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

{"title":"Health Professional’s Experience Of Telehealth Usability In The Care Of Patients With Non-Communicable Diseases (NCDS), From The COVID-19 Pandemic Onwards: A Cross-Sectional Study Protocol","authors":"R. L. Gonçalves, A. Pagano, K. Brackstone, S. Afagbedzi, Michael Head, T. Lopes, S. A. Cordeiro, J. M. Nunes, Wagner Meira Junior, L. Zambrano, James Batchelor, A. L. P. Ribeiro","doi":"10.21801/ppcrj.2023.91.10","DOIUrl":"https://doi.org/10.21801/ppcrj.2023.91.10","url":null,"abstract":"Introduction: Even with the increased use of telehealth from the COVID-19 pandemic onward, there needs to be more knowledge about its usability for patients with non-communicable diseases from the point of view of the health professional, which is the main objective of this study. The secondary objectives will be to describe the user’s profile, discuss the usability of telehealth in different contexts and correlate it with the characteristics of the user’s profile. Methods: Protocol of the cross-sectional, prospective, multicenter, international study involving Brazil, Ghana, Honduras, and the United Kingdom. We will evaluate the usability of telehealth systems with an electronic form with the usability questionnaire of the Usability Scale System (SUS). The study has obtained ethical approval in each country and will be carried out independently. This analysis will consider the use context, such as country and geosocial conditions, age, gender, profession, and user experience. We will analyze usability (continuous dependent variable) with simple statistics with measures of central tendency. We will use ANOVA/Kruskal Wallis to analyze the usability difference between countries. If there are differences, we will use Bonferroni post hoc tests (p<0.05). We will use the Pearson/Spearman correlation coefficient to correlate the characteristics of the user’s profile with usability. If the dependent variable data are normally distributed, we will use linear regression to correct for known confounders. Discussion: Studying the usability of a system allows for understanding the subjective factors that determine its practical use, improving the experience of human-computer interaction.","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43289332","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 Efficacy and Safety of Epicutaneous Immunotherapy for Milk Allergy: A Systematic Review","authors":"Laura M. Alvarez-Florian, Waynice N. Paula-Garcia, Geovanny Gutierrez-Brito, V. Vaisberg, Himadri Vakharia, G. Moralez, M. Armeno, Gabriela García-Nieto, C. Ndikom, V. A. Ayapati, Valentina Contreras, Adriana Montalvan, Yosra M. El khatem Ahmed Hassan, Aalia Omer Yousif Mohamedahmed, Raquel Horowitz","doi":"10.21801/ppcrj.2023.91.3","DOIUrl":"https://doi.org/10.21801/ppcrj.2023.91.3","url":null,"abstract":"Introduction: Cow’s milk allergy (CMA) is rising among children and adults, affecting 2-3% of children in affluent countries. Currently, the only standard of care is dairy restriction. However, epicutaneous immunotherapy (EPIT) is being studied as a potential treatment involving transdermal administration of an allergen to induce tolerance. EPIT has been proven safe for managing other food allergies in children and adolescents, but its efficacy for CMA is yet to be determined. Methods: A systematic search of four databases (PubMed, ScienceDirect, SCOPUS, and clinicaltrials.gov) was conducted in September 2022 by three independent reviewers. Additional studies were found by manual reference browsing. All published articles and randomized controlled trials (RCTs) that assessed the effect of EPIT on CMA in children and adolescents aged ≤18 years were included. The search terms used were “epicutaneous immunotherapy” or “immunotherapy” or “EPIT”; “milk allergy” or “cow’s milk allergy” or “CMA” or “CMPA”; “children” or “young” or “kids.” Results: Six studies were included after a systematic search of 123 studies, with three RCTs evaluating the safety and efficacy of EPIT in children with CMA and three meta-analyses and reviews on EPIT for CMA. The findings were inconclusive but suggested the possibility of treating cow’s milk allergy. Discussion: EPIT shows promise in treating food allergies, including CMA. Evidence