scholarly journals Deficiencies of effectiveness of intervention studies in veterinary medicine: a cross-sectional survey of ten leading veterinary and medical journals

PeerJ ◽  
2016 ◽  
Vol 4 ◽  
pp. e1649 ◽  
Author(s):  
Nicola Di Girolamo ◽  
Reint Meursinge Reynders
Keyword(s):  
Random Sequence ◽  
Allocation Concealment ◽  
Estimation Methods ◽  
Random Allocation ◽  
Cross Sectional Survey ◽  
Cross Sectional ◽  
Medical Journals ◽  
Sequence Generation ◽  
Random Sequence Generation

The validity of studies that assess the effectiveness of an intervention (EoI) depends on variables such as the type of study design, the quality of their methodology, and the participants enrolled. Five leading veterinary journals and 5 leading human medical journals were hand-searched for EoI studies for the year 2013. We assessed (1) the prevalence of randomized controlled trials (RCTs) among EoI studies, (2) the type of participants enrolled, and (3) the methodological quality of the selected studies. Of 1707 eligible articles, 590 were EoI articles and 435 RCTs. Random allocation to the intervention was performed in 52% (114/219; 95%CI:45.2–58.8%) of veterinary EoI articles, against 87% (321/371; 82.5–89.7%) of human EoI articles (adjusted OR:9.2; 3.4–24.8). Veterinary RCTs were smaller (median: 26 animals versus 465 humans) and less likely to enroll real patients, compared with human RCTs (OR:331; 45–2441). Only 2% of the veterinary RCTs, versus 77% of the human RCTs, reported power calculations, primary outcomes, random sequence generation, allocation concealment and estimation methods. Currently, internal and external validity of veterinary EoI studies is limited compared to human medical ones. To address these issues, veterinary interventional research needs to improve its methodology, increase the number of published RCTs and enroll real clinical patients.

scholarly journals Is Scientific Medical Literature Related to Endometriosis Treatment Evidence-Based? A Systematic Review on Methodological Quality of Randomized Clinical Trials

Medicina ◽  
2019 ◽  
Vol 55 (7) ◽  
pp. 372
Author(s):  
Roxana-Denisa Capraş ◽  
Andrada Elena Urda-Cîmpean ◽  
Sorana D. Bolboacă
Keyword(s):  
Randomized Clinical Trials ◽  
Random Sequence ◽  
Scientific Evidence ◽  
Allocation Concealment ◽  
Sequence Generation ◽  
Hierarchy Of Evidence ◽  
Random Sequence Generation ◽  
Level 1 ◽  
Double Blinded

Background and objectives: Informed decision-making requires the ability to identify and integrate high-quality scientific evidence in daily practice. We aimed to assess whether randomized controlled trials (RCTs) on endometriosis therapy follow methodological criteria corresponding to the RCTs’ specific level in the hierarchy of evidence in such details to allow the reproduction and replication of the study. Materials and Methods: Using the keywords “therapy” and “endometriosis” and “efficacy” three bibliographic databases were searched for English written scientific articles published from 1 January 2008 to 3 March 2018. Only the randomized clinical trials (RCTs) were evaluated in terms of whether they provided the appropriate level of scientific evidence, equivalent to level 1, degree 1b in the hierarchy of evidence. A list of criteria to ensure study replication and reproduction, considering CONSORT guideline and MECIR standards, was developed and used to evaluate RCTs’ methodological soundness, and scores were granted. Three types of bias, namely selection bias (random sequence generation and allocation concealment), detection bias (blinding of outcome assessment), and attrition bias (incomplete outcome data) were also evaluated. Results: We found 387 articles on endometriosis therapy, of which 38 were RCTs: 30 double-blinded RCTs and 8 open-label RCTs. No article achieved the maximum score according to the evaluated methodological criteria. Even though 73.3% of the double-blinded RCTs had clear title, abstract, introduction, and objectives, only 13.3% provided precise information regarding experimental design and randomization, and also showed a low risk of bias. The blinding method was poorly reported in 43.3% of the double-blinded RCTs, while allocation concealment and random sequence generation were inadequate in 33.3% of them. Conclusions: None of the evaluated RCTs met all the methodological criteria, none had only a low risk of bias and provided sufficient details on methods and randomization to allow for the reproduction and replication of the study. Consequently, the appropriate level of scientific evidence (level 1, degree 1b) could not be granted. On endometriosis therapy, this study evaluated the quality of reporting in RCTs and not the quality of how the studies were performed.

