scholarly journals Publication bias in pediatric emergence delirium: a cross-sectional analysis of ClinicalTrials.gov and ClinicalTrialsRegister.eu

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e037346
Author(s):  
Jochen Meyburg ◽  
Markus Ries

ObjectivesEmergence delirium (ED) is a frequent and potentially serious complication of general anaesthesia in children. Although there are various treatment strategies, no general management recommendations can be made. Selective reporting of study results may impair clinical decision-making. We, therefore, analysed whether the results of completed registered clinical studies in patients with paediatric ED are publicly available or remain unpublished.DesignCross-sectional analysis.SettingClinicalTrials.gov and ClinicalTrialsRegister.eu.Participants and outcome measuresWe determined the proportion of published and unpublished studies registered at ClinicalTrials.gov and ClinicalTrialsRegister.eu that were marked as completed by 1st September 2018. The major trial and literature databases were used to search for publications. In addition, the study investigators were contacted directly. For published trials, time to publication was calculated as the difference in months between study completion date and publication date.ResultsOf the 44 registered studies on paediatric ED, only 24 (54%) were published by September 2019. Published trials contained data from n=2556 patients, whereas n=1644 patients were enrolled in unpublished trials. Median time to publication was 19 months. Studies completed in recent years were published faster, but still only 9 of 24 trials were published within 12 months of completion.ConclusionThere is a distinct publication gap in clinical research in paediatric ED that may have an impact on meta-analyses and clinical practice.

2020 ◽  
Author(s):  
Jochen Meyburg ◽  
Markus Ries

AbstractObjectivesEmergence delirium (ED) is a frequent and potentially serious complication of general anesthesia in children. Although there are various treatment strategies, no general management recommendations can be made. Selective reporting of study results may impair clinical decision making. We therefore analyzed whether the results of completed registered clinical studies in patients with pediatric ED are publically available or remain unpublished.DesignCross sectional analysis.SettingClinicalTrials.gov and ClinicalTrialsRegister.euParticipants and outcome measuresWe determined the proportion of published and unpublished studies registered at ClinicalTrials.gov and ClinicalTrialsRegister.eu that were marked as completed by September 1st 2018. The major trial and literature databases were used to search for publications. In addition, the study investigators were contacted directly.ResultsOf the 44 registered studies on pediatric ED, only 24 (54%) have been published by September 2019. Published trials contained data from n=2556 patients, whereas n=1644 patients were enrolled in unpublished trials. Median time to publication was 19 months. Studies completed in recent years were published faster, but still only 9 of 25 trials were published within 12 months after completion.ConclusionThere is a distinct publication gap in clinical research in pediatric ED that may have an impact on meta-analyses and clinical practice.Strengths and limitations of this studyThis study quantitates the amount of research waste in pediatric emergence delirium assessed as a) the number and b) sample sizes of published and unpublished completed clinical studiesThe precise reasons for non-publication of the studies included in this analysis remain unknownStrengths of findings as well as directions of individual unpublished studies remain unknownStudy registers other than ClinicalTrials.gov and ClinicalTrialsRegister.eu were not analyzedFunding statementThis research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors.


Sexual Health ◽  
2021 ◽  
Vol 18 (1) ◽  
pp. 95
Author(s):  
Cara O'Connor ◽  
Katerina Leyritana ◽  
Kris Calica ◽  
Randeep Gill ◽  
Aoife M. Doyle ◽  
...  

Background The Philippines HIV epidemic is one of the fastest growing, globally. Infections among men who have sex with men (MSM) are rising at an alarming rate, necessitating targeted evidence-based interventions to reach epidemic control. Treatment as prevention is a key strategy to end AIDS, making it a priority to explore novel approaches to retain people living with HIV (PLHIV) in care, support adherence, and reach viral suppression. Methods: This cross-sectional analysis describes HIV-related risk behaviours and adherence to antiretroviral therapy (ART) in a population of HIV-positive patients at a clinic in Metro Manila, Philippines participating in the Philippines Connect for LifeTM cohort study. Results: Among 426 HIV-positive adults taking ART, 79% reported ≥95% adherence over the prior 30 days. Longer time on treatment was associated with reduced adherence to ART (adjusted odds ratio (AOR) = 0.87 per year, P = 0.027). Being in a serodiscordant relationship, in which the subject’s primary partner was HIV negative, increased adherence (AOR = 3.19, P = 0.006). Inconsistent condom use (AOR = 0.50, P = 0.103) and injection drug use (AOR = 0.54, P = 0.090) are potentially associated with reduced adherence to ART. Patients used drugs and alcohol at significantly higher rates than the general population.? Conclusions: The study found that patients in this setting require intervention to address treatment fatigue. Interventions to improve social support of PLHIV, as well as harm-reduction approaches for drug and alcohol use, could improve adherence in this population, strengthening the test-and-treat strategy to control the epidemic.


