The Fragility of Statistically Significant Findings From Randomized Trials in Sports Surgery: A Systematic Survey

2016 ◽  
Vol 45 (9) ◽  
pp. 2164-2170 ◽  
Author(s):  
Moin Khan ◽  
Nathan Evaniew ◽  
Mark Gichuru ◽  
Anthony Habib ◽  
Olufemi R. Ayeni ◽  
...  

Background: High-quality, evidence-based orthopaedic care relies on the generation and translation of robust research evidence. The Fragility Index is a novel method for evaluating the robustness of statistically significant findings from randomized controlled trials (RCTs). It is defined as the minimum number of patients in 1 arm of a trial that would have to change status from a nonevent to an event to alter the results of the trial from statistically significant to nonsignificant. Purpose: To calculate the Fragility Index of statistically significant results from clinical trials in sports medicine and arthroscopic surgery to characterize the robustness of the RCTs in these fields. Methods: A search was conducted in Medline, EMBASE, and PubMed for RCTs related to sports medicine and arthroscopic surgery from January 1, 2005, to October 30, 2015. Two reviewers independently assessed titles and abstracts for study eligibility, performed data extraction, and assessed risk of bias. The Fragility Index was calculated using the Fisher exact test for all statistically significant dichotomous outcomes from parallel-group RCTs. Bivariate correlation was performed to evaluate associations between the Fragility Index and trial characteristics. Results: A total of 48 RCTs were included. The median sample size was 64 (interquartile range [IQR], 48.5-89.5), and the median total number of outcome events was 19 (IQR, 10-27). The median Fragility Index was 2 (IQR, 1-2.8), meaning that changing 2 patients from a nonevent to an event in the treatment arm changed the result to a statistically nonsignificant result, or P ≥ .05. Conclusion: Most statistically significant RCTs in sports medicine and arthroscopic surgery are not robust because their statistical significance can be reversed by changing the outcome status on only a few patients in 1 treatment group. Future work is required to determine whether routine reporting of the Fragility Index enhances clinicians’ ability to detect trial results that should be viewed cautiously.

2020 ◽  
Vol 41 (3) ◽  
pp. 192-197
Author(s):  
Sherry S. Zhou ◽  
Alan P. Baptist

Background: There has been a striking increase in electronic cigarette (EC) use in the United States. The beliefs and practices toward ECs among physicians are unknown. Objective: The purpose of this study was to investigate EC practice patterns among allergists, pulmonologists, and primary care physicians. Methods: An anonymous survey was sent to physicians. The survey contained 32 questions and addressed issues related to demographics, cessation counseling behaviors, personal use, and knowledge and beliefs about ECs. Statistical analysis was performed by using analysis of variance, the Pearson χ2 test, Fisher exact test, and logistic regression. Results: A total of 291 physicians completed the survey (222 primary care physicians, 33 pulmonologists, and 36 allergists) for a response rate of 46%. The allergists asked about tobacco cigarette use as frequently as did the pulmonologists and more than the primary care physicians (p < 0.001), but they rarely asked about EC use. The pulmonologists scored highest on self-reported knowledge on ECs, although all the groups answered <40% of the questions correctly. The allergists did not feel as comfortable about providing EC cessation counseling as did the pulmonologists and primary care physicians (p < 0.001). All three groups were equally unlikely to recommend ECs as a cessation tool for tobacco cigarette users. Conclusion: Allergists lacked knowledge and confidence in providing education and cessation counseling for EC users. As the number of patients who use these products continues to increase, there is an urgent need for all physicians to be comfortable and knowledgeable with counseling about ECs.


Author(s):  
Samer Mheissen ◽  
Haris Khan ◽  
Mohammed Almuzian ◽  
Emad Eddin Alzoubi ◽  
Nikolaos Pandis

