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  1. Article: Boerhaave Syndrome: An Unexpected Complication of Diabetic Ketoacidosis.

    Wiggins, Brandon / Banno, Fady / Knight, Kyle T / Fladie, Ian / Miller, Justin

    Cureus

    2022  Volume 14, Issue 5, Page(s) e25279

    Abstract: Boerhaave syndrome (BS) is a rare gastrointestinal condition related to esophageal rupture that carries a high mortality rate without prompt medical attention. BS is commonly associated with repeated episodes of severe retching, straining, or vomiting. ... ...

    Abstract Boerhaave syndrome (BS) is a rare gastrointestinal condition related to esophageal rupture that carries a high mortality rate without prompt medical attention. BS is commonly associated with repeated episodes of severe retching, straining, or vomiting. Diabetic ketoacidosis (DKA), a serious acute complication of diabetes, is characterized in part by laboratory findings of profound hyperglycemia and ketoacidosis. Clinically, nausea and vomiting are seen commonly in DKA patients, which can often include repeated forceful retching, but rarely associated with esophageal rupture. In this article, we will describe a case of BS secondary to repeated episodes of emesis in the setting of DKA.
    Language English
    Publishing date 2022-05-24
    Publishing country United States
    Document type Case Reports
    ZDB-ID 2747273-5
    ISSN 2168-8184
    ISSN 2168-8184
    DOI 10.7759/cureus.25279
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  2. Article ; Online: Lowering the threshold of statistical significance in gastroenterology trials.

    Walters, Corbin / Meyer, Chase / Fladie, Ian / Wayant, Cole / Vassar, Matt

    Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology

    2020  Volume 39, Issue 1, Page(s) 92–96

    Abstract: A multidisciplinary international cohort of 72 expert statisticians and researchers recently proposed lowering the p value threshold from 0.05 to 0.005 to mitigate distortion of trial results and decrease bias. We hereby explored how a change to the p ... ...

    Abstract A multidisciplinary international cohort of 72 expert statisticians and researchers recently proposed lowering the p value threshold from 0.05 to 0.005 to mitigate distortion of trial results and decrease bias. We hereby explored how a change to the p value threshold may alter the statistical significance of primary endpoints in gastroenterology (GE) randomized control trials (RCTs). We analyzed RCTs published in the 20 highest ranked GE and medicine journals. For each trial, we extracted the p values for the corresponding primary endpoints. We retrieved 233 RCTs, of which 159 were included in the final analysis yielding 202 primary endpoints. Of these endpoints, 60% had a p value less than 0.05 and when a threshold of less than 0.005 was applied, approximately 50% retained significance. We endorse a lower p value threshold as an actionable, provisional measure for improving statistical inference in GE RCTs until more long-term solutions become available.
    MeSH term(s) Clinical Trials as Topic/standards ; Gastroenterology ; Humans
    Language English
    Publishing date 2020-03-04
    Publishing country India
    Document type Journal Article
    ZDB-ID 632595-6
    ISSN 0975-0711 ; 0254-8860
    ISSN (online) 0975-0711
    ISSN 0254-8860
    DOI 10.1007/s12664-019-01007-9
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    In stock of ZB MED Cologne/Königswinter

    Zs.A 2085: Show issues Location:
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    Jg. 1995 - 2021: Lesesall (1.OG)
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  3. Article ; Online: An evaluation of reproducibility and transparency indicators in orthopedic literature.

    Fladie, Ian / Evans, Sheridan / Checketts, Jake / Tritz, Daniel / Norris, Brent / Vassar, Matt

    Journal of evidence-based medicine

    2021  Volume 14, Issue 4, Page(s) 281–284

    MeSH term(s) Biomedical Research ; Publications ; Reproducibility of Results
    Language English
    Publishing date 2021-10-29
    Publishing country England
    Document type Letter
    ZDB-ID 2474496-7
    ISSN 1756-5391 ; 1756-5383
    ISSN (online) 1756-5391
    ISSN 1756-5383
    DOI 10.1111/jebm.12457
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  4. Article ; Online: An Evaluation of Research Publications for General Surgery Residents And its Influence on the Future Pursuit of Fellowship or Academic Career.

    Fladie, Ian / Wise, Audrey / Carr, Marvin / Johnson, Austin L / Kinder, Nicholas / Jackson, Erin / Shweikeh, Faris / Hartwell, Micah / Vassar, Matt

    Journal of surgical education

    2022  Volume 80, Issue 3, Page(s) 352–359

    Abstract: Introduction: Traditionally, the Accreditation Council for Graduate Medical Education (ACGME) requires residency programs to implement research and other scholarly activities into their training curriculum. Encouraging residents to publish during ... ...

