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.

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.

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

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.

Do the CONSORT and STRICTA Checklists Improve the Reporting Quality of Acupuncture and Moxibustion Randomized Controlled Trials Published in Chinese Journals? A Systematic Review and Analysis of Trends.

PubMed

Ma, Bin; Chen, Zhi-min; Xu, Jia-ke; Wang, Ya-nan; Chen, Kuang-yang; Ke, Fa-yong; Niu, Jun-qiang; Li, Li; Huang, Cheng-ben; Zheng, Jian-xun; Yang, Jia-Hui; Zhu, Qian-ge; Wang, Ya-ping

2016-01-01

We investigated whether there had been an improvement in the quality of reporting for randomised controlled trials of acupuncture and moxibustion published in Chinese journals. We compared the compliance rate for the quality of reporting following the publication of both the STRICTA and CONSORT recommendations in China. Four Chinese databases were searched for RCTs of acupuncture from January 1978 through to December 2012. The CONSORT and STRICTA checklists were used to assess the quality of reporting. Data were collected using a standardised form. All included RCTs were divided into three distinct time periods based on the time that CONSORT and STRICTA were introduced in China, respectively. Pearson's χ2 test and/or Fisher's exact test were used to assess differences in reporting among three groups. A total of 1978 RCTs were identified. Although the percentage of all the items has increased over time with the introduction of CONSORT and STRICTA in China, the actual compliance in several important methodological components, including sample size calculation (0% vs. 0% vs. 1.2%, for pre-CONSORT and pre-STRICTA, post-CONSORT but pre-STRICTA, and post-CONSORT and post-STRICTA, respectively), randomisation sequence generation (1.4% vs. 15% vs. 26.3%) and implementation (0% vs. 0% vs. 1.3%), allocation concealment (0% vs. 1.4% vs. 4.9%), and blinding (0% vs. 5.7% vs. 9.1%), remains low. Moreover, no RCTs have reported the setting and context of treatment and no descriptions of the participating acupuncturists have been provided thus far. Overall, the quality of the reporting of RCTs of acupuncture and moxibustion published in Chinese journals has improved since CONSORT and STRICTA were introduced in China, though the actual compliance rate of some important items were still low as of 2012. In the future, Chinese journals should enhance the adoption of the CONSORT and STRICTA statement to improve the reporting quality of the RCTs of acupuncture and moxibustion and to ensure the truth and reliability of the conclusions.

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.

Compliance with the CONSORT checklist in obstetric anaesthesia randomised controlled trials.

PubMed

Halpern, S H; Darani, R; Douglas, M J; Wight, W; Yee, J

2004-10-01

The Consolidated Standards for Reporting of Trials (CONSORT) checklist is an evidence-based approach to help improve the quality of reporting randomised controlled trials. The purpose of this study was to determine how closely randomised controlled trials in obstetric anaesthesia adhere to the CONSORT checklist. We retrieved all randomised controlled trials pertaining to the practice of obstetric anaesthesia and summarised in Obstetric Anesthesia Digest between March 2001 and December 2002 and compared the quality of reporting to the CONSORT checklist. The median number of correctly described CONSORT items was 65% (range 36% to 100%). Information pertaining to randomisation, blinding of the assessors, sample size calculation, reliability of measurements and reporting of the analysis were often omitted. It is difficult to determine the value and quality of many obstetric anaesthesia clinical trials because journal editors do not insist that this important information is made available to readers. Both clinicians and clinical researchers would benefit from uniform reporting of randomised trials in a manner that allows rapid data retrieval and easy assessment for relevance and quality.

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/

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

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.

A systematic review of orthopaedic manual therapy randomized clinical trials quality

PubMed Central

Riley, Sean P.; Swanson, Brian; Brismée, Jean-Michel; Sawyer, Steven F.

2016-01-01

Study Design: Systematic review and meta-analysis. Objectives: To conduct a systematic review and meta-analysis of randomized clinical trials (RCTs) in the orthopaedic manual therapy (OMT) literature from January 2010 to June 2014 in order to determine if the CONSORT checklist and Cochrane Risk of Bias (RoB) assessment tools: (1) are reliable; (2) have improved the reporting and decreased the risk of bias in RCTs in the OMT literature; (3) differ based on journal impact factor (JIF); and (4) scores are associated with each other. Background: The CONSORT statement is used to improve the accuracy of reporting within RCTs. The Cochrane RoB tool was designed to assess the risk of bias within RCTs. To date, no evaluation of the quality of reporting and risk of bias in OMT RCTs has been published. Methods: Relevant RCTs were identified by a literature review from January 2010 to June 2014. The identified RCTs were assessed by two individual reviewers utilizing the 2010 CONSORT checklist and the RoB tool. Agreement and a mean composite total score for each tool were attained in order to determine if the CONSORT and RoB tools were reliable and varied by year and impact factor. Results: A total of 72 RCTs in the OMT literature were identified. A number of categories within the CONSORT and RoB tools demonstrated prevalence-adjusted bias-adjusted kappa (PABAK) scores of less than 0.20 and from 0.20 to 0.40. The total CONSORT and RoB scores were correlated to each other (r = 0.73; 95% CI 0.60 to 0.82; p < 0.0001). There were no statistically significant differences in CONSORT or RoB scores by year. There was a statistically significant correlation between both CONSORT scores and JIF (r = 0.64, 95% CI 0.47 to 0.76; p < 0.0001), and between RoB scores and JIF (r = 0.42, 95% confidence interval 0.21–0.60; p < 0.001). There was not a statistically significant correlation between JIF and year of publication. Conclusion: Our findings suggest that the CONSORT and RoB have a number of items that are unclear and unreliable, and that the quality of reporting in OMT trials has not improved in recent years. Improvements in reporting are necessary to allow advances in OMT practice. Level of Evidence: 1A PMID:27956817

Endorsement of the CONSORT Statement by High-Impact Medical Journals in China: A Survey of Instructions for Authors and Published Papers

PubMed Central

Zhou, Qing-hui; Moher, David; Chen, Hong-yun; Wang, Fu-zhe; Ling, Chang-quan

2012-01-01

Background The CONSORT Statement is a reporting guideline for authors when reporting randomized controlled trials (RCTs). It offers a standard way for authors to prepare RCT reports. It has been endorsed by many high-impact medical journals and by international editorial groups. This study was conducted to assess the endorsement of the CONSORT Statement by high-impact medical journals in China by reviewing their instructions for authors. Methodology/Principal Findings A total of 200 medical journals were selected according to the Chinese Science and Technology Journal Citation Reports, 195 of which publish clinical research papers. Their instructions for authors were reviewed and all texts mentioning the CONSORT Statement or CONSORT extension papers were extracted. Any mention of the Uniform Requirements for Manuscripts Submitted to Biomedical Journals (URM) developed by the International Committee of Medical Journal Editors (ICMJE) or ‘clinical trial registration’ was also extracted. For journals endorsing the CONSORT Statement, their most recently published RCT reports were retrieved and evaluated to assess whether the journals have followed what the CONSORT Statement required. Out of the 195 medical journals publishing clinical research papers, only six (6/195, 3.08%) mentioned ‘CONSORT’ in their instructions for authors; out of the 200 medical journals surveyed, only 14 (14/200, 7.00%) mentioned ‘ICMJE’ or ‘URM’ in their instructions for authors, and another five journals stated in their instructions for authors that clinical trials should have trial registration numbers and that priority would be given to clinical trials which had been registered. Among the 62 RCT reports published in the six journals endorsing the CONSORT Statement, 20 (20/62, 32.26%) contained flow diagrams and only three (3/62, 4.84%) provided trial registration information. Conclusions/Significance Medical journals in China endorsing either the CONSORT Statement or the ICMJE's URM constituted a small percentage of the total; all of these journals used ambiguous language regarding what was expected of authors. PMID:22348017

A systematic review of randomized controlled trials and reviews in the management of ventral hernias.

PubMed

Holihan, Julie L; Nguyen, Duyen H; Flores-Gonzalez, Juan R; Alawadi, Zeinab M; Nguyen, Mylan T; Ko, Tien C; Kao, Lillian S; Liang, Mike K

2016-08-01

The literature supporting ventral hernia management is growing; however, it is unclear whether the quality of work is improving. We hypothesize that the quality of clinical ventral hernia research has improved over the past 2.5 decades. A review of MEDLINE, Scopus, and Cochrane databases was conducted for all ventral hernia studies from January 1, 1980 to May 1, 2015. Relevant abstracts were assigned a level according to the Oxford Center for Evidence-Based Medicine. Reviews, and meta-analyses were graded using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) Checklist and randomized controlled trials (RCTs) using the Consolidated Standards of Reporting Trials (CONSORT) checklist. Studies that did not fulfill at least 70% of the elements for the PRISMA (19/27) or CONSORT (26/37) checklists were considered to contain substantial methodological flaws. Of 12,431 citations, 1336 met criteria for quality evaluation. Level 1 studies were sparse (n = 104, 7.8%), and most were level 2 or 3 (n = 463, 34.7%) or 4 (n = 769, 57.6%). Of the level 1 studies, 37 (35.6%) were RCTs, 61(58.7%) were reviews and/or meta-analyses, and 6 (5.8%) were consensus statements. Most RCTs and reviews and/or meta-analyses contained substantial methodological flaws (75.7%, 75.8%). Critical areas of weakness in RCTs were explaining losses and exclusions after randomization and/or allocation and reporting determination of sample size. For reviews and/or meta-analyses, areas of weakness were presenting an electronic search strategy and providing an assessment of risk of bias before pooling data. Linear regressions of PRISMA and CONSORT scores demonstrated improvement over time (PRISMA slope 0.95, R(2) = 0.24; CONSORT slope 0.34, R(2) = 0.08). Although the quality of literature guiding ventral hernia management has improved over time, there is room for improvement. Copyright © 2016 Elsevier Inc. All rights reserved.

CONSORT Statement for Randomized Trials of Nonpharmacologic Treatments: A 2017 Update and a CONSORT Extension for Nonpharmacologic Trial Abstracts.

PubMed

Boutron, Isabelle; Altman, Douglas G; Moher, David; Schulz, Kenneth F; Ravaud, Philippe

2017-07-04

Incomplete and inadequate reporting is an avoidable waste that reduces the usefulness of research. The CONSORT (Consolidated Standards of Reporting Trials) Statement is an evidence-based reporting guideline that aims to improve research transparency and reduce waste. In 2008, the CONSORT Group developed an extension to the original statement that addressed methodological issues specific to trials of nonpharmacologic treatments (NPTs), such as surgery, rehabilitation, or psychotherapy. This article describes an update of that extension and presents an extension for reporting abstracts of NPT trials. To develop these materials, the authors reviewed pertinent literature published up to July 2016; surveyed authors of NPT trials; and conducted a consensus meeting with editors, trialists, and methodologists. Changes to the CONSORT Statement extension for NPT trials include wording modifications to improve readers' understanding and the addition of 3 new items. These items address whether and how adherence of participants to interventions is assessed or enhanced, description of attempts to limit bias if blinding is not possible, and specification of the delay between randomization and initiation of the intervention. The CONSORT extension for abstracts of NPT trials includes 2 new items that were not specified in the original CONSORT Statement for abstracts. The first addresses reporting of eligibility criteria for centers where the intervention is performed and for care providers. The second addresses reporting of important changes to the intervention versus what was planned. Both the updated CONSORT extension for NPT trials and the CONSORT extension for NPT trial abstracts should help authors, editors, and peer reviewers improve the transparency of NPT trial reports.

Reporting quality of randomised controlled trial abstracts among high-impact general medical journals: a review and analysis

PubMed Central

Hays, Meredith; Andrews, Mary; Wilson, Ramey; Callender, David; O'Malley, Patrick G; Douglas, Kevin

2016-01-01

Objective The aim of this study was to assess adherence to the Consolidated Standards of Reporting Trials (CONSORT) for Abstracts by five high-impact general medical journals and to assess whether the quality of reporting was homogeneous across these journals. Design This is a descriptive, cross-sectional study. Setting Randomised controlled trial (RCT) abstracts in five high-impact general medical journals. Participants We used up to 100 RCT abstracts published between 2011 and 2014 from each of the following journals: The New England Journal of Medicine (NEJM), the Annals of Internal Medicine (Annals IM), The Lancet, the British Medical Journal (The BMJ) and the Journal of the American Medical Association (JAMA). Main outcome The primary outcome was per cent overall adherence to the 19-item CONSORT for Abstracts checklist. Secondary outcomes included per cent adherence in checklist subcategories and assessing homogeneity of reporting quality across the individual journals. Results Search results yielded 466 abstracts, 3 of which were later excluded as they were not RCTs. Analysis was performed on 463 abstracts (97 from NEJM, 66 from Annals IM, 100 from The Lancet, 100 from The BMJ, 100 from JAMA). Analysis of all scored items showed an overall adherence of 67% (95% CI 66% to 68%) to the CONSORT for Abstracts checklist. The Lancet had the highest overall adherence rate (78%; 95% CI 76% to 80%), whereas NEJM had the lowest (55%; 95% CI 53% to 57%). Adherence rates to 8 of the checklist items differed by >25% between journals. Conclusions Among the five highest impact general medical journals, there is variable and incomplete adherence to the CONSORT for Abstracts reporting checklist of randomised trials, with substantial differences between individual journals. Lack of adherence to the CONSORT for Abstracts reporting checklist by high-impact medical journals impedes critical appraisal of important studies. We recommend diligent assessment of adherence to reporting guidelines by authors, reviewers and editors to promote transparency and unbiased reporting of abstracts. PMID:27470506

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 among high-impact general medical journals: a review and analysis.

PubMed

Hays, Meredith; Andrews, Mary; Wilson, Ramey; Callender, David; O'Malley, Patrick G; Douglas, Kevin

2016-07-28

The aim of this study was to assess adherence to the Consolidated Standards of Reporting Trials (CONSORT) for Abstracts by five high-impact general medical journals and to assess whether the quality of reporting was homogeneous across these journals. This is a descriptive, cross-sectional study. Randomised controlled trial (RCT) abstracts in five high-impact general medical journals. We used up to 100 RCT abstracts published between 2011 and 2014 from each of the following journals: The New England Journal of Medicine (NEJM), the Annals of Internal Medicine (Annals IM), The Lancet, the British Medical Journal (The BMJ) and the Journal of the American Medical Association (JAMA). The primary outcome was per cent overall adherence to the 19-item CONSORT for Abstracts checklist. Secondary outcomes included per cent adherence in checklist subcategories and assessing homogeneity of reporting quality across the individual journals. Search results yielded 466 abstracts, 3 of which were later excluded as they were not RCTs. Analysis was performed on 463 abstracts (97 from NEJM, 66 from Annals IM, 100 from The Lancet, 100 from The BMJ, 100 from JAMA). Analysis of all scored items showed an overall adherence of 67% (95% CI 66% to 68%) to the CONSORT for Abstracts checklist. The Lancet had the highest overall adherence rate (78%; 95% CI 76% to 80%), whereas NEJM had the lowest (55%; 95% CI 53% to 57%). Adherence rates to 8 of the checklist items differed by >25% between journals. Among the five highest impact general medical journals, there is variable and incomplete adherence to the CONSORT for Abstracts reporting checklist of randomised trials, with substantial differences between individual journals. Lack of adherence to the CONSORT for Abstracts reporting checklist by high-impact medical journals impedes critical appraisal of important studies. We recommend diligent assessment of adherence to reporting guidelines by authors, reviewers and editors to promote transparency and unbiased reporting of abstracts. 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/

Cars, CONSORT 2010, and clinical practice.

PubMed

Williams, Hywel C

2010-03-24

Just like you would not buy a car without key information such as service history, you would not "buy" a clinical trial report without key information such as concealment of allocation. Implementation of the updated CONSORT 2010 statement enables the reader to see exactly what was done in a trial, to whom and when. A fully "CONSORTed" trial report does not necessarily mean the trial is a good one, but at least the reader can make a judgement. Clear reporting is a pre-requisite for judgement of study quality. The CONSORT statement evolves as empirical research moves on. CONSORT 2010 is even clearer than before and includes some new items with a particular emphasis on selective reporting of outcomes. The challenge is for everyone to use it.

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.

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.

The Consolidated Standards of Reporting Trials (CONSORT) Statement applied to allergen-specific immunotherapy with inhalant allergens: a Global Allergy and Asthma European Network (GA(2)LEN) article.

PubMed

Bousquet, Philippe J; Calderón, Moisés A; Demoly, Pascal; Larenas, Désirée; Passalacqua, Giovanni; Bachert, Claus; Brozek, Jan; Canonica, G Walter; Casale, Thomas; Fonseca, Joao; Dahl, Ronald; Durham, Stephen R; Merk, Hans; Worm, Margitta; Wahn, Ulrich; Zuberbier, Torsten; Schünemann, Holger J; Bousquet, Jean

2011-01-01

Randomized trials provide evidence to inform treatment decisions. The Consolidated Standards of Reporting Trials (CONSORT) Statement is a set of recommendations for the reporting of trials. We sought to assess the quality of reporting allergen-specific immunotherapy trials according to CONSORT criteria. The reporting of the procedure, randomization, dropouts, strict conduct of intention-to-treat (ITT) analysis, and sample size calculation according to CONSORT were assessed in the 46 subcutaneous and 48 sublingual immunotherapy (SLIT) blind, placebo-controlled randomized trials published between 1996 and 2009 in English. One subcutaneous immunotherapy (2.2%) and 3 SLIT (6.6%) trials met CONSORT Statement criteria. These were used for the registration of sublingual tablets to the European Medicines Agency. In subcutaneous immunotherapy, 16 (35%) studies reported a CONSORT flow chart, and 12 (26%) provided a description of dropouts. Adequate randomization was reported in 9 (35%) studies, and incomplete randomization was reported in 15 (33%). Power analysis was reported in 15 (33%) studies. In SLIT, 20 (42%) studies reported a CONSORT flow chart, and 16 (32%) a description of dropouts. ITT analysis was carried out in 1 (2.2%) SLIT study, and a modified ITT analysis was used in 1 (2.2%) subcutaneous immunotherapy study and 2 (4.4%) SLIT studies. Adequate randomization was reported in 6 (12%) studies, and incomplete randomization was reported in 16 (32%). Power analysis was reported in 15 (27%) studies. As in other areas of medicine, the quality of reporting of most immunotherapy trials is low, and only 4.2% of SLIT randomized controlled trials met all of the criteria of the CONSORT Statement. Use of the CONSORT criteria should be encouraged. Copyright © 2010 American Academy of Allergy, Asthma & Immunology. Published by Mosby, Inc. All rights reserved.

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.

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.

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

PubMed

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

2015-11-01

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

The 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.

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.

[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.

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.

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

PubMed

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

2013-10-22

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

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.

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.

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.

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.

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.

Active implementation strategy of CONSORT adherence by a dental specialty journal improved randomized clinical trial reporting.

PubMed

Pandis, Nikolaos; Shamseer, Larissa; Kokich, Vincent G; Fleming, Padhraig S; Moher, David

2014-09-01

To describe a novel CONsolidated Standards of Reporting Trials (CONSORT) adherence strategy implemented by the American Journal of Orthodontics and Dentofacial Orthopedics (AJO-DO) and to report its impact on the completeness of reporting of published trials. The AJO-DO CONSORT adherence strategy, initiated in June 2011, involves active assessment of randomized clinical trial (RCT) reporting during the editorial process. The completeness of reporting CONSORT items was compared between trials submitted and published during the implementation period (July 2011 to September 2013) and trials published between August 2007 and July 2009. Of the 42 RCTs submitted (July 2011 to September 2013), 23 were considered for publication and assessed for completeness of reporting, seven of which were eventually published. For all published RCTs between 2007 and 2009 (n = 20), completeness of reporting by CONSORT item ranged from 0% to 100% (Median = 40%, interquartile range = 60%). All published trials in 2011-2013, reported 33 of 37 CONSORT (sub) items. Four CONSORT 2010 checklist items remained problematic even after implementation of the adherence strategy: changes to methods (3b), changes to outcomes (6b) after the trial commenced, interim analysis (7b), and trial stopping (14b), which are typically only reported when applicable. Trials published following implementation of the AJO-DO CONSORT adherence strategy completely reported more CONSORT items than those published or submitted previously. Copyright © 2014 Elsevier Inc. All rights reserved.

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.

Reporting quality and risk of bias in randomised trials in health professions education.

PubMed

Horsley, Tanya; Galipeau, James; Petkovic, Jennifer; Zeiter, Jeanie; Hamstra, Stanley J; Cook, David A

2017-01-01

Complete reporting of research is essential to enable consumers to accurately appraise, interpret and apply findings. Quality appraisal checklists are giving way to tools that judge the risk for bias. We sought to determine the prevalence of these complementary aspects of research reports (completeness of reporting and perceived risk for bias) of randomised studies in health professions education. We searched bibliographic databases for randomised studies of health professions education. We appraised two cohorts representing different time periods (2008-2010 and 2014, respectively) and worked in duplicate to apply the CONSORT guidelines and Cochrane Risk of Bias tool. We explored differences between time periods using independent-samples t-tests or the chi-squared test, as appropriate. We systematically identified 180 randomised studies (2008-2010, n = 150; 2014, n = 30). Frequencies of reporting of CONSORT elements within full-text reports were highly variable and most elements were reported in fewer than 50% of studies. We found a statistically significant difference in the CONSORT reporting index (maximum score: 500) between the 2008-2010 (mean ± standard deviation [SD]: 242.7 ± 55.6) and 2014 (mean ± SD: 311.6 ± 53.2) cohorts (p < 0.001). High or unclear risk for bias was most common for allocation concealment (157, 87%) and blinding of participants (147, 82%), personnel (152, 84%) and outcome assessors (112, 62%). Most risk for bias elements were judged to be unclear (range: 51-84%). Risk for bias elements significantly improved over time for blinding of participants (p = 0.007), incomplete data (p < 0.001) and the presence of other sources of bias (p < 0.001). Reports of randomised studies in health professions education frequently omit elements recommended by the CONSORT statement. Most reports were assessed as having a high or unclear risk for bias. Greater attention to how studies are reported at study outset and in manuscript preparation could improve levels of complete transparent reporting. © 2016 John Wiley & Sons Ltd and The Association for the Study of Medical Education.

Assessment of the quality of harms reporting in non-randomised studies and randomised controlled studies of topiramate for the treatment of epilepsy using CONSORT criteria.

PubMed

Carmichael, Katie; Nolan, Sarah J; Weston, Jennifer; Tudur Smith, Catrin; Marson, Anthony G

2015-08-01

Treatment decisions should be informed by high quality evidence of both the potential benefit and harms of treatment alternatives. Randomised controlled trials (RCTs) provide the best evidence regarding benefits; however information relating to serious, rare and long-term harms is usually available only from non-randomised studies (NRSs). The aim of this study was to use a checklist based on the CONSORT (Consolidating Standards for Reporting Trials) extension for harms recommendations to assess the quality of reporting of harms data in both NRSs and RCTs of antiepileptic drugs, using studies of topiramate as an example. Seventy-eight studies were included from an online search of seven databases. Harms data was extracted from each study using a 25-point checklist. The mean number of items met was 11.5 (SD 2.96) per study. Commercially funded studies met on average 12.7 items and non-commercially funded studies met 10.08 (p value < 0.001). RCTs met on average 13.0 items and NRSs met 10.8 (p = 0.001). Multi-centre studies and commercially funded studies met significantly more items than single centre and non-commercially funded studies respectively. There was no significant difference in the mean number of items met by studies that had included adult vs. child participants, or studies published pre- vs. post-CONSORT extension for harms in 2004. Reporting of harms is significantly better in RCTs than in NRSs of TPM, but is suboptimal overall and has not improved since the publication of CONSORT extension for harms in 2004. There is a need to improve the reporting of harms in order to better inform treatment decisions. Copyright © 2015 Elsevier B.V. All rights reserved.

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

PubMed

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

2017-04-01

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

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.

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.

Relation of completeness of reporting of health research to journals’ endorsement of reporting guidelines: systematic review

PubMed Central

Stevens, Adrienne; Shamseer, Larissa; Weinstein, Erica; Yazdi, Fatemeh; Turner, Lucy; Thielman, Justin; Altman, Douglas G; Hirst, Allison; Hoey, John; Palepu, Anita; Schulz, Kenneth F

2014-01-01

Objective To assess whether the completeness of reporting of health research is related to journals’ endorsement of reporting guidelines. Design Systematic review. Data sources Reporting guidelines from a published systematic review and the EQUATOR Network (October 2011). Studies assessing the completeness of reporting by using an included reporting guideline (termed “evaluations”) (1990 to October 2011; addendum searches in January 2012) from searches of either Medline, Embase, and the Cochrane Methodology Register or Scopus, depending on reporting guideline name. Study selection English language reporting guidelines that provided explicit guidance for reporting, described the guidance development process, and indicated use of a consensus development process were included. The CONSORT statement was excluded, as evaluations of adherence to CONSORT had previously been reviewed. English or French language evaluations of included reporting guidelines were eligible if they assessed the completeness of reporting of studies as a primary intent and those included studies enabled the comparisons of interest (that is, after versus before journal endorsement and/or endorsing versus non-endorsing journals). Data extraction Potentially eligible evaluations of included guidelines were screened initially by title and abstract and then as full text reports. If eligibility was unclear, authors of evaluations were contacted; journals’ websites were consulted for endorsement information where needed. The completeness of reporting of reporting guidelines was analyzed in relation to endorsement by item and, where consistent with the authors’ analysis, a mean summed score. Results 101 reporting guidelines were included. Of 15 249 records retrieved from the search for evaluations, 26 evaluations that assessed completeness of reporting in relation to endorsement for nine reporting guidelines were identified. Of those, 13 evaluations assessing seven reporting guidelines (BMJ economic checklist, CONSORT for harms, PRISMA, QUOROM, STARD, STRICTA, and STROBE) could be analyzed. Reporting guideline items were assessed by few evaluations. Conclusions The completeness of reporting of only nine of 101 health research reporting guidelines (excluding CONSORT) has been evaluated in relation to journals’ endorsement. Items from seven reporting guidelines were quantitatively analyzed, by few evaluations each. Insufficient evidence exists to determine the relation between journals’ endorsement of reporting guidelines and the completeness of reporting of published health research reports. Journal editors and researchers should consider collaborative prospectively designed, controlled studies to provide more robust evidence. Systematic review registration Not registered; no known register currently accepts protocols for methodology systematic reviews. PMID:24965222

Relation of completeness of reporting of health research to journals' endorsement of reporting guidelines: systematic review.

PubMed

Stevens, Adrienne; Shamseer, Larissa; Weinstein, Erica; Yazdi, Fatemeh; Turner, Lucy; Thielman, Justin; Altman, Douglas G; Hirst, Allison; Hoey, John; Palepu, Anita; Schulz, Kenneth F; Moher, David

2014-06-25

To assess whether the completeness of reporting of health research is related to journals' endorsement of reporting guidelines. Systematic review. Reporting guidelines from a published systematic review and the EQUATOR Network (October 2011). Studies assessing the completeness of reporting by using an included reporting guideline (termed "evaluations") (1990 to October 2011; addendum searches in January 2012) from searches of either Medline, Embase, and the Cochrane Methodology Register or Scopus, depending on reporting guideline name. English language reporting guidelines that provided explicit guidance for reporting, described the guidance development process, and indicated use of a consensus development process were included. The CONSORT statement was excluded, as evaluations of adherence to CONSORT had previously been reviewed. English or French language evaluations of included reporting guidelines were eligible if they assessed the completeness of reporting of studies as a primary intent and those included studies enabled the comparisons of interest (that is, after versus before journal endorsement and/or endorsing versus non-endorsing journals). Potentially eligible evaluations of included guidelines were screened initially by title and abstract and then as full text reports. If eligibility was unclear, authors of evaluations were contacted; journals' websites were consulted for endorsement information where needed. The completeness of reporting of reporting guidelines was analyzed in relation to endorsement by item and, where consistent with the authors' analysis, a mean summed score. 101 reporting guidelines were included. Of 15,249 records retrieved from the search for evaluations, 26 evaluations that assessed completeness of reporting in relation to endorsement for nine reporting guidelines were identified. Of those, 13 evaluations assessing seven reporting guidelines (BMJ economic checklist, CONSORT for harms, PRISMA, QUOROM, STARD, STRICTA, and STROBE) could be analyzed. Reporting guideline items were assessed by few evaluations. The completeness of reporting of only nine of 101 health research reporting guidelines (excluding CONSORT) has been evaluated in relation to journals' endorsement. Items from seven reporting guidelines were quantitatively analyzed, by few evaluations each. Insufficient evidence exists to determine the relation between journals' endorsement of reporting guidelines and the completeness of reporting of published health research reports. Journal editors and researchers should consider collaborative prospectively designed, controlled studies to provide more robust evidence. Not registered; no known register currently accepts protocols for methodology systematic reviews. © Stevens et al 2014.

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.

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.

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

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

PubMed

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

2018-03-01

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

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

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

PubMed

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

2015-07-01

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

Quality of reporting in infertility journals.

PubMed

Glujovsky, Demian; Boggino, Carolina; Riestra, Barbara; Coscia, Andrea; Sueldo, Carlos E; Ciapponi, Agustín

2015-01-01

To evaluate whether fertility and top gynecology journals indexed in PubMed require the use of reporting guidelines and to identify the percentage of randomized controlled trials (RCTs) published in 2013 that were written following CONSORT guidelines in the top four fertility journals (by their highest impact factor). Cross-sectional study evaluating instructions for authors and RCTs published in fertility journals. Academic institution. None. None. Proportion of instruction-for-authors documents that suggested or required the use of reporting guidelines, and proportion of RCTs published in 2013 that accomplished the CONSORT checklist. In 47% (16/34) of the journals one or more reporting guidelines were mentioned in the instructions for authors' documents. PRISMA and CONSORT were the most commonly mentioned reporting guidelines. None of the analyzed RCTs completed the 25 items of CONSORT guideline. Sequence generation or allocation concealment was not described in 69% of the studies. One-third of the journals did not publish a flowchart, 72% did not show relative and absolute size-effect measures, and 42% did not use measures of imprecision. In the summaries, 42% did not discuss the limitations of the study and 78% did not mention the generalizability of the results. Less than half of the analyzed peer-reviewed journals request the authors to use reporting guidelines. Nevertheless, among the top fertility and gynecology journals, reporting guidelines are widely mentioned. Overall, accomplishment of CONSORT items was suboptimal. Editorial boards, reviewers, and authors should join efforts to improve the quality of reporting. Copyright © 2015 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

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

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.

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.

Research Reporting Guidelines in Dentistry: A Survey of Editors.

PubMed

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

2017-01-01

The use of reporting guidelines has an important role in the development of health research, improving the quality and precision of the publications. This study evaluated how dental journals use reporting guidelines. All editors of dental journals registered on the 2013 Journal Citation Reports list (n=81) were invited to participate. The data were collected by a self-reported web-based questionnaire. Information about the profile of journal/editor and on the use of reporting guidelines by journals was gathered. Information/recommendations about the use of reporting guidelines were collected from the websites of all journals. Data were descriptively analyzed and frequencies were summarized. Thirty-four (42%) editors completed the questionnaire. Most journals are members of Committee on Publication Ethics (64.7%) and/or follow the International Committee of Medical Journal Editors recommendations (20.6%), while 26.5% are not members of any editorial group. Most editors are unfamiliar with the EQUATOR Network (55.9%), do not work full time (85.3%) and 88.2% have some income/payment. Most of them received educational training for this position (55.9%). The CONSORT Statement was endorsed by 61.8% of journals. Information from websites showed that 44.4% journals do not recommend any reporting guideline, 51.9% mention CONSORT Statement in the website and 28.4% only recommend the use of CONSORT Statement. There is clearly room for improving the use of reporting guidelines in dental journals. Broadening the understanding and the endorsement/adherence/implementation of reporting guidelines by journals may promote quality and transparence of published dental research.

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.

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.

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

Assessment of the Reporting Quality of Placebo-controlled Randomized Trials on the Treatment of Type 2 Diabetes With Traditional Chinese Medicine in Mainland China: A PRISMA-Compliant Systematic Review.

PubMed

Zhao, Xiyan; Zhen, Zhong; Guo, Jing; Zhao, Tianyu; Ye, Ru; Guo, Yu; Chen, Hongdong; Lian, Fengmei; Tong, Xiaolin

2016-01-01

Placebo-controlled randomized trials are often used to evaluate the absolute effect of new treatments and are considered gold standard for clinical trials. No studies, however, have yet been conducted evaluating the reporting quality of placebo-controlled randomized trials. The current study aims to assess the reporting quality of placebo-controlled randomized trials on treatment of diabetes with Traditional Chinese Medicine (TCM) in Mainland China and to provide recommendations for improvements.China National Knowledge Infrastructure database, Wanfang database, China Biology Medicine database, and VIP database were searched for placebo-controlled randomized trials on treatment of diabetes with TCM. Review, animal experiment, and randomized controlled trials without placebo control were excluded. According to Consolidated Standards of Reporting Trials (CONSORT) 2010 checklists items, each item was given a yes or no depending on whether it was reported or not.A total of 68 articles were included. The reporting percentage in each article ranged from 24.3% to 73%, and 30.9% articles reported more than 50% of the items. Seven of the 37 items were reported more than 90% of the items, whereas 7 items were not mentioned at all. The average reporting for "title and abstract," "introduction," "methods," "results," "discussion," and "other information" was 43.4%, 78.7%, 40.1%, 49.9%, 71.1%, and 17.2%, respectively. The percentage of each section had increased after 2010. In addition, the reporting of multiple study centers, funding, placebo species, informed consent forms, and ethical approvals were 14.7%, 50%, 36.85%, 33.8%, and 4.4%, respectively.Although a scoring system was created according to the CONSORT 2010 checklist, it was not designed as an assessment tool. According to CONSORT 2010, the reporting quality of placebo-controlled randomized trials on the treatment of diabetes with TCM improved after 2010. Future improvements, however, are still needed, particularly in methods sections.

Methodological reporting of randomized trials in five leading Chinese nursing journals.

PubMed

Shi, Chunhu; Tian, Jinhui; Ren, Dan; Wei, Hongli; Zhang, Lihuan; Wang, Quan; Yang, Kehu

2014-01-01

Randomized controlled trials (RCTs) are not always well reported, especially in terms of their methodological descriptions. This study aimed to investigate the adherence of methodological reporting complying with CONSORT and explore associated trial level variables in the Chinese nursing care field. In June 2012, we identified RCTs published in five leading Chinese nursing journals and included trials with details of randomized methods. The quality of methodological reporting was measured through the methods section of the CONSORT checklist and the overall CONSORT methodological items score was calculated and expressed as a percentage. Meanwhile, we hypothesized that some general and methodological characteristics were associated with reporting quality and conducted a regression with these data to explore the correlation. The descriptive and regression statistics were calculated via SPSS 13.0. In total, 680 RCTs were included. The overall CONSORT methodological items score was 6.34 ± 0.97 (Mean ± SD). No RCT reported descriptions and changes in "trial design," changes in "outcomes" and "implementation," or descriptions of the similarity of interventions for "blinding." Poor reporting was found in detailing the "settings of participants" (13.1%), "type of randomization sequence generation" (1.8%), calculation methods of "sample size" (0.4%), explanation of any interim analyses and stopping guidelines for "sample size" (0.3%), "allocation concealment mechanism" (0.3%), additional analyses in "statistical methods" (2.1%), and targeted subjects and methods of "blinding" (5.9%). More than 50% of trials described randomization sequence generation, the eligibility criteria of "participants," "interventions," and definitions of the "outcomes" and "statistical methods." The regression analysis found that publication year and ITT analysis were weakly associated with CONSORT score. The completeness of methodological reporting of RCTs in the Chinese nursing care field is poor, especially with regard to the reporting of trial design, changes in outcomes, sample size calculation, allocation concealment, blinding, and statistical methods.

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.

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.

Methodological Reporting of Randomized Trials in Five Leading Chinese Nursing Journals

PubMed Central

Shi, Chunhu; Tian, Jinhui; Ren, Dan; Wei, Hongli; Zhang, Lihuan; Wang, Quan; Yang, Kehu

2014-01-01

Background Randomized controlled trials (RCTs) are not always well reported, especially in terms of their methodological descriptions. This study aimed to investigate the adherence of methodological reporting complying with CONSORT and explore associated trial level variables in the Chinese nursing care field. Methods In June 2012, we identified RCTs published in five leading Chinese nursing journals and included trials with details of randomized methods. The quality of methodological reporting was measured through the methods section of the CONSORT checklist and the overall CONSORT methodological items score was calculated and expressed as a percentage. Meanwhile, we hypothesized that some general and methodological characteristics were associated with reporting quality and conducted a regression with these data to explore the correlation. The descriptive and regression statistics were calculated via SPSS 13.0. Results In total, 680 RCTs were included. The overall CONSORT methodological items score was 6.34±0.97 (Mean ± SD). No RCT reported descriptions and changes in “trial design,” changes in “outcomes” and “implementation,” or descriptions of the similarity of interventions for “blinding.” Poor reporting was found in detailing the “settings of participants” (13.1%), “type of randomization sequence generation” (1.8%), calculation methods of “sample size” (0.4%), explanation of any interim analyses and stopping guidelines for “sample size” (0.3%), “allocation concealment mechanism” (0.3%), additional analyses in “statistical methods” (2.1%), and targeted subjects and methods of “blinding” (5.9%). More than 50% of trials described randomization sequence generation, the eligibility criteria of “participants,” “interventions,” and definitions of the “outcomes” and “statistical methods.” The regression analysis found that publication year and ITT analysis were weakly associated with CONSORT score. Conclusions The completeness of methodological reporting of RCTs in the Chinese nursing care field is poor, especially with regard to the reporting of trial design, changes in outcomes, sample size calculation, allocation concealment, blinding, and statistical methods. PMID:25415382

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

PubMed

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

2014-03-01

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

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®.

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.

Evaluating the effectiveness of peer-based intervention in managing type I diabetes mellitus among children and adolescents: A systematic review

PubMed Central

Kazemi, Sepideh; Parvizy, Soroor; Atlasi, Rasha; Baradaran, Hamid R

2016-01-01

Background: Type 1 diabetes is one of the chronic metabolic disorders among children and adolescents. Peers are also important units in diabetes management through adolescence. This study aimed to evaluate the effectiveness of peer-based intervention in managing type 1 diabetes mellitus among children and adolescents. Methods: Searching articles published prior to December 2013 in PubMed, Web of Science, Cochrane library, Science Direct, Google scholar, CINAHL and Scopus, we found 8,548 publications. The first reviewer critically appraised the retrieved articles, using the CONSORT and the TREND checklists and then the second-assessor checked them. All abstracts were screened, and only eight full text articles remained for evaluation based on inclusion criteria Results: Eight studies, including five randomized controlled trials, one controlled trial, and two pre-post trials were critically appraised based on CONSORT and the TREND checklists. The outcomes of these studies were as follows: knowledge (three studies), attitude (two studies), performance (one study), clinical parameters— exclusively HbA1c—(four studies), and psychosocial parameters—such as quality of life, coping, self-care, selfconfidence, satisfaction with the perceived social support, social skills, and diabetes-related conflicts Conclusion: The findings of this systematic review revealed that peer-based interventions could help to manage diabetes. While there is a lack of professional or family-based interventions and education, peers can be involved in the process of patient education. As there are few studies in the area of peer-based diabetes management, conducting further interventional studies with robust methodology is highly recommended. PMID:28210607

Engaging parents to increase youth physical activity a systematic review.

PubMed

O'Connor, Teresia M; Jago, Russell; Baranowski, Tom

2009-08-01

Parents are often involved in interventions to engage youth in physical activity, but it is not clear which methods for involving parents are effective. A systematic review was conducted of interventions with physical activity and parental components among healthy youth to identify how best to involve parents in physical activity interventions for children. Identified intervention studies were reviewed in 2008 for study design, description of family components, and physical activity outcomes. The quality of reporting was assessed using the CONSORT checklist for reporting on trials of nonpharmacologic treatments. The literature search identified 1227 articles, 35 of which met review criteria. Five of the 14 RCTs met > or =70% of CONSORT checklist items. Five general procedures for involving parents were identified: (1) face-to-face educational programs or parent training, (2) family participatory exercise programs, (3) telephone communication, (4) organized activities, and (5) educational materials sent home. Lack of uniformity in reporting trials, multiple pilot studies, and varied measurements of physical activity outcomes prohibited systematic conclusions. Interventions with educational or training programs during family visits or via telephone communication with parents appear to offer some promise. There is little evidence for effectiveness of family involvement methods in programs for promoting physical activity in children, because of the heterogeneity of study design, study quality, and outcome measures used. There is a need to build an evidence base of more-predictive models of child physical activity that include parent and child mediating variables and procedures that can effect changes in these variables for future family-based physical activity interventions.

Evaluating the effectiveness of peer-based intervention in managing type I diabetes mellitus among children and adolescents: A systematic review.

PubMed

Kazemi, Sepideh; Parvizy, Soroor; Atlasi, Rasha; Baradaran, Hamid R

2016-01-01

Background: Type 1 diabetes is one of the chronic metabolic disorders among children and adolescents. Peers are also important units in diabetes management through adolescence. This study aimed to evaluate the effectiveness of peer-based intervention in managing type 1 diabetes mellitus among children and adolescents. Methods: Searching articles published prior to December 2013 in PubMed, Web of Science, Cochrane library, Science Direct, Google scholar, CINAHL and Scopus, we found 8,548 publications. The first reviewer critically appraised the retrieved articles, using the CONSORT and the TREND checklists and then the second-assessor checked them. All abstracts were screened, and only eight full text articles remained for evaluation based on inclusion criteria Results: Eight studies, including five randomized controlled trials, one controlled trial, and two pre-post trials were critically appraised based on CONSORT and the TREND checklists. The outcomes of these studies were as follows: knowledge (three studies), attitude (two studies), performance (one study), clinical parameters- exclusively HbA1c-(four studies), and psychosocial parameters-such as quality of life, coping, self-care, selfconfidence, satisfaction with the perceived social support, social skills, and diabetes-related conflicts Conclusion: The findings of this systematic review revealed that peer-based interventions could help to manage diabetes. While there is a lack of professional or family-based interventions and education, peers can be involved in the process of patient education. As there are few studies in the area of peer-based diabetes management, conducting further interventional studies with robust methodology is highly recommended.

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.

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.

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.

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

SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials

PubMed Central

Tetzlaff, Jennifer M; Gøtzsche, Peter C; Altman, Douglas G; Mann, Howard; Berlin, Jesse A; Dickersin, Kay; Hróbjartsson, Asbjørn; Schulz, Kenneth F; Parulekar, Wendy R; Krleža-Jerić, Karmela; Laupacis, Andreas; Moher, David

2013-01-01

High quality protocols facilitate proper conduct, reporting, and external review of clinical trials. However, the completeness of trial protocols is often inadequate. To help improve the content and quality of protocols, an international group of stakeholders developed the SPIRIT 2013 Statement (Standard Protocol Items: Recommendations for Interventional Trials). The SPIRIT Statement provides guidance in the form of a checklist of recommended items to include in a clinical trial protocol. This SPIRIT 2013 Explanation and Elaboration paper provides important information to promote full understanding of the checklist recommendations. For each checklist item, we provide a rationale and detailed description; a model example from an actual protocol; and relevant references supporting its importance. We strongly recommend that this explanatory paper be used in conjunction with the SPIRIT Statement. A website of resources is also available (www.spirit-statement.org). The SPIRIT 2013 Explanation and Elaboration paper, together with the Statement, should help with the drafting of trial protocols. Complete documentation of key trial elements can facilitate transparency and protocol review for the benefit of all stakeholders. PMID:23303884

SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials.

PubMed

Chan, An-Wen; Tetzlaff, Jennifer M; Gøtzsche, Peter C; Altman, Douglas G; Mann, Howard; Berlin, Jesse A; Dickersin, Kay; Hróbjartsson, Asbjørn; Schulz, Kenneth F; Parulekar, Wendy R; Krleza-Jeric, Karmela; Laupacis, Andreas; Moher, David

2013-01-08

High quality protocols facilitate proper conduct, reporting, and external review of clinical trials. However, the completeness of trial protocols is often inadequate. To help improve the content and quality of protocols, an international group of stakeholders developed the SPIRIT 2013 Statement (Standard Protocol Items: Recommendations for Interventional Trials). The SPIRIT Statement provides guidance in the form of a checklist of recommended items to include in a clinical trial protocol. This SPIRIT 2013 Explanation and Elaboration paper provides important information to promote full understanding of the checklist recommendations. For each checklist item, we provide a rationale and detailed description; a model example from an actual protocol; and relevant references supporting its importance. We strongly recommend that this explanatory paper be used in conjunction with the SPIRIT Statement. A website of resources is also available (www.spirit-statement.org). The SPIRIT 2013 Explanation and Elaboration paper, together with the Statement, should help with the drafting of trial protocols. Complete documentation of key trial elements can facilitate transparency and protocol review for the benefit of all stakeholders.

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.

Quality of reporting of trial abstracts needs to be improved: using the CONSORT for abstracts to assess the four leading Chinese medical journals of traditional Chinese medicine.

PubMed

Wang, Ling; Li, Yulin; Li, Jing; Zhang, Mingming; Xu, Lin; Yuan, Wenming; Wang, Gang; Hopewell, Sally

2010-07-08

Due to language limitations, the abstract of journal article may be the only way for people of non-Chinese speaking countries to know about trials in traditional Chinese medicine (TCM). However, little is known about the reporting quality of these trial abstracts. Our study is to assess the reporting quality of abstracts of randomized controlled trials (RCT) published in four leading Chinese medical journals of TCM, and to identify any differences in reporting between the Chinese and English version of the same abstract publication. Two reviewers hand-searched the Chinese Journal of Integrated Traditional and Western Medicine, the Chinese Journal of Integrative Medicine, the China Journal of Chinese Materia Medica and the Chinese Acupuncture & Moxibustion for all abstracts of RCTs published between 2006 and 2007. Two reviewers independently assessed the reporting quality of the Chinese and English version of all eligible abstracts based on a modified version of the CONSORT for reporting randomised trials in journal and conference abstracts (CONSORT for abstracts). We identified a total of 345 RCTs of TCM with both a Chinese and English abstract. More than half of Chinese abstracts reported details of the trial participants (68%; 234/345), control group intervention (52%; 179/345), the number of participants randomized (73%; 253/345) and benefits when interpreting the trial results (55%; 190/345). Reporting of methodological quality or key features of trial design and trial results were poor; only 2% (7/345) included details of the trial design, 3% (11/345) defined the primary outcome, 5% (17/345) described the methods of random sequence generation, and only 4% (13/345) reported the number of participants analyzed. No abstracts provided details on allocation concealment and trial registration. The percentage agreement in reporting (between the Chinese and English version of the same abstract) ranged from 84% to 100% across individual checklist item. The reporting quality of abstracts of RCTs published in these four TCM journals needs to be improved. Since none of the four journals adopted CONSORT for Abstracts, we hope that the introduction and adoption of CONSORT for Abstracts by TCM journals will lead to an improvement in reporting quality.

Quality of reporting of trial abstracts needs to be improved: using the CONSORT for abstracts to assess the four leading Chinese medical journals of traditional Chinese medicine

PubMed Central

2010-01-01

Background Due to language limitations, the abstract of journal article may be the only way for people of non-Chinese speaking countries to know about trials in traditional Chinese medicine (TCM). However, little is known about the reporting quality of these trial abstracts. Our study is to assess the reporting quality of abstracts of randomized controlled trials (RCT) published in four leading Chinese medical journals of TCM, and to identify any differences in reporting between the Chinese and English version of the same abstract publication. Method Two reviewers hand-searched the Chinese Journal of Integrated Traditional and Western Medicine, the Chinese Journal of Integrative Medicine, the China Journal of Chinese Materia Medica and the Chinese Acupuncture & Moxibustion for all abstracts of RCTs published between 2006 and 2007. Two reviewers independently assessed the reporting quality of the Chinese and English version of all eligible abstracts based on a modified version of the CONSORT for reporting randomised trials in journal and conference abstracts (CONSORT for abstracts). Results We identified a total of 345 RCTs of TCM with both a Chinese and English abstract. More than half of Chinese abstracts reported details of the trial participants (68%; 234/345), control group intervention (52%; 179/345), the number of participants randomized (73%; 253/345) and benefits when interpreting the trial results (55%; 190/345). Reporting of methodological quality or key features of trial design and trial results were poor; only 2% (7/345) included details of the trial design, 3% (11/345) defined the primary outcome, 5% (17/345) described the methods of random sequence generation, and only 4% (13/345) reported the number of participants analyzed. No abstracts provided details on allocation concealment and trial registration. The percentage agreement in reporting (between the Chinese and English version of the same abstract) ranged from 84% to 100% across individual checklist item. Conclusion The reporting quality of abstracts of RCTs published in these four TCM journals needs to be improved. Since none of the four journals adopted CONSORT for Abstracts, we hope that the introduction and adoption of CONSORT for Abstracts by TCM journals will lead to an improvement in reporting quality. PMID:20615225

A CONSORT analysis of randomised controlled trials for the treatment of invasive aspergillosis.

PubMed

Jones, Brian L; Richardson, Malcolm D; Ingram, Patricia M; Agrawal, Samir G

2017-08-01

There is no assessment of the reporting quality of antifungal randomized, controlled trials (RCT), upon which guidelines for the treatment of invasive aspergillosis (IA) in patients with hematological malignancy are based. Trial reports were identified through Trip, Cochrane, Medline, and Embase database searches. Report quality was assessed using the 25-item CONSORT checklist and a rating scale of 1 (strongly disagree) to 4 (strongly agree). The primary endpoint was quality as assessed by mean group-scores among papers published at the time of the most recent IA treatment guidelines. Seven RCTs were identified for analysis. Overall mean group-score for all seven papers was 2.44 (out of a total of four). There were significant differences between publications regarding overall reporting quality (P < .001) and specifically for the Methods and Results (P = .004 and P = .010, respectively), which best reflect data quality. The Cornely trial report achieved the highest mean group-score overall (3.15 ± 0.93; 95% CI, 2.82, 3.47), as well as for Methods (3.36) and Results (3.40). Mean group scores also showed that it was of significantly higher overall quality than the other six publications (P-value range; .012 to <.001), and of higher quality for Methods than five publications (P-value range; .013 to <.001). Incorporating this CONSORT analysis into the evidence-based grading systems in North American (IDSA), European (ECIL and ESCMID) IA guidelines could alter the value placed on these RCTs, thereby impacting on clinical recommendations. © The Author 2016. Published by Oxford University Press on behalf of The International Society for Human and Animal Mycology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Express Authorization Questions and Answers about What is Generally the Content of a Program Revision Application?

EPA Pesticide Factsheets

Frequently asked questions about express authorization with answers organized into five categories: attorney general's statement, statutory checklist, rule checklists, program description, and state initiated regulatory changes.

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.

Selenium intake and metabolic syndrome: A systematic review.

PubMed

Retondario, Anabelle; Fernandes, Ricardo; Rockenbach, Gabriele; Alves, Mariane de Almeida; Bricarello, Liliana Paula; Trindade, Erasmo Benicio Santos de Moraes; Vasconcelos, Francisco de Assis Guedes de

2018-03-02

Metabolic syndrome is a multi-causal disease. Its treatment includes lifestyle changes with a focus on weight loss. This systematic review assessed the association between Selenium intake and metabolic syndrome. Data were collected mainly from four databases: PubMed, CENTRAL (Cochrane), Scopus and Web of Knowledge. Keywords related to metabolic syndrome, selenium, as well as metabolic syndrome features were searched. This review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) Statement. A systematic review protocol was registered at PROSPERO (n. 42016046321). Two reviewers independently screened 2957 abstracts. Six studies were included to perform data extraction with standardized spreadsheets. The risk of bias was assessed by using specific tools according to the design of the relevant studies. An assessment was carried out based on the appropriateness of the study reports accordingly to STROBE and the CONSORT-based checklist for each study design. Three studies found no association between Selenium intake and metabolic syndrome; two of them found an inverse association; and one study found a direct association between Selenium intake and metabolic syndrome. One study also showed an inverse association between Selenium intake and the prevalence of high waist circumference, high diastolic blood pressure, and hyperglycaemia in women. Overall, based on the argumentation and results of this study, it is possible to conclude that Selenium intake and metabolic syndrome are not clearly associated in adults and elderly. Copyright © 2018 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

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.

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.

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.

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.

A retrospective survey of research design and statistical analyses in selected Chinese medical journals in 1998 and 2008.

PubMed

Jin, Zhichao; Yu, Danghui; Zhang, Luoman; Meng, Hong; Lu, Jian; Gao, Qingbin; Cao, Yang; Ma, Xiuqiang; Wu, Cheng; He, Qian; Wang, Rui; He, Jia

2010-05-25

High quality clinical research not only requires advanced professional knowledge, but also needs sound study design and correct statistical analyses. The number of clinical research articles published in Chinese medical journals has increased immensely in the past decade, but study design quality and statistical analyses have remained suboptimal. The aim of this investigation was to gather evidence on the quality of study design and statistical analyses in clinical researches conducted in China for the first decade of the new millennium. Ten (10) leading Chinese medical journals were selected and all original articles published in 1998 (N = 1,335) and 2008 (N = 1,578) were thoroughly categorized and reviewed. A well-defined and validated checklist on study design, statistical analyses, results presentation, and interpretation was used for review and evaluation. Main outcomes were the frequencies of different types of study design, error/defect proportion in design and statistical analyses, and implementation of CONSORT in randomized clinical trials. From 1998 to 2008: The error/defect proportion in statistical analyses decreased significantly ( = 12.03, p<0.001), 59.8% (545/1,335) in 1998 compared to 52.2% (664/1,578) in 2008. The overall error/defect proportion of study design also decreased ( = 21.22, p<0.001), 50.9% (680/1,335) compared to 42.40% (669/1,578). In 2008, design with randomized clinical trials remained low in single digit (3.8%, 60/1,578) with two-third showed poor results reporting (defects in 44 papers, 73.3%). Nearly half of the published studies were retrospective in nature, 49.3% (658/1,335) in 1998 compared to 48.2% (761/1,578) in 2008. Decreases in defect proportions were observed in both results presentation ( = 93.26, p<0.001), 92.7% (945/1,019) compared to 78.2% (1023/1,309) and interpretation ( = 27.26, p<0.001), 9.7% (99/1,019) compared to 4.3% (56/1,309), some serious ones persisted. Chinese medical research seems to have made significant progress regarding statistical analyses, but there remains ample room for improvement regarding study designs. Retrospective clinical studies are the most often used design, whereas randomized clinical trials are rare and often show methodological weaknesses. Urgent implementation of the CONSORT statement is imperative.

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.

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

PubMed

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

2015-01-01

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

Evidence-based dentistry: a model for clinical practice.

PubMed

Faggion, Clóvis M; Tu, Yu-Kang

2007-06-01

Making decisions in dentistry should be based on the best evidence available. The objective of this study was to demonstrate a practical procedure and model that clinicians can use to apply the results of well-conducted studies to patient care by critically appraising the evidence with checklists and letter grade scales. To demonstrate application of this model for critically appraising the quality of research evidence, a hypothetical case involving an adult male with chronic periodontitis is used as an example. To determine the best clinical approach for this patient, a four-step, evidence-based model is demonstrated, consisting of the following: definition of a research question using the PICO format, search and selection of relevant literature, critical appraisal of identified research reports using checklists, and the application of evidence. In this model, the quality of research evidence was assessed quantitatively based on different levels of quality that are assigned letter grades of A, B, and C by evaluating the studies against the QUOROM (Quality of Reporting Meta-Analyses) and CONSORT (Consolidated Standards of Reporting Trials) checklists in a tabular format. For this hypothetical periodontics case, application of the model identified the best available evidence for clinical decision making, i.e., one randomized controlled trial and one systematic review of randomized controlled trials. Both studies showed similar answers for the research question. The use of a letter grade scale allowed an objective analysis of the quality of evidence. A checklist-driven model that assesses and applies evidence to dental practice may substantially improve dentists' decision making skill.

PIM-Check: development of an international prescription-screening checklist designed by a Delphi method for internal medicine patients.

PubMed

Desnoyer, Aude; Blanc, Anne-Laure; Pourcher, Valérie; Besson, Marie; Fonzo-Christe, Caroline; Desmeules, Jules; Perrier, Arnaud; Bonnabry, Pascal; Samer, Caroline; Guignard, Bertrand

2017-07-31

Potentially inappropriate medication (PIM) occurs frequently and is a well-known risk factor for adverse drug events, but its incidence is underestimated in internal medicine. The objective of this study was to develop an electronic prescription-screening checklist to assist residents and young healthcare professionals in PIM detection. Five-step study involving selection of medical domains, literature review and 17 semistructured interviews, a two-round Delphi survey, a forward/back-translation process and an electronic tool development. 22 University and general hospitals from Canada, Belgium, France and Switzerland. 40 physicians and 25 clinical pharmacists were involved in the study.Agreement with the checklist statements and their usefulness for healthcare professional training were evaluated using two 6-point Likert scales (ranging from 0 to 5). Agreement and usefulness ratings were defined as: >65% of the experts giving the statement a rating of 4 or 5, during the first Delphi-round and >75% during the second. 166 statements were generated during the first two steps. Mean agreement and usefulness ratings were 4.32/5 (95% CI 4.28 to 4.36) and 4.11/5 (4.07 to 4.15), respectively, during the first Delphi-round and 4.53/5 (4.51 to 4.56) and 4.36/5 (4.33 to 4.39) during the second (p<0.001). The final checklist includes 160 statements in 17 medical domains and 56 pathologies. An algorithm of approximately 31 000 lines was developed including comorbidities and medications variables to create the electronic tool. PIM-Check is the first electronic prescription-screening checklist designed to detect PIM in internal medicine. It is intended to help young healthcare professionals in their clinical practice to detect PIM, to reduce medication errors and to improve patient safety. © 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.

