reporting guideline in the CONSORT tradition for single-case research used in the behavioral sciences. We developed the Single-Case Reporting guideline In BEhavioural interventions (SCRIBE) 2016 to meet this need. This Statement article describes the methodology of the development of the SCRIBE 2016, along with the outcome of 2 Delphi surveys and a consensus meeting of experts. We present the resulting 26-item SCRIBE 2016 checklist. The article complements the more detailed SCRIBE 2016 Explanation and Elaboration article (Tate et al., 2016) that provides a rationale for each of the items and examples of adequate reporting from the literature. Both these resources will assist authors to prepare reports of single-case research with clarity, completeness, accuracy, and transparency. They will also provide journal reviewers and editors with a practical checklist against which such reports may be critically evaluated. Supplemental materials: http://dx.doi.org/10.1037/arc0000026.supp. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

A Consensus-Based Interpretation of the Benchmark Evidence from South American Trials: Treatment of Intracranial Pressure Trial.

PubMed

Chesnut, Randall M; Bleck, Thomas P; Citerio, Giuseppe; Classen, Jan; Cooper, D James; Coplin, William M; Diringer, Michael N; Grände, Per-Olof; Hemphill, J Claude; Hutchinson, Peter J; Le Roux, Peter; Mayer, Stephan A; Menon, David K; Myburgh, John A; Okonkwo, David O; Robertson, Claudia S; Sahuquillo, Juan; Stocchetti, Nino; Sung, Gene; Temkin, Nancy; Vespa, Paul M; Videtta, Walter; Yonas, Howard

2015-11-15

Widely-varying published and presented analyses of the Benchmark Evidence From South American Trials: Treatment of Intracranial Pressure (BEST TRIP) randomized controlled trial of intracranial pressure (ICP) monitoring have suggested denying trial generalizability, questioning the need for ICP monitoring in severe traumatic brain injury (sTBI), re-assessing current clinical approaches to monitored ICP, and initiating a general ICP-monitoring moratorium. In response to this dissonance, 23 clinically-active, international opinion leaders in acute-care sTBI management met to draft a consensus statement to interpret this study. A Delphi method-based approach employed iterative pre-meeting polling to codify the group's general opinions, followed by an in-person meeting wherein individual statements were refined. Statements required an agreement threshold of more than 70% by blinded voting for approval. Seven precisely-worded statements resulted, with agreement levels of 83% to 100%. These statements, which should be read in toto to properly reflect the group's consensus positions, conclude that the BEST TRIP trial: 1) studied protocols, not ICP-monitoring per se; 2) applies only to those protocols and specific study groups and should not be generalized to other treatment approaches or patient groups; 3) strongly calls for further research on ICP interpretation and use; 4) should be applied cautiously to regions with much different treatment milieu; 5) did not investigate the utility of treating monitored ICP in the specific patient group with established intracranial hypertension; 6) should not change the practice of those currently monitoring ICP; and 7) provided a protocol, used in non-monitored study patients, that should be considered when treating without ICP monitoring. Consideration of these statements can clarify study interpretation.

Clinical trials in Brazilian journals of ophthalmology: where we are.

PubMed

Lira, Rodrigo Pessoa Cavalcanti; Leal, Franz Schubert; Gonçalves, Fauze Abdulmassih; Amorim, Fernando Henrique Ramos; Felix, João Paulo Fernandes; Arieta, Carlos Eduardo Leite

2013-01-01

To compare clinical trials published in Brazilian journals of ophthalmology and in foreign journals of ophthalmology with respect to the number of citations and the quality of reporting [by applying the Consolidated Standards for Reporting Trials (CONSORT) statement writing standards]. The sample of this systematic review comprised the two Brazilian journals of ophthalmology indexed at Science Citation Index Expanded and six of the foreign journals of ophthalmology with highest Impact Factor® according ISI. All clinical trials (CTs) published from January 2009 to December 2010 at the Brazilians journals and a 1:1 randomized sample of the foreign journals were included. The primary outcome was the number of citations through the end of 2011. Subgroup analysis included language. The secondary outcome included likelihood of citation (cited at least once versus no citation), and presence or absence of CONSORT statement indicators. The citation counts were statistically significantly higher (P<0.001) in the Foreign Group (10.50) compared with the Brazilian Group (0.45). The likelihood citation was statistically significantly higher (P<0.001) in the Foreign Group (20/20 - 100%) compared with the Brazilian Group (8/20 - 40%). The subgroup analysis of the language influence in Brazilian articles showed that the citation counts were statistically significantly higher in the papers published in English (P<0.04). Of 37 possible CONSORT items, the mean for the Foreign Group was 20.55 and for the Brazilian Group was 13.65 (P<0.003). The number of citations and the quality of reporting of clinical trials in Brazilian journals of ophthalmology still are low when compared with the foreign journals of ophthalmology with highest Impact Factor®.

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

PubMed

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.

Quality of reporting in clinical trials of preharvest food safety interventions and associations with treatment effect.

PubMed

Sargeant, Jan M; Saint-Onge, Jacqueline; Valcour, James; Thompson, Adam; Elgie, Robyn; Snedeker, Kate; Marcynuk, Pasha

2009-10-01

Randomized controlled trials (RCTs) are the gold standard for evaluating treatment efficacy. Therefore, it is important that RCTs are conducted with methodological rigor to prevent biased results and report results in a manner that allows the reader to evaluate internal and external validity. Most human health journals now require manuscripts to meet the Consolidated Standards of Reporting Trials (CONSORT) criteria for reporting of RCTs. Our objective was to evaluate preharvest food safety trials using a modification of the CONSORT criteria to assess methodological quality and completeness of reporting, and to investigate associations between reporting and treatment effects. One hundred randomly selected trials were evaluated using a modified CONSORT statement. The majority of the selected trials (84%) used a deliberate disease challenge, with the remainder representing natural pathogen exposure. There were widespread deficiencies in the reporting of many trial features. Randomization, double blinding, and the number of subjects lost to follow-up were reported in only 46%, 0%, and 43% of trials, respectively. The inclusion criteria for study subjects were only described in 16% of trials, and the number of animals housed together was only stated in 52% of the trials. Although 91 trials had more than one outcome, no trials specified the primary outcome of interest. There were significant bivariable associations between the proportion of positive treatment effects and failure to report the number of subjects lost to follow-up, the number of animals housed together in a group, the level of treatment allocation, and possible study limitations. The results suggest that there are substantive deficiencies in reporting of preharvest food safety trials, and that these deficiencies may be associated with biased treatment effects. The creation and adoption of standards for reporting in preharvest food safety trials will help to ensure the inclusion of important trial details in all publications.

[Evaluation of reporting quality of RCT on nephrotoxicity of Tripterygium wilfordii preparations according to CONSORT HARMs statement].

PubMed

Feng, Xue; Fang, Sai-Nan; Gao, Yu-Xin; Liu, Jian-Ping; Chen, Wei

2018-02-01

To evaluate the quality of randomized controlled trials(RCT) on nephrotoxicity of Tripterygium wilfordii preparations according to the CONSORT HARMs statement. The report quality of each included study was evaluated according to the CONSORT HARMs statement， and the number of entries that comply with CONSORT HARMs statement was calculated in each study to evaluate the report quality on nephrotoxicity-related adverse reactions of T. wilfordii preparations and summarize the problems in domestic studies on nephrotoxicity-related adverse reactions. A total of 16 RCTs were included， with an average of 7 entries complying with CONSORT HARMs statement per study. The report of the nephrotoxic-associated RCT of T. wilfordii preparations was of poor quality and the most non-repeating entries included the following ones： using validated tools to report adverse effects， standards for coding of the adverse reactions， describing how and when to collect data on adverse reactions in Method， describing how adverse reactions are attributed to T. wilfordii， clearly stating who has reported the adverse reactions， describing the analysis method of adverse reactions， describing the method of collecting recurrent adverse reaction data， describing any subgroup analysis and exploratory analysis associated with the hazard. We suggest that the studies on adverse reactions of traditional Chinese medicine should strictly report the entries according to the CONSORT HARMs statement， and take the characteristics of traditional Chinese medicine into account to report the details of the Chinese medicine like compositions， dose， taking time， combined medication and the dialectical typology of research objects. Copyright© by the Chinese Pharmaceutical Association.

Reporting of adverse drug reactions in randomised controlled trials – a systematic survey

PubMed Central

Loke, Yoon Kong; Derry, Sheena

2001-01-01

Background Decisions on treatment are guided, not only by the potential for benefit, but also by the nature and severity of adverse drug reactions. However, some researchers have found numerous deficiencies in trial reports of adverse effects. We sought to confirm these findings by evaluating trials of drug therapy published in seven eminent medical journals in 1997. Methods Literature review to determine whether the definition, recording and reporting of adverse drug reactions in clinical trials were in accordance with published recommendations on structured reporting. Results Of the 185 trials reviewed, 25 (14%) made no mention of adverse drug reactions. Data in a further 60 (32%) could not be fully evaluated, either because numbers were not given for each treatment arm (31 trials), or because a generic statement was made without full details (29 trials). When adverse drug reactions such as clinical events or patient symptoms were mentioned in the reports, details on how they had been recorded were given in only 14/95 (15%) and 18/104 (17%) trials respectively. Of the 86 trials that mentioned severity of adverse drug reactions, only 42 (49%) stated how severity had been defined. The median amount of space used for safety data in the Results and Discussion sections was 5.8%. Conclusions Trial reports often failed to provide details on how adverse drug reactions were defined or recorded. The absence of such methodological information makes comparative evaluation of adverse reaction rates potentially unreliable. Authors and journals should adopt recommendations on the structured reporting of adverse effects. PMID:11591227

Reporting of methods was better in the Clinical Trials Registry-India than in Indian journal publications.

PubMed

Tharyan, Prathap; George, Aneesh Thomas; Kirubakaran, Richard; Barnabas, Jabez Paul

2013-01-01

We sought to evaluate if editorial policies and the reporting quality of randomized controlled trials (RCTs) had improved since our 2004-05 survey of 151 RCTs in 65 Indian journals, and to compare reporting quality of protocols in the Clinical Trials Registry-India (CTRI). An observational study of endorsement of Consolidated Standards for the Reporting of Trials (CONSORT) and International Committee of Medical Journal Editors (ICMJE) requirements in the instructions to authors in Indian journals, and compliance with selected requirements in all RCTs published during 2007-08 vs. our previous survey and between all RCT protocols in the CTRI on August 31, 2010 and published RCTs from both surveys. Journal policies endorsing the CONSORT statement (22/67, 33%) and ICMJE requirements (35/67, 52%) remained suboptimal, and only 4 of 13 CONSORT items were reported in more than 50% of the 145 RCTs assessed. Reporting of ethical issues had improved significantly, and that of methods addressing internal validity had not improved. Adequate methods were reported significantly more frequently in 768 protocols in the CTRI, than in the 296 published trials. The CTRI template facilitates the reporting of valid methods in registered trial protocols. The suboptimal compliance with CONSORT and ICMJE requirements in RCTs published in Indian journals reduces credibility in the reliability of their results. Copyright © 2013 Elsevier Inc. All rights reserved.

Glucagon-Like Peptide-1 Receptor Agonists for the Treatment of Type 2 Diabetes Mellitus: A Position Statement of the Korean Diabetes Association.

PubMed

Kim, Hyun Jin; Park, Seok O; Ko, Seung Hyun; Rhee, Sang Youl; Hur, Kyu Yeon; Kim, Nan Hee; Moon, Min Kyong; Lee, Byung Wan; Kim, Jin Hwa; Choi, Kyung Mook

2017-12-01

The glucagon-like peptide-1 receptor agonists (GLP-1RAs) were recommended as a monotherapy or combination therapy with oral hypoglycemic agents or basal insulin in the position statement of the Korean Diabetes Association 2017 for pharmacological therapy. Many randomized clinical trials and systematic reviews report that GLP-1RAs have considerable glucose-lowering effect and lead to weight reduction and low risk of hypoglycemia when used as a monotherapy or combination therapy. The cardiovascular safety of GLP-1RAs has been assessed in several randomized clinical trials and systematic reviews. The results of cardiovascular outcome trials of long-acting GLP-1RAs (liraglutide, semaglutide) demonstrated cardiovascular benefits in subjects with type 2 diabetes mellitus and a high risk of cardiovascular disease. The GLP-1RA may be a choice of therapy when weight control and avoidance of hypoglycemia are important, and patients with high risk of cardiovascular disease might also favor choosing GLP-1RA. Copyright © 2017 Korean Diabetes Association.

Fifth Ovarian Cancer Consensus Conference of the Gynecologic Cancer InterGroup: first-line interventions.

PubMed

Karam, A; Ledermann, J A; Kim, J-W; Sehouli, J; Lu, K; Gourley, C; Katsumata, N; Burger, R A; Nam, B-H; Bacon, M; Ng, C; Pfisterer, J; Bekkers, R L M; Casado Herráez, A; Redondo, A; Fujiwara, H; Gleeson, N; Rosengarten, O; Scambia, G; Zhu, J; Okamoto, A; Stuart, G; Ochiai, K

2017-04-01

The consensus statements regarding first-line therapies in women with ovarian cancer, reached at the Fifth Ovarian Cancer Consensus Conference held in Tokyo, Japan, in November 2015 are reported. Three topics were reviewed and the following statements are recommended: (i) Surgery: the subgroups that should be considered in first-line ovarian cancer clinical trials should be (a) patients undergoing primary debulking surgery and (b) patients receiving neo-adjuvant chemotherapy. The amount of residual disease following surgery should further stratify patients into those with absent gross residual disease and others. (ii) Control arms for chemotherapy: for advanced stage ovarian cancer the standard is intravenous 3-weekly carboplatin and paclitaxel. Acceptable alternatives, which should be stratified variables in trials when more than one regimen is offered, include weekly paclitaxel plus 3-weekly carboplatin, the addition of bevacizumab to 3-weekly carboplatin and paclitaxel, and intraperitoneal therapy. (iii) Trial Endpoints: overall survival is the preferred primary endpoint for first-line clinical trials with or without a maintenance component. Progression-free survival (PFS) is an alternative primary endpoint, but if PFS is chosen overall survival must be measured as a secondary endpoint and PFS must be supported by additional endpoints, including predefined patient reported outcomes and time to first or second subsequent therapy. For neoadjuvant therapy, additional 'window of opportunity' endpoints should be included. © The Author 2017. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Standardized reporting of bleeding complications for clinical investigations in acute coronary syndromes: a proposal from the academic bleeding consensus (ABC) multidisciplinary working group.

PubMed

Rao, Sunil V; Eikelboom, John; Steg, Ph Gabriel; Lincoff, A Michael; Weintraub, William S; Bassand, Jean-Pierre; Rao, A Koneti; Gibson, C Michael; Petersen, John L; Mehran, Roxana; Manoukian, Steven V; Charnigo, Richard; Lee, Kerry L; Moscucci, Mauro; Harrington, Robert A

2009-12-01

Clinical trials of antithrombotic agents for the treatment of ACS routinely assess bleeding as a safety endpoint, but variation in bleeding definitions makes comparison of the relative safety of these agents difficult. The ABC Multidisciplinary Working Group, an informal working group comprising clinical researchers and representatives from the US Food and Drug Administration, the National Institutes of Health, and the pharmaceutical industry, sought to develop a consensus approach to measuring the incidence and severity of bleeding complications during clinical trials of acute coronary syndromes (ACS). A meeting of the ABC was convened in April 2008 in Washington, DC, with the goal of developing a consensus approach to measuring the incidence and severity of hemorrhagic complications during clinical trials of ACS. Relevant literature on bleeding was reviewed through a series of short lectures and intensive group discussion. Using existing evidence on bleeding and outcomes as well as clinical judgment, criteria for the assessment of bleeding were developed through expert consensus. This consensus statement divides bleeding-related data elements into three categories: essential, recommended, and optional. The ABC Group recommendations for collection and reporting of bleeding complications provide a framework for consistency in the collection of information on hemorrhagic complications in trials of ACS. Widespread adoption of the statement recommendations will facilitate understanding of the mechanisms of adverse outcomes after bleeding and comparisons of the relative safety of antithrombotic agents, as well as the interpretation of safety results from future studies.

Adverse event reporting in cancer clinical trial publications.

PubMed

Sivendran, Shanthi; Latif, Asma; McBride, Russell B; Stensland, Kristian D; Wisnivesky, Juan; Haines, Lindsay; Oh, William K; Galsky, Matthew D

2014-01-10

Reporting adverse events is a critical element of a clinical trial publication. In 2003, the Consolidated Standards of Reporting Trials (CONSORT) group generated recommendations regarding the appropriate reporting of adverse events. The degree to which these recommendations are followed in oncology publications has not been comprehensively evaluated. A review of citations from PubMed, Medline, and Embase published between Jan 1, 2009 and December 31, 2011, identified eligible randomized, controlled phase III trials in metastatic solid malignancies. Publications were assessed for 14 adverse event-reporting elements derived from the CONSORT harms extension statement; a completeness score (range, 0 to 14) was calculated by adding the number of elements reported. Linear regression analysis identified which publication characteristics associated with reporting completeness. A total of 175 publications, with data for 96,125 patients, were included in the analysis. The median completeness score was eight (range, three to 12). Most publications (96%) reported only adverse events occurring above a threshold rate or severity, 37% did not specify the criteria used to select which adverse events were reported, and 88% grouped together adverse events of varying severity. Regression analysis revealed that trials without a stated funding source and with an earlier year of publication had significantly lower completeness scores. Reporting of adverse events in oncology publications of randomized trials is suboptimal and characterized by substantial selectivity and heterogeneity. The development of oncology-specific standards for adverse event reporting should be established to ensure consistency and provide critical information required for medical decision-making.

Impact of a web-based tool (WebCONSORT) to improve the reporting of randomised trials: results of a randomised controlled trial.

PubMed

Hopewell, Sally; Boutron, Isabelle; Altman, Douglas G; Barbour, Ginny; Moher, David; Montori, Victor; Schriger, David; Cook, Jonathan; Gerry, Stephen; Omar, Omar; Dutton, Peter; Roberts, Corran; Frangou, Eleni; Clifton, Lei; Chiocchia, Virginia; Rombach, Ines; Wartolowska, Karolina; Ravaud, Philippe

2016-11-28

The CONSORT Statement is an evidence-informed guideline for reporting randomised controlled trials. A number of extensions have been developed that specify additional information to report for more complex trials. The aim of this study was to evaluate the impact of using a simple web-based tool (WebCONSORT, which incorporates a number of different CONSORT extensions) on the completeness of reporting of randomised trials published in biomedical publications. We conducted a parallel group randomised trial. Journals which endorsed the CONSORT Statement (i.e. referred to it in the Instruction to Authors) but do not actively implement it (i.e. require authors to submit a completed CONSORT checklist) were invited to participate. Authors of randomised trials were requested by the editor to use the web-based tool at the manuscript revision stage. Authors registering to use the tool were randomised (centralised computer generated) to WebCONSORT or control. In the WebCONSORT group, they had access to a tool allowing them to combine the different CONSORT extensions relevant to their trial and generate a customised checklist and flow diagram that they must submit to the editor. In the control group, authors had only access to a CONSORT flow diagram generator. Authors, journal editors, and outcome assessors were blinded to the allocation. The primary outcome was the proportion of CONSORT items (main and extensions) reported in each article post revision. A total of 46 journals actively recruited authors into the trial (25 March 2013 to 22 September 2015); 324 author manuscripts were randomised (WebCONSORT n = 166; control n = 158), of which 197 were reports of randomised trials (n = 94; n = 103). Over a third (39%; n = 127) of registered manuscripts were excluded from the analysis, mainly because the reported study was not a randomised trial. Of those included in the analysis, the most common CONSORT extensions selected were non-pharmacologic (n = 43; n = 50), pragmatic (n = 20; n = 16) and cluster (n = 10; n = 9). In a quarter of manuscripts, authors either wrongly selected an extension or failed to select the right extension when registering their manuscript on the WebCONSORT study site. Overall, there was no important difference in the overall mean score between WebCONSORT (mean score 0.51) and control (0.47) in the proportion of CONSORT and CONSORT extension items reported pertaining to a given study (mean difference, 0.04; 95% CI -0.02 to 0.10). This study failed to show a beneficial effect of a customised web-based CONSORT checklist to help authors prepare more complete trial reports. However, the exclusion of a large number of inappropriately registered manuscripts meant we had less precision than anticipated to detect a difference. Better education is needed, earlier in the publication process, for both authors and journal editorial staff on when and how to implement CONSORT and, in particular, CONSORT-related extensions. ClinicalTrials.gov: NCT01891448 [registered 24 May 2013].

ERS statement on protracted bacterial bronchitis in children.

PubMed

Kantar, Ahmad; Chang, Anne B; Shields, Mike D; Marchant, Julie M; Grimwood, Keith; Grigg, Jonathan; Priftis, Kostas N; Cutrera, Renato; Midulla, Fabio; Brand, Paul L P; Everard, Mark L

2017-08-01

This European Respiratory Society statement provides a comprehensive overview on protracted bacterial bronchitis (PBB) in children. A task force of experts, consisting of clinicians from Europe and Australia who manage children with PBB determined the overall scope of this statement through consensus. Systematic reviews addressing key questions were undertaken, diagrams in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement constructed and findings of relevant studies summarised. The final content of this statement was agreed upon by all members.The current knowledge regarding PBB is presented, including the definition, microbiology data, known pathobiology, bronchoalveolar lavage findings and treatment strategies to manage these children. Evidence for the definition of PBB was sought specifically and presented. In addition, the task force identified several major clinical areas in PBB requiring further research, including collecting more prospective data to better identify the disease burden within the community, determining its natural history, a better understanding of the underlying disease mechanisms and how to optimise its treatment, with a particular requirement for randomised controlled trials to be conducted in primary care. Copyright ©ERS 2017.

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

PubMed

Nobre, Moacyr Roberto Cuce; da Costa, Frnanda Marques

2012-02-01

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

SPIRIT 2013 Statement: defining standard protocol items for clinical trials.

PubMed

Chan, An-Wen; Tetzlaff, Jennifer M; Altman, Douglas G; Laupacis, Andreas; Gøtzsche, Peter C; Krle A-Jerić, Karmela; Hrobjartsson, Asbjørn; Mann, Howard; Dickersin, Kay; Berlin, Jesse A; Dore, Caroline J; Parulekar, Wendy R; Summerskill, William S M; Groves, Trish; Schulz, Kenneth F; Sox, Harold C; Rockhold, Frank W; Rennie, Drummond; Moher, David

2015-12-01

The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol. The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.

SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials

PubMed Central

Chan, An-Wen; Tetzlaff, Jennifer M.; Altman, Douglas G.; Laupacis, Andreas; Gøtzsche, Peter C.; Krleža-Jerić, Karmela; Hróbjartsson, Asbjørn; Mann, Howard; Dickersin, Kay; Berlin, Jesse A.; Doré, Caroline J.; Parulekar, Wendy R.; Summerskill, William S.M.; Groves, Trish; Schulz, Kenneth F.; Sox, Harold C.; Rockhold, Frank W.; Rennie, Drummond; Moher, David

2016-01-01

The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol. The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders. PMID:23295957

SPIRIT 2013 statement: defining standard protocol items for clinical trials.

PubMed

Chan, An-Wen; Tetzlaff, Jennifer M; Altman, Douglas G; Laupacis, Andreas; Gøtzsche, Peter C; Krleža-Jerić, Karmela; Hróbjartsson, Asbjørn; Mann, Howard; Dickersin, Kay; Berlin, Jesse A; Doré, Caroline J; Parulekar, Wendy R; Summerskill, William S M; Groves, Trish; Schulz, Kenneth F; Sox, Harold C; Rockhold, Frank W; Rennie, Drummond; Moher, David

2013-02-05

The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol.The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.

Treatment of Internet gaming disorder: An international systematic review and CONSORT evaluation.

PubMed

King, Daniel L; Delfabbro, Paul H; Wu, Anise M S; Doh, Young Yim; Kuss, Daria J; Pallesen, Ståle; Mentzoni, Rune; Carragher, Natacha; Sakuma, Hiroshi

2017-06-01

Treatment services for Internet gaming disorder are becoming increasingly prevalent worldwide, particularly in East Asia. This international systematic review was designed to appraise the quality standards of the gaming disorder treatment literature, a task previously undertaken by King et al. (2011) prior to the inclusion of Internet gaming disorder in Section III of the DSM-5 and 'Gaming disorder' in the draft ICD-11. The reporting quality of 30 treatment studies conducted from 2007 to 2016 was assessed. Reporting quality was defined according to the 2010 Consolidating Standards of Reporting Trials (CONSORT) statement. The results reaffirmed previous criticisms of these trials, namely: (a) inconsistencies in the definition, diagnosis, and measurement of disordered use; (b) lack of randomization and blinding; (c) lack of controls; and (d) insufficient information on recruitment dates, sample characteristics, and effect sizes. Although cognitive-behavioral therapy has a larger evidence base than other therapies, it remains difficult to make definitive statements on its benefits. Study design quality has not improved over the last decade, indicating a need for greater consistency and standardization in this area. Continuing international efforts to understand the core psychopathology of gaming disorder are vital to developing a model of best practice in treatment. Copyright © 2017 Elsevier Ltd. All rights reserved.

Cognitive restructuring and exposure with a compulsive washer: a test of reciprocal inhibition.

PubMed

Giles, T R

1982-09-01

Reciprocal inhibition was tested with a compulsive washer using the affect elicited by rational self-statements as the response competitor to anxiety. Three conditions, CS alone, CS plus irrational self-statements, and CS plus rational self-statements, were randomly and continuously repeated over six trials. The CS was presented both imaginally and in vivo. It was hypothesized: (1) that subjective anxiety in all conditions would substantially diminish by the experiment's end; (2) that the rational self-statement condition would reduce (inhibit) subjective anxiety to a significantly greater degree than the other two conditions; and (3) that significant anxiety reduction would occur only during the rational restructuring trials. All three hypotheses were supported by the results.

Adherence to the CONSORT Statement in the Reporting of Randomized Controlled Trials on Pharmacological Interventions Published in Iranian Medical Journals

PubMed Central

Sarveravan, Pooneh; Astaneh, Behrooz; Shokrpour, Nasrin

2017-01-01

Background: Among manuscripts submitted to biomedical journals, randomized controlled trials (RCTs) form the backbone of evidence-based medicine. Hence, their protocol should be designed rigorously and their results should be reported clearly. To improve the quality of RCT reporting, researchers developed the CONSORT Statement in 1996 and updated it in 2010. This study was designed to assess the quality of RCT reporting vis-à-vis adherence to CONSORT among articles published in Iranian medical journals (English, Persian, CONSORT-endorsing, and non-CONSORT-endorsing). Methods: In this cross-sectional study, all RCTs published in all Iranian medical journals from September 2012 to September 2013 were retrieved to evaluate their adherence to CONSORT. The journals’ instructions for authors were also reviewed to find out whether or not they endorsed CONSORT. The CONSORT 2010 Checklist was used. Microsoft Excel 2007 was applied to analyze the data, and MedCalc was employed to compare the groups. Results: Totally, 492 pharmacological RCTs that met our inclusion criteria were identified. Twenty-five items were reported in fewer than 50% of the articles. The differences between the articles published in Persian and English language journals were statistically significant in 17 items. The differences between the articles published in the CONSORT-endorsing and non-CONSORT-endorsing journals were significant in 8 items. Conclusion: Our findings showed very weak adherence to CONSORT. Authors, reviewers, and editors should be trained to use standards expressed by the CONSORT Group in reporting RCTs. PMID:29184261

Two implant retained overdentures--a review of the literature supporting the McGill and York consensus statements.

PubMed

Thomason, J M; Kelly, S A M; Bendkowski, A; Ellis, J S

2012-01-01

The McGill consensus statement on overdentures (14) was published following a symposium held at McGill University in Montreal, Canada in 2002. A panel of relevant experts in the field stated that: The evidence currently available suggests that the restoration of the edentulous mandible with a conventional denture is no longer the most appropriate first choice prosthodontic treatment. There is now overwhelming evidence that a two-implant overdenture should become the first choice of treatment for the edentulous mandible (14). In 2009, a further consensus statement was released as a support and follow-up to the McGill consensus statement. This report was jointly created by members of the BSSPD (British Society for the Study of Prosthetic Dentistry) Council and the panel of presenters at the BSSPD conference in York, UK in April 2009 (15). This report also highlighted that since the McGill statement in 2002, uptake by dentists of implant technology for complete denture wearers has been slow. The York statement concluded that 'a substantial body of evidence is now available demonstrating that patients' satisfaction and quality of life with ISOD mandibular overdentures is significantly greater than for conventional dentures. Much of this data comes from randomised controlled trials (15). Whilst it is accepted that the two-implant overdenture is not the gold standard of implant therapy it is the minimum standard that should be sufficient for most people, taking into account performance, patient satisfaction, cost and clinical time. Copyright © 2011 Elsevier Ltd. All rights reserved.

"It is not guaranteed that you will benefit": True but misleading?

PubMed

Kim, Scott Y H; Wilson, Renee; De Vries, Raymond; Kim, H Myra; Holloway, Robert G; Kieburtz, Karl

2015-08-01

Participants of early-phase intervention trials for serious conditions provide high estimates of likelihood of benefit, even when informed consent forms do not promise such benefits. However, some technically correct, negatively stated benefits statements—such as "it is not guaranteed that you will benefit"—could play a role in raising expectations of benefit because in ordinary English usage such statements denote a likely but not a certain-to-occur event. An experimental online survey of 584 English-speaking adults recruited online. They were randomized to receive one of two benefit statements ("not guaranteed" vs "some but very small chance"), using a hypothetical scenario of an early-phase clinical trial testing an intervention to treat amyotrophic lateral sclerosis. We assessed respondents' willingness to consider participating in the amyotrophic lateral sclerosis trial, their estimates of likelihood of benefit, and their explanations for those estimates. The two arms did not differ in willingness to consider participation in the amyotrophic lateral sclerosis trial. Those receiving "not guaranteed" benefit statement had higher estimates of benefit than those receiving "some but very small chance" statement (35.7% (standard deviation 20.2) vs 28.3% (standard deviation 22.0), p < 0.0001). A total of 43% of all respondents chose expressions of positive sentiment (hope and need to stay positive) as explanations of their estimates; these respondents' estimates of benefit were higher than others but similar between the two arms. The effect of benefit statements was greatest among those who chose "Those are just the facts" as the explanation for their estimate (31.0% (standard deviation 22.4%) in "not guaranteed" arm vs 18.9% (standard deviation 21.0%) in comparison arm, p = 0.008). The use of "not guaranteed" language in benefit statements, when compared to "small but very small chance" language, appeared to increase the perception of likelihood of benefit of entering an early-phase trial, especially among those who view their estimates of benefits as "facts." Such "no guarantee" benefit statements may be misleading and should not be used in informed consent forms. © The Author(s) 2015.

Authors of clinical trials reported individual and financial conflicts of interest more frequently than institutional and nonfinancial ones: a methodological survey.

PubMed

Hakoum, Maram B; Jouni, Nahla; Abou-Jaoude, Eliane A; Hasbani, Divina Justina; Abou-Jaoude, Elias A; Lopes, Luciane Cruz; Khaldieh, Mariam; Hammoud, Mira Z; Al-Gibbawi, Mounir; Anouti, Sirine; Guyatt, Gordon; Akl, Elie A

2017-07-01

Conflicts of interest (COIs) are increasingly recognized as important to disclose and manage in health research. The objective of this study was to assess the reporting of both financial and nonfinancial COI by authors of randomized controlled trials published in a representative sample of clinical journals. We searched Ovid Medline and included a random sample of 200 randomized controlled trials published in 2015 in one of the 119 Core Clinical Journals. We classified COI using a comprehensive framework that includes the following: individual COIs (financial, professional, scholarly, advocatory, personal) and institutional COIs (financial, professional, scholarly, and advocatory). We conducted descriptive and regression analyses. Of the 200 randomized controlled trials, 188 (94%) reported authors' COI disclosures that were available in the main document (92%) and as International Committee of Medical Journal Editors forms accessible online (12%). Of the 188 trials, 57% had at least one author reporting at least one COI; in all these trials, at least one author reported financial COI. Institutional COIs (11%) and nonfinancial COIs (4%) were less commonly reported. References to COI disclosure statements for editors (1%) and medical writers (0%) were seldom present. Regression analyses showed positive associations between reporting individual financial COI and higher journal impact factor (odds ratio [OR] = 1.06, 95% confidence interval [CI] = 1.02-1.10), larger number of authors (OR = 1.10, 95% CI 1.02-1.20), affiliation with an institution from a high-income country (OR = 16.75, 95% CI 3.38-82.87), and trials reporting on pharmacological interventions (OR = 2.28, 95% CI 1.13-4.62). More than half of published randomized controlled trials report that at least one author has a COI. Trial authors report financial COIs more often than nonfinancial COIs and individual COIs more frequently than institutional COIs. Copyright © 2017 Elsevier Inc. All rights reserved.

Update on the endorsement of CONSORT by high impact factor journals: a survey of journal "Instructions to Authors" in 2014.

PubMed

Shamseer, Larissa; Hopewell, Sally; Altman, Douglas G; Moher, David; Schulz, Kenneth F

2016-06-24

The CONsolidated Standards Of Reporting Trials (CONSORT) Statement provides a minimum standard set of items to be reported in published clinical trials; it has received widespread recognition within the biomedical publishing community. This research aims to provide an update on the endorsement of CONSORT by high impact medical journals. We performed a cross-sectional examination of the online "Instructions to Authors" of 168 high impact factor (2012) biomedical journals between July and December 2014. We assessed whether the text of the "Instructions to Authors" mentioned the CONSORT Statement and any CONSORT extensions, and we quantified the extent and nature of the journals' endorsements of these. These data were described by frequencies. We also determined whether journals mentioned trial registration and the International Committee of Medical Journal Editors (ICMJE; other than in regards to trial registration) and whether either of these was associated with CONSORT endorsement (relative risk and 95 % confidence interval). We compared our findings to the two previous iterations of this survey (in 2003 and 2007). We also identified the publishers of the included journals. Sixty-three percent (106/168) of the included journals mentioned CONSORT in their "Instructions to Authors." Forty-four endorsers (42 %) explicitly stated that authors "must" use CONSORT to prepare their trial manuscript, 38 % required an accompanying completed CONSORT checklist as a condition of submission, and 39 % explicitly requested the inclusion of a flow diagram with the submission. CONSORT extensions were endorsed by very few journals. One hundred and thirty journals (77 %) mentioned ICMJE, and 106 (63 %) mentioned trial registration. The endorsement of CONSORT by high impact journals has increased over time; however, specific instructions on how CONSORT should be used by authors are inconsistent across journals and publishers. Publishers and journals should encourage authors to use CONSORT and set clear expectations for authors about compliance with CONSORT.

Reporting non-adherence in cluster randomised trials: A systematic review.

PubMed

Agbla, Schadrac C; DiazOrdaz, Karla

2018-06-01

Treatment non-adherence in randomised trials refers to situations where some participants do not receive their allocated treatment as intended. For cluster randomised trials, where the unit of randomisation is a group of participants, non-adherence may occur at the cluster or individual level. When non-adherence occurs, randomisation no longer guarantees that the relationship between treatment receipt and outcome is unconfounded, and the power to detect the treatment effects in intention-to-treat analysis may be reduced. Thus, recording adherence and estimating the causal treatment effect adequately are of interest for clinical trials. To assess the extent of reporting of non-adherence issues in published cluster trials and to establish which methods are currently being used for addressing non-adherence, if any, and whether clustering is accounted for in these. We systematically reviewed 132 cluster trials published in English in 2011 previously identified through a search in PubMed. One-hundred and twenty three cluster trials were included in this systematic review. Non-adherence was reported in 56 cluster trials. Among these, 19 reported a treatment efficacy estimate: per protocol in 15 and as treated in 4. No study discussed the assumptions made by these methods, their plausibility or the sensitivity of the results to deviations from these assumptions. The year of publication of the cluster trials included in this review (2011) could be considered a limitation of this study; however, no new guidelines regarding the reporting and the handling of non-adherence for cluster trials have been published since. In addition, a single reviewer undertook the data extraction. To mitigate this, a second reviewer conducted a validation of the extraction process on 15 randomly selected reports. Agreement was satisfactory (93%). Despite the recommendations of the Consolidated Standards of Reporting Trials statement extension to cluster randomised trials, treatment adherence is under-reported. Among the trials providing adherence information, there was substantial variation in how adherence was defined, handled and reported. Researchers should discuss the assumptions required for the results to be interpreted causally and whether these are scientifically plausible in their studies. Sensitivity analyses to study the robustness of the results to departures from these assumptions should be performed.

Hypofractionated whole breast radiation and partial breast radiation for early-stage breast cancers: an update on progress.

PubMed

McCormick, Beryl

2012-09-01

This article provides an update of recent progress using partial breast irradiation (PBI) for the treatment of early-stage breast cancer, rather than whole breast radiotherapy (WBRT), which is the standard of care. Several large, prospective, randomized trials are nearing target accrual or have been completed, including the NSABP/RTOG trial, the Milan-based intraoperative radiation trial, and the international TARGIT trial, and the status of each is discussed. The American Society for Radiation Oncology has also published a consensus statement to guide the use of PBI until some of the phase III trials are more mature. Finally, several articles have appeared recently, reporting unexpected adverse effects of PBI in small series, and this information is reviewed. Several recent prospective trials of WBRT are also discussed, with the theme of comparing the standard 25 fractions to a shortened, hypofractionated trial arm delivering equivalent doses of WBRT in approximately 15 treatments, another radiation strategy for a shortened course of treatment after breast-conserving surgery.

Transparency of outcome reporting and trial registration of randomized controlled trials in top psychosomatic and behavioral health journals: A systematic review.

PubMed

Milette, Katherine; Roseman, Michelle; Thombs, Brett D

2011-03-01

The most reliable evidence for evaluating healthcare interventions comes from well-designed and conducted randomized controlled trials (RCTs). The extent to which published RCTs reflect the efficacy of interventions, however, depends on the completeness and accuracy of published results. The Consolidated Standards of Reporting Trials statement, initially developed in 1996, provides guidelines intended to improve the transparency of published RCT reports. A policy of the International Committee of Medical Journal Editors, initiated in 2005, requires clinical trials published in member journals to be registered in publicly accessible registries prior to patient enrollment. The objective of this study was to assess the clarity of outcome reporting, proportion of registered trials, and adequacy of outcome registration in RCTs published in top behavioral health journals. Eligible studies were primary or secondary reports of RCTs published in Annals of Behavioral Medicine, Health Psychology, Journal of Psychosomatic Research, and Psychosomatic Medicine from January 2008 to September 2009. Data were extracted for each study on adequacy of outcome reporting and registration. Of 63 articles reviewed, only 25 (39.7%) had adequately declared primary or secondary outcomes, whereas 38 (60.3%) had multiple primary outcomes or did not define outcomes. Only 13 studies (20.6%) were registered. Only 1 study registered sufficiently precise outcome information to compare with published outcomes, and registered and published outcomes were discrepant in that study. Greater attention to outcome reporting and trial registration by researchers, peer reviewers, and journal editors will increase the likelihood that effective behavioral health interventions are readily identified and made available to patients. Copyright © 2011 Elsevier Inc. All rights reserved.

Storytelling in Legal Settings: A Case Study from a Crown Prosecutor's Opening Statement

ERIC Educational Resources Information Center

Lipovsky, Caroline

2017-01-01

A number of linguistic studies on courtroom discourse deal with witness examinations, however counsels' opening statements have been given relatively little attention. Drawing on the analysis of a Crown Prosecutor's opening statement in a murder trial held at the Supreme Court of New South Wales in Sydney, Australia, and using the Systemic…

Measuring affiliation in group therapy for substance use disorders in the Women's Recovery Group study: Does it matter whether the group is all-women or mixed-gender?

PubMed

Sugarman, Dawn E; Wigderson, Sara B; Iles, Brittany R; Kaufman, Julia S; Fitzmaurice, Garrett M; Hilario, E Yvette; Robbins, Michael S; Greenfield, Shelly F

2016-10-01

A Stage II, two-site randomized clinical trial compared the manualized, single-gender Women's Recovery Group (WRG) to mixed-gender group therapy (Group Drug Counseling; GDC) and demonstrated efficacy. Enhanced affiliation and support in the WRG is a hypothesized mechanism of efficacy. This study sought to extend results of the previous small Stage I trial that showed the rate of supportive affiliative statements occurred more frequently in WRG than GDC. Participants (N = 158; 100 women, 58 men) were 18 years or older, substance dependent, and had used substances within the past 60 days. Women were randomized to WRG (n = 52) or GDC (n = 48). Group therapy videos were coded by two independent raters; Rater 1 coded 20% of videos (n = 74); Rater 2 coded 25% of videos coded by Rater 1 (n = 19). The number of affiliative statements made in WRG was 66% higher than in GDC. Three of eight affiliative statement categories occurred more frequently in WRG than GDC: supportive, shared experience, and strategy statements. This larger Stage II trial provided a greater number of group therapy tapes available for analysis. Results extended our previous findings, demonstrating both greater frequency of all affiliative statements, as well as specific categories of statements, made in single-gender WRG than mixed-gender GDC. Greater frequency of affiliative statements among group members may be one mechanism of enhanced support and efficacy in women-only WRG compared with standard mixed-gender group therapy for substance use disorders. (Am J Addict 2016;25:573-580). © 2016 American Academy of Addiction Psychiatry.

Meta-analyses with industry involvement are massively published and report no caveats for antidepressants.

PubMed

Ebrahim, Shanil; Bance, Sheena; Athale, Abha; Malachowski, Cindy; Ioannidis, John P A

2016-02-01

To identify the impact of industry involvement in the publication and interpretation of meta-analyses of antidepressant trials in depression. Using MEDLINE, we identified all meta-analyses evaluating antidepressants for depression published in January 2007-March 2014. We extracted data pertaining to author affiliations, conflicts of interest, and whether the conclusion of the abstract included negative statements on whether the antidepressant(s) were effective or safe. We identified 185 eligible meta-analyses. Fifty-four meta-analyses (29%) had authors who were employees of the assessed drug manufacturer, and 147 (79%) had some industry link (sponsorship or authors who were industry employees and/or had conflicts of interest). Only 58 meta-analyses (31%) had negative statements in the concluding statement of the abstract. Meta-analyses including an author who were employees of the manufacturer of the assessed drug were 22-fold less likely to have negative statements about the drug than other meta-analyses [1/54 (2%) vs. 57/131 (44%); P < 0.001]. There is a massive production of meta-analyses of antidepressants for depression authored by or linked to the industry, and they almost never report any caveats about antidepressants in their abstracts. Our findings add a note of caution for meta-analyses with ties to the manufacturers of the assessed products. Copyright © 2016 Elsevier Inc. All rights reserved.

An Official American Thoracic Society Statement: Update on the Mechanisms, Assessment, and Management of Dyspnea

PubMed Central

Parshall, Mark B.; Schwartzstein, Richard M.; Adams, Lewis; Banzett, Robert B.; Manning, Harold L.; Bourbeau, Jean; Calverley, Peter M.; Gift, Audrey G.; Harver, Andrew; Lareau, Suzanne C.; Mahler, Donald A.; Meek, Paula M.; O'Donnell, Denis E.

2012-01-01

Background: Dyspnea is a common, distressing symptom of cardiopulmonary and neuromuscular diseases. Since the ATS published a consensus statement on dyspnea in 1999, there has been enormous growth in knowledge about the neurophysiology of dyspnea and increasing interest in dyspnea as a patient-reported outcome. Purpose: The purpose of this document is to update the 1999 ATS Consensus Statement on dyspnea. Methods: An interdisciplinary committee of experts representing ATS assemblies on Nursing, Clinical Problems, Sleep and Respiratory Neurobiology, Pulmonary Rehabilitation, and Behavioral Science determined the overall scope of this update through group consensus. Focused literature reviews in key topic areas were conducted by committee members with relevant expertise. The final content of this statement was agreed upon by all members. Results: Progress has been made in clarifying mechanisms underlying several qualitatively and mechanistically distinct breathing sensations. Brain imaging studies have consistently shown dyspnea stimuli to be correlated with activation of cortico-limbic areas involved with interoception and nociception. Endogenous and exogenous opioids may modulate perception of dyspnea. Instruments for measuring dyspnea are often poorly characterized; a framework is proposed for more consistent identification of measurement domains. Conclusions: Progress in treatment of dyspnea has not matched progress in elucidating underlying mechanisms. There is a critical need for interdisciplinary translational research to connect dyspnea mechanisms with clinical treatment and to validate dyspnea measures as patient-reported outcomes for clinical trials. PMID:22336677

The Effect of Sodium Hypochlorite and Chlorhexidine as Irrigant Solutions for Root Canal Disinfection: A Systematic Review of Clinical Trials.

PubMed

Gonçalves, Lucio Souza; Rodrigues, Renata Costa Val; Andrade Junior, Carlos Vieira; Soares, Renata G; Vettore, Mario Vianna

2016-04-01

This systematic review aimed to compare the effectiveness of sodium hypochlorite and chlorhexidine for root canal disinfection during root canal therapy. A literature search for clinical trials was made on the PubMed (MEDLINE), Web of Knowledge, SCOPUS, and Science Direct databases and in the reference lists of the identified articles up to January 2015. Quality assessment of the selected studies was performed according to the Consolidated Standards of Reporting Trials statement. One clinical trial and 4 randomized clinical trials were selected from the 172 articles initially identified. There was heterogeneity in the laboratory methods used to assess the root canal disinfection as well as in the concentrations of the irrigants used. Therefore, meta-analysis was not performed. Two studies reported effective and similar reductions in bacterial levels for both irrigants. Sodium hypochlorite was more effective than chlorhexidine in reducing microorganisms in 1 study, and another reported opposite findings. Both root irrigants were ineffective in eliminating endotoxins from necrotic pulp root canals in 1 study. Trial design and information regarding randomization procedures were not clearly described in the clinical trials. No study compared laboratory results with clinical outcomes. The available evidence on this topic is scarce, and the findings of studies were not consistent. Additional randomized clinical trials using clinical outcomes to compare the use of sodium hypochlorite and chlorhexidine during root canal therapy are needed. Copyright © 2016 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

An assessment of quality characteristics of randomised control trials published in dental journals.

PubMed

Pandis, Nikolaos; Polychronopoulou, Argy; Eliades, Theodore

2010-09-01

The purpose of this study was to investigate the quality of reporting of randomised clinical trials (RCTs) published in dental specialty journals. The journals possessing the highest impact factor (2008 data) in the six major dental specialties were included in the study. The contents of the 24 most recent issues of each journal were hand-searched and research articles identified as randomised controlled trials (RCTs) were selected. Quality evaluation was performed using the modified Consolidated Standards of Reporting Trials (CONSORT) statement checklist. The data were analysed using descriptive statistics followed by univariate and multivariate examination of statistical associations (alpha=0.05). Ninety-five RCTs were identified with generally suboptimal scores on quality reporting on key CONSORT areas. Significant differences were found among journals with the Journal of Clinical Periodontology achieving the highest score, followed by the American Journal of Orthodontics and Dentofacial Orthopedics. There was a positive association between quality score and number of authors, involvement of statistician/epidemiologist, and multicentre trials. The quality scores of RCTs in major dental journals are considered suboptimal in key CONSORT areas. This receives critical importance considering that improved quality of RCTs is a fundamental prerequisite for improved dental care. Copyright 2010 Elsevier Ltd. All rights reserved.

Aloe vera herbal dentifrices for plaque and gingivitis control: a systematic review.

PubMed

Dhingra, K

2014-04-01

To evaluate the effectiveness of aloe vera containing herbal dentifrices in improving plaque control and gingival health. A manual and electronic literature (MEDLINE and Cochrane Central Register of Controlled Trials) search was performed up to July 2012, for randomized controlled trials presenting clinical, microbiological, immunological, and patient-centered data for the efficacy of aloe vera herbal dentifrices for controlling plaque and gingival inflammation in patients with gingivitis. From 79 titles and abstracts, eight full-text articles were screened and finally two randomized controlled trials were selected. These randomized controlled trials reported that aloe vera dentifrices were similar in efficacy to control dentifrices in effectively reducing plaque and gingival inflammation in gingivitis patients based on the assessment of clinical, microbiological, and patient-centered treatment outcomes. However, many important details (composition and characteristics of aloe vera and control dentifrices along with appropriate randomization, blinding, and outcomes assessed) were lacking in these trials, and therefore, the quality of reporting and methods was generally flawed with high risk of bias. Even though there are some promising results, the clinical effectiveness of aloe vera herbal dentifrices is not sufficiently defined at present and warrants further investigations based on reporting guidelines of herbal CONSORT statement. © 2013 John Wiley & Sons A/S.

CONSORT for Reporting Randomized Controlled Trials in Journal and Conference Abstracts: Explanation and Elaboration

PubMed Central

Hopewell, Sally; Clarke, Mike; Moher, David; Wager, Elizabeth; Middleton, Philippa; Altman, Douglas G; Schulz, Kenneth F

2008-01-01

Background Clear, transparent, and sufficiently detailed abstracts of conferences and journal articles related to randomized controlled trials (RCTs) are important, because readers often base their assessment of a trial solely on information in the abstract. Here, we extend the CONSORT (Consolidated Standards of Reporting Trials) Statement to develop a minimum list of essential items, which authors should consider when reporting the results of a RCT in any journal or conference abstract. Methods and Findings We generated a list of items from existing quality assessment tools and empirical evidence. A three-round, modified-Delphi process was used to select items. In all, 109 participants were invited to participate in an electronic survey; the response rate was 61%. Survey results were presented at a meeting of the CONSORT Group in Montebello, Canada, January 2007, involving 26 participants, including clinical trialists, statisticians, epidemiologists, and biomedical editors. Checklist items were discussed for eligibility into the final checklist. The checklist was then revised to ensure that it reflected discussions held during and subsequent to the meeting. CONSORT for Abstracts recommends that abstracts relating to RCTs have a structured format. Items should include details of trial objectives; trial design (e.g., method of allocation, blinding/masking); trial participants (i.e., description, numbers randomized, and number analyzed); interventions intended for each randomized group and their impact on primary efficacy outcomes and harms; trial conclusions; trial registration name and number; and source of funding. We recommend the checklist be used in conjunction with this explanatory document, which includes examples of good reporting, rationale, and evidence, when available, for the inclusion of each item. Conclusions CONSORT for Abstracts aims to improve reporting of abstracts of RCTs published in journal articles and conference proceedings. It will help authors of abstracts of these trials provide the detail and clarity needed by readers wishing to assess a trial's validity and the applicability of its results. PMID:18215107

[CONSORT for reporting randomized controlled trials in journal and conference abstracts: explanation and elaboration].

PubMed

Hopewel, Sally; Clarke, Mike; Moher, David; Wager, Elizabeth; Middleton, Philippa; Altman, Douglas G; Schulz, Kenneth F; The, Consort Group

2008-03-01

Clear, transparent, and sufficiently detailed abstracts of conferences and journal articles related to randomized controlled trials (RCTs) are important, because readers often base their assessment of a trial solely on information in the abstract. Here, we extend the CONSORT (Consolidated Standards of Reporting Trials) Statement to develop a minimum list of essential items, which authors should consider when reporting the results of a RCT in any journal or conference abstract. We generated a list of items from existing quality assessment tools and empirical evidence. A three-round, modified-Delphi process was used to select items. In all, 109 participants were invited to participate in an electronic survey; the response rate was 61%. Survey results were presented at a meeting of the CONSORT Group in Montebello, Canada, January 2007, involving 26 participants, including clinical trialists, statisticians, epidemiologists, and biomedical editors. Checklist items were discussed for eligibility into the final checklist. The checklist was then revised to ensure that it reflected discussions held during and subsequent to the meeting. CONSORT for Abstracts recommends that abstracts relating to RCTs have a structured format. Items should include details of trial objectives; trial design (e.g., method of allocation, blinding/masking); trial participants (i.e., description, numbers randomized, and number analyzed); interventions intended for each randomized group and their impact on primary efficacy outcomes and harms; trial conclusions; trial registration name and number; and source of funding. We recommend the checklist be used in conjunction with this explanatory document, which includes examples of good reporting, rationale, and evidence, when available, for the inclusion of each item. CONSORT for Abstracts aims to improve reporting of abstracts of RCTs published in journal articles and conference proceedings. It will help authors of abstracts of these trials provide the detail and clarity needed by readers wishing to assess a trial's validity and the applicability of its results.

Quality of full and final publications reporting acute stroke trials: a systematic review.

PubMed

Bath, F J; Owen, V E; Bath, P M

1998-10-01

Several studies have shown that the quality of reporting of trials throughout medicine is variable and often poor. We report on the quality of the final reports of randomized controlled trials (RCTs) of drug therapies assessed in acute stroke. English-language reports published up to the end of 1996 relating to completed RCTs in acute stroke were identified from electronic searches of the Cochrane Stroke Review Group database of stroke trials and the Cochrane Controlled Trials Register (CD-ROM issue 1, 1997, of the Cochrane Library). Report quality was assessed with the 33 criteria of the CONSORT statement and 53 additional factors relevant to acute stroke or trials in general. Trial quality was also assessed with a 7-point scale. Up to 1996, 114 RCTs were published which involved 20 536 patients (median, 80; range, 16 to 1267 per trial); 39 (35.5%) of these were published in Stroke. The median total report quality was 40/86 (range, 15 to 61) for all criteria and 19/33 (range, 9 to 29) for the CONSORT criteria alone. Although adequate information was given in the introduction and discussion sections of most reports, insufficient details were given on methods, assignment of patients to treatment groups, statistical analyses, the prevalence of risk factors, and assessment of outcomes. Report quality has improved between 1956 and 1996 (Spearman correlation coefficient [rs], 0.575; 95% confidence interval [CI], 0. 439 to 0.685) and was superior in large trials (rs=0.434; 95% CI, 0. 274 to 0.571). Although report quality was related to trial quality (rs=0.675; 95% CI, 0.563 to 0.763), it was not related to journal impact factor (rs=0.170; 95% CI, -0.015 to 0.344). Trials with a positive outcome tended to be less well reported than those with a neutral or negative outcome (rs=-0.192; 95% CI, -0.351 to -0.011). The overall quality of study reports for parallel group RCTs in acute stroke is poor but appears to be improving with time and in parallel with an increase in trial size. Reports often lack detailed information on the methods of randomization, concealment of allocation, and statistical analysis, all factors which can, if undertaken poorly, affect trial results and validity. It is vital that future trials are adequately reported; we believe that authors should follow the CONSORT guidelines and that referees and editors should ensure this happens.

Bayesian survival analysis in clinical trials: What methods are used in practice?

PubMed

Brard, Caroline; Le Teuff, Gwénaël; Le Deley, Marie-Cécile; Hampson, Lisa V

2017-02-01

Background Bayesian statistics are an appealing alternative to the traditional frequentist approach to designing, analysing, and reporting of clinical trials, especially in rare diseases. Time-to-event endpoints are widely used in many medical fields. There are additional complexities to designing Bayesian survival trials which arise from the need to specify a model for the survival distribution. The objective of this article was to critically review the use and reporting of Bayesian methods in survival trials. Methods A systematic review of clinical trials using Bayesian survival analyses was performed through PubMed and Web of Science databases. This was complemented by a full text search of the online repositories of pre-selected journals. Cost-effectiveness, dose-finding studies, meta-analyses, and methodological papers using clinical trials were excluded. Results In total, 28 articles met the inclusion criteria, 25 were original reports of clinical trials and 3 were re-analyses of a clinical trial. Most trials were in oncology (n = 25), were randomised controlled (n = 21) phase III trials (n = 13), and half considered a rare disease (n = 13). Bayesian approaches were used for monitoring in 14 trials and for the final analysis only in 14 trials. In the latter case, Bayesian survival analyses were used for the primary analysis in four cases, for the secondary analysis in seven cases, and for the trial re-analysis in three cases. Overall, 12 articles reported fitting Bayesian regression models (semi-parametric, n = 3; parametric, n = 9). Prior distributions were often incompletely reported: 20 articles did not define the prior distribution used for the parameter of interest. Over half of the trials used only non-informative priors for monitoring and the final analysis (n = 12) when it was specified. Indeed, no articles fitting Bayesian regression models placed informative priors on the parameter of interest. The prior for the treatment effect was based on historical data in only four trials. Decision rules were pre-defined in eight cases when trials used Bayesian monitoring, and in only one case when trials adopted a Bayesian approach to the final analysis. Conclusion Few trials implemented a Bayesian survival analysis and few incorporated external data into priors. There is scope to improve the quality of reporting of Bayesian methods in survival trials. Extension of the Consolidated Standards of Reporting Trials statement for reporting Bayesian clinical trials is recommended.