is lacking to determine its efficacy for CMA. More clinical trials with different dosages and longer follow-ups are needed. Results should be interpreted with caution due to limited studies.","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48593092","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 Mini-Review of Curcumin Therapy in Pain Treatment","authors":"Fabiana Cerulli, J. Obeso, T. Méry, V. Montero, S. Afonseca, Milena Akamatsu, Marianna Daibes, Michael Apostolou, Vivian Gagliardi, M. Gómez, David Guardamino, Andreina Guzman, S. Mohamed, Jorge Sakon, Erik Simon, Rene Tovar, Katarzyna Kresse-Walczak","doi":"10.21801/ppcrj.2023.91.7","DOIUrl":"https://doi.org/10.21801/ppcrj.2023.91.7","url":null,"abstract":"","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46781188","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 Video Games or Virtual Reality in Reducing Symptoms of Cognitive Deficits in Children and Adolescents with ADHD: A Systematic Review","authors":"L. Ambrosio, Sibin Marian, Rodrigo Rosa Gameiro, T. Mohammed, Ana Paula Couto Moreira, André Ricardo Mateus, B. C. Coimbra, Bruna Fornazieri Piotto, Claudia Sheyla Alvarez Huaman, Daniel Athayde Junger de Oliveira, Dante Altenfelder Silva Mesquita Arra, E. Lincango, Elizabeth Guzmán Ledesma, Emiliano Garza Frias, É. J. F. Peixoto de Miranda, Erika Elizabeth Morales Ubico, Maria V. Velasquez Hammerle, Marta Maria Moreira Lemos, Rafael Correa Coelho, Raissa Pavoni Gomes de Molla, Valentina Guatibonza-García, Roberta R Grudtner","doi":"10.21801/ppcrj.2023.91.4","DOIUrl":"https://doi.org/10.21801/ppcrj.2023.91.4","url":null,"abstract":"Introduction: Attention-deficit hyperactivity disorder (ADHD) is one of the most frequent neurodevelopmental diseases affecting children and adolescents worldwide. Standard treatments often include a combination of pharmacotherapy and cognitive interventions. In the last decade, the effects of video game- and virtual reality (VR)-based treatments have been investigated as viable additional strategies to tackle ADHD symptoms. Methods: A systematic literature review was conducted to identify studies that compared video game or VR-based interventions with standard care in children and adolescents affected by ADHD, evaluating cognitive, motor, and behavioral outcomes. The RoB-2 and MINORS tools were utilized to assess the risk of bias in included studies. Results: Five studies published between 2001 and 2021 were included (437 patients, mean age: 10.74). Four studies investigated a video game-based intervention, and the remaining study employed VR. Collectively, the studies showed little to no effects on investigated outcomes. However, most of them were also affected by severe methodological issues carrying a moderate-to-high risk of bias. Discussion: ADHD is a complex disorder often needing a multi-dimensional, individualized therapeutical approach. Video games and VR carry substantial advantages, such as higher patient involvement, cost-effectiveness, and subtle improvements in cognitive and behavioral outcomes. However, additional well-designed clinical trials are needed to prove their efficacy in pediatric patients with ADHD.","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49179122","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":"Effects of transcranial direct current stimulation on COVID-19 neurological symptoms: a mini-review","authors":"Thais Pereira Monteiro, Angelica Arceo, R. Bonifacio, Roseli Anderson, Angie Pichardo, J. Garnier, Lucas Guilherme Gomide de Paula, Luciana Daniela Garlisi Torales, Lucas Lerro, Malaz Elzubair Mohamed Khalil, Denisse Moncada, L. D. Dos Santos, Astrid Carolina Barco Guillen, Amaro Medina, Alvaro Delgado, S. A. Almarzoky Abuhussain, S. Maximiano de Oliveira","doi":"10.21801/ppcrj.2022.84.11","DOIUrl":"https://doi.org/10.21801/ppcrj.2022.84.11","url":null,"abstract":"Introduction: COVID-19 patients can experience long-term effects including neurological symptoms as part of the long COVID syndrome. The most common neurological symptoms associated with this syndrome are cognitive impairments, such as brain fog, memory issues or loss of concentration, and mood changes, such as depression and anxiety. Non-invasive brain stimulation, for instance, transcranial direct current