PIM-Check: development of an international prescription-screening checklist designed by a Delphi method for internal medicine patients

PubMed Central

Desnoyer, Aude; Blanc, Anne-Laure; Pourcher, Valérie; Besson, Marie; Fonzo-Christe, Caroline; Desmeules, Jules; Perrier, Arnaud; Bonnabry, Pascal; Samer, Caroline; Guignard, Bertrand

2017-01-01

Objectives Potentially inappropriate medication (PIM) occurs frequently and is a well-known risk factor for adverse drug events, but its incidence is underestimated in internal medicine. The objective of this study was to develop an electronic prescription-screening checklist to assist residents and young healthcare professionals in PIM detection. Design Five-step study involving selection of medical domains, literature review and 17 semistructured interviews, a two-round Delphi survey, a forward/back-translation process and an electronic tool development. Setting 22 University and general hospitals from Canada, Belgium, France and Switzerland. Participants 40 physicians and 25 clinical pharmacists were involved in the study. Agreement with the checklist statements and their usefulness for healthcare professional training were evaluated using two 6-point Likert scales (ranging from 0 to 5). Primary and secondary outcome measures Agreement and usefulness ratings were defined as: >65% of the experts giving the statement a rating of 4 or 5, during the first Delphi-round and >75% during the second. Results 166 statements were generated during the first two steps. Mean agreement and usefulness ratings were 4.32/5 (95% CI 4.28 to 4.36) and 4.11/5 (4.07 to 4.15), respectively, during the first Delphi-round and 4.53/5 (4.51 to 4.56) and 4.36/5 (4.33 to 4.39) during the second (p<0.001). The final checklist includes 160 statements in 17 medical domains and 56 pathologies. An algorithm of approximately 31 000 lines was developed including comorbidities and medications variables to create the electronic tool. Conclusion PIM-Check is the first electronic prescription-screening checklist designed to detect PIM in internal medicine. It is intended to help young healthcare professionals in their clinical practice to detect PIM, to reduce medication errors and to improve patient safety. PMID:28760793

The "Trouble Shooting" Checklist for School-Based Settings (Manual).

ERIC Educational Resources Information Center

Manning, Brad A.

The "Trouble Shooting Checklist" (TSC) is a diagnostic and predictive instrument designed to aid educational change agents, faculty, and administrators in estimating the effects of particular variables on an institution's potential for successfully adopting innovations. The TSC consists of 100 descriptive statements that are broken down into seven…

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.

Review and critical appraisal of studies mapping from quality of life or clinical measures to EQ-5D: an online database and application of the MAPS statement.

PubMed

Dakin, Helen; Abel, Lucy; Burns, Richéal; Yang, Yaling

2018-02-12

The Health Economics Research Centre (HERC) Database of Mapping Studies was established in 2013, based on a systematic review of studies developing mapping algorithms predicting EQ-5D. The Mapping onto Preference-based measures reporting Standards (MAPS) statement was published in 2015 to improve reporting of mapping studies. We aimed to update the systematic review and assess the extent to which recently-published studies mapping condition-specific quality of life or clinical measures to the EQ-5D follow the guidelines published in the MAPS Reporting Statement. A published systematic review was updated using the original inclusion criteria to include studies published by December 2016. We included studies reporting novel algorithms mapping from any clinical measure or patient-reported quality of life measure to either the EQ-5D-3L or EQ-5D-5L. Titles and abstracts of all identified studies and the full text of papers published in 2016 were assessed against the MAPS checklist. The systematic review identified 144 mapping studies reporting 190 algorithms mapping from 110 different source instruments to EQ-5D. Of the 17 studies published in 2016, nine (53%) had titles that followed the MAPS statement guidance, although only two (12%) had abstracts that fully addressed all MAPS items. When the full text of these papers was assessed against the complete MAPS checklist, only two studies (12%) were found to fulfil or partly fulfil all criteria. Of the 141 papers (across all years) that included abstracts, the items on the MAPS statement checklist that were fulfilled by the largest number of studies comprised having a structured abstract (95%) and describing target instruments (91%) and source instruments (88%). The number of published mapping studies continues to increase. Our updated database provides a convenient way to identify mapping studies for use in cost-utility analysis. Most recent studies do not fully address all items on the MAPS checklist.

Reporting Quality of Social and Psychological Intervention Trials: A Systematic Review of Reporting Guidelines and Trial Publications

PubMed Central

Grant, Sean P.; Mayo-Wilson, Evan; Melendez-Torres, G. J.; Montgomery, Paul

2013-01-01

Background Previous reviews show that reporting guidelines have improved the quality of trial reports in medicine, yet existing guidelines may not be fully suited for social and psychological intervention trials. Objective/Design We conducted a two-part study that reviewed (1) reporting guidelines for and (2) the reporting quality of social and psychological intervention trials. Data Sources (1) To identify reporting guidelines, we systematically searched multiple electronic databases and reporting guideline registries. (2) To identify trials, we hand-searched 40 journals with the 10 highest impact factors in clinical psychology, criminology, education, and social work. Eligibility (1) Reporting guidelines consisted of articles introducing a checklist of reporting standards relevant to social and psychological intervention trials. (2) Trials reported randomised experiments of complex interventions with psychological, social, or health outcomes. Results (1) We identified 19 reporting guidelines that yielded 147 reporting standards relevant to social and psychological interventions. Social and behavioural science guidelines included 89 standards not found in CONSORT guidelines. However, CONSORT guidelines used more recommended techniques for development and dissemination compared to other guidelines. (2) Our review of trials (n = 239) revealed that many standards were poorly reported, such as identification as a randomised trial in titles (20% reported the information) and abstracts (55%); information about blinding (15%), sequence generation (23%), and allocation concealment (17%); and details about actual delivery of experimental (43%) and control interventions (34%), participant uptake (25%), and service environment (28%). Only 11 of 40 journals referenced reporting guidelines in “Instructions to Authors.” Conclusion Existing reporting guidelines have important limitations in content, development, and/or dissemination. Important details are routinely missing from trial publications; most leading journals in social and behavioural sciences do not ask authors to follow reporting standards. Findings demonstrate a need to develop a CONSORT extension with updated standards for social and psychological intervention trials. PMID:23734256

Quality of reporting in abstracts of randomized controlled trials published in leading journals of periodontology and implant dentistry: a survey.

PubMed

Faggion, Clovis Mariano; Giannakopoulos, Nikolaos Nikitas

2012-10-01

Most readers, reviewers, and editors rely on abstracts to decide whether to assess the full text of an article. A research abstract should, therefore, be as informative as possible. The standard of reporting in abstracts of randomized controlled trials (RCTs) in periodontology and implant dentistry has not yet been assessed. The objectives of this review are: 1) to assess the quality of reporting in abstracts of RCTs in periodontology and implant dentistry, and 2) to investigate changes in the quality of reporting by comparing samples from different periods. The authors searched the PubMed electronic database, independently and in duplicate, for abstracts of RCTs published in seven leading journals of periodontology and implant dentistry from 2005 to 2007 and from 2009 to 2011. The quality of reporting in selected abstracts with reference to the CONSORT (Consolidated Standards of Reporting Trials) for Abstracts checklist published in January 2008 was assessed independently and in duplicate. Cohen κ statistic was used to determine the extent of agreement of the reviewers. Pearson χ(2) test and/or Fisher exact test were used to assess differences in reporting in the two samples. Level of significance was set at P <0.05. Three hundred ninety-two abstracts are included in this review. Three items (intervention, objective, and conclusions) were almost fully reported in both samples. In contrast, other items (randomization, trial registration, and funding) were never reported. There were significant changes in reporting for only two items, trial design and title (items better reported in the pre- and post-CONSORT samples, respectively). Most topics, however, were similarly poorly reported in both samples of abstracts. The quality of reporting in abstracts of RCTs in periodontology and implant dentistry can be improved. Authors should follow the CONSORT for Abstracts guidelines, and journal editors should promote clear rules to improve authors' adherence to these guidelines.

Draft Environmental Impact Statement, West Bank Hurricane Protection Levee, Jefferson Parish, Louisiana.

DTIC Science & Technology

1984-02-01

Checklist of Predominant Plants . .......... . . 9-35 9.4 Checklist of Predominant Mammals .......... 9-41 9o5 Checklist of Predominant Birds... plant species and contains many preferred foods for wildlife (U. S. Army Corps of Engineers, 1982). Estimates of net primary production for fresh marshes...in Louisi na baE.zd on the measured productivity of selected plants is 2,200 g/m /yr (Gosselink et al., 1977; Boyd, 1969). Bahr and Hebrard (1976

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.

Reporting Guidelines and Checklists Improve the Reliability and Rigor of Research Reports.

PubMed

Abbott, J Haxby

2016-03-01

The Journal of Orthopaedic & Sports Physical Therapy (JOSPT) requires the use of robust research reporting guidelines for all research report submissions, including the newly adopted RECORD (REporting of studies Conducted using Observational Routinely-collected health Data) statement. We remind authors submitting research to JOSPT to identify the appropriate guideline and checklist for their study design, and to submit a completely and accurately completed checklist with their manuscript. J Orthop Sports Phys Ther 2016;46(3):130. doi:10.2519/jospt.2016.0105.

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.

Reporting Guidelines for Music-based Interventions

PubMed Central

Robb, Sheri L.; Burns, Debra S.; Carpenter, Janet S.

2013-01-01

Music-based interventions are used to address a variety of problems experienced by individuals across the developmental lifespan (infants to elderly adults). In order to improve the transparency and specificity of reporting music-based interventions, a set of specific reporting guidelines is recommended. Recommendations pertain to reporting seven different components of music-based interventions including intervention theory, intervention content, intervention delivery schedule, interventionist, treatment fidelity, setting, and unit of delivery. Recommendations are intended to support CONSORT and TREND statements for transparent reporting of interventions while taking into account the variety, complexity, and uniqueness of music-based interventions. PMID:23646227

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.

75 FR 54524 - Defense Federal Acquisition Regulation Supplement; Guidance on Personal Services (DFARS Case 2009...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-08

... parts 211 and 237 are being amended to (1) require that statements of work or performance work statements clearly distinguish between Government employees and contractor employees and (2) ensure that... Department, including several checklists currently used. This interim rule adopts best practices and...

The quality of reporting of randomized controlled trials of traditional Chinese medicine: a survey of 13 randomly selected journals from mainland China.

PubMed

Wang, Gang; Mao, Bing; Xiong, Ze-Yu; Fan, Tao; Chen, Xiao-Dong; Wang, Lei; Liu, Guan-Jian; Liu, Jia; Guo, Jia; Chang, Jing; Wu, Tai-Xiang; Li, Ting-Qian

2007-07-01

The number of randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) is increasing. However, there have been few systematic assessments of the quality of reporting of these trials. This study was undertaken to evaluate the quality of reporting of RCTs in TCM journals published in mainland China from 1999 to 2004. Thirteen TCM journals were randomly selected by stratified sampling of the approximately 100 TCM journals published in mainland China. All issues of the selected journals published from 1999 to 2004 were hand-searched according to guidelines from the Cochrane Centre. All reviewers underwent training in the evaluation of RCTs at the Chinese Centre of Evidence-based Medicine. A comprehensive quality assessment of each RCT was completed using a modified version of the Consolidated Standards of Reporting Trials (CONSORT) checklist (total of 30 items) and the Jadad scale. Disagreements were resolved by consensus. Seven thousand four hundred twenty-two RCTs were identified. The proportion of published RCTs relative to all types of published clinical trials increased significantly over the period studied, from 18.6% in 1999 to 35.9% in 2004 (P < 0.001). The mean (SD) Jadad score was 1.03 (0.61) overall. One RCT had a Jadad score of 5 points; 14 had a score of 4 points; and 102 had a score of 3 points. The mean (SD) Jadad score was 0.85 (0.53) in 1999 (746 RCTs) and 1.20 (0.62) in 2004 (1634 RCTs). Across all trials, 39.4% of the items on the modified CONSORT checklist were reported, which was equivalent to 11.82 (5.78) of the 30 items. Some important methodologic components of RCTs were incompletely reported, such as sample-size calculation (reported in 1.1% of RCTs), randomization sequence (7.9%), allocation concealment (0.3 %), implementation of the random-allocation sequence (0%), and analysis of intention to treat (0%). The findings of this study indicate that the quality of reporting of RCTs of TCM has improved, but remains poor.

Quality of randomised controlled trials in medical education reported between 2012 and 2013: a systematic review protocol.

PubMed

Tolsgaard, Martin G; Ku, Cheryl; Woods, Nicole N; Kulasegaram, Kulamakan Mahan; Brydges, Ryan; Ringsted, Charlotte

2014-07-30

Research in medical education has increased in volume over the past decades but concerns have been raised regarding the quality of trials conducted within this field. Randomised controlled trials (RCTs) involving educational interventions that are reported in biomedical journals have been criticised for their insufficient conceptual, theoretical framework. RCTs published in journals dedicated to medical education, on the other hand, have been questioned regarding their methodological rigour. The aim of this study is therefore to assess the quality of RCTs of educational interventions reported in 2012 and 2013 in journals dedicated to medical education compared to biomedical journals with respect to objective quality criteria. RCTs published between 1 January 2012 and 31 December 2013 in English are included. The search strategy is developed with the help of experienced librarians to search online databases for key terms. All of the identified RCTs are screened based on their titles and abstracts individually by the authors and then compared in pairs to assess agreement. Data are extracted from the included RCTs by independently scoring each RCT using a data collection form. The data collection form consists of four steps. Step 1 includes confirmation of RCT eligibility; step 2 consists of the CONSORT checklist; step 3 consists of the Medical Education Research Study Quality Instrument framework; step 4 consists of a Medical Education Extension (MEdEx) to the CONSORT checklist. The MEdEx includes the following elements: Description of scientific background, explanation of rationale, quality of research questions and hypotheses, clarity in the description of the use of the intervention and control as well as interpretation of results. This review is the first to systematically examine the quality of RCTs conducted in medical education. We plan to disseminate the results through publications and presentation at relevant conferences. Ethical approval is not sought for this review. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: explanation and elaboration

PubMed Central

Liberati, Alessandro; Altman, Douglas G; Tetzlaff, Jennifer; Mulrow, Cynthia; Gøtzsche, Peter C; Ioannidis, John P A; Clarke, Mike; Devereaux, P J; Kleijnen, Jos; Moher, David

2009-01-01

Systematic reviews and meta-analyses are essential to summarise evidence relating to efficacy and safety of healthcare interventions accurately and reliably. The clarity and transparency of these reports, however, are not optimal. Poor reporting of systematic reviews diminishes their value to clinicians, policy makers, and other users. Since the development of the QUOROM (quality of reporting of meta-analysis) statement—a reporting guideline published in 1999—there have been several conceptual, methodological, and practical advances regarding the conduct and reporting of systematic reviews and meta-analyses. Also, reviews of published systematic reviews have found that key information about these studies is often poorly reported. Realising these issues, an international group that included experienced authors and methodologists developed PRISMA (preferred reporting items for systematic reviews and meta-analyses) as an evolution of the original QUOROM guideline for systematic reviews and meta-analyses of evaluations of health care interventions. The PRISMA statement consists of a 27-item checklist and a four-phase flow diagram. The checklist includes items deemed essential for transparent reporting of a systematic review. In this explanation and elaboration document, we explain the meaning and rationale for each checklist item. For each item, we include an example of good reporting and, where possible, references to relevant empirical studies and methodological literature. The PRISMA statement, this document, and the associated website (www.prisma-statement.org/) should be helpful resources to improve reporting of systematic reviews and meta-analyses. PMID:19622552

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 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.

Toward improved guideline quality: using the COGS statement with GEM.

PubMed

Shiffman, Richard N; Michel, Georges

2004-01-01

The Conference on Guideline Standardization (COGS) was convened to create a standardized documentation checklist for clinical practice guidelines in an effort to promote guideline quality and facilitate implementation. The statement was created by a multidisciplinary panel using a rigorous consensus development methodology. The Guideline Elements Model (GEM) provides a standardized approach to representing guideline documents using XML. In this work, we demonstrate the sufficiency of GEM for describing COGS components. Using the mapping between COGS and GEM elements we built an XSLT application to examine a guideline's adherence (or non-adherence) to the COGS checklist. Once a guideline has been marked up according to the GEM hierarchy, its knowledge content can be reused in multiple ways.

A Retrospective Survey of Research Design and Statistical Analyses in Selected Chinese Medical Journals in 1998 and 2008

PubMed Central

Jin, Zhichao; Yu, Danghui; Zhang, Luoman; Meng, Hong; Lu, Jian; Gao, Qingbin; Cao, Yang; Ma, Xiuqiang; Wu, Cheng; He, Qian; Wang, Rui; He, Jia

2010-01-01

Background High quality clinical research not only requires advanced professional knowledge, but also needs sound study design and correct statistical analyses. The number of clinical research articles published in Chinese medical journals has increased immensely in the past decade, but study design quality and statistical analyses have remained suboptimal. The aim of this investigation was to gather evidence on the quality of study design and statistical analyses in clinical researches conducted in China for the first decade of the new millennium. Methodology/Principal Findings Ten (10) leading Chinese medical journals were selected and all original articles published in 1998 (N = 1,335) and 2008 (N = 1,578) were thoroughly categorized and reviewed. A well-defined and validated checklist on study design, statistical analyses, results presentation, and interpretation was used for review and evaluation. Main outcomes were the frequencies of different types of study design, error/defect proportion in design and statistical analyses, and implementation of CONSORT in randomized clinical trials. From 1998 to 2008: The error/defect proportion in statistical analyses decreased significantly ( = 12.03, p<0.001), 59.8% (545/1,335) in 1998 compared to 52.2% (664/1,578) in 2008. The overall error/defect proportion of study design also decreased ( = 21.22, p<0.001), 50.9% (680/1,335) compared to 42.40% (669/1,578). In 2008, design with randomized clinical trials remained low in single digit (3.8%, 60/1,578) with two-third showed poor results reporting (defects in 44 papers, 73.3%). Nearly half of the published studies were retrospective in nature, 49.3% (658/1,335) in 1998 compared to 48.2% (761/1,578) in 2008. Decreases in defect proportions were observed in both results presentation ( = 93.26, p<0.001), 92.7% (945/1,019) compared to 78.2% (1023/1,309) and interpretation ( = 27.26, p<0.001), 9.7% (99/1,019) compared to 4.3% (56/1,309), some serious ones persisted. Conclusions/Significance Chinese medical research seems to have made significant progress regarding statistical analyses, but there remains ample room for improvement regarding study designs. Retrospective clinical studies are the most often used design, whereas randomized clinical trials are rare and often show methodological weaknesses. Urgent implementation of the CONSORT statement is imperative. PMID:20520824

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

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.

A survey to identify barriers of implementing an antibiotic checklist.

PubMed

van Daalen, F V; Geerlings, S E; Prins, J M; Hulscher, M E J L

2016-04-01

A checklist is an effective implementation tool, but addressing barriers that might impact on the effectiveness of its use is crucial. In this paper, we explore barriers to the uptake of an antibiotic checklist that aims to improve antibiotic use in daily hospital care. We performed an online questionnaire survey among medical specialists and residents with various professional backgrounds from nine Dutch hospitals. The questionnaire consisted of 23 statements on anticipated barriers hindering the uptake of the checklist. Furthermore, it gave the possibility to add comments. We included 219 completed questionnaires (122 medical specialists and 97 residents) in our descriptive analysis. The top six anticipated barriers included: (1) lack of expectation of improvement of antibiotic use, (2) lack of expected patients' satisfaction by checklist use, (3) lack of feasibility of the checklist, (4) negative previous experiences with other checklists, (5) the complexity of the antibiotic checklist and (6) lack of nurses' expectation of checklist use. Remarkably, 553 comments were made, mostly (436) about the content of the checklist. These insights can be used to improve the specific content of the checklist and to develop an implementation strategy that addresses the identified barriers.

Pharmacy journal abstracts published in PubMed that abide by the CONsolidated Standards Of Reporting Trials (CONSORT) guidelines

PubMed Central

Blair, Daniel A.; Woolley, Thomas W.

2014-01-01

The purpose of this research was to determine the proportion of abstracts in pharmacy journals that are prepared according to the CONsolidated Standards Of Reporting Trials (CONSORT) criteria for abstracts. Certain abstracts for randomized controlled clinical trials (RCTs) indexed in PubMed were eligible for inclusion, with the primary endpoint being median overall compliance to CONSORT recommendations for abstracts. A total of 63 RCT abstracts were included in the analysis, with only 56% of the recommended CONSORT items represented in the sample. It is recommended that pharmacy journals encourage authors to follow CONSORT recommendations for abstracts when submitting RCTs for publication. PMID:24860268

A Reporting Tool for Practice Guidelines in Health Care: The RIGHT Statement.

PubMed

Chen, Yaolong; Yang, Kehu; Marušic, Ana; Qaseem, Amir; Meerpohl, Joerg J; Flottorp, Signe; Akl, Elie A; Schünemann, Holger J; Chan, Edwin S Y; Falck-Ytter, Yngve; Ahmed, Faruque; Barber, Sarah; Chen, Chiehfeng; Zhang, Mingming; Xu, Bin; Tian, Jinhui; Song, Fujian; Shang, Hongcai; Tang, Kun; Wang, Qi; Norris, Susan L

2017-01-17

The quality of reporting practice guidelines is often poor, and there is no widely accepted guidance or standards for such reporting in health care. The international RIGHT (Reporting Items for practice Guidelines in HealThcare) Working Group was established to address this gap. The group followed an existing framework for developing guidelines for health research reporting and the EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network approach. It developed a checklist and an explanation and elaboration statement. The RIGHT checklist includes 22 items that are considered essential for good reporting of practice guidelines: basic information (items 1 to 4), background (items 5 to 9), evidence (items 10 to 12), recommendations (items 13 to 15), review and quality assurance (items 16 and 17), funding and declaration and management of interests (items 18 and 19), and other information (items 20 to 22). The RIGHT checklist can assist developers in reporting guidelines, support journal editors and peer reviewers when considering guideline reports, and help health care practitioners understand and implement a guideline.

CONSORT Extension for Chinese Herbal Medicine Formulas 2017: Recommendations, Explanation, and Elaboration (Traditional Chinese Version).

PubMed

Cheng, Chung-Wah; Wu, Tai-Xiang; Shang, Hong-Cai; Li, You-Ping; Altman, Douglas G; Moher, David; Bian, Zhao-Xiang

2017-07-18

Editors' Note: This article is the traditional Chinese version of the CONSORT Extension for Chinese Herbal Medicine Formulas 2017: Recommendations, Explanation, and Elaboration. (Cheng C, Wu T, Shang H, Li, Y, Altman D, Moher D; CONSORT-CHM Formulas 2017 Group. CONSORT Extension for Chinese Herbal Medicine Formulas 2017: Recommendations, Explanation, and Elaboration. Ann Intern Med. 2017;167:112-21. [Epub 27 June 2017]. doi:10.7326/M16-2977).

CONSORT Extension for Chinese Herbal Medicine Formulas 2017: Recommendations, Explanation, and Elaboration (Simplified Chinese Version).

PubMed

Cheng, Chung-Wah; Wu, Tai-Xiang; Shang, Hong-Cai; Li, You-Ping; Altman, Douglas G; Moher, David; Bian, Zhao-Xiang

2017-07-18

Editors' Note: This article is the simplified Chinese version of the CONSORT Extension for Chinese Herbal Medicine Formulas 2017: Recommendations, Explanation, and Elaboration. (Cheng C, Wu T, Shang H, Li, Y, Altman D, Moher D; CONSORT-CHM Formulas 2017 Group. CONSORT Extension for Chinese Herbal Medicine Formulas 2017: Recommendations, Explanation, and Elaboration. Ann Intern Med. 2017;167:112-21. [Epub 27 June 2017]. doi:10.7326/M16-2977).

Outcome following phrenic nerve transfer to musculocutaneous nerve in patients with traumatic brachial palsy: a qualitative systematic review.

PubMed

de Mendonça Cardoso, Marcio; Gepp, Ricardo; Correa, José Fernando Guedes

2016-09-01

The phrenic nerve can be transferred to the musculocutaneous nerve in patients with traumatic brachial plexus palsy in order to recover biceps strength, but the results are controversial. There is also a concern about pulmonary function after phrenic nerve transection. In this paper, we performed a qualitative systematic review, evaluating outcomes after this procedure. A systematic review of published studies was undertaken in accordance with the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement. Data were extracted from the selected papers and related to: publication, study design, outcome (biceps strength in accordance with BMRC and pulmonary function) and population. Study quality was assessed using the "strengthening the reporting of observational studies in epidemiology" (STROBE) standard or the CONSORT checklist, depending on the study design. Seven studies were selected for this systematic review after applying inclusion and exclusion criteria. One hundred twenty-four patients completed follow-up, and most of them were graded M3 or M4 (70.1 %) for biceps strength at the final evaluation. Pulmonary function was analyzed in five studies. It was not possible to perform a statistical comparison between studies because the authors used different parameters for evaluation. Most of the patients exhibited a decrease in pulmonary function tests immediately after surgery, with recovery in the following months. Study quality was determined using STROBE in six articles, and the global score varied from 8 to 21. Phrenic nerve transfer to the musculocutaneous nerve can recover biceps strength ≥M3 (BMRC) in most patients with traumatic brachial plexus injury. Early postoperative findings revealed that the development of pulmonary symptoms is rare, but it cannot be concluded that the procedure is safe because there is no study evaluating pulmonary function in old age.

Infantile colic: a systematic review of medical and conventional therapies.

PubMed

Hall, Belinda; Chesters, Janice; Robinson, Anske

2012-02-01

Infantile colic is a prevalent and distressing condition for which there is no proven standard therapy. The aim of this paper is to review medical and conventional treatments for infantile colic. A systematic literature review was undertaken of studies on medical and conventional interventions for infantile colic from 1980 to March 2009. The results and methodological rigour of included studies were analysed using the CONSORT (Consolidated Standards Of Reporting Trials) 2001 statement checklist and Centre for Evidence Based Medicine critical appraisal tools. Nineteen studies and two literature reviews were included for review. Pharmacological studies on Simethicone gave conflicting results and with Dicyclomine hydrochloride and Cimetropium bromide results were favourable but side effects were noted along with issues in study methodology. Some nutritional studies reported favourable results for the use of hydrolysed formulas in bottle-fed infants or low-allergen maternal diets in breastfed infants but not for the use of additional fibre or lactase. There were several issues in regards to methodological rigour. Behavioural studies on the use of increased stimulation gave unfavourable results, whereas results from the use of decreased stimulation and contingent music were favourable. These studies demonstrated poor methodological rigour. There is some scientific evidence to support the use of a casein hydrolysate formula in formula-fed infants or a low-allergen maternal diet in breastfed infants with infantile colic. However, there is little scientific evidence to support the use of Simethicone, Dicyclomine hydrochloride, Cimetropium bromide, lactase, additional fibre or behavioural interventions. Further research of good methodological quality on low-allergenic formulas and maternal diets is indicated. © 2011 The Authors. Journal of Paediatrics and Child Health © 2011 Paediatrics and Child Health Division (Royal Australasian College of Physicians).

The MAPS Reporting Statement for Studies Mapping onto Generic Preference-Based Outcome Measures: Explanation and Elaboration.

PubMed

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

2015-10-01

The process of "mapping" is increasingly being used to predict health utilities, for application within health economic evaluations, using data on other indicators or measures of health. Guidance for the reporting of mapping studies is currently lacking. The overall objective of this research was to develop a checklist of essential items, which authors should consider when reporting mapping studies. The MAPS (MApping onto Preference-based measures reporting Standards) statement is a checklist, which aims to promote complete and transparent reporting by researchers. This paper provides a detailed explanation and elaboration of the items contained within the MAPS statement. In the absence of previously published reporting checklists or reporting guidance documents, a de novo list of reporting items and accompanying explanations was created. 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, (i) title and abstract, (ii) introduction, (iii) methods, (iv) results, (v) discussion and (vi) other. For each item, we summarise the recommendation, illustrate it using an exemplar of good reporting practice identified from the published literature, and provide a detailed explanation to accompany the recommendation. It is anticipated that the MAPS statement will promote clarity, transparency and completeness of reporting of mapping studies. It is targeted at researchers developing mapping algorithms, peer reviewers and editors involved in the manuscript review process for mapping studies, and the funders of the research. The MAPS working group plans to assess the need for an update of the reporting checklist in 5 years' time.

Pediatric "pet consort dermatitis"-Allergic contact dermatitis from transfer of bronopol from a pet cat.

PubMed

Hamann, Dathan; Ridpath, Alyson; Fernandez Faith, Esteban

2018-06-26

Consort dermatitis refers to an allergic contact dermatitis caused by transfer from an intimate contact to a sensitized patient. Although close contact with other humans most commonly provokes consort dermatitis, pets have been the source in a minority of cases. We present a unique case of transfer dermatitis from a patient's cat litter to her forearms. Pediatric dermatologists should be aware of the possibility of consort or "transfer" allergic contact dermatitis from pets. © 2018 Wiley Periodicals, Inc.

48 CFR 2937.103-70 - Department of Labor checklist to aid analysis and review of requirements for service contracts.

Code of Federal Regulations, 2012 CFR

2012-10-01

... requirements for service contracts. Contracting specialists and contracting officers must work in close... review of requirements for service contracts. (1) Is the statement of work complete, with a clear-cut division of responsibility between the contracting parties? (2) Is the statement of work discussed in terms...

48 CFR 2937.103-70 - Department of Labor checklist to aid analysis and review of requirements for service contracts.

Code of Federal Regulations, 2014 CFR

2014-10-01

... requirements for service contracts. Contracting specialists and contracting officers must work in close... review of requirements for service contracts. (1) Is the statement of work complete, with a clear-cut division of responsibility between the contracting parties? (2) Is the statement of work discussed in terms...

Should male consorts of women with bacterial vaginosis be treated?

PubMed Central

Moi, H; Erkkola, R; Jerve, F; Nelleman, G; Bymose, B; Alaksen, K; Tornqvist, E

1989-01-01

Nitroimidazoles have been shown to be the drugs of choice to treat women with bacterial vaginosis, but the recurrence rate is high. Some workers have suggested that the recurrence of symptoms may in fact be reinfection by male consorts, but no controlled studies have been undertaken to confirm this. In an international, multicentre, randomised, double blind trial, the recurrence rate was studied in 241 women with a clinical diagnosis of bacterial vaginosis. All women were treated with 2 g metronidazole twice at an interval of two days. The patients were randomly allocated to two groups, one contained 123 women, whose consorts were given the same dose of metronidazole, the other consisted of 118 women whose consorts were given inert but identical placebo tablets. The women were evaluated at weeks 1, 4, and 12 after treatment. At week 1, the cure rate was 97% (115/119) in women whose consorts had been treated and 98% (111/113) in the others. At week 4 bacterial vaginosis had recurred in 17% (19/112) of women whose consorts had been treated and in 13% (14/106) of those whose consorts had received placebo. At week 12 the recurrence rates were 21% (20/95) in women with treated consorts, and 16% (15/95) in the others. The differences in recurrence rates between the two groups of women were not significant. In conclusion, treating the sexual partners of women with bacterial vaginosis does not seem to increase the cure rate. PMID:2680896

Oncology trial abstracts showed suboptimal improvement in reporting: a comparative before-and-after evaluation using CONSORT for Abstract guidelines.

PubMed

Ghimire, Saurav; Kyung, Eunjung; Lee, Heeyoung; Kim, Eunyoung

2014-06-01

The aims of this study were to evaluate the quality of randomized controlled trial (RCT) abstracts published in the field of oncology and identify characteristics associated with better reporting quality. All phase III trials published during 2005-2007 [before Consolidated Standards of Reporting Trials (CONSORT)] and 2010-2012 (after CONSORT) were searched electronically in MEDLINE/PubMed and retrieved for review using an 18-point overall quality score (OQS) for reporting based on the CONSORT for Abstract guidelines. Descriptive statistics followed by multivariate linear regression were used to identify features associated with improved reporting quality. The mean OQS was 8.2 (range: 5-13; 95% confidence interval (CI): 8.0, 8.3) and 9.9 (range: 5-18; 95% CI: 9.7, 10.2) in the pre- and post-CONSORT periods, respectively. The method for random sequence generation, allocation concealment, blinding details, and funding sources were missing in pre-CONSORT abstracts and insufficiently reported (<20%) in post-CONSORT abstracts. A high impact factor (P < 0.001) and the journal of publication (P < 0.001) were independent factors that were significantly associated with higher reporting quality on multivariate analysis. The reporting quality of RCT abstracts in oncology showed suboptimal improvement over time. Thus, stricter adherence to the CONSORT for Abstract guidelines is needed to improve the reporting quality of RCT abstracts published in oncology. Copyright © 2014 Elsevier Inc. All rights reserved.

The PRISMA Statement for Reporting Systematic Reviews and Meta-Analyses of Studies That Evaluate Health Care Interventions: Explanation and Elaboration

PubMed Central

Liberati, Alessandro; Altman, Douglas G.; Tetzlaff, Jennifer; Mulrow, Cynthia; Gøtzsche, Peter C.; Ioannidis, John P. A.; Clarke, Mike; Devereaux, P. J.; Kleijnen, Jos; Moher, David

2009-01-01

Systematic reviews and meta-analyses are essential to summarize evidence relating to efficacy and safety of health care interventions accurately and reliably. The clarity and transparency of these reports, however, is not optimal. Poor reporting of systematic reviews diminishes their value to clinicians, policy makers, and other users. Since the development of the QUOROM (QUality Of Reporting Of Meta-analysis) Statement—a reporting guideline published in 1999—there have been several conceptual, methodological, and practical advances regarding the conduct and reporting of systematic reviews and meta-analyses. Also, reviews of published systematic reviews have found that key information about these studies is often poorly reported. Realizing these issues, an international group that included experienced authors and methodologists developed PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses) as an evolution of the original QUOROM guideline for systematic reviews and meta-analyses of evaluations of health care interventions. The PRISMA Statement consists of a 27-item checklist and a four-phase flow diagram. The checklist includes items deemed essential for transparent reporting of a systematic review. In this Explanation and Elaboration document, we explain the meaning and rationale for each checklist item. For each item, we include an example of good reporting and, where possible, references to relevant empirical studies and methodological literature. The PRISMA Statement, this document, and the associated Web site (http://www.prisma-statement.org/) should be helpful resources to improve reporting of systematic reviews and meta-analyses. PMID:19621070

[A reporting tool for practice guidelines in health care: the RIGHT statement].

PubMed

Chen, Yaolong; Yang, Kehu; Marušić, Ana; Qaseem, Amir; Meerpohl, Joerg J; Flottorp, Signe; Akl, Elie A; Schünemann, Holger J; Chan, Edwin S Y; Falck-Ytter, Yngve; Ahmed, Faruque; Barber, Sarah; Chen, Chiehfeng; Zhang, Mingming; Xu, Bin; Tian, Jinhui; Song, Fujian; Shang, Hongcai; Tang, Kun; Wang, Qi; Norris, Susan L; Labonté, Valérie C; Möhler, Ralph; Kopp, Ina; Nothacker, Monika; Meerpohl, Joerg J

2017-11-01

The quality of reporting practice guidelines is often poor, and there is no widely accepted guidance or standards for such reporting in health care. The international RIGHT (Reporting Items for practice Guidelines in HealThcare) Working Group was established to address this gap. The group followed an existing framework for developing guidelines for health research reporting and the EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network approach. A checklist and an explanation and elaboration statement were developed. The RIGHT checklist includes 22 items that are considered essential for good reporting of practice guidelines: basic information (items 1 to 4), background (items 5 to 9), evidence (items 10 to 12), recommendations (items 13 to 15), review and quality assurance (items 16 and 17), funding and declaration and management of interests (items 18 and 19), and other information (items 20 to 22). The RIGHT checklist can assist developers in reporting guidelines, support journal editors and peer reviewers when considering guideline reports, and help health care practitioners understand and implement a guideline. Copyright © 2017. Published by Elsevier GmbH.

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.

Is Pilates an effective rehabilitation tool? A systematic review.

PubMed

Byrnes, Keira; Wu, Ping-Jung; Whillier, Stephney

2018-01-01

Pilates is a system of exercise focusing upon controlled movement, stretching and breathing. Pilates is popular today not only for physical fitness but also for rehabilitation programs. This paper is a review of the literature on the effectiveness of Pilates as a rehabilitation tool in a wide range of conditions in an adult population. A systematic literature review was carried out according to the PRISMA guidelines. Electronic databases were searched for cohort studies or randomised controlled trials (RCTs), and inclusion and exclusion criteria were applied. The final RCTs were assessed using the PEDro and CONSORT 2010 checklists. Twenty-three studies, published between 2005 and 2016, met the inclusion criteria. These papers assessed the efficacy of Pilates in the rehabilitation of low back pain, ankylosing spondylitis, multiple sclerosis, post-menopausal osteoporosis, non-structural scoliosis, hypertension and chronic neck pain. Nineteen papers found Pilates to be more effective than the control or comparator group at improving outcomes including pain and disability levels. When assessed using the CONSORT and PEDro scales, the quality of the papers varied, with more falling toward the upper end of the scale. The majority of the clinical trials in the last five years into the use of Pilates as a rehabilitation tool have found it to be effective in achieving desired outcomes, particularly in the area of reducing pain and disability. It indicates the need for further research in these many areas, and especially into the benefits of particular Pilates exercises in the rehabilitation of specific conditions. Copyright © 2017 Elsevier Ltd. All rights reserved.

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

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.

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.

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

48 CFR 252.215-7009 - Proposal adequacy checklist.

Code of Federal Regulations, 2014 CFR

2014-10-01

... estimating relationships (labor hours or material) proposed on other than a discrete basis? 10. FAR 15.408... descriptions—(e.g.; Statement of Work reference, applicable CLIN, Work Breakdown Structure, rationale for...

The Society for Obstetric Anesthesia and Perinatology consensus statement on the management of cardiac arrest in pregnancy.

PubMed

Lipman, Steven; Cohen, Sheila; Einav, Sharon; Jeejeebhoy, Farida; Mhyre, Jill M; Morrison, Laurie J; Katz, Vern; Tsen, Lawrence C; Daniels, Kay; Halamek, Louis P; Suresh, Maya S; Arafeh, Julie; Gauthier, Dodi; Carvalho, Jose C A; Druzin, Maurice; Carvalho, Brendan

2014-05-01

This consensus statement was commissioned in 2012 by the Board of Directors of the Society for Obstetric Anesthesia and Perinatology to improve maternal resuscitation by providing health care providers critical information (including point-of-care checklists) and operational strategies relevant to maternal cardiac arrest. The recommendations in this statement were designed to address the challenges of an actual event by emphasizing health care provider education, behavioral/communication strategies, latent systems errors, and periodic testing of performance. This statement also expands on, interprets, and discusses controversial aspects of material covered in the American Heart Association 2010 guidelines.

Reporting adverse events in randomized controlled trials in periodontology: a systematic review.

PubMed

Faggion, Clovis M; Tu, Yu-Kang; Giannakopoulos, Nikolaos N

2013-09-01

Reporting of adverse events is of paramount importance in randomized controlled trials (RCTs) to guide the implementation of new therapeutic approaches in clinical practice. The aim of this study was to assess the quality of adverse events reporting in RCTs published in the periodontal literature. Two authors (CMF and NNG) searched the PubMed and LILACS electronic databases independently and in duplicate to identify RCTs published in periodontology from 2002 to 2003 and from 2011 to 2012. Reporting quality in RCTs was assessed with reference to the 2004 CONSORT Extension for Harms checklist. Differences in adverse events reporting between industry- and non-industry-funded RCTs were also determined. Cohen's kappa statistic was used to determine the extent of inter-reviewer agreement. Fischer's exact test was used to assess differences in reporting between the two samples. The analysis included 246 publications. One hundred twenty-four of 990 (13%) items and 223 of 1460 (15%) items were adequately reported in publications from 2002 to 2003 and from 2011 to 2012 respectively. Three checklist topics were significantly better reported in the 2011-2012 sample; two recommendations were better reported in non-industry-funded trials in publications from both periods. Improvement and standardization of adverse events reporting in periodontology are needed. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Low gravity investigations in suborbital rockets

NASA Technical Reports Server (NTRS)

Wessling, Francis C.; Lundquist, Charles A.

1990-01-01

Two series of suborbital rocket missions are outlined which are intended to support materials and biotechnology investigations under microgravity conditions and enhance commercial rocket activity. The Consort series of missions employs the two-stage Starfire I rocket and recovery systems as well as a payload of three sealed or vented cylindrical sections. The Consort 1 and 2 missions are described which successfully supported six classes of experiments each. The Joust program is the second series of rocket missions, and the Prospector rocket is employed to provide comparable payload masses with twice as much microgravity time as the Consort series. The Joust and Consort missions provide 6-8 and 13-15 mins, respectively, of microgravity flight to support such experiments as polymer processing, scientific apparatus testing, and electrodeposition.

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.

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

PRESS Peer Review of Electronic Search Strategies: 2015 Guideline Statement.

PubMed

McGowan, Jessie; Sampson, Margaret; Salzwedel, Douglas M; Cogo, Elise; Foerster, Vicki; Lefebvre, Carol

2016-07-01

To develop an evidence-based guideline for Peer Review of Electronic Search Strategies (PRESS) for systematic reviews (SRs), health technology assessments, and other evidence syntheses. An SR, Web-based survey of experts, and consensus development forum were undertaken to identify checklists that evaluated or validated electronic literature search strategies and to determine which of their elements related to search quality or errors. Systematic review: No new search elements were identified for addition to the existing (2008-2010) PRESS 2015 Evidence-Based Checklist, and there was no evidence refuting any of its elements. Results suggested that structured PRESS could identify search errors and improve the selection of search terms. Web-based survey of experts: Most respondents felt that peer review should be undertaken after the MEDLINE search had been prepared but before it had been translated to other databases. Consensus development forum: Of the seven original PRESS elements, six were retained: translation of the research question; Boolean and proximity operators; subject headings; text word search; spelling, syntax and line numbers; and limits and filters. The seventh (skilled translation of the search strategy to additional databases) was removed, as there was consensus that this should be left to the discretion of searchers. An updated PRESS 2015 Guideline Statement was developed, which includes the following four documents: PRESS 2015 Evidence-Based Checklist, PRESS 2015 Recommendations for Librarian Practice, PRESS 2015 Implementation Strategies, and PRESS 2015 Guideline Assessment Form. The PRESS 2015 Guideline Statement should help to guide and improve the peer review of electronic literature search strategies. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

A novel diagram and complement to the CONSORT chart for presenting multimodal clinical trials.

PubMed

Schuller, Jan C; Mayer, Michael; Lanz, Doris; Schmitz, Shu-Fang Hsu; Brauchli, Peter; Leupin, Nicolas

2009-05-01

We developed a novel diagram to depict patient flow and outcomes in clinical trials. In contrast to flow diagrams such as the CONSORT chart, our diagram enables individual patient histories to be traced and depicts important patterns of treatment administration and outcomes, such as response and adverse events. Also, it is particularly useful for multimodal treatments or a sequence of different therapies where the CONSORT flow chart is less informative and can be confusing.

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.

Improving Relationship Skills for Parent Conferences.

ERIC Educational Resources Information Center

Perl, James

1995-01-01

Suggestions are offered to special educators for improving communication at parent-teacher conferences, including relationship skills such as demonstrating genuine caring, building rapport, listening, showing empathy, reflecting affect, and using clarifying statements. A checklist for self-monitoring in these areas is included. (DB)

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.

10 CFR 609.6 - Submission of Applications.

Code of Federal Regulations, 2011 CFR

2011-01-01

... checklist for the equity and debt to the extent available; (16) Applicant's business plan on which the project is based and Applicant's financial model presenting project pro forma statements for the proposed... backing, together with business and financial interests of controlling or commonly controlled...

Bibliographic Instruction Handbook.

ERIC Educational Resources Information Center

Association of Coll. and Research Libraries, Chicago, IL.

Based on the ACRL Guidelines for Bibliographic Instruction, this handbook is intended not only to provide guidance in the development of instruction programs, but also to stimulate discussion within the profession. It consists of the guidelines, five model statements and checklists, a glossary, and a pathfinder. The guidelines present generally…

Utility of action checklists as a consensus building tool

PubMed Central

KIM, Yeon-Ha; YOSHIKAWA, Etsuko; YOSHIKAWA, Toru; KOGI, Kazutaka; JUNG, Moon-Hee

2014-01-01

The present study’s objective was to determine the mechanisms for enhancing the utility of action checklists applied in participatory approach programs for workplace improvements, to identify the benefits of building consensus and to compare their applicability in Asian countries to find the most appropriate configuration for action checklists. Data were collected from eight trainees and 43 trainers with experience in Participatory Action-Oriented Training. Statistical analysis was performed in SPSS using the package PASW, version 19.0. The difference in the mean score for the degree of the utility of action checklists between countries was analyzed using ANOVA methods. Factor analysis was performed to validate the action checklists’ utility. Pearson Correlation Coefficients were then calculated to determine the direction and strength of the relationship between these factors. Using responses obtained from trainees’ in-depth interviews, we identified 33 key statements that were then classified into 11 thematic clusters. Five factors were extracted, namely “ease of application”, “practical solutions”, “group interaction”, “multifaceted perspective” and “active involvement”. The action checklist was useful for facilitating a participatory process among trainees and trainers for improving working conditions. Action checklists showed similar patterns of utility in various Asian countries; particularly when adjusted to local conditions. PMID:25224334

[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.

Transparent Reporting of a Multivariable Prediction Model for Individual Prognosis or Diagnosis (TRIPOD)

PubMed Central

Reitsma, Johannes B.; Altman, Douglas G.; Moons, Karel G.M.

2015-01-01

Background— 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. Methods— 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. Results— 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. Conclusions— 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:25561516

Core Outcome Set–STAndards for Reporting: The COS-STAR Statement

PubMed Central

Kirkham, Jamie J.; Gorst, Sarah; Altman, Douglas G.; Blazeby, Jane M.; Clarke, Mike; Devane, Declan; Moher, David; Schmitt, Jochen; Tugwell, Peter; Tunis, Sean; Williamson, Paula R.

2016-01-01

Background Core outcome sets (COS) can enhance the relevance of research by ensuring that outcomes of importance to health service users and other people making choices about health care in a particular topic area are measured routinely. Over 200 COS to date have been developed, but the clarity of these reports is suboptimal. COS studies will not achieve their goal if reports of COS are not complete and transparent. Methods and Findings In recognition of these issues, an international group that included experienced COS developers, methodologists, journal editors, potential users of COS (clinical trialists, systematic reviewers, and clinical guideline developers), and patient representatives developed the Core Outcome Set–STAndards for Reporting (COS-STAR) Statement as a reporting guideline for COS studies. The developmental process consisted of an initial reporting item generation stage and a two-round Delphi survey involving nearly 200 participants representing key stakeholder groups, followed by a consensus meeting. The COS-STAR Statement consists of a checklist of 18 items considered essential for transparent and complete reporting in all COS studies. The checklist items focus on the introduction, methods, results, and discussion section of a manuscript describing the development of a particular COS. A limitation of the COS-STAR Statement is that it was developed without representative views of low- and middle-income countries. COS have equal relevance to studies conducted in these areas, and, subsequently, this guideline may need to evolve over time to encompass any additional challenges from developing COS in these areas. Conclusions With many ongoing COS studies underway, the COS-STAR Statement should be a helpful resource to improve the reporting of COS studies for the benefit of all COS users. PMID:27755541

Protocol for the development of a CONSORT-equity guideline to improve reporting of health equity in randomized trials.

PubMed

Welch, Vivian; Jull, J; Petkovic, J; Armstrong, R; Boyer, Y; Cuervo, L G; Edwards, Sjl; Lydiatt, A; Gough, D; Grimshaw, J; Kristjansson, E; Mbuagbaw, L; McGowan, J; Moher, D; Pantoja, T; Petticrew, M; Pottie, K; Rader, T; Shea, B; Taljaard, M; Waters, E; Weijer, C; Wells, G A; White, H; Whitehead, M; Tugwell, P

2015-10-21

Health equity concerns the absence of avoidable and unfair differences in health. Randomized controlled trials (RCTs) can provide evidence about the impact of an intervention on health equity for specific disadvantaged populations or in general populations; this is important for equity-focused decision-making. Previous work has identified a lack of adequate reporting guidelines for assessing health equity in RCTs. The objective of this study is to develop guidelines to improve the reporting of health equity considerations in RCTs, as an extension of the Consolidated Standards of Reporting Trials (CONSORT). A six-phase study using integrated knowledge translation governed by a study executive and advisory board will assemble empirical evidence to inform the CONSORT-equity extension. To create the guideline, the following steps are proposed: (1) develop a conceptual framework for identifying "equity-relevant trials," (2) assess empirical evidence regarding reporting of equity-relevant trials, (3) consult with global methods and content experts on how to improve reporting of health equity in RCTs, (4) collect broad feedback and prioritize items needed to improve reporting of health equity in RCTs, (5) establish consensus on the CONSORT-equity extension: the guideline for equity-relevant trials, and (6) broadly disseminate and implement the CONSORT-equity extension. This work will be relevant to a broad range of RCTs addressing questions of effectiveness for strategies to improve practice and policy in the areas of social determinants of health, clinical care, health systems, public health, and international development, where health and/or access to health care is a primary outcome. The outcomes include a reporting guideline (CONSORT-equity extension) for equity-relevant RCTs and a knowledge translation strategy to broadly encourage its uptake and use by journal editors, authors, and funding agencies.

Standards for reporting randomized controlled trials in medical informatics: a systematic review of CONSORT adherence in RCTs on clinical decision support

PubMed Central

Berntsen, G; Lassen, K; Bellika, J G; Wootton, R; Lindsetmo, R O

2011-01-01

Introduction The Consolidated Standards for Reporting Trials (CONSORT) were published to standardize reporting and improve the quality of clinical trials. The objective of this study is to assess CONSORT adherence in randomized clinical trials (RCT) of disease specific clinical decision support (CDS). Methods A systematic search was conducted of the Medline, EMBASE, and Cochrane databases. RCTs on CDS were assessed against CONSORT guidelines and the Jadad score. Result 32 of 3784 papers identified in the primary search were included in the final review. 181 702 patients and 7315 physicians participated in the selected trials. Most trials were performed in primary care (22), including 897 general practitioner offices. RCTs assessing CDS for asthma (4), diabetes (4), and hyperlipidemia (3) were the most common. Thirteen CDS systems (40%) were implemented in electronic medical records, and 14 (43%) provided automatic alerts. CONSORT and Jadad scores were generally low; the mean CONSORT score was 30.75 (95% CI 27.0 to 34.5), median score 32, range 21–38. Fourteen trials (43%) did not clearly define the study objective, and 11 studies (34%) did not include a sample size calculation. Outcome measures were adequately identified and defined in 23 (71%) trials; adverse events or side effects were not reported in 20 trials (62%). Thirteen trials (40%) were of superior quality according to the Jadad score (≥3 points). Six trials (18%) reported on long-term implementation of CDS. Conclusion The overall quality of reporting RCTs was low. There is a need to develop standards for reporting RCTs in medical informatics. PMID:21803926

The reliability of a modified Kalamazoo Consensus Statement Checklist for assessing the communication skills of multidisciplinary clinicians in the simulated environment.

PubMed

Peterson, Eleanor B; Calhoun, Aaron W; Rider, Elizabeth A

2014-09-01

With increased recognition of the importance of sound communication skills and communication skills education, reliable assessment tools are essential. This study reports on the psychometric properties of an assessment tool based on the Kalamazoo Consensus Statement Essential Elements Communication Checklist. The Gap-Kalamazoo Communication Skills Assessment Form (GKCSAF), a modified version of an existing communication skills assessment tool, the Kalamazoo Essential Elements Communication Checklist-Adapted, was used to assess learners in a multidisciplinary, simulation-based communication skills educational program using multiple raters. 118 simulated conversations were available for analysis. Internal consistency and inter-rater reliability were determined by calculating a Cronbach's alpha score and intra-class correlation coefficients (ICC), respectively. The GKCSAF demonstrated high internal consistency with a Cronbach's alpha score of 0.844 (faculty raters) and 0.880 (peer observer raters), and high inter-rater reliability with an ICC of 0.830 (faculty raters) and 0.89 (peer observer raters). The Gap-Kalamazoo Communication Skills Assessment Form is a reliable method of assessing the communication skills of multidisciplinary learners using multi-rater methods within the learning environment. The Gap-Kalamazoo Communication Skills Assessment Form can be used by educational programs that wish to implement a reliable assessment and feedback system for a variety of learners. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Reporting of participant flow diagrams in published reports of randomized trials.

PubMed

Hopewell, Sally; Hirst, Allison; Collins, Gary S; Mallett, Sue; Yu, Ly-Mee; Altman, Douglas G

2011-12-05

Reporting of the flow of participants through each stage of a randomized trial is essential to assess the generalisability and validity of its results. We assessed the type and completeness of information reported in CONSORT (Consolidated Standards of Reporting Trials) flow diagrams published in current reports of randomized trials. A cross sectional review of all primary reports of randomized trials which included a CONSORT flow diagram indexed in PubMed core clinical journals (2009). We assessed the proportion of parallel group trial publications reporting specific items recommended by CONSORT for inclusion in a flow diagram. Of 469 primary reports of randomized trials, 263 (56%) included a CONSORT flow diagram of which 89% (237/263) were published in a CONSORT endorsing journal. Reports published in CONSORT endorsing journals were more likely to include a flow diagram (62%; 237/380 versus 29%; 26/89). Ninety percent (236/263) of reports which included a flow diagram had a parallel group design, of which 49% (116/236) evaluated drug interventions, 58% (137/236) were multicentre, and 79% (187/236) compared two study groups, with a median sample size of 213 participants. Eighty-one percent (191/236) reported the overall number of participants assessed for eligibility, 71% (168/236) the number excluded prior to randomization and 98% (231/236) the overall number randomized. Reasons for exclusion prior to randomization were more poorly reported. Ninety-four percent (223/236) reported the number of participants allocated to each arm of the trial. However, only 40% (95/236) reported the number who actually received the allocated intervention, 67% (158/236) the number lost to follow up in each arm of the trial, 61% (145/236) whether participants discontinued the intervention during the trial and 54% (128/236) the number included in the main analysis. Over half of published reports of randomized trials included a diagram showing the flow of participants through the trial. However, information was often missing from published flow diagrams, even in articles published in CONSORT endorsing journals. If important information is not reported it can be difficult and sometimes impossible to know if the conclusions of that trial are justified by the data presented.

Ensuring Data Quality in Extension Research and Evaluation Studies

ERIC Educational Resources Information Center

Radhakrishna, Rama; Tobin, Daniel; Brennan, Mark; Thomson, Joan

2012-01-01

This article presents a checklist as a guide for Extension professionals to use in research and evaluation studies they carry out. A total of 40 statements grouped under eight data quality components--relevance, objectivity, validity, reliability, integrity, generalizability, completeness, and utility--are identified to ensure that research…

Preferred Reporting Items for a Systematic Review and Meta-analysis of Diagnostic Test Accuracy Studies: The PRISMA-DTA Statement.

PubMed

McInnes, Matthew D F; Moher, David; Thombs, Brett D; McGrath, Trevor A; Bossuyt, Patrick M; Clifford, Tammy; Cohen, Jérémie F; Deeks, Jonathan J; Gatsonis, Constantine; Hooft, Lotty; Hunt, Harriet A; Hyde, Christopher J; Korevaar, Daniël A; Leeflang, Mariska M G; Macaskill, Petra; Reitsma, Johannes B; Rodin, Rachel; Rutjes, Anne W S; Salameh, Jean-Paul; Stevens, Adrienne; Takwoingi, Yemisi; Tonelli, Marcello; Weeks, Laura; Whiting, Penny; Willis, Brian H

2018-01-23

Systematic reviews of diagnostic test accuracy synthesize data from primary diagnostic studies that have evaluated the accuracy of 1 or more index tests against a reference standard, provide estimates of test performance, allow comparisons of the accuracy of different tests, and facilitate the identification of sources of variability in test accuracy. To develop the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) diagnostic test accuracy guideline as a stand-alone extension of the PRISMA statement. Modifications to the PRISMA statement reflect the specific requirements for reporting of systematic reviews and meta-analyses of diagnostic test accuracy studies and the abstracts for these reviews. Established standards from the Enhancing the Quality and Transparency of Health Research (EQUATOR) Network were followed for the development of the guideline. The original PRISMA statement was used as a framework on which to modify and add items. A group of 24 multidisciplinary experts used a systematic review of articles on existing reporting guidelines and methods, a 3-round Delphi process, a consensus meeting, pilot testing, and iterative refinement to develop the PRISMA diagnostic test accuracy guideline. The final version of the PRISMA diagnostic test accuracy guideline checklist was approved by the group. The systematic review (produced 64 items) and the Delphi process (provided feedback on 7 proposed items; 1 item was later split into 2 items) identified 71 potentially relevant items for consideration. The Delphi process reduced these to 60 items that were discussed at the consensus meeting. Following the meeting, pilot testing and iterative feedback were used to generate the 27-item PRISMA diagnostic test accuracy checklist. To reflect specific or optimal contemporary systematic review methods for diagnostic test accuracy, 8 of the 27 original PRISMA items were left unchanged, 17 were modified, 2 were added, and 2 were omitted. The 27-item PRISMA diagnostic test accuracy checklist provides specific guidance for reporting of systematic reviews. The PRISMA diagnostic test accuracy guideline can facilitate the transparent reporting of reviews, and may assist in the evaluation of validity and applicability, enhance replicability of reviews, and make the results from systematic reviews of diagnostic test accuracy studies more useful.

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. 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 Joint copyright. The Authors and Annals of Internal Medicine. Diabetic Medicine published by John Wiley Ltd. on behalf of Diabetes UK.