Thinking clearly about the FIRST trial: addressing ethical challenges in cluster randomised trials of policy interventions involving health providers.

PubMed

Horn, Austin R; Weijer, Charles; Hey, Spencer Phillips; Brehaut, Jamie; Fergusson, Dean A; Goldstein, Cory E; Grimshaw, Jeremy; Taljaard, Monica

2018-04-27

The ethics of the Flexibility In duty hour Requirements for Surgical Trainees (FIRST) trial have been vehemently debated. Views on the ethics of the FIRST trial range from it being completely unethical to wholly unproblematic. The FIRST trial illustrates the complex ethical challenges posed by cluster randomised trials (CRTs) of policy interventions involving healthcare professionals. In what follows, we have three objectives. First, we critically review the FIRST trial controversy, finding that commentators have failed to sufficiently identify and address many of the relevant ethical issues. The 2012 Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials provides researchers and research ethics committees with specific guidance for the ethical design and conduct of CRTs. Second, we aim to demonstrate how the Ottawa Statement provides much-needed clarity to the ethical issues in the FIRST trial, including: research participant identification; consent requirements; gatekeeper roles; benefit-harm analysis and identification of vulnerable participants. We nonetheless also find that the FIRST trial raises ethical issues not adequately addressed by the Ottawa Statement. Hence, third and finally, we raise important questions requiring further ethical analysis and guidance, including: Does clinical equipoise apply to policy interventions with little or no evidence-base? Do healthcare providers have an obligation to participate in research? Does the power-differential in certain healthcare settings render healthcare providers vulnerable to duress and coercion to participant in research? If so, what safeguards might be implemented to protect providers, while allowing important research to proceed? © 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.

A review of reporting of participant recruitment and retention in RCTs in six major journals

PubMed Central

Toerien, Merran; Brookes, Sara T; Metcalfe, Chris; de Salis, Isabel; Tomlin, Zelda; Peters, Tim J; Sterne, Jonathan; Donovan, Jenny L

2009-01-01

Background Poor recruitment and retention of participants in randomised controlled trials (RCTs) is problematic but common. Clear and detailed reporting of participant flow is essential to assess the generalisability and comparability of RCTs. Despite improved reporting since the implementation of the CONSORT statement, important problems remain. This paper aims: (i) to update and extend previous reviews evaluating reporting of participant recruitment and retention in RCTs; (ii) to quantify the level of participation throughout RCTs. Methods We reviewed all reports of RCTs of health care interventions and/or processes with individual randomisation, published July–December 2004 in six major journals. Short, secondary or interim reports, and Phase I/II trials were excluded. Data recorded were: general RCT details; inclusion of flow diagram; participant flow throughout trial; reasons for non-participation/withdrawal; target sample sizes. Results 133 reports were reviewed. Overall, 79% included a flow diagram, but over a third were incomplete. The majority reported the flow of participants at each stage of the trial after randomisation. However, 40% failed to report the numbers assessed for eligibility. Percentages of participants retained at each stage were high: for example, 90% of eligible individuals were randomised, and 93% of those randomised were outcome assessed. On average, trials met their sample size targets. However, there were some substantial shortfalls: for example 21% of trials reporting a sample size calculation failed to achieve adequate numbers at randomisation, and 48% at outcome assessment. Reporting of losses to follow up was variable and difficult to interpret. Conclusion The majority of RCTs reported the flow of participants well after randomisation, although only two-thirds included a complete flow chart and there was great variability over the definition of "lost to follow up". Reporting of participant eligibility was poor, making assessments of recruitment practice and external validity difficult. Reporting of participant flow throughout RCTs could be improved by small changes to the CONSORT chart. PMID:19591685

A review of reporting of participant recruitment and retention in RCTs in six major journals.

PubMed

Toerien, Merran; Brookes, Sara T; Metcalfe, Chris; de Salis, Isabel; Tomlin, Zelda; Peters, Tim J; Sterne, Jonathan; Donovan, Jenny L

2009-07-10

Poor recruitment and retention of participants in randomised controlled trials (RCTs) is problematic but common. Clear and detailed reporting of participant flow is essential to assess the generalisability and comparability of RCTs. Despite improved reporting since the implementation of the CONSORT statement, important problems remain. This paper aims: (i) to update and extend previous reviews evaluating reporting of participant recruitment and retention in RCTs; (ii) to quantify the level of participation throughout RCTs. We reviewed all reports of RCTs of health care interventions and/or processes with individual randomisation, published July-December 2004 in six major journals. Short, secondary or interim reports, and Phase I/II trials were excluded. Data recorded were: general RCT details; inclusion of flow diagram; participant flow throughout trial; reasons for non-participation/withdrawal; target sample sizes. 133 reports were reviewed. Overall, 79% included a flow diagram, but over a third were incomplete. The majority reported the flow of participants at each stage of the trial after randomisation. However, 40% failed to report the numbers assessed for eligibility. Percentages of participants retained at each stage were high: for example, 90% of eligible individuals were randomised, and 93% of those randomised were outcome assessed. On average, trials met their sample size targets. However, there were some substantial shortfalls: for example 21% of trials reporting a sample size calculation failed to achieve adequate numbers at randomisation, and 48% at outcome assessment. Reporting of losses to follow up was variable and difficult to interpret. The majority of RCTs reported the flow of participants well after randomisation, although only two-thirds included a complete flow chart and there was great variability over the definition of "lost to follow up". Reporting of participant eligibility was poor, making assessments of recruitment practice and external validity difficult. Reporting of participant flow throughout RCTs could be improved by small changes to the CONSORT chart.

Poor reporting of scientific leadership information in clinical trial registers.

PubMed

Sekeres, Melanie; Gold, Jennifer L; Chan, An-Wen; Lexchin, Joel; Moher, David; Van Laethem, Marleen L P; Maskalyk, James; Ferris, Lorraine; Taback, Nathan; Rochon, Paula A

2008-02-20

In September 2004, the International Committee of Medical Journal Editors (ICMJE) issued a Statement requiring that all clinical trials be registered at inception in a public register in order to be considered for publication. The World Health Organization (WHO) and ICMJE have identified 20 items that should be provided before a trial is considered registered, including contact information. Identifying those scientifically responsible for trial conduct increases accountability. The objective is to examine the proportion of registered clinical trials providing valid scientific leadership information. We reviewed clinical trial entries listing Canadian investigators in the two largest international and public trial registers, the International Standard Randomized Controlled Trial Number (ISRCTN) register, and ClinicalTrials.gov. The main outcome measures were the proportion of clinical trials reporting valid contact information for the trials' Principal Investigator (PI)/Co-ordinating Investigator/Study Chair/Site PI, and trial e-mail contact address, stratified by funding source, recruiting status, and register. A total of 1388 entries (142 from ISRCTN and 1246 from ClinicalTrials.gov) comprised our sample. We found non-compliance with mandatory registration requirements regarding scientific leadership and trial contact information. Non-industry and partial industry funded trials were significantly more likely to identify the individual responsible for scientific leadership (OR = 259, 95% CI: 95-701) and to provide a contact e-mail address (OR = 9.6, 95% CI: 6.6-14) than were solely industry funded trials. Despite the requirements set by WHO and ICMJE, data on scientific leadership and contact e-mail addresses are frequently omitted from clinical trials registered in the two leading public clinical trial registers. To promote accountability and transparency in clinical trials research, public clinical trials registers should ensure adequate monitoring of trial registration to ensure completion of mandatory contact information fields identifying scientific leadership.

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

PubMed

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.

Subgroup analyses in randomised controlled trials: cohort study on trial protocols and journal publications.

PubMed

Kasenda, Benjamin; Schandelmaier, Stefan; Sun, Xin; von Elm, Erik; You, John; Blümle, Anette; Tomonaga, Yuki; Saccilotto, Ramon; Amstutz, Alain; Bengough, Theresa; Meerpohl, Joerg J; Stegert, Mihaela; Olu, Kelechi K; Tikkinen, Kari A O; Neumann, Ignacio; Carrasco-Labra, Alonso; Faulhaber, Markus; Mulla, Sohail M; Mertz, Dominik; Akl, Elie A; Bassler, Dirk; Busse, Jason W; Ferreira-González, Ignacio; Lamontagne, Francois; Nordmann, Alain; Gloy, Viktoria; Raatz, Heike; Moja, Lorenzo; Rosenthal, Rachel; Ebrahim, Shanil; Vandvik, Per O; Johnston, Bradley C; Walter, Martin A; Burnand, Bernard; Schwenkglenks, Matthias; Hemkens, Lars G; Bucher, Heiner C; Guyatt, Gordon H; Briel, Matthias

2014-07-16

To investigate the planning of subgroup analyses in protocols of randomised controlled trials and the agreement with corresponding full journal publications. Cohort of protocols of randomised controlled trial and subsequent full journal publications. Six research ethics committees in Switzerland, Germany, and Canada. 894 protocols of randomised controlled trial involving patients approved by participating research ethics committees between 2000 and 2003 and 515 subsequent full journal publications. Of 894 protocols of randomised controlled trials, 252 (28.2%) included one or more planned subgroup analyses. Of those, 17 (6.7%) provided a clear hypothesis for at least one subgroup analysis, 10 (4.0%) anticipated the direction of a subgroup effect, and 87 (34.5%) planned a statistical test for interaction. Industry sponsored trials more often planned subgroup analyses compared with investigator sponsored trials (195/551 (35.4%) v 57/343 (16.6%), P<0.001). Of 515 identified journal publications, 246 (47.8%) reported at least one subgroup analysis. In 81 (32.9%) of the 246 publications reporting subgroup analyses, authors stated that subgroup analyses were prespecified, but this was not supported by 28 (34.6%) corresponding protocols. In 86 publications, authors claimed a subgroup effect, but only 36 (41.9%) corresponding protocols reported a planned subgroup analysis. Subgroup analyses are insufficiently described in the protocols of randomised controlled trials submitted to research ethics committees, and investigators rarely specify the anticipated direction of subgroup effects. More than one third of statements in publications of randomised controlled trials about subgroup prespecification had no documentation in the corresponding protocols. Definitive judgments regarding credibility of claimed subgroup effects are not possible without access to protocols and analysis plans of randomised controlled trials. © The DISCO study group 2014.

Improving the reporting of clinical trials of infertility treatments (IMPRINT): modifying the CONSORT statement†‡.

PubMed

Legro, Richard S; Wu, Xiaoke; Barnhart, Kurt T; Farquhar, Cynthia; Fauser, Bart C J M; Mol, Ben

2014-10-10

Clinical trials testing infertility treatments often do not report on the major outcomes of interest to patients and clinicians and the public (such as live birth) nor on the harms, including maternal risks during pregnancy and fetal anomalies. This is complicated by the multiple participants in infertility trials which may include a woman (mother), a man (father), and result in a third individual if successful, their offspring (child), who is also the desired outcome of treatment. The primary outcome of interest and many adverse events occur after cessation of infertility treatment and during pregnancy and the puerperium, which create a unique burden of follow-up for clinical trial investigators and participants. In 2013, because of the inconsistencies in trial reporting and the unique aspects of infertility trials not adequately addressed by existing Consolidated Standards of Reporting Trials (CONSORT) statements, we convened a consensus conference in Harbin, China, with the aim of planning modifications to the CONSORT checklist to improve the quality of reporting of clinical trials testing infertility treatment. The consensus group recommended that the preferred primary outcome of all infertility trials is live birth (defined as any delivery of a live infant ≥20 weeks gestations) or cumulative live birth, defined as the live birth per women over a defined time period (or number of treatment cycles). In addition, harms to all participants should be systematically collected and reported, including during the intervention, any resulting pregnancy, and during the neonatal period. Routine information should be collected and reported on both male and female participants in the trial. We propose to track the change in quality that these guidelines may produce in published trials testing infertility treatments. Our ultimate goal is to increase the transparency of benefits and risks of infertility treatments to provide better medical care to affected individuals and couples. © The Author 2014. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Systematic review finds major deficiencies in sample size methodology and reporting for stepped-wedge cluster randomised trials

PubMed Central

Martin, James; Taljaard, Monica; Girling, Alan; Hemming, Karla

2016-01-01

Background Stepped-wedge cluster randomised trials (SW-CRT) are increasingly being used in health policy and services research, but unless they are conducted and reported to the highest methodological standards, they are unlikely to be useful to decision-makers. Sample size calculations for these designs require allowance for clustering, time effects and repeated measures. Methods We carried out a methodological review of SW-CRTs up to October 2014. We assessed adherence to reporting each of the 9 sample size calculation items recommended in the 2012 extension of the CONSORT statement to cluster trials. Results We identified 32 completed trials and 28 independent protocols published between 1987 and 2014. Of these, 45 (75%) reported a sample size calculation, with a median of 5.0 (IQR 2.5–6.0) of the 9 CONSORT items reported. Of those that reported a sample size calculation, the majority, 33 (73%), allowed for clustering, but just 15 (33%) allowed for time effects. There was a small increase in the proportions reporting a sample size calculation (from 64% before to 84% after publication of the CONSORT extension, p=0.07). The type of design (cohort or cross-sectional) was not reported clearly in the majority of studies, but cohort designs seemed to be most prevalent. Sample size calculations in cohort designs were particularly poor with only 3 out of 24 (13%) of these studies allowing for repeated measures. Discussion The quality of reporting of sample size items in stepped-wedge trials is suboptimal. There is an urgent need for dissemination of the appropriate guidelines for reporting and methodological development to match the proliferation of the use of this design in practice. Time effects and repeated measures should be considered in all SW-CRT power calculations, and there should be clarity in reporting trials as cohort or cross-sectional designs. PMID:26846897

Inadequacy of ethical conduct and reporting of stepped wedge cluster randomized trials: Results from a systematic review.

PubMed

Taljaard, Monica; Hemming, Karla; Shah, Lena; Giraudeau, Bruno; Grimshaw, Jeremy M; Weijer, Charles

2017-08-01

Background/aims The use of the stepped wedge cluster randomized design is rapidly increasing. This design is commonly used to evaluate health policy and service delivery interventions. Stepped wedge cluster randomized trials have unique characteristics that complicate their ethical interpretation. The 2012 Ottawa Statement provides comprehensive guidance on the ethical design and conduct of cluster randomized trials, and the 2010 CONSORT extension for cluster randomized trials provides guidelines for reporting. Our aims were to assess the adequacy of the ethical conduct and reporting of stepped wedge trials to date, focusing on research ethics review and informed consent. Methods We conducted a systematic review of stepped wedge cluster randomized trials in health research published up to 2014 in English language journals. We extracted details of study intervention and data collection procedures, as well as reporting of research ethics review and informed consent. Two reviewers independently extracted data from each trial; discrepancies were resolved through discussion. We identified the presence of any research participants at the cluster level and the individual level. We assessed ethical conduct by tabulating reporting of research ethics review and informed consent against the presence of research participants. Results Of 32 identified stepped wedge trials, only 24 (75%) reported review by a research ethics committee, and only 16 (50%) reported informed consent from any research participants-yet, all trials included research participants at some level. In the subgroup of 20 trials with research participants at cluster level, only 4 (20%) reported informed consent from such participants; in 26 trials with individual-level research participants, only 15 (58%) reported their informed consent. Interventions (regardless of whether targeting cluster- or individual-level participants) were delivered at the group level in more than two-thirds of trials; nine trials (28%) had no identifiable data collected from any research participants. Overall, only three trials (9%) indicated that a waiver of consent had been granted by a research ethics committee. When considering the combined requirement of research ethics review and informed consent (or a waiver), only one in three studies were compliant. Conclusion The ethical conduct and reporting of key ethical protections in stepped wedge trials, namely, research ethics review and informed consent, are inadequate. We recommend that stepped wedge trials be classified as research and reviewed and approved by a research ethics committee. We also recommend that researchers appropriately identify research participants (which may include health professionals), seek informed consent or appeal to an ethics committee for a waiver of consent, and include explicit details of research ethics approval and informed consent in the trial report.

Effectiveness of Azadirachta indica (neem) mouthrinse in plaque and gingivitis control: a systematic review.

PubMed

Dhingra, K; Vandana, K L

2017-02-01

The aim of this systematic review was to evaluate the effectiveness of Azadirachta indica (neem)-based herbal mouthrinse in improving plaque control and gingival health. Literature search was accomplished using electronic databases (PubMed, Cochrane Central Register of Controlled Trials and EMBASE) and manual searching, up to February 2015, for randomized controlled trials (RCTs) presenting clinical data for efficacy of neem mouthrinses when used alone or as an adjunct to mechanical oral hygiene as compared to chlorhexidine mouthrinses for controlling plaque and gingival inflammation in patients with gingivitis. Of the total 206 articles searched, three randomized controlled trials evaluating neem-based herbal mouthrinses were included. Due to marked heterogeneity observed in study characteristics, meta-analysis was not performed. These studies reported that neem mouthrinse was as effective as chlorhexidine mouthrinse when used as an adjunct to toothbrushing in reducing plaque and gingival inflammation in gingivitis patients. However, the quality of reporting and evidence along with methods of studies was generally flawed with unclear risk of bias. Despite the promising results shown in existing randomized controlled trials, the evidence concerning the clinical use of neem mouthrinses is lacking and needs further reinforcement with high-quality randomized controlled trials based on the reporting guidelines of herbal CONSORT statement. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Consensus on Exercise Reporting Template (CERT): Explanation and Elaboration Statement.

PubMed

Slade, Susan C; Dionne, Clermont E; Underwood, Martin; Buchbinder, Rachelle

2016-10-05

Exercise is effective for prevention and management of acute and chronic health conditions. However, trial descriptions of exercise interventions are often suboptimal, leaving readers unclear about the content of effective programmes. To address this, the 16-item internationally endorsed Consensus on Exercise Reporting Template (CERT) was developed. The aim is to present the final template and provide an Explanation and Elaboration Statement to operationalise the CERT. Development of the CERT was based on the EQUATOR Network methodological framework for developing reporting guidelines. We used a modified Delphi technique to gain consensus of international exercise experts and conducted 3 sequential rounds of anonymous online questionnaires and a Delphi workshop. The 16-item CERT is the minimum data set considered necessary to report exercise interventions. The contents may be included in online supplementary material, published as a protocol or located on websites and other electronic repositories. The Explanation and Elaboration Statement is intended to enhance the use, understanding and dissemination of the CERT and presents the meaning and rationale for each item, together with examples of good reporting. The CERT is designed specifically for the reporting of exercise programmes across all evaluative study designs for exercise research. The CERT can be used by authors to structure intervention reports, by reviewers and editors to assess completeness of exercise descriptions and by readers to facilitate the use of the published information. The CERT has the potential to increase clinical uptake of effective exercise programmes, enable research replication, reduce research waste and improve patient outcomes. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

A quality assessment of randomized controlled trial reports in endodontics.

PubMed

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

2017-03-01

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

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

PubMed

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.

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

PubMed

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.

Comparison of content of FDA letters not approving applications for new drugs and associated public announcements from sponsors: cross sectional study

PubMed Central

Chahal, Harinder S; Sigelman, Daniel W; Stacy, Sylvie; Sclar, Joshua; Ddamulira, Barbara

2015-01-01

Objectives To describe the content of non-public complete response letters issued by the US Food and Drug Administration (FDA) when they do not approve marketing applications from sponsors (drug companies) and to compare them with the content any subsequent press releases issued by those sponsors Design Cross sectional study. Data sources All applications for which FDA’s Center for Drug Evaluation and Research initially issued complete response letters (n=61) from 11 August 2008 to 27 June 2013. Complete response letters and press releases were divided into discrete statements related to seven domains and 64 subdomains and assessed to determine whether they matched. Results 48% (29) of complete response letters cited deficiencies in both the safety and efficacy domains, and only 13% cited neither safety nor efficacy deficiencies. No press release was issued for 18% (11) of complete response letters, and 21% (13) of press releases did not match any statements from the letters. Press release statements matched 93 of the 687 statements (14%), including 16% (30/191) of efficacy and 15% (22/150) of safety statements. Of 32 complete response letters that called for a new clinical trial for safety or efficacy, 59% (19) had matching press release statements. Seven complete response letters reported higher mortality rates in treated participants; only one associated press release mentioned this fact. Conclusions FDA generally issued complete response letters to sponsors for multiple substantive reasons, most commonly related to safety and/or efficacy deficiencies. In many cases, press releases were not issued in response to those letters and, when they were, omitted most of the statements in the complete response letters. Press releases are incomplete substitutes for the detailed information contained in complete response letters. PMID:26063327

A quantitative and qualitative evaluation of reports of clinical trials published in six Brazilian dental journals indexed in the Scientific Electronic Library Online (SciELO)

PubMed Central

de SOUZA, Raphael Freitas; CHAVES, Carolina de Andrade Lima; CHAVES, Carolina de Andrade Lima; CHAVES, Carolina de Andrade Lima; NASSER, Mona; FEDOROWICZ, Zbys

2010-01-01

Open access publishing is becoming increasingly popular within the biomedical sciences. SciELO, the Scientific Electronic Library Online, is a digital library covering a selected collection of Brazilian scientific journals many of which provide open access to full-text articles. This library includes a number of dental journals some of which may include reports of clinical trials in English, Portuguese and/or Spanish. Thus, SciELO could play an important role as a source of evidence for dental healthcare interventions especially if it yields a sizeable number of high quality reports. Objective The aim of this study was to identify reports of clinical trials by handsearching of dental journals that are accessible through SciELO, and to assess the overall quality of these reports. Material and methods Electronic versions of six Brazilian dental Journals indexed in SciELO were handsearched at www.scielo.br in September 2008. Reports of clinical trials were identified and classified as controlled clinical trials (CCTs - prospective, experimental studies comparing 2 or more healthcare interventions in human beings) or randomized controlled trials (RCTs - a random allocation method is clearly reported), according to Cochrane eligibility criteria. Criteria to assess methodological quality included: method of randomization, concealment of treatment allocation, blinded outcome assessment, handling of withdrawals and losses and whether an intention-totreat analysis had been carried out. Results The search retrieved 33 CCTs and 43 RCTs. A majority of the reports provided no description of either the method of randomization (75.3%) or concealment of the allocation sequence (84.2%). Participants and outcome assessors were reported as blinded in only 31.2% of the reports. Withdrawals and losses were only clearly described in 6.5% of the reports and none mentioned an intention-totreat analysis or any similar procedure. Conclusions The results of this study indicate that a substantial number of reports of trials and systematic reviews are available in the dental journals listed in SciELO, and that these could provide valuable evidence for clinical decision making. However, it is clear that the quality of a number of these reports is of some concern and that improvement in the conduct and reporting of these trials could be achieved if authors adhered to internationally accepted guidelines, e.g. the CONSORT statement. PMID:20485919

A quantitative and qualitative evaluation of reports of clinical trials published in six Brazilian dental journals indexed in the Scientific Electronic Library Online (SciELO).

PubMed

de Souza, Raphael Freitas; Chaves, Carolina de Andrade Lima; Nasser, Mona; Fedorowicz, Zbys

2010-01-01

Open access publishing is becoming increasingly popular within the biomedical sciences. SciELO, the Scientific Electronic Library Online, is a digital library covering a selected collection of Brazilian scientific journals many of which provide open access to full-text articles.This library includes a number of dental journals some of which may include reports of clinical trials in English, Portuguese and/or Spanish. Thus, SciELO could play an important role as a source of evidence for dental healthcare interventions especially if it yields a sizeable number of high quality reports. The aim of this study was to identify reports of clinical trials by handsearching of dental journals that are accessible through SciELO, and to assess the overall quality of these reports. Electronic versions of six Brazilian dental Journals indexed in SciELO were handsearched at www.scielo.br in September 2008. Reports of clinical trials were identified and classified as controlled clinical trials (CCTs - prospective, experimental studies comparing 2 or more healthcare interventions in human beings) or randomized controlled trials (RCTs - a random allocation method is clearly reported), according to Cochrane eligibility criteria. CRITERIA TO ASSESS METHODOLOGICAL QUALITY INCLUDED: method of randomization, concealment of treatment allocation, blinded outcome assessment, handling of withdrawals and losses and whether an intention-to-treat analysis had been carried out. The search retrieved 33 CCTs and 43 RCTs. A majority of the reports provided no description of either the method of randomization (75.3%) or concealment of the allocation sequence (84.2%). Participants and outcome assessors were reported as blinded in only 31.2% of the reports. Withdrawals and losses were only clearly described in 6.5% of the reports and none mentioned an intention-to-treat analysis or any similar procedure. The results of this study indicate that a substantial number of reports of trials and systematic reviews are available in the dental journals listed in SciELO, and that these could provide valuable evidence for clinical decision making. However, it is clear that the quality of a number of these reports is of some concern and that improvement in the conduct and reporting of these trials could be achieved if authors adhered to internationally accepted guidelines, e.g. the CONSORT statement.

Quantifying risk: the role of absolute and relative measures in interpreting risk of adverse reactions from product labels of antipsychotic medications.

PubMed

Citrome, Leslie

2009-09-01

Pharmaceutical product labeling as approved by regulatory agencies include statements of adverse event risk. Product labels include descriptive statements such as whether events are uncommon or rare, as well as percentage occurrence for more common events. In addition tables are provided with the frequencies of the latter events for both product and placebo as observed in clinical trials. Competing products are not mentioned in a specific drug's product labeling but indirect comparisons can be made using the corresponding label information for the alternate product. Two types of tools are easily used for this purpose: absolute measures such as number needed to harm (NNH), and relative measures such as relative risk increase (RRI). The calculations for both of these types of quantitative measures are presented using as examples the oral first-line second-generation antipsychotic medications. Among three sample outcomes selected a priori, akathisia, weight gain, and discontinuation from a clinical trial because of an adverse reaction, there appears to be differences among the different antipsychotics versus placebo. Aripiprazole was associated with the highest risk for akathisia, particularly when used as adjunctive treatment of major depressive disorder (NNH 5, 95% CI 4-7; RRI 525%, 95% CI 267%-964%). Although insufficient information was available in product labeling to calculate the CI, olanzapine was associated with the highest risk for weight gain of at least 7% from baseline (NNH 6, RRI 640% for adults; NNH 4, RRI 314% for adolescents), and quetiapine for the indication of bipolar depression was associated with the highest risk of discontinuation from a clinical trial because of an adverse reaction (NNH 8, RRI 265% for 600 mg/d; NNH 15, RRI 137% for 300 mg/d). In conclusion, with certain limitations, it is possible for the clinician to extract information from medication product labeling regarding the frequency with which certain adverse reactions can be expected. This supplements, but does not replace, information reported directly in clinical trial reports.

Reporting and Disclosing Intragovernmental Transactions for the FY 1997 DOD Consolidated Financial Statements.

DTIC Science & Technology

1998-09-21

This report discusses the reporting and disclosing of intragovernmental transactions on FY 1997 DoD Component and FY 1997 DoD Consolidated Financial Statements . The...comply with the law, DoD prepared financial statements for the 16 reporting entities to be included in the FY 1997 DoD Consolidated Financial Statements . The...Consolidated Financial Statement. The overall audit objective was to determine whether the FY 1997 DoD Consolidated Financial Statements were presented

Industry funding and the reporting quality of large long-term weight loss trials

PubMed Central

Thomas, Olivia; Thabane, Lehana; Douketis, James; Chu, Rong; Westfall, Andrew O.; Allison, David B.

2009-01-01

Background Quality of reporting (QR) in industry-funded research is a concern of the scientific community. Greater scrutiny of industry-sponsored research reporting has been suggested, although differences in QR by sponsorship type have not been evaluated in weight loss interventions. Objective To evaluate the association of funding source and QR of long-term obesity randomized clinical trials. Methods We analyzed papers that reported long-term weight loss trials. Articles were obtained through searches of MEDLINE, HealthStar, and the Cochrane Controlled Trials Register between the years 1966–2003. QR scores were determined for each study based upon expanded criteria from the Consolidated Standards for Reporting Trials (CONSORT) checklist for a maximum score of 44 points. Studies were coded by category of industry support (0=no industry support, 1= industry support, 2= in kind contribution from industry and 3=duality of interest reported). Individual CONSORT reporting criteria were tabulated by funding type. An independent samples t-test compared differences in QR scores by funding source and the Wilcox-Mann-Whitney test and generalized estimating equations (GEE) were used for sensitivity analyses. Results Of the 63 RCTs evaluated, 67% were industry-supported trials. Industry funding was associated with higher QR score in long-term weight loss trials compared to non-industry funded studies (Mean QR (SD): Industry = 27.9 (4.1), Non-Industry =23.4 (4.1); p < 0.0005). The Wilcox-Mann-Whitney test confirmed this result (p<0.0005). Controlling for the year of publication and whether paper was published before the CONSORT statement was released in a GEE regression analysis, the direction and magnitude of effect was similar and statistically significant (p=0.035). Of the individual criteria that prior research has associated with biases, industry funding was associated with greater reporting of intent-to-treat analysis (p=0.0158), but was not different from non-industry studies in reporting of treatment allocation and blinding. Conclusion Our findings suggest that efforts to improve reporting quality be directed at all obesity RCTs irrespective of funding source. PMID:18711388

Reporting funding source or conflict of interest in abstracts of randomized controlled trials, no evidence of a large impact on general practitioners' confidence in conclusions, a three-arm randomized controlled trial.

PubMed

Buffel du Vaure, Céline; Boutron, Isabelle; Perrodeau, Elodie; Ravaud, Philippe

2014-04-28

Systematic reporting of funding sources is recommended in the CONSORT Statement for abstracts. However, no specific recommendation is related to the reporting of conflicts of interest (CoI). The objective was to compare physicians' confidence in the conclusions of abstracts of randomized controlled trials of pharmaceutical treatment indexed in PubMed. We planned a three-arm parallel-group randomized trial. French general practitioners (GPs) were invited to participate and were blinded to the study's aim. We used a representative sample of 75 abstracts of pharmaceutical industry-funded randomized controlled trials published in 2010 and indexed in PubMed. Each abstract was standardized and reported in three formats: 1) no mention of the funding source or CoI; 2) reporting the funding source only; and 3) reporting the funding source and CoI. GPs were randomized according to a computerized randomization on a secure Internet system at a 1:1:1 ratio to assess one abstract among the three formats. The primary outcome was GPs' confidence in the abstract conclusions (0, not at all, to 10, completely confident). The study was planned to detect a large difference with an effect size of 0.5. Between October 2012 and June 2013, among 605 GPs contacted, 354 were randomized, 118 for each type of abstract. The mean difference (95% confidence interval) in GPs' confidence in abstract findings was 0.2 (-0.6; 1.0) (P = 0.84) for abstracts reporting the funding source only versus no funding source or CoI; -0.4 (-1.3; 0.4) (P = 0.39) for abstracts reporting the funding source and CoI versus no funding source and CoI; and -0.6 (-1.5; 0.2) (P = 0.15) for abstracts reporting the funding source and CoI versus the funding source only. We found no evidence of a large impact of trial report abstracts mentioning funding sources or CoI on GPs' confidence in the conclusions of the abstracts. ClinicalTrials.gov identifier: NCT01679873.

Industry funding and the reporting quality of large long-term weight loss trials.

PubMed

Thomas, O; Thabane, L; Douketis, J; Chu, R; Westfall, A O; Allison, D B

2008-10-01

Quality of reporting (QR) in industry-funded research is a concern of the scientific community. Greater scrutiny of industry-sponsored research reporting has been suggested, although differences in QR by sponsorship type have not been evaluated in weight loss interventions. To evaluate the association of funding source and QR of long-term obesity randomized clinical trials (RCT). We analysed papers that reported long-term weight loss trials. Articles were obtained through searches of Medline, HealthStar, and the Cochrane Controlled Trials Register between the years 1966 and 2003. QR scores were determined for each study based upon expanded criteria from the Consolidated Standards for Reporting Trials (CONSORT) checklist for a maximum score of 44 points. Studies were coded by category of industry support (0=no industry support, 1=industry support, 2=in kind contribution from industry and 3=duality of interest reported). Individual CONSORT reporting criteria were tabulated by funding type. An independent samples t-test compared the differences in QR scores by funding source and the Wilcox-Mann-Whitney test and generalised estimating equations (GEE) were used for sensitivity analyses. Of the 63 RCTs evaluated, 67% were industry-supported trials. Industry funding was associated with higher QR score in long-term weight loss trials compared with nonindustry-funded studies (mean QR (s.d.): industry=27.9 (4.1), nonindustry=23.4 (4.1); P<0.0005). The Wilcox-Mann-Whitney test confirmed this result (P<0.0005). Controlling for the year of publication and whether the paper was published before the CONSORT statement was released in the GEE regression analysis, the direction and magnitude of effect were similar and statistically significant (P=0.035). Of the individual criteria that prior research has associated with biases, industry funding was associated with greater reporting of intent-to-treat analysis (P=0.0158), but was not different from nonindustry studies in reporting of treatment allocation and blinding. Our findings suggest that the efforts to improve reporting quality be directed to all obesity RCTs, irrespective of funding source.

Conflict of interest reporting in dentistry meta-analyses: A systematic review

PubMed Central

Beyari, Mohammed M.; Strain, Dan; Lamfon, Hanadi A.

2014-01-01

Objectives: The issue of reporting conflicts of interest (COI) in medical research has come under scrutiny over the past decade. Absolute transparency is important when dealing with conflicts of interest to provide readers with all essential information required to make an informative decision of the results. The key objective of this study was to examine the prevalence of reporting conflicts of interest in therapeutic dental meta-analyses of Randomized Control Trials (RCTs), and to investigate possible associations with other categorical variables. Study Design: We conducted an extensive literature search across multiple databases to search for relevant review articles for this study. We utilized pre-determined key words, and relied on three reviewers to test and review the use of a data extraction form that was used for the meta-analyses. Data regarding study characteristics, direction of results, and the significance of the results from each meta-analysis were extracted. Results: There were 129 meta-analyses used in this review, and the reporting on conflict of interest was low with only 50 (38.8%) of the articles possessing a conflict of interest statement (either confirming of denying COI). Of these 50 articles, there were only 4 (8%) studies that reported an actual conflict of interest. A statement of conflicts of interest was found in 29 (35.3%) of the papers that reported significant findings, whereas 35% of the papers that reported positive results reported on conflict of interest. Prior to 2009, only 17 (25%) papers reported conflicts of interest, but since 2009, 54.1% of papers collected had a conflict of interest statement. Conclusions: Meta-analyses published in the field of dentistry do not routinely report author conflicts of interest. Although few conflicts appear to exist, the field of dentistry should continue to ensure that best evidence reports provide clear and transparent reporting of potential conflicts of interest in academic journals. Key words:Dentistry, dentition, meta-analysis, quantitative review. PMID:25136431

Systematic review of efficacy of nutraceuticals to alleviate clinical signs of osteoarthritis.

PubMed

Vandeweerd, J-M; Coisnon, C; Clegg, P; Cambier, C; Pierson, A; Hontoir, F; Saegerman, C; Gustin, P; Buczinski, S

2012-01-01

Various treatments of osteoarthritis (OA) have been described, including use of nutraceuticals. To review systematically the literature about the effects of nutraceuticals on clinical signs of pain or abnormal locomotion in horses, dogs, and cats, and to discuss methodological aspects of trials and systematic reviews. A systematic search of controlled trials evaluating the impact of nutraceuticals on OA in horses, dogs, and cats was performed, using Medline, CAB Abstracts, and Google Scholar. Scientific evidence was evaluated by means of criteria proposed by the Food and Drug Administration (FDA), and a scoring system adapted from both the CONsolidated Standards of Reporting Trials (CONSORT) statement and recommendations for assessing trials by the Center of Evidence Based Medicine of Oxford. Twenty-two papers were selected and reviewed, with 5 studies performed in horses, 16 in dogs, and 1 in cats. The strength of evidence was low for all nutraceuticals except for omega-3 fatty acid in dogs. There were limited numbers of rigorous randomized controlled trials and of participants in clinical trials. The evidence of efficacy of nutraceuticals is poor, with the exception of diets supplemented with omega-3 fatty acids in dogs. Greater access to systematic reviews must be part of the objectives of the veterinary science in the future. Their reporting would be improved by internationally agreed-upon criteria for standards and guidelines. Copyright © 2012 by the American College of Veterinary Internal Medicine.

Objectives of Financial Statements. Report of the Study Group on the Objectives of Financial Statements.

ERIC Educational Resources Information Center

American Inst. of Certified Public Accountants, New York, NY.

This report discusses the objectives of financial statements. Emphasis is placed on the function of objectives; users, their goals, and their information needs; the primary enterprise goal and earning power; accountability and financial statements; financial statements--reporting on the goal attainment of business enterprises; financial…

Effect of a Reminder Statement on Echocardiography Reports on Referrals for Implantable Cardioverter-Defibrillators for Primary Prevention.

PubMed

Chokshi, Moulin; McNamara, Robert L; Rajeswaran, Yasotha; Lampert, Rachel

2017-02-01

Numerous trials show the benefit of implantable cardioverter-defibrillators (ICDs) for primary prevention in patients with low ejection fraction (EF), a class I indication. However, underutilization is well documented. We retrospectively reviewed charts to see whether placing a reminder statement into echocardiogram reports for appropriate patients increased adherence to guidelines. From January through June 2013, a brief reminder of the ICD guidelines was automatically inserted into echocardiogram reports with EF ≤ 35% (reminder period). Charts were reviewed to determine if these patients (1) were referred to Electrophysiology (EP) within 6 months of the index echo and (2) received an ICD within 6 months of EP referral. Chart review of all patients who had an echocardiogram performed between March and August 2012 with an EF ≤ 35% provided a control period. More patients were referred to EP in the reminder period compared with control period, 68% (54 of 80) versus 51% (53 of 104), p = 0.03. There was also a higher rate of discussions in the reminder period between patients and physicians about ICD therapy (71% vs 54%, p = 0.02). Among patients appropriate for ICD, 52% of patients during the reminder period received an ICD versus 38% of patients during the control period (p = 0.11). A simple reminder statement on echocardiography reports led to a significant improvement in appropriate EP referrals and a trend toward increased ICD implantation in appropriate patients. Copyright © 2016 Elsevier Inc. All rights reserved.

An interrupted time series analysis showed suboptimal improvement in reporting quality of trial abstract.

PubMed

Chhapola, Viswas; Tiwari, Soumya; Brar, Rekha; Kanwal, Sandeep Kumar

2016-03-01

To assess and compare the immediate and long-term change in reporting quality of randomized controlled trial (RCT) abstracts published in Pediatrics, The Journal of Pediatrics, and JAMA Pediatrics before and after the publication of Consolidated Standards of Reporting Trial (CONSORT)-abstract statement. Study had "Interrupted time-series" design. Eligible RCT abstracts were retrieved by PubMed search in two study periods from January 2003 to December 2007 (pre-CONSORT) and January 2010 to December 2014 (post-CONSORT). These abstracts were matched with the CONSORT checklist for abstracts. The primary outcome measure was CONSORT-abstract score defined as number of CONSORT items correctly reported divided by 18 and expressed as percentage. The mean percentage scores were used to compare reporting quality between pre- and post-CONSORT using segmented linear regression. A total of 424 RCT abstracts in pre-CONSORT and 467 in post-CONSORT were analyzed. A significant change in slope of regression line between two time periods (0.151 [confidence interval CI, 0.004-0.298], P = 0.044) was observed. Intercepts did not show a significant difference (-2.39 [CI, 4.93-0.157], P = 0.065). The overall reporting quality of RCT abstracts in the high-impact pediatrics journals was suboptimal (<50%); however, it improved when assessed over a 5-year period, implying slow but gradual adoption of guideline. Copyright © 2016 Elsevier Inc. All rights reserved.

Reporting quality of randomised controlled trials published in prosthodontic and implantology journals.

PubMed

Kloukos, D; Papageorgiou, S N; Doulis, I; Petridis, H; Pandis, N

2015-12-01

The purpose of this study was to examine the reporting quality of randomised controlled trials (RCTs) published in prosthodontic and implantology journals. Thirty issues of nine journals in prosthodontics and implant dentistry were searched for RCTs, covering the years 2005-2012: The Journal of Prosthetic Dentistry, Journal of Oral Rehabilitation, The International Journal of Prosthodontics, The International Journal of Periodontics & Restorative Dentistry, Clinical Oral Implants Research, Clinical Implant Dentistry & Related Research, The International Journal of Oral & Maxillofacial Implants, Implant Dentistry and Journal of Dentistry. The reporting quality was assessed using a modified Consolidated Standards of Reporting Trials (CONSORT) statement checklist. Data were analysed using descriptive statistics followed by univariable and multivariable examination of statistical associations (α = 0·05). A total of 147 RCTs were identified with a mean CONSORT score of 69·4 (s.d. = 9·7). Significant differences were found among journals with the Journal of Oral Rehabilitation achieving the highest score (80·6, s.d. = 5·5) followed by Clinical Oral Implants Research (73·7, s.d. = 8·3). Involvement of a statistician/methodologist was significantly associated with increased CONSORT scores. Overall, the reporting quality of RCTs in major prosthodontic and implantology journals requires improvement. This is of paramount importance considering that optimal reporting of RCTs is an important prerequisite for clinical decision-making. © 2015 John Wiley & Sons Ltd.

Cause-effect relationships in nutritional intervention studies for health claims substantiation: guidance for trial design.

PubMed

Navas-Carretero, Santiago; Martinez, J Alfredo

2015-07-01

The growing worldwide interest on functional food research has been accompanied by increasing regulatory guidelines in this area, with the aim of ensuring that any claimed effect in foods, beyond their nutritional role, is based on scientific unequivocal evidence. In order to assess the cause-effect relationship between the regular consumption of a food or a food component and the beneficial outcome for the consumer, an appropriate study design is required. Previous knowledge and research on the specific claimed food or product may be an adequate basis for defining a hypothesis and accurate objectives. Other key factors to take into account are based on the outcomes studied, the length of the trial, sample size and type, as well as the transparency on reporting the results obtained. Based on the Consolidated Standards on Reporting Trials statement (CONSORT), together with the specific guidelines published by the European Food Safety Authority (EFSA) Panel on Dietetic Products, Nutrition and Allergies, the present article aims at summarizing key questions conducting to the most appropriate study design for solid health claim substantiation.

NIH State-of-the-Science Conference Statement on management of menopause-related symptoms.

PubMed

To provide health care providers, patients, and the general public with a responsible assessment of currently available data on the management of menopause-related symptoms. A non-DHHS, nonadvocate 12-member panel representing the fields of obstetrics and gynecology, general internal medicine, endocrinology, rheumatology, family and health psychology, geriatric medicine, health services research, demography, biochemistry, epidemiology, clinical research, and biostatistics. In addition, 26 experts in fields related to the conference topic presented data to the panel and to the conference audience. Presentations by experts and a systematic review of the medical literature prepared by the Oregon Evidence-based Practice Center, through the Agency for Healthcare Research and Quality's Evidence-based Practice Centers Program. Scientific evidence was given precedence over clinical anecdotal experience. Answering pre-determined questions, the panel drafted its statement based on scientific evidence presented in open forum and on the published scientific literature. The draft statement was read in its entirety on the final day of the conference and circulated to the audience for comment. The panel then met in executive session to consider the comments received, and released a revised statement later that day at http://consensus.nih.gov. This statement is an independent report of the panel and is not a policy statement of the NIH or the Federal Government. A final copy of this statement is available, along with other recent conference statements, at the same web address of http://consensus.nih.gov. Menopause is the permanent cessation of menstrual periods that occurs naturally in women, usually in their early 50s. Many women have few or no symptoms; these women are not in need of medical treatment. Premenopausal or perimenopausal women who have menopause induced by surgery, chemotherapy, or radiation are more likely to experience bothersome and even disabling symptoms. These women need safe and effective treatment. It is difficult to differentiate those symptoms that are truly associated with menopause from those due to aging. Hot flashes, night sweats, and vaginal dryness are clearly tied to the menopausal transition, and there is some positive evidence of a menopausal link for sleep disturbance. Vasomotor symptoms are reported with high frequency during the menopausal transition. Estrogen, either by itself or with progestins, is the most consistently effective therapy for these symptoms. However, the Women's Health Initiative (WHI) has identified important risk factors associated with use of these therapies. Decision making for women regarding treatment for menopausal symptoms requires personal knowledge and balancing of these risks. There are many potential alternatives to estrogen. However, their effectiveness and long-term safety need to be studied in rigorous clinical trials in diverse populations of women. Much more research is needed to clearly define the natural history of menopause, associated symptoms, and effectiveness and safety of treatments for bothersome symptoms. Natural histories are important for both science and policy. Knowing how many women transit menopause with few or no symptoms, and how many manage menopause largely on their own, can lead to public health information that empowers women and increases their self-reliance. Medical care and future clinical trials are best focused on women with the most severe and prolonged symptoms. The state of the science in management of menopausal symptoms should be reassessed periodically. Menopause is "medicalized" in contemporary U.S. society. There is great need to develop and disseminate information that emphasizes menopause as a normal, healthy phase of women's lives and promotes its demedicalization. Medical care and future clinical trials are best focused on women with the most severe and prolonged symptoms. Barriers to professional care for these women should be removed.

Reporting quality of randomized controlled trials in patients with HIV on antiretroviral therapy: a systematic review.

PubMed

Nagai, Kaori; Saito, Akiko M; Saito, Toshiki I; Kaneko, Noriyo

2017-12-28

To allow for correct evaluation of clinical trial results, readers require comprehensive, clear, and highly transparent information on the methodology used and the results obtained. This study aimed to evaluate the quality of reporting in articles on randomized controlled trials (RCTs) of antiretroviral therapy (ART) in the field of HIV/AIDS. We searched for original articles on RCTs of ART developed in the field of HIV/AIDS in PubMed database by 5 April 2016. Searched articles were divided into three groups based on the revision year in which the Consolidated Standards of Reporting Trials (CONSORT) guidelines were published: Period 1 (1996-2001); Period 2 (2002-2010); and Period 3 (2011-2016). We evaluated the articles using the reporting rates of the 37 items in the CONSORT 2010 checklist, five items in the protocol deviation, and the three items in the ethics. Fifty-two articles were extracted and included in this study. Many of the reporting rates calculated using the CONSORT 2010 checklist showed a significantly increasing trend over the successive periods (65% in Period 1, 67% in Period 2, 79% in Period 3; p < 0.0001). The items with reporting rates < 50% were "the presence or absence of a protocol change and the reason for such a change," "randomization and blinding," and "where the full trial protocol can be accessed." Reporting rates of deviations were as low as < 30%, while the reporting rates for patient compliance were the highest (>80% in Period 3) among the five items. The reporting rates for obtaining informed consent and approval by the ethics committee or institutional review board were high (>88%), regardless of the time period assessed. In terms of representative RCT articles in the field of HIV/AIDS, the reporting rate of the items defined by CONSORT was approximately 70%, improving over the successive CONSORT statement revision periods.

Does the CONSORT checklist for abstracts improve the quality of reports of randomized controlled trials on clinical pathways?

PubMed

Cui, Qi; Tian, Jinhui; Song, Xuping; Yang, Kehu

2014-12-01

The extension of the Consolidated Standards of Reporting Trials (CONSORT) statement provides reporting guidelines to improve the reporting quality of randomized controlled trials (RCTs). This present study was aim to assess the reporting quality of abstracts of RCTs on clinical pathway. Eight databases were searched from inception to November 2012 to identify RCTs. We extracted basic information and CONSORT items from abstracts. Each abstract was assessed independently by two reviewers. Statistical analyses were performed with SPSS 13.0. Level of significance was set at P < 0.05. 328 abstracts were included. 300 (91.5%) were published in Chinese, of which 292 were published on high impact factor journals. 28 English abstracts were all published on Science Citation Index (SCI) journals. (1) Intervention, objective and outcome were almost fully reported in all abstracts, while recruitment and funding were never reported. (2) There are nine items (P < 0.05) in Chinese that were of low quality compared with in English. There was statistically difference on total score between Chinese and English abstracts (P < 0.00001). (3) There was no difference in any items between high and low impact factor journal in China. (4) In SCI journals, there were significant changes in reporting for three items trial design (P = 0.026), harms (P = 0.039) and trial registration (P = 0.019) in different periods (pre- and post-CONSORT), but only the numbers of randomized (P = 0.003) changed in Chinese abstracts. The reporting quality of abstracts of RCTs on clinical pathway still should be improved. After the publication of CONSORT for abstracts guideline, the RCT abstracts reporting quality were improvement to some extent. The abstracts in Chinese journals showed non-adherence to the CONSORT for abstracts guidelines. © 2014 John Wiley & Sons, Ltd.

Consensus statement on essential patient characteristics in systemic treatment trials for metastatic colorectal cancer: Supported by the ARCAD Group.

PubMed

Goey, Kaitlyn K H; Sørbye, Halfdan; Glimelius, Bengt; Adams, Richard A; André, Thierry; Arnold, Dirk; Berlin, Jordan D; Bodoky, György; de Gramont, Aimery; Díaz-Rubio, Eduardo; Eng, Cathy; Falcone, Alfredo; Grothey, Axel; Heinemann, Volker; Hochster, Howard S; Kaplan, Richard S; Kopetz, Scott; Labianca, Roberto; Lieu, Christopher H; Meropol, Neal J; Price, Timothy J; Schilsky, Richard L; Schmoll, Hans-Joachim; Shacham-Shmueli, Einat; Shi, Qian; Sobrero, Alberto F; Souglakos, John; Van Cutsem, Eric; Zalcberg, John; van Oijen, Martijn G H; Punt, Cornelis J A; Koopman, Miriam

2018-06-21

Patient characteristics and stratification factors are key features influencing trial outcomes. However, there is substantial heterogeneity in reporting of patient characteristics and use of stratification factors in phase 3 trials investigating systemic treatment of metastatic colorectal cancer (mCRC). We aimed to develop a minimum set of essential baseline characteristics and stratification factors to include in such trials. We performed a modified, two-round Delphi survey among international experts with wide experience in the conduct and methodology of phase 3 trials of systemic treatment of mCRC. Thirty mCRC experts from 15 different countries completed both consensus rounds. A total of 14 patient characteristics were included in the recommended set: age, performance status, primary tumour location, primary tumour resection, prior chemotherapy, number of metastatic sites, liver-only disease, liver involvement, surgical resection of metastases, synchronous versus metachronous metastases, (K)RAS and BRAF mutation status, microsatellite instability/mismatch repair status and number of prior treatment lines. A total of five patient characteristics were considered the most relevant stratification factors: RAS/BRAF mutation status, performance status, primary tumour sidedness and liver-only disease. This survey provides a minimum set of essential baseline patient characteristics and stratification factors to include in phase 3 trials of systemic treatment of mCRC. Inclusion of these patient characteristics and strata in study protocols and final study reports will improve interpretation of trial results and facilitate cross-study comparisons. Copyright © 2018 Elsevier Ltd. All rights reserved.

Impact of a stress coping strategy on perceived stress levels and performance during a simulated cardiopulmonary resuscitation: a randomized controlled trial

PubMed Central

2013-01-01

Background Cardiopulmonary resuscitation (CPR) causes significant stress for the rescuers which may cause deficiencies in attention and increase distractibility. This may lead to misjudgements of priorities and delays in CPR performance, which may further increase mental stress (vicious cycle). This study assessed the impact of a task-focusing strategy on perceived stress levels and performance during a simulated CPR scenario. Methods This prospective, randomized-controlled trial was conducted at the simulator-center of the University Hospital Basel, Switzerland. A total of 124 volunteer medical students were randomized to receive a 10 minute instruction to cope with stress by loudly posing two task-focusing questions (“what is the patient’s condition?”, “what immediate action is needed?”) when feeling overwhelmed by stress (intervention group) or a control group. The primary outcome was the perceived levels of stress and feeling overwhelmed (stress/overload); secondary outcomes were hands-on time, time to start CPR and number of leadership statements. Results Participants in the intervention group reported significantly less stress/overload levels compared to the control group (mean difference: -0.6 (95% CI −1.3, -0.1), p=0.04). Higher stress/overload was associated with less hands-on time. Leadership statements did not differ between groups, but the number of leadership statements did relate to performance. Hands-on time was longer in the intervention- group, but the difference was not statistically significant (difference 5.5 (95% CI −3.1, 14.2), p=0.2); there were no differences in time to start CPR (difference −1.4 (95% CI −8.4, 5.7), p=0.71). Conclusions A brief stress-coping strategy moderately decreased perceived stress without significantly affecting performance in a simulated CPR. Further studies should investigate more intense interventions for reducing stress. Trial registration NCT01645566 PMID:23607331

Training to use motivational interviewing techniques for depression: a cluster randomized trial.

PubMed

Keeley, Robert D; Burke, Brian L; Brody, David; Dimidjian, Sona; Engel, Matthew; Emsermann, Caroline; deGruy, Frank; Thomas, Marshall; Moralez, Ernesto; Koester, Steve; Kaplan, Jessica

2014-01-01

The goal of this study was to assess the effects of training primary care providers (PCPs) to use Motivational Interviewing (MI) when treating depressed patients on providers' MI performance and patients' expressions of interest in depression treatment ("change talk") and short-term treatment adherence. This was a cluster randomized trial in urban primary care clinics (3 intervention, 4 control). We recruited 21 PCPs (10 intervention, 11 control) and 171 English-speaking patients with newly diagnosed depression (85 intervention, 86 control). MI training included a baseline and up to 2 refresher classroom trainings, along with feedback on audiotaped patient encounters. We report summary measures of technical (rate of MI-consistent statements per 10 minutes during encounters) and relational (global rating of "MI Spirit") MI performance, the association between MI performance and number of MI trainings attended (0, 1, 2, or 3), and rates of patient change talk regarding depression treatments (physical activity, antidepressant medication). We report PCP use of physical activity recommendations and antidepressant prescriptions and patients' short-term physical activity level and prescription fill rates. Use of MI-consistent statements was 26% higher for MI-trained versus control PCPs (P = .005). PCPs attending all 3 MI trainings (n = 6) had 38% higher use of MI-consistent statements (P < .001) and were over 5 times more likely to show beginning proficiency in MI Spirit (P = .036) relative to control PCPs. Although PCPs' use of physical activity recommendations and antidepressant prescriptions was not significantly different by randomization arm, patients seen by MI-trained PCPs had more frequent change talk (P = .001). Patients of MI-trained PCPs also expressed change talk about physical activity 3 times more frequently (P = .01) and reported more physical activity (3.05 vs 1.84 days in the week after the visit; P = .007) than their counterparts visiting untrained PCPs. Change talk about antidepressant medication and fill rates were similar by randomization arm (P > .05 for both). MI training resulted in improved MI performance, more depression-related patient change talk, and better short-term adherence. © Copyright 2014 by the American Board of Family Medicine.

Update of the SEPD position statement on the use of biosimilars for inflammatory bowel disease.

PubMed

Argüelles Arias, Federico; Hinojosa Del Val, Joaquín; Vera Mendoza, Isabel

2018-03-12

In 2013, the European Medicines Agency (EMA) approved the biosimilar infliximab (CT-P13) for the full range of indications of the originator product, based on data from two trials conducted in rheumatoid arthritis and ankylosing spondylitis. The same year, our Society published a position statement that was later reviewed.

78 FR 48871 - Proposed Agency Information Collection Activities; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-12

..., including the proposed reporting form and instructions, supporting statement, and other documentation will... the Following Report Report title: Financial Statements for Holding Companies.\\1\\ \\1\\ This family of... Only Financial Statements for Large Bank Holding Companies (FR Y-9LP), the Financial Statements for...

Financial Audit: EPA’s Financial Statements for Fiscal Years 1988 and 1987

DTIC Science & Technology

1990-03-16

consolidated financial statements for the fiscal years ended September 30, 1988 and 1987, and our reports on internal accounting controls and compliance...Cognizant Officials 20 Report on Compliance 21 With Laws and Regulations Financial Statements 22 Consolidated Statement of Financial Position 22 Consolidated ...Statement of Operations 23 Consolidated Statement of Changes in Financial Position 24 and Reconciliation to Budget Notes to Financial Statements 25

Effects of disclosing financial interests on attitudes toward clinical research.