Summary Background In orthodontic trials, longitudinal designs with multiple outcome measurements over time are common. The aim of this epidemiological study was to examine whether optimal statistical analysis approaches have been used in longitudinal orthodontic trials. Methods Pubmed was searched in August 2021 for longitudinal orthodontic trials with at least three time points of outcome assessment published in the 2017–20 period. Study selection and data extraction were done independently and in duplicate. The analysis approaches undertaken were tabulated and associations between study characteristics and the use of optimal analysis or not were assessed using Fisher’s exact test and logistic regression. Results One hundred forty-seven out of 563 unique records were deemed eligible for inclusion. Only 26.50% of these trials used an optimal statistical analysis for longitudinal data where the data structure is accounted for. None of the study characteristics except the statistical significance of the results were associated with the appropriateness of the statistical analysis. The odds of significant results in studies with suboptimal analyses were higher than that in studies with optimal longitudinal analyses (odds ratio: 3.48, 95% confidence interval: 1.62, 7.46, P = 0.001). For the studies with optimal analysis, the most frequent test was repeated-measure analysis of variance (RM-ANOVA). The reporting of the statistical analysis section was suboptimal in the majority of the trials. Conclusion Most longitudinal orthodontic trials are not analysed using optimal statistical approaches. Inferences and interpretation of their results are likely to be compromised.


CJEM ◽  
2016 ◽  
Vol 18 (S1) ◽  
pp. S46-S46 ◽  
Author(s):  
B.H. Rowe ◽  
N. Arrotta ◽  
J. Hill ◽  
E. Dennett ◽  
M. Harries

Introduction: Patients with asthma frequently present to the emergency department (ED) with exacerbations; however, a select number of patients require admission to hospital. The objective of this study was to summarize the evidence regarding asthma-related hospital admissions and factors associated with these admissions following ED presentation. Methods: Comprehensive literature searches were conducted in seven electronic databases (database inception to 2015); manual and grey literature searches were also performed. Studies reporting disposition for adults after ED presentation were included. Study quality was assessed using the Newcastle-Ottawa Scale (NOS); standardized data-collection forms were used for data extraction. Admission proportions and factors associated with admission at a statistical significance level (p<0.05) were reported. Results: Out of an initial 5865 identified articles, 37 articles met full inclusion criteria. Admission proportions were reported in 25/37 studies, ranged from 1% to 37%, and collectively demonstrated a decline of ~9% in admissions between 1993 and 2012. Studies including a >50% Caucasian ethnicity were found to have a median admission proportion of 13% (interquartile range [IQR]= 7, 20) versus studies with >50% non-Caucasian ethnicity at 22% (IQR=20, 28). Age, female sex, and previous hospitalizations for asthma exacerbation were the most individually identifiable factors associated with admission. Presenting features and medication profile were the most frequent domains associated with admission. Conclusion: Admission rates have decreased approximately 9% in a nearly 20-year span and seem to be higher in studies involving mostly non-Caucasian ethnic groups. Demographic factors, markers of severity obtained by history or at ED presentation, and medication profile could be assessed by ED clinicians to effectively discern patients at high risk for admission.


Author(s):  
Christina Kantarakia ◽  
Maria E. Tsoumani ◽  
Antonis Galanos ◽  
Alexander G. Mathioudakis ◽  
Eleni Giannoulaki ◽  
...  

Ζoonotic parasitic diseases that can occur through animal contact pose risks to pets, their owners and to their bond. This study aims to assess the level of knowledge about zoonoses, specifically echinococcosis and toxocariasis, among cat/dog owners and non-pet owners in Greece. Multiple-choice questionnaires were designed to obtain data regarding the knowledge of pet and non-pet owners on echinococcosis and toxocariasis, including signs and symptoms of these zoonoses, ways of transmission and precautions that need to be taken into account in order to avoid it. A total of 185 questionnaires were retrieved and data was expressed as absolute (Ν) and relative frequencies (%). Associations between pet ownership, residence and outcome variables were evaluated using the Fisher exact test and Chi-squared test, respectively. Multifactorial linear regression analysis was used to investigate the cross-sectional association between demographic characteristics and the awareness of helminthic zoonoses. All tests were two-sided and statistical significance was set at p < 0.05. Our study revealed a disturbing lack of awareness of echinococcosis and toxocariasis (mean zoonotic knowledge score 8.11 ± 3.18) independently of pet ownership. Surprisingly, in some cases the ignorance of pet owners exceeded that of non-pet owners. Given the progressive impact of toxocariasis in public health and the high prevalence of echinococcosis in the Mediterranean region, measures should be taken to inform people about zoonoses and eliminate their putative transmission.