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."

Outcomes associated with virtual reality in psychological interventions: where are we now?

PubMed

Turner, Wesley A; Casey, Leanne M

2014-12-01

The impending commercial release of affordable VR systems is likely to accelerate both the opportunity and demand for VR applications that specifically target psychological conditions. The aim of this study was to conduct a meta-analysis of outcomes associated with VR psychological interventions and to examine the methodological rigour used in these interventions. Literature search was conducted via Ovid, ProQuest Psychology Journals and ScienceDirect (Psychology) databases. Interventions were required to: be published between 1980 to 2014; use a randomised controlled trial design; be published in a scholarly journal; focused primarily on psychological/behavioural intervention; include validated measures; include reported means and standard deviations of outcome measures; and include one group with clinical/subclinical disorders, syndromes or distressing behaviours. Thirty eligible studies were identified. Random effects meta-analysis found an overall moderate effect size for VR interventions. Individual meta-analyses found an overall large effect size against non-intervention wait-lists and an overall moderate effect size against active interventions. No correlation was found between treatment outcomes and methodological rigour. Limitations may include limited study numbers, the use of a single coder, a need for more in-depth analyses of variation in form VR intervention, and omission of presence as a moderating factor. The current review supports VR interventions as efficacious, promising forms of psychological treatment. Use of reporting guidelines such as the CONSORT and CONSORT-EHEALTH statements should promote greater emphasis on methodological rigour, providing a firm foundation for the further development of clinical VR applications. Copyright © 2014 Elsevier Ltd. All rights reserved.

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

PubMed Central

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

2016-01-01

Objectives Authors may choose to work with professional medical writers when writing up their research for publication. We examined the relationship between medical writing support and the quality and timeliness of reporting of the results of randomised controlled trials (RCTs). Design Cross-sectional study. Study sample Primary reports of RCTs published in BioMed Central journals from 2000 to 16 July 2014, subdivided into those with medical writing support (n=110) and those without medical writing support (n=123). Main outcome measures Proportion of items that were completely reported from a predefined subset of the Consolidated Standards of Reporting Trials (CONSORT) checklist (12 items known to be commonly poorly reported), overall acceptance time (from manuscript submission to editorial acceptance) and quality of written English as assessed by peer reviewers. The effect of funding source and publication year was examined. Results The number of articles that completely reported at least 50% of the CONSORT items assessed was higher for those with declared medical writing support (39.1% (43/110 articles); 95% CI 29.9% to 48.9%) than for those without (21.1% (26/123 articles); 95% CI 14.3% to 29.4%). Articles with declared medical writing support were more likely than articles without such support to have acceptable written English (81.1% (43/53 articles); 95% CI 67.6% to 90.1% vs 47.9% (23/48 articles); 95% CI 33.5% to 62.7%). The median time of overall acceptance was longer for articles with declared medical writing support than for those without (167 days (IQR 114.5–231 days) vs 136 days (IQR 77–193 days)). Conclusions In this sample of open-access journals, declared professional medical writing support was associated with more complete reporting of clinical trial results and higher quality of written English. Medical writing support may play an important role in raising the quality of clinical trial reporting. PMID:26899254

Quality of Reporting Nutritional Randomized Controlled Trials in Patients With Cystic Fibrosis.

PubMed

Daitch, Vered; Babich, Tanya; Singer, Pierre; Leibovici, Leonard

2016-08-01

Randomized controlled trials (RCTs) have a major role in the making of evidence-based guidelines. The aim of the present study was to critically appraise the RCTs that addressed nutritional interventions in patients with cystic fibrosis. Embase, PubMed, and the Cochrane Library were systematically searched until July 2015. Methodology and reporting of nutritional RCTs were evaluated by the Consolidated Standards of Reporting Trials (CONSORT) checklist and additional dimensions relevant to patients with CF. Fifty-one RCTs were included. Full details on methods were provided in a minority of studies. The mean duration of intervention was <6 months. 56.9% of the RCTs did not define a primary outcome; 70.6% of studies did not provide details on sample size calculation; and only 31.4% reported on the subgroup or separated between important subgroups. The examined RCTs were characterized by a weak methodology, a small number of patients with no sample size calculations, a relatively short intervention, and many times did not examine the outcomes that are important to the patient. Improvement over the years has been minor.

Strengthening the Reporting of Observational Studies in Epidemiology for Newborn Infection (STROBE-NI): an extension of the STROBE statement for neonatal infection research.

PubMed

Fitchett, Elizabeth J A; Seale, Anna C; Vergnano, Stefania; Sharland, Michael; Heath, Paul T; Saha, Samir K; Agarwal, Ramesh; Ayede, Adejumoke I; Bhutta, Zulfiqar A; Black, Robert; Bojang, Kalifa; Campbell, Harry; Cousens, Simon; Darmstadt, Gary L; Madhi, Shabir A; Meulen, Ajoke Sobanjo-Ter; Modi, Neena; Patterson, Janna; Qazi, Shamim; Schrag, Stephanie J; Stoll, Barbara J; Wall, Stephen N; Wammanda, Robinson D; Lawn, Joy E

2016-10-01

Neonatal infections are estimated to account for a quarter of the 2·8 million annual neonatal deaths, as well as approximately 3% of all disability-adjusted life-years. Despite this burden, few data are available on incidence, aetiology, and outcomes, particularly regarding impairment. We aimed to develop guidelines for improved scientific reporting of observational neonatal infection studies, to increase comparability and to strengthen research in this area. This checklist, Strengthening the Reporting of Observational Studies in Epidemiology for Newborn Infection (STROBE- NI), is an extension of the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) statement. STROBE-NI was developed following systematic reviews of published literature (1996-2015), compilation of more than 130 potential reporting recommendations, and circulation of a survey to relevant professionals worldwide, eliciting responses from 147 professionals from 37 countries. An international consensus meeting of 18 participants (with expertise in infectious diseases, neonatology, microbiology, epidemiology, and statistics) identified priority recommendations for reporting, additional to the STROBE statement. Implementation of these STROBE-NI recommendations, and linked checklist, aims to improve scientific reporting of neonatal infection studies, increasing data utility and allowing meta-analyses and pathogen-specific burden estimates to inform global policy and new interventions, including maternal vaccines. Copyright © 2016 Elsevier Ltd. All rights reserved.

Reporting of participant flow diagrams in published reports of randomized trials

PubMed Central

2011-01-01

Background Reporting of the flow of participants through each stage of a randomized trial is essential to assess the generalisability and validity of its results. We assessed the type and completeness of information reported in CONSORT (Consolidated Standards of Reporting Trials) flow diagrams published in current reports of randomized trials. Methods A cross sectional review of all primary reports of randomized trials which included a CONSORT flow diagram indexed in PubMed core clinical journals (2009). We assessed the proportion of parallel group trial publications reporting specific items recommended by CONSORT for inclusion in a flow diagram. Results Of 469 primary reports of randomized trials, 263 (56%) included a CONSORT flow diagram of which 89% (237/263) were published in a CONSORT endorsing journal. Reports published in CONSORT endorsing journals were more likely to include a flow diagram (62%; 237/380 versus 29%; 26/89). Ninety percent (236/263) of reports which included a flow diagram had a parallel group design, of which 49% (116/236) evaluated drug interventions, 58% (137/236) were multicentre, and 79% (187/236) compared two study groups, with a median sample size of 213 participants. Eighty-one percent (191/236) reported the overall number of participants assessed for eligibility, 71% (168/236) the number excluded prior to randomization and 98% (231/236) the overall number randomized. Reasons for exclusion prior to randomization were more poorly reported. Ninety-four percent (223/236) reported the number of participants allocated to each arm of the trial. However, only 40% (95/236) reported the number who actually received the allocated intervention, 67% (158/236) the number lost to follow up in each arm of the trial, 61% (145/236) whether participants discontinued the intervention during the trial and 54% (128/236) the number included in the main analysis. Conclusions Over half of published reports of randomized trials included a diagram showing the flow of participants through the trial. However, information was often missing from published flow diagrams, even in articles published in CONSORT endorsing journals. If important information is not reported it can be difficult and sometimes impossible to know if the conclusions of that trial are justified by the data presented. PMID:22141446

"Every Child Counts": Testing Policy Effectiveness Using a Randomised Controlled Trial, Designed, Conducted and Reported to CONSORT Standards

ERIC Educational Resources Information Center

Torgerson, Carole; Wiggins, Andy; Torgerson, David; Ainsworth, Hannah; Hewitt, Catherine

2013-01-01

We report a randomised controlled trial evaluation of an intensive one-to-one numeracy programme--"Numbers Count"--which formed part of the previous government's numeracy policy intervention--"Every Child Counts." We rigorously designed and conducted the trial to CONSORT guidelines. We used a pragmatic waiting list design to…

Consort 1 flight results: a synopsis.

PubMed

Wessling, F C; Lundquist, C A; Maybee, G W

1990-09-01

Consort 1 was the first low gravity materials processing payload to be launched by a commercially licensed rocket in the U.S.A. It carried six experiments which operated as planned during approx. 7 min of suborbital, low gravity flight (10(-5) g) and were returned in excellent condition to the investigators within 4 h of launch. Nearly 150 physical samples supported by measurements and photographs made during the flight were obtained for analysis. In addition to the experimental data returned, the success of Consort 1 demonstrated the ability of industry, working with university centers and government agencies, to rapidly prepare and launch payloads. A brief description of the rocket flight and payload configuration is given. Experiment objectives and methods are described and preliminary results and conclusions are presented.

Your Unofficial Job-Application Checklist

ERIC Educational Resources Information Center

Perlmutter, David D.

2012-01-01

A month ago, the author wrote about the "official" materials one submits for a tenure-track academic hire, like a statement of one's teaching philosophy and a list of references. But in the Internet age, the "unofficial" part of an application is what exists about a person online. In 2009 the author wrote columns about the role of social media,…

A Procedure for Evaluating Environmental Impact.

ERIC Educational Resources Information Center

Leopold, Luna B.; And Others

This report contains one of the first procedures available to environmental impact statements. The heart of the system is a matrix which is general enough to be used as a reference checklist or a reminder of the full range of actions and impacts on the environment that may relate to any proposed action. This comparatively simple system is intended…

48 CFR 2937.103-70 - Department of Labor checklist to aid analysis and review of requirements for service contracts.

Code of Federal Regulations, 2011 CFR

2011-10-01

... and open competition)? (4) Is the statement of work performance-based to the maximum extent possible... significantly influence agency policy development or decision-making? (2) Does the quality assurance plan... access to source selection or proprietary information not available to other offerors competing for the...

Dimorphic ejaculates and sperm release strategies associated with alternative mating behaviors in the squid.

PubMed

Apostólico, Lígia H; Marian, José E A R

2017-11-01

Sperm competition is a powerful postcopulatory selective force influencing male adaptations associated with increasing fertilization success, and it is usually related to the evolution of different strategies of ejaculate expenditure between individuals. Ejaculates may also be influenced by additional selective pressures associated with sperm competition, such as timing between insemination and fertilization, female reproductive tract morphology, and fertilization environment. Also, males that adopt alternative mating tactics may face distinct sperm competition pressures, which may lead to the evolution of intraspecific diversity in ejaculates. In loliginid squids, males with alternative reproductive tactics (sneakers and consorts) differ not only in mating behavior, but also transfer spermatophores into two distinct sites within the female. Here, we compared structure and functioning of spermatophores between sneakers and consorts in the squid Doryteuthis plei applying microscopy techniques and in vitro experiments. Sneakers and consorts exhibit differences in spermatophore structure that lead to distinct spermatophoric reactions and spermatangium morphologies. Moreover, in sneakers, sperm release lasts longer and their sperm show an aggregative behavior not detected in consorts. Slow sperm release may be a strategy to guarantee longer sperm provision, given the wide interval between sneaker mating and egg release. For consorts, in turn, intense and quick sperm discharge may be advantageous, as timing between mating and egg-laying is relatively short. Within the complex squid mating system, factors such as (i) different fertilization sites and (ii) interval between mating and egg release may also influence sperm competition, and ultimately shape the evolution of divergent ejaculates between dimorphic males. © 2017 Wiley Periodicals, Inc.

Low level laser therapy and hair regrowth: an evidence-based review.

PubMed

Zarei, Mina; Wikramanayake, Tongyu C; Falto-Aizpurua, Leyre; Schachner, Lawrence A; Jimenez, Joaquin J

2016-02-01

Despite the current treatment options for different types of alopecia, there is a need for more effective management options. Recently, low-level laser therapy (LLLT) was evaluated for stimulating hair growth. Here, we reviewed the current evidence on the LLLT effects with an evidence-based approach, focusing more on randomized controlled studies by critically evaluating them. In order to investigate whether in individuals presenting with hair loss (male pattern hair loss (MPHL), female pattern hair loss (FPHL), alopecia areata (AA), and chemotherapy-induced alopecia (CIA)) LLLT is effective for hair regrowth, several databases including PubMed, Google Scholar, Medline, Embase, and Cochrane Database were searched using the following keywords: Alopecia, Hair loss, Hair growth, Low level laser therapy, Low level light therapy, Low energy laser irradiation, and Photobiomodulation. From the searches, 21 relevant studies were summarized in this review including 2 in vitro, 7 animal, and 12 clinical studies. Among clinical studies, only five were randomized controlled trials (RCTs), which evaluated LLLT effect on male and female pattern hair loss. The RCTs were critically appraised using the created checklist according to the Critical Appraisal for Therapy Articles Worksheet created by the Center of Evidence-Based Medicine, Oxford. The results demonstrated that all the performed RCTs have moderate to high quality of evidence. However, only one out of five studies performed intention-to-treat analysis, and only another study reported the method of randomization and subsequent concealment of allocation clearly; all other studies did not include this very important information in their reports. None of these studies reported the treatment effect of factors such as number needed to treat. Based on this review on all the available evidence about effect of LLLT in alopecia, we found that the FDA-cleared LLLT devices are both safe and effective in patients with MPHL and FPHL who did not respond or were not tolerant to standard treatments. Future randomized controlled trials of LLLT are strongly encouraged to be conducted and reported according to the Consolidated Standards of Reporting Trials (CONSORT) statement to facilitate analysis and comparison.

Illness Management & Recovery (IMR) in the Netherlands; a naturalistic pilot study to explore the feasibility of a randomized controlled trial.

PubMed

Roosenschoon, Bert-Jan; van Weeghel, Jaap; Bogaards, Moniek; Deen, Mathijs L; Mulder, Cornelis L

2016-11-09

Illness Management & Recovery (IMR) is a curriculum-based program for people with severe and persistent mental illness. To date, four randomized controlled trials (RCTs) have been published on it. As these produced mixed results, we conducted a pilot study to test the feasibility of conducting a new RCT in a Dutch psychiatric institute. Because our primary objective was to evaluate support for implementing IMR on a broader scale, we examined participant recruitment, client outcomes, and clients' and clinicians' satisfaction. Secondary objectives were to evaluate fidelity, trainers' training and supervision, and to explore program duration, dropout, and client characteristics related to dropout. For reporting, we used the checklist for pilot studies adopted from the CONSORT Statement. This program evaluation included a process-evaluation and an outcome evaluation with a One Group Pre-Posttest Design (N = 81). Interviews and internal reports were used to monitor participant numbers, program duration, dropout, and completers' characteristics. Clients' and clinicians' satisfaction and provision of trainers' training and supervision were assessed through interviews. Fidelity was assessed on the IMR Fidelity Scale; client outcomes were assessed on the IMR scale (client and clinician versions) and the Recovery Markers Questionnaire (RMQ). Eighty-one participants were recruited of 167 people who were assessed for eligibility. Completers and clinicians were satisfied, and scores for completers improved significantly on the IMR scale (clinician version) (d = 0.84) and RMQ (d = 0.52), and not significantly on the IMR scale client version (d = 0.41). Mean fidelity was good, but three groups had only moderate fidelity. Our feasibility criterion for trainers' education and supervision was partly attained. Dropout from treatment was 51 %; female participants and people who scored higher on both IMR-scales at baseline had a significantly lower chance of dropping out. The duration of IMR varied (M = 12.7 months, SD = 2.87). Results suggested that feasibility of conducting an RCT on IMR was good. Special attention is required to fidelity, IMR duration, trainers' education and supervision, and dropout, especially of men. One study limitation was our inability to conduct follow-up measurements of non-completers.

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.

Preoperative flap-site injection with ropivacaine and epinephrine in BABA robotic and endoscopic thyroidectomy safely reduces postoperative pain: A CONSORT-compliant double-blinded randomized controlled study (PAIN-BREKOR trial).

PubMed

Lee, Joon-Hyop; Suh, Yong Joon; Song, Ra-Yeong; Yi, Jin Wook; Yu, Hyeong Won; Kwon, Hyungju; Choi, June Young; Lee, Kyu Eun

2017-06-01

Clinical trials on bilateral axillo-breast approach (BABA) thyroidectomy show that levobupivacaine and ropivacaine significantly reduce postoperative pain, but they focused on BABA robotic thyroidectomy only and did not identify specific sites of significant pain relief. Our objective was to assess the pain reduction at various sites and safety of ropivacaine-epinephrine flap injection in BABA thyroidectomy. This prospective double-blinded randomized controlled trial was conducted in compliance with the revised CONSORT statement (ClinicalTrials.gov registration no. NCT02112370). Patients were randomized into the ropivacaine-epinephrine arm or control (normal saline) arm. From January 2014 to May 2016, 148 patients participated. The primary endpoint was site-specific pain, as measured by numeric rating scale 12 hours after surgery. The ropivacaine-epinephrine group exhibited significantly less swallowing difficulty (P = .008), anterior neck pain (P = .016), and right (P = .019) and left (P = .035) chest pain. Secondary endpoints were systolic (P = .402), diastolic (P = .827) blood pressure, and pulse rate (P = .397) after injection before incision and during surgery. The vital signs of the groups just after injection did not differ. During surgery, the ropivacaine-epinephrine patients had higher pulse rates (99 ± 13.3 vs 88 ± 16.1, P < .001) but within normal range. There were no adverse events such as postoperative nausea and vomiting. There was no significant difference in pain scores in either patient group between patients who underwent robotic or endoscopic interventions. BABA flap-site injection with ropivacaine and epinephrine mix before incision effectively and safely reduced postoperative pain. Future studies should focus on tailoring ropivacaine and epinephrine dosage for individuals.

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

2015-06-01

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). 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. Copyright © 2014 The Authors. Published by Elsevier B.V. All rights reserved.

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.

Scientific and technological results from the Consort rocket program.

PubMed

Naumann, R J

1995-12-01

The Consort suborbital rocket program was initiated to allow industrial researchers working through the various NASA Centers for Commercial Development of Space to have ready access to 6 to 7 min of microgravity environment for the purpose of trying out new ideas and for testing apparatus being developed for longer duration Shuttle flights. The 6 Consort flights have provided a wealth of experimental data, some of which has not been published in the open literature. The purpose of this paper is to document the experiments that have been flown and what has been learned. A fairly extensive bibliography of the published results has been included, and the investigator team responsible for the various experiments has been included so that interested parties may contact the various investigators directly for more details.

The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement: guidelines for reporting observational studies.

PubMed

von Elm, Erik; Altman, Douglas G; Egger, Matthias; Pocock, Stuart J; Gøtzsche, Peter C; Vandenbroucke, Jan P

2014-12-01

Much biomedical research is observational. The reporting of such research is often inadequate, which hampers the assessment of its strengths and weaknesses and of a study's generalisability. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Initiative developed recommendations on what should be included in an accurate and complete report of an observational study. We defined the scope of the recommendations to cover three main study designs: cohort, case-control, and cross-sectional studies. We convened a 2-day workshop in September 2004, with methodologists, researchers, and journal editors to draft a checklist of items. This list was subsequently revised during several meetings of the coordinating group and in e-mail discussions with the larger group of STROBE contributors, taking into account empirical evidence and methodological considerations. The workshop and the subsequent iterative process of consultation and revision resulted in a checklist of 22 items (the STROBE Statement) that relate to the title, abstract, introduction, methods, results, and discussion sections of articles. 18 items are common to all three study designs and four are specific for cohort, case-control, or cross-sectional studies. A detailed Explanation and Elaboration document is published separately and is freely available on the Web sites of PLoS Medicine, Annals of Internal Medicine, and Epidemiology. We hope that the STROBE Statement will contribute to improving the quality of reporting of observational studies. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

New insights on antimicrobial efficacy of copper surfaces in the healthcare environment: a systematic review.

PubMed

Chyderiotis, S; Legeay, C; Verjat-Trannoy, D; Le Gallou, F; Astagneau, P; Lepelletier, D

2018-03-29

Hospital-acquired infections (HAIs) are a major public health issue. The potential of antimicrobial copper surfaces in reducing HAIs' rates is of interest but remains unclear. We conducted a systematic review of studies assessing the activity of copper surfaces (colony-forming unit (CFU)/surface, both in vitro and in situ) as well as clinical studies. In vitro study protocols were analysed through a tailored checklist developed specifically for this review, in situ studies and non-randomized clinical studies were assessed using the ORION (Outbreak Reports and Intervention studies Of Nosocomial infection) checklist and randomized clinical studies using the CONSORT guidelines. The search was conducted using PubMed database with the keywords 'copper' and 'surfaces' and 'healthcare associated infections' or 'antimicrobial'. References from relevant articles, including reviews, were assessed and added when appropriate. Articles were added until 30 August 2016. Overall, 20 articles were selected for review including 10 in vitro, eight in situ and two clinical studies. Copper surfaces were found to have variable antimicrobial activity both in vitro and in situ, although the heterogeneity in the designs and the reporting of the results prevented conclusions from being drawn regarding their spectrum and activity/time compared to controls. Copper effect on HAIs incidence remains unclear because of the limited published data and the lack of robust designs. Most studies have potential conflicts of interest with copper industries. Copper surfaces have demonstrated an antimicrobial activity but the implications of this activity in healthcare settings are still unclear. No clear effect on healthcare associated infections has been demonstrated yet. Copyright © 2018 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

Medical students' agenda-setting abilities during medical interviews.

PubMed

Roh, HyeRin; Park, Kyung Hye; Jeon, Young-Jee; Park, Seung Guk; Lee, Jungsun

2015-06-01

Identifying patients' agendas is important; however, the extent of Korean medical students' agenda-setting abilities is unknown. The study aim was to investigate the patterns of Korean medical students' agenda solicitation. A total of 94 third-year medical students participated. One scenario involving a female patient with abdominal pain was created. Students were video-recorded as they interviewed the patient. To analyze whether students identify patients' reasons for visiting, a checklist was developed based on a modified version of the Calgary-Cambridge Guide to the Medical Interview: Communication Process checklist. The duration of the patient's initial statement of concerns was measured in seconds. The total number of patient concerns expressed before interruption and the types of interruption effected by the medical students were determined. The medical students did not explore the patients' concerns and did not negotiate an agenda. Interruption of the patient's opening statement occurred in 4.62±2.20 seconds. The most common type of initial interruption was a recompleter (79.8%). Closed-ended questions were the most common question type in the second and third interruptions. Agenda setting should be emphasized in the communication skills curriculum of medical students. The Korean Clinical Skills Exam must assess medical students' ability to set an agenda.

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

2015-01-07

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 three 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).To encourage dissemination of the TRIPOD Statement, this article is freely accessible on the Annals of Internal Medicine Web site (www.annals.org) and will be also published in BJOG, British Journal of Cancer, British Journal of Surgery, BMC Medicine, The BMJ, Circulation, Diabetic Medicine, European Journal of Clinical Investigation, European Urology, and Journal of Clinical Epidemiology. The authors jointly hold the copyright of this article. An accompanying explanation and elaboration article is freely available only on www.annals.org; Annals of Internal Medicine holds copyright for that article. © BMJ Publishing Group Ltd 2014.

System safety checklist Skylab program report

NASA Technical Reports Server (NTRS)

Mcnail, E. M.

1974-01-01

Design criteria statement applicable to a wide variety of flight systems, experiments and other payloads, associated ground support equipment and facility support systems are presented. The document reflects a composite of experience gained throughout the aerospace industry prior to Skylab and additional experience gained during the Skylab Program. It has been prepared to provide current and future program organizations with a broad source of safety-related design criteria and to suggest methods for systematic and progressive application of the criteria beginning with preliminary development of design requirements and specifications. Recognizing the users obligation to shape the checklist to his particular needs, a summary of the historical background, rationale, objectives, development and implementation approach, and benefits based on Skylab experience has been included.

Quality of patient-reported outcome reporting across cancer randomized controlled trials according to the CONSORT patient-reported outcome extension: A pooled analysis of 557 trials.

PubMed

Efficace, Fabio; Fayers, Peter; Pusic, Andrea; Cemal, Yeliz; Yanagawa, Jane; Jacobs, Marc; la Sala, Andrea; Cafaro, Valentina; Whale, Katie; Rees, Jonathan; Blazeby, Jane

2015-09-15

The main objectives of this study were to identify the number of randomized controlled trials (RCTs) including a patient-reported outcome (PRO) endpoint across a wide range of cancer specialties and to evaluate the completeness of PRO reporting according to the Consolidated Standards of Reporting Trials (CONSORT) PRO extension. RCTs with a PRO endpoint that had been performed across several cancer specialties and published between 2004 and 2013 were considered. Studies were evaluated on the basis of previously defined criteria, including the CONSORT PRO extension and the Cochrane Collaboration's tool for assessing the risk of bias of RCTs. Analyses were also conducted by the type of PRO endpoint (primary vs secondary) and by the cancer disease site. A total of 56,696 potentially eligible records were scrutinized, and 557 RCTs with a PRO evaluation, enrolling 254,677 patients overall, were identified. PROs were most frequently used in RCTs of breast (n = 123), lung (n = 85), and colorectal cancer (n = 66). Overall, PROs were secondary endpoints in 421 RCTs (76%). Four of 6 evaluated CONSORT PRO items were documented in less than 50% of the RCTs. The level of reporting was higher in RCTs with a PRO as a primary endpoint. The presence of a supplementary report was the only statistically significant factor associated with greater completeness of reporting for both RCTs with PROs as primary endpoints (β = .19, P = .001) and RCTs with PROs as secondary endpoints (β = .30, P < .001). Implementation of the CONSORT PRO extension is equally important across all cancer specialties. Its use can also contribute to revealing the robust PRO design of some studies, which might be obscured by poor outcome reporting. © 2015 American Cancer Society.

[Report quality of randomized controlled trials of moxibustion for knee osteoarthritis based on CONSORT and STRICTOM].

PubMed

Xiong, Jun; Zhu, Daocheng; Chen, Rixin; Ye, Wenguo

2015-08-01

The report quality of randomized controlled trials (RCTs) of moxibustion for knee osteoarthritis (KOA) in China was evaluated by Consolidated Standards for Reporting of Trials (CONSORT) and Standards for Reporting Interventions in Controlled Trials of Moxibustion (STRICTOM). Computer and manual retrieval was used. Four databases of China National Knowledge Infrastructure (CNKD, China Biomedicine (CBM), VIP and WNFANG were searched in combination with manual retrieval for relevant journals to screen the literature that: met the inclusive criteria, and CONSORT and STRICTOM were used to assess the report quality. A total of 52 RCTs were included. It was found that unclear description of random methods, low use of blind methods, no allocation concealment, no sample size calculation, no intention-to-treat analysis,inadequate report of moxibustion details and no mention of practitioners background existed in the majority of the RCTs. Although the quality of RCTs of moxibustion for KOA was generally low, reducing the reliability and homogeneous comparability of the reports ,the quality of heat-sensitive moxibustion RCTs was high. It was believed that in order to improve the reliability and quality of RCTs of moxibustion, CONSORT and STRICTOM should be introduced into the RCT design of moxibustion and be strictly performed.

Practitioners' opinions on Food and Nutrition Care Indicators in assisted living facilities for older adults.

PubMed

Chao, Shirley Y; Dwyer, Johanna T; Houser, Robert F; Tennstedt, Sharon; Jacques, Paul

2008-09-01

This study assessed the utility of the 57-indicator Food and Nutrition Care Indicators Checklist for assessing food and nutrition services in assisted-living facilities for older adults among registered dietitians (RDs). They were members of two American Dietetic Association practice groups focusing on aging and long-term care and were also employed in assisted-living facilities. The 1,281 respondents rated the importance of each checklist item and provided their views on the role of assisted-living facilities and their level of agreement with statements regarding the importance of residents' autonomy for making food choices and their ability to make wise dietary choices. Registered dietitians practicing in assisted-living facilities considered all of the domains on food and nutrition quality indicators on the Food and Nutrition Care Indicators Checklist to be highly important (92% of dining room environment items, 83% of foodservice operations, 92% of general nutrition, and 89% of therapeutic nutrition items). They preferred a service style that included both health and amenities, as did national health and aging experts. Registered dietitians should work with other professionals to further validate the checklist, promote its use, and establish optimal service models for food and nutrition services in assisted-living facilities for older adults.

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.

Use of the kalamazoo essential elements communication checklist (adapted) in an institutional interpersonal and communication skills curriculum.

PubMed

Joyce, Barbara L; Steenbergh, Timothy; Scher, Eric

2010-06-01

This study examined the psychometric properties of the Kalamazoo Essential Elements Communication Checklist (Adapted) (KEECC-A), which addresses 7 key elements of physician communication identified in the Kalamazoo Consensus Statement, in a sample of 135 residents in multiple specialties at a large urban medical center in 2008-2009. The KEECC-A was used by residents, standardized patients, and faculty as the assessment tool in a broader institutional curriculum initiative. Three separate KEECC-A scores (self-ratings, faculty ratings, and standardized patient ratings) were calculated for each resident to assess the internal consistency and factor structure of the checklist. In addition, we analyzed KEECC-A ratings by gender and US versus international medical graduates, and collected American Board of Internal Medicine Patient Satisfaction Questionnaire (PSQ) scores for a subsample of internal medicine residents (n  =  28) to examine the relationship between this measure and the KEECC-A ratings to provide evidence of convergent validity. The KEECC-A ratings generated by faculty, standardized patients, and the residents themselves demonstrated a high degree of internal consistency. Factor analyses of the 3 different sets of KEECC-A ratings produced a consistent single-factor structure. We could not examine the relationship between KEECC-A and the PSQ because of substantial range restriction in PSQ scores. No differences were seen in the communication scores of men versus women. Faculty rated US graduates significantly higher than international medical graduates. Our study provides evidence for the reliability and validity of the KEECC-A as a measure of physician communication skills. The KEECC-A appears to be a psychometrically sound, user-friendly communication tool, linked to an expert consensus statement, that can be quickly and accurately completed by multiple raters across diverse specialties.

The Quality of Randomized Controlled Trials in Pediatric Orthopaedics: Are We Improving?

PubMed

Dodwell, Emily; Dua, Shiv; Dulai, Sukhdeep K; Astone, Kristina; Mulpuri, Kishore

2015-01-01

The quality of randomized controlled trials (RCTs) in orthopaedics is a topic of considerable importance, as RCTs play a major role in guiding clinical practice. The quality of RCTs published between 1995 and 2005 has previously been documented. The purpose of the current study was to assess and describe the quality of pediatric orthopaedic RCTs published from 2005 to 2012, by identifying study characteristics associated with higher quality and outlining areas for improvement. A standardized literature search was used to identify pediatric orthopaedic RCTs published in 7 well-recognized journals between September 2005 and July 2012 inclusive. The Detsky Quality Assessment Scale and the CONSORT checklist for Non-Pharmacologic Trials were used to assess the quality of the RCTs. Scores for the Detsky and CONSORT were calculated by 2 independent blinded orthopaedic surgeon reviewers with epidemiologic training. Forty RCTs were included in this analysis. The mean percentage score on the Detsky quality scale was 67%. Sixteen (40%) of the articles satisfied the threshold for a satisfactory level of methodological quality (Detsky >75%). Twenty-five (63%) of these studies were negative studies, concluding no difference between treatment arms. In 52% of the negative studies, an a priori sample size analysis was absent, and 28% were self-described as underpowered. In multiple variable regression analysis, only working with a statistician was significantly associated with higher Detsky percentage scores (P=0.01). There is a trend for improving quality in pediatric orthopaedic RCTs. Compared with past reports, the mean Detsky score improved from 53% to 67%, and the proportion meeting an acceptable level of quality improved from 19% to 40%. One of the most concerning findings of this study was the lack of attention to sample size and power analysis, and the potential for underpowered studies. Ongoing efforts are necessary to improve the conduct and reporting of clinical trials in pediatric orthopaedics. Pediatric orthopaedic surgeons, JPO, and POSNA are working toward improving levels of quality in pediatric orthopaedic research. This paper highlights progress that has been made, and addresses some high-yield areas for future improvement.

A protocol of a cross-sectional study evaluating an online tool for early career peer reviewers assessing reports of randomised controlled trials.

PubMed

Chauvin, Anthony; Moher, David; Altman, Doug; Schriger, David L; Alam, Sabina; Hopewell, Sally; Shanahan, Daniel R; Recchioni, Alessandro; Ravaud, Philippe; Boutron, Isabelle

2017-09-15

Systematic reviews evaluating the impact of interventions to improve the quality of peer review for biomedical publications highlighted that interventions were limited and have little impact. This study aims to compare the accuracy of early career peer reviewers who use an innovative online tool to the usual peer reviewer process in evaluating the completeness of reporting and switched primary outcomes in completed reports. This is a cross-sectional study of individual two-arm parallel-group randomised controlled trials (RCTs) published in the BioMed Central series medical journals, BMJ , BMJ Open and Annals of Emergency Medicine and indexed with the publication type 'Randomised Controlled Trial'. First, we will develop an online tool and training module based (a) on the Consolidated Standards of Reporting Trials (CONSORT) 2010 checklist and the Explanation and Elaboration document that would be dedicated to junior peer reviewers for assessing the completeness of reporting of key items and (b) the Centre for Evidence-Based Medicine Outcome Monitoring Project process used to identify switched outcomes in completed reports of the primary results of RCTs when initially submitted. Then, we will compare the performance of early career peer reviewers who use the online tool to the usual peer review process in identifying inadequate reporting and switched outcomes in completed reports of RCTs at initial journal submission. The primary outcome will be the mean number of items accurately classified per manuscript. The secondary outcomes will be the mean number of items accurately classified per manuscript for the CONSORT items and the sensitivity, specificity and likelihood ratio to detect the item as adequately reported and to identify a switch in outcomes. We aim to include 120 RCTs and 120 early career peer reviewers. The research protocol was approved by the ethics committee of the INSERM Institutional Review Board (21 January 2016). The study is based on voluntary participation and informed written consent. NCT03119376. © 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.

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

PubMed

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

2016-02-21

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

Nonspecific aerobic vaginitis and pregnancy.

PubMed

Curzik, D; Drazancić, A; Hrgović, Z

2001-01-01

During the period 1996-1998, cervical swabs of 50 pregnant women with subacute amniotic infection syndrome (AIS) and the semen of their consorts were bacteriologically analyzed. In the control group were 50 healthy pregnant women and their consorts too. Pathogenic bacteria (the most common were Escherichia coli, Staphylococcus haemolyticus, Chlamydia trachomatis and Ureaplasma urealyticum) were isolated from the cervical swab of 50 pregnant patients with AIS in 86.0% of them, while in the control group of healthy pregnant women in 28.0%. Pathogenic bacteria were present in 70.0% of semen of consorts pregnant women with AIS and only in 30.0% of semen of the control group. The congruity of pathogenic bacteria in the cervical swab and semen in the investigated group was 69.2%, while only 35.7% in the control group. Following erythromycin, cefuroxime and local tetracyclin treatment, the negativization of the cervical swab resulted in 30 pregnant patients with AIS, while the colonization persisted in 20 of them. The outcome of pregnancy was significantly better in cases with negativization of the cervical swab: perinatal loss was 6.7%, while in cases with persistent infection it was 55.0%. The authors presume the amniotic infection syndrome should be ascending manifestation of nonspecific vaginitis, which is maintained by the consort's urogenital infection. AIS should be classified as a 'sexually-transmitted disease'. Copyright 2001 S. Karger AG, Basel

STARD 2015 guidelines for reporting diagnostic accuracy studies: explanation and elaboration

PubMed Central

Cohen, Jérémie F; Korevaar, Daniël A; Altman, Douglas G; Bruns, David E; Gatsonis, Constantine A; Hooft, Lotty; Irwig, Les; Levine, Deborah; Reitsma, Johannes B; de Vet, Henrica C W; Bossuyt, Patrick M M

2016-01-01

Diagnostic accuracy studies are, like other clinical studies, at risk of bias due to shortcomings in design and conduct, and the results of a diagnostic accuracy study may not apply to other patient groups and settings. Readers of study reports need to be informed about study design and conduct, in sufficient detail to judge the trustworthiness and applicability of the study findings. The STARD statement (Standards for Reporting of Diagnostic Accuracy Studies) was developed to improve the completeness and transparency of reports of diagnostic accuracy studies. STARD contains a list of essential items that can be used as a checklist, by authors, reviewers and other readers, to ensure that a report of a diagnostic accuracy study contains the necessary information. STARD was recently updated. All updated STARD materials, including the checklist, are available at http://www.equator-network.org/reporting-guidelines/stard. Here, we present the STARD 2015 explanation and elaboration document. Through commented examples of appropriate reporting, we clarify the rationale for each of the 30 items on the STARD 2015 checklist, and describe what is expected from authors in developing sufficiently informative study reports. PMID:28137831

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.

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.

Environmental Impact Statement for Proposed Closure of Myrtle Beach Air Force Base, South Carolina

DTIC Science & Technology

1990-05-01

1983 Checklist of North American Birds. 6th ed. Allen Press, Inc., Lawrence, Kansas. Beckett , T. 1971 A Summary of Red-Cockaded Woodpecker...Representative Liston Barfield Myrtle Beach City Council Representative Kenneth Corbett Honorable Phil Newsome Representative Dick Elliott Myrtle Beach...Honorable Phil Tighman Briarcliffe Acres Town Council Mayor of North Myrtle Beach Honorable Debra Carter Honorable James P. Grappo Briarcliffe Acres Town

Reporting guidance considerations from a statistical perspective: overview of tools to enhance the rigour of reporting of randomised trials and systematic reviews.

PubMed

Hutton, Brian; Wolfe, Dianna; Moher, David; Shamseer, Larissa

2017-05-01

Research waste has received considerable attention from the biomedical community. One noteworthy contributor is incomplete reporting in research publications. When detailing statistical methods and results, ensuring analytic methods and findings are completely documented improves transparency. For publications describing randomised trials and systematic reviews, guidelines have been developed to facilitate complete reporting. This overview summarises aspects of statistical reporting in trials and systematic reviews of health interventions. A narrative approach to summarise features regarding statistical methods and findings from reporting guidelines for trials and reviews was taken. We aim to enhance familiarity of statistical details that should be reported in biomedical research among statisticians and their collaborators. We summarise statistical reporting considerations for trials and systematic reviews from guidance documents including the Consolidated Standards of Reporting Trials (CONSORT) Statement for reporting of trials, the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Statement for trial protocols, the Statistical Analyses and Methods in the Published Literature (SAMPL) Guidelines for statistical reporting principles, the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) Statement for systematic reviews and PRISMA for Protocols (PRISMA-P). Considerations regarding sharing of study data and statistical code are also addressed. Reporting guidelines provide researchers with minimum criteria for reporting. If followed, they can enhance research transparency and contribute improve quality of biomedical publications. Authors should employ these tools for planning and reporting of their research. 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/.

Needs of disabled children and their families.

PubMed Central

Milner, J; Bungay, C; Jellinek, D; Hall, D M

1996-01-01

In the new NHS those who provide services for disabled children need to measure and demonstrate their effectiveness, but there are no easily available outcome measures for use by child development centres and teams. The development of an alternative approach, using a series of statements of good practice, is described. Parents of children with cerebral palsy were asked to participate in semistructured interviews, to ascertain the value and relevance of these quality statements. Parents were most concerned about the standard of news breaking and early follow up, the sharing of information, and the supply and repair of equipment. The findings were used to modify the quality checklist and it is proposed that this should form the basis of a "charter for disabled children and their families'. PMID:8957952

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.

Are Peer Reviewers Encouraged to Use Reporting Guidelines? A Survey of 116 Health Research Journals

PubMed Central

Hirst, Allison; Altman, Douglas G.

2012-01-01

Background Pre-publication peer review of manuscripts should enhance the value of research publications to readers who may wish to utilize findings in clinical care or health policy-making. Much published research across all medical specialties is not useful, may be misleading, wasteful and even harmful. Reporting guidelines are tools that in addition to helping authors prepare better manuscripts may help peer reviewers in assessing them. We examined journals' instructions to peer reviewers to see if and how reviewers are encouraged to use them. Methods We surveyed websites of 116 journals from the McMaster list. Main outcomes were 1) identification of online instructions to peer reviewers and 2) presence or absence of key domains within instructions: on journal logistics, reviewer etiquette and addressing manuscript content (11 domains). Findings Only 41/116 journals (35%) provided online instructions. All 41 guided reviewers about the logistics of their review processes, 38 (93%) outlined standards of behaviour expected and 39 (95%) contained instruction about evaluating the manuscript content. There was great variation in explicit instruction for reviewers about how to evaluate manuscript content. Almost half of the online instructions 19/41 (46%) mentioned reporting guidelines usually as general statements suggesting they may be useful or asking whether authors had followed them rather than clear instructions about how to use them. All 19 named CONSORT for reporting randomized trials but there was little mention of CONSORT extensions. PRISMA, QUOROM (forerunner of PRISMA), STARD, STROBE and MOOSE were mentioned by several journals. No other reporting guideline was mentioned by more than two journals. Conclusions Although almost half of instructions mentioned reporting guidelines, their value in improving research publications is not being fully realised. Journals have a responsibility to support peer reviewers. We make several recommendations including wider reference to the EQUATOR Network online library (www.equator-network.org/). PMID:22558178

Consort 1 sounding rocket flight

NASA Technical Reports Server (NTRS)

Wessling, Francis C.; Maybee, George W.

1989-01-01

This paper describes a payload of six experiments developed for a 7-min microgravity flight aboard a sounding rocket Consort 1, in order to investigate the effects of low gravity on certain material processes. The experiments in question were designed to test the effect of microgravity on the demixing of aqueous polymer two-phase systems, the electrodeposition process, the production of elastomer-modified epoxy resins, the foam formation process and the characteristics of foam, the material dispersion, and metal sintering. The apparatuses designed for these experiments are examined, and the rocket-payload integration and operations are discussed.

Behavioural ecology: transient sexual mimicry leads to fertilization.

PubMed

Hanlon, Roger T; Naud, Marié-Jose; Shaw, Paul W; Havenhand, Jon N

2005-01-20

Sexual mimicry among animals is widespread, but does it impart a fertilization advantage in the widely accepted 'sneak-guard' model of sperm competition? Here we describe field results in which a dramatic facultative switch in sexual phenotype by sneaker-male cuttlefish leads to immediate fertilization success, even in the presence of the consort male. These results are surprising, given the high rate at which females reject copulation attempts by males, the strong mate-guarding behaviour of consort males, and the high level of sperm competition in this complex mating system.

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

Effectiveness and implementation aspects of interventions for preventing falls in elderly people in long-term care facilities: a systematic review of RCTs.

PubMed

Neyens, Jacques C; van Haastregt, Jolanda C; Dijcks, Béatrice P; Martens, Mark; van den Heuvel, Wim J; de Witte, Luc P; Schols, Jos M

2011-07-01

There is extensive literature on interventions to prevent or reduce falls in elderly people. These findings, however, were based mainly on studies of community-living persons. The primary aim of the present study was to report the effectiveness and implementation aspects of interventions aimed at reducing falls in elderly residents in long-term care facilities: a systematic review of randomized controlled trials (RCTs). MEDLINE, EMBASE, CINAHL, and hand searching of reference lists of included RCTs. RCTs that assessed fall incidents (falls, fallers, recurrent fallers, fall-related injuries) among elderly residents in long-term care facilities were included in this narrative review. Two independent reviewers abstracted data: general program characteristics (setting, population, intervention program) and outcomes, detailed program characteristics (assessment, intervention content, individually tailored, multidisciplinary), and implementation aspects (feasibility, implications for practice). The CONSORT Statement 2001 Checklist was used regarding the quality of reporting RCTs. Twenty trials met the inclusion criteria. Seven trials, 4 multifactorial and 3 monofactorial, showed a significant reduction in the fall rate, the percentage of recurrent fallers, or both the fall rate and the percentage of persons sustaining femoral fractures. The positive effective programs were as follows: a comprehensive structured individual assessment with specific safety recommendations; a multidisciplinary program including general strategies tailored to the setting and strategies tailored specifically to residents; a multifaceted intervention including education, environmental adaptation, balance, resistance training, and hip protector; calcium plus vitamin D supplementation; vitamin D supplementation; a clinical medication review; and a multifactorial intervention (fall risk evaluation, specific and general interventions). In general, because of the limited number of included trials, the evidence is inconclusive for multifaceted and single interventions in long-term care facilities. Most of the reviewed studies did not find a significant positive effect on fall incidents. However, our data support the conclusions of Gillespie et al. that multifactorial interventions in long-term care populations seem more likely to be beneficial. However, single interventions (eg, targeting vitamin D insufficiency) can be effective. Furthermore, a careful approach is needed as programs to prevent falls in these settings may be ineffective or even may have adverse effects. This may occur especially when a program is not feasible for the setting in which it is implemented. Copyright © 2011 American Medical Directors Association. Published by Elsevier Inc. All rights reserved.

Standards for Reporting Implementation Studies (StaRI): explanation and elaboration document

PubMed Central

Pinnock, Hilary; Barwick, Melanie; Carpenter, Christopher R; Eldridge, Sandra; Grandes, Gonzalo; Griffiths, Chris J; Rycroft-Malone, Jo; Meissner, Paul; Murray, Elizabeth; Patel, Anita; Sheikh, Aziz; Taylor, Stephanie J C

2017-01-01

Objectives Implementation studies are often poorly reported and indexed, reducing their potential to inform the provision of healthcare services. The Standards for Reporting Implementation Studies (StaRI) initiative aims to develop guidelines for transparent and accurate reporting of implementation studies. Methods An international working group developed the StaRI guideline informed by a systematic literature review and e-Delphi prioritisation exercise. Following a face-to-face meeting, the checklist was developed iteratively by email discussion and critical review by international experts. Results The 27 items of the checklist are applicable to the broad range of study designs employed in implementation science. A key concept is the dual strands, represented as 2 columns in the checklist, describing, on the one hand, the implementation strategy and, on the other, the clinical, healthcare or public health intervention being implemented. This explanation and elaboration document details each of the items, explains the rationale and provides examples of good reporting practice. Conclusions Previously published reporting statements have been instrumental in improving reporting standards; adoption by journals and authors may achieve a similar improvement in the reporting of implementation strategies that will facilitate translation of effective interventions into routine practice. PMID:28373250

The explicit mentioning of reporting guidelines in urogynecology journals in 2013: A bibliometric study.

PubMed

Koch, Marianne; Riss, Paul; Umek, Wolfgang; Hanzal, Engelbert

2016-03-01

Poor reporting of research may limit critical appraisal and reproducibility, whereas adherence to reporting guidelines (RG) can guarantee completeness and transparency. We aimed to determine the explicit citing of RGs (CONSORT, PRISMA, STROBE) in urogynecology articles in 2013, the requirements of relevant journals and a potential difference between urogynecology and general gynecology journals. All urogynecologic articles published between January and December 2013 in the journals NAU, IUJ, FPMRS, GREEN, AJOG, and BJOG were included. Issues were searched for systematic reviews, RCTs, cohort studies, case-control studies and cross-sectional studies. Each electronic article was searched for the term PRISMA, CONSORT, or STROBE according to the study design. Instructions to Authors of the six journals were screened for requirement of using RGs. We included 296 articles (243 observational studies, 40 RCTs, and 13 systematic reviews). The use of PRISMA guidelines was explicitly declared in 54% of systematic reviews, CONSORT guidelines were referenced in 25% of RCTs and STROBE in 1.2% of observational studies. The use of CONSORT is required by all journals except FPMRS. PRISMA and STROBE are only compulsory in the journals GREEN, AJOG, and BJOG. The overall rate of explicit mentioning of RGs comparing urogynecology and general gynecology journals was 6.7% versus 7.1%, respectively. The explicit mentioning of RGs was on a relatively low level. A slightly higher adherence was recognized among general gynecology journals compared to urogynecology journals. Stronger efforts should be taken to further promote the use of RGs in urogynecology. © 2015 Wiley Periodicals, Inc.

Integrative omics analysis reveals differentially distributed proteins in dimorphic euspermatozoa of the squid, Loligo bleekeri.

PubMed

Yoshida, Masa-aki; Yamada, Lixy; Ochi, Hiroe; Iwata, Yoko; Tamura-Nakano, Miwa; Sawada, Hitoshi; Sauer, Warwick H H; Ogura, Atsushi; Hirohashi, Noritaka

2014-08-01

In the coastal squid Loligo bleekeri, each male produces one of two types of fertilization-competent spermatozoa (eusperm) that exhibit morphological and behavioral differences. Large "consort" males produce short-tailed spermatozoa that display free-swimming behavior when ejaculated into seawater. Small "sneaker" males, on the other hand, produce long-tailed spermatozoa that exhibit a self-swarming trait after ejaculation. To understand the molecular basis for adaptive traits employed by alternative male mating tactics, we performed the transcriptome deep sequencing (RNA-seq) and proteome analyses to search for differences in testicular mRNAs and sperm proteins, respectively. From mature male testes we identified a total of 236,455 contigs (FPKM ≧1) where 3789 and 2789 were preferentially (≧10-fold) expressed in consort and sneaker testes, respectively. A proteomic analysis detected 4302 proteins in the mature sperm as post-translational products. A strongly biased (≧10-fold) distribution occurred in 55 consort proteins and 61 sneaker proteins. There was no clear mRNA-protein correlation, making a ballpark estimate impossible for not only overall protein abundance but also the degree of biased sperm type expressed in the spermatozoa. A family encoding dynein heavy chain gene, however, was found to be biased towards sneakers, whereas many enzymes involving energy metabolism were heavily biased towards consort spermatozoa. The difference in flagellar length matched exactly the different amount of tubulins. From these results we hypothesize that discrete differential traits in dimorphic eusperm arose from a series of innovative alterations in the intracellular components of spermatozoa. Copyright © 2014 Elsevier Inc. All rights reserved.

Safety, Tolerability and Efficacy of Drugs for Treating Behavioural Insomnia in Children with Attention-Deficit/Hyperactivity Disorder: A Systematic Review with Methodological Quality Assessment.

PubMed

Anand, Shweta; Tong, Henry; Besag, Frank M C; Chan, Esther W; Cortese, Samuele; Wong, Ian C K

2017-06-01

A large proportion of paediatric patients with attention-deficit/hyperactivity disorder (ADHD) have associated sleep problems which not only affect the child's wellbeing but also impact family functioning. Management of sleep problems is consequently an important aspect of overall ADHD management in paediatric patients. Although some drugs are being used off-label for the management of paediatric insomnia, there is scant clinical evidence supporting their use. Our aim was to identify and assess the quality of published studies reporting the safety, tolerability and efficacy of drugs used for treating behavioural insomnia in children with ADHD. After an initial screen to determine which drugs were most commonly used, we conducted a systematic review of English-language publications from searches of PubMed, EMBASE, PsycINFO and two trial register databases to February 2017, using keywords 'clonidine', 'melatonin', 'zolpidem', 'eszopiclone', 'L-theanine', 'guanfacine', 'ADHD', 'sleep disorder' and 'children'. For quality assessment of included studies, we used the CONSORT checklist for randomised control trials (RCTs) and the Downs and Black checklist for non-RCTs. Twelve studies were included. Two case series for clonidine, two RCTs and four observational studies for melatonin and one RCT each for zolpidem, eszopiclone, L-theanine and guanfacine. Of the 12 included studies, only one on eszopiclone scored excellent for quality. The quality of the rest of the studies varied from moderate to low. For clonidine, melatonin and L-theanine, improvements in sleep-onset latency and total sleep duration were reported; however, zolpidem, eszopiclone and guanfacine failed to show any improvement when compared with placebo. Clonidine, melatonin, L-theanine, eszopiclone and guanfacine were well tolerated with mild to moderate adverse events; zolpidem was associated with neuropsychiatric adverse effects. There is generally poor evidence for prescribing drugs for behavioural insomnia in children with ADHD. Further controlled studies are warranted.

Examination of participant flow in the CONSORT diagram can improve the understanding of the generalizability of study results.

PubMed

Andrade, Chittaranjan

2015-11-01

A fundamental principle in research is that the findings of a study can only be generalized to the population from which the sample of the study was drawn. What this population was can be discerned from an examination of the study selection criteria. Additional insights can sometimes be gleaned from the study flowchart or CONSORT diagram, which may show sample attenuation between subject screening and final recruitment. Such sample attenuation, if present, implies further limitation to the generalizability of the study outcomes. Two large, 2-year, randomized controlled maintenance therapy trials are described to illustrate sample attenuation that limits study generalizability, one in the context of mindfulness-based cognitive therapy versus antidepressant drugs for recurrent major depressive disorder and the other in the context of quetiapine versus placebo for bipolar disorder. Readers therefore need to examine both study selection criteria and the CONSORT diagram in order to better understand the extent to which study results apply to the patients whom they see. © Copyright 2015 Physicians Postgraduate Press, Inc.

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.

Has the quality of reporting in periodontology changed in 14 years? A systematic review.

PubMed

Leow, Natalie M; Hussain, Zahra; Petrie, Aviva; Donos, Nikolaos; Needleman, Ian G

2016-10-01

Quality of reporting randomized controlled trials (RCTs) in periodontology has been poor. Consolidated Standards of Reporting Trials guidelines and an extension for non-pharmacologic trials (CONSORT-NPE), were introduced to aid in improving this. The aim of this study was to assess the quality of reporting in periodontology, changes over the last 14 years, and adherence to CONSORT-NPE. Randomized controlled trials in humans, published in three periodontal journals, from 2013 to 2015 were included. Search was conducted through Medline, Embase and hand searching. One hundred and seventy-three full-text articles included. Two reviewers screened for reporting quality (κ = 0.69, 95% CI 0.60-0.76). 84% of studies (n = 145) described randomization methods, 74% (n = 128) highlighted examiner blinding and 87% (n = 151) accounted for patients at study conclusion. Patient and caregiver blinding was addressed in 50% (n = 70) and 50% (n = 27) of studies respectively. 64% (n = 110) described adequate allocation concealment. Compared with Montenegro et al. (2002, Journal of Dental Research, 81, 866), improvements seen in describing randomization (2002, 16.5%; 2016, 84%), allocation concealment (2002, 6.5%; 2016, 64%), caregiver masking (2002, 17%; 2016, 50%). CONSORT-NPE; 62% (n = 107) had detailed explanations of all treatments, 88% (n = 152) lacked protocols for adherence of caregivers' to an intervention. Only 17% (n = 29) described caregivers' expertise and case volume. Substantial improvements have occurred. Attention is required for statistical analysis of patient losses and masking. CONSORT-NPE aspects were poorly reported. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Perspective: An Extension of the STROBE Statement for Observational Studies in Nutritional Epidemiology (STROBE-nut): Explanation and Elaboration

PubMed Central

Berg, Christina; Forsum, Elisabet; Larsson, Christel; Sonestedt, Emily; Åkesson, Agneta; Lachat, Carl; Hawwash, Dana; Kolsteren, Patrick; Byrnes, Graham; De Keyzer, Willem; Van Camp, John; Cade, Janet E; Greenwood, Darren C; Slimani, Nadia; Cevallos, Myriam; Egger, Matthias; Huybrechts, Inge; Wirfält, Elisabet

2017-01-01

Nutritional epidemiology is an inherently complex and multifaceted research area. Dietary intake is a complex exposure and is challenging to describe and assess, and links between diet, health, and disease are difficult to ascertain. Consequently, adequate reporting is necessary to facilitate comprehension, interpretation, and generalizability of results and conclusions. The STrengthening the Reporting of OBservational studies in Epidemiology (STROBE) statement is an international and collaborative initiative aiming to enhance the quality of reporting of observational studies. We previously presented a checklist of 24 reporting recommendations for the field of nutritional epidemiology, called “the STROBE-nut.” The STROBE-nut is an extension of the general STROBE statement, intended to complement the STROBE recommendations to improve and standardize the reporting in nutritional epidemiology. The aim of the present article is to explain the rationale for, and elaborate on, the STROBE-nut recommendations to enhance the clarity and to facilitate the understanding of the guidelines. Examples from the published literature are used as illustrations, and references are provided for further reading. PMID:28916567

Evaluating psychiatric case-control studies using the STROBE (STrengthening the Reporting of OBservational Studies in Epidemiology) statement.

PubMed

Goi, Pedro Domingues; Goi, Julia Domingues; Cordini, Kariny Larissa; Ceresér, Keila Mendes; Rocha, Neusa Sica da

2014-01-01

Case-control studies are important in developing clinical and public health knowledge. The STROBE statement (STrengthening the Reporting of OBservational Studies in Epidemiology) was developed to establish a checklist of items that should be included in articles reporting observational studies. Our aim was to analyze whether the psychiatric case-control articles published in Brazilian journals with CAPES Qualis rating B1/B2 in 2009 conformed with the STROBE statement. Descriptive study on psychiatric papers published in Brazilian journals, within the Postgraduate Medical Program on Psychiatry, at Universidade Federal do Rio Grande do Sul. All psychiatric case-control studies from Brazilian Qualis B1/B2 journals of psychiatry, neurology and public health in 2009 were analyzed. The four most specific items of the STROBE statement were used to evaluate whether these studies fitted within the case-control parameters: 1) selection of cases and controls; 2) controlling for bias; 3) statistical analysis; and 4) presentation of results. Sixteen case-control studies were identified, of which eleven (68.75%) were in psychiatry-focused journals. From analysis using the STROBE statement, all of the articles conformed with item 1; two (12.5%) completely conformed with item 2; none completely conformed with item 3; and only three (18.8%) conformed with item 4. The case-control studies analyzed here did not completely conform with the four STROBE statement items for case-control design. In view of the inadequate methodology of the published studies, these findings justify focusing on research and methodology and expanding the investigations on adherence of studies to their designs.