scholarly journals Risk of bias assessment of randomised controlled trials referenced in the 2015 American Heart Association guidelines update for cardiopulmonary resuscitation and emergency cardiovascular care: a cross-sectional review

BMJ Open ◽  
2019 ◽  
Vol 9 (5) ◽  
pp. e023725 ◽  
Author(s):  
Yongil Cho ◽  
Changsun Kim ◽  
Bossng Kang
Keyword(s):  
Random Sequence ◽  
Heart Association ◽  
Allocation Concealment ◽  
Risk Of Bias ◽  
Cross Sectional ◽  
Sequence Generation ◽  
Random Sequence Generation ◽  
Randomised Controlled ◽  
Cardiovascular Care ◽  
Unclear Risk

ObjectivesTo identify the risk of bias of randomised controlled trials (RCTs) referenced in the 2015 American Heart Association (AHA) guidelines update for cardiopulmonary resuscitation (CPR) and emergency cardiovascular care (ECC).DesignA cross-sectional review.SettingAll RCTs cited as references in the 2015 AHA guidelines update for CPR and ECC were extracted. After excluding non-human trials, studies that analysed existing RCTs, and RCTs published in a letter format, two reviewers assessed the risk of bias among RCTs included in this study.Outcome measuresThe Cochrane Collaboration’s tool for assessing the risk of bias in six domains (random sequence generation, allocation concealment, blinding of participants and personnel, blinding of outcome assessment, incomplete outcome data and selective reporting) was used.ResultsTwo hundred seventy-three RCTs were selected for the analyses. Of these RCTs, 78.8% had a high risk of bias for blinding of participants and personnel, mostly (87.7%) non-drug trials. In drug trials, the proportion of trials with a low risk of bias for blinding of participants and personnel was 73.0%. The proportion of RCTs with an unclear risk of bias were higher for random sequence generation (38.5%) and allocation concealment (34.1%) than in other domains. Unclear risk of bias proportions was 65.4% for random sequence generation and 57.7% for allocation concealment before the introduction of Consolidated Standards of Reporting Trials (CONSORT) but decreased to 31.3% and 32.2% after the 2010 CONSORT update, respectively.ConclusionsThe proportion of RCTs with an unclear risk of bias was still high for random sequence generation and allocation concealment in the 2015 AHA guidelines for CPR and ECC. The risk of bias should be considered when interpreting and applying the CPR guidelines. Authors should plan and report their research using CONSORT guidelines and the Cochrane Collaboration’s tool to reduce the risk of bias.

scholarly journals The methodological quality of 176,620 randomized controlled trials published between 1966 and 2018 reveals a positive trend but also an urgent need for improvement

PLoS Biology ◽  
2021 ◽  
Vol 19 (4) ◽  
pp. e3001162
Author(s):  
Christiaan H. Vinkers ◽  
Herm J. Lamberink ◽  
Joeri K. Tijdink ◽  
Pauline Heus ◽  
Lex Bouter ◽  
...  
Keyword(s):  
Outcome Assessment ◽  
Random Sequence ◽  
Consort Statement ◽  
Allocation Concealment ◽  
Risk Of Bias ◽  
Sequence Generation ◽  
Randomized Controlled ◽  
The Consort Statement ◽  
Random Sequence Generation

Many randomized controlled trials (RCTs) are biased and difficult to reproduce due to methodological flaws and poor reporting. There is increasing attention for responsible research practices and implementation of reporting guidelines, but whether these efforts have improved the methodological quality of RCTs (e.g., lower risk of bias) is unknown. We, therefore, mapped risk-of-bias trends over time in RCT publications in relation to journal and author characteristics. Meta-information of 176,620 RCTs published between 1966 and 2018 was extracted. The risk-of-bias probability (random sequence generation, allocation concealment, blinding of patients/personnel, and blinding of outcome assessment) was assessed using a risk-of-bias machine learning tool. This tool was simultaneously validated using 63,327 human risk-of-bias assessments obtained from 17,394 RCTs evaluated in the Cochrane Database of Systematic Reviews (CDSR). Moreover, RCT registration and CONSORT Statement reporting were assessed using automated searches. Publication characteristics included the number of authors, journal impact factor (JIF), and medical discipline. The annual number of published RCTs substantially increased over 4 decades, accompanied by increases in authors (5.2 to 7.8) and institutions (2.9 to 4.8). The risk of bias remained present in most RCTs but decreased over time for allocation concealment (63% to 51%), random sequence generation (57% to 36%), and blinding of outcome assessment (58% to 52%). Trial registration (37% to 47%) and the use of the CONSORT Statement (1% to 20%) also rapidly increased. In journals with a higher impact factor (>10), the risk of bias was consistently lower with higher levels of RCT registration and the use of the CONSORT Statement. Automated risk-of-bias predictions had accuracies above 70% for allocation concealment (70.7%), random sequence generation (72.1%), and blinding of patients/personnel (79.8%), but not for blinding of outcome assessment (62.7%). In conclusion, the likelihood of bias in RCTs has generally decreased over the last decades. This optimistic trend may be driven by increased knowledge augmented by mandatory trial registration and more stringent reporting guidelines and journal requirements. Nevertheless, relatively high probabilities of bias remain, particularly in journals with lower impact factors. This emphasizes that further improvement of RCT registration, conduct, and reporting is still urgently needed.

