Principles and practice of clinical research (2015)最新文献

{"title":"The long road to learn the meaning of p-value in medical schools: challenges for a research methodology training in medical schools","authors":"Meghan Whalen, Talita Sansoni, Estefanía Henríquez Luthje, Fernanda Martins Maia, P. Cortêz, Sofia Leonardo, Francisco Borja Ponce, Luís Fábio Barbosa Botelho, Pedro Mendes, Felipe Ridolfi, Marize da Cunha Rezende, M. Favarato, Olga Lioliou, J. Piedra, A. Matos, F. Fregni","doi":"10.21801/PPCRJ.2021.71.7","DOIUrl":"https://doi.org/10.21801/PPCRJ.2021.71.7","url":null,"abstract":"The movement towards evidence-based medicine has been highly successful (Fregni, 2019). Clinicians understand the need to practice based on solid and unbiased evidence. However, the pathway towards full use of evidence-based medicine (EBM) has not been completed. There is still a long way to go. One of the main obstacles to the better use of EBM in clinical practice is the lack of research methodology training. It is clear that there is not enough time in the curriculum of medical students to cover the complex field of research methodology (Fregni, 2019). Also, the current methods of teaching have been far from optimal, and therefore, students usually tend to dislike statistics and epidemiology early on, which provides them fewer tools to use EBM in their clinical profession effectively. In this editorial, we convened a group of clinicians and educators (from the Teaching, Learning and Innovation Initiative) from several countries to briefly discuss some of the main challenges we see in medical students' current education that applies to EBM teaching.","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-07-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43642283","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Continuing Professional Development: Provision and Adaptation of Clinical Education within the Primary Health Care Setting in Qatar during the COVID-19 Pandemic","authors":"N. Almutawa, Mohamed H. Mahmoud, Chaitali Rao, M. Main","doi":"10.21801/PPCRJ.2021.71.6","DOIUrl":"https://doi.org/10.21801/PPCRJ.2021.71.6","url":null,"abstract":"Background: The discovery of the COVID-19 virus and the subsequent rapid pandemic has had a significant impact not only on public health but also on clinical education. Continuing Professional Development (CPD) within the Primary Health Care Corporation (PHCC) had to be adapted, especially regarding the methods of delivery. Social distancing was a requirement from the Public Health directives, impacting the practicalities of face-to-face didactic and simulated clinical educational sessions. Given the challenges that the pandemic generated across the globe in terms of education, new ways of offering education were required as a matter of urgency. This evaluative study was undertaken to describe the PHCC Workforce Training and Development’s (WTD) response to achieve maximum efficacy of our delivered CPD.\u0000Methods: The purpose of this descriptive study was to explore the interventions utilized by the WTD directorate within PHCC. The evaluation and comparison of teaching and learning interventions (in terms of subject matter and delivery method) were described. It was based upon a three-month period from pre-COVID-19 (2019) and mid-COVID19 (2020). Staff who attend CPD programs within PHCC included: Physicians, Nurses, Dentists, and allied health care professionals.\u0000Results: During a three-month period from the pre-COVID-19 year (2019), 68 CPD courses were delivered mainly face-to-face, and individual accreditation varied from 1 to 30.25 educational accreditation points. During the mid-COVID year (2020), 38 CPD courses were delivered as online webinars and individual accreditation varied from 1 to 3.75 educational accreditation points. It was found that a greater number of participants were able to undertake web-based learning with individual sessions than face-to-face ones. Microsoft Teams was successfully utilized. The remote online host lecturer has facilitated significant interaction with most participants. The lecturers received the Learning Management System (LMS) training prior to the Pandemic; thus, we have experienced an easier integration of ongoing online clinical education during these challenging times.