The effect of grapefruits (Citrus paradisi) on body weight and cardiovascular risk factors: A systematic review and meta-analysis of randomized clinical trials.

PubMed

Onakpoya, Igho; O'Sullivan, Jack; Heneghan, Carl; Thompson, Matthew

2017-02-11

The aim of this systematic review was to evaluate the evidence for or against the effectiveness of grapefruits (Citrus paradisi) on body weight, blood pressure, and lipid profile. Electronic searches were conducted in MEDLINE, EMBASE, AMED, and the Cochrane Clinical Trials databases to identify relevant human randomized clinical trials (RCTs). Hand searches of bibliographies were also conducted. Only overweight and obese subjects were included. The reporting quality was assessed using the CONSORT checklist, and the strength of the overall body of evidence was rated based on the GRADE criteria. One hundred and fifty four citations were identified and three RCTs with a total of 250 participants were included. The RCTs were of moderate quality. A meta-analysis for change in body weight failed to reveal a significant difference between grapefruits and controls, MD: -0.45 kg (95% CI: -1.06 to 0.16; I 2 = 53%, but analysis revealed a significant decrease in systolic blood pressure, MD: -2.43 mmHg (95% CI: -4.77 to -0.09; I 2 = 0%). Paucity in the number of RCTs, short durations of interventions, and lack of an established minimum effective dose limit the conclusions that can be drawn about the effects of grapefruit on body weight and metabolic parameters. Further clinical trials evaluating the effects of grapefruit are warranted.

Reporting Magnetic Resonance Imaging in Men on Active Surveillance for Prostate Cancer: The PRECISE Recommendations-A Report of a European School of Oncology Task Force.

PubMed

Moore, Caroline M; Giganti, Francesco; Albertsen, Peter; Allen, Clare; Bangma, Chris; Briganti, Alberto; Carroll, Peter; Haider, Masoom; Kasivisvanathan, Veeru; Kirkham, Alex; Klotz, Laurence; Ouzzane, Adil; Padhani, Anwar R; Panebianco, Valeria; Pinto, Peter; Puech, Philippe; Rannikko, Antti; Renard-Penna, Raphaele; Touijer, Karim; Turkbey, Baris; van Poppel, Heinrik; Valdagni, Riccardo; Walz, Jochen; Schoots, Ivo

2017-04-01

Published data on prostate magnetic resonance imaging (MRI) during follow-up of men on active surveillance are lacking. Current guidelines for prostate MRI reporting concentrate on prostate cancer (PCa) detection and staging. A standardised approach to prostate MRI reporting for active surveillance will facilitate the robust collection of evidence in this newly developing area. To develop preliminary recommendations for reporting of individual MRI studies in men on active surveillance and for researchers reporting the outcomes of cohorts of men having MRI on active surveillance. The RAND/UCLA Appropriateness Method was used. Experts in urology, radiology, and radiation oncology developed a set of 394 statements relevant to prostate MRI reporting in men on active surveillance for PCa. Each statement was scored for agreement on a 9-point scale by each panellist prior to a panel meeting. Each statement was discussed and rescored at the meeting. Measures of agreement and consensus were calculated for each statement. The most important statements, derived from both group discussion and scores of agreement and consensus, were used to create the Prostate Cancer Radiological Estimation of Change in Sequential Evaluation (PRECISE) checklist and case report form. Key recommendations include reporting the index lesion size using absolute values at baseline and at each subsequent MRI. Radiologists should assess the likelihood of true change over time (ie, change in size or change in lesion characteristics on one or more sequences) on a 1-5 scale. A checklist of items for reporting a cohort of men on active surveillance was developed. These items were developed based on expert consensus in many areas in which data are lacking, and they are expected to develop and change as evidence is accrued. The PRECISE recommendations are designed to facilitate the development of a robust evidence database for documenting changes in prostate MRI findings over time of men on active surveillance. If used, they will facilitate data collection to distinguish measurement error and natural variability in MRI appearances from true radiologic progression. Few published reports are available on how to use and interpret magnetic resonance imaging for men on active surveillance for prostate cancer. The PRECISE panel recommends that data should be collected in a standardised manner so that natural variation in the appearance and measurement of cancer over time can be distinguished from changes indicating significant tumour progression. Copyright © 2016 European Association of Urology. All rights reserved.

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.

Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 statement.

PubMed

Moher, David; Shamseer, Larissa; Clarke, Mike; Ghersi, Davina; Liberati, Alessandro; Petticrew, Mark; Shekelle, Paul; Stewart, Lesley A

2015-01-01

Systematic reviews should build on a protocol that describes the rationale, hypothesis, and planned methods of the review; few reviews report whether a protocol exists. Detailed, well-described protocols can facilitate the understanding and appraisal of the review methods, as well as the detection of modifications to methods and selective reporting in completed reviews. We describe the development of a reporting guideline, the Preferred Reporting Items for Systematic reviews and Meta-Analyses for Protocols 2015 (PRISMA-P 2015). PRISMA-P consists of a 17-item checklist intended to facilitate the preparation and reporting of a robust protocol for the systematic review. Funders and those commissioning reviews might consider mandating the use of the checklist to facilitate the submission of relevant protocol information in funding applications. Similarly, peer reviewers and editors can use the guidance to gauge the completeness and transparency of a systematic review protocol submitted for publication in a journal or other medium.

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

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

CONSORT to community: translation of an RCT to a large-scale community intervention and learnings from evaluation of the upscaled program.

PubMed

Moores, Carly Jane; Miller, Jacqueline; Perry, Rebecca Anne; Chan, Lily Lai Hang; Daniels, Lynne Allison; Vidgen, Helen Anna; Magarey, Anthea Margaret

2017-11-29

Translation encompasses the continuum from clinical efficacy to widespread adoption within the healthcare service and ultimately routine clinical practice. The Parenting, Eating and Activity for Child Health (PEACH™) program has previously demonstrated clinical effectiveness in the management of child obesity, and has been recently implemented as a large-scale community intervention in Queensland, Australia. This paper aims to describe the translation of the evaluation framework from a randomised controlled trial (RCT) to large-scale community intervention (PEACH™ QLD). Tensions between RCT paradigm and implementation research will be discussed along with lived evaluation challenges, responses to overcome these, and key learnings for future evaluation conducted at scale. The translation of evaluation from PEACH™ RCT to the large-scale community intervention PEACH™ QLD is described. While the CONSORT Statement was used to report findings from two previous RCTs, the REAIM framework was more suitable for the evaluation of upscaled delivery of the PEACH™ program. Evaluation of PEACH™ QLD was undertaken during the project delivery period from 2013 to 2016. Experiential learnings from conducting the evaluation of PEACH™ QLD to the described evaluation framework are presented for the purposes of informing the future evaluation of upscaled programs. Evaluation changes in response to real-time changes in the delivery of the PEACH™ QLD Project were necessary at stages during the project term. Key evaluation challenges encountered included the collection of complete evaluation data from a diverse and geographically dispersed workforce and the systematic collection of process evaluation data in real time to support program changes during the project. Evaluation of large-scale community interventions in the real world is challenging and divergent from RCTs which are rigourously evaluated within a more tightly-controlled clinical research setting. Constructs explored in an RCT are inadequate in describing the enablers and barriers of upscaled community program implementation. Methods for data collection, analysis and reporting also require consideration. We present a number of experiential reflections and suggestions for the successful evaluation of future upscaled community programs which are scarcely reported in the literature. PEACH™ QLD was retrospectively registered with the Australian New Zealand Clinical Trials Registry on 28 February 2017 (ACTRN12617000315314).

Reporting and methodological quality of sample size calculations in cluster randomized trials could be improved: a review.

PubMed

Rutterford, Clare; Taljaard, Monica; Dixon, Stephanie; Copas, Andrew; Eldridge, Sandra

2015-06-01

To assess the quality of reporting and accuracy of a priori estimates used in sample size calculations for cluster randomized trials (CRTs). We reviewed 300 CRTs published between 2000 and 2008. The prevalence of reporting sample size elements from the 2004 CONSORT recommendations was evaluated and a priori estimates compared with those observed in the trial. Of the 300 trials, 166 (55%) reported a sample size calculation. Only 36 of 166 (22%) reported all recommended descriptive elements. Elements specific to CRTs were the worst reported: a measure of within-cluster correlation was specified in only 58 of 166 (35%). Only 18 of 166 articles (11%) reported both a priori and observed within-cluster correlation values. Except in two cases, observed within-cluster correlation values were either close to or less than a priori values. Even with the CONSORT extension for cluster randomization, the reporting of sample size elements specific to these trials remains below that necessary for transparent reporting. Journal editors and peer reviewers should implement stricter requirements for authors to follow CONSORT recommendations. Authors should report observed and a priori within-cluster correlation values to enable comparisons between these over a wider range of trials. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

A research protocol for developing a Point-Of-Care Key Evidence Tool 'POCKET': a checklist for multidimensional evidence reporting on point-of-care in vitro diagnostics.

PubMed

Huddy, Jeremy R; Ni, Melody; Mavroveli, Stella; Barlow, James; Williams, Doris-Ann; Hanna, George B

2015-07-10

Point-of-care in vitro diagnostics (POC-IVD) are increasingly becoming widespread as an acceptable means of providing rapid diagnostic results to facilitate decision-making in many clinical pathways. Evidence in utility, usability and cost-effectiveness is currently provided in a fragmented and detached manner that is fraught with methodological challenges given the disruptive nature these tests have on the clinical pathway. The Point-of-care Key Evidence Tool (POCKET) checklist aims to provide an integrated evidence-based framework that incorporates all required evidence to guide the evaluation of POC-IVD to meet the needs of policy and decisionmakers in the National Health Service (NHS). A multimethod approach will be applied in order to develop the POCKET. A thorough literature review has formed the basis of a robust Delphi process and validation study. Semistructured interviews are being undertaken with POC-IVD stakeholders, including industry, regulators, commissioners, clinicians and patients to understand what evidence is required to facilitate decision-making. Emergent themes will be translated into a series of statements to form a survey questionnaire that aims to reach a consensus in each stakeholder group to what needs to be included in the tool. Results will be presented to a workshop to discuss the statements brought forward and the optimal format for the tool. Once assembled, the tool will be field-tested through case studies to ensure validity and usability and inform refinement, if required. The final version will be published online with a call for comments. Limitations include unpredictable sample representation, development of compromise position rather than consensus, and absence of blinding in validation exercise. The Imperial College Joint Research Compliance Office and the Imperial College Hospitals NHS Trust R&D department have approved the protocol. The checklist tool will be disseminated through a PhD thesis, a website, peer-reviewed publication, academic conferences and formal presentations. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

A writer's guide to education scholarship: Qualitative education scholarship (part 2).

PubMed

Chan, Teresa M; Ting, Daniel K; Hall, Andrew Koch; Murnaghan, Aleisha; Thoma, Brent; McEwen, Jill; Yarris, Lalena M

2018-03-01

Education scholarship can be conducted using a variety of methods, from quantitative experiments to qualitative studies. Qualitative methods are less commonly used in emergency medicine (EM) education research but are well-suited to explore complex educational problems and generate hypotheses. We aimed to review the literature to provide resources to guide educators who wish to conduct qualitative research in EM education. We conducted a scoping review to outline: 1) a list of journals that regularly publish qualitative educational papers; 2) an aggregate set of quality markers for qualitative educational research and scholarship; and 3) a list of quality checklists for qualitative educational research and scholarship. We found nine journals that have published more than one qualitative educational research paper in EM. From the literature, we identified 39 quality markers that were grouped into 10 themes: Initial Grounding Work (preparation, background); Goals, Problem Statement, or Question; Methods (general considerations); Sampling Techniques; Data Collection Techniques; Data Interpretation and Theory Generation; Measures to Optimize Rigour and Trustworthiness; Relevance to the Field; Evidence of Reflective Practice; Dissemination and Reporting. Lastly, five quality checklists were found for guiding educators in reporting their qualitative work. Many problems that EM educators face are well-suited to exploration using qualitative methods. The results of our scoping review provide publication venues, quality indicators, and checklists that may be useful to EM educators embarking on qualitative projects.

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.

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.

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

Extending the PRISMA statement to equity-focused systematic reviews (PRISMA-E 2012): explanation and elaboration.

PubMed

Welch, Vivian; Petticrew, Mark; Petkovic, Jennifer; Moher, David; Waters, Elizabeth; White, Howard; Tugwell, Peter

2016-02-01

The promotion of health equity, the absence of avoidable and unfair differences in health outcomes, is a global imperative. Systematic reviews are an important source of evidence for health decision makers but have been found to lack assessments of the intervention effects on health equity. The Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) is a 27-item checklist intended to improve transparency and reporting of systematic reviews. We developed an equity extension for PRISMA (PRISMA-E 2012) to help systematic reviewers identify, extract, and synthesize evidence on equity in systematic reviews. In this explanation and elaboration article, we provide the rationale for each extension item. These items are additions or modifications to the existing PRISMA statement items, to incorporate a focus on equity. An example of good reporting is provided for each item as well as the original PRISMA item. This explanation and elaboration document is intended to accompany the PRISMA-E 2012 statement and the PRISMA statement to improve understanding of the reporting guideline for users. The PRISMA-E 2012 reporting guideline is intended to improve transparency and completeness of reporting of equity-focused systematic reviews. Improved reporting can lead to better judgment of applicability by policy makers which may result in more appropriate policies and programs and may contribute to reductions in health inequities. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

Strengthening the Reporting of Molecular Epidemiology for Infectious Diseases (STROME-ID): an extension of the STROBE statement.

PubMed

Field, Nigel; Cohen, Ted; Struelens, Marc J; Palm, Daniel; Cookson, Barry; Glynn, Judith R; Gallo, Valentina; Ramsay, Mary; Sonnenberg, Pam; Maccannell, Duncan; Charlett, Andre; Egger, Matthias; Green, Jonathan; Vineis, Paolo; Abubakar, Ibrahim

2014-04-01

Molecular data are now widely used in epidemiological studies to investigate the transmission, distribution, biology, and diversity of pathogens. Our objective was to establish recommendations to support good scientific reporting of molecular epidemiological studies to encourage authors to consider specific threats to valid inference. The statement Strengthening the Reporting of Molecular Epidemiology for Infectious Diseases (STROME-ID) builds upon the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) initiative. The STROME-ID statement was developed by a working group of epidemiologists, statisticians, bioinformaticians, virologists, and microbiologists with expertise in control of infection and communicable diseases. The statement focuses on issues relating to the reporting of epidemiological studies of infectious diseases using molecular data that were not addressed by STROBE. STROME-ID addresses terminology, measures of genetic diversity within pathogen populations, laboratory methods, sample collection, use of molecular markers, molecular clocks, timeframe, multiple-strain infections, non-independence of infectious-disease data, missing data, ascertainment bias, consistency between molecular and epidemiological data, and ethical considerations with respect to infectious-disease research. In total, 20 items were added to the 22 item STROBE checklist. When used, the STROME-ID recommendations should advance the quality and transparency of scientific reporting, with clear benefits for evidence reviews and health-policy decision making. Copyright © 2014 Elsevier Ltd. All rights reserved.

[A standardised German translation of the STAndards for Reporting of Diagnostic accuracy studies (STARD statement)*: Methodological aspects].

PubMed

Breuer, Jan-Philipp; Seeling, Matthes; Barz, Michael; Baldini, Timo; Scholtz, Kathrin; Spies, Claudia

2012-01-01

In order to be comprehensible and comparable scientific data should be reported according to a certain standard. One example is the 'STAndards for Reporting of Diagnostic Accuracy (STARD) Statement', a 25-item checklist for the appropriate conduct and reporting of diagnostic studies. Usually such scientific standards are published in English. The International Society for Pharmacoeconomics and Outcome Research (ISPOR) has developed guidelines for the translation and cultural adaptation of written medical instruments. The aim was to apply these ISPOR criteria to the German translation of the STARD Statement in order to allow for authorisation to be conferred by the original authors. In cooperation with the original authors the STARD statement was translated according to the ISPOR steps: (1) Preparation, (2) Forward Translation, (3) Reconciliation, (4) Back Translation, (5) Back Translation Review, (6) Harmonisation, (7) Cognitive Debriefing, which evaluated comprehensiveness and linguistic style with marks from 1 (very good) to 6 (insufficient), and (8) Review of Cognitive Debriefing Results and Finalisation. Die ISPOR criteria applied reasonably to the translation process, which required the work input and energy of four scientists and one professional translator and 177 accumulated working hours. The cognitive debriefing resulted in average grades 1.62±0.33 and 1.72±0.39 for comprehensiveness and linguistic style, respectively. Finally, the German STARD version was authorised by the original authors. Die ISPOR guidelines seem to be a suitable means to facilitate the structured adaptation of defined criteria for the reporting of studies, such as the STARD statement, to other languages. Copyright © 2012. Published by Elsevier GmbH.

Participation of adults with visual and severe or profound intellectual disabilities: Definition and operationalization.

PubMed

Hanzen, Gineke; van Nispen, Ruth M A; van der Putten, Annette A J; Waninge, Aly

2017-02-01

The available opinions regarding participation do not appear to be applicable to adults with visual and severe or profound intellectual disabilities (VSPID). Because a clear definition and operationalization are lacking, it is difficult for support professionals to give meaning to participation for adults with VSPID. The purpose of the present study was to develop a definition and operationalization of the concept of participation of adults with VSPID. Parents or family members, professionals, and experts participated in an online concept mapping procedure. This procedure includes generating statements, clustering them, and rating their importance. The data were analyzed quantitatively using multidimensional scaling and qualitatively with triangulation. A total of 53 participants generated 319 statements of which 125 were clustered and rated. The final cluster map of the statements contained seven clusters: (1) Experience and discover; (2) Inclusion; (3) Involvement; (4) Leisure and recreation; (5) Communication and being understood; (6) Social relations; and (7) Self-management and autonomy. The average importance rating of the statements varied from 6.49 to 8.95. A definition of participation of this population was developed which included these seven clusters. The combination of the developed definition, the clusters, and the statements in these clusters, derived from the perceptions of parents or family members, professionals, and experts, can be employed to operationalize the construct of participation of adults with VSPID. This operationalization supports professionals in their ability to give meaning to participation in these adults. Future research will focus on using the operationalization as a checklist of participation for adults with VSPID. Copyright © 2016 Elsevier Ltd. All rights reserved.

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.

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.

[How to write high-quality epidemiological research paper Ⅵ. Strengthening the Reporting of Observational Studies in Epidemiology-Nutritional Epidemiology (STROBE-nut)].

PubMed

Ding, C Y; Cao, Y; Yang, C; Sun, F; Zhan, S Y

2017-01-10

Concerns have been raised about the reporting quality in nutritional epidemiology. Therefore, strengthening the reporting of observational studies in epidemiology-nutritional epidemiology (STROBE-nut) has been proposed by extending the STROBE statement to include additional recommendations on issues related to nutritional epidemiology and dietary assessment, aiming to provide more specific guidelines on how to report observational research in the field. This paper presents a brief introduction to STROBE-nut and also an explanation of the key points in the additional items, with an example illustrating the application of the checklist.

Review of guidelines for good practice in decision-analytic modelling in health technology assessment.

PubMed

Philips, Z; Ginnelly, L; Sculpher, M; Claxton, K; Golder, S; Riemsma, R; Woolacoot, N; Glanville, J

2004-09-01

To identify existing guidelines and develop a synthesised guideline plus accompanying checklist. In addition to provide guidance on key theoretical, methodological and practical issues and consider the implications of this research for what might be expected of future decision-analytic models. Electronic databases. A systematic review of existing good practice guidelines was undertaken to identify and summarise guidelines currently available for assessing the quality of decision-analytic models that have been undertaken for health technology assessment. A synthesised good practice guidance and accompanying checklist was developed. Two specific methods areas in decision modelling were considered. The first method's topic is the identification of parameter estimates from published literature. Parameter searches were developed and piloted using a case-study model. The second topic relates to bias in parameter estimates; that is, how to adjust estimates of treatment effect from observational studies where there are risks of selection bias. A systematic literature review was conducted to identify those studies looking at quantification of bias in parameter estimates and the implication of this bias. Fifteen studies met the inclusion criteria and were reviewed and consolidated into a single set of brief statements of good practice. From this, a checklist was developed and applied to three independent decision-analytic models. Although the checklist provided excellent guidance on some key issues for model evaluation, it was too general to pick up on the specific nuances of each model. The searches that were developed helped to identify important data for inclusion in the model. However, the quality of life searches proved to be problematic: the published search filters did not focus on those measures specific to cost-effectiveness analysis and although the strategies developed as part of this project were more successful few data were found. Of the 11 studies meeting the criteria on the effect of selection bias, five concluded that a non-randomised trial design is associated with bias and six studies found 'similar' estimates of treatment effects from observational studies or non-randomised clinical trials and randomised controlled trials (RCTs). One purpose of developing the synthesised guideline and checklist was to provide a framework for critical appraisal by the various parties involved in the health technology assessment process. First, the guideline and checklist can be used by groups that are reviewing other analysts' models and, secondly, the guideline and checklist could be used by the various analysts as they develop their models (to use it as a check on how they are developing and reporting their analyses). The Expert Advisory Group (EAG) that was convened to discuss the potential role of the guidance and checklist felt that, in general, the guidance and checklist would be a useful tool, although the checklist is not meant to be used exclusively to determine a model's quality, and so should not be used as a substitute for critical appraisal. The review of current guidelines showed that although authors may provide a consistent message regarding some aspects of modelling, in other areas conflicting attributes are presented in different guidelines. In general, the checklist appears to perform well, in terms of identifying those aspects of the model that should be of particular concern to the reader. The checklist cannot, however, provide answers to the appropriateness of the model structure and structural assumptions, as these may be seen as a general problem with generic checklists and do not reflect any shortcoming with the synthesised guidance and checklist developed here. The assessment of the checklist, as well as feedback from the EAG, indicated the importance of its use in conjunction with a more general checklist or guidelines on economic evaluation. Further methods research into the following areas would be valuable: the quantification of selection bias in non-controlled studies and in controlled observational studies; the level of bias in the different non-RCT study designs; a comparison of results from RCTs with those from other non-randomised studies; assessment of the strengths and weaknesses of alternative ways to adjust for bias in a decision model; and how to prioritise searching for parameter estimates.

The use of glyburide in the management of gestational diabetes mellitus: a meta-analysis.

PubMed

Zeng, Ya-chang; Li, Mu-jun; Chen, Yue; Jiang, Li; Wang, Su-mei; Mo, Xiao-liang; Li, Bin-Yi

2014-03-01

Glyburide has been used for managing gestational diabetes mellitus (GDM) in a number of countries. It is rather inexpensive. However, its efficacy and safety remain controversial. With this meta-analysis, we evaluated glyburide in comparison with insulin. With a systematic literature search strategy, a total of 93 randomized controlled trials (RCTs) with insulin and glyburide comparison were identified. Based on the revised Consolidated Standards of Reporting Trials (CONSORT) checklist, five of them met the inclusion criteria and were included in this meta-analysis. Six hundred and seventy four subjects were included in these five RCTs. When compared with insulin, glyburide had an increased relative risk (RR) for neonatal hypoglycemia (RR: 1.98; 95% confidence interval [CI]: 1.17, 3.36). Estimation of standard mean differences (SMD) showed that both fetal birth weight and incidence of macrosomia were higher in subjects receiving glyburide than in those receiving insulin (SMD: 0.21; 95% CI: 0.06, 0.36; RR: 2.22; 95% CI: 1.07, 4.61 respectively). There were no significant differences in maternal glucose control, glycated hemoglobin, the rate of Cesarean section, large-for-gestational age, neonatal hypocalcemia, length of stay for neonatal ICU admissions, preterm birth, or congenital anomalies. Our study suggested that in women with GDM, glyburide is as effective as insulin, but the risks of neonatal hypoglycemia, high fetal birth weight, and macrosomia were higher. Copyright © 2014. Published by Elsevier Urban & Partner Sp. z o.o.

Developing a reporting guideline for social and psychological intervention trials

PubMed Central

2013-01-01

Social and psychological interventions are often complex. Understanding randomised controlled trials (RCTs) of these complex interventions requires a detailed description of the interventions tested and the methods used to evaluate them; however, RCT reports often omit, or inadequately report, this information. Incomplete and inaccurate reporting hinders the optimal use of research, wastes resources, and fails to meet ethical obligations to research participants and consumers. In this paper, we explain how reporting guidelines have improved the quality of reports in medicine, and describe the ongoing development of a new reporting guideline for RCTs: CONSORT-SPI (an Extension for social and psychological interventions). We invite readers to participate in the project by visiting our website, in order to help us reach the best-informed consensus on these guidelines (http://tinyurl.com/CONSORT-study). PMID:23915044

Using the STROBE statement to assess reporting in blindness prevalence surveys in low and middle income countries.

PubMed

Ramke, Jacqueline; Palagyi, Anna; Jordan, Vanessa; Petkovic, Jennifer; Gilbert, Clare E

2017-01-01

Cross-sectional blindness prevalence surveys are essential to plan and monitor eye care services. Incomplete or inaccurate reporting can prevent effective translation of research findings. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement is a 32 item checklist developed to improve reporting of observational studies. The aim of this study was to assess the completeness of reporting in blindness prevalence surveys in low and middle income countries (LMICs) using STROBE. MEDLINE, EMBASE and Web of Science databases were searched on April 8 2016 to identify cross-sectional blindness prevalence surveys undertaken in LMICs and published after STROBE was published in December 2007. The STROBE tool was applied to all included studies, and each STROBE item was categorized as 'yes' (met criteria), 'no' (did not meet criteria) or 'not applicable'. The 'Completeness of reporting (COR) score' for each manuscript was calculated: COR score = yes / [yes + no]. In journals with included studies the instructions to authors and reviewers were checked for reference to STROBE. The 89 included studies were undertaken in 32 countries and published in 37 journals. The mean COR score was 60.9% (95% confidence interval [CI] 58.1-63.7%; range 30.8-88.9%). The mean COR score did not differ between surveys published in journals with author instructions referring to STROBE (10/37 journals; 61.1%, 95%CI 56.4-65.8%) or in journals where STROBE was not mentioned (60.9%, 95%CI 57.4-64.3%; p = 0.93). While reporting in blindness prevalence surveys is strong in some areas, others need improvement. We recommend that more journals adopt the STROBE checklist and ensure it is used by authors and reviewers.

Thermographic imaging in sports and exercise medicine: A Delphi study and consensus statement on the measurement of human skin temperature.

PubMed

Moreira, Danilo Gomes; Costello, Joseph T; Brito, Ciro J; Adamczyk, Jakub G; Ammer, Kurt; Bach, Aaron J E; Costa, Carlos M A; Eglin, Clare; Fernandes, Alex A; Fernández-Cuevas, Ismael; Ferreira, José J A; Formenti, Damiano; Fournet, Damien; Havenith, George; Howell, Kevin; Jung, Anna; Kenny, Glen P; Kolosovas-Machuca, Eleazar S; Maley, Matthew J; Merla, Arcangelo; Pascoe, David D; Priego Quesada, Jose I; Schwartz, Robert G; Seixas, Adérito R D; Selfe, James; Vainer, Boris G; Sillero-Quintana, Manuel

2017-10-01

The importance of using infrared thermography (IRT) to assess skin temperature (t sk ) is increasing in clinical settings. Recently, its use has been increasing in sports and exercise medicine; however, no consensus guideline exists to address the methods for collecting data in such situations. The aim of this study was to develop a checklist for the collection of t sk using IRT in sports and exercise medicine. We carried out a Delphi study to set a checklist based on consensus agreement from leading experts in the field. Panelists (n = 24) representing the areas of sport science (n = 8; 33%), physiology (n = 7; 29%), physiotherapy (n = 3; 13%) and medicine (n = 6; 25%), from 13 different countries completed the Delphi process. An initial list of 16 points was proposed which was rated and commented on by panelists in three rounds of anonymous surveys following a standard Delphi procedure. The panel reached consensus on 15 items which encompassed the participants' demographic information, camera/room or environment setup and recording/analysis of t sk using IRT. The results of the Delphi produced the checklist entitled "Thermographic Imaging in Sports and Exercise Medicine (TISEM)" which is a proposal to standardize the collection and analysis of t sk data using IRT. It is intended that the TISEM can also be applied to evaluate bias in thermographic studies and to guide practitioners in the use of this technique. Copyright © 2017 Elsevier Ltd. All rights reserved.

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

Current status of evidence-based sports medicine.

PubMed

Harris, Joshua D; Cvetanovich, Gregory; Erickson, Brandon J; Abrams, Geoffrey D; Chahal, Jaskarndip; Gupta, Anil K; McCormick, Frank M; Bach, Bernard R

2014-03-01

The purpose of this investigation is to determine the proportion of sports medicine studies that are labeled as Level I Evidence in 5 journals and compare the quality of surgical and nonsurgical studies using simple quality assessment tools (Consolidated Standards of Reporting Trials [CONSORT] and Jadad). By use of PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines over the prior 2 years in the top 5 (citation and impact factor based) sports medicine journals, only Level I Evidence studies were eligible for inclusion and were analyzed. All study types (therapeutic, prognostic, diagnostic, and economic) were analyzed. Study quality was assessed with the level of evidence, Jadad score, and CONSORT 2010 guidelines. Study demographic data were compared among journals and between surgical and nonsurgical studies by use of χ(2), 1-way analysis of variance, and 2-sample Z tests. We analyzed 190 Level I Evidence studies (10% of eligible studies) (119 randomized controlled trials [RCTs]). Therapeutic, nonsurgical, single-center studies from the United States were the most common studies published. Sixty-two percent of studies reported a financial conflict of interest. The knee was the most common body part studied, and track-and-field/endurance sports were the most common sports analyzed. Significant differences (P < .05) were shown in Jadad and CONSORT scores among the journals reviewed. Overall, the Jadad and CONSORT scores were 2.71 and 77%, respectively. No differences (P > .05) were shown among journals based on the proportion of Level I studies or appropriate randomization. Significant strengths and limitations of RCTs were identified. This study showed that Level I Evidence and RCTs comprise 10% and 6% of contemporary sports medicine literature, respectively. Therapeutic, nonsurgical, single-center studies are the most common publications with Level I Evidence. Significant differences across sports medicine journals were found in study quality. Surgical studies appropriately described randomization, blinding, and patient enrollment significantly more than nonsurgical studies. Level I, systematic review of Level I studies. Copyright © 2014 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

Going digital: a checklist in preparing for hospital-wide electronic medical record implementation and digital transformation.

PubMed

Scott, Ian A; Sullivan, Clair; Staib, Andrew

2018-05-24

Objective In an era of rapid digitisation of Australian hospitals, practical guidance is needed in how to successfully implement electronic medical records (EMRs) as both a technical innovation and a major transformative change in clinical care. The aim of the present study was to develop a checklist that clearly and comprehensively defines the steps that best prepare hospitals for EMR implementation and digital transformation. Methods The checklist was developed using a formal methodological framework comprised of: literature reviews of relevant issues; an interactive workshop involving a multidisciplinary group of digital leads from Queensland hospitals; a draft document based on literature and workshop proceedings; and a review and feedback from senior clinical leads. Results The final checklist comprised 19 questions, 13 related to EMR implementation and six to digital transformation. Questions related to the former included organisational considerations (leadership, governance, change leaders, implementation plan), technical considerations (vendor choice, information technology and project management teams, system and hardware alignment with clinician workflows, interoperability with legacy systems) and training (user training, post-go-live contingency plans, roll-out sequence, staff support at point of care). Questions related to digital transformation included cultural considerations (clinically focused vision statement and communication strategy, readiness for change surveys), management of digital disruption syndromes and plans for further improvement in patient care (post-go-live optimisation of digital system, quality and benefit evaluation, ongoing digital innovation). Conclusion This evidence-based, field-tested checklist provides guidance to hospitals planning EMR implementation and separates readiness for EMR from readiness for digital transformation. What is known about the topic? Many hospitals throughout Australia have implemented, or are planning to implement, hospital wide electronic medical records (EMRs) with varying degrees of functionality. Few hospitals have implemented a complete end-to-end digital system with the ability to bring about major transformation in clinical care. Although the many challenges in implementing EMRs have been well documented, they have not been incorporated into an evidence-based, field-tested checklist that can practically assist hospitals in preparing for EMR implementation as both a technical innovation and a vehicle for major digital transformation of care. What does this paper add? This paper outlines a 19-question checklist that was developed using a formal methodological framework comprising literature review of relevant issues, proceedings from an interactive workshop involving a multidisciplinary group of digital leads from hospitals throughout Queensland, including three hospitals undertaking EMR implementation and one hospital with complete end-to-end EMR, and review of a draft checklist by senior clinical leads within a statewide digital healthcare improvement network. The checklist distinguishes between issues pertaining to EMR as a technical innovation and EMR as a vehicle for digital transformation of patient care. What are the implications for practitioners? Successful implementation of a hospital-wide EMR requires senior managers, clinical leads, information technology teams and project management teams to fully address key operational and strategic issues. Using an issues checklist may help prevent any one issue being inadvertently overlooked or underemphasised in the planning and implementation stages, and ensure the EMR is fully adopted and optimally used by clinician users in an ongoing digital transformation of care.

The association between gay men's stereotypic beliefs about drag queens and their endorsement of hypermasculinity.

PubMed

Bishop, C J; Kiss, Mark; Morrison, Todd G; Rushe, Damien M; Specht, Jacqueline

2014-01-01

To date, few researchers have investigated gay men's stereotypic beliefs about drag queens and the association between these beliefs and individual difference variables such as hypermasculinity. To address this omission, 118 men self-identifying as non-heterosexual completed an online survey consisting of an adjective checklist about drag queens and a psychometrically sound indicant of hypermasculinity. As predicted, participants who were more likely to endorse hypermasculine belief statements tended to perceive negatively valenced attributes as more characteristic of drag queens. Possible explanations for this relationship, limitations associated with the current study, and directions for future research are delineated.

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.

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.

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

Symptom clusters at midlife: A four-country comparison of checklist and qualitative responses

PubMed Central

Sievert, Lynnette Leidy; Obermeyer, Carla Makhlouf

2011-01-01

Objectives The purpose of this study was to examine the frequency and clustering of somatic symptoms as reported by women aged 45-55 years in four countries, to compare women's responses to open-ended questions with those derived from structured checklists, and to assess the extent to which bodily symptoms grouped with emotional complaints. Methods The Decisions at Menopause Study (DAMES) recruited 1,193 women from the general population in Beirut, Lebanon; Rabat, Morocco; Madrid, Spain; and central Massachusetts. Women participated in semi-structured interviews about health, menopause, and bodily changes at midlife. Women's responses to symptom checklists and their statements in response to open-ended questions were analyzed through factor analysis and textual analysis. Results There was considerable consistency between the frequencies of quantitative and qualitative responses, and the analyses of qualitative data illustrate the extent to which women associate somatic and emotional complaints. In open-ended responses, women in Massachusetts and Spain did not often cluster somatic symptoms together with emotional symptoms. In Morocco, dizziness, fatigue, and headaches were clustered with emotional symptoms. Women in Lebanon explicitly associated shortness of breath, chest pain, palpitations, dizziness, fatigue, gastro-intestinal complaints, headaches, and, to a lesser extent, joint pain and numbness with emotional symptoms. Conclusions The number of volunteered symptom responses was small because respondents were relatively healthy; however, the extent and pattern of association between somatic and emotional symptoms varied across sites. Certain somatic symptoms may be more likely to communicate psychosocial distress in particular cultures. These results have implications for patterns of health care utilization. PMID:22042326

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

2016-01-01

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. PMID:27279674

A systematic review of the PTSD Checklist's diagnostic accuracy studies using QUADAS.

PubMed

McDonald, Scott D; Brown, Whitney L; Benesek, John P; Calhoun, Patrick S

2015-09-01

Despite the popularity of the PTSD Checklist (PCL) as a clinical screening test, there has been no comprehensive quality review of studies evaluating its diagnostic accuracy. A systematic quality assessment of 22 diagnostic accuracy studies of the English-language PCL using the Quality Assessment of Diagnostic Accuracy Studies (QUADAS) assessment tool was conducted to examine (a) the quality of diagnostic accuracy studies of the PCL, and (b) whether quality has improved since the 2003 STAndards for the Reporting of Diagnostic accuracy studies (STARD) initiative regarding reporting guidelines for diagnostic accuracy studies. Three raters independently applied the QUADAS tool to each study, and a consensus among the 4 authors is reported. Findings indicated that although studies generally met standards in several quality areas, there is still room for improvement. Areas for improvement include establishing representativeness, adequately describing clinical and demographic characteristics of the sample, and presenting better descriptions of important aspects of test and reference standard execution. Only 2 studies met each of the 14 quality criteria. In addition, study quality has not appreciably improved since the publication of the STARD Statement in 2003. Recommendations for the improvement of diagnostic accuracy studies of the PCL are discussed. (c) 2015 APA, all rights reserved).

[STandardized Reporting Of Secondary data Analyses (STROSA)—a recommendation].

PubMed

Swart, Enno; Schmitt, Jochen

2014-01-01

Secondary data analyses will play an increasingly important role in health services research. But to date, there is no guideline for the systematic, transparent and complete reporting of secondary data. We investigated whether the STROBE statement, i.e., the recommendations for reporting observational studies, satisfies the specific characteristics of secondary data analyses and whether any specifications/modifications and extensions are necessary. For the majority of the 22 STROBE criteria, specifications and extensions are needed to meet the requirements of systematic, transparent and complete reporting of secondary data analysis. Seven aspects of secondary data analysis not covered by STROBE (legal aspects, data flow, protocol, unit of analysis, internal validations/definitions, advantages of secondary data utilisation, role of data owners) should be considered as a specific complement to STROBE. The so called STROSA (STandardized Reporting Of Secondary data Analyses) checklist therefore includes 29 items that relate to the title/abstract, introduction, methods, results and discussion sections of articles. The STROSA checklist is intended to support authors and readers in the critical appraisal of secondary data analyses. This proposal will now be subject to continued scientific discussions. Copyright © 2014. Published by Elsevier GmbH.

Extending the PRISMA statement to equity-focused systematic reviews (PRISMA-E 2012): explanation and elaboration.

PubMed

Welch, Vivian; Petticrew, Mark; Petkovic, Jennifer; Moher, David; Waters, Elizabeth; White, Howard; Tugwell, Peter

2015-10-08

The promotion of health equity, the absence of avoidable and unfair differences in health outcomes, is a global imperative. Systematic reviews are an important source of evidence for health decision-makers, but have been found to lack assessments of the intervention effects on health equity. The Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) is a 27 item checklist intended to improve transparency and reporting of systematic reviews. We developed an equity extension for PRISMA (PRISMA-E 2012) to help systematic reviewers identify, extract, and synthesise evidence on equity in systematic reviews. In this explanation and elaboration paper we provide the rationale for each extension item. These items are additions or modifications to the existing PRISMA Statement items, in order to incorporate a focus on equity. An example of good reporting is provided for each item as well as the original PRISMA item. This explanation and elaboration document is intended to accompany the PRISMA-E 2012 Statement and the PRISMA Statement to improve understanding of the reporting guideline for users. The PRISMA-E 2012 reporting guideline is intended to improve transparency and completeness of reporting of equity-focused systematic reviews. Improved reporting can lead to better judgement of applicability by policy makers which may result in more appropriate policies and programs and may contribute to reductions in health inequities. To encourage wide dissemination of this article it is accessible on the International Journal for Equity in Health, Journal of Clinical Epidemiology, and Journal of Development Effectiveness web sites.

Catchment virtual observatory for sharing flow and transport models outputs: using residence time distribution to compare contrasting catchments

NASA Astrophysics Data System (ADS)

Thomas, Zahra; Rousseau-Gueutin, Pauline; Kolbe, Tamara; Abbott, Ben; Marcais, Jean; Peiffer, Stefan; Frei, Sven; Bishop, Kevin; Le Henaff, Geneviève; Squividant, Hervé; Pichelin, Pascal; Pinay, Gilles; de Dreuzy, Jean-Raynald

2017-04-01

The distribution of groundwater residence time in a catchment provides synoptic information about catchment functioning (e.g. nutrient retention and removal, hydrograph flashiness). In contrast with interpreted model results, which are often not directly comparable between studies, residence time distribution is a general output that could be used to compare catchment behaviors and test hypotheses about landscape controls on catchment functioning. In this goal, we created a virtual observatory platform called Catchment Virtual Observatory for Sharing Flow and Transport Model Outputs (COnSOrT). The main goal of COnSOrT is to collect outputs from calibrated groundwater models from a wide range of environments. By comparing a wide variety of catchments from different climatic, topographic and hydrogeological contexts, we expect to enhance understanding of catchment connectivity, resilience to anthropogenic disturbance, and overall functioning. The web-based observatory will also provide software tools to analyze model outputs. The observatory will enable modelers to test their models in a wide range of catchment environments to evaluate the generality of their findings and robustness of their post-processing methods. Researchers with calibrated numerical models can benefit from observatory by using the post-processing methods to implement a new approach to analyzing their data. Field scientists interested in contributing data could invite modelers associated with the observatory to test their models against observed catchment behavior. COnSOrT will allow meta-analyses with community contributions to generate new understanding and identify promising pathways forward to moving beyond single catchment ecohydrology. Keywords: Residence time distribution, Models outputs, Catchment hydrology, Inter-catchment comparison

Spillover effects on health outcomes in low- and middle-income countries: a systematic review

PubMed Central

Benjamin-Chung, Jade; Abedin, Jaynal; Berger, David; Clark, Ashley; Jimenez, Veronica; Konagaya, Eugene; Tran, Diana; Arnold, Benjamin F; Hubbard, Alan E; Luby, Stephen P; Miguel, Edward; Colford, John M

2017-01-01

Abstract Background Many interventions delivered to improve health may benefit not only direct recipients but also people in close physical or social proximity. Our objective was to review all published literature about the spillover effects of interventions on health outcomes in low-middle income countries and to identify methods used in estimating these effects. Methods We searched 19 electronic databases for articles published before 2014 and hand-searched titles from 2010 to 2013 in five relevant journals. We adapted the Cochrane Collaboration’s quality grading tool for spillover estimation and rated the quality of evidence. Results A total of 54 studies met inclusion criteria. We found a wide range of terminology used to describe spillovers, a lack of standardization among spillover methods and poor reporting of spillovers in many studies. We identified three primary mechanisms of spillovers: reduced disease transmission, social proximity and substitution of resources within households. We found the strongest evidence for spillovers through reduced disease transmission, particularly vaccines and mass drug administration. In general, the proportion of a population receiving an intervention was associated with improved health. Most studies were of moderate or low quality. We found evidence of publication bias for certain spillover estimates but not for total or direct effects. To facilitate improved reporting and standardization in future studies, we developed a reporting checklist adapted from the CONSORT framework specific to reporting spillover effects. Conclusions We found the strongest evidence for spillovers from vaccines and mass drug administration to control infectious disease. There was little high quality evidence of spillovers for other interventions. PMID:28449030

Short report: Influence of culture and trauma history on autobiographical memory specificity.

PubMed

Humphries, Clare; Jobson, Laura

2012-01-01

This study investigated the influence of culture and trauma history on autobiographical memory specificity. Chinese international and British undergraduate university students (N=64) completed the autobiographical memory test, Hopkins symptom checklist-25, twenty statements test, trauma history questionnaire, and impact of events scale-revised. The results indicated that the British group provided significantly more specific memories than the Chinese group. The high trauma exposure group provided significantly fewer specific autobiographical memories than the low trauma exposure group. The interaction was not significant. The findings suggest that even in cultures where specificity is not as evident in autobiographical remembering style, trauma exposure appears to exert similar influence on autobiographical memory specificity.

Reporting Guidelines for Clinical Pharmacokinetic Studies: The ClinPK Statement.

PubMed

Kanji, Salmaan; Hayes, Meghan; Ling, Adam; Shamseer, Larissa; Chant, Clarence; Edwards, David J; Edwards, Scott; Ensom, Mary H H; Foster, David R; Hardy, Brian; Kiser, Tyree H; la Porte, Charles; Roberts, Jason A; Shulman, Rob; Walker, Scott; Zelenitsky, Sheryl; Moher, David

2015-07-01

Transparent reporting of all research is essential for assessing the validity of any study. Reporting guidelines are available and endorsed for many types of research but are lacking for clinical pharmacokinetic studies. Such tools promote the consistent reporting of a minimal set of information for end users, and facilitate knowledge translation of research. The objective of this study was to create a guideline to assist in the transparent and complete reporting of clinical pharmacokinetic studies. Preliminary content to be considered was identified from a systematic search of the literature and regulatory documents. Stakeholders were identified to participate in a modified Delphi exercise and a virtual meeting to generate consensus for items considered essential in the reporting of clinical pharmacokinetic studies. The proposed checklist was pilot tested on 100 recently published clinical pharmacokinetic studies. Overall and itemized compliance with the proposed guidance was determined for each study. Sixty-eight stakeholders from nine countries consented to participate. Four rounds of a modified Delphi survey and a series of small virtual meetings were required to generate consensus for a 24-item checklist considered to be essential to the reporting of clinical pharmacokinetic studies. When applied to the 100 most recently published clinical pharmacokinetic studies, 45 were determined to be compliant with at least 80 % of the checklist items. Explanatory text was prepared using examples of compliant reporting from these and other relevant studies. The reader's ability to judge the validity of pharmacokinetic research can be greatly compromised by the incomplete reporting of study information. Using consensus methods, we have developed a tool to guide transparent and accurate reporting of clinical pharmacokinetic studies. Endorsement and implementation of these guidelines by researchers, clinicians and journals would promote more consistent reporting of these studies and allow for better assessment of utility for clinical applications.

Using Simulation as an Investigational Methodology to Explore the Impact of Technology on Team Communication and Patient Management: A Pilot Evaluation of the Effect of an Automated Compression Device.

PubMed

Gittinger, Matthew; Brolliar, Sarah M; Grand, James A; Nichol, Graham; Fernandez, Rosemarie

2017-06-01

This pilot study used a simulation-based platform to evaluate the effect of an automated mechanical chest compression device on team communication and patient management. Four-member emergency department interprofessional teams were randomly assigned to perform manual chest compressions (control, n = 6) or automated chest compressions (intervention, n = 6) during a simulated cardiac arrest with 2 phases: phase 1 baseline (ventricular tachycardia), followed by phase 2 (ventricular fibrillation). Patient management was coded using an Advanced Cardiovascular Life Support-based checklist. Team communication was categorized in the following 4 areas: (1) teamwork focus; (2) huddle events, defined as statements focused on re-establishing situation awareness, reinforcing existing plans, and assessing the need to adjust the plan; (3) clinical focus; and (4) profession of team member. Statements were aggregated for each team. At baseline, groups were similar with respect to total communication statements and patient management. During cardiac arrest, the total number of communication statements was greater in teams performing manual compressions (median, 152.3; interquartile range [IQR], 127.6-181.0) as compared with teams using an automated compression device (median, 105; IQR, 99.5-123.9). Huddle events were more frequent in teams performing automated chest compressions (median, 4.0; IQR, 3.1-4.3 vs. 2.0; IQR, 1.4-2.6). Teams randomized to the automated compression intervention had a delay to initial defibrillation (median, 208.3 seconds; IQR, 153.3-222.1 seconds) as compared with control teams (median, 63.2 seconds; IQR, 30.1-397.2 seconds). Use of an automated compression device may impact both team communication and patient management. Simulation-based assessments offer important insights into the effect of technology on healthcare teams.

[Clinical applicability of evidence-based orthopedics--a cross-sectional study of the quality of orthopedic evidence].

PubMed

Vavken, P; Culen, G; Dorotka, R

2008-01-01

The demand to routinely apply evidence-based methods in orthopedic surgery increases steadily. In order to do so, however, the validity and reliability of the "evidence" has to be scrutinized. The object of this study was to assess the quality of the most recent orthopedic evidence and to determine variables that have an influence on quality. All 2006 controlled trials from orthopedic journals with high impact factors were analysed in a cross-sectional study. A score based on the CONSORT statement was used to assess study quality. Selected variables were tested for their influence on the quality of the study. Two independent blinded observers reviewed 126 studies. The overall quality was moderate to high. The most neglected parameters were power analysis, intention-to-treat, and concealment. The participation of a methodologically trained investigator increases study quality significantly. There was no difference in study quality irrespective of whether or not there was statistically significant result. Using our quality score we were able show fairly good results for recent orthopedic studies. The most frequently neglected issues in orthopedic research are blinding, power analysis, and intention-to-treat. This may distort the results of clinical investigations considerably and, especially, lack of concealment causes false-positive findings. Our data show furthermore that participation of a methodologist significantly increases quality of the study and consequently strengthens the reliability of results.

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.

Video modelling and reducing anxiety related to dental injections - a randomised clinical trial.

PubMed

Al-Namankany, A; Petrie, A; Ashley, P

2014-06-01

This study was part of a successfully completed PhD and was presented at the IADR/AADR General Session (2013) in Seattle, Washington, USA. The report of this clinical trial conforms to the CONSORT statement. A randomised controlled trial to investigate if video modelling can influence a child's anxiety before the administration of local anaesthesia (LA). A sample of 180 (6- to 12-year-old) children due to have dental treatments under LA were randomly allocated to the modelling video or the control video (oral hygiene instruction). The level of anxiety was recorded before and after watching the video on the Abeer Children Dental Anxiety Scale (ACDAS) and the child's ability to cope with the subsequent procedure was assessed on the visual analogue scale (VAS). A two group chi-square test was used as the basis for the sample size calculation; a significance level of 0.025 was chosen rather than the conventional 0.05 to avoid spurious results arising from multiple testing. Children in the test group had significantly less anxiety after watching the video than children in the control group throughout the subsequent dental procedure; in particular at the time of the LA administration (p <0.001). Video modelling appeared to be effective at reducing dental anxiety and has a significant impact on needle phobia in children.

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.

Ginning efficiency - research progress

USDA-ARS?s Scientific Manuscript database

In the past few years, there has been a consorted effort between cotton geneticists/breeders, ginning engineers and molecular scientists to understand ‘ginning efficiency’ in upland cotton. Ginning efficiency includes ginning rate (measured in g lint sec-1) and net gin stand energy (measured in Wh k...

Sneaker Male Squid Produce Long-lived Spermatozoa by Modulating Their Energy Metabolism *

PubMed Central

Hirohashi, Noritaka; Tamura-Nakano, Miwa; Nakaya, Fumio; Iida, Tomohiro; Iwata, Yoko

2016-01-01

Spermatozoa released by males should remain viable until fertilization. Hence, sperm longevity is governed by intrinsic and environmental factors in accordance with the male mating strategy. However, whether intraspecific variation of insemination modes can impact sperm longevity remains to be elucidated. In the squid Heterololigo bleekeri, male dimorphism (consort and sneaker) is linked to two discontinuous insemination modes that differ in place and time. Notably, only sneaker male spermatozoa inseminated long before egg spawning can be stored in the seminal receptacle. We found that sneaker spermatozoa exhibited greater persistence in fertilization competence and flagellar motility than consort ones because of a larger amount of flagellar glycogen. Sneaker spermatozoa also showed higher capacities in glucose uptake and lactate efflux. Lactic acidosis was considered to stabilize CO2-triggered self-clustering of sneaker spermatozoa, thus establishing hypoxia-induced metabolic changes and sperm survival. These results, together with comparative omics analyses, suggest that postcopulatory reproductive contexts define sperm longevity by modulating the inherent energy levels and metabolic pathways. PMID:27385589

PRISMA-Children (C) and PRISMA-Protocol for Children (P-C) Extensions: a study protocol for the development of guidelines for the conduct and reporting of systematic reviews and meta-analyses of newborn and child health research.

PubMed

Kapadia, Mufiza Z; Askie, Lisa; Hartling, Lisa; Contopoulos-Ioannidis, Despina; Bhutta, Zulfiqar A; Soll, Roger; Moher, David; Offringa, Martin

2016-04-18

Paediatric systematic reviews differ from adult systematic reviews in several key aspects such as considerations of child tailored interventions, justifiable comparators, valid outcomes and child sensitive search strategies. Available guidelines, including PRISMA-P (2015) and PRISMA (2009), do not cover all the complexities associated with reporting systematic reviews in the paediatric population. Using a collaborative, multidisciplinary structure, we aim to develop evidence-based and consensus-based PRISMA-P-C (Protocol for Children) and PRISMA-C (Children) Extensions to guide paediatric systematic review protocol and completed review reporting. This project's methodology follows published recommendations for developing reporting guidelines and involves the following six phases; (1) establishment of a steering committee representing key stakeholder groups; (2) a scoping review to identify potential Extension items; (3) three types of consensus activities including meetings of the steering committee to achieve high-level decisions on the content and methodology of the Extensions, a survey of key stakeholders to generate a list of possible items to include in the Extensions and a formal consensus meeting to select the reporting items to add to, or modify for, the Extension; (4) the preliminary checklist items generated in phase III will be evaluated against the existing evidence and reporting practices in paediatric systematic reviews; (5) extension statements and explanation and elaboration documents will provide detailed advice for each item and examples of good reporting; (6) development and implementation of effective knowledge translation of the extension checklist, and an evaluation of the Extensions by key stakeholders. This protocol was considered a quality improvement project by the Hospital for Sick Children's Ethics Committee and did not require ethical review. The resultant checklists, jointly developed with all relevant stakeholders, will be disseminated through peer-reviewed journals as well as national and international conference presentations. Endorsement of the checklist will be sought simultaneously in multiple journals. 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/

PRISMA-Children (C) and PRISMA-Protocol for Children (P-C) Extensions: a study protocol for the development of guidelines for the conduct and reporting of systematic reviews and meta-analyses of newborn and child health research

PubMed Central

Kapadia, Mufiza Z; Askie, Lisa; Hartling, Lisa; Contopoulos-Ioannidis, Despina; Bhutta, Zulfiqar A; Soll, Roger; Moher, David; Offringa, Martin

2016-01-01

Introduction Paediatric systematic reviews differ from adult systematic reviews in several key aspects such as considerations of child tailored interventions, justifiable comparators, valid outcomes and child sensitive search strategies. Available guidelines, including PRISMA-P (2015) and PRISMA (2009), do not cover all the complexities associated with reporting systematic reviews in the paediatric population. Using a collaborative, multidisciplinary structure, we aim to develop evidence-based and consensus-based PRISMA-P-C (Protocol for Children) and PRISMA-C (Children) Extensions to guide paediatric systematic review protocol and completed review reporting. Methods and analysis This project's methodology follows published recommendations for developing reporting guidelines and involves the following six phases; (1) establishment of a steering committee representing key stakeholder groups; (2) a scoping review to identify potential Extension items; (3) three types of consensus activities including meetings of the steering committee to achieve high-level decisions on the content and methodology of the Extensions, a survey of key stakeholders to generate a list of possible items to include in the Extensions and a formal consensus meeting to select the reporting items to add to, or modify for, the Extension; (4) the preliminary checklist items generated in phase III will be evaluated against the existing evidence and reporting practices in paediatric systematic reviews; (5) extension statements and explanation and elaboration documents will provide detailed advice for each item and examples of good reporting; (6) development and implementation of effective knowledge translation of the extension checklist, and an evaluation of the Extensions by key stakeholders. Ethics and Dissemination This protocol was considered a quality improvement project by the Hospital for Sick Children's Ethics Committee and did not require ethical review. The resultant checklists, jointly developed with all relevant stakeholders, will be disseminated through peer-reviewed journals as well as national and international conference presentations. Endorsement of the checklist will be sought simultaneously in multiple journals. PMID:27091820

78 FR 46372 - Manufacturer of Controlled Substances; Notice of Application; Apertus Pharmaceuticals

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-31

... DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Application; Apertus Pharmaceuticals Pursuant to Sec. 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), this is notice that on June 14, 2013, Apertus Pharmaceuticals, 331 Consort...

Enhancing transparency in reporting the synthesis of qualitative research: ENTREQ

PubMed Central

2012-01-01

Background The syntheses of multiple qualitative studies can pull together data across different contexts, generate new theoretical or conceptual models, identify research gaps, and provide evidence for the development, implementation and evaluation of health interventions. This study aims to develop a framework for reporting the synthesis of qualitative health research. Methods We conducted a comprehensive search for guidance and reviews relevant to the synthesis of qualitative research, methodology papers, and published syntheses of qualitative health research in MEDLINE, Embase, CINAHL and relevant organisational websites to May 2011. Initial items were generated inductively from guides to synthesizing qualitative health research. The preliminary checklist was piloted against forty published syntheses of qualitative research, purposively selected to capture a range of year of publication, methods and methodologies, and health topics. We removed items that were duplicated, impractical to assess, and rephrased items for clarity. Results The Enhancing transparency in reporting the synthesis of qualitative research (ENTREQ) statement consists of 21 items grouped into five main domains: introduction, methods and methodology, literature search and selection, appraisal, and synthesis of findings. Conclusions The ENTREQ statement can help researchers to report the stages most commonly associated with the synthesis of qualitative health research: searching and selecting qualitative research, quality appraisal, and methods for synthesising qualitative findings. The synthesis of qualitative research is an expanding and evolving methodological area and we would value feedback from all stakeholders for the continued development and extension of the ENTREQ statement. PMID:23185978

Systematic review of the evidence on the effectiveness of sexual and reproductive health interventions in humanitarian crises.

