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1.
BMC Urol ; 22(1): 102, 2022 Jul 11.
Article in English | MEDLINE | ID: mdl-35820886

ABSTRACT

BACKGROUND: Reproducibility is essential for the integrity of scientific research. Reproducibility is measured by the ability of different investigators to replicate the outcomes of an original publication using the same materials and procedures. Unfortunately, reproducibility is not currently a standard being met by most scientific research. METHODS: For this review, we sampled 300 publications in the field of urology to assess for 14 indicators of reproducibility including material availability, raw data availability, analysis script availability, pre-registration information, links to protocols, and if the publication was available free to the public. Publications were also assessed for statements about conflicts of interest and funding sources. RESULTS: Of the 300 sample publications, 171 contained empirical data available for analysis of reproducibility. Of the 171 articles with empirical data to analyze, 0.58% provided links to protocols, 4.09% provided access to raw data, 3.09% provided access to materials, and 4.68% were pre-registered. None of the studies provided analysis scripts. Our review is cross-sectional in nature, including only PubMed indexed journals-published in English-and within a finite time period. Thus, our results should be interpreted in light of these considerations. CONCLUSION: Current urology research does not consistently provide the components needed to reproduce original studies. Collaborative efforts from investigators and journal editors are needed to improve research quality while minimizing waste and patient risk.


Subject(s)
Urology , Cross-Sectional Studies , Humans , Reproducibility of Results
2.
Eur J Obstet Gynecol Reprod Biol ; 269: 24-29, 2022 Feb.
Article in English | MEDLINE | ID: mdl-34954422

ABSTRACT

OBJECTIVE: Reproducibility is a core tenet of scientific research. A reproducible study is one where the results can be recreated by using the same methodology and materials as the original researchers. Unfortunately, reproducibility is not a standard to which the majority of research is currently adherent. METHODS: Our cross-sectional survey evaluated 300 trials in the field of Obstetrics and Gynecology. Our primary objective was to identify nine indicators of reproducibility and transparency. These indicators include availability of data, analysis scripts, pre-registration information, study protocols, funding source, conflict of interest statements and whether or not the study was available via Open Access. RESULTS: Of the 300 trials in our sample, 208 contained empirical data that could be assessed for reproducibility. None of the trials in our sample provided a link to their protocols or provided a statement on availability of materials. None were replication studies. Just 10.58% provided a statement regarding their data availability, while only 5.82% provided a statement on preregistration. 25.85% failed to report the presence or absence of conflicts of interest and 54.08% did not state the origin of their funding. CONCLUSION: In the studies we examined, research in the field of Obstetrics and Gynecology is not consistently reproducible and frequently lacks conflict of interest disclosure. Consequences of this could be far-reaching and include increased research waste, widespread acceptance of misleading results and erroneous conclusions guiding clinical decision-making.


Subject(s)
Gynecology , Obstetrics , Cross-Sectional Studies , Disclosure , Female , Humans , Pregnancy , Reproducibility of Results
3.
J Cancer Policy ; 27: 100268, 2021 03.
Article in English | MEDLINE | ID: mdl-35559938

ABSTRACT

BACKGROUND: While spin - i.e., a reporting practice that embellishes positive findings and understates negative ones - is prevalent in randomized controlled trials, it has yet to be investigated in the context of systematic reviews. Owing to their significant role in clinical decision making and patient outcomes, this study seeks to identify and evaluate the severity of spin in the abstracts of systematic reviews on breast cancer. METHODS: We searched MEDLINE and Embase for systematic reviews and meta-analyses focused on breast cancer treatment, screening, and post-treatment quality of life between 1987 and 2020. Investigators independently screened for study selection, extracted spin data, and appraised the methodological quality of reviews using AMSTAR 2. In this cross-sectional study, 11,717 articles were identified, of which 581 met inclusion criteria. Following randomization, the first 200 were evaluated and 21 % contained evidence of at least one of nine types of spin. RESULTS: We identified spin types one, three, four, five, and six but not two, seven, eight, or nine. In particular, pharmacological (AOR 4.36, 95 % CI [1.18-16.01]) and surgical (AOR, 10.10 95 % CI [1.60-63.68]) intervention-type studies were highly associated with spin. There were no other associations between study characteristics and spin. While these results are significant, they contain a wide confidence interval and the reader should draw conclusions accordingly. CONCLUSIONS: There is evidence of spin in meta-analyses and systematic reviews regarding breast cancer treatment and quality of life outcomes. Accordingly, readers of systematic review abstracts related to breast cancer could be misled by distorted presentation of findings. POLICY SUMMARY: This study aims to improve the standards of reporting in systematic reviews and meta-analyses related to cancer.