    Abstract Introduction: Traditionally, the Accreditation Council for Graduate Medical Education (ACGME) requires residency programs to implement research and other scholarly activities into their training curriculum. Encouraging residents to publish during residency is believed to promote research throughout their careers; however, the rate of research outcomes among general surgery residents remains unknown. Our study aims to determine associated factors that influence publication rates before, during, and after general surgery residency.
    Methods: This observational study employed a cross-sectional design. We examined whether research outcomes during general surgery residency was associated with academic advancement or continued research involvement after residency. We identified 321 general surgery residency programs on the Doximity website and randomly selected 50 to include in our sample. Of these programs, graduate rosters for 31 programs were located and subsequently included. Of the 405 residency graduates identified, we recorded the number of peer-reviewed publications, H-indices, fellowships, and whether the graduate pursued a career in private practice or academia.
    Results: Among the 405 physicians analyzed, 3815 total publications were identified with a mean of 9.4 (SD 11.8) per person. The most reported study design was observational studies (46.5%; 1775/3815) and the least reported was systematic reviews/meta-analyses (1.4%; 52/3815). The number of publications before residency positively correlated with having a higher h-index (r = 0.4). We also found that physicians who completed a fellowship had more publications during residency (mean = 4.7, SD = 6.5) than those not pursuing a fellowship (mean = 1.5, SD = 2.7; t= -4.3. p ≤ 0.001). We observed a statistically significant increase in the likelihood a physician pursued a career in academic medicine if they pursued a fellowship (OR: 3.77, 95% CI: 2.0-7.2) and if they had published research as a primary author (OR 1.25, 95% CI: 1.0-1.5).
    Conclusion: Increased research productivity was associated with continued academic pursuits and an increased likelihood of pursuing fellowship training after residency.
    MeSH term(s) Humans ; Fellowships and Scholarships ; Cross-Sectional Studies ; Education, Medical, Graduate ; Internship and Residency ; Efficiency ; Career Choice
    Language English
    Publishing date 2022-11-01
    Publishing country United States
    Document type Observational Study ; Journal Article
    ZDB-ID 2277538-9
    ISSN 1878-7452 ; 1931-7204
    ISSN (online) 1878-7452
    ISSN 1931-7204
    DOI 10.1016/j.jsurg.2022.10.004
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    Uk I Zs.230: Show issues Location:
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  5. Article ; Online: Are randomized controlled trials being conducted with the right justification?

    Walters, Corbin / Torgerson, Trevor / Fladie, Ian / Clifton, Angela / Meyer, Chase / Vassar, Matt

    Journal of evidence-based medicine

    2020  Volume 13, Issue 3, Page(s) 181–182

    Abstract: Objective: It has been estimated that much of health research may be wasted, resulting in billions of dollars in wasteful research spending worldwide each year. Given the increased use of randomized trials and their influence on medicine, one method to ... ...

    Abstract Objective: It has been estimated that much of health research may be wasted, resulting in billions of dollars in wasteful research spending worldwide each year. Given the increased use of randomized trials and their influence on medicine, one method to combat research waste is to conduct randomized clinical trials (RCTs) only when a systematic review (SR) suggests more data are needed or when no previous SRs are identified. Here, we analyzed RCTs to determine whether SRs were cited as justification for conducting a trial.
    Methods: We analyzed phase III RCTs published between 2016 and 2018 in New England Journal of Medicine, Lancet, and JAMA. We performed duplicate and independent data extraction to ensure the accuracy and validity of our data. For each trial, we extracted whether SRs were cited as justification for conducting the clinical trial.
    Results: We examined 637 RCTs that cited 728 SRs. Overall, 38.1% (243/637) of RCTs cited an SR as either verbatim (6.9%, 44/637) or inferred (31.2%, 199/637) for trial justification. The 79 remaining RCTs cited SRs in other ways. Approximately, 49.5% (315/637) of RCTs did not cite a SR.
    Conclusions: Less than half of the analyzed clinical trials cited a SRs as the basis for undertaking the trial. We believe trialists should be required to present relevant SRs to an ethics or peer review committee demonstrating an unmet need prior to initiating a trial. Eliminating research waste is both a scientific and ethical responsibility.
    Language English
    Publishing date 2020-07-02
    Publishing country England
    Document type Journal Article
    ISSN 1756-5391
    ISSN (online) 1756-5391
    DOI 10.1111/jebm.12405
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  6. Article ; Online: An Evaluation of Nephrology Literature for Transparency and Reproducibility Indicators: Cross-Sectional Review.

    Fladie, Ian A / Adewumi, Tomi M / Vo, Nam H / Tritz, Daniel J / Vassar, Matt B

    Kidney international reports

    2019  Volume 5, Issue 2, Page(s) 173–181

    Abstract: Introduction: Reproducibility is critical to diagnostic accuracy and treatment implementation. Concurrent with clinical reproducibility, research reproducibility establishes whether the use of identical study materials and methodologies in replication ... ...