PubMed

Warren, Emily; Post, Nathan; Hossain, Mazeda; Blanchet, Karl; Roberts, Bayard

2015-12-18

This systematic review aims to evaluate evidence on the effectiveness of sexual and reproductive health (SRH) interventions delivered in humanitarian crises. Crisis affected low-income or middle-income countries. Crisis-affected populations in low-income or middle-income countries. Peer-reviewed and grey literature sources were systematically searched for relevant papers detailing interventions from 1 January 1980 until the search date on 30 April 2013. Data from included studies were then extracted, and the papers' quality evaluated using criteria based on modified STROBE and CONSORT checklists. Primary outcomes include, but are not limited to, changes in morbidity, mortality, sexually transmitted infection (STI) diagnosis or gender-based violence. Secondary outcomes include, but are not limited to, reported condom use or skilled attendance at birth. Primary outputs include, but are not limited to, condoms distributed or education courses taught. Of 7149 returned citations, 15 studies met the inclusion criteria. Only one randomised controlled trial was identified. The remaining observational studies were of moderate quality, demonstrating limited use of controls and inadequate attempts to address bias. Evidence of effectiveness was available for the following interventions: impregnated bed nets for pregnant women, subsidised refugee healthcare, female community health workers, and tiered community reproductive health services. The limited evidence base for SRH interventions highlights the need for improved research on the effectiveness of public health interventions in humanitarian crises. While interventions proven efficacious in stable settings are being used in humanitarian efforts, more evidence is required to demonstrate the effectiveness of delivering and scaling-up such interventions in humanitarian crises. 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/

The evidence for Shiatsu: a systematic review of Shiatsu and acupressure

PubMed Central

2011-01-01

Background Shiatsu, similar to acupressure, uses finger pressure, manipulations and stretches, along Traditional Chinese Medicine meridians. Shiatsu is popular in Europe, but lacks reviews on its evidence-base. Methods Acupressure and Shiatsu clinical trials were identified using the MeSH term 'acupressure' in: EBM reviews; AMED; BNI; CINAHL; EMBASE; MEDLINE; PsycARTICLES; Science Direct; Blackwell Synergy; Ingenta Select; Wiley Interscience; Index to Theses and ZETOC. References of articles were checked. Inclusion criteria were Shiatsu or acupressure administered manually/bodily, published after January 1990. Two reviewers performed independent study selection and evaluation of study design and reporting, using standardised checklists (CONSORT, TREND, CASP and STRICTA). Results Searches identified 1714 publications. Final inclusions were 9 Shiatsu and 71 acupressure studies. A quarter were graded A (highest quality). Shiatsu studies comprised 1 RCT, three controlled non-randomised, one within-subjects, one observational and 3 uncontrolled studies investigating mental and physical health issues. Evidence was of insufficient quantity and quality. Acupressure studies included 2 meta-analyses, 6 systematic reviews and 39 RCTs. Strongest evidence was for pain (particularly dysmenorrhoea, lower back and labour), post-operative nausea and vomiting. Additionally quality evidence found improvements in sleep in institutionalised elderly. Variable/poor quality evidence existed for renal disease symptoms, dementia, stress, anxiety and respiratory conditions. Appraisal tools may be inappropriate for some study designs. Potential biases included focus on UK/USA databases, limited grey literature, and exclusion of qualitative and pre-1989 studies. Conclusions Evidence is improving in quantity, quality and reporting, but more research is needed, particularly for Shiatsu, where evidence is poor. Acupressure may be beneficial for pain, nausea and vomiting and sleep. PMID:21982157

QUALITY MANAGEMENT PLAN FOR THE NATIONAL CHILDREN'S STUDY

EPA Science Inventory

EPA has taken the lead, in consort with NIH, in developing the Quality Management Plan (QMP) for the National Children's Study (NCS); the QMP will delineate a systematic planning process for the implementation of the NCS. The QMP will state the goals and objectives of the NCS, th...

A Collaborative, Alternative Teacher Certification Program.

ERIC Educational Resources Information Center

Securro, Samuel, Jr.; And Others

In the summer of 1986, three institutions (West Virginia State College, West Virigina College of Graduate Studies, and West Virgina Institute of Technology) consorted to design an alternative teacher certification program to attract and retain a qualified pool of mathematics and science teachers. Known as the Field-Based Training Program (FBTP),…

Dyadic Death: A Typology.

ERIC Educational Resources Information Center

Berman, Alan L.

1996-01-01

Describes and illustrates distinct types of dyadic death (where a second victim acts in consort with or is killed by a person who then commits suicide). Suggests an organizing dynamic of dyadic death and claims that levels of dominance, dependence-enmeshment, and the presence or absence of hostility influence the proposed typology. (RJM)

The Effect of an Electronic Checklist on Critical Care Provider Workload, Errors, and Performance.

PubMed

Thongprayoon, Charat; Harrison, Andrew M; O'Horo, John C; Berrios, Ronaldo A Sevilla; Pickering, Brian W; Herasevich, Vitaly

2016-03-01

The strategy used to improve effective checklist use in intensive care unit (ICU) setting is essential for checklist success. This study aimed to test the hypothesis that an electronic checklist could reduce ICU provider workload, errors, and time to checklist completion, as compared to a paper checklist. This was a simulation-based study conducted at an academic tertiary hospital. All participants completed checklists for 6 ICU patients: 3 using an electronic checklist and 3 using an identical paper checklist. In both scenarios, participants had full access to the existing electronic medical record system. The outcomes measured were workload (defined using the National Aeronautics and Space Association task load index [NASA-TLX]), the number of checklist errors, and time to checklist completion. Two independent clinician reviewers, blinded to participant results, served as the reference standard for checklist error calculation. Twenty-one ICU providers participated in this study. This resulted in the generation of 63 simulated electronic checklists and 63 simulated paper checklists. The median NASA-TLX score was 39 for the electronic checklist and 50 for the paper checklist (P = .005). The median number of checklist errors for the electronic checklist was 5, while the median number of checklist errors for the paper checklist was 8 (P = .003). The time to checklist completion was not significantly different between the 2 checklist formats (P = .76). The electronic checklist significantly reduced provider workload and errors without any measurable difference in the amount of time required for checklist completion. This demonstrates that electronic checklists are feasible and desirable in the ICU setting. © The Author(s) 2014.

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

PubMed

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

2012-03-01

Randomized controlled trial (RCT) is considered as the gold standard for the efficacy assessment of medicines. With the increasing number of Chinese patent drugs for treatment of type 2 diabetes, the methodology of post-marketing RCTs evaluating the efficacy and specific effect has become more important. To investigate post-marketing Chinese patent drugs for treatment of type 2 diabetes, as well as the methodological quality of post-marketing RCTs. Literature was searched from the books of Newly Compiled Traditional Chinese Patent Medicine and Chinese Pharmacopeia, the websites of the State Food and Drug Administration and the Ministry of Human Resources and Social Security of the People's Republic of China, China National Knowledge Infrastructure Database, Chongqing VIP Chinese Science and Technology Periodical Database, Chinese Biomedical Database (SinoMed) and Wanfang Data. The time period for searching ran from the commencement of each database to August 2011. RCTs of post-marketing Chinese patent drugs for treatment of type 2 diabetes with intervention course no less than 3 months. Two authors independently evaluated the research quality of the RCTs by the checklist of risk bias assessment and the data collection forms based on the CONSORT Statement. Independent double data-extraction was performed. The authors identified a total of 149 Chinese patent drugs for treatment of type 2 diabetes. According to different indicative syndromes, the Chinese patent drugs can be divided into the following types, namely, yin deficiency and interior heat (n=48, 32%), dual deficiency of qi and yin (n=58, 39%) and dual deficiency of qi and yin combined with blood stasis (n=22, 15%). A total of 41 RCTs meeting the inclusion criteria were included. Neither multicenter RCTs nor endpoint outcome reports were found. Risk bias analysis showed that 81% of the included studies reported randomization for grouping without sequence generation, 98% of these studies did not report concealment of random numbers, 5% used placebo, 10% reported outcome attrition bias and no study employed the analysis of intention-to-treat and 98% reported the diagnostic criteria for type 2 diabetes. The participants mainly consisted of outpatients without complications (76%). The minimum and maximum sample size was 40 and 300 (106 ± 60), respectively. The inclusion and exclusion criteria and outcome measures did not match the purposes and contents of post-marketing research in the included studies. They also failed to reflect the basic principles of traditional Chinese medicine in the process of diagnosis and treatment. The demographic characteristics of the patients, the indications for medicine and the syndrome differentiation process were not reported sufficiently and transparently. In order to improve the post-marketing research and promote the rational use of Chinese patent drugs, it is recommended that phase IV clinical trials should establish clear research purpose as well as hypothesis first, and choose scientific and evidence-based study design and outcome measures. In addition, guidelines for implementation of post-marketing research should be developed.

Research Design and Statistical Methods in Indian Medical Journals: A Retrospective Survey

PubMed Central

Hassan, Shabbeer; Yellur, Rajashree; Subramani, Pooventhan; Adiga, Poornima; Gokhale, Manoj; Iyer, Manasa S.; Mayya, Shreemathi S.

2015-01-01

Good quality medical research generally requires not only an expertise in the chosen medical field of interest but also a sound knowledge of statistical methodology. The number of medical research articles which have been published in Indian medical journals has increased quite substantially in the past decade. The aim of this study was to collate all evidence on study design quality and statistical analyses used in selected leading Indian medical journals. Ten (10) leading Indian medical journals were selected based on impact factors and all original research articles published in 2003 (N = 588) and 2013 (N = 774) were categorized and reviewed. A validated checklist on study design, statistical analyses, results presentation, and interpretation was used for review and evaluation of the articles. Main outcomes considered in the present study were – study design types and their frequencies, error/defects proportion in study design, statistical analyses, and implementation of CONSORT checklist in RCT (randomized clinical trials). From 2003 to 2013: The proportion of erroneous statistical analyses did not decrease (χ2=0.592, Φ=0.027, p=0.4418), 25% (80/320) in 2003 compared to 22.6% (111/490) in 2013. Compared with 2003, significant improvement was seen in 2013; the proportion of papers using statistical tests increased significantly (χ2=26.96, Φ=0.16, p<0.0001) from 42.5% (250/588) to 56.7 % (439/774). The overall proportion of errors in study design decreased significantly (χ2=16.783, Φ=0.12 p<0.0001), 41.3% (243/588) compared to 30.6% (237/774). In 2013, randomized clinical trials designs has remained very low (7.3%, 43/588) with majority showing some errors (41 papers, 95.3%). Majority of the published studies were retrospective in nature both in 2003 [79.1% (465/588)] and in 2013 [78.2% (605/774)]. Major decreases in error proportions were observed in both results presentation (χ2=24.477, Φ=0.17, p<0.0001), 82.2% (263/320) compared to 66.3% (325/490) and interpretation (χ2=25.616, Φ=0.173, p<0.0001), 32.5% (104/320) compared to 17.1% (84/490), though some serious ones were still present. Indian medical research seems to have made no major progress regarding using correct statistical analyses, but error/defects in study designs have decreased significantly. Randomized clinical trials are quite rarely published and have high proportion of methodological problems. PMID:25856194

Research design and statistical methods in Indian medical journals: a retrospective survey.

PubMed

Hassan, Shabbeer; Yellur, Rajashree; Subramani, Pooventhan; Adiga, Poornima; Gokhale, Manoj; Iyer, Manasa S; Mayya, Shreemathi S

2015-01-01

Good quality medical research generally requires not only an expertise in the chosen medical field of interest but also a sound knowledge of statistical methodology. The number of medical research articles which have been published in Indian medical journals has increased quite substantially in the past decade. The aim of this study was to collate all evidence on study design quality and statistical analyses used in selected leading Indian medical journals. Ten (10) leading Indian medical journals were selected based on impact factors and all original research articles published in 2003 (N = 588) and 2013 (N = 774) were categorized and reviewed. A validated checklist on study design, statistical analyses, results presentation, and interpretation was used for review and evaluation of the articles. Main outcomes considered in the present study were - study design types and their frequencies, error/defects proportion in study design, statistical analyses, and implementation of CONSORT checklist in RCT (randomized clinical trials). From 2003 to 2013: The proportion of erroneous statistical analyses did not decrease (χ2=0.592, Φ=0.027, p=0.4418), 25% (80/320) in 2003 compared to 22.6% (111/490) in 2013. Compared with 2003, significant improvement was seen in 2013; the proportion of papers using statistical tests increased significantly (χ2=26.96, Φ=0.16, p<0.0001) from 42.5% (250/588) to 56.7 % (439/774). The overall proportion of errors in study design decreased significantly (χ2=16.783, Φ=0.12 p<0.0001), 41.3% (243/588) compared to 30.6% (237/774). In 2013, randomized clinical trials designs has remained very low (7.3%, 43/588) with majority showing some errors (41 papers, 95.3%). Majority of the published studies were retrospective in nature both in 2003 [79.1% (465/588)] and in 2013 [78.2% (605/774)]. Major decreases in error proportions were observed in both results presentation (χ2=24.477, Φ=0.17, p<0.0001), 82.2% (263/320) compared to 66.3% (325/490) and interpretation (χ2=25.616, Φ=0.173, p<0.0001), 32.5% (104/320) compared to 17.1% (84/490), though some serious ones were still present. Indian medical research seems to have made no major progress regarding using correct statistical analyses, but error/defects in study designs have decreased significantly. Randomized clinical trials are quite rarely published and have high proportion of methodological problems.

Using Cloud Collaboration for Writing Assignments by Students with Disabilities: A Case Study Using Action Research

ERIC Educational Resources Information Center

Keane, Kjrsten; Russell, Miriam

2014-01-01

Though separated by geographical distance, a student with disabilities, his advisor, and his writing coach consorted in the Cloud using Google applications to achieve a writing goal. Our scenario demonstrates how emerging technologies can bridge transactional distance and "virtually" supplant face-to-face conferencing around a college…

Ginning efficiency in upland cotton - a value-added trait in cotton improvement

USDA-ARS?s Scientific Manuscript database

In the past few years, there has been some consorted effort between cotton geneticists and ginning engineers to understand "ginning efficiency" in upland cotton. Ginning efficiency includes ginning rate (measured in gm lint sec -1) and net gin stand energy (measured in Wh kg -1 lint). Improved ginn...

Sneaker Male Squid Produce Long-lived Spermatozoa by Modulating Their Energy Metabolism.

PubMed

Hirohashi, Noritaka; Tamura-Nakano, Miwa; Nakaya, Fumio; Iida, Tomohiro; Iwata, Yoko

2016-09-09

Spermatozoa released by males should remain viable until fertilization. Hence, sperm longevity is governed by intrinsic and environmental factors in accordance with the male mating strategy. However, whether intraspecific variation of insemination modes can impact sperm longevity remains to be elucidated. In the squid Heterololigo bleekeri, male dimorphism (consort and sneaker) is linked to two discontinuous insemination modes that differ in place and time. Notably, only sneaker male spermatozoa inseminated long before egg spawning can be stored in the seminal receptacle. We found that sneaker spermatozoa exhibited greater persistence in fertilization competence and flagellar motility than consort ones because of a larger amount of flagellar glycogen. Sneaker spermatozoa also showed higher capacities in glucose uptake and lactate efflux. Lactic acidosis was considered to stabilize CO2-triggered self-clustering of sneaker spermatozoa, thus establishing hypoxia-induced metabolic changes and sperm survival. These results, together with comparative omics analyses, suggest that postcopulatory reproductive contexts define sperm longevity by modulating the inherent energy levels and metabolic pathways. © 2016 by The American Society for Biochemistry and Molecular Biology, Inc.

An assessment of the compliance of systematic review articles published in craniofacial surgery with the PRISMA statement guidelines: A systematic review.

PubMed

Pidgeon, Thomas Edward; Wellstead, Georgina; Sagoo, Harkiran; Jafree, Daniyal J; Fowler, Alexander J; Agha, Riaz A

2016-10-01

Systematic review evidence is increasing within craniofacial surgery. Compliance with recognised reporting guidelines for systematic review evidence has not been assessed. To assess the compliance of systematic reviews published in craniofacial journals with the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting criteria. Thomson Reuters impact factor was used to identify three top craniofacial journals. A search for all systematic review articles published in these journals from 1st May 2010 to 30th April 2015 was conducted using MEDLINE PubMed. Two independent researchers assessed each study for inclusion and performed the data extraction. Data included the article reference information; the pathology and interventions examined and compliance of each review article with the PRISMA checklist. 97 studies were returned by the search. 62 studies proceeded to data extraction. The mean percentage of applicable PRISMA items that were met across all studies was 72.5% (range 28.6-96.2%). The area of poorest compliance was with the declaration of a study protocol (19.4% of studies). Only 37.1% of studies declared their source of funding. Compliance of systematic review articles within craniofacial surgery with areas of the PRISMA checklist could be improved. Copyright © 2016 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

Seroprevalence and risk factors for leptospirosis in cattle, sheep, and goats at consorted rearing from the State of Piauí, northeastern Brazil.

PubMed

Campos, Ângela Piauilino; Miranda, Dayane Francisca Higino; Rodrigues, Huanna Waleska Soares; da Silva Carneiro Lustosa, Micherlene; Martins, Gustavo Henrique Chaves; Mineiro, Ana Lys Bezerra Barradas; Castro, Vanessa; Azevedo, Sérgio Santos; de Sousa Silva, Silvana Maria Medeiros

2017-06-01

Leptospirosis is an endemic disease in Latin America, caused by pathogenic bacteria of the genus Leptospira. It is considered one of the main causes responsible for the negative economic impact on global livestock by causing reproductive problems. The research aimed to determine the prevalence of leptospirosis in cattle, sheep, and goats at consorted rearing in the micro-region of Teresina, Piauí state, northeastern Brazil, as well as to identify prevalent serovars and risk factors associated with seroprevalence. Serum samples were analyzed in 336 sheep, 292 goats, and 253 cattle using microscopic agglutination test (MAT). Overall, 378 samples were positive to MAT, with seroprevalence of 42.9%. The prevalences in cattle, sheep, and goats were 50.5, 40.5, and 34.6%, respectively. All herds presented at least one seropositive animal; the Hardjo/Wolffi serovar association was the most common in cattle and Icterohaemorrhagiae in goats and sheep. Beef production (OR = 4.9), cattle herd over 35 animals (OR = 4.0), feeding on pasture (OR = 6.4), weir and/or stream as water source (OR = 2.1), and no veterinary services (OR = 2.9) were risk factors for cattle infection. For sheep, intensive management system (OR = 5.3), suspended slatted facilities (OR = 2.2), more than 20 sheep in reproductive age (OR = 1.9), and absence of deworming (OR = 3.5) were the risk factors, while for goats, the identified risk factors were sheep herd over 52 animals (OR = 1.9) and no veterinary services (OR = 1.8). We conclude that the infection was spreading in consorted herds in this region. Thus, it would be interesting and important to conduct educative activities to farmers on the economic impacts of this disease and the need of preventive and control strategies mainly focused on sanitary measures and animal handling.

A Review of Recruitment, Adherence and Drop-Out Rates in Omega-3 Polyunsaturated Fatty Acid Supplementation Trials in Children and Adolescents.

PubMed

van der Wurff, Inge S M; Meyer, Barbara J; de Groot, Renate H M

2017-05-10

The influence of n -3 long-chain polyunsaturated fatty acids ( n -3 LCPUFA) supplementation on health outcomes has been studied extensively with randomized controlled trials (RCT). In many research fields, difficulties with recruitment, adherence and high drop-out rates have been reported. However, what is unknown is how common these problems are in n -3 LCPUFA supplementation studies in children and adolescents. Therefore, this paper will review n -3 LCPUFA supplementation studies in children and adolescents with regard to recruitment, adherence and drop-out rates. The Web of Science, PubMed and Ovid databases were searched for papers reporting on RCT supplementing children and adolescents (2-18 years) with a form of n -3 LCPUFA (or placebo) for at least four weeks. As a proxy for abiding to CONSORT guidelines, we noted whether manuscripts provided a flow-chart and provided dates defining the period of recruitment and follow-up. Ninety manuscripts (reporting on 75 studies) met the inclusion criteria. The majority of the studies did not abide by the CONSORT guidelines: 55% did not provide a flow-chart, while 70% did not provide dates. The majority of studies provided minimal details about the recruitment process. Only 25 of the 75 studies reported an adherence rate which was on average 85%. Sixty-five of the 75 studies included drop-out rates which were on average 17%. Less than half of the included studies abided by the CONSORT guidelines (45% included a flow chart, while 30% reported dates). Problems with recruitment and drop-out seem to be common in n -3 LCPUFA supplementation trials in children and adolescents. However, reporting about recruitment, adherence and dropout rates was very heterogeneous and minimal in the included studies. Some techniques to improve recruitment, adherence and dropout rates were identified from the literature, however these techniques may need to be tailored to n -3 LCPUFA supplementation studies in children and adolescents.

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.

Effectiveness of web-based versus folder support interventions for young informal carers of persons with mental illness: a randomized controlled trial.

PubMed

Ali, Lilas; Krevers, Barbro; Sjöström, Nils; Skärsäter, Ingela

2014-03-01

Compare the impact of two interventions, a web-based support and a folder support, for young persons who care for people who suffer from mental illness. This study was a randomized control trial, following the CONSORT statements, which compared the impact of two interventions. Primary outcome variable was stress, and secondary outcome variables were caring situation, general self-efficacy, well-being, health, and quality of life of young informal carers (N=241). Data were collected in June 2010 to April 2011, with self-assessment questionnaires, comparing the two interventions and also to detect changes. The stress levels were high in both groups at baseline, but decreased in the folder group. The folder group had improvement in their caring situation (also different from the web group), general self-efficacy, well-being, and quality of life. The web group showed increase in well-being. Young informal carers who take on the responsibility for people close to them; suffer consequences on their own health. They live in a life-situation characterized by high stress and low well-being. This signals a need for support. The non-significant differences show that each intervention can be effective, and that it depends upon the individual's preferences. This highlights the importance of adopting person-centered approach, in which young persons can themselves choose support strategy. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

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

Computer-Based Cognitive Training for Executive Functions after Stroke: A Systematic Review

PubMed Central

van de Ven, Renate M.; Murre, Jaap M. J.; Veltman, Dick J.; Schmand, Ben A.

2016-01-01

Background: Stroke commonly results in cognitive impairments in working memory, attention, and executive function, which may be restored with appropriate training programs. Our aim was to systematically review the evidence for computer-based cognitive training of executive dysfunctions. Methods: Studies were included if they concerned adults who had suffered stroke or other types of acquired brain injury, if the intervention was computer training of executive functions, and if the outcome was related to executive functioning. We searched in MEDLINE, PsycINFO, Web of Science, and The Cochrane Library. Study quality was evaluated based on the CONSORT Statement. Treatment effect was evaluated based on differences compared to pre-treatment and/or to a control group. Results: Twenty studies were included. Two were randomized controlled trials that used an active control group. The other studies included multiple baselines, a passive control group, or were uncontrolled. Improvements were observed in tasks similar to the training (near transfer) and in tasks dissimilar to the training (far transfer). However, these effects were not larger in trained than in active control groups. Two studies evaluated neural effects and found changes in both functional and structural connectivity. Most studies suffered from methodological limitations (e.g., lack of an active control group and no adjustment for multiple testing) hampering differentiation of training effects from spontaneous recovery, retest effects, and placebo effects. Conclusions: The positive findings of most studies, including neural changes, warrant continuation of research in this field, but only if its methodological limitations are addressed. PMID:27148007

Study Healthy Ageing and Intellectual Disabilities: Recruitment and Design

ERIC Educational Resources Information Center

Hilgenkamp, Thessa I. M.; Bastiaanse, Luc P.; Hermans, Heidi; Penning, Corine; van Wijck, Ruud; Evenhuis, Heleen M.

2011-01-01

Problems encountered in epidemiologic health research in older adults with intellectual disabilities (ID) are how to recruit a large-scale sample of participants and how to measure a range of health variables in such a group. This cross-sectional study into healthy ageing started with founding a consort of three large care providers with a total…

Relationship between Quality and Editorial Leadership of Biomedical Research Journals: A Comparative Study of Italian and UK Journals

PubMed Central

Matarese, Valerie

2008-01-01

Background The quality of biomedical reporting is guided by statements of several organizations. Although not all journals adhere to these guidelines, those that do demonstrate “editorial leadership” in their author community. To investigate a possible relationship between editorial leadership and journal quality, research journals from two European countries, one Anglophone and one non-Anglophone, were studied and compared. Quality was measured on a panel of bibliometric parameters while editorial leadership was evaluated from journals' instructions to authors. Methodology/Principal Findings The study considered all 76 Italian journals indexed in Medline and 76 randomly chosen UK journals; only journals both edited and published in these countries were studied. Compared to UK journals, Italian journals published fewer papers (median, 60 vs. 93; p = 0.006), less often had online archives (43 vs. 74; p<0.001) and had lower median values of impact factor (1.2 vs. 2.7, p<0.001) and SCImago journal rank (0.09 vs. 0.25, p<0.001). Regarding editorial leadership, Italian journals less frequently required manuscripts to specify competing interests (p<0.001), authors' contributions (p = 0.005), funding (p<0.001), informed consent (p<0.001), ethics committee review (p<0.001). No Italian journal adhered to COPE or the CONSORT and QUOROM statements nor required clinical trial registration, while these characteristics were observed in 15%–43% of UK journals (p<0.001). At multiple regression, editorial leadership predicted 37.1%–49.9% of the variance in journal quality defined by citation statistics (p<0.0001); confounding variables inherent to a cross-cultural comparison had a relatively small contribution, explaining an additional 6.2%–13.8% of the variance. Conclusions/Significance Journals from Italy scored worse for quality and editorial leadership than did their UK counterparts. Editorial leadership predicted quality for the entire set of journals. Greater appreciation of international initiatives to improve biomedical reporting may help low-quality journals achieve higher status. PMID:18596938

Parents on the web: risks for quality management of cough in children.

PubMed

Pandolfini, C; Impicciatore, P; Bonati, M

2000-01-01

Health information on the Internet, with respect to common, self-limited childhood illnesses, has been found to be unreliable. Therefore, parents navigating on the Internet risk finding advice that is incomplete or, more importantly, not evidence-based. The importance that a resource such as the Internet as a source of quality health information for consumers should, however, be taken into consideration. For this reason, studies need to be performed regarding the quality of material provided. Various strategies have been proposed that would allow parents to distinguish trustworthy web documents from unreliable ones. One of these strategies is the use of a checklist for the appraisal of web pages based on their technical aspects. The purpose of this study was to assess the quality of information present on the Internet regarding the home management of cough in children and to examine the applicability of a checklist strategy that would allow consumers to select more trustworthy web pages. The Internet was searched for web pages regarding the home treatment of cough in children with the use of different search engines. Medline and the Cochrane database were searched for available evidence concerning the management of cough in children. Three checklists were created to assess different aspects of the web documents. The first checklist was designed to allow for a technical appraisal of the web pages and was based on components such as the name of the author and references used. The second was constructed to examine the completeness of the health information contained in the documents, such as causes and mechanism of cough, and pharmacological and nonpharmacological treatment. The third checklist assessed the quality of the information by measuring it against a gold standard document. This document was created by combining the policy statement issued by the American Academy of Pediatrics regarding the pharmacological treatment of cough in children with the guide of the World Health Organization on drugs for children. For each checklist, the web page contents were analyzed and quantitative measurements were assigned. Of the 19 web pages identified, 9 explained the purpose and/or mechanism of cough and 14 the causes. The most frequently mentioned pharmacological treatments were single-ingredient suppressant preparations, followed by single-ingredient expectorants. Dextromethorphan was the most commonly referred to suppressant and guaifenesin the most common expectorant. No documents discouraged the use of suppressants, although 4 of the 10 web documents that addressed expectorants discouraged their use. Sixteen web pages addressed nonpharmacological treatment, 14 of which suggested exposure to a humid environment and/or extra fluid. In most cases, the criteria in the technical appraisal checklist were not present in the web documents; moreover, 2 web pages did not provide any of the items. Regarding content completeness, 3 web pages satisfied all the requirements considered in the checklist and 2 documents did not meet any of the criteria. Of the 3 web pages that scored highest in technical aspect, 2 also supplied complete information. No relationship was found, however, between the technical aspect and the content completeness. Concerning the quality of the health information supplied, 10 pages received a negative score because they contained more incorrect than correct information, and 1 web page received a high score. This document was 1 of the 2 that also scored high in technical aspect and content completeness. No relationship was found, however, among quality of information, technical aspect, and content completeness. As the results of this study show, a parent navigating the Internet for information on the home management of cough in children will no doubt find incorrect advice among the search results. (ABSTRACT TRUNCATED)

Patient safety in phlebology: The ACP Phlebology Safety Checklist.

PubMed

Collares, Felipe Birchal; Sonde, Mehru; Harper, Kenneth; Armitage, Michael; Neuhardt, Diana L; Fronek, Helane S

2018-05-01

Objectives To assess the current use of safety checklists among the American College of Phlebology (ACP) members and their interest in implementing a checklist supported by the ACP on their clinical practices; and to develop a phlebology safety checklist. Method Online surveys were sent to ACP members, and a phlebology safety checklist was developed by a multispecialty team through the ACP Leadership Academy. Results Forty-seven percent of respondents are using a safety checklist in their practices; 23% think that a phlebology safety checklist would interfere or disrupt workflow; 79% answered that a phlebology safety checklist could improve procedure outcomes or prevent complications; and 85% would be interested in implementing a phlebology safety checklist approved by the ACP. Conclusion A phlebology safety checklist was developed with the intent to increase awareness on patient safety and improve outcome in phlebology practice.

The Powers of the Feminine. Sacred Images of India and Southeast Asia. Teacher's Packet.

ERIC Educational Resources Information Center

Asian Art Museum of San Francisco, CA.

Sacred women have been portrayed throughout the history of India and Southeast Asia. Some were depicted as consorts to the Hindu gods and regarded as the necessary force that activates male energy. Other images arose out of local fertility cults and represented uncontrolled feminine energy that could be terrifying in aspect. The calmer Buddhist…

The different types of sperm morphology and behavior within a single species: Why do sperm of squid sneaker males form a cluster?

PubMed

Hirohashi, Noritaka; Iwata, Yoko

2013-11-01

Some coastal squids exhibit male dimorphism (large and small body size) that is linked to mating behaviors. Large "consort" males compete with other, rival males to copulate with a female, and thereby transfer their spermatophores to her internal site around the oviduct. Small "sneaker" males rush to a single female or copulating pair and transfer spermatophores to her external body surface around the seminal receptacle near the mouth. We previously found that in Loligo bleekeri, sneaker sperm are ~50% longer than consort sperm, and only the sneaker sperm, once ejaculated from the spermatophore (sperm mass), form a cluster because of chemoattraction toward their own respiratory CO2. Here, we report that sperm clusters are able to move en masse. Because a fraction of ejaculated sperm from a sneaker's spermatophore are eventually located in the female's seminal receptacle, we hypothesize that sperm clustering facilitates collective migration to the seminal receptacle or an egg micropyle. Sperm clustering is regarded as a cooperative behavior that may have evolved by sperm competition and/or physical and physiological constraints imposed by male mating tactics.

Meaningful use and good catches: More appropriate metrics for checklist effectiveness.

PubMed

Putnam, Luke R; Anderson, Kathryn T; Diffley, Michael B; Hildebrandt, Aubrey A; Caldwell, Kelly M; Minzenmayer, Andrew N; Covey, Sarah E; Kawaguchi, Akemi L; Lally, Kevin P; Tsao, KuoJen

2016-12-01

The benefit of utilizing surgical safety checklists has been recently questioned. We evaluated our checklist performance after implementing a program that includes checklist-related good catches. Multifaceted interventions aimed at the preincision checklist and 5 prospective audits were conducted from 2011-2015. We documented adherence to the checklist (verbalization of each checkpoint), fidelity (meaningful performance of each checkpoint), and good catches (events with the potential to cause the patient harm but that were prevented from occurring). Good catches were divided into quality improvement-based categories (processes, medication, safety, communication, and equipment). A total of 1,346 checklist performances were observed (range, 144-373/yr). Adherence to the preincision checklist improved from 30% to 95% (P < .001), while adherence to the preinduction and debriefing checklists decreased (71% to 56%, P = .002) and remained unchanged (76%), respectively. Preincision fidelity decreased from 86% to 76% (P = .012). Good catches were identified during 16% of preincision checklist performances; process issues were most common (32%) followed by issues of medication administration (30%) and safety (22%). Implementation of a systematic checklist program resulted in significant and sustainable improvement in performance. Meaningful use and associated good catches may be more appropriate metric than actual patient harm for measuring checklist effectiveness. Although not previously described, checklist-related good catches represent an unknown benefit of checklists. Copyright © 2016 Elsevier Inc. All rights reserved.

Quality of meta-analyses in major leading gastroenterology and hepatology journals: A systematic review.

PubMed

Liu, Pengfei; Qiu, Yuanyu; Qian, Yuting; Chen, Xiao; Wang, Yiran; Cui, Jin; Zhai, Xiao

2017-01-01

To appraise the current reporting methodological quality of meta-analyses in five leading gastroenterology and hepatology journals, and to identify the variables associated with the reporting quality. We systematically searched the literature of meta-analyses in Gastroenterology, Gut, Hepatology, Journal of Hepatology (J HEPATOL) and American Journal of Gastroenterology (AM J GASTROENTEROL) from 2006 to 2008 and from 2012 to 2014. Characteristics were extracted based on the PRISMA statement and the AMSTAR tool. Country, number of patients, funding source were also revealed and descriptively reported. A total of 127 meta-analyses were enrolled in this study and were compared among journals, study years, and other characters. Compliances with the PRISMA statement and the AMSTAR checklist were 20.8 ± 4.2 out of a maximum of 27 and 7.6 ± 2.4 out of a maximum of 11, respectively. Some domains were poorly reported including describing a protocol and/or registration (item 5, 0.0%), describing methods, and giving results of additional analyses (item 16, 45.7% and item 23, 48.0%) for PRISMA and duplicating study selection and data extraction (item 2, 53.5%), and providing a list of included and excluded studies (item 5, 14.2%) for AMSTAR. Publication in recent years showed a significantly better methodological quality than those published in previous years. This study shows that methodological reporting quality of MAs in the major gastroenterology and hepatology journals has improved in recent years after the publication of the developed PRISMA statement, and it can be further improved. © 2016 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.

Adult Bronchoscopy Training

PubMed Central

Wahidi, Momen M.; Read, Charles A.; Buckley, John D.; Addrizzo-Harris, Doreen J.; Shah, Pallav L.; Herth, Felix J. F.; de Hoyos Parra, Alberto; Ornelas, Joseph; Yarmus, Lonny; Silvestri, Gerard A.

2015-01-01

BACKGROUND: The determination of competency of trainees in programs performing bronchoscopy is quite variable. Some programs provide didactic lectures with hands-on supervision, other programs incorporate advanced simulation centers, whereas others have a checklist approach. Although no single method has been proven best, the variability alone suggests that outcomes are variable. Program directors and certifying bodies need guidance to create standards for training programs. Little well-developed literature on the topic exists. METHODS: To provide credible and trustworthy guidance, rigorous methodology has been applied to create this bronchoscopy consensus training statement. All panelists were vetted and approved by the CHEST Guidelines Oversight Committee. Each topic group drafted questions in a PICO (population, intervention, comparator, outcome) format. MEDLINE data through PubMed and the Cochrane Library were systematically searched. Manual searches also supplemented the searches. All gathered references were screened for consideration based on inclusion criteria, and all statements were designated as an Ungraded Consensus-Based Statement. RESULTS: We suggest that professional societies move from a volume-based certification system to skill acquisition and knowledge-based competency assessment for trainees. Bronchoscopy training programs should incorporate multiple tools, including simulation. We suggest that ongoing quality and process improvement systems be introduced and that certifying agencies move from a volume-based certification system to skill acquisition and knowledge-based competency assessment for trainees. We also suggest that assessment of skill maintenance and improvement in practice be evaluated regularly with ongoing quality and process improvement systems after initial skill acquisition. CONCLUSIONS: The current methods used for bronchoscopy competency in training programs are variable. We suggest that professional societies and certifying agencies move from a volume- based certification system to a standardized skill acquisition and knowledge-based competency assessment for pulmonary and thoracic surgery trainees. PMID:25674901

[Use of multiple regression models in observational studies (1970-2013) and requirements of the STROBE guidelines in Spanish scientific journals].

PubMed

Real, J; Cleries, R; Forné, C; Roso-Llorach, A; Martínez-Sánchez, J M

In medicine and biomedical research, statistical techniques like logistic, linear, Cox and Poisson regression are widely known. The main objective is to describe the evolution of multivariate techniques used in observational studies indexed in PubMed (1970-2013), and to check the requirements of the STROBE guidelines in the author guidelines in Spanish journals indexed in PubMed. A targeted PubMed search was performed to identify papers that used logistic linear Cox and Poisson models. Furthermore, a review was also made of the author guidelines of journals published in Spain and indexed in PubMed and Web of Science. Only 6.1% of the indexed manuscripts included a term related to multivariate analysis, increasing from 0.14% in 1980 to 12.3% in 2013. In 2013, 6.7, 2.5, 3.5, and 0.31% of the manuscripts contained terms related to logistic, linear, Cox and Poisson regression, respectively. On the other hand, 12.8% of journals author guidelines explicitly recommend to follow the STROBE guidelines, and 35.9% recommend the CONSORT guideline. A low percentage of Spanish scientific journals indexed in PubMed include the STROBE statement requirement in the author guidelines. Multivariate regression models in published observational studies such as logistic regression, linear, Cox and Poisson are increasingly used both at international level, as well as in journals published in Spanish. Copyright © 2015 Sociedad Española de Médicos de Atención Primaria (SEMERGEN). Publicado por Elsevier España, S.L.U. All rights reserved.

Instructor feedback versus no instructor feedback on performance in a laparoscopic virtual reality simulator: a randomized trial.

PubMed

Strandbygaard, Jeanett; Bjerrum, Flemming; Maagaard, Mathilde; Winkel, Per; Larsen, Christian Rifbjerg; Ringsted, Charlotte; Gluud, Christian; Grantcharov, Teodor; Ottesen, Bent; Sorensen, Jette Led

2013-05-01

To investigate the impact of instructor feedback versus no instructor feedback when training a complex operational task on a laparoscopic virtual reality simulator. : Simulators are now widely accepted as a training tool, but there is insufficient knowledge about how much feedback is necessary, which is useful for sustainable implementation. A randomized trial complying with CONSORT Statement. All participants had to reach a predefined proficiency level for a complex operational task on a virtual reality simulator. The intervention group received standardized instructor feedback a maximum of 3 times. The control group did not receive instructor feedback. Participants were senior medical students without prior laparoscopic experience (n = 99). Outcome measures were time, repetitions, and performance score to reach a predefined proficiency level. Furthermore, influence of sex and perception of own surgical skills were examined. Time (in minutes) and repetitions were reduced in the intervention group (162 vs 342 minutes; P < 0.005) and (29 vs 65 repetitions; P < 0.005). The control group achieved a higher performance score than the intervention group (57% vs 49%; P = 0.004). Men used less time (in minutes) than women (P = 0.037), but no sex difference was observed for repetitions (P = 0.20). Participants in the intervention group had higher self-perception regarding surgical skills after the trial (P = 0.011). Instructor feedback increases the efficiency when training a complex operational task on a virtual reality simulator; time and repetitions used to achieve a predefined proficiency level were significantly reduced in the group that received instructor feedback compared with the control group. NCT01497782.

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

Instructor feedback versus no instructor feedback on performance in a laparoscopic virtual reality simulator: a randomized educational trial.

PubMed

Oestergaard, Jeanett; Bjerrum, Flemming; Maagaard, Mathilde; Winkel, Per; Larsen, Christian Rifbjerg; Ringsted, Charlotte; Gluud, Christian; Grantcharov, Teodor; Ottesen, Bent; Soerensen, Jette Led

2012-02-28

Several studies have found a positive effect on the learning curve as well as the improvement of basic psychomotor skills in the operating room after virtual reality training. Despite this, the majority of surgical and gynecological departments encounter hurdles when implementing this form of training. This is mainly due to lack of knowledge concerning the time and human resources needed to train novice surgeons to an adequate level. The purpose of this trial is to investigate the impact of instructor feedback regarding time, repetitions and self-perception when training complex operational tasks on a virtual reality simulator. The study population consists of medical students on their 4th to 6th year without prior laparoscopic experience. The study is conducted in a skills laboratory at a centralized university hospital. Based on a sample size estimation 98 participants will be randomized to an intervention group or a control group. Both groups have to achieve a predefined proficiency level when conducting a laparoscopic salpingectomy using a surgical virtual reality simulator. The intervention group receives standardized instructor feedback of 10 to 12 min a maximum of three times. The control group receives no instructor feedback. Both groups receive the automated feedback generated by the virtual reality simulator. The study follows the CONSORT Statement for randomized trials. Main outcome measures are time and repetitions to reach the predefined proficiency level on the simulator. We include focus on potential sex differences, computer gaming experience and self-perception. The findings will contribute to a better understanding of optimal training methods in surgical education. NCT01497782.

Implementing a pediatric surgical safety checklist in the OR and beyond.

PubMed

Norton, Elizabeth K; Rangel, Shawn J

2010-07-01

An international study about implementation of the World Health Organization Surgical Safety Checklist showed that use of the checklist reduced complication and death rates in adult surgical patients. Clinicians at Children's Hospital Boston, Massachusetts, modified the Surgical Safety Checklist for pediatric populations. We pilot tested the Pediatric Surgical Safety Checklist and created a large checklist poster for each OR to allow the entire surgical team to view the checklist simultaneously and to promote shared responsibility for conducting the time out. Results of the pilot test showed improvements in teamwork, communication, and adherence to process measures. Parallel efforts were made in other areas of the hospital where invasive procedures are performed. Compliance with the checklist at our facility has been good, and team members have expressed satisfaction with the flow and content of the checklist. Copyright (c) 2010 AORN, Inc. Published by Elsevier Inc. All rights reserved.

Comparing the accuracy of performing digital and paper checklists using a feedback package during normal workload conditions in simulated flight

NASA Astrophysics Data System (ADS)

Rantz, William Gene

This study examined whether pilots completed airplane digital or paper checklists more accurately when they received post-flight graphic and verbal feedback. Participants were 6 college student pilots with instrument rating. The task consisted of flying flight patterns using a Frasca 241 Flight Training Device which emulates a Cirrus SR20 aircraft. The main dependent variable was the number of checklist items completed correctly per flight. An alternating treatment, multiple baseline design across pairs with reversal, was used. During baseline, the average percent of correctly completed items per flight varied considerably across participants, ranging from 13% to 57% for traditional paper checklists and ranging from 11% to 67% for digital checklists. Checklist performance increased to an average of 90% for paper checklist and an average of 89% for digital checklists after participants were given feedback and praise, and continued to improve to an average of nearly 100% for paper checklists and an average of 99% for digital checklists after the feedback and praise were removed. A slight decrement in performance was observed during a post-experiment probe between 60--90 days. Visual inspection and statistical analysis of the data suggest that paper checklist accuracy does not differ significantly from digital checklist accuracy. The results suggest that graphic feedback and praise can be used to increase the extent to which pilots use both digital and paper checklists accurately during normal workload conditions.

What is the value of the SAGES/AORN MIS checklist? A multi-institutional practical assessment.

PubMed

Benham, Emily; Richardson, William; Dort, Jonathan; Lin, Henry; Tummers, A Michael; Walker, Travelyan M; Stefanidis, Dimitrios

2017-04-01

Surgical safety checklists reduce perioperative complications and mortality. Given that minimally invasive surgery (MIS) is dependent on technology and vulnerable to equipment failure, SAGES and AORN partnered to create a MIS checklist to optimize case flow and minimize errors. The aim of this project was to evaluate the effectiveness of the SAGES/AORN checklist in preventing disruptions and determine its ease of use. The checklist was implemented across four institutions and completed by the operating team. To assess its effectiveness, we recorded how often the checklist identified problems and how frequently each of the 45 checklist items were not completed. The perceived usefulness, ease of use, and frustration associated with checklist use were rated on a 5-point Likert scale by the surgeon. We assessed any differences dependent on timing of checklist completion and among institutions. The checklist was performed during MIS procedures (n = 114). When used before the procedure (n = 36), the checklist identified missing items in 13 cases (36.11 %). When used after the procedure (n = 61), the checklist identified missing items in 18 cases (29.51 %) that caused a delay of 4.1 ± 11.1 min. The most frequently missed items included preference card review (14.0 %), readiness of the carbon dioxide insufflator (8.7 %), and availability of the Veress needle (3.6 %). The checklist took an average of 3.6 ± 2.7 min to complete with its usefulness rated 2.6 ± 1.5, ease of use 2.0 ± 1.2, and frustration 1.3 ± 1.1. The checklist identified problems in 24 % of cases that led to preventable delays. The checklist was easy to complete and not frustrating, indicating it could improve operative flow. This study also identified the most useful items which may help abbreviate the checklist, minimizing the frustration and time taken to complete it while maximizing its utility. These attributes of the SAGES/AORN MIS checklist should be explored in future larger-scale studies.

Measuring allostatic load in the workforce: a systematic review

PubMed Central

MAUSS, Daniel; LI, Jian; SCHMIDT, Burkhard; ANGERER, Peter; JARCZOK, Marc N.

2014-01-01

The Allostatic Load Index (ALI) has been used to establish associations between stress and health-related outcomes. This review summarizes the measurement and methodological challenges of allostatic load in occupational settings. Databases of Medline, PubPsych, and Cochrane were searched to systematically explore studies measuring ALI in working adults following the PRISMA statement. Study characteristics, biomarkers and methods were tabulated. Methodological quality was evaluated using a standardized checklist. Sixteen articles (2003–2013) met the inclusion criteria, with a total of 39 (range 6–17) different variables used to calculate ALI. Substantial heterogeneity was observed in the number and type of biomarkers used, the analytic techniques applied and study quality. Particularly, primary mediators were not regularly included in ALI calculation. Consensus on methods to measure ALI in working populations is limited. Research should include longitudinal studies using multi-systemic variables to measure employees at risk for biological wear and tear. PMID:25224337

Procurement of Architectural and Engineering Services for Sustainable Buildings: A Guide for Federal Project Managers

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

Not Available

2004-06-01

This guide was prepared to be a resource for federal construction project managers and others who want to integrate the principles of sustainable design into the procurement of professional building design and consulting services. To economize on energy costs and improve the safety, comfort, and health of building occupants, building design teams can incorporate daylighting, energy efficiency, renewable energy, and passive solar design into all projects in which these elements are technically and economically feasible. The information presented here will help project leaders begin the process and manage the inclusion of sustainable design in the procurement process. The section onmore » establishing selection criteria contains key elements to consider before selecting an architectural and engineering (A/E) firm. The section on preparing the statement of work discusses the broad spectrum of sustainable design services that an A/E firm can provide. Several helpful checklists are included.« less

Epidemiology, methodological and reporting characteristics of systematic reviews of nursing interventions published in China.

PubMed

Shi, Chunhu; Zhu, Lin; Wang, Xue; Qin, Chunxia; Xu, Qi; Tian, Jinhui

2014-12-01

The importance of systematic reviews (SRs) of nursing interventions' impact on practice makes their methodological quality and reporting characteristics especially important as it directly influence their utility for clinicians, patients and policy makers.The study aims to assess the methodological quality and reporting characteristics of SRs of nursing interventions in Chinese nursing journals. Three Chinese databases were searched for SRs of nursing interventions from inception to October 2011. The assessment of multiple systematic reviews (AMSTAR) and Preferred Reporting Items for Systematic Reviews and Meta Analyses (PRISMA) statements were used to assess methodological quality and reporting characteristics. Seventy-four SRs were included. The proportion of SRs complying with AMSTAR checklist items ranged from 0% to 82.4%. No SRs reported an 'a priori' design or conflict of interest. Only four items were found to be reported in more than 50% of the SRs: a list of included and excluded studies, the scientific quality of included studies, the appropriate use of methods to combine findings, and formulating conclusions appropriately. The majority of SRs of nursing interventions in China had major methodological and reporting flaws that limited their value to guide decisions. Chinese authors and journals should adopt and keep up with the AMSTAR and PRISMA statements to improve the quality of SRs in this field. © 2014 Wiley Publishing Asia Pty Ltd.

Reporting standards for studies of diagnostic test accuracy in dementia

PubMed Central

Noel-Storr, Anna H.; McCleery, Jenny M.; Richard, Edo; Ritchie, Craig W.; Flicker, Leon; Cullum, Sarah J.; Davis, Daniel; Quinn, Terence J.; Hyde, Chris; Rutjes, Anne W.S.; Smailagic, Nadja; Marcus, Sue; Black, Sandra; Blennow, Kaj; Brayne, Carol; Fiorivanti, Mario; Johnson, Julene K.; Köpke, Sascha; Schneider, Lon S.; Simmons, Andrew; Mattsson, Niklas; Zetterberg, Henrik; Bossuyt, Patrick M.M.; Wilcock, Gordon

2014-01-01

Objective: To provide guidance on standards for reporting studies of diagnostic test accuracy for dementia disorders. Methods: An international consensus process on reporting standards in dementia and cognitive impairment (STARDdem) was established, focusing on studies presenting data from which sensitivity and specificity were reported or could be derived. A working group led the initiative through 4 rounds of consensus work, using a modified Delphi process and culminating in a face-to-face consensus meeting in October 2012. The aim of this process was to agree on how best to supplement the generic standards of the STARD statement to enhance their utility and encourage their use in dementia research. Results: More than 200 comments were received during the wider consultation rounds. The areas at most risk of inadequate reporting were identified and a set of dementia-specific recommendations to supplement the STARD guidance were developed, including better reporting of patient selection, the reference standard used, avoidance of circularity, and reporting of test-retest reliability. Conclusion: STARDdem is an implementation of the STARD statement in which the original checklist is elaborated and supplemented with guidance pertinent to studies of cognitive disorders. Its adoption is expected to increase transparency, enable more effective evaluation of diagnostic tests in Alzheimer disease and dementia, contribute to greater adherence to methodologic standards, and advance the development of Alzheimer biomarkers. PMID:24944261

New contraceptive eligibility checklists for provision of combined oral contraceptives and depot-medroxyprogesterone acetate in community-based programmes.

PubMed Central

Stang, A.; Schwingl, P.; Rivera, R.

2000-01-01

Community-based services (CBS) have long used checklists to determine eligibility for contraceptive method use, in particular for combined oral contraceptives (COCs) and the 3-month injectable contraceptive depot-medroxyprogesterone acetate (DMPA). As safety information changes, however, checklists can quickly become outdated. Inconsistent checklists and eligibility criteria often cause uneven access to contraceptives. In 1996, WHO produced updated eligibility criteria for the use of all contraceptive methods. Based on these criteria, new checklists for COCs and DMPA were developed. This article describes the new checklists and their development. Several rounds of expert review produced checklists that were correct, comprehensible and consistent with the eligibility requirements. Nevertheless, field-testing of the checklists revealed that approximately half (48%) of the respondents felt that one or more questions still needed greater comprehensibility. These findings indicated the need for a checklist guide. In March 2000, WHO convened a meeting of experts to review the medical eligibility criteria for contraceptive use. The article reflects also the resulting updated checklist. PMID:10994285

Human factors of flight-deck checklists: The normal checklist

NASA Technical Reports Server (NTRS)

Degani, Asaf; Wiener, Earl L.

1991-01-01

Although the aircraft checklist has long been regarded as the foundation of pilot standardization and cockpit safety, it has escaped the scrutiny of the human factors profession. The improper use, or the non-use, of the normal checklist by flight crews is often cited as the probable cause or at least a contributing factor to aircraft accidents. An attempt is made to analyze the normal checklist, its functions, format, design, length, usage, and the limitations of the humans who must interact with it. The development of the checklist from the certification of a new model to its delivery and use by the customer are discussed. The influence of the government, particularly the FAA Principle Operations Inspector, the manufacturer's philosophy, the airline's culture, and the end user, the pilot, influence the ultimate design and usage of this device. The effects of airline mergers and acquisitions on checklist usage and design are noted. In addition, the interaction between production pressures and checklist usage and checklist management are addressed. Finally, a list of design guidelines for normal checklists is provided.

Citicoline for traumatic brain injury: a systematic review & meta-analysis

PubMed Central

Meshkini, Ali; Meshkini, Mohammad; Sadeghi-Bazargani, Homayoun

2017-01-01

Abstract: Background: Traumatic Brain Injury (TBI) is the leading cause of mortality and morbidity especially in young ages. Despite over 30 years of using Neuroprotective agents for TBI management, there is no absolute recommended agent for the condition yet. Methods: This study is a part of a scoping review thesis on "Neuroprotective agents using for Traumatic Brain Injury: a systematic review & meta-analyses", which had a wide proposal keywords and ran in "Cochrane CENTRAL", "MedLine/PubMed", "SCOPUS", "Thomson Reuters Web of Science", "SID.ir", "Barket Foundation", and "clinicaltrials.gov" databases up to September 06, 2015. This study limits the retrieved search results only to those which used \\citicoline for TBI management. The included Randomized Clinical Trials’ (RCTs) were assessed for their quality of reporting by adapting CONSORT-checklist prior to extracting their data into meta-analysis. Meta-analyses of this review were conducted by Glasgow Outcome Scale (GOS) in acute TBI patients and total neuropsychological assessments in both acute and chronic TBI management, mortalities and adverse-effects. Results: Four RCTs were retrieved and included in this review with 1196 participants (10 were chronic TBI impaired patients); the analysis of 1128 patients for their favorable GOS outcomes in two studies showed no significant difference between the study groups; however, neuropsychological outcomes were significantly better in placebo/control group of 971 patients of three studies. Mortality rates and adverse-effects analysis based on two studies with 1429 patients showed no significant difference between the study groups. However, two other studies have neither mortality nor adverse effects reports due to their protocol. Conclusions: Citicoline use for acute TBI seems to have no field of support anymore, whereas it may have some benefits in improving the neuro-cognitive state in chronic TBI patients. It’s also recommended to keep in mind acute interventions like Psychological First Aid (PFA) during acute TBI management. PMID:28039682

Impact of peer review on reports of randomised trials published in open peer review journals: retrospective before and after study

PubMed Central

Collins, Gary S; Boutron, Isabelle; Yu, Ly-Mee; Cook, Jonathan; Shanyinde, Milensu; Wharton, Rose; Shamseer, Larissa; Altman, Douglas G

2014-01-01

Objective To investigate the effectiveness of open peer review as a mechanism to improve the reporting of randomised trials published in biomedical journals. Design Retrospective before and after study. Setting BioMed Central series medical journals. Sample 93 primary reports of randomised trials published in BMC-series medical journals in 2012. Main outcome measures Changes to the reporting of methodological aspects of randomised trials in manuscripts after peer review, based on the CONSORT checklist, corresponding peer reviewer reports, the type of changes requested, and the extent to which authors adhered to these requests. Results Of the 93 trial reports, 38% (n=35) did not describe the method of random sequence generation, 54% (n=50) concealment of allocation sequence, 50% (n=46) whether the study was blinded, 34% (n=32) the sample size calculation, 35% (n=33) specification of primary and secondary outcomes, 55% (n=51) results for the primary outcome, and 90% (n=84) details of the trial protocol. The number of changes between manuscript versions was relatively small; most involved adding new information or altering existing information. Most changes requested by peer reviewers had a positive impact on the reporting of the final manuscript—for example, adding or clarifying randomisation and blinding (n=27), sample size (n=15), primary and secondary outcomes (n=16), results for primary or secondary outcomes (n=14), and toning down conclusions to reflect the results (n=27). Some changes requested by peer reviewers, however, had a negative impact, such as adding additional unplanned analyses (n=15). Conclusion Peer reviewers fail to detect important deficiencies in reporting of the methods and results of randomised trials. The number of these changes requested by peer reviewers was relatively small. Although most had a positive impact, some were inappropriate and could have a negative impact on reporting in the final publication. PMID:24986891

Effectiveness of a patient education plan on knowledge of post-op venous thromboembolism survival skills.

PubMed

Green, Julie; Bernhofer, Esther I

2018-04-01

To investigate the effectiveness of a multimethod venous thromboembolism prevention patient education plan on participants' knowledge retention. A potential complication of surgery requiring general anaesthesia, worldwide, is the development of life-threatening venous thromboembolism. Patients need education on preventing, recognising and immediately responding to a suspected thromboembolism. Written instructional materials given to patients at discharge may be inadequate. A randomised controlled trial. Setting was multiple general surgery units at a large Midwestern United States academic medical centre. Sample included patients recovering from surgery with general anaesthesia: (N = 66), 68% female, 34 = experimental, 32 = usual care. Prior to discharge, participants in the experimental group were given a multimethod venous thromboembolism prevention education plan including a video, pamphlet and verbal instruction; control group received usual instructional pamphlet. Both groups received a knowledge test immediately before instruction. Two weeks following discharge, a phone call was made to participants to complete the postinstruction test. The relevant EQUATOR guideline, CONSORT checklist, was used for reporting this study. There were no statistically significant differences in age, gender, race, length of stay, surgery and history of venous thromboembolism among participants and group or test score results. No statistically significant difference in postinstruction score was found between groups. However, there was a trend in greater perception of importance in all groups and higher knowledge scores in the experimental group, with the percentage of participants in the experimental group answering all questions correctly rising from 38.2% correct to 73.5% correct. Teaching patients the importance of knowing venous thromboembolism signs and preventive/survival skills is potentially life-saving and nurses must know the importance of using the most effective methods for the learning needs of their patients. Further research including different education methods and testing is suggested. © 2018 John Wiley & Sons Ltd.

Citicoline for traumatic brain injury: a systematic review & meta-analysis.

