Evaluating Reproducibility and Transparency in Emergency Medicine Publications (Preprint)

2019 ◽  
Author(s):  
Bradley Johnson ◽  
Shelby Rauh ◽  
Daniel Tritz ◽  
Michael Schiesel ◽  
Ben Matthew Vassar
Keyword(s):  
Emergency Medicine ◽  
Data Analysis ◽  
English Language ◽  
Data Extraction ◽  
Inclusion Criteria ◽  
Raw Data ◽  
Medicine Research ◽  
Funding Agencies ◽  
Pubmed Search ◽  
Peer Reviewers

BACKGROUND Reproducibility is the backbone to ensuring reliable and transparent research. However, evidence reveals reproducibility may be lacking within emergency medicine. Reproducibility is defined by the replication of a study design and obtaining similar findings. Studies that share research components such as raw data, protocols, and analysis scripts increase the overall reproducibility by aiding study replication. Due to the evidence reproducibility in emergency medicine research may be lacking, investigation of the sharing of these research components is warranted. OBJECTIVE We aimed to assess the reproducibility of empirical research by determining the availability of components required for replication of a study, including materials, raw data, analysis scripts, protocols, and preregistration. METHODS The National Library of Medicine catalog was used to identify English language and MEDLINE-indexed emergency medicine journals. From 30 journals that met the inclusion criteria, 300 publications from January 1, 2014, to December 31, 2018, were randomly sampled using a refined PubMed search. Two investigators were trained for data extraction and analysis and were blinded for independent extraction of data. Extracted data included statements regarding the availability of materials, data, analysis scripts, protocols, and registration. RESULTS After search criteria were set, 25,473 articles were found, from which we randomly selected a sample of 300. Of the 300 articles, only 290 articles were accessible, and of these, 178 articles contained empirical data to analyze. Of the empirical articles eligible for each type of statement, 3.94% (95% confidence interval [95% CI] 1.74% to 6.14%) provided a materials statement, 9.42% (95% CI 6.11% to 12.73%) provided a data statement, 0.72% (95% CI 0% to 1.68%) provided access to the analysis scripts, 2.17% (95% CI 0.52% to 3.82%) linked the protocol, and 7.25% (95% CI 4.31% to 10.18%) were preregistered. CONCLUSIONS Emergency medicine studies are lacking indicators required for reproducibility. The vast majority of studies fail to report factors needed to reproduce research to ensure credibility, which requires an intervention that can be achieved through the collaboration of researchers, peer reviewers, funding agencies, and journals.

scholarly journals Evaluating Reproducibility and Transparency in Emergency Medicine Publications

2021 ◽  
Vol 22 (4) ◽  
pp. 963-971
Author(s):  
Bradley Johnson ◽  
Shelby Rauh ◽  
Daniel Tritz ◽  
Michael Schiesel ◽  
Matt Vassar
Keyword(s):  
Emergency Medicine ◽  
Data Analysis ◽  
Confidence Interval ◽  
General Medicine ◽  
High Impact ◽  
Inclusion Criteria ◽  
National Library ◽  
Funding Agencies ◽  
Pubmed Search ◽  
Peer Reviewers

Introduction: We aimed to assess the reproducibility of empirical research by determining the availability of components required for replication of a study, including materials, raw data, analysis scripts, protocols, and preregistration. Methods: We used the National Library of Medicine catalog to identify MEDLINE-indexed emergency medicine (EM) journals. Thirty journals met the inclusion criteria. From January 1, 2014– December 31, 2018, 300 publications were randomly sampled using a PubMed search. Additionally, we included four high-impact general medicine journals, which added 106 publications. Two investigators were blinded for independent extraction. Extracted data included statements regarding the availability of materials, data, analysis scripts, protocols, and registration. Results: After the search, we found 25,473 articles, from which we randomly selected 300. Of the 300, only 287 articles met the inclusion criteria. Additionally, we added 106 publications from high- impact journals of which 77 met the inclusion criteria. Together, 364 publications were included, of which 212 articles contained empirical data to analyze. Of the eligible empirical articles, 2.49%, (95% confidence interval [CI], 0.33% to 4.64%] provided a material statement, 9.91% (95% CI, 5.88% to 13.93%) provided a data statement, 0 provided access to analysis scripts, 25.94% (95% CI, 20.04% to 31.84%) linked the protocol, and 39.15% (95% CI, 32.58% to 45.72%) were preregistered. Conclusion: Studies in EM lack indicators required for reproducibility. The majority of studies fail to report factors needed to reproduce research to ensure credibility. Thus, an intervention is required and can be achieved through the collaboration of researchers, peer reviewers, funding agencies, and journals.

