scholarly journals Encouraging student-driven clinical research in Germany: the CHIR-Net SIGMA network

2017 ◽  
Vol 2 (4) ◽  
pp. 255-260 ◽  
Author(s):  
Pia-Elena Frey ◽  
Mirco Friedrich ◽  
Lukas Rädeker ◽  
Christoph A. Fink ◽  
Alexander Leuck ◽  
...  
Keyword(s):  
Clinical Research ◽  
Clinical Care ◽  
Research Network ◽  
Multicenter Observational Study ◽  
Randomized Controlled ◽  
Clinical Trial Network ◽  
German Surgical Society ◽  
Based Medicine ◽  
New Evidence ◽  
Study Center

AbstractEvidence should define and guide modern clinical care, yet many relevant questions in surgical practice remain unconfirmed by substantial data. Evidence-based medicine requires both the implementation of its principles in day-to-day work and the acquisition of new evidence preferably by randomized controlled trials and systematic reviews. Meaningful clinical research, however, is challenging to conduct, and its overall infrastructure in Germany was, until recently, considered poor compared to other leading countries. Although this has been significantly improved after the establishment of the Study Center of the German Surgical Society (SDGC) and the surgical clinical trial network CHIR-Net, limited focus has been put on the training, teaching, and recruitment of medical students to become competent clinical researchers and clinician scientists. To ensure continuing comprehensive clinical research in surgery, CHIR-Net aims to establish a student-driven multicenter research network in Germany, which is embedded in both the national CHIR-Net and the pan-European and international frameworks. Student-Initiated German Medical Audits (SIGMA) is a product of the strong collaboration between clinical scientists and medical trainees, enabling students to contribute to high-quality clinical trials. Additionally, participants are offered extensive training to support the next generation of research-active clinicians. Starting on 2018, SIGMA will perform its first multicenter observational study in Germany.

scholarly journals Pivoting during a pandemic: lessons learned from transitioning a multisite randomized controlled trial to a remote protocol in response to COVID-19

2021 ◽  
Author(s):  
Hailey Inverso ◽  
Fayo Abadula ◽  
Troy Morrow ◽  
Lauren LeStourgeon ◽  
Angelee Parmar ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Research ◽  
Controlled Trial ◽  
Clinical Care ◽  
Lessons Learned ◽  
Diabetes Distress ◽  
Randomized Controlled ◽  
Testing Strategies ◽  
Glycemic Outcomes

Abstract THR1VE! is an ongoing multisite randomized clinical trial of a positive psychology intervention designed to treat diabetes distress and improve glycemic outcomes in teens with type 1 diabetes. Due to the COVID-19 pandemic restrictions on clinical research and changes in diabetes clinical care, THR1VE! was adapted from an in-person enrollment protocol to a remote protocol through a series of development and testing strategies. We discuss the process of transitioning the protocol and the demonstrated feasibility of ongoing recruitment, enrollment, and retention outcomes. These findings offer support for a remotely transitioned protocol that has larger applications for ongoing and future clinical research.

scholarly journals Diagnostic Justice

2021 ◽  
Vol 17 (2) ◽  
Author(s):  
Ashley Graham Kennedy ◽  
Bryan Cwik
Keyword(s):  
Public Health ◽  
Clinical Research ◽  
Disease Surveillance ◽  
Ethical Issues ◽  
Clinical Care ◽  
Diagnostic Testing ◽  
Trial Participation ◽  
Ethical Considerations ◽  
Randomized Controlled ◽  
Active Surveillance Testing

Diagnostic testing can be used for many purposes, including testing to facilitate the clinical care of individual patients, testing as an inclusion criterion for clinical trial participation, and both passive and active surveillance testing of the general population in order to facilitate public health outcomes, such as the containment or mitigation of an infectious disease. As such, diagnostic testing presents us with ethical questions that are, in part, already addressed in the literature on clinical care as well as clinical research (such as the rights of patients to refuse testing or treatment in the clinical setting or the rights of participants in randomized controlled trials to withdraw from the trial at any time). However, diagnostic testing, for the purpose of disease surveillance also raises ethical issues that we do not encounter in these settings, and thus have not been much discussed. In this paper we will be concerned with the similarities and differences between the ethical considerations in these three domains: clinical care, clinical research, and public health, as they relate to diagnostic testing specifically. Via an examination of the COVID-19 case we will show how an appeal to the concept of diagnostic justice helps us to make sense of the (at times competing) ethical considerations in these three domains.

