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ALTEX 2021The use of in vitro assays to inform decision-making requires robust and reproducible results across studies, laboratories, and time. Experiments using positive control...
The use of in vitro assays to inform decision-making requires robust and reproducible results across studies, laboratories, and time. Experiments using positive control materials are an integral component of an assay procedure to demonstrate the extent to which the measurement system is performing as expected. This paper reviews ten characteristics that should be considered when selecting a positive control material for an in vitro assay: 1) the biological mechanism of action, 2) ease of preparation, 3) chemical purity, 4) verifiable physical properties, 5) stability, 6) ability to generate responses spanning the dynamic range of the assay, 7) technical or biological interference, 8) commercial availability, 9) user toxicity, and 10) disposability. Examples and a case study of the monocyte activation test are provided to demonstrate the application of these characteristics for identification and selection of potential positive control materials. Because specific positive control materials are often written into testing standards for in vitro assays, selection of the positive control material based on these characteristics can aid in ensuring the long-term relevance and usability of these standards.
Topics: Biological Assay; Laboratories; Research Design
PubMed: 33637998
DOI: 10.14573/altex.2102111 -
Journal of Robotic Surgery Aug 2023RAPN training usually takes place in-vivo and methods vary across countries/institutions. No common system exists to objectively assess trainee capacity to perform RAPN...
RAPN training usually takes place in-vivo and methods vary across countries/institutions. No common system exists to objectively assess trainee capacity to perform RAPN at predetermined performance levels prior to in-vivo practice. The identification of objective performance metrics for RAPN training is a crucial starting point to improve training and surgical outcomes. The authors sought to examine the reliability, construct and discriminative validity of objective intraoperative performance metrics which best characterize the optimal and suboptimal performance of a reference approach for training novice RAPN surgeons. Seven Novice and 9 Experienced RAPN surgeons video recorded one or two independently performed RAPN procedures in the human. The videos were anonymized and two experienced urology surgeons were trained to reliably score RAPN performance, using previously developed metrics. The assessors were blinded to the performing surgeon, hospital and surgeon group. They independently scored surgeon RAPN performance. Novice and Experienced group performance scores were compared for procedure steps completed and errors made. Each group was divided at the median for Total Errors score, and subgroup scores (i.e., Novice HiErrs and LoErrs, Experienced HiErrs and LoErrs) were compared. The mean inter-rater reliability (IRR) for scoring was 0.95 (range 0.84-1). Compared with Novices, Experienced RAPN surgeons made 69% fewer procedural Total Errors. This difference was accentuated when the LoErr Expert RAPN surgeon's performance was compared with the HiErrs Novice RAPN surgeon's performance with an observed 170% fewer Total Errors. GEARS showed poor reliability (Mean IRR = 0.44; range 0.0-0.8), for scoring RAPN surgical performance. The RAPN procedure metrics reliably distinguish Novice and Experienced surgeon performances. They further differentiated performance levels within a group with similar experiences. Reliable and valid metrics will underpin quality-assured novice RAPN surgical training.
Topics: Humans; Robotic Surgical Procedures; Robotics; Reproducibility of Results; Surgeons; Clinical Competence; Nephrectomy
PubMed: 36689078
DOI: 10.1007/s11701-023-01521-1 -
Journal of Thoracic Disease Aug 2021Percutaneous tracheostomy is a commonly performed procedure for patients in the intensive care unit (ICU) and offers many benefits, including decreasing ICU length of... (Review)
Review
Percutaneous tracheostomy is a commonly performed procedure for patients in the intensive care unit (ICU) and offers many benefits, including decreasing ICU length of stay and need for sedation while improving patient comfort, effective communication, and airway clearance. However, there is no consensus on the optimal timing of tracheostomy in ICU patients. Ultrasound (US) and bronchoscopy are useful adjunct tools to optimize procedural performance. US can be used pre-procedurally to identify vascular structures and to select the optimal puncture site, intra-procedurally to assist with accurate placement of the introducer needle, and post-procedurally to evaluate for a pneumothorax. Bronchoscopy provides real-time visual guidance from within the tracheal lumen and can reduce complications, such as paratracheal puncture and injury to the posterior tracheal wall. A step-by-step detailed procedural guide, including preparation and procedural technique, is provided with a team-based approach. Technical aspects, such as recommended equipment and selection of appropriate tracheostomy tube type and size, are discussed. Certain procedural considerations to minimize the risk of complications should be given in circumstances of patient obesity, coagulopathy, or neurologic illness. Herein, we provide a practical state of the art review of percutaneous tracheostomy in ICU patients. Specifically, we will address pre-procedural preparation, procedural technique, and post-tracheostomy management.
