Evaluating the Landscape of Clinical Research in Neurosurgery

Neurosurgery ◽  
2019 ◽  
Vol 85 (3) ◽  
pp. E485-E493 ◽  
Author(s):  
Herschel W Wilde ◽  
Jared C Reese ◽  
Mohammed A Azab ◽  
Michael Karsy ◽  
Jian Guan ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Publication Rate ◽  
Observational Research ◽  
Funding Source ◽  
Chi Square ◽  
Private Funding ◽  
Publication Rates ◽  
Patients At Risk ◽  
New Research ◽  
Study Type

Abstract BACKGROUND Many clinical trials and observational research never reach publication in peer-reviewed journals. Unpublished research results, including neutral study findings, hinder generation of new research questions, utilize healthcare resources without benefit, and may place patients at risk without benefit. OBJECTIVE To examine the publication of neurosurgery trials listed in ClinicalTrials.gov. METHODS Clinical neurosurgery research was identified by searching the registry and categorized by study type. Associated publications were identified on Pubmed.gov. RESULTS Among the 709 studies identified, spine (292, 41.2%) studies were most common, followed by tumor and cranial (each 114, 16.1%). Funding was predominantly private (482, 68.0%), followed by industry (135, 19.0%) and National Institutes of Health (9, 1.3%). A lower proportion of published studies (vs unpublished) received private funding in functional (33.3 vs 65.3%) and tumor (80.0 vs 68.7%). Only 104/464 (22.4%) studies had an associated publication. The mean time from listed study completion to first publication was 31.0 ± 27.5 mo. Most published studies had significant study differences between treatment arms (n = 72, 69.2%); studies with neutral findings were less likely to be published (n = 13, 12.5%). Surgical discipline (P = .1), funding source (P = .8), patient age (P = .4), planned enrollment (P = .1), phase of trial (P = .3), and study type (P = .2) did not affect publication rates. However, the interaction between study category and funding source significantly affected publication rate (P = .04, generalized linear model, R2 = 0.05). Publication timing (1-way analysis of variance, P = .5) and frequency (chi-square, P = .2) did not differ among disciplines. CONCLUSION Clinical trials and observational research in neurosurgery are often not published promptly, especially if results were nonsignificant or the trial had private funding.

scholarly journals Comparison of Publication Rates for Musculoskeletal Oncology Abstracts Presented at National Meetings

Sarcoma ◽  
2021 ◽  
Vol 2021 ◽  
pp. 1-8
Author(s):  
Christopher D. Collier ◽  
Humzah A. Quereshy ◽  
Patrick J. Getty
Keyword(s):  
Statistical Significance ◽  
Publication Rate ◽  
Rank Test ◽  
Chi Square ◽  
Musculoskeletal Tumor ◽  
Musculoskeletal Tumor Society ◽  
Publication Rates ◽  
Scientific Meetings ◽  
New Research ◽  
Musculoskeletal Oncology