scholarly journals Can Orthopaedics become the Gold Standard for Reproducibility? A Roadmap to Success

2019 ◽  
Author(s):  
Ian A. Fladie ◽  
Sheridan Evans ◽  
Jake Checketts ◽  
Daniel Tritz ◽  
Brent Norris ◽  
...  
Keyword(s):  
Empirical Data ◽  
Orthopaedic Surgery ◽  
English Language ◽  
Data Extraction ◽  
Data Availability ◽  
Data Sets ◽  
Level Of Evidence ◽  
Pubmed Search ◽  
Peer Reviewers ◽  
Research Findings

AbstractBackgroundScientific research is replete with poor accessibility to data, materials, and protocol, which limits the reproducibility of a study. Transparency with regard to materials, protocols, and raw data sets enhances reproducibility by providing the critical information necessary to verify, replicate, and resynthesize research findings. The extent to which transparency and reproducibility exist in the field of orthopaedics is unclear. In our study, we aimed to evaluate transparency and reproducibility-related characteristics of randomly sampled publications in orthopaedic journals.MethodsWe used the National Library of Medicine catalog to identify English language and MEDLINE-indexed orthopaedic journals. From the 74 journals meeting our inclusion criteria, we randomly sampled 300 publications using a refined PubMed search that were published between January 1, 2014, and December 31, 2018. Two investigators were trained for data extraction and analysis. Both investigators were blinded and independently extracted data from the 300 studies.ResultsOur initial search yielded 68,102 publications, from which we drew a random sample of 300 publications. Of these 300 publications, 286 were screened for empirical data and 14 were inaccessible. For analysis purposes, we excluded publications without empirical data. Of the 182 with empirical data, 13 studies (7.1%) included a data availability statement, 9 (4.9%) reported materials were available, none (0.0%) provided analysis scripts, 2 (1.1%) provided access to the protocol used, 5 (2.7%) were preregistered, and only 2 (1.1%) provided a statement about being a replicated study.ConclusionsComponents necessary for reproducibility are lacking in orthopaedic surgery journals. The vast majority of publications did not provide data or material availability statements, protocols, or analysis scripts, and had no preregistration statements. Intervention is needed to improve reproducibility in the field of orthopaedics. The current state of reproducibility in orthopaedic surgery could be improved by combined efforts from funding agencies, authors, peer reviewers, and journals alike.Level of EvidenceN/A

scholarly journals SARS-CoV-2-associated gastrointestinal and liver diseases: what is known and what is needed to explore

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Dina Sweed ◽  
Eman Abdelsameea ◽  
Esraa A. Khalifa ◽  
Heba Abdallah ◽  
Heba Moaz ◽  
...  
Keyword(s):  
English Language ◽  
Data Extraction ◽  
Oral Route ◽  
Main Body ◽  
Disease Manifestation ◽  
Gi Symptoms ◽  
Septic Focus ◽  
Pubmed Search ◽  
Risk Patients ◽  
Respiratory Droplets