PubMed

Weinfurt, Kevin P; Hall, Mark A; Dinan, Michaela A; DePuy, Venita; Friedman, Joëlle Y; Allsbrook, Jennifer S; Sugarman, Jeremy

2008-06-01

The effects of disclosing financial interests to potential research participants are not well understood. To examine the effects of financial interest disclosures on potential research participants' attitudes toward clinical research. Computerized experiment conducted with 3,623 adults in the United States with either diabetes mellitus or asthma, grouped by lesser and greater severity. Respondents read a description of a hypothetical clinical trial relevant to their diagnosis that included a financial disclosure statement. Respondents received 1 of 5 disclosure statements. Willingness to participate in the hypothetical clinical trial, relative importance of information about the financial interest, change in trust after reading the disclosure statement, surprise regarding the financial interest, and perceived effect of the financial interest on the quality of the clinical trial. Willingness to participate in the hypothetical clinical trial did not differ substantially among the types of financial disclosures. Respondents viewed the disclosed information as less important than other factors in deciding to participate. Disclosures were associated with some respondents trusting the researchers less, although trust among some respondents increased. Most respondents were not surprised to learn of financial interests. Researchers owning equity were viewed as more troubling than researchers who were compensated for the costs of research through per capita payments. Aside from a researcher holding an equity interest, the disclosure to potential research participants of financial interests in research, as recommended in recent policies, is unlikely to affect willingness to participate in research.

11 CFR 108.3 - Filing copies of reports and statements in connection with the campaign of any congressional...

Code of Federal Regulations, 2010 CFR

2010-01-01

... 11 Federal Elections 1 2010-01-01 2010-01-01 false Filing copies of reports and statements in... Elections FEDERAL ELECTION COMMISSION GENERAL FILING COPIES OF REPORTS AND STATEMENTS WITH STATE OFFICERS (2 U.S.C. 439) § 108.3 Filing copies of reports and statements in connection with the campaign of any...

Statement of Facts for 1976 City-Wide Mock Trial Competitions. United States v. Percy W. Snodgrass.

ERIC Educational Resources Information Center

National Inst. for Citizen Education in the Law, Washington, DC.

Prepared by the District of Columbia Street Law Project for its annual city-wide mock trial competition, this instructional handout provides material for a murder trial. The defendant shot the victim in the course of a violent dispute. The prosecution charges murder while the defendant claims to have acted in self-defense. The handout clarifies…

Sentinel node biopsy for prostate cancer: report from a consensus panel meeting.

PubMed

van der Poel, Henk G; Wit, Esther M; Acar, Cenk; van den Berg, Nynke S; van Leeuwen, Fijs W B; Valdes Olmos, Renato A; Winter, Alexander; Wawroschek, Friedhelm; Liedberg, Fredrik; Maclennan, Steven; Lam, Thomas

2017-08-01

To explore the evidence and knowledge gaps in sentinel node biopsy (SNB) in prostate cancer through a consensus panel of experts. A two-round Delphi survey among experts was followed by a consensus panel meeting of 16 experts in February 2016. Agreement voting was performed using the research and development project/University of California, Los Angeles Appropriateness Methodology on 150 statements in nine domains. The disagreement index based on the interpercentile range, adjusted for symmetry score, was used to assess consensus and non-consensus among panel members. Consensus was obtained on 91 of 150 statements (61%). The main outcomes were: (1) the results from an extended lymph node dissection (eLND) are still considered the 'gold standard', and sentinel node (SN) detection should be combined with eLND, at least in patients with intermediate- and high-risk prostate cancer; (2) the role of SN detection in low-risk prostate cancer is unclear; and (3) future studies should contain oncological endpoints as number of positive nodes outside the eLND template, false-negative and false-positive SN procedures, and recurrence-free survival. A high rate of consensus was obtained regarding outcome measures of future clinical trials on SNB (89%). Consensus on tracer technology was only obtained in 47% of statements, reflecting a need for further research and standardization in this area. The low-level evidence in the available literature and the composition of mainly SNB users in the panel constitute the major limitations of the study. Consensus on a majority of elementary statements on SN detection in prostate cancer was obtained.; therefore, the results from this consensus report will provide a basis for the design of further studies in the field. A group of experts identified evidence and knowledge gaps on SN detection in prostate cancer and its application in daily practice. Information from the consensus statements can be used to direct further studies. © 2017 The Authors BJU International © 2017 BJU International Published by John Wiley & Sons Ltd.

32 CFR 9.6 - Conduct of the trial.

Code of Federal Regulations, 2014 CFR

2014-07-01

... prior trials and proceedings, sworn or unsworn written statements, physical evidence, or scientific or... and surrebuttal. (8) The Prosecution shall present argument to the Commission. Defense Counsel shall be permitted to present argument in response, and then the Prosecution may reply in rebuttal. (9...

32 CFR 9.6 - Conduct of the trial.

Code of Federal Regulations, 2013 CFR

2013-07-01

... prior trials and proceedings, sworn or unsworn written statements, physical evidence, or scientific or... and surrebuttal. (8) The Prosecution shall present argument to the Commission. Defense Counsel shall be permitted to present argument in response, and then the Prosecution may reply in rebuttal. (9...

Toward Earlier Inclusion of Pregnant and Postpartum Women in Tuberculosis Drug Trials: Consensus Statements From an International Expert Panel

PubMed Central

Gupta, Amita; Mathad, Jyoti S.; Abdel-Rahman, Susan M.; Albano, Jessica D.; Botgros, Radu; Brown, Vikki; Browning, Renee S.; Dawson, Liza; Dooley, Kelly E.; Gnanashanmugam, Devasena; Grinsztejn, Beatriz; Hernandez-Diaz, Sonia; Jean-Philippe, Patrick; Kim, Peter; Lyerly, Anne D.; Mirochnick, Mark; Mofenson, Lynne M.; Montepiedra, Grace; Piper, Jeanna; Sahin, Leyla; Savic, Radojka; Smith, Betsy; Spiegel, Hans; Swaminathan, Soumya; Watts, D. Heather; White, Amina

2016-01-01

Tuberculosis is a major cause of morbidity and mortality in women of childbearing age (15–44 years). Despite increased tuberculosis risk during pregnancy, optimal clinical treatment remains unclear: safety, tolerability, and pharmacokinetic data for many tuberculosis drugs are lacking, and trials of promising new tuberculosis drugs exclude pregnant women. To advance inclusion of pregnant and postpartum women in tuberculosis drug trials, the US National Institutes of Health convened an international expert panel. Discussions generated consensus statements (>75% agreement among panelists) identifying high-priority research areas during pregnancy, including: (1) preventing progression of latent tuberculosis infection, especially in women coinfected with human immunodeficiency virus; (2) evaluating new agents/regimens for treatment of multidrug-resistant tuberculosis; and (3) evaluating safety, tolerability and pharmacokinetics of tuberculosis drugs already in use during pregnancy and postpartum. Incorporating pregnant women into clinical trials would extend evidence-based tuberculosis prevention and treatment standards to this special population. PMID:26658057

Association between berries intake and cardiovascular diseases risk factors: a systematic review with meta-analysis and trial sequential analysis of randomized controlled trials.

PubMed

Luís, Ângelo; Domingues, Fernanda; Pereira, Luísa

2018-02-21

The main goal of this work was to clarify the effects of the consumption of berries on cardiovascular disease (CVD) risk factors by performing a systematic review according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analysis) statement, followed by a meta-analysis and a trial sequential analysis (TSA) of randomized controlled trials (RCTs). The electronic search was conducted in PubMed, Scopus, SciELO, Web of Science and Cochrane Library between April and June 2016. To be included, RCTs had to report 1 or more of the following outcomes: total cholesterol (TC), HDL-cholesterol (HDL), LDL-cholesterol (LDL), triglycerides (TG), blood pressure (BP), C-reactive protein (CRP), tumour necrosis factor-α (TNF-α), interleukin-6 (IL-6), vascular cell adhesion molecule-1 (VCAM), intercellular adhesion molecule-1 (ICAM), glucose, insulin, apolipoprotein A-I (Apo A-I) or apolipoprotein B (Apo B). It was observed that the intake of berries reduces TC, LDL, TG, and BP while increasing the level of HDL, suggesting a beneficial effect on the control of CVDs' risk factors. Thus, the intake of berries as nutraceuticals or functional foods could be suggested for the prevention and control of CVDs.

Efficacy of Therapies for Postural Tachycardia Syndrome: A Systematic Review and Meta-analysis.

PubMed

Wells, Rachel; Elliott, Adrian D; Mahajan, Rajiv; Page, Amanda; Iodice, Valeria; Sanders, Prashanthan; Lau, Dennis H

2018-06-21

To identify the evidence base and evaluate the efficacy of each treatment for postural tachycardia syndrome (POTS) in light of a recent consensus statement highlighting the lack of treatment options with clear benefit to risk ratios for this debilitating condition. The CENTRAL (Cochrane Central Register of Controlled Trials), PubMed, and Embase databases from inception to May 2017 were searched using the terms postural AND tachycardia AND syndrome. A total of 135 full-text publications were screened after excluding duplicates (n=681), conference abstracts (n=467), and records that did not relate to POTS therapy (n=876). We included 28 studies with at least 4 patients with POTS in which symptomatic response was reported after more than 4 weeks of therapy. This review was performed according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) statement. Two investigators independently performed the data extraction and evaluated the quality of evidence. This study comprised 25 case series and 3 small randomized controlled trials that evaluated 755 and 103 patients with POTS, respectively. Interventions directed at increasing intravascular volume, increasing peripheral or splanchnic vascular tone, controlling heart rate, and increasing exercise tolerance demonstrate moderate efficacy (range, 51%-72%). Few data exist on their comparative effectiveness. Significant heterogeneities were seen in terms of patient age, symptom severity, and the measures used to evaluate treatment efficacy. The current evidence base to guide optimal management of patients with POTS is extremely limited. More high-quality collaborative research with standardized reporting of symptom response and treatment tolerability is urgently needed. Copyright © 2018 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.

Evaluation of Health Economics in Radiation Oncology: A Systematic Review

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

Nguyen, Timothy K.; Goodman, Chris D.; Boldt, R. Gabriel

Purpose: Despite the rising costs in radiation oncology, the impact of health economics research on radiation therapy practice analysis patterns is unclear. We performed a systematic review of cost-effectiveness analyses (CEAs) and cost-utility analyses (CUAs) to identify trends in reporting quality in the radiation oncology literature over time. Methods and Materials: A systematic review of radiation oncology economic evaluations up to 2014 was performed, using MEDLINE and EMBASE databases. The Consolidated Health Economic Evaluation Reporting Standards guideline informed data abstraction variables including study demographics, economic parameters, and methodological details. Tufts Medical Center CEA registry quality scores provided a basis formore » qualitative assessment of included studies. Studies were stratified by 3 time periods (1995-2004, 2005-2009, and 2010-2014). The Cochran-Armitage trend test and linear trend test were used to identify trends over time. Results: In total, 102 articles were selected for final review. Most studies were in the context of a model (61%) or clinical trial (28%). Many studies lacked a conflict of interest (COI) statement (67%), a sponsorship statement (48%), a reported study time horizon (35%), and the use of discounting (29%). There was a significant increase over time in the reporting of a COI statement (P<.001), health care payer perspective (P=.019), sensitivity analyses using multivariate (P=.043) or probabilistic methods (P=.011), incremental cost-effectiveness threshold (P<.001), secondary source utility weights (P=.010), and cost effectiveness acceptability curves (P=.049). There was a trend toward improvement in Tuft scores over time (P=.065). Conclusions: Recent reports demonstrate improved reporting rates in economic evaluations; however, there remains significant room for improvement as reporting rates are still suboptimal. As fiscal pressures rise, we will rely on economic assessments to guide our practice decisions and policies. We recommend improved adherence to published guidelines and further research to determine the clinical implications of our findings.« less

Evaluation of Health Economics in Radiation Oncology: A Systematic Review.

PubMed

Nguyen, Timothy K; Goodman, Chris D; Boldt, R Gabriel; Warner, Andrew; Palma, David A; Rodrigues, George B; Lock, Michael I; Mishra, Mark V; Zaric, Gregory S; Louie, Alexander V

2016-04-01

Despite the rising costs in radiation oncology, the impact of health economics research on radiation therapy practice analysis patterns is unclear. We performed a systematic review of cost-effectiveness analyses (CEAs) and cost-utility analyses (CUAs) to identify trends in reporting quality in the radiation oncology literature over time. A systematic review of radiation oncology economic evaluations up to 2014 was performed, using MEDLINE and EMBASE databases. The Consolidated Health Economic Evaluation Reporting Standards guideline informed data abstraction variables including study demographics, economic parameters, and methodological details. Tufts Medical Center CEA registry quality scores provided a basis for qualitative assessment of included studies. Studies were stratified by 3 time periods (1995-2004, 2005-2009, and 2010-2014). The Cochran-Armitage trend test and linear trend test were used to identify trends over time. In total, 102 articles were selected for final review. Most studies were in the context of a model (61%) or clinical trial (28%). Many studies lacked a conflict of interest (COI) statement (67%), a sponsorship statement (48%), a reported study time horizon (35%), and the use of discounting (29%). There was a significant increase over time in the reporting of a COI statement (P<.001), health care payer perspective (P=.019), sensitivity analyses using multivariate (P=.043) or probabilistic methods (P=.011), incremental cost-effectiveness threshold (P<.001), secondary source utility weights (P=.010), and cost effectiveness acceptability curves (P=.049). There was a trend toward improvement in Tuft scores over time (P=.065). Recent reports demonstrate improved reporting rates in economic evaluations; however, there remains significant room for improvement as reporting rates are still suboptimal. As fiscal pressures rise, we will rely on economic assessments to guide our practice decisions and policies. We recommend improved adherence to published guidelines and further research to determine the clinical implications of our findings. Copyright © 2016 Elsevier Inc. All rights reserved.

The effect of chlorogenic acid on blood pressure: a systematic review and meta-analysis of randomized clinical trials.

PubMed

Onakpoya, I J; Spencer, E A; Thompson, M J; Heneghan, C J

2015-02-01

Several dietary supplements are currently marketed for management of hypertension, but the evidence for effectiveness is conflicting. Our objective was to critically appraise and evaluate the evidence for the effectiveness of chlorogenic acids (CGAs) on blood pressure, using data from published randomized clinical trials (RCTs). Electronic searches were conducted in Medline, Embase, Amed, Cinahl and The Cochrane Library. We also hand-searched the bibliographies of all retrieved articles. Two reviewers independently determined the eligibility of studies and extracted the data. The reporting quality of all included studies was assessed by the use of a quality assessment checklist adapted from the Consolidated Standard of Reporting Trials Statement. Disagreements were resolved through discussion. Seven eligible studies were identified, and five including 364 participants were included. There were variations in the reporting quality of the included RCTs. Meta-analysis revealed a statistically significant reduction in systolic blood pressure in favour of CGA (mean difference (MD): -4.31 mm Hg; 95% confidence interval (CI): -5.60 to -3.01; I(2)=65%; P<0.00001). Meta-analysis also showed a significant reduction in diastolic blood pressure favouring CGA (MD: -3.68 mm Hg; 95% CI: -3.91 to -3.45; I(2)=97%; P<0.00001). All studies reported no adverse events. In conclusion, the evidence from published RCTs suggests that CGA intake causes statistically significant reductions in systolic and diastolic blood pressures. The size of the effect is moderate. Few clinical trials have been conducted; they vary in design and methodology and are confined to Asian populations and funded by CGA manufacturers. Large independent trials evaluating the effects of CGA on blood pressure are warranted.

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

PubMed

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

2018-05-11

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

46 CFR 298.42 - Reporting requirements-financial statements.

Code of Federal Regulations, 2010 CFR

2010-10-01

... statements be in accordance with generally accepted accounting principles, by accountants as described in... report and an annual financial report, prepared in accordance with generally accepted accounting... 46 Shipping 8 2010-10-01 2010-10-01 false Reporting requirements-financial statements. 298.42...

Statement of Facts for 1993 City-Wide Mock Trial Competitions. Sandra W. v. Gregg M.

ERIC Educational Resources Information Center

National Inst. for Citizen Education in the Law, Washington, DC.

Prepared by the District of Columbia Street Law Project for its 22nd annual city-wide mock trial competition, this instructional handout provides the material for a mock civil trial in which Sandra Williams sues Gregg Mason for negligent transmission of the Human Immuno-Deficient Virus (HIV). On the night of May 15, 1990, Sandra and Gregg engaged…

U.S. Government Financial Statements: FY 2000 Reporting Underscores the Need to Accelerate Federal Financial Management Reform

DTIC Science & Technology

2001-03-30

I am pleased to be here today to discuss our report on the U.S. government’s consolidated financial statements for fiscal year 2000. Both the... consolidated financial statements and our report are included in the Fiscal Year 2000 Financial Report of the United States Government (Financial Report...CFO Act agencies), beginning with fiscal year 1996, and consolidated financial statements for the U.S. government, beginning with fiscal year 1997.

2017 ACC/AAP/AHA Health Policy Statement on Opportunities and Challenges in Pediatric Drug Development: Learning From Sildenafil

PubMed Central

Sable, Craig A.; Ivy, D. Dunbar; Beekman, Robert H.; Clayton-Jeter, Helene D.; Jenkins, Kathy J.; Mahle, William T.; Morrow, William R.; Murphy, Mary Dianne; Nelson, Robert M.; Rosenthal, Geoffrey L.; Stockbridge, Norman; Wessel, David L.

2017-01-01

The STARTS-1 and -2 trials (Sildenafil in Treatment-Naive Children, Aged 1 to 17 Years, With Pulmonary Arterial Hypertension) and subsequent 2012 U.S. Food and Drug Administration (FDA) product labeling for sildenafil use in pediatric patients with pulmonary hypertension highlight many of the challenges to the development and approval of medications for children. This experience served as the impetus for direct collaboration between FDA representatives and the Joint Council on Congenital Heart Disease (JCCHD) (representing the pediatric cardiology leadership of the American College of Cardiology, the American Heart Association, and the American Academy of Pediatrics) to improve communication and realign missions with regard to pediatric drug trials. These discussions led to the joint FDA/JCCHD development of this statement, which describes the current environment and identifies possible future directions for reducing barriers to pediatric drug trials. PMID:28663437

Refining the structure and content of clinical genomic reports.

PubMed

Dorschner, Michael O; Amendola, Laura M; Shirts, Brian H; Kiedrowski, Lesli; Salama, Joseph; Gordon, Adam S; Fullerton, Stephanie M; Tarczy-Hornoch, Peter; Byers, Peter H; Jarvik, Gail P

2014-03-01

To effectively articulate the results of exome and genome sequencing we refined the structure and content of molecular test reports. To communicate results of a randomized control trial aimed at the evaluation of exome sequencing for clinical medicine, we developed a structured narrative report. With feedback from genetics and non-genetics professionals, we developed separate indication-specific and incidental findings reports. Standard test report elements were supplemented with research study-specific language, which highlighted the limitations of exome sequencing and provided detailed, structured results, and interpretations. The report format we developed to communicate research results can easily be transformed for clinical use by removal of research-specific statements and disclaimers. The development of clinical reports for exome sequencing has shown that accurate and open communication between the clinician and laboratory is ideally an ongoing process to address the increasing complexity of molecular genetic testing. © 2014 Wiley Periodicals, Inc.

Refining the Structure and Content of Clinical Genomic Reports

PubMed Central

DORSCHNER, MICHAEL O.; AMENDOLA, LAURA M.; SHIRTS, BRIAN H.; KIEDROWSKI, LESLI; SALAMA, JOSEPH; GORDON, ADAM S.; FULLERTON, STEPHANIE M.; TARCZY-HORNOCH, PETER; BYERS, PETER H.; JARVIK, GAIL P.

2014-01-01

To effectively articulate the results of exome and genome sequencing we refined the structure and content of molecular test reports. To communicate results of a randomized control trial aimed at the evaluation of exome sequencing for clinical medicine, we developed a structured narrative report. With feedback from genetics and non-genetics professionals, we developed separate indication-specific and incidental findings reports. Standard test report elements were supplemented with research study-specific language, which highlighted the limitations of exome sequencing and provided detailed, structured results, and interpretations. The report format we developed to communicate research results can easily be transformed for clinical use by removal of research-specific statements and disclaimers. The development of clinical reports for exome sequencing has shown that accurate and open communication between the clinician and laboratory is ideally an ongoing process to address the increasing complexity of molecular genetic testing. PMID:24616401

Fracture healing: a consensus report from the International Osteoporosis Foundation Fracture Working Group.

PubMed

Silverman, S L; Kupperman, E S; Bukata, S V

2016-07-01

We used the RAND UCLA appropriateness method to decide appropriateness of use of osteoporosis medication after incident fracture and potential for fracture healing and make suggestions for trial design for clinical and preclinical research. To develop appropriateness criteria to assist in the use and study of osteoporosis medications in patients with recent fracture and in the potential use of osteoporosis medications to enhance delayed fracture healing. To promote further research by suggesting preclinical and clinical trial design for studies where fracture healing is the endpoint. RAND/UCLA appropriateness method (RUAM). A panel of experts, both members and non-members of the International Osteoporosis Foundation Fracture Working Group, were identified consisting of geriatricians, rheumatologists, orthopedists, endocrinologists, and internists. This resulted in a round 1 panel of 15 panelists, round 2 panel of 15 members, and a round 3 panel of 14 members. Agreement on statements and scenarios using RUAM. Three rounds of voting by panelists took place. Agreement in a third round was reached for 111 statements and scenarios, measured by median panel ratings and the amount of dispersion of panel ratings, based on the interpercentile range. An expert panel validated a set of statements and scenarios about the use of osteoporosis medications after incident fracture and use of these medications to enhance delayed fracture healing and made recommendations for study designs to investigate the effect of osteoporosis medications on fracture healing. The result of this exercise is intended to assist in improving patient care by identifying the appropriateness of use of osteoporosis medications after fracture and in fracture healing and to make suggestions for further preclinical and clinical research.

Language and Implicit Attributions in the Nuremberg Trials: Analyzing Prosecutors' and Defense Attorneys' Closing Speeches.

ERIC Educational Resources Information Center

Schmid, Jeannette; Fiedler, Klaus

1996-01-01

Investigates attributional implications of prosecutors' and defense attorneys' language strategies using the protocols of the historical Nuremberg trials. States that apart from more positive statements regarding the defendants being made by defense lawyers than prosecutors, both sides used a number of subtler strategies. (PA)

The use of gabapentin in the management of postoperative pain after total hip arthroplasty: a meta-analysis of randomised controlled trials.

PubMed

Han, Chao; Li, Xiao-Dan; Jiang, Hong-Qiang; Ma, Jian-Xiong; Ma, Xin-Long

2016-07-12

Pain management after total hip arthroplasty (THA) varies and has been widely studied in recent years. Gabapentin as a third-generation antiepileptic drug that selectively affects the nociceptive process has been used for pain relief after THA. This meta-analysis was conducted to examine the efficacy of gabapentin in THA. An electronic-based search was conducted using the following databases: PubMed, EMBASE, Ovid MEDLINE, ClinicalTrials.gov, and Cochrane Central Register of Controlled Trials (CENTRAL). Randomised controlled trials (RCTs) involving gabapentin and a placebo for THA were included. The meta-analysis was performed following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. Five trials met the inclusion criteria. The cumulative narcotic consumption and the visual analogue scale (VAS) scores at 24 and 48 h postoperatively were used for postoperative pain assessment. There was a significant decrease in morphine consumption at 24 h (P = 0.00). Compared with the control group, the VAS score (at rest) at 48 h was less in the gabapentin group (P = 0.00). The administration of gabapentin is effective in decreasing postoperative narcotic consumption and the VAS score.

Patient-Oriented Eczema Measure (POEM), a core instrument to measure symptoms in clinical trials: a Harmonising Outcome Measures for Eczema (HOME) statement.

PubMed

Spuls, P I; Gerbens, L A A; Simpson, E; Apfelbacher, C J; Chalmers, J R; Thomas, K S; Prinsen, C A C; von Kobyletzki, L B; Singh, J A; Williams, H C; Schmitt, J

2017-04-01

The Harmonising Outcome Measures for Eczema (HOME) initiative has defined four core outcome domains for a core outcome set (COS) to be measured in all atopic eczema (AE) trials to ensure cross-trial comparison: clinical signs, symptoms, quality of life and long-term control. The aim of this paper is to report on the consensus process that was used to select the core instrument to consistently assess symptoms in all future AE trials. Following the HOME roadmap, two systematic reviews were performed which identified three instruments that had sufficient evidence of validity, reliability and feasibility to be considered for the final COS. At the fourth international HOME meeting, there was broad consensus among all stakeholders that the Patient-Oriented Eczema Measure (POEM) should be used as the core instrument (87·5% agreed, 9·4% unsure, 3·1% disagreed). All relevant stakeholders are encouraged to use POEM as the chosen instrument to measure the core domain of symptoms in all future AE clinical trials. Other instruments of interest can be used in addition to POEM. © 2016 British Association of Dermatologists.

Ophthalmic randomized controlled trials reports: the statement of the hypothesis.

PubMed

Lee, Chun Fan; Cheng, Andy Chi On; Fong, Daniel Yee Tak

2014-01-01

To evaluate whether the ophthalmic randomized controlled trials (RCTs) were designed properly, their hypotheses stated clearly, and their conclusions drawn correctly. A systematic review of 206 ophthalmic RCTs. The objective statement, methods, and results sections and the conclusions of RCTs published in 4 major general clinical ophthalmology journals from 2009 through 2011 were assessed. The clinical objective and specific hypothesis were the main outcome measures. The clinical objective of the trial was presented in 199 (96.6%) studies and the hypothesis was specified explicitly in 56 (27.2%) studies. One hundred ninety (92.2%) studies tested superiority. Among them, 17 (8.3%) studies comparing 2 or more active treatments concluded equal or similar effectiveness between the 2 arms after obtaining insignificant results. There were 5 noninferiority studies and 4 equivalence studies. How the treatments were compared was not mentioned in 1 of the noninferiority studies. Two of the equivalence studies did not specify the equivalence margin and used tests for detecting difference rather than confirming equivalence. The clinical objective commonly was stated, but the prospectively defined hypothesis tended to be understated in ophthalmic RCTs. Superiority was the most common type of comparison. Conclusions made in some of them with negative results were not consistent with the hypothesis, indicating that noninferiority or equivalence may be a more appropriate design. Flaws were common in the noninferiority and equivalence studies. Future ophthalmic researchers should choose the type of comparison carefully, specify the hypothesis clearly, and draw conclusions that are consistent with the hypothesis. Copyright © 2014 Elsevier Inc. All rights reserved.

Conflict of Interest Disclosure in Off-Label Oncology Clinical Trials

PubMed Central

Irwin, Blair; Hirsch, Bradford R.; Samsa, Gregory P.; Abernethy, Amy P.

2012-01-01

Purpose: We sought to determine the prevalence, reliability, and predictors of conflict of interest (COI) and funding disclosure statements for studies of anticancer targeted therapies conducted in the off-label prescribing setting. Methods: As a part of a federally funded systematic review, manuscripts were included in the analysis if they were used to support one of 19 indications for cancer targeted therapies that were off-label but reimbursable according to compendia published in 2006 or before. Studies were categorized according to trial design, trial results, average impact factor of journals, and presence of COI and funding disclosure statements. Results: Among the 69 included studies, prevalence of COI and funding disclosures was low, at 33% and 58% respectively; time trends showed some improvement between 2002 to 2007, but only 60% of studies had disclosures by 2007. Predictors of COI disclosure were publication in high-impact-factor journals (P < .001), large study sample size (P = .001), enrollment exclusively in the United States (P = .04), and study of the targeted therapy in combination with other agents as opposed to the study drug alone (P = .03). Conclusion: Disclosure of potential sources of bias in COI and funding statements in studies of off-label indications for anticancer targeted therapies was low and did not increase substantially over time. PMID:23277767

17 CFR 240.15d-2 - Special financial report.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 17 Commodity and Securities Exchanges 3 2010-04-01 2010-04-01 false Special financial report. 240....15d-2 Special financial report. (a) If the registration statement under the Securities Act of 1933 did... registration statement, file a special report furnishing certified financial statements for such last full...

Effect evaluation of a heated ambulance mattress-prototype on body temperatures and thermal comfort - an experimental study

PubMed Central

2014-01-01

Background Exposure to cold temperatures is, often, a neglected problem in prehospital care. One of the leading influences of the overall sensation of cold discomfort is the cooling of the back. The aim of this study was to evaluate the effect of a heated ambulance mattress-prototype on body temperatures and thermal comfort in an experimental study. Method Data were collected during four days in November, 2011 inside and outside of a cold chamber. All participants (n = 23) participated in two trials each. In one trial, they were lying on a stretcher with a supplied heated mattress and in the other trial without a heated mattress. Outcomes were back temperature, finger temperature, core body temperature, Cold Discomfort Scale (CDS), four statements from the state-trait anxiety – inventory (STAI), and short notes of their experiences of the two mattresses. Data were analysed both quantitatively and qualitatively. A repeated measure design was used to evaluate the effect of the two mattresses. Results A statistical difference between the regular mattress and the heated mattress was found in the back temperature. In the heated mattress trial, the statement “I am tense” was fewer whereas the statements “I feel comfortable”, “I am relaxed” and “I feel content” were higher in the heated mattress trial. The qualitative analyses of the short notes showed that the heated mattress, when compared to the unheated mattress, was experienced as warm, comfortable, providing security and was easier to relax on. Conclusions Heat supply from underneath the body results in increased comfort and may prevent hypothermia which is important for injured and sick patients in ambulance care. PMID:25103366

12 CFR 263.105 - Statement of net worth.

Code of Federal Regulations, 2010 CFR

2010-01-01

... initiation of the adversary adjudication. Unaudited financial statements are acceptable for individual... judge or the Board otherwise requires. Financial statements or reports filed with or reported to a... 12 Banks and Banking 3 2010-01-01 2010-01-01 false Statement of net worth. 263.105 Section 263.105...

Effectiveness guidance document (EGD) for Chinese medicine trials: a consensus document

PubMed Central

2014-01-01

Background There is a need for more Comparative Effectiveness Research (CER) on Chinese medicine (CM) to inform clinical and policy decision-making. This document aims to provide consensus advice for the design of CER trials on CM for researchers. It broadly aims to ensure more adequate design and optimal use of resources in generating evidence for CM to inform stakeholder decision-making. Methods The Effectiveness Guidance Document (EGD) development was based on multiple consensus procedures (survey, written Delphi rounds, interactive consensus workshop, international expert review). To balance aspects of internal and external validity, multiple stakeholders, including patients, clinicians, researchers and payers were involved in creating this document. Results Recommendations were developed for “using available data” and “future clinical studies”. The recommendations for future trials focus on randomized trials and cover the following areas: designing CER studies, treatments, expertise and setting, outcomes, study design and statistical analyses, economic evaluation, and publication. Conclusion The present EGD provides the first systematic methodological guidance for future CER trials on CM and can be applied to single or multi-component treatments. While CONSORT statements provide guidelines for reporting studies, EGDs provide recommendations for the design of future studies and can contribute to a more strategic use of limited research resources, as well as greater consistency in trial design. PMID:24885146

Elements of a Research Report.

ERIC Educational Resources Information Center

Schurter, William J.

This guide for writing research or technical reports discusses eleven basic elements of such reports and provides examples of "good" and "bad" wordings. These elements are the title, problem statement, purpose statement, need statement, hypothesis, assumptions, procedures, limitations, terminology, conclusion and recommendations. This guide is…

17 CFR 4.22 - Reporting to pool participants.

Code of Federal Regulations, 2010 CFR

2010-04-01

..., the financial statements are not required to include consolidated information for all series. (7) For... event that the International Financial Reporting Standards require consolidated financial statements for... reporting pool's consolidated financial statements. (ii) The commodity pool operator of a pool that meets...

Deficiencies in FY 1998 DOD Financial Statements and Progress Toward Improved Financial Reporting

DTIC Science & Technology

1999-11-26

DEFICIENCIES IN FY 1998 DOD FINANCIAL STATEMENTS AND PROGRESS TOWARD IMPROVED FINANCIAL REPORTING Report No. D-2000-041 November 26, 1999 Office... Financial Reporting (Report No. D-2000-041) We are providing this audit report for information and use. It identifies and summarizes the major...8FI-2025.02) Deficiencies in FY 1998 DoD Financial Statements and Progress Toward Improved Financial Reporting Executive Summary Introduction

Are pediatric Open Access journals promoting good publication practice? An analysis of author instructions.

PubMed

Meerpohl, Joerg J; Wolff, Robert F; Antes, Gerd; von Elm, Erik

2011-04-09

Several studies analyzed whether conventional journals in general medicine or specialties such as pediatrics endorse recommendations aiming to improve publication practice. Despite evidence showing benefits of these recommendations, the proportion of endorsing journals has been moderate to low and varied considerably for different recommendations. About half of pediatric journals indexed in the Journal Citation Report referred to the Uniform Requirements for Manuscripts of the International Committee of Medical Journal Editors (ICMJE) but only about a quarter recommended registration of trials. We aimed to investigate to what extent pediatric open-access (OA) journals endorse these recommendations. We hypothesized that a high proportion of these journals have adopted recommendations on good publication practice since OA electronic publishing has been associated with a number of editorial innovations aiming at improved access and transparency. We identified 41 journals publishing original research in the subject category "Health Sciences, Medicine (General), Pediatrics" of the Directory of Open Access Journals http://www.doaj.org. From the journals' online author instructions we extracted information regarding endorsement of four domains of editorial policy: the Uniform Requirements for Manuscripts, trial registration, disclosure of conflicts of interest and five major reporting guidelines such as the CONSORT (Consolidated Standards of Reporting Trials) statement. Two investigators collected data independently. The Uniform Requirements were mentioned by 27 (66%) pediatric OA journals. Thirteen (32%) required or recommended trial registration prior to publication of a trial report. Conflict of interest policies were stated by 25 journals (61%). Advice about reporting guidelines was less frequent: CONSORT was referred to by 12 journals (29%) followed by other reporting guidelines (MOOSE, PRISMA or STARD) (8 journals, 20%) and STROBE (3 journals, 7%). The EQUATOR network, a platform of several guideline initiatives, was acknowledged by 4 journals (10%). Journals published by OA publishing houses gave more guidance than journals published by professional societies or other publishers. Pediatric OA journals mentioned certain recommendations such as the Uniform Requirements or trial registration more frequently than conventional journals; however, endorsement is still only moderate. Further research should confirm these exploratory findings in other medical fields and should clarify what the motivations and barriers are in implementing such policies.

Are pediatric Open Access journals promoting good publication practice? An analysis of author instructions

PubMed Central

2011-01-01

Background Several studies analyzed whether conventional journals in general medicine or specialties such as pediatrics endorse recommendations aiming to improve publication practice. Despite evidence showing benefits of these recommendations, the proportion of endorsing journals has been moderate to low and varied considerably for different recommendations. About half of pediatric journals indexed in the Journal Citation Report referred to the Uniform Requirements for Manuscripts of the International Committee of Medical Journal Editors (ICMJE) but only about a quarter recommended registration of trials. We aimed to investigate to what extent pediatric open-access (OA) journals endorse these recommendations. We hypothesized that a high proportion of these journals have adopted recommendations on good publication practice since OA electronic publishing has been associated with a number of editorial innovations aiming at improved access and transparency. Methods We identified 41 journals publishing original research in the subject category "Health Sciences, Medicine (General), Pediatrics" of the Directory of Open Access Journals http://www.doaj.org. From the journals' online author instructions we extracted information regarding endorsement of four domains of editorial policy: the Uniform Requirements for Manuscripts, trial registration, disclosure of conflicts of interest and five major reporting guidelines such as the CONSORT (Consolidated Standards of Reporting Trials) statement. Two investigators collected data independently. Results The Uniform Requirements were mentioned by 27 (66%) pediatric OA journals. Thirteen (32%) required or recommended trial registration prior to publication of a trial report. Conflict of interest policies were stated by 25 journals (61%). Advice about reporting guidelines was less frequent: CONSORT was referred to by 12 journals (29%) followed by other reporting guidelines (MOOSE, PRISMA or STARD) (8 journals, 20%) and STROBE (3 journals, 7%). The EQUATOR network, a platform of several guideline initiatives, was acknowledged by 4 journals (10%). Journals published by OA publishing houses gave more guidance than journals published by professional societies or other publishers. Conclusions Pediatric OA journals mentioned certain recommendations such as the Uniform Requirements or trial registration more frequently than conventional journals; however, endorsement is still only moderate. Further research should confirm these exploratory findings in other medical fields and should clarify what the motivations and barriers are in implementing such policies. PMID:21477335

Updated consensus statement on the use of rituximab in patients with rheumatoid arthritis

PubMed Central

Buch, Maya H; Smolen, Josef S; Betteridge, Neil; Breedveld, Ferdinand C; Burmester, Gerd; Dörner, Thomas; Ferraccioli, Gianfranco; Gottenberg, Jacques-Eric; Isaacs, John; Kvien, Tore K; Mariette, Xavier; Martin-Mola, Emilio; Pavelka, Karel; Tak, Paul P; van der Heijde, Desiree; van Vollenhoven, Ronald F; Emery, Paul

2011-01-01

Background Since initial approval for the treatment of rheumatoid arthritis (RA), rituximab has been evaluated in clinical trials involving various populations with RA. Information has also been gathered from registries. This report therefore updates the 2007 consensus document on the use of rituximab in the treatment of RA. Methods Preparation of this new document involved many international experts experienced in the treatment of RA. Following a meeting to agree upon the core agenda, a systematic literature review was undertaken to identify all relevant data. Data were then interrogated by a drafting committee, with subsequent review and discussion by a wider expert committee leading to the formulation of an updated consensus statement. These committees also included patients with RA. Results The new statement covers wide-ranging issues including the use of rituximab in earlier RA and impact on structural progression, and aspects particularly pertinent to rituximab such as co-medication, optimal dosage regimens, repeat treatment cycles and how to manage non-response. Biological therapy following rituximab usage is also addressed, and safety concerns including appropriate screening for hepatitis, immunoglobulin levels and infection risk. This consensus statement will support clinicians and inform patients when using B-cell depletion in the management of RA, providing up-to-date information and highlighting areas for further research. Conclusion New therapeutic strategies and treatment options for RA, a chronic destructive and disabling disease, have expanded over recent years. These have been summarised in general strategic suggestions and specific management recommendations, emphasising the importance of expedient disease-modifying antirheumatic drug implementation and tight disease control. This consensus statement is in line with these fundamental principles of management. PMID:21378402

78 FR 54906 - Draft Supplemental Environmental Impact Report/Environmental Impact Statement for a Proposed...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-06

...-FF08ECAR00] Draft Supplemental Environmental Impact Report/Environmental Impact Statement for a Proposed... Conservation Commission (CVCC), has prepared a joint draft Supplemental Environmental Impact Report/Environmental Impact Statement (draft Supplemental EIR/EIS) under the National Environmental Policy Act (NEPA...

Antibiotics for preventing recurrent sore throat.

PubMed

Ng, Gareth J Y; Tan, Stephanie; Vu, Anh N; Del Mar, Chris B; van Driel, Mieke L

2015-07-14

Antibiotics are sometimes used to prevent recurrent sore throat, despite concern about resistance. However, there is conflicting primary evidence regarding their effectiveness. To assess the effects of antibiotics in patients with recurrent sore throat. The Cochrane Ear, Nose and Throat Disorders Group (CENTDG) Trials Search Co-ordinator searched the CENTDG Trials Register; Central Register of Controlled Trials (CENTRAL 2015, Issue 5); PubMed; EMBASE; CINAHL; Web of Science; Clinicaltrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 25 June 2015. Randomised controlled trials (RCTs) of antibiotics in adults and children suffering from pre-existing recurrent sore throat, defined as three or more sore throats in a year, examining the incidence of sore throat recurrence, with follow-up of at least 12 months post-antibiotic therapy. Two authors independently assessed trial quality and extracted data. Multiple attempts to contact the authors of one study yielded no response. We identified no trials that met the inclusion criteria for the review. We discarded the majority of the references retrieved from our search following screening of the title and abstract. We formally excluded four studies following review of the full-text report. There is insufficient evidence to determine the effectiveness of antibiotics for preventing recurrent sore throat. This finding must be balanced against the known adverse effects and cost of antibiotic therapy, when considering antibiotics for this purpose. There is a need for high quality RCTs that compare the effects of antibiotics versus placebo in adults and children with pre-existing recurrent sore throat on the following outcomes: incidence of sore throat recurrence, adverse effects, days off work and absence from school, and the incidence of complications. Future studies should be conducted and reported according to the CONSORT statement.

Nicotinamide and skin cancer chemoprevention: The jury is still out.

PubMed

Gilmore, Stephen J

2018-02-01

Following the publication of the results of a Phase III trial, the administration of oral nicotinamide has been widely advocated as effective in non-melanoma skin cancer chemoprevention in high-risk individuals. However, I performed a Bayesian analysis of the reported findings and show there is insufficient evidence to demonstrate its efficacy, highlighting the significant probability that the positive conclusions drawn will not be reproducible. Given the potential widespread use of oral nicotinamide, future position statements regarding its efficacy are likely to require higher standards of evidence. © 2017 The Australasian College of Dermatologists.

Review: Assessment of completeness of reporting in intervention studies using livestock: an example from pain mitigation interventions in neonatal piglets.

PubMed

O'Connor, A; Anthony, R; Bergamasco, L; Coetzee, J F; Dzikamunhenga, R S; Johnson, A K; Karriker, L A; Marchant-Forde, J N; Martineau, G P; Millman, S T; Pajor, E A; Rutherford, K; Sprague, M; Sutherland, M A; von Borell, E; Webb, S R

2016-04-01

Accurate and complete reporting of study methods, results and interpretation are essential components for any scientific process, allowing end-users to evaluate the internal and external validity of a study. When animals are used in research, excellence in reporting is expected as a matter of continued ethical acceptability of animal use in the sciences. Our primary objective was to assess completeness of reporting for a series of studies relevant to mitigation of pain in neonatal piglets undergoing routine management procedures. Our second objective was to illustrate how authors can report the items in the Reporting guidElines For randomized controLled trials for livEstoCk and food safety (REFLECT) statement using examples from the animal welfare science literature. A total of 52 studies from 40 articles were evaluated using a modified REFLECT statement. No single study reported all REFLECT checklist items. Seven studies reported specific objectives with testable hypotheses. Six studies identified primary or secondary outcomes. Randomization and blinding were considered to be partially reported in 21 and 18 studies, respectively. No studies reported the rationale for sample sizes. Several studies failed to report key design features such as units for measurement, means, standard deviations, standard errors for continuous outcomes or comparative characteristics for categorical outcomes expressed as either rates or proportions. In the discipline of animal welfare science, authors, reviewers and editors are encouraged to use available reporting guidelines to ensure that scientific methods and results are adequately described and free of misrepresentations and inaccuracies. Complete and accurate reporting increases the ability to apply the results of studies to the decision-making process and prevent wastage of financial and animal resources.

Financial Statement: Major Deficiencies in Financial Reporting for Other Defense Organizations-General Funds

DTIC Science & Technology

2002-05-31

Financial Statement May 31, 2002 Office of the Inspector General of the Department of Defense Major Deficiencies in Financial Reporting for Other...Subtitle Financial Statement: Major Deficiencies in Financial Reporting for Other Defense Organizations-General Funds Contract Number Grant Number...use the financial reports of the Other Defense Organizations-General Funds to make management decisions. It explains major financial reporting deficiencies

46 CFR 232.5 - Income Statement Accounts.

Code of Federal Regulations, 2010 CFR

2010-10-01

... ACTIVITIES UNIFORM FINANCIAL REPORTING REQUIREMENTS Income Statement § 232.5 Income Statement Accounts. (a... Expense Accounts. The income and expense accounts shall show for each reporting period the amount of money... accounted for to facilitate reporting the source of revenue by trade route or service area. (iii) All other...

12 CFR 208.36 - Reporting requirements for State member banks subject to the Securities Exchange Act of 1934.

Code of Federal Regulations, 2010 CFR

2010-01-01

... recent fiscal year, and no foreign offices, may elect to substitute for the financial statements required... qualifying for and electing to file financial statements from its quarterly report of condition pursuant to... statement or schedule, only the particular financial statement or schedule need be included. All copies of...

Academic Freedom on Trial: 100 Years of Sifting and Winnowing at the University of Wisconsin-Madison.

ERIC Educational Resources Information Center

Hansen, W. Lee, Ed.

The 29 papers in this collection celebrate academic freedom at the University of Wisconsin-Madison and are organized around the 1894 "trial" of Richard T. Ely, an economist who was exonerated of fomenting unrest and discussing "dangerous" ideas in a Board of Regents Statement which stressed the importance of "sifting and…

The reporting quality of randomized controlled trials in orthodontics.

PubMed

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 © 2014 Elsevier Inc. All rights reserved.

37 CFR 201.29 - Access to, and confidentiality of, Statements of Account, Verification Auditor's Reports, and...

Code of Federal Regulations, 2010 CFR

2010-07-01

... confidentiality of, Statements of Account, Verification Auditor's Reports, and other verification information... GENERAL PROVISIONS § 201.29 Access to, and confidentiality of, Statements of Account, Verification Auditor... Account, including the Primary Auditor's Reports, filed under 17 U.S.C. 1003(c) and access to a Verifying...

Report: South Carolina Drinking Water State Revolving Fund Program Financial Statements with Independent Auditor’s Report, June 30, 2002

EPA Pesticide Factsheets

Report #2003-1-00138, September 17, 2003. We have audited the balance sheet of the SCDWSRF Program as of June 30, 2002, the related statement of revenues, expenses, and changes in fund equity, and the statement of cash flows for the year then ended.

12 CFR 623.2 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-01-01

...; (2) The preparation or certification of any statement, opinion, report of financial condition and performance, financial statement, appraisal report, audit report, or other document or report by any attorney...

17 CFR 240.12b-36 - Use of financial statements filed under other acts.

Code of Federal Regulations, 2012 CFR

2012-04-01

... administered by the Commission are filed with a statement or report, the accountant's certificate shall be... consent of the accountant to such incorporation by reference shall be filed with the statement or report...

17 CFR 240.12b-36 - Use of financial statements filed under other acts.

Code of Federal Regulations, 2013 CFR

2013-04-01

... administered by the Commission are filed with a statement or report, the accountant's certificate shall be... consent of the accountant to such incorporation by reference shall be filed with the statement or report...

17 CFR 240.12b-36 - Use of financial statements filed under other acts.

Code of Federal Regulations, 2014 CFR

2014-04-01

... administered by the Commission are filed with a statement or report, the accountant's certificate shall be... consent of the accountant to such incorporation by reference shall be filed with the statement or report...

17 CFR 240.12b-36 - Use of financial statements filed under other acts.

Code of Federal Regulations, 2010 CFR

2010-04-01

... administered by the Commission are filed with a statement or report, the accountant's certificate shall be... consent of the accountant to such incorporation by reference shall be filed with the statement or report...

17 CFR 240.12b-36 - Use of financial statements filed under other acts.

Code of Federal Regulations, 2011 CFR

2011-04-01

... administered by the Commission are filed with a statement or report, the accountant's certificate shall be... consent of the accountant to such incorporation by reference shall be filed with the statement or report...

Consensus on Recording Deep Endometriosis Surgery: the CORDES statement.

PubMed

Vanhie, A; Meuleman, C; Tomassetti, C; Timmerman, D; D'Hoore, A; Wolthuis, A; Van Cleynenbreugel, B; Dancet, E; Van den Broeck, U; Tsaltas, J; Renner, S P; Ebert, A D; Carmona, F; Abbott, J; Stepniewska, A; Taylor, H; Saridogan, E; Mueller, M; Keckstein, J; Pluchino, N; Janik, G; Zupi, E; Minelli, L; Cooper, M; Dunselman, G; Koh, C; Abrao, M S; Chapron, C; D'Hooghe, T

2016-06-01

Which essential items should be recorded before, during and after endometriosis surgery and in clinical outcome based surgical trials in patients with deep endometriosis (DE)? A DE surgical sheet (DESS) was developed for standardized reporting of the surgical treatment of DE and an international expert consensus proposal on relevant items that should be recorded in surgical outcome trials in women with DE. Surgery is an important treatment for symptomatic DE. So far, data have been reported in such a way that comparison of different surgical techniques is impossible. Therefore, we present an international expert proposal for standardized reporting of surgical treatment and surgical outcome trials in women with DE. International expert consensus based on a systematic review of literature. Taking into account recommendations from Consolidated Standards of Reporting Trials (CONSORT), the Innovation Development Exploration Assessment and Long-term Study (IDEAL), the Initiative on Methods, Measurement and Pain Assessment in Clinical trials (IMMPACT) and the World Endometriosis Research Foundation Phenome and Biobanking Harmonisation Project (WERF EPHect), a systematic literature review on surgical treatment of DE was performed and resulted in a proposal for standardized reporting, adapted by contributions from eight members of the multidisciplinary Leuven University Hospitals Endometriosis Care Program, from 18 international experts and from audience feedback during three international meetings. We have developed the DESS to record in detail the surgical procedures for DE, and an international consensus on pre-, intra- and post-operative data that should be recorded in surgical outcome trials on DE. The recommendations in this paper represent a consensus among international experts based on a systematic review of the literature. For several items and recommendations, high-quality RCTs were not available. Further research is needed to validate and evaluate the recommendations presented here. This international expert consensus for standardized reporting of surgical treatment in women with DE, based on a systematic literature review and international consensus, can be used as a guideline to record and report surgical management of patients with DE and as a guideline to design, execute, interpret and compare clinical trials in this patient population. None of the authors received funding for the development of this paper. M.A. reports personal fees and non-financial support from Bayer Pharma outside the submitted work; H.T. reports a grant from Pfizer and personal fees for being on the advisory board of Perrigo, Abbvie, Allergan and SPD. N/A. © The Author 2016. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Inspector General, DoD, Oversight of the Air Force Audit Agency Audit of the FY 1996 Air Force Consolidated Financial Statements.

DTIC Science & Technology

1997-04-10

financial statements . We delegated the audit of the FY 1996 Air Force consolidated financial statements to the Air Force Audit Agency on May 17, 1996...This report provides our endorsement of the Air Force Audit Agency disclaimer of opinion on the Air Force consolidated financial statements for FY...1996, along with the Air Force Audit Agency Report of Audit, ’Opinion on Fiscal Year 1996 Air Force Consolidated Financial Statements .’

Statement of Facts for 1982 City-Wide Mock Trial Competitions. Vincent Taylor, Plaintiff v. Lance Memorial Hospital for Women, Raymond Miller, M.D., and Dorothy Dillon, R.N., Defendants. No. MT-82.

ERIC Educational Resources Information Center

National Inst. for Citizen Education in the Law, Washington, DC.

Prepared by the District of Columbia Street Law Project for its 11th annual city-wide mock trial competition, this instructional handout provides material for a civil trial over a disputed discriminatory termination of employment. Vincent Taylor claims that the Lance Memorial Hospital for Women fired him on the basis of his sex. The hospital…

Consensus statement on blocking the effects of interleukin-6 and in particular by interleukin-6 receptor inhibition in rheumatoid arthritis and other inflammatory conditions

PubMed Central

Smolen, Josef S; Schoels, Monika M; Nishimoto, Norihiro; Breedveld, Ferdinand C; Burmester, Gerd R; Dougados, Maxime; Emery, Paul; Ferraccioli, Gianfranco; Gabay, Cem; Gibofsky, Allan; Gomez-Reino, Juan Jesus; Jones, Graeme; Kvien, Tore K; Murakami, Miho; Betteridge, Neil; Bingham, Clifton O; Bykerk, Vivian; Choy, Ernest H; Combe, Bernard; Cutolo, Maurizio; Graninger, Winfried; Lanas, Angel; Martin-Mola, Emilio; Montecucco, Carlomaurizio; Ostergaard, Mikkel; Pavelka, Karel; Rubbert-Roth, Andrea; Sattar, Naveed; Scholte-Voshaar, Marieke; Tanaka, Yoshiya; Trauner, Michael; Valentini, Gabriele; Winthrop, Kevin L; de Wit, Maarten; van der Heijde, Désirée

2013-01-01

Background Since approval of tocilizumab (TCZ) for treatment of rheumatoid arthritis (RA) and juvenile idiopathic arthritis (JIA), interleukin 6 (IL-6) pathway inhibition was evaluated in trials of TCZ and other agents targeting the IL-6 receptor and ligand in various RA populations and other inflammatory diseases. This consensus document informs on interference with the IL-6 pathway based on evidence and expert opinion. Methods Preparation of this document involved international experts in RA treatment and RA patients. A systematic literature search was performed that focused on TCZ and other IL6-pathway inhibitors in RA and other diseases. Subsequently, incorporating available published evidence and expert opinion, the steering committee and a broader expert committee (both including RA patients) formulated the current consensus statement. Results The consensus statement covers use of TCZ as combination- or monotherapy in various RA populations and includes clinical, functional and structural aspects. The statement also addresses the second approved indication in Europe JIA and non-approved indications. Also early phase trials involving additional agents that target the IL-6 receptor or IL-6 were evaluated. Safety concerns, including haematological, hepatic and metabolic issues as well as infections, are addressed likewise. Conclusions The consensus statement identifies points to consider when using TCZ, regarding indications, contraindications, screening, dose, comedication, response evaluation and safety. The document is aimed at supporting clinicians and informing patients, administrators and payers on opportunities and limitations of IL-6 pathway inhibition. PMID:23172750

Can Cranberries Contribute to Reduce the Incidence of Urinary Tract Infections? A Systematic Review with Meta-Analysis and Trial Sequential Analysis of Clinical Trials.

PubMed

Luís, Ângelo; Domingues, Fernanda; Pereira, Luísa

2017-09-01

We sought to clarify the association between cranberry intake and the prevention of urinary tract infections. This systematic review, which complies with the PRISMA (Preferred Reporting Items for Systematic Review and Meta-Analysis) statement, was done as a meta-analysis and trial sequential analysis of clinical trials. The findings clearly showed the potential use of cranberries for the clinical condition of urinary tract infection. Cranberry products significantly reduced the incidence of urinary tract infections as indicated by the weighted risk ratio (0.6750, 95% CI 0.5516-0.7965, p <0.0001). The results of subgroup analysis demonstrated that patients at some risk for urinary tract infections were more susceptible to the effects of cranberry ingestion. The results of the current study could be used by physicians to recommend cranberry ingestion to decrease the incidence of urinary tract infections, particularly in individuals with recurrent urinary tract infections. This would also reduce the administration of antibiotics, which could be beneficial since antibiotics can lead to the worldwide emergence of antibiotic resistant microorganisms. Copyright © 2017 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

Documentation of study medication dispensing in a prospective large randomized clinical trial: experiences from the ARISTOTLE Trial.

PubMed

Alexander, John H; Levy, Elliott; Lawrence, Jack; Hanna, Michael; Waclawski, Anthony P; Wang, Junyuan; Califf, Robert M; Wallentin, Lars; Granger, Christopher B

2013-09-01

In ARISTOTLE, apixaban resulted in a 21% reduction in stroke, a 31% reduction in major bleeding, and an 11% reduction in death. However, approval of apixaban was delayed to investigate a statement in the clinical study report that "7.3% of subjects in the apixaban group and 1.2% of subjects in the warfarin group received, at some point during the study, a container of the wrong type." Rates of study medication dispensing error were characterized through reviews of study medication container tear-off labels in 6,520 participants from randomly selected study sites. The potential effect of dispensing errors on study outcomes was statistically simulated in sensitivity analyses in the overall population. The rate of medication dispensing error resulting in treatment error was 0.04%. Rates of participants receiving at least 1 incorrect container were 1.04% (34/3,273) in the apixaban group and 0.77% (25/3,247) in the warfarin group. Most of the originally reported errors were data entry errors in which the correct medication container was dispensed but the wrong container number was entered into the case report form. Sensitivity simulations in the overall trial population showed no meaningful effect of medication dispensing error on the main efficacy and safety outcomes. Rates of medication dispensing error were low and balanced between treatment groups. The initially reported dispensing error rate was the result of data recording and data management errors and not true medication dispensing errors. These analyses confirm the previously reported results of ARISTOTLE. © 2013.

Randomized clinical trials presented at the World Congress of Endourology: how is the quality of reporting?