Background. Scientific meetings provide a forum to disseminate new research and advance patient care. The American Academy of Orthopaedic Surgeons (AAOS), Connective Tissue Oncology Society (CTOS), and Musculoskeletal Tumor Society (MSTS) annual meetings are examples of such gatherings in the field of musculoskeletal oncology. After a review of select MSTS abstracts from 1991 to 1999 revealed a 41% publication rate in scientific journals, previous authors cautioned meeting attendees that the majority of abstracts may not survive rigorous peer review and may not be scientifically valid. Since two decades have passed, this study reexamined publication rates and characteristics in a contemporary and expanded cohort of oncology abstracts presented at the AAOS, CTOS, and MSTS annual meetings. Methods. 1408 podium and poster abstracts from the AAOS (oncology-focused from 2013 to 2015), CTOS (2012 to 2014), and MSTS (2012 to 2014) annual meetings were reviewed to allow for a four-year publication window. Searches were performed with PubMed and Google Scholar databases to identify full-text publications using abstract keywords. Characteristics of each abstract and resulting publication were collected. Statistical analysis was performed using the chi-square and Kruskal-Wallis tests for time-independent comparisons, and the log-rank test after reverse Kaplan-Meier analysis for time-dependent comparisons. Results. Abstract publication rates overall were higher for podium presentations (67%, 280 of 415) compared to poster presentations (53%, 530 of 993; p < 0.001 ). When both abstract types were combined, differences between meetings did not meet statistical significance (AAOS: 65%, 106 of 162; CTOS: 57%, 521 of 909; MSTS: 54%, 183 of 337, p = 0.06 ). Abstracts from AAOS meetings were more often published prior to the first day of the meeting (AAOS: 24%, 25 of 106; CTOS: 10%, 52 of 521; MSTS: 14%, 25 of 183; p < 0.01 ). After excluding previously published abstracts, AAOS abstracts had the shortest time to publication (median: 10.8 months, interquartile range (IQR): 4.4 to 18.8 months), compared to those from CTOS (16.0 months, 8.4 to 25.9 months, p < 0.01 ) and MSTS (15 months, 7.9 to 25.0 months, p < 0.01 ) meetings. CTOS abstracts were published in higher impact journals (median: 3.7, IQR: 2.9 to 5.9), compared to those from AAOS (2.9, 1.9 to 3.2, p < 0.01 ) and MSTS (3.1, 2.3 to 3.1, p < 0.01 ) meetings. Finally, 7.7% (62 of 810) of published abstracts were presented at more than one meeting. Conclusions. Publication rates in this study were higher than previous reports in musculoskeletal oncology and comparable or better than recent reports for other orthopedic meetings. Comparisons across the AAOS, CTOS, and MSTS annual meetings highlight notable differences but suggest similarity overall in the quality of evidence presented with little overlap between meetings. Taken together, this study points to progress in the review processes used by the program committees, reaffirms the importance of critical appraisal when considering abstract findings, and supports the continued organization of multiple scientific meetings in musculoskeletal oncology.

The Fate of Abstracts Presented at the 2013 and 2014 Annual Meetings of the Romanian Society of Gastroenterology and Hepatology

2016 ◽  
Vol 25 (4) ◽  
pp. 533-536 ◽  
Author(s):  
Anca Trifan ◽  
Catalin-Alexandru Chihaia ◽  
Oana Tanase ◽  
Cristina-Maria Lungu ◽  
Carol Stanciu
Keyword(s):  
Full Text ◽  
Research Work ◽  
Publication Rate ◽  
British Society ◽  
Impact Factors ◽  
Original Research ◽  
New Research ◽  
Poster Presentations ◽  
Study Type ◽  
Oral Presentations

Background: Oral and poster presentations at annual national meetings of the Romanian Society of Gastroenterology and Hepatology (RSGH) provide a forum for education, communication and discussion of new research. However, for the wide-spread dissemination of the new research work, each presentation should be subsequently published as a full-text article in peer-reviewed, indexed journals. Aim: to evaluate the publication rate of full-text articles in peer-reviewed journals after being first presented as abstracts at two consecutive RSGH annual meetings. Methods: A retrospective review of all abstracts presented at the annual meetings in 2013 and 2014 was performed. PubMed and Google Scholar were searched using abstract titles, first author’s name and affiliation, and key words from the title to identify whether an abstract resulted in a peer-reviewed publication. Abstracts published in full-text were subsequently assessed for study type, study center, topics, publication year, journals and their impact factors (IFs). We chose the 2013 and 2014 meetings to ensure a minimum two-year follow-up period since the last meeting for the publication as full-length articles. Results: A total of 562 abstracts were presented (275 in 2013, 287 in 2014). There were 150 oral presentations (93 in 2013, 57 in 2014) and 412 poster presentations (182 in 2013, 230 in 2014). Fifty seven of them (10.1%) were published as full-text articles, among them 26 (17.3%) after oral presentations and 31 (7.5%) after poster presentations (P=0.001). University affiliation and original research work were most likely to be published. The average IFs of the journals which published the articles were 2.42 in 2013 and 1.87 in 2014. Conclusion: The publication rate for the annual RSGH meetings abstracts as full-text articles in peer-reviewed journals is very low compared to the analyses performed in gastroenterology or other medical specialities from other countries. It is not clear yet what are the factors responsible for the failure of publication. Abbreviations: RSGH: Romanian Society of Gastroenterology and Hepatology; JGLD: Journal of Gastrointestinal and Liver Diseases; IF: impact factor; BSG: British Society of Gastroenterology; DDW: Digestive Diseases Week.