Subject(s)
Breast Neoplasms , Quality of Life , Breast Neoplasms/diagnosis , Cross-Sectional Studies , Early Detection of Cancer , Female , Humans , Meta-Analysis as Topic , Systematic Reviews as Topic
4.
Sex Med ; 9(1): 100284, 2020 Dec 05.
Article in English | MEDLINE | ID: mdl-33291041

ABSTRACT

INTRODUCTION: It is predicted that erectile dysfunction will affect around 322 million men worldwide by 2025. Because of the large volume of literature on the topic, physicians often turn to systematic reviews and meta-analyses-and particularly abstracts of such articles-for clinical guidance. Thus, it is crucial that findings are not misrepresented in abstracts. In this study, we evaluated the use of spin (ie, the misreporting of study findings by overstating or selectively reporting efficacy results, minimizing harms, or making unwarranted clinical recommendations) in the abstracts of systematic reviews on erectile dysfunction. METHODS: A search strategy was developed using the MEDLINE and Embase databases to retrieve systematic reviews focused on treatments for erectile dysfunction. 2 investigators independently screened the titles and abstracts from the reviews for study inclusion. Investigators analyzed the included systematic reviews for 9 of the most severe types of spin using a previously developed classification scheme and rated them for methodological quality using the revised A MeaSurement Tool to Assess systematic Reviews (AMSTAR) in a masked, duplicate manner. Study characteristics for each review were also extracted in duplicate. RESULTS: Our search returned 2,224 articles, of which 102 systematic reviews and meta-analyses were included in the final analysis. A total of 31.4% (32/102) of systematic reviews contained spin. 8 types of spin were identified in our sample. Type 3 (selective reporting of or overemphasis on efficacy outcomes) and type 5 (conclusion claims beneficial effect despite high risk of bias) were the most common types of spin, each occurring in 10.8% (11/102) of abstracts. There was no significant association between the presence of spin and the extracted study characteristics or methodological quality. CONCLUSION: Spin was present in systematic reviews and meta-analyses covering erectile dysfunction treatments. Steps should be taken to improve the reporting quality of abstracts on erectile dysfunction treatment. Reddy AK, Lulkovich K, Ottwell R, et al. Evaluation of Spin in Abstracts of Systematic Reviews and Meta-analyses Focused on Treatments of Erectile Dysfunction: A Cross-sectional Analysis. Sex Med 2020;9:100284.