PubMed

Autorino, Riccardo; Borges, Claudio; White, Michael A; Altunrende, Fatih; Perdoná, Sisto; Haber, Georges-Pascal; De Sio, Marco; Khanna, Rakesh; Stein, Robert J; Kaouk, Jihad H

2010-12-01

To assess the quality of reporting of randomized controlled trials (RCTs) presented in abstract form at the annual World Congress of Endourology (WCE) and evaluate their course of subsequent publication. All RCTs presented in abstract form at the 2004, 2005, and 2006 WCE annual meetings were identified for review. Quality of reporting was assessed by applying a standardized 14-item evaluation tool based on the Consolidated Standards for the Reporting of Trials (CONSORT) statement. The subsequent publication rate for the corresponding studies by scanning Medline was also evaluated. Appropriate statistical analysis was performed. A total of 94 RCTs (3.5% of 2669) were identified for review: 21 in 2004, 36 in 2005, and 37 in 2006. Overall, 45 (47.3% of the total) were subsequently published as a full length indexed manuscript with a mean time to publication of 16.4 ± 13.2 months. Approximately 61 (60%) identified the study design as RCT in the abstract title. None reported the method of randomization. In studies that reported blinding (seven, 11% of 62), five were double blinded and two single blinded. Adverse events were reported in 38% of cases. Only 10% of the abstracts complied fully with more than 10 items according to our CONSORT-based checklist, whereas the majority of them failed to comply with most of the CONSORT requirements. Although representing a small portion of the overall number of abstracts, there has been a steady increase of presentation of RCTs at the WCE over the assessed 3-year period. Most of the time they are recognized as RCTs in the abstract title. When applying the CONSORT criteria, necessary information to assess their methodologic quality is incomplete in some cases.

Policy-into-practice for rheumatoid arthritis: randomized controlled trial and cohort study of e-learning targeting improved physiotherapy management.

PubMed

Fary, Robyn E; Slater, Helen; Chua, Jason; Ranelli, Sonia; Chan, Madelynn; Briggs, Andrew M

2015-07-01

To examine the effectiveness of a physiotherapy-specific, web-based e-learning platform, "RAP-el," in best-practice management of rheumatoid arthritis (RA) using a single-blind, randomized controlled trial (RCT) and prospective cohort study. Australian-registered physiotherapists were electronically randomized into intervention and control groups. The intervention group accessed RAP-eL over 4 weeks. Change in self-reported confidence in knowledge and skills was compared between groups at the end of the RCT using linear regression conditioned for baseline scores by a blinded assessor, using intent-to-treat analysis. Secondary outcomes included physiotherapists' satisfaction with RA management and responses to RA-relevant clinical statements and practice-relevant vignettes. Retention was evaluated in a cohort study 8 weeks after the RCT. Eighty physiotherapists were randomized into the intervention and 79 into the control groups. Fifty-six and 48, respectively, provided baseline data. Significant between-group differences were observed for change in confidence in knowledge (mean difference 8.51; 95% confidence interval [95% CI] 6.29, 10.73; effect size 1.62) and skills (mean difference 7.26; 95% CI 5.1, 9.4; effect size 1.54), with the intervention group performing better. Satisfaction in ability to manage RA, 4 of the 6 clinical statements, and responses to vignettes demonstrated significant improvement in the intervention group. Although 8-week scores showed declines in most outcomes, their clinical significance remains uncertain. RAP-eL can improve self-reported confidence, likely practice behaviors and satisfaction in physiotherapists' ability to manage people with RA, and improve their clinical knowledge in several areas of best-practice RA management in the short term. © 2015, American College of Rheumatology.

Do health technology assessments comply with QUOROM diagram guidance? An empirical study.

PubMed

Hind, Daniel; Booth, Andrew

2007-11-20

The Quality of Reporting of Meta-analyses (QUOROM) statement provides guidance for improving the quality of reporting of systematic reviews and meta-analyses. To make the process of study selection transparent it recommends "a flow diagram providing information about the number of RCTs identified, included, and excluded and the reasons for excluding them". We undertook an empirical study to identify the extent of compliance in the UK Health Technology Assessment (HTA) programme. We searched Medline to retrieve all systematic reviews of therapeutic interventions in the HTA monograph series published from 2001 to 2005. Two researchers recorded whether each study contained a meta-analysis of controlled trials, whether a QUOROM flow diagram was presented and, if so, whether it expressed the relationship between the number of citations and the number of studies. We used Cohen's kappa to test inter-rater reliability. 87 systematic reviews were retrieved. There was good and excellent inter-rater reliability for, respectively, whether a review contained a meta-analysis and whether each diagram contained a citation-to-study relationship. 49% of systematic reviews used a study selection flow diagram. When only systematic reviews containing a meta-analysis were analysed, compliance was only 32%. Only 20 studies (23% of all systematic reviews; 43% of those having a study selection diagram) had a diagram which expressed the relationship between citations and studies. Compliance with the recommendations of the QUOROM statement is not universal in systematic reviews or meta-analyses. Flow diagrams make the conduct of study selection transparent only if the relationship between citations and studies is clearly expressed. Reviewers should understand what they are counting: citations, papers, studies and trials are fundamentally different concepts which should not be confused in a diagram.

Combining Parent and Child Training for Young Children with ADHD

PubMed Central

Webster-Stratton, Carolyn

2011-01-01

The efficacy of the Incredible Years parent and child training programs is established in children diagnosed with oppositional defiant disorder (ODD) but not among young children whose primary diagnosis is attention-deficit/hyperactivity disorder (ADHD). We conducted a randomized control trial evaluating the combined parent and child program interventions among 99 children diagnosed with ADHD (ages 4–6). Mother reported significant treatment effects for appropriate and harsh discipline, use of physical punishment, and monitoring, whereas fathers reported no significant parenting changes. Independent observations revealed treatment effects for mothers' praise and coaching, mothers' critical statements, and child total deviant behaviors. Both mothers and fathers reported treatment effects for children's externalizing, hyperactivity, inattentive and oppositional behaviors, and emotion regulation and social competence. There were also significant treatment effects for children's emotion vocabulary and problem-solving ability. At school teachers reported treatment effects for externalizing behaviors and peer observations indicated improvements in treated children's social competence. PMID:21391017

Impact of STROBE statement publication on quality of observational study reporting: interrupted time series versus before-after analysis.

PubMed

Bastuji-Garin, Sylvie; Sbidian, Emilie; Gaudy-Marqueste, Caroline; Ferrat, Emilie; Roujeau, Jean-Claude; Richard, Marie-Aleth; Canoui-Poitrine, Florence

2013-01-01

In uncontrolled before-after studies, CONSORT was shown to improve the reporting of randomised trials. Before-after studies ignore underlying secular trends and may overestimate the impact of interventions. Our aim was to assess the impact of the 2007 STROBE statement publication on the quality of observational study reporting, using both uncontrolled before-after analyses and interrupted time series. For this quasi-experimental study, original articles reporting cohort, case-control, and cross-sectional studies published between 2004 and 2010 in the four dermatological journals having the highest 5-year impact factors (≥ 4) were selected. We compared the proportions of STROBE items (STROBE score) adequately reported in each article during three periods, two pre STROBE period (2004-2005 and 2006-2007) and one post STROBE period (2008-2010). Segmented regression analysis of interrupted time series was also performed. Of the 456 included articles, 187 (41%) reported cohort studies, 166 (36.4%) cross-sectional studies, and 103 (22.6%) case-control studies. The median STROBE score was 57% (range, 18%-98%). Before-after analysis evidenced significant STROBE score increases between the two pre-STROBE periods and between the earliest pre-STROBE period and the post-STROBE period (median score2004-05 48% versus median score2008-10 58%, p<0.001) but not between the immediate pre-STROBE period and the post-STROBE period (median score2006-07 58% versus median score2008-10 58%, p = 0.42). In the pre STROBE period, the six-monthly mean STROBE score increased significantly, by 1.19% per six-month period (absolute increase 95%CI, 0.26% to 2.11%, p = 0.016). By segmented analysis, no significant changes in STROBE score trends occurred (-0.40%; 95%CI, -2.20 to 1.41; p = 0.64) in the post STROBE statement publication. The quality of reports increased over time but was not affected by STROBE. Our findings raise concerns about the relevance of uncontrolled before-after analysis for estimating the impact of guidelines.

Impact of STROBE Statement Publication on Quality of Observational Study Reporting: Interrupted Time Series versus Before-After Analysis

PubMed Central

Bastuji-Garin, Sylvie; Sbidian, Emilie; Gaudy-Marqueste, Caroline; Ferrat, Emilie; Roujeau, Jean-Claude; Richard, Marie-Aleth; Canoui-Poitrine, Florence

2013-01-01

Background In uncontrolled before-after studies, CONSORT was shown to improve the reporting of randomised trials. Before-after studies ignore underlying secular trends and may overestimate the impact of interventions. Our aim was to assess the impact of the 2007 STROBE statement publication on the quality of observational study reporting, using both uncontrolled before-after analyses and interrupted time series. Methods For this quasi-experimental study, original articles reporting cohort, case-control, and cross-sectional studies published between 2004 and 2010 in the four dermatological journals having the highest 5-year impact factors (≥4) were selected. We compared the proportions of STROBE items (STROBE score) adequately reported in each article during three periods, two pre STROBE period (2004–2005 and 2006–2007) and one post STROBE period (2008–2010). Segmented regression analysis of interrupted time series was also performed. Results Of the 456 included articles, 187 (41%) reported cohort studies, 166 (36.4%) cross-sectional studies, and 103 (22.6%) case-control studies. The median STROBE score was 57% (range, 18%–98%). Before-after analysis evidenced significant STROBE score increases between the two pre-STROBE periods and between the earliest pre-STROBE period and the post-STROBE period (median score2004–05 48% versus median score2008–10 58%, p<0.001) but not between the immediate pre-STROBE period and the post-STROBE period (median score2006–07 58% versus median score2008–10 58%, p = 0.42). In the pre STROBE period, the six-monthly mean STROBE score increased significantly, by 1.19% per six-month period (absolute increase 95%CI, 0.26% to 2.11%, p = 0.016). By segmented analysis, no significant changes in STROBE score trends occurred (−0.40%; 95%CI, −2.20 to 1.41; p = 0.64) in the post STROBE statement publication. Interpretation The quality of reports increased over time but was not affected by STROBE. Our findings raise concerns about the relevance of uncontrolled before-after analysis for estimating the impact of guidelines. PMID:23990867

The use of low-level light therapy in the treatment of androgenetic alopecia and female pattern hair loss.

PubMed

Gupta, Aditya K; Daigle, Deanne

2014-04-01

Androgenetic alopecia (AGA) or female pattern hair loss (FPHL) is the most common form of hair loss in men and women. Despite its common occurrence, our understanding of the etiology of AGA and FPHL remains incomplete. As such, traditional therapies demonstrate modest efficacies and new therapies continue to be sought. Low-level light therapy (LLLT) is a relatively new technique used to promote hair growth in both men and women with AGA and FPHL. Currently, there exist several LLLT devices marketed for the treatment of alopecia, which claim to stimulate hair growth; yet marketing these devices only requires that safety, not efficacy, be established. A handful of studies have since investigated the efficacy of LLLT for alopecia with mixed results. These studies suffered from power, confounding and analysis issues which resulted in a high risk of bias in LLLT studies. Due to the paucity of well-conducted randomized controlled trials, the efficacy of LLLT devices remains unclear. Randomized controlled trials of LLLT conducted and reported according to the Consolidated Standards of Reporting Trials (CONSORT) statement would greatly increase the credibility of the evidence and clarify the ambiguity of the effectiveness of LLLT in the treatment of AGA and FPHL.

Review of Clinical Pharmacology of Aloe vera L. in the Treatment of Psoriasis.

PubMed

Miroddi, Marco; Navarra, Michele; Calapai, Fabrizio; Mancari, Ferdinando; Giofrè, Salvatore Vincenzo; Gangemi, Sebastiano; Calapai, Gioacchino

2015-05-01

Aloe vera L., is a plant used worldwide as folk remedy for the treatment of various ailments, including skin disorders. Its gel is present in cosmetics, medicinal products and food supplements. Psoriasis, an immune-mediated chronic inflammatory disease, involving mainly the skin, affects about the 2-3% of general population. Conventional pharmacological treatments for psoriasis can have limited effectiveness and can cause adverse reactions. For this reason often psoriatic patients look for alternative treatments based on natural products containing Aloe vera. We conducted a systematic review of clinical trials assessing effectiveness and safety of aloe for the treatment of psoriasis. Clinical studies published in English were considered; a total of four clinical trials met inclusion criteria. Studies were also evaluated by using the Jadad scale and Consort Statement in Reporting Clinical trials of Herbal Medicine Intervention. Quality and methodological accuracy of considered studies varied considerably, and some crucial information to reproduce clinical results was missing. We conclude that administration of aloe as cutaneous treatment is generally well tolerated, as no serious side effects were reported. Results on the effectiveness of Aloe vera are contradictory; our analysis reveals the presence of methodological gaps preventing to reach final conclusions. Copyright © 2015 John Wiley & Sons, Ltd.

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

PubMed Central

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

2017-01-01

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

Relationship between sponsorship and failure rate of dental implants: a systematic approach.

PubMed

Popelut, Antoine; Valet, Fabien; Fromentin, Olivier; Thomas, Aurélie; Bouchard, Philippe

2010-04-21

The number of dental implant treatments increases annually. Dental implants are manufactured by competing companies. Systematic reviews and meta-analysis have shown a clear association between pharmaceutical industry funding of clinical trials and pro-industry results. So far, the impact of industry sponsorship on the outcomes and conclusions of dental implant clinical trials has never been explored. The aim of the present study was to examine financial sponsorship of dental implant trials, and to evaluate whether research funding sources may affect the annual failure rate. A systematic approach was used to identify systematic reviews published between January 1993 and December 2008 that specifically deal with the length of survival of dental implants. Primary articles were extracted from these reviews. The failure rate of the dental implants included in the trials was calculated. Data on publication year, Impact Factor, prosthetic design, periodontal status reporting, number of dental implants included in the trials, methodological quality of the studies, presence of a statistical advisor, and financial sponsorship were extracted by two independent reviewers (kappa = 0.90; CI(95%) [0.77-1.00]). Univariate quasi-Poisson regression models and multivariate analysis were used to identify variables that were significantly associated with failure rates. Five systematic reviews were identified from which 41 analyzable trials were extracted. The mean annual failure rate estimate was 1.09%.(CI(95%) [0.84-1.42]). The funding source was not reported in 63% of the trials (26/41). Sixty-six percent of the trials were considered as having a risk of bias (27/41). Given study age, both industry associated (OR = 0.21; CI(95%) [0.12-0.38]) and unknown funding source trials (OR = 0.33; (CI(95%) [0.21-0.51]) had a lower annual failure rates compared with non-industry associated trials. A conflict of interest statement was disclosed in 2 trials. When controlling for other factors, the probability of annual failure for industry associated trials is significantly lower compared with non-industry associated trials. This bias may have significant implications on tooth extraction decision making, research on tooth preservation, and governmental health care policies.

Northeast Corridor Improvement Project Electrification - New Haven, CT to Boston, MA : Final Environmental Impact Statement/Report - v. 3. Response to Comments on Draft Environmental Impact Statement/Report

DOT National Transportation Integrated Search

1994-10-31

This document is the final environmental impact statement and final environmental impact report (FEIS/R) on the proposal by the National Railroad Passenger Corporation (Amtrak) to complete the electrification of the Northeast Corridor main line by ex...

Report: State of Utah Drinking Water State Revolving Fund Financial Statements with Independent Auditor’s Report, June 30, 2002

EPA Pesticide Factsheets

Report #2003-1-00110, June 3, 2003.Audit of the net assets statement of the Utah Dept of Env Quality Drinking Water State Revolving Fund Prog as of June 30, 2002, and the statements of revenues, expenses and changes in fund net assets, and 2002 cash flows.

The use of fund accounting and the need for single fund reporting by institutional healthcare providers. Principles and Practices Board Statement No. 8. Healthcare Financial Management Association.

PubMed

1986-06-01

For many years, hospitals and other institutional healthcare providers used fund accounting as a basis for presenting their financial statements. Recently, authoritative literature has placed less emphasis on separate fund reporting. This is evidenced by the reduction of fund classifications specified in the literature. This trend seems to follow the recognition that institutional healthcare activities should be reported in a manner comparable to other businesses. The Principles and Practices Board (P&P Board) of the Healthcare Financial management Association believes that general purpose financial statements of institutional healthcare providers should be comparable to reporting by other businesses. That is, all assets, liabilities, and equity are presented in a single aggregated balance sheet without differentiation by fund. This form of presentation, referred to in this statement as single fund reporting, should be used by all institutional healthcare providers including those that are part of HMOs, universities, municipalities, and other larger entities when separate reports of the provider are issued. The P&P Board is studying other significant issues concerning the reporting of revenues and components of equity and changes therein. The conclusion in this statement can be implemented even though conclusions on these related subjects are not yet complete. The P&P Board recognizes that certain circumstances may require detailed records and reports for special purposes. This statement deals only with those general purpose financial statements on which an independent accountant's opinion is expressed.

Report: Nevada Drinking Water State Revolving Fund Financial Statements with Independent Auditor's Report

EPA Pesticide Factsheets

Examination of the balance sheet of the Nevada Drinking Water State Revolving Fund Program as of June 30, 2001, the related statement of revenues, expenses, and changes in retained earnings, and the statement of 2001 cash flows.

Herbal Medicine for Low Back Pain: A Cochrane Review.

PubMed

Gagnier, Joel J; Oltean, Hanna; van Tulder, Maurits W; Berman, Brian M; Bombardier, Claire; Robbins, Christopher B

2016-01-01

Systematic review of randomized controlled trials (RCTs). To determine the effectiveness of herbal medicine for nonspecific low back pain (LBP). Many people with chronic LBP use complementary and alternative medicine (CAM), visit CAM practitioners, or both. Several herbal medicines have been purported for use in treating people with LBP. This is an update of a Cochrane Review first published in 2006. We searched numerous electronic databases up to September 2014; checked reference lists in review articles, guidelines and retrieved trials; and personally contacted individuals with expertise in this area. We included RCTs examining adults (over 18 years of age) suffering from acute, sub-acute, or chronic nonspecific LBP. The interventions were herbal medicines that we defined as plants used for medicinal purposes in any form. Primary outcome measures were pain and function. Two review authors assessed risk of bias, GRADE criteria (GRADE 2004), and CONSORT compliance and a random subset were compared with assessments by a third individual. Two review authors assessed clinical relevance and resolved any disagreements by consensus. Fourteen RCTs (2050 participants) were included. Capsicum frutescens (cayenne) reduces pain more than placebo. Although Harpagophytum procumbens (devil's claw), Salix alba (white willow bark), Symphytum officinale L. (comfrey), Solidago chilensis (Brazilian arnica), and lavender essential oil also seem to reduce pain more than placebo, evidence for these substances was of moderate quality at best. No significant adverse events were noted within the included trials. Additional well-designed large trials are needed to test these herbal medicines against standard treatments. In general, the completeness of reporting in these trials was poor. Trialists should refer to the CONSORT statement extension for reporting trials of herbal medicine interventions. N/A.

Statement of Facts for 1977 City-Wide Mock Trial Competitions. Walker Thomas v. Sam Nomad.

ERIC Educational Resources Information Center

National Inst. for Citizen Education in the Law, Washington, DC.

Prepared by the District of Columbia Street Law Project for its annual city-wide mock trial competition, this instructional handout provides material for a civil case over an automobile accident. Walker Thomas is suing Sam Nomad for damages that resulted from a collision, for which both parties blame the other. The handout clarifies the laws and…

Impact of Contextual Factors on the Effect of Interventions to Improve Health Worker Performance in Sub-Saharan Africa: Review of Randomised Clinical Trials.

PubMed

Blacklock, Claire; Gonçalves Bradley, Daniela C; Mickan, Sharon; Willcox, Merlin; Roberts, Nia; Bergström, Anna; Mant, David

2016-01-01

Africa bears 24% of the global burden of disease but has only 3% of the world's health workers. Substantial variation in health worker performance adds to the negative impact of this significant shortfall. We therefore sought to identify interventions implemented in sub-Saharan African aiming to improve health worker performance and the contextual factors likely to influence local effectiveness. A systematic search for randomised controlled trials of interventions to improve health worker performance undertaken in sub-Saharan Africa identified 41 eligible trials. Data were extracted to define the interventions' components, calculate the absolute improvement in performance achieved, and document the likelihood of bias. Within-study variability in effect was extracted where reported. Statements about contextual factors likely to have modified effect were subjected to thematic analysis. Interventions to improve health worker performance can be very effective. Two of the three trials assessing mortality impact showed significant reductions in death rates (age<5 case fatality 5% versus 10%, p<0.01; maternal in-hospital mortality 6.8/1000 versus 10.3/1000; p<0.05). Eight of twelve trials focusing on prescribing had a statistically significant positive effect, achieving an absolute improvement varying from 9% to 48%. However, reported range of improvement between centres within trials varied substantially, in many cases exceeding the mean effect. Nine contextual themes were identified as modifiers of intervention effect across studies; most frequently cited were supply-line failures, inadequate supervision or management, and failure to follow-up training interventions with ongoing support, in addition to staff turnover. Interventions to improve performance of existing staff and service quality have the potential to improve patient care in underserved settings. But in order to implement interventions effectively, policy makers need to understand and address the contextual factors which can contribute to differences in local effect. Researchers therefore must recognise the importance of reporting how context may modify effect size.

Impact of Contextual Factors on the Effect of Interventions to Improve Health Worker Performance in Sub-Saharan Africa: Review of Randomised Clinical Trials

PubMed Central

Mickan, Sharon; Willcox, Merlin; Roberts, Nia; Bergström, Anna; Mant, David

2016-01-01

Background Africa bears 24% of the global burden of disease but has only 3% of the world’s health workers. Substantial variation in health worker performance adds to the negative impact of this significant shortfall. We therefore sought to identify interventions implemented in sub-Saharan African aiming to improve health worker performance and the contextual factors likely to influence local effectiveness. Methods and Findings A systematic search for randomised controlled trials of interventions to improve health worker performance undertaken in sub-Saharan Africa identified 41 eligible trials. Data were extracted to define the interventions’ components, calculate the absolute improvement in performance achieved, and document the likelihood of bias. Within-study variability in effect was extracted where reported. Statements about contextual factors likely to have modified effect were subjected to thematic analysis. Interventions to improve health worker performance can be very effective. Two of the three trials assessing mortality impact showed significant reductions in death rates (age<5 case fatality 5% versus 10%, p<0.01; maternal in-hospital mortality 6.8/1000 versus 10.3/1000; p<0.05). Eight of twelve trials focusing on prescribing had a statistically significant positive effect, achieving an absolute improvement varying from 9% to 48%. However, reported range of improvement between centres within trials varied substantially, in many cases exceeding the mean effect. Nine contextual themes were identified as modifiers of intervention effect across studies; most frequently cited were supply-line failures, inadequate supervision or management, and failure to follow-up training interventions with ongoing support, in addition to staff turnover. Conclusions Interventions to improve performance of existing staff and service quality have the potential to improve patient care in underserved settings. But in order to implement interventions effectively, policy makers need to understand and address the contextual factors which can contribute to differences in local effect. Researchers therefore must recognise the importance of reporting how context may modify effect size. PMID:26731097

Explanation and Elaboration Document for the STROBE-Vet Statement: Strengthening the Reporting of Observational Studies in Epidemiology-Veterinary Extension.

PubMed

O'Connor, A M; Sargeant, J M; Dohoo, I R; Erb, H N; Cevallos, M; Egger, M; Ersbøll, A K; Martin, S W; Nielsen, L R; Pearl, D L; Pfeiffer, D U; Sanchez, J; Torrence, M E; Vigre, H; Waldner, C; Ward, M P

2016-11-01

The STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) statement was first published in 2007 and again in 2014. The purpose of the original STROBE was to provide guidance for authors, reviewers, and editors to improve the comprehensiveness of reporting; however, STROBE has a unique focus on observational studies. Although much of the guidance provided by the original STROBE document is directly applicable, it was deemed useful to map those statements to veterinary concepts, provide veterinary examples, and highlight unique aspects of reporting in veterinary observational studies. Here, we present the examples and explanations for the checklist items included in the STROBE-Vet statement. Thus, this is a companion document to the STROBE-Vet statement methods and process document (JVIM_14575 "Methods and Processes of Developing the Strengthening the Reporting of Observational Studies in Epidemiology-Veterinary (STROBE-Vet) Statement" undergoing proofing), which describes the checklist and how it was developed. Copyright © 2016 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals, Inc. on behalf of the American College of Veterinary Internal Medicine.

GASB 34 Financial Statements Are Easier With the Right Tools.

ERIC Educational Resources Information Center

Heinfeld, Gary; Arvizu, C. Christopher; Herrera, Michael L.

2001-01-01

Describes experience with certain tools and resources to help school business officials implement the Governmental Accounting Standards Board Statement 34. Focuses on Association of School Business Officials International's new Certificate of Excellence in Financial Reporting guidebook and financial-statement report-writer software called…

Statement of Facts for 1980 City-Wide Mock Trial Competitions. Albert Banks and Virginia Smallwood, for Herself and on Behalf of Her Minor Son, Dwayne Jones, Plaintiffs v. Potomac Properties, Inc., Thomas R. Baldwin, and Victoria Reese, Defendants. No. MT-80.

ERIC Educational Resources Information Center

National Inst. for Citizen Education in the Law, Washington, DC.

Prepared by the District of Columbia Street Law Project for its ninth annual city-wide mock trial competition, this instructional handout provides the material for a civil trial over housing discrimination. The plaintiffs are an unmarried couple with a disabled child whose application to live at Waterfront Gardens, a property owned by Potomac…

Statement of Facts for 1975 City-Wide Mock Trial Competitions. Georgia Floyd, Individually and as Parent and Next Friend of Minor, Nelson Floyd v. Fix-It Home Remodeling, Inc. and Sam Baldwin.

ERIC Educational Resources Information Center

National Inst. for Citizen Education in the Law, Washington, DC.

Prepared by the District of Columbia Street Law Project for its annual city-wide mock trial competition, this instructional handout provides material for a civil trial over a claim for damages. During an argument, a friend pushed Nelson Floyd against the railing of a porch. Falling onto the concrete below, Nelson was injured with a broken shin…

Surrogate endpoints for overall survival in metastatic melanoma: a meta-analysis of randomised controlled trials

PubMed Central

Flaherty, Keith T; Hennig, Michael; Lee, Sandra J; Ascierto, Paolo A; Dummer, Reinhard; Eggermont, Alexander M M; Hauschild, Axel; Kefford, Richard; Kirkwood, John M; Long, Georgina V; Lorigan, Paul; Mackensen, Andreas; McArthur, Grant; O'Day, Steven; Patel, Poulam M; Robert, Caroline; Schadendorf, Dirk

2015-01-01

Summary Background Recent phase 3 trials have shown an overall survival benefit in metastatic melanoma. We aimed to assess whether progression-free survival (PFS) could be regarded as a reliable surrogate for overall survival through a meta-analysis of randomised trials. Methods We systematically reviewed randomised trials comparing treatment regimens in metastatic melanoma that included dacarbazine as the control arm, and which reported both PFS and overall survival with a standard hazard ratio (HR). We correlated HRs for overall survival and PFS, weighted by sample size or by precision of the HR estimate, assuming fixed and random effects. We did sensitivity analyses according to presence of crossover, trial size, and dacarbazine dose. Findings After screening 1649 reports and meeting abstracts published before Sept 8, 2013, we identified 12 eligible randomised trials that enrolled 4416 patients with metastatic melanoma. Irrespective of weighting strategy, we noted a strong correlation between the treatment effects for PFS and overall survival, which seemed independent of treatment type. Pearson correlation coefficients were 0.71 (95% CI 0.29–0.90) with a random-effects assumption, 0.85 (0.59–0.95) with a fixed-effects assumption, and 0.89 (0.68–0.97) with sample-size weighting. For nine trials without crossover, the correlation coefficient was 0.96 (0.81–0.99), which decreased to 0.93 (0.74–0.98) when two additional trials with less than 50% crossover were included. Inclusion of mature follow-up data after at least 50% crossover (in vemurafenib and dabrafenib phase 3 trials) weakened the PFS to overall survival correlation (0.55, 0.03–0.84). Inclusion of trials with no or little crossover with the random-effects assumption yielded a conservative statement of the PFS to overall survival correlation of 0.85 (0.51–0.96). Interpretation PFS can be regarded as a robust surrogate for overall survival in dacarbazine-controlled randomised trials of metastatic melanoma; we postulate that this association will hold as treatment standards evolve and are adopted as the control arm in future trials. Funding None. PMID:24485879

Management of high blood pressure in Blacks: an update of the International Society on Hypertension in Blacks consensus statement.

PubMed

Flack, John M; Sica, Domenic A; Bakris, George; Brown, Angela L; Ferdinand, Keith C; Grimm, Richard H; Hall, W Dallas; Jones, Wendell E; Kountz, David S; Lea, Janice P; Nasser, Samar; Nesbitt, Shawna D; Saunders, Elijah; Scisney-Matlock, Margaret; Jamerson, Kenneth A

2010-11-01

Since the first International Society on Hypertension in Blacks consensus statement on the "Management of High Blood Pressure in African American" in 2003, data from additional clinical trials have become available. We reviewed hypertension and cardiovascular disease prevention and treatment guidelines, pharmacological hypertension clinical end point trials, and blood pressure-lowering trials in blacks. Selected trials without significant black representation were considered. In this update, blacks with hypertension are divided into 2 risk strata, primary prevention, where elevated blood pressure without target organ damage, preclinical cardiovascular disease, or overt cardiovascular disease for whom blood pressure consistently <135/85 mm Hg is recommended, and secondary prevention, where elevated blood pressure with target organ damage, preclinical cardiovascular disease, and/or a history of cardiovascular disease, for whom blood pressure consistently <130/80 mm Hg is recommended. If blood pressure is ≤10 mm Hg above target levels, monotherapy with a diuretic or calcium channel blocker is preferred. When blood pressure is >15/10 mm Hg above target, 2-drug therapy is recommended, with either a calcium channel blocker plus a renin-angiotensin system blocker or, alternatively, in edematous and/or volume-overload states, with a thiazide diuretic plus a renin-angiotensin system blocker. Effective multidrug therapeutic combinations through 4 drugs are described. Comprehensive lifestyle modifications should be initiated in blacks when blood pressure is ≥115/75 mm Hg. The updated International Society on Hypertension in Blacks consensus statement on hypertension management in blacks lowers the minimum target blood pressure level for the lowest-risk blacks, emphasizes effective multidrug regimens, and de-emphasizes monotherapy.

Pre-referral rectal artesunate in severe malaria: flawed trial.

PubMed

Hirji, Karim F; Premji, Zulfiqarali G

2011-08-08

Immediate injectable treatment is essential for severe malaria. Otherwise, the afflicted risk lifelong impairment or death. In rural areas of Africa and Asia, appropriate care is often miles away. In 2009, Melba Gomes and her colleagues published the findings of a randomized, placebo-controlled trial of rectal artesunate for suspected severe malaria in such remote areas. Enrolling nearly 18,000 cases, the aim was to evaluate whether, as patients were in transit to a health facility, a pre-referral artesunate suppository blocked disease progression sufficiently to reduce these risks. The affirmative findings of this, the only trial on the issue thus far, have led the WHO to endorse rectal artesunate as a pre-referral treatment for severe malaria. In the light of its public health importance and because its scientific quality has not been assessed for a systematic review, our paper provides a detailed evaluation of the design, conduct, analysis, reporting, and practical features of this trial. We performed a checklist-based and an in-depth evaluation of the trial. The evaluation criteria were based on the CONSORT statement for reporting clinical trials, the clinical trial methodology literature, and practice in malaria research. Our main findings are: The inclusion and exclusion criteria and the sample size justification are not stated. Many clearly ineligible subjects were enrolled. The training of the recruiters does not appear to have been satisfactory. There was excessive between center heterogeneity in design and conduct. Outcome evaluation schedule was not defined, and in practice, became too wide. Large gaps in the collection of key data were evident. Primary endpoints were inconsistently utilized and reported; an overall analysis of the outcomes was not done; analyses of time to event data had major flaws; the stated intent-to-treat analysis excluded a third of the randomized subjects; the design-indicated stratified or multi-variate analysis was not done; many improper subgroups were analyzed in a post-hoc fashion; the analysis and reporting metric was deficient. There are concerns relating to patient welfare at some centers. Exclusion of many cases from data analysis compromised external validity. A bias-controlled reanalysis of available data does not lend support to the conclusions drawn by the authors. This trial has numerous serious deficiencies in design, implementation, and methods of data analysis. Interpretation and manner of reporting are wanting, and the applicability of the findings is unclear. The trial conduct could have been improved to better protect patient welfare. The totality of these problems make it a flawed study whose conclusions remain subject to appreciable doubt.

12 CFR 620.2 - Preparing and filing the reports.

Code of Federal Regulations, 2010 CFR

2010-01-01

... annual and quarterly financial statements on a combined or consolidated basis shall also include in the...: (a) Copies of each report required by this part, including financial statements and related schedules... from accounting policies of the combined or consolidated statements. (2) Any bank that prepares its...

Elevating the quality of disability and rehabilitation research: mandatory use of the reporting guidelines.

PubMed

Chan, Leighton; Heinemann, Allen W; Roberts, Jason

2014-01-01

Note from the AJOT Editor-in-Chief: Since 2010, the American Journal of Occupational Therapy (AJOT) has adopted reporting standards based on the Consolidated Standards of Reporting Trials (CONSORT) Statement and American Psychological Association (APA) guidelines in an effort to publish transparent clinical research that can be easily evaluated for methodological and analytical rigor (APA Publications and Communications Board Working Group on Journal Article Reporting Standards, 2008; Moher, Schulz, & Altman, 2001). AJOT has now joined 28 other major rehabilitation and disability journals in a collaborative initiative to enhance clinical research reporting standards through adoption of the EQUATOR Network reporting guidelines, described below. Authors will now be required to use these guidelines in the preparation of manuscripts that will be submitted to AJOT. Reviewers will also use these guidelines to evaluate the quality and rigor of all AJOT submissions. By adopting these standards we hope to further enhance the quality and clinical applicability of articles to our readers. Copyright © 2014 by the American Occupational Therapy Association, Inc.

Systematic Evaluation of the Patient-Reported Outcome (PRO) Content of Clinical Trial Protocols

PubMed Central

Kyte, Derek; Duffy, Helen; Fletcher, Benjamin; Gheorghe, Adrian; Mercieca-Bebber, Rebecca; King, Madeleine; Draper, Heather; Ives, Jonathan; Brundage, Michael; Blazeby, Jane; Calvert, Melanie

2014-01-01

Background Qualitative evidence suggests patient-reported outcome (PRO) information is frequently absent from clinical trial protocols, potentially leading to inconsistent PRO data collection and risking bias. Direct evidence regarding PRO trial protocol content is lacking. The aim of this study was to systematically evaluate the PRO-specific content of UK National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme trial protocols. Methods and Findings We conducted an electronic search of the NIHR HTA programme database (inception to August 2013) for protocols describing a randomised controlled trial including a primary/secondary PRO. Two investigators independently reviewed the content of each protocol, using a specially constructed PRO-specific protocol checklist, alongside the ‘Standard Protocol Items: Recommendations for Interventional Trials’ (SPIRIT) checklist. Disagreements were resolved through discussion with a third investigator. 75 trial protocols were included in the analysis. Protocols included a mean of 32/51 (63%) SPIRIT recommendations (range 16–41, SD 5.62) and 11/33 (33%) PRO-specific items (range 4–18, SD 3.56). Over half (61%) of the PRO items were incomplete. Protocols containing a primary PRO included slightly more PRO checklist items (mean 14/33 (43%)). PRO protocol content was not associated with general protocol completeness; thus, protocols judged as relatively ‘complete’ using SPIRIT were still likely to have omitted a large proportion of PRO checklist items. Conclusions The PRO components of HTA clinical trial protocols require improvement. Information on the PRO rationale/hypothesis, data collection methods, training and management was often absent. This low compliance is unsurprising; evidence shows existing PRO guidance for protocol developers remains difficult to access and lacks consistency. Study findings suggest there are a number of PRO protocol checklist items that are not fully addressed by the current SPIRIT statement. We therefore advocate the development of consensus-based supplementary guidelines, aimed at improving the completeness and quality of PRO content in clinical trial protocols. PMID:25333349

Nurses' Attitudes toward Clinical Research: Experience of the Therapeutic Hypothermia after Pediatric Cardiac Arrest Trials

PubMed Central

Browning, Brittan; Page, Kent E.; Kuhn, Renee L.; DiLiberto, Mary Ann; Deschenes, Jendar; Taillie, Eileen; Tomanio, Elyse; Holubkov, Richard; Dean, J. Michael; Moler, Frank W.; Meert, Kathleen; Pemberton, Victoria L.

2016-01-01

Objectives To understand factors affecting nurses' attitudes towards the Therapeutic Hypothermia after Pediatric Cardiac Arrest (THAPCA) trials and association with approach/consent rates. Design, setting and participants Cross sectional survey of pediatric/cardiac intensive care nurses' perceptions of the trials, conducted at 16 of 38 self-selected study sites. Measurements The primary outcome was the proportion of nurses with positive perceptions, as defined by agree or strongly agree with the statement “I am happy to take care of a THAPCA patient”. Associations between perceptions and study approach/consent rates were also explored. Results Of 2241 nurses invited, 1387 (62%) completed the survey and 77% reported positive perceptions of the trials. Nurses, who felt positively about the scientific question, the study team, and training received, were more likely to have positive perceptions of the trials (p <0.001). Nurses who had previously cared for a research patient had significantly more positive perceptions of THAPCA compared with those who had not (79% vs. 54%, p<0.001). Of the 754 nurses who cared for a THAPCA patient, 82% had positive perceptions, despite 86% reporting it required more work. Sixty-nine percent believed that hypothermia reduces brain injury and mortality; sites had lower consent rates when their nurses believed that hypothermia was beneficial. Institution-specific approach rates were positively correlated with nurses' perceptions of institutional support for the trial (r=0.54, p=0.04), intensive care unit support (r=0.61, p=0.02), and the importance of conducting the trial in children (r=0.61, p=0.01). Conclusions The majority of nurses had positive perceptions of the THAPCA trials. Institutional, colleague and study team support and training were contributing factors. Despite increased work, nurses remained enthusiastic demonstrating that studies with intensive bedside nursing procedures are feasible. Institutions whose nurses believed hypothermia was beneficial had lower consent rates suggesting that educating nurses on study rationale and equipoise may enhance study participation. PMID:26669643

7 CFR 1775.21 - Audit or financial statements.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 12 2010-01-01 2010-01-01 false Audit or financial statements. 1775.21 Section 1775... Audit or financial statements. The grantee will provide an audit report or financial statements as... year. (b) Grantees expending less than $500,000 will provide annual financial statements covering the...

78 FR 13082 - Draft Environmental Impact Report/Environmental Impact Statement/Environmental Impact Statement...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-26

... Impact Statement/ Environmental Impact Statement, Upper Truckee River and Marsh Restoration Project, El... Statement (EIR/EIS/EIS) for the Upper Truckee River Restoration and Marsh Restoration Project (Project). The... prepare email comments for the Project. The public hearings will be held at 128 Market Street, Stateline...

It's Time to Implement GASB Statement 54

ERIC Educational Resources Information Center

Heinfeld, Gary; Nuehring, Bert

2012-01-01

In February 2009, the Governmental Accounting Standards Board (GASB) issued Statement No. 54, "Find Balance Reporting and Governmental Fund Type Definitions." This statement changes how a fund balance is classified on the face of the government fund financial statements and refines the definitions for government fund types. The statement's…

Eliminating Entries.

DTIC Science & Technology

1997-03-31

included in the FY 1996 DoD-wide Consolidated Financial Statements . The entities’ assets reported by DoD in FY 1995, excluding Other Defense...Organizations, totaled $1,306 billion, and revenues totaled $303 billion. When an entity prepares consolidated financial statements , it should eliminate the...series of reports on the FY 1996 DoD-wide Consolidated Financial Statements . We determined whether eliminating entries were properly reported on the FY

Financial Statements: Disclosures and Presentations.

DTIC Science & Technology

1985-12-01

may be rendered when the financial statements are p;eaed in full compliance with GAAP , consistently applied. Inadequate disclosures as well as other...after the end of the current year, respectively. (Delaney et al., GAAP Interpretation and Application, pp. 52-53. ) Beginning Measurement Disposal End...Of Changing Prices In Financial Reports GAAP for reporting changing prices in financial reports is promulgated in FASB Statements 33, 39, 40, 41, 46

Implementation Recommendations for School Districts. GASB Statement No. 34.

ERIC Educational Resources Information Center

Association of School Business Officials International, Reston, VA.

Statement 34 is the most significant change in the history of governmental accounting. It is a dramatic change in the way school districts report and present financial information. This new reporting model affects every public-school organization that issues financial statements in conformity with generally accepted accounting principles (GAAP).…

48 CFR 2052.211-72 - Financial status report.

Code of Federal Regulations, 2014 CFR

2014-10-01

...-approved CSP projections, a written statement to that effect is sufficient in lieu of submitting a detailed... no property was acquired during the month, include a statement to that effect. The same information... was acquired under the contract, provide a statement to that effect. The report should note any...

48 CFR 2052.211-72 - Financial status report.

Code of Federal Regulations, 2012 CFR

2012-10-01

...-approved CSP projections, a written statement to that effect is sufficient in lieu of submitting a detailed... no property was acquired during the month, include a statement to that effect. The same information... was acquired under the contract, provide a statement to that effect. The report should note any...

48 CFR 2052.211-72 - Financial status report.

Code of Federal Regulations, 2010 CFR

2010-10-01

...-approved CSP projections, a written statement to that effect is sufficient in lieu of submitting a detailed... no property was acquired during the month, include a statement to that effect. The same information... was acquired under the contract, provide a statement to that effect. The report should note any...

Applying Statement 34's Capital Asset Requirements.

ERIC Educational Resources Information Center

Finden, Randal

2001-01-01

Discusses common issues and offers recommendations related to revisions in Governmental Accounting Standards Board Statement 34 wherein the financial reporting of the general fixed-assets account group is eliminated and instead a school district's general capital assets are reported and depreciated on the new statement of net assets and statement…

11 CFR 9008.3 - Eligibility for payments; registration and reporting.

Code of Federal Regulations, 2010 CFR

2010-01-01

... application statement. Any changes in the information provided in the application statement must be reported to the Commission within 10 days following the change. The application statement shall include: (i... designated by the national committee to sign requests for payments; and (v) The name and address of the...

11 CFR 9008.3 - Eligibility for payments; registration and reporting.

Code of Federal Regulations, 2011 CFR

2011-01-01

... application statement. Any changes in the information provided in the application statement must be reported to the Commission within 10 days following the change. The application statement shall include: (i... designated by the national committee to sign requests for payments; and (v) The name and address of the...

Alberta Learning Annual Report, 1999/2000.

ERIC Educational Resources Information Center

Alberta Learning, Edmonton.

This annual report of the Ministry of Learning contains the minister's accountability statement, the audited consolidated financial statements of the ministry, and a comparison of actual performance results with desired results set out in the ministry business plan. It also includes the financial statements of entities making up the ministry,…

48 CFR 222.406-6 - Payrolls and statements.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 3 2010-10-01 2010-10-01 false Payrolls and statements... Labor Standards for Contracts Involving Construction 222.406-6 Payrolls and statements. (a) Submission..., Statement of Compliance, with each payroll report. ...

Effect of different financial competing interest statements on readers' perceptions of clinical educational articles: study protocol for a randomised controlled trial.

PubMed

Schroter, Sara; Pakpoor, Julia; Morris, Julie; Chew, Mabel; Godlee, Fiona

2016-06-10

Financial ties with industry are varied and common among academics, doctors and institutions. Clinical educational articles are intended to guide patient care and convey authors' own interpretation of selected data. Author biases in educational articles tend to be less visible to readers compared to those in research papers. Little is known about which types of competing interest statements affect readers' interpretation of the credibility of these articles. This study aims to investigate how different competing interest statements in educational articles affect clinical readers' perceptions of the articles. 2040 doctors who are members of the British Medical Association (BMA) and receive a copy of the British Medical Journal (The BMJ) each week will be randomly selected and invited by an email to participate in the study. They will be randomised to receive 1 of 2 Clinical Reviews, each with 1 of 4 possible competing interest statements. Versions of each review will be identical except for permutations of the competing interest statement. Study participants will be asked to read their article and complete an online questionnaire. The questionnaire will ask participants to rate their confidence in the conclusions drawn in the article, the importance of the article, their level of interest in the article and their likeliness to change their practice from the article. Factorial analyses of variance and analyses of covariance will be carried out to assess the impact of the type of competing interest statement and Clinical Review on level of confidence, importance, interest and likeliness to change practice. The study protocol, questionnaire and letter of invitation to participants have been reviewed by members of The BMJ's Ethics Committee for ethical concerns. The trial results will be disseminated to participants and published in a peer-reviewed journal. NCT02548312; Pre-results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Insulin therapy for adult patients with type 2 diabetes mellitus: a position statement of the Korean Diabetes Association, 2017.

PubMed

Lee, Byung-Wan; Kim, Jin Hwa; Ko, Seung-Hyun; Hur, Kyu Yeon; Kim, Nan-Hee; Rhee, Sang Youl; Kim, Hyun Jin; Moon, Min Kyong; Park, Seok-O; Choi, Kyung Mook

2017-11-01

The Korean Diabetes Association (KDA) has regularly updated its Clinical Practice Guidelines. In 2017, the KDA published a position statement on the use of antihyperglycemic agents for patients with type 2 diabetes mellitus (T2DM). Growing evidence from new multinational clinical trials using novel and traditional insulin analogues has also been accumulated. Following global trends, many results of clinical trials, especially concerning the clinical efficacy and safety of insulin therapy, have been published about Korean patients with T2DM. After a systematic search of recent evidence, the KDA updated and modified its clinical practice recommendations regarding the initiation, choice, and intensification of insulin and created an insulin treatment algorithm for the first time to guide physicians caring for adult Korean patients with T2DM.

Mechanical thrombectomy in acute ischemic stroke: Consensus statement by ESO-Karolinska Stroke Update 2014/2015, supported by ESO, ESMINT, ESNR and EAN.

PubMed

Wahlgren, Nils; Moreira, Tiago; Michel, Patrik; Steiner, Thorsten; Jansen, Olav; Cognard, Christophe; Mattle, Heinrich P; van Zwam, Wim; Holmin, Staffan; Tatlisumak, Turgut; Petersson, Jesper; Caso, Valeria; Hacke, Werner; Mazighi, Mikael; Arnold, Marcel; Fischer, Urs; Szikora, Istvan; Pierot, Laurent; Fiehler, Jens; Gralla, Jan; Fazekas, Franz; Lees, Kennedy R

2016-01-01

The original version of this consensus statement on mechanical thrombectomy was approved at the European Stroke Organisation (ESO)-Karolinska Stroke Update conference in Stockholm, 16-18 November 2014. The statement has later, during 2015, been updated with new clinical trials data in accordance with a decision made at the conference. Revisions have been made at a face-to-face meeting during the ESO Winter School in Berne in February, through email exchanges and the final version has then been approved by each society. The recommendations are identical to the original version with evidence level upgraded by 20 February 2015 and confirmed by 15 May 2015. The purpose of the ESO-Karolinska Stroke Update meetings is to provide updates on recent stroke therapy research and to discuss how the results may be implemented into clinical routine. Selected topics are discussed at consensus sessions, for which a consensus statement is prepared and discussed by the participants at the meeting. The statements are advisory to the ESO guidelines committee. This consensus statement includes recommendations on mechanical thrombectomy after acute stroke. The statement is supported by ESO, European Society of Minimally Invasive Neurological Therapy (ESMINT), European Society of Neuroradiology (ESNR), and European Academy of Neurology (EAN). © 2016 World Stroke Organization.

Standards for definitions and use of outcome measures for clinical effectiveness research in perioperative medicine: European Perioperative Clinical Outcome (EPCO) definitions: a statement from the ESA-ESICM joint taskforce on perioperative outcome measures.

PubMed

Jammer, Ib; Wickboldt, Nadine; Sander, Michael; Smith, Andrew; Schultz, Marcus J; Pelosi, Paolo; Leva, Brigitte; Rhodes, Andrew; Hoeft, Andreas; Walder, Bernhard; Chew, Michelle S; Pearse, Rupert M

2015-02-01

There is a need for large trials that test the clinical effectiveness of interventions in the field of perioperative medicine. Clinical outcome measures used in such trials must be robust, clearly defined and patient-relevant. Our objective was to develop standards for the use of clinical outcome measures to strengthen the methodological quality of perioperative medicine research. A literature search was conducted using PubMed and opinion leaders worldwide were invited to nominate papers that they believed the group should consider. The full texts of relevant articles were reviewed by the taskforce members and then discussed to reach a consensus on the required standards. The report was then circulated to opinion leaders for comment and review. This report describes definitions for 22 individual adverse events with a system of severity grading for each. In addition, four composite outcome measures were identified, which were designed to evaluate postoperative outcomes. The group also agreed on standards for four outcome measures for the evaluation of healthcare resource use and quality of life. Guidance for use of these outcome measures is provided, with particular emphasis on appropriate duration of follow-up. This report provides clearly defined and patient-relevant outcome measures for large clinical trials in perioperative medicine. These outcome measures may also be of use in clinical audit. This report is intended to complement and not replace other related work to improve assessment of clinical outcomes following specific surgical procedures.

Compilation of FY 1997 Air Force General Funds Consolidated Financial Statements at the Defense Finance and Accounting Service Denver Center.

DTIC Science & Technology

1998-10-05

Consolidated Financial Statements to the Air Force Audit Agency. The Defense Finance and Accounting Service Denver Center maintained accounting records and prepared the FY 1997 financial statements for the Air Force. More than $343 billion in total assets was reported at year’s end in these statements, and total revenues for the year exceeded $64 billion. The Air Force Audit Agency disclaimed an opinion on these statements. Additionally, although the Office of Management and Budget does not require budgetary resource reporting until FY 1998, the Air Force

Explanation and Elaboration Document for the STROBE-Vet Statement: Strengthening the Reporting of Observational Studies in Epidemiology - Veterinary Extension.

PubMed

O'Connor, A M; Sargeant, J M; Dohoo, I R; Erb, H N; Cevallos, M; Egger, M; Ersbøll, A K; Martin, S W; Nielsen, L R; Pearl, D L; Pfeiffer, D U; Sanchez, J; Torrence, M E; Vigre, H; Waldner, C; Ward, M P

2016-12-01

The STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) statement was first published in 2007 and again in 2014. The purpose of the original STROBE was to provide guidance for authors, reviewers and editors to improve the comprehensiveness of reporting; however, STROBE has a unique focus on observational studies. Although much of the guidance provided by the original STROBE document is directly applicable, it was deemed useful to map those statements to veterinary concepts, provide veterinary examples and highlight unique aspects of reporting in veterinary observational studies. Here, we present the examples and explanations for the checklist items included in the STROBE-Vet Statement. Thus, this is a companion document to the STROBE-Vet Statement Methods and process document, which describes the checklist and how it was developed. © 2016 The Authors. Zoonoses and Public Health published by Blackwell Verlag GmbH.

Methodological and ethical aspects of randomized controlled clinical trials in minors with malignant diseases.

PubMed

Rothenberger, Lillian G; Henschel, Andreas Dirk; Schrey, Dominik; Becker, Andreas; Boos, Joachim

2011-10-01

Due to the new European regulations for pediatric medications, future clinical trials will include an increasing number of minors. It is therefore important to reconsider and evaluate recent methodological and ethical aspects of clinical trials in minors. The following questions were investigated: How are randomized controlled clinical trials (RCTs) performed in practice? Do investigators take into consideration biomedical ethical principles, explicated for example by Beauchamp and Childress, when planning and conducting a trial? The study was conducted in a descriptive manner. A systematic, algorithm-guided search focusing on RCTs in minors with malignant diseases was carried out in PubMed. One-thousand-nine-hundred-sixty-two publications from 2001 to 2005 were randomized in sequence. The first 1,000 publications were screened according to a priori defined inclusion criteria. One hundred seventy-five publications met the criteria and were reviewed using the SIGN methodological checklist (2004), the CONSORT Statement (2001, section Methods, items 3-12) and indicators for ethical aspects. Seventeen publications were checked by two raters. Information on randomization and blinding was often equivocal. The publications were mainly rated positive for the criteria of the SIGN checklist, and mostly rated negative for the additional items of the CONSORT Statement. Regarding the ethical principles, only few contributions were found in the publications. Inter-rater reliability was good. In the publications analyzed, we found only limited information concerning methods and reflections on ethical principles of the trials. Improvements are thus necessary and possible. We suggest how such trials and their respective publications can be optimized for these aspects. Copyright © 2011 Wiley-Liss, Inc.

Reporting quality of randomised controlled trial abstracts on age-related macular degeneration health care: a cross-sectional quantification of the adherence to CONSORT abstract reporting recommendations.

PubMed

Baulig, Christine; Krummenauer, Frank; Geis, Berit; Tulka, Sabrina; Knippschild, Stephanie

2018-05-22

To assess the reporting quality of randomised controlled trial (RCT) abstracts on age-related macular degeneration (AMD) healthcare, to evaluate the adherence to the Consolidated Standards of Reporting Trials (CONSORT) statement's recommendations on minimum abstract information and to identify journal characteristics associated with abstract reporting quality. Cross-sectional evaluation of RCT abstracts on AMD healthcare. A PubMed search was implemented to identify RCT abstracts on AMD healthcare published in the English language between January 2004 and December 2013. Data extraction was performed by two parallel readers independently by means of a documentation format in accordance with the 16 items of the CONSORT checklist for abstracts. The total number of criteria fulfilled by an abstract was derived as primary endpoint of the investigation; incidence rate ratios (IRRs) with unadjusted 95% CI were estimated by means of multiple Poisson regression to identify journal and article characteristics (publication year, multicentre design, structured abstract recommendations, effective sample size, effective abstract word counts and journal impact factor) possibly associated with the total number of fulfilled items. 136 of 673 identified abstracts (published in 36 different journals) fulfilled all eligibility criteria. The median number of fulfilled items was 7 (95% CI 7 to 8). No abstract reported all 16 recommended items; the maximum total number was 14, the minimum 3 of 16 items. Multivariate analysis only demonstrated the abstracts' word counts as being significantly associated with a better reporting of abstracts (Poisson regression-based IRR 1.002, 95% CI 1.001 to 1.003). Reporting quality of RCT abstracts on AMD investigations showed a considerable potential for improvement to meet the CONSORT abstract reporting recommendations. Furthermore, word counts of abstracts were identified as significantly associated with the overall abstract reporting quality. © 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.

Financial Reporting under GASB Statement No. 34 and ASBO International Certificate of Excellence Financial Reporting.

ERIC Educational Resources Information Center

Heinfeld, Gary

This guide presents a financial model that affects all governmental entities that issue financial statements in conformity with Generally Accepted Accounting Principles (GAAP). The model was prepared to provide school business officials specific examples of school system financial-statement presentations. The guide is divided into six chapters.…

17 CFR 240.14c-101 - Schedule 14C. Information required in information statement.

Code of Federal Regulations, 2014 CFR

2014-04-01

... separate copy of the annual report to security holders, information statement, or Notice of Internet... annual reports to security holders, information statements, or Notices of Internet Availability of Proxy... 17 Commodity and Securities Exchanges 4 2014-04-01 2014-04-01 false Schedule 14C. Information...

17 CFR 240.14c-101 - Schedule 14C. Information required in information statement.

Code of Federal Regulations, 2013 CFR

2013-04-01

... separate copy of the annual report to security holders, information statement, or Notice of Internet... annual reports to security holders, information statements, or Notices of Internet Availability of Proxy... 17 Commodity and Securities Exchanges 3 2013-04-01 2013-04-01 false Schedule 14C. Information...

17 CFR 240.14c-101 - Schedule 14C. Information required in information statement.

Code of Federal Regulations, 2012 CFR

2012-04-01

... separate copy of the annual report to security holders, information statement, or Notice of Internet... annual reports to security holders, information statements, or Notices of Internet Availability of Proxy... 17 Commodity and Securities Exchanges 3 2012-04-01 2012-04-01 false Schedule 14C. Information...