scholarly journals Effectiveness, quality and process evaluation of interventions to prevent childhood obesity.

2020 ◽  
Vol 79 (OCE2) ◽  
Author(s):  
Miguel Seral-Cortes ◽  
Pilar De Miguel-Etayo ◽  
Paola Zapata ◽  
Luis Moreno-Aznar
Keyword(s):  
Childhood Obesity ◽  
Process Evaluation ◽  
Systematic Reviews ◽  
Random Sequence ◽  
Allocation Concealment ◽  
Risk Of Bias ◽  
Global Public Health ◽  
Program Outcomes ◽  
Sequence Generation ◽  
Random Sequence Generation

AbstractChildhood obesity is one of the most serious global public health challenges of the 21stcentury. Health and scientific organizations demand early interventions, although their complexity generates difficulties in their implementation. In systematic reviews, quality assessments are intended to limit mislead reporting and it is important they are conducted in a manner that minimizes bias. Process evaluation (PE) is used to monitor and document program implementation and can aid in understanding the relationship between specific program elements and program outcomes. Failure to deliver an intervention as intended can lead to unclear conclusions about the effectiveness of the intervention. The aim of the present study is to evaluate the effectiveness of the studies based on the process evaluation and the quality on its interventions. We performed a systematic review of randomized control trials aiming to prevent childhood obesity. The Cochrane Handbook for Systematic Reviews of Interventions tool was used to assess and report methodological risk of bias. Each item was judged as being at high (HR), low (LR) or unclear (UN) risk of bias as per criteria. Key domains random sequence generation and allocation concealment were also assessed. Effectiveness was estimated when the study showed changes in body composition as the main outcome (BMI z-score or waist circumference). Process evaluation was evaluated if at least one process evaluation indicator was identified as being adequately implemented. From the 41 studies, 26 showed any degree of effectiveness and 15 were not effective. Almost half of studies scored high risk of bias: 20/41 (Effective 13/26; non effective 7/15). Moreover, 16/41 studies reported to have unclear risk of bias (effective 10/26; and non-effective 6/15). Only 5/41 articles reported to have low risk (effective 3/26; non effective 2/15). Regarding random sequence generation, there was no difference according to the quality of the studies (effective: LR 25/26, UN 1/26 AND HR 0/26; non effective: LR 15/15, UN 0/15 AND HR 0/15). Concerning the allocation concealment domain, there were no differences found either (effective: LR 11/26, UN 10/26 AND HR 5/26; non effective: LR 7/15, UN 5/15 AND HR 3/15). PE was used in 7 papers (effective 3/7 and non-effective 4/7). Quality seems to have slightly more influence in the non-effective studies (LR 13.3%) than in the effective studies (LR 11.5%). The non-effective studies showed the highest proportion of performing PE. There seems to be a relationship between the quality and PE performance.

Reporting and communication of randomisation procedures is suboptimal in veterinary trials

2017 ◽  
Vol 181 (8) ◽  
pp. 195-195 ◽  
Author(s):  
N. Di Girolamo ◽  
M. A. Giuffrida ◽  
A. L. Winter ◽  
R. Meursinge Reynders
Keyword(s):  
Veterinary Medicine ◽  
Random Sequence ◽  
Research Waste ◽  
Sequence Generation ◽  
Published Evidence ◽  
Random Sequence Generation ◽  
Email Correspondence ◽  
Year 2013