5.
Clin Respir J ; : 287-292, 2020 Oct 20.
Article in English | MEDLINE | ID: mdl-33080096

ABSTRACT

OBJECTIVE: We investigated the randomized controlled trials (RCTs) related to acute respiratory distress syndrome (ARDS) to assess the presentation and frequency of misrepresented research findings, also known as spin. METHODS: We searched PubMed (MEDLINE) for studies published from January 1, 2011 to December 31, 2019. We included randomized controlled trials with an ARDS intervention and a nonsignificant primary endpoint. Trial screening and data extraction was performed on all studies independently and in duplicate. The primary endpoint was to investigate the frequency and manifestation of spin in RCT abstracts. Our secondary endpoint was to investigate associations between funding source and spin. RESULTS: Our PubMed search returned 766 articles with 37 meeting inclusion criteria. Spin was present in 14 (14/37, 37.8%; 95% CI 22.5%-55.2%) abstracts. The most common manifestations of spin were claiming benefit based on a significant secondary endpoint (6/14, 42.9%), followed by the use of 'trend' statements, such as 'trend toward significance' (2/14, 14.3%; 95% CI 1.8%-42.8%). The most common spin in abstract conclusions was in the form of claiming benefit due to a significant secondary endpoint (3/4, 75%; 95% CI 19.4%-99.4%). Our secondary endpoint did not identify a significant difference in the prevalence of spin in publicly funded (5/19, 26.3%; 95% CI 9.1%-51.2%) compared to privately funded (4/12, 33.3%; 95% CI 9.9%-65.1%) studies (p>.05). CONCLUSIONS: RCTs of ARDS interventions with nonsignificant primary endpoints often included spin in the abstract. Spin in the abstract may influence clinician appraisal and interpretation of diagnostic or treatment modalities.

6.
Breast Dis ; 39(2): 85-90, 2020.
Article in English | MEDLINE | ID: mdl-32250286

ABSTRACT

INTRODUCTION: Breast cancer is the most common cancer in women, affecting approximately 1 in 8 women worldwide. Additionally, it is either the most or second-most lethal cancer depending on ethnicity. Many women and concerned family members turn to the internet for information regarding the signs, symptoms, diagnosis and treatment of this life-altering condition. We sought to objectively evaluate the quality of the information available on YouTube concerning breast cancer. METHODS: We searched YouTube for videos relating to breast cancer. We included videos that were less than 20 minutes in length, were in the top 200 for most views and were available in English, either subtitled or narrated. Videos were independently and blindly scored using a standardized scoring form. Possible scores ranged from negative infinity to 25.5 with one point being deducted for each misleading statement or claim. RESULTS: After exclusions, 133 videos in our sample were evaluated. Out of a possible 25.5 points, the true mean was 3.90 with a standard deviation of 1.38. There were only 30 videos (22.5%) that scored more than 7 points. 12 (9.0%) videos scored 0 points or fewer. 12 (9.0%) of the videos in our sample contained at least one misleading statement with 9 of those contained multiple misleading statements with some videos having up to 10 such statements. CONCLUSION: While YouTube is an important source of information regarding breast cancer, few videos contain a significant amount of quality information and many of the videos contain false or misleading statements. In an area where patients are often scared and searching for answers, there is a significant need for more high-quality videos to educate patients and dispel myths and pseudoscience.


Subject(s)
Breast Neoplasms/epidemiology , Information Seeking Behavior , Social Media , Breast Neoplasms/diagnosis , Breast Neoplasms/drug therapy , Female , Humans , Video Recording , Web Browser
7.
BMJ Evid Based Med ; 25(2): 1-2, 2020 Apr.
Article in English | MEDLINE | ID: mdl-31427352

ABSTRACT

Publication bias can arise in systematic reviews when unpublished data are omitted and lead to inaccurate clinical decision making and adverse clinical outcomes. By conducting searches of clinical trial registries (CTRs), researchers can create more accurate systematic reviews and mitigate the risk of publication bias. The aims of this study are: to evaluate CTR use in systematic reviews and meta-analyses within the minimally invasive surgical oncology (MISO) literature; to conduct a search of ClinicalTrials.gov for a subset of reviews to determine if eligible trials exist that could have been used. This is a cross-sectional study of 197 systematic reviews and meta-analyses retrieved from PubMed. Of 137 included studies, 18 (13.1%) reported searching a CTR. Our ClinicalTrials.gov search revealed that of the 25 randomly selected systematic reviews that failed to conduct a trial registry search, 16 (64.0%) would have identified additional data sources. MISO systematic reviews and meta-analyses do not regularly use CTRs in their data collection, despite eligible trials being freely available.