2019 ◽  
Vol 35 (S1) ◽  
pp. 26-26
Author(s):  
Eliane Würdig Roesch ◽  
Victorya Raabe ◽  
Alexandre da Silva ◽  
Maria Angélica Pires Ferreira

IntroductionThe Xpert™ Clostridium difficile kit is a nucleic acid amplification test indicated after discrepant results from an enzymatic test; was submitted for incorporation in a teaching hospital in Brazil. In order to evaluate the potential for improvement with Xpert™ incorporation, the performance of the available technology (enzymatic test) was assessed using a real word evidence approach. Additionally, the association between enzymatic test results and the agreement to the Infectious Diseases Society of America (IDSA) recommendations for stool test submission (≥ 3 unformed stools in 24 hours without laxatives) for Clostridium difficile were evaluated.MethodsThis is a retrospective cohort study conducted at a tertiary teaching hospital. We included all consecutive tested patients that were submitted for enzyme immunoassay – glutamate dehydrogenase (GDH) plus toxin detection from 15 March to 8 May 2018. Data referent to episodes of unformed stools in 24 hours and use of laxatives were recorded. Statistical significance was tested by Fisher Exact test (α = 0.05).ResultsOne hundred and thirty-eight consecutive patients were tested: 4 (2.9 percent) were positive for GDH and toxin (group III); 114 (82.6 percent) were negative for both (group I). Twenty (14.5 percent) cases were discrepant, all being positive to GDH and negative for toxin (group II). There were not negative GDH and positive toxin cases. The IDSA guidelines were followed in 33 (28.9%), 3 (15%) and 3(75%) test orders in groups I, II and III, respectively (p = 0.03).ConclusionsOnly a minority of patients had discrepant results in enzymatic tests and would be candidates for the Xpert™ test. The low adherence to IDSA guidelines could explain the low positivity rate of enzymatic tests at the hospital. Considering the uncertainty about the potential of the new test for changing infection control practices, Xpert™ was not recommended for incorporation. Using real world evidence data is important for contextualized health technology studies in hospitals.


2013 ◽  
Vol 5 (2) ◽  
pp. 21-25
Author(s):  
Manjunath. Shankariah ◽  
Malapati Sudhakar Rao ◽  
Kalappa T Muthanna

ABSTRACT Background The blood aspiration technique before the injection of local anesthetic solution is an essential procedure, because it prevents possible systemic’ complications. The purpose of this study is to evaluate the incidence of intravascular injection in different techniques of inferior alveolar nerve block and to know the technique which has very low incidence of vascular penetration. Methods Fifty patients in the ages of 17-70 years irrespective of sex, who were indicated for bilateral extractions of mandibular teeth were selected for this study. Patients were randomly divided into two divisions consisting of 25 patients requiring bilateral extraction procedures. In first division classical technique of inferior alveolar nerve block was administered on one side and on 2nd appointment Angelo Sargenti technique was administered on the other side. In the second division of 25 patients, indirect technique was administered on one side in 1st appointment and Clark and Holmes technique was administered on the other side in next appointment. Incidence of positive aspiration due to inadvertent penetration of inferior alveolar vessels was recorded. Results In group I positive aspiration rate was 8%, group II it was 4%, group III it was 4% and group IV it was 8%. Chi-square and fisher exact test was used and statistically there was no significant difference in the incidence of positive aspiration in all four groups. We found an overall aspiration rate of 6% in all four groups. Conclusion The incidence of positive aspiration was evaluated in all the 4 groups. There was no statistical significance in the rate of positive aspiration in all the groups included in our study.


2018 ◽  
Vol 44 (4) ◽  
pp. 260-265 ◽  
Author(s):  
Mehmet Ali Altay ◽  
Alper Sindel ◽  
Öznur Özalp ◽  
Nelli Yildirimyan ◽  
Dinçer Kader ◽  
...  