Temporal trends in surgical procedures for pediatric hydrocephalus: an analysis of the Hydrocephalus Clinical Research Network Core Data Project

2020 ◽  
pp. 1-8
Author(s):  
Mandeep S. Tamber ◽  
John R. W. Kestle ◽  
Ron W. Reeder ◽  
Richard Holubkov ◽  
Jessica Alvey ◽  
...  
Keyword(s):  
Clinical Research ◽  
Temporal Trends ◽  
Patient Characteristics ◽  
Research Network ◽  
Third Ventriculostomy ◽  
Study Cohort ◽  
Core Data ◽  
Pediatric Hydrocephalus ◽  
Short Period ◽  
New Procedures

OBJECTIVEAnalysis of temporal trends in patient populations and procedure types may provide important information regarding the evolution of hydrocephalus treatment. The purpose of this study was to use the Hydrocephalus Clinical Research Network’s Core Data Project to identify meaningful trends in patient characteristics and the surgical management of pediatric hydrocephalus over a 9-year period.METHODSThe Core Data Project prospectively collected patient and procedural data on the study cohort from 9 centers between 2008 and 2016. Logistic and Poisson regression were used to test for significant temporal trends in patient characteristics and new and revision hydrocephalus procedures.RESULTSThe authors analyzed 10,149 procedures in 5541 patients. New procedures for hydrocephalus (shunt or endoscopic third ventriculostomy [ETV]) decreased by 1.5%/year (95% CI −3.1%, +0.1%). During the study period, new shunt insertions decreased by 6.5%/year (95% CI −8.3%, −4.6%), whereas new ETV procedures increased by 12.5%/year (95% CI 9.3%, 15.7%). Revision procedures for hydrocephalus (shunt or ETV) decreased by 4.2%/year (95% CI −5.2%, −3.1%), driven largely by a decrease of 5.7%/year in shunt revisions (95% CI −6.8%, −4.6%). Concomitant with the observed increase in new ETV procedures was an increase in ETV revisions (13.4%/year, 95% CI 9.6%, 17.2%). Because revisions decreased at a faster rate than new procedures, the Revision Quotient (ratio of revisions to new procedures) for the Network decreased significantly over the study period (p = 0.0363). No temporal change was observed in the age or etiology characteristics of the cohort, although the proportion of patients with one or more complex chronic conditions significantly increased over time (p = 0.0007).CONCLUSIONSOver a relatively short period, important changes in hydrocephalus care have been observed. A significant temporal decrease in revision procedures amid the backdrop of a more modest change in new procedures appears to be the most notable finding and may be indicative of an improvement in the quality of surgical care for pediatric hydrocephalus. Further studies will be directed at elucidation of the possible drivers of the observed trends.

scholarly journals Patient Experience in Home Respiratory Therapies: Where We Are and Where to Go

2019 ◽  
Vol 8 (4) ◽  
pp. 555 ◽  
Author(s):  
Cátia Caneiras ◽  
Cristina Jácome ◽  
Sagrario Mayoralas-Alises ◽  
José Ramon Calvo ◽  
João Almeida Fonseca ◽  
...  
Keyword(s):  
Clinical Research ◽  
Patient Experience ◽  
Clinical Care ◽  
Research Priorities ◽  
Specific Patient ◽  
Quality Healthcare ◽  
Body Of Knowledge ◽  
Number Of Patients ◽  
Patient Reported ◽  
System Sustainability