To evaluate randomisation mechanisms in the veterinary literature, all trials defined as ‘randomised’ were extracted from five leading veterinary journals for the year 2013. Three blinded investigators evaluated (1) if the random sequence generation was actually non-random, and (2) whether method (CONSORT item 8A) and (3) type of randomisation (CONSORT item 8B) were reported. Trialists were contacted via email to establish (1) willingness to respond to questions on randomisation procedures, (2) whether reporting of randomisation improved following a suggestion to use the CONSORT 2010 guideline. Seven per cent ((95 per cent CI 2 to 12 per cent); 8/114) of the trials defined as ‘randomised’ explicitly used methods that are considered non-random. Almost half of the trials (49 per cent (40 to 59 per cent); 52/106) did not report any mechanism of randomisation. Only 13 trials (12.3 per cent (6 to 19 per cent); 13/106) reported both items. 39 of 114 (34.2 per cent) trialists contacted were willing to respond to further questions on randomisation mechanisms; 4 (3.5 per cent) trialists were unwilling and 71 (62.3 per cent) trialists did not respond. Email correspondence resulted in a mean clarification of 0.7 items (95 per cent CI 0.4 to 1.0) for the 15 trials for trialists that replied. Improved adherence to CONSORT guidelines and trialists communication is imperative to increase the quality of published evidence in veterinary medicine and to reduce research waste.

scholarly journals Randomized clinical trial quality has improved over time but is still not good enough: an analysis of 176,620 randomized controlled trials published between 1966 and 2018

2020 ◽  
Author(s):  
Christiaan H. Vinkers ◽  
Herm J. Lamberink ◽  
Joeri K. Tijdink ◽  
Pauline Heus ◽  
Lex Bouter ◽  
...  
Keyword(s):  
Random Sequence ◽  
Allocation Concealment ◽  
Risk Of Bias ◽  
Trial Registration ◽  
Controlled Trials ◽  
Sequence Generation ◽  
Randomized Controlled ◽  
Random Sequence Generation ◽  
Over Time ◽  
Number Of Authors

AbstractBackgroundMany randomized controlled trials (RCTs) are biased and difficult to reproduce due to methodological flaws and poor reporting. There is increasing attention for responsible research practices including reporting guidelines, but it is unknown whether these efforts have improved RCT quality (i.e. reduced risk of bias). We therefore mapped trends over time in trial publication, trial registration, reporting according to CONSORT, and characteristics of publication and authors.MethodsMeta-information of 176,620 RCTs published between 1966 and 2018 was extracted. Risk of bias probability (four domains: random sequence generation, allocation concealment, blinding of patients/personnel, and blinding of outcome assessment) was assessed using validated risk-of-bias machine learning tools. In addition, trial registration and reporting according to CONSORT were assessed with automated searches. Characteristics were extracted related to publication (number of authors, journal impact factor, medical discipline) and authors (gender and Hirsch-index).FindingsThe annual number of published RCTs substantially increased over four decades, accompanied by increases in the number of authors (5.2 to 7.8), institutions (2.9 to 4.8), female authors (20 to 42%, first authorship; 17 to 29%, last authorship), and Hirsch-indices (10 to 14, first authorship; 16 to 28, last authorship). Risk of bias remained present in most RCTs but decreased over time for the domains allocation concealment (63 to 51%), random sequence generation (57 to 36%), and blinding of outcome assessment (58 to 52%). Trial registration (37 to 47%) and CONSORT (1 to 20%) rapidly increased in the latest period. In journals with higher impact factor (>10), risk of bias was consistently lower, higher levels of trial registration more frequent, and mentioning CONSORT.InterpretationThe likelihood of bias in RCTs has generally decreased over the last decades. This may be driven by increased knowledge and improved education, augmented by mandatory trial registration, and more stringent reporting guidelines and journal requirements. Nevertheless, relatively high probabilities of bias remain, particularly in journals with lower impact factors. This emphasizes that further improvement of RCT registration, conduct, and reporting is still urgently needed.FundingThis study was funded by The Netherlands Organisation for Health Research and Development (445001002).

scholarly journals Disagreements in risk of bias assessment for randomised controlled trials included in more than one Cochrane systematic reviews: a research on research study using cross-sectional design

BMJ Open ◽  
2019 ◽  
Vol 9 (4) ◽  
pp. e028382 ◽  
Author(s):  
Lorenzo Bertizzolo ◽  
Patrick Bossuyt ◽  
Ignacio Atal ◽  
Philippe Ravaud ◽  
Agnes Dechartres
Keyword(s):  
Random Sequence ◽  
Cochrane Review ◽  
Risk Of Bias ◽  
Cross Sectional ◽  
Bias Assessment ◽  
Research On Research ◽  
Sequence Generation ◽  
Study Report ◽  
Random Sequence Generation ◽  
Randomised Controlled