PubMed: 34527365
DOI: 10.21037/jtd-19-4121 -
Journal of Science and Medicine in Sport Oct 2021Soldier performance in the Arctic depends on planning and training, protective equipment, and human physiological limits. The purpose of this review was to highlight the... (Review)
Review
OBJECTIVES
Soldier performance in the Arctic depends on planning and training, protective equipment, and human physiological limits. The purpose of this review was to highlight the span of current research on enhancing soldier effectiveness in extreme cold and austere environments.
METHODS
The practices of seasoned soldiers who train in the Arctic and cold-dwelling natives inform performance strategies. We provide examples of research and technology that build on these concepts.
RESULTS
Examples of current performance research include evaluation of equipment and tactics such as the bioenergetics of load carriage over snow in Norwegian exercises; Canadian field monitoring of hand temperatures and freezing cold injuries for better protection of manual dexterity; and Dutch predictive modeling of cold-wet work tolerances. Healthy young men can respond to cold with a substantial thermogenic response based on US and Canadian studies on brown adipose tissue and other mechanisms of non-shivering thermogenesis; the potential advantage of greater fat insulation is offset in obese unfit subjects by a smaller thermogenic response. Current physiological studies are addressing previously unanswered problems of cold acclimation procedures, thermogenic enhancement and regulation, and modulation of sympathetic activation, all of which may further enhance cold survival and expand the performance envelope.
CONCLUSION
There is an inseparable behavioral component to soldier performance in the Arctic, and even the best equipment does not benefit soldiers who have not trained in the actual environment. Training inexperienced soldiers to performance limits may be helped with personal monitoring technologies and predictive models.
Topics: Equipment Design; Extreme Cold; Humans; Military Health; Military Medicine; Military Personnel; Personal Protective Equipment; Research Design; Thermogenesis
PubMed: 33358087
DOI: 10.1016/j.jsams.2020.11.010 -
Neuroscience and Biobehavioral Reviews Sep 2021Transcranial direct current stimulation (tDCS) is widely used to explore the role of various cortical regions for reactive response inhibition. In recent years, tDCS... (Review)
Review
Transcranial direct current stimulation (tDCS) is widely used to explore the role of various cortical regions for reactive response inhibition. In recent years, tDCS studies reported polarity-, time- and stimulation-site dependent effects on response inhibition. Given the large parameter space in which study designs, tDCS procedures and task procedures can differ, it is crucial to systematically explore the existing tDCS literature to increase the current understanding of potential modulatory effects and limitations of different approaches. We performed a systematic review on the modulatory effects of tDCS on response inhibition as measured by the Stop-Signal Task. The final dataset shows a large variation in methodology and heterogeneous effects of tDCS on performance. The most consistent result across studies is a performance enhancement due to anodal tDCS over the right prefrontal cortex. Partially sub-optimal choices in study design, methodology and lacking consistency in reporting procedures may impede valid conclusions and obscured the effects of tDCS on response inhibition in some previous studies. Finally, we outline future directions and areas to improve research.
Topics: Humans; Prefrontal Cortex; Reaction Time; Reactive Inhibition; Research Design; Transcranial Direct Current Stimulation
PubMed: 34271027
DOI: 10.1016/j.neubiorev.2021.07.013 -
Journal of Clinical Epidemiology Dec 2022To explore the impact of methodological choices on the results of meta-analyses (MAs), with acupuncture for smoking cessation as a case study. (Review)
Review
OBJECTIVE
To explore the impact of methodological choices on the results of meta-analyses (MAs), with acupuncture for smoking cessation as a case study.