PubMed

Meshkini, Ali; Meshkini, Mohammad; Sadeghi-Bazargani, Homayoun

2017-01-01

Traumatic Brain Injury (TBI) is the leading cause of mortality and morbidity especially in young ages. Despite over 30 years of using Neuroprotective agents for TBI management, there is no absolute recommended agent for the condition yet. This study is a part of a scoping review thesis on "Neuroprotective agents using for Traumatic Brain Injury: a systematic review & meta-analyses", which had a wide proposal keywords and ran in "Cochrane CENTRAL", "MedLine/PubMed", "SCOPUS", "Thomson Reuters Web of Science", "SID.ir", "Barket Foundation", and "clinicaltrials.gov" databases up to September 06, 2015. This study limits the retrieved search results only to those which used citicoline for TBI management. The included Randomized Clinical Trials' (RCTs) were assessed for their quality of reporting by adapting CONSORT-checklist prior to extracting their data into me-ta-analysis. Meta-analyses of this review were conducted by Glasgow Outcome Scale (GOS) in acute TBI patients and total neuropsychological assessments in both acute and chronic TBI management, mortalities and adverse-effects. Four RCTs were retrieved and included in this review with 1196 participants (10 were chronic TBI impaired patients); the analysis of 1128 patients for their favorable GOS outcomes in two studies showed no significant difference between the study groups; however, neuropsychological outcomes were significantly better in placebo/control group of 971 patients of three studies. Mortality rates and adverse-effects analysis based on two studies with 1429 patients showed no significant difference between the study groups. However, two other studies have neither mortality nor adverse effects reports due to their protocol. Citicoline use for acute TBI seems to have no field of support anymore, whereas it may have some benefits in improving the neuro-cognitive state in chronic TBI patients. It's also recommended to keep in mind acute interventions like Psychological First Aid (PFA) during acute TBI management. © 2017 KUMS, All rights reserved.

The effectiveness of e-& mHealth interventions to promote physical activity and healthy diets in developing countries: A systematic review.

PubMed

Müller, Andre Matthias; Alley, Stephanie; Schoeppe, Stephanie; Vandelanotte, Corneel

2016-10-10

Promoting physical activity and healthy eating is important to combat the unprecedented rise in NCDs in many developing countries. Using modern information-and communication technologies to deliver physical activity and diet interventions is particularly promising considering the increased proliferation of such technologies in many developing countries. The objective of this systematic review is to investigate the effectiveness of e-& mHealth interventions to promote physical activity and healthy diets in developing countries. Major databases and grey literature sources were searched to retrieve studies that quantitatively examined the effectiveness of e-& mHealth interventions on physical activity and diet outcomes in developing countries. Additional studies were retrieved through citation alerts and scientific social media allowing study inclusion until August 2016. The CONSORT checklist was used to assess the risk of bias of the included studies. A total of 15 studies conducted in 13 developing countries in Europe, Africa, Latin-and South America and Asia were included in the review. The majority of studies enrolled adults who were healthy or at risk of diabetes or hypertension. The average intervention length was 6.4 months, and text messages and the Internet were the most frequently used intervention delivery channels. Risk of bias across the studies was moderate (55.7 % of the criteria fulfilled). Eleven studies reported significant positive effects of an e-& mHealth intervention on physical activity and/or diet behaviour. Respectively, 50 % and 70 % of the interventions were effective in promoting physical activity and healthy diets. The majority of studies demonstrated that e-& mHealth interventions were effective in promoting physical activity and healthy diets in developing countries. Future interventions should use more rigorous study designs, investigate the cost-effectiveness and reach of interventions, and focus on emerging technologies, such as smart phone apps and wearable activity trackers. The review protocol can be retrieved from the PROSPERO database (Registration ID: CRD42015029240 ).

Bacillus thuringiensis israelensis (Bti) for the control of dengue vectors: systematic literature review.

PubMed

Boyce, R; Lenhart, A; Kroeger, A; Velayudhan, R; Roberts, B; Horstick, O

2013-05-01

To systematically review the literature on the effectiveness of Bacillus thuringiensis israelensis (Bti), when used as a single agent in the field, for the control of dengue vectors. Systematic literature search of the published and grey literature was carried out using the following databases: MEDLINE, EMBASE, Global Health, Web of Science, the Cochrane Library, WHOLIS, ELDIS, the New York Academy of Medicine Gray Literature Report, Africa-Wide and Google. All results were screened for duplicates and assessed for eligibility. Relevant data were extracted, and a quality assessment was conducted using the CONSORT 2010 checklist. Fourteen studies satisfied the eligibility criteria, incorporating a wide range of interventions and outcome measures. Six studies were classified as effectiveness studies, and the remaining eight examined the efficacy of Bti in more controlled settings. Twelve (all eight efficacy studies and 4 of 6 effectiveness studies) reported reductions in entomological indices with an average duration of control of 2-4 weeks. The two effectiveness studies that did not report significant entomological reductions were both cluster-randomised study designs that utilised basic interventions such as environmental management or general education on environment control practices in their respective control groups. Only one study described a reduction in entomological indices together with epidemiological data, reporting one dengue case in the treated area compared to 15 dengue cases in the untreated area during the observed study period. While Bti can be effective in reducing the number of immature Aedes in treated containers in the short term, there is very limited evidence that dengue morbidity can be reduced through the use of Bti alone. There is currently insufficient evidence to recommend the use of Bti as a single agent for the long-term control of dengue vectors and prevention of dengue fever. Further studies examining the role of Bti in combination with other strategies to control dengue vectors are warranted. © 2013 Blackwell Publishing Ltd.

Efficacy and safety of Pueraria candollei var. mirifica (Airy Shaw & Suvat.) Niyomdham for menopausal women: A systematic review of clinical trials and the way forward.

PubMed

Kongkaew, Chuenjid; Scholfield, Norman C; Dhippayom, Teerapon; Dilokthornsakul, Piyameth; Saokaew, Surasak; Chaiyakunapruk, Nathorn

2018-04-24

Pueraria candollei var. mirifica (Airy Shaw & Suvat.) Niyomdham (commonly termed P. mirifica, PM) growing in upland Thailand has a long history as a postmenopausal rejuvenant therapy for indigenants. Its amelioration of menopause symptoms in clinical trials was assessed. International and Thai databases were searched from inception to February 2017. Clinical trials investigating effects of PM menopausal or postmenopausal women were included. Outcomes were self-reported menopausal symptoms, serum reproductive hormones, urino-genital tract function, and bone surrogates. Methodological quality was assessed by Cochrane risk-of-bias v2.0, and a 22-parameter quality score based on the CONSORT checklist for herbal medicines. Eight studies (9 articles) used data from 309 menopausal patients. Five-studies demonstrated that PM was associated with climacteric scores reduced by ~50% compared to baseline. Other PM studies using limited numbers of placebo participants suggested improved vaginal and other urogenital tract symptoms. Bone alkaline phosphatase halved (suggesting lowered bone turnover). Variable serum reproductive hormone levels suggested menopausal status differed between studies. PM active ingredients and sources were not defined. Adverse event rates (mastodynia, vaginal spotting, dizziness) were similar in all groups (PM, conjugated equine estrogen, and placebos) but serum C-reactive protein doubled. These studies had design and reporting deficiencies, high risks of biases, and low quality scores. The efficacy of PM on menopausal symptoms remains inconclusive because of methodological short-comings especially placebo effects inherent in self-assessment/recall questionnaires and no PM standardization. PM efficacy and safety need a fundamental re-appraisal by: (i) cohort (retro- and prospective) studies on current users to define its traditional use for rejuvenation; (ii) tightly coupling long-term efficacy to safety of well-defined PM and multiple end-points; (iii) using study design related to current understanding of menopause progression and estrogen pharmacology (iv) robust pharmacovigilance. Copyright © 2018 Elsevier B.V. All rights reserved.

Could ginseng-based medicines be better than nitrates in treating ischemic heart disease? A systematic review and meta-analysis of randomized controlled trials.

PubMed

Jia, Yongliang; Zhang, Shikai; Huang, Fangyi; Leung, Siu-wai

2012-06-01

Ginseng-based medicines and nitrates are commonly used in treating ischemic heart disease (IHD) angina pectoris in China. Hundreds of randomized controlled trials (RCTs) reported in Chinese language claimed that ginseng-based medicines can relieve the symptoms of IHD. This study provides the first PRISMA-compliant systematic review with sensitivity and subgroup analyses to evaluate the RCTs comparing the efficacies of ginseng-based medicines and nitrates in treating ischemic heart disease, particularly angina pectoris. Past RCTs published up to 2010 on ginseng versus nitrates in treating IHD for 14 or more days were retrieved from major English and Chinese databases, including PubMed, Science Direct, Cochrane Library, WangFang Data, and Chinese National Knowledge Infrastructure. The qualities of included RCTs were assessed with Jadad scale, a refined Jadad scale called M scale, CONSORT 2010 checklist, and Cochrane risk of bias tool. Meta-analysis was performed on the primary outcomes including the improvement of symptoms and electrocardiography (ECG). Subgroup analysis, sensitivity analysis, and meta-regression were performed to evaluate the effects of study characteristics of RCTs, including quality, follow-up periods, and efficacy definitions on the overall effect size of ginseng. Eighteen RCTs with 1549 participants were included. Overall odds ratios for comparing ginseng-based medicines with nitrates were 3.00 (95% CI: 2.27-3.96) in symptom improvement (n=18) and 1.61 (95% CI: 1.20-2.15) in ECG improvement (n=10). Subgroup analysis, sensitivity analysis, and meta-regression found no significant difference in overall effects among all study characteristics, indicating that the overall effects were stable. The meta-analysis of 18 eligible RCTs demonstrates moderate evidence that ginseng is more effective than nitrates for treating angina pectoris. However, further RCTs for higher quality, longer follow-up periods, lager sample size, multi-center/country, and are still required to verify the efficacy. Crown Copyright © 2011. Published by Elsevier Ltd. All rights reserved.

Surgical checklists: a systematic review of impacts and implementation

PubMed Central

Treadwell, Jonathan R; Lucas, Scott; Tsou, Amy Y

2014-01-01

Background Surgical complications represent a significant cause of morbidity and mortality with the rate of major complications after inpatient surgery estimated at 3–17% in industrialised countries. The purpose of this review was to summarise experience with surgical checklist use and efficacy for improving patient safety. Methods A search of four databases (MEDLINE, CINAHL, EMBASE and the Cochrane Database of Controlled Trials) was conducted from 1 January 2000 to 26 October 2012. Articles describing actual use of the WHO checklist, the Surgical Patient Safety System (SURPASS) checklist, a wrong-site surgery checklist or an anaesthesia equipment checklist were eligible for inclusion (this manuscript summarises all but the anaesthesia equipment checklists, which are described in the Agency for Healthcare Research and Quality publication). Results We included a total of 33 studies. We report a variety of outcomes including avoidance of adverse events, facilitators and barriers to implementation. Checklists have been adopted in a wide variety of settings and represent a promising strategy for improving the culture of patient safety and perioperative care in a wide variety of settings. Surgical checklists were associated with increased detection of potential safety hazards, decreased surgical complications and improved communication among operating staff. Strategies for successful checklist implementation included enlisting institutional leaders as local champions, incorporating staff feedback for checklist adaptation and avoiding redundancies with existing systems for collecting information. Conclusions Surgical checklists represent a relatively simple and promising strategy for addressing surgical patient safety worldwide. Further studies are needed to evaluate to what degree checklists improve clinical outcomes and whether improvements may be more pronounced in particular settings. PMID:23922403

Checklists change communication about key elements of patient care.

PubMed

Newkirk, Michelle; Pamplin, Jeremy C; Kuwamoto, Roderick; Allen, David A; Chung, Kevin K

2012-08-01

Combat casualty care is distributed across professions and echelons of care. Communication within it is fragmented, inconsistent, and prone to failure. Daily checklists used during intensive care unit (ICU) rounds have been shown to improve compliance with evidence-based practices, enhance communication, promote consistency of care, and improve outcomes. Checklists are criticized because it is difficult to establish a causal link between them and their effect on outcomes. We investigated how checklists used during ICU rounds affect communication. We conducted this project in two military ICUs (burn and surgical/trauma). Checklists contained up to 21 questions grouped according to patient population. We recorded which checklist items were discussed during rounds before and after implementation of a "must address" checklist and compared the frequency of discussing items before checklist prompting. Patient discussions addressed more checklist items before prompting at the end of the 2-week evaluation compared with the 2-week preimplementation period (surgical trauma ICU, 36% vs. 77%, p < 0.0001; burn ICU, 47% vs. 72 %, p < 0.001). Most items were addressed more frequently in both ICUs after implementation. Key items such as central line removal, reduction of laboratory testing, medication reconciliation, medication interactions, bowel movements, sedation holidays, breathing trials, and lung protective ventilation showed significant improvements. Checklists modify communication patterns. Improved communication facilitated by checklists may be one mechanism behind their effectiveness. Checklists are powerful tools that can rapidly alter patient care delivery. Implementing checklists could facilitate the rapid dissemination of clinical practice changes, improve communication between echelons of care and between individuals involved in patient care, and reduce missed information.

Checklists and Monitoring in the Cockpit: Why Crucial Defenses Sometimes Fail

NASA Technical Reports Server (NTRS)

Dismukes, R. Key; Berman, Ben

2010-01-01

Checklists and monitoring are two essential defenses against equipment failures and pilot errors. Problems with checklist use and pilots failures to monitor adequately have a long history in aviation accidents. This study was conducted to explore why checklists and monitoring sometimes fail to catch errors and equipment malfunctions as intended. Flight crew procedures were observed from the cockpit jumpseat during normal airline operations in order to: 1) collect data on monitoring and checklist use in cockpit operations in typical flight conditions; 2) provide a plausible cognitive account of why deviations from formal checklist and monitoring procedures sometimes occur; 3) lay a foundation for identifying ways to reduce vulnerability to inadvertent checklist and monitoring errors; 4) compare checklist and monitoring execution in normal flights with performance issues uncovered in accident investigations; and 5) suggest ways to improve the effectiveness of checklists and monitoring. Cognitive explanations for deviations from prescribed procedures are provided, along with suggestions for countermeasures for vulnerability to error.

The Development and Implementation of Cognitive Aids for Critical Events in Pediatric Anesthesia: The Society for Pediatric Anesthesia Critical Events Checklists.

PubMed

Clebone, Anna; Burian, Barbara K; Watkins, Scott C; Gálvez, Jorge A; Lockman, Justin L; Heitmiller, Eugenie S

2017-03-01

Cognitive aids such as checklists are commonly used in modern operating rooms for routine processes, and the use of such aids may be even more important during critical events. The Quality and Safety Committee of the Society for Pediatric Anesthesia (SPA) has developed a set of critical-event checklists and cognitive aids designed for 3 purposes: (1) as a repository of the latest evidence-based and expert opinion-based information to guide response and management of critical events, (2) as a source of just-in-time information during critical events, and (3) as a method to facilitate a shared understanding of required actions among team members during a critical event. Committee members, who represented children's hospitals from across the nation, used the recent literature and established guidelines (where available) and incorporated the expertise of colleagues at their institutions to develop these checklists, which included relevant factors to consider and steps to take in response to critical events. Human factors principles were incorporated to enhance checklist usability, facilitate error-free accomplishment, and ensure a common approach to checklist layout, formatting, structure, and design.The checklists were made available in multiple formats: a PDF version for easy printing, a mobile application, and at some institutions, a Web-based application using the anesthesia information management system. After the checklists were created, training commenced, and plans for validation were begun. User training is essential for successful implementation and should ideally include explanation of the organization of the checklists; familiarization of users with the layout, structure, and formatting of the checklists; coaching in how to use the checklists in a team environment; reviewing of the items; and simulation of checklist use. Because of the rare and unpredictable nature of critical events, clinical trials that use crisis checklists are difficult to conduct; however, recent and future simulation studies with adult checklists provide a promising avenue for future validation of the SPA checklists. This article will review the developmental steps in producing the SPA crisis checklists, including creation of content, incorporation of human factors elements, and validation in simulation. Critical-events checklists have the potential to improve patient care during emergency events, and it is hoped that incorporating the elements presented in this article will aid in successful implementation of these essential cognitive aids.

Resource Conservation and Recovery Act (RCRA) Statutory Checklist

EPA Pesticide Factsheets

The RCRA Statutory Checklist which follows includes the statutory provisions listed on the original State Legislation Checklist, which States completed as part of the Base Program authorization, and the HSWA Statutory Checklist.

Osteogenic Potential of Dental Mesenchymal Stem Cells in Preclinical Studies: A Systematic Review Using Modified ARRIVE and CONSORT Guidelines

PubMed Central

Ramamoorthi, Murali; Bakkar, Mohammed; Jordan, Jack; Tran, Simon D.

2015-01-01

Background and Objective. Dental stem cell-based tissue engineered constructs are emerging as a promising alternative to autologous bone transfer for treating bone defects. The purpose of this review is to systematically assess the preclinical in vivo and in vitro studies which have evaluated the efficacy of dental stem cells on bone regeneration. Methods. A literature search was conducted in Ovid Medline, Embase, PubMed, and Web of Science up to October 2014. Implantation of dental stem cells in animal models for evaluating bone regeneration and/or in vitro studies demonstrating osteogenic potential of dental stem cells were included. The preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines were used to ensure the quality of the search. Modified ARRIVE (Animal research: reporting in invivo experiments) and CONSORT (Consolidated reporting of trials) were used to critically analyze the selected studies. Results. From 1914 citations, 207 full-text articles were screened and 137 studies were included in this review. Because of the heterogeneity observed in the studies selected, meta-analysis was not possible. Conclusion. Both in vivo and in vitro studies indicate the potential use of dental stem cells in bone regeneration. However well-designed randomized animal trials are needed before moving into clinical trials. PMID:26106427

Effect of clinically discriminating, evidence-based checklist items on the reliability of scores from an Internal Medicine residency OSCE.

PubMed

Daniels, Vijay J; Bordage, Georges; Gierl, Mark J; Yudkowsky, Rachel

2014-10-01

Objective structured clinical examinations (OSCEs) are used worldwide for summative examinations but often lack acceptable reliability. Research has shown that reliability of scores increases if OSCE checklists for medical students include only clinically relevant items. Also, checklists are often missing evidence-based items that high-achieving learners are more likely to use. The purpose of this study was to determine if limiting checklist items to clinically discriminating items and/or adding missing evidence-based items improved score reliability in an Internal Medicine residency OSCE. Six internists reviewed the traditional checklists of four OSCE stations classifying items as clinically discriminating or non-discriminating. Two independent reviewers augmented checklists with missing evidence-based items. We used generalizability theory to calculate overall reliability of faculty observer checklist scores from 45 first and second-year residents and predict how many 10-item stations would be required to reach a Phi coefficient of 0.8. Removing clinically non-discriminating items from the traditional checklist did not affect the number of stations (15) required to reach a Phi of 0.8 with 10 items. Focusing the checklist on only evidence-based clinically discriminating items increased test score reliability, needing 11 stations instead of 15 to reach 0.8; adding missing evidence-based clinically discriminating items to the traditional checklist modestly improved reliability (needing 14 instead of 15 stations). Checklists composed of evidence-based clinically discriminating items improved the reliability of checklist scores and reduced the number of stations needed for acceptable reliability. Educators should give preference to evidence-based items over non-evidence-based items when developing OSCE checklists.

Five years' experience with a customized electronic checklist for radiation therapy planning quality assurance in a multicampus institution.

PubMed

Berry, Sean L; Tierney, Kevin P; Elguindi, Sharif; Mechalakos, James G

2017-12-24

An electronic checklist has been designed with the intention of reducing errors while minimizing user effort in completing the checklist. We analyze the clinical use and evolution of the checklist over the past 5 years and review data in an incident learning system (ILS) to investigate whether it has contributed to an improvement in patient safety. The checklist is written as a standalone HTML application using VBScript. User selection of pertinent demographic details limits the display of checklist items only to those necessary for the particular clinical scenario. Ten common clinical scenarios were used to illustrate the difference between the maximum possible number of checklist items available in the code versus the number displayed to the user at any one time. An ILS database of errors and near misses was reviewed to evaluate whether the checklist influenced the occurrence of reported events. Over 5 years, the number of checklist items available in the code nearly doubled, whereas the number displayed to the user at any one time stayed constant. Events reported in our ILS related to the beam energy used with pacemakers, projection of anatomy on digitally reconstructed radiographs, orthogonality of setup fields, and field extension beyond match lines, did not recur after the items were added to the checklist. Other events related to bolus documentation and breakpoints continued to be reported. Our checklist is adaptable to the introduction of new technologies, transitions between planning systems, and to errors and near misses recorded in the ILS. The electronic format allows us to restrict user display to a small, relevant, subset of possible checklist items, limiting the planner effort needed to review and complete the checklist. Copyright © 2018. Published by Elsevier Inc.

Towards a standardised approach for evaluating guidelines and guidance documents on palliative sedation: study protocol

PubMed Central

2014-01-01

Background Sedation in palliative care has received growing attention in recent years; and so have guidelines, position statements, and related literature that provide recommendations for its practice. Yet little is known collectively about the content, scope and methodological quality of these materials. According to research, there are large variations in palliative sedation practice, depending on the definition and methodology used. However, a standardised approach to comparing and contrasting related documents, across countries, associations and governmental bodies is lacking. This paper reports on a protocol designed to enable thorough and systematic comparison of guidelines and guidance documents on palliative sedation. Methods and design A multidisciplinary and international group of palliative care researchers, identified themes and clinical issues on palliative sedation based on expert consultations and evidence drawn from the EAPC (European Association of Palliative Care) framework for palliative sedation and AGREE II (Appraisal Guideline Research and Evaluation) instrument for guideline assessment. The most relevant themes were selected and built into a comprehensive checklist. This was tested on people working closely with practitioners and patients, for user-friendliness and comprehensibility, and modified where necessary. Next, a systematic search was conducted for guidelines in English, Dutch, Flemish, or Italian. The search was performed in multiple databases (PubMed, CancerLit, CNAHL, Cochrane Library, NHS Evidence and Google Scholar), and via other Internet resources. Hereafter, the final version of the checklist will be used to extract data from selected literature, and the same will be compiled, entered into SPSS, cleaned and analysed systematically for publication. Discussion We have together developed a comprehensive checklist in a scientifically rigorous manner to allow standardised and systematic comparison. The protocol is applicable to all guidelines on palliative sedation, and the approach will contribute to rigorous and systematic comparison of international guidelines on any challenging topic such as this. Results from the study will provide valuable insights into common core elements and differences between the selected guidelines, and the extent to which recommendations are derived from, or match those in the EAPC framework. The outcomes of the study will be disseminated via peer-reviewed journals and directly to appropriate audiences. PMID:25028571

Towards a standardised approach for evaluating guidelines and guidance documents on palliative sedation: study protocol.

PubMed

Abarshi, Ebun; Rietjens, Judith; Caraceni, Augusto; Payne, Sheila; Deliens, Luc; Van Den Block, Lieve

2014-01-01

Sedation in palliative care has received growing attention in recent years; and so have guidelines, position statements, and related literature that provide recommendations for its practice. Yet little is known collectively about the content, scope and methodological quality of these materials. According to research, there are large variations in palliative sedation practice, depending on the definition and methodology used. However, a standardised approach to comparing and contrasting related documents, across countries, associations and governmental bodies is lacking. This paper reports on a protocol designed to enable thorough and systematic comparison of guidelines and guidance documents on palliative sedation. A multidisciplinary and international group of palliative care researchers, identified themes and clinical issues on palliative sedation based on expert consultations and evidence drawn from the EAPC (European Association of Palliative Care) framework for palliative sedation and AGREE II (Appraisal Guideline Research and Evaluation) instrument for guideline assessment. The most relevant themes were selected and built into a comprehensive checklist. This was tested on people working closely with practitioners and patients, for user-friendliness and comprehensibility, and modified where necessary. Next, a systematic search was conducted for guidelines in English, Dutch, Flemish, or Italian. The search was performed in multiple databases (PubMed, CancerLit, CNAHL, Cochrane Library, NHS Evidence and Google Scholar), and via other Internet resources. Hereafter, the final version of the checklist will be used to extract data from selected literature, and the same will be compiled, entered into SPSS, cleaned and analysed systematically for publication. We have together developed a comprehensive checklist in a scientifically rigorous manner to allow standardised and systematic comparison. The protocol is applicable to all guidelines on palliative sedation, and the approach will contribute to rigorous and systematic comparison of international guidelines on any challenging topic such as this. Results from the study will provide valuable insights into common core elements and differences between the selected guidelines, and the extent to which recommendations are derived from, or match those in the EAPC framework. The outcomes of the study will be disseminated via peer-reviewed journals and directly to appropriate audiences.

Evaluation of a countrywide implementation of the world health organisation surgical safety checklist in Madagascar

PubMed Central

White, Michelle C.; Baxter, Linden S.; Close, Kristin L.; Ravelojaona, Vaonandianina A.; Rakotoarison, Hasiniaina N.; Bruno, Emily; Herbert, Alison; Andean, Vanessa; Callahan, James; Andriamanjato, Hery H.; Shrime, Mark G.

2018-01-01

Background The 2009 World Health Organisation (WHO) surgical safety checklist significantly reduces surgical mortality and morbidity (up to 47%). Yet in 2016, only 25% of East African anesthetists regularly use the checklist. Nationwide implementation of the checklist is reported in high-income countries, but in low- and middle-income countries (LMICs) reports of successful implementations are sparse, limited to single institutions and require intensive support. Since checklist use leads to the biggest improvements in outcomes in LMICs, methods of wide-scale implementation are needed. We hypothesized that, using a three-day course, successful wide-scale implementation of the checklist could be achieved, as measured by at least 50% compliance with six basic safety processes at three to four months. We also aimed to determine predictors for checklist utilization. Materials and methods Using a blended educational implementation strategy based on prior pilot studies we designed a three-day dynamic educational course to facilitate widespread implementation of the WHO checklist. The course utilized lectures, film, small group breakouts, participant feedback and simulation to teach the knowledge, skills and behavior changes needed to implement the checklist. In collaboration with the Ministry of Health and local hospital leadership, the course was delivered to 427 multi-disciplinary staff at 21 hospitals located in 19 of 22 regions of Madagascar between September 2015 and March 2016. We evaluated implementation at three to four months using questionnaires (with a 5-point Likert scale) and focus groups. Multivariate linear regression was used to test predictors of checklist utilization. Results At three to four months, 65% of respondents reported always using the checklist, with another 13% using it in part. Participant’s years in practice, hospital size, or surgical volume did not predict checklist use. Checklist use was associated with counting instruments (p< 0.05), but not with verifying: patient identity, difficult intubation risk, risk of blood loss, prophylactic antibiotic administration, or counting needles and sponges. Conclusion Use of a multi-disciplinary three-day course for checklist implementation resulted in 78% of participants using the checklist, at three months; and an increase in counting surgical instruments. Successful checklist implementation was not predicted by participant length of medical service, hospital size or surgical volume. If reproducible in other countries, widespread implementation in LMICs becomes a realistic possibility. PMID:29401465

Evaluation of a countrywide implementation of the world health organisation surgical safety checklist in Madagascar.

PubMed

White, Michelle C; Baxter, Linden S; Close, Kristin L; Ravelojaona, Vaonandianina A; Rakotoarison, Hasiniaina N; Bruno, Emily; Herbert, Alison; Andean, Vanessa; Callahan, James; Andriamanjato, Hery H; Shrime, Mark G

2018-01-01

The 2009 World Health Organisation (WHO) surgical safety checklist significantly reduces surgical mortality and morbidity (up to 47%). Yet in 2016, only 25% of East African anesthetists regularly use the checklist. Nationwide implementation of the checklist is reported in high-income countries, but in low- and middle-income countries (LMICs) reports of successful implementations are sparse, limited to single institutions and require intensive support. Since checklist use leads to the biggest improvements in outcomes in LMICs, methods of wide-scale implementation are needed. We hypothesized that, using a three-day course, successful wide-scale implementation of the checklist could be achieved, as measured by at least 50% compliance with six basic safety processes at three to four months. We also aimed to determine predictors for checklist utilization. Using a blended educational implementation strategy based on prior pilot studies we designed a three-day dynamic educational course to facilitate widespread implementation of the WHO checklist. The course utilized lectures, film, small group breakouts, participant feedback and simulation to teach the knowledge, skills and behavior changes needed to implement the checklist. In collaboration with the Ministry of Health and local hospital leadership, the course was delivered to 427 multi-disciplinary staff at 21 hospitals located in 19 of 22 regions of Madagascar between September 2015 and March 2016. We evaluated implementation at three to four months using questionnaires (with a 5-point Likert scale) and focus groups. Multivariate linear regression was used to test predictors of checklist utilization. At three to four months, 65% of respondents reported always using the checklist, with another 13% using it in part. Participant's years in practice, hospital size, or surgical volume did not predict checklist use. Checklist use was associated with counting instruments (p< 0.05), but not with verifying: patient identity, difficult intubation risk, risk of blood loss, prophylactic antibiotic administration, or counting needles and sponges. Use of a multi-disciplinary three-day course for checklist implementation resulted in 78% of participants using the checklist, at three months; and an increase in counting surgical instruments. Successful checklist implementation was not predicted by participant length of medical service, hospital size or surgical volume. If reproducible in other countries, widespread implementation in LMICs becomes a realistic possibility.

Invited review: Recommendations for reporting intervention studies on reproductive performance in dairy cattle: Improving design, analysis, and interpretation of research on reproduction.

PubMed

Lean, Ian J; Lucy, Matthew C; McNamara, John P; Bradford, Barry J; Block, Elliot; Thomson, Jennifer M; Morton, John M; Celi, Pietro; Rabiee, Ahmad R; Santos, José E P; Thatcher, William W; LeBlanc, Stephen J

2016-01-01

Abundant evidence from the medical, veterinary, and animal science literature demonstrates that there is substantial room for improvement of the clarity, completeness, and accuracy of reporting of intervention studies. More rigorous reporting guidelines are needed to improve the quality of data available for use in comparisons of outcomes (or meta-analyses) of multiple studies. Because of the diversity of factors that affect reproduction and the complexity of interactions between these, a systematic approach is required to design, conduct, and analyze basic and applied studies of dairy cattle reproduction. Greater consistency, clarity, completeness, and correctness of design and reporting will improve the value of each report and allow for greater depth of evaluation in meta-analyses. Each of these benefits will improve understanding and application of current knowledge and better identify questions that require additional modeling or primary research. The proposed guidelines and checklist will aid in the design, conduct, analysis, and reporting of intervention studies. We propose an adaptation of the REFLECT (Reporting Guidelines for Randomized Controlled Trials for Livestock and Food Safety) statement to provide guidelines and a checklist specific to reporting intervention studies in dairy cattle reproduction. Furthermore, we provide recommendations that will assist investigators to produce studies with greater internal and external validity that can more often be included in systematic reviews and global meta-analyses. Such studies will also assist the development of models to describe the physiology of reproduction. Copyright © 2016 American Dairy Science Association. Published by Elsevier Inc. All rights reserved.

A Checklist to Improve Patient Safety in Interventional Radiology

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

Koetser, Inge C. J.; Vries, Eefje N. de; Delden, Otto M. van

2013-04-15

To develop a specific RADiological Patient Safety System (RADPASS) checklist for interventional radiology and to assess the effect of this checklist on health care processes of radiological interventions. On the basis of available literature and expert opinion, a prototype checklist was developed. The checklist was adapted on the basis of observation of daily practice in a tertiary referral centre and evaluation by users. To assess the effect of RADPASS, in a series of radiological interventions, all deviations from optimal care were registered before and after implementation of the checklist. In addition, the checklist and its use were evaluated by interviewingmore » all users. The RADPASS checklist has two parts: A (Planning and Preparation) and B (Procedure). The latter part comprises checks just before starting a procedure (B1) and checks concerning the postprocedural care immediately after completion of the procedure (B2). Two cohorts of, respectively, 94 and 101 radiological interventions were observed; the mean percentage of deviations of the optimal process per intervention decreased from 24 % before implementation to 5 % after implementation (p < 0.001). Postponements and cancellations of interventions decreased from 10 % before implementation to 0 % after implementation. Most users agreed that the checklist was user-friendly and increased patient safety awareness and efficiency. The first validated patient safety checklist for interventional radiology was developed. The use of the RADPASS checklist reduced deviations from the optimal process by three quarters and was associated with less procedure postponements.« less

Special Consolidated Checklists for Land Disposal Restrictions (unchanged since 1992)

EPA Pesticide Factsheets

This checklist consolidates LDR rules from the first rule promulgated on November 7, 1986 through June 30, 1992, including the Third Third Scheduled wastes (i.e., from Revision Checklist 34 through Revision Checklist 106, 57 FR 28628, June 26, 1992).

Reductions in invasive device use and care costs after institution of a daily safety checklist in a pediatric critical care unit.

PubMed

Tarrago, Rod; Nowak, Jeffrey E; Leonard, Christopher S; Payne, Nathaniel R

2014-06-01

In the critical care unit, complexity of care can contribute to both medical errors and increased costs, particularly when clinicians are forced to rely on memory. Checklists can be used to improve safety and reduce cost. A number of omission-related adverse events in 2010 prompted the development of a checklist to reduce the possibility of similar future events. The PICU Safety Checklist was implemented in the pediatric ICU (PICU) at Children's Hospitals and Clinics of Minnesota. During a 21-month period, the checklist was used to prompt the care team to address quality and safety items during rounds. The initial checklist was paper, with two subsequent versions being incorporated into the electronic medical record (EMR). The daily safety checklist was successfully implemented in the PICU. Work-flow improvements based on regular multidisciplinary feedback led to more consistent use of the checklist. Improvements on all quality and safety metrics were identified, including invasive device use, medication costs, antibiotic and laboratory test use, and compliance with standards of care. Staff satisfaction rates were > 80% for safety, communication, and collaboration. By using a daily safety checklist in the pediatric critical care unit, we improved quality and safety, as well as the collaborative culture among all clinicians. Incorporating the checklist into the EMR improved compliance and accountability, ensuring its application to all patients. Clinicians now often individually address many checklist items outside the formal rounding process, indicating that the checklist content has become part of their usual practice. A successful implementation showing tangible clinical improvements can lead to interest and adoption in other clinical areas within the institution.

A meta-model for computer executable dynamic clinical safety checklists.

PubMed

Nan, Shan; Van Gorp, Pieter; Lu, Xudong; Kaymak, Uzay; Korsten, Hendrikus; Vdovjak, Richard; Duan, Huilong

2017-12-12

Safety checklist is a type of cognitive tool enforcing short term memory of medical workers with the purpose of reducing medical errors caused by overlook and ignorance. To facilitate the daily use of safety checklists, computerized systems embedded in the clinical workflow and adapted to patient-context are increasingly developed. However, the current hard-coded approach of implementing checklists in these systems increase the cognitive efforts of clinical experts and coding efforts for informaticists. This is due to the lack of a formal representation format that is both understandable by clinical experts and executable by computer programs. We developed a dynamic checklist meta-model with a three-step approach. Dynamic checklist modeling requirements were extracted by performing a domain analysis. Then, existing modeling approaches and tools were investigated with the purpose of reusing these languages. Finally, the meta-model was developed by eliciting domain concepts and their hierarchies. The feasibility of using the meta-model was validated by two case studies. The meta-model was mapped to specific modeling languages according to the requirements of hospitals. Using the proposed meta-model, a comprehensive coronary artery bypass graft peri-operative checklist set and a percutaneous coronary intervention peri-operative checklist set have been developed in a Dutch hospital and a Chinese hospital, respectively. The result shows that it is feasible to use the meta-model to facilitate the modeling and execution of dynamic checklists. We proposed a novel meta-model for the dynamic checklist with the purpose of facilitating creating dynamic checklists. The meta-model is a framework of reusing existing modeling languages and tools to model dynamic checklists. The feasibility of using the meta-model is validated by implementing a use case in the system.

Process Improvement in Thoracic Donor Organ Procurement: Implementation of a Donor Assessment Checklist.

PubMed

Loor, Gabriel; Shumway, Sara J; McCurry, Kenneth R; Keshavamurthy, Suresh; Hussain, Syed; Weide, Garry D; Spratt, John R; Al Salihi, Mazin; Koch, Colleen G

2016-12-01

Donor organs are often procured by junior staff in stressful, unfamiliar environments where a single adverse event can be catastrophic. A formalized checklist focused on preprocedural processes related to thoracic donor organ procurement could improve detection and prevention of near miss events. A checklist was developed centered on patient identifiers, organ compatibility and quality, and team readiness. It went through five cycles of feedback and revision using a panel of expert procurement surgeons. Educational in-service sessions were held on the use of the checklist as well as best organ assessment practices. Near miss events before the survey were tallied by retrospective review of 20 procurements, and near misses after checklist implementation were prospectively recorded. We implemented the checklist for 40 donor lung and heart procurements: 20 from Cleveland Clinic and 20 from the University of Minnesota. A final survey assessment was used to determine ease of use. Nine near miss events were reported in 20 procurements before use of the checklist. Thirty-one near miss events of 40 organ procurements were identified and potentially prevented by the checklist. Eighty-seven percent of fellows found the checklist to be unobtrusive to work flow, and 100% believed its use should be mandatory. Mortality was the same before and after implementation of the checklist despite increased patient volumes. Implementation of a simple checklist for use during thoracic organ procurement uncovered a substantial number of near miss events. A preprocedural checklist for all thoracic organ transplants in the United States and abroad is feasible and would likely reduce adverse events. Copyright © 2016 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

The Value of a Checklist for Child Abuse in Out-of-Hours Primary Care: To Screen or Not to Screen.

PubMed

Schouten, Maartje Cm; van Stel, Henk F; Verheij, Theo Jm; Houben, Michiel L; Russel, Ingrid Mb; Nieuwenhuis, Edward Es; van de Putte, Elise M

2017-01-01

To assess the diagnostic value of the screening instrument SPUTOVAMO-R2 (checklist, 5 questions) for child abuse at Out-of-hours Primary Care locations (OPC), by comparing the test outcome with information from Child Protection Services (CPS). Secondary, to determine whether reducing the length of the checklist compromises diagnostic value. All children (<18 years) attending one of the participating OPCs in the region of Utrecht, the Netherlands, in a year time, were included. The checklist is an obligatory field in the electronic patient file. CPS provided data on all checklist positives and a sample of 5500 checklist negatives (dataset). The checklist outcome was compared with a report to CPS in 10 months follow up after the OPC visit. The checklist was filled in for 50671 children; 108 (0.2%) checklists were positive. Within the dataset, 61 children were reported to CPS, with emotional neglect as the most frequent type of abuse (32.8%). The positive predictive value (PPV) of the checklist for child abuse was 8.3 (95% CI 3.9-15.2). The negative predictive value (NPV) was 99.1 (98.8-99.3), with 52 false negatives. When the length of the checklist was reduced to two questions closely related to the medical process (SPUTOVAMO-R3), the PPV was 9.1 (3.7-17.8) and the NPV 99.1 (98.7-99.3). These two questions are on the injury in relation to the history, and the interaction between child and parents. The checklist SPUTOVAMO-R2 has a low detection rate of child abuse within the OPC setting, and a high false positive rate. Therefore, we recommend to use the shortened checklist only as a tool to increase the awareness of child abuse and not as a diagnostic instrument.

The Value of a Checklist for Child Abuse in Out-of-Hours Primary Care: To Screen or Not to Screen

PubMed Central

van Stel, Henk F.; Verheij, Theo JM; Houben, Michiel L.; Russel, Ingrid MB; Nieuwenhuis, Edward ES; van de Putte, Elise M.

2017-01-01

Objectives To assess the diagnostic value of the screening instrument SPUTOVAMO-R2 (checklist, 5 questions) for child abuse at Out-of-hours Primary Care locations (OPC), by comparing the test outcome with information from Child Protection Services (CPS). Secondary, to determine whether reducing the length of the checklist compromises diagnostic value. Methods All children (<18 years) attending one of the participating OPCs in the region of Utrecht, the Netherlands, in a year time, were included. The checklist is an obligatory field in the electronic patient file. CPS provided data on all checklist positives and a sample of 5500 checklist negatives (dataset). The checklist outcome was compared with a report to CPS in 10 months follow up after the OPC visit. Results The checklist was filled in for 50671 children; 108 (0.2%) checklists were positive. Within the dataset, 61 children were reported to CPS, with emotional neglect as the most frequent type of abuse (32.8%). The positive predictive value (PPV) of the checklist for child abuse was 8.3 (95% CI 3.9–15.2). The negative predictive value (NPV) was 99.1 (98.8–99.3), with 52 false negatives. When the length of the checklist was reduced to two questions closely related to the medical process (SPUTOVAMO-R3), the PPV was 9.1 (3.7–17.8) and the NPV 99.1 (98.7–99.3). These two questions are on the injury in relation to the history, and the interaction between child and parents. Conclusions The checklist SPUTOVAMO-R2 has a low detection rate of child abuse within the OPC setting, and a high false positive rate. Therefore, we recommend to use the shortened checklist only as a tool to increase the awareness of child abuse and not as a diagnostic instrument. PMID:28045904

The effect of a performance-based intra-procedural checklist on a simulated emergency laparoscopic task in novice surgeons.

PubMed

El Boghdady, Michael; Tang, Benjie; Alijani, Afshin

2017-05-01

Surgical checklists are in use as means to reduce errors. Checklists are infrequently applied during emergency situations in surgery. We aimed to study the effect of a simple self-administered performance-based checklist on the laparoscopic task when applied during an emergency-simulated scenario. The aviation checklist for unexpected situations is commonly used for simulated training of pilots to handle emergency during flights. This checklist was adopted for use as a standardised-performance-based checklist during emergency surgical tasks. Thirty consented laparoscopic novices were exposed unexpectedly to a bleeding vessel in a laparoscopic virtual reality simulator as an emergency scenario. The task consisted of using laparoscopic clips to achieve haemostasis. Subjects were randomly allocated into two equal groups; those using the checklist that was applied once every 20 s (checklist group) and those without (control group). The checklist group performed significantly better in 5 out of 7 technical factors when compared to the control group: right instrument path length (m), median (IQR) 1.44 [1.22] versus 2.06 [1.70] (p = 0.029), right instrument angular path (degree) 312.10 (269.44 versus 541.80 [455.16] (p = 0.014), left instrument path length (m) 1.20 [0.60] versus 2.08 [2.02] (p = 0.004), and left instrument angular path (degree) 277.62 [132.11] versus 385.88 [428.42] (p = 0.017). The checklist group committed significantly fewer number of errors in the application of haemostatic clips, 3 versus 28 (p = 0.006). Although statistically not significant, total blood loss (lit) decreased in the checklist group from 0.83 [1.23] to 0.78 [0.28] (p = 0.724) and total time (sec) from 186.51 [145.69] to 125.14 [101.46] (p = 0.165). The performance-based intra-procedural checklist significantly enhanced the surgical task performance of novices in an emergency-simulated scenario.

Incidence of ventilator-associated pneumonia in Australasian intensive care units: use of a consensus-developed clinical surveillance checklist in a multisite prospective audit

PubMed Central

Elliott, Doug; Elliott, Rosalind; Burrell, Anthony; Harrigan, Peter; Murgo, Margherita; Rolls, Kaye; Sibbritt, David

2015-01-01

Objectives With disagreements on diagnostic criteria for ventilator-associated pneumonia (VAP) hampering efforts to monitor incidence and implement preventative strategies, the study objectives were to develop a checklist for clinical surveillance of VAP, and conduct an audit in Australian/New Zealand intensive care units (ICUs) using the checklist. Setting Online survey software was used for checklist development. The prospective audit using the checklist was conducted in 10 ICUs in Australia and New Zealand. Participants Checklist development was conducted with members of a bi-national professional society for critical care physicians using a modified Delphi technique and survey. A 30-day audit of adult patients mechanically ventilated for >72 h. Primary and secondary outcome measures Presence of items on the screening checklist; physician diagnosis of VAP, clinical characteristics, investigations, treatments and patient outcome. Results A VAP checklist was developed with five items: decreasing gas exchange, sputum changes, chest X-ray infiltrates, inflammatory response, microbial growth. Of the 169 participants, 17% (n=29) demonstrated characteristics of VAP using the checklist. A similar proportion had an independent physician diagnosis (n=30), but in a different patient subset (only 17% of cases were identified by both methods). The VAP rate per 1000 mechanical ventilator days for the checklist and clinician diagnosis was 25.9 and 26.7, respectively. The item ‘inflammatory response’ was most associated with the first episode of physician-diagnosed VAP. Conclusions VAP rates using the checklist and physician diagnosis were similar to ranges reported internationally and in Australia. Of note, different patients were identified with VAP by the checklist and physicians. While the checklist items may assist in identifying patients at risk of developing VAP, and demonstrates synergy with the recently developed Centers for Disease Control (CDC) guidelines, decision-making processes by physicians when diagnosing VAP requires further exploration. PMID:26515685

A Checklist Intervention to Assess Resident Diagnostic Knee and Shoulder Arthroscopic Efficiency.

PubMed

Nwachukwu, Benedict; Gaudiani, Michael; Hammann-Scala, Jennifer; Ranawat, Anil

The purpose of this investigation was to apply an arthroscopic shoulder and knee checklist in the evaluation of orthopedic resident arthroscopic skill efficiency and to demonstrate the use of a surgical checklist for assessing resident surgical efficiency over the course of a surgical rotation. Orthopedic surgery residents rotating on the sports medicine service at our institution between 2011 and 2015 were enrolled in this study. Residents were administered a shoulder and knee arthroscopy assessment tool at the beginning and end of their 6-week rotation. The assessment tools consisted of checklist items for knee and shoulder arthroscopy skills. Residents were timed while performing these checklist tasks. The primary outcome measure was resident improvement as a function of time to completion for the checklist items, and the intervention was participation in a 6-week resident rotation with weekly arthroscopy didactics, cadaver simulator work, and operating room experience. A paired t test was used to compare means. Mean time to checklist completion during week 1 among study participants for the knee checklist was 787.4 seconds for the knee checklist and 484.4 seconds at the end of the rotation. Mean time to checklist completion during week 1 among study participants for the shoulder checklist was 1655.3 seconds and 832.7 seconds for the shoulder checklist at the end of the rotation. Mean improvement in time to completion was 303 seconds (p = 0.0006, SD = 209s) and 822.6 seconds (p = 0.00008, SD = 525.2s) for the arthroscopic knee and shoulder assessments, respectively. An arthroscopic checklist is 1 method to evaluate and assess resident efficiency and improvement during surgical training. Among residents participating in this study, we found statistically significant improvements in time for arthroscopic task completion. II. Copyright © 2016 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.

Validity and reliability of the Movement Assessment Battery for Children-2 Checklist for children with and without motor impairments.

PubMed

Schoemaker, Marina M; Niemeijer, Anuschka S; Flapper, Boudien C T; Smits-Engelsman, Bouwien C M

2012-04-01

The aim of this study was to investigate the validity and reliability of the Movement Assessment Battery for Children-2 Checklist (MABC-2). Teachers completed the Checklist for 383 children (age range 5-8y; mean age 6y 9mo; 190 males; 193 females) and the parents of 130 of these children completed the Developmental Disorder Coordination Questionnaire 2007 (DCDQ'07). All children were assessed with the MABC-2 Test. The internal consistency of the 30 items of the Checklist was determined to measure reliability. Construct validity was investigated using factor analysis and discriminative validity was assessed by comparing the scores of children with and without movement difficulties. Concurrent validity was measured by calculating correlations between the Checklist, Test, and the DCDQ'07. Incremental validity was assessed to determine whether the Checklist was a better predictor of motor impairment than the DCDQ'07. Sensitivity and specificity were investigated using the MABC-2 Test as reference standard (cut-off 15th centile). The Checklist items measure the same construct. Six factors were obtained after factor analysis. This implies that a broad range of functional activities can be assessed with the Checklist, which renders the Checklist useful for assessing criterion B of the diagnostic criteria for DCD. The mean Checklist scores for children with and without motor impairments significantly differed (p<0.001). The scores for the Checklist/Test and DCDQ'07 were significantly correlated (r(S) =-0.38 and p<0.001, and r(S) =-0.36 and p<0.001, respectively). The Checklist better predicted motor impairment than the DCDQ'07. Overall, the sensitivity was low (41%) and the specificity was acceptable (88%). The Checklist meets standards for validity and reliability. © The Authors. Developmental Medicine & Child Neurology © 2012 Mac Keith Press.

A challenge-response endoscopic sinus surgery specific checklist as an add-on to standard surgical checklist: an evaluation of potential safety and quality improvement issues.

PubMed

Sommer, Doron D; Arbab-Tafti, Sadaf; Farrokhyar, Forough; Tewfik, Marc; Vescan, Allan; Witterick, Ian J; Rotenberg, Brian; Chandra, Rakesh; Weitzel, Erik K; Wright, Erin; Ramakrishna, Jayant

2018-02-27

The goal of this study was to develop and evaluate the impact of an aviation-style challenge and response sinus surgery-specific checklist on potential safety and equipment issues during sinus surgery at a tertiary academic health center. The secondary goal was to assess the potential impact of use of the checklist on surgical times during, before, and after surgery. This initiative is designed to be utilized in conjunction with the "standard" World Health Organization (WHO) surgical checklist. Although endoscopic sinus surgery is generally considered a safe procedure, avoidable complications and potential safety concerns continue to occur. The WHO surgical checklist does not directly address certain surgery-specific issues, which may be of particular relevance for endoscopic sinus surgery. This prospective observational pilot study monitored compliance with and compared the occurrence of safety and equipment issues before and after implementation of the checklist. Forty-seven consecutive endoscopic surgeries were audited; the first 8 without the checklist and the following 39 with the checklist. The checklist was compiled by evaluating the patient journey, utilizing the available literature, expert consensus, and finally reevaluation with audit type cases. The final checklist was developed with all relevant stakeholders involved in a Delphi method. Implementing this specific surgical checklist in 39 cases at our institution, allowed us to identify and rectify 35 separate instances of potentially unsafe, improper or inefficient preoperative setup. These incidents included issues with labeling of topical vasoconstrictor or injectable anesthetics (3, 7.7%) and availability, function and/or position of video monitors (2, 5.1%), endoscope (6, 15.4%), microdebrider (6, 15.4%), bipolar cautery (6, 15.4%), and suctions (12, 30.8%). The design and integration of this checklist for endoscopic sinus surgery, has helped improve efficiency and patient safety in the operating room setting. © 2018 ARS-AAOA, LLC.

A Feminist Family Therapist Behavior Checklist.

ERIC Educational Resources Information Center

Chaney, Sita E.; Piercy, Fred P.

1988-01-01

Developed Feminist Family Therapist Behavior Checklist to identify feminist family therapy skills. Used checklist to rate family therapy sessions of 60 therapists in variety of settings. Checklist discriminated between self-reported feminists and nonfeminists, between men and women, and between expert categorizations of feminist and nonfeminist…

42 CFR 37.95 - Specifications for performing spirometry examinations.

Code of Federal Regulations, 2014 CFR

2014-10-01

... examinations must include the following: (1) Pre-test checklist. A short Spirometry Pre-Test Checklist (Form... spirometry examinations electronically with content as specified in § 37.96(b), pre-test screening checklists... spirometry examinations, pre-test checklists, and standardized respiratory assessment results in electronic...

CHECKLIST OF DIATOMS FROM THE LAURENTIAN GREAT LAKES

EPA Science Inventory

An updated diatom checklist for the Great Lakes is provided. The present checklist supplants the preliminary checklist published in The Journal for Great Lakes Research in 1978 and effectively represents a 20-year update. A series of procedures were used in this update which incl...

Arms Control and European Security

DTIC Science & Technology

2012-08-01

There is an instructive contrast between the adaptation of the CFE Treaty with the complex and long-running 19th century Schleswig- Holstein Question... Holstein business—the Prince Consort, who is dead—a German professor, who has gone mad—and 2 I, who have forgotten all about it.” The group of spe...cialist policymakers and academic commentators for CFE/ACFE often seems only slightly larger. Both the Schleswig- Holstein and CFE questions were not only

Implementation of safety checklists in surgery: a realist synthesis of evidence.

PubMed

Gillespie, Brigid M; Marshall, Andrea

2015-09-28

The aim of this review is to present a realist synthesis of the evidence of implementation interventions to improve adherence to the use of safety checklists in surgery. Surgical safety checklists have been shown to improve teamwork and patient safety in the operating room. Yet, despite the benefits associated with their use, universal implementation of and compliance with these checklists has been inconsistent. An overview of the literature from 2008 is examined in relation to checklist implementation, compliance, and sustainability. Pawson's and Rycroft-Malone's realist synthesis methodology was used to explain the interaction between context, mechanism, and outcome. This approach incorporated the following: defining the scope of the review, searching and appraising the evidence, extracting and synthesising the findings, and disseminating, implementing, and evaluating the evidence. We identified two theories a priori that explained contextual nuances associated with implementation and evaluation of checklists in surgery: the Normalisation Process Theory and Responsive Regulation Theory. We identified four a priori propositions: (1) Checklist protocols that are prospectively tailored to the context are more likely to be used and sustained in practice, (2) Fidelity and sustainability is increased when checklist protocols can be seamlessly integrated into daily professional practice, (3) Routine embedding of checklist protocols in practice is influenced by factors that promote or inhibit clinicians' participation, and (4) Regulation reinforcement mechanisms that are more contextually responsive should lead to greater compliance in using checklist protocols. The final explanatory model suggests that the sustained use of surgical checklists is discipline-specific and is more likely to occur when medical staff are actively engaged and leading the process of implementation. Involving clinicians in tailoring the checklist to better fit their context of practice and giving them the opportunity to reflect and evaluate the implementation intervention enables greater participation and ownership of the process. A major limitation in the surgical checklist literature is the lack of robust descriptions of intervention methods and implementation strategies. Despite this, two consequential findings have emerged through this realist synthesis: First, the sustained use of surgical checklists is discipline-specific and is more successful when physicians are actively engaged and leading implementation. Second, involving clinicians in tailoring the checklist to their context and encouraging them to reflect on and evaluate the implementation process enables greater participation and ownership.

Checklist for Change.

ERIC Educational Resources Information Center

Sills, Angelyn C.

1995-01-01

Describes a straightforward, workable strategy that involves a teacher checklist and short individual or student group conferences, with the goal of academic or behavioral improvements. Teachers can easily tick off marks on the checklist and return the form to the counselor; additionally, students can easily understand the format of the checklist.…

Intranet Effectiveness: A Public Relations Paper-and-Pencil Checklist.

ERIC Educational Resources Information Center

Murgolo-Poore, Marie E.; Pitt, Leyland F.; Ewing, Michael T.

2002-01-01

Describes a process directed at developing a simple paper-and-pencil checklist to assess Intranet effectiveness. Discusses the checklist purification procedure, and attempts to establish reliability and validity for the list. Concludes by identifying managerial applications of the checklist, recognizing the limitations of the approach, and…

Evaluation and Customization of WHO Safety Checklist for Patient Safety in Otorhinolaryngology.

PubMed

Dabholkar, Yogesh; Velankar, Haritosh; Suryanarayan, Sneha; Dabholkar, Twinkle Y; Saberwal, Akanksha A; Verma, Bhavika

2018-03-01

The WHO has designed a safe surgery checklist to enhance communication and awareness of patient safety during surgery and to minimise complications. WHO recommends that the check-list be evaluated and customised by end users as a tool to promote safe surgery. The aim of present study was to evaluate the impact of WHO safety checklist on patient safety awareness in otorhinolaryngology and to customise it for the speciality. A prospective structured questionnaire based study was done in ENT operating room for duration of 1 month each for cases, before and after implementation of safe surgery checklist. The feedback from respondents (surgeons, nurses and anaesthetists) was used to arrive at a customised checklist for otolaryngology as per WHO guidelines. The checklist significantly improved team member's awareness of patient's identity (from 17 to 86%) and each other's identity and roles (from 46 to 94%) and improved team communication (from 73 to 92%) in operation theatre. There was a significant improvement in preoperative check of equipment and critical events were discussed more frequently. The checklist could be effectively customised to suit otolaryngology needs as per WHO guidelines. The modified checklist needs to be validated by otolaryngology associations. We conclude from our study that the WHO Surgical safety check-list has a favourable impact on patient safety awareness, team-work and communication of operating team and can be customised for otolaryngology setting.

Paramedic Checklists do not Accurately Identify Post-ictal or Hypoglycaemic Patients Suitable for Discharge at the Scene.

PubMed

Tohira, Hideo; Fatovich, Daniel; Williams, Teresa A; Bremner, Alexandra; Arendts, Glenn; Rogers, Ian R; Celenza, Antonio; Mountain, David; Cameron, Peter; Sprivulis, Peter; Ahern, Tony; Finn, Judith

2016-06-01

The objective of this study was to assess the accuracy and safety of two pre-defined checklists to identify prehospital post-ictal or hypoglycemic patients who could be discharged at the scene. A retrospective cohort study of lower acuity, adult patients attended by paramedics in 2013, and who were either post-ictal or hypoglycemic, was conducted. Two self-care pathway assessment checklists (one each for post-ictal and hypoglycemia) designed as clinical decision tools for paramedics to identify patients suitable for discharge at the scene were used. The intention of the checklists was to provide paramedics with justification to not transport a patient if all checklist criteria were met. Actual patient destination (emergency department [ED] or discharge at the scene) and subsequent events (eg, ambulance requests) were compared between patients who did and did not fulfill the checklists. The performance of the checklists against the destination determined by paramedics was also assessed. Totals of 629 post-ictal and 609 hypoglycemic patients were identified. Of these, 91 (14.5%) and 37 (6.1%) patients fulfilled the respective checklist. Among those who fulfilled the checklist, 25 (27.5%) post-ictal and 18 (48.6%) hypoglycemic patients were discharged at the scene, and 21 (23.1%) and seven (18.9%) were admitted to hospital after ED assessment. Amongst post-ictal patients, those fulfilling the checklist had more subsequent ambulance requests (P=.01) and ED attendances with seizure-related conditions (P=.04) within three days than those who did not. Amongst hypoglycemic patients, there were no significant differences in subsequent events between those who did and did not meet the criteria. Paramedics discharged five times more hypoglycemic patients at the scene than the checklist predicted with no significant differences in the rate of subsequent events. Four deaths (0.66%) occurred within seven days in the hypoglycemic cohort, and none of them were attributed directly to hypoglycemia. The checklists did not accurately identify patients suitable for discharge at the scene within the Emergency Medical Service. Patients who fulfilled the post-ictal checklist made more subsequent health care service requests within three days than those who did not. Both checklists showed similar occurrence of subsequent events to paramedics' decision, but the hypoglycemia checklist identified fewer patients who could be discharged at the scene than paramedics actually discharged. Reliance on these checklists may increase transportations to ED and delay initiation of appropriate treatment at a hospital. Tohira H , Fatovich D , Williams TA , Bremner A , Arendts G , Rogers IR , Celenza A , Mountain D , Cameron P , Sprivulis P , Ahern T , Finn J . Paramedic checklists do not accurately identify post-ictal or hypoglycaemic patients suitable for discharge at the scene. Prehosp Disaster Med. 2016;31(3):282-293.

