scholarly journals Subject Retention in Prehospital Stroke Research Using a Telephone-Based Physician-Investigator Driven Enrollment Method

2019 ◽  
Vol 9 (2) ◽  
pp. 72-76
Author(s):  
Bryant J. Rosell ◽  
Kristina Shkirkova ◽  
Jeffrey L. Saver ◽  
David S. Liebeskind ◽  
Sidney Starkman ◽  
...  

Background and Purpose: Subject retention into clinical trials is vital, and prehospital enrollment may be associated with higher rates of subject withdrawal than more traditional methods of enrollment. We describe rates of subject retention in a prehospital trial of acute stroke therapy. Methods: All subjects were enrolled into the NIH Field Administration of Stroke Therapy-Magnesium (FAST-MAG) phase 3 clinical trial. Paramedics screened eligible subjects and contacted the physician-investigator using a dedicated in-ambulance cellular phone. Physician-investigators obtained explicit informed consent from the subject or on-scene legally authorized representative (LAR) who reviewed and signed a consent form. Exception from informed consent (EFIC) was utilized in later stages of the study. Results: There were 1,700 subjects enrolled; 1,017 provided consent (60%), 662 were enrolled via LAR (39%), and 21 were enrolled via EFIC (1%). Of the 1,700 patients, 1,413 (83%) completed the 90-day visit, 265 (16%) died prior to the 90-day visit, and 22 (1.3%) withdrew from the study before completion. There were no differences in rates of withdrawal by method of study enrolment, i.e., self-consent (n = 14), 1.4%; LAR (n = 8), 1.2%; EFIC (n = 0) 0%. Conclusion: There was a high rate of retention when subjects were enrolled into prehospital stroke research using a phone-based method to obtain explicit consent.

Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Bryant J Rosell ◽  
Jeffrey L Saver ◽  
David S Liebeskind ◽  
Sidney Starkman ◽  
May Kim-Tenser ◽  
...  

Background: Explicit informed consent for prehospital research can be achieved by physician-investigators using cellular phones to communicate with potential subjects or legally authorized representatives (LAR). Subject retention into clinical trials is vital, and prehospital enrollment may be associated with higher rates of subject withdrawal than more traditional methods of enrollment. Objective: To describe rates of subject retention in a prehospital trial of acute stroke therapy and to determine if method of consent was associated with subject withdrawal. Methods: All subjects were enrolled in the NIH Field Administration of Stroke Therapy-Magnesium (FAST-MAG) clinical trial. Paramedics screen eligible subjects, contact the physician-investigator using dedicated in-ambulance cellular phone. Physician-investigators obtain explicit informed consent from the subject or on-scene LAR. In the later years of study, enrolment under exception from informed consent (EFIC) was permitted. The consent provider was given a consent form, which they reviewed with the physician investigator on the phone and signed prior to study initiation. Retention, defined as study subject completion without withdrawal. Results: There were 1700 subjects enrolled; 1,017 provided consent (60%), 662 enrolled via LAR (39%) and 21 via EFIC (1%). Of 1,700 patients, 1413 (83%) completed the 90-day cvisit, 265 (16%) died prior to the 90-day visit and 22 (1.3%) withdrew from the study before completion. Of the 22 cases what withdrew, 11 were lost to follow-up, 11 had the patient or LAR withdraw consent. There were no differences in rates of withdrawal by method of study enrolment: Self consent (n=14) 1.4%, LAR (n=8) 1.2%, EFIC (n=0) 0%. Potential factors related to higher rates of withdrawal were evaluated including language of consent (Spanish 4/165, 2.1%, English 18/1248, 1.2%), but none were significant. The most common reason for withdrawal of consent was family objection to continued participation in research. Conclusion: There was a high rate of retention when subjects were enrolled into prehospital stroke research using a phone-based method to obtain explicit consent. We were not able to identify factors associated with study withdrawal, likely due to high retention.