Subject(s)
Clinical Trials as Topic , Meta-Analysis as Topic , Minimally Invasive Surgical Procedures , Neoplasms/surgery , Registries/statistics & numerical data , Systematic Reviews as Topic , Clinical Trials as Topic/statistics & numerical data , Cross-Sectional Studies , Humans , Minimally Invasive Surgical Procedures/methods , Minimally Invasive Surgical Procedures/standards , Minimally Invasive Surgical Procedures/statistics & numerical data , Surgical Oncology/standards , Surgical Oncology/statistics & numerical data
8.
Int J Evid Based Healthc ; 18(1): 125-137, 2020 Mar.
Article in English | MEDLINE | ID: mdl-31567602

ABSTRACT

AIM: The fragility index is calculated by changing one outcome event to a nonevent within a trial until the associated P value exceeds 0.05. In this study, we assessed the robustness, risk of bias (RoB), and power of randomized controlled trials that underlie recommendations set forth by the American College of Gastroenterology (ACG) on managing dyspepsia and Helicobacter pylori infections. METHODS: All citations referenced in the guidelines were screened for inclusion criteria. The fragility indexes for eligible trials were then calculated. The likelihood and sources of bias in the included trials were evaluated by the Cochrane 'RoB' Tool 2.0. RESULTS: The median fragility index for the 52 trials was three events. Five studies (9.6%) resulted in a fragility index of 0 when statistical analysis was applied. For the 52 trials, 12 (23.1%) were at a low RoB, 15 (28.8%) had some concerns, and 25 (48.1%) were at a high RoB. High RoB was most commonly due to bias of selection in the reported result (15.5%). CONCLUSION: A median of three events was needed to nullify statistical significance in 52 trials that underpin guideline recommendations on the management of dyspepsia and H. pylori infections. In addition, concerns for RoB were found for these trials.


Subject(s)
Dyspepsia/therapy , Helicobacter Infections/therapy , Randomized Controlled Trials as Topic/methods , Randomized Controlled Trials as Topic/standards , Bias , Helicobacter pylori , Humans , Practice Guidelines as Topic , Research Design
9.
J Surg Res ; 247: 323-331, 2020 03.
Article in English | MEDLINE | ID: mdl-31708197

ABSTRACT

OBJECTIVE: To determine the extent to which systematic reviews published in surgery journals reported a clinical trial registry search as part of their search strategy and whether systematic reviews that omitted such searches would have located additional trials for inclusion. BACKGROUND: Systematic reviews are used by clinicians to guide clinical decision making. When conducting systematic reviews, the comprehensive search strategy is particularly critical to identify all studies-whether published or not-for producing an overall summary effect. Inclusion of only published studies may lead to overestimated and inaccurate summary effects; thus, it is important to consider unpublished studies. Here, we investigate the extent of clinical trial registry searches performed in surgical systematic reviews because trial registries may be the most viable approach to locate unpublished trial data. METHODS: We retrieved systematic reviews from the top surgery journals and the Cochrane Collaboration. Each was reviewed to determine which bibliographic databases were used and which, if any, trial registries were searched. RESULTS: Of 996 total systematic reviews, 252 (25.3%) reported having included a clinical trial registry search, with systematic reviews published in journals reporting searches of unpublished research at a rate of 6.4% (47/737). Reviews published by the Cochrane Collaboration included searches of unpublished research 79.2% of the time (205/259). CONCLUSIONS: Many systematic reviews published in surgery journals include only published research, which may contribute to publication bias. We recommend that authors maximize available information by using unpublished trial data found in clinical trial registries.