BMJ Open ◽  
2018 ◽  
Vol 8 (7) ◽  
pp. e021684 ◽  
Author(s):  
Thomas Breil ◽  
Michael Boettcher ◽  
Georg F Hoffmann ◽  
Markus Ries

ObjectiveAppendicitis is considered the most frequent surgical emergency in children. While the management of paediatric appendicitis is evolving, the precise amount of unpublished completed trials, potentially introducing bias into meta-analyses, is unknown. Controversial issues include the appropriate choice of surgical procedures, criteria for diagnosis of appendicitis, the role of antibiotic treatment and pain management. Selective reporting may introduce bias into evidence-based clinical decision-making, and the current, precise extent of unpublished results in paediatric appendicitis is unknown. We therefore assessed the publication status of completed clinical studies involving children registered on ClinicalTrials.gov.DesignCross sectional analysis. STrengthening the Reporting of OBservational studies in Epidemiology criteria were applied for design and analysis.Setting and participantsClinicalTrials.gov was queried for completed studies which were matched to publications on ClinicalTrials.gov, PubMed or Google Scholar. If no publication could be identified, principal investigators were contacted.Interventions/exposureObservational analysis.Primary and secondary outcome measuresThe proportion of published and unpublished studies was calculated. Subgroup analysis included studies on surgical procedures, diagnosis, antibiotic treatment and pain management.ResultsOut of n=52 completed clinical studies involving children with appendicitis, n=33 (63%) were published and n=19 (37%) were unpublished. Eighty-three per cent (n=43/52) of clinical trials assessed the above-listed controversial issues. Diagnostic studies were most rigorously published (91% of trials reported), data on surgical procedures, antibiotic and pain management were less transparent. Sixty-six per cent of interventional studies and 60% of randomised studies were published. Median time-to-publication, for example, the delay between completion of the trial until public availability of the results was 24 (IQR 12–36), range 2–92 months.ConclusionDespite the importance of appendicitis in clinical practice for the paediatric surgeon, there remains scientific uncertainty due to unpublished clinical trial results with room for improvement in the future. These data are helpful in framing the shifting paradigms in paediatric appendicitis because it adds transparency to the debate.


2016 ◽  
Vol 10 (2) ◽  
pp. 253-260 ◽  
Author(s):  
Mark X. Cicero ◽  
Frank Overly ◽  
Linda Brown ◽  
Jorge Yarzebski ◽  
Barbara Walsh ◽  
...  

AbstractBackgroundIt is unclear which pediatric disaster triage (PDT) strategy yields the best accuracy or best patient outcomes.MethodsWe conducted a cross-sectional analysis on a sample of emergency medical services providers from a prospective cohort study comparing the accuracy and triage outcomes for 2 PDT strategies (Smart and JumpSTART) and clinical decision-making (CDM) with no algorithm. Participants were divided into cohorts by triage strategy. We presented 10-victim, multi-modal disaster simulations. A Delphi method determined patients’ expected triage levels. We compared triage accuracy overall and for each triage level (RED/Immediate, YELLOW/Delayed, GREEN/Ambulatory, BLACK/Deceased).ResultsThere were 273 participants (71 JumpSTART, 122 Smart, and 81 CDM). There was no significant difference between Smart triage and CDM. When JumpSTART triage was used, there was greater accuracy than with either Smart (P<0.001; OR [odds ratio]: 2.03; interquartile range [IQR]: 1.30, 3.17) or CDM (P=0.02; OR: 1.76; IQR: 1.10, 2.82). JumpSTART outperformed Smart for RED patients (P=0.05; OR: 1.48; IQR: 1.01,2.17), and outperformed both Smart (P<0.001; OR: 3.22; IQR: 1.78,5.88) and CDM (P<0.001; OR: 2.86; IQR: 1.53,5.26) for YELLOW patients. Furthermore, JumpSTART outperformed CDM for BLACK patients (P=0.01; OR: 5.55; IQR: 1.47, 20.0).ConclusionOur simulation-based comparison suggested that JumpSTART triage outperforms both Smart and CDM. JumpSTART outperformed Smart for RED patients and CDM for BLACK patients. For YELLOW patients, JumpSTART yielded more accurate triage results than did Smart triage or CDM. (Disaster Med Public Health Preparedness. 2016;10:253–260)