\u0000Conclusion: It was acknowledged that the WTD directorate at PHCC was in a fortunate position, due to the integration of the online LMS training prior to the pandemic. Both the clinical and educational staff were able to implement and deliver this method effectively at short notice, with similar academic accredited standards and quality. It is expected that following the pandemic, a higher uptake, demand, and motivation for innovative learning approaches will occur. It is thought that the use of the blended learning approach will dramatically increase.","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-07-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41354058","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effect of Low dose Naltrexone versus Naproxen Extended-release for Pain Relief in knee osteoarthritis, a Triple-blinded, Non-inferiority Phase II Randomized Controlled Trial (FREEDOM) - Study Protocol","authors":"Caio C. Kasai","doi":"10.21801/PPCRJ.2021.71.3","DOIUrl":"https://doi.org/10.21801/PPCRJ.2021.71.3","url":null,"abstract":": Background and objectives: Osteoarthritis (OA) is a degenerative articular disease that affects approximately 240 million people worldwide, with knee OA accounting for 80% of this burden. One of the aims of pharmacological treatment in OA is to reduce pain. Non-steroidal anti-inflammatory drugs (NSAIDs) are effective for pain relief in OA but have considerable renal, hepatic, cardiovascular, and gastrointestinal adverse effects, with the resultant increase in morbidity and mortality. Naltrexone is an orally activated opioid antagonist that has varied dose-dependent pharmacodynamic effects: Analgesic and anti-inflammatory effects are exhibited only at low dosage ranges of 0.5mg to 4.5mg (Low Dose Naltrexone LDN) while retaining a favorable adverse effect profile. This study aims to test the non-inferiority of LDN against Naproxen. Methodology: This is a prospective phase II triple-blinded, two-arm, parallel-group, non-inferiority randomized controlled trial. The intervention group will receive low dose naltrexone 4.5 mg once daily, and the control group will receive extended-release naproxen 1000 mg once daily during the 12 week trial duration. Our sample size will be 118 patients recruited from a single Orthopedic referral center in the USA. Discussion: The use of LDN for pain relief in osteoarthritis (OA) may be beneficial due to its favorable adverse effect profile. To the best of our knowledge, there is no published data on LDN use in OA even though preliminary evidence has documented its safety and tolerability in a variety of chronic pain conditions.","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48513350","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy and Safety of Experimental versus Approved CAR T-cell Therapies in Large B-cell Lymphoma Using Matching Adjusted Indirect Comparisons: A Systematic Review and Meta-Analysis Protocol","authors":"Bayarmagnai Munkhjargal, B. Muresan, S. Solano, A. Macedo, Yoonjung Lee, Gwang-Jin Kim, C. Camargo, Yeseul Ahn, D. Carpenter, Yuchen Su, Gabriela M. Henriquez Luthje","doi":"10.21801/PPCRJ.2021.71.5","DOIUrl":"https://doi.org/10.21801/PPCRJ.2021.71.5","url":null,"abstract":"Background: Relapsed and refractory large B cell lymphomas (RR-LBCL) have a poor prognosis. Chimeric antigen receptor (CAR) T-cell therapies have shown considerably high response rates even in RR-LBCL patients who fail to achieve remission after multiple chemotherapy lines. Currently, three CAR T-cell treatments axicabtagene ciloleucel (Yescarta), tisagenlecleucel (Kymriah), and lisocabtagene maraleucel (Breyanzi) have been approved for adults with RR-LBCL by regulatory agencies. Non-pivotal clinical trials have independently examined different types of CAR T-cells and have demonstrated remarkable clinical benefit and safety. Yet, no comparison of the experimental and approved CAR T-cells","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44149080","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"HYP-FAST trial study protocol: a phase II, single-center, open-label RCT comparing the effect of early time-restricted feeding on blood pressure control versus standard of care in individuals with primary hypertension","authors":"A. Valentini, J. E. Loyola, Joice Inglez, R. Ferreira, J. Souza, Juan Santana-Guerrero, Daniela Yucumá, V. Liutti, Salma Abdelrahman, Michelle Pirazzoli, N. Kaegi-Braun, H. Reyes, Islam G. Ahmed, Hiba Elhiday, A. Guimarães, J. Oller, M. Friend, Jéssica Sanches, Álvaro Sierra Mencia, A. Kann, M. Rosa","doi":"10.21801/PPCRJ.2021.71.2","DOIUrl":"https://doi.org/10.21801/PPCRJ.2021.71.2","url":null,"abstract":": Background : Primary arterial hypertension is the most prevalent chronic disease globally and significantly impacts public health. It is hypothesized that 16:8 early time-restricted feeding (eTRF) bolsters blood pressure management. To date, there are no randomized trials evaluating its benefits in the treatment of hypertension as a primary outcome. Objective: To determine if eTRF combined with lifestyle modifications is superior to the standard lifestyle modifications treatment of primary hypertension recommended by the 2018 European hypertension guidelines. Methods: This will be a superiority, parallel, open-label, randomized, phase II trial carried out in a single center in Zurich, Switzerland. Participants between 30 and 60 years of age, recently diagnosed with high normal and grade I hypertension will be randomly assigned to the eTRF 18:6 plus lifestyle modifications group or the standard lifestyle interventions group. The primary outcome will be the difference between the mean systolic blood pressure at eight weeks with the baseline measurement. Discussion: This will be