Subject(s)
Clinical Trials as Topic/statistics & numerical data , General Surgery/methods , Publication Bias , Registries/statistics & numerical data , Systematic Reviews as Topic , Cross-Sectional Studies , General Surgery/statistics & numerical data , Meta-Analysis as Topic
10.
BMJ Evid Based Med ; : 178-181, 2019 Aug 05.
Article in English | MEDLINE | ID: mdl-31383725

ABSTRACT

We have identified 'spin' in abstracts of randomised controlled trials (RCTs) with nonsignificant primary endpoints in psychiatry and psychology journals. This is a cross-sectional review of clinical trials with nonsignificant primary endpoints published in psychiatry and psychology journals from January 2012 to December 2017. The main outcome was the frequency and manifestation of spin in the abstracts. We define spin as the 'use of specific reporting strategies, from whatever motive, to highlight that the experimental treatment is beneficial, despite a statistically nonsignificant difference for the primary outcome, or to distract the reader from statistically nonsignificant results'. We have also assessed the relationship between industry funding and spin. Of the 486 RCTs examined, 116 were included in our analysis of spin. Spin was identified in 56% (n=65) of those included. Spin was found in 2 (2%) titles, 24 (21%) abstract results sections and 57 (49.1%) abstract conclusion sections. Evidence of spin was simultaneously identified in both results and conclusions sections in 15% of RCTs (n=17). Twelve articles reported industry funding (10%). Industry funding was not associated with increased odds of spin in the abstract (unadjusted OR: 1.0; 95% CI: 0.3 to 3.2). We found no relationship between industry funding and spin in abstracts. These findings raise concerns about the effects spin may have on clinicians. Further steps could be taken to address spin, including inviting reviewers to comment on the presence of spin and updating Consolidated Standards of Reporting Trials guidelines to contain language discouraging spin.

11.
Indian J Gastroenterol ; 38(3): 247-262, 2019 06.
Article in English | MEDLINE | ID: mdl-31270778

ABSTRACT

BACKGROUND: Clinical practice guidelines help practitioners manage patients in an effective and systematic way, and they assist in making evidence-based decisions related to diagnosis and treatment. Each recommendation is ranked based on evidence. The goal of this study is to determine gaps in research for inflammatory bowel diseases (IBD) by using the low-level evidence recommendations. METHODS: We extracted low-level evidence recommendations set forth by the American College of Gastroenterology in IBD, ulcerative colitis (UC), and Crohn's disease. ClinicalTrials.gov , the World Health Organization's International Clinical Trials Registry Platform and PubMed were then used to locate studies relevant to the recommendations. RESULTS: There were 30 low-level evidence recommendations, and 23 had recent or ongoing studies addressing them. We screened 2938 trials and 4321 published articles, 221 of which addressed low-quality recommendations. There were five recommendations that received the majority of research attention (143/221, 65%). CONCLUSION: This study used clinical practice guidelines to help determine areas of needed research in IBD, UC, and Crohn's disease. By searching trial registries and articles indexed on PubMed, we identified the extent to which studies were being conducted to address research gaps. Of the gaps identified, five recommendations received most of the attention. While most of the significant gaps had some recent or ongoing research, our study found several areas where investigation is still needed. Clinical practice guidelines are an effective method to prioritize future research.


Subject(s)
Bibliometrics , Biomedical Research , Colitis, Ulcerative/drug therapy , Crohn Disease/drug therapy , Practice Guidelines as Topic , Adrenal Cortex Hormones/administration & dosage , Anti-Infective Agents/therapeutic use , Clinical Trials as Topic , Evidence-Based Medicine , Humans , Metronidazole/therapeutic use
12.
Am J Emerg Med ; 37(12): 2229-2238, 2019 12.
Article in English | MEDLINE | ID: mdl-30940409