The increasing number of patients receiving home respiratory therapy (HRT) is imposing a major impact on routine clinical care and healthcare system sustainability. The current challenge is to continue to guarantee access to HRT while maintaining the quality of care. The patient experience is a cornerstone of high-quality healthcare and an emergent area of clinical research. This review approaches the assessment of the patient experience in the context of HRT while highlighting the European contribution to this body of knowledge. This review demonstrates that research in this area is still limited, with no example of a prescription model that incorporates the patient experience as an outcome and no specific patient-reported experience measures (PREMs) available. This work also shows that Europe is leading the research on HRT provision. The development of a specific PREM and the integration of PREMs into the assessment of prescription models should be clinical research priorities in the next several years.

scholarly journals 947. Stroke demographics and risk factor profile in HIV infected individuals in Florida

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S506-S506
Author(s):  
Folusakin Ayoade ◽  
Dushyantha Jayaweera
Keyword(s):  
Risk Factors ◽  
Risk Factor ◽  
Clinical Research ◽  
Stroke Risk ◽  
Research Network ◽  
Categorical Variables ◽  
People Living With Hiv ◽  
Risk Factor Profile ◽  
Stroke Risk Factors ◽  
Living With Hiv

Abstract Background The risk of ischemic stroke (IS) is known to be higher in people living with HIV (PLWH) than uninfected controls. However, information about the demographics and risk factors for hemorrhagic stroke (HS) in PLWH is scant. Specifically, very little is known about the differences in the stroke risk factors between HS and IS in PLWH. The goal of this study was to determine the demographics and risk factor differences between HS and IS in PLWH. Methods We retrospectively analyzed the demographic and clinical data of PLWH in OneFlorida (1FL) Clinical Research Consortium from October 2015 to December 2018. 1FL is a large statewide clinical research network and database which contains health information of over 15 million patients, 1240 clinical practices, and 22 hospitals. We compared HS and IS based on documented ICD 9 and 10 diagnostic codes and extracted information about sociodemographic data, traditional stroke risk factors, Charlson comorbidity scores, habits, HIV factors, diagnostic modalities and medications. Statistical significance was determined using 2-sample T-test for continuous variables and adjusted Pearson chi square for categorical variables. Odds ratio (OR) and 95% confidence intervals (CI) between groups were compared. Results Overall, from 1FL sample of 13986 people living with HIV, 574 subjects had strokes during the study period. The rate of any stroke was 18.2/1000 person-years (PYRS). The rate of IS was 10.8/1000 PYRS while the rate of HS was 3.7/1000 PYRS, corresponding to 25.4% HS of all strokes in the study. Table 1 summarizes the pertinent demographic and risk factors for HS and IS in PLWH in the study. Table 1: Summary of pertinent demographic and risk factors for hemorrhagic and ischemic strokes in people living with HIV from One Florida database Conclusion In this large Floridian health database, demographics and risk factor profile differs between HS and IS in PLWH. Younger age group is associated with HS than IS. However, hypertension, hyperlipidemia and coronary artery disease are more likely to contribute to IS than HS in PLWH. Further research is needed to better understand the interplay between known and yet unidentified risk factors that may be contributing to HS and IS in PLWH. Disclosures All Authors: No reported disclosures

scholarly journals A guide to do randomized controlled trials in the field of otolaryngology

2021 ◽  
Vol 37 (1) ◽  
Author(s):  
Sameh M. Zamzam ◽  
Mosaad Abdel-Aziz ◽  
Ahmed Atef ◽  
Usama Abdel-Naseer ◽  
Mostafa Hamoda ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Study Groups ◽  
Controlled Trials ◽  
Main Body ◽  
Main Research ◽  
Randomized Controlled ◽  
New Treatment ◽  
Meta Analyses ◽  
Based Medicine