Northeast Corridor Improvement Project Electrification - New Haven, CT to Boston, MA : Final Environmental Impact and Statement/Report and 4(f) Statement v. 1

DOT National Transportation Integrated Search

1994-10-31

This document is the final environmental impact statement and final environmental impact report (FEIS/R) on the proposal by the National Railroad Passenger Corporation (Amtrak) to complete the electrification of the Northeast Corridor main line by ex...

29 CFR 2520.104-50 - Short plan years, deferral of accountant's examination and report.

Code of Federal Regulations, 2010 CFR

2010-07-01

...) Financial statements and accompanying schedules prepared in conformity with the requirements of section 103... respect to the financial statements and accompanying schedules for both of the two plan years. (2) The annual report for the second of the two consecutive plan years shall include: (i) Financial statements...

Does message framing predict willingness to participate in a hypothetical HIV vaccine trial: an application of Prospect Theory.

PubMed

Evangeli, Michael; Kafaar, Zuhayr; Kagee, Ashraf; Swartz, Leslie; Bullemor-Day, Philippa

2013-01-01

It is vital that enough participants are willing to participate in clinical trials to test HIV vaccines adequately. It is, therefore, necessary to explore what affects peoples' willingness to participate (WTP) in such trials. Studies have only examined individual factors associated with WTP and not the effect of messages about trial participation on potential participants (e.g., whether losses or gains are emphasized, or whether the outcome is certain or uncertain). This study explores whether the effects of message framing on WTP in a hypothetical HIV vaccine trial are consistent with Prospect Theory. This theory suggests that people are fundamentally risk averse and that (1) under conditions of low risk and high certainty, gain-framed messages will be influential (2) under conditions of high risk and low certainty, loss-framed messages will be influential. This cross-sectional study recruited 283 HIV-negative students from a South African university who were given a questionnaire that contained matched certain gain-framed, certain loss-framed, uncertain gain-framed, and uncertain loss-framed statements based on common barriers and facilitators of WTP. Participants were asked to rate how likely each statement was to result in their participation in a hypothetical preventative HIV vaccine trial. Consistent with Prospect Theory predictions, for certain outcomes, gain-framed messages were more likely to result in WTP than loss-framed messages. Inconsistent with predictions, loss-framed message were not more likely to be related to WTP for uncertain outcomes than gain-framed messages. Older students were less likely to express their WTP across the different message frames. Recruitment for HIV vaccine trials should pay attention to how messages about the trial are presented to potential participants.

Alaska Power Administration combined financial statements, schedules and supplemental reports, September 30, 1995 and 1994

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

NONE

1995-12-31

This report presents the results of the independent certified public accountant`s audit of the Department of Energy`s Alaska Power Administration`s (Alaska) financial statements as of September 30, 1995. The auditors have expressed an unqualified opinion on the 1995 statements. Their reports on Alaska`s internal control structure and on compliance with laws and regulations are also provided. The Alaska Power Administration operates and maintains two hydroelectric projects that include five generator units, three power tunnels and penstocks, and over 88 miles of transmission line. Additional information about Alaska Power Administration is provided in the notes to the financial statements. The 1995more » financial statement audit was made under the provisions of the Inspector General Act (5 U.S.C. App.), as amended, the Chief Financial Officers (CFO) Act (31 U.S.C. 1500), and Office of Management and Budget implementing guidance to the CFO Act. The auditor`s work was conducted in accordance with generally accepted government auditing standards. To fulfill the audit responsibilities, the authors contracted with the independent public accounting firm of KPMG Peat Marwick (KPMG) to conduct the audit for us, subject to review. The auditor`s report on Alaska`s internal control structure disclosed no reportable conditions that could have a material effect on the financial statements. The auditor also considered the overview and performance measure data for completeness and material consistency with the basic financial statements, as noted in the internal control report. The auditor`s report on compliance with laws and regulations disclosed no instances of noncompliance by Alaska.« less

10 CFR 51.53 - Postconstruction environmental reports.

Code of Federal Regulations, 2011 CFR

2011-01-01

... impact statement; supplements to the final environmental impact statement, including supplements prepared at the license renewal stage; NRC staff-prepared final generic environmental impact statements; and... reflect new information in addition to that discussed in the final environmental impact statement prepared...

Usual and Unusual Care: Existing Practice Control Groups In Randomized Controlled Trials of Behavioral Interventions

PubMed Central

Freedland, Kenneth E.; Mohr, David C.; Davidson, Karina W.; Schwartz, Joseph E.

2011-01-01

Objective To examine the use of existing practice control groups in randomized controlled trials of behavioral interventions, and the role of extrinsic healthcare services in the design and conduct of behavioral trials. Method Selective qualitative review. Results Extrinsic healthcare services, also known as nonstudy care, have important but under-recognized effects on the design and conduct of behavioral trials. Usual care, treatment as usual, standard of care, and other existing practice control groups pose a variety of methodological and ethical challenges, but they play a vital role in behavioral intervention research. Conclusion This review highlights the need for a scientific consensus statement on control groups in behavioral trials. PMID:21536837

Usual and unusual care: existing practice control groups in randomized controlled trials of behavioral interventions.

PubMed

Freedland, Kenneth E; Mohr, David C; Davidson, Karina W; Schwartz, Joseph E

2011-05-01

To evaluate the use of existing practice control groups in randomized controlled trials of behavioral interventions and the role of extrinsic health care services in the design and conduct of behavioral trials. Selective qualitative review. Extrinsic health care services, also known as nonstudy care, have important but under-recognized effects on the design and conduct of behavioral trials. Usual care, treatment-as-usual, standard of care, and other existing practice control groups pose a variety of methodological and ethical challenges, but they play a vital role in behavioral intervention research. This review highlights the need for a scientific consensus statement on control groups in behavioral trials.

International Psychogeriatric Association consensus statement on defining and measuring treatment benefits in dementia.

PubMed

Katona, Cornelius; Livingston, Gill; Cooper, Claudia; Ames, David; Brodaty, Henry; Chiu, Edmond

2007-06-01

Current symptomatic treatments for dementia have only modest efficacy. Assessing meaningful benefits in this variably progressive syndrome is complex and difficult. This consensus statement was generated by an international group representing caregivers, organizations and professionals with expertise in dementia. We recommend the statement of clear, pre-defined diagnostic and severity criteria and outcome measures, which include functional and executive capacity, in treatment trials. Outcomes can include effects on people with dementia (PWD) with regard to cognition, behavioral and psychological symptoms, quality of life, global assessments, and activities of daily living, and must be tailored to the education and culture of the participants. Outcomes can also appropriately encompass effects on caregivers. New instruments may be needed, as validation of many existing measures has been in relatively homogenous populations. Treatment goals can be to prevent dementia emerging, or in those with established dementia to slow deterioration, and to postpone, stabilize or improve symptoms. Comparisons between treatment groups should be on the basis of clinically relevant measures with both risk and benefit reported for all participants regardless of whether or not they continue to receive treatment throughout the trial. Characterization of any groups that respond well to treatment has been unsuccessful to date, but may be facilitated in the future by measurement of putative biomarkers. Despite considerable recent progress and several 'candidate' biomarkers, none is yet satisfactory for determining diagnosis, severity, progression or prediction of response. To provide meaningful data, economic analyses should use up-to-date, country-specific data. Health economic measures should be incorporated as secondary outcomes in all Phase 3 trials since health systems are concerned with cost-effectiveness as well as clinical outcome. Health utility measures are not, however, validated satisfactorily in dementia, thus calling into question previous health economic analyses. While current drugs appear to reduce the amount of family caregiver time required by PWD, these costs fall in the main on older individuals who often exert little political leverage, rather than on society at large. Traditionally, elderly people have been marginalized in the political process. The growth in the older population across the world, and their potential for increasing political empowerment may lead to a radical re-evaluation of the economics of treatment in dementia.

Patients' Use and Evaluation of an Online System to Annotate Radiology Reports with Lay Language Definitions.

PubMed

Cook, Tessa S; Oh, Seong Cheol; Kahn, Charles E

2017-09-01

The increasing availability of personal health portals has made it easier for patients to obtain their imaging results online. However, the radiology report typically is designed to communicate findings and recommendations to the referring clinician, and may contain many terms unfamiliar to lay readers. We sought to evaluate a web-based interface that presented reports of knee MRI (magnetic resonance imaging) examinations with annotations that included patient-oriented definitions, anatomic illustrations, and hyperlinks to additional information. During a 7-month observational trial, a statement added to all knee MRI reports invited patients to view their annotated report online. We tracked the number of patients who opened their reports, the terms they hovered over to view definitions, and the time hovering over each term. Patients who accessed their annotated reports were invited to complete a survey. Of 1138 knee MRI examinations during the trial period, 185 patients (16.3%) opened their report in the viewing portal. Of those, 141 (76%) hovered over at least one term to view its definition, and 121 patients (65%) viewed a mean of 27.5 terms per examination and spent an average of 3.5 minutes viewing those terms. Of the 22 patients who completed the survey, 77% agreed that the definitions helped them understand the report and 91% stated that the illustrations were helpful. A system that provided definitions and illustrations of the medical and technical terms in radiology reports has potential to improve patients' understanding of their reports and their diagnoses. Copyright © 2017 The Association of University Radiologists. Published by Elsevier Inc. All rights reserved.

Completeness of reporting in abstracts from clinical trials of pre-harvest interventions against foodborne pathogens.

PubMed

Snedeker, Kate G; Canning, Paisley; Totton, Sarah C; Sargeant, Jan M

2012-04-01

Abstracts are the most commonly read part of a journal article, and play an important role as summaries of the articles, and search and screening tools. However, research on abstracts in human biomedicine has shown that abstracts often do not report key methodological features and results. Little research has been done to examine reporting of such features in abstracts from papers detailing pre-harvest food safety trials. Thus, the objective of this study was to assess the quality of reporting of key factors in abstracts detailing trials of pre-harvest food safety interventions. A systematic search algorithm was used to identify all in vivo trials of pre-harvest interventions against foodborne pathogens in PubMed and CAB Direct published from 1999 to October 2009. References were screened for relevance, and 150 were randomly chosen for inclusion in the study. A checklist based on the CONSORT abstract extension and the REFLECT Statement was used to assess the reporting of methodological features and results. All screening and assessment was performed by two independent reviewers with disagreements resolved by consensus. The systematic search returned 3554 unique citations; 356 were found to be relevant and 150 were randomly selected for inclusion. The abstracts were from 51 different journals, and 13 out of 150 were structured. Of the 124 abstracts that reported whether the trial design was deliberate disease challenge or natural exposure, 113 were deliberate challenge and 11 natural exposure. 103 abstracts detailed studies involving poultry, 20 cattle and 15 swine. Most abstracts reported the production stage of the animals (135/150), a hypothesis or objective (123/150), and results for all treatment groups (136/150). However, few abstracts reported on how animals were grouped in housing (25/150), the location of the study (5/150), the primary outcome (2/126), level of treatment allocation (15/150), sample size (63/150) or whether study units were lost to follow up (4/150). Forty-eight (48/150) abstracts reported the name, mode of administration, dose and duration of the intervention(s), while 102 (102/150) reported at least one of these elements. Nine (9/150) abstracts specified that allocation of study units to treatments was randomized, and none of the abstracts reported whether blinding was used (0/150). These results reveal gaps in reporting of methodological features and results. Thus, improving reporting quality in abstracts should be a crucial goal to be pursued by authors, reviewers and journal editors. Copyright © 2011 Elsevier B.V. All rights reserved.

42 CFR 460.208 - Financial statements.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 4 2010-10-01 2010-10-01 false Financial statements. 460.208 Section 460.208... ELDERLY (PACE) Data Collection, Record Maintenance, and Reporting § 460.208 Financial statements. (a... must submit a certified financial statement that includes appropriate footnotes. (2) The financial...

Longitudinal analysis of reporting and quality of systematic reviews in high-impact surgical journals.

PubMed

Chapman, S J; Drake, T M; Bolton, W S; Barnard, J; Bhangu, A

2017-02-01

The PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) Statement aims to optimize the reporting of systematic reviews. The performance of the PRISMA Statement in improving the reporting and quality of surgical systematic reviews remains unclear. Systematic reviews published in five high-impact surgical journals between 2007 and 2015 were identified from online archives. Manuscripts blinded to journal, publication year and authorship were assessed according to 27 reporting criteria described by the PRISMA Statement and scored using a validated quality appraisal tool (AMSTAR, Assessing the Methodological Quality of Systematic Reviews). Comparisons were made between studies published before (2007-2009) and after (2011-2015) its introduction. The relationship between reporting and study quality was measured using Spearman's rank test. Of 281 eligible manuscripts, 80 were published before the PRISMA Statement and 201 afterwards. Most manuscripts (208) included a meta-analysis, with the remainder comprising a systematic review only. There was no meaningful change in median compliance with the PRISMA Statement (19 (i.q.r. 16-21) of 27 items before versus 19 (17-22) of 27 after introduction of PRISMA) despite achieving statistical significance (P = 0·042). Better reporting compliance was associated with higher methodological quality (r s  = 0·70, P < 0·001). The PRISMA Statement has had minimal impact on the reporting of surgical systematic reviews. Better compliance was associated with higher-quality methodology. © 2016 BJS Society Ltd Published by John Wiley & Sons Ltd.

Statement of Facts for 1983 City-Wide Mock Trial Competitions. The Case of Vickers v. Hearst. No. MT-84.

ERIC Educational Resources Information Center

National Inst. for Citizen Education in the Law, Washington, DC.

Prepared by the District of Columbia Street Law Project for its annual city-wide mock trial competition, this instructional handout provides material for a civil case over an automobile accident. After drinking heavily at a party hosted by Sandy Hearst, Dana Ivy ran a stop sign and struck the car of Terry Vickers, causing him to sustain a broken…

17 CFR 270.8b-12 - Requirements as to paper, printing and language.

Code of Federal Regulations, 2012 CFR

2012-04-01

..., printing and language. 270.8b-12 Section 270.8b-12 Commodity and Securities Exchanges SECURITIES AND... Requirements as to paper, printing and language. (a) Registration statements and reports shall be filed on good.... (d) The body of all printed registration statements and reports and all notes to financial statements...

North Dakota University System Annual Financial Report, Fiscal Year Ended June 30, 2007

ERIC Educational Resources Information Center

North Dakota University System, 2007

2007-01-01

This report provides financial data for the North Dakota University System (the "System") for the fiscal year ended June 30, 2007. The Management Discussion and Analysis; the Statement of Net Assets; the Statement of Revenues, Expenses, and Changes in Net Assets; and the Statement of Cash Flows provide information on the System as a…

12 CFR 350.5 - Alternative annual disclosure statements.

Code of Federal Regulations, 2010 CFR

2010-01-01

... bank subsidiary of a holding company which provides only the consolidated financial statements of the... audited financial statements, by copies of the audited financial statements and the certificate or report... the Securities and Exchange Commission or by sections in the holding company's consolidated financial...

Unethical randomised controlled trial of cervical screening in India: US Freedom of Information Act disclosures.

PubMed

Suba, Eric J; Ortega, Robert E; Mutch, David G

2017-01-01

A randomised controlled trial conducted in Mumbai, India, compared invasive cervical cancer rates among women offered cervical screening with invasive cervical cancer rates among women offered no-screening. The US Office for Human Research Protections determined the Mumbai trial was unethical because informed consent was not obtained from trial participants. Reportedly, cervical screening in the Mumbai trial reduced invasive cervical cancer mortality rates, but not invasive cervical cancer incidence rates. Documents obtained through the US Freedom of Information Act disclose that the US National Cancer Institute funded the Mumbai trial from 1997 to 2015 to study 'visual inspection/downstaging' tests. However, 'visual inspection/downstaging' tests had been judged unsatisfactory for cancer control before the Mumbai trial began. 'Visual inspection/downstaging' tests failed to reduce invasive cervical cancer incidence rates in Mumbai because 'visual inspection/downstaging' tests, by design, failed to detect preinvasive cervical lesions. None of the 151 538 Mumbai trial participants, in either the intervention or control arms, received cervical screening tests that detected preinvasive cervical lesions. Because of missing/discrepant clinical staging data, it is uncertain whether 'visual inspection/downstaging' tests actually reduced invasive cervical cancer mortality rates in Mumbai. Documents obtained through the US Freedom of Information Act disclose that US National Cancer Institute leaders avoided accountability by making false and misleading statements to Congressional oversight staff. Our findings contradict assurances given to President Barack Obama that regulations pertaining to global health research supported by the US government adequately protect human participants from unethical treatment. US National Cancer Institute leaders should develop policies to compensate victims of unethical global health research. All surviving Mumbai trial participants should finally receive cervical screening tests that detect preinvasive cervical lesions.

Glycemic Control for Patients With Type 2 Diabetes Mellitus: Our Evolving Faith in the Face of Evidence.

PubMed

Rodríguez-Gutiérrez, René; Montori, Victor M

2016-09-01

We sought to determine the concordance between the accumulating evidence about the impact of tight versus less tight glycemic control in patients with type 2 diabetes mellitus since the publication of UKPDS (UK Prospective Diabetes Study) in 1998 until 2015 with the views about that evidence published in journal articles and practice guidelines. We searched in top general medicine and specialty journals for articles referring to glycemic control appearing between 2006 and 2015 and identified the latest practice guidelines. To summarize the evidence, we included all published systematic reviews and meta-analyses of contemporary randomized trials of glycemic control measuring patient-important microvascular and macrovascular outcomes, and completed a meta-analysis of their follow-up extensions. We identified 16 guidelines and 328 statements. The body of evidence produced estimates warranting moderate confidence. This evidence reported no significant impact of tight glycemic control on the risk of dialysis/transplantation/renal death, blindness, or neuropathy. In the past decade, however, most published statements (77%-100%) and guidelines (95%) unequivocally endorsed benefit. There is also no significant effect on all-cause mortality, cardiovascular mortality, or stroke; however, there is a consistent 15% relative-risk reduction of nonfatal myocardial infarction. Between 2006 and 2008, most statements (47%-83%) endorsed the benefit; after 2008 (ACCORD), only a minority (21%-36%) did. Discordance exists between the research evidence and academic and clinical policy statements about the value of tight glycemic control to reduce micro- and macrovascular complications. This discordance may distort priorities in the research and practice agendas designed to improve the lives of patients with type 2 diabetes mellitus. © 2016 American Heart Association, Inc.

Insulin Therapy for Adult Patients with Type 2 Diabetes Mellitus: A Position Statement of the Korean Diabetes Association, 2017.

PubMed

Lee, Byung Wan; Kim, Jin Hwa; Ko, Seung Hyun; Hur, Kyu Yeon; Kim, Nan Hee; Rhee, Sang Youl; Kim, Hyun Jin; Moon, Min Kyong; Park, Seok O; Choi, Kyung Mook

2017-10-01

The Korean Diabetes Association (KDA) has regularly updated its Clinical Practice Guidelines. In 2017, the KDA published a position statement on the use of antihyperglycemic agents for patients with type 2 diabetes mellitus (T2DM). Growing evidence from new multinational clinical trials using novel and traditional insulin analogues has also been accumulated. Following global trends, many results of clinical trials, especially concerning the clinical efficacy and safety of insulin therapy, have been published about Korean patients with T2DM. After a systematic search of recent evidence, the KDA updated and modified its clinical practice recommendations regarding the initiation, choice, and intensification of insulin and created an insulin treatment algorithm for the first time to guide physicians caring for adult Korean patients with T2DM. Copyright © 2017 Korean Diabetes Association.

Financial Management: Corps of Engineers Equipment Reporting on Financial Statements for FY 2002

DTIC Science & Technology

2003-08-20

U.S. Army Corps of Engineers civil service and uniformed officers responsible for financial reporting of equipment should read this report. It...discusses the management controls that are necessary to support the financial reporting of equipment on financial statements.

IG Statement: Arthur A. Elkins, Jr., on OIG report Early Warning Report: Main EPA Headquarters Warehouse in Landover, Maryland, Requires Immediate EPA Attention

EPA Pesticide Factsheets

Statement of Inspector General Arthur A. Elkins, Jr., on the Office of Inspector General (OIG) report Early Warning Report: Main EPA Headquarters Warehouse in Landover, Maryland, Requires Immediate EPA Attention.

17 CFR 210.8-03 - Interim financial statements.

Code of Federal Regulations, 2010 CFR

2010-04-01

... (§ 249.308(a) of this chapter) must be reviewed by an independent public accountant using professional... interim financial statements have been reviewed by an independent public accountant, a report of the accountant on the review must be filed with the interim financial statements. Interim financial statements...

Relationship between Sponsorship and Failure Rate of Dental Implants: A Systematic Approach

PubMed Central

Popelut, Antoine; Valet, Fabien; Fromentin, Olivier; Thomas, Aurélie; Bouchard, Philippe

2010-01-01

Background The number of dental implant treatments increases annually. Dental implants are manufactured by competing companies. Systematic reviews and meta-analysis have shown a clear association between pharmaceutical industry funding of clinical trials and pro-industry results. So far, the impact of industry sponsorship on the outcomes and conclusions of dental implant clinical trials has never been explored. The aim of the present study was to examine financial sponsorship of dental implant trials, and to evaluate whether research funding sources may affect the annual failure rate. Methods and Findings A systematic approach was used to identify systematic reviews published between January 1993 and December 2008 that specifically deal with the length of survival of dental implants. Primary articles were extracted from these reviews. The failure rate of the dental implants included in the trials was calculated. Data on publication year, Impact Factor, prosthetic design, periodontal status reporting, number of dental implants included in the trials, methodological quality of the studies, presence of a statistical advisor, and financial sponsorship were extracted by two independent reviewers (kappa  = 0.90; CI95% [0.77–1.00]). Univariate quasi-Poisson regression models and multivariate analysis were used to identify variables that were significantly associated with failure rates. Five systematic reviews were identified from which 41 analyzable trials were extracted. The mean annual failure rate estimate was 1.09%.(CI95% [0.84–1.42]). The funding source was not reported in 63% of the trials (26/41). Sixty-six percent of the trials were considered as having a risk of bias (27/41). Given study age, both industry associated (OR = 0.21; CI95% [0.12–0.38]) and unknown funding source trials (OR = 0.33; (CI95% [0.21–0.51]) had a lower annual failure rates compared with non-industry associated trials. A conflict of interest statement was disclosed in 2 trials. Conclusions When controlling for other factors, the probability of annual failure for industry associated trials is significantly lower compared with non-industry associated trials. This bias may have significant implications on tooth extraction decision making, research on tooth preservation, and governmental health care policies. PMID:20422000

AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY 2016 OUTPATIENT GLUCOSE MONITORING CONSENSUS STATEMENT.

PubMed

Bailey, Timothy S; Grunberger, George; Bode, Bruce W; Handelsman, Yehuda; Hirsch, Irl B; Jovanovič, Lois; Roberts, Victor Lawrence; Rodbard, David; Tamborlane, William V; Walsh, John

2016-02-01

This document represents the official position of the American Association of Clinical Endocrinologists and American College of Endocrinology. Where there were no randomized controlled trials or specific U.S. FDA labeling for issues in clinical practice, the participating clinical experts utilized their judgment and experience. Every effort was made to achieve consensus among the committee members. Position statements are meant to provide guidance, but they are not to be considered prescriptive for any individual patient and cannot replace the judgment of a clinician.

Report: Fiscal 2004 and 2003 Financial Statements for the Pesticides Reregistration and Expedited Processing Fund

EPA Pesticide Factsheets

Report #2005-1-00081, May 4, 2005. We identified the following reportable conditions: We could not assess the adequacy of automated controls. EPA needs to improve financial statement preparation and quality control.

12 CFR 563d.3b-6 - Liability for certain statements by savings associations.

Code of Federal Regulations, 2011 CFR

2011-01-01

... the time such statements are made or reaffirmed, either: (A) The issuer is subject to the reporting... issuer is not subject to the reporting requirements of section 13(a) or 15(d) of the Act, the statements... under the Investment Company Act of 1940; (2) Information (i) relating to the effects of changing prices...

12 CFR 563d.3b-6 - Liability for certain statements by savings associations.

Code of Federal Regulations, 2010 CFR

2010-01-01

... the time such statements are made or reaffirmed, either: (A) The issuer is subject to the reporting... issuer is not subject to the reporting requirements of section 13(a) or 15(d) of the Act, the statements... under the Investment Company Act of 1940; (2) Information (i) relating to the effects of changing prices...

Advanced Vehicle Power Technology Alliance Technical Workshop and Operations Report

DTIC Science & Technology

2011-10-05

Vehicle Exhaust TEG 2016 1 TEG: Thermo-Electric Generator UNCLASSIFIED: Distribution Statement A. Approved for public release. E16...Equipment 2016 Validation Data: − Power Electronics ― 2020 ― ― UNCLASSIFIED: Distribution Statement A. Approved for public release...Materiel Command (AMC) UNCLASSIFIED: Distribution Statement A. Approved for Public Release Report Documentation Page Form ApprovedOMB No. 0704-0188

Reporting of DOD Inventory and Operating Materials and Supplies on the FY 1997 DOD Consolidated Financial Statements.

DTIC Science & Technology

1998-11-05

The overall audit objective was to determine whether the FY 1997 DoD Consolidated Financial Statements were presented fairly in accordance with the...disclaimer of opinion on the FY 1997 DoD Consolidated Financial Statements . We issued our report on internal controls and compliance with laws and regulations on June 22, 1998.

GASB's New Standard on Reporting Entity for School Districts.

ERIC Educational Resources Information Center

Harmer, W. Gary

1991-01-01

Explains the impact on school district financial reporting of the Governmental Accounting Standards Board Statement 14, "The Financial Reporting Entity." One of Statement 14's objectives is for financial report users to be able to distinguish between the primary government and its component units. (MLF)

Consolidation Process for FY 1997 Financial Statements for Other Defense Organizations.

DTIC Science & Technology

1998-10-06

requires DoD and other Government agencies to prepare consolidated financial statements for FY 1996 and each succeeding year. The DoD Consolidated ... Financial Statements for FY 1997 include financial statements for a reporting entity entitled "Other Defense Organizations." This entity represents a

Highlights: Selected Statements from the Literature on Collaboration and Coordination.

ERIC Educational Resources Information Center

Roberts, Jane

Thirty documents selected from the literature on educational change, social systems, and management and organization were searched for statements considered relevant to collaboration and coordination between organizational units. These statements, either quoted or paraphrased, are listed in this report along with their sources. The statements are…

12 CFR 308.177 - Statement of net worth.

Code of Federal Regulations, 2010 CFR

2010-01-01

.... Unaudited financial statements are acceptable unless the administrative law judge or the Board of Directors otherwise requires. Financial statements or reports to a Federal or state agency, prepared before the... 12 Banks and Banking 4 2010-01-01 2010-01-01 false Statement of net worth. 308.177 Section 308.177...

Guidelines for the Design and Conduct of Clinical Studies in Knee Articular Cartilage Repair

PubMed Central

Mithoefer, Kai; Saris, Daniel B.F.; Farr, Jack; Kon, Elizaveta; Zaslav, Kenneth; Cole, Brian J.; Ranstam, Jonas; Yao, Jian; Shive, Matthew; Levine, David; Dalemans, Wilfried; Brittberg, Mats

2011-01-01

Objective: To summarize current clinical research practice and develop methodological standards for objective scientific evaluation of knee cartilage repair procedures and products. Design: A comprehensive literature review was performed of high-level original studies providing information relevant for the design of clinical studies on articular cartilage repair in the knee. Analysis of cartilage repair publications and synopses of ongoing trials were used to identify important criteria for the design, reporting, and interpretation of studies in this field. Results: Current literature reflects the methodological limitations of the scientific evidence available for articular cartilage repair. However, clinical trial databases of ongoing trials document a trend suggesting improved study designs and clinical evaluation methodology. Based on the current scientific information and standards of clinical care, detailed methodological recommendations were developed for the statistical study design, patient recruitment, control group considerations, study endpoint definition, documentation of results, use of validated patient-reported outcome instruments, and inclusion and exclusion criteria for the design and conduct of scientifically sound cartilage repair study protocols. A consensus statement among the International Cartilage Repair Society (ICRS) and contributing authors experienced in clinical trial design and implementation was achieved. Conclusions: High-quality clinical research methodology is critical for the optimal evaluation of current and new cartilage repair technologies. In addition to generally applicable principles for orthopedic study design, specific criteria and considerations apply to cartilage repair studies. Systematic application of these criteria and considerations can facilitate study designs that are scientifically rigorous, ethical, practical, and appropriate for the question(s) being addressed in any given cartilage repair research project. PMID:26069574

Preferred reporting items for studies mapping onto preference-based outcome measures: The MAPS statement.

PubMed

Petrou, Stavros; Rivero-Arias, Oliver; Dakin, Helen; Longworth, Louise; Oppe, Mark; Froud, Robert; Gray, Alastair

2015-08-01

'Mapping' onto generic preference-based outcome measures is increasingly being used as a means of generating health utilities for use within health economic evaluations. Despite publication of technical guides for the conduct of mapping research, guidance for the reporting of mapping studies is currently lacking. The MAPS (MApping onto Preference-based measures reporting Standards) statement is a new checklist, which aims to promote complete and transparent reporting of mapping studies. The primary audiences for the MAPS statement are researchers reporting mapping studies, the funders of the research, and peer reviewers and editors involved in assessing mapping studies for publication.A de novo list of 29 candidate reporting items and accompanying explanations was created by a working group comprised of six health economists and one Delphi methodologist. Following a two-round, modified Delphi survey with representatives from academia, consultancy, health technology assessment agencies and the biomedical journal editorial community, a final set of 23 items deemed essential for transparent reporting, and accompanying explanations, was developed. The items are contained in a user friendly 23 item checklist. They are presented numerically and categorised within six sections, namely: (i) title and abstract; (ii) introduction; (iii) methods; (iv) results; (v) discussion; and (vi) other. The MAPS statement is best applied in conjunction with the accompanying MAPS explanation and elaboration document.It is anticipated that the MAPS statement will improve the clarity, transparency and completeness of reporting of mapping studies. To facilitate dissemination and uptake, the MAPS statement is being co-published by eight health economics and quality of life journals, and broader endorsement is encouraged. The MAPS working group plans to assess the need for an update of the reporting checklist in five years' time.This statement was published jointly in Applied Health Economics and Health Policy, Health and Quality of Life Outcomes, International Journal of Technology Assessment in Health Care, Journal of Medical Economics, Medical Decision Making, PharmacoEconomics, and Quality of Life Research.

Report on Fiscal Year 1991 financial statement audit of the Low-Level Radioactive Waste Surcharge Escrow Account (CR-FC-92-1)

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

Not Available

1992-06-26

The attached audit report on the subject account presents the opinion of the independent certified public accounts on financial statements as of September 30, 1991. In their opinion, the Surcharge Account statements are fairly presented in all material respects in accordance with generally accepted accounting principles. Also attached are reports on the internal control structure and compliance with laws and regulations, ass well as management`s letter on addressing needed improvements.

Report on Fiscal Year 1991 financial statement audit of the Low-Level Radioactive Waste Surcharge Escrow Account (CR-FC-92-1)

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

Not Available

1992-06-26

The attached audit report on the subject account presents the opinion of the independent certified public accounts on financial statements as of September 30, 1991. In their opinion, the Surcharge Account statements are fairly presented in all material respects in accordance with generally accepted accounting principles. Also attached are reports on the internal control structure and compliance with laws and regulations, ass well as management's letter on addressing needed improvements.

Statement of Facts for 1986 City-Wide Mock Trial Competitions. United States Department of Justice Executive Office for Immigration Review in the Matter of Toni Radcliffe. No. MT-86.

ERIC Educational Resources Information Center

National Inst. for Citizen Education in the Law, Washington, DC.

Prepared by the District of Columbia Street Law Project for its 15th annual city-wide mock trial competition, this instructional handout provides the material for a deportation hearing. The Immigration and Naturalization Service denied political asylum to Toni Radcliffe and seeks authority to deport him. Radcliffe claims that the articles that he…

Statement of Facts for 1978 City-Wide Mock Trial Competitions. Martha Winstead v. Church of the New Family and Albert Smith.

ERIC Educational Resources Information Center

National Inst. for Citizen Education in the Law, Washington, DC.

Prepared by the District of Columbia Street Law Project for its annual city-wide mock trial competition, this instructional handout provides material for the hearing of a custody dispute. Martha Winstead petitions the court to order the Church of the New Family to turn over her 18-year-old son, Jeremiah, to her and to allow her custody. Jeremiah…

Official 1997 Mock Trial Materials for the Twenty-Fifth Annual District of Columbia Public Schools Mock Trail Program: Ricki Jones, Plaintiff v. Metro City, Defendant.

ERIC Educational Resources Information Center

Henderson, Kamina A.; Roe, Richard L.

This packet of materials contains law-related materials for students to conduct a mock trial. In this case a faulty water system, containing the parasite Pindia, contributed to the death of an AIDS patient. Statements from the plaintiff, a representative of the Metro City Water Department, health officials, and others are presented. New releases,…

75 FR 61365 - Revisions to Forms, Statements, and Reporting Requirements for Natural Gas Pipelines

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-05

... proposing to revise certain financial reporting forms required to be filed by natural gas companies (FERC... the above-referenced proceeding \\1\\ proposing to revise certain financial reporting forms required by...] Revisions to Forms, Statements, and Reporting Requirements for Natural Gas Pipelines September 24, 2010...

Report: New Hampshire Clean Water State Revolving Fund Program Financial Statements with Independent Auditor’s Report, June 30, 2002

EPA Pesticide Factsheets

Report #2003-1-00086, March 26, 2003. The audit contains reports on the financial statements, internal controls, and compliance requirements applicable to the Clean Water State Revolving Fund program in New Hampshire for the year ended June 30, 2002.

Difficulty in detecting discrepancies in a clinical trial report: 260-reader evaluation

PubMed Central

Cole, Graham D; Shun-Shin, Matthew J; Nowbar, Alexandra N; Buell, Kevin G; Al-Mayahi, Faisal; Zargaran, David; Mahmood, Saliha; Singh, Bharpoor; Mielewczik, Michael; Francis, Darrel P

2015-01-01

Background: Scientific literature can contain errors. Discrepancies, defined as two or more statements or results that cannot both be true, may be a signal of problems with a trial report. In this study, we report how many discrepancies are detected by a large panel of readers examining a trial report containing a large number of discrepancies. Methods: We approached a convenience sample of 343 journal readers in seven countries, and invited them in person to participate in a study. They were asked to examine the tables and figures of one published article for discrepancies. 260 participants agreed, ranging from medical students to professors. The discrepancies they identified were tabulated and counted. There were 39 different discrepancies identified. We evaluated the probability of discrepancy identification, and whether more time spent or greater participant experience as academic authors improved the ability to detect discrepancies. Results: Overall, 95.3% of discrepancies were missed. Most participants (62%) were unable to find any discrepancies. Only 11.5% noticed more than 10% of the discrepancies. More discrepancies were noted by participants who spent more time on the task (Spearman’s ρ = 0.22, P < 0.01), and those with more experience of publishing papers (Spearman’s ρ = 0.13 with number of publications, P = 0.04). Conclusions: Noticing discrepancies is difficult. Most readers miss most discrepancies even when asked specifically to look for them. The probability of a discrepancy evading an individual sensitized reader is 95%, making it important that, when problems are identified after publication, readers are able to communicate with each other. When made aware of discrepancies, the majority of readers support editorial action to correct the scientific record. PMID:26174517

The PRISMA extension statement for reporting of systematic reviews incorporating network meta-analyses of health care interventions: checklist and explanations.

PubMed

Hutton, Brian; Salanti, Georgia; Caldwell, Deborah M; Chaimani, Anna; Schmid, Christopher H; Cameron, Chris; Ioannidis, John P A; Straus, Sharon; Thorlund, Kristian; Jansen, Jeroen P; Mulrow, Cynthia; Catalá-López, Ferrán; Gøtzsche, Peter C; Dickersin, Kay; Boutron, Isabelle; Altman, Douglas G; Moher, David

2015-06-02

The PRISMA statement is a reporting guideline designed to improve the completeness of reporting of systematic reviews and meta-analyses. Authors have used this guideline worldwide to prepare their reviews for publication. In the past, these reports typically compared 2 treatment alternatives. With the evolution of systematic reviews that compare multiple treatments, some of them only indirectly, authors face novel challenges for conducting and reporting their reviews. This extension of the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analyses) statement was developed specifically to improve the reporting of systematic reviews incorporating network meta-analyses. A group of experts participated in a systematic review, Delphi survey, and face-to-face discussion and consensus meeting to establish new checklist items for this extension statement. Current PRISMA items were also clarified. A modified, 32-item PRISMA extension checklist was developed to address what the group considered to be immediately relevant to the reporting of network meta-analyses. This document presents the extension and provides examples of good reporting, as well as elaborations regarding the rationale for new checklist items and the modification of previously existing items from the PRISMA statement. It also highlights educational information related to key considerations in the practice of network meta-analysis. The target audience includes authors and readers of network meta-analyses, as well as journal editors and peer reviewers.

Louisiana State University System General Purpose Financial Statements and Independent Auditor's Reports as of and for the Year Ended June 30, 1998, with Supplemental Information Schedules.

ERIC Educational Resources Information Center

Louisiana State Legislative Auditor, Baton Rouge.

This report presents results of a financial audit of the Louisiana State University (LSU) system. The auditors also rendered opinions on financial statements of separate, incorporated foundations which oversee the investment of various university endowments, the financial statements for which were prepared by other auditors. An accompanying letter…

DOD Financial Management: Improved Documentation Needed to Support the Air Force’s Military Payroll and Meet Audit Readiness Goals

DTIC Science & Technology

2015-12-01

balances to match Treasury balances. 19The financial reporting system collects and consolidates information for financial statement presentation...2The financial reporting system collects and consolidates information for financial statement presentation. 3Subsistence...efforts to achieve auditability of its financial statements , the Air Force in July 2014 asserted audit readiness for its Schedule of Budgetary

Federal Energy Regulatory Commission financial statements, September 30, 1995 and 1994

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

NONE

1996-02-12

The attached report presents the results of the independent certified public accountant`s audit of the Federal Energy Regulatory Commission`s (FERC) financial statements as of September 30, 1995 and 1994. The auditors have expressed an unqualified opinion on the 1995 statements. Their reports on FERC`s internal control structure and on compliance with laws and regulations, and management letter are also provided.

The Effectiveness of Parent Training as a Treatment for Preschool Attention-Deficit/Hyperactivity Disorder: Study Protocol for a Randomized Controlled, Multicenter Trial of the New Forest Parenting Program in Everyday Clinical Practice

PubMed Central

Daley, David; Frydenberg, Morten; Rask, Charlotte U; Sonuga-Barke, Edmund; Thomsen, Per H

2016-01-01

Background Parent training is recommended as the first-line treatment for attention-deficit/hyperactivity disorder (ADHD) in preschool children. The New Forest Parenting Programme (NFPP) is an evidence-based parenting program developed specifically to target preschool ADHD. Objective The objective of this trial is to investigate whether the NFPP can be effectively delivered for children referred through official community pathways in everyday clinical practice. Methods A multicenter randomized controlled parallel arm trial design is employed. There are two treatment arms, NFPP and treatment as usual. NFPP consists of eight individually delivered parenting sessions, where the child attends during three of the sessions. Outcomes are examined at three time points (T1, T2, T3): T1 (baseline), T2 (week 12, post intervention), and T3 (6 month follow/up). 140 children between the ages of 3-7, with a clinical diagnosis of ADHD, informed by the Development and Well Being Assessment, and recruited from three child and adolescent psychiatry departments in Denmark will take part. Randomization is on a 1:1 basis, stratified for age and gender. Results The primary endpoint is change in ADHD symptoms as measured by the Preschool ADHD-Rating Scale (ADHD-RS) by T2. Secondary outcome measures include: effects on this measure at T3 and T2 and T3 measures of teacher reported Preschool ADHD-RS scores, parent and teacher rated scores on the Strength & Difficulties Questionnaire, direct observation of ADHD behaviors during Child’s Solo Play, observation of parent-child interaction, parent sense of competence, and family stress. Results will be reported using the standards set out in the Consolidated Standards of Reporting Trials Statement for Randomized Controlled Trials of nonpharmacological treatments. Conclusions The trial will provide evidence as to whether NFPP is a more effective treatment for preschool ADHD than the treatment usually offered in everyday clinical practice. Trial Registration ClinicalTrials.gov NCT01684644; https://clinicaltrials.gov/ct2/show/NCT01684644?term= NCT01684644&rank=1 (Archived by WebCite at http://www.webcitation/6eOOAe8Qe) PMID:27076496

Causal interpretation of correlational studies - Analysis of medical news on the website of the official journal for German physicians.

PubMed

Buhse, Susanne; Rahn, Anne Christin; Bock, Merle; Mühlhauser, Ingrid

2018-01-01

Media frequently draws inappropriate causal statements from observational studies. We analyzed the reporting of study results in the Medical News section of the German medical journal Deutsches Ärzteblatt (DÄ). Study design: Retrospective quantitative content analysis of randomly selected news reports and related original journal articles and press releases. A medical news report was selected if headlines comprised at least two linked variables. Two raters independently categorized the headline and text of each news report, conclusions of the abstract and full text of the related journal article, and the press release. The assessment instrument comprised five categories from 'neutral' to 'unconditionally causal'. Outcome measures: degree of matching between 1) news headlines and conclusions of the journal article, 2) headlines and text of news reports, 3) text and conclusions, and 4) headlines and press releases. We analyzed whether news headlines rated as unconditionally causal based on randomized controlled trials (RCTs). One-thousand eighty-seven medical news reports were published between April 2015 and May 2016. The final random sample comprised 176 news reports and 100 related press releases. Degree of matching: 1) 45% (79/176) for news headlines and journal article conclusions, 2) 55% (97/176) for headlines and text, 3) 53% (93/176) for text and conclusions, and 4) 41% (41/100) for headlines and press releases. Exaggerations were found in 45% (80/176) of the headlines compared to the conclusions of the related journal article. Sixty-five of 137 unconditionally causal statements of the news headlines were phrased more weakly in the subsequent news text body. Only 52 of 137 headlines (38%) categorized as unconditionally causal reported RCTs. Reporting of medical news in the DÄ medical journal is misleading. Most headlines that imply causal associations were not based on RCTs. Medical journalists should follow standards of reporting scientific study results.

Causal interpretation of correlational studies – Analysis of medical news on the website of the official journal for German physicians

PubMed Central

Rahn, Anne Christin; Bock, Merle; Mühlhauser, Ingrid

2018-01-01

Background Media frequently draws inappropriate causal statements from observational studies. We analyzed the reporting of study results in the Medical News section of the German medical journal Deutsches Ärzteblatt (DÄ). Methods Study design: Retrospective quantitative content analysis of randomly selected news reports and related original journal articles and press releases. A medical news report was selected if headlines comprised at least two linked variables. Two raters independently categorized the headline and text of each news report, conclusions of the abstract and full text of the related journal article, and the press release. The assessment instrument comprised five categories from ‘neutral’ to ‘unconditionally causal’. Outcome measures: degree of matching between 1) news headlines and conclusions of the journal article, 2) headlines and text of news reports, 3) text and conclusions, and 4) headlines and press releases. We analyzed whether news headlines rated as unconditionally causal based on randomized controlled trials (RCTs). Results One-thousand eighty-seven medical news reports were published between April 2015 and May 2016. The final random sample comprised 176 news reports and 100 related press releases. Degree of matching: 1) 45% (79/176) for news headlines and journal article conclusions, 2) 55% (97/176) for headlines and text, 3) 53% (93/176) for text and conclusions, and 4) 41% (41/100) for headlines and press releases. Exaggerations were found in 45% (80/176) of the headlines compared to the conclusions of the related journal article. Sixty-five of 137 unconditionally causal statements of the news headlines were phrased more weakly in the subsequent news text body. Only 52 of 137 headlines (38%) categorized as unconditionally causal reported RCTs. Conclusion Reporting of medical news in the DÄ medical journal is misleading. Most headlines that imply causal associations were not based on RCTs. Medical journalists should follow standards of reporting scientific study results. PMID:29723258

The Mexican consensus on probiotics in gastroenterology.

PubMed

Valdovinos, M A; Montijo, E; Abreu, A T; Heller, S; González-Garay, A; Bacarreza, D; Bielsa-Fernández, M; Bojórquez-Ramos, M C; Bosques-Padilla, F; Burguete-García, A I; Carmona-Sánchez, R; Consuelo-Sánchez, A; Coss-Adame, E; Chávez-Barrera, J A; de Ariño, M; Flores-Calderón, J; Gómez-Escudero, O; González-Huezo, M S; Icaza-Chávez, M E; Larrosa-Haro, A; Morales-Arámbula, M; Murata, C; Ramírez-Mayans, J A; Remes-Troche, J M; Rizo-Robles, T; Peláez-Luna, M; Toro-Monjaraz, E M; Torre, A; Urquidi-Rivera, M E; Vázquez, R; Yamamoto-Furusho, J K; Guarner, F

Probiotics are frequently prescribed in clinical practice. Their efficacy in treating gastrointestinal disorders is supported by a significant number of clinical trials. However, the correct prescription of these agents is hampered due to a lack of knowledge of the scientific evidence and to the different presentations and microbial compositions of the probiotics that are currently available. To provide the clinician with a consensus review of probiotics and recommendations for their use in gastroenterology. Controlled clinical trials, meta-analyses, and systematic reviews published up to 2015 were selected, using the MESH terms: probiotics, gastrointestinal diseases, humans, adults, AND children. The Delphi method was employed. Eighteen gastroenterologists treating adult patients and 14 pediatric gastroenterologists formulated statements that were voted on until agreement>70% was reached. The level of evidence based on the GRADE system was evaluated for each statement. Eleven statements on the general concepts of probiotics and 27 statements on the use of probiotics in gastrointestinal diseases in both adults and children were formulated. The consensus group recommends the use of probiotics under the following clinical conditions: the prevention of diarrhea associated with antibiotics, the treatment of acute infectious diarrhea, the prevention of Clostridium difficile infection and necrotizing enterocolitis, the reduction of adverse events from Helicobacter pylori eradication therapy, relief from irritable bowel syndrome symptoms, the treatment of functional constipation in the adult, and the induction and maintenance of remission in patients with ulcerative colitis and pouchitis, and the treatment of covert and overt hepatic encephalopathy. Copyright © 2016 Asociación Mexicana de Gastroenterología. Publicado por Masson Doyma México S.A. All rights reserved.

Preferred reporting items for studies mapping onto preference-based outcome measures: The MAPS statement.

PubMed

Petrou, Stavros; Rivero-Arias, Oliver; Dakin, Helen; Longworth, Louise; Oppe, Mark; Froud, Robert; Gray, Alastair

2015-01-01

'Mapping' onto generic preference-based outcome measures is increasingly being used as a means of generating health utilities for use within health economic evaluations. Despite publication of technical guides for the conduct of mapping research, guidance for the reporting of mapping studies is currently lacking. The MAPS (MApping onto Preference-based measures reporting Standards) statement is a new checklist, which aims to promote complete and transparent reporting of mapping studies. The primary audiences for the MAPS statement are researchers reporting mapping studies, the funders of the research, and peer reviewers and editors involved in assessing mapping studies for publication. A de novo list of 29 candidate reporting items and accompanying explanations was created by a working group comprised of six health economists and one Delphi methodologist. Following a two-round, modified Delphi survey with representatives from academia, consultancy, health technology assessment agencies and the biomedical journal editorial community, a final set of 23 items deemed essential for transparent reporting, and accompanying explanations, was developed. The items are contained in a user friendly 23 item checklist. They are presented numerically and categorised within six sections, namely: (i) title and abstract; (ii) introduction; (iii) methods; (iv) results; (v) discussion; and (vi) other. The MAPS statement is best applied in conjunction with the accompanying MAPS explanation and elaboration document. It is anticipated that the MAPS statement will improve the clarity, transparency and completeness of reporting of mapping studies. To facilitate dissemination and uptake, the MAPS statement is being co-published by seven health economics and quality of life journals, and broader endorsement is encouraged. The MAPS working group plans to assess the need for an update of the reporting checklist in five years' time.

Preferred Reporting Items for Studies Mapping onto Preference-Based Outcome Measures: The MAPS Statement.

PubMed

Petrou, Stavros; Rivero-Arias, Oliver; Dakin, Helen; Longworth, Louise; Oppe, Mark; Froud, Robert; Gray, Alastair

2015-10-01

'Mapping' onto generic preference-based outcome measures is increasingly being used as a means of generating health utilities for use within health economic evaluations. Despite the publication of technical guides for the conduct of mapping research, guidance for the reporting of mapping studies is currently lacking. The MAPS (MApping onto Preference-based measures reporting Standards) statement is a new checklist, which aims to promote complete and transparent reporting of mapping studies. The primary audiences for the MAPS statement are researchers reporting mapping studies, the funders of the research, and peer reviewers and editors involved in assessing mapping studies for publication. A de novo list of 29 candidate reporting items and accompanying explanations was created by a working group comprising six health economists and one Delphi methodologist. Following a two-round modified Delphi survey with representatives from academia, consultancy, health technology assessment agencies and the biomedical journal editorial community, a final set of 23 items deemed essential for transparent reporting, and accompanying explanations, was developed. The items are contained in a user-friendly 23-item checklist. They are presented numerically and categorised within six sections, namely: (1) title and abstract; (2) introduction; (3) methods; (4) results; (5) discussion; and (6) other. The MAPS statement is best applied in conjunction with the accompanying MAPS explanation and elaboration document. It is anticipated that the MAPS statement will improve the clarity, transparency and completeness of reporting of mapping studies. To facilitate dissemination and uptake, the MAPS statement is being co-published by seven health economics and quality-of-life journals, and broader endorsement is encouraged. The MAPS working group plans to assess the need for an update of the reporting checklist in 5 years' time.

17 CFR 240.14b-1 - Obligation of registered brokers and dealers in connection with the prompt forwarding of certain...

Code of Federal Regulations, 2011 CFR

2011-04-01

... security holders, proxy statement, information statement, or Notice of Internet Availability of Proxy...(e)(1) (with respect to annual reports to security holders, proxy statements, and Notices of Internet..., information statements, and Notices of Internet Availability of Proxy Materials) applicable to registrants...

17 CFR 240.14b-1 - Obligation of registered brokers and dealers in connection with the prompt forwarding of certain...

Code of Federal Regulations, 2013 CFR

2013-04-01

... security holders, proxy statement, information statement, or Notice of Internet Availability of Proxy...(e)(1) (with respect to annual reports to security holders, proxy statements, and Notices of Internet..., information statements, and Notices of Internet Availability of Proxy Materials) applicable to registrants...

17 CFR 240.14b-1 - Obligation of registered brokers and dealers in connection with the prompt forwarding of certain...

Code of Federal Regulations, 2010 CFR

2010-04-01

... security holders, proxy statement, information statement, or Notice of Internet Availability of Proxy...(e)(1) (with respect to annual reports to security holders, proxy statements, and Notices of Internet..., information statements, and Notices of Internet Availability of Proxy Materials) applicable to registrants...

17 CFR 240.14b-1 - Obligation of registered brokers and dealers in connection with the prompt forwarding of certain...

Code of Federal Regulations, 2012 CFR

2012-04-01

... security holders, proxy statement, information statement, or Notice of Internet Availability of Proxy...(e)(1) (with respect to annual reports to security holders, proxy statements, and Notices of Internet..., information statements, and Notices of Internet Availability of Proxy Materials) applicable to registrants...

17 CFR 240.14b-1 - Obligation of registered brokers and dealers in connection with the prompt forwarding of certain...

Code of Federal Regulations, 2014 CFR

2014-04-01

... security holders, proxy statement, information statement, or Notice of Internet Availability of Proxy...(e)(1) (with respect to annual reports to security holders, proxy statements, and Notices of Internet..., information statements, and Notices of Internet Availability of Proxy Materials) applicable to registrants...

17 CFR 210.2-04 - Examination of financial statements of persons other than the registrant.

Code of Federal Regulations, 2010 CFR

2010-04-01

... SECURITIES AND EXCHANGE COMMISSION FORM AND CONTENT OF AND REQUIREMENTS FOR FINANCIAL STATEMENTS, SECURITIES... Qualifications and Reports of Accountants § 210.2-04 Examination of financial statements of persons other than the registrant. If a registrant is required to file financial statements of any other person, such...

Internal Controls and Compliance with Laws and Regulations for the FY 1997 Financial Statements of Other Defense Organizations

DTIC Science & Technology

1998-07-13

requires DoD and other Government agencies to prepare consolidated financial statements for FY 1996 and each succeeding year. The DoD Consolidated ... Financial Statements for FY 1997 include financial statements for a reporting entity entitled Other Defense Organizations. This entity represents a

Insurance based lie detection: Enhancing the verifiability approach with a model statement component.

PubMed

Harvey, Adam C; Vrij, Aldert; Leal, Sharon; Lafferty, Marcus; Nahari, Galit

2017-03-01

The Verifiability Approach (VA) is verbal lie detection tool that has shown promise when applied to insurance claims settings. This study examined the effectiveness of incorporating a Model Statement comprised of checkable information to the VA protocol for enhancing the verbal differences between liars and truth tellers. The study experimentally manipulated supplementing (or withholding) the VA with a Model Statement. It was hypothesised that such a manipulation would (i) encourage truth tellers to provide more verifiable details than liars and (ii) encourage liars to report more unverifiable details than truth tellers (compared to the no model statement control). As a result, it was hypothesized that (iii) the model statement would improve classificatory accuracy of the VA. Participants reported 40 genuine and 40 fabricated insurance claim statements, in which half the liars and truth tellers where provided with a model statement as part of the VA procedure, and half where provide no model statement. All three hypotheses were supported. In terms of accuracy, the model statement increased classificatory rates by the VA considerably from 65.0% to 90.0%. Providing interviewee's with a model statement prime consisting of checkable detail appears to be a useful refinement to the VA procedure. Copyright © 2017 Elsevier B.V. All rights reserved.

Target haemoglobin to aim for with erythropoiesis-stimulating agents: a position statement by ERBP following publication of the Trial to reduce cardiovascular events with Aranesp therapy (TREAT) study.

PubMed

Locatelli, Francesco; Aljama, Pedro; Canaud, Bernard; Covic, Adrian; De Francisco, Angel; Macdougall, Iain C; Wiecek, Andrzej; Vanholder, Raymond

2010-09-01

The European Renal Best Practice (ERBP), which are issued by ERA-EDTA, are suggestions for clinical practice in areas in which evidence is lacking or weak, together with position statements on recently published randomized controlled trials, or on existing guidelines and recommendations. In 2009, the Anaemia Working Group of ERBP published its first position statement about the haemoglobin target to aim for with erythropoietin-stimulating agents (ESA) and on issues that were not covered by K-DOQI in 2006-07. This second position paper of the group follows the publication of the Trial to Reduce Cardiovascular Events with Aranesp Therapy (TREAT) Study. This multi-centre, placebo-controlled trial compared cardiovascular and renal outcomes in 4038 patients with type 2 diabetes, chronic kidney disease not on dialysis, and anaemia who were randomized to complete anaemia correction (haemoglobin target of 13 g/dL using darbepoetin alpha) or placebo (with a haemoglobin rescue value of 9 g/dL). Following the findings of the TREAT study, the Anaemia Working Group of ERBP maintains its view that 'Hb values of 11-12 g/dL should be generally sought in the CKD population without intentionally exceeding 13 g/dL' and that the doses of ESA therapy to achieve the target haemoglobin should also be considered. More caution is suggested when treating anaemia with ESA therapy in patients with type 2 diabetes not undergoing dialysis (and probably in diabetics at all CKD stages). In those with ischaemic heart disease or with a previous history of stroke, possible benefits should be weighed up against an increased risk of stroke recurrence, when deciding which Hb level to aim for. These recommendations are not intended to represent a new guideline as they are not the result of a systematic review of the evidence.

Foundation for Ichthyosis & Related Skin Types

MedlinePlus

... Our Community Learn How About Us Mission Statement/Core Values History Annual Report & Financials Board of Directors ... Ichthyosis New Parent Information About Us Mission Statement & Core Values History Annual Report & Financials Board of Directors ...