ABSTRACT

BACKGROUND: The fragility index (FI) is calculated by iteratively changing one outcome "event" to a "non-event" within a trial until the associated p-value exceeds 0.05. PURPOSE: To investigate the FI and fragility quotient (FQ) of trial endpoints referenced in the ACCF/AHA/SCAI guidelines in the management of ST-elevation myocardial infarctions. Secondarily, we assess the post-hoc power and risk of bias for these specific outcomes and whether differences exist between adequately and inadequately powered studies on fragility measures. BASIC PROCEDURES: All citations referenced in the guideline were screened for inclusion criteria. The FI and FQ for all included trials were then calculated. The Cochrane 'risk of bias' Tool 2.0 was used to evaluate the likelihood and sources of bias in the included trials. MAIN FINDINGS: Forty-two randomized controlled trials were included for assessment. The median FI was 10 with a FQ of 0.0055. Seven trials were at a high risk of bias, all due to bias in the randomization process. Fifteen trials were found to be underpowered. Adequately powered studies had higher FIs and FQs compared to underpowered studies. PRINCIPAL CONCLUSIONS: Our findings support the use of FI and FQ analyses with power analyses in future methodology of randomized control trials. With understanding and reporting of FI and FQ, evidence of studies can be readily available and quickly eliminate some readers' concern for possible study limitations.


Subject(s)
Practice Guidelines as Topic , Randomized Controlled Trials as Topic/standards , ST Elevation Myocardial Infarction/therapy , Bias , Data Interpretation, Statistical , Humans , Research Design
13.
PLoS One ; 13(10): e0204720, 2018.
Article in English | MEDLINE | ID: mdl-30281671

ABSTRACT

BACKGROUND: Clinical practice guidelines contain recommendations for physicians to determine the most appropriate care for patients. These guidelines systematically combine scientific evidence and clinical judgment, culminating in recommendations intended to optimize patient care. The recommendations in CPGs are supported by evidence which varies in quality. We aim to survey the clinical practice guidelines created by the American College of Gastroenterology, report the level of evidence supporting their recommendations, and identify areas where evidence can be improved with additional research. METHODS: We extracted 1328 recommendations from 39 clinical practice guidelines published by the American College of Gastroenterology. Several of the clinical practice guidelines used the differing classifications of evidence for their recommendations. To standardize our results, we devised a uniform system for evidence. RESULTS: A total of 39 clinical practice guidelines were surveyed in our study. Together they account for 1328 recommendations. 693 (52.2%) of the recommendations were based on low evidence, indicating poor evidence or expert opinion. Among individual guidelines, 13/39 (33.3%) had no recommendations based on high evidence. CONCLUSION: Very few recommendations made by the American College of Gastroenterology are supported by high levels of evidence. More than half of all recommendations made by the American College of Gastroenterology are based on low-quality evidence or expert opinion.


Subject(s)
Gastroenterology , Practice Guidelines as Topic , Societies, Medical , Evidence-Based Medicine/standards , Gastroenterology/standards , Humans , Practice Guidelines as Topic/standards , Societies, Medical/standards , United States
14.
Eur Urol ; 74(3): 348-354, 2018 09.
Article in English | MEDLINE | ID: mdl-29747945

ABSTRACT

BACKGROUND: Recent studies have highlighted the presence of disclosed and undisclosed financial conflicts of interest among authors of clinical practice guidelines. OBJECTIVE: We sought to determine to what extent urology guideline authors receive and report industry payments in accordance with the Physician Payment Sunshine Act. DESIGN, SETTING, AND PARTICIPANTS: We selected the 13 urology guidelines that were published by the American Urological Association (AUA) after disclosure was mandated by the Physician Payment Sunshine Act. Payments received by guideline authors were searched independently by two investigators using the Open Payments database. OUTCOME MEASURES AND STATISTICAL ANALYSIS: Our primary outcome measure was the number of authors receiving payments from industry, stratified by amount thresholds. Our secondary outcome measure was the number of authors with accurate conflict of interest disclosure statements. RESULTS AND LIMITATIONS: We identified a total of 54 author disclosures. Thirty-two authors (59.3%) received at least one payment from industry. Twenty (37.0%) received >$10 000 and six (11.1%) received >$50 000. Median total payments were $578 (interquartile range $0-19 228). Twenty (37.0%) disclosure statements were inaccurate. Via Dollars for Docs, we identified $74 195.13 paid for drugs and devices directly related to guideline recommendations. We were limited in our ability to determine when authors began working on guideline panels, as this information was not provided, and by the lack of specificity in Dollars for Docs. CONCLUSIONS: Many of the AUA guideline authors received payments from industry, some in excess of $50 000. A significant portion of disclosure statements were inaccurate, indicating a need for more stringent enforcement of the AUA disclosure policy. PATIENT SUMMARY: Pharmaceutical company payments to doctors have been shown to influence how doctors treat patients. If these doctors are charged with making clinical recommendations to other doctors, in the form of clinical practice guidelines, the issue of industry payments becomes more severe. We found that many urologists on guideline panels receive money from industry and that a significant portion did not disclose all payments received.


