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

{"title":"Interaction Between Professors, Medical Students and Patients in the COVID-19 Era: An Educational Experience Report","authors":"M. Rigatto, A. M. Sandri","doi":"10.21801/PPCRJ.2020.64.7","DOIUrl":"https://doi.org/10.21801/PPCRJ.2020.64.7","url":null,"abstract":"In March 2020, the novel coronavirus (COVID-19) was declared a pandemic with high rates of transmission and mortality (World Health Organization, 2020). Since then, presential educational activities were suspended in Brazil and shifted to an online format. Medical education was a particularly challenging area for this adaptation due to its practical training characteristics, which traditionally takes place at the patient ́s bedside. We believe that direct contact with patients brings an emotional involvement that enhances students’ willingness to learn. Translating this learning process to exclusively theoretical online lectures did not seem to be an adequate alternative (Althwanay, 2020). Training students for remote contact with patients could be an alternative to maintain practical activities in the context of the COVID-19 pandemic (Ianco, 2020). This has already been incorporated in some medical schools in the last decades with the advance of telemedicine (Waseh, 2019) and gained special importance in the current scenario. Here, we describe an educational experience during the COVID-19 pandemic. Our objective is to provide a narrative description of the adaptations made for online learning and describe students’ perceptions about it. MATERIALS AND METHODS","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2020-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45066394","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 home-based transcranial direct current stimulation associated with nutritional counseling therapy on clinical and electrophysiological measures in Binge eating disorder: a study protocol for a blind, randomized, controlled clinical trial","authors":"J. L. Elkfury, Luciana C Antunes, J. Bandeira, A. Brietzke, Gabriela Melos Vieira, Pascoal Mainardi Luca, Iraci L S Torres, F. Fregni, W. Caumo","doi":"10.21801/ppcrj.2020.64.1","DOIUrl":"https://doi.org/10.21801/ppcrj.2020.64.1","url":null,"abstract":"Background: Binge Eating Disorder (BED) is a psychiatric disorder that has several medical and social consequences. Cognitive Behavioral Therapy (CBT) is the reference treatment, but presents significant dropout rates and elevated failure of therapeutic response. Therefore, new therapies targeting Central Nervous System (CNS) modulation, such as transcranial direct current stimulation (tDCS), might improve therapeutical responses, by modulating cognitive control over eating behavior and/or by enhancing inhibitory control due to synergistic action when combined with the current treatments available.\u0000Methods: Women with moderated BED, aged between 18 and 65 years and BMI ≥ 25 Kg/m² will be included. The participants will be divided into one of four groups: (1) Active tDCS; (2) Nutritional Counseling Therapy (NCT); (3) Active tDCS + NCT; (4) Sham tDCS + NCT. The electrodes of the tDCS will be positioned over the right Dorsolateral Pre-Frontal Cortex (DLPFC) - anode and left DLPFC - cathode. The participants will have a weekly appointment for 8 weeks where they will undergo the stimulation and/or the NCT. The groups that have the tDCS therapy will also receive the stimulation at home 4x/week in the first 5 weeks. The follow up is 8 weeks. The primary outcomes are the severity of symptoms, measured by the Binge Eating Scale (BES), and the inhibitory parameters of cortical excitability, measured by Transcranial Magnetic Stimulation (TMS) - Short Intracortical Inhibition (SICI). The secondary outcomes are weight loss, eating behavior, inhibitory control (Go/No-go), parameters of cortical excitability (Intracortical Facilitation (ICF) and cortical silent period (CSP)), and serum levels of leptin.\u0000Discussion: Cumulative research has provided evidence that tDCS improves disordered eating behaviors. Nevertheless, studies investigating the efficacy of long-term tDCS combined to standard treatment to BED are scarce. Based on exciting findings in trials that have associated tDCS and cognitive-behavioral approaches in Major Depressive Disorder (MDD), we hypothesize that the proposed protocol will be able to amplify therapeutical responses by reducing the severity of BED symptoms and enhancing inhibitory pathways assessed by cortical excitability parameters.","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2020-12-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44446206","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":"The Psychological Impact of COVID-19 Pandemic over the Family Medicine Program: Lessons to Learn and Actions to be taken","authors":"Khalid Al-Karbi, Yosaf Alrabeei, A. Bawazir, M. Almohannadi, M. Aseel, F. Alhor, Mohamed