STUDY DESIGN AND SETTING
After performing an umbrella review (using MEDLINE, the COCHRANE Library, the Wan Fang database, and the Chinese Journal Full-text Database/March 2018) of MAs exploring the use of acupuncture for smoking cessation, we extracted all randomized controlled trials. Numerous MAs were performed as per every possible combination of various methodological choices (e.g., characteristics of the intervention and control procedures, outcome, publication status, language) to assess their vibration of effects or more precisely the existence of a Janus effect, that is, whether the 10th and 90th percentiles in the distribution of effect sizes were in opposite directions.
RESULTS
After including 7 MAs and 39 randomized controlled trials, we performed 496,528 MAs. The effect size was negative at the 10th percentile (-0.1, favoring controls) and positive at the 90th percentile (1.17, favoring acupuncture). In all, 104,491 MAs showed a statistically significant difference in favor of acupuncture, whereas 392,037 failed to demonstrate the efficacy of acupuncture (including 96 that showed a statistically significant difference in favor of the control).
CONCLUSION
The methodological choices made in performing pairwise MAs can result in substantial vibration of effects, occasionally leading to opposite results.
Topics: Humans; Acupuncture Therapy; Databases, Factual; Physical Therapy Modalities; Smoking Cessation; Vibration; Meta-Analysis as Topic; Randomized Controlled Trials as Topic
PubMed: 36150547
DOI: 10.1016/j.jclinepi.2022.09.001 -
Dental Press Journal of Orthodontics 2021The efficiency of clinical procedures is based on practical and theoretical knowledge. Countless daily information is available to the orthodontist, but it is up to this...
INTRODUCTION
The efficiency of clinical procedures is based on practical and theoretical knowledge. Countless daily information is available to the orthodontist, but it is up to this professional to know how to select what really has an impact on clinical practice. Evidence-based orthodontics ends up requiring the clinician to know the basics of biostatistics to understand the results of scientific publications. Such concepts are also important for researchers, for correct data planning and analysis.
OBJECTIVE
This article aims to present, in a clear way, some essential concepts of biostatistics that assist the clinical orthodontist in understanding scientific research, for an evidence-based clinical practice. In addition, an updated version of the tutorial to assist in choosing the appropriate statistical test will be presented. This PowerPoint® tool can be used to assist the user in finding answers to common questions about biostatistics, such as the most appropriate statistical test for comparing groups, choosing graphs, performing correlations and regressions, analyzing casual, random or systematic errors.
CONCLUSION
Researchers and clinicians must acquire or recall essential concepts to understand and apply an appropriate statistical analysis. It is important that journal readers and reviewers can identify when statistical analyzes are being inappropriately used.
Topics: Biostatistics; Humans; Research Design; Research Personnel
PubMed: 33729294
DOI: 10.1590/2177-6709.26.1.E21SPE1 -
Nigerian Journal of Clinical Practice Dec 2023The flexible bronchoscopy procedure, which is performed in awake conditions or under local anesthesia, is a difficult and complicated procedure for patients and... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
The flexible bronchoscopy procedure, which is performed in awake conditions or under local anesthesia, is a difficult and complicated procedure for patients and physicians. Propofol is a fast-acting sedative-hypnotic anesthetic with a rapid return. Ketamine hydrochloride is a fast-acting general anesthetic producing an anesthetic state characterized by deep analgesia, normal pharyngeal, and laryngeal reflexes.
MATERIALS AND METHOD
The study was planned in a randomized, prospective, and double-blind design. The drug(s) administered by the anesthesiologist was not known to the bronchoscopist and the patient. A total of 64 cases were included in the study (34/propofol, 30/ketamine-propofol (ketofol) group). Group propofol received 0.1 mL/kg propofol, and group ketofol received 0.1 mL/kg ketofol intravenously over approximately 30 seconds. Vital signs, non-invasive blood pressure, peripheral oxygen saturation, and pulse values of all cases were measured three times and were recorded just before the start of the procedure, after entering the trachea, and after the procedure was terminated. The Visual Analogue Scale (VAS) and The Ramsay scoring were additionally used in the present study.
RESULTS
Statistically significant differences were detected between the groups in terms of blood pressure and heart rates. Statistically significant differences were detected between the two groups according to The VAS scoring and additional dose requirement.