Subject(s)
Authorship , Compensation and Redress , Conflict of Interest/economics , Health Care Sector/economics , Practice Guidelines as Topic , Urologists/economics , Urology/economics , Authorship/standards , Compensation and Redress/ethics , Health Care Sector/ethics , Health Care Sector/standards , Humans , Practice Guidelines as Topic/standards , Truth Disclosure , Urologists/ethics , Urologists/standards , Urology/ethics , Urology/standards
15.
J Surg Res ; 224: 233-239, 2018 04.
Article in English | MEDLINE | ID: mdl-29506846

ABSTRACT

BACKGROUND: Recent studies have highlighted the risk of bias and the fragility of results in randomized controlled trials (RCTs). The aim of our study was to evaluate the clinical practice guidelines created by the Society for Gastrointestinal and Endoscopic Surgeons (SAGES) for fragility, statistical power, and risk of bias. MATERIALS AND METHODS: We screened the SAGES clinical practice guideline references for qualifying RCTs. RCTs were assessed for risk of bias using the Cochrane Collaboration Risk of Bias tool 2.0. We used the fragility index and fragility quotient to evaluate the robustness of trial results and conducted a power analysis using G*Power to determine if trials were adequately powered. RESULTS: Twenty-two (40.7%) of the 54 trials that we assessed were rated as having a high risk of bias, 17 (31.5%) were rated as having a low risk of bias, and 15 (27.8%) were rated as having some concerns. The median fragility index was 2.5 (interquartile range 1-7). The median fragility quotient was 0.021 (interquartile range 0.003-0.045). Mean sample size was 108, and the mean loss to follow-up was eight patients. Eight of 33 trials (24.2%) were found to be underpowered according to the sample size used in the primary outcome. CONCLUSIONS: Guidelines created by SAGES are supported by RCTs that are frequently fragile or underpowered or have a high risk of bias. Future RCTs should utilize the Consolidated Standards of Reporting Trials statement, implement strategies to minimize loss to follow-up, and use properly powered sample sizes.


Subject(s)
Endoscopy/standards , Laparoscopy/standards , Practice Guidelines as Topic/standards , Randomized Controlled Trials as Topic/standards , Bias , Humans
16.
Heart ; 104(9): 753-759, 2018 05.
Article in English | MEDLINE | ID: mdl-29092915

ABSTRACT

OBJECTIVE: This study investigated the policies of cardiac and cardiovascular system journals concerning clinical trial registration and guideline adoption to understand how frequently journals use these mechanisms to improve transparency, trial reporting and overall study quality. METHODS: We selected the top 20 (by impact factor) journals cited in the subcategory 'Cardiac and Cardiovascular Systems' of the Expanded Science Citation Index of the 2014 Journal Citation Reports to extract journal policies concerning the 17 guidelines we identified. In addition, trial and systematic review registration adherence statements were extracted. 300 randomised controlled trials published in 2016 in the top 20 journals were searched for clinical trial registry numbers and CONSORT diagrams. RESULTS: Of the 19 cardiac and cardiovascular system journals included in our analysis, eight journals (42%) did not require or recommend trial or review registration. Seven (37%) did not recommend or require a single guideline within their instructions to authors. Consolidated Standards for Reporting Trials guidelines (10/19, 53%) were recommended or required most often. Of the trials surveyed, 122/285 (42.8%) published a CONSORT diagram in their manuscript, while 236/292 (80.8%) published a trial registry number. DISCUSSION: Cardiac and cardiovascular system journals infrequently require, recommend or enforce the use of reporting guidelines. Furthermore, too few require or enforce the use of clinical trial registration. Cardiology journal editors should consider guideline adoption due to their potential to limit bias and increase transparency.


