Clinical Trial Quality Assessment in Adult Spinal Surgery: What Do Publication Status, Funding Source, and Result Reporting Tell Us?

Study Design Narrative Review Objectives The objective of this study was to compare publication status of clinical trials in adult spine surgery registered on ClinicalTrials.gov by funding source as well as to identify other trends in clinical trials in adult spine surgery. Methods All prospective, comparative, therapeutic (intervention-based) trials of adult spinal disease that were registered on ClinicalTrials.gov with a start date of January 1, 2000 and completion date before December 17, 2018 were included. Primary outcome was publication status of published or unpublished. A bivariate analysis was used to compare publication status to funding source of industry vs non-industry. Results Our search identified 107 clinical trials. The most common source of funding was industry (62 trials, 57.9% of total), followed by University funding (26 trials, 24.3%). The results of 76 trials (71.0%) were published, with industry-funded trials less likely to be published compared to non–industry-funded trials (62.9% compared to 82.2%, P = .03). Of the 31 unpublished studies, 13 did not report any results on ClinicalTrials.gov , and of those with reported results, none was a positive trial. Conclusions Clinician researchers in adult spine surgery should be aware that industry-funded trials are less likely to go on to publication compared to non–industry-funded trials, and that negative trials are frequently not published. Future opportunities include improvement in result reporting and in publishing negative studies.

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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

European Heart Journal ◽

10.1093/ehjci/ehaa946.3067 ◽

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

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Postoperative Wound Infections Complicating Adult Spine Surgery

Journal of Spinal Disorders ◽

10.1097/00002517-199209000-00005 ◽

1992 ◽

Vol 5 (3) ◽

pp. 277-285 ◽

Cited By ~ 74

Author(s):

Jeffery L. Stambough ◽

Donald Beringer

Keyword(s):

Spine Surgery ◽

Wound Infections ◽

Postoperative Wound ◽

Adult Spine

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Efficacy of perioperative pharmacological and regional pain interventions in adult spine surgery: a network meta-analysis and systematic review of randomised controlled trials

British Journal of Anaesthesia ◽

10.1016/j.bja.2021.08.034 ◽

2021 ◽

Author(s):

Sandy Bae ◽

Abdulrahman Alboog ◽

Katherine S. Esquivel ◽

Alina Abbasi ◽

James Zhou ◽

...

Keyword(s):

Systematic Review ◽

Spine Surgery ◽

Randomised Controlled Trials ◽

Meta Analysis ◽

Controlled Trials ◽

Randomised Controlled ◽

Adult Spine

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Quick and effective method of bone marrow mesenchymal stem cell extraction

Open Medicine ◽

10.1515/med-2015-0008 ◽

2015 ◽

Vol 10 (1) ◽

Cited By ~ 7

Author(s):

Zivile Gudleviciene ◽

Gabrielis Kundrotas ◽

Regina Liudkeviciene ◽

Jelena Rascon ◽

Marcin Jurga

Keyword(s):

Bone Marrow ◽

Clinical Trials ◽

Density Gradient ◽

Tissue Regeneration ◽

Immune Regulation ◽

Small Volume ◽

Extraction Methods ◽

Common Source ◽

Human Mscs ◽

Clinical Use

AbstractBackground. Mesenchymal stem cells (MSCs) are currently exploited in numerous clinical trials to investigate their potential in immune regulation, hematopoesis or tissue regeneration. The most common source of MSCs for clinical use is human bone marrow. To generate sufficient numbers of cells relevant to clinical use in most cases the high volumes (20-50 ml) of bone marrow aspirates are taken. Methods. In this pilot study, 8 healthy bone marrow donors were included. Two different MSC extraction methods were evaluated: MSCs extraction from 60 ml of bone marrow using density gradient and MSCs extraction from 6 ml using red blood cell (RBC) lysis. Results. Our results showed that after RBC lysis the efficient amount of human MSCs can be isolated from 10 times less bone marrow volume (6 ml). Moreover, using small volume of bone marrow the adequate therapeutical dose of MSCs could be achieved during similar period of time (3-4 weeks). In conclusion, we have shown that MSCs isolation using RBC lysis is an effective and more advantageous method in comparison to standard MSCs isolation using density-gradient. Using RBC lysis from small volume of bone marrow the same amount of MSCs were obtained as usually using large volume and density-gradient.