Consensus statement AIGO/SICCR diagnosis and treatment of chronic constipation and obstructed defecation (Part II: Treatment)

PubMed Central

Bove, Antonio; Bellini, Massimo; Battaglia, Edda; Bocchini, Renato; Gambaccini, Dario; Bove, Vincenzo; Pucciani, Filippo; Altomare, Donato Francesco; Dodi, Giuseppe; Sciaudone, Guido; Falletto, Ezio; Piloni, Vittorio

2012-01-01

The second part of the Consensus Statement of the Italian Association of Hospital Gastroenterologists and Italian Society of Colo-Rectal Surgery reports on the treatment of chronic constipation and obstructed defecation. There is no evidence that increasing fluid intake and physical activity can relieve the symptoms of chronic constipation. Patients with normal-transit constipation should increase their fibre intake through their diet or with commercial fibre. Osmotic laxatives may be effective in patients who do not respond to fibre supplements. Stimulant laxatives should be reserved for patients who do not respond to osmotic laxatives. Controlled trials have shown that serotoninergic enterokinetic agents, such as prucalopride, and prosecretory agents, such as lubiprostone, are effective in the treatment of patients with chronic constipation. Surgery is sometimes necessary. Total colectomy with ileorectostomy may be considered in patients with slow-transit constipation and inertia coli who are resistant to medical therapy and who do not have defecatory disorders, generalised motility disorders or psychological disorders. Randomised controlled trials have established the efficacy of rehabilitative treatment in dys-synergic defecation. Many surgical procedures may be used to treat obstructed defecation in patients with acquired anatomical defects, but none is considered to be the gold standard. Surgery should be reserved for selected patients with an impaired quality of life. Obstructed defecation is often associated with pelvic organ prolapse. Surgery with the placement of prostheses is replacing fascial surgery in the treatment of pelvic organ prolapse, but the efficacy and safety of such procedures have not yet been established. PMID:23049207

Human Antibodies Against Middle East Respiratory Syndrome Coronavirus | NCI Technology Transfer Center | TTC

Cancer.gov

The National Cancer Institute is seeking statements of capability or interest from parties interested in collaborative research to co-develop antibody-based therapeutic against MERS-CoV, including animal studies, cGMP manufacturing, and clinical trials.

Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement.

PubMed

Husereau, Don; Drummond, Michael; Petrou, Stavros; Carswell, Chris; Moher, David; Greenberg, Dan; Augustovski, Federico; Briggs, Andrew H; Mauskopf, Josephine; Loder, Elizabeth

2013-06-01

Economic evaluations of health interventions pose a particular challenge for reporting. There is also a need to consolidate and update existing guidelines and promote their use in a user friendly manner. The Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement is an attempt to consolidate and update previous health economic evaluation guidelines efforts into one current, useful reporting guidance. The primary audiences for the CHEERS statement are researchers reporting economic evaluations and the editors and peer reviewers assessing them for publication. The need for new reporting guidance was identified by a survey of medical editors. A list of possible items based on a systematic review was created. A two round, modified Delphi panel consisting of representatives from academia, clinical practice, industry, government, and the editorial community was conducted. Out of 44 candidate items, 24 items and accompanying recommendations were developed. The recommendations are contained in a user friendly, 24 item checklist. A copy of the statement, accompanying checklist, and this report can be found on the ISPOR Health Economic Evaluations Publication Guidelines Task Force website ( www.ispor.org/TaskForces/EconomicPubGuidelines.asp). We hope CHEERS will lead to better reporting, and ultimately, better health decisions. To facilitate dissemination and uptake, the CHEERS statement is being co-published across 10 health economics and medical journals. We encourage other journals and groups, to endorse CHEERS. The author team plans to review the checklist for an update in five years.

Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement.

PubMed

Husereau, Don; Drummond, Michael; Petrou, Stavros; Carswell, Chris; Moher, David; Greenberg, Dan; Augustovski, Federico; Briggs, Andrew H; Mauskopf, Josephine; Loder, Elizabeth

2013-04-01

Economic evaluations of health interventions pose a particular challenge for reporting. There is also a need to consolidate and update existing guidelines and promote their use in a user friendly manner. The Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement is an attempt to consolidate and update previous health economic evaluation guidelines efforts into one current, useful reporting guidance. The primary audiences for the CHEERS statement are researchers reporting economic evaluations and the editors and peer reviewers assessing them for publication. The need for new reporting guidance was identified by a survey of medical editors. A list of possible items based on a systematic review was created. A two round, modified Delphi panel consisting of representatives from academia, clinical practice, industry, government, and the editorial community was conducted. Out of 44 candidate items, 24 items and accompanying recommendations were developed. The recommendations are contained in a user friendly, 24 item checklist. A copy of the statement, accompanying checklist, and this report can be found on the ISPOR Health Economic Evaluations Publication Guidelines Task Force website (www.ispor.org/TaskForces/EconomicPubGuidelines.asp). We hope CHEERS will lead to better reporting, and ultimately, better health decisions. To facilitate dissemination and uptake, the CHEERS statement is being co-published across 10 health economics and medical journals. We encourage other journals and groups, to endorse CHEERS. The author team plans to review the checklist for an update in five years.

Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement.

PubMed

Husereau, Don; Drummond, Michael; Petrou, Stavros; Carswell, Chris; Moher, David; Greenberg, Dan; Augustovski, Federico; Briggs, Andrew H; Mauskopf, Josephine; Loder, Elizabeth

2013-05-01

Economic evaluations of health interventions pose a particular challenge for reporting. There is also a need to consolidate and update existing guidelines and promote their use in a user friendly manner. The Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement is an attempt to consolidate and update previous health economic evaluation guidelines efforts into one current, useful reporting guidance. The primary audiences for the CHEERS statement are researchers reporting economic evaluations and the editors and peer reviewers assessing them for publication.The need for new reporting guidance was identified by a survey of medical editors. A list of possible items based on a systematic review was created. A two round, modified Delphi panel consisting of representatives from academia, clinical practice, industry, government, and the editorial community was conducted. Out of 44 candidate items, 24 items and accompanying recommendations were developed. The recommendations are contained in a user friendly, 24 item checklist. A copy of the statement, accompanying checklist, and this report can be found on the ISPOR Health Economic Evaluations Publication Guidelines Task Force website ( www.ispor.org/TaskForces/EconomicPubGuidelines.asp ).We hope CHEERS will lead to better reporting, and ultimately, better health decisions. To facilitate dissemination and uptake, the CHEERS statement is being co-published across 10 health economics and medical journals. We encourage other journals and groups, to endorse CHEERS. The author team plans to review the checklist for an update in five years.

Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement.

PubMed

Husereau, Don; Drummond, Michael; Petrou, Stavros; Carswell, Chris; Moher, David; Greenberg, Dan; Augustovski, Federico; Briggs, Andrew H; Mauskopf, Josephine; Loder, Elizabeth

2013-03-25

Economic evaluations of health interventions pose a particular challenge for reporting. There is also a need to consolidate and update existing guidelines and promote their use in a user friendly manner. The Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement is an attempt to consolidate and update previous health economic evaluation guidelines efforts into one current, useful reporting guidance. The primary audiences for the CHEERS statement are researchers reporting economic evaluations and the editors and peer reviewers assessing them for publication. The need for new reporting guidance was identified by a survey of medical editors. A list of possible items based on a systematic review was created. A two round, modified Delphi panel consisting of representatives from academia, clinical practice, industry, government, and the editorial community was conducted. Out of 44 candidate items, 24 items and accompanying recommendations were developed. The recommendations are contained in a user friendly, 24 item checklist. A copy of the statement, accompanying checklist, and this report can be found on the ISPOR Health Economic Evaluations Publication Guidelines Task Force website (www.ispor.org/TaskForces/EconomicPubGuidelines.asp). We hope CHEERS will lead to better reporting, and ultimately, better health decisions. To facilitate dissemination and uptake, the CHEERS statement is being co-published across 10 health economics and medical journals. We encourage other journals and groups, to endorse CHEERS. The author team plans to review the checklist for an update in five years.

The effect of including a 'psychooncological statement' in the discharge summary on patient-physician communication: a randomized controlled trial.

PubMed

Book, Katrin; Dinkel, Andreas; Henrich, Gerhard; Stuhr, Claudia; Peuker, Mareike; Härtl, Kristin; Brähler, Elmar; Herschbach, Peter

2013-12-01

The objective of this study is to determine whether the inclusion of a 'psychooncological statement' (PO-statement) in the discharge summary enhances patient-physician communication about psychosocial issues across the inpatient and outpatient sector. A total of 1416 cancer patients were randomly assigned to the intervention (with PO-statement in the discharge summary) or control group (discharge summary without PO-statement). Shortly before discharge from the hospital (T1), patients from the intervention group were screened for psychosocial distress. Based on the electronic clinical documentation system, screening results were subsequently integrated into the discharge summary, which automatically generated a PO-statement. To determine the effect of the PO-statement, patients as well as their primary care physicians (n = 596) were asked during follow-up care (T2) whether psychosocial distress was discussed during the last consultation. Including a PO-statement in the discharge summary did not result in more frequent discussions about psychosocial issues compared with the control group from the patients' and physicians' perspectives. Instead, discussions about psychosocial well-being were significantly associated with women of the patient (p = <0.001) and the physician (p = 0.011), medical discipline (gynecologists; p = 0.002), cancer diagnosis (gynecological cancer; p = 0.002), metastases (p = <0.001), professional training of patients (none, p = 0.026), and psychosocial qualification of physicians (p = 0.018). Written information on psychosocial distress in the discharge summary alone does not affect communication. Copyright © 2013 John Wiley & Sons, Ltd.

12 CFR 363.2 - Annual reporting requirements.

Code of Federal Regulations, 2010 CFR

2010-01-01

...) Audited financial statements. Each insured depository institution shall prepare annual financial... financial statements must reflect all material correcting adjustments necessary to conform with GAAP that... the institution's annual financial statements, for establishing and maintaining an adequate internal...

12 CFR 630.2 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-01-01

... Act of 1971, as amended (Act). (b) Combined financial statements means financial statements prepared... includes financial data of the bank's consolidated subsidiaries. (c) Disclosure entity means any Farm... means a report that presents the Systemwide combined financial statements, supplemental financial...

Defense Departmental Reporting System-Budgetary Was Not Effectively Implemented for the Army General Fund

DTIC Science & Technology

2012-05-31

or events. Unsupported journal vouchers increase the risk of materially misstated balances reported on the AGF financial statements. DFAS...with U.S. generally accepted accounting principles and that the Army automated systems did not support material amounts on the financial statements...files, abnormal balance detection , journal vouchers, and reconciliations between Army and OMB SF 133s and the Statements of Budgetary Resources

Western Area Power Administration combined power system financial statements, 30 September 1995 and 1994

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

NONE

1995-12-31

The attached report presents the results of the independent certified public accountant`s audit of the Department of Energy`s Western Area Power Administration`s (Western) combined financial statements as of September 30, 1995. The auditors have expressed an unqualified opinion on Western`s 1995 statements. Their reports on Western`s internal control structure and on compliance with laws and regulations are also provided.

Temperature Management After Cardiac Arrest: An Advisory Statement by the Advanced Life Support Task Force of the International Liaison Committee on Resuscitation and the American Heart Association Emergency Cardiovascular Care Committee and the Council on Cardiopulmonary, Critical Care, Perioperative and Resuscitation.

PubMed

Donnino, Michael W; Andersen, Lars W; Berg, Katherine M; Reynolds, Joshua C; Nolan, Jerry P; Morley, Peter T; Lang, Eddy; Cocchi, Michael N; Xanthos, Theodoros; Callaway, Clifton W; Soar, Jasmeet

2016-01-01

For more than a decade, mild induced hypothermia (32 °C-34 °C) has been standard of care for patients remaining comatose after resuscitation from out-of-hospital cardiac arrest with an initial shockable rhythm, and this has been extrapolated to survivors of cardiac arrest with initially nonshockable rhythms and to patients with in-hospital cardiac arrest. Two randomized trials published in 2002 reported a survival and neurological benefit with mild induced hypothermia. One recent randomized trial reported similar outcomes in patients treated with targeted temperature management at either 33 °C or 36 °C. In response to these new data, the International Liaison Committee on Resuscitation Advanced Life Support Task Force performed a systematic review to evaluate 3 key questions: (1) Should mild induced hypothermia (or some form of targeted temperature management) be used in comatose post-cardiac arrest patients? (2) If used, what is the ideal timing of the intervention? (3) If used, what is the ideal duration of the intervention? The task force used Grading of Recommendations Assessment, Development and Evaluation methodology to assess and summarize the evidence and to provide a consensus on science statement and treatment recommendations. The task force recommends targeted temperature management for adults with out-of-hospital cardiac arrest with an initial shockable rhythm at a constant temperature between 32 °C and 36 °C for at least 24 hours. Similar suggestions are made for out-of-hospital cardiac arrest with a nonshockable rhythm and in-hospital cardiac arrest. The task force recommends against prehospital cooling with rapid infusion of large volumes of cold intravenous fluid. Additional and specific recommendations are provided in the document. Copyright © 2015. Published by Elsevier Ireland Ltd.

Temperature Management After Cardiac Arrest: An Advisory Statement by the Advanced Life Support Task Force of the International Liaison Committee on Resuscitation and the American Heart Association Emergency Cardiovascular Care Committee and the Council on Cardiopulmonary, Critical Care, Perioperative and Resuscitation.

PubMed

Donnino, Michael W; Andersen, Lars W; Berg, Katherine M; Reynolds, Joshua C; Nolan, Jerry P; Morley, Peter T; Lang, Eddy; Cocchi, Michael N; Xanthos, Theodoros; Callaway, Clifton W; Soar, Jasmeet

2015-12-22

For more than a decade, mild induced hypothermia (32 °C-34 °C) has been standard of care for patients remaining comatose after resuscitation from out-of-hospital cardiac arrest with an initial shockable rhythm, and this has been extrapolated to survivors of cardiac arrest with initially nonshockable rhythms and to patients with in-hospital cardiac arrest. Two randomized trials published in 2002 reported a survival and neurological benefit with mild induced hypothermia. One recent randomized trial reported similar outcomes in patients treated with targeted temperature management at either 33 °C or 36 °C. In response to these new data, the International Liaison Committee on Resuscitation Advanced Life Support Task Force performed a systematic review to evaluate 3 key questions: (1) Should mild induced hypothermia (or some form of targeted temperature management) be used in comatose post-cardiac arrest patients? (2) If used, what is the ideal timing of the intervention? (3) If used, what is the ideal duration of the intervention? The task force used Grading of Recommendations Assessment, Development and Evaluation methodology to assess and summarize the evidence and to provide a consensus on science statement and treatment recommendations. The task force recommends targeted temperature management for adults with out-of-hospital cardiac arrest with an initial shockable rhythm at a constant temperature between 32 °C and 36 °C for at least 24 hours. Similar suggestions are made for out-of-hospital cardiac arrest with a nonshockable rhythm and in-hospital cardiac arrest. The task force recommends against prehospital cooling with rapid infusion of large volumes of cold intravenous fluid. Additional and specific recommendations are provided in the document. © 2015 by the American Heart Association, Inc., and the European Resuscitation Council.

48 CFR 52.204-10 - Reporting Executive Compensation and First-Tier Subcontract Awards.

Code of Federal Regulations, 2010 CFR

2010-10-01

... appreciation rights. Use the dollar amount recognized for financial statement reporting purposes with respect to the fiscal year in accordance with the Statement of Financial Accounting Standards No. 123...

Executive defensive. As the Scrushy case finally goes before an Alabama jury, the Sarbanes-Oxley Act and its impact are also on trial.

PubMed

Mantone, Joseph

2005-01-31

With the trial of Richard Scrushy, left, finally under way in Alabama, it isn't just the former HealthSouth executive being scrutinized. It's the first courtroom test for the Sarbanes-Oxley Act of 2002, which holds CEOs accountable for false financial statements. Scrushy's defense attorneys have already begun laying the groundwork to blame underlings for the 2.64 billion dollar accounting fraud.

Financial Reporting for Tennessee Public Colleges and Universities.

ERIC Educational Resources Information Center

Tennessee Higher Education Commission, Nashville.

This manual provides a framework for accounting practices, budgeting and reporting procedures for Tennessee public higher education institutions. Emphasis is placed on principles and procedures of accounting and financial reporting; the balance sheet; statement of changes in fund balances; statement of current funds revenues, expenditures, and…

14 CFR 67.403 - Applications, certificates, logbooks, reports, and records: Falsification, reproduction, or...

Code of Federal Regulations, 2010 CFR

2010-01-01

..., reports, and records: Falsification, reproduction, or alteration; incorrect statements. 67.403 Section 67..., logbooks, reports, and records: Falsification, reproduction, or alteration; incorrect statements. (a) No... reproduction, for fraudulent purposes, of any medical certificate under this part; or (4) An alteration of any...

14 CFR 67.403 - Applications, certificates, logbooks, reports, and records: Falsification, reproduction, or...

Code of Federal Regulations, 2011 CFR

2011-01-01

..., reports, and records: Falsification, reproduction, or alteration; incorrect statements. 67.403 Section 67..., logbooks, reports, and records: Falsification, reproduction, or alteration; incorrect statements. (a) No... reproduction, for fraudulent purposes, of any medical certificate under this part; or (4) An alteration of any...

17 CFR 210.2-05 - Examination of financial statements by more than one accountant.

Code of Federal Regulations, 2010 CFR

2010-04-01

... statements by more than one accountant. 210.2-05 Section 210.2-05 Commodity and Securities Exchanges... Qualifications and Reports of Accountants § 210.2-05 Examination of financial statements by more than one accountant. If, with respect to the examination of the financial statements, part of the examination is made...

17 CFR 210.2-05 - Examination of financial statements by more than one accountant.

Code of Federal Regulations, 2011 CFR

2011-04-01

... statements by more than one accountant. 210.2-05 Section 210.2-05 Commodity and Securities Exchanges... Qualifications and Reports of Accountants § 210.2-05 Examination of financial statements by more than one accountant. If, with respect to the examination of the financial statements, part of the examination is made...

Herbal medicine for low back pain: a Cochrane review.

PubMed

Gagnier, Joel J; van Tulder, Maurits W; Berman, Brian; Bombardier, Claire

2007-01-01

A systematic review of randomized controlled trials. To determine the effectiveness of herbal medicine compared with placebo, no intervention, or "standard/accepted/conventional treatments" for nonspecific low back pain. Low back pain is a common condition and a substantial economic burden in industrialized societies. A large proportion of patients with chronic low back pain use complementary and alternative medicine (CAM) and/or visit CAM practitioners. Several herbal medicines have been purported for use in low back pain. The following databases were searched: Medline (1966 to April 2003), Embase (1980 to April 2003), Cochrane Controlled Trials Register (Issue 1, 2003), and Cochrane Complementary Medicine (CM) field Trials Register. Additionally, reference lists in review articles, guidelines, and in the retrieved trials were checked. Randomized controlled trials (RCTs), using adults (>18 years of age) suffering from acute, subacute, or chronic nonspecific low back pain. Types of interventions included herbal medicines defined as a plant that is used for medicinal purposes in any form. Primary outcome measures were pain and function. Two reviewers (J.J.G. and M.W.T.) conducted electronic searches in all databases. One reviewer (J.J.G.) contacted content experts and acquired relevant citations. Authors, title, subject headings, publication type, and abstract of the isolated studies were downloaded or a hard copy was retrieved. Methodologic quality and clinical relevance were assessed separately by two individuals (J.J.G. and M.W.T.). Disagreements were resolved by consensus. Ten trials were included in this review. Two high-quality trials utilizing Harpagophytum procumbens (Devil's claw) found strong evidence for short-term improvements in pain and rescue medication for daily doses standardized to 50 mg or 100 mg harpagoside with another high-quality trial demonstrating relative equivalence to 12.5 mg per day of rofecoxib. Two moderate-quality trials utilizing Salix alba (White willow bark) found moderate evidence for short-term improvements in pain and rescue medication for daily doses standardized to 120 mg or 240 mg salicin with an additional trial demonstrating relative equivalence to 12.5 mg per day of rofecoxib. Three low-quality trials using Capsicum frutescens (Cayenne) using various topical preparations found moderate evidence for favorable results against placebo and one trial found equivalence to a homeopathic ointment. Harpagophytum procumbens, Salix alba, and Capsicum frutescens seem to reduce pain more than placebo. Additional trials testing these herbal medicines against standard treatments will clarify their equivalence in terms of efficacy. The quality of reporting in these trials was generally poor; thus, trialists should refer to the CONSORT statement in reporting clinical trials of herbal medicines.

Consensus statements from the Workshop "Probiotics and Health: Scientific evidence".

PubMed

Guarner, F; Requena, T; Marcos, A

2010-01-01

This report shows the level of scientific consensus on definition, characteristics and health benefits of probiotics. The content of the report has derived from the scientific meeting: Workshop on Probiotics and Health. Scientific evidence, that congregated several Spanish experts, including gastroenterologists, microbiologists, nutritionists, immunologists and food technologists, among others, who have agreed with the statements shown in this document. Each statement has been sustained with the most relevant scientific aspects that were discussed during the Workshop and the following evaluation of the report by all experts who approved and signed it.

CONSENSUS STATEMENT BY THE AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY ON THE COMPREHENSIVE TYPE 2 DIABETES MANAGEMENT ALGORITHM--2015 EXECUTIVE SUMMARY.

PubMed

Garber, Alan J; Abrahamson, Martin Julian; Barzilay, Joshua I; Blonde, Lawrence; Bloomgarden, Zachary T; Bush, Michael A; Dagogo-Jack, Samuel; Davidson, Michael B; Einhorn, Daniel; Garber, Jeffrey R; Garvey, W Timothy; Grunberger, George; Handelsman, Yehuda; Hirsch, Irl B; Jellinger, Paul S; McGill, Janet B; Mechanick, Jeffrey I; Rosenblit, Paul David; Umpierrez, Guillermo E

2015-12-01

This document represents the official position of the American Association of Clinical Endocrinologists and the American College of Endocrinology. Where there were no randomized controlled trials or specific U.S. FDA labeling for issues in clinical practice, the participating clinical experts utilized their judgment and experience. Every effort was made to achieve consensus among the committee members. Position statements are meant to provide guidance, but they are not to be considered prescriptive for any individual patient and cannot replace the judgment of a clinician.

AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY POSITION STATEMENT ON TESTING FOR AUTONOMIC AND SOMATIC NERVE DYSFUNCTION.

PubMed

Vinik, Aaron I; Camacho, Pauline M; Davidson, Jaime A; Handelsman, Yehuda; Lando, Howard M; Leddy, Anne L; Reddy, Sethu K; Cook, Richard; Spallone, Vicenza; Tesfaye, Solomon; Ziegler, Dan

2017-12-01

This document represents the official position of the American Association of Clinical Endocrinologists and the American College of Endocrinology. Where there were no randomized controlled trials or specific U.S. FDA labeling for issues in clinical practice, the participating clinical experts utilized their judgment and experience. Every effort was made to achieve consensus among the committee members. Position statements are meant to provide guidance, but they are not to be considered prescriptive for any individual patient and cannot replace the judgment of a clinician.

AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY POSITION STATEMENT ON THE ASSOCIATION OF TESTOSTERONE AND CARDIOVASCULAR RISK.

PubMed

Goodman, Neil; Guay, Andre; Dandona, Paresh; Dhindsa, Sandeep; Faiman, Charles; Cunningham, Glenn R

2015-09-01

This document represents the official position of the American Association of Clinical Endocrinologists and the American College of Endocrinology. Where there were no randomized controlled trials or specific U.S. FDA labeling for issues in clinical practice, the participating clinical experts utilized their judgment and experience. Every effort was made to achieve consensus among the committee members. Position statements are meant to provide guidance, but they are not to be considered prescriptive for any individual patient and cannot replace the judgment of a clinician.

Escitalopram: superior to citalopram or a chiral chimera?

PubMed

Svensson, Staffan; Mansfield, Peter R

2004-01-01

Escitalopram is the active isomer of the antidepressant citalopram. In theory single-isomer drugs may be superior but few have been found to have clinically significant advantages. The manufacturer claims that escitalopram has more efficacy and a faster onset of effect than citalopram. The purpose of this study was to assess how far these claims are justified. Relevant trial reports were requested from H. Lundbeck A/S and the Swedish drug regulatory authority. The trials consisted of a pooled analysis of 1,321 patients from one unpublished, one partly published and one published eight-week trial, as well as a 24-week trial with 357 patients published as a poster. The studies compared escitalopram with placebo and/or citalopram in outpatients aged or=18 years who met specified criteria for depression. The trials' quality was assessed with Moncrieff et al.'s quality assessment instrument and the results compared with the claims from the advertisements. The advertising claims are not justified because they are based on secondary outcomes, non-intention-to-treat analyses and arbitrarily defined subgroups. The subgroup results are inconsistent. Methodological flaws in the trials could account for the differences found. Even if the differences claimed were real they appear too small to justify higher prices. On the evidence available to us the manufacturer's claims of superiority for escitalopram over citalopram are unwarranted. The Swedish and Danish drug regulatory authorities reached similar conclusions. This highlights the need for wider dissemination of national authorities' statements to other countries affected by the European Union's mutual recognition procedure. Copyright 2004 S. Karger AG, Basel

12 CFR 363.1 - Scope and definitions.

Code of Federal Regulations, 2010 CFR

2010-01-01

... accepted accounting principles for the insured depository institution or its holding company and financial statements prepared for regulatory reporting purposes. For recognition and measurement purposes, financial statements prepared for regulatory reporting purposes shall conform to generally accepted accounting...

17 CFR 210.2-02 - Accountants' reports and attestation reports.

Code of Federal Regulations, 2010 CFR

2010-04-01

... respect of the financial statements covered by the report and the accounting principles and practices... accounting principles, or as to any changes in such principles which have a material effect on the financial... COMMISSION FORM AND CONTENT OF AND REQUIREMENTS FOR FINANCIAL STATEMENTS, SECURITIES ACT OF 1933, SECURITIES...

49 CFR 830.15 - Reports and statements to be filed.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 7 2010-10-01 2010-10-01 false Reports and statements to be filed. 830.15 Section 830.15 Transportation Other Regulations Relating to Transportation (Continued) NATIONAL TRANSPORTATION SAFETY BOARD NOTIFICATION AND REPORTING OF AIRCRAFT ACCIDENTS OR INCIDENTS AND OVERDUE AIRCRAFT, AND PRESERVATION OF AIRCRAFT WRECKAGE, MAIL,...

Report: State of Washington Water Pollution Control State Revolving Fund Financial Statements with Independent Auditor's Report, June 30, 2003

EPA Pesticide Factsheets

Report #2004-1-00067, May 26, 2004. The financial statements referred to in the first paragraph present fairly the financial position of the Washington Department of Ecology Water Pollution Control State Revolving Fund as of June 30, 2003.

Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): Explanation and Elaboration

PubMed Central

Vandenbroucke, Jan P; von Elm, Erik; Altman, Douglas G; Gøtzsche, Peter C; Mulrow, Cynthia D; Pocock, Stuart J; Poole, Charles; Schlesselman, James J; Egger, Matthias

2007-01-01

Much medical research is observational. The reporting of observational studies is often of insufficient quality. Poor reporting hampers the assessment of the strengths and weaknesses of a study and the generalisability of its results. Taking into account empirical evidence and theoretical considerations, a group of methodologists, researchers, and editors developed the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) recommendations to improve the quality of reporting of observational studies. The STROBE Statement consists of a checklist of 22 items, which relate to the title, abstract, introduction, methods, results and discussion sections of articles. Eighteen items are common to cohort studies, case-control studies and cross-sectional studies and four are specific to each of the three study designs. The STROBE Statement provides guidance to authors about how to improve the reporting of observational studies and facilitates critical appraisal and interpretation of studies by reviewers, journal editors and readers. This explanatory and elaboration document is intended to enhance the use, understanding, and dissemination of the STROBE Statement. The meaning and rationale for each checklist item are presented. For each item, one or several published examples and, where possible, references to relevant empirical studies and methodological literature are provided. Examples of useful flow diagrams are also included. The STROBE Statement, this document, and the associated Web site (http://www.strobe-statement.org/) should be helpful resources to improve reporting of observational research. PMID:17941715

Consolidated Health Economic Evaluation Reporting Standards (CHEERS)--explanation and elaboration: a report of the ISPOR Health Economic Evaluation Publication Guidelines Good Reporting Practices Task Force.

PubMed

Husereau, Don; Drummond, Michael; Petrou, Stavros; Carswell, Chris; Moher, David; Greenberg, Dan; Augustovski, Federico; Briggs, Andrew H; Mauskopf, Josephine; Loder, Elizabeth

2013-01-01

Economic evaluations of health interventions pose a particular challenge for reporting because substantial information must be conveyed to allow scrutiny of study findings. Despite a growth in published reports, existing reporting guidelines are not widely adopted. There is also a need to consolidate and update existing guidelines and promote their use in a user-friendly manner. A checklist is one way to help authors, editors, and peer reviewers use guidelines to improve reporting. The task force's overall goal was to provide recommendations to optimize the reporting of health economic evaluations. The Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement is an attempt to consolidate and update previous health economic evaluation guidelines into one current, useful reporting guidance. The CHEERS Elaboration and Explanation Report of the ISPOR Health Economic Evaluation Publication Guidelines Good Reporting Practices Task Force facilitates the use of the CHEERS statement by providing examples and explanations for each recommendation. The primary audiences for the CHEERS statement are researchers reporting economic evaluations and the editors and peer reviewers assessing them for publication. The need for new reporting guidance was identified by a survey of medical editors. Previously published checklists or guidance documents related to reporting economic evaluations were identified from a systematic review and subsequent survey of task force members. A list of possible items from these efforts was created. A two-round, modified Delphi Panel with representatives from academia, clinical practice, industry, and government, as well as the editorial community, was used to identify a minimum set of items important for reporting from the larger list. Out of 44 candidate items, 24 items and accompanying recommendations were developed, with some specific recommendations for single study-based and model-based economic evaluations. The final recommendations are subdivided into six main categories: 1) title and abstract, 2) introduction, 3) methods, 4) results, 5) discussion, and 6) other. The recommendations are contained in the CHEERS statement, a user-friendly 24-item checklist. The task force report provides explanation and elaboration, as well as an example for each recommendation. The ISPOR CHEERS statement is available online via Value in Health or the ISPOR Health Economic Evaluation Publication Guidelines Good Reporting Practices - CHEERS Task Force webpage (http://www.ispor.org/TaskForces/EconomicPubGuidelines.asp). We hope that the ISPOR CHEERS statement and the accompanying task force report guidance will lead to more consistent and transparent reporting, and ultimately, better health decisions. To facilitate wider dissemination and uptake of this guidance, we are copublishing the CHEERS statement across 10 health economics and medical journals. We encourage other journals and groups to consider endorsing the CHEERS statement. The author team plans to review the checklist for an update in 5 years. Copyright © 2013 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Teaching school children basic life support improves teaching and basic life support skills of medical students: A randomised, controlled trial.

PubMed

Beck, Stefanie; Meier-Klages, Vivian; Michaelis, Maria; Sehner, Susanne; Harendza, Sigrid; Zöllner, Christian; Kubitz, Jens Christian

2016-11-01

The "kids save lives" joint-statement highlights the effectiveness of training all school children worldwide in cardiopulmonary resuscitation (CPR) to improve survival after cardiac arrest. The personnel requirement to implement this statement is high. Until now, no randomised controlled trial investigated if medical students benefit from their engagement in the BLS-education of school children regarding their later roles as physicians. The objective of the present study is to evaluate if medical students improve their teaching behaviour and CPR-skills by teaching school children in basic life support. The study is a randomised, single blind, controlled trial carried out with medical students during their final year. In total, 80 participants were allocated alternately to either the intervention or the control group. The intervention group participated in a CPR-instructor-course consisting of a 4h-preparatory seminar and a teaching-session in BLS for school children. The primary endpoints were effectiveness of teaching in an objective teaching examination and pass-rates in a simulated BLS-scenario. The 28 students who completed the CPR-instructor-course had significantly higher scores for effective teaching in five of eight dimensions and passed the BLS-assessment significantly more often than the 25 students of the control group (Odds Ratio (OR): 10.0; 95%-CI: 1.9-54.0; p=0.007). Active teaching of BLS improves teaching behaviour and resuscitation skills of students. Teaching school children in BLS may prepare medical students for their future role as a clinical teacher and support the implementation of the "kids save lives" statement on training all school children worldwide in BLS at the same time. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Preferred Reporting Items for Studies Mapping onto Preference-Based Outcome Measures: The MAPS Statement.

PubMed

Petrou, Stavros; Rivero-Arias, Oliver; Dakin, Helen; Longworth, Louise; Oppe, Mark; Froud, Robert; Gray, Alastair

2015-10-01

'Mapping' onto generic preference-based outcome measures is increasingly being used as a means of generating health utilities for use within health economic evaluations. Despite publication of technical guides for the conduct of mapping research, guidance for the reporting of mapping studies is currently lacking. The MAPS (MApping onto Preference-based measures reporting Standards) statement is a new checklist, which aims to promote complete and transparent reporting of mapping studies. In the absence of previously published reporting checklists or reporting guidance documents, a de novo list of reporting items was created by a working group comprising six health economists and one Delphi methodologist. A two-round, modified Delphi survey, with representatives from academia, consultancy, health technology assessment agencies and the biomedical journal editorial community, was used to identify a list of essential reporting items from this larger list. From the initial de novo list of 29 candidate items, a set of 23 essential reporting items was developed. The items are presented numerically and categorized within six sections: (1) title and abstract; (2) introduction; (3) methods; (4) results; (5) discussion; and (6) other. The MAPS statement is best applied in conjunction with the accompanying MAPS Explanation and Elaboration paper. It is anticipated that the MAPS statement will improve the clarity, transparency and completeness of the reporting of mapping studies. To facilitate dissemination and uptake, the MAPS statement is being co-published by seven health economics and quality-of-life journals, and broader endorsement is encouraged. The MAPS working group plans to assess the need for an update of the reporting checklist in 5 years' time.

Preferred Reporting Items for Studies Mapping onto Preference-Based Outcome Measures: The MAPS Statement.

PubMed

Petrou, Stavros; Rivero-Arias, Oliver; Dakin, Helen; Longworth, Louise; Oppe, Mark; Froud, Robert; Gray, Alastair

2015-08-01

"Mapping" onto generic preference-based outcome measures is increasingly being used as a means of generating health utilities for use within health economic evaluations. Despite the publication of technical guides for the conduct of mapping research, guidance for the reporting of mapping studies is currently lacking. The MAPS (MApping onto Preference-based measures reporting Standards) statement is a new checklist that aims to promote complete and transparent reporting of mapping studies. In the absence of previously published reporting checklists or reporting guidance documents, a de novo list of reporting items was created by a working group comprised of 6 health economists and 1 Delphi methodologist. A 2-round, modified Delphi survey with representatives from academia, consultancy, health technology assessment agencies, and the biomedical journal editorial community was used to identify a list of essential reporting items from this larger list. From the initial de novo list of 29 candidate items, a set of 23 essential reporting items was developed. The items are presented numerically and categorized within 6 sections, namely: (i) title and abstract; (ii) introduction; (iii) methods; (iv) results; (v) discussion; and (vi) other. The MAPS statement is best applied in conjunction with the accompanying MAPS explanation and elaboration document. It is anticipated that the MAPS statement will improve the clarity, transparency, and completeness of reporting of mapping studies. To facilitate dissemination and uptake, the MAPS statement is being co-published by 7 health economics and quality-of-life journals, and broader endorsement is encouraged. The MAPS working group plans to assess the need for an update of the reporting checklist in 5 years.

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

PubMed Central

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

2012-01-01

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

Diabetes in pregnancy outcomes: a systematic review and proposed codification of definitions.

PubMed

Feig, Denice S; Corcoy, Rosa; Jensen, Dorte Moller; Kautzky-Willer, Alexandra; Nolan, Christopher J; Oats, Jeremy J N; Sacks, David A; Caimari, Francisca; McIntyre, H David

2015-10-01

Rising rates of diabetes in pregnancy have led to an escalation in research in this area. As in any area of clinical research, definitions of outcomes vary from study to study, making it difficult to compare research findings and draw conclusions. Our aim was to compile and create a repository of definitions, which could then be used universally. A systematic review of the literature was performed on published and ongoing randomized controlled trials in the area of diabetes in pregnancy between 01 Jan 2000 and 01 Jun 2012. Other sources included the World Health Organization and Academic Society Statements. The advice of experts was sought when appropriate definitions were lacking. Among the published randomized controlled trials on diabetes and pregnancy, 171 abstracts were retrieved, 64 full texts were reviewed and 53 were included. Among the ongoing randomized controlled trials published in ClinicalTrials.gov, 90 protocols were retrieved and 25 were finally included. The definitions from these were assembled and the final maternal definitions and foetal definitions were agreed upon by consensus. It is our hope that the definitions we have provided (i) will be widely used in the reporting of future studies in the area of diabetes in pregnancy, that they will (ii) facilitate future systematic reviews and formal meta analyses and (iii) ultimately improve outcomes for mothers and babies. Copyright © 2015 John Wiley & Sons, Ltd.

Endorsement of PRISMA statement and quality of systematic reviews and meta-analyses published in nursing journals: a cross-sectional study

PubMed Central

Tam, Wilson W S; Lo, Kenneth K H; Khalechelvam, Parames

2017-01-01

Objective Systematic reviews (SRs) often poorly report key information, thereby diminishing their usefulness. Previous studies evaluated published SRs and determined that they failed to meet explicit criteria or characteristics. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement was recommended as a reporting guideline for SR and meta-analysis (MA), but previous studies showed that adherence to the statement was not high for SRs published in different medical fields. Thus, the aims of this study are twofold: (1) to investigate the number of nursing journals that have required or recommended the use of the PRISMA statement for reporting SR, and (2) to examine the adherence of SRs and/or meta-analyses to the PRISMA statement published in nursing journals. Design A cross-sectional study. Methods Nursing journals listed in the ISI journal citation report were divided into 2 groups based on the recommendation of PRISMA statement in their ‘Instruction for Authors’. SRs and meta-analyses published in 2014 were searched in 3 databases. 37 SRs and meta-analyses were randomly selected in each group. The adherence of each item to the PRISMA was examined and summarised using descriptive statistics. The quality of the SRs was assessed by Assessing the Methodological Quality of Systematic Reviews. The differences between the 2 groups were compared using the Mann-Whitney U test. Results Out of 107 nursing journals, 30 (28.0%) recommended or required authors to follow the PRISMA statement when they submit SRs or meta-analyses. The median rates of adherence to the PRISMA statement for reviews published in journals with and without PRISMA endorsement were 64.9% (IQR: 17.6–92.3%) and 73.0% (IQR: 59.5–94.6%), respectively. No significant difference was observed in any of the items between the 2 groups. Conclusions The median adherence of SRs and meta-analyses in nursing journals to PRISMA is low at 64.9% and 73.0%, respectively. Nonetheless, the adherence level of nursing journals to the PRISMA statement does not significantly vary whether they endorse or recommend such a guideline. PMID:28174224

17 CFR 210.3-03 - Instructions to income statement requirements.

Code of Federal Regulations, 2011 CFR

2011-04-01

... businesses, it may at its option include statements of income and cash flows (which may be unaudited) for the... statements of income and cash flows for the interim periods specified. (c) If a period or periods reported on...

17 CFR 210.3-03 - Instructions to income statement requirements.

Code of Federal Regulations, 2010 CFR

2010-04-01

... businesses, it may at its option include statements of income and cash flows (which may be unaudited) for the... statements of income and cash flows for the interim periods specified. (c) If a period or periods reported on...

Transparent reporting of a multivariable prediction model for individual prognosis or diagnosis (TRIPOD): the TRIPOD statement.

PubMed

Collins, G S; Reitsma, J B; Altman, D G; Moons, K G M

2015-01-20

Prediction models are developed to aid health-care providers in estimating the probability or risk that a specific disease or condition is present (diagnostic models) or that a specific event will occur in the future (prognostic models), to inform their decision making. However, the overwhelming evidence shows that the quality of reporting of prediction model studies is poor. Only with full and clear reporting of information on all aspects of a prediction model can risk of bias and potential usefulness of prediction models be adequately assessed. The Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis (TRIPOD) Initiative developed a set of recommendations for the reporting of studies developing, validating, or updating a prediction model, whether for diagnostic or prognostic purposes. This article describes how the TRIPOD Statement was developed. An extensive list of items based on a review of the literature was created, which was reduced after a Web-based survey and revised during a 3-day meeting in June 2011 with methodologists, health-care professionals, and journal editors. The list was refined during several meetings of the steering group and in e-mail discussions with the wider group of TRIPOD contributors. The resulting TRIPOD Statement is a checklist of 22 items, deemed essential for transparent reporting of a prediction model study. The TRIPOD Statement aims to improve the transparency of the reporting of a prediction model study regardless of the study methods used. The TRIPOD Statement is best used in conjunction with the TRIPOD explanation and elaboration document. To aid the editorial process and readers of prediction model studies, it is recommended that authors include a completed checklist in their submission (also available at www.tripod-statement.org).

Transparent reporting of a multivariable prediction model for individual prognosis or diagnosis (TRIPOD): the TRIPOD Statement.

PubMed

Collins, Gary S; Reitsma, Johannes B; Altman, Douglas G; Moons, Karel G M

2015-02-01

Prediction models are developed to aid healthcare providers in estimating the probability or risk that a specific disease or condition is present (diagnostic models) or that a specific event will occur in the future (prognostic models), to inform their decision-making. However, the overwhelming evidence shows that the quality of reporting of prediction model studies is poor. Only with full and clear reporting of information on all aspects of a prediction model can risk of bias and potential usefulness of prediction models be adequately assessed. The Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis (TRIPOD) initiative developed a set of recommendations for the reporting of studies developing, validating or updating a prediction model, whether for diagnostic or prognostic purposes. This article describes how the TRIPOD Statement was developed. An extensive list of items based on a review of the literature was created, which was reduced after a Web-based survey and revised during a 3-day meeting in June 2011 with methodologists, healthcare professionals and journal editors. The list was refined during several meetings of the steering group and in e-mail discussions with the wider group of TRIPOD contributors. The resulting TRIPOD Statement is a checklist of 22 items, deemed essential for transparent reporting of a prediction model study. The TRIPOD Statement aims to improve the transparency of the reporting of a prediction model study regardless of the study methods used. The TRIPOD Statement is best used in conjunction with the TRIPOD explanation and elaboration document. To aid the editorial process and readers of prediction model studies, it is recommended that authors include a completed checklist in their submission (also available at www.tripod-statement.org). © 2015 Stichting European Society for Clinical Investigation Journal Foundation.

Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis (TRIPOD): the TRIPOD Statement.

PubMed

Collins, G S; Reitsma, J B; Altman, D G; Moons, K G M

2015-02-01

Prediction models are developed to aid healthcare providers in estimating the probability or risk that a specific disease or condition is present (diagnostic models) or that a specific event will occur in the future (prognostic models), to inform their decision-making. However, the overwhelming evidence shows that the quality of reporting of prediction model studies is poor. Only with full and clear reporting of information on all aspects of a prediction model can risk of bias and potential usefulness of prediction models be adequately assessed. The Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis (TRIPOD) Initiative developed a set of recommendations for the reporting of studies developing, validating or updating a prediction model, whether for diagnostic or prognostic purposes. This article describes how the TRIPOD Statement was developed. An extensive list of items based on a review of the literature was created, which was reduced after a web-based survey and revised during a 3-day meeting in June 2011 with methodologists, healthcare professionals and journal editors. The list was refined during several meetings of the steering group and in e-mail discussions with the wider group of TRIPOD contributors. The resulting TRIPOD Statement is a checklist of 22 items, deemed essential for transparent reporting of a prediction model study. The TRIPOD Statement aims to improve the transparency of the reporting of a prediction model study regardless of the study methods used. The TRIPOD Statement is best used in conjunction with the TRIPOD explanation and elaboration document. A complete checklist is available at http://www.tripod-statement.org. © 2015 American College of Physicians.

Transparent Reporting of a multivariable prediction model for Individual Prognosis or Diagnosis (TRIPOD): the TRIPOD statement.

PubMed

Collins, Gary S; Reitsma, Johannes B; Altman, Douglas G; Moons, Karel G M

2015-01-06

Prediction models are developed to aid health care providers in estimating the probability or risk that a specific disease or condition is present (diagnostic models) or that a specific event will occur in the future (prognostic models), to inform their decision making. However, the overwhelming evidence shows that the quality of reporting of prediction model studies is poor. Only with full and clear reporting of information on all aspects of a prediction model can risk of bias and potential usefulness of prediction models be adequately assessed. The Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis (TRIPOD) Initiative developed a set of recommendations for the reporting of studies developing, validating, or updating a prediction model, whether for diagnostic or prognostic purposes. This article describes how the TRIPOD Statement was developed. An extensive list of items based on a review of the literature was created, which was reduced after a Web-based survey and revised during a 3-day meeting in June 2011 with methodologists, health care professionals, and journal editors. The list was refined during several meetings of the steering group and in e-mail discussions with the wider group of TRIPOD contributors. The resulting TRIPOD Statement is a checklist of 22 items, deemed essential for transparent reporting of a prediction model study. The TRIPOD Statement aims to improve the transparency of the reporting of a prediction model study regardless of the study methods used. The TRIPOD Statement is best used in conjunction with the TRIPOD explanation and elaboration document. To aid the editorial process and readers of prediction model studies, it is recommended that authors include a completed checklist in their submission (also available at www.tripod-statement.org).

Transparent reporting of a multivariable prediction model for individual prognosis or diagnosis (TRIPOD): The TRIPOD statement

PubMed Central

Collins, G S; Reitsma, J B; Altman, D G; Moons, K G M

2015-01-01

Prediction models are developed to aid health-care providers in estimating the probability or risk that a specific disease or condition is present (diagnostic models) or that a specific event will occur in the future (prognostic models), to inform their decision making. However, the overwhelming evidence shows that the quality of reporting of prediction model studies is poor. Only with full and clear reporting of information on all aspects of a prediction model can risk of bias and potential usefulness of prediction models be adequately assessed. The Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis (TRIPOD) Initiative developed a set of recommendations for the reporting of studies developing, validating, or updating a prediction model, whether for diagnostic or prognostic purposes. This article describes how the TRIPOD Statement was developed. An extensive list of items based on a review of the literature was created, which was reduced after a Web-based survey and revised during a 3-day meeting in June 2011 with methodologists, health-care professionals, and journal editors. The list was refined during several meetings of the steering group and in e-mail discussions with the wider group of TRIPOD contributors. The resulting TRIPOD Statement is a checklist of 22 items, deemed essential for transparent reporting of a prediction model study. The TRIPOD Statement aims to improve the transparency of the reporting of a prediction model study regardless of the study methods used. The TRIPOD Statement is best used in conjunction with the TRIPOD explanation and elaboration document. To aid the editorial process and readers of prediction model studies, it is recommended that authors include a completed checklist in their submission (also available at www.tripod-statement.org). PMID:25562432

Transparent reporting of a multivariable prediction model for individual prognosis or diagnosis (TRIPOD): the TRIPOD statement.

PubMed

Collins, G S; Reitsma, J B; Altman, D G; Moons, K G M

2015-02-01

Prediction models are developed to aid health care providers in estimating the probability or risk that a specific disease or condition is present (diagnostic models) or that a specific event will occur in the future (prognostic models), to inform their decision making. However, the overwhelming evidence shows that the quality of reporting of prediction model studies is poor. Only with full and clear reporting of information on all aspects of a prediction model can risk of bias and potential usefulness of prediction models be adequately assessed. The Transparent Reporting of a multivariable prediction model for Individual Prognosis or Diagnosis (TRIPOD) Initiative developed a set of recommendations for the reporting of studies developing, validating, or updating a prediction model, whether for diagnostic or prognostic purposes. This article describes how the TRIPOD Statement was developed. An extensive list of items based on a review of the literature was created, which was reduced after a Web-based survey and revised during a 3-day meeting in June 2011 with methodologists, health care professionals, and journal editors. The list was refined during several meetings of the steering group and in e-mail discussions with the wider group of TRIPOD contributors. The resulting TRIPOD Statement is a checklist of 22 items, deemed essential for transparent reporting of a prediction model study. The TRIPOD Statement aims to improve the transparency of the reporting of a prediction model study regardless of the study methods used. The TRIPOD Statement is best used in conjunction with the TRIPOD explanation and elaboration document. To aid the editorial process and readers of prediction model studies, it is recommended that authors include a completed checklist in their submission (also available at www.tripod-statement.org). © 2015 Royal College of Obstetricians and Gynaecologists.

Transparent reporting of a multivariable prediction model for individual prognosis or diagnosis (TRIPOD): the TRIPOD statement. The TRIPOD Group.

PubMed

Collins, Gary S; Reitsma, Johannes B; Altman, Douglas G; Moons, Karel G M

2015-01-13

Prediction models are developed to aid health care providers in estimating the probability or risk that a specific disease or condition is present (diagnostic models) or that a specific event will occur in the future (prognostic models), to inform their decision making. However, the overwhelming evidence shows that the quality of reporting of prediction model studies is poor. Only with full and clear reporting of information on all aspects of a prediction model can risk of bias and potential usefulness of prediction models be adequately assessed. The Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis (TRIPOD) Initiative developed a set of recommendations for the reporting of studies developing, validating, or updating a prediction model, whether for diagnostic or prognostic purposes. This article describes how the TRIPOD Statement was developed. An extensive list of items based on a review of the literature was created, which was reduced after a Web-based survey and revised during a 3-day meeting in June 2011 with methodologists, health care professionals, and journal editors. The list was refined during several meetings of the steering group and in e-mail discussions with the wider group of TRIPOD contributors. The resulting TRIPOD Statement is a checklist of 22 items, deemed essential for transparent reporting of a prediction model study. The TRIPOD Statement aims to improve the transparency of the reporting of a prediction model study regardless of the study methods used. The TRIPOD Statement is best used in conjunction with the TRIPOD explanation and elaboration document. To aid the editorial process and readers of prediction model studies, it is recommended that authors include a completed checklist in their submission (also available at www.tripod-statement.org). © 2015 The Authors.

Transparent reporting of a multivariable prediction model for individual prognosis or diagnosis (TRIPOD): the TRIPOD Statement.

PubMed

Collins, Gary S; Reitsma, Johannes B; Altman, Douglas G; Moons, Karel G M

2015-01-06

Prediction models are developed to aid health care providers in estimating the probability or risk that a specific disease or condition is present (diagnostic models) or that a specific event will occur in the future (prognostic models), to inform their decision making. However, the overwhelming evidence shows that the quality of reporting of prediction model studies is poor. Only with full and clear reporting of information on all aspects of a prediction model can risk of bias and potential usefulness of prediction models be adequately assessed. The Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis (TRIPOD) Initiative developed a set of recommendations for the reporting of studies developing, validating, or updating a prediction model, whether for diagnostic or prognostic purposes. This article describes how the TRIPOD Statement was developed. An extensive list of items based on a review of the literature was created, which was reduced after a Web-based survey and revised during a 3-day meeting in June 2011 with methodologists, health care professionals, and journal editors. The list was refined during several meetings of the steering group and in e-mail discussions with the wider group of TRIPOD contributors. The resulting TRIPOD Statement is a checklist of 22 items, deemed essential for transparent reporting of a prediction model study. The TRIPOD Statement aims to improve the transparency of the reporting of a prediction model study regardless of the study methods used. The TRIPOD Statement is best used in conjunction with the TRIPOD explanation and elaboration document. To aid the editorial process and readers of prediction model studies, it is recommended that authors include a completed checklist in their submission (also available at www.tripod-statement.org).

Transparent reporting of a multivariable prediction model for Individual Prognosis or Diagnosis (TRIPOD): the TRIPOD statement.

PubMed

Collins, Gary S; Reitsma, Johannes B; Altman, Douglas G; Moons, Karel G M

2015-02-01

Prediction models are developed to aid health care providers in estimating the probability or risk that a specific disease or condition is present (diagnostic models) or that a specific event will occur in the future (prognostic models), to inform their decision making. However, the overwhelming evidence shows that the quality of reporting of prediction model studies is poor. Only with full and clear reporting of information on all aspects of a prediction model can risk of bias and potential usefulness of prediction models be adequately assessed. The Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis (TRIPOD) Initiative developed a set of recommendations for the reporting of studies developing, validating, or updating a prediction model, whether for diagnostic or prognostic purposes. This article describes how the TRIPOD Statement was developed. An extensive list of items based on a review of the literature was created, which was reduced after a Web-based survey and revised during a 3-day meeting in June 2011 with methodologists, health care professionals, and journal editors. The list was refined during several meetings of the steering group and in e-mail discussions with the wider group of TRIPOD contributors. The resulting TRIPOD Statement is a checklist of 22 items, deemed essential for transparent reporting of a prediction model study. The TRIPOD Statement aims to improve the transparency of the reporting of a prediction model study regardless of the study methods used. The TRIPOD Statement is best used in conjunction with the TRIPOD explanation and elaboration document. To aid the editorial process and readers of prediction model studies, it is recommended that authors include a completed checklist in their submission (also available at www.tripod-statement.org). Copyright © 2015 Elsevier Inc. All rights reserved.

Framework for Financial Ratio Analysis of Audited Federal Financial Reports

DTIC Science & Technology

1999-12-01

franchising operations, allowing them to lower costs and share administrative support services with other agencies. [Ref. 60:sec. 402-403] The GMRA also...96 Federal Financial Reporting Statement of Net Cost Report Format 97 Federal Financial Reporting Statement of Changes in Net Position Report Format...analysis for sales, profitability, efficiency, marketing, investment, debt and capital analysis. Monitor growth Monitor costs Measure profitability and

Accelerated Partial Breast Irradiation Consensus Statement From the American Society for Radiation Oncology (ASTRO)

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

Smith, Benjamin D.; Department of Radiation Oncology, University of Texas M. D. Anderson Cancer Center, Houston, TX; Arthur, Douglas W.

2009-07-15

Purpose: To present guidance for patients and physicians regarding the use of accelerated partial-breast irradiation (APBI), based on current published evidence complemented by expert opinion. Methods and Materials: A systematic search of the National Library of Medicine's PubMed database yielded 645 candidate original research articles potentially applicable to APBI. Of these, 4 randomized trials and 38 prospective single-arm studies were identified. A Task Force composed of all authors synthesized the published evidence and, through a series of meetings, reached consensus regarding the recommendations contained herein. Results: The Task Force proposed three patient groups: (1) a 'suitable' group, for whom APBImore » outside of a clinical trial is acceptable, (2) a 'cautionary' group, for whom caution and concern should be applied when considering APBI outside of a clinical trial, and (3) an 'unsuitable' group, for whom APBI outside of a clinical trial is not generally considered warranted. Patients who choose treatment with APBI should be informed that whole-breast irradiation (WBI) is an established treatment with a much longer track record that has documented long-term effectiveness and safety. Conclusion: Accelerated partial-breast irradiation is a new technology that may ultimately demonstrate long-term effectiveness and safety comparable to that of WBI for selected patients with early breast cancer. This consensus statement is intended to provide guidance regarding the use of APBI outside of a clinical trial and to serve as a framework to promote additional clinical investigations into the optimal role of APBI in the treatment of breast cancer.« less

Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement

PubMed Central

2013-01-01

Economic evaluations of health interventions pose a particular challenge for reporting. There is also a need to consolidate and update existing guidelines and promote their use in a user friendly manner. The Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement is an attempt to consolidate and update previous health economic evaluation guidelines efforts into one current, useful reporting guidance. The primary audiences for the CHEERS statement are researchers reporting economic evaluations and the editors and peer reviewers assessing them for publication. The need for new reporting guidance was identified by a survey of medical editors. A list of possible items based on a systematic review was created. A two round, modified Delphi panel consisting of representatives from academia, clinical practice, industry, government, and the editorial community was conducted. Out of 44 candidate items, 24 items and accompanying recommendations were developed. The recommendations are contained in a user friendly, 24 item checklist. A copy of the statement, accompanying checklist, and this report can be found on the ISPOR Health Economic Evaluations Publication Guidelines Task Force website (http://www.ispor.org/TaskForces/EconomicPubGuidelines.asp). We hope CHEERS will lead to better reporting, and ultimately, better health decisions. To facilitate dissemination and uptake, the CHEERS statement is being co-published across 10 health economics and medical journals. We encourage other journals and groups, to endorse CHEERS. The author team plans to review the checklist for an update in five years. PMID:23531108

Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement

PubMed Central

2013-01-01

Economic evaluations of health interventions pose a particular challenge for reporting. There is also a need to consolidate and update existing guidelines and promote their use in a user friendly manner. The Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement is an attempt to consolidate and update previous health economic evaluation guidelines efforts into one current, useful reporting guidance. The primary audiences for the CHEERS statement are researchers reporting economic evaluations and the editors and peer reviewers assessing them for publication. The need for new reporting guidance was identified by a survey of medical editors. A list of possible items based on a systematic review was created. A two round, modified Delphi panel consisting of representatives from academia, clinical practice, industry, government, and the editorial community was conducted. Out of 44 candidate items, 24 items and accompanying recommendations were developed. The recommendations are contained in a user friendly, 24 item checklist. A copy of the statement, accompanying checklist, and this report can be found on the ISPOR Health Economic Evaluations Publication Guidelines Task Force website (http://www.ispor.org/TaskForces/EconomicPubGuidelines.asp). We hope CHEERS will lead to better reporting, and ultimately, better health decisions. To facilitate dissemination and uptake, the CHEERS statement is being co-published across 10 health economics and medical journals. We encourage other journals and groups, to endorse CHEERS. The author team plans to review the checklist for an update in five years. PMID:23531194

Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement.