stimulation (tDCS), is a treatment currently being tested to improve cognitive deficits and mood disorders in long COVID. Methods: We performed a systematic literature search for articles on long COVID and non-invasive brain stimulation. Electronic searches were performed in MEDLINE (via PubMed) and Cochrane databases. The Joanna Briggs Institute Critical Appraisal tool was used for quality assessment. Data regarding population, intervention, outcomes, study design, and sources of funding were collected. Results: The search returned 21 articles, of which two case reports were included in the discussion. Three patients with long COVID and cognitive symptoms were treated with tDCS. Although these studies reported promising results, they had methodological differences, no control groups were used and the sample size is insufficient to draw definitive conclusions. Discussion: Neuromodulation treatments like tDCS are currently being considered to treat long COVID, since they have been found to improve cognition, but so far only in observational studies with few patients. In the future, randomized clinical trials using tDCS for long COVID patients with cognitive impairment might demonstrate the effectiveness of this intervention.","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43588185","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":"Low-load exercise program and platelet-rich plasma for intrasubstance tear in lateral elbow tendinopathy: protocol for a double-blinded randomized clinical trial","authors":"Guillermo Droppelmann, Alexis Torrez, Nicolás García, C. Greene","doi":"10.21801/ppcrj.2022.84.1","DOIUrl":"https://doi.org/10.21801/ppcrj.2022.84.1","url":null,"abstract":"Background: Lateral elbow tendinopathy (LET) is one of the most common musculoskeletal conditions. Treatment includes a series of therapeutic alternatives. However, the resolution takes nearly 24 months. Platelet-rich plasma (PRP) is an effective option, especially when the tendon presents an intrasubstance tear (IST). It is unknown what type of rehabilitation plan is more effective after this treatment. Aim: To perform a study protocol of a double-blinded, randomized clinical trial to determine the efficacy of a specific low-load exercise program in patients with LET and IST treatment with PRP under US-guided Methods: A single-center, parallel-controlled, randomized, double-blinded, phase III trial was pro-posed. Patients over 18 years-old diagnosed with LET and IST treated with US-guided PRP will be selected. Two arms of treatment will be allocated with a ratio a 1:1 ratio (low-load exercise protocol vs. conventional exercise program). The principal outcome will be the reduction of the tendon tear size. Secondary outcomes will include Patient-Rated Tennis Elbow Evaluation score, visual analogue scale, and handgrip at baseline, 3, 6, and 12 months of follow-up. Statistical tests will be 2-sided t-test with an alpha level (significance level) of 0.05. Discussion: The intervention aims to significantly reduce tendon tear size and improve pain and functionality in patients with LET and IST treated with US-guided PRP. We proposed one of the first studies in the literature that considered a detailed standardized exercise protocol applied to these patients. The result could be used to speed up treatment save time and money, help evaluate guidelines, and improve patients' and athletes' quality of life.","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46297609","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":"Assessment of the painDETECT questionnaire as a tool for screening and treatment evaluation in trigeminal neuralgia","authors":"J. Klein, G. Schackert","doi":"10.21801/ppcrj.2022.84.6","DOIUrl":"https://doi.org/10.21801/ppcrj.2022.84.6","url":null,"abstract":"Introduction: Although trigeminal neuralgia (TN) is diagnosed clinically and most cases can be easily identified, misdiagnoses are frequent and lead to delayed treatment. Therefore, we evaluated the painDETECT questionnaire, an established tool for detecting neuropathic pain components, as a screening tool in TN. Methods: We conducted a retrospective chart review of all patients who had presented to our neuro-surgical outpatient department complaining of craniofacial pain between January 2019 and