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A longitudinal survey of adult spine and peripheral nerve case entries during neurosurgery residency training

Journal of Neurosurgery Spine ◽

10.3171/2018.3.spine171370 ◽

2018 ◽

Vol 29 (4) ◽

pp. 442-447 ◽

Cited By ~ 1

Author(s):

Nitin Agarwal ◽

Michael D. White ◽

D. Kojo Hamilton

Keyword(s):

Peripheral Nerve ◽

Residency Training ◽

Spine Surgery ◽

Linear Regression Analysis ◽

Critical Role ◽

Senior Resident ◽

Case Volume ◽

Minimum Requirements ◽

The Mean ◽

Adult Spine

OBJECTIVECurrently, there is a lack of research assessing residents’ operative experience and caseload variability. The current study utilizes data from the Accreditation Council for Graduate Medical Education (ACGME) case log system to analyze national trends in neurosurgical residents’ exposure to adult spinal procedures.METHODSProspectively populated ACGME resident case logs from 2013 to 2017 were retrospectively reviewed. The reported number of spinal procedures was compared to the ACGME minimum requirements for each surgical category pertaining to adult spine surgery. A linear regression analysis was conducted to identify changes in operative caseload by residents graduating during the study period, as well as a one-sample t-test using IBM SPSS software to compare the mean number of procedures in each surgical category to the ACGME required minimums.RESULTSA mean of 427.42 total spinal procedures were performed throughout residency training for each of the 877 residents graduating between 2013 and 2017. The mean number of procedures completed by graduating residents increased by 19.96 (r2 = 0.95) cases per year. The number of cases in every procedural subspecialty, besides peripheral nerve operations, significantly increased during this time. The two procedural categories with the largest changes were anterior and posterior cervical approaches for decompression/stabilization, which increased by 8.78% per year (r2 = 0.95) and 9.04% per year (r2 = 0.95), respectively. There was also a trend of increasing cases logged for lead resident surgeons and a decline in cases logged for senior resident surgeons. Residents’ mean caseloads during residency were found to be vastly greater than the ACGME required minimums: residents performed at least twice as many procedures as the required minimums in every surgical category.CONCLUSIONSGraduating neurosurgical residents reported increasing case volumes for adult spinal cases during this 5-year interval. An increase in logged cases for lead resident surgeons as opposed to senior resident surgeons indicates that residents were logging more cases in which they had a more critical role in the procedure. Moreover, the average resident was noted to perform more than twice the number of procedures required by the ACGME in every surgical category, indicating that neurosurgical residents are getting greater exposure to spine surgery than expected. Given the known correlation between case volume and improved surgical outcomes, this data demonstrates each graduating neurosurgical residency class experiences an augmented training in spine surgery.

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EFFICACY OF SPIRULINA FOR ALLERGIC RHINITIS

10.1101/2021.10.21.21265199 ◽

2021 ◽

Author(s):

Iury Gomes Batista ◽

Osmar Cleyton Person ◽

Fernando Veiga Angelico Junior ◽

Priscila Bogar

Keyword(s):