scholarly journals Publication characteristics of studies published in the The Spine Journal from 2005 to 2015

2019 ◽  
Author(s):  
Joseph Park ◽  
Joseph A. Gil ◽  
Justin Kleiner ◽  
Adam E.M. Eltorai ◽  
Alan H. Daniels
Keyword(s):  
Clinical Decision Making ◽  
Fold Increase ◽  
Clinical Decision ◽  
Funding Source ◽  
Chi Square ◽  
Level Of Evidence ◽  
Level I ◽  
High Level ◽  
Study Type ◽  
Number Of Citations

BACKGROUND CONTEXT: There is a growing demand for evidence-based- practices and informed clinical decision making supported by reliable, high-quality research.PURPOSE: To analyze trends in the level of evidence of publications and to evaluate the publication characteristics that influence the quality of research in The Spine Journal (TSJ)STUDY DESIGN: Comprehensive publication assessment.SAMPLE: All studies published in TSJ from the years 2005, 2007, 2009, 2011, 2013, and 2015 were reviewed and analyzed.OUTCOME MEASURES: Level of evidence, study type, funding source, author country, author department, and number of citations.METHODS:  Multivariable logistic regression, and multivariable linear regression analyses, and chi square tests were used to analyze the trends of published studies level of evidence, study type, the specialties of authors, author countries, number of citations, and funding sources.RESULTS: A total of 1,456 articles were evaluated. There was a decrease in the percentage of high level evidence (level 1 and 2) studies from 73.6% in 2005 to 49.8% in 2015 (p=0.0045). There was a significant increase in the percentage studies with reporting funding support (p<0.0001). Funded studies were more likely to have a higher level of evidence (p<0.0001). The percentage of studies from international authors increased from 17.8% in 2005 to 69.1% in 2015 (p<0.0001). The percentage of studies with orthopedic authors decreased from 67% in 2005 to 44.9% in 2015 with a corresponding increase in the percentage of studies with neurosurgeon authors from 14.4% in 2005 to 23.2% by 2015, as well as an increase in the percentage of studies with a collaboration of authors from both specialties from 5.1% in 2005 to 8.7% in 2015 (p = 0.0007). Orthopedic and neurosurgery collaboration in authorship did not affect the level of evidence of the studies nor the number of citations of the studies (p=0.7583). Earlier studies had a higher SCOPUS citation number but were not affected by the level of evidence (p=0.2515) nor the department of the author(s) (p=0.9107).CONCLUSIONS: The publication characteristics of articles in TSJ have evolved between 2005 and 2015 with a 3.9-fold increase in International authorship and a 32% decrease in the proportion of Level I and Level II studies. Inter-departmental collaboration, funding source, and country of origin may affect level of evidence and number of citations. Continued efforts to increase level of evidence should be considered.

Publication rates of hematology/oncology abstracts presented at major pharmacy association meetings

2021 ◽  
pp. 107815522110047
Author(s):  
Kiley M Wooten ◽  
Justin R Arnall ◽  
Kiarra M Bowser ◽  
Laurie J Pennell ◽  
Jazmin N Wade-Davis ◽  
...  
Keyword(s):  
Annual Meeting ◽  
Clinical Pharmacy ◽  
Pharmacy Practice ◽  
Publication Rate ◽  
Full Publication ◽  
Publication Rates ◽  
Research Findings ◽  
American Society ◽  
Study Type ◽  
Abstract Presentation