the first trial to evaluate the effects of intermittent fasting in patients with primary hypertension. Potential limitations include patient compliance to the intervention. However, in a previous study, self-reported adherence was observed in 1128 of 1351 participants (83.50%). In addition, this study seeks strategies to improve adherence. Conclusion: We hope that this trial directs other authors to carry out future studies aiming for higher external validity and evaluation of long-term effects of intermittent fasting for the treatment of primary hypertension.","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47984622","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Home-based transcranial direct current stimulation (tDCS) and motor imagery for phantom limb pain using statistical learning to predict treatment response: an open-label study protocol.","authors":"Kevin Pacheco-Barrios, Alejandra Cardenas-Rojas, Paulo S de Melo, Anna Marduy, Paola Gonzalez-Mego, Luis Castelo-Branco, Augusto J Mendes, Karen Vásquez-Ávila, Paulo E P Teixeira, Anna Carolyna Lepesteur Gianlorenco, Felipe Fregni","doi":"10.21801/ppcrj.2021.74.2","DOIUrl":"10.21801/ppcrj.2021.74.2","url":null,"abstract":"<p><strong>Background: </strong>Phantom limb pain (PLP) management has been a challenge due to its response heterogeneity and lack of treatment access. This study will evaluate the feasibility of a remotely home-based M1 anodal tDCS combined with motor imagery in phantom limb patients and assess the preliminary efficacy, safety, and predictors of response of this therapy.</p><p><strong>Methods: </strong>This is a pilot, single-arm, open-label trial in which we will recruit 10 subjects with phantom limb pain. The study will include 20 sessions. All participants will receive active anodal M1 tDCS combined with phantom limb motor imagery training. Our primary outcome will be the acceptability and feasibility of this combined intervention. Moreover, we will assess preliminary clinical (pain intensity) and physiological (motor inhibition tasks and heart rate variability) changes after treatment. Finally, we will implement a supervised statistical learning (SL) model to identify predictors of treatment response (to tDCS and phantom limb motor imagery) in PLP patients. We will also use data from our previous clinical trial (total observations=224 [n=112 x timepoints = 2)) for our statistical learning algorithms. The new prospective data from this open-label study will be used as an independent test dataset.</p><p><strong>Discussion: </strong>This protocol proposes to assess the feasibility of a novel, neuromodulatory combined intervention that will allow the design of larger remote clinical trials, thus increasing access to safe and effective treatments for PLP patients. Moreover, this study will allow us to identify possible predictors of pain response and PLP clinical endotypes.</p>","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9009528/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73036703","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Neuromodulation of premotor and posterior parietal cortices for enhancing explicit motor sequence learning in healthy individuals: a randomized, sham-controlled crossover trial","authors":"C. Russo, M. Carneiro, G. Vallar, N. Bolognini","doi":"10.21801/PPCRJ.2020.64.3","DOIUrl":"https://doi.org/10.21801/PPCRJ.2020.64.3","url":null,"abstract":"Background: Anodal transcranial Direct Current Stimulation (tDCS) has been shown to be effective in improving human motor learning when applied over the contralateral primary motor cortex (M1). However, the stimulation of other cortical areas, such as the posterior parietal (PPC) and premotor (PMC) cortices, may be also beneficial.\u0000Methods: The present study (crossover design) investigated the effects of tDCS applied over PPC, PMC, and M1 on the acquisition and retention of a new motor skill, and on the generalization of such learned skill in healthy individuals. During a sequential finger-tapping task (FTT), performed with the non-dominant (left) hand, participants received real or sham anodal tDCS (1.5 mA, 20 min) over PPC, PMC, and the M1 of the right hemisphere. Explicit motor sequence learning was measured online (during the training with tDCS; primary outcome) and 24 hours after tDCS (retention, secondary outcome). A new, untrained, sequence was used to assess generalization effects (secondary outcome).\u0000Results: Anodal tDCS of M1 improved both online learning and retention. PMC tDCS facilitated the generalization of the learning effect to the untrained motor sequence. In contrast, neuromodulation of the PPC does not influence motor sequence learning.