Abstract Background The pandemic of COVID19 which is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was first described in China as an unexplained pneumonia transmitted by respiratory droplets. Gastrointestinal (GI) and liver injury associated with SARS-CoV-2 infection were reported as an early or sole disease manifestation, mainly outside China. The exact mechanism and incidence of GI and liver involvement are not well elucidated. Main body We conducted a PubMed search for all articles written in the English language about SARS-CoV-2 affecting the GI and liver. Following data extraction, 590 articles were selected. In addition to respiratory droplets, SARS-CoV-2 may reach the GI system through the fecal-oral route, saliva, and swallowing of nasopharyngeal fluids, while breastmilk and blood transmission were not implicated. Moreover, GI infection may act as a septic focus for viral persistence and transmission to the liver, appendix, and brain. In addition to the direct viral cytopathic effect, the mechanism of injury is multifactorial and is related to genetic and demographic variations. The most frequently reported GI symptoms are diarrhea, nausea, vomiting, abdominal pain, and bleeding. However, liver infection is generally discovered during laboratory testing or a post-mortem. Radiological imaging is the gold standard in diagnosing COVID-19 patients and contributes to understanding the mechanism of extra-thoracic involvement. Medications should be prescribed with caution, especially in chronic GI and liver patients. Conclusion GI manifestations are common in COVID-19 patients. Special care should be paid for high-risk patients, older males, and those with background liver disease.

Brexanolone: A Novel Drug for the Treatment of Postpartum Depression

2020 ◽  
pp. 089719002097962
Author(s):  
Edna Patatanian ◽  
David R. Nguyen
Keyword(s):  
Adverse Effects ◽  
Postpartum Depression ◽  
English Language ◽  
Neuronal Excitability ◽  
Data Extraction ◽  
Background Information ◽  
Pharmacologic Therapy ◽  
Loss Of Consciousness ◽  
Efficacy And Safety ◽  
Pubmed Search

Objectives: To review the pharmacology, efficacy, and safety of Brexanolone and define its role in the treatment of postpartum depression. Date Sources: A MEDLINE/PubMed search was conducted (1980-May 2020) using the following keywords: postpartum depression, antidepressants, pharmacologic therapy, drug therapy, and brexanolone to identify relevant articles. Study Selection/Data Extraction: Literature search was limited to human studies published in the English language. Phase I, II, and III studies evaluating the pharmacology, efficacy, safety of brexanolone for postpartum depression were included. Bibliographies of relevant articles evaluating postpartum depression and treatment were reviewed for additional citations and background information. Data Synthesis: Brexanolone is a soluble, proprietary, injectable formulation of allopregnanolone, a neuroactive steroid that modulates neuronal excitability. Allopregnanolone levels increase during pregnancy and decrease substantially after birth. These fluctuations have profound effects on anxiety and depression. Three clinical trials established the efficacy and safety of brexanolone in the treatment of postpartum depression. In all 3 trials, brexanolone had an acceptable safety profile and was well tolerated. The most common adverse effects were loss of consciousness, sedation, dry mouth, headache, dizziness, and flushing. Due to sudden loss of consciousness and excessive sedation, continuous pulse oximetry is recommended. Conclusion: Brexanolone has a novel mechanism of action and appears to be safe and effective for the treatment of moderate to severe postpartum depression. At present, high cost, serious adverse effects, and restricted access may limit its use in clinical practice.

Lead in Mineral or Multivitamin-Multimineral Products

2021 ◽  
pp. 106002802110233
Author(s):  
C. Michael White
Keyword(s):  
English Language ◽  
Data Extraction ◽  
The United States ◽  
Third Party ◽  
Reference Level ◽  
Study Selection ◽  
Pubmed Search ◽  
Zinc Supplements ◽  
Average Lead ◽  
Year 2000