    Abstract Introduction: Reproducibility is critical to diagnostic accuracy and treatment implementation. Concurrent with clinical reproducibility, research reproducibility establishes whether the use of identical study materials and methodologies in replication efforts permits researchers to arrive at similar results and conclusions. In this study, we address this gap by evaluating nephrology literature for common indicators of transparent and reproducible research.
    Methods: We searched the National Library of Medicine catalog to identify 36 MEDLINE-indexed, English-language nephrology journals. We randomly sampled 300 publications published between January 1, 2014, and December 31, 2018.
    Results: Our search yielded 28,835 publications, of which we randomly sampled 300 publications. Of the 300 publications, 152 (50.7%) were publicly available, whereas 143 (47.7%) were restricted through paywall and 5 (1.7%) were inaccessible. Of the remaining 295 publications, 123 were excluded because they lack empirical data necessary for reproducibility. Of the 172 publications with empirical data, 43 (25%) reported data availability statements and 4 (2.3%) analysis scripts. Of the 71 publications analyzed for preregistration and protocol availability, 0 (0.0%) provided links to a protocol and 8 (11.3%) were preregistered.
    Conclusion: Our study found that reproducible and transparent research practices are infrequently used by the nephrology research community. Greater efforts should be made by both funders and journals. In doing so, an open science culture may eventually become the norm rather than the exception.
    Language English
    Publishing date 2019-11-13
    Publishing country United States
    Document type Journal Article
    ISSN 2468-0249
    ISSN (online) 2468-0249
    DOI 10.1016/j.ekir.2019.11.001
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  7. Article ; Online: Quality of Intervention Reporting in Randomized Clinical Trials Published in Urology Journals.

    Johnson, Bradley S / Fladie, Ian / Jellison, Sam / McMurray, Megan / Narayan, Vikram / Vassar, Matt

    European urology

    2019  Volume 77, Issue 3, Page(s) 296–298

    Abstract: We used the Template for Intervention Description and Replication (TIDieR) to find evidence that intervention reporting in urology randomized controlled trials is suboptimal. Action to improve intervention reporting is warranted and we advise extending ... ...

    Abstract We used the Template for Intervention Description and Replication (TIDieR) to find evidence that intervention reporting in urology randomized controlled trials is suboptimal. Action to improve intervention reporting is warranted and we advise extending TIDieR into Consolidated Standards for Reporting Trials guidelines.
    MeSH term(s) Humans ; Periodicals as Topic ; Publishing ; Randomized Controlled Trials as Topic/methods ; Randomized Controlled Trials as Topic/standards ; Research Design/standards ; Urology
    Language English
    Publishing date 2019-11-14
    Publishing country Switzerland
    Document type Editorial ; Research Support, Non-U.S. Gov't ; Research Support, U.S. Gov't, Non-P.H.S.
    ZDB-ID 193790-x
    ISSN 1873-7560 ; 1421-993X ; 0302-2838
    ISSN (online) 1873-7560 ; 1421-993X
    ISSN 0302-2838
    DOI 10.1016/j.eururo.2019.10.029
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    In stock of ZB MED Cologne/Königswinter

    Zs.A 1247: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
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    Jg. 1995 - 2021: Lesesall (1.OG)
    ab Jg. 2022: Lesesaal (EG)
    Zs.MO 294: Show issues

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  8. Article ; Online: Rates of Discontinuation and Nonpublication of Head and Neck Cancer Randomized Clinical Trials.

    Johnson, Austin L / Fladie, Ian / Anderson, J Michael / Lewis, David M / Mons, Bradley R / Vassar, Matt

    JAMA otolaryngology-- head & neck surgery

    2019  Volume 146, Issue 2, Page(s) 176–182

    Abstract: Importance: Randomized clinical trials (RCTs) play an important role in clinical decision-making, and discontinuation or nonpublication of these trials are causes of great concern. The extent of discontinued or unpublished RCTs about head and neck ... ...