Introduction Professional conferences are where research findings are initially presented. Studies suggest many research ideas presented at conferences are never published. Previous studies have demonstrated that the full publication rate of abstracts presented at pharmacy meetings is approximately 20%. The objective of this study was to determine the full publication rate of hematology/oncology abstracts presented at major pharmacy organization annual meetings. Methods A systematic search of PubMed and Google Scholar was performed. Publication status was evaluated for hematology/oncology abstracts presented at annual meetings for the following organizations: American College of Clinical Pharmacy Annual Meeting, American Society of Health-System Pharmacists Midyear Clinical Meeting, Hematology/Oncology Pharmacy Association Annual Meeting, and International Society of Oncology Pharmacy Practitioners Annual Meeting. Data collected included the meeting of abstract presentation, number of authors, abstract study type, country of origin, journal of publication, and type of publication. Abstracts presented as trainee research were excluded. Results Of 451 oncology abstracts evaluated, the most common topic categories included pharmacotherapy (n = 244; 54.1%), clinical pharmacy practice (n = 84; 18.6%), and operational/compounding (n = 69; 15.3%). The overall publication rate was 17.5% (n = 79). Abstracts were published as full manuscripts over a spread of 48 different journals. Factors associated with full publication included abstracts with more than 5 authors (OR 3.86, 95% CI 2.32-6.43; p < 0.0001) and abstracts presented at oncology-focused pharmacy meetings (OR 2.92, 95% CI 1.49-5.72; p = 0.0018). Conclusion This study showed an overall publication rate of 17.5% for abstracts presented at pharmacy meetings, consistent with prior studies.

scholarly journals Publication Rates of Registered Clinical Trials in Diabetic Macular Edema

2021 ◽  
Vol 15 (1) ◽  
pp. 5-8
Author(s):  
Patrick J. Hughes ◽  
Richard N. Polo ◽  
Howard F. Fine ◽  
Jonathan L. Prenner
Keyword(s):  
Clinical Trials ◽  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Late Phase ◽  
Publication Rate ◽  
Therapeutic Approaches ◽  
Primary Analysis ◽  
Publication Rates ◽  
Search Terms ◽  
Early Phase Trials

Introduction: To determine the publication rate of registered clinical trials evaluating therapeutic approaches for diabetic macular edema (DME). Methods: Using the search terms “Diabetic Macular Edema,” the National Institute of Health’s ClinicalTrials.gov online registry was searched to identify all clinical trials concerning DME. Non-interventional trials, terminated trials, trials not concerning DME, and those not completed between 2005 and 2015 were excluded. Publication status of each trial was determined using searches of the study title, keywords, author(s), and NCT number on PubMed.gov and Google Scholar. Results: A total of two hundred and forty-seven studies were identified in the primary analysis. Of the 97 trials meeting inclusion criteria, 60 (61.9%) were published. Late-phase trials were published at higher rate (74.5% [35/47]) than early phase trials (50% [25/50]) (p = 0.01). Trial location, date of completion, and industry involvement did not significantly affect the publication rate. Conclusion: Of the registered trials listed in the ClinicalTrials.gov registry investigating DME, 61.9% were published.

Hubungan Status Gizi Dengan Proses Penyembuhan Luka Di Rsud H. Andi Sulthan Daeng Radja Kabupaten Bulukumba

2017 ◽  
Vol 2 (1) ◽  
pp. 20-28
Author(s):  
Fitriani ◽  
Tenriwati
Keyword(s):  
Wound Healing ◽  
Nutritional Status ◽  
Healing Process ◽  
Data Retrieval ◽  
Observational Research ◽  
Wound Healing Process ◽  
P Value ◽  
Chi Square ◽  
Cross Sectional ◽  
Chi Square Test

At present, the incidence of injuries in Indonesia is quite high, as seen from data on traffic accidents in the general public. There are several factors that affect wound healing, one of which is nutritional status. Based on the preliminary data retrieval conducted by researchers in the seruni surgery room in the last 1 month namely in March, it was found that the number of wounded patients was 109 patients, where the number of men was 78 (71.56%) while the number of women was 31 ( 28.44%) The purpose of this study was to determine the relationship between nutritional status and the wound healing process in RSUD. H. Andi. Sulthan Daeng Radja Kab. Bulukumba. This research uses the type of design of this research is quantitative research. This type of research uses analytic observational research with cross sectional approach. The sample of this study were 41 respondents taken by purposive sampling method. Data analysis in this study used the chi-square test (chi square test). The results of the analysis used the chi-square statistical test with a confidence level (α = 0.05). Based on the results of this test, the p value is 0.001, thus p <α (0.001 <0.05), then Ho is rejected and Ha is accepted. The conclusion of this study is that there is a relationship between nutritional status and the process of wound healing in RSUD. H. Andi. Sulthan Daeng Radja Kab. Bulukumba. Researchers suggest that this study be used as a material consideration in the fulfillment of nutrition in wound care patients in RSUD.H.A. Sulthan Daeng Radja Kab. Bulukumba and this research can be continued by conducting research related to the wound healing process and linking it with other variables.