Design Challenges in Converting a Paper Checklist to Digital Format for Dynamic Medical Settings

PubMed Central

Sarcevic, Aleksandra; Rosen, Brett J.; Kulp, Leah J.; Marsic, Ivan; Burd, Randall S.

2016-01-01

We describe a mobile digital checklist that we designed and developed for trauma resuscitation—a dynamic, fast-paced medical process of treating severely injured patients. The checklist design was informed by our analysis of user interactions with a paper checklist that was introduced to improve team performance during resuscitations. The design process followed an iterative approach and involved several medical experts. We discuss design challenges in converting a paper checklist to its digital counterpart, as well as our approaches for addressing those challenges. While we show that using a digital checklist during a fast-paced medical event is feasible, we also recognize several design constraints, including limited display size, difficulties in entering notes about the medical process and patient, and difficulties in replicating user experience with paper checklists. PMID:28480116

Health and Safety Checklist for Early Care and Education Programs to Assess Key National Health and Safety Standards.

PubMed

Alkon, Abbey; Rose, Roberta; Wolff, Mimi; Kotch, Jonathan B; Aronson, Susan S

2016-01-01

The project aims were to (1) develop an observational Health and Safety Checklist to assess health and safety practices and conditions in early care and education (ECE) programs using Stepping Stones To Caring For Our Children, 3rd Edition national standards, (2) pilot test the Checklist, completed by nurse child care health consultants, to assess feasibility, ease of completion, objectivity, validity, and reliability, and (3) revise the Checklist based on the qualitative and quantitative results of the pilot study. The observable national health and safety standards were identified and then rated by health, safety, and child care experts using a Delphi technique to validate the standards as essential to prevent harm and promote health. Then, child care health consultants recruited ECE centers and pilot tested the 124-item Checklist. The pilot study was conducted in Arizona, California and North Carolina. The psychometric properties of the Checklist were assessed. The 37 participating ECE centers had 2627 children from ethnically-diverse backgrounds and primarily low-income families. The child care health consultants found the Checklist easy to complete, objective, and useful for planning health and safety interventions. The Checklist had content and face validity, inter-rater reliability, internal consistency, and concurrent validity. Based on the child care health consultant feedback and psychometric properties of the Checklist, the Checklist was revised and re-written at an 8th grade literacy level. The Health and Safety Checklist provides a standardized instrument of observable, selected national standards to assess the quality of health and safety in ECE centers.

Barriers to implementing the World Health Organization's Trauma Care Checklist: A Canadian single-center experience.

PubMed

Nolan, Brodie; Zakirova, Rimma; Bridge, Jennifer; Nathens, Avery B

2014-11-01

Management of trauma patients is difficult because of their complexity and acuity. In an effort to improve patient care and reduce morbidity and mortality, the World Health Organization developed a trauma care checklist. Local stakeholder input led to a modified 16-item version that was subsequently piloted. Our study highlights the barriers and challenges associated with implementing this checklist at our hospital. The checklist was piloted over a 6-month period at St. Michael's Hospital, a Level 1 trauma center in Toronto, Canada. At the end of the pilot phase, individual, semistructured interviews were held with trauma team leaders and nursing staff regarding their experiences with the checklist. Axial coding was used to create a typology of attitudes and barriers toward the checklist, and then, vertical coding was used to further explore each identified barrier. Checklist compliance was assessed for the first 7 months. Checklist compliance throughout the pilot phase was 78%. Eight key barriers to implementing the checklist were identified as follows: perceived lack of time for the use of the checklist in critically ill patients, unclear roles, no memory trigger, no one to enforce completion, not understanding its importance or purpose, difficulty finding physicians at the end of resuscitation, staff/trainee changes, and professional hierarchy. The World Health Organization Trauma Care Checklist was a well-received tool; however, consideration of barriers to the implementation and staff adoption must be done for successful integration, with special attention to its use in critically ill patients. Therapeutic/care management, level V.

The effectiveness of an intensive care quick reference checklist manual--a randomized simulation-based trial.

PubMed

Just, Katja S; Hubrich, Svenja; Schmidtke, Daniel; Scheifes, Andrea; Gerbershagen, Mark U; Wappler, Frank; Grensemann, Joern

2015-04-01

We aimed to test the effectiveness of checklists for emergency procedures on medical staff performance in intensive care crises. This is a prospective single-center randomized trial in a high-fidelity simulation center modeling an intensive care unit (ICU) in a tertiary care hospital in Germany. Teams consisted of 1 ICU resident and 2 ICU nurses (in total, n = 48). All completed 4 crisis scenarios, in which they were randomized to use checklists or to perform without any aid. In 2 of the scenarios, checklists could be used immediately (type 1 scenarios); and for the remaining, some further steps, for example, confirming diagnosis, were required first (type 2 scenarios). Outcome measurements were number of predefined items and time to completion of more than 50% and more than 75% of steps, respectively. When using checklists, participants initiated items faster and more completely according to appropriate treatment guidelines (9 vs 7 items with and without checklists, P < .05). Benefit of checklists was better in type 2 scenarios than in type 1 scenarios (2 vs 1 additional item, P < .05). In type 2 scenarios, time to complete 50% and 75% of items was faster with the use of checklists (P < .005). Use of checklists in ICU crises has a benefit on the completion of critical treatment steps. Within the type 2 scenarios, items were fulfilled faster with checklists. The implementation of checklists for intensive care crises is a promising approach that may improve patients' care. Copyright © 2014 Elsevier Inc. All rights reserved.

Introducing radiology report checklists among residents: adherence rates when suggesting versus requiring their use and early experience in improving accuracy.

PubMed

Powell, Daniel K; Lin, Eaton; Silberzweig, James E; Kagetsu, Nolan J

2014-03-01

To retrospectively compare resident adherence to checklist-style structured reporting for maxillofacial computed tomography (CT) from the emergency department (when required vs. suggested between two programs). To compare radiology resident reporting accuracy before and after introduction of the structured report and assess its ability to decrease the rate of undetected pathology. We introduced a reporting checklist for maxillofacial CT into our dictation software without specific training, requiring it at one program and suggesting it at another. We quantified usage among residents and compared reporting accuracy, before and after counting and categorizing faculty addenda. There was no significant change in resident accuracy in the first few months, with residents acting as their own controls (directly comparing performance with and without the checklist). Adherence to the checklist at program A (where it originated and was required) was 85% of reports compared to 9% of reports at program B (where it was suggested). When using program B as a secondary control, there was no significant difference in resident accuracy with or without using the checklist (comparing different residents using the checklist to those not using the checklist). Our results suggest that there is no automatic value of checklists for improving radiology resident reporting accuracy. They also suggest the importance of focused training, checklist flexibility, and a period of adjustment to a new reporting style. Mandatory checklists were readily adopted by residents but not when simply suggested. Copyright © 2014 AUR. Published by Elsevier Inc. All rights reserved.

Developing an English Language Textbook Evaluation Checklist

ERIC Educational Resources Information Center

Mukundan, Jayakaran; Hajimohammadi, Reza; Nimehchisalem, Vahid

2011-01-01

The paper describes the considerations that were taken into account in the development of a tentative English language textbook evaluation checklist. A brief review of the related literature precedes the crucial issues that should be considered in developing checklists. In the light of the previous evaluation checklists the developers created a…

Consolidated Checklist for C8 Title 40 of the Code of Federal Regulations (CFR) Part 268

EPA Pesticide Factsheets

This Consolidated Checklist corresponds to the 40 CFR Part 268, published on July 1, 2002, and as amended by the following final rules: 67 FR 48393, July 24, 2002 (Revision Checklist 200); and 67 FR 62618, October 7, 2002 (Revision Checklist 201).

Indoor Air Quality Tools for Schools Action Kit. Second Edition.

ERIC Educational Resources Information Center

Environmental Protection Agency, Washington, DC.

This kit contains materials to assist a school indoor air quality (IAQ) coordinator in conducting a school IAQ program. The kit contains the following: IAQ coordinator's guide; IAQ coordinator forms; IAQ backgrounder; teacher's classroom checklist; administrative staff checklist; health officer/school nurse checklist; ventilation checklist and…

A feedback intervention to increase digital and paper checklist performance in technically advanced aircraft simulation.

PubMed

Rantz, William G; Van Houten, Ron

2011-01-01

This study examined whether pilots operating a flight simulator completed digital or paper flight checklists more accurately after receiving postflight graphic and verbal feedback. The dependent variable was the number of checklist items completed correctly per flight. Following treatment, checklist completion with paper and digital checklists increased from 38% and 39%, respectively, to nearly 100% and remained close to 100% after feedback and praise for improvement were withdrawn. Performance was maintained at or near 100% during follow-up probes.

Patient Safety in Interventional Radiology: A CIRSE IR Checklist

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

Lee, M. J., E-mail: mlee@rcsi.ie; Fanelli, F.; Haage, P.

2012-04-15

Interventional radiology (IR) is an invasive speciality with the potential for complications as with other invasive specialities. The World Health Organization (WHO) produced a surgical safety checklist to decrease the morbidity and mortality associated with surgery. The Cardiovascular and Interventional Society of Europe (CIRSE) set up a task force to produce a checklist for IR. Use of the checklist will, we hope, reduce the incidence of complications after IR procedures. It has been modified from the WHO surgical safety checklist and the RAD PASS from Holland.

Surgical checklists: A detailed review of their emergence, development, and relevance to neurosurgical practice

PubMed Central

McConnell, Douglas J.; Fargen, Kyle M.; Mocco, J

2012-01-01

In the fall of 1999, the Institute of Medicine released “To Err is Human: Building a Safer Health System,” a sobering report on the safety of the American healthcare industry. This work and others like it have ushered in an era where the science of quality assurance has quickly become an integral facet of the practice of medicine. One critical component of this new era is the development, application, and refinement of checklists. In a few short years, the checklist has evolved from being perceived as an assault on the practitioner’ integrity to being welcomed as an important tool in reducing complications and preventing medical errors. In an effort to further expand the neurosurgical community's acceptance of surgical checklists, we review the rationale behind checklists, discuss the history of medical and surgical checklists, and remark upon the future of checklists within our field. PMID:22347672

A systematic review of randomised controlled trials in rheumatoid arthritis: the reporting and handling of missing data in composite outcomes.

PubMed

Ibrahim, Fowzia; Tom, Brian D M; Scott, David L; Prevost, Andrew Toby

2016-06-02

Most reported outcome measures in rheumatoid arthritis (RA) trials are composite, whose components comprise single measures that are combined into one outcome. The aims of this review were to assess the range of missing data rates in primary composite outcomes and to document the current practice for handling and reporting missing data in published RA trials compared to the Consolidated Standards of Reporting Trials (CONSORT) recommendations. A systematic search for randomised controlled trials was conducted for RA trials published between 2008 and 2013 in four rheumatology and four high impact general medical journals. A total of 51 trials with a composite primary outcome were identified, of which 38 (75 %) used the binary American College of Rheumatology responder index and 13 (25 %) used the Disease Activity Score for 28 joints (DAS28). Forty-four trials (86 %) reported on an intention-to-treat analysis population, while 7 trials (14 %) analysed according to a modified intention-to-treat population. Missing data rates for the primary composite outcome ranged from 2-53 % and were above 30 % in 9 trials, 20-30 % in 11 trials, 10-20 % in 18 trials and below 10 % in 13 trials. Thirty-eight trials (75 %) used non-responder imputation and 10 (20 %) used last observation carried forward to impute missing composite outcome data at the primary time point. The rate of dropout was on average 61 % times higher in the placebo group compared to the treatment group in the 34 placebo controlled trials (relative rate 1.61, 95 % CI: 1.29, 2.02). Thirty-seven trials (73 %) did not report the use of sensitivity analyses to assess the handling of missing data in the primary analysis as recommended by CONSORT guidelines. This review highlights an improvement in rheumatology trial practice since the revision of CONSORT guidelines, in terms of power calculation and participant's flow diagram. However, there is a need to improve the handling and reporting of missing composite outcome data and their components in RA trials. In particular, sensitivity analyses need to be more widely used in RA trials because imputation is widespread and generally uses single imputation methods, and in this area the missing data rates are commonly differentially higher in the placebo group.

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.

Telemedicine for patients with rheumatic diseases: Systematic review and proposal for research agenda.

PubMed

Piga, Matteo; Cangemi, Ignazio; Mathieu, Alessandro; Cauli, Alberto

2017-08-01

To systematically review the scientific literature regarding tele-rheumatology and draw conclusions about feasibility, effectiveness, and patient satisfaction. PubMed, Scopus, and Cochrane database searches were performed (April 2016) using relevant MeSH and keyword terms for telemedicine and rheumatic diseases. Articles were selected if reporting outcomes for feasibility, effectiveness, and patient satisfaction and methodologically appraised using the Cochrane Collaboration's tool for assessing risk of bias and a modified version of CONSORT 2010 Statement. A total of 177 articles were screened, 23 were selected for the present review but only 9 were RCTs. Five studies reported on feasibility, 14 effectiveness, and 9 satisfaction rates for different tele-rheumatology interventions grouped in synchronous (remotely delivered consultation) and asynchronous (remote disease activity assessment; tele-monitoring of treatment strategies or rehabilitation; and remotely delivered self-management programs). Seven studies (30.4%) were on rheumatoid arthritis, 2 (8.7%) were on systemic sclerosis (1 including also rheumatoid arthritis patients), 5 (21.7%) on fibromyalgia, 2 (8.7%) on osteoarthritis, 3 (13.0%) on juvenile idiopathic arthritis and 4 (17.4%) on mixed disease cohorts. Interventions and outcomes heterogeneity prevented meta-analysis of results. Overall, feasibility and patient satisfaction rates were high or very high across intervention types. Effectiveness was equal or higher than standard face-to-face approach in controlled trials which, however, were affected by small sample size and lack of blinding participants according to appraisal tools. Telemedicine may provide a well-accepted way to remotely deliver consultation, treatment and monitoring disease activity in rheumatology. Higher quality RCTs demonstrating effectiveness of different tele-rheumatology interventions are needed. Copyright © 2017 Elsevier Inc. All rights reserved.

Identification and description of controlled clinical trials published in Spanish Gynaecology and Obstetrics journals and risk of bias assessment of trials on assisted reproductive techniques.

PubMed

Gutarra-Vilchez, Rosa B; Pardo-Hernandez, Hector; Arévalo-Rodríguez, Ingrid; Buitrago, Diana; Bonfill, Xavier

2016-08-01

To identify and describe controlled clinical trials (CCTs) published in Spanish Gynaecology and Obstetrics journals. In addition, to assess the quality of the CCTs on Assisted Reproduction Techniques (ART) identified in this project. In order to identify eligible CCTs, all Spanish Gynaecology and Obstetrics journals were handsearched. Handsearching was conducted following the guidelines provided by the Cochrane Collaboration, which state that each journal article must be carefully reviewed, including original articles and other types of studies, letters to the editor, abstracts, and conference presentations. The results of the handsearching process were compared with an electronic search conducted in MEDLINE (PubMed). A descriptive analysis of the main characteristics of the identified CCTs was performed, as well as a methodological assessment of CCTs on ART. Sixteen Gynaecology and Obstetrics journals were identified, four of which have been indexed in MEDLINE at some point, although not currently. The journal with the most CCTs was "Progresos de Obstetricia y Ginecología". A total of 235 CCTs were published in these journals, of which 29 were on ART. Most CCTs (216, 91.9%) were carried out in a hospital setting; 201 (89.4%) were unicentric. Obstetrics was the most studied subspecialty (46.4%). Among CCTs on ART, the risk of bias was predominantly high. The number of CCTs published in Spanish Gynaecology and Obstetrics journals is limited. CCTs on ART present deficiencies in the report of results and low methodological quality. It is advised that authors and journals adhere to the CONSORT statement and to the Cochrane Collaboration recommendations to reduce risk of bias when designing and disseminating research projects. Copyright © 2016 Elsevier Ireland Ltd. 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

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

Acuña Mora, Mariela; Sparud-Lundin, Carina; Bratt, Ewa-Lena; Moons, Philip

2017-04-17

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. 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). 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. NCT02675361; 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/.

A Systematic Review of End-of-Life Care Communication Skills Training for Generalist Palliative Care Providers: Research Quality and Reporting Guidance.

PubMed

Brighton, Lisa Jane; Koffman, Jonathan; Hawkins, Amy; McDonald, Christine; O'Brien, Suzanne; Robinson, Vicky; Khan, Shaheen A; George, Rob; Higginson, Irene J; Selman, Lucy Ellen

2017-09-01

End-of-life care (EoLC) communication skills training for generalist palliative care providers is recommended in policy guidance globally. Although many training programs now exist, there has been no comprehensive evidence synthesis to inform future training delivery and evaluation. To identify and appraise how EoLC communication skills training interventions for generalist palliative care providers are developed, delivered, evaluated, and reported. Systematic review. Ten electronic databases (inception to December 2015) and five relevant journals (January 2004 to December 2015) were searched. Studies testing the effectiveness of EoLC communication skills training for generalists were included. Two independent authors assessed study quality. Descriptive statistics and narrative synthesis are used to summarize the findings. From 11,441 unique records, 170 reports were identified (157 published, 13 unpublished), representing 160 evaluation studies of 153 training interventions. Of published papers, eight were of low quality, 108 medium, and 41 high. Few interventions were developed with service user involvement (n = 7), and most were taught using a mixture of didactics (n = 123), reflection and discussion (n = 105), and role play (n = 86). Evaluation designs were weak: <30% were controlled, <15% randomized participants. Over half (n = 85) relied on staff self-reported outcomes to assess effectiveness, and 49% did not cite psychometrically validated measures. Key information (e.g., training duration, participant flow) was poorly reported. Despite a proliferation of EoLC communication skills training interventions in the literature, evidence is limited by poor reporting and weak methodology. Based on our findings, we present a CONSORT statement supplement to improve future reporting and encourage more rigorous testing. Copyright © 2017 The Author(s). Published by Elsevier Inc. All rights reserved.

Change in quality of life in older people with dementia participating in Paro-activity: a cluster-randomized controlled trial.

PubMed

Jøranson, Nina; Pedersen, Ingeborg; Rokstad, Anne Marie Mork; Ihlebaek, Camilla

2016-12-01

The aim of this study was to investigate effects of robot-assisted group activity with Paro on quality of life in older people with dementia. Nursing home residents with severe dementia often experience social withdrawal and lower quality of life, which are suggested to be enhanced by non-pharmacological interventions. A cluster-randomized controlled trial. Ten nursing home units were randomized to robot-assisted intervention or control group (treatment as usual). Data were collected between March 2013-September 2014. 27 participants participated in group activity for 30 minutes twice a week over 12 weeks, 26 participated in the control group. Change in quality of life was assessed by local nurses through the Quality of Life in Late-Stage Dementia scale at baseline, after end of intervention and at 3 months follow-up. The scale and regular psychotropic medication were analysed stratified by dementia severity. Analysis using mixed model, one-way anova and linear regression were performed. An effect was found among participants with severe dementia from baseline to follow-up showing stable quality of life in the intervention group compared with a decrease in the control group. The intervention explained most of the variance in change in the total scale and in the subscales describing Tension and Well-being for the group with severe dementia. The intervention group used significantly less psychotropic medication compared with the control group after end of intervention. Pleasant and engaging activities facilitated by nursing staff, such as group activity with Paro, could improve quality of life in people with severe dementia. The trial is in adherence with the CONSORT statement and is registered at www.clinicaltrials.gov (study ID number: NCT02008630). © 2016 John Wiley & Sons Ltd.

Persian Diabetes Self-Management Education (PDSME) program: evaluation of effectiveness in Iran.

PubMed

Shakibazadeh, Elham; Bartholomew, Leona Kay; Rashidian, Arash; Larijani, Bagher

2016-09-01

Despite increasing rate of diabetes, no standard self-management education protocol has been developed in Iran. We designed Persian Diabetes Self-Management Education (PDSME) program using intervention mapping. Effectiveness of program was assessed in newly diagnosed people with type 2 diabetes and those who had received little self-management education. Individuals aged 18 and older (n = 350) were recruited in this prospective controlled trial during 2009-2011 in Tehran, Iran. Patients were excluded if they were pregnant, were housebound or had reduced cognitive ability. Participants were randomly allocated in intervention and control groups. PDSME patients attended eight workshops over 4-week period following two follow-up sessions. Validated questionnaires assessed cognitive outcomes at baseline, 2 and 8 weeks. HbA1c was assessed before and 18-21 months after intervention in both groups. The CONSORT statement was adhered to where possible. A total of 280 individuals (80%) attended the program. By 18-21 months, the PDSME group showed significant improvements in mean HbA1c (-1.1 versus +0.2%, p =0.008, repeated measure ANOVA (RMA)). Diabetes knowledge improved more in PDSME patients treated with oral antidiabetic agents than in those receiving usual care over time (RMA, F = 67.08, p < 0.001). Statistically significant improvements were seen in PDSME patients for self-care behaviors, health beliefs, attitudes toward diabetes, stigma, self-efficacy and patient satisfaction. PDSME program was effective in improving self-management cognitive and clinical outcomes. Results support use of intervention mapping for planning effective interventions. Given the large number of people with diabetes and lack of affordable diabetes education, PDSME deserves consideration for implementation. © The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Impact of implant–abutment connection and positioning of the machined collar/microgap on crestal bone level changes: a systematic review

PubMed Central

Schwarz, Frank; Hegewald, Andrea; Becker, Jürgen

2014-01-01

Objectives To address the following focused question: What is the impact of implant–abutment configuration and the positioning of the machined collar/microgap on crestal bone level changes? Material and methods Electronic databases of the PubMed and the Web of Knowledge were searched for animal and human studies reporting on histological/radiological crestal bone level changes (CBL) at nonsubmerged one-/two-piece implants (placed in healed ridges) exhibiting different abutment configurations, positioning of the machined collar/microgap (between 1992 and November 2012: n = 318 titles). Quality assessment of selected full-text articles was performed according to the ARRIVE and CONSORT statement guidelines. Results A total of 13 publications (risk of bias: high) were eligible for the review. The weighted mean difference (WMD) (95% CI) between machined collars placed either above or below the bone crest amounted to 0.835 mm favoring an epicrestal positioning of the rough/smooth border (P <  0.001) (P-value for heterogeneity: 0.885, I2: 0.000% = no heterogeneity). WMD (95% CI) between microgaps placed either at or below the bone crest amounted to −0.479 mm favoring a subcrestal position of the implant neck (P <  0.001) (P-value for heterogeneity: 0.333, I2: 12.404% = low heterogeneity). Only two studies compared different implant–abutment configurations. Due to a high heterogeneity, a meta-analysis was not feasible. Conclusions While the positioning of the machined neck and microgap may limit crestal bone level changes at nonsubmerged implants, the impact of the implant–abutment connection lacks documentation. PMID:23782338

Instructor feedback versus no instructor feedback on performance in a laparoscopic virtual reality simulator: a randomized educational trial

PubMed Central

2012-01-01

Abstract Background Several studies have found a positive effect on the learning curve as well as the improvement of basic psychomotor skills in the operating room after virtual reality training. Despite this, the majority of surgical and gynecological departments encounter hurdles when implementing this form of training. This is mainly due to lack of knowledge concerning the time and human resources needed to train novice surgeons to an adequate level. The purpose of this trial is to investigate the impact of instructor feedback regarding time, repetitions and self-perception when training complex operational tasks on a virtual reality simulator. Methods/Design The study population consists of medical students on their 4th to 6th year without prior laparoscopic experience. The study is conducted in a skills laboratory at a centralized university hospital. Based on a sample size estimation 98 participants will be randomized to an intervention group or a control group. Both groups have to achieve a predefined proficiency level when conducting a laparoscopic salpingectomy using a surgical virtual reality simulator. The intervention group receives standardized instructor feedback of 10 to 12 min a maximum of three times. The control group receives no instructor feedback. Both groups receive the automated feedback generated by the virtual reality simulator. The study follows the CONSORT Statement for randomized trials. Main outcome measures are time and repetitions to reach the predefined proficiency level on the simulator. We include focus on potential sex differences, computer gaming experience and self-perception. Discussion The findings will contribute to a better understanding of optimal training methods in surgical education. Trial Registration NCT01497782 PMID:22373062

Pain control after primary total knee replacement. A prospective randomised controlled trial of local infiltration versus single shot femoral nerve block.

PubMed

Ashraf, Anam; Raut, Videsh V; Canty, Stephen J; McLauchlan, George J

2013-10-01

We report a prospective blinded randomised trial of local infiltration versus femoral nerve block in patients undergoing primary total knee replacement (TKR), in accordance with the CONSORT statement 2010. Fifty patients in a teaching hospital were consented for the study. The study arms were intraoperative local anaesthesia (150ml 0.2% ropivacaine/1ml 1:1000 adrenaline/30mg ketolorac) and femoral nerve block (30ml 0.2% ropivacaine) with a primary outcome of pain score at 4h post operatively. Secondary outcomes were pain at 2h, pain scores before and after physiotherapy on day one, total opiate administered, time to physiotherapy goals and length of stay. Randomisation was by sealed envelope. The assessor was blinded and the patients partially blinded to the intervention. Ten patients were excluded, eight before randomisation. The trial is complete. Forty patients were analysed for the primary outcome measure. The local infiltration group had significantly lower pain scores at 4h post-operatively; mean [SD] score 2.1 [2.6] versus 6.8 [3.2], p<0.00001 and on post-operative day one prior to physiotherapy; mean score 2.4 [2.3] versus 4.4 [2.3], p<0.05. Total opiate use was also significantly lower in the local infiltration group; mean total 115 [50.3]mg versus 176.5 [103.5]mg, p<0.01. There was no difference in any other outcome. There were no harms as a result of either intervention. Intraoperative local infiltration gives superior pain relief compared to single shot femoral nerve block over the first 24h following primary TKR and minimises post-operative opiate use. Copyright © 2013 Elsevier B.V. All rights reserved.

Microbial colonization at the implant-abutment interface and its possible influence on periimplantitis: A systematic review and meta-analysis.

PubMed

Tallarico, Marco; Canullo, Luigi; Caneva, Martina; Özcan, Mutlu

2017-07-01

The aim of this systematic review and meta-analysis was to evaluate the microbial colonization at the implant-abutment interfaces (IAI) on bone-level implants and to identify possible association with peri-implant conditions. The focus question aimed to answer whether two-piece osseointegrated implants, in function for at least 1 year, in human, relate to higher bacterial count and the onset of periimplantitis, compared to healthy peri-implant conditions. Search strategy encompassed the on-line (MedLine, Google scholar, Cochrane library) literature from 1990 up to March 2015 published in English using combinations of MeSH (Medical Subject Headings) and search terms. Quality assessment of selected full-text articles was performed according to the ARRIVE and CONSORT statement guidelines. For data analysis, the total bacterial count of Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola, Prevotella intermedia, and Fusobacterium nucleatum was calculated and compared to IAI with or without peri-implant pathology. A total of 14 articles, reporting data from 1126 implants, fulfilled the inclusion criteria and subjected to quality assessment. The selected studies revealed contamination of the IAI, in patients who received two-piece implant systems. Meta-analysis indicated significant difference in total bacterial count between implants affected by periimplantitis versus healthy peri-implant tissues (0.387±0.055; 95% CI 0.279-0.496). Less bacterial counts were identified in the healthy IAI for all the investigated gram-negative bacteria except for T. forsythia. Significantly higher bacterial counts were found for periodontal pathogenic bacteria within the IAI of implants in patients with periimplantitis compared to those implants surrounded by healthy peri-implant tissues. Copyright © 2017 Japan Prosthodontic Society. Published by Elsevier Ltd. All rights reserved.

40 CFR 53.9 - Conditions of designation.

Code of Federal Regulations, 2012 CFR

2012-07-01

... continue to do so only so long as updates of the Product Manufacturing Checklist set forth in subpart E of this part are submitted annually. In the event that an annual Checklist update is not received by EPA within 12 months of the date of the last such submitted Checklist or Checklist update, EPA shall notify...

40 CFR 53.9 - Conditions of designation.

Code of Federal Regulations, 2013 CFR

2013-07-01

... FEM may continue to do so only so long as updates of the Product Manufacturing Checklist set forth in subpart E of this part are submitted annually. In the event that an annual Checklist update is not received by EPA within 12 months of the date of the last such submitted Checklist or Checklist update, EPA...

40 CFR 53.9 - Conditions of designation.

Code of Federal Regulations, 2014 CFR

2014-07-01

... FEM may continue to do so only so long as updates of the Product Manufacturing Checklist set forth in subpart E of this part are submitted annually. In the event that an annual Checklist update is not received by EPA within 12 months of the date of the last such submitted Checklist or Checklist update, EPA...

A Feedback Intervention to Increase Digital and Paper Checklist Performance in Technically Advanced Aircraft Simulation

ERIC Educational Resources Information Center

Rantz, William G.; Van Houten, Ron

2011-01-01

This study examined whether pilots operating a flight simulator completed digital or paper flight checklists more accurately after receiving postflight graphic and verbal feedback. The dependent variable was the number of checklist items completed correctly per flight. Following treatment, checklist completion with paper and digital checklists…

Migrant & Seasonal Head Start Mental Health Services Checklist: Supporting MSHS Mental Health Programs

ERIC Educational Resources Information Center

Academy for Educational Development, 2006

2006-01-01

This is a checklist of suggested systems, policies and procedures for supporting Mental Health and wellness services within Migrant & Seasonal Head Start programs. This checklist was developed in accordance with the Head Start Program Performance Standards and represents a comprehensive best practice model. In this checklist you will find…

Systematic survey of the design, statistical analysis, and reporting of studies published in the 2008 volume of the Journal of Cerebral Blood Flow and Metabolism.

PubMed

Vesterinen, Hanna M; Vesterinen, Hanna V; Egan, Kieren; Deister, Amelie; Schlattmann, Peter; Macleod, Malcolm R; Dirnagl, Ulrich

2011-04-01

Translating experimental findings into clinically effective therapies is one of the major bottlenecks of modern medicine. As this has been particularly true for cerebrovascular research, attention has turned to the quality and validity of experimental cerebrovascular studies. We set out to assess the study design, statistical analyses, and reporting of cerebrovascular research. We assessed all original articles published in the Journal of Cerebral Blood Flow and Metabolism during the year 2008 against a checklist designed to capture the key attributes relating to study design, statistical analyses, and reporting. A total of 156 original publications were included (animal, in vitro, human). Few studies reported a primary research hypothesis, statement of purpose, or measures to safeguard internal validity (such as randomization, blinding, exclusion or inclusion criteria). Many studies lacked sufficient information regarding methods and results to form a reasonable judgment about their validity. In nearly 20% of studies, statistical tests were either not appropriate or information to allow assessment of appropriateness was lacking. This study identifies a number of factors that should be addressed if the quality of research in basic and translational biomedicine is to be improved. We support the widespread implementation of the ARRIVE (Animal Research Reporting In Vivo Experiments) statement for the reporting of experimental studies in biomedicine, for improving training in proper study design and analysis, and that reviewers and editors adopt a more constructively critical approach in the assessment of manuscripts for publication.

Systematic survey of the design, statistical analysis, and reporting of studies published in the 2008 volume of the Journal of Cerebral Blood Flow and Metabolism

PubMed Central

Vesterinen, Hanna V; Egan, Kieren; Deister, Amelie; Schlattmann, Peter; Macleod, Malcolm R; Dirnagl, Ulrich

2011-01-01

Translating experimental findings into clinically effective therapies is one of the major bottlenecks of modern medicine. As this has been particularly true for cerebrovascular research, attention has turned to the quality and validity of experimental cerebrovascular studies. We set out to assess the study design, statistical analyses, and reporting of cerebrovascular research. We assessed all original articles published in the Journal of Cerebral Blood Flow and Metabolism during the year 2008 against a checklist designed to capture the key attributes relating to study design, statistical analyses, and reporting. A total of 156 original publications were included (animal, in vitro, human). Few studies reported a primary research hypothesis, statement of purpose, or measures to safeguard internal validity (such as randomization, blinding, exclusion or inclusion criteria). Many studies lacked sufficient information regarding methods and results to form a reasonable judgment about their validity. In nearly 20% of studies, statistical tests were either not appropriate or information to allow assessment of appropriateness was lacking. This study identifies a number of factors that should be addressed if the quality of research in basic and translational biomedicine is to be improved. We support the widespread implementation of the ARRIVE (Animal Research Reporting In Vivo Experiments) statement for the reporting of experimental studies in biomedicine, for improving training in proper study design and analysis, and that reviewers and editors adopt a more constructively critical approach in the assessment of manuscripts for publication. PMID:21157472

Competency checklists for strabismus surgery and retinopathy of prematurity examination.

PubMed

McClatchey, Scott K; Lane, R Gary; Kubis, Kenneth C; Boisvert, Chantal

2012-02-01

To evaluate two checklist tools that are designed to guide, document, and assess resident training in strabismus surgery and examination of infants at risk for retinopathy of prematurity (ROP). A panel of staff surgeons from several teaching institutions evaluated the checklists and provided constructive feedback. All former residents who had been trained via the use of these checklist tools were asked to take self-assessment surveys on competency in strabismus surgery and ROP examination. A Likert 5-point scale was used for all evaluations, with 1 being the lowest rating and 5 the highest rating. Six experts in strabismus and seven in ROP rated the checklists. Their comments were used to revise the checklists, which were sent to the same group for reevaluation. The mean Likert score for the final checklists was 4.9 of 5.0 for both checklists. Of 16 former residents, 9 responded to the self-assessments with a mean overall score of 4.1 (of 5.0) for strabismus surgery and 3.9 for ROP examination. These checklist tools can be used to assess the quality of a resident's training and experience in these specific ophthalmology skills. They are complementary to other curriculum and assessment tools and can serve to organize the educational experience while ensuring a uniformity of training. Published by Mosby, Inc.

Checklists in the operating room: Help or hurdle? A qualitative study on health workers' experiences

PubMed Central

2010-01-01

Background Checklists have been used extensively as a cognitive aid in aviation; now, they are being introduced in many areas of medicine. Although few would dispute the positive effects of checklists, little is known about the process of introducing this tool into the health care environment. In 2008, a pre-induction checklist was implemented in our anaesthetic department; in this study, we explored the nurses' and physicians' acceptance and experiences with this checklist. Method Focus group interviews were conducted with a purposeful sample of checklist users (nurses and physicians) from the Department of Anaesthesia and Intensive Care in a tertiary teaching hospital. The interviews were analysed qualitatively using systematic text condensation. Results Users reported that checklist use could divert attention away from the patient and that it influenced workflow and doctor-nurse cooperation. They described senior consultants as both sceptical and supportive; a head physician with a positive attitude was considered crucial for successful implementation. The checklist improved confidence in unfamiliar contexts and was used in some situations for which it was not intended. It also revealed insufficient equipment standardisation. Conclusion Our findings suggest several issues and actions that may be important to consider during checklist use and implementation. PMID:21171967

Checklists for the Assessment of Correct Inhalation Therapy.

PubMed

Knipel, V; Schwarz, S; Magnet, F S; Storre, J H; Criée, C P; Windisch, W

2017-02-01

Introduction  For the long-term treatment of obstructive lung diseases inhalation therapy with drugs being delivered directly to the lungs as an aerosol has become the method of choice. However, patient-related mistakes in inhalation techniques are frequent and recognized to be associated with reduced disease control. Since the assessment of patient-mistakes in inhalation has yet not been standardized, the present study was aimed at developing checklists for the assessment of correct inhalation. Methods  Checklists were developed in German by an expert panel of pneumologists and professionally translated into English following back-translation procedures. The checklists comparably assessed three major steps of inhalation: 1) inhalation preparation, 2) inhalation routine, and 3) closure of inhalation. Results  Checklists for eight frequently used inhalers were developed: Aerolizer, Breezhaler, Diskus (Accuhaler), metered-dose inhaler, Handihaler, Novolizer, Respimat, Turbohaler. Each checklist consists of ten items: three for inhalation preparation, six for inhalation routine, and one for closure of inhalation. Discussion  Standardized checklists for frequently used inhalers are available in German and English. These checklists can be used for clinical routines or for clinical trials. All checklists can be downloaded free of charge for non-profit application from the homepage of the German Airway League (Deutsche Atemwegsliga e. V.): www.atemwegsliga.de. © Georg Thieme Verlag KG Stuttgart · New York.

Requirements for the design and implementation of checklists for surgical processes.

PubMed

Verdaasdonk, E G G; Stassen, L P S; Widhiasmara, P P; Dankelman, J

2009-04-01

The use of checklists is a promising strategy for improving patient safety in all types of surgical processes inside and outside the operating room. This article aims to provide requirements and implementation of checklists for surgical processes. The literature on checklist use in the operating room was reviewed based on research using Medline, Pubmed, and Google Scholar. Although all the studies showed positive effects and important benefits such as improved team cohesion, improved awareness of safety issues, and reduction of errors, their number still is limited. The motivation of team members is considered essential for compliance. Currently, no general guidelines exist for checklist design in the surgical field. Based on the authors' experiences and on guidelines used in the aviation industry, requirements for the checklist design are proposed. The design depends on the checklist purpose, philosophy, and method chosen. The methods consist of the "call-do-response" approach," the "do-verify" approach, or a combination of both. The advantages and disadvantages of paper versus electronic solutions are discussed. Furthermore, a step-by-step strategy of how to implement a checklist in the clinical situation is suggested. The use of structured checklists in surgical processes is most likely to be effective because it standardizes human performance and ensures that procedures are followed correctly instead of relying on human memory alone. Several studies present promising and positive first results, providing a solid basis for further investigation. Future research should focus on the effect of various checklist designs and strategies to ensure maximal compliance.

A checklist is associated with increased quality of reporting preclinical biomedical research: A systematic review

PubMed Central

Olonisakin, Tolani F.; Pribis, John P.; Zupetic, Jill; Yoon, Joo Heung; Holleran, Kyle M.; Jeong, Kwonho; Shaikh, Nader; Rubio, Doris M.; Lee, Janet S.

2017-01-01

Irreproducibility of preclinical biomedical research has gained recent attention. It is suggested that requiring authors to complete a checklist at the time of manuscript submission would improve the quality and transparency of scientific reporting, and ultimately enhance reproducibility. Whether a checklist enhances quality and transparency in reporting preclinical animal studies, however, has not been empirically studied. Here we searched two highly cited life science journals, one that requires a checklist at submission (Nature) and one that does not (Cell), to identify in vivo animal studies. After screening 943 articles, a total of 80 articles were identified in 2013 (pre-checklist) and 2015 (post-checklist), and included for the detailed evaluation of reporting methodological and analytical information. We compared the quality of reporting preclinical animal studies between the two journals, accounting for differences between journals and changes over time in reporting. We find that reporting of randomization, blinding, and sample-size estimation significantly improved when comparing Nature to Cell from 2013 to 2015, likely due to implementation of a checklist. Specifically, improvement in reporting of the three methodological information was at least three times greater when a mandatory checklist was implemented than when it was not. Reporting the sex of animals and the number of independent experiments performed also improved from 2013 to 2015, likely from factors not related to a checklist. Our study demonstrates that completing a checklist at manuscript submission is associated with improved reporting of key methodological information in preclinical animal studies. PMID:28902887

A Call to Digital Health Practitioners: New Guidelines Can Help Improve the Quality of Digital Health Evidence

PubMed Central

Agarwal, Smisha; Lefevre, Amnesty E

2017-01-01

Background Despite the rapid proliferation of health interventions that employ digital tools, the evidence on the effectiveness of such approaches remains insufficient and of variable quality. To address gaps in the comprehensiveness and quality of reporting on the effectiveness of digital programs, the mHealth Technical Evidence Review Group (mTERG), convened by the World Health Organization, proposed the mHealth Evidence Reporting and Assessment (mERA) checklist to address existing gaps in the comprehensiveness and quality of reporting on the effectiveness of digital health programs. Objective We present an overview of the mERA checklist and encourage researchers working in the digital health space to use the mERA checklist for reporting their research. Methods The development of the mERA checklist consisted of convening an expert group to recommend an appropriate approach, convening a global expert review panel for checklist development, and pilot-testing the checklist. Results The mERA checklist consists of 16 core mHealth items that define what the mHealth intervention is (content), where it is being implemented (context), and how it was implemented (technical features). Additionally, a 29-item methodology checklist guides authors on reporting critical aspects of the research methodology employed in the study. We recommend that the core mERA checklist is used in conjunction with an appropriate study-design specific checklist. Conclusions The mERA checklist aims to assist authors in reporting on digital health research, guide reviewers and policymakers in synthesizing evidence, and guide journal editors in assessing the completeness in reporting on digital health studies. An increase in transparent and rigorous reporting can help identify gaps in the conduct of research and understand the effects of digital health interventions as a field of inquiry. PMID:28986340

Changes in safety climate and teamwork in the operating room after implementation of a revised WHO checklist: a prospective interventional study.

PubMed

Erestam, Sofia; Haglind, Eva; Bock, David; Andersson, Annette Erichsen; Angenete, Eva

2017-01-01

Inter-professional teamwork in the operating room is important for patient safety. The World Health Organization (WHO) checklist was introduced to improve intraoperative teamwork. The aim of this study was to evaluate the safety climate in a Swedish operating room setting before and after an intervention, using a revised version of the WHO checklist to improve teamwork. This study is a single center prospective interventional study. Participants were personnel working in operating room teams including surgeons, anesthesiologists, scrub nurses, nurse anaesthetists and nurse assistants. The study started with pre-interventional observations of the WHO checklist use followed by education on safety climate, the WHO checklist, and non-technical skills in the operating room. Thereafter a revised version of the WHO checklist was introduced. Post-interventional observations regarding the performance of the WHO checklist were carried out. The Safety Attitude Questionnaire was used to assess safety climate at baseline and post-intervention. At baseline we discovered a need for improved teamwork and communication. The participants considered teamwork to be important for patient safety, but had different perceptions of good teamwork between professions. The intervention, a revised version of the WHO checklist, did not affect teamwork climate. Adherence to the revision of the checklist was insufficient, dominated by a lack of structure. There was no significant change in teamwork climate by use of the revised WHO checklist, which may be due to insufficient implementation, as a lack of adherence to the WHO checklist was detected. We found deficiencies in teamwork and communication. Further studies exploring how to improve safety climate are needed. NCT02329691.

Developing and Testing a Checklist to Enhance Quality in Ethics Consultation

PubMed Central

Flicker, Lauren Sydney; Rose, Susannah L.; Eves, Margot M.; Flamm, Anne Lederman; Sanghani, Ruchi; Smith, Martin L.

2015-01-01

Checklists have been used to improve quality in many industries, including healthcare. The use of checklists, however, has not been extensively evaluated in clinical ethics consultation. This article seeks to fill this gap by exploring the efficacy of using a checklist in ethics consultation, as tested by an empirical investigation of the use of the checklist at a large academic medical system (Cleveland Clinic). The specific aims of this project are as follows: (1) to improve the quality of ethics consultations by providing reminders to ethics consultants about process steps that are important for most patient-centered ethics consultations, (2) to create consistency in the ethics consultation process across the medical system, and (3) to establish an effective educational tool for trainers and trainees in clinical ethics consultation. The checklist was developed after a thorough literature review and an iterative process of revising and testing by a group of experienced ethics consultants. To pilot test the checklist, it was distributed to 46 ethics professionals. After a six-month pilot period in which ethics professionals used the checklist during their clinical activities, a survey was distributed to all of those who used the checklist. The 10-item survey examined consultants' perceptions regarding the three aims listed above. Of the 25 survey respondents, 11 self-reported as experts in ethics consultation, nine perceived themselves to have mid-level expertise, and five self-reported as novices. The majority (68 percent) of all respondents, regardless of expertise, believed that the checklist could be a “helpful” or “very helpful” tool in the consultation process generally. Novices were more likely than experts to believe that the checklist would be useful in conducting consultations. The limitations of this study include: reduced generalizability given that this project was conducted at one medical system, utilized a small sample size, and used self-reported quality outcome measures. Despite these limitations, to the authors' knowledge this is the first investigatation of the use of a checklist systematically to improve quality in ethics consultation. Importantly, our findings shed light on ways this checklist can be used to improve ethics consultation, including its use as an educational tool. The authors hope to test the checklist with consultants in other healthcare systems to explore its usefulness in different healthcare environments. PMID:25517564

Investment Strategy for DoD Automatic Test Systems. Volume 2. Supporting Data

DTIC Science & Technology

1994-01-01

DESCOM Col Steve Dasher PM, TMDE Col William Deegan SAALC/LDA Mr. Don Desilets NVWC NPT (8314) Mr. W. Devers IDA Lt Col Easley HQ USAF (SOF) Mr. Bit Frank...OOALCJFISEA Mr. Craig Wall ASC/SMG Mr. Frank Wiilis OOALCMTISADC LCDR Patrick Witt NAWCADLKE 0 F- F-4 S Industry Participants (Briefings and Interviews...Effectiveness Analysis) COEA) Update (MSIIIB Report). January 1992 VXI Consortion. VXI (VXE Bus Extensions for Instrumentation) Briefing. Wall, Craig . ASD/ENEM

Characteristics and quality of reporting of cluster randomized trials in children: reporting needs improvement.

PubMed

Walleser, Silke; Hill, Suzanne R; Bero, Lisa A

2011-12-01

To describe the characteristics and quality of reporting of cluster randomized trials (CRTs) in children published from 2004 to 2010. Four databases were searched for reports of CRTs in children (0-18 years). Characteristics of the studies were summarized and the quality of reporting assessed using consolidated standards of reporting trial-CRT (CONSORT-CRT). Of 1,949 identified references, 106 were included. The number of published CRTs in children increased since 2004. The greatest proportion of CRTs was undertaken in Europe (29%), whereas 40% was conducted in low- and middle-income countries. Most studies were of complex rather than simple interventions (83%); were preventive rather than treatment interventions (76%); and most frequently addressed infectious disease (21%), diet/physical activity interventions (19%), health-risk behaviors (15%), and undernutrition (13%). The majority used schools as units of randomization (72%) and enrolled 1,000-10,000 children per study (51%). Reporting was generally poor, with 34% of CRTs inadequately reporting on more than half of the CONSORT-CRT criteria. Although 85% of CRTs reported that they had ethics approval for the study, consent or assent was not obtained from children in most studies. Children-specific elements of reporting are needed to improve the quality of reporting of CRTs and consequently their planning and implementation. Copyright © 2011 Elsevier Inc. All rights reserved.

A systematic review of the therapeutic effects of Reiki.

PubMed

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

2009-11-01

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

Using Checklists in a Gross Anatomy Laboratory Improves Learning Outcomes and Dissection Quality

ERIC Educational Resources Information Center

Hofer, Ryan Engebretson; Nikolaus, O. Brant; Pawlina, Wojciech

2011-01-01

Checklists have been widely used in the aviation industry ever since aircraft operations became more complex than any single pilot could reasonably remember. More recently, checklists have found their way into medicine, where cognitive function can be compromised by stress and fatigue. The use of checklists in medical education has rarely been…

Safety for Older Consumers. Home Safety Checklist.

ERIC Educational Resources Information Center

Consumer Product Safety Commission, Washington, DC.

A home safety checklist geared to the needs of older adults is presented in this document. The beginning of the checklist highlights potential hazards which may need to be checked in more than one area of the home, such as electric cords, smoke detectors, rugs, telephone areas, and emergency exit plans. The rest of the checklist is organized…

A FEEDBACK INTERVENTION TO INCREASE DIGITAL AND PAPER CHECKLIST PERFORMANCE IN TECHNICALLY ADVANCED AIRCRAFT SIMULATION

PubMed Central

Rantz, William G; Van Houten, Ron

2011-01-01

This study examined whether pilots operating a flight simulator completed digital or paper flight checklists more accurately after receiving postflight graphic and verbal feedback. The dependent variable was the number of checklist items completed correctly per flight. Following treatment, checklist completion with paper and digital checklists increased from 38% and 39%, respectively, to nearly 100% and remained close to 100% after feedback and praise for improvement were withdrawn. Performance was maintained at or near 100% during follow-up probes. PMID:21541133

Improving the preoperative care of patients with femoral neck fractures through the development and implementation of a checklist.

PubMed

Agha, Riaz; Edison, Eric; Fowler, Alexander

2014-01-01

The incidence of femoral neck fractures (FNFs) is expected to rise with life expectancy. It is important to improve the safety of these patients whilst under the care of orthopaedic teams. This study aimed to increase the performance of vital preoperative tasks in patients admitted for femoral neck fracture operations by producing and implementing a checklist as an aide memoir. The checklist was designed primarily for use by senior house officers (SHOs) admitting patients from the emergency department. A list of 12 preoperative tasks was identified. A baseline audit of 10 random patients showed that the mean proportion of the 12 tasks completed was 53% (range 25% - 83%). A survey of 14 nurses and surgeons found that the majority of respondents agreed that there was a problem with the performance of most of the tasks. The tasks were incorporated into a checklist which was refined in three plan-do-study-act cycles and introduced into the femoral neck fracture pathway. In the week following the introduction of the checklist, 77% of the checklist tasks were completed, 24% more than at the baseline audit (53%). In week 3, the completion of checklist tasks rose to 88% and to 95% in week 4. In conclusion, a simple checklist can markedly improve the performance and recording of preoperative tasks by SHOs. We recommend the wider adoption of the new checklist to be produced as a sticker for patients' medical records. Further study is required to ascertain the effect of the checklist on clinical outcomes.

Barriers to the implementation of checklists in the office-based procedural setting.

PubMed

Shapiro, Fred E; Fernando, Rohesh J; Urman, Richard D

2014-01-01

Patient safety is critical for the patients, providers, and risk managers in the office-based procedural setting, and the same standard of care should be maintained regardless of the healthcare environment. Checklists may improve patient safety and potentially decrease risk. This study explored utilization of checklists in the office-based setting and the potential barriers to their implementation. A cross-sectional prospective study was performed by using a 19-question anonymous survey designed with REDCap®. Medical providers including physicians and nurses from 25 different offices that performed procedures participated, and 38 individual responses were included in the study. Only 50% of offices surveyed use safety checklists in their practice. Only 34% had checklists or equivalent protocol for emergencies such as anaphylaxis or failed airway. As many as 23.7% of respondents indicated that they encountered barriers to implementing checklists. The top barriers identified in the study were no incentive to use a checklist (77.8%), no mandate from a local or federal regulatory agency (44.4%), being too time consuming (33.3%), and lack of training (33.3%). Reasons identified that would encourage providers to use checklists included a clear mandate (36.8%) and evidence-based research (26.3%). Checklists are not being universally utilized in the office-based setting. There are barriers preventing their successful implementation. Risk managers may be able to improve patient safety and decrease risk by encouraging practitioners, possibly through incentives, to use customizable safety checklists. © 2014 American Society for Healthcare Risk Management of the American Hospital Association.

Evaluating Checklist Use in Companion Animal Wellness Visits in a Veterinary Teaching Hospital: A Preliminary Study.

PubMed

Nappier, Michael T; Corrigan, Virginia K; Bartl-Wilson, Lara E; Freeman, Mark; Werre, Stephen; Tempel, Eric

2017-01-01

The number of companion animal wellness visits in private practice has been decreasing, and one important factor cited is the lack of effective communication between veterinarians and pet owners regarding the importance of preventive care. Checklists have been widely used in many fields and are especially useful in areas where a complex task must be completed with multiple small steps, or when cognitive fatigue is evident. The use of checklists in veterinary medical education has not yet been thoroughly evaluated as a potential strategy to improve communication with pet owners regarding preventive care. The authors explored whether the use of a checklist based on the American Animal Hospital Association/American Veterinary Medical Association canine and feline preventive care guidelines would benefit senior veterinary students in accomplishing more complete canine and feline wellness visits. A group of students using provided checklists was compared to a control group of students who did not use checklists on the basis of their medical record notes from the visits. The students using the checklists were routinely more complete in several areas of a wellness visit vs. those who did not use the checklists. However, neither group of students routinely discussed follow-up care recommendations such as frequency or timing of follow-up visits. The study authors recommend considering checklist use for teaching and implementing wellness in companion animal primary care veterinary clinical teaching settings.

A Safety Checklist: Know Your Candidates!

ERIC Educational Resources Information Center

Roy, Ken

2003-01-01

Explains the benefits and strengths of having safety checklists in science laboratories. Presents a checklist that reflects important components of safety that address many situations in school laboratories. (NB)

Medical simulation: a tool for recognition of and response to risk.

PubMed

Ruddy, Richard M; Patterson, Mary Deffner

2008-11-01

The use of simulation and team training has become an excellent tool to reduce errors in high-risk industry such as the commercial airlines and in the nuclear energy field. The health care industry has begun to use similar tools to improve the outcome of high-risk areas where events are relatively rare but where practice with a tactical team can significantly reduce the chance of bad outcome. There are two parts to this review: first, we review the rationale of why simulation is a key element in improving our error rate, and second, we describe specific tools that have great use at the clinical bedside for improving the care of patients. These cross different (i.e. medical and surgical) specialties and practices within specialties in the health care setting. Tools described will include the pinch, brief/debriefing, read-backs, call-outs, dynamic skepticism, assertive statements, two-challenge rules, checklists and step back (hold points). Examples will assist the clinician in practical daily use to improve their bedside care of children.

A systematic review of health literacy interventions for people living with HIV

PubMed Central

Perazzo, Joseph; Reyes, Darcel; Webel, Allison

2017-01-01

Health literacy significantly impacts health-related outcomes among people living with HIV. Our aim was to systematically review current literature on health literacy interventions for people living with HIV. The authors conducted a thorough literature search following the PRISMA statement and the AMSTAR checklist as a guide, and found six studies that met inclusion/exclusion criteria. The majority of these interventions were designed to improve HIV treatment adherence as well as HIV knowledge and treatment-related skills, with one study focusing on e-Health literacy. Several of the studies demonstrated trends toward improvement in medication adherence, but most did not achieve statistical significance primarily due to methodological limitations. Significant improvements in knowledge, behavioral skills, and e-Health literacy were found following interventions (p = 0·001–0·05). Health literacy interventions have the potential to promote HIV-related knowledge, behavioral skills, and self-management practices. More research is needed to assess the efficacy of interventions to promote a variety of self-management practices. PMID:26864691

Checklists for powder inhaler technique: a review and recommendations.

PubMed

Basheti, Iman A; Bosnic-Anticevich, Sinthia Z; Armour, Carol L; Reddel, Helen K

2014-07-01

Turbuhaler and Diskus are commonly used powder inhaler devices for patients with respiratory disease. Their effectiveness is limited in part by a patient's ability to use them correctly. This has led to numerous studies being conducted over the last decade to assess the correct use of these devices by patients and health care professionals. These studies have generally used device-specific checklists to assess technique, this being the most feasible and accessible method for assessment. However, divergence between the checklists and scoring systems for the same device in different studies makes direct comparison of results difficult and at times inappropriate. Little evidence is available to assess the relative importance of different criteria; however, brief patient training based on specific inhaler technique checklists leads to significant improvement in asthma outcomes. This paper reviews common checklists and scoring systems used for Turbuhaler and Diskus, discusses the problem of heterogeneity between different checklists, and finally recommends suitable checklists and scoring systems for these devices based on the literature and previous findings. Only when similar checklists are used across different research studies will accurate comparisons and meta-analysis be possible. Copyright © 2014 by Daedalus Enterprises.

Use of the WHO surgical safety checklist in trauma and orthopaedic patients.

PubMed

Sewell, Mathew; Adebibe, Miriam; Jayakumar, Prakash; Jowett, Charlie; Kong, Kin; Vemulapalli, Krishna; Levack, Brian

2011-06-01

The World Health Organisation (WHO) recommends routine use of a surgical safety checklist prior to all surgical operations. The aim of this study was to prospectively audit checklist use in orthopaedic patients before and after implementation of an educational programme designed to increase use and correlate this with early complications, mortality and staff perceptions. Data was collected on 480 patients before the educational program and 485 patients after. Pre-training checklist use was 7.9%. The rates of early complications and mortality were 8.5% and 1.9%, respectively. Forty-seven percent thought the checklist improved team communication. Following an educational program, checklist use significantly increased to 96.9% (RR12.2; 95% CI 9.0-16.6). The rate of early complications and mortality was 7.6% (RR 0.89; 95% CI 0.58-1.37) and 1.6% (RR 0.88; 95% CI 0.34-2.26), respectively. Seventy-seven percent thought the checklist improved team communication. Checklist use was not associated with a significant reduction in early complications and mortality in patients undergoing orthopaedic surgery. Education programs can significantly increase accurate use and staff perceptions following implementation.

Checklist content on a standardized patient assessment: an ex post facto review.