August 2021. The patients were categorized as likely having TN (TN group) or likely having pain of a different etiology (non-TN). Patients with other neuropathic facial pain syndromes or those in whom TN could not be diagnosed nor ruled out with sufficient confidence were excluded. The painDETECT scores were compared, along with other outcome parameters. Results: We identified 52 patients with craniofacial pain. After exclusion of 14 patients, 25 patients were included in the TN group and 13 in the non-TN group. The mean painDETECT score was 17.0±4.7 and 12.7±6.1, respectively (p=0.02). The positive predictive value for TN at a cutoff value of 19 points was 80%, the negative predictive value was 39%. In patients who underwent surgery, the correlation between the postoperative painDETECT score and the postoperative numeric rating scale score was 0.73 (p=0.01). Discussion: The painDETECT questionnaire is of limited use as a screening tool for possible TN. It can be utilized to track treatment outcomes if data collection beyond daily clinical use is desired.","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48515915","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":"Author's response - Letter in response to: A Practical Guide to Perform a Systematic Literature Review and Meta-analysis","authors":"A. F. Herrera Ortiz","doi":"10.21801/ppcrj.2022.84.12","DOIUrl":"https://doi.org/10.21801/ppcrj.2022.84.12","url":null,"abstract":"","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47469434","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":"Neuromuscular Electrical Stimulation for Dysphonia and Dysarthria: A Systematic Review","authors":"Franziska Schreiber, Nayara de Lima Froio, R. Coll-Fernández, Fernanda Queiroz Petrus, Bethânia Soares dos Santos, Angélica Flores Flores, L. M. Morales Ojeda, Laura De Leon Benedetti, Vinicius Trindade, Mustafa Reha Dodurgali, Claudia Renata Dos Santos Barros, Bianca Barros Parron Fernandes, Christiany M. Tapia Argudo, Cristina Stephan, F. Buffone","doi":"10.21801/ppcrj.2022.84.10","DOIUrl":"https://doi.org/10.21801/ppcrj.2022.84.10","url":null,"abstract":"Introduction: People with speech disorders such as dysarthria and dysphonia have difficulty producing speech, which is often related to speech muscle dysfunction. Neuromuscular electrical stimulation (NMES) can activate motor units and improve their tropism and functionality. Therefore, this systematic review aimed to evaluate the effects of NMES on the phonation, voice quality, intelligibility, speech muscle strength, and quality of life of patients with dysarthria and dysphonia. Methods: This systematic review was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. In September 2022, we searched the EMBASE, Pub-Med, and Cochrane databases for studies that evaluated the effect of NMES on dysarthria and dysphonia. Randomized controlled trials, observational studies, case series, and case reports were included in the search strategy. The risk of bias in each study was assessed using the ROBINS-I tool. Results: This review included four studies designed as case studies or non-randomized trials with a low risk of bias. NMES showed a positive effect on voice quality and phonation in patients with dysarthria and/or dysphonia. Reported improvements included restored function of the muscles responsible for laryngeal elevation, a reduction in voice breathiness and strain, and enhanced articulation. Discussion: NMES seems to be a promising tool for the rehabilitation of patients with speech disorders. Randomized clinical trials should be conducted to confirm these benefits.","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42370115","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":"Letter in response to: A Practical Guide to Perform a Systematic Literature Review and Meta-analysis","authors":"Kirsten Elliott","doi":"10.21801/ppcrj.2022.84.3","DOIUrl":"https://doi.org/10.21801/ppcrj.2022.84.3","url":null,"abstract":"This letter is a response to a guide to performing systematic reviews which points out several significant problems with the advice given and calls for retraction or extensive revision of that article.","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49516045","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}