Sensors ◽  
2022 ◽  
Vol 22 (2) ◽  
pp. 483
Author(s):  
Tomasz Czarnecki ◽  
Kacper Bloch

The subject of this work is the analysis of methods of detecting soiling of photovoltaic panels. Environmental and weather conditions affect the efficiency of renewable energy sources. Accumulation of soil, dust, and dirt on the surface of the solar panels reduces the power generated by the panels. This paper presents several variants of the algorithm that uses various statistical classifiers to classify photovoltaic panels in terms of soiling. The base material was high-resolution photos and videos of solar panels and sets dedicated to solar farms. The classifiers were tested and analyzed in their effectiveness in detecting soiling. Based on the study results, a group of optimal classifiers was defined, and the classifier selected that gives the best results for a given problem. The results obtained in this study proved experimentally that the proposed solution provides a high rate of correct detections. The proposed innovative method is cheap and straightforward to implement, and allows use in most photovoltaic installations.


2021 ◽  
pp. 147775092110704
Author(s):  
Chloe Bell ◽  
Nathan Emmerich

There have been many reports of medical students performing pelvic exams on anaesthetised patients without the necessary consent being provided or even sought. These cases have led to an ongoing discussion regarding the need to ensure informed consent has been secured and furthermore, how it might be best obtained. We consider the importance of informed consent, the potential harm to both the patient and medical student risked by the suboptimal consent process, as well as alternatives to teaching pelvic examinations within medical school. The subsequent discussion focuses on whether medical students should perform pelvic examinations on anaesthetised patients without personally ensuring that they have given their explicit consent. Whilst we question the need to conduct pelvic examinations on anaesthetised patients in any circumstance, we argue that medical students should not perform such exams without personally securing the patients informed consent.


2021 ◽  
Vol 9 (2) ◽  
pp. 46-53
Author(s):  
Ji-Young Lee ◽  
◽  
Se-Hyun Hwang ◽  
Hyun-Ju Lim ◽  
◽  
...  

Objectives: This study examines dental hygiene students’ knowledge of and compliance with coughing etiquette; it also seeks to identify factors that influence dental hygiene students’ compliance with coughing etiquette. Methods: An online questionnaire was distributed to students currently majoring in dental hygiene at two colleges in the Busan area. The subjects were informed of the purpose of the study; all participants provided informed consent to take part in the study. Results: The findings show that factors that impact compliance with coughing etiquette include knowledge of coughing etiquette, carrying tissues, and awareness of coughing etiquette. Conclusions: Dental hygiene students’ compliance with coughing etiquette was significantly influenced by knowledge of coughing etiquette, carrying tissues, and awareness of coughing etiquette


2021 ◽  
Vol 10 (2) ◽  
pp. 61-67
Author(s):  
Kelly Canham ◽  
Claire Newcomb

Introduction/Study Objectives: Etanercept is a tumour necrosis factor inhibitor indicated for the treatment of several inflammatory disorders. Patients with these diseases may experience manual dexterity challenges. Autoinjectors may improve dose accuracy, treatment adherence and quality of life; and reduce injection-site reactions. Studies have indicated patients prefer autoinjectors to other injection methods, however, patients must be able to demonstrate safe and effective use of an autoinjector for it to be a viable option. The YLB113 etanercept autoinjector may be a substitutable biosimilar to reference etanercept (Pfizer Manufacturing, Puurs, Belgium). This study sought to confirm intended users of the YLB113 etanercept autoinjector could demonstrate safe and effective use. Methods: The evaluation was performed among 79 participants representative of intended YLB113 etanercept autoinjector users; and included patients, caregivers and healthcare providers (HCPs). Results: All participants successfully delivered two simulated doses of etanercept into the foam pad using the autoinjector. Some participants experienced user errors, use difficulties, or close calls while simulating injection or answering knowledge questions. Discussion: In this usability evaluation, study patients, caregivers and HCPs demonstrated a high rate of injection success using the YLB113 etanercept autoinjector. Conclusions: The study results support demonstration of safe and effective use of the YLB113 etanercept autoinjector, a substitutable biosimilar to reference etanercept.


Stroke ◽  
2012 ◽  
Vol 43 (suppl_1) ◽  
Author(s):  
Waimei A Tai ◽  
Archana Purushotham ◽  
Matus Straka ◽  
Rebecca M Sugg ◽  
Naveed Akhtar ◽  
...  