PubMed

Husereau, D; Drummond, M; Petrou, S; Carswell, C; Moher, D; Greenberg, D; Augustovski, F; Briggs, A H; Mauskopf, J; Loder, E

2013-05-01

Economic evaluations of health interventions pose a particular challenge for reporting. There is also a need to consolidate and update existing guidelines and promote their use in a user friendly manner. The Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement is an attempt to consolidate and update previous health economic evaluation guidelines efforts into one current, useful reporting guidance.The primary audiences for the CHEERS statement are researchers reporting economic evaluations and the editors and peer reviewers assessing them for publication. The need for new reporting guidance was identified by a survey of medical editors. A list of possible items based on a systematic review was created. A two round, modified Delphi panel consisting of representatives from academia, clinical practice, industry, government, and the editorial community was conducted. Out of 44 candidate items, 24 items and accompanying recommendations were developed. The recommendations are contained in a user friendly, 24 item checklist. A copy of the statement, accompanying checklist, and this report can be found on the ISPOR Health Economic Evaluations Publication Guidelines Task Force website (www.ispor.org/TaskForces/EconomicPubGuidelines.asp). We hope CHEERS will lead to better reporting, and ultimately, better health decisions. To facilitate dissemination and uptake, the CHEERS statement is being co-published across 10 health economics and medical journals. We encourage other journals and groups, to endorse CHEERS. The author team plans to review the checklist for an update in 5 years. © 2013 The Authors BJOG An International Journal of Obstetrics and Gynaecology © 2013 RCOG.

Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement.

PubMed

Husereau, Don; Drummond, Michael; Petrou, Stavros; Carswell, Chris; Moher, David; Greenberg, Dan; Augustovski, Federico; Briggs, Andrew H; Mauskopf, Josephine; Loder, Elizabeth

2013-03-25

Economic evaluations of health interventions pose a particular challenge for reporting. There is also a need to consolidate and update existing guidelines and promote their use in a user friendly manner. The Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement is an attempt to consolidate and update previous health economic evaluation guidelines efforts into one current, useful reporting guidance. The primary audiences for the CHEERS statement are researchers reporting economic evaluations and the editors and peer reviewers assessing them for publication.The need for new reporting guidance was identified by a survey of medical editors. A list of possible items based on a systematic review was created. A two round, modified Delphi panel consisting of representatives from academia, clinical practice, industry, government, and the editorial community was conducted. Out of 44 candidate items, 24 items and accompanying recommendations were developed. The recommendations are contained in a user friendly, 24 item checklist. A copy of the statement, accompanying checklist, and this report can be found on the ISPOR Health Economic Evaluations Publication Guidelines Task Force website (http://www.ispor.org/TaskForces/EconomicPubGuidelines.asp).We hope CHEERS will lead to better reporting, and ultimately, better health decisions. To facilitate dissemination and uptake, the CHEERS statement is being co-published across 10 health economics and medical journals. We encourage other journals and groups, to endorse CHEERS. The author team plans to review the checklist for an update in five years.

Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement.

PubMed

Husereau, Don; Drummond, Michael; Petrou, Stavros; Carswell, Chris; Moher, David; Greenberg, Dan; Augustovski, Federico; Briggs, Andrew H; Mauskopf, Josephine; Loder, Elizabeth

2013-01-01

Economic evaluations of health interventions pose a particular challenge for reporting. There is also a need to consolidate and update existing guidelines and promote their use in a user friendly manner. The Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement is an attempt to consolidate and update previous health economic evaluation guidelines efforts into one current, useful reporting guidance. The primary audiences for the CHEERS statement are researchers reporting economic evaluations and the editors and peer reviewers assessing them for publication. The need for new reporting guidance was identified by a survey of medical editors. A list of possible items based on a systematic review was created. A two round, modified Delphi panel consisting of representatives from academia, clinical practice, industry, government, and the editorial community was conducted. Out of 44 candidate items, 24 items and accompanying recommendations were developed. The recommendations are contained in a user friendly, 24 item checklist. A copy of the statement, accompanying checklist, and this report can be found on the ISPOR Health Economic Evaluations Publication Guidelines Task Force website: (www.ispor.org/TaskForces/EconomicPubGuidelines.asp). We hope CHEERS will lead to better reporting, and ultimately, better health decisions. To facilitate dissemination and uptake, the CHEERS statement is being co-published across 10 health economics and medical journals. We encourage other journals and groups, to endorse CHEERS. The author team plans to review the checklist for an update in five years. Copyright © 2013. Published by Elsevier Inc.

Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement.

PubMed

Husereau, Don; Drummond, Michael; Petrou, Stavros; Carswell, Chris; Moher, David; Greenberg, Dan; Augustovski, Federico; Briggs, Andrew H; Mauskopf, Josephine; Loder, Elizabeth

2013-04-01

Economic evaluations of health interventions pose a particular challenge for reporting. There is also a need to consolidate and update existing guidelines and promote their use in a user friendly manner. The Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement is an attempt to consolidate and update previous health economic evaluation guidelines efforts into one current, useful reporting guidance. The primary audiences for the CHEERS statement are researchers reporting economic evaluations and the editors and peer reviewers assessing them for publication. The need for new reporting guidance was identified by a survey of medical editors. A list of possible items based on a systematic review was created. A two round, modified Delphi panel consisting of representatives from academia, clinical practice, industry, government, and the editorial community was conducted. Out of 44 candidate items, 24 items and accompanying recommendations were developed. The recommendations are contained in a user friendly, 24 item checklist. A copy of the statement, accompanying checklist, and this report can be found on the ISPOR Health Economic Evaluations Publication Guidelines Task Force website: (www.ispor.org/TaskForces/EconomicPubGuidelines.asp). We hope CHEERS will lead to better reporting, and ultimately, better health decisions. To facilitate dissemination and uptake, the CHEERS statement is being co-published across 10 health economics and medical journals. We encourage other journals and groups, to endorse CHEERS. The author team plans to review the checklist for an update in five years. Copyright © 2013. Published by EM Inc USA.

Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement.

PubMed

Husereau, Don; Drummond, Michael; Petrou, Stavros; Carswell, Chris; Moher, David; Greenberg, Dan; Augustovski, Federico; Briggs, Andrew H; Mauskopf, Josephine; Loder, Elizabeth

2013-01-01

Economic evaluations of health interventions pose a particular challenge for reporting. There is also a need to consolidate and update existing guidelines and promote their use in a user-friendly manner. The Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement is an attempt to consolidate and update previous health economic evaluation guidelines efforts into one current, useful reporting guidance. The primary audiences for the CHEERS statement are researchers reporting economic evaluations and the editors and peer reviewers assessing them for publication. The need for new reporting guidance was identified by a survey of medical editors. A list of possible items based on a systematic review was created. A two round, modified Delphi panel consisting of representatives from academia, clinical practice, industry, government, and the editorial community was conducted. Out of 44 candidate items, 24 items and accompanying recommendations were developed. The recommendations are contained in a user-friendly, 24-item checklist. A copy of the statement, accompanying checklist, and this report can be found on the ISPOR Health Economic Evaluations Publication Guidelines Task Force website (www.ispor.org/TaskForces/EconomicPubGuidelines.asp). The hope is that CHEERS will lead to better reporting and, ultimately, better health decisions. To facilitate dissemination and uptake, the CHEERS statement is being co-published across 10 health economics and medical journals. Other journals and groups are encouraged to endorse CHEERS. The author team plans to review the checklist for an update in 5 years.

Uterine Artery Embolization for Heavy Menstrual Bleeding

PubMed Central

Moss, Jonathan; Christie, Andrew

2016-01-01

Uterine artery embolization (UAE) as a treatment option for fibroids was first reported by Ravina in 1995. Although rapidly adopted by enthusiasts, many were skeptical and its introduction varied widely across the globe. It was not until randomized controlled trials and registries were published and national guidance statements issued that UAE was accepted as a safe and proven treatment for fibroids. The technique is now established as one of the treatment options to be discussed with patients as an alternative to surgery for fibroid-associated heavy menstrual bleeding. Research is on-going to evaluate the relative merits of UAE compared with other medical and surgical treatment options for heavy menstrual bleeding, particularly for women wishing to maintain their fertility. PMID:26756068

An approach for utilizing clinical statements in HL7 RIM to evaluate eligibility criteria.

PubMed

Bache, Richard; Daniel, Christel; James, Julie; Hussain, Sajjad; McGilchrist, Mark; Delaney, Brendan; Taweel, Adel

2014-01-01

The HL7 RIM (Reference Information Model) is a commonly used standard for the exchange of clinical data and can be employed for integrating the patient care and clinical research domains. Yet it is not sufficiently well specified to ensure a canonical representation of structured clinical data when used for the automated evaluation of eligibility criteria from a clinical trial protocol. We present an approach to further constrain the RIM to create a common information model to hold clinical data. In order to demonstrate our approach, we identified 132 distinct data elements from 10 rich clinical trails. We then defined a taxonomy to (i) identify the types of data elements that would need to be stored and (ii) define the types of predicate that would be used to evaluate them. This informed the definition of a pattern used to represent the data, which was shown to be sufficient for storing and evaluating the clinical statements required by the trials.

Antihyperglycemic agent therapy for adult patients with type 2 diabetes mellitus 2017: a position statement of the Korean Diabetes Association.

PubMed

Ko, Seung-Hyun; Hur, Kyu Yeon; Rhee, Sang Youl; Kim, Nan-Hee; Moon, Min Kyong; Park, Seok-O; Lee, Byung-Wan; Kim, Hyun Jin; Choi, Kyung Mook; Kim, Jin Hwa

2017-11-01

In 2017, the Korean Diabetes Association (KDA) published a position statement on the use of antihyperglycemic agents for patients with type 2 diabetes mellitus (T2DM). The KDA regularly updates its Clinical Practice Guidelines, but since the last update in 2015, many results from clinical trials have been introduced, and domestic data from studies performed in Korean patients with T2DM have been published. Recently, evidence from large clinical studies assessing cardiovascular outcomes following the use of sodium-glucose cotransporter 2 inhibitors and glucagon-like peptide 1 receptor agonists in patients with T2DM were incorporated into the recommendations. Additionally, new data from clinical trials using dipeptidyl peptidase 4 inhibitors and thiazolidinediones in Korean patients with T2DM were added. Following a systematic review and assessment of recent evidence, the KDA updated and modified its clinical practice recommendations regarding the use of antihyperglycemic agents and revised the treatment algorithm for Korean adult patients with T2DM.

23 CFR 635.119 - False statements.

Code of Federal Regulations, 2013 CFR

2013-04-01

... CONSTRUCTION AND MAINTENANCE Contract Procedures § 635.119 False statements. The following notice shall be... submission of plans, maps, specifications, contracts, or costs of construction of any highway or related... statement, false representation, false report, or false claim with respect to the character, quality...

23 CFR 635.119 - False statements.

Code of Federal Regulations, 2011 CFR

2011-04-01

... CONSTRUCTION AND MAINTENANCE Contract Procedures § 635.119 False statements. The following notice shall be... submission of plans, maps, specifications, contracts, or costs of construction of any highway or related... statement, false representation, false report, or false claim with respect to the character, quality...

23 CFR 635.119 - False statements.

Code of Federal Regulations, 2010 CFR

2010-04-01

... CONSTRUCTION AND MAINTENANCE Contract Procedures § 635.119 False statements. The following notice shall be... submission of plans, maps, specifications, contracts, or costs of construction of any highway or related... statement, false representation, false report, or false claim with respect to the character, quality...

23 CFR 635.119 - False statements.

Code of Federal Regulations, 2014 CFR

2014-04-01

... CONSTRUCTION AND MAINTENANCE Contract Procedures § 635.119 False statements. The following notice shall be... submission of plans, maps, specifications, contracts, or costs of construction of any highway or related... statement, false representation, false report, or false claim with respect to the character, quality...

23 CFR 635.119 - False statements.

Code of Federal Regulations, 2012 CFR

2012-04-01

... CONSTRUCTION AND MAINTENANCE Contract Procedures § 635.119 False statements. The following notice shall be... submission of plans, maps, specifications, contracts, or costs of construction of any highway or related... statement, false representation, false report, or false claim with respect to the character, quality...

Inspector General, DOD, Oversight of the Air Force Audit Agency Audit of the FY 1995 Air Force Consolidated Financial Statements.

DTIC Science & Technology

1996-04-18

financial statements . We delegated the audit of the FY 1995 Air Force consolidated financial statements to the Air Force Audit Agency. On March 1...1996, the Air Force Audit Agency issued its "Report of Audit: Opinion on Fiscal Year 1995 Air Force Consolidated Financial Statements " (Project 94053001...disclaimer of opinion. The audit objective was to determine the accuracy and completeness of the audit of the FY 1995 Air Force consolidated financial statements conducted

10 CFR Appendix A to Subpart S of... - Compliance Statement for Metal Halide Lamp Ballasts

Code of Federal Regulations, 2011 CFR

2011-01-01

... Equipment: Metal Halide Lamp Ballasts Manufacturer's or Private Labeler's Name and Address: [Company name] (“the company”) submits this Compliance Statement under 10 CFR Part 431 (Energy Efficiency Program for... Reports submitted by or on behalf of this company. All information in such Certification Report(s) and in...

10 CFR 300.5 - Submission of an entity statement.

Code of Federal Regulations, 2010 CFR

2010-01-01

... report as a large emitter in all future years in order to ensure a consistent time series of reports... average annual emissions over a continuous period not to exceed four years of time ending in its chosen... necessary, update their entity statements. (2) From time to time, a reporting entity may choose to change...

10 CFR 300.5 - Submission of an entity statement.

Code of Federal Regulations, 2011 CFR

2011-01-01

... report as a large emitter in all future years in order to ensure a consistent time series of reports... average annual emissions over a continuous period not to exceed four years of time ending in its chosen... necessary, update their entity statements. (2) From time to time, a reporting entity may choose to change...

10 CFR 300.5 - Submission of an entity statement.

Code of Federal Regulations, 2012 CFR

2012-01-01

... report as a large emitter in all future years in order to ensure a consistent time series of reports... average annual emissions over a continuous period not to exceed four years of time ending in its chosen... necessary, update their entity statements. (2) From time to time, a reporting entity may choose to change...

10 CFR 300.5 - Submission of an entity statement.

Code of Federal Regulations, 2014 CFR

2014-01-01

... report as a large emitter in all future years in order to ensure a consistent time series of reports... average annual emissions over a continuous period not to exceed four years of time ending in its chosen... necessary, update their entity statements. (2) From time to time, a reporting entity may choose to change...

10 CFR 300.5 - Submission of an entity statement.

Code of Federal Regulations, 2013 CFR

2013-01-01

... report as a large emitter in all future years in order to ensure a consistent time series of reports... average annual emissions over a continuous period not to exceed four years of time ending in its chosen... necessary, update their entity statements. (2) From time to time, a reporting entity may choose to change...

Opening Statement; Hearings on the Surgeon General's Report.

ERIC Educational Resources Information Center

Pastore, John O.

The opening statement of Senator John O. Pastore for the hearings on the Surgeon General's Report on Television and Social Behavior is presented. His first few comments are directed toward summarizing the history of the report and of the Scientific Advisory Committee, with some remarks about the selection of the Committee. The critical importance…

The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) Statement

PubMed Central

Benchimol, Eric I.; Smeeth, Liam; Guttmann, Astrid; Harron, Katie; Moher, David; Petersen, Irene; Sørensen, Henrik T.; von Elm, Erik; Langan, Sinéad M.

2015-01-01

Routinely collected health data, obtained for administrative and clinical purposes without specific a priori research goals, are increasingly used for research. The rapid evolution and availability of these data have revealed issues not addressed by existing reporting guidelines, such as Strengthening the Reporting of Observational Studies in Epidemiology (STROBE). The REporting of studies Conducted using Observational Routinely collected health Data (RECORD) statement was created to fill these gaps. RECORD was created as an extension to the STROBE statement to address reporting items specific to observational studies using routinely collected health data. RECORD consists of a checklist of 13 items related to the title, abstract, introduction, methods, results, and discussion section of articles, and other information required for inclusion in such research reports. This document contains the checklist and explanatory and elaboration information to enhance the use of the checklist. Examples of good reporting for each RECORD checklist item are also included herein. This document, as well as the accompanying website and message board (http://www.record-statement.org), will enhance the implementation and understanding of RECORD. Through implementation of RECORD, authors, journals editors, and peer reviewers can encourage transparency of research reporting. PMID:26440803

The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statement.

PubMed

Benchimol, Eric I; Smeeth, Liam; Guttmann, Astrid; Harron, Katie; Moher, David; Petersen, Irene; Sørensen, Henrik T; von Elm, Erik; Langan, Sinéad M

2015-10-01

Routinely collected health data, obtained for administrative and clinical purposes without specific a priori research goals, are increasingly used for research. The rapid evolution and availability of these data have revealed issues not addressed by existing reporting guidelines, such as Strengthening the Reporting of Observational Studies in Epidemiology (STROBE). The REporting of studies Conducted using Observational Routinely collected health Data (RECORD) statement was created to fill these gaps. RECORD was created as an extension to the STROBE statement to address reporting items specific to observational studies using routinely collected health data. RECORD consists of a checklist of 13 items related to the title, abstract, introduction, methods, results, and discussion section of articles, and other information required for inclusion in such research reports. This document contains the checklist and explanatory and elaboration information to enhance the use of the checklist. Examples of good reporting for each RECORD checklist item are also included herein. This document, as well as the accompanying website and message board (http://www.record-statement.org), will enhance the implementation and understanding of RECORD. Through implementation of RECORD, authors, journals editors, and peer reviewers can encourage transparency of research reporting.

[The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statement].

PubMed

Benchimol, Eric I; Smeeth, Liam; Guttmann, Astrid; Harron, Katie; Hemkens, Lars G; Moher, David; Petersen, Irene; Sørensen, Henrik T; von Elm, Erik; Langan, Sinéad M

2016-10-01

Routinely collected health data, obtained for administrative and clinical purposes without specific a priori research goals, are increasingly used for research. The rapid evolution and availability of these data have revealed issues not addressed by existing reporting guidelines, such as Strengthening the Reporting of Observational Studies in Epidemiology (STROBE). The REporting of studies Conducted using Observational Routinely collected health Data (RECORD) statement was created to fill these gaps. RECORD was created as an extension to the STROBE statement to address reporting items specific to observational studies using routinely collected health data. RECORD consists of a checklist of 13 items related to the title, abstract, introduction, methods, results, and discussion section of articles, and other information required for inclusion in such research reports. This document contains the checklist as well as explanatory and elaboration information to enhance the use of the checklist. Examples of good reporting for each RECORD checklist item are also included. This document, as well as the accompanying website and message board (http://www.record-statement.org), will improve the implementation and understanding of RECORD. By implementing RECORD, authors, journals editors, and peer reviewers can enhance transparency of research reporting. Copyright © 2016. Published by Elsevier GmbH.

Report of the 2016-17 Academic Affairs Standing Committee: Entrustable Professional Activities Implementation Roadmap.

PubMed

Pittenger, Amy L; Copeland, Debra A; Lacroix, Matthew M; Masuda, Quamrun N; Mbi, Peter; Medina, Melissa S; Miller, Susan M; Stolte, Scott K; Plaza, Cecilia M

2017-06-01

The purpose of this report is to: 1) Identify linkages across the EPA statements, Center for the Advancement of Pharmacy Education 2013 Educational Outcomes (CAPE 2013) and the Joint Commission of Pharmacy Practitioners' Pharmacist Patient Care Process (PPCP); 2) Provide ways EPA statements can be used to communicate core skills that are part of the entry-level pharmacist identity; 3) Suggest a potential roadmap for AACP members on how to implement EPA statements.

Occupational Education in the Large Five Cities. Statement before the New York State Assembly Education Committee (Albany, New York, March 2, 1988). Capsule Report 88-11-CR-A.

ERIC Educational Resources Information Center

Sobol, Thomas

This document reports the policy statement of the President of the University of the State of New York regarding vocational education in the five largest cities in the state. The statement provides background on how changes in the economy and the organization of work will affect the skills needed by the work force of the future. It also indicates…

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

PubMed

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.

A clinical knowledge measurement tool to assess the ability of community pharmacists to detect drug-related problems.

PubMed

Williams, Mackenzie; Peterson, Gregory M; Tenni, Peter C; Bindoff, Ivan K

2012-08-01

Drug-related problems (DRPs) are associated with significant morbidity and mortality, with most DRPs thought to be preventable. Community pharmacists can detect and either prevent or resolve many of these DRPs. A survey-based clinical knowledge measurement tool was designed and validated to estimate a community pharmacist's clinical knowledge and ability to detect and appropriately resolve DRPs. Nine clinical cases with seven multiple-choice statements (63 statements in total) were constructed, based on scenarios that were found to occur frequently in Australian community pharmacies. The statements aimed to assess a pharmacist's ability to identify, gather relevant information about and make appropriate recommendations to resolve, a DRP. The survey was pilot tested with 18 academics at three Australian pharmacy schools, resulting in the removal of 23 statements. The survey was then administered to undergraduate pharmacy students (28 fourth-year, 41 third-year and 42 first-year students) and to 433 Australian community pharmacists who were participating in an intervention documentation trial. The pharmacists' resultant survey scores were correlated against their actual rate of documenting clinical interventions. The tool had relatively good internal consistency. Significant differences were seen between the three groups of students (P < 0.01). Community pharmacists with additional clinical qualifications had a significantly higher score than other participating pharmacists (P < 0.01). A moderate, but significant, correlation was seen between the pharmacists' survey score and their clinical intervention rate in practice during the trial (P < 0.01). The clinical knowledge measurement tool appeared to estimate a pharmacist's ability to detect and resolve DRPs within the community pharmacy environment. © 2012 The Authors. IJPP © 2012 Royal Pharmaceutical Society.

Report: Audit of EPA’s Fiscal 2002 and 2001 Financial Statements

EPA Pesticide Factsheets

Report #2003-1-00045, January 29, 2003. We did not identify any inconsistencies between the info presented in EPA’s financial statements and the info presented in EPA’s RSSI, Required Supplemental Information, and Management Discussion and Analysis.

Report: AUDIT OF EPA’S FISCAL 2000 FINANCIAL STATEMENTS

EPA Pesticide Factsheets

Report #2001-1-00107, Feb 28, 2001. We did not identify any material inconsistencies between the info presented in EPA’s financial statements and the info presented in EPA’s RSSI, Required Supplemental Information, and Management Discussion and Analysis.

Inspector General, DOD, Oversight of the Army Audit Agency Audit of the FY 1999 U.S. Army Corps of Engineers, Civil Works Program, Financial Statements

DTIC Science & Technology

2000-02-28

iIÄ»lllilil^» P «lMlii fport INSPECTOR GENERAL, DOD, OVERSIGHT OF THE ARMY AUDIT AGENCY AUDIT OF THE FY 1999 U.S. ARMY CORPS OF ENGINEERS, CIVIL...WORKS PROGRAM, FINANCIAL STATEMENTS Report No. D -2000-093 February 28, 2000 pnc QXIAUTY mm®™* i 0ffice Qf ±Q hispdCtor General Department of...Works Program, Financial Statements (Report No. D -2000-093) We are providing this audit report for your information and use and for transmittal to

Paradoxical effects of alcohol information on alcohol outcome expectancies.

PubMed

Krank, Marvin D; Ames, Susan L; Grenard, Jerry L; Schoenfeld, Tara; Stacy, Alan W

2010-07-01

Cognitive associations with alcohol predict both current and future use in youth and young adults. Much cognitive and social cognitive research suggests that exposure to information may have unconscious influences on thinking and behavior. The present study assessed the impact of information statements on the accessibility of alcohol outcome expectancies. The 2 studies reported here investigated the effects of exposure to alcohol statements typical of informational approaches to prevention on the accessibility of alcohol outcome expectancies. High school and university students were presented with information statements about the effects of alcohol and other commercial products. The alcohol statements were taken from expectancy questionnaires. Some of these statements were presented as facts and others as myths. The retention of detailed information about these statements was manipulated by (i) divided attention versus focused attention or (ii) immediate versus delayed testing. Accessibility of personal alcohol outcome expectancies was subsequently measured using an open-ended question about the expected effects of alcohol. Participants reported more alcohol outcomes seen during the information task as personal expectations about the effects of alcohol use than similar unseen items. Paradoxically, myth statements were also more likely to be reported as expectancies than unseen items in all conditions. Additionally, myth statements were generated less often than fact statements only under the condition of immediate testing with strong content processing instructions. These observations are consistent with findings from cognitive research where familiarity in the absence of explicit memory can have an unconscious influence on performance. In particular, the exposure to these items in an informational format increases accessibility of the seen items even when the participants were told that they were myths. The findings have implications for the development of effective prevention materials.

Paradoxical Effects of Alcohol Information on Alcohol Outcome Expectancies

PubMed Central

Krank, Marvin D.; Ames, Susan L.; Grenard, Jerry L.; Schoenfeld, Tara; Stacy, Alan W.

2014-01-01

Background Cognitive associations with alcohol predict both current and future use in youth and young adults. Much cognitive and social cognitive research suggests that exposure to information may have unconscious influences on thinking and behavior. The present study assessed the impact of information statements on the accessibility of alcohol outcome expectancies. Methods The 2 studies reported here investigated the effects of exposure to alcohol statements typical of informational approaches to prevention on the accessibility of alcohol outcome expectancies. High school and university students were presented with information statements about the effects of alcohol and other commercial products. The alcohol statements were taken from expectancy questionnaires. Some of these statements were presented as facts and others as myths. The retention of detailed information about these statements was manipulated by (i) divided attention versus focused attention or (ii) immediate versus delayed testing. Accessibility of personal alcohol outcome expectancies was subsequently measured using an open-ended question about the expected effects of alcohol. Results Participants reported more alcohol outcomes seen during the information task as personal expectations about the effects of alcohol use than similar unseen items. Paradoxically, myth statements were also more likely to be reported as expectancies than unseen items in all conditions. Additionally, myth statements were generated less often than fact statements only under the condition of immediate testing with strong content processing instructions. Conclusions These observations are consistent with findings from cognitive research where familiarity in the absence of explicit memory can have an unconscious influence on performance. In particular, the exposure to these items in an informational format increases accessibility of the seen items even when the participants were told that they were myths. The findings have implications for the development of effective prevention materials. PMID:20477773

Herbal medicine for low back pain.

PubMed

Gagnier, J J; van Tulder, M; Berman, B; Bombardier, C

2006-04-19

Low-back pain is a common condition and a substantial economic burden in industrialized societies. A large proportion of patients with chronic low-back pain use complementary and alternative medicine (CAM), visit CAM practitioners, or both. Several herbal medicines have been purported for use in low-back pain. To determine the effectiveness of herbal medicine for non-specific low-back pain. We searched the following electronic databases: Cochrane Complementary Medicine Field Trials Register (Issue 3, 2005), MEDLINE (1966 to July 2005), EMBASE (1980 to July 2005); checked reference lists in review articles, guidelines and retrieved trials; and personally contacted individuals with expertise in this very specialized area. We included randomized controlled trials, examining adults (over 18 years of age) suffering from acute, sub-acute or chronic non-specific low-back pain. The interventions were herbal medicines, defined as plants that are used for medicinal purposes in any form. Primary outcome measures were pain and function. Two authors (JJG & MVT) conducted the database searches. One author contacted content experts and acquired relevant citations. Full references and abstracts of the identified studies were downloaded. A hard copy was retrieved for final inclusion decisions. Methodological quality and clinical relevance were assessed separately by two individuals. Disagreements were resolved by consensus. Ten trials were included in this review. Two high quality trials examining the effects of Harpagophytum Procumbens (Devil's Claw) found strong evidence that daily doses standardized to 50 mg or 100 mg harpagoside were better than placebo for short-term improvements in pain and rescue medication. Another high quality trial demonstrated relative equivalence to 12.5 mg per day of rofecoxib (Vioxx). Two trials examining the effects of Salix Alba (White Willow Bark) found moderate evidence that daily doses standardized to 120 mg or 240 mg salicin were better than placebo for short-term improvements in pain and rescue medication. An additional trial demonstrated relative equivalence to 12.5 mg per day of rofecoxib. Three low quality trials on Capsicum Frutescens (Cayenne), examining various topical preparations, found moderate evidence that Capsicum Frutescens produced more favourable results than placebo and one trial found equivalence to a homeopathic ointment. Harpagophytum Procumbens, Salix Alba and Capsicum Frutescens seem to reduce pain more than placebo. Additional trials testing these herbal medicines against standard treatments are needed. The quality of reporting in these trials was generally poor. Trialists should refer to the CONSORT statement extension for reporting trials of herbal medicine interventions.

Optimal Implantable Cardioverter Defibrillator Programming.

PubMed

Shah, Bindi K

Optimal programming of implantable cardioverter defibrillators (ICDs) is essential to appropriately treat ventricular tachyarrhythmias and to avoid unnecessary and inappropriate shocks. There have been a series of large clinical trials evaluating tailored programming of ICDs. We reviewed the clinical trials evaluating ICD therapies and detection, and the consensus statement on ICD programming. In doing so, we found that prolonged ICD detection times, higher rate cutoffs, and antitachycardia pacing (ATP) programming decreases inappropriate and painful therapies in a primary prevention population. The use of supraventricular tachyarrhythmia discriminators can also decrease inappropriate shocks. Tailored ICD programming using the knowledge gained from recent ICD trials can decrease inappropriate and unnecessary ICD therapies and decrease mortality.

Academic, Industry and Student Perspectives on the Inclusion of "Vocational Knowledge" in a "Learning and Teaching Academic Standards Statement" for Agriculture

ERIC Educational Resources Information Center

Acuña, Tina Botwright; Kelder, Jo-Anne; Able, Amanda J.; Guisard, Yann; Bellotti, William D.; McDonald, Glenn; Doyle, Richard; Wormell, Paul; Meinke, Holger

2014-01-01

This paper reports on the perspective of industry stakeholders in a national project to develop a Learning and Teaching Academic Standards (LTAS) Statement for the Agriculture discipline. The AgLTAS Statement will be aligned with the Science LTAS Statement published in 2011 and comprise a discourse on the nature and extent of the Agriculture…

Exercise effects on bone mineral density in older men: a systematic review with special emphasis on study interventions.

PubMed

Kemmler, W; Shojaa, M; Kohl, M; von Stengel, S

2018-04-05

This systematic review detected only limited positive effects of exercise on bone mineral density in older men. Further, based on the present literature, we were unable to suggest dedicated exercise prescriptions for this male cohort that might differ from recommendations based on studies with postmenopausal women. The primary aim of this systematic review was to determine the effect of exercise on bone mineral density (BMD) in healthy older men. A systematic review of the literature according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement included only randomized or non-randomized controlled trials of exercise training ≥ 6 months with study groups of ≥ eight healthy men aged 50 years or older, not using bone-relevant pharmacological therapy, that determined BMD by dual-energy X-ray absorptiometry. We searched PubMed, Scopus, Web of Science, Cochrane, Science Direct, and Eric up to November 2016. Risk of bias was assessed using the PEDro scale. We identified eight trials with 789 participants (PEDro-score, mean value 6 of 10) which satisfied our eligibility criteria. Studies vary considerably with respect to type and composition of exercise. Study interventions of six trials were considered to be appropriate for successfully addressing BMD in this cohort. Between-group differences were not or not consistently reported by three studies. Three studies reported significant exercise effects on BMD for proximal femur; one of them determined significant differences between the exercise groups. None of the exercise trials determined significant BMD effects at the lumbar spine. Based on the present studies, there is only limited evidence for a favorable effect of exercise on BMD in men. More well-designed and sophisticated studies on BMD in healthy older men have to address this topic. Further, there is a need to define intervention quality standards and implement a universal scoring system that allows this pivotal determinant to be addressed much more intensively.

Financial Audit: District of Columbia Highway Trust Fund's 1996 Financial Statements

DOT National Transportation Integrated Search

1997-12-15

This report presents the results of efforts to audit the financial statements of the District of Columbia Highway Trust Fund for the 14-month period ended September 30, 1996, and to examine the 5-year forecasted statements of the Fund's expected cond...

UK quality statements on end of life care in dementia: a systematic review of research evidence.

PubMed

Candy, Bridget; Elliott, Margaret; Moore, Kirsten; Vickerstaff, Victoria; Sampson, Elizabeth; Jones, Louise

2015-10-19

Globally, the number of people who die with dementia is increasing. The importance of a palliative approach in the care of people with dementia is recognised and there are national polices to enhance current care. In the UK implementation of these polices is promoted by the National Institute for Health and Care Excellence (NICE) Dementia Quality Standards (QS). Since publication of the QS new care interventions have been developed. To explore critically the current international research evidence on effect available to inform NICE Dementia QS relevant to end of life (EOL) care. We used systematic review methods to seek the research evidence for three statements within the Dementia QS. These are those that recommend: (1) a case management approach, (2) discussing and consideration of making a statement about future care (SFC) and (3) a palliative care assessment (PCA). We included evaluative studies of relevant interventions that used a comparative design, such as trials and cohort studies, and measured EOL care outcomes for persons dying with moderate to severe dementia. Our primary outcome of interest was whether the intervention led to a measurable impact on wellbeing for the person with dementia and their family. We assessed included studies for quality using a scale by Higginson and colleagues (2002) for assessment of quality of studies in palliative care, and two authors undertook key review processes. Data sources included Cinahl, Embase, and PsychINFO from 2001 to August 2014. Our search strategy included free text and medical subject headings relevant to population and recommended care. We found seven studies evaluating a care intervention; four assessed SFC, three PCA. None assessed case management. Studies were of weak design; all used retrospective data and relied on others for precise record keeping and for accurate recall of events. There was limited overlap in outcome measurements. Overall reported benefits were mixed. Quality statements relevant to EOL care are useful to advance practice however they have a limited evidence base. High quality empirical work is needed to establish that the recommendations in these statements are best practice.

Lactoferrin or ferrous salts for iron deficiency anemia in pregnancy: A meta-analysis of randomized trials.

PubMed

Abu Hashim, Hatem; Foda, Osama; Ghayaty, Essam

2017-12-01

This systematic review and meta-analysis aimed to evaluate the efficacy of daily oral bovine lactoferrin versus daily oral ferrous iron preparations for treatment of iron deficiency anemia (IDA) during pregnancy. Searches were conducted on PubMed, ScienceDirect, ClinicalTrials.gov and CENTRAL databases from inception to February 2017 and the bibliographies of retrieved articles were screened. The PRISMA Statement was followed. Published English language randomized trials comparing lactoferrin with oral ferrous iron preparations in pregnant women with iron deficiency anemia were included. Quasi-randomized, non- randomized or studies including other known cause of anemia, gestational or pre-existent maternal diseases were excluded. Accordingly, 4 eligible trials (600 women) were analyzed. Primary outcome was change in hemoglobin level at 4 weeks of treatment. Secondary outcomes were; change in serum ferritin and iron, rates of gastrointestinal side effects, preterm birth, low birthweight, neonatal death and mean birthweight. Quality assessment was performed by the Cochrane risk of bias tool. Odds ratio and mean difference were used to integrate dichotomous and continuous outcomes respectively. Pooled estimates for change in hemoglobin levels at four weeks favored daily oral lactoferrin over daily oral ferrous sulphate (mean difference 0.77; 95% confidence interval [CI] 0.04-1.55; P=0.04, 4 trials, 600 women). However, after subgroup analysis (degree of anemia), no significant difference in hemoglobin levels were found between both groups in mild anemia (mean difference 0.80; 95% CI -0.21 to 1.82, 3 trials, 372 women), but a significant increase favoring lactoferrin was reported in moderate anemia (mean difference 0.68; 95% CI 0.53-0.83; P<0.00001, one trial, 228 women). Significantly less gastrointestinal side effects were reported with lactoferrin treatment. No significant differences existed with regard to other outcomes. In conclusion, for pregnant women with IDA, daily oral bovine lactoferrin is just as good as ferrous sulfate in improving hematological parameters with fewer gastrointestinal side effects. Thereby, lactoferrin should be the iron replacement agent of choice for treatment of IDA in pregnancy. Copyright © 2017 Elsevier B.V. All rights reserved.

Asphalt, Fleets, Bricks, and Mortar.

ERIC Educational Resources Information Center

Green, Tim; Williamson, Margie E.; Endris, William L., Jr.

2000-01-01

The new reporting model propounded in Governmental Accounting Board Statement No. 34 dictates that consumption of capital assets be reported through a charge in the governmentwide statement of activities for depreciation expense. The present method of "rolling forward" capital asset amounts will not suffice. (MLH)

Report: Agreed-Upon Procedures on EPA’s Fiscal Year 2009 First Quarter Financial Statements

EPA Pesticide Factsheets

Report #09-2-0161, June 8, 2009. We compared the statements with EPA’s crosswalk, recomputed them for mathematical accuracy, and compared them with balances separately generated by us. Except for immaterial rounding differences, the amounts agreed.

14 CFR Sec. 2-5 - Revenue and accounting practices.

Code of Federal Regulations, 2011 CFR

2011-01-01

... date of all subaccounts supporting the Air Traffic Liability control account; the subsidiary trial balance must agree with the Air Traffic Liability control account or a reconciliation statement furnished... ledger. If the sales listing is not in agreement with the Air Traffic Liability control account, the...

37 CFR 11.306 - Trial publicity.

Code of Federal Regulations, 2014 CFR

2014-07-01

... statement that the practitioner knows or reasonably should know will be disseminated by means of public communication and will have a substantial likelihood of materially prejudicing an adjudicative proceeding in the...) Information contained in a public record; (3) That an investigation of a matter is in progress; (4) The...

37 CFR 11.306 - Trial publicity.

Code of Federal Regulations, 2013 CFR

2013-07-01

... statement that the practitioner knows or reasonably should know will be disseminated by means of public communication and will have a substantial likelihood of materially prejudicing an adjudicative proceeding in the...) Information contained in a public record; (3) That an investigation of a matter is in progress; (4) The...

Preferred reporting items for studies mapping onto preference-based outcome measures: the MAPS statement.

PubMed

Petrou, Stavros; Rivero-Arias, Oliver; Dakin, Helen; Longworth, Louise; Oppe, Mark; Froud, Robert; Gray, Alastair

2016-02-01

'Mapping' onto generic preference-based outcome measures is increasingly being used as a means of generating health utilities for use within health economic evaluations. Despite publication of technical guides for the conduct of mapping research, guidance for the reporting of mapping studies is currently lacking. The MApping onto Preference-based measures reporting Standards (MAPS) statement is a new checklist, which aims to promote complete and transparent reporting of mapping studies. In the absence of previously published reporting checklists or reporting guidance documents, a de novo list of reporting items was created by a working group comprised of six health economists and one Delphi methodologist. A two-round, modified Delphi survey with representatives from academia, consultancy, health technology assessment agencies and the biomedical journal editorial community was used to identify a list of essential reporting items from this larger list. From the initial de novo list of 29 candidate items, a set of 23 essential reporting items was developed. The items are presented numerically and categorised within six sections, namely (1) title and abstract; (2) introduction; (3) methods; (4) results; (5) discussion; and (6) other. The MAPS statement is best applied in conjunction with the accompanying MAPS explanation and elaboration document. It is anticipated that the MAPS statement will improve the clarity, transparency and completeness of reporting of mapping studies. To facilitate dissemination and uptake, the MAPS statement is being co-published by seven health economics and quality of life journals, and broader endorsement is encouraged. The MAPS working group plans to assess the need for an update of the reporting checklist in 5 years' time.

PREFERRED REPORTING ITEMS FOR STUDIES MAPPING ONTO PREFERENCE-BASED OUTCOME MEASURES: THE MAPS STATEMENT.

PubMed

Petrou, Stavros; Rivero-Arias, Oliver; Dakin, Helen; Longworth, Louise; Oppe, Mark; Froud, Robert; Gray, Alastair

2015-01-01

"Mapping" onto generic preference-based outcome measures is increasingly being used as a means of generating health utilities for use within health economic evaluations. Despite publication of technical guides for the conduct of mapping research, guidance for the reporting of mapping studies is currently lacking. The MAPS (MApping onto Preference-based measures reporting Standards) statement is a new checklist, which aims to promote complete and transparent reporting of mapping studies. In the absence of previously published reporting checklists or reporting guidance documents, a de novo list of reporting items was created by a working group comprised of six health economists and one Delphi methodologist. A two-round, modified Delphi survey with representatives from academia, consultancy, health technology assessment agencies, and the biomedical journal editorial community was used to identify a list of essential reporting items from this larger list. From the initial de novo list of twenty-nine candidate items, a set of twenty-three essential reporting items was developed. The items are presented numerically and categorized within six sections, namely: (i) title and abstract, (ii) introduction, (iii) methods, (iv) results, (v) discussion, and (vi) other. The MAPS statement is best applied in conjunction with the accompanying MAPS explanation and elaboration document. It is anticipated that the MAPS statement will improve the clarity, transparency. and completeness of reporting of mapping studies. To facilitate dissemination and uptake, the MAPS statement is being co-published by seven health economics and quality of life journals, and broader endorsement is encouraged. The MAPS working group plans to assess the need for an update of the reporting checklist in five years' time.

Improved inter-observer agreement of an expert review panel in an oncology treatment trial--Insights from a structured interventional process.

PubMed

Nestle, Ursula; Rischke, Hans Christian; Eschmann, Susanne Martina; Holl, Gabriele; Tosch, Marco; Miederer, Matthias; Plotkin, Michail; Essler, Markus; Puskas, Cornelia; Schimek-Jasch, Tanja; Duncker-Rohr, Viola; Rühl, Friederike; Leifert, Anja; Mix, Michael; Grosu, Anca-Ligia; König, Jochem; Vach, Werner

2015-11-01

Oncologic imaging is a key for successful cancer treatment. While the quality assurance (QA) of image acquisition protocols has already been focussed, QA of reading and reporting offers still room for improvement. The latter was addressed in the context of a prospective multicentre trial on fluoro-deoxyglucose (FDG)-positron-emission tomography (PET)/CT-based chemoradiotherapy for locally advanced non-small cell lung cancer (NSCLC). An expert panel was prospectively installed performing blinded reviews of mediastinal NSCLC involvement in FDG-PET/CT. Due to a high initial reporting inter-observer disagreement, the independent data monitoring committee (IDMC) triggered an interventional harmonisation process, which overall involved 11 experts uttering 6855 blinded diagnostic statements. After assessing the baseline inter-observer agreement (IOA) of a blinded re-review (phase 1), a discussion process led to improved reading criteria (phase 2). Those underwent a validation study (phase 3) and were then implemented into the study routine. After 2 months (phase 4) and 1 year (phase 5), the IOA was reassessed. The initial overall IOA was moderate (kappa 0.52 CT; 0.53 PET). After improvement of reading criteria, the kappa values improved substantially (kappa 0.61 CT; 0.66 PET), which was retained until the late reassessment (kappa 0.71 CT; 0.67 PET). Subjective uncertainty was highly predictive for low IOA. The IOA of an expert panel was significantly improved by a structured interventional harmonisation process which could be a model for future clinical trials. Furthermore, the low IOA in reporting nodal involvement in NSCLC may bear consequences for individual patient care. Copyright © 2015 Elsevier Ltd. All rights reserved.

Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): explanation and elaboration.

PubMed

Vandenbroucke, Jan P; von Elm, Erik; Altman, Douglas G; Gøtzsche, Peter C; Mulrow, Cynthia D; Pocock, Stuart J; Poole, Charles; Schlesselman, James J; Egger, Matthias

2014-12-01

Much medical research is observational. The reporting of observational studies is often of insufficient quality. Poor reporting hampers the assessment of the strengths and weaknesses of a study and the generalisability of its results. Taking into account empirical evidence and theoretical considerations, a group of methodologists, researchers, and editors developed the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) recommendations to improve the quality of reporting of observational studies. The STROBE Statement consists of a checklist of 22 items, which relate to the title, abstract, introduction, methods, results and discussion sections of articles. Eighteen items are common to cohort studies, case-control studies and cross-sectional studies and four are specific to each of the three study designs. The STROBE Statement provides guidance to authors about how to improve the reporting of observational studies and facilitates critical appraisal and interpretation of studies by reviewers, journal editors and readers. This explanatory and elaboration document is intended to enhance the use, understanding, and dissemination of the STROBE Statement. The meaning and rationale for each checklist item are presented. For each item, one or several published examples and, where possible, references to relevant empirical studies and methodological literature are provided. Examples of useful flow diagrams are also included. The STROBE Statement, this document, and the associated Web site (http://www.strobe-statement.org/) should be helpful resources to improve reporting of observational research. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

A review of the ethics of the use of placebo in clinical trials for relapsing-remitting multiple sclerosis therapeutics.

PubMed

Solomon, Andrew J; Bernat, James L

2016-05-01

Randomized placebo-controlled clinical trials have been considered the most rigorous method of evaluating the efficacy of novel treatment interventions. The first effective disease-modifying therapies (DMTs) for relapsing-remitting multiple sclerosis (RRMS) were approved in the 1990s after a number of pivotal placebo-controlled trials. Since then, the ethics of the continued use of placebo in clinical trials of new DMTs for RRMS has been the subject of repeated policy statements and recommendations by international committees. As further data have accumulated demonstrating a reduction in long-term morbidity and mortality with early initiation of DMT, a growing consensus has emerged that further inclusion of placebo arms in clinical trials of novel RRMS therapies is no longer ethical. Copyright © 2016 Elsevier B.V. All rights reserved.

Data Supporting the Environmental Liability Reported on the FY 2000 Financial Statements

DTIC Science & Technology

2001-08-10

consolidated financial statements . This audit supports our audit of the FY 2000 DoD Agency-Wide Financial Statements, specifically the line item for environmental liabilities. The Army, the Navy, and the General Accounting Office also issued audit reports related to the reliability, completeness, and supportability of environmental liabilities for FY 2000. Environmental liabilities included estimated amounts for future cleanup of contamination resulting from waste disposal methods, leaks, spills, and other past activity which have created a public health or

US Department of Energy Naval Petroleum and Oil Shale Reserves combined financial statements and management overview and supplemental financial and management information, September 30, 1995 and 1994

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

NONE

1996-02-15

This report presents the results of the independent certified public accountant`s audit of the Department of Energy`s (Department) Naval Petroleum and Oil Shale Reserves (NPOSR) financial statements as of September 30, 1995. The auditors have expressed an unqualified opinion on the 1995 statements. Their reports on the NPOSR internal control structure and compliance with laws and regulations are also provided.

A study of the review and comment phase of the environmental impact statement : draft and negative.

DOT National Transportation Integrated Search

1972-01-01

This study examined the agencies that review the environmental impact statements (EIS) prepared on highway projects and was an attempt to shed light on the functions, personnel, and problems of the offices that saw the statements. The report covered ...

19 CFR 200.735-117 - Supplementary statements.

Code of Federal Regulations, 2010 CFR

2010-04-01

... under this section, each employee shall at all times avoid acquiring a financial interest that could... CONDUCT Provisions Governing Statements of Employment and Financial Interests § 200.735-117 Supplementary... and financial interests shall be reported in a supplementary statement as of June 30 each year. If no...

76 FR 4516 - Revisions to Forms, Statements, and Reporting Requirements for Natural Gas Pipelines

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-26

...; Order No. 710-B] Revisions to Forms, Statements, and Reporting Requirements for Natural Gas Pipelines... for natural gas companies, contained in FERC Form Nos. 2, 2-A, and 3-Q, to include functionalized fuel..., and reports for natural gas companies, contained in FERC Form Nos. 2, 2-A, and 3-Q, to include...

77 FR 11084 - Intent To Prepare a Draft Environmental Impact Statement/Environmental Impact Report for the...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-24

... Environmental Impact Statement/ Environmental Impact Report for the Proposed Cambria Water Supply Project, San... Report (EIS/EIR) to study, plan, and implement a project to provide for a reliable water supply for the... the area relying solely upon local groundwater for its current water supply. The groundwater supplies...

Oakton Community College Annual Report to the Community, Fiscal Year 1996.

ERIC Educational Resources Information Center

Oakton Community Coll., Des Plaines, IL.

This 1996 annual report from Oakton Community College in Illinois was prepared to inform the community about the college's operations and finances, but in a more condensed, user friendly format than the comprehensive financial report. It includes statements from the board chairman and president, a mission statement, and a description of the board…

A systematic scoping review of adherence to reporting guidelines in health care literature

PubMed Central

Samaan, Zainab; Mbuagbaw, Lawrence; Kosa, Daisy; Debono, Victoria Borg; Dillenburg, Rejane; Zhang, Shiyuan; Fruci, Vincent; Dennis, Brittany; Bawor, Monica; Thabane, Lehana

2013-01-01

Background Reporting guidelines have been available for the past 17 years since the inception of the Consolidated Standards of Reporting Trials statement in 1996. These guidelines were developed to improve the quality of reporting of studies in medical literature. Despite the widespread availability of these guidelines, the quality of reporting of medical literature remained suboptimal. In this study, we assess the current adherence practice to reporting guidelines; determine key factors associated with better adherence to these guidelines; and provide recommendations to enhance adherence to reporting guidelines for future studies. Methods We undertook a systematic scoping review of systematic reviews of adherence to reporting guidelines across different clinical areas and study designs. We searched four electronic databases (Cumulative Index to Nursing and Allied Health Literature, Web of Science, Embase, and Medline) from January 1996 to September 2012. Studies were included if they addressed adherence to one of the following guidelines: Consolidated Standards of Reporting Trials (CONSORT), Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA), Quality of Reporting of Meta-analysis (QUOROM), Transparent Reporting of Evaluations with Nonrandomized Designs (TREND), Meta-analysis Of Observational Studies in Epidemiology (MOOSE) and Strengthening the Reporting of Observational Studies in Epidemiology (STROBE). A protocol for this study was devised. A literature search, data extraction, and quality assessment were performed independently by two authors in duplicate. This study reporting follows the PRISMA guidelines. Results Our search retrieved 5159 titles, of which 50 were eligible. Overall, 86.0% of studies reported suboptimal levels of adherence to reporting guidelines. Factors associated with better adherence included journal impact factor and endorsement of guidelines, publication date, funding source, multisite studies, pharmacological interventions and larger studies. Conclusion Reporting guidelines in the clinical literature are important to improve the standards of reporting of clinical studies; however, adherence to these guidelines remains suboptimal. Action is therefore needed to enhance the adherence to these standards. Strategies to enhance adherence include journal editorial policies endorsing these guidelines. PMID:23671390

Economic values and corporate financial statements.

PubMed

Magness, Vanessa

2003-07-01

Corporate financial statements do not include environmental values. This deficiency has contributed to the criticism that company managers do not include environmental impacts in the internal decision-making process. The accounting profession has not developed effective environmental reporting guidelines. This situation contributes to a second problem: the apparent inability of corporate reports to provide useful information to external parties. It has been suggested that by using nonmarket valuation methodologies, financial statements can be used to measure progress toward sustainable development. Nonmarket valuations are not generally accepted by the accounting profession. They are too subjective to support effective decisions, and too costly to obtain. Furthermore, demand for this sort of information appears small. Some of these issues may be resolved over time. The most serious challenge, however, concerns how enhanced financial reports would be used. Financial statements are supposed to help investors assess the amount, timing, and uncertainty of future cash flows. A substantial portion of environmental value is based on nonuse benefits, much of which will never be realized in company cash flows. In other words, the role of financial statements would have to change. Furthermore, since there is no general agreement as to the meaning of "sustainable development," efforts to operationalize the term have been fraught with difficulty. Moreover, monetization of environmental values could jeopardize their preservation, leaving some to question the overall objective of this form of reporting. For these reasons, while it is to be hoped that better reporting of environmental impacts will be forthcoming, the greatest advances will likely be outside the financial statements themselves.

[An investigation of the statistical power of the effect size in randomized controlled trials for the treatment of patients with type 2 diabetes mellitus using Chinese medicine].

PubMed

Ma, Li-Xin; Liu, Jian-Ping

2012-01-01

To investigate whether the power of the effect size was based on adequate sample size in randomized controlled trials (RCTs) for the treatment of patients with type 2 diabetes mellitus (T2DM) using Chinese medicine. China Knowledge Resource Integrated Database (CNKI), VIP Database for Chinese Technical Periodicals (VIP), Chinese Biomedical Database (CBM), and Wangfang Data were systematically recruited using terms like "Xiaoke" or diabetes, Chinese herbal medicine, patent medicine, traditional Chinese medicine, randomized, controlled, blinded, and placebo-controlled. Limitation was set on the intervention course > or = 3 months in order to identify the information of outcome assessement and the sample size. Data collection forms were made according to the checking lists found in the CONSORT statement. Independent double data extractions were performed on all included trials. The statistical power of the effects size for each RCT study was assessed using sample size calculation equations. (1) A total of 207 RCTs were included, including 111 superiority trials and 96 non-inferiority trials. (2) Among the 111 superiority trials, fasting plasma glucose (FPG) and glycosylated hemoglobin HbA1c (HbA1c) outcome measure were reported in 9% and 12% of the RCTs respectively with the sample size > 150 in each trial. For the outcome of HbA1c, only 10% of the RCTs had more than 80% power. For FPG, 23% of the RCTs had more than 80% power. (3) In the 96 non-inferiority trials, the outcomes FPG and HbA1c were reported as 31% and 36% respectively. These RCTs had a samples size > 150. For HbA1c only 36% of the RCTs had more than 80% power. For FPG, only 27% of the studies had more than 80% power. The sample size for statistical analysis was distressingly low and most RCTs did not achieve 80% power. In order to obtain a sufficient statistic power, it is recommended that clinical trials should establish clear research objective and hypothesis first, and choose scientific and evidence-based study design and outcome measurements. At the same time, calculate required sample size to ensure a precise research conclusion.

Towards early inclusion of children in tuberculosis drugs trials: a consensus statement.

PubMed

Nachman, Sharon; Ahmed, Amina; Amanullah, Farhana; Becerra, Mercedes C; Botgros, Radu; Brigden, Grania; Browning, Renee; Gardiner, Elizabeth; Hafner, Richard; Hesseling, Anneke; How, Cleotilde; Jean-Philippe, Patrick; Lessem, Erica; Makhene, Mamodikoe; Mbelle, Nontombi; Marais, Ben; McIlleron, Helen; McNeeley, David F; Mendel, Carl; Murray, Stephen; Navarro, Eileen; Anyalechi, E Gloria; Porcalla, Ariel R; Powell, Clydette; Powell, Mair; Rigaud, Mona; Rouzier, Vanessa; Samson, Pearl; Schaaf, H Simon; Shah, Seema; Starke, Jeff; Swaminathan, Soumya; Wobudeya, Eric; Worrell, Carol

2015-06-01

Children younger than 18 years account for a substantial proportion of patients with tuberculosis worldwide. Available treatments for paediatric drug-susceptible and drug-resistant tuberculosis, albeit generally effective, are hampered by high pill burden, long duration of treatment, coexistent toxic effects, and an overall scarcity of suitable child-friendly formulations. Several new drugs and regimens with promising activity against both drug-susceptible and drug-resistant strains have entered clinical development and are either in various phases of clinical investigation or have received marketing authorisation for adults; however, none have data on their use in children. This consensus statement, generated from an international panel of opinion leaders on childhood tuberculosis and incorporating reviews of published literature from January, 2004, to May, 2014, addressed four key questions: what drugs or regimens should be prioritised for clinical trials in children? Which populations of children are high priorities for study? When can phase 1 or 2 studies be initiated in children? What are the relevant elements of clinical trial design? The consensus panel found that children can be included in studies at the early phases of drug development and should be an integral part of the clinical development plan, rather than studied after regulatory approval in adults is obtained. Copyright © 2015 Elsevier Ltd. All rights reserved.