Author(s):  
Rishad Khan ◽  
Juana Li ◽  
Michael A Scaffidi ◽  
Nikko Gimpaya ◽  
Bianca Pivetta ◽  
...  

Abstract Background Financial conflicts of interest (FCOIs) are widespread in inflammatory bowel disease (IBD) and may be particularly important in point-of-care (POC) resources, such as UpToDate, that are used to aid clinical decision making. In this study, we determined the prevalence of industry payments from companies making biologic medications for IBD to contributors of UpToDate articles on IBD. Methods This cross-sectional analysis included UpToDate articles that mention the use of biologic medications for IBD. We collected the names of the contributors (authors and editors) and their disclosures on UpToDate. We then searched for their names on the Center for Medicare and Medicaid Open Payments database and compared the payment information from 2013 to 2018 with UpToDate's disclosures. We presented data per episode, which describes one instance of participation by one person in one article, regardless of whether that person contributed to multiple articles. Results We identified 23 articles on the treatment of Crohn's disease and ulcerative colitis that mentioned the use of biologic medications, with 86 total episodes. Sixty-two (72%) episodes involved FCOIs. The median payment associated with each episode was $$55 (interquartile range = $44 to $145,241). Contributors did not fully disclose FCOIs in 41 (48%) episodes. Deputy editors, who are required to be free of FCOIs, in general did not have substantial episodes involving FCOI. Conclusions We found that UpToDate articles on inflammatory bowel disease involve substantial FCOI, many of which are not disclosed. The presence of these FCOIs may hamper trust in the objectivity of treatment recommendations.


2012 ◽  
Vol 58 (4) ◽  
pp. 472-476 ◽  
Author(s):  
Caroline Filla Rosaneli ◽  
Flavia Auler ◽  
Carla Barreto Manfrinato ◽  
Claudine Filla Rosaneli ◽  
Caroline Sganzerla ◽  
...  

2017 ◽  
Vol 48 (S 01) ◽  
pp. S1-S45
Author(s):  
M. Zielonka ◽  
S. Garbade ◽  
S. Kölker ◽  
G. Hoffmann ◽  
M. Ries

2019 ◽  
Author(s):  
Patricia Clark ◽  
Annarella Barbato ◽  
Miguel Angel Guagnelli ◽  
Jose Alberto Rascon ◽  
Edgar Denova ◽  
...  

Diabetes ◽  
2020 ◽  
Vol 69 (Supplement 1) ◽  
pp. 2174-PUB
Author(s):  
NARAYANAN NK ◽  
CS DWARAKANATH ◽  
VENKATARAMAN S ◽  
MANIKANDAN RM ◽  
NARENDRA BS ◽  
...  

Author(s):  
B. Domengès ◽  
P. Poirier

Abstract In this study, the resistance of FIB prepared vias was characterized by the Kelvin probe technique and their physical characteristics studied using cross-sectional analysis. Two domains of resistivity were isolated in relation to the ion beam current used for the deposition of the via metal (Pt). Also submicrometer vias were investigated on 4.2 µm deep metal lines of a BiCMOS aluminum based design and a CMOS 090 copper based one. It is shown that the controlling parameter is the shape and volume of the contact, and that the contact formation is favored by the amount of over-mill of the via into the metal line it will contact.


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