Introduction: The use of mismatch between the ischemic core and penumbra to select patients who are likely to benefit from acute stroke therapy has gained popularity. Interpretation of the ischemic core and penumbra on standard CT-perfusion (CTP) maps is subjective. This may lead to variability among physicians in the decision if a patient is a good candidate for acute stroke therapy. A CTP-Mismatch map with outlines of the ischemic core and penumbra could limit this variability. The goal of this study was to determine if inter-observer agreement regarding a patient’s suitability for acute stroke therapy improves with the use of a CTP-Mismatch map. The figure shows a typical CTP-Mismatch map. Methods: Ninety-six consecutive patients evaluated with CTP prior to intra-arterial therapy at St. Lukes Hospital in 2008-09 were included. 79 patients had adequate quality CTP for this analysis. Standard CTP maps (CBV, CBF, MTT, and Tmax) and a CTP-Mismatch map were generated with a fully automated program for processing of CTP source images (RAPID). RAPID assessed the ischemic core using a CBF threshold <30% of the contralateral hemisphere (rCBF<30%). The ischemic penumbra was defined by a Tmax threshold of >6 sec (Tmax>6s). The standard CTP maps and the CTP-Mismatch map were independently analyzed by two vascular neurologists in a blinded fashion. The raters assessed a patient's suitability for intra-arterial therapy based on the following mismatch criteria: (1) a ratio between (Tmax>6s) and (rCBF<30%) volumes >1.8 and (2) an absolute difference between (Tmax>6s) and (CBF<30%) volumes >15ml. Interobserver reliability was assessed with Cohen’s kappa. Results: When assessment of suitability for intra-arterial therapy was based on interpretation of standard CTP maps, the two raters agreed in 58 of 79 patients (kappa=0.46; 95% CI=0.24-0.60). The agreement between observers improved when suitability was determined using CTP-Mismatch maps (agreement in 76 of 79 cases; kappa=0.92; 95% CI=0.75-0.92; p<0.001 for difference between kappa values). The 3 cases with inter-observer disagreement had artifact on the CTP-Mismatch map. Following concensus adjudication of these 3 cases, 40 of the 79 patients (51%) were deemed suitable candidates for acute stroke therapy. Conclusion: CTP-Mismatch maps with estimates of ischemic core and penumbra volumes markedly improve inter-observer agreement regarding assessment of suitability for acute stroke therapy. Such maps, which can be generated automatically, may help standardize decision making algorithms for evaluation of potential intra-arterial therapy candidates.


1976 ◽  
Vol 10 (3) ◽  
pp. 279-312 ◽  
Author(s):  
R. A. Burchell

Studies of the Massachusetts communities of Newburyport and Boston have revealed a high rate of geographical mobility for their populations, in excess of what had been previously thought. Because of the difficulty in tracing out-migrants these works have concentrated on persisters, though to do so is to give an incomplete picture of communal progress. Peter R. Knights in his study of Boston between 1830 and 1860 attempted to follow his out-migrants but was only able to trace some 27 per cent of them. The problem of out-migration is generally regarded as being too large for solution through human effort, but important enough now to engage the computer. What follows bears on the subject of out-migration, for it is an analysis of where part of the migrating populations of the east went in the third quarter of the nineteenth century, namely to San Francisco.


1996 ◽  
Vol 29 (2) ◽  
pp. 147-165 ◽  
Author(s):  
Don Weatherburn ◽  
Bronwyn Linc

Until recently, criminal matters finalised by way of a trial in the NSW District Court have been the subject of substantial delays. In 1990–93, there was a significant drop in the backlog of trial cases pending in the court but the corresponding reduction in trial court delay has been less substantial than might have been expected. The article draws on past research showing that adjournments contribute significantly to trial court delay and considers the question of whether the practice of 'judge shopping' might in part be responsible for the high rate of adjournments. Evidence is presented showing that there are substantial disparities in the use of imprisonment by District Court judges and that this appears to be a determining factor in the willingness of defendants to proceed to trial.


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