Subject(s)
Cardiology , Clinical Trials as Topic/standards , Guideline Adherence , Periodicals as Topic , Practice Guidelines as Topic , Editorial Policies , Humans , Registries
17.
Am J Emerg Med ; 36(4): 630-636, 2018 Apr.
Article in English | MEDLINE | ID: mdl-28970025

ABSTRACT

BACKGROUND: It is estimated that as many as 1 in 10 individuals who complete suicide had been seen in emergency departments within the prior 2months. However, very little evidence underlies the current recommendations on managing patients with suicidal ideation presenting to the emergency department. The American College of Emergency Physicians (ACEP) and Veterans Affairs/Department of Defense (VA/DoD) have developed clinical practice guidelines for the screening and treatment of patients with suicidal ideation who present to emergency departments. In this study we investigated the extent to which new and ongoing studies are being conducted to address the current limitations in suicide screening in emergency departments. METHODS: We identified low-level recommendations in clinical practice guidelines that have been set forth by the ACEP and VA/DoD. PICO questions were then created to help identify relevant studies pertaining to screening patients with suicidal ideation in the emergency department. PICO questions were used to develop search strings, which were then used to locate studies from ClinicalTrials.gov and the World Health Organization's International Clinical Trials Registry Platform. RESULTS: Seventeen PICO questions were created for this study. We found 11 studies addressing gaps identified in the clinical practice guidelines. Of the 17 PICO questions created, 10 were being addressed by 11 studies. CONCLUSIONS: Little research is being done to improve suicide risk assessment tools in the emergency department. Further research in this area may decrease health care costs, improve patient care, and save the lives of those at risk of dying by suicide.


Subject(s)
Emergency Service, Hospital/statistics & numerical data , Mass Screening/standards , Suicidal Ideation , Suicide, Attempted/prevention & control , Emergency Service, Hospital/standards , Humans , Practice Guidelines as Topic , Randomized Controlled Trials as Topic , Risk Assessment , Surveys and Questionnaires , United States
18.
J Arthroplasty ; : 1247-1252.e1, 2017 Nov 09.
Article in English | MEDLINE | ID: mdl-29174763

ABSTRACT

BACKGROUND: Subspecialty conferences are an important forum for disseminating the latest research relevant to clinical practice. The purpose of this study was to identify publication rates in podium and poster abstracts for the American Association of Hip and Knee Surgeons (AAHKS) Annual Meeting and to identify the most common journals of publication and the reasons for nonpublication. METHODS: Six hundred ten accepted abstracts (182 podium presentations, 428 posters) from the 2012-2014 AAHKS meetings were searched using Google, Google Scholar, and PubMed. If an abstract could not be found after efforts by multiple searchers, the first author was emailed to determine where the research was published or why it was not published. For articles that were published, the journal, time to publication, and journal impact factor were noted. RESULTS: The overall rate of publication was 71% (436/610). Podium presentations (164/182, 90%) were published at a higher rate than posters (271/428, 63%). The most common journal of publication was the Journal of Arthroplasty (218/436, 50%), followed by Clinical Orthopaedics and Related Research (77/436, 18%) and The Journal of Bone and Joint Surgery (40/436, 9%). Average time to publication was 14.5 months (range, -4 to 44 months) from the date of the conference in which it was presented. CONCLUSION: Presentations at the AAHKS annual meeting have an impressive rate of publication. The research presented at the meeting is impactful and high quality, warranting consideration for future publication.

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