Objective Assess the current daily interim reference level of lead and the amount contained in current mineral and multivitamin-multimineral (MVM) products. Data Sources PubMed search from 1980 to May 15, 2021, limited to the English language, via the search strategy ((mineral OR multivitamin OR calcium OR iron OR magnesium OR copper OR zinc OR chromium OR selenium) AND (heavy metals OR Pb OR lead)). Study Selection and Data Extraction Narrative review of studies assessing lead content in mineral or MVM products. Data Synthesis Products containing different calcium forms (dolomite, bone meal, natural carbonate) have historically had higher lead levels than others (refined carbonate, lactate, gluconate, acetate, sevelamer), but the gap has closed considerably since the year 2000. Although only limited assessments of magnesium and zinc supplements have been conducted, no alarming average lead amounts were found. MVM products assessed since 2007 had low median or mean lead concentrations. However, large interproduct differences exist, with many products having very little lead and some products having concerning amounts. Relevance to Patient Care and Clinical Practice It is difficult for pharmacists and consumers to know the amount of lead in an actual product unless it is tested in an independent third-party lab. The United States Pharmacopeia and NSF International will provide a seal on the products stating that the products have a low level of lead, but even so, children could receive more lead than the Food and Drug Administration’s Interim Reference Level. Conclusions The threat from lead exposure in mineral and MVM products have diminsihed considerably over time but some products can still have excessive amounts. Without third-party testing, it is difficult for clinicians and consumers to know which outlier products to avoid.

scholarly journals Promoting Diet and Physical Activity in Nurses

2016 ◽  
Vol 31 (1) ◽  
pp. 19-27 ◽  
Author(s):  
Luciana Torquati ◽  
Toby Pavey ◽  
Tracy Kolbe-Alexander ◽  
Michael Leveritt
Keyword(s):  
Physical Activity ◽  
English Language ◽  
Data Extraction ◽  
Student Nurses ◽  
Inclusion Criteria ◽  
Exclusion Criteria ◽  
Data Synthesis ◽  
Diet And Physical Activity ◽  
Data Source

Objective. To systematically review the effectiveness of intervention studies promoting diet and physical activity (PA) in nurses. Data Source. English language manuscripts published between 1970 and 2014 in PubMed, Scopus, CINAHL, and EMBASE, as well as those accessed with the PICO tool, were reviewed. Study Inclusion and Exclusion Criteria. Inclusion criteria comprised (1) nurses/student nurses working in a health care setting and (2) interventions where PA and/or diet behaviors were the primary outcome. Exclusion criteria were (1) non–peer-reviewed articles or conference abstracts and (2) interventions focused on treatment of chronic conditions or lifestyle factors other than PA or diet in nurses. Data Extraction. Seventy-one full texts were retrieved and assessed for inclusion by two reviewers. Data were extracted by one reviewer and checked for accuracy by a second reviewer. Data Synthesis. Extracted data were synthesized in a tabular format and narrative summary. Results. Nine (n = 737 nurses) studies met the inclusion criteria. Quality of the studies was low to moderate. Four studies reported an increase in self-reported PA through structured exercise and goal setting. Dietary outcomes were generally positive, but were only measured in three studies with some limitations in the assessment methods. Two studies reported improved body composition without significant changes in diet or PA. Conclusions. Outcomes of interventions to change nurses’ PA and diet behavior are promising, but inconsistent. Additional and higher quality interventions that include objective and validated outcome measures and appropriate process evaluation are required.

scholarly journals Reproducible and Transparent Research Practices in Published Neurology Research

2019 ◽  
Author(s):  
Shelby Rauh ◽  
Trevor Torgerson ◽  
Austin L. Johnson ◽  
Jonathan Pollard ◽  
Daniel Tritz ◽  
...  
Keyword(s):  
Systematic Review ◽  
Conflict Of Interest ◽  
Data Extraction ◽  
Meta Analysis ◽  
Research Practices ◽  
Raw Data ◽  
Replication Studies ◽  
Study Materials ◽  
Funding Sources ◽  
Pubmed Search