Abstract Background Randomized controlled trials (RCTs) are prospective comparative studies in which study groups are allocated randomly to intervention or serve as controls. RCT is the mainstay to achieve evidence in the literature in clinical research. A RCT is the main research design to study the effect of an intervention and the only way to confirm the value of a new treatment. Main body RCT also gives the way to generate meta-analyses and systematic reviews giving a stronger evidence for clinical practice. Evidence-based medicine (EBM) is crucial for safe, effective, and standardized patient care. Although there is an agreement on the importance of performing RCT, it can be challenging to do it efficiently including different aspects like study design, funding, randomization, blinding, follow-up, data analysis, statistics, generalization of results, and reporting of quality of the studies. Conclusion In this article, we gave a comprehensive review for RCT in otolaryngology discussing their importance, advantages, and drawbacks, types, steps, challenges, reporting their quality and their prevalence in the literature.

scholarly journals Implementation of Rapid Molecular Diagnostic Tests and Antimicrobial Stewardship Involvement in Acute-Care Hospitals

2020 ◽  
Vol 41 (S1) ◽  
pp. s278-s279
Author(s):  
Maiko Kondo ◽  
Matthew Simon ◽  
Esther Babady ◽  
Angela Loo ◽  
David Calfee
Keyword(s):  
Antimicrobial Stewardship ◽  
Diagnostic Tests ◽  
New Technology ◽  
Clinical Care ◽  
Bloodstream Infections ◽  
Clinical Decision ◽  
Research Network ◽  
Molecular Diagnostic ◽  
Financial Outcomes ◽  
Stewardship Program

Background: In recent years, several rapid molecular diagnostic tests (RMDTs) for infectious diseases diagnostics, such as bloodstream infections (BSIs), have become available for clinical use. The extent to which RMDTs have been adopted and how the results of these tests have been incorporated into clinical care are currently unknown. Methods: We surveyed members of the Society for Healthcare Epidemiology of America Research Network to characterize utilization of RMDT in hospitals and antimicrobial stewardship program (ASP) involvement in result communication and interpretation. The survey was administered using Qualtrics software, and data were analyzed using Stata and Excel software. Results: Overall, 57 responses were received (response rate, 59%), and 72% were from academic hospitals; 50 hospitals (88%) used at least 1 RMDT for BSI (Fig. 1). The factors most commonly reported to have been important in the decision to adopt RMDT were improvements in antimicrobial usage (82%), clinical outcomes (74%), and laboratory efficiency (52%). Among 7 hospitals that did not use RMDT for BSI, the most common reason was cost of new technology. In 50 hospitals with RMDT for BSI, 54% provided written guidelines for optimization or de-escalation of antimicrobials based upon RMDT results. In 40 hospitals (80%), microbiology laboratories directly notified a healthcare worker of the RMDT results: 70% provided results to a physician, nurse practitioner, or physician assistant; 48% to the ASP team; and 33% to a nurse. Furthermore, 11 hospitals (22%) had neither guidelines nor ASP intervention. In addition, 24 hospitals (48%) reported performing postimplementation evaluation of RMDT impact. Reported findings included reduction in time to antibiotic de-escalation (75%), reduction in length of stay (25%), improved laboratory efficiency (20%), and reduction in mortality and overall costs (12%). Among the 47 hospitals with both RMDT and ASP, 79% reported that the ASP team routinely reviewed blood culture RMDT results, and 53.2% used clinical decision support software to do so. Finally, 53 hospitals (93%) used 1 or more RMDT for non–bloodstream infections (Fig. 1). Fewer than half of hospitals provided written guidelines to assist clinicians in interpreting these RMDT results. Conclusions: RMDTs have been widely adopted by participating hospitals and are associated with positive self-reported clinical, logistic, and financial outcomes. However, nearly 1 in 4 hospitals did not have guidelines or ASP interventions to assist clinicians with optimization of antimicrobial prescribing based on RMDT results for BSI. Also, most hospitals did not have guidelines for RMDT results for non-BSI. These findings suggest that opportunities exist to further enhance the potential benefits of RMDT.Funding: NoneDisclosures: None

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