Clinical Trials ◽

Allergic Rhinitis ◽

Randomized Clinical Trials ◽

Nasal Congestion ◽

Control Group ◽

Cochrane Central Register ◽

Level Of Evidence ◽

Runny Nose ◽

Trial Quality ◽

Central Register

Introduction: Allergic rhinitis is a condition of high prevalence in the population and widely studied, with several treatments being consecrated for its control. Spirulina is a dietary supplement that modulates immune function, and has been shown to modulate the inflammatory response of allergic rhinitis. Purpose: To evaluate spirulina in the treatment and control of allergic rhinitis. Material and Methods: This is a systematic review of randomized clinical trials. Searches were performed for randomized clinical trials relating spirulina to allergic rhinitis in five electronic databases: Cochrane - Central Register of Controlled Trials - CENTRAL (2021), PUBMED (1966-2021), EMBASE (1974-2021), LILACS (1982-2021) AND SCOPUS (2021). Two investigators independently extracted data and assessed trial quality. Results: Two clinical trials involving a total of 215 patients were included. Both studies assessed the efficacy of spirulina in improving allergic rhinitis as the primary outcome. The first study described a significant reduction in runny nose, nasal congestion and itching over time of medication use (p 0.001) and in the second study the prevalence of rhinorrhea (P = 0.021), nasal congestion or obstruction (P = 0.039) and decreased smell (P = 0.030) were significantly less in the experimental group than in the control group. Conclusions: The included studies were in favor of the use of spirrulina. However, the level of evidence is very low and limited. We should have caution due to the small number of clinical trials and participants in these studies. It is recommended to carry out new RCTs following the CONSORT standardization.

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The Impact of the COVID-19 Pandemic on Scheduled Adult Spine Surgery in Toronto Academic Health Sciences Centres (AHSC): A Wave 1 Through Early Wave 2 Experience

OrthoMedia ◽

10.1302/3114-220946 ◽

2022 ◽

Keyword(s):

Spine Surgery ◽

Health Sciences ◽

Academic Health ◽

Adult Spine ◽

The Impact

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Paediatric drugs trials in China

BMJ Paediatrics Open ◽

10.1136/bmjpo-2019-000618 ◽

2020 ◽

Vol 4 (1) ◽

pp. e000618

Author(s):

Guo-Xiang Hao ◽

Xiao-Xiao Yuan ◽

Wei Guo ◽

Xi-Yu Quan ◽

Xue-Jie Qi ◽

...

Keyword(s):

Clinical Trials ◽

Drug Trials ◽

Clinical Trial Registry ◽

Non Profit ◽

Paediatric Drug ◽

Start Date ◽

Size Number ◽

Rational Drug ◽

Registration Number ◽

Research Stage

ObjectiveClinical trials of children’s drugs are of great significance to rational drug use in children. However, paediatric drugs trials in China are facing complex challenges. At present, the investigation data on registration status of paediatric drug trials in China are still relatively lacking, and relevant research is urgently needed.MethodsThe advanced retrieval function is used to retrieve clinical trials data in the Clinical Trial.gov and Chinese Clinical Trial Registry databases in 22 April 2019. Fifteen key items were analysed to describe trial characteristics, including: registration number, study start date (year), mode of funding, type of disease, medicine type, research stage, research design, sample size, number of experimental groups, placebo group, blind method, implementation centre, child specific, newborn specific and participant age.ResultsA total of 1388 clinical trials of paediatric drugs conducted in China were registered. The number of paediatric drug trials grew steadily over time, from less than 20 per year before 2005 to more than 100 per year after 2012. Most clinical trials were postmarketing (n=800, 57.6%), single-centre (n=1045, 75.3%), intervention studies (n=1161, 83.6%) without blinded methods (1169, 84.2%) and funded by non-profit organisations (n=838, 60.4%). The number of clinical trials for antineoplastic agents (n=254, 18.3%), anti-infectives (n=156, 11.2%) and vaccines (n=154, 11.1%) is the largest.ConclusionPaediatric drug trials in China made a significant progress in recent years. Innovative method and trial design optimisation should be encouraged to accelerate paediatric clinical research. Pharmaceutical companies need to be further stimulated to carry out more high-quality paediatric clinical trials with support of paediatric drug legislation.

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