AbstractBackgroundThe objective of this study was to evaluate the nature and extent of reproducible and transparent research practices in neurology research.MethodsThe NLM catalog was used to identify MEDLINE-indexed neurology journals. A PubMed search of these journals was conducted to retrieve publications over a 5-year period from 2014 to 2018. A random sample of publications was extracted. Two authors conducted data extraction in a blinded, duplicate fashion using a pilot-tested Google form. This form prompted data extractors to determine whether publications provided access to items such as study materials, raw data, analysis scripts, and protocols. In addition, we determined if the publication was included in a replication study or systematic review, was preregistered, had a conflict of interest declaration, specified funding sources, and was open access.ResultsOur search identified 223,932 publications meeting the inclusion criteria, from which 300 were randomly sampled. Only 290 articles were accessible, yielding 202 publications with empirical data for analysis. Our results indicate that 8.99% provided access to materials, 9.41% provided access to raw data, 0.50% provided access to the analysis scripts, 0.99% linked the protocol, and 3.47% were preregistered. A third of sampled publications lacked funding or conflict of interest statements. No publications from our sample were included in replication studies, but a fifth were cited in a systematic review or meta-analysis.ConclusionsCurrent research in the field of neurology does not consistently provide information needed for reproducibility. The implications of poor research reporting can both affect patient care and increase research waste. Collaborative intervention by authors, peer reviewers, journals, and funding sources is needed to mitigate this problem.

Esketamine: A Novel Option for Treatment-Resistant Depression

2019 ◽  
Vol 54 (6) ◽  
pp. 567-576 ◽  
Author(s):  
Kevin M. Bozymski ◽  
Ericka L. Crouse ◽  
Erika N. Titus-Lay ◽  
Carol A. Ott ◽  
Jill L. Nofziger ◽  
...  
Keyword(s):  
English Language ◽  
Rating Scale ◽  
Data Extraction ◽  
Fixed Dose ◽  
Depression Symptoms ◽  
Treatment Resistant Depression ◽  
Treatment Resistant ◽  
Pubmed Search ◽  
Resistant Depression ◽  
Suicidal Thoughts And Behaviors

Objective:To review the pharmacology, pharmacokinetics, efficacy, safety, use requirements, and place in therapy of esketamine for treatment-resistant depression (TRD). Data Sources: A comprehensive PubMed search (1966 to October 2019) was conducted using the search terms depression, treatment-resistant, suicide, intranasal, esketamine, and JNJ-54135419. Additional data were obtained from references of identified articles, governmental sources, manufacturer product labeling, and Clinicaltrials.gov . Study Selection and Data Extraction: All English-language trials evaluating intranasal esketamine for TRD were included and discussed. Data Synthesis: Intranasal esketamine was approved by the US Food and Drug Administration, in conjunction with an oral antidepressant, for treating TRD in adults. Two short-term trials (TRANSFORM-1 and -2) found statistically significant reduction in the Montgomery-Asberg Depression Rating Scale score at day 28 for the fixed 56-mg dose (−4.1; 95% CI = −7.69 to −0.49; P = 0.027 [exploratory]) and flexible-dosed arms (−4.0; 95% CI = −7.31 to −0.64; P = 0.02), though the fixed-dose 84-mg arm (−3.2; 95% CI = −6.88 to 0.45; P = 0.088) of TRANSFORM-1 and TRANSFORM-3 did not (−3.6; 95% CI = −7.2 to 0.07; P = 0.059). Two long-term trials (SUSTAIN-1 and -2) suggested maintenance of response with continued use. Esketamine’s adverse effects include dizziness, dysgeusia, somnolence, dissociation, suicidal thoughts and behaviors, and increased heart rate and blood pressure. Relevance to Patient Care and Clinical Practice: Although providing a novel antidepressant mechanism and formulation for TRD, esketamine’s role in treatment will likely be limited by cost, administration, and diversion concerns. Conclusion: Intranasal esketamine significantly reduced depression symptoms in TRD, though with tolerability issues.

scholarly journals The Progression of Hemophilic Arthropathy: The Role of Biomarkers