PubMed

Boulet, John R; van Zanten, Marta; de Champlain, André; Hawkins, Richard E; Peitzman, Steven J

2008-03-01

While checklists are often used to score standardized patient based clinical assessments, little research has focused on issues related to their development or the level of agreement with respect to the importance of specific items. Five physicians independently reviewed checklists from 11 simulation scenarios that were part of the former Educational Commission for Foreign Medical Graduate's Clinical Skills Assessment and classified the clinical appropriateness of each of the checklist items. Approximately 78% of the original checklist items were judged to be needed, or indicated, given the presenting complaint and the purpose of the assessment. Rater agreement was relatively poor with pairwise associations (Kappa coefficient) ranging from 0.09 to 0.29. However, when only consensus indicated items were included, there was little change in examinee scores, including their reliability over encounters. Although most checklist items in this sample were judged to be appropriate, some could potentially be eliminated, thereby minimizing the scoring burden placed on the standardized patients. Periodic review of checklist items, concentrating on their clinical importance, is warranted.

The Image Gently pediatric digital radiography safety checklist: tools for improving pediatric radiography.

PubMed

John, Susan D; Moore, Quentin T; Herrmann, Tracy; Don, Steven; Powers, Kevin; Smith, Susan N; Morrison, Greg; Charkot, Ellen; Mills, Thalia T; Rutz, Lois; Goske, Marilyn J

2013-10-01

Transition from film-screen to digital radiography requires changes in radiographic technique and workflow processes to ensure that the minimum radiation exposure is used while maintaining diagnostic image quality. Checklists have been demonstrated to be useful tools for decreasing errors and improving safety in several areas, including commercial aviation and surgical procedures. The Image Gently campaign, through a competitive grant from the FDA, developed a checklist for technologists to use during the performance of digital radiography in pediatric patients. The checklist outlines the critical steps in digital radiography workflow, with an emphasis on steps that affect radiation exposure and image quality. The checklist and its accompanying implementation manual and practice quality improvement project are open source and downloadable at www.imagegently.org. The authors describe the process of developing and testing the checklist and offer suggestions for using the checklist to minimize radiation exposure to children during radiography. Copyright © 2013 American College of Radiology. All rights reserved.

Low Reporting Quality of the Meta-Analyses in Diagnostic Pathology.

PubMed

Liu, Xulei; Kinzler, Michael; Yuan, Jiangfan; He, Guozhong; Zhang, Lanjing

2017-03-01

- Little is known regarding the reporting quality of meta-analyses in diagnostic pathology. - To compare reporting quality of meta-analyses in diagnostic pathology and medicine and to examine factors associated with reporting quality of diagnostic pathology meta-analyses. - Meta-analyses were identified in 12 major diagnostic pathology journals without specifying years and 4 major medicine journals in 2006 and 2011 using PubMed. Reporting quality of meta-analyses was evaluated using the 27-item checklist of Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement published in 2009. A higher PRISMA score indicates higher reporting quality. - Forty-one diagnostic pathology meta-analyses and 118 medicine meta-analyses were included. Overall, reporting quality of meta-analyses in diagnostic pathology was lower than that in medicine (median [interquartile range] = 22 [15, 25] versus 27 [23, 28], P < .001). Compared with medicine meta-analyses, diagnostic pathology meta-analyses less likely reported 23 of the 27 items (85.2%) on the PRISMA checklist, but more likely reported the data items. Higher reporting quality of diagnostic pathology meta-analyses was associated with recent publication years (later than 2009 versus 2009 or earlier, P = .002) and non-North American first authors (versus North American, P = .001), but not journal publisher's location (P = .11). Interestingly, reporting quality was not associated with adjusted citation ratio for meta-analyses in either diagnostic pathology or medicine (P = .40 and P = .09, respectively). - Meta-analyses in diagnostic pathology had lower reporting quality than those in medicine. Reporting quality of diagnostic pathology meta-analyses is linked to publication year and first author's location, but not to journal publisher's location or article's adjusted citation ratios. More research and education on meta-analysis methodology may improve the reporting quality of diagnostic pathology meta-analyses.

Cerebral Palsy Checklist: Babies & Preschoolers (Birth to age 5)

MedlinePlus

... Staying Safe Videos for Educators Search English Español Cerebral Palsy Checklist: Babies & Preschoolers KidsHealth / For Parents / Cerebral Palsy Checklist: Babies & Preschoolers What's in this article? Step ...

Family Child Care Health and Safety Checklist: A Packet for Family Child Care Providers [with Videotape].

ERIC Educational Resources Information Center

Kendrick, Abby Shapiro; Gravell, Joanne

This checklist and accompanying video are designed to help family child care providers assess the health and safety of the child care home. The checklist includes suggestions for conducting the self-evaluation and for creating a safer, healthier home environment. The areas of the checklist are: your home, out of bounds areas, gates and guards,…

Implementation of the WHO Surgical Safety Checklist in an Ethiopian Referral Hospital

PubMed Central

2014-01-01

Background The WHO Surgical Safety Checklist has a growing evidence base to support its role in improving perioperative safety, although its impact is likely to be directly related to the effectiveness of its implementation. There remains a paucity of documented experience from low-resource settings on Checklist implementation approaches. We report an implementation strategy in a public referral hospital in Addis Ababa, Ethiopia, based on consultation, local leadership, formal introduction, and supported supervision with subsequent audit and feedback. Methods Planning, implementation and assessment took place from December 2011 to December 2012. The planning phase, from December 2011 until April 2012, involved a multidisciplinary consultative approach using local leaders, volunteer clinicians, and staff from non-governmental organisations, to draw up a locally agreed and appropriate Checklist. Implementation in April 2012 involved formal teaching and discussion, simulation sessions and role play, with supportive supervision following implementation. Assessment was performed using completed Checklist analysis and staff satisfaction questionnaires at one month and further Checklist analysis combined with semi-structured interviews in December 2012. Results and discussion Checklist compliance rates were 83% for general anaesthetics at one month after implementation, with an overall compliance rate of 65% at eight months. There was a decrease in Checklist compliance over the period of the study to less than 20% by the end of the study period. The ‘Sign out’ section was reported as being the most difficult section of the Checklist to complete, and was missed completely in 21% of cases. The most commonly missed single item was the team introduction at the start of each case. However, we report high staff satisfaction with the Checklist and enthusiasm for its continued use. Conclusion We report a detailed implementation strategy for introducing the WHO Surgical Safety Checklist to a low-resource setting. We show that this approach can lead to high completion rates and high staff satisfaction, albeit with a drop in completion rates over time. We argue that maximal benefit of the Surgical Safety Checklist is likely to be when it engenders a conversation around patient safety within a department, and when there is local ownership of this process. PMID:24678854

A Call to Digital Health Practitioners: New Guidelines Can Help Improve the Quality of Digital Health Evidence.

PubMed

Agarwal, Smisha; Lefevre, Amnesty E; Labrique, Alain B

2017-10-06

Despite the rapid proliferation of health interventions that employ digital tools, the evidence on the effectiveness of such approaches remains insufficient and of variable quality. To address gaps in the comprehensiveness and quality of reporting on the effectiveness of digital programs, the mHealth Technical Evidence Review Group (mTERG), convened by the World Health Organization, proposed the mHealth Evidence Reporting and Assessment (mERA) checklist to address existing gaps in the comprehensiveness and quality of reporting on the effectiveness of digital health programs. We present an overview of the mERA checklist and encourage researchers working in the digital health space to use the mERA checklist for reporting their research. The development of the mERA checklist consisted of convening an expert group to recommend an appropriate approach, convening a global expert review panel for checklist development, and pilot-testing the checklist. The mERA checklist consists of 16 core mHealth items that define what the mHealth intervention is (content), where it is being implemented (context), and how it was implemented (technical features). Additionally, a 29-item methodology checklist guides authors on reporting critical aspects of the research methodology employed in the study. We recommend that the core mERA checklist is used in conjunction with an appropriate study-design specific checklist. The mERA checklist aims to assist authors in reporting on digital health research, guide reviewers and policymakers in synthesizing evidence, and guide journal editors in assessing the completeness in reporting on digital health studies. An increase in transparent and rigorous reporting can help identify gaps in the conduct of research and understand the effects of digital health interventions as a field of inquiry. ©Smisha Agarwal, Amnesty E Lefevre, Alain B Labrique. Originally published in JMIR Mhealth and Uhealth (http://mhealth.jmir.org), 06.10.2017.

Person-centered endoscopy safety checklist: Development, implementation, and evaluation

PubMed Central

Dubois, Hanna; Schmidt, Peter T; Creutzfeldt, Johan; Bergenmar, Mia

2017-01-01

AIM To describe the development and implementation of a person-centered endoscopy safety checklist and to evaluate the effects of a “checklist intervention”. METHODS The checklist, based on previously published safety checklists, was developed and locally adapted, taking patient safety aspects into consideration and using a person-centered approach. This novel checklist was introduced to the staff of an endoscopy unit at a Stockholm University Hospital during half-day seminars and team training sessions. Structured observations of the endoscopy team’s performance were conducted before and after the introduction of the checklist. In addition, questionnaires focusing on patient participation, collaboration climate, and patient safety issues were collected from patients and staff. RESULTS A person-centered safety checklist was developed and introduced by a multi-professional group in the endoscopy unit. A statistically significant increase in accurate patient identity verification by the physicians was noted (from 0% at baseline to 87% after 10 mo, P < 0.001), and remained high among nurses (93% at baseline vs 96% after 10 mo, P = nonsignificant). Observations indicated that the professional staff made frequent attempts to use the checklist, but compliance was suboptimal: All items in the observed nurse-led “summaries” were included in 56% of these interactions, and physicians participated by directly facing the patient in 50% of the interactions. On the questionnaires administered to the staff, items regarding collaboration and the importance of patient participation were rated more highly after the introduction of the checklist, but this did not result in statistical significance (P = 0.07/P = 0.08). The patients rated almost all items as very high both before and after the introduction of the checklist; hence, no statistical difference was noted. CONCLUSION The intervention led to increased patient identity verification by physicians - a patient safety improvement. Clear evidence of enhanced person-centeredness or team work was not found. PMID:29358869

Cerebral Palsy Checklist: Teens & Young Adult (13 to 21)

MedlinePlus

... Staying Safe Videos for Educators Search English Español Cerebral Palsy Checklist: Teens & Young Adults KidsHealth / For Parents / Cerebral Palsy Checklist: Teens & Young Adults What's in this article? ...

Participatory design of a preliminary safety checklist for general practice

PubMed Central

Bowie, Paul; Ferguson, Julie; MacLeod, Marion; Kennedy, Susan; de Wet, Carl; McNab, Duncan; Kelly, Moya; McKay, John; Atkinson, Sarah

2015-01-01

Background The use of checklists to minimise errors is well established in high reliability, safety-critical industries. In health care there is growing interest in checklists to standardise checking processes and ensure task completion, and so provide further systemic defences against error and patient harm. However, in UK general practice there is limited experience of safety checklist use. Aim To identify workplace hazards that impact on safety, health and wellbeing, and performance, and codesign a standardised checklist process. Design and setting Application of mixed methods to identify system hazards in Scottish general practices and develop a safety checklist based on human factors design principles. Method A multiprofessional ‘expert’ group (n = 7) and experienced front-line GPs, nurses, and practice managers (n = 18) identified system hazards and developed and validated a preliminary checklist using a combination of literature review, documentation review, consensus building workshops using a mini-Delphi process, and completion of content validity index exercise. Results A prototype safety checklist was developed and validated consisting of six safety domains (for example, medicines management), 22 sub-categories (for example, emergency drug supplies) and 78 related items (for example, stock balancing, secure drug storage, and cold chain temperature recording). Conclusion Hazards in the general practice work system were prioritised that can potentially impact on the safety, health and wellbeing of patients, GP team members, and practice performance, and a necessary safety checklist prototype was designed. However, checklist efficacy in improving safety processes and outcomes is dependent on user commitment, and support from leaders and promotional champions. Although further usability development and testing is necessary, the concept should be of interest in the UK and internationally. PMID:25918338

[Proposal and preliminary validation of a check-list for the assessment of occupational exposure to repetitive movements of the upper lims].

PubMed

Colombini, D; Occhipinti, E; Cairoli, S; Baracco, A

2000-01-01

Over the last few years the Authors developed and implemented, a specific check-list for a "rapid" assessment of occupational exposure to repetitive movements and exertion of the upper limbs, after verifying the lack of such a tool which also had to be coherent with the latest data in the specialized literature. The check-list model and the relevant application procedures are presented and discussed. The check-list was applied by trained factory technicians in 46 different working tasks where the OCRA method previously proposed by the Authors was also applied by independent observers. Since 46 pairs of observation data were available (OCRA index and check-list score) it was possible to verify, via parametric and nonparametric statistical tests, the level of association between the two variables and to find the best simple regression function (exponential in this case) of the OCRA index from the check-list score. By means of this function, which was highly significant (R2 = 0.98, p < 0.0000), the values of the check-list score which better corresponded to the critical values (for exposure assessment) of the OCRA index looked for. The following correspondance values between OCRA Index and check-list were then established with a view to classifying exposure levels. The check-list "critical" scores were established considering the need for obtaining, in borderline cases, a potential effect of overestimation of the exposure level. On the basis of practical application experience and the preliminary validation results, recommendations are made and the caution needed in the use of the check-list is suggested.

A Family-Centered Rounds Checklist, Family Engagement, and Patient Safety: A Randomized Trial

PubMed Central

Jacobsohn, Gwen C.; Rajamanickam, Victoria P.; Carayon, Pascale; Kelly, Michelle M.; Wetterneck, Tosha B.; Rathouz, Paul J.; Brown, Roger L.

2017-01-01

BACKGROUND AND OBJECTIVES: Family-centered rounds (FCRs) have become standard of care, despite the limited evaluation of FCRs’ benefits or interventions to support high-quality FCR delivery. This work examines the impact of the FCR checklist intervention, a checklist and associated provider training, on performance of FCR elements, family engagement, and patient safety. METHODS: This cluster randomized trial involved 298 families. Two hospital services were randomized to use the checklist; 2 others delivered usual care. We evaluated the performance of 8 FCR checklist elements and family engagement from 673 pre- and postintervention FCR videos and assessed the safety climate with the Children’s Hospital Safety Climate Questionnaire. Random effects regression models were used to assess intervention impact. RESULTS: The intervention significantly increased the number of FCR checklist elements performed (β = 1.2, P < .001). Intervention rounds were significantly more likely to include asking the family (odds ratio [OR] = 2.43, P < .05) or health care team (OR = 4.28, P = .002) for questions and reading back orders (OR = 12.43, P < .001). Intervention families’ engagement and reports of safety climate were no different from usual care. However, performance of specific checklist elements was associated with changes in these outcomes. For example, order read-back was associated with significantly more family engagement. Asking families for questions was associated with significantly better ratings of staff’s communication openness and safety of handoffs and transitions. CONCLUSIONS: The performance of FCR checklist elements was enhanced by checklist implementation and associated with changes in family engagement and more positive perceptions of safety climate. Implementing the checklist improves delivery of FCRs, impacting quality and safety of care. PMID:28557720

Feasibility and Acceptability of a Best Supportive Care Checklist among Clinicians.

PubMed

Boucher, Nathan A; Nicolla, Jonathan; Ogunseitan, Adeboye; Kessler, Elizabeth R; Ritchie, Christine S; Zafar, Yousuf Y

2018-04-23

Best supportive care (BSC) is often not standardized across sites, consistent with best evidence, or sufficiently described. We developed a consensus-based checklist to document BSC delivery, including symptom management, decision making, and care planning. We hypothesized that BSC can be feasibly documented with this checklist consistent with consolidated standards of reporting trials. To determine feasibility/acceptability of a BSC checklist among clinicians. To test feasibility of a BSC checklist in standard care, we enrolled a sample of clinicians treating patients with advanced cancer at four centers. Clinicians were asked to complete the checklist at eligible patient encounters. We surveyed enrollees regarding checklist use generating descriptive statistics and frequencies. We surveyed 15 clinicians and 9 advanced practice providers. Mean age was 41 (SD = 7.9). Mean years since fellowship for physicians was 7.2 (SD = 4.5). Represented specialties are medical oncology (n = 8), gynecologic oncology (n = 4), palliative care (n = 2), and other (n = 1). For "overall impact on your delivery of supportive/palliative care," 40% noted improved impact with using BSC. For "overall impact on your documentation of supportive/palliative care," 46% noted improvement. Impact on "frequency of comprehensive symptom assessment" was noted to be "increased" by 33% of providers. None noted decreased frequency or worsening impact on any measure with use of BSC. Regarding feasibility of integrating the checklist into workflow, 73% agreed/strongly agreed that checklists could be easily integrated, 73% saw value in integration, and 80% found it easy to use. Clinicians viewed the BSC checklist favorably illustrating proof of concept, minor workflow impact, and potential of benefit to patients.

Checklists in Neurosurgery to Decrease Preventable Medical Errors: A Review

PubMed Central

Enchev, Yavor

2015-01-01

Neurosurgery represents a zero tolerance environment for medical errors, especially preventable ones like all types of wrong site surgery, complications due to the incorrect positioning of patients for neurosurgical interventions and complications due to failure of the devices required for the specific procedure. Following the excellent and encouraging results of the safety checklists in intensive care medicine and in other surgical areas, the checklist was naturally introduced in neurosurgery. To date, the reported world experience with neurosurgical checklists is limited to 15 series with fewer than 20,000 cases in various neurosurgical areas. The purpose of this review was to study the reported neurosurgical checklists according to the following parameters: year of publication; country of origin; area of neurosurgery; type of neurosurgical procedure-elective or emergency; person in charge of the checklist completion; participants involved in completion; whether they prevented incorrect site surgery; whether they prevented complications due to incorrect positioning of the patients for neurosurgical interventions; whether they prevented complications due to failure of the devices required for the specific procedure; their specific aims; educational preparation and training; the time needed for checklist completion; study duration and phases; number of cases included; barriers to implementation; efforts to implementation; team appreciation; and safety outcomes. Based on this analysis, it could be concluded that neurosurgical checklists represent an efficient, reliable, cost-effective and time-saving tool for increasing patient safety and elevating the neurosurgeons’ self-confidence. Every neurosurgical department must develop its own neurosurgical checklist or adopt and modify an existing one according to its specific features and needs in an attempt to establish or develop its safety culture. The world, continental, regional and national neurosurgical societies could promote safety checklists and their benefits. PMID:26740891

A novel briefing checklist at shift handoff in an emergency department improves situational awareness and safety event identification.

PubMed

Mullan, Paul C; Macias, Charles G; Hsu, Deborah; Alam, Sartaj; Patel, Binita

2015-04-01

Emergency department (ED) shift handoffs are sources of potential medical error, delays in care, and medicolegal liabilities. Few handoff studies exist in the ED literature. We aimed to describe the implementation of a standardized checklist for improving situational awareness during physician handoffs in a pediatric ED. This is a descriptive observational study in a large academic pediatric ED. Checklists were evaluated for rates of use, completion, and identification of potential safety events. We defined a complete checklist as 80% or more of items checked.  A user perception survey was used. After 1 year, all checklist users (residents, fellows, faculty, and charge nurses with ED experience before and after checklist implementation) were anonymously surveyed to assess the checklist's usability, perceived contributions to Institute of Medicine quality domains, and situational awareness. The electronically administered survey used Likert frequency scales. Of 732 handoffs, 98% used the checklist, and 89% were complete. A mean of 1.7 potential safety events were identified per handoff. The most frequent potential safety events were identification of intensive care unit-level patients in the ED (48%), equipment problems (46%), staffing issues (21%), and intensive care unit-level patients in transport (16%). Eighty-one subjects (88%) responded to the survey. The users agreed that the checklist promoted better communication, safety, efficiency, effective care, and situational awareness. The Physician Active Shift Signout in the Emergency Department briefing checklist was used often and at a high completion rate, frequently identifying potential safety events. The users found that it improved the quality of care and team communication. Future studies on outcomes and processes are needed.

How do performance-based financing programmes measure quality of care? A descriptive analysis of 68 quality checklists from 28 low- and middle-income countries

PubMed Central

Josephson, Erik; Gergen, Jessica; Coe, Martha; Ski, Samantha; Madhavan, Supriya; Bauhoff, Sebastian

2017-01-01

Abstract This paper seeks to systematically describe the length and content of quality checklists used in performance-based financing programmes, their similarities and differences, and how checklists have evolved over time. We compiled a list of supply-side, health facility-based performance-based financing (PBF) programmes in low- and lower middle-income countries based on a document review. We then solicited PBF manuals and quality checklists from implementers and donors of these PBF mechanisms. We entered each indicator from each quality checklist into a database verbatim in English, and translated into English from French where appropriate, and categorized each indicator according to the Donabedian framework and an author-derived categorization. We extracted 8,490 quality indicators from 68 quality checklists across 32 PBF implementations in 28 countries. On average, checklists contained 125 indicators; within the same program, checklists tend to grow as they are updated. Using the Donabedian framework, 80% of indicators were structure-type, 19% process-type, and less than 1% outcome-type. The author-derived categorization showed that 57% of indicators relate to availability of resources, 24% to managing the facility and 17% assess knowledge and effort. There is a high degree of similarity in a narrow set of indicators used in checklists for common service types such as maternal, neonatal and child health. We conclude that performance-based financing offers an appealing approach to targeting specific quality shortfalls and advancing toward the Sustainable Development Goals of high quality coverage. Currently most indicators focus on structural issues and resource availability. There is scope to rationalize and evolve the quality checklists of these programs to help achieve national and global goals to improve quality of care. PMID:28549142

Mixed methods study on the use of and attitudes towards safety checklists in interventional radiology.

PubMed

Munn, Zachary; Giles, Kristy; Aromataris, Edoardo; Deakin, Anita; Schultz, Timothy; Mandel, Catherine; Peters, Micah Dj; Maddern, Guy; Pearson, Alan; Runciman, William

2018-02-01

The use of safety checklists in interventional radiology is an intervention aimed at reducing mortality and morbidity. Currently there is little known about their practical use in Australian radiology departments. The primary aim of this mixed methods study was to evaluate how safety checklists (SC) are used and completed in radiology departments within Australian hospitals, and attitudes towards their use as described by Australian radiologists. A mixed methods approach employing both quantitative and qualitative techniques was used for this study. Direct observations of checklist use during radiological procedures were performed to determine compliance. Medical records were also audited to investigate whether there was any discrepancy between practice (actual care measured by direct observation) and documentation (documented care measured by an audit of records). A focus group with Australian radiologists was conducted to determine attitudes towards the use of checklists. Among the four participating radiology departments, overall observed mean completion of the components of the checklist was 38%. The checklist items most commonly observed to be addressed by the operating theatre staff as noted during observations were correct patient (80%) and procedure (60%). Findings from the direct observations conflicted with the medical record audit, where there was a higher percentage of completion (64% completion) in comparison to the 38% observed. The focus group participants spoke of barriers to the use of checklists, including the culture of radiology departments. This is the first study of safety checklist use in radiology within Australia. Overall completion was low across the sites included in this study. Compliance data collected from observations differed markedly from reported compliance in medical records. There remain significant barriers to the proper use of safety checklists in Australian radiology departments. © 2017 The Royal Australian and New Zealand College of Radiologists.

An embedded checklist in the Anesthesia Information Management System improves pre-anaesthetic induction setup: a randomised controlled trial in a simulation setting.

PubMed

Wetmore, Douglas; Goldberg, Andrew; Gandhi, Nishant; Spivack, John; McCormick, Patrick; DeMaria, Samuel

2016-10-01

Anaesthesiologists work in a high stress, high consequence environment in which missed steps in preparation may lead to medical errors and potential patient harm. The pre-anaesthetic induction period has been identified as a time in which medical errors can occur. The Anesthesia Patient Safety Foundation has developed a Pre-Anesthetic Induction Patient Safety (PIPS) checklist. We conducted this study to test the effectiveness of this checklist, when embedded in our institutional Anesthesia Information Management System (AIMS), on resident performance in a simulated environment. Using a randomised, controlled, observer-blinded design, we compared performance of anaesthesiology residents in a simulated operating room under production pressure using a checklist in completing a thorough pre-anaesthetic induction evaluation and setup with that of residents with no checklist. The checklist was embedded in the simulated operating room's electronic medical record. Data for 38 anaesthesiology residents shows a statistically significant difference in performance in pre-anaesthetic setup and evaluation as scored by blinded raters (maximum score 22 points), with the checklist group performing better by 7.8 points (p<0.01). The effects of gender and year of residency on total score were not significant. Simulation duration (time to anaesthetic agent administration) was increased significantly by the use of the checklist. Required use of a pre-induction checklist improves anaesthesiology resident performance in a simulated environment. The PIPS checklist as an integrated part of a departmental AIMS warrant further investigation as a quality measure. 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/

14 CFR 431.39 - Mission rules, procedures, contingency plans, and checklists.

Code of Federal Regulations, 2012 CFR

2012-01-01

... mission rules, procedures, checklists, emergency plans, and contingency abort plans, if any, that ensure..., procedures, checklists, emergency plans, and contingency abort plans must be contained in a safety directive...

14 CFR 431.39 - Mission rules, procedures, contingency plans, and checklists.

Code of Federal Regulations, 2014 CFR

2014-01-01

... mission rules, procedures, checklists, emergency plans, and contingency abort plans, if any, that ensure..., procedures, checklists, emergency plans, and contingency abort plans must be contained in a safety directive...

14 CFR 431.39 - Mission rules, procedures, contingency plans, and checklists.

Code of Federal Regulations, 2013 CFR

2013-01-01

... mission rules, procedures, checklists, emergency plans, and contingency abort plans, if any, that ensure..., procedures, checklists, emergency plans, and contingency abort plans must be contained in a safety directive...

Un-Alerted Smoke and Fire: Checklist Content and Intended Crew Response

NASA Technical Reports Server (NTRS)

Burian, Barbara K.

2015-01-01

An in-flight smoke or fire event is an emergency unlike almost any other. The early cues for un-alerted conditions, such as air conditioning smoke or fire, are often ambiguous and elusive. The checklists crews use for these conditions must help them respond quickly and effectively and must guide their decisions. Ten years ago an industry committee developed a template to guide the content of Part 121 checklists for un-alerted smoke and fire events. This template is based upon a new philosophy about how crews should use the checklists and respond to the events. To determine the degree to which current un-alerted checklists of in-flight smoke or fire comply or are consistent with the guidance outlined in the template, I collected and analysed checklists from North American air carriers.

Assessing validity of observational intervention studies - the Benchmarking Controlled Trials.

PubMed

Malmivaara, Antti

2016-09-01

Benchmarking Controlled Trial (BCT) is a concept which covers all observational studies aiming to assess impact of interventions or health care system features to patients and populations. To create and pilot test a checklist for appraising methodological validity of a BCT. The checklist was created by extracting the most essential elements from the comprehensive set of criteria in the previous paper on BCTs. Also checklists and scientific papers on observational studies and respective systematic reviews were utilized. Ten BCTs published in the Lancet and in the New England Journal of Medicine were used to assess feasibility of the created checklist. The appraised studies seem to have several methodological limitations, some of which could be avoided in planning, conducting and reporting phases of the studies. The checklist can be used for planning, conducting, reporting, reviewing, and critical reading of observational intervention studies. However, the piloted checklist should be validated in further studies. Key messages Benchmarking Controlled Trial (BCT) is a concept which covers all observational studies aiming to assess impact of interventions or health care system features to patients and populations. This paper presents a checklist for appraising methodological validity of BCTs and pilot-tests the checklist with ten BCTs published in leading medical journals. The appraised studies seem to have several methodological limitations, some of which could be avoided in planning, conducting and reporting phases of the studies. The checklist can be used for planning, conducting, reporting, reviewing, and critical reading of observational intervention studies.

Implementing the WHO Safe Childbirth Checklist: lessons from a global collaboration

PubMed Central

Perry, WRG; Bagheri Nejad, S; Tuomisto, K; Kara, N; Roos, N; Dilip, TR; Hirschhorn, LR; Larizgoitia, I; Semrau, K; Mathai, M; Dhingra-Kumar, N

2017-01-01

The WHO Safe Childbirth Checklist (SCC) was developed to ensure the delivery of essential maternal and perinatal care practices around the time of childbirth. A research collaboration was subsequently established to explore factors that influence use of the Checklist in a range of settings around the world. This analysis article presents an overview of the WHO SCC Collaboration and the lessons garnered from implementing the Checklist across a diverse range of settings. Project leads from each collaboration site were asked to distribute two surveys. The first was given to end users, and the second to implementation teams to describe their respective experiences using the Checklist. A total of 134 end users and 38 implementation teams responded to the surveys, from 19 countries across all levels of income. End users were willing to adopt the SCC and found it easy to use. Training and the provision of supervision while using the Checklist, alongside leadership engagement and local ownership, were important factors which helped facilitate initial implementation and successful uptake of the Checklist. Teams identified several challenges, but more importantly successfully implemented the WHO SCC. A critical step in all settings was the adaptation of the Checklist to reflect local context and national protocols and standards. These findings were invaluable in developing the final version of the WHO SCC and its associated implementation guide. Our experience will provide useful insights for any institution wishing to implement the Checklist. PMID:29082003

Using checklists in a gross anatomy laboratory improves learning outcomes and dissection quality.

PubMed

Hofer, Ryan Engebretson; Nikolaus, O Brant; Pawlina, Wojciech

2011-01-01

Checklists have been widely used in the aviation industry ever since aircraft operations became more complex than any single pilot could reasonably remember. More recently, checklists have found their way into medicine, where cognitive function can be compromised by stress and fatigue. The use of checklists in medical education has rarely been reported, especially in the basic sciences. We explored whether the use of a checklist in the gross anatomy laboratory would improve learning outcomes, dissection quality, and students' satisfaction in the first-year Human Structure didactic block at Mayo Medical School. During the second half of a seven-week anatomy course, dissection teams were each day given a hardcopy checklist of the structures to be identified during that day's dissection. The first half of the course was considered the control, as students did not receive any checklists to utilize during dissection. The measured outcomes were scored on four practice practical examinations and four dissection quality assessments, two each from the first half (control) and second half of the course. A student satisfaction survey was distributed at the end of the course. Examination and dissection scores were analyzed for correlations between practice practical examination score and checklist use. Our data suggest that a daily hardcopy list of anatomical structures for active use in the gross anatomy laboratory increases practice practical examination scores and dissection quality. Students recommend the use of these checklists in future anatomy courses. Copyright © 2011 American Association of Anatomists.

Impact of Checklist Use on Wellness and Post-Elective Surgery Appointments in a Veterinary Teaching Hospital.

PubMed

Ruch-Gallie, Rebecca; Weir, Heather; Kogan, Lori R

Cognitive functioning is often compromised with increasing levels of stress and fatigue, both of which are often experienced by veterinarians. Many high-stress fields have implemented checklists to reduce human error. The use of these checklists has been shown to improve the quality of medical care, including adherence to evidence-based best practices and improvement of patient safety. Although it has been recognized that veterinary medicine would likely demonstrate similar benefits, there have been no published studies to date evaluating the use of checklists for improving quality of care in veterinary medicine. The purpose of the current study was to evaluate the impact of checklists during wellness and post-elective surgery appointments conducted by fourth-year veterinary students within their Community Practice rotation at a US veterinary teaching hospital. Students were randomly assigned to one of two groups: those who were specifically asked to use the provided checklists during appointments, and those who were not asked to use the checklists but had them available. Two individuals blinded to the study reviewed the tapes of all appointments in each study group to determine the amount and type of medical information offered by veterinary students. Students who were specifically asked to use the checklists provided significantly more information to owners, with the exception of keeping the incision clean. Results indicate the use of checklists helps students provide more complete information to their clients, thereby potentially enhancing animal care.

Analysis of reliability of professor recommendation letters based on concordance with self-introduction letter.

PubMed

Kim, Sang Hyun

2013-12-01

The purpose of this study was to examine the concordance between a checklist's categories of professor recommendation letters and characteristics of the self-introduction letter. Checklists of professor recommendation letters were analyzed and classified into cognitive, social, and affective domains. Simple correlation was performed to determine whether the characteristics of the checklists were concordant with those of the self-introduction letter. The difference in ratings of the checklists by pass or fail grades was analyzed by independent sample t-test. Logistic regression analysis was performed to determine whether a pass or fail grade was influenced by ratings on the checklists. The Cronbach alpha value of the checklists was 0.854. Initiative, as an affective domain, in the professor's recommendation letter was highly ranked among the six checklist categories. Self-directed learning in the self-introduction letter was influenced by a pass or fail grade by logistic regression analysis (p<0.05). Successful applicants received higher ratings than those who failed in every checklist category, particularly in problem-solving ability, communication skills, initiative, and morality (p<0.05). There was a strong correlation between cognitive and affective characteristics in the professor recommendation letters and the sum of all characteristics in the self-introduction letter.

Inter-rater reliability of an observation-based ergonomics assessment checklist for office workers.

PubMed

Pereira, Michelle Jessica; Straker, Leon Melville; Comans, Tracy Anne; Johnston, Venerina

2016-12-01

To establish the inter-rater reliability of an observation-based ergonomics assessment checklist for computer workers. A 37-item (38-item if a laptop was part of the workstation) comprehensive observational ergonomics assessment checklist comparable to government guidelines and up to date with empirical evidence was developed. Two trained practitioners assessed full-time office workers performing their usual computer-based work and evaluated the suitability of workstations used. Practitioners assessed each participant consecutively. The order of assessors was randomised, and the second assessor was blinded to the findings of the first. Unadjusted kappa coefficients between the raters were obtained for the overall checklist and subsections that were formed from question-items relevant to specific workstation equipment. Twenty-seven office workers were recruited. The inter-rater reliability between two trained practitioners achieved moderate to good reliability for all except one checklist component. This checklist has mostly moderate to good reliability between two trained practitioners. Practitioner Summary: This reliable ergonomics assessment checklist for computer workers was designed using accessible government guidelines and supplemented with up-to-date evidence. Employers in Queensland (Australia) can fulfil legislative requirements by using this reliable checklist to identify and subsequently address potential risk factors for work-related injury to provide a safe working environment.

Special Consolidated Checklists for Toxicity Characteristics Revisions

EPA Pesticide Factsheets

This checklist consolidates the changes to the Federal code addressed by the Toxicity Characteristic (TC) Rule [55 FR 11798; March 29, 1990; Revision Checklist 74] and subsequent revisions which have occurred through December 31, 2002.

Checklist for clinical readiness published

Cancer.gov

Scientists from NCI, together with collaborators from outside academic centers, have developed a checklist of criteria to evaluate the readiness of complex molecular tests that will guide decisions made during clinical trials. The checklist focuses on tes

Lesson 6: Using the Checklist to Work through System Requirements

EPA Pesticide Factsheets

Lesson 6 describes how these same requirements are presented in the CROMERR System Checklist (which was introduced in Lesson 4). You may want to refer to the checklist as you step through this lesson.

Special Consolidated Checklists for Organic Air Emission Standards

EPA Pesticide Factsheets

This checklist consolidates changes made to the Federal code by the December 6, 1994 final rule regarding Subpart CC standards [(59 FR 62896); Revision Checklist 154] and subsequent revisions which have occurred through December 31, 2002.

Checklists for 45/90 Preliminary Technical Screen

EPA Pesticide Factsheets

We use checklists to ensure that the application is ready for in depth review, as required by FIFRA. Applicants can use them to help ensure their applications are complete. You may submit the checklist with the application.

A treatment goal checklist for people with personality disorder.

PubMed

Wood, Katherine; McMurran, Mary

2013-11-01

Agreement between client and therapist on treatment goals has been consistently linked with improved treatment outcomes. Having clear and collaborative goals may be particularly important when working with clients diagnosed with personality disorders who are often difficult to engage and test the boundaries of therapy. This paper outlines the development of a personality disorder treatment goal checklist aimed at helping clients and therapists to identify and prioritize their goals for therapy. The checklist was developed using self-reported problems of the first 90 participants randomized into the psychoeducation and problem solving (PEPS) trial. Problems were coded and categorized into problem areas. The checklist was viewed by two service users who gave suggestions for improvements. The final checklist consists of 161 items in 16 problem areas. The checklist may provide a clinically useful tool for working with this client group. Copyright © 2013 John Wiley & Sons, Ltd.

Human Factors Checklist: Think Human Factors - Focus on the People

NASA Technical Reports Server (NTRS)

Miller, Darcy; Stelges, Katrine; Barth, Timothy; Stambolian, Damon; Henderson, Gena; Dischinger, Charles; Kanki, Barbara; Kramer, Ian

2016-01-01

A quick-look Human Factors (HF) Checklist condenses industry and NASA Agency standards consisting of thousands of requirements into 14 main categories. With support from contractor HF and Safety Practitioners, NASA developed a means to share key HF messages with Design, Engineering, Safety, Project Management, and others. It is often difficult to complete timely assessments due to the large volume of HF information. The HF Checklist evolved over time into a simple way to consider the most important concepts. A wide audience can apply the checklist early in design or through planning phases, even before hardware or processes are finalized or implemented. The checklist is a good place to start to supplement formal HF evaluation. The HF Checklist was based on many Space Shuttle processing experiences and lessons learned. It is now being applied to ground processing of new space vehicles and adjusted for new facilities and systems.

Assessing validity of observational intervention studies – the Benchmarking Controlled Trials

PubMed Central

Malmivaara, Antti

2016-01-01

Abstract Background: Benchmarking Controlled Trial (BCT) is a concept which covers all observational studies aiming to assess impact of interventions or health care system features to patients and populations. Aims: To create and pilot test a checklist for appraising methodological validity of a BCT. Methods: The checklist was created by extracting the most essential elements from the comprehensive set of criteria in the previous paper on BCTs. Also checklists and scientific papers on observational studies and respective systematic reviews were utilized. Ten BCTs published in the Lancet and in the New England Journal of Medicine were used to assess feasibility of the created checklist. Results: The appraised studies seem to have several methodological limitations, some of which could be avoided in planning, conducting and reporting phases of the studies. Conclusions: The checklist can be used for planning, conducting, reporting, reviewing, and critical reading of observational intervention studies. However, the piloted checklist should be validated in further studies.Key messagesBenchmarking Controlled Trial (BCT) is a concept which covers all observational studies aiming to assess impact of interventions or health care system features to patients and populations.This paper presents a checklist for appraising methodological validity of BCTs and pilot-tests the checklist with ten BCTs published in leading medical journals. The appraised studies seem to have several methodological limitations, some of which could be avoided in planning, conducting and reporting phases of the studies.The checklist can be used for planning, conducting, reporting, reviewing, and critical reading of observational intervention studies. PMID:27238631

The GUIDES checklist: development of a tool to improve the successful use of guideline-based computerised clinical decision support.

PubMed

Van de Velde, Stijn; Kunnamo, Ilkka; Roshanov, Pavel; Kortteisto, Tiina; Aertgeerts, Bert; Vandvik, Per Olav; Flottorp, Signe

2018-06-25

Computerised decision support (CDS) based on trustworthy clinical guidelines is a key component of a learning healthcare system. Research shows that the effectiveness of CDS is mixed. Multifaceted context, system, recommendation and implementation factors may potentially affect the success of CDS interventions. This paper describes the development of a checklist that is intended to support professionals to implement CDS successfully. We developed the checklist through an iterative process that involved a systematic review of evidence and frameworks, a synthesis of the success factors identified in the review, feedback from an international expert panel that evaluated the checklist in relation to a list of desirable framework attributes, consultations with patients and healthcare consumers and pilot testing of the checklist. We screened 5347 papers and selected 71 papers with relevant information on success factors for guideline-based CDS. From the selected papers, we developed a 16-factor checklist that is divided in four domains, i.e. the CDS context, content, system and implementation domains. The panel of experts evaluated the checklist positively as an instrument that could support people implementing guideline-based CDS across a wide range of settings globally. Patients and healthcare consumers identified guideline-based CDS as an important quality improvement intervention and perceived the GUIDES checklist as a suitable and useful strategy. The GUIDES checklist can support professionals in considering the factors that affect the success of CDS interventions. It may facilitate a deeper and more accurate understanding of the factors shaping CDS effectiveness. Relying on a structured approach may prevent that important factors are missed.

Sample Federal Facility Land Use Control ROD Checklist and Suggested Language (LUC Checklist)

EPA Pesticide Factsheets

The LUC Checklist provides direction on describing and documenting land use controls (LUCs) in federal facility actrions under CERCLA in Records of Decision (RODs), remedial designs (RDs), and remedial action work plans (RAWPs).

Development of a Child Abuse Checklist to Evaluate Prehospital Provider Performance.

PubMed

Alphonso, Aimee; Auerbach, Marc; Bechtel, Kirsten; Bilodeau, Kyle; Gawel, Marcie; Koziel, Jeannette; Whitfill, Travis; Tiyyagura, Gunjan Kamdar

2017-01-01

To develop and provide validity evidence for a performance checklist to evaluate the child abuse screening behaviors of prehospital providers. Checklist Development: We developed the first iteration of the checklist after review of the relevant literature and on the basis of the authors' clinical experience. Next, a panel of six content experts participated in three rounds of Delphi review to reach consensus on the final checklist items. Checklist Validation: Twenty-eight emergency medical services (EMS) providers (16 EMT-Basics, 12 EMT-Paramedics) participated in a standardized simulated case of physical child abuse to an infant followed by one-on-one semi-structured qualitative interviews. Three reviewers scored the videotaped performance using the final checklist. Light's kappa and Cronbach's alpha were calculated to assess inter-rater reliability (IRR) and internal consistency, respectively. The correlation of successful child abuse screening with checklist task completion and with participant characteristics were compared using Pearson's chi squared test to gather evidence for construct validity. The Delphi review process resulted in a final checklist that included 24 items classified with trichotomous scoring (done, not done, or not applicable). The overall IRR of the three raters was 0.70 using Light's kappa, indicating substantial agreement. Internal consistency of the checklist was low, with an overall Cronbach's alpha of 0.61. Of 28 participants, only 14 (50%) successfully screened for child abuse in simulation. Participants who successfully screened for child abuse did not differ significantly from those who failed to screen in terms of training level, past experience with child abuse reporting, or self-reported confidence in detecting child abuse (all p > 0.30). Of all 24 tasks, only the task of exposing the infant significantly correlated with successful detection of child abuse (p < 0.05). We developed a child abuse checklist that demonstrated strong content validity and substantial inter-rater reliability, but successful item completion did not correlate with other markers of provider experience. The validated instrument has important potential for training, continuing education, and research for prehospital providers at all levels of training.

Promoting transparent and accurate reporting of research studies in rheumatology: endorsement of reporting guidelines in rheumatology journals.

PubMed

Marušić, Ana; Gasparyan, Armen Yuri; Kitas, George D

2013-10-01

To adequately translate research into practice, research results should be reported in a way that is useful to practicing clinicians and policymakers. Based on evidence from systematic reviews, the implementation of reporting guidelines, such as CONSORT for randomized controlled trials, may improve the quality of research reporting. We assessed the endorsement of reporting guidelines in rheumatology journals. We analyzed guidelines for authors of all (n = 28) journals indexed in the "Rheumatology" Subject Category of the Journal Citation Reports published in 2012. Journal websites were reviewed for information relevant to reporting guidelines. Out of 28 indexed journals, only about a third (n = 10) endorsed 1 or more reporting guidelines, most commonly CONSORT. General editorial policies, such as those from the International Committee of Medical Journal editors (ICMJE), were endorsed by 19 journals (all 10 journals with and 9 out of 18 without reporting guidelines). Two rheumatology journals introduced specific reporting guidelines about economic studies and genetic association studies. The endorsement of reporting guidelines is low in rheumatology journals. To continue to serve their research community, rheumatology journals should provide the platform for the discussion on most relevant reporting guidelines and adopt them as a group, especially those specific for rheumatology research. Coordinated action of journals and other stakeholders in rheumatology research in the promotion of accurate and transparent reporting of health research studies would be an important part of knowledge translation into practice and well-being of rheumatology patients. Copyright © 2013 Elsevier Inc. All rights reserved.

Summary of Resource Conservation and Recovery Act (RCRA) State Authorization Rule Checklist 3006(f)

EPA Pesticide Factsheets

This checklist is an electronic version of the original document found in the 1986 State Consolidated RCRA Authorization Manual (SCRAM). The checklist has not undergone any formal legal review since publication in the SCRAM.

Good oral health, adequate nutrient consumption and family support are associated with a reduced risk of being underweight amongst older Malaysian residents of publicly funded shelter homes.

PubMed

Visvanathan, Renuka; Ahmad, Zaiton

2006-01-01

A low body mass index in older people has been associated with increased mortality. The main objective of this study was to identify factors associated with low body mass indices [ BMIs] (< 18.5 kg/m2) in older residents of shelter care facilities in Peninsular Malaysia. 1081 elderly people (59% M) over the age of 60 years were surveyed using questionnaires determining baseline demographics, nutritional and cognitive status, physical function and psychological well being. Body mass index was also determined. Subjects were recruited from publicly funded shelter homes in Peninsular Malaysia. 14.3% of residents had BMIs < 18.5 kg/m2. Multivariate analyses (adjusted for age and sex) revealed that having no family (RR 1.98[95%CI 1.40-2.82], p<0.001) and negative responses to statement 3 [I eat few fruits or vegetables or milk products] (RR 0.62 [95% CI 0.42-0.90]; P= 0.013) and statement 5 [I have tooth or mouth problems that make it hard for me to eat] (RR 0.69 [95%CI 0.50-0.96]; P= 0.023) of the ' Determine Your Nutritional Health Checklist' were independently associated with low BMIs (<18.5 kg/m2). Older people with no family support were at risk of becoming underweight. Older people who consumed fruits, vegetables or milk or had good oral health were less likely to be underweight. Nutrient intake, oral health and social support were important in ensuring healthy body weight in older Malaysians.

A cluster randomized trial for the implementation of an antibiotic checklist based on validated quality indicators: the AB-checklist.

PubMed

van Daalen, Frederike V; Prins, Jan M; Opmeer, Brent C; Boermeester, Marja A; Visser, Caroline E; van Hest, Reinier M; Hulscher, Marlies E J L; Geerlings, Suzanne E

2015-03-19

Recently we developed and validated generic quality indicators that define 'appropriate antibiotic use' in hospitalized adults treated for a (suspected) bacterial infection. Previous studies have shown that with appropriate antibiotic use a reduction of 13% of length of hospital stay can be achieved. Our main objective in this project is to provide hospitals with an antibiotic checklist based on these quality indicators, and to evaluate the introduction of this checklist in terms of (cost-) effectiveness. The checklist applies to hospitalized adults with a suspected bacterial infection for whom antibiotic therapy is initiated, at first via the intravenous route. A stepped wedge study design will be used, comparing outcomes before and after introduction of the checklist in nine hospitals in the Netherlands. At least 810 patients will be included in both the control and the intervention group. The primary endpoint is length of hospital stay. Secondary endpoints are appropriate antibiotic use measured by the quality indicators, admission to and duration of intensive care unit stay, readmission within 30 days, mortality, total antibiotic use, and costs associated with implementation and hospital stay. Differences in numerical endpoints between the two periods will be evaluated with mixed linear models; for dichotomous outcomes generalized estimating equation models will be used. A process evaluation will be performed to evaluate the professionals' compliance with use of the checklist. The key question for the economic evaluation is whether the benefits of the checklist, which include reduced antibiotic use, reduced length of stay and associated costs, justify the costs associated with implementation activities as well as daily use of the checklist. If (cost-) effective, the AB-checklist will provide physicians with a tool to support appropriate antibiotic use in adult hospitalized patients who start with intravenous antibiotics. Dutch trial registry: NTR4872.

An Independent Human Factors Analysis and Evaluation of the Emergency Medical Protocol Checklist for the International Space Station

NASA Technical Reports Server (NTRS)

Marshburn, Thomas; Whitmore, Mihriban; Ortiz, Rosie; Segal, Michele; Smart, Kieran; Hughes, Catherine

2003-01-01

Emergency medical capabilities aboard the ISS include a Crew Medical Officer (CMO) (not necessarily a physician), and back-up, resuscitation equipment, and a medical checklist. It is essential that CMOs have reliable, usable and informative medical protocols that can be carried out independently in flight. The study evaluates the existing ISS Medical Checklist layout against a checklist updated to reflect a human factors approach to structure and organization. Method: The ISS Medical checklist was divided into non-emergency and emergency sections, and re-organized based on alphabetical and a body systems approach. A desk-top evaluation examined the ability of subjects to navigate to specific medical problems identified as representative of likely non-emergency events. A second evaluation aims to focus on the emergency section of the Medical Checklist, based on the preliminary findings of the first. The final evaluation will use Astronaut CMOs as subjects comparing the original checklist against the updated layout in the task of caring for a "downed crewmember" using a Human Patient Simulator [Medical Education Technologies, Inc.]. Results: Initial results have demonstrated a clear improvement of the re-organized sections to determine the solution to the medical problems. There was no distinct advantage for either alternative, although subjects stated having a preference for the body systems approach. In the second evaluation, subjects will be asked to identify emergency medical conditions, with measures including correct diagnosis, time to completion and solution strategy. The third evaluation will compare the original and fully updated checklists in clinical situations. Conclusions: Initial findings indicate that the ISS Medical Checklist will benefit from a reorganization. The present structure of the checklist has evolved over recent years without systematic testing of crewmember ability to diagnose medical problems. The improvements are expected to enable ISS Crewmembers to more speedily and accurately respond to medical situations on the ISS.

Heuristic Evaluation on Mobile Interfaces: A New Checklist

PubMed Central

Yáñez Gómez, Rosa; Cascado Caballero, Daniel; Sevillano, José-Luis

2014-01-01

The rapid evolution and adoption of mobile devices raise new usability challenges, given their limitations (in screen size, battery life, etc.) as well as the specific requirements of this new interaction. Traditional evaluation techniques need to be adapted in order for these requirements to be met. Heuristic evaluation (HE), an Inspection Method based on evaluation conducted by experts over a real system or prototype, is based on checklists which are desktop-centred and do not adequately detect mobile-specific usability issues. In this paper, we propose a compilation of heuristic evaluation checklists taken from the existing bibliography but readapted to new mobile interfaces. Selecting and rearranging these heuristic guidelines offer a tool which works well not just for evaluation but also as a best-practices checklist. The result is a comprehensive checklist which is experimentally evaluated as a design tool. This experimental evaluation involved two software engineers without any specific knowledge about usability, a group of ten users who compared the usability of a first prototype designed without our heuristics, and a second one after applying the proposed checklist. The results of this experiment show the usefulness of the proposed checklist for avoiding usability gaps even with nontrained developers. PMID:25295300

Measurement properties and implementation of a checklist to assess leadership skills during interdisciplinary rounds in the intensive care unit.

PubMed

Ten Have, Elsbeth C M; Nap, Raoul E; Tulleken, Jaap E

2015-01-01

The implementation of interdisciplinary teams in the intensive care unit (ICU) has focused attention on leadership behavior. A daily recurrent situation in ICUs in which both leadership behavior and interdisciplinary teamwork are integrated concerns the interdisciplinary rounds (IDRs). Although IDRs are recommended to provide optimal interdisciplinary and patient-centered care, there are no checklists available for leading physicians. We tested the measurement properties and implementation of a checklist to assess the quality of leadership skills in interdisciplinary rounds. The measurement properties of the checklist, which included 10 essential quality indicators, were tested for interrater reliability and internal consistency and by factor analysis. The interrater reliability among 3 raters was good (κ, 0.85) and the internal consistency was acceptable (α, 0.74). Factor analysis showed all factor loadings on 1 domain (>0.65). The checklist was further implemented during videotaped IDRs which were led by senior physicians and in which 99 patients were discussed. Implementation of the checklist showed a wide range of "no" and "yes" scores among the senior physicians. These results may underline the need for such a checklist to ensure tasks are synchronized within the team.

A checklist to assess the quality of reports on spa therapy and balneotherapy trials was developed using the Delphi consensus method: the SPAC checklist.

PubMed

Kamioka, Hiroharu; Kawamura, Yoichi; Tsutani, Kiichiro; Maeda, Masaharu; Hayasaka, Shinya; Okuizum, Hiroyasu; Okada, Shinpei; Honda, Takuya; Iijima, Yuichi

2013-08-01

The purpose of this study was to develop a checklist of items that describes and measures the quality of reports of interventional trials assessing spa therapy. The Delphi consensus method was used to select the number of items in the checklist. A total of eight individuals participated, including an epidemiologist, a clinical research methodologist, clinical researchers, a medical journalist, and a health fitness programmer. Participants ranked on a 9-point Likert scale whether an item should be included in the checklist. Three rounds of the Delphi method were conducted to achieve consensus. The final checklist contained 19 items, with items related to title, place of implementation (specificity of spa), care provider influence, and additional measures to minimize the potential bias from withdrawals, loss to follow-up, and low treatment adherence. This checklist is simple and quick to complete, and should help clinicians and researchers critically appraise the medical and healthcare literature, reviewers assess the quality of reports included in systematic reviews, and researchers plan interventional trials of spa therapy. Copyright © 2013 Elsevier Ltd. All rights reserved.

An Investigation of Diagnostic Accuracy and Confidence Associated with Diagnostic Checklists as Well as Gender Biases in Relation to Mental Disorders.

PubMed

Cwik, Jan C; Papen, Fabienne; Lemke, Jan-Erik; Margraf, Jürgen

2016-01-01

This study examines the utility of checklists in attaining more accurate diagnoses in the context of diagnostic decision-making for mental disorders. The study also aimed to replicate results from a meta-analysis indicating that there is no association between patients' gender and misdiagnoses. To this end, 475 psychotherapists were asked to judge three case vignettes describing patients with Major Depressive Disorder (MDD), Generalized Anxiety Disorder, and Borderline Personality Disorder. Therapists were randomly assigned to experimental conditions in a 2 (diagnostic method: with using diagnostic checklists vs. without using diagnostic checklists) × 2 (gender: male vs. female case vignettes) between-subjects design. Multinomial logistic and linear regression analyses were used to examine the association between the usage of diagnostic checklists as well as patients' gender and diagnostic decisions. The results showed that when checklists were used, fewer incorrect co-morbid diagnoses were made, but clinicians were less likely to diagnose MDD even when the criteria were met. Additionally, checklists improved therapists' confidence with diagnostic decisions, but were not associated with estimations of patients' characteristics. As expected, there were no significant associations between gender and diagnostic decisions.

The effect of music therapy on cognitive functioning among older adults: a systematic review and meta-analysis.

PubMed

Li, Hui-Chi; Wang, Hsiu-Hung; Chou, Fan-Hao; Chen, Kuei-Min

2015-01-01

To conduct a systematic review and a meta-analysis of current studies to determine whether music therapy affects the cognitive function of older people. The databases surveyed include PsycINFO, PsycARTICLES, PubMed, MEDLINE, CINAHL, AgeLine, Cochrane Library, and the Chinese Electronic Periodical Services (CEPS) as well as the reference lists of the included studies. The Consolidated Standards of Reporting Trials (CONSORT) extension checklist for nonpharmacologic treatment was used to evaluate the literature. Music therapy intervention offered in nursing homes, hospitals, or communities. A total of 234 participants from 5 studies were assessed in the meta-analysis, with a mean age per study of 71.4 to 82.0 years. Cognitive outcome domains were analyzed in a systematic review. The short-term effects of music therapy in Mini-Mental State Examination data for meta-analysis were compiled. A forest plot was constructed using a fixed effect model to obtain a pooled mean difference. Active music therapy comprising singing and other musical activities was generally determined to effect a significant improvement in the Mini-Mental State Examination according to individual retrieval studies. However, this study showed no significant improvement in the short-term effects of music therapy when all related studies in meta-analysis were combined. The pooled mean difference was 0.73 (95% confidence interval -0.07 to 1.54; Z = 1.79; P = .07) for using music therapy overall and 0.74 (95% confidence interval -0.08 to 1.56; Z = 1.76; P = .08) for using active music therapy. The findings of the meta-analysis indicate that the short-term effects of music therapy do not improve the cognitive function of older people. Future studies that utilize a good quality methodology with a long-term design and diversified active music therapy are recommended. Copyright © 2015 AMDA – The Society for Post-Acute and Long-Term Care Medicine. Published by Elsevier Inc. All rights reserved.

Developing standards for reporting implementation studies of complex interventions (StaRI): a systematic review and e-Delphi.

PubMed

Pinnock, Hilary; Epiphaniou, Eleni; Sheikh, Aziz; Griffiths, Chris; Eldridge, Sandra; Craig, Peter; Taylor, Stephanie J C

2015-03-30

Dissemination and implementation of health care interventions are currently hampered by the variable quality of reporting of implementation research. Reporting of other study types has been improved by the introduction of reporting standards (e.g. CONSORT). We are therefore developing guidelines for reporting implementation studies (StaRI). Using established methodology for developing health research reporting guidelines, we systematically reviewed the literature to generate items for a checklist of reporting standards. We then recruited an international, multidisciplinary panel for an e-Delphi consensus-building exercise which comprised an initial open round to revise/suggest a list of potential items for scoring in the subsequent two scoring rounds (scale 1 to 9). Consensus was defined a priori as 80% agreement with the priority scores of 7, 8, or 9. We identified eight papers from the literature review from which we derived 36 potential items. We recruited 23 experts to the e-Delphi panel. Open round comments resulted in revisions, and 47 items went forward to the scoring rounds. Thirty-five items achieved consensus: 19 achieved 100% agreement. Prioritised items addressed the need to: provide an evidence-based justification for implementation; describe the setting, professional/service requirements, eligible population and intervention in detail; measure process and clinical outcomes at population level (using routine data); report impact on health care resources; describe local adaptations to the implementation strategy and describe barriers/facilitators. Over-arching themes from the free-text comments included balancing the need for detailed descriptions of interventions with publishing constraints, addressing the dual aims of reporting on the process of implementation and effectiveness of the intervention and monitoring fidelity to an intervention whilst encouraging adaptation to suit diverse local contexts. We have identified priority items for reporting implementation studies and key issues for further discussion. An international, multidisciplinary workshop, where participants will debate the issues raised, clarify specific items and develop StaRI standards that fit within the suite of EQUATOR reporting guidelines, is planned. The protocol is registered with Equator: http://www.equator-network.org/library/reporting-guidelines-under-development/#17 .