\u0000Conclusions: These findings show that, in addition to M1, higher-order associative cortical regions (PMC and PPC) are involved in explicit online motor sequence learning, retention and generalization playing different roles, as indicated by the differential modulatory effects of anodal tDCS.","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48571075","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy of transcutaneous electrical nerve stimulation as a treatment for phantom limb pain","authors":"R. Costa, P. Bastos, João Gustavo dos Anjos Morais Oliveira, L. E. Requião, Ana Flávia Paiva Bandeira Assis, Luís Emanuel Reis dos Santos, Gilcielma Gomes de Lemos","doi":"10.21801/PPCRJ.2020.S1.10","DOIUrl":"https://doi.org/10.21801/PPCRJ.2020.S1.10","url":null,"abstract":"","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47601804","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Advanced Closed-loop Ventilation System versus Manual Mechanical Ventilation in COVID-19 induced ARDS in Intensive Care Unit patients: A Single-Center Randomized Phase II Clinical Trial Protocol","authors":"Mateo E. Garland","doi":"10.21801/PPCRJ.2020.64.6","DOIUrl":"https://doi.org/10.21801/PPCRJ.2020.64.6","url":null,"abstract":"Introduction: COVID-19 complications manifest with a disproportionately high rate of respiratory failure and Acute Respiratory Distress Syndrome (ARDS) overwhelming healthcare systems worldwide. In comparison with lung-protective mechanical ventilation, the mainstay treatment of ARDS ventilatory support, INTELLiVENT-ASV® (I-ASV) has shown higher efficiency with reduced weaning, ventilation times, and improved safety by eliminating human errors while providing automate and individually optimized respiratory support.\u0000Objective: This study aims to determine the efficacy and safety of I-ASV compared to conventional mechanical ventilation in the context of COVID-19 ARDS (CARDS).\u0000Methods: In this phase II trial protocol we describe a single-center, randomized, superiority, open-label, parallel two-arm (1:1 ratio) and active-controlled trial, comparing conventional mechanical ventilation with Volume Assist Mode (VAC) vs I-ASV, both following the lung-protective protocol in 463 adult patients diagnosed with CARDS requiring ventilation support. The primary outcome will be weaning time. Secondary outcomes will include total ventilation time, ICU time to discharge, extubation failure rate, and adverse events. We propose a competing risk analysis for improved accuracy by accounting for mortality in all time-to-event data analysis. Fisher’s exact test will be used to test the difference between trial arms in terms of binary secondary outcomes.  \u0000Discussion: Given the limitations in conventional mechanical ventilation modes, automated closed-loop devices such as I-ASV could significantly benefit patients with CARDS while increasing resource efficiency thus extended care for the patients in need.","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45396095","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development of the distance education course Principles and Practice of Clinical Research: 9 years of experience in the Dominican Republic","authors":"Vahid Nouri Kandany, A. Gutierrez, Elly Pichardo, M. Garcia, Alma Sanchez-Jimenez, Maria Zunilda Nuñez","doi":"10.21801/PPCRJ.2020.64.2","DOIUrl":"https://doi.org/10.21801/PPCRJ.2020.64.2","url":null,"abstract":"Introduction: Critical thinking is an ideal tool for evaluating information as a guiding action. With the conjunct use of the internet and applied pedagogy, PPCR looks to develop its alumni’s superior cognitive skills. We aim to characterize alumni and their experiences in the Dominican Republic for over nine years.\u0000Method: This descriptive, cross-sectional study used a survey instrument formatted with closed and semi-closed questions, which was sent to each participant’s email. The survey had two segments, the first with twelve questions related to the participant’s personal information and characteristics related to their background education and profession. The second section evaluated satisfaction during their participation in the PPCR course.\u0000Results: Out of a total of 62 graduates from 2012 to 2019, data was collected from 52 participants, of which 92% are medical doctors. The mean age was 36 years, with a predominance of the female gender (56%). The vast majority of participants are Dominican (90%), with a postgraduate program (61.2%). More than half carry out university teaching activities (54%), and a part of them continued to be affiliated in the program as Teaching Assistants, performing pedagogical assistance tasks (38%). The global satisfaction rate was high (92%), with a low dropout rate (2%).\u0000Conclusions: Based on our study’s characteristics, this course is estimated to be a novel element capable of promoting scientific production and promoting clinical research activities in developing countries. It creates connections and exploits virtuality to improve knowledge through the critical analysis of information. This experience plays a prominent role in the enrichment of many teachers by providing them with methodological tools, developing the excellent training of educators.","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47097682","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}