2020 ◽  
Vol 21 (19) ◽  
pp. 7292
Author(s):  
Gianluigi Pasta ◽  
Salvatore Annunziata ◽  
Alberto Polizzi ◽  
Laura Caliogna ◽  
Eugenio Jannelli ◽  
...  
Keyword(s):  
Clinical Practice ◽  
English Language ◽  
Hemophilia A ◽  
Data Extraction ◽  
A Priori ◽  
Inclusion Criteria ◽  
Hemophilic Arthropathy ◽  
Study Selection ◽  
Potential Use

Background: Hemophilia A and B are X-linked congenital bleeding disorders characterized by recurrent hemarthroses leading to specific changes in the synovium and cartilage, which finally result in the destruction of the joint: this process is called hemophilic arthropathy (HA). This review highlights the most prominent molecular biomarkers found in the literature to discuss their potential use in the clinical practice to monitor bleeding, to assess the progression of the HA and the effectiveness of treatments. Methods: A review of the literature was performed on PubMed and Embase, from 3 to 7 August 2020. Study selection and data extraction were achieved independently by two authors and the following inclusion criteria were determined a priori: English language, available full text and articles published in peer-reviewed journal. In addition, further articles were identified by checking the bibliography of relevant articles and searching for the studies cited in all the articles examined. Results: Eligible studies obtained at the end of the search and screen process were seventy-three (73). Conclusions: Despite the surge of interest in the clinical use of biomarkers, current literature underlines the lack of their standardization and their potential use in the clinical practice preserving the role of physical examination and imaging in early diagnosis.

scholarly journals Utility of Percutaneous Ultrasonic Tenotomy for Tendinopathies: A Systematic Review

2020 ◽  
pp. 194173812095176
Author(s):  
Sravya Vajapey ◽  
Sennay Ghenbot ◽  
Michael R. Baria ◽  
Robert A. Magnussen ◽  
W. Kelton Vasileff
Keyword(s):  
Plantar Fasciitis ◽  
English Language ◽  
Data Extraction ◽  
Achilles Tendinopathy ◽  
Treatment Technique ◽  
Inclusion Criteria ◽  
Invasive Treatment ◽  
Level Of Evidence ◽  
Modest Improvement ◽  
Patient Reported

Context: Chronic tendinopathy is a challenging problem that can lead to significant disability and limitation in not only athletics but also activities of daily living. While there are many treatment techniques described for this overuse injury, no single modality has been proven superior to all others. With recent advances in medical technology, percutaneous ultrasonic tenotomy (PUT) for tendinosis has gained traction with promising results. Objective: To examine the data published on PUT for treatment of tendinopathy, analyze the outcomes of the procedure, including duration of pain relief and patient-reported outcomes, and assess the rate of complications associated with the procedure. Data Sources: PubMed, MEDLINE, EMBASE, and Google Scholar. Study Selection: The following combination of keywords was entered into the electronic search engines: ultrasonic tenotomy, ultrasound tenotomy, Tenex, and ultrasonic percutaneous tenotomy. The search results were screened for studies relevant to the topic. Only English-language studies were considered for inclusion. Studies consisting of level 4 evidence or higher and those involving human participants were included for more detailed evaluation. Level of Evidence: Level 4. Data Extraction: Articles meeting the inclusion criteria were sorted and reviewed. Type of tendinopathy studied, outcome measures, and complications were recorded. Both quantitative and qualitative analyses were performed on the data collected. Results: There were a total of 7 studies that met the inclusion criteria and quality measures—5 studies involving the treatment of elbow tendinopathy and 1 study each involving the management of Achilles tendinopathy and plantar fasciitis. PUT resulted in decreased pain/disability scores and improved functional outcome scores for chronic elbow tendinopathy and plantar fasciitis. Results for Achilles tendinopathy showed modest improvement in the short term, but long-term data are lacking. Conclusion: PUT is a minimally invasive treatment technique that can be considered in patients with tendinopathy refractory to conservative treatment measures. Further higher quality studies are necessary to accurately assess the comparative effectiveness of this treatment modality.

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