scholarly journals Publication Rate and Characteristics of Lung Cancer Clinical Trials

2019 ◽  
Vol 2 (11) ◽  
pp. e1914531
Author(s):  
Ghassan Al-Shbool ◽  
Hira Latif ◽  
Saira Farid ◽  
Shuqi Wang ◽  
Jaeil Ahn ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Clinical Trials ◽  
Publication Rate ◽  
Cancer Clinical Trials

scholarly journals Impact of timing of randomization after an acute coronary syndrome and subsequent events in patients with type 2 diabetes mellitus: an analysis of the EXAMINE trial

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
M Elharram ◽  
A Sharma ◽  
W White ◽  
G Bakris ◽  
P Rossignol ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Clinical Trials ◽  
Type 2 Diabetes Mellitus ◽  
Acute Coronary Syndrome ◽  
Primary Outcome ◽  
Funding Source ◽  
Coronary Syndrome ◽  
The Impact

Abstract Background The timing of enrolment following an acute coronary syndrome (ACS) may influence cardiovascular (CV) outcomes and potentially treatment effect in clinical trials. Using a large contemporary trial in patients with type 2 diabetes mellitus (T2DM) post-ACS, we examined the impact of timing of enrolment on subsequent CV outcomes. Methods EXAMINE was a randomized trial of alogliptin versus placebo in 5380 patients with T2DM and a recent ACS. The primary outcome was a composite of CV death, non-fatal myocardial infarction [MI], or non-fatal stroke. The median follow-up was 18 months. In this post hoc analysis, we examined the occurrence of subsequent CV events by timing of enrollment divided by tertiles of time from ACS to randomization: 8–34, 35–56, and 57–141 days. Results Patients randomized early (compared to the latest times) had less comorbidities at baseline including a history of heart failure (HF; 24.7% vs. 33.0%), prior coronary artery bypass graft (9.6% vs. 15.9%), or atrial fibrillation (5.9% vs. 9.4%). Despite the reduced comorbidity burden, the risk of the primary outcome was highest in patients randomized early compared to the latest time (adjusted hazard ratio [aHR] 1.47; 95% CI 1.21–1.74) (Figure 1). Similarly, patients randomized early had an increased risk of recurrent MI (aHR 1.51; 95% CI 1.17–1.96) and HF hospitalization (1.49; 95% CI 1.05–2.10). Conclusion In a contemporary cohort of T2DM with a recent ACS, early randomization following the ACS increases the risk of CV events including recurrent MI and HF hospitalization. This should be taken into account when designing future clinical trials. Figure 1 Funding Acknowledgement Type of funding source: Private grant(s) and/or Sponsorship. Main funding source(s): Takeda Pharmaceutical

scholarly journals EQ-5D-3L full health state discriminates between drug and placebo in clinical trials of systemic lupus erythematosus

Rheumatology ◽  
2021 ◽  
Author(s):  
Julius Lindblom ◽  
Alvaro Gomez ◽  
Alexander Borg ◽  
Sharzad Emamikia ◽  
Dimitris Ladakis ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Lupus Erythematosus ◽  
Damage Index ◽  
Patient Reported Outcome ◽  
Health State ◽  
Full Health ◽  
Chi Square ◽  
Discriminative Ability ◽  
Exact Test ◽  
Patient Reported