    Abstract Importance: Randomized clinical trials (RCTs) play an important role in clinical decision-making, and discontinuation or nonpublication of these trials are causes of great concern. The extent of discontinued or unpublished RCTs about head and neck cancer remains unclear.
    Objective: To assess the rate of discontinuation or nonpublication of RCTs involving patients with head and neck cancer. This objective was measured by observing 3 domains: discontinuation of trial, nonpublication of trial data, and feasibility of contacting trial investigators of aforementioned trials.
    Evidence review: For this study, the sample was derived using the ClinicalTrials.gov advanced search feature on March 18, 2019, to locate completed and discontinued RCTs pertaining to head and neck cancer registered before this date. Trials were analyzed to identify reasons for trial discontinuation and publication status of each trial. If publication status or reason for trial discontinuation was not allocated through the systematic search of ClinicalTrials.gov, the corresponding author was emailed to determine publication status.
    Findings: After exclusions, 130 RCTs were included. Of these trials, 92 (70.8%) were completed and 38 (29.2%) were discontinued for various reasons. The most common reason for discontinuation of trials was committee recommendations. Of the 130 analyzed trials, 67 (51.5%) were published in a peer-reviewed journal and 63 (48.5%) were unpublished trials. Of the 92 completed trials, 55 (59.8%) were published and 37 (40.2%) remained unpublished 3 or more years after trial completion. Trials funded by other sources (private, nonprofit, or the National Institutes of Health) were more likely to reach publication than industry-funded RCTs (unadjusted odds ratio, 4.3 [95% CI, 1.3-14.0]; adjusted odds ratio, 4.1 [95% CI, 1.2-14.3]).
    Conclusions and relevance: Of RCTs in head and neck cancer, 29.2% were discontinued and 40.2% completed trials never reached publication. The findings suggest that needs exist for RCT guidance of head and neck cancer. The reporting of reasons for trial discontinuation appears to be lacking, and trial publication rates were low. This study is relevant to many physicians and researchers because it identifies potential sources of decreased research productivity and ethics.
    MeSH term(s) Early Termination of Clinical Trials/ethics ; Early Termination of Clinical Trials/statistics & numerical data ; Ethics Committees, Research ; Head and Neck Neoplasms ; Humans ; Publication Bias ; Publishing/statistics & numerical data ; Randomized Controlled Trials as Topic/ethics ; Randomized Controlled Trials as Topic/statistics & numerical data
    Language English
    Publishing date 2019-10-24
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2701825-8
    ISSN 2168-619X ; 2168-6181
    ISSN (online) 2168-619X
    ISSN 2168-6181
    DOI 10.1001/jamaoto.2019.3967
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    Ul II Zs.87: Show issues Location:
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    ab Jg. 2022: Lesesaal (EG)

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  9. Article ; Online: Evaluation of intervention reporting in published emergency medicine clinical trials.

    Fladie, Ian A / Rorah, Drayton / Pollard, Jonathan / Jellison, Samuel / Thabane, Lehana / Murray, Kelly / Gardner, Gavin / Vassar, Matt

    The American journal of emergency medicine

    2020  Volume 38, Issue 6, Page(s) 1171–1177

    Abstract: Objective: The extent of intervention reporting in emergency medicine journals remains unclear. The primary objective is to assess overall completion of the Template for Intervention Description and Replication (TIDieR) checklist described in emergency ... ...

    Abstract Objective: The extent of intervention reporting in emergency medicine journals remains unclear. The primary objective is to assess overall completion of the Template for Intervention Description and Replication (TIDieR) checklist described in emergency medicine randomized clinical trials (RCTs). The secondary outcomes were to (1) compare reporting before and after TIDieR publication; (2) evaluate factors associated with intervention reporting.
    Methods: Our cross-sectional study used Google Scholar's metrics to identify seven emergency medicine journals; of which, we randomly sampled 300 articles. Using two PubMed searches, we extracted 150 RCTs before and after publications of TIDieR. Two investigators independently extracted data. The primary analysis to measure overall completion included descriptive statistics for each checklist item. Our secondary analysis used an interrupted time series analysis and generalized estimating equations to determine the effect of TIDieR publication on intervention reporting.
    Results: Our initial search yielded 635 articles; from which, we randomly sampled 300 articles. We excluded 67 articles, leaving 233 for analysis. The mean number of TIDieR items reported was 5.4 (standard deviation = 1.18). Of the 233 trials, 42.9% provided information about materials, 67% provided intervention procedures, and 99.1% provided intervention delivery. The least reported items were intervention modifications (2.6%), intervention adherence assessment methods (3.4%), and intervention adherence assessment outcomes (2.2%).
    Conclusions: The completeness of intervention reporting is suboptimal in emergency medicine journals, necessitating improvement. The current state of adherence could be improved through the combined efforts of journal editors, major editorial organizations, and authors.
    MeSH term(s) Checklist/instrumentation ; Checklist/methods ; Checklist/statistics & numerical data ; Clinical Trials as Topic/instrumentation ; Clinical Trials as Topic/standards ; Clinical Trials as Topic/statistics & numerical data ; Cross-Sectional Studies ; Guideline Adherence/standards ; Guideline Adherence/statistics & numerical data ; Humans ; Peer Review/methods ; Publishing/instrumentation ; Publishing/standards ; Publishing/statistics & numerical data ; Research Design/standards ; Research Design/statistics & numerical data
    Language English
    Publishing date 2020-04-13
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 605890-5
    ISSN 1532-8171 ; 0735-6757
    ISSN (online) 1532-8171
    ISSN 0735-6757
    DOI 10.1016/j.ajem.2019.12.030
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    Zs.A 2005: Show issues Location:
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