Report: State of New Hampshire Drinking Water State Revolving Fund Program Financial Statements for the Year Ended June 30, 2005

EPA Pesticide Factsheets

Report #2007-1-00044, February 26, 2007. We rendered an unqualified opinion on the New Hampshire Drinking Water State Revolving Fund (DWSRF) Program financial statements for the year ended June 30, 2005.

29 CFR 1910.1096 - Ionizing radiation.

Code of Federal Regulations, 2010 CFR

2010-07-01

... test tubes, used transiently in laboratory procedures, when the user is present. (iv) Where containers... shall contain the following statement: “You should preserve this report for future reference.” (n... statement: “You should preserve this report for future reference.” (2) [Reserved] (p) Nuclear Regulatory...

26 CFR 1.451-4 - Accounting for redemption of trading stamps and coupons.

Code of Federal Regulations, 2010 CFR

2010-04-01

... reports (including consolidated financial statements) to shareholders, partners, beneficiaries, other... section) that the taxpayer uses for purposes of all reports (including consolidated financial statements... financial reporting—(1) Estimated future redemptions. For taxable years beginning after August 22, 1972, the...

Update on Prevention of Cardiovascular Disease in Adults With Type 2 Diabetes Mellitus in Light of Recent Evidence: A Scientific Statement From the American Heart Association and the American Diabetes Association

PubMed Central

Golden, Sherita Hill; Anderson, Cheryl; Bray, George A.; Burke, Lora E.; de Boer, Ian H.; Deedwania, Prakash; Eckel, Robert H.; Ershow, Abby G.; Fradkin, Judith; Inzucchi, Silvio E.; Kosiborod, Mikhail; Nelson, Robert G.; Patel, Mahesh J.; Pignone, Michael; Quinn, Laurie; Schauer, Philip R.; Selvin, Elizabeth; Vafiadis, Dorothea K.

2015-01-01

Cardiovascular disease risk factor control as primary prevention in patients with type 2 diabetes mellitus has changed substantially in the past few years. The purpose of this scientific statement is to review the current literature and key clinical trials pertaining to blood pressure and blood glucose control, cholesterol management, aspirin therapy, and lifestyle modification. We present a synthesis of the recent literature, new guidelines, and clinical targets, including screening for kidney and subclinical cardiovascular disease for the contemporary management of patients with type 2 diabetes mellitus. PMID:26246459

The effects of crisis plans for patients with psychotic and bipolar disorders: a randomised controlled trial.

PubMed

Ruchlewska, A; Mulder, C L; Smulders, R; Roosenschoon, B J; Koopmans, G; Wierdsma, A

2009-07-09

Crises and (involuntary) admissions have a strong impact on patients and their caregivers. In some countries, including the Netherlands, the number of crises and (involuntary) admissions have increased in the last years. There is also a lack of effective interventions to prevent their occurrence. Previous research has shown that a form of psychiatric advance statement - joint crisis plan - may prevent involuntary admissions, but another study showed no significant results for another form. The question remains which form of psychiatric advance statement may help to prevent crisis situations. This study examines the effects of two other psychiatric advance statements. The first is created by the patient with help from a patient's advocate (Patient Advocate Crisis Plan: PACP) and the second with the help of a clinician only (Clinician facilitated Crisis Plan: CCP). We investigate whether patients with a PACP or CCP show fewer emergency visits and (involuntary) admissions as compared to patients without a psychiatric advance statement. Furthermore, this study seeks to identify possible mechanisms responsible for the effects of a PACP or a CCP. This study is a randomised controlled trial with two intervention groups and one control condition. Both interventions consist of a crisis plan, facilitated through the patient's advocate or the clinician respectively.Outpatients with psychotic or bipolar disorders, who experienced at least one psychiatric crisis during the previous two years, are randomly allocated to one of the three groups. Primary outcomes are the number of emergency (after hour) visits, (involuntary) admissions and the length of stay in hospital. Secondary outcomes include psychosocial functioning and treatment satisfaction. The possible mediator variables of the effects of the crisis plans are investigated by assessing the patient's involvement in the creation of the crisis plan, working alliance, insight into illness, recovery style, social support, locus of control, service engagement and coping with crises situations. The interviews take place before randomisation, nine month later and finally eighteen months after randomisation. This study examines the effects of two types of crisis plans. In addition, the results offer an understanding of the way these advance statements work and whether it is more effective to include a patients' advocate in the process of creating a psychiatric advance statement. These statements may be an intervention to prevent crises and the use of compulsion in mental health care. The strength and limitations of this study are discussed. Current Controlled Trails NTR1166.

Blinded interpretation of study results can feasibly and effectively diminish interpretation bias.

PubMed

Järvinen, Teppo L N; Sihvonen, Raine; Bhandari, Mohit; Sprague, Sheila; Malmivaara, Antti; Paavola, Mika; Schünemann, Holger J; Guyatt, Gordon H

2014-07-01

Controversial and misleading interpretation of data from randomized trials is common. How to avoid misleading interpretation has received little attention. Herein, we describe two applications of an approach that involves blinded interpretation of the results by study investigators. The approach involves developing two interpretations of the results on the basis of a blinded review of the primary outcome data (experimental treatment A compared with control treatment B). One interpretation assumes that A is the experimental intervention and another assumes that A is the control. After agreeing that there will be no further changes, the investigators record their decisions and sign the resulting document. The randomization code is then broken, the correct interpretation chosen, and the manuscript finalized. Review of the document by an external authority before finalization can provide another safeguard against interpretation bias. We found the blinded preparation of a summary of data interpretation described in this article practical, efficient, and useful. Blinded data interpretation may decrease the frequency of misleading data interpretation. Widespread adoption of blinded data interpretation would be greatly facilitated were it added to the minimum set of recommendations outlining proper conduct of randomized controlled trials (eg, the Consolidated Standards of Reporting Trials statement). Copyright © 2014 The Authors. Published by Elsevier Inc. All rights reserved.

Effectiveness of personalized face-to-face and telephone nursing counseling interventions for cardiovascular risk factors: a controlled clinical trial 1

PubMed Central

Vílchez Barboza, Vivian; Klijn, Tatiana Paravic; Salazar Molina, Alide; Sáez Carrillo, Katia Lorena

2016-01-01

Abstract Objective: to evaluate the effect and gender differences of an innovative intervention involving in-person and telephone nursing counseling to control cardiovascular risk factors (arterial hypertension, dyslipidemia, and overweight), improve health-related quality of life and strengthen self-efficacy and social support in persons using the municipal health centers' cardiovascular health program. Method: a randomized controlled clinical trial involving participants randomized into the intervention group who received traditional consultation plus personalized and telephone nursing counseling for 7 months (n = 53) and the control group (n = 56). The study followed the Consolidated Standards of Reporting Trials Statement. Results: women in the intervention group presented a significant increase in the physical and mental health components compared to the control group, with decreases in weight, abdominal circumference, total cholesterol, low-density lipoprotein cholesterol, and the atherogenic index. The effects attributable to the intervention in the men in the intervention group were increased physical and emotional roles and decreased systolic and diastolic pressure, waist circumference, total cholesterol, low-density lipoprotein cholesterol, atherogenic index, cardiovascular risk factor, and 10-year coronary risk. Conclusion: this intervention is an effective strategy for the control of three cardiovascular risk factors and the improvement of health-related quality of life. PMID:27508917

Exercise and Sports Science Australia (ESSA) position statement on exercise prescription for the prevention and management of osteoporosis.

PubMed

Beck, Belinda R; Daly, Robin M; Singh, Maria A Fiatarone; Taaffe, Dennis R

2017-05-01

Osteoporotic fractures are associated with substantial morbidity and mortality. Although exercise has long been recommended for the prevention and management of osteoporosis, existing guidelines are often non-specific and do not account for individual differences in bone health, fracture risk and functional capacity. The aim of the current position statement is to provide health practitioners with specific, evidence-based guidelines for safe and effective exercise prescription for the prevention or management of osteoporosis, accommodating a range of potential comorbidities. Position statement. Interpretation and application of research reports describing the effects of exercise interventions for the prevention and management of low bone mass, osteoporosis and osteoporotic fracture. Evidence from animal and human trials indicates that bone responds positively to impact activities and high intensity progressive resistance training. Furthermore, the optimisation of muscle strength, balance and mobility minimises the risk of falls (and thereby fracture), which is particularly relevant for individuals with limited functional capacity and/or a very high risk of osteoporotic fracture. It is important that all exercise programs be accompanied by sufficient calcium and vitamin D, and address issues of comorbidity and safety. For example, loaded spine flexion is not recommended, and impact activities may require modification in the presence of osteoarthritis or frailty. Specific guidelines for safe and effective exercise for bone health are presented. Individual exercise prescription must take into account existing bone health status, co-morbidities, and functional or clinical risk factors for falls and fracture. Copyright © 2016 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

Evaluation of an Internet-Based Behavioral Intervention to Improve Psychosocial Health Outcomes in Children With Insomnia (Better Nights, Better Days): Protocol for a Randomized Controlled Trial

PubMed Central

Reid, Graham J; Hall, Wendy A; Godbout, Roger; Stremler, Robyn; Weiss, Shelly K; Gruber, Reut; Witmans, Manisha; Chambers, Christine T; Begum, Esmot Ara; Andreou, Pantelis; Rigney, Gabrielle

2018-01-01

Background Up to 25% of 1- to 10-year-old children experience insomnia (ie, resisting bedtime, trouble falling asleep, night awakenings, and waking too early in the morning). Insomnia can be associated with excessive daytime sleepiness and negative effects on daytime functioning across multiple domains (eg, behavior, mood, attention, and learning). Despite robust evidence supporting the effectiveness of behavioral treatments for insomnia in children, very few children with insomnia receive these treatments, primarily due to a shortage of available treatment resources. Objective The Better Nights, Better Days (BNBD) internet-based program provides a readily accessible electronic health (eHealth) intervention to support parents in providing evidence-based care for insomnia in typically developing children. The purpose of the randomized controlled trial (RCT) is to evaluate the effectiveness of BNBD in treating insomnia in children aged between 1 and 10 years. Methods BNBD is a fully automated program, developed based on evidence-based interventions previously tested by the investigators, as well as on the extant literature on this topic. We describe the 2-arm RCT in which participants (500 primary caregivers of children with insomnia residing in Canada) are assigned to intervention or usual care. Results The effects of this behavioral sleep eHealth intervention will be assessed at 4 and 8 months postrandomization. Assessment includes both sleep (actigraphy, sleep diary) and daytime functioning of the children and daytime functioning of their parents. Results will be reported using the standards set out in the Consolidated Standards of Reporting Trials statement. Conclusions If the intervention is supported by the results of the RCT, we plan to commercialize this program so that it is sustainable and available at a low cost to all families with internet access. Trial Registration ClinicalTrials.gov NCT02243501; https://clinicaltrials.gov/show/NCT02243501 (Archived by WebCite at http://www.webcitation.org/6x8Z5pBui) PMID:29581089

Exploring the uptake and framing of research evidence on universal screening for intimate partner violence against women: a knowledge translation case study

PubMed Central

2013-01-01

Background Significant emphasis is currently placed on the need to enhance health care decision-making with research-derived evidence. While much has been written on specific strategies to enable these “knowledge-to-action” processes, there is less empirical evidence regarding what happens when knowledge translation (KT) processes do not proceed as planned. The present paper provides a KT case study using the area of health care screening for intimate partner violence (IPV). Methods A modified citation analysis method was used, beginning with a comprehensive search (August 2009 to October 2012) to capture scholarly and grey literature, and news reports citing a specific randomized controlled trial published in a major medical journal on the effectiveness of screening women, in health care settings, for exposure to IPV. Results of the searches were extracted, coded and analysed using a multi-step mixed qualitative and quantitative content analysis process. Results The trial was cited in 147 citations from 112 different sources in journal articles, commentaries, books, and government and news reports. The trial also formed part of the evidence base for several national-level practice guidelines and policy statements. The most common interpretations of the trial were “no benefit of screening”, “no harms of screening”, or both. Variation existed in how these findings were represented, ranging from summaries of the findings, to privileging one outcome over others, and to critical qualifications, especially with regard to methodological rigour of the trial. Of note, interpretations were not always internally consistent, with the same evidence used in sometimes contradictory ways within the same source. Conclusions Our findings provide empirical data on the malleability of “evidence” in knowledge translation processes, and its potential for multiple, often unanticipated, uses. They have implications for understanding how research evidence is used and interpreted in policy and practice, particularly in contested knowledge areas. PMID:23587155

Exploring the uptake and framing of research evidence on universal screening for intimate partner violence against women: a knowledge translation case study.

PubMed

Wathen, C Nadine; Macgregor, Jennifer Cd; Sibbald, Shannon L; Macmillan, Harriet L

2013-04-12

Significant emphasis is currently placed on the need to enhance health care decision-making with research-derived evidence. While much has been written on specific strategies to enable these "knowledge-to-action" processes, there is less empirical evidence regarding what happens when knowledge translation (KT) processes do not proceed as planned. The present paper provides a KT case study using the area of health care screening for intimate partner violence (IPV). A modified citation analysis method was used, beginning with a comprehensive search (August 2009 to October 2012) to capture scholarly and grey literature, and news reports citing a specific randomized controlled trial published in a major medical journal on the effectiveness of screening women, in health care settings, for exposure to IPV. Results of the searches were extracted, coded and analysed using a multi-step mixed qualitative and quantitative content analysis process. The trial was cited in 147 citations from 112 different sources in journal articles, commentaries, books, and government and news reports. The trial also formed part of the evidence base for several national-level practice guidelines and policy statements. The most common interpretations of the trial were "no benefit of screening", "no harms of screening", or both. Variation existed in how these findings were represented, ranging from summaries of the findings, to privileging one outcome over others, and to critical qualifications, especially with regard to methodological rigour of the trial. Of note, interpretations were not always internally consistent, with the same evidence used in sometimes contradictory ways within the same source. Our findings provide empirical data on the malleability of "evidence" in knowledge translation processes, and its potential for multiple, often unanticipated, uses. They have implications for understanding how research evidence is used and interpreted in policy and practice, particularly in contested knowledge areas.

Impact of e-learning on nurses' and student nurses knowledge, skills, and satisfaction: a systematic review and meta-analysis.

PubMed

Lahti, Mari; Hätönen, Heli; Välimäki, Maritta

2014-01-01

To review the impact of e-learning on nurses' and nursing student's knowledge, skills and satisfaction related to e-learning. We conducted a systematic review and meta-analysis of randomized controlled trials (RCT) to assess the impact of e-learning on nurses' and nursing student's knowledge, skills and satisfaction. Electronic databases including MEDLINE (1948-2010), CINAHL (1981-2010), Psychinfo (1967-2010) and Eric (1966-2010) were searched in May 2010 and again in December 2010. All RCT studies evaluating the effectiveness of e-learning and differentiating between traditional learning methods among nurses were included. Data was extracted related to the purpose of the trial, sample, measurements used, index test results and reference standard. An extraction tool developed for Cochrane reviews was used. Methodological quality of eligible trials was assessed. 11 trials were eligible for inclusion in the analysis. We identified 11 randomized controlled trials including a total of 2491 nurses and student nurses'. First, the random effect size for four studies showed some improvement associated with e-learning compared to traditional techniques on knowledge. However, the difference was not statistically significant (p=0.39, MD 0.44, 95% CI -0.57 to 1.46). Second, one study reported a slight impact on e-learning on skills, but the difference was not statistically significant, either (p=0.13, MD 0.03, 95% CI -0.09 to 0.69). And third, no results on nurses or student nurses' satisfaction could be reported as the statistical data from three possible studies were not available. Overall, there was no statistical difference between groups in e-learning and traditional learning relating to nurses' or student nurses' knowledge, skills and satisfaction. E-learning can, however, offer an alternative method of education. In future, more studies following the CONSORT and QUOROM statements are needed to evaluate the effects of these interventions. Copyright © 2013 Elsevier Ltd. All rights reserved.

77 FR 42489 - Notice of Availability of the Draft Feasibility Study; Environmental Impact Statement for the...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-19

... Draft Feasibility Study; Environmental Impact Statement for the Chatfield Reservoir Storage Reallocation.... Army Corps of Engineers has prepared a Draft Feasibility Report/Environmental Impact Statement (FR/EIS) for the Chatfield Reservoir Storage Reallocation Study, Littleton, Colorado and by this notice is...

Inspector General, DOD, Oversight of the Audit of the FY 2000 Military Retirement Fund Financial Statements

DTIC Science & Technology

2001-02-28

statements and to report on the adequacy of internal controls and compliance with laws and regulations. We contracted the audit of the FY 2000 Military...performed on the oversight of the audit of the FY 2000 Military Retirement Fund Financial Statements.

37 CFR 270.5 - Designated collection and distribution organizations for records of use of sound recordings under...

Code of Federal Regulations, 2010 CFR

2010-07-01

..., Statements of Account, Auditor's Reports, and other verification information filed in the Copyright Office... statements of account under compulsory license for making/distributing phonorecords of 201.19 Nondramatic... works, Royalties and statements of account under compulsory license for making/distributing 201.19...

Financial audit : District of Columbia highway trust fund's fiscal year 1999 and 1998 financial statements

DOT National Transportation Integrated Search

2000-10-01

This report presents the results of our audits of the financial statements of the District of Columbia Highway Trust Fund for the fiscal years ended September 30, 1999 and 1998, and our examination of the forecasted statements of the Fund's expected ...

17 CFR 270.8b-16 - Amendments to registration statement.

Code of Federal Regulations, 2010 CFR

2010-04-01

... (CONTINUED) RULES AND REGULATIONS, INVESTMENT COMPANY ACT OF 1940 § 270.8b-16 Amendments to registration statement. (a) Every registered management investment company which is required to file a semi-annual report... management investment company whose registration statement was filed on Form N-2; provided that the following...

17 CFR 210.8-08 - Age of financial statements.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 17 Commodity and Securities Exchanges 2 2011-04-01 2011-04-01 false Age of financial statements. 210.8-08 Section 210.8-08 Commodity and Securities Exchanges SECURITIES AND EXCHANGE COMMISSION FORM... Smaller Reporting Companies § 210.8-08 Age of financial statements. At the date of filing, financial...

46 CFR 232.6 - Financial report filing requirement.

Code of Federal Regulations, 2012 CFR

2012-10-01

... certified public accountants (CPAs) licensed to practice by a state or other political subdivision of the... accounting period. If certified (CPA) statements are not available when required, company certified statements are to be submitted within the due dates, and the CPA statements shall be submitted as soon as...

46 CFR 232.6 - Financial report filing requirement.

Code of Federal Regulations, 2014 CFR

2014-10-01

... certified public accountants (CPAs) licensed to practice by a state or other political subdivision of the... accounting period. If certified (CPA) statements are not available when required, company certified statements are to be submitted within the due dates, and the CPA statements shall be submitted as soon as...

46 CFR 232.6 - Financial report filing requirement.

Code of Federal Regulations, 2011 CFR

2011-10-01

... certified public accountants (CPAs) licensed to practice by a state or other political subdivision of the... accounting period. If certified (CPA) statements are not available when required, company certified statements are to be submitted within the due dates, and the CPA statements shall be submitted as soon as...

46 CFR 232.6 - Financial report filing requirement.

Code of Federal Regulations, 2013 CFR

2013-10-01

... certified public accountants (CPAs) licensed to practice by a state or other political subdivision of the... accounting period. If certified (CPA) statements are not available when required, company certified statements are to be submitted within the due dates, and the CPA statements shall be submitted as soon as...

78 FR 75346 - Proposed Agency Information Collection Activities; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-11

... banks file and the Consolidated Financial Statements for Holding Companies (FR Y-9C; OMB No. 7100-0128... holding companies and are consolidated into the financial statements of their parent organizations.... Report title: Financial Statements of U.S. Nonbank Subsidiaries of U.S. Holding Companies and the...

Accounting: Teaching the Worksheet: The "What,""Why," and "How."

ERIC Educational Resources Information Center

Simpson, Kawanna J.; Musselman, Donald

1979-01-01

Techniques to enable accounting teachers to present the accounting worksheet are given, with examples of worksheet columns for income statement, balance sheet, revenue and expense, owner's equity, trial balance, and adjustments. The techniques also show the student the reasons (why) for and the mechanics (how) of the worksheet. (MF)

Healthcare Financial Management Association, Principles and Practices Board. Statement no. 15: Valuation and financial statement presentation of charity service and bad debts by institutional healthcare providers.

PubMed

1993-02-01

Principles and Practices Board (P&P Board) Statement No. 2, issued in 1978, provided a basis for differentiating between charity service and bad debts. The statement acknowledged that, while the differentiation was helpful, the financial accounting and reporting of charity service and bad debts were the same. In 1990, the American Institute of Certified Public Accountants (AICPA) published (after review and approval by the Financial Accounting Standards Board and the Governmental Accounting Standards Board) an extensive revision of the guide titled "Audits of Providers of Health Care Services." The revised guide substantially changed the reporting of bad debts and eliminated charity service from revenue. Disclosure of the entity's policy for providing charity service and the level of charity service provided is required by the revised guide. The P&P Board decided that a substantive revision of its Statement No. 2 was required to bring it into conformity with the revised guide and to provide direction on implementation of the revised guide's requirements. This statement supersedes Statement No. 2 and deals with the same issues, including bad debts.

Strengthening the Reporting of Observational Studies in Epidemiology—Nutritional Epidemiology (STROBE-nut): An Extension of the STROBE Statement

PubMed Central

Hawwash, Dana; Ocké, Marga C.; Berg, Christina; Forsum, Elisabet; Sonestedt, Emily; Wirfält, Elisabet; Åkesson, Agneta; Kolsteren, Patrick; Byrnes, Graham; De Keyzer, Willem; Van Camp, John; Slimani, Nadia; Cevallos, Myriam; Egger, Matthias; Huybrechts, Inge

2016-01-01

Background Concerns have been raised about the quality of reporting in nutritional epidemiology. Research reporting guidelines such as the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement can improve quality of reporting in observational studies. Herein, we propose recommendations for reporting nutritional epidemiology and dietary assessment research by extending the STROBE statement into Strengthening the Reporting of Observational Studies in Epidemiology—Nutritional Epidemiology (STROBE-nut). Methods and Findings Recommendations for the reporting of nutritional epidemiology and dietary assessment research were developed following a systematic and consultative process, coordinated by a multidisciplinary group of 21 experts. Consensus on reporting guidelines was reached through a three-round Delphi consultation process with 53 external experts. In total, 24 recommendations for nutritional epidemiology were added to the STROBE checklist. Conclusion When used appropriately, reporting guidelines for nutritional epidemiology can contribute to improve reporting of observational studies with a focus on diet and health. PMID:27270749

The Diabetes Surgery Summit consensus conference: recommendations for the evaluation and use of gastrointestinal surgery to treat type 2 diabetes mellitus.

PubMed

Rubino, Francesco; Kaplan, Lee M; Schauer, Philip R; Cummings, David E

2010-03-01

To develop guidelines for the use of gastrointestinal surgery to treat type 2 diabetes and to craft an agenda for further research. Increasing evidence demonstrates that bariatric surgery can dramatically ameliorate type 2 diabetes. Not surprisingly, gastrointestinal operations are now being used throughout the world to treat diabetes in association with obesity, and increasingly, for diabetes alone. However, the role for surgery in diabetes treatment is not clearly defined and there are neither clear guidelines for these practices nor sufficient plans for clinical trials to evaluate the risks and benefits of such "diabetes surgery." A multidisciplinary group of 50 voting delegates from around the world gathered in Rome, Italy for the first International Conference on Gastrointestinal Surgery to Treat Type 2 Diabetes--(the "Diabetes Surgery Summit"). During the meeting, available scientific evidence was examined and critiqued by the entire group to assess the strength of evidence and to draft consensus statements. Through an iterative process, draft statements were then serially discussed, debated, edited, reassessed, and finally presented for formal voting. After the Rome meeting, statements that achieved consensus were summarized and distributed to all voting delegates for further input and final approval. These statements were then formally critiqued by representatives of several sientific societies at the 1st World Congress on Interventional Therapies for T2DM (New York, Sept 2008). Input from this discussion was used to generate the current position statement. A Diabetes Surgery Summit (DSS) Position Statement consists of recommendations for clinical and research issues, as well as general concepts and definitions in diabetes surgery. The DSS recognizes the legitimacy of surgical approaches to treat diabetes in carefully selected patients. For example, gastric bypass was deemed a reasonable treatment option for patients with poorly controlled diabetes and a body mass index > or =30 kg/m. Clinical trials to investigate the exact role of surgery in patients with less severe obesity and diabetes are considered a priority. Furthermore, investigations on the mechanisms of surgical control of diabetes are strongly encouraged, as they may help advance the understanding of diabetes pathophysiology. The DSS consensus document embodies the foundations of "diabetes surgery," and represents a timely attempt by leading scholars to improve access to surgical options supported by sound evidence, while also preventing harm from inappropriate use of unproven procedures.

Endorsement of PRISMA statement and quality of systematic reviews and meta-analyses published in nursing journals: a cross-sectional study.

PubMed

Tam, Wilson W S; Lo, Kenneth K H; Khalechelvam, Parames

2017-02-07

Systematic reviews (SRs) often poorly report key information, thereby diminishing their usefulness. Previous studies evaluated published SRs and determined that they failed to meet explicit criteria or characteristics. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement was recommended as a reporting guideline for SR and meta-analysis (MA), but previous studies showed that adherence to the statement was not high for SRs published in different medical fields. Thus, the aims of this study are twofold: (1) to investigate the number of nursing journals that have required or recommended the use of the PRISMA statement for reporting SR, and (2) to examine the adherence of SRs and/or meta-analyses to the PRISMA statement published in nursing journals. A cross-sectional study. Nursing journals listed in the ISI journal citation report were divided into 2 groups based on the recommendation of PRISMA statement in their 'Instruction for Authors'. SRs and meta-analyses published in 2014 were searched in 3 databases. 37 SRs and meta-analyses were randomly selected in each group. The adherence of each item to the PRISMA was examined and summarised using descriptive statistics. The quality of the SRs was assessed by Assessing the Methodological Quality of Systematic Reviews. The differences between the 2 groups were compared using the Mann-Whitney U test. Out of 107 nursing journals, 30 (28.0%) recommended or required authors to follow the PRISMA statement when they submit SRs or meta-analyses. The median rates of adherence to the PRISMA statement for reviews published in journals with and without PRISMA endorsement were 64.9% (IQR: 17.6-92.3%) and 73.0% (IQR: 59.5-94.6%), respectively. No significant difference was observed in any of the items between the 2 groups. The median adherence of SRs and meta-analyses in nursing journals to PRISMA is low at 64.9% and 73.0%, respectively. Nonetheless, the adherence level of nursing journals to the PRISMA statement does not significantly vary whether they endorse or recommend such a guideline. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

49 CFR 1200.1 - Financial statements released by carriers.

Code of Federal Regulations, 2010 CFR

2010-10-01

..., except in reports to this Board, based on generally accepted accounting principles for which there is... 49 Transportation 9 2010-10-01 2010-10-01 false Financial statements released by carriers. 1200.1... TRANSPORTATION BOARD, DEPARTMENT OF TRANSPORTATION (CONTINUED) ACCOUNTS, RECORDS AND REPORTS GENERAL ACCOUNTING...

Northeast Corridor Improvement Project Electrification - New Haven, CT to Boston, MA : Draft Environmental Impact Statement/Report. Volume 3.

DOT National Transportation Integrated Search

1993-10-01

This document is the final environmental impact statement and final environmental impact report (FEIS/R) on the proposal by the National Railroad Passenger Corporation (Amtrak) to complete the electrification of the Northeast Corridor main line by ex...

Reports of Public Scoping Meetings for the Supplemental Environmental Impact Statement for the Designation of Dredged Material Disposal Sites in Eastern Long Island Sound

EPA Pesticide Factsheets

These reports provide summaries of the scoping meetings as part of the Supplemental Environmental Impact Statement (SEIS) process for the designation of dredged material disposal sites in Eastern Long Island Sound.

75 FR 26922 - Magnesium Metal From the Russian Federation: Preliminary Results of Antidumping Duty...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-13

... AVISMA calculated based on the amounts reported in AVISMA's 2008 fiscal-year audited consolidated financial statements prepared in accordance with International Financial Reporting Standards. For more... indirect selling expenses related to commercial activity in the United States. See also Statement of...

Does packaging with a calendar feature improve adherence to self-administered medication for long-term use? A systematic review.

PubMed

Zedler, Barbara K; Kakad, Priyanka; Colilla, Susan; Murrelle, Lenn; Shah, Nirav R

2011-01-01

The therapeutic benefit of self-administered medications for long-term use is limited by an average 50% nonadherence rate. Patient forgetfulness is a common factor in unintentional nonadherence. Unit-of-use packaging that incorporates a simple day-and-date feature (calendar packaging) is designed to improve adherence by prompting patients to maintain the prescribed dosing schedule. To review systematically, in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement, randomized controlled trial evidence of the adherence benefits and harms of calendar blister packaging (CBP) and calendar pill organizers (CPO) for self-administered, long-term medication use. Data sources included the MEDLINE and Web of Science and Cochrane Library databases from their inception to September 2010 and communication with researchers in the field. Key search terms included blister-calendar pack, blister pack, drug packaging, medication adherence, medication compliance, medication compliance devices, medication containers, medication organizers, multicompartment compliance aid, persistence, pill-box organizers, prescription refill, randomized controlled trials, and refill compliance. Selected studies had an English-language title; a randomized controlled design; medication packaged in CBP or CPO; a requirement of solid, oral medication self-administered daily for longer than 1 month in community-dwelling adults; and at least 1 quantitative outcome measure of adherence. Two reviewers extracted data independently on study design, sample size, type of intervention and control, and outcomes. Ten trials with a total of 1045 subjects met the inclusion criteria, and 9 also examined clinical outcomes (seizures, blood pressure, psychiatric symptoms) or health care resource utilization. Substantial heterogeneity among trials precluded meta-analysis. In 3 studies, calendar packaging was part of a multicomponent adherence intervention. Six of 10 trials reported higher adherence, but it was associated with clinically significant improvement in only 1 study: 50% decreased seizure frequency with a CPO-based, multicomponent intervention. No study reported sufficient information to examine conclusively potential harms related to calendar packaging. All trials had significant methodological limitations, such as inadequate randomization or blinding, or reported insufficient information regarding enrolled subjects and attrition, which resulted in a moderate-to-high risk of bias and, in 2 studies, unevaluable outcome data. Trials were generally short and sample sizes small, with heterogeneous adherence outcome measures. Calendar packaging, especially in combination with education and reminder strategies, may improve medication adherence. Methodological limitations preclude definitive conclusions about the effect size of adherence and clinical benefits or harms associated with CBP and CPO. High-quality trials of adequate size and duration are needed to assess the clinical effectiveness of such interventions. Copyright © 2011 Elsevier HS Journals, Inc. All rights reserved.

Effects of a Problem-Solving Intervention (COPE) on Quality of Life for Patients with Advanced Cancer on Clinical Trials and their Caregivers: Simultaneous Care Educational Intervention (SCEI): Linking Palliation and Clinical Trials

PubMed Central

Carducci, Michael; Loscalzo, Matthew J.; Linder, John; Greasby, Tamara; Beckett, Laurel A.

2011-01-01

Abstract Context Patients on investigational clinical trials and their caregivers experience poor quality of life (QOL), which declines as the disease progresses. Objective To examine the effect of a standardized cognitive–behavioral problem-solving educational intervention on the QOL of patients enrolled on investigational clinical trials and their caregivers. Design Prospective, multi-institution, randomized trial. QOL was measured repeatedly over 6 months. Participants Patients were simultaneously enrolled onto phase 1, 2, or 3 Institutional Review Board (IRB)-approved cancer clinical trials. Intervention Intervention arm dyads participated in three conjoint educational sessions during the first month, learning the COPE problem solving model. Nonintervention arm dyads received usual care. Outcome Measures Global QOL was measured by the City of Hope Quality of Life Instruments for Patients or Caregivers; problem solving skills were measured by the Social Problem Solving Inventory-Revised. Results The results are reported using the CONSORT statement. The analytic data set included 476 dyads including 1596 patient data points and 1576 care giver data points. Patient QOL showed no significant difference in the rate of change between the intervention and usual care arms (p = 0.70). Caregiver QOL scores in the intervention arm declined, but at less than half the rate in the control arm (p = 0.02). Conclusions The COPE intervention enabled the average caregiver to come much closer to stable QOL over the 6-month follow-up. Future studies should enroll subjects much earlier in the cancer illness trajectory, a common patient/caregiver theme. The maximum effect was seen in caregivers who completed the 6-month follow-up, suggesting that the impact may increase over time. PMID:21413846

The Medicare Cost Report and the limits of hospital accountability: improving financial accounting data.

PubMed

Kane, N M; Magnus, S A

2001-02-01

Health policy makers, legislators, providers, payers, and a broad range of other players in the health care market routinely seek information on hospital financial performance. Yet the data at their disposal are limited, especially since hospitals' audited financial statements--the "gold standard" in hospital financial reporting--are not publicly available in many states. As a result, the Medicare Cost Report (MCR), filed annually by most U.S. hospitals in order to receive payment for treating Medicare patients, has become the primary public source of hospital financial information. However, financial accounting elements in the MCR are unreliable, poorly defined, and lacking in critical detail. Comparative analyses of MCRs and matched, audited financial statements reveal long-standing problems with the MCR's data, including major differences in reported profits; variations in the reporting of both revenues and expenses; an absence of relevant details, such as charity care, bad debt, operating versus nonoperating income, and affiliate transactions; an inconsistent classification of changes in net assets; and a failure to provide cash flow statements. Because of these problems, MCR financial data give only a limited and often inaccurate picture of the financial position of hospitals. Audited financial statements provide a more complete perspective, enabling analysts to address important questions left unanswered by the MCR data. Regulatory action is needed to create a national database of financial information based upon audited statements.

The Harmonising Outcome Measures for Eczema (HOME) statement to assess clinical signs of atopic eczema in trials.

PubMed

Schmitt, Jochen; Spuls, Phyllis I; Thomas, Kim S; Simpson, Eric; Furue, Masutaka; Deckert, Stefanie; Dohil, Magdalene; Apfelbacher, Christian; Singh, Jasvinder A; Chalmers, Joanne; Williams, Hywel C

2014-10-01

The lack of core outcome sets for atopic eczema (AE) is a major obstacle for advancing evidence-based treatment. The global Harmonising Outcome Measures for Eczema (HOME) initiative has already defined clinical signs, symptoms, quality of life, and long-term control of flares as core outcome domains for AE trials. This article deals with the standardization of measurement instruments to assess clinical signs of AE. To resolve the current lack of standardization of the assessment of clinical signs of AE, we followed a structured process of systematic reviews and international consensus sessions to identify 1 core outcome measurement instrument for assessment of clinical signs in all future AE trials. Systematic reviews indicated that from 16 different instruments identified to assess clinical signs of AE, only the Eczema Area and Severity Index (EASI) and the objective Scoring Atopic Dermatitis (SCORAD) index were identified as extensively validated. The EASI has adequate validity, responsiveness, internal consistency, and intraobserver reliability. The objective SCORAD index has adequate validity, responsiveness, and interobserver reliability but unclear intraobserver reliability to measure clinical signs of AE. In an international consensus study, patients, physicians, nurses, methodologists, and pharmaceutical industry representatives agreed that the EASI is the preferred core instrument to measure clinical signs in all future AE trials. All stakeholders involved in designing, reporting, and using clinical trials on AE are asked to comply with this consensus to enable better evidence-based decision making, clearer scientific communication, and improved patient care. Copyright © 2014 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

Person-centred transition programme to empower adolescents with congenital heart disease in the transition to adulthood: a study protocol for a hybrid randomised controlled trial (STEPSTONES project)

PubMed Central

Acuña Mora, Mariela; Sparud-Lundin, Carina; Bratt, Ewa-Lena; Moons, Philip

2017-01-01

Introduction When a young person grows up, they evolve from an independent child to an empowered adult. If an individual has a chronic condition, this additional burden may hamper adequate development and independence. Transition programmes for young persons with chronic disorders aim to provide the necessary skills for self-management and participation in care. However, strong evidence on the effects of these interventions is lacking. Therefore, as part of the STEPSTONES project (Swedish Transition Effects Project Supporting Teenagers with chrONic mEdical conditionS), we propose a trial to assess the effectiveness of a structured, person-centred transition programme to empower adolescents with congenital heart disease in the transition to adulthood. Methods/design STEPSTONES will use a hybrid experimental design in which a randomised controlled trial is embedded in a longitudinal, observational study. It will be conducted in 4 paediatric cardiology centres in Sweden. 2 centres will be allocated to the randomised controlled trial group, assigning patients randomly to the intervention group (n=63) or the comparison group (n=63). The other 2 centres will form the intervention-naïve control group (n=63). The primary outcome is the level of patient empowerment, as measured by the Gothenburg Young Persons Empowerment Scale (GYPES). Ethics and dissemination The study has been approved by the Regional Ethical Board of Gothenburg, Sweden. Findings will be reported following the CONSORT statement and disseminated at international conferences and as published papers in peer-reviewed journals. Trial registration number NCT02675361; pre-results. PMID:28420661

Vasopressor use following traumatic injury: protocol for a systematic review

PubMed Central

Hylands, Mathieu; Toma, Augustin; Beaudoin, Nicolas; Frenette, Anne-Julie; D'Aragon, Frederick; Belley-Côté, Emilie; Hylander, Morten; Lauzier, François; Siemieniuk, Reed Alexander; Charbonney, Emmanuel; Kwong, Joey; Laake, Jon Henrik; Guyatt, Gordon; Vandvik, Per Olav; Rochwerg, Bram; Green, Robert; Ball, Ian; Scales, Damon; Murthy, Srinivas; Rizoli, Sandro; Asfar, Pierre; Lamontagne, François

2017-01-01

Introduction Worldwide, traumatic casualties are projected to exceed 8 million by year 2020. Haemorrhagic shock and brain injury are the leading causes of death following trauma. While intravenous fluids have traditionally been used to support organ perfusion in the setting of haemorrhage, recent investigations have suggested that restricting fluid therapy by tolerating more severe hypotension may improve survival. However, the safety of permissive hypotension remains uncertain, particularly among patients who have suffered a traumatic brain injury. Vasopressors preferentially vasoconstrict blood vessels that supply non-vital organs and capacitance vessels, thereby mobilising the unstressed blood volume. Used as fluid-sparing adjuncts, these drugs can complement resuscitative measures by correcting hypotension without diluting clotting factors or increasing the risk for tissue oedema. Methods and analysis We will identify randomised control trials comparing early resuscitation with vasopressors versus placebo or standard care in adults following traumatic injury. Data sources will include MEDLINE, EMBASE, CENTRAL, clinical trial registries and conference proceedings. Two reviewers will independently determine trial eligibility. For each included trial, we will conduct duplicate independent data extraction and risk of bias assessment. We will assess the overall quality of the data for each individual outcome using the GRADE approach. Ethics and dissemination We will report this review in accordance with the PRISMA statement. We will disseminate our findings at critical care and trauma conferences and through a publication in a peer-reviewed journal. We will also use this systematic review to create clinical guidelines (http://www.magicapp.org), which will be disseminated in a standalone publication. Trial registration number CRD42016033437. PMID:28246141

GASB 35 Implementation Guide: Questions and Answers for Public Colleges and Universities Using Business Type Activity (BTA) Reporting. A Supplement to GASB's Implementation Guide for Statement 34

ERIC Educational Resources Information Center

National Association of College and University Business Officers (NJ1), 2001

2001-01-01

This guide was prepared for public institution business officers as a supplement to the "Guide to Implementation of GASB Statement 54 on Basic Financial Statements--and Management's Discussion and Analysis--for State and Local Governments, published in April 2000 by the Governmental Accounting Standards Board (GASB) on GASB Statements 34 and 35.…

Internal Users and Uses of Financial Statements within the Federal Government

DTIC Science & Technology

2012-06-01

income statement, a statement of cash flows, and a statement of changes in stockholders’ equity. The uses and users of private-sector financial...financial reports to identify issues of risk and opportunities based upon 6 significant year-to-year changes, long term liabilities or cash position, or...for the first time (i.e., reconciling cash with the Treasury’s balance) and has constructed an effective audit response infrastructure “enabling the

13 CFR 307.14 - Revolving Loan Fund semi-annual report and Income and Expense Statement.

Code of Federal Regulations, 2013 CFR

2013-01-01

... RLF Plan to ensure effective use of the RLF as a strategic financing tool. (c) RLF Income and Expense... for administrative costs in a six-month (6) Reporting Period must submit to EDA a completed Income and Expense Statement (Form ED-209I or any successor form) for that Reporting Period in electronic format...

13 CFR 307.14 - Revolving Loan Fund semi-annual report and Income and Expense Statement.

Code of Federal Regulations, 2012 CFR

2012-01-01

... RLF Plan to ensure effective use of the RLF as a strategic financing tool. (c) RLF Income and Expense... for administrative costs in a six-month (6) Reporting Period must submit to EDA a completed Income and Expense Statement (Form ED-209I or any successor form) for that Reporting Period in electronic format...

13 CFR 307.14 - Revolving Loan Fund semi-annual report and Income and Expense Statement.

Code of Federal Regulations, 2014 CFR

2014-01-01

... RLF Plan to ensure effective use of the RLF as a strategic financing tool. (c) RLF Income and Expense... for administrative costs in a six-month (6) Reporting Period must submit to EDA a completed Income and Expense Statement (Form ED-209I or any successor form) for that Reporting Period in electronic format...

Methods and Processes of Developing the Strengthening the Reporting of Observational Studies in Epidemiology-Veterinary (STROBE-Vet) Statement.

PubMed

Sargeant, J M; O'Connor, A M; Dohoo, I R; Erb, H N; Cevallos, M; Egger, M; Ersbøll, A K; Martin, S W; Nielsen, L R; Pearl, D L; Pfeiffer, D U; Sanchez, J; Torrence, M E; Vigre, H; Waldner, C; Ward, M P

2016-12-01

Reporting of observational studies in veterinary research presents challenges that often are not addressed in published reporting guidelines. Our objective was to develop an extension of the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) statement that addresses unique reporting requirements for observational studies in veterinary medicine related to health, production, welfare, and food safety. We conducted a consensus meeting with 17 experts in Mississauga, Canada. Experts completed a premeeting survey about whether items in the STROBE statement should be modified or added to address unique issues related to observational studies in animal species with health, production, welfare, or food safety outcomes. During the meeting, each STROBE item was discussed to determine whether or not rewording was recommended, and whether additions were warranted. Anonymous voting was used to determine consensus. Six items required no modifications or additions. Modifications or additions were made to the STROBE items 1 (title and abstract), 3 (objectives), 5 (setting), 6 (participants), 7 (variables), 8 (data sources and measurement), 9 (bias), 10 (study size), 12 (statistical methods), 13 (participants), 14 (descriptive data), 15 (outcome data), 16 (main results), 17 (other analyses), 19 (limitations), and 22 (funding). The methods and processes used were similar to those used for other extensions of the STROBE statement. The use of this STROBE statement extension should improve reporting of observational studies in veterinary research by recognizing unique features of observational studies involving food-producing and companion animals, products of animal origin, aquaculture, and wildlife.

The SQUIRE (Standards for QUality Improvement Reporting Excellence) guidelines for quality improvement reporting: explanation and elaboration

PubMed Central

Ogrinc, G; Mooney, S E; Estrada, C; Foster, T; Goldmann, D; Hall, L W; Huizinga, M M; Liu, S K; Mills, P; Neily, J; Nelson, W; Pronovost, P J; Provost, L; Rubenstein, L V; Speroff, T; Splaine, M; Thomson, R; Tomolo, A M; Watts, B

2008-01-01

As the science of quality improvement in health care advances, the importance of sharing its accomplishments through the published literature increases. Current reporting of improvement work in health care varies widely in both content and quality. It is against this backdrop that a group of stakeholders from a variety of disciplines has created the Standards for QUality Improvement Reporting Excellence, which we refer to as the SQUIRE publication guidelines or SQUIRE statement. The SQUIRE statement consists of a checklist of 19 items that authors need to consider when writing articles that describe formal studies of quality improvement. Most of the items in the checklist are common to all scientific reporting, but virtually all of them have been modified to reflect the unique nature of medical improvement work. This “Explanation and Elaboration” document (E & E) is a companion to the SQUIRE statement. For each item in the SQUIRE guidelines the E & E document provides one or two examples from the published improvement literature, followed by an analysis of the ways in which the example expresses the intent of the guideline item. As with the E & E documents created to accompany other biomedical publication guidelines, the purpose of the SQUIRE E & E document is to assist authors along the path from completion of a quality improvement project to its publication. The SQUIRE statement itself, this E & E document, and additional information about reporting improvement work can be found at http://www.squire-statement.org. PMID:18836062

Evaluation of the Endorsement of the STrengthening the REporting of Genetic Association Studies (STREGA) Statement on the Reporting Quality of Published Genetic Association Studies

PubMed Central

Nedovic, Darko; Panic, Nikola; Pastorino, Roberta; Ricciardi, Walter; Boccia, Stefania

2016-01-01

The STrengthening the REporting of Genetic Association studies (STREGA) statement was based on the STrengthening the REporting of OBservational studies in Epidemiology (STROBE) statement, and it was published in 2009 in order to improve the reporting of genetic association (GA) studies. Our aim was to evaluate the impact of STREGA endorsement on the quality of reporting of GA studies published in journals in the field of genetics and heredity (GH). Quality of reporting was evaluated by assessing the adherence of papers to the STREGA checklist. After identifying the GH journals that endorsed STREGA in their instructions for authors, we randomly appraised papers published in 2013 from journals endorsing STREGA that published GA studies (Group A); in GH journals that never endorsed STREGA (Group B); in GH journals endorsing STREGA, but in the year preceding its endorsement (Group C); and in the same time period as Group C from GH journals that never endorsed STREGA (Group D). The STREGA statement was referenced in 29 (18.1%) of 160 GH journals, of which 18 (62.1%) journals published GA studies. Among the 18 journals endorsing STREGA, we found a significant increase in the overall adherence to the STREGA checklist over time (A vs C; P < 0.0001). Adherence to the STREGA checklist was significantly higher in journals endorsing STREGA compared to those that did not endorse the statement (A vs B; P = 0.04). No significant improvement was detected in the adherence to STREGA items in journals not endorsing STREGA over time (B vs D; P > 0.05). The endorsement of STREGA resulted in an increase in quality of reporting of GA studies over time, while no similar improvement was reported for journals that never endorsed STREGA. PMID:27349199

Oral treatments for fungal infections of the skin of the foot.

PubMed

Margarido, Leontina da Conceição

2014-01-01

About 15% of the world population have fungal infections of the feet (tinea pedis or athlete's foot). There are many clinical presentations of tinea pedis, and most commonly, tinea pedis is seen between the toes (interdigital) and on the soles, heels, and sides of the foot (plantar). Plantar tinea pedis is known as moccasin foot. Once acquired, the infection can spread to other sites including the nails, which can be a source of re-infection. Oral therapy is usually used for chronic conditions or when topical treatment has failed. To assess the effects of oral treatments for fungal infections of the skin of the foot (tinea pedis). For this update we searched the following databases to July 2012: the Cochrane Skin Group Specialized Register, CENTRAL in The Cochrane Library, MEDLINE (from 1946), EMBASE (from 1974), and CINAHL (from 1981). We checked the bibliographies of retrieved trials for further references to relevant trials, and we searched online trials registers. Randomized controlled trials of oral treatments in participants who have a clinically diagnosed tinea pedis, confirmed by microscopy and growth of dermatophytes (fungi) in culture. Two review authors independently undertook study selection, "Risk of bias" assessment, and data extraction. We included 15 trials, involving 1,438 participants. The 2 trials (71 participants) comparing terbinafine and griseofulvin produced a pooled risk ratio (RR) of 2.26 (95% confidence interval (CI) 1.49 to 3.44) in favors of terbinafine's ability to cure infection. No significant difference was detected between terbinafine and itraconazole, fluconazole and itraconazole, fluconazole and ketoconazole, or between griseofulvin and ketoconazole, although the trials were generally small. Two trials showed that terbinafine and itraconazole were effective compared with placebo: terbinafine (31 participants, RR 24.54, 95%CI 1.57 to 384.32) and itraconazole (72 participants, RR 6.67, 95%CI 2.17 to 20.48). All drugs reported adverse effects, with gastrointestinal effects most commonly reported. Ten of the trials were published over 15 years ago, and this is reflected by the poor reporting of information from which to make a clear "Risk of bias" assessment. Only one trial was at low risk of bias overall. The majority of the remaining trials were judged as "unclear" risk of bias because of the lack of clear statements with respect to methods of generating the randomization sequence and allocation concealment. More trials achieved blinding of participants and personnel than blinding of the outcome assessors, which was again poorly reported. The evidence suggests that terbinafine is more effective than griseofulvin; and terbinafine and itraconazole are more effective than no treatment. In order to produce more reliable data , a rigorous evaluation of different drug therapies needs to be undertaken with larger sample sizes to ensure they are large enough to show any real difference when two treatments are being compared. It is also important to continue to follow up and collect data , preferably for six months after the end of the intervention period, to establish whether or not the infection recurred.

Oral treatments for fungal infections of the skin of the foot.

PubMed

Bell-Syer, Sally E M; Khan, Sameena M; Torgerson, David J

2012-10-17

About 15% of the world population have fungal infections of the feet (tinea pedis or athlete's foot). There are many clinical presentations of tinea pedis, and most commonly, tinea pedis is seen between the toes (interdigital) and on the soles, heels, and sides of the foot (plantar). Plantar tinea pedis is known as moccasin foot. Once acquired, the infection can spread to other sites including the nails, which can be a source of re-infection. Oral therapy is usually used for chronic conditions or when topical treatment has failed. To assess the effects of oral treatments for fungal infections of the skin of the foot (tinea pedis). For this update we searched the following databases to July 2012: the Cochrane Skin Group Specialised Register, CENTRAL in The Cochrane Library, MEDLINE (from 1946), EMBASE (from 1974), and CINAHL (from 1981). We checked the bibliographies of retrieved trials for further references to relevant trials, and we searched online trials registers. Randomised controlled trials of oral treatments in participants who have a clinically diagnosed tinea pedis, confirmed by microscopy and growth of dermatophytes (fungi) in culture. Two review authors independently undertook study selection, 'Risk of bias' assessment, and data extraction. We included 15 trials, involving 1438 participants. The 2 trials (71 participants) comparing terbinafine and griseofulvin produced a pooled risk ratio (RR) of 2.26 (95% confidence interval (CI) 1.49 to 3.44) in favour of terbinafine's ability to cure infection. No significant difference was detected between terbinafine and itraconazole, fluconazole and itraconazole, fluconazole and ketoconazole, or between griseofulvin and ketoconazole, although the trials were generally small. Two trials showed that terbinafine and itraconazole were effective compared with placebo: terbinafine (31 participants, RR 24.54, 95% CI 1.57 to 384.32) and itraconazole (72 participants, RR 6.67, 95% CI 2.17 to 20.48). All drugs reported adverse effects, with gastrointestinal effects most commonly reported. Ten of the trials were published over 15 years ago, and this is reflected by the poor reporting of information from which to make a clear 'Risk of bias' assessment. Only one trial was at low risk of bias overall. The majority of the remaining trials were judged as 'unclear' risk of bias because of the lack of clear statements with respect to methods of generating the randomisation sequence and allocation concealment. More trials achieved blinding of participants and personnel than blinding of the outcome assessors, which was again poorly reported. The evidence suggests that terbinafine is more effective than griseofulvin, and terbinafine and itraconazole are more effective than no treatment. In order to produce more reliable data, a rigorous evaluation of different drug therapies needs to be undertaken with larger sample sizes to ensure they are large enough to show any real difference when two treatments are being compared. It is also important to continue to follow up and collect data, preferably for six months after the end of the intervention period, to establish whether or not the infection recurred.

Measuring financial performance: an overview of financial statements.

PubMed

Dalsted, N L

1995-07-01

Financial management has emerged as a critical component in the long-term viability of today's ranches and farms. Proper and timely financial reporting and analysis of financial statements are valuable tools that agricultural producers can use to monitor, coordinate, and plan their operational production and marketing schemes and strategies. A side note to preparation of financial statements. With the concerns over lender liability issues associated with statements either assisted with or prepared by a lending officer, agricultural producers will be responsible for preparing their own statements. The lending institutions may prepare their own statements in their assessment of the financial condition of a business and or individual, but, ultimately, the responsibility of financial statements is the borrower's. Some of the material presented in this article provides important input for use in such analytical programs as the National Cattlemen's Association, Integrated Resource Committees, and Standard Performance Analysis (SPA). SPA techniques and associated software have been or currently are under development for cow-calf, stocker, seedstock, and sheep enterprises. Critical to the analysis is having complete and correct financial statements. These analytical programs build on the financial statements. These analytical programs build on the financial statements as recommended by the FFSTF. Proper financial reporting is critical not only to a SPA assessment but also to the overall financial management of today's farms and ranches. Recognizing the importance of financial management in production agriculture is not enough, taking a proactive stance in one's financial plan is paramount to success. Failure to do so will only enhance the exit rates of producers from production agriculture.

Methodology Series Module 4: Clinical Trials.

PubMed

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.

Methodology Series Module 4: Clinical Trials

PubMed Central

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. PMID:27512184

Allergy-immunology practice parameters and strength of recommendation data: an evolutionary perspective.

PubMed

Park, Matthew H; Banks, Taylor A; Nelson, Michael R

2016-03-01

The practice parameters for allergy and immunology (A/I) are a valuable tool guiding practitioners' clinical practice. The A/I practice parameters have evolved over time in the context of evidence-based medicine milestones. To identify evolutionary trends in the character, scope, and evidence underlying recommendations in the A/I practice parameters. Practice parameters that have guided A/I from 1995 through 2014 were analyzed. Statements and recommendations with strength of recommendation categories A and B were considered to have a basis in evidence from controlled trials. Forty-three publications and updates covering 25 unique topics were identified. There was great variability in the number of recommendations made and the proportion of statements with controlled trial evidence. The mean number of recommendations made per practice parameter has decreased significantly, from 95.8 to a mean of 38.3. There also is a trend toward an increased proportion of recommendations based on controlled trial evidence in practice parameters with fewer recommendations, with a mean of 30.7% in practice parameters with at least 100 recommendations based on controlled trial evidence compared with 48.3% in practice parameters with 30 to 100 recommendations and 51.0% in those with fewer than 30 recommendations. The A/I practice parameters have evolved significantly over time. Encouragingly, greater controlled trial evidence is associated with updated practice parameters and a recent trend of more narrowly focused topics. These findings should only bolster and inspire confidence in the utility of the A/I practice parameters in assisting practitioners to navigate through the uncertainty that is intrinsic to medicine in making informed decisions with patients. Published by Elsevier Inc.

14 CFR 60.33 - Applications, logbooks, reports, and records: Fraud, falsification, or incorrect statements.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 14 Aeronautics and Space 2 2011-01-01 2011-01-01 false Applications, logbooks, reports, and records: Fraud, falsification, or incorrect statements. 60.33 Section 60.33 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AIRMEN FLIGHT SIMULATION TRAINING DEVICE...

14 CFR 60.33 - Applications, logbooks, reports, and records: Fraud, falsification, or incorrect statements.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 14 Aeronautics and Space 2 2013-01-01 2013-01-01 false Applications, logbooks, reports, and records: Fraud, falsification, or incorrect statements. 60.33 Section 60.33 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AIRMEN FLIGHT SIMULATION TRAINING DEVICE...