Abstract Objectives To investigate the discriminative ability of EQ-5D-3L full health state (FHS) in clinical trials of SLE, and identify factors associated with FHS after treatment. Methods Data from the BLISS-52 (NCT00424476) and BLISS-76 (NCT00410384) trials of belimumab (N = 1684) were utilised. FHS was defined as a response of no problems in all five EQ-5D-3L dimensions, yielding an index score of 1. The Pearson’s chi-square or Fisher’s exact test was employed for comparisons, and logistic regression for adjustments and assessment of independence. Results We demonstrated higher EQ-5D-3L FHS frequencies among patients given standard therapy (ST) plus the licensed belimumab dose versus ST alone (26.1% versus 19.4%; P = 0.001; week 52), and within SRI-4 responders versus non-responders (27.0% versus 19.8%; P &lt; 0.001; week 52) from week 36 to 52. In multivariable regression analysis, SLEDAI-2K (OR: 0.90; 95% CI: 0.87 − 0.94; P &lt; 0.001) and SLICC/ACR Damage Index (OR: 0.79; 95% CI: 0.69 − 0.91; P = 0.001) scores were independently associated with lower FHS frequencies at week 52, while adding monthly infusions of belimumab 10 mg/kg to ST favoured FHS perception (OR: 1.60; 95% CI: 1.15 − 2.24; P = 0.006). Add-on belimumab 10 mg/kg yielded higher FHS frequencies in antimalarial users versus non-users (29.9% versus 20.1%; P = 0.011), and in anti-dsDNA and anti-Sm positive versus negative patients (31.4% versus 13.4%; P &lt; 0.001 and 33.0% versus 22.6%; P = 0.010, respectively), whereas no significant differences were observed in patients given ST alone. Conclusion EQ-5D-3L FHS distinguished belimumab from placebo and responders from non-responders, and exhibited known-group validity in subgroup analysis. FHS may prove a useful patient-reported outcome in SLE studies.

Abstract TP409: Reporting of Key Demographic Characteristics in Neurological Trials Registered on ClinicalTrials.gov

Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Kush Fansiwala ◽  
Lauren Southwick ◽  
Emily Goldmann ◽  
Nina S Parikh ◽  
Joy Madubuonwu ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Race And Ethnicity ◽  
Neurological Diseases ◽  
Demographic Characteristics ◽  
Mandatory Reporting ◽  
Trial Participation ◽  
Limited Participation ◽  
Chi Square ◽  
Before And After ◽  
Race Ethnicity

Introduction: To increase the transparency of clinical trial information, U.S. Congress passed the Food and Drug Administration (FDA) Amendments Act of 2007, which expanded prior legislation to mandate inclusion of specific trial characteristics, such as funding source and gender demographics, in a new basic results section on ClinicalTrials.gov. Few studies have examined the extent to which key demographic characteristics such as sex and race/ethnicity are reported for neurological trials on ClinicalTrials.gov. Methods: As part of the National Initiative for Minority Involvement in Neurological Clinical Trials (NIMICT), we systematically identified neurological clinical trials on ClinicalTrials.gov (for stroke, epilepsy, Alzheimer’s Disease [AD]) and examined the proportion that reported sex, race, and ethnicity (Hispanic/Latino or not) of study participants. We used the website’s advanced search feature to evaluate demographic information reported from trials conducted between 1999 and 2015. We first calculated frequencies of trials reporting these characteristics, then assessed differences in reporting of each characteristic (yes/no) by condition (stroke, epilepsy, AD) and between trials conducted before and after the basic results section update (pre- and post-2008) using chi-square tests. Results: Our sample comprised 251,847 subjects across 393 trials (147 stroke, 127 epilepsy, 115 AD). Overall, sex was reported for nearly all trials (99.0%), while reporting of race and ethnicity was low (ethnicity: 14.0%, race: 19.8%). Reporting of these characteristics did not differ significantly across the three conditions or between periods preceding and following the FDA act. Conclusion: While ClinicalTrials.gov mandates reporting of sex, it does not require reporting of race/ethnicity, and few trials report these characteristics. This lack of information prevents understanding of neurological trial participation and how interventions might impact patients differently by race/ethnicity. Mandatory reporting of race/ethnicity would enhance transparency and increase awareness of the limited participation of racial/ethnic minorities-who suffer disproportionately from neurological diseases-in neurological trials.

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