ObjectivesAssess the frequency and reasons for disagreements in risk of bias assessments for randomised controlled trials (RCTs) included in more than one Cochrane review.DesignResearch on research study, using cross-sectional design.Data sources2796 Cochrane reviews published between March 2011 and September 2014.Data selectionRCTs included in more than one review.Data extractionRisk of bias assessment and support for judgement for five key risk of bias items.Data synthesisFor each item, we compared risk of bias assessment made in each review and calculated proportion of agreement. Two reviewers independently analysed 50% of all disagreements by comparing support for each judgement with information from study report to evaluate whether disagreements were related to a difference in information (eg, contact the study author) or a difference in interpretation (same support for judgement but different interpretation). They also identified main reasons for different interpretation.Results1604 RCTs were included in more than one review. Proportion of agreement ranged from 57% (770/1348 trials) for incomplete outcome data to 81% for random sequence generation (1193/1466). Most common source of disagreement was difference in interpretation of the same information, ranging from 65% (88/136) for random sequence generation to 90% (56/62) for blinding of participants and personnel. Access to different information explained 32/136 (24%) disagreements for random sequence generation and 38/205 (19%) for allocation concealment. Disagreements related to difference in interpretation were frequently related to incomplete or unclear reporting in the study report (83% of disagreements related to different interpretation for random sequence generation).ConclusionsRisk of bias judgements of RCTs included in more than one Cochrane review differed substantially. Most disagreements were related to a difference in interpretation of an incomplete or unclear description in the study report. A clearer guidance on common causes of incomplete information may improve agreement.

ON A CERTAIN MODEL OF CRYPTOGRAPHIC KEY MANAGEMENT

2020 ◽  
Vol 8 (4) ◽  
pp. 15-22
Author(s):  
S.E. Nyssanbayeva ◽  
◽  
N.A. Kapalova ◽  
A. Haumen
Keyword(s):  
Key Management ◽  
Random Sequence ◽  
Management Model ◽  
Generation Algorithm ◽  
Sequence Generation ◽  
Secure Storage ◽  
The World ◽  
Random Sequence Generation ◽  
Cryptographic Key

Cryptographic technologies that have become widespread in the world are inex- tricably linked to the issues of secure storage, use of keys, and key exchange. Often, insecure key management reduces the quality of even exceptionally good systems, since the security of the algorithm is concentrated mainly in the key. This paper proposes a key management model in cryptographic systems. The model is based on creating a unified key database for all users. This database is filled with keys of a certain length, which are generated using a pseudo-random sequence generation algorithm.

Applied Status and Quality of Graphs in Five Academic Medical Journals in Shanghai (Preprint)

2018 ◽  
Author(s):  
Zisheng Ai ◽  
Yuhong Tang ◽  
Jiaqi Zheng ◽  
Sanyou Wu ◽  
Ying Wu
Keyword(s):  
Evaluation Criteria ◽  
Cross Sectional Study ◽  
Cross Sectional ◽  
Medical Journals ◽  
Graph Type ◽  
Academic Medical ◽  
Substantial Problem ◽  
Error Bias ◽  
Important Form

BACKGROUND Figures are an important form of expressing results commonly found in medical papers and make data easy to read and compare. The quality of graphs in original papers has improved in western medical journals. However, some figures fail to correctly express the results of a paper. Additionally, graph quality and application has not been assessed in medical journals outside western countries. OBJECTIVE To determine the frequency and types of data graphs used in Chinese academic medical journals and evaluate the quality of graphs used in original medical papers. METHODS A total of 783 papers were surveyed from the medical journals of five colleges and universities in Shanghai from 2011 to 2015. A cross-sectional study was used to analyse the applied status and graph quality. The evaluation criteria of graphs mainly included graph type, visual clarity, completeness, and special standards. RESULTS Most authors prefer to use simple charts, and bar charts with 95% CI were the most widely used. More than 60% of charts have problems with visual clarity, completeness, and special standards. Of 841 incorrect graphs, 10 (0.58%) graphs had three combined problems of graph characteristics, and 292 (34.72%) graphs had any two combined problems of graph characteristics. For detailed errors, the absence of variance description was the most substantial problem, especially in 2014 and in some academic medical journals. CONCLUSIONS Graphs are less commonly applied in the five university journals. However, the quality of papers using graphs was not properly controlled. Editors and journal quality management should strengthen the quality control of charts in papers. Authors should also avoid error bias and distorting their conclusions.

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