H. Mahmoud","doi":"10.21801/PPCRJ.2020.63.7","DOIUrl":"https://doi.org/10.21801/PPCRJ.2020.63.7","url":null,"abstract":"","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2020-12-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44512673","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":"The use of Sprint in Scientific Thinking","authors":"Erica V. Stelmaszewski, Gonzalo Damián Santos, F. Fregni","doi":"10.21801/PPCRJ.2020.63.6","DOIUrl":"https://doi.org/10.21801/PPCRJ.2020.63.6","url":null,"abstract":"","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2020-11-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44888075","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":"A Protocol for a Phase-II Trial to Evaluate the Effect of a Mindfulness Intervention via a Mobile Application on Resident Physicians’ Burnout","authors":"Dalia Ahmed, M. V. Osten, Marco A. Grudtner, E. Mazzon, Jesús Serrato, Ximena Milagros Garcìa Felipa, S. Lemouche, H. Abushama, Natacha De Jesus Vargas Disla, Mohamed Fathy Mohamed Abdelgelil, S. Gorantla, C. Villarreal-Garza","doi":"10.21801/PPCRJ.2020.63.1","DOIUrl":"https://doi.org/10.21801/PPCRJ.2020.63.1","url":null,"abstract":"Background:  Burnout is a highly prevalent occupation-related syndrome that impacts both physicians and patients. Resident physicians face unique challenges and stressors during their training, causing burnout, which affects the quality of care, patient outcomes, and the physician well being. In addition, mitigation of physician burnout creates a resilient future physician workforce. Mobile-based mindfulness interventions showed promising results in reducing physicians’ burnout. This paper describes the rationale and design of the first global multi-centered prospective randomized control study to assess the impact of mobile-based mindfulness on resident physician burnout. \u0000Methods: We plan to conduct a multicenter cluster-randomized two-arms (1:1 ratio), double-blinded clinical trial. Institutions will be randomly assigned to the use of the Smiling Mind app or a dummy app. Participants will be reassessed at 30 and 60 days for the 3 aspects of the Maslach Burnout Inventory Scale (MBIS). The primary outcome for analysis is the emotional exhaustion aspect of the MBIS at 30 days. A linear mixed regression model with adjustments for clusters will be used. \u0000Discussion: Burnout is a major issue especially among the particularly vulnerable and time-constrained group of physicians-in-training. Mindfulness-Based Stress Reduction programs are time-consuming. This study will offer the opportunity to investigate the effect of a brief mobile-based mindfulness intervention on resident physicians burnout.","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2020-09-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47446223","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":"Exercise-induced pain threshold modulation in healthy subjects: a systematic review and meta-analysis.","authors":"Kevin Pacheco-Barrios,&nbsp;Anna Carolyna Gianlorenço,&nbsp;Roberto Machado,&nbsp;Marcos Queiroga,&nbsp;Huiyan Zeng,&nbsp;Emad Shaikh,&nbsp;Yiling Yang,&nbsp;Beatriz Nogueira,&nbsp;Luis Castelo-Branco,&nbsp;Felipe Fregni","doi":"10.21801/ppcrj.2020.63.2","DOIUrl":"https://doi.org/10.21801/ppcrj.2020.63.2","url":null,"abstract":"<p><strong>Background: </strong>The use of exercise is a potential treatment option to modulate pain (exercise-induced hypoalgesia). The pain threshold (PT) response is a measure of pain sensitivity that may be a useful marker to assess the effect of physical exercise on pain modulation.</p><p><strong>Aim: </strong>The aim of this systematic review and meta-analysis is to evaluate the PT response to exercise in healthy subjects.</p><p><strong>Methods: </strong>We searched in MEDLINE, EMBASE, Web of Science, Lilacs, and Scopus using a search strategy with the following search terms: \"exercise\" OR \"physical activity\" AND \"Pain Threshold\" from inception to December 2nd, 2019. As criteria for inclusion of appropriate studies: randomized controlled trials or quasi-experimental studies that enrolled healthy subjects; performed an exercise intervention; assessed PT. Hedge's effect sizes of PT response and their 95% confidence intervals were calculated, and random-effects meta-analyses were performed.</p><p><strong>Results: </strong>For the final analysis, thirty-six studies were included (n=1326). From this we found a significant and homogenous increase in PT in healthy subjects (ES=0.19, 95% CI= 0.11 to 0.27, I2=7.5%). According to subgroup analysis the effect was higher in studies: with women (ES=0.36); performing strength exercise (ES=0.34), and with moderate intensity (ES=0.27), and no differences by age were found. Confirmed by the meta-regression analysis.</p><p><strong>Conclusion: </strong>This meta-analysis provides evidence of small to moderate effects of exercise on PT in healthy subjects, being even higher for moderate strength exercise and in women. These results support the idea of modulation of the endogenous pain system due to exercise and highlight the need of clinical translation to chronic pain population.