CONCLUSION
It must be noted that flexible bronchoscopy procedures, which are performed with local anesthesia by both the patient and the physician with a high degree of difficulty, especially combined drugs to be applied with anesthesia support, are more effective/comfortable/reliable, and have fewer complications and higher tolerability if there are no contraindications.
Topics: Humans; Propofol; Ketamine; Prospective Studies; Anesthetics, Intravenous; Bronchoscopy; Anesthesia; Double-Blind Method
PubMed: 38158347
DOI: 10.4103/njcp.njcp_245_23 -
Journal of the American Medical... Jan 2021Real-world data (RWD), defined as routinely collected healthcare data, can be a potential catalyst for addressing challenges faced in clinical trials. We performed a... (Review)
Review
OBJECTIVE
Real-world data (RWD), defined as routinely collected healthcare data, can be a potential catalyst for addressing challenges faced in clinical trials. We performed a scoping review of database-specific RWD applications within clinical trial contexts, synthesizing prominent uses and themes.
MATERIALS AND METHODS
Querying 3 biomedical literature databases, research articles using electronic health records, administrative claims databases, or clinical registries either within a clinical trial or in tandem with methodology related to clinical trials were included. Articles were required to use at least 1 US RWD source. All abstract screening, full-text screening, and data extraction was performed by 1 reviewer. Two reviewers independently verified all decisions.
RESULTS
Of 2020 screened articles, 89 qualified: 59 articles used electronic health records, 29 used administrative claims, and 26 used registries. Our synthesis was driven by the general life cycle of a clinical trial, culminating into 3 major themes: trial process tasks (51 articles); dissemination strategies (6); and generalizability assessments (34). Despite a diverse set of diseases studied, <10% of trials using RWD for trial process tasks evaluated medications or procedures (5/51). All articles highlighted data-related challenges, such as missing values.
DISCUSSION
Database-specific RWD have been occasionally leveraged for various clinical trial tasks. We observed underuse of RWD within conducted medication or procedure trials, though it is subject to the confounder of implicit report of RWD use.
CONCLUSION
Enhanced incorporation of RWD should be further explored for medication or procedure trials, including better understanding of how to handle related data quality issues to facilitate RWD use.
Topics: Clinical Trials as Topic; Databases as Topic; Electronic Health Records; Humans; Registries; Research Design; United States
PubMed: 33164065
DOI: 10.1093/jamia/ocaa224 -
Canadian Medical Education Journal Nov 2023Internal Medicine (IM) residents are required to perform bedside procedures for diagnostic and therapeutic purposes. Residents' experiences with procedures vary widely,...
BACKGROUND
Internal Medicine (IM) residents are required to perform bedside procedures for diagnostic and therapeutic purposes. Residents' experiences with procedures vary widely, for unclear reasons.
OBJECTIVE
To explore IM residents' experiences with performing bedside procedures and to identify barriers and facilitators to obtaining sufficient experience.
METHODS
Using an inductive, thematic approach, we conducted five individual semi-structured interviews and one focus group with seven IM residents (12 residents in total) during the 2017-2018 academic year at a Canadian tertiary care centre. We used iterative, open-ended questions to elicit residents' experiences, and barriers and facilitators, to performing bedside procedures. Transcripts were analyzed for themes using Braun and Clarke's method.
RESULTS
We identified four themes 1) Patient-specific factors such as body habitus and procedure urgency; 2) Systems factors such as time constraints and accessibility of materials; 3) Faculty factors including availability to supervise, comfort level, and referral preferences, and 4) Resident-specific factors including preparation, prior experiences, and confidence. Some residents expressed procedure-related anxiety and avoidance.
CONCLUSION
Educational interventions aimed to improve procedural efficiency and ensure availability of supervisors may help facilitate residents to perform procedures, yet may not address procedure-related anxiety. Further study is required to understand better how procedure-averse residents can gain confidence to seek out procedures.
Topics: Humans; Internship and Residency; Education, Medical, Graduate; Canada; Focus Groups; Referral and Consultation
PubMed: 38045067
DOI: 10.36834/cmej.73122