The success of osseointegration is influenced by several factors that affect bone metabolism and by certain systemic medications. Selective serotonin reuptake inhibitors (SSRIs) have been previously suggested to be among these medications. This study aims to investigate the association between systemic intake of SSRIs and failure of osseointegration in patients rehabilitated with dental implants. A retrospective cohort study was conducted, including a total of 2055 osseointegrated dental implants in 631 patients (109 implants in 36 SSRI \users and 1946 in 595 nonusers). Predictor and outcome variables were SSRI intake and osseointegration failure, respectively. The data were analyzed with Mann–Whitney test or Fisher exact test accordingly. Both patient-level and implant-level models were implemented to evaluate the effect of SSRI exposure on the success of osseointegration of dental implants. Median duration of follow-up was 21.5 months (range = 4–56 months) for SSRI users and 23 months (range –60 months) for nonusers (P = .158). Two of 36 SSRI users had 1 failed implant each; thus, the failure rate was 5.6%. Eleven nonusers also had 1 failed implant each; thus, the failure rate was 1.85%. The difference between the 2 groups failed to reach statistical significance at patient and implant levels (P = .166, P = .149, respectively). The odds of implant failure were 3.123 times greater for SSRI users compared with nonusers. Patients using SSRIs were found to be 3.005 times more likely to experience early implant failure than nonusers. The results of this study suggest that SSRIs may lead to increase in the rate of osseointegration failure, although not reaching statistical significance.


2019 ◽  
Vol 37 (27_suppl) ◽  
pp. 12-12
Author(s):  
Titas Banerjee ◽  
Jason Harold Mendler ◽  
Nabeel Badri ◽  
Dwight Hettler ◽  
Julie Ann Berkhof ◽  
...  

12 Background: Inpatient mortality, defined as death within 30 days of an acute hospital admission, is often used as a quality benchmark for healthcare institutions and is an important metric for evaluating quality of care of patients with advanced malignancies. In this study we aimed to utilize QOPI performance data to identify areas of weakness in our practice that may contribute to inpatient mortality. Methods: We analyzed 11 EOL measures within the QOPI database which we collected between 2015 and 2018. These included all EOL measures related to hospice enrollment (measure IDs 42-47), chemotherapy administered within the last 2 weeks of life (ID 48), percentage of patients who died from cancer with at least one emergency department (ED) visit in the last 30 days of life (ID 49ed), and the percentage of patients who died from cancer admitted to the Intensive Care Unit (ICU) in the last 30 days of life (ID 49icu). Our rate was calculated for each measure and compared against QOPI aggregate data. We used a fisher’s exact test to determine statistical significance for each metric. Results: The number of patients from our institution included in each analysis ranged from 27 to 46. Compared to our peers, patients treated at our institution were more likely to visit an ED in the last 30 days of life (68% vs. 32%; P < 0.0001), more likely to be admitted to the ICU in the last 30 days of life (29% vs. 9%; P = 0.0003), and more likely to be enrolled on hospice within the last 7 days of death (63% vs. 32%; P = 0.001). Conclusions: Analysis of QOPI EOL performance scores identified several metrics that may contribute to inpatient mortality at URMC. Ongoing participation in QOPI with a focus on EOL metrics will strengthen this analysis. We plan to use this data to guide quality improvement initiatives aimed at reducing impatient mortality and improving end of life care at our institution.


Author(s):  
Fernando Collado-Mesa ◽  
Monica M Yepes ◽  
Kristopher Arheart

Abstract Objective To explore current practice patterns of reporting and issuing recommendations based on the presence of breast arterial calcifications on mammography and existing knowledge of their prevalence and associated factors. Methods An online anonymous 19-question survey was distributed to 2583 practicing radiologists who were members of the Society of Breast Imaging. Questions covered demographics, breast imaging training, practice type, and knowledge regarding the epidemiology and potential clinical significance of breast arterial calcifications detected on mammograms. Differences between groups were calculated using the chi-square test or Fisher exact test. An α level of 0.05 was used to determine statistical significance. Results Response rate was 22% (364/1662). The median age of respondents was 51 years (range: 29–76) and most were female (248/323, 77%). The most prevalent characteristics among respondents were as follows: 69% (223/323) had completed a breast imaging fellowship, 55% (179/323) were in private practice, 49% (158/323) practiced dedicated breast imaging, and 38% (124/323) had been in practice for more than 20 years. The prevalence of breast arterial calcifications was correctly estimated to be 1%–30% by 39% (125/323) of respondents. Most respondents correctly recognized the growing evidence of an association between breast arterial calcifications and coronary artery disease (275/323, 85%). However, only 15% (48/323) always reported the presence of these calcifications, and of those who report them at any time, only 0.7% (2/274) always issued recommendations. Conclusion There are differences in both knowledge of the epidemiology of breast arterial calcifications and practices around their reporting amongst breast radiologists.


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