</p>","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":"6 3","pages":"11-28"},"PeriodicalIF":0.0,"publicationDate":"2020-09-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7785086/pdf/nihms-1630620.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39126051","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":"Ten strategies to formulate a strong research question","authors":"A. Mendes, K. Pacheco-Barrios, Paola Gonzalez-Mego, Alma Tamara Sanchez, F. Fregni","doi":"10.21801/ppcrj.2020.62.4","DOIUrl":"https://doi.org/10.21801/ppcrj.2020.62.4","url":null,"abstract":"1Neuromodulation Center and Center for Clinical Research Learning, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, Boston, USA. 2Neurotherapeutics and Experimental Psychopathology Group, Psychological Neuroscience Laboratory, CIPsi, School of Psychology, University of Minho, Braga, Portugal. 3Principles and Practice of Clinical Research (PPCR) Course, Executive and Continuing Professional Education, Harvard T.H. Chan School of Public Health, Boston, USA. #These authors have contributed equally to this work. *Corresponding author: Felipe Fregni MD, PhD, MPH. Neuromodulation Center and Center for Clinical Research Learning, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, Boston, USA. Email: Fregni.felipe@mgh.harvard.edu","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2020-07-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42272338","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":"Evidence-based decision making during COVID-19 pandemic.","authors":"Kevin Pacheco-Barrios, Felipe Fregni","doi":"10.21801/ppcrj.2020.61.1","DOIUrl":"10.21801/ppcrj.2020.61.1","url":null,"abstract":"","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":"6 1","pages":"1-2"},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7406121/pdf/nihms-1589781.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38242452","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":"The Analgesic Effect of Transcranial Direct Current Stimulation (tDCS) combined with Physical Therapy on Common Musculoskeletal Conditions: A Systematic Review and Meta-Analysis.","authors":"Paulo E P Teixeira, Laila Alawdah, Hassan Adam A Alhassan, Matteo Guidetti, Alberto Priori, Stefania Papatheodorou, Felipe Fregni","doi":"10.21801/ppcrj.2020.61.5","DOIUrl":"10.21801/ppcrj.2020.61.5","url":null,"abstract":"<p><strong>Background: </strong>The analgesic effects of transcranial Direct Current Stimulation (tDCS) combined with physical therapy remain unclear.</p><p><strong>Objective: </strong>To systematically review available evidence comparing tDCS with any physical therapy modality (PTM) to PTM alone or PTM with sham tDCS on pain relief on common musculoskeletal (MSK) conditions, namely knee osteoarthritis (KOA), chronic low back pain (CLBP), myofascial pain syndrome (MPS) and fibromyalgia.</p><p><strong>Methods: </strong>EMBASE and MEDLINE were searched from inception to April 2019 for randomized controlled trials. Reviewers independently assessed the studies quality and extracted data according to the PRISMA protocol. The GRADE approach was used to asses quality of evidence and a \"Summary of Findings\" table was created. The analyses used random-effects model. The primary outcome was pain reduction after treatment.</p><p><strong>Results: </strong>Eight articles were included. Only one study had low risk of bias. Quality of evidence was considered low or very low. Significant reduction in pain scores were found for fibromyalgia and KOA (Standardized mean difference (SMD) = -1.94 [95% CI: -3.37 to -0.49; <i>I</i> ²=76.4%] and SMD = -2.35 [95% CI: -3.63 to -1.06; <i>I</i> ²=69.7%] respectively). Subgroup analysis considering the type of PTM despite MSK condition revealed significant reduction in pain scores for exercise, SMD = -1.20 [95% CI: -1.683 to -0.717; <i>I</i> ²=10.8%].</p><p><strong>Conclusions: </strong>Large heterogeneity and low quality of evidence and limited number of studies were found. Results suggest a potential analgesic effect of tDCS in combination with a PTM for fibromyalgia and KOA. Subgroup analysis suggests a stronger effect of tDCS when combined with an exercise based PTM.</p>","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":"6 1","pages":"23-26"},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7406123/pdf/nihms-1599994.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38242455","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":"Identifying, Understanding, and Managing Patient Safety and Clinical Risks in the Clinical Research Environment","authors":"Laura M. Lee, D. Henderson","doi":"10.1016/B978-0-12-849905-4.00036-8","DOIUrl":"https://doi.org/10.1016/B978-0-12-849905-4.00036-8","url":null,"abstract":"","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":"1 1","pages":"633 - 644"},"PeriodicalIF":0.